Jean Elizabeth Glass
         JEGLASS@MAILHOST.TCS.TULANE.EDU
          "Imagination is more important than knowledge."  --Einstein


> Subject: America:  Living with AIDS
> 
>       Executive Summary  
> 
>       The people of the United States have arrived at a crossroads in the
> history of the HIV epidemic.  In the months to come they must either engage
> seriously the issues and needs posed by this deadly disease or face
> relentless, expanding tragedy in the decades ahead.  In just ten years the
> human immunodeficiency virus (HIV), the causative agent of AIDS, has claimed
> more American lives than did the Korean and Vietnam wars combined.  If, from
> this day forward, there were never another instance of new infection, the
> upcoming decade would still certainly be much worse.  The amount of human
> suffering and number of deaths will be much greater. 
> 
>       The face of AIDS will change as well;  thus far it has focused its
> devastation predominantly on young men.  In addition, it is also a disease
> that affects an entire family_now, all too often, mothers, fathers, and
> children die swiftly, one following the other, leaving a few orphans as a
> grim reminder of what was once a family.   Workers on the front lines are
> struggling heroically to cope with illness and death, but their tools have
> been too few, their resources too constrained, and their logistics too
> crippled by the sabotage of disbelief, prejudice, ignorance, and fear. Nor
> has the virus followed rules of fair play.  Gay and bisexual men still bear
> much of the burden of HIV disease.  
> 
>       Disproportionately and increasingly the epidemic has attacked segments
> of society already at a disadvantage_communities of color, women and men
> grappling with poverty and drug use, and adolescents who have not been
> effectively warned of this new risk to their futures.  And with these shifts
> have come new anger, mistrust, and attempts to assign blame, which have
> drowned out the warnings that should signal the magnitude of the mounting
> crisis.  Sadly, this has permitted too many Americans to detach from the
> fray, to feel the problem is that of others different from themselves, and to
> retreat into resentful indifference.  Diversity, which should be our greatest
> strength as a nation, has for the moment become a weakness, and has
> sanctioned a begrudging and sometimes callous response.  Even the language of
> prevention, which should be tailored to the myriad subcultures and
> ethnicities of people at risk, is constrained in the name of morality,
> withholding potentially lifesaving information and devices in order to avoid
> offending a public presumed to be in agreement with such constraints. 
> 
>       Astonishingly, even our most basic efforts to better understand and
> respond to this new plague have been hampered. Efforts have been made to
> constrain or forbid behavioral re- search;  in the face of the most deadly
> sexually transmitted disease ever to confront humanity, some would prohibit
> even the study of the human behaviors that put our children at risk.  Thus we
> disarm ourselves in the midst of lethal battle. 
> 
>       Worst of all, the country has responded with indifference.  It is as if
> the HIV crisis were a televised portrayal of someone else's troubles.  It has
> even appeared relatively painless; many of the torments are hidden because so
> many people do their suffering and grieving in secret, out of fear of stigma,
> discrimination, or rejection.  But the epidemic will not remain painless much
> longer even for the most indifferent observer;  soon everyone will know
> someone who has died of AIDS.  If we are to honor our fundamental social
> contract with our fellow citizens, with ourselves, and with our children, we
> must somehow develop a sense of urgency.  For there is only a little time
> left to recognize at a deep and fundamental level that the threat of HIV is
> all around us and that we must all join in this battle for the sake of future
> generations.  In order to have any chance of winning, we must first energize
> our nation and transform indifference into informed action. We have used
> arresting language because Americans readily understand the need to mobilize
> rapidly for collective action in response to external threats to life.  AIDS
> is a life-threatening disease of global proportions, and it requires the same
> national resolve and commitment to address it effectively that we exhibit in
> times of war. 
> 
>       But the military analogy does not work well in this crisis.  In war, we
> tend to look for a human enemy to attack, and alas thus far this tendency has
> been all too evident in our response to HIV.  But in confronting AIDS, our
> response must be just the opposite.  Compassion and concern for human
> suffering must direct our efforts.  It is against the virus, not those
> infected, that this war must be waged.  Tragically, to date, too many of us
> have failed to understand this fundamental distinction or acknowledge what a
> massive national effort is needed to contain the epidemic. The sapping of our
> collective strength comes from many directions.  There has been a dominant
> undercurrent of hostility toward many people with HIV disease, as if they are
> somehow to blame.  But no one gets this virus on purpose.  We do not withhold
> compassion from people who suffer from other diseases related to behavior. 
> As President Bush stated in his single speech about AIDS, "Once disease
> strikes we don't blame those who are suffering.  We don't spurn the accident
> victim who didn't wear a seat belt;  we don't reject the cancer patient who
> didn't quit smoking.  We try to love them and care for them and comfort
> them."  We must replace the innocent/guilty mindset with sympathy and care
> for people with HIV disease. 
> 
>       Our nation's leaders have not done well.  In the past decade, the White
> House has rarely broken its silence on the topic of AIDS.  Congress has shown
> leadership in developing critical legislation, but has often failed to
> provide adequate funding for AIDS programs.  Articulate leadership guiding
> Americans toward a proper response to AIDS has been notably absent.  We are
> accustomed to hearing from the "bully pulpit" about national problems and how
> we should address them, so perhaps the public cannot be blamed for assuming
> that such a silence means that nothing important is happening.  Their false
> calm is reinforced by politicians who declare that enough has been done about
> AIDS, since it is "just one disease," and that we should redirect our
> attention to other diseases that currently kill more people. 
> 
>       But we cannot turn away from what is coming, lest we be blind-sided. 
> There are at least one million Americans silently infected with HIV.  Most of
> them will get sick during the next decade.  And in the absence of a national
> effort, the virus continues to spread.  The cumulative deaths of the first
> ten years of AIDS will more than double in the next two:  by the end of 1993,
> the toll will rise from 120,000 to over 350,000.  AIDS is already the leading
> cause of death for young men and women in many parts of the country and is
> climbing relentlessly up the list of causes of "years of potential life
> lost."  
> 
>       What makes these numbers particularly tragic is that there is so much
> that we can do to turn the tide of HIV through prevention of further spread,
> and so much that we must do to provide more humane and compassionate care to
> those who have already been caught in the path of the virus.  But there are
> two destructive attitudes within our borders that hamper these actions.  They
> are a thinly veiled feeling that those who acquire the virus are getting what
> they deserve and a collective indifference to their fate.  As long as these
> attitudes persist there will be reluctance to engage in the effort required
> to surmount HIV disease.  Overcoming these attitudes will require
> leadership_leadership from the highest levels of government and the private
> sector. 
> 
>       To accomplish the tasks that loom ahead, we must, as a society, find a
> way to convert anger, fear, and indifference into informed action.  We must
> deal effectively with discrimination and prejudice, overcome present
> governmental inertia, rededicate ourselves to maintaining a necessary
> intensity of research endeavor, educate the public to replace panic with an
> informed awareness of what is needed to prevent infection, and coordinate our
> resources to meet the urgent health care needs of the sick in cost-efficient
> ways that take full advantage of our powerful science.  We must recognize our
> obligations to future generations in these tasks, for further indifference or
> misdirected efforts spells doom for millions. 
> 
>       For two years, the National Commission on AIDS has pursued its mandate
> from Congress to make recommendations to Congress and the President "for a
> consistent national policy concerning AIDS" and the HIV epidemic.  We have
> held hearings, site visits, and consultations;  we have heard from over one
> thousand voices across the country in direct testimony, voices that have
> described the horror of the HIV tragedy and the heroism of brave men, women,
> and children as they grapple with HIV.  Some have told of their struggle with
> their own illnesses.  Some have told of remarkable commitment to care for and
> about others.  We have been heartened and inspired by the thousands of people
> throughout the land who have selflessly given of themselves to develop
> programs of prevention, care, and advocacy in their communities.  It has been
> a privilege to experience the richness of diversity that could give
> unconquerable strength to our efforts if it were honored and fully harnessed;
> and it has been a source of constant sorrow to witness the accelerating loss
> of talent as young adults die of AIDS in ever increasing numbers. 
> 
>       This report attempts to address a number of the central themes that
> have emerged from this process.  It brings out the fact that, in an important
> sense, the only thing new about our present quandary is the virus, that most
> of what we are experiencing represents old problems that have been poorly
> patched and bandaged or ignored entirely.  The HIV epidemic did not leave 37
> million or more Americans without ways to finance their medical care_but it
> did dramatize their plight.  The HIV epidemic did not cause the problem of
> homelessness_but it has expanded it and made it more visible.  The HIV
> epidemic did not cause collapse of the health care system_but it has
> accelerated the disintegration of our public hospitals and intensified their
> financing problems.  The HIV epidemic did not directly augment problems of
> substance use_but it has made the need for drug treatment for all who request
> it a matter of urgent national priority.  Rural health care, prison health
> care, access to health care for uninsured and underinsured working men and
> women_these issues and many more form the fabric of our concern.  The report
> is not all-encompassing, for we have focused on certain issues that the
> Commission viewed as most important during our first two years of work.   
> 
>       The Introduction, the first chapter, paints an overview of the current
> status of the epidemic in America.  It notes that, in endeavoring to solve
> problems of HIV care in the context of our current epidemic crisis, we can
> develop better ways to manage other chronic relapsing illnesses, innovations
> that will serve society well in the years to come.  By taking away our right
> to procrastinate further, HIV presses us to confront the shortfalls in our
> health care system more honestly. 
> 
>       The second chapter deals with issues of prevention and education.  It
> points out that prevention is currently our only hope of altering the course
> of the HIV epidemic and that efforts in this sector have been grossly
> underutilized_further, that prevention strategies will remain key even after
> the development of effective drugs or vaccines.  It develops the theme that
> frank communication is our best defense for our children against the twin
> epidemics of HIV and drugs.  Elements common to successful programs are
> highlighted, including the importance of cultural sensitivity, cultural
> competence, and community involvement.  Effective progress in the prevention
> of HIV disease associated with illicit drug use is noted.  Finally, a call is
> made for a comprehensive national HIV prevention initiative that would
> integrate federal, state, county, and municipal governments, community-based
> organizations, and affected populations to achieve a common goal of HIV
> prevention. The third chapter discusses how health care for people with HIV
> disease can be improved.  It takes note of the substantial progress that has
> been made in enhancing the quality and extending the duration of lives of
> people with HIV.  It describes who should be involved in the delivery of
> health care and social services to those with HIV disease, the sites where
> care should be available, and how those care services can best be organized. 
> Ideally, such care involves an interdisciplinary group in a continuum of
> services delivered in the least restrictive, least institutional settings at
> the lowest possible costs.  Common elements link counseling and testing with
> primary care in out-of-hospital settings, coordination of that care with the
> hospital, access to investigational drugs and integration of illicit drug use
> treatment with HIV care.  The point is made that existing health care
> providers must be better trained to manage the care of people with HIV
> disease and that future needs for more health care professionals must be
> anticipated.  Finally, continued efforts must be devoted to improving
> communication strategies so that minimal delay occurs between development of
> new therapies and their availability. 
> 
>       The fourth chapter deals directly with the difficult issues of health
> care financing in the context of HIV.  The Commission came to the conclusion
> that systemic reform will be necessary to achieve genuinely appropriate
> access to health care for all Americans.  Only in this way will those with
> HIV disease be assured of needed care.  Thus we have not confined our
> discussion to the arena of HIV disease alone, but have instead discussed
> solutions to problems of financing that are consistent with the broader
> initiatives of health system reform currently under discussion.  However, our
> recommendations are specific to problems of HIV, and thus we offer a series
> of options that could improve the lot of HIV infected people and we cost out
> their implications.  We remain firm in our conviction that these short-term
> measures should give way as quickly as possible to nationwide reform of the
> American health care system, reform that ensures financial access to care for
> all of our citizens. 
> 
>       The fifth chapter focuses on clinical trials and treatment-related
> research.  To date, our deliberations have not focused on the nation's
> vitally important biomedical research enterprise.  Further, we have paused
> only briefly to underscore the manifest importance of social and behavioral
> research in achieving ultimate control of the HIV epidemic.  In this chapter,
> the discussion is directed to currently dynamic issues of clinical trials and
> the search for new therapeutic agents for people with HIV disease.  Problems
> of assuring access to drug trials for diverse populations with HIV disease
> while maintaining orderly studies that will permit sound scientific
> assessment of therapies are considered.  Issues of delivery of care in the
> context of experimental therapy and the use of new drugs in expanded access
> programs are also covered.   In the sixth and final chapter, the
> responsibilities and opportunities for government to intervene and interact
> with other components of society are examined.  It is noted that at all
> levels of government greater leadership is needed.  At the federal level, we
> note that within the U.S. Public Health Service there has been a real effort
> to coordinate responses, but that there is a need for much greater
> cooperation and coordination across many departments at the cabinet level. 
> State and local governmental roles are critical and distinctive.  Of
> particular concern is the current fiscal crisis occurring in many of the
> states with the highest incidence of AIDS.  The need to fully fund the Ryan
> White CARE Act is underscored, and the importance of providing the funding to
> evaluate programs is stressed. 
> 
>       After each chapter the Commission has offered a short series of
> recommendations for action.  They have been purposely kept few with the hope
> that they will all receive careful consideration.  They overlap.  Prevention
> of HIV infection, care and treatment of those with HIV disease, the financing
> of that care, and the research necessary to improve treatment are all
> intimately interwoven and inseparable.   
> 
>       To transform what now obtains into effective action requires
> simultaneous attention to all facets of this epidemic which is now causing
> such pain and loss of life.
> 
>       Recommendations  
> 
>       1.  A comprehensive national HIV plan should be developed with the full
> participation of involved federal agencies and with input from national
> organizations representing various levels of government to identify
> priorities and resources necessary for preventing and treating HIV disease. 
>   
> 
>       2.  Universal health care coverage should be provided for all persons
> living in the United States to ensure access to quality health care services. 
> 
> 
>       3.  The federal government should establish a comprehensive national
> HIV prevention initiative.  
> 
>       4.  Government should assure access to a system of health care for all
> people with HIV disease.  
> 
>       5.  Medicaid should cover all low-income people with HIV disease.  
> 
>       6.  States and/or the federal government should pay the COBRA premiums
> for low-income people with HIV disease who have left their jobs and cannot
> afford to pay the health insurance premium.  
> 
>       7.  Medicaid payment rates for providers should be increased
> sufficiently to ensure adequate participation in the Medicaid program.  
> 
>       8.  Social Security Disability Insurance (SSDI) beneficiaries who are
> disabled and have HIV disease or another serious chronic health condition
> should have the option of purchasing Medicare during the current two-year
> waiting period.    
> 
>       9.  Congress and the Administration should work together to adequately
> raise the Medicaid cap on funds directed to the Commonwealth of Puerto Rico
> to ensure equal access to care and treatment.  
> 
>       10. Policies should be developed now to address future plans for the
> distribution of AIDS vaccines and the ethical and liability issues that will
> arise when vaccines become available.  
> 
>       11. The federal government should fund the Ryan White CARE Act at the
> fully authorized level.  
> 
>       12. Congress should remove the government restrictions that have been
> imposed on the use of funds for certain kinds of HIV education, services, and
> research.  
> 
>       13. The Secretary of Health and Human Services should direct the
> National Institutes of Health, the Health Care Financing Administration, and
> the Health Resources and Services Administration to work together to develop
> a series of recommendations to address the obstacles that keep many people
> from participating in HIV-related clinical trials, as well as the variables
> that force some people to seek participation in trials because they have no
> other health care options.  
> 
>       14. HIV-related services should be expanded to facilities where
> underserved populations receive health care and human services, in part to
> ensure their increased participation in trials of investigational new
> therapies.  
> 
>       15. Current efforts at the National Institutes of Health (NIH) to
> expand the recruitment of underrepresented populations in the AIDS Clinical
> Trials Group should be continued and increased.  
> 
>       16. HIV education and training programs for health care providers
> should be improved and expanded and better methods should be developed to
> disseminate state-of-the-art clinical information about HIV disease, as well
> as drug and alcohol use, to the full range of health care providers.  
> 
>       17. Greater priority and funding should be given to behavioral, social
> science, and health services research.  
> 
>       18. The Food and Drug Administration should aggressively pursue all
> options for permitting the early use of promising new therapies for
> conditions for which there is no standard therapy or for patients who have
> failed or are intolerant of standard therapy.  
> 
>       19. The National Institutes of Health should develop a formal mechanism
> for disseminating state-of-the-art treatment information in an expeditious
> and far-reaching manner.  
> 
>       20. The Department of Health and Human Services should conduct a study
> to determine the policies of third-party payers regarding the payments of
> certain health service costs that are provided as part of an individual's
> participation in clinical trials conducted in the development of HIV-related
> drugs.  
> 
>       21. Implementation of the Americans with Disabilities Act should be
> carefully monitored, and states and localities should evaluate the adequacy
> of existing state and local antidiscrimination laws and ordinances for people
> with disabilities, including people living with HIV disease. 
> 
>       22. The federal government should expand drug abuse treatment so that
> all who apply for treatment can be accepted into treatment programs.  The
> federal government should also continually work to improve the quality and
> effectiveness of drug abuse treatment.  
> 
>       23. Legal barriers to the purchase and possession of injection
> equipment should be removed.  
> 
>       24. The following interim steps to improve access to expensive
> HIV-related drugs should be taken: 
> 
>             (a) adequately reimburse for the purchase of drugs required in
>       the prevention and treatment of HIV disease, including clotting factor
>       for hemophilia;   
> 
>             (b) undertake, through the Department of Health and Human
>       Services, a consolidated purchase and distribution of drugs used in the
>       prevention and treatment of HIV disease;   
> 
>             (c) amend the Orphan Drug Act to set a maximum sales cap for
>       covered drugs.  
> 
>       25. All levels of government should develop comprehensive HIV plans
> that establish priorities, ensure consistent and comprehensive policies, and
> allocate resources.  
> 
>       26. Federal, state, and local governments should join forces with the
> private sector in providing long-term support to community-based
> organizations.  
> 
>       27. The U.S. Public Health Service should expand and promote
> comprehensive programs for technical assistance and capacity building for
> effective long-term prevention efforts.  
> 
>       28. Federal, state, and local entities should provide support for
> training, technical assistance, supervisory staff, and program coordination
> to acknowledge and support the family members, friends, and volunteers who
> are an integral part of the care system of a person with HIV disease.  
> 
>       29. The federal government should develop an evaluation and technical
> assistance component for all federally funded HIV-related programs.  
> 
>       30. Elected officials at all levels of government have the
> responsibility to be leaders in this time of health care crisis and should
> exercise leadership in the HIV epidemic based on sound science and informed
> public health practices.       
> 
>       Chapter 1  
> 
>       Introduction   
> 
>       Since scientists first began to understand the dynamics that govern
> transmission of the human immunodeficiency virus (HIV), it has been possible
> to predict with chilling accuracy the toll the epidemic would exact in
> sickness and in lives lost.  As the nation enters the second decade of the
> HIV epidemic, the accuracy of predictions made in the mid-1980s stand as a
> silent rebuke.  One need take only a brief look at these statistics to
> understand the impact that AIDS has had in the United States.   By the end of
> 1990, more than 100,000 people in the United States had died of AIDS, and
> nearly a third of those deaths occurred that year.  
> 
>       Now more than a hundred people die in the United States every day of
> AIDS_one every 15 minutes_and the pace is accelerating.  As of June 1991,
> 182,834 cases of AIDS in the United States and its commonwealths and
> territories had been reported to the federal Centers for Disease Control
> (CDC).  Between March 1990 and March 1991, the reported number of new cases
> in the United States rose by more than one third.  These numbers are a
> telling indication that our efforts at prevention must be redoubled.    
> 
>       During the earliest years of the epidemic, from 1981 to 1982, nearly 80
> percent of all reported AIDS cases were from six large metropolitan areas in
> five states_New York City, San Francisco, Los Angeles, Miami, Newark, and
> Houston.  So far in 1991, 31 metropolitan areas and 25 states and the
> Commonwealth of Puerto Rico have reported one thousand or more cumulative
> AIDS cases_and the number of communities, counties, and states affected by
> HIV disease continues to expand. 
> 
>       While the majority of new AIDS cases have been from metropolitan areas,
> there has been a significant increase in new cases in municipalities with
> populations less than 500,000.  Lack of access to adequate health care has
> denied the benefits of advances in treatment to many in these smaller cities
> and rural communities, despite the dedication of stalwart health care
> providers and volunteers.  More ominous still, failure to acknowledge the
> dimensions of the crisis has resulted in insufficient attention to AIDS
> education and prevention programs. 
> 
>       HIV disease has had a disproportionate impact on some communities.  The
> HIV epidemic continues to affect gay and bisexual men more than any other
> single group of Americans; these individuals compose 64 percent of the cases
> of AIDS reported since the beginning of the epidemic.  African-Americans
> constitute 12 percent of the United States population, but nearly 28 percent
> of AIDS cases.  Hispanics constitute 9 percent of the population, but 16
> percent of AIDS cases.  Unless sustained support for targeted interventions
> that facilitate access to a broad range of health and social services is
> given, there is every indication that these communities will continue to be
> disproportionately represented among AIDS cases in the future. 
> 
>       The number of women and children infected with HIV_particularly within
> communities of color_continues to grow dramatically.  In fact, AIDS cases
> among women are growing faster than AIDS cases among men.  As of June 1991,
> women accounted for 10 percent of all AIDS cases.  In 1991 AIDS is projected
> to become one of the top five causes of death for young women. 
> 
>       Increasingly, parents who are themselves infected are forced to make
> agonizing choices for themselves, their infected children, and their
> uninfected children.  Parents may sacrifice their own health as they seek
> care for their children and must struggle with issues of how to provide for
> both sick and healthy children after their death.  New York City officials
> project an "orphan burden" of approximately 20,000 children who will need to
> be cared for by relatives or placed in foster homes when their parents die of
> AIDS in the next few years.  About one fourth of these children will be HIV
> positive themselves.  Intravenous drug use has contributed significantly to
> this new trend.  
> 
>       Approximately 70 percent of all pediatric AIDS cases are directly
> related to maternal exposure to HIV through intravenous drug use or sex with
> an intravenous drug user. Communities all across the United States are
> struggling to confront the twin epidemics of HIV and substance use.  The
> nexus between HIV and substance use is unarguable.  Already, approximately 31
> percent of all AIDS cases can be linked, either directly or indirectly, to
> intravenous drug use. Cases of HIV infection related to unprotected sexual
> activity under the influence of crack cocaine, alcohol, or other substances
> is another disturbing trend, especially among adolescents.  Drug treatment
> centers are ill equip- ped to deal with the growing numbers of substance
> users with HIV disease.  The lack of treatment slots, training, and funding
> only perpetuates this insidious link. 
> 
>       The number of reported AIDS cases does not, however, accurately portray
> the scope of the epidemic because such figures represent only 10 to 15
> percent of the total number of people now infected with  HIV in the United
> States.  CDC estimates that, at present, approximately one adult male in 100
> in the United States is HIV positive and one adult female in 600 is similarly
> infected.  In all, CDC estimates that at least one million people in this
> country have HIV infection.   
> 
>       Moreover, HIV affects people of all ages.  Adolescents are often
> forgotten as discussions center on adults and children.  Presently,
> adolescents with hemophilia represent a majority of reported AIDS cases among
> those aged 13_19.  In addition, adolescents practice many of the same
> behaviors that put adults at risk.  Given the length of time between
> infection and diagnosis, it is clear that the large numbers of individuals
> diagnosed with AIDS in their mid to late twenties were infected during their
> teens.  
> 
>       The disproportionate impact of AIDS on young people is further
> dramatized by the "years of potential life lost."  Health economists have
> tallied up the years of potential life lost before age 65 to describe the
> extent to which deaths from AIDS occur primarily in young people.  In 1987
> the years of potential life lost due to AIDS was 432,000.  This figure
> compared with 246,000 for stroke, 1.5 million for heart disease, and 1.8
> million for cancer.  While the rates for these other major diseases remain
> stable, the years of potential life lost due to AIDS continues to increase. 
> In 1991 estimates place the years of potential life lost due to AIDS between
> 1.2 and 1.4 million, ranking it third among all diseases.  By 1992 the years
> of potential life lost due to AIDS will grow to between 1.5 and 2.1 million. 
> By 1993 AIDS will clearly outstrip all other diseases in lost human
> potential. 
> 
>       HIV disease has a devastating impact on those who are already
> marginalized members of society.  Growing numbers of HIV infection and AIDS
> cases occur among poor residents of inner cities.  For the members of the
> National Commission on AIDS, the statistics of HIV disease were brought to
> life by the testimony of nearly one thousand witnesses at hearings and site
> visits across the country.  The Commission met with people living with HIV
> disease and with caregivers on the front lines.  Its members met with people
> at homeless shelters in New York City, at a needle exchange program in
> Seattle, in Native American communities in four states, in private homes in
> rural Georgia, at primary health clinics and drug outreach centers in Puerto
> Rico, at a Veterans Administration hospital in Los Angeles, and at hospitals,
> HIV antibody testing centers, drug treatment clinics, and comprehensive
> hemophilia treatment centers throughout the nation.  
> 
>       A mere tally of cases only sketches part of the picture.  It quickly
> became clear during the Commission's travels that HIV disease could not be
> understood outside the context of racism, homophobia, poverty, and
> unemployment_pervasive factors that foster the spread of the disease.  This
> web of associated social ills has been referred to as "a synergy of plagues." 
> Poverty and unemployment in the inner cities of the United States entail much
> more than an inability to pay the bills.  In 1991 being poor is a generic
> risk factor, for it is associated with in- creased risks of becoming
> homeless, dying a violent death, and suffering and perhaps dying from a
> multitude of preventable illnesses.  
> 
>       A 1990 study of mortality in New York City's Harlem found that black
> men in that community were less likely to reach the age of 65 than were men
> in Bangladesh. The association of poverty, homelessness, and disease is
> perhaps best dramatized by the impact of the HIV epidemic on those in inner
> cities who are living at the margins of society.  Without permanent addresses
> or steady incomes, the homeless and many of America's poor often are isolated
> from all but the most rudimentary health care.  Public hospitals that serve
> low-income communities and the overwhelming majority of people with AIDS in
> large cities are overcrowded, their staffs are beleaguered, and their
> substandard funding is shrinking with each additional municipal budget
> crisis.  
> 
>       Those most in need of health care are typically the ones who can least
> afford it.  When illness strikes, the emergency room becomes the "family
> physician."  The increase in numbers of HIV cases is placing a strain on a
> system already on the verge of collapse. In some areas of the country the
> sheer number of people with AIDS has forced a greater awareness and
> understanding of the challenges people with HIV disease face.  However,
> although recent opinion polls reflect a moderation of harsh attitudes toward
> people living with HIV disease, HIV-related discrimination has not
> disappeared.  This discrimination reflects the racism and homophobia that
> pervade our society and, like poverty, limit people's access to care and
> compassion.  AIDS has been sufficiently controversial to have earned the
> status of the most litigated disease in American history.  There is,
> moreover, a further disquieting trend.  Surveys of court cases and complaints
> to human rights commissions show that rather than disappearing, AIDS
> discrimination is changing.  Subtle prejudices involving denial of basic
> health services are replacing overt forms of bias, and these subtle biases
> are more difficult to fight legally. 
> 
>       As the epidemic worsens, opportunities to mobilize effective responses
> diminish each day that we fail to act decisively.  Education for prevention
> of further HIV spread through the avoidance of risk behavior has been greatly
> underutilized.  Despite a slow start, there is much that can be done now to
> prevent new HIV infections from occurring and to enhance the quality and
> length of life of those already infected.  In recent years there have been
> heartening developments in treatments for HIV disease.   Guaranteeing access
> to all of these treatments is essential.  The Commission has witnessed
> firsthand the efforts of many people, particularly individuals working at the
> community level, who are providing these and other services to people with
> HIV disease.  The nation must be awakened to the enormity of the HIV crisis
> and to the potential for individual and collective action.  There is no lack
> of options or remedies.  We are not without hope. The nation's response must
> be commensurate with the threat posed by the epidemic.  The report that
> follows offers concrete proposals for action.  
> 
>       Selected Bibliography  
> 
>       Angell, M.  1991.  A dual approach to the AIDS epidemic.  New England
> Journal of Medicine 324:1498_1500.  
> 
>       Arno, P.S., D. Shenson, N.F. Siegal, P. Franks, and P.R. Lee.  1989. 
> Economic and policy implications of early intervention in HIV disease. 
> Journal of the American Medical Association 262:1493_1498.  
> 
>       Bayer, R.  1991.  Private Acts, Social Consequences:  AIDS and the
> Politics of Public Health.  New Brunswick, N.J.:  Rutgers University Press. 
> 
> 
>       Bayer, R.  1991.  Public health policy and the AIDS epidemic:  An end
> to AIDS exceptionalism?  New England Journal of Medicine 324:1500_1504.   
> 
>       Beauchamp, D.E.  1988.  The Health of the Republic:  Epidemics,
> Medicine, and Moralism as Challenges to Democracy.  Philadelphia, Pa.: 
> Temple University Press.  
> 
>       Berk, R., ed.  1988.  The Social Impact of AIDS in the U.S.  Cambridge,
> Mass.:  Abt Books.  
> 
>       Brandt, A.  1987.  No Magic Bullet:  A Social History of Venereal
> Diseases in the United States from 1880.  Expanded edition.  New York: 
> Oxford University Press.  
> 
>       Brandt, A.M.  1988.  AIDS and metaphor:  Toward the social meaning of
> epidemic disease.  Social Research 55:413_432.  
> 
>       Burris, S.  1989.  Rationality review and the politics of public
> health.  Villanova Law Review 34:909_932.  
> 
>       Crimp, D., ed.  1988.  AIDS:  Cultural Analysis, Cultural Activism. 
> Cambridge, Mass.:  The MIT Press.  
> 
>       Dalton, H.  1989.  AIDS in blackface.  Daedalus 118:205_227.  
> 
>       Fee, E., and D.M. Fox, eds.  1988.  AIDS:  The Burdens of History. 
> Berkeley, Calif.:  University of California Press.  
> 
>       Gostin, L.O.  1990.  The AIDS litigation project:  A national review of
> courts and human rights decisions.  Part I:  The social impact of AIDS. 
> Journal of the American Medical Association 263:1461_1970.  
> 
>       Institute of Medicine.  1988.  Confronting AIDS:  Update 1988. 
> Washington, D.C.:  National Academy Press.  
> 
>       Institute of Medicine.  1988.  The Future of Public Health. 
> Washington, D.C.:  National Academy Press.    
> 
>       Institute of Medicine.  1991.  HIV Screening of Pregnant Women and
> Newborns.  Washington, D.C.:  National Academy Press.    McCord, C., and H.P.
> Freeman.  1990.  Excess mortality in Harlem.  New England Journal of Medicine
> 322:173_177.  
> 
>       Murphy, T.F.  1991.  No time for an AIDS backlash.  Hastings Center
> Report 21(2):7_11.  
> 
>       Shilts, R.  1988.  And the Band Played On:  Politics, People, and the
> AIDS Epidemic.  New York:  Penguin.  
> 
>       Wallace, R.  1988.  A synergism of plagues:  "Planned shrinkage," 
> contagious housing destruction, and AIDS in the Bronx.  Environmental
> Research 47:1_33.    
> 
>       Introduction  
> 
>       Side bar pull out information:     
> 
>       We must learn to practice the justice, freedoms, and compassions that
> we take so much pride in talking  about in civics classes and teaching our
> children about when we tell them what it is to be an American.  
> 
>       Our  response to AIDS must take into account how all people with AIDS
> and HIV live and recognize that we aren't all in San Francisco or New York
> using systems that are collapsing from the weight of us.  Some of us are in 
> Kentucky and Alabama and Missouri and Iowa, still trying to find a doctor
> willing to treat us or a home care agency that will send the nurse without
> requiring a baseline antibody test for her. . . .  
> 
>       I have to say that people living with AIDS and HIV want nothing more or
> nothing less than what all  of you take for granted today_a place to live,
> the right to have a job, decent medical care, and to live our lives out
> without unreasonable barriers.  
> 
>       We are not asking for extras, only to be included in what America
> already delivers to her privileged people.  
> 
>       I'm thirty-one this year and my life has been blessed with two healthy
> children_a six-year-old daughter, and a son who is almost three.  Relatively
> speaking, I'm not in bad shape and I used to hope that I would be able to
> live long enough to see my children, with the help of their father, accept
> and adapt to the inevitability of my death.  More lately I've been hoping
> that when I'm gone they wouldn't continue to be stigmatized by the shadow
> thrown by my public life.  
> 
>       But compassion is not going to happen because of a report that we make
> or an edict that somebody in Washington delivers.  It will begin in the small
> towns in the quiet country throughout America when people understand that
> people living with AIDS and HIV are just like us because they are us.   
> 
>       Belinda Mason 
>       September 1989       
> 
> 
>       The AIDS/HIV epidemic has focused more attention on long-standing
> problems and has made it clear that it's time for sweeping policy and
> systemic changes in how America cares for its most needy.  
> 
>       Don Schmidt 
>       July 1990    
> 
> 
>       I worry about my daughter who is not infected, but affected by her
> family's situation.  I not only worry about her, but all the siblings that
> are not infected because I think the system tends to forget about these
> children. . . .  If they lose their parents, if they lose their infected
> siblings, the public views these children as now over the trauma.  Well,
> those children's trauma is just beginning.   
> 
>       Toni P.  
>       March 1991     
> 
> 
>       By 1992 the years of potential life lost due to AIDS will grow to
> between 1.5 and 2.1 million.  By 1993 AIDS will clearly outstrip all other
> diseases in lost human potential.   
> 
>       There were no support groups, no social workers, nobody, so I retreated
> even further into my community.  But even that was wrong.  I had people
> coming to my door wanting to beat me up_they didn't want AIDS in their
> community_even though these were my relatives.... But because I had AIDS I
> was no longer human.  I was a disease.  I no longer had feelings.  I no
> longer was given the opportunity to plan, to have goals, to contribute.     
> 
>       Willie Bettelyoun, M.A. 
>       September 1989  
> 
> 
>       Chapter 2   
> 
>       Prevention and Education    
> 
>       Until a cure or a vaccine is found, education and prevention are the
> only hope for altering the course of the HIV epidemic.  This actually
> understates the importance of prevention, for prevention strategies will
> continue to be a key component of HIV containment far beyond the advent of
> successful drug treatments or vaccines.  There are valuable lessons to be
> learned from earlier experiences with sexually transmitted diseases. 
> Effective and inexpensive treatments for many of these diseases have long
> been available, yet drugs alone have not stemmed the tide of infections,
> especially among young people and those living in poverty.  Those prior
> experiences are underscored by the rapid reemergence of syphilis, and it can
> be said with certainty that medical science alone will not be able to
> vanquish AIDS, even with a magic bullet.   
> 
>       There is an urgent need for implementation of carefully designed
> strategies to prevent new HIV infections (primary prevention) and to prevent
> disease progression for HIV-infected individuals through early diagnosis,
> prompt treatment, and continuing care and support (secondary and/or tertiary
> prevention).  Educational programs are also necessary to alter the public's
> perceptions that HIV disease is someone else's problem.  The discrimination
> that occurs against people with HIV disease results largely from fear and
> ignorance, and the best weapon against these is education.   
> 
>       Some of the most encouraging news thus far in the HIV epidemic comes
> from the success of certain health education programs that have resulted in
> dramatic, sustained reduction in risk behavior.  There is clear evidence that
> prevention is possible; changes in attitudes and behavior can occur as a
> result of carefully tailored, targeted, and credible prevention efforts. 
> Such success is less dramatic to the public than a laboratory breakthrough,
> but probably more important.  This chapter considers an array of education
> and prevention strategies, highlights some prevention success stories, and
> offers recommendations to focus prevention efforts for the second decade of
> the epidemic.  As we move into the second decade, the Commission believes
> policies should be developed now to address future plans for the distribution
> of AIDS vaccines as well as the ethical and liability issues that will arise
> when vaccines become available.  
> 
>       A Disease of Behaviors:  Clinical and Epidemiologic Aspects of HIV When
> considering prevention strategies to alter the course of the HIV epidemic it
> is important to keep in mind the manner in which the virus is transmitted. 
> The limited modes of transmission of HIV have been well documented.  HIV can
> be transmitted through sexual contact;  by the sharing of contaminated
> injection equipment;  through exposure to infected blood or blood products; 
> and, during gestation or at birth, from an infected mother to a newborn. 
> Breastfeeding has also been identified as a potential mode of transmission. 
>  
> 
>       Understanding these modes of transmission has enabled the development
> of some practical strategies for use in stopping the spread of the virus. 
> Screening of blood and voluntary deferral of blood donors at risk of HIV
> infection has significantly reduced the transmission of HIV through the blood
> supply.  Sophisticated purification techniques, blood screening, and
> voluntary self-deferral have eliminated new HIV infections from occurring
> through the use of blood clotting factors to people with hemophilia. 
> "Universal precautions" can help patients and health care workers avoid
> exposure to HIV.  Such precautions involve the avoidance of all potentially
> infected blood or body fluids through barrier methods, without regard to the
> serostatus of patients or health care workers.  The efficacy of universal
> precautions can be strongly inferred by a substantial drop in hepatitis B
> transmission (hepatitis is a hundred times more infectious than HIV). 
> Appropriate use of condoms can decrease the risk of HIV during sexual
> intercourse.  It is also possible to disinfect injection equipment with
> bleach so that the sharing of needles and syringes does not spread the virus. 
>  
>       In addition to the strategies available to prevent new infections, much
> more is now known about how to delay progression to AIDS in HIV-infected
> individuals.  Until a few years ago, treatment regimens for HIV disease had
> been offered only to those exhibiting symptoms.  In recent years, the
> clinical management of HIV disease has improved with the development of
> therapeutic strategies involving the use of treatments such as zidovudine
> (AZT) and aerosolized pentamidine for HIV-infected individuals who are still
> asymptomatic.  This early intervention has enhanced well-being in addition to
> delaying the onset of AIDS, but its availability or lack thereof raises
> important issues of access.  To bring the benefits of early intervention to
> people in need, additional and better coordinated services will be
> required_not only greater outreach, HIV testing, counseling, laboratory
> monitoring, medications, and primary health care, but also improved
> laboratory services, better coordinated systems of care, and public and
> private financing strategies to pay for care.  
> 
>       Developing Prevention Messages 
> 
>       Frank Talk About Sex and Drugs  
> 
>       Most of the disagreement about HIV prevention is not over goals, but
> over methods to achieve goals and over who should decide which methods ought
> to be used.  As noted above, there are a number of simple, readily available
> technologies that will contribute significantly to reduction in the spread of
> HIV infection.  Yet AIDS education and prevention efforts continue to be
> stymied by an unwillingness to talk frankly about sexual and drug use
> behaviors that risk the spread of HIV.  Constraints on discussions of sex,
> whether imposed by law, political considerations, issues of morality,
> language, or culture, have been a substantial barrier to the creation and
> implementation of effective HIV prevention programs.  There is a cruel irony
> at work here, for reticence about discussing sex has become an obstacle to
> the implementation of lifesaving prevention programs.  This withholding of
> potentially lifesaving information raises serious ethical problems. 
> 
>       In the early years of the AIDS epidemic messages concerning HIV were
> couched in euphemisms.  There were warnings about the danger posed by the
> "exchange of bodily fluids" when the phrase eluded public understanding. 
> Generic, incomplete, and ambiguous messages such as this fostered
> misunderstandings about the actual dimensions of risk and the ways to avoid
> the threat posed by HIV disease. 
> 
>       Research in many areas of health education has shown that to encourage
> behavior change, prevention messages must be transmitted in a language and
> manner that can be understood by the people to whom they are directed.  Those
> who design and implement education and prevention programs must be able to
> use unvarnished language and communications that are both meaningful and
> acceptable to the particular community or group being addressed.  Where the
> communications are targeted to a specific group, the potential offensiveness
> to others to whom the message is not directed should not and need not be a
> barrier.  Congress should remove the government restrictions that have been
> imposed on the use of funds for certain kinds of HIV education, services, and
> research. In addition to crafting clear and explicit messages that are
> relevant to those at risk, a greater realism is needed in approaches to
> altering sexual behavior and drug use.  For example, although teenagers are
> encouraged to delay sexual intercourse until marriage or at least until
> adulthood, a majority of young people have not heeded such advice, regardless
> of how forcefully this message has been delivered.  In view of this stark and
> dangerous reality, advice concerning abstinence must be supplemented by frank
> talk about AIDS, and about how to avoid sexually transmitted diseases and
> unintended pregnancies.  In addition, it must reach children at a young age. 
> 
>       A similar set of problems has existed in discussions and attitudes
> about drug use as it relates to HIV transmission.  The predominant policy
> approach has characterized drug use as a criminal rather than a public health
> problem.  Here too the approach must be more than "just say no."  A more
> realistic strategy is crucial to the prevention of HIV transmission related
> to drug use.  Some of those at risk will be able to stop using drugs on their
> own, or will stop with the help of formal treatment, self-help, or
> "twelve-step" programs modeled on Alcoholics Anonymous.  Access to drug
> treatment is an absolutely fundamental element of prevention in those
> populations.  Those who find it impossible to stop using drugs, or who
> relapse following a period of abstinence from drugs, must be encouraged to
> practice safer sex and safer drug use and must be taught how to do so.    
> 
>       The Commission reiterates the recommendations made in its fifth interim
> report to the President and the Congress concerning the twin epidemics of HIV
> disease and substance use.  The federal government should expand drug
> treatment so that all who apply for treatment can be accepted into treatment
> programs.  The federal government should also continually work to improve the
> quality and effectiveness of drug use treatment.  In addition, legal barriers
> to the purchase and possession of injection equipment should be removed. 
> Legal barriers do not reduce illicit drug injection.  They do, however, limit
> the availability of new, clean injection equipment, thereby encouraging the
> sharing of injection equipment, and the increase in HIV transmission.    
>       Cultural Sensitivity _and Cultural Competence 
> 
>       As part of the need to deal realistically with issues about sex and
> drugs, it is critical that these subjects be addressed in a manner that is
> not only culturally sensitive but also culturally competent.  Especially
> since sex and drugs are sensitive topics, it is clear that the best
> prevention messages will be those developed by and for the people the
> messages are intended to reach, through community-based efforts at the local
> level.  It is essential to include people living with HIV disease in HIV
> prevention efforts.  For many communities, seeing people in education and
> prevention efforts who are directly affected by HIV will bring home the
> reality of HIV and help overcome the denial that "this cannot happen to me or
> my loved ones."  When gay men, women, people of color, and persons using
> drugs are not consulted in the design and implementation of prevention
> programs, programs directed toward these audiences will not be effective.   
>  
>       Strategies in HIV Prevention 
> 
>       The Web of Illness, Poverty, _and Alienation  
> 
>       HIV disease is associated with a host of related health and social
> problems; strategies to prevent the further spread of HIV disease must take
> these problems into account.  Other sexually transmitted diseases (e.g.,
> syphilis, gonorrhea, chlamydia, herpes, hepatitis, and venereal warts) may
> act synergistically with HIV, enhancing HIV transmission or disease
> progression.  Drug use is significantly associated with HIV disease. 
> Injection drug use poses the most direct threat of HIV transmission when
> contaminated injection equipment is shared; this is a risk for intravenous
> users of any drug, including heroin, cocaine, and steroids.  It has been less
> widely recognized that crack cocaine, alcohol, and other psychoactive drugs
> also represent serious threats when multiple sexual partners and impaired
> judgment about risk are involved.   
> 
>       From New York City to Waycross, Georgia, from San Juan, Puerto Rico, to
> Seattle, Washington, in hearings and site visits the Commission has seen how
> poverty, homelessness, lack of basic health care, lack of prevention
> services, and lack of drug treatment combine with the alienation experienced
> by gay men, poor women of color, and drug users to exacerbate the spread of
> the virus.  A dramatic example of this is the increase in sexually
> transmitted diseases in many urban and rural areas in the United States.  
> 
>       Essential Elements of Prevention Programs  
> 
>       To intervene effectively in the spread of HIV it is essential to
> consider the broader social context of the HIV epidemic, for it involves not
> only individuals at risk, but also families, cultural and social groups,
> neighborhoods, and communities at risk of multiple problems.  Although this
> adds to the complexity of HIV intervention, it also means that successful HIV
> prevention efforts will not only reduce the spread of HIV, but also are
> likely to have an impact on the rates of other sexually transmitted diseases,
> teenage pregnancy, and drug use. 
> 
>       A mix of strategies is being used throughout the country in the design
> of HIV prevention programs.  From grass roots efforts to federally sponsored
> programs, these varied approaches draw on a number of different fields,
> disciplines, perspectives, and experiences.  The potential for success in
> prevention is enhanced by government policies that are not restrictive and
> that create a climate in which prevention efforts can be creative,
> cooperative, and comprehensive.  Other interventions that have helped to
> create a positive context for HIV prevention efforts include laws guarding
> confidentiality and protecting against discrimination.  Without assurances
> that people can avail themselves of HIV prevention opportunities without
> risking the loss of jobs, housing, and health insurance, it is next to
> impossible for prevention and education services to reach those at greatest
> risk of HIV.   
> 
>       If prevention efforts are to be successful they require sustained
> commitment to change over the long term, rather than an expectation of
> short-term results.  They also require support of multiple interventions and
> strategies, rather than investment in a single "solution."  Support must be
> continuous and predictable.  Prevention programs must be accountable,
> progress and results must be measurable, and training and support must be
> provided to those administering the programs. 
> 
>       Some important prevention strategies include:  sex and HIV education
> appropriate to age levels;  treatment programs for substance users; 
> education about bleach and clean needle and syringe programs for those who
> are unable to stop using drugs;  efforts to control sexually transmitted
> diseases;  outreach programs to provide contraception to women of
> childbearing age;  easily accessible HIV antibody testing and essential
> counseling;  peer counseling; street outreach efforts;  and readily available
> condoms supported by a social marketing program that encourages their use.  
> 
>       Individual and Community Approaches 
> 
>       Efforts designed to control HIV infection create change by intervening
> at many levels.  Technological approaches will not work without changes in
> knowledge, attitudes, beliefs and behaviors.  In this second decade of the
> HIV epidemic, there will be an increasing need to supplement individual
> behavior change strategies with a concept of communitywide prevention. 
> Similar interventions aimed at changing the norms of entire communities are
> among the most promising HIV prevention strategies.  These interventions have
> proven to be effective in promoting a variety of health behaviors, such as
> family planning and cardiovascular risk reduction, including smoking
> cessation.  
> 
>          .  common identities such as gender, sexual orientation, race or
>             ethnicity, language, religious affiliation, age groupo, or a
>             genetic condition such as hemophilia; 
> 
>          .  behavior such as same-gender sex, injection drug use or needle
>             sharing, and non-injection drug use, including alcohol use;   
> 
>          .  location or setting such as hospitals, clinics, prisons,
>             churches, work environments, and schools;                     
> 
>          .  other circumstances such as possible exposure to HIV infrection
>             through blood transfusions or other use of blood products.   
> 
>       Communitywide models are designed to utilize multiple settings,
> channels, and organizations in their design, implementation, and evaluation. 
> Each community has distinct features; no two communities will be alike in
> their response to HIV disease, and thus the process by which a response to
> the HIV epidemic is mobilized in communities will also vary.  Understanding
> more about how to respond to AIDS involves understanding and respecting what
> the community regards as problems and priorities, acknowledging social
> organization and structure, and then identifying the community's available
> resources and what solutions it will be ready to employ.  These efforts must
> be supported, funded, documented, and evaluated to broaden the reach of our
> prevention efforts.  Federal, state, and local governments should join forces
> with the private sector in providing long-term support to community-based
> organizations.  As a part of this effort, the U.S. Public Health Service
> (PHS) should expand and promote comprehensive programs for technical
> assistance and capacity building for effective long-term prevention efforts. 
> 
>       Reducing Sexual Transmission of HIV 
> 
>       Substantial progress has been made in reducing sexual transmission of
> HIV infection among certain populations in some areas of the country. 
> Nevertheless, sexual transmission of HIV continues to be a major route of
> infection.  Although many more people are now aware of the types of sexual
> behaviors that risk the spread of HIV, the gulf between awareness of risk and
> long-term behavioral change can be wide.  Sexual conduct is influenced by
> complex factors, including biological drives, religious beliefs, customs, and
> cultural and community norms and values.  These aspects of sexual behavior
> make changes difficult to inculcate.  Consider how difficult it is to get
> people to stop smoking, even when they know how dangerous it is; or how much
> effort it has taken to encourage people to wear seat belts, despite the
> manifest risks of not doing so.  A psychiatrist who testified before the
> Commission made a telling comparison: "We are essentially asking people to go
> on a diet and never cheat for their entire life.  Unlike a diet, cheating may
> be lethal."  
> 
>       Same-Gender Transmission 
> 
>       Homosexual and bisexual men still bear much of the burden of HIV
> disease in the United States across all racial and ethnic groups.  In cities
> with large gay communities, such as San Francisco and New York, a substantial
> portion of gay men are infected with HIV.  The validity of programs of
> prevention is dramatically underscored by studies in the last several years
> of white gay men in urban epicenters of the HIV epidemic.  Sustained changes
> in sexual behavior have been accompanied by a marked lowering of the rate of
> incidence of new infections.  Interpretation of these trends is further
> supported by stable or falling rates of sexually transmitted diseases.   
> 
>       A dramatic change in peer behavioral norms among gay men is one of the
> heartening stories of the HIV epidemic.  Early in the epidemic, programs were
> established to impart information, to help motivate change, and to bolster
> skills necessary to change behavior, such as ways to negotiate safer sex. 
> Many of these programs came from within the gay community and relied to a
> large extent on volunteers, as many governmental agencies were not
> confronting the epidemic.  The result of these programs was that many gay men
> increased condom use, adopted safer sex practices, and reduced the number of
> their sexual partners.   Although many gay men have made remarkable changes
> in sexual behavior, these changes should not be taken as evidence that the
> job of education and prevention has been done, but rather that it can be
> done.  There are many men who engage in same-gender sex but do not perceive
> of themselves as being gay or as belonging to any gay social or political
> community.  These men are particularly difficult to reach with gay-specific
> HIV prevention messages.  Targeted messages about behavior change may have
> passed them by.  In addition, as the epidemic matures, sustained efforts will
> be necessary to prevent "relapse" among gay men who have made changes in
> their sexual behavior.  More attention to the relationship between alcohol
> and drug use and sexual behavior is warranted, as those who combine sex with
> alcohol and other drugs are more likely to engage in sexual activities that
> carry a high risk of HIV transmission. 
> 
>       Gay and bisexual men are the largest segment of people with AIDS among
> blacks and Hispanics (36 and 40 percent of cumulative cases, respectively, as
> of June 1991).  A total of 28 percent of gay and bisexual men with AIDS are
> black or Hispanic.  Despite these realities, epidemiologic and behavioral
> studies in HIV disease had until recently focused overwhelmingly on white gay
> men.  Gay men of color may face special risk-reduction challenges.  More must
> be done to reach out to these men and empower them through prevention
> efforts.   
> 
>       Women who have sex with other women have been neglected in HIV
> prevention efforts.  The lack of attention to this group of women is due in
> part to a tendency toward rigid categorization that belies the true variety
> of human sexual experience.  Lesbians are still viewed by many in terms of
> their status as members of a group rather than the behaviors they may
> practice and thus are often overlooked in prevention efforts.  Many of these
> women may have a false sense of security about their risk of HIV infection
> and consequently neglect to practice safer sex habits.  Lesbians must be
> given information about how to reduce the risk of HIV transmission and must
> be encouraged to practice safer sex with both female and male sexual partners
> and to use safe injection procedures if they use injection drugs. 
> 
>       Adolescents who are just entering a phase of sexual experimentation or
> who are beginning to express their sexual identity may be at special risk for
> HIV infection.  The well-known tendency of teenagers to deny risk is abetted
> in the case of gay youth by the lengthy incubation period of the AIDS
> virus_as many as five to ten years may pass between infection with HIV and
> development of clinical symptoms.  Approximately 20 percent of AIDS cases
> have occurred among individuals aged 20 to 29; most of these people were
> probably infected during their teenage years.  Gay males in their teens and
> twenties outside urban epicenters of HIV are significantly more likely than
> older men to engage in unprotected anal intercourse and to do so with more
> partners, according to current studies reviewed by the Committee on AIDS
> Research and the Behavioral, Social, and Statistical Sciences of the National
> Research Council.  Young gay men often wrongly perceive the risk to be solely
> from older men, deriving a false sense of security from having sex with other
> young men who appear healthy, but who actually may be HIV infected.      
> 
>       Heterosexual Transmission 
> 
>       Over the past few years concern over AIDS cases in the United States
> attributed to heterosexual contact has grown.  Cumulatively, 6 percent of all
> AIDS cases in the United States are due to heterosexual contact.  In this
> exposure category, women are at greater risk than men of acquiring infection
> through heterosexual contact.  Thirty-three percent of all women with AIDS as
> opposed to 2 percent of all men with AIDS report exposure through
> heterosexual contact.  It is important to note that a majority of female
> heterosexual cases are related to unprotected sex with an HIV-positive
> intravenous drug user.  Women of color have been particularly heavily
> affected.   
> 
>       These statistics are particularly troubling because many women believe
> they are not at risk and do not need to practice safer sex or change
> potentially dangerous behaviors.  Prevention messages are not effectively
> reaching large populations of women.  Much of the attention women have
> received in the HIV epidemic has been related to the potential for the spread
> of HIV to their sexual partners or offspring; women are frequently
> characterized, explicitly or implicitly, as "vessels of infection" or as
> "vectors of perinatal transmission."  Women need attention in their own
> right, not only in the development and evaluation of HIV prevention
> strategies, but in all aspects of HIV policy development.   
> 
>       Many prevention messages have not been grounded in the realities of
> women's lives.  Not surprisingly, such messages have not been very effective. 
> Perhaps the most unrealistic prevention message for women is the nearly
> exclusive focus on the use of condoms, advice that is naive regarding
> anatomy, gender roles, and power relationships.  The emphasis on condoms grew
> out of the early years of the HIV epidemic when sex between men was a
> predominate concern.  As more knowledge has been gained about the epidemic,
> the need for alternative prevention methods has been clearly indicated. 
> Condom use requires the active involvement of the male partner, and the woman
> must secure his cooperation or convince him to terminate the sexual
> interaction if he refuses.  The use of condoms may be complicated by the
> perception that their use is an admission of infidelity, hence threatening
> relationships of long standing.  In fact, many men report using condoms "on
> the side," but not in their primary relationships. 
> 
>       That condom use is inherently limited as a method for preventing the
> heterosexual spread of AIDS does not imply that attempts to encourage their
> use should be abandoned, but rather that such efforts should be redoubled. 
> The United States has yet to embark on campaigns such as have been undertaken
> in other countries to foster fundamental changes in social attitudes about
> condoms, through advertising, social marketing, and intensive outreach and
> reinforcement strategies.   
> 
>       Across categories of exposure, individuals for whom condoms might
> reduce risk report only limited consistent use of them.  Condoms must be made
> more widely available and information on how they can be effectively used
> must be provided.  Further, their use must be promoted through sophisticated
> social marketing strategies.  The de facto ban on network television
> advertising of condoms continues to impede their social acceptability.  These
> and other impediments to the use of condoms should be recognized and
> addressed.  More behavioral research is needed to develop methods of HIV
> prevention during sexual contact that are acceptable to both women and men. 
> 
>       While attempts to promote greater use of condoms to reduce transmission
> of HIV should continue, it is equally important that research funds and
> personnel be devoted to the exploration of alternative methods of preventing
> HIV transmission.  Increased efforts are necessary to develop a wider array
> of chemical and physical barriers to block vaginal HIV transmission that do
> not depend entirely on the male partner's cooperation.  These include gels,
> suppositories, or sponges that might be used before or after intercourse. 
> More research is needed on chemicals that kill viruses (virucides).  A female
> condom is also in development.  The diaphragm should be evaluated in terms of
> its potential role in HIV prophylaxis. 
> 
>       In considering alternatives to condoms that might be more relevant for
> women, it is important to consider not only efficacy (the probability of
> preventing HIV transmission given optimal or correct use of a prevention
> technique or device), but also effectiveness (efficacy plus the extent to
> which the device or technique will be used correctly and therefore contribute
> to a slowing of the epidemic).  Even surefire methods of prevention are
> worthless unless people are willing to use them.   Teenagers tend to deny
> risk.  Yet, even when they recognize the risks of HIV, many adolescents still
> feel they are invincible or discount the risk of HIV because other risks in
> their environment are perceived as greater and more immediate. Adolescents
> are at risk, not only from their own perceptions of lack of risk, but also
> because adults often ignore the special needs of adolescents or deny that
> adolescents are sexually active. Abstinence is an efficacious means of
> eliminating the risk of sexual transmission of HIV.  However, although many
> young people have been encouraged to delay intercourse until marriage or
> adulthood, some teenagers will choose to begin sexual behaviors during
> adolescence.  In fact, studies in 1988 revealed that by age 15, 27 percent of
> girls and 33 percent of boys were sexually active.  Half of girls had had sex
> by age 17 and half of boys by age 16; three out of four unmarried 19-year-old
> women and five out of six unmarried 19-year-old men had had sexual
> intercourse.   
> 
>       Moreover, unprotected sexual activity is clearly occurring among teen-
> agers.  Other clear evidence for adolescent sexual behavior is found in the
> high rates of sexually transmitted diseases among sexually active adolescents
> and the fact that approximately one million teenage girls become pregnant
> each year.  According to a study conducted by the National Research Council,
> entitled Risking the Future, more than 400,000 of these pregnancies occurred
> in young women 15_17 years of age.  Pregnancy still remains the focus of many
> health and sex education programs.  If birth control is the sole objective,
> an oral contraceptive may be used instead of a barrier method that would also
> help to prevent HIV and sexually transmitted diseases.  Some young women
> practice anal or oral sex as a birth control method, which may pose increased
> risks for transmission of HIV.  Education messages to young women and men
> must be twofold, teaching ways to prevent both pregnancy and disease. 
> 
>       Adolescents need clear, realistic, unequivocal prevention messages
> about the risks of HIV transmission associated with unprotected sexual
> activity, sharing of injection equipment, and sexual activity in conjunction
> with substance use.  Adolescents must also be provided with the tools
> necessary to engage in safe behaviors.  Adults must use their knowledge to
> impart information despite their own embarrassment or reluctance to discuss
> sex. 
> 
>       Although many adolescents practice risk behaviors, some have a more
> difficult time than others finding information or avoiding risk behaviors. 
> These adolescents need targeted programs.  Some studies have shown
> African-Americans, Hispanics, and other youth from communities of color to be
> less aware of what places them at risk for HIV transmission than white youth. 
> Special attention should be given to these communities.  Young people who are
> infected with the virus need counseling and education to deal with the
> difficulties of living with HIV disease.  
> 
>       Sexual Transmission Related to Substance Use 
> 
>       Sexual transmission of HIV related to substance use concerns sexually
> active individuals, whether gay, lesbian, or heterosexual, whether adult or
> adolescent.  Injection drug use is clearly linked to sexual transmission of
> HIV.  It is less well known that sexual activity in conjunction with the use
> of other psychoactive substances, including alcohol and crack cocaine, poses
> a substantial risk.  Sexual transmission with regard to substance use occurs
> when judgment about safer sex is impaired as well as when sex is traded for
> drugs.  
> 
>       Prevention messages about sexual behavior as well as drug use may be
> effectively conveyed in drug treatment programs.  Unfortunately, drug
> treatment opportunities, deficient for men, are in even shorter supply for
> women.  This problem is in part a continuation of prior inequities, for women
> have traditionally had difficulty gaining access to drug treatment
> facilities, which for the most part have been oriented toward the needs of
> men.  Women with children and pregnant women who use drugs often have special
> difficulty finding drug treatment that meets their needs.  Women in need of
> treatment are often single parents who attend to their children's needs
> before their own.  Even when pregnant drug users are accepted into treatment,
> a significant opportunity for intervention may be missed, since there are
> often no provisions for prenatal care. Sexual partners of individuals who use
> intravenous drugs are often unaware of the risks they face, either because
> their partner's drug use is covert, or part of the past, or because they are
> unaware of the associated risks of HIV.  Those who are aware of the risks may
> still face difficulty in seeking counseling for risk reduction.  Thus, the
> simple steps that must be taken to prevent AIDS, such as condom use, may not
> be so simple after all.   
> 
>       Adolescents may be at heightened risk for transmission through sexual
> activity in conjunction with the use of substances other than injection
> drugs.  While some studies indicate that adolescents may avoid intravenous
> drug use, the use of alcohol and the growing use (especially in low-income
> urban communities) of crack cocaine places these individuals at increased
> risk.  It is extremely important, therefore, not to assume that intravenous
> drug use is the only link between drugs and sexual transmission.  
> 
>       Reducing HIV Transmission Related to _Intravenous Drug Use Successful
> and sustained risk reduction among injection drug users is vital to slowing
> the spread of HIV infection.  Injection drug users place themselves at risk
> through a variety of behaviors, and may spread the virus not only to their
> needle-sharing peers, but also to their sexual partners and at birth to their
> offspring.  Hence, any potentially successful program must address drug use
> and sexual behaviors simultaneously.  It is also important to provide
> prevention education to all those who engage in the risk behavior of sharing
> injection equipment, including athletes who inject steroids and individuals
> who inject vitamins and medications.   Although there is a commonly held
> misconception that drug users in the throes of addiction are impervious to
> messages about the risk of HIV transmission, the evidence suggests otherwise. 
> Drug users know a great deal about how HIV is transmitted and are willing to
> make the changes necessary to reduce risk of transmission when encouraged to
> do so.  There is evidence that HIV prevention strategies targeting injection
> drug users can result in decreased needle sharing, increased needle cleaning,
> increased demand for sterile needles on the street, and stable or declining
> seroprevalence rates among drug users.  In addition, when such HIV-related
> interventions are offered, there is often an increased demand both for
> treatment for addiction and for primary care.  
> 
>       Some consistent messages have emerged from studies of the impact of HIV
> on drug use behaviors.  Most drug users report changing their behavior in
> response to AIDS.  There is no single method of reducing HIV risks that will
> work for all drug users; prevention strategies must encourage both cessation
> of use and the adoption of safer injection practices for those who continue
> use.  Finally, more drug users have reported changes in drug use practices
> than changes in sexual behaviors, and yet, of course, both are essential. 
> Thus, renewed efforts to encourage behavioral changes related to both sex and
> drug use are necessary. HIV associated with drug use has potential for
> extremely rapid spread.  Some cities have already experienced this, with up
> to 50 percent of intravenous drug users HIV seropositive.  In other cities
> with large populations of intravenous drug users, HIV seroprevalence remains
> at much lower levels.  The geographic variation in HIV seroprevalence among
> intravenous drug users underscores the opportunities for heading off the
> spread of HIV disease.  HIV prevention strategies targeting injection drug
> users now include clinic-based interventions, street outreach projects,
> community-based information and awareness campaigns, and both publicly
> supported and unsanctioned needle exchange programs. 
> 
>       As the Commission noted in its recent report, The Twin Epidemics of
> Substance Use and HIV, the unmet need for treatment on demand is critical. 
> In cities hard hit by both drug use and HIV disease the situation is
> extremely serious.  New York City, for example, has an estimated 200,000
> intravenous drug users, approximately half of whom are HIV positive.  Yet New
> York has only 38,000 publicly funded drug treatment slots.  Outreach efforts
> have had the positive side effect of referring individuals to treatment
> programs, but these gains will be lost if there are not enough treatment
> slots available.  
> 
>       Among the most important AIDS prevention efforts are those aimed at
> encouraging injection drug users to adopt safer injection practices, either
> by using bleach or by participating in needle exchange and distribution
> programs.  These programs have frequently been delayed or blocked by
> political and community opposition and by laws that make possession of drug
> injection equipment a criminal offense.  In some localities, criminal justice
> officials have looked the other way as local public health officials and
> activists have mounted needle exchange and distribution programs.  On
> occasion, local prevention activists charged with crimes for distributing
> clean needles have defended their actions in court, claiming that any
> violations of law in distributing clean needles were justified by the need to
> save lives.  This was borne out in the recent decision of a Manhattan judge
> who overturned criminal charges against AIDS activists engaged in
> distributing sterile needles by stating, "The nature of the crisis facing the
> city, coupled with the medical evidence offered, warranted the defendants'
> action."  Courts in Massachussetts and California have also failed to convict
> people conducting needle exchange programs. Fears that needle and syringe
> exchange and distribution programs might encourage drug use and create a new
> class of drug injectors have not materialized.  Where such programs have been
> operating, they have provided a means of encouraging injection drug users to
> join treatment programs.  Needle and syringe distribution programs deserve
> further experimentation, and laws and regulations that block implementation
> and study of such programs should be repealed. 
> 
>       Reducing Perinatal Transmission 
> 
>       HIV prevention strategies and messages for women who wish to consider
> becoming pregnant may have to be quite different than those for women who are
> willing to delay having children.  Issues of disease prevention are often
> conflated with questions of pregnancy and reproductive choice.  A number of
> steps aimed at preventing pregnancies, such as vasectomies, intrauterine
> devices, and oral contraceptives, may have little or no impact on
> interrupting the spread of HIV disease.     In recent years there has been
> much debate about whether HIV antibody testing of pregnant women or newborns
> ought to be mandatory, routine, or merely available.  The backdrop against
> which these debates are taking place is a set of clinical studies that reveal
> that transmission of the virus from HIV-positive mothers to newborn children
> is less than previously thought, approximately 30 percent or less.  HIV
> antibody testing of newborns only definitively establishes whether the
> mothers are HIV positive.  Newborns who test HIV positive may or may not be
> infected.  Some will test positive only because of the presence of maternal
> antibodies that will eventually disappear.  Debates have centered on whether
> testing or screening ought to involve all pregnant women or merely those at
> "high risk" of HIV and the extent to which counseling ought to be directive
> in discouraging HIV-infected women from becoming pregnant or bearing
> children.  HIV antibody screening of pregnant women and newborns raises
> profound moral, legal, and policy issues that are dealt with at considerable
> length in recent reports on the subject by the Institute of Medicine (1991)
> and other policy groups. 
> 
>       All women of childbearing years who are considering pregnancy or are
> pregnant must be apprised of all the options available to them_they must be
> informed of their options but not coerced into any particular decision.  Just
> as much of the advice to date for women about how to prevent the sexual
> transmission of HIV may have been of little relevance to their lives, there
> is a growing realization that  blanket advice for HIV-positive women to avoid
> becoming pregnant may not be appropriate.  As noted in a report by the
> Institute of Medicine, HIV Screening of Pregnant Women and Newborns, ". . .
> limited studies to date offer little evidence to suggest that knowledge of
> HIV infection status significantly affects women's decisions regarding
> continuation of a pregnancy or future childbearing."  For many women, having
> children is a large part of being a woman; thus, fully informed women may
> decide that it is worth running the risk of perinatal transmission to give
> birth.   
> 
>       Research and Evaluation Regarding Prevention Programs During the first
> decade of the HIV epidemic the need for epidemiologic and behavioral research
> was recognized.  The published literature that resulted consists primarily of
> a mosaic of small-scale studies, examples of behavioral interventions
> demonstrated to be effective either in reducing new HIV infections or in
> making substantial modifications to high-risk behaviors in narrowly defined
> populations.  In the earliest phases of the epidemic, a great deal was
> learned about appropriate prevention strategies among those identified to be
> at risk, especially white, self-identified gay men in urban areas. 
> 
>       There remains, however, a lack of knowledge in several areas crucial to
> education and prevention_sexual and other behavior patterns in people of
> varied cultural, racial, and ethnic groups; frequency of different types of
> sexual behavior among adolescents or adults; family or community approaches
> to prevention; technological approaches to prevention, including female-based
> research on virucides and barrier methods of prevention; large-scale studies
> of needle exchange programs in the United States; and innovative approaches
> in prevention, including communitywide approaches.     
> 
>       Greater priority and funding should be given to behavioral, social
> science, and health services research. Social marketing and communications
> research are also necessary to find out whether national mass media
> campaigns, such as CDC's "America Responds to AIDS" campaign are effective,
> among what groups, and for what purposes.  The number of racial and ethnic
> minority health professionals must be increased.  Every effort must be made
> to identify, nurture, and support researchers indigenous to the community. 
> 
>       It is critical that researchers clearly establish what does and does
> not work in prevention.  The cost of not knowing will be measured not only in
> dollars spent and opportunities missed, but also in lives lost.  Future
> prevention efforts are greatly hindered by insufficient evaluation of HIV
> prevention services and programs within CDC and other federal agencies, as
> well as within local communities.  The National Research Council (NRC) has
> proposed an evaluation strategy based on three key questions: 
> 
>       1. What interventions are actually delivered? 
> 
>       2. Do the interventions make a difference? 
> 
>       3. What interventions or variations work better? 
> 
>       As NRC notes,  "The evaluation of AIDS intervention programs is not an
> easy task:  it will take time, and it will also require a long-term
> commitment of effort and resources. . . . The nature of the HIV/AIDS epidemic
> demands an unwavering commitment to prevention programs, and ongoing
> prevention programs require a similar commitment to their evaluation."  NRC
> recommends a full complement of evaluation research, encompassing formative,
> process, and outcome evaluation (NRC, 1991). The Commission agrees that
> evaluation is needed at every step of development and implementation of HIV
> prevention programs.  Participatory evaluation_which includes groups targeted
> by the programs and groups providing the programs, as well as funding
> agencies_is a critical aspect of evaluation that has been frequently
> overlooked.  
> 
>       Communities should not be viewed by academic evaluators as a place for
> experimentation without consultation or collaboration.  There is a need for
> greater collaboration among federal agencies, especially CDC and the Alcohol,
> Drug Abuse, and Mental Health Administration (ADAMHA), related to research
> and evaluation strategies and HIV prevention.  The federal behavioral
> research establishment has an important role to play in "meta analysis"_the
> collation and comparison of various small-scale research studies.  It can
> also provide mechanisms so that those responsible for the development of
> prevention programs can be kept abreast of the latest developments. 
> 
>       But even the best efforts to increase the knowledge base and to improve
> information dissemination strategies will be for naught if the knowledge
> gained is not effectively applied.  Unfortunately, the findings of research
> on HIV education and behavioral interventions are only partially applied
> because of restrictions placed on prevention messages by the U.S. Congress. 
> In the area of prevention, it is also important that the United States
> consider adopting successful prevention models developed in other countries. 
> Examples would include sexual education programs in Scandinavia that have led
> to low rates of sexually transmitted diseases and unintended pregnancies
> (though rates of sexual activity are comparable to the United States) and
> programs of over-the-counter sales of needles and needle exchanges throughout
> Europe and Australia that have reduced needle sharing without leading to
> increased intravenous drug use. 
> 
>       A Comprehensive National HIV Prevention Initiative 
> 
>       The federal government should establish a comprehensive national HIV
> prevention initiative that integrates the approaches of federal, state,
> county, and municipal government; community-based organizations; the private
> sector; and affected populations.  This strategy should ensure both central
> coordination and local autonomy.  At the federal level, a plan should be
> established within the Public Health Service and across other federal
> agencies to coordinate development of effective HIV prevention programs,
> rather than allowing each agency or institute to pursue potentially
> idiosyncratic activities.  Emphasis should be placed on linking health care
> and prevention efforts.  The Commission stresses the urgent need for
> implementation of carefully designed strategies to prevent new HIV infections
> and to prevent disease progression for HIV-infected individuals through early
> diagnosis, prompt treatment, and continuing care and support.  Offering
> advice about changes in behavior and making referrals to education,
> counseling, and prevention services is a critical aspect of delivering HIV
> care.   
> 
>       Although some states and localities have built infrastructures to
> enable them to mount effective primary and secondary prevention programs,
> others have not.  Community-based organizations, often the heart of primary
> prevention efforts, are even less likely to have the strong administrative
> and fiscal structures that would ensure that their programs remain sound. 
> Many community-based organizations have relied upon seed money or
> demonstration grants from governmental or private foundation sources.  The
> fragility of funding streams has made it difficult to plan, implement, and
> evaluate programs, especially for newer groups in minority communities. 
> Rigid requirements hinder attempts to develop and sustain meaningful
> programs.  Delayed reimbursements jeopardize the very existence of
> community-based organizations, which are a critical element of HIV prevention
> activities nationwide. 
> 
>       Communities must find better ways to mobilize, plan, design, and
> implement comprehensive communitywide HIV prevention efforts.  Public health
> departments, community-based organizations, and affected populations must be
> able to work through and resolve conflicts.  CDC, the Health Resources and
> Services Administration, ADAMHA, states, county and municipal governments,
> and community-based organizations need flexibility in funding.  The concept
> of HIV care consortia, as in the Ryan White CARE Act, merits consideration in
> HIV prevention efforts.  The National Institute of Mental Health's model for
> mobilizing communities around issues related to the severely mentally ill may
> be another potential model.  
> 
>       The primary and secondary prevention of HIV disease deserves a place on
> everyone's agenda.  It is within our capacity as individuals, as members of
> various communities, and as a nation to halt the further spread of HIV and to
> extend and enhance the quality of life for those already infected.  We must
> learn to draw upon our diversity in order to bring people together to
> confront the challenges posed by HIV.   
> 
>       Recommendations  
> 
>       1. The federal government should establish a comprehensive national HIV
> prevention initiative.  
> 
>          This initiative should be authorized by Congress and developed by
> the Department of Health and Human Services.  It should provide flexible
> resources to state and local government and other public or private nonprofit
> entities for communitywide HIV prevention efforts.  It must also include
> input from individuals who have expertise through experience, education, or
> training.  The prevention initiative is an essential component of a national
> HIV plan.  
> 
>       2. Greater priority and funding should be given to behavioral, social
> science, and health services research. 
> 
>          Behavioral, social science, and health services research are
> currently grossly underfunded.  The Commission believes there must be a more
> appropriate balance of funding between these areas of study and biomedical
> research.  
> 
>       3. Congress should remove the government restrictions that have been
> imposed on the use of funds for certain kinds of HIV education, services, and
> research. 
> 
>          Government restrictions on certain HIV programs and on behavior-
> oriented research studies impede the fight against HIV disease.  HIV
> prevention programs and research into sexual and drug using behaviors must be
> conducted and evaluated.  Results from these and other health promotion and
> disease prevention efforts must be shared and rapidly incorporated into HIV
> prevention and education strategies.  
> 
>       4. The U.S. Public Health Service should expand and promote
> comprehensive programs for technical assistance and capacity building for
> effective long-term prevention efforts.  
> 
>       5. Federal, state, and local governments should join forces with the
> private sector in providing long-term support to community-based
> organizations. 
> 
>          Community-based efforts are now and will continue to be an integral
> part of any HIV prevention strategy.  The role of people with HIV disease
> must be recognized, encouraged, and supported.  In designing services,
> community-based organizations and their programs must be accountable, yet
> they must be afforded sufficient flexibility to implement programs that will
> best serve communities in need.  
> 
>       6. Policies should be developed now to address future plans for the
> distribution of AIDS vaccines and the ethical and liability issues that will
> arise when vaccines become available.  
> 
>       7. The federal government should expand drug abuse treatment so that
> all who apply for treatment can be accepted into treatment programs.  The
> federal government should also continually work to improve the quality and
> effectiveness of drug abuse treatment.  
> 
>       8. Legal barriers to the purchase and possession of injection equipment
> should be removed. 
> 
>          Legal barriers do not reduce illicit drug injection.  They do,
> however, limit the availability of new, clean injection equipment, thereby
> encouraging the sharing of injection equipment, and the increase in HIV
> transmission.  
> 
>       Selected Bibliography  
> 
>       Amaro, H. 1991.  AIDS/HIV Related Knowledge, Attitudes, Beliefs and
> Behaviors Among Hispanics in the Northeast and Puerto Rico.  Study conducted
> by the Northeast Hispanic AIDS Consortium.  Boston, Mass.:  Boston University
> School of Public Health.  
> 
>       Bandura, A. In press.  A social cognitive approach to the exercise of
> control over AIDS infection.  In R. DiClemente, ed.,  Adolescents and AIDS: 
> A Generation in Jeopardy.  Newbury Park, Calif.:  Sage Publications.  
> 
>       Bayer, R. 1991.  Private Acts, Social Consequences:  AIDS and the
> Politics of Public Health.  New Brunswick, N.J.: Rutgers University Press.  
> 
>       Becker, M.A., and J.G. Joseph.  1988.  AIDS and behavioral change to
> reduce risk:  A review.  American Journal of Public Health 78:394_410.  
> 
>       Brindis, C.D.  1991.  Adolescent Pregnancy Prevention:  A Guidebook for
> Communities.  Palo Alto, Calif.:  Health Promotion Resource Center/Stanford
> Center for Research in Disease Prevention.  
> 
>       Cates, W., and G.S. Bowen.  1989. Education for AIDS prevention:  Not
> our only voluntary weapon.  American Journal of Public Health 79:871_874.  
> 
>       Centers for Disease Control.  1990.  CDC Plan for Preventing Human
> Immunodeficiency Virus (HIV) Infection:  A Blueprint for the 1990s.  Atlanta,
> Ga.:  U.S. Department of Health and Human Services.  
> 
>       Centers for Disease Control.  1990.  HIV-prevalence estimates and AIDS
> case projections: Results.  Morbidity and Mortality Weekly Report 39:27_31. 
> 
>       Centers for Disease Control.  1991.  CDC HIV/AIDS Prevention:  Special
> Report on Evaluation.  Atlanta, Ga.:  U.S. Department of Health and Human
> Services.  
> 
>       Centers for Disease Control.  1991.  Mortality attributable to HIV
> infection/AIDS_United States, 1981_1990.  Morbidity and Mortality Weekly
> Report 40:41_44.  
> 
>       Coalition for AIDS Prevention and Education, National Organizations
> Responding to AIDS.  No date.  AIDS Primary Prevention Recommendations. 
> Washington, D.C.:  National Organizations Responding to AIDS.  
> 
>       Coates, T.J.  1990.  Strategies for modifying sexual behavior for
> primary and secondary prevention of HIV disease.  Journal of Consulting and
> Clinical Psychology 58:57_69.  
> 
>       Coates, T.J., S. Kegeles, R.D. Stall, B. Lo, and S. Morin.  1988.  AIDS
> antibody testing:  Will it stop the AIDS epidemic?  Will it help persons
> infected with HIV?  American Psychologist 43:859_864.  
> 
>       DeJong, W.  1989.  Condom promotion:  The need for a social marketing
> program in America's inner cities.  American Journal of Health Promotion
> 3:5_16.  
> 
>       Francis, D.P., R.E. Anderson, M.E. Gorman, M. Fenstersheib, and N.S.
> Padian.  1989. Targeting AIDS prevention and treatment toward HIV-1-infected
> persons.  Journal of the American Medical Association 262:2572_2576.  
> 
>       General Accounting Office.  1987.  AIDS Prevention:  Views on the
> Administration's Budget Proposals.  Washington, D.C.:  U.S. Government
> Printing Office.  
> 
>       General Accounting Office.  1990.  AIDS Education:  Programs for
> Out-of-School Youth Slowly Evolving.  Washington, D.C.:  U.S. Superindendent
> of Documents.  
> 
>       General Accounting Office.  1990.  Drug Abuse:  Research on Treatment
> May Not Address Current Needs.  Washington, D.C.:  U.S. Government Printing
> Office.  
> 
>       Guydish, J.R., A. Abramowitz, W. Weeds, D. Black, and J. Sorensen. 
> 1990.  Changes in needle sharing behavior among intravenous drug users:  San
> Francisco 1986_88.  American Journal of Public Health 80:995_997.  
> 
>       Institute of Medicine.  1988.  Confronting AIDS:  Update 1988. 
> Washington, D.C.:  National Academy Press.    
> 
>       Institute of Medicine.  1988.  The Future of Public Health. 
> Washington, D.C.:  National Academy Press.  
> 
>       Institute of Medicine.  1991.  HIV Screening of Pregnant Women and
> Newborns.  Washington, D.C.:  National Academy Press.  
> 
>       Kelly, J.A., and J.S. St. Lawrence.  1990.  The impact of
> community-based groups to help persons reduce HIV infection risk behaviors. 
> AIDS Care 2:25_36.  
> 
>       Kelly, J.A., and J.S. St. Lawrence.  1990.  A skills-training group
> intervention model to assist persons in reducing risk behaviors for HIV
> infection.  AIDS Education and Prevention 2:24_35.  
> 
>       Marin, G.  No date.  Culturally Appropriate Interventions in Health
> Promotion:  Why and How.  San Francisco, Calif.:  University of San
> Francisco.  
> 
>       National Organizations Responding to AIDS.  1991.  AIDS Appropriations
> Recommendations.  Fiscal Year 1992. Washington, D.C.:  National Organizations
> Responding to AIDS.  
> 
>       National Research Council.  1987.  Risking the Future:  Adolescent
> Sexuality, Pregnancy, and Childbearing.  Washington, D.C.:  National Academy
> Press.  
> 
>       National Research Council.  1989.  Turner, C.F., H.G. Miller, and L.E.
> Moses, eds.,  AIDS:  Sexual Behavior and Intravenous Drug Use.  Washington,
> D.C.:  National Academy Press.  
> 
>       National Research Council.  1990.  Miller, H.G., C.F. Turner, and L.E.
> Moses, eds.,  AIDS:  The Second Decade.  Washington, D.C.:  National Academy
> Press.  
> 
>       National Research Council.  1991.  Coyle, S.L., R.F. Boruch, and C.F.
> Turner, eds.,  Evaluating AIDS Prevention Programs.  Expanded edition. 
> Washington, D.C.:  National Academy Press.  
> 
>       Nelkin, D., D.P. Willis, and S.V. Parris, eds.  1990.  A Disease of
> Society:  Cultural Responses to AIDS.  New York:  Cambridge University Press. 
> 
> 
>       Office of the Assistant Secretary for Health, Public Health Service,
> U.S. Department of Health and Human Services.  1990. Healthy People 2000: 
> National Health Promotion and Disease Prevention Objectives.  Washington,
> D.C.:  U.S. Department of Health and Human Services.    
> 
>       Office of Disease Prevention and Health Promotion, Public Health
> Service, U.S. Department of Health and Human Services.  1980. Toward a
> Healthy Community.  Washington, D.C.:  U.S. Department of Health and Human
> Services.    
>       Office of the Secretary, U.S. Department of Health and Human Services. 
> 1990.  Comprehensive Report on AIDS Expenditures.  Washington, D.C.:  U.S.
> Department of Health and Human Services.  
> 
>       Office of Technology Assessment, U.S. Congress.  1985.  Review of the
> Public Health Service's Response to AIDS.  Technical Memorandum.  Washington,
> D.C.:  Office of Technology Assessment.  
> 
>       Office of Technology Assessment, U.S. Congress.  1988.  AIDS-related
> Issues:  How Effective is AIDS Education?  Staff Paper 3.  Washington, D.C.: 
> U.S. Superintendent of Documents.  
> 
>       Panem, S.  1988.  The AIDS Bureaucracy.  Cambridge, Mass.:  Harvard
> University Press.  
> 
>       Peterson, J., and G. Marin.  1988.  Issues in the prevention of AIDS
> among Black and Hispanic men.  American Psychologist 43:871_877.  
> 
>       Petrow, S., P. Franks, and T.R. Wolfred, eds.  1990.  Ending the HIV
> Epidemic:  Community Strategies in Disease Prevention and Health Promotion. 
> Santa Cruz, Calif.:  ETR Associates/Network Publications.  
> 
>       Presidential Commission on the Human Immunodeficiency Virus Epidemic. 
> 1988.  Report of the Presidential Commission on the Human Immunodeficiency
> Virus Epidemic.  Washington, D.C.: U.S. Government Printing Office.  
> 
>       Public Health Service, U.S. Department of Health and Human Services. 
> 1987.  Information/Education Plan to Prevent and Control AIDS in the United
> States.  Washington, D.C.:  U.S. Department of Health and Human Services.  
> 
>       Robert Wood Johnson Foundation.  1990.  Proceedings:  AIDS Prevention
> and Services Workshop:  February 15_16, Washington, D.C.  Princeton, N.J.: 
> Robert Wood Johnson Foundation Communications Office.  
> 
>       Solomon, M., and W. DeJong.  1986.  Recent sexually transmitted disease
> prevention efforts and their implications for AIDS health education.  Health
> Education Quarterly 13:301_316.  
> 
>       Solomon, M., and W. DeJong.  1989.  Preventing AIDS and other STDs
> through condom promotion:  A patient education intervention.  American
> Journal of Public Health 79:453_458.  
> 
>       Stall, R.D., T.J. Coates, and C. Hoff.  1988.  Behavioral risk
> reduction for HIV infection among gay and bisexual men:  A comparison of
> published results from the United States.  American Psychologist 43:859_864. 
> 
> 
>       Surgeon General, Centers for Disease Control, Public Health Service,
> U.S. Department of Health and Human Services.  1988.  Understanding AIDS. 
> Washington, D.C.:  U.S. Government Printing Office.  
> 
>       Surgeon General, Public Health Service, U.S. Department of Health and
> Human Services.  No date.  Surgeon General's Report on Acquired Immune
> Deficiency Syndrome.  Washington, D.C.:  U.S. Department of Health and Human
> Services.  
> 
>       U.S. Congress.  House.  101st Congress, 2nd Session. 1990.  Report
> 101-591.  Departments of Labor, Health and Human Services, Education, and
> Related Agencies.  Appropriation Bill, 1991.  July 12.  
> 
>       U.S. Congress.  House.  101st Congress, 2nd Session.  1990. Report
> 101-908.  Making Appropriations for the Departments of Labor, Health and
> Human Services, Education, and Related Agencies for the Fiscal Year Ending
> September 30, 1991, and for Other Purposes.  October 20.  
> 
>       U.S. Congress.  Senate.  101st Congress, 2nd Session.  1990.  Report
> 101-516.  Departments of Labor, Health and Human Services, Education, and
> Related Agencies.  Appropriation Bill, 1991. October 10.   
> 
>       U.S. Government Accounting Office.  1988.  AIDS Education:  Reaching
> Populations at Higher Risk.  Washington, D.C.:  U.S. Government Accounting
> Office.  
> 
>       U.S. Government Accounting Office.  1989.  AIDS Education:  Issues
> Affecting Counseling and Testing Programs.  Washington, D.C.:  U.S.
> Government Accounting Office.  
> 
>       U.S. Government Accounting Office.  1989.  AIDS Education:  Staffing
> and Funding Problems Impair Progress.  Washington, D.C.:  U.S. Government
> Accounting Office.  
> 
>       U.S. Government Accounting Office.  1990.  AIDS Education:  Public
> School Programs Require More Student Information and Teacher Training. 
> Washington, D.C.:  U.S. Government Accounting Office.  
> 
>       Valdiserri, R.O.  1989.  Preventing AIDS:  The Design of Effective
> Programs.  New Brunswick, N.J.:  Rutgers University Press.  
> 
>       Watters, J.K., Y.-T. Cheng, M. Segal, J. Lorvick, and P. Case.  1990. 
> Epidemiology and prevention of HIV in heterosexual IV Drug Users in San
> Francisco, 1986_1989.  Presented at the Sixth International Conference on
> AIDS, San Francisco, Calif., June 20_24.  
> 
>       The White House.  1991.  National Drug Control Consequences:  AIDS and
> the Politics of Public Health.  New Brunswick, N.J.:  Rutgers University
> Press.   
> 
>       Prevention and Education 
> 
>       Side bar pull out information:   
> 
>       It's not good enough to say that we serve everyone.  It's not good
> enough to say that our programs are open  to all.  If we don't specifically
> design our programs in such a  way that they reach out into the community,
> that they become part of the community, and the community becomes part of
> them, they are not as functional as they need to be.  
> 
>       Coupled with our efforts to ensure access, representation, and
> inclusion is the essential work of stopping the progression of the disease
> through education and prevention activity, focusing on risk reduction and
> behavioral change. . . .  
> 
>       In communities of color, as in the majority of communities, much of the
> average behavior is clandestine, behind closed doors and unnamed or named
> differently_i.e., gay versus sex with men_so that a singular outreach
> strategy will only reach the most physically and obviously adverse
> population.  
> 
>       In our communities it is just as likely that we will reach at-risk
> people at church functions, at the barber  and beauty shop, at the WICs
> program, in jail or work release, and topless clubs, in minor camps, in the
> social clubs, at the food bank, at the pow wow, or other community events, at
> the kind of local community gathering where people are together and where
> information flows.   
> 
>       P. Catlin Fullwood 
>       July 1990  
> 
>       The present situation in Puerto Rico shows the island as having such a
> high incidence of HIV that there exists a sense of panic about being
> infected. . . .   Ignorance is evident at all levels of living_among
> employers, in public transportation, as well as funeral parlors overcharging
> for burials because they claim to be at risk of infection.  
> 
>       I feel it is urgent to bring more forceful education throughout the
> island to attempt to change the attitudes of panic and rejection suffered by
> so many patients, to become instead an environment of faith, hope and
> concern.  
> 
>       Luis Maldonado 
>       November 1990  
> 
>       When you go and talk to community people about becoming part of an AIDS
> project, they will say, "who is in charge?"  And then they will, as we say in
> our community, do a reading of that person.  
> 
>       Alyce Gullattee, M.D., F.A.P.A. 
>       December 1990     
> 
>       It's hard to educate a woman who is homeless and hungry.  
> 
>       Sandra Vining-Bethea 
>       January 1991   
> 
>       "-No mueras por ignorancia!" (Do not die because of ignorance!); "La
> Familia Hispana Contra el SIDA" (The Hispanic Family Against AIDS); "Informe
> SIDA" (AIDS Bulletin); HACER (The Hispanic AIDS Committee for Education and
> Resources); Proyecto "Vecino a Vecino" (Neighbor to Neighbor Project);
> "Iluminate.  (Como vas a manejar?  (Vivo o muerto? (Know Yourself.  How will
> you manage?  Dead or Alive?); "Las Almas de Dios" (the Souls of God); "Noche
> de Ronda" (Night of Serenades); "La Cl2nica Esperanza" (Clinic of Hope);
> CURAS, Comunidad Unida en Respuesta al SIDA (Community United in Response to
> AIDS).  
> 
>       These and many more are the collective response of the Latino/ Hispanic
> community's fight against AIDS in this country: from Miami to New York City
> and north, Cleveland, Ohio, to Salt Lake City, Utah, and south, to Texas and
> on to California and Washington State.   
> 
>       Adolfo Mata 
>       March 1991    
> 
>       What honor can there be in being a hero in a losing battle?  History
> teaches us that those who exhibit valor on behalf of the conquered become
> forgotten.  There's an increasingly large body of evidence that suggests that
> those of us who are ourselves infected with the HIV virus are already
> forgotten, especially if we are black and gay or bisexual.   
> 
>       Phill Wilson 
>       January 1990   
> 
>       Thirty-three percent of all women with AIDS as opposed to 2 percent of 
> all men with AIDS report exposure through heterosexual contact.   
> 
>       I am twenty-one years old.  I have hemophilia and am HIV positive.  I
> found out my HIV status when I was fourteen_when they thought it could mean
> I was immune.  It didn't really matter what they thought then anyway.  Death
> means absolutely nothing to a fourteen-year-old.  I thought  I was immortal
> until just about a year ago when my girlfriend at the time and I were  going
> to find out the results of her first AIDS test.  Meanwhile, most of my
> friends still think they are immortal.  This is one of the basic tricky
> aspects of AIDS for the adolescent and the young adult.  It is extremely hard
> to have a mid-life crisis and acknowledge the fact that you are going to die
> when life has just begun.  The other is the fact that this acknowledgement of
> death comes through something that is the reaffirmation of life and love_sex. 
> 
> 
>       T. H. 
>       April 1991    
> 
>       The hopelessness that is connected with adult life for young minority
> people is a future of which they are aware.  If we don't change the fact that
> they have no hopeful future, I'm not sure we can take the pressure off the
> wish to find whatever joyous escape exists in the present.  
> 
>       Mindy Fullilove, M.D. 
>       March 1991     
> 
>       We have over twenty identified Asian/Pacific communities here in
> southern California.  We speak different languages.  We come from very
> different cultures, ethnic backgrounds.  Language is a barrier for us, not
> just English.  Along with language, we have cultural barriers_gan-barr, the
> barrier of denial, bringing shame to the family.  Homophobia and/or
> homoignorance.  These are all issues and barriers that exist within our
> community.   
> 
>       Dean Goishi 
>       January 1990   
> 
>       What do we do now?  We do what many cities have been doing for several
> years now.  We take it to the street.  We take treatment to the user.  We
> take intervention to the user.  We take education to the user.  We take
> prevention to the children and families.  Prevention is all of the above.  We
> take hope to people who have no hope.  We become advocates.  We become
> transportation.  We bring food and clothing to those who have no food and
> clothing.  We let the user, the addict, and the persons living with HIV and
> AIDS know that we truly care.  We open doors for them that previously were
> shut_treatment doors, emergency care doors, medical care doors, and whatever 
> doors remain locked.  
> 
>       Edmund Baca 
>       January 1991   
> 
>       New York City, has an estimated 200,000 intravenous drug users,
> approximately half of whom are HIV positive.                   
> 
>       Yet New York has only 38,000 publicly funded drug treatment slots.  
> 
>       The medium is the message.  You can't have safe sex at Cabrini Green
> Projects.  It's not a safe place.  
> 
>       Michael James 
>       March 1991    
> 
>       Chapter 3  
> 
>       Caring for People with HIV Disease    
> 
>       Ideally, care for people with HIV disease includes a broad range of
> health care and social services designed to enhance the quality of life,
> maximize individual choice, and minimize hospital and institution-based care. 
> Such services should be rendered with compassion in a manner that allows
> people with HIV disease and their loved ones to act as partners with their
> caregivers.  This chapter recommends ways of moving toward this goal. 
> 
>       HIV disease, especially in its later stages, presents complex
> challenges for caregivers.  The host of opportunistic infections that
> characterize AIDS may attack virtually any part of the body.  HIV disease
> stubbornly refuses to be limited to any single organ or treatment strategy,
> since its fundamental mechanism is the pervasive malfunction of the immune
> system.  As long as ten years may pass between infection with the virus and
> development of full-blown AIDS.  Given the great variability in the natural
> history of HIV, care needs vary greatly over the course of the disease. 
> 
>       Care needs also vary among different populations.  HIV disease in women
> is manifested quite differently than in men; HIV disease in children is
> manifested quite differently than in adults.  Intravenous drug users often
> suffer from extensive concomitant health problems that are exacerbated by HIV
> disease.  Neurological complications of HIV disease may pose unique
> challenges.  Individuals with HIV disease also have unique social and
> psychological needs as a result of the dire nature of the illness and the
> stigma that accompanies diagnosis. 
> 
>       The epidemic is widening most rapidly among poor people in inner
> cities_a group that historically has had difficulty in gaining access to and
> finding payment for primary care services.  The epidemic also primarily
> strikes young adults, whereas systems of care for the chronically ill or
> disabled tend to be tailored to the needs of the elderly.  The sheer volume
> of people who have HIV disease or are at risk of HIV infection in certain
> hard-hit cities complicates care strategies still further.  There are many in
> the early phases of infection who could benefit from treatments designed to
> retard the onset of symptoms, as well as benefit from social and mental
> health services.  Unfortunately, many of these people have no point of entry
> into the health care system.  Millions of Americans have no health coverage,
> and even those people living with HIV disease who have some form of public or
> private insurance may still face formidable barriers in gaining access to
> needed care. 
> 
>       Developing a Continuum of Care 
> 
>       There is a range of services needed by people living with HIV disease
> and increasing agreement about where and how to provide such services.
> Ideally what is needed is a continuum of care ranging from minor help for
> people living at home to congregate living facilities with support services
> to skilled nursing care for more dependent persons in nursing homes.  There
> is no single model of care that is appropriate for all communities. 
> Nevertheless, in its travels around the country, the Commission discovered a
> number of elements indispensable for delivering continuous and comprehensive
> services for people with HIV disease.  These include: 
> 
>          y  HIV antibody testing that is voluntary and must be accompanied by
>             counseling_both anonymous and confidential testing contribute in
>             different ways and both options should be available; 
> 
>          y  education and counseling to help foster and maintain behavioral
>             changes to reduce transmission of the virus; 
> 
>          y  medical care, including drug therapy and frequent diagnostic
>             monitoring, ongoing primary care, coordination of inpatient and 
>              outpatient care, access to investigational new therapies, and
>             adequate options for long-term care; 
> 
>          y  psychological care, including mental health counseling and
>             spiritual support, that is helpful in coping with a frightening
>             and sometimes overwhelming condition; 
> 
>          y  drug treatment to help individuals stop using or injecting drugs
>             or adopt safer drug use practices; and 
> 
>          y  social services, including a range of housing options and income
>             maintenance, without which medical advances may be beyond   the
>             grasp of those who could most benefit from them. The medical
>             services needed by people living with HIV disease require a
>             multidisciplinary care approach in which a team of health care
>             providers_ including primary care physicians and consultants in
>             fields such as infectious diseases, oncology, pulmonary diseases,
>             psychopharmacology, and neurology_works together with patients,
>             their loved ones, and families to develop a plan for care.   
> 
>       A basic goal in developing plans of care for people with HIV disease,
> as with other illnesses, is to provide dignified and appropriate care in the
> least restrictive and least institutional setting possible at the lowest
> possible cost.  Cooperation among caregivers is essential in ensuring that a
> true continuum of care is available, from the time an individual first
> becomes aware he or she is at risk or learns of HIV seropositivity all the
> way through the care and support needed in the terminal phases of illness.
> Primary care practitioners and medical specialists can provide only some of
> the services needed by people living with HIV disease.  Nurses,
> psychologists, home health care workers, nutritionists, and other health care
> and mental health care workers are equally essential in ensuring the
> availability of a continuum of care.  Also crucial are social workers, case
> managers, patient advocates, and others who help people living with HIV
> disease find jobs, food, and housing_services that must be available if
> medical care is to be effective.  In some instances, especially where
> discrimination based on HIV status is involved, people with HIV disease will
> need legal advice to gain access to basic health and social services and to
> ensure that their wishes are carried out regarding decisions about terminal
> care.  It is also critical that the patient/provider relationship be based
> upon mutual respect and cooperation.  The patient must feel comfortable that
> providers are approachable about the full range of care and treatment
> options.  For example, more and more individuals are seeking advice about or
> are using nontraditional and alternative therapies, usually in conjunction
> with conventional medical treatments.  It is important to establish a
> relationship in which both the patient and provider are comfortable asking
> questions. 
> 
>       Throughout its tenure the Commission has heard testimony on local
> efforts to better coordinate care under the rubric of "case management."  The
> goal of case management is to guide patients efficiently and humanely through
> the health and social services labyrinths.  Case managers serve
> simultaneously as gatekeepers, advocates, educators, diagnosticians, brokers,
> and caregivers.  They are responsible for far more than coordinating medical
> care services; they often help find housing, help connect people with
> specific entitlement programs and other sources of income support and payment
> for health care, and link people with HIV disease with programs of volunteer
> support. 
> 
>       A variety of case management styles has emerged to meet the needs of
> people with HIV disease.  Depending upon the model involved, a case manager
> may be a nurse, a social worker, or a primary care physician.  In some
> instances, case management is funded by government, is hospital based, and is
> linked primarily to discharge planning.  Other case management programs are
> more community based and follow individuals both in and out of the hospital. 
> In some states case management is provided by Medicaid programs, this is
> especially so in those states with home and community-based waiver programs. 
> Yet other programs have emanated from prepaid, managed care programs in
> health maintenance organizations.  The success of a case management program
> is to a certain extent contingent upon the availability of a spectrum of
> necessary services. 
> 
>       The Commission believes that case management programs should be
> supported and further refined to meet the particular needs of people with HIV
> disease.  Case management offers not only the potential for saving costs,
> limiting hospital stays, and bringing coherence to service delivery, but also
> may enhance satisfaction and quality of life for those with HIV disease.  
> 
>       Assuring Availability of Health Care Providers 
> 
>       As the number of people with HIV disease grows, the availability of
> health care practitioners is an increasing concern.  The complexity of care
> for HIV disease (especially in its later stages) is such that no single
> medical specialty or discipline encompasses all the necessary skills.
> Infectious disease and oncology specialists were initially  cast in the role
> of primary caregivers in the HIV epidemic.  However, as the epidemic has
> progressed, internists, family medicine practitioners, obstetrician/
> gynecologists, and pediatricians have had to incorporate the care of HIV
> disease into their general practice.  The Commission believes that primary
> care providers should be able to counsel about HIV transmission risks;
> diagnose and treat early HIV disease;  monitor patient care; and recognize
> complications later in the disease process that require consultations from
> specialists or referrals.     
> 
>       Despite the great need for services for people with HIV disease, health
> care providers have often been reluctant to care for them.  The reasons
> include low reimbursement rates for people whose care is paid for by
> Medicaid; a lack of familiarity with and understanding of treatment for the
> disease;  fear of becoming infected during the course of treating patients; 
> discomfort in treating gay men or intravenous drug users; and unease in
> dealing with the psychological stresses of caring for dying young patients
> with multiple physical and psychological needs. 
> 
>       The Commission believes health care practitioners have an ethical
> responsibility to provide care to those with HIV disease.  Lack of
> specialized knowledge, concerns about the risk of HIV transmission, increased
> stress, or disaffection with those who are at risk are not reasons to avoid
> caring for individuals with HIV disease, although these concerns are real,
> pervasive, and must be dealt with directly.  The following section looks at
> ways to address these concerns in order to attract, train, and support
> sufficient numbers of health care providers to meet the challenge of HIV
> disease.  
> 
>       Educating Caregivers 
> 
>       HIV education and training programs for health care providers must be
> improved and expanded, and better methods developed to disseminate
> state-of-the-art clinical information to the full range of health care
> providers, including physicians, nurses, physicians' assistants, social
> workers, psychologists, and other health and mental health care providers. 
> The AIDS Education and Training Centers, federally funded by the Health
> Resources and Services Administration, have the potential for training
> thousands of care providers. Education and training programs will require the
> combined support of government agencies and professional associations. 
> Primary care providers must be trained in HIV care, and specialty backup of
> technical advice and consultation must be provided.  A few states have made
> continuing medical education in HIV care a condition of relicensure.  Some
> medical professional associations have developed extensive training programs. 
> But they should not be expected to carry the full load.  
> 
>       A greater sense of urgency is necessary in the development and
> dissemination of professional standards of care for HIV disease. The Agency
> for Health Care Policy and Research has just begun to develop standards of
> clinical care for asymptomatic HIV infection.  Professional associations of
> health care workers, with mechanisms in place for reaching their memberships,
> have a key role to play in standard setting. Fellowship programs and career
> development awards for individuals devoted to the care of people with HIV
> disease are ways of rewarding professionals and helping to establish role
> models for subsequent trainees. Career development and career advancement for
> individuals who choose to make AIDS care and education a significant part of
> their professional life should be available. 
> 
>       The adoption of "universal precautions"_avoidance of exposure to blood
> and body fluids regardless of whether or not patients or health care workers
> are believed to be infected_provides the best means of minimizing risks from
> HIV for both patients and caregivers in the health care setting.  Health care
> workers should be encouraged to  adhere vigorously to guidelines for
> infection control.  Concerted efforts must be made to work with health
> professionals at the earliest stages of training on attitudinal issues and
> ways to best manage occupational risks.  Medical schools, dental schools,
> nursing schools, and schools of allied health should incorporate into their
> required curricula training on proper ways to avoid risks from blood-borne
> pathogens.  Such programs must be continued during postgraduate training when
> young professionals form lifelong habits of practice. 
> 
>       The growing chorus of demands for mandatory, widespread HIV antibody
> testing of health care workers (HCWs) and patients threatens to drive a wedge
> between patients and their caregivers.  It also misses the point.  As the
> Centers for Disease Control (CDC) has stated, 
> 
>                  Mandatory testing of HCWs for HIV antibody, HBsAg, or HBeAg
> is not recommended. The current assessment of the risk that infected HCWs
> will transmit HIV or HBV to patients during exposure-prone procedures does
> not support the diversion of resources that would be required to implement
> mandatory testing programs. Compliance by HCWs with recommendations can be
> increased through education, training, and appropriate confidentiality
> safeguards.   
> 
>       Mass screening programs would interfere with the doctor-patient
> relationship, would encourage a false sense of security because of the time
> between when infection develops and the time when it can be measured by
> clinical tests, and would imply a significant risk of infection transmission
> in health care settings when such risk is actually very small, particularly,
> as CDC has stated, "when HCWs adhere to recommended infection control
> procedures."   
> 
>       Where Care is Provided 
> 
>       In most cities the care of HIV disease is concentrated in a few
> hospitals, often in public facilities or teaching hospitals.  Many of these
> hospitals have centralized AIDS care or established AIDS-dedicated units. 
> Hospitals and oupatient care should be linked to community-based services to
> ensure the continuum of services identified above.  HIV-related services must
> be expanded to include facilities where underserved populations already
> receive health care and human services, such as community health centers,
> migrant health centers, Indian Health Service programs, and the like. In
> addition, counseling, testing, and care related to HIV disease must be made
> available in settings where providers speak the language of the communities
> they serve. 
> 
>       Ongoing research is needed to determine what works best where and how
> to deliver care to people living with HIV disease.  Lessons can be learned
> from the organization of care for diseases other than HIV.  For example, in
> the context of hemophilia treatment, a system of regional comprehensive
> treatment centers provides both increased quality and cost-effectiveness by
> combining sufficient numbers of patients so that economies of scale can
> justify the single-center multidisciplinary team approach.  The AIDS program
> of the Department of Veterans Affairs, administered by its Veterans Health
> Administration, has become the largest single source of direct health care
> services available for treating AIDS patients in the United States. 
> Implementing findings from health services research can help ensure that
> decisions about where to deliver care are based on individual needs and not
> administrative convenience or the exigencies of particular reimbursement
> strategies. Health services research can also help identify the variables
> that would contribute to a community's decision to centralize care in one
> unit or hospital. While centralized AIDS care or AIDS-dedicated units may be
> appropriate for some communities, they may not be practical for others. 
> Evaluating the different approaches as to where and how care can be provided
> would be very helpful to those communities  beginning to organize HIV-related
> care services.  
> 
>       Alternatives to Hospitalization 
> 
>       Many people with HIV disease would in certain stages of their illness
> fare better in a less intensive and less expensive setting, but they languish
> in hospitals because of a lack of access to rental housing, congregate living
> facilities, nursing homes, and hospices. 
> 
>       Many nursing homes have been reluctant to admit people with HIV
> disease, citing the fears of other clients, inexperience with managing
> infectious diseases, and lack of adequate reimbursement.  People with HIV
> disease are typically much younger than most nursing home clients.  Moreover,
> nursing homes may not always meet the needs of people with HIV disease who
> alternate between periods of illness and relative well-being.  The Commission
> believes that nursing homes must overcome their reluctance to accept people
> with HIV disease.  At the same time, other options for long-term skilled care
> should be developed and encouraged. There may also be a poor fit between HIV
> care needs and traditional hospice services.  Hospice clients have
> traditionally been cancer patients whose prognosis and decline could be
> predicted with relative certainty.  HIV disease is much more unpredictable. 
> People with HIV disease in hospices sometimes wish to seek readmission to a
> hospital or to undergo therapies (such as ventilator assistance) that would
> otherwise be unavailable in a traditional hospice setting, where the focus is
> exclusively on palliative care.  In a number of cities, hospices have been
> created exclusively for people with AIDS.  Both options should be available.
> People with HIV disease are at the forefront of a trend toward minimizing
> unnecessary hospitalization by moving treatment to less intensive and more
> familiar settings. Many procedures formerly requiring hospitalizations, such
> as lumbar puncture, chemotherapy, and transfusions, are increasingly
> performed in outpatient settings in the context of HIV care. The ability to
> receive care outside of the hospital can enhance quality of life, foster
> autonomy, improve outlook and attitudes, and allow people with HIV disease to
> spend more time with, and sometimes be cared for by, their loved ones.   
> 
>       The desire of people living with HIV disease to remain at home and be
> cared for at home has coincided with fiscal pressures to reduce health care
> costs and shorten the length of hospital stays, fostering the growth of the
> home health care industry.  Scores of companies now offer intravenous,
> intramuscular, and aerosolized home therapy.  AIDS care constitutes a
> significant portion of this rapidly growing sector of the health care system. 
> Rules and regulations for third-party payment must be adjusted to meet new
> realities and opportunities for home health care.  As home health care
> efforts grow, increasing attention will be necessary to the quality and cost
> of such care.   
> 
>       Linking HIV Prevention with Primary Care 
> 
>       Behavioral change will continue to be the greatest hope for altering
> the course of the epidemic.  Prevention and education programs will continue
> to be of paramount importance in encouraging such change.  Of particular
> interest in the health care context are programs of HIV antibody testing and
> counseling.  There is a longstanding consensus that HIV antibody testing
> alone will not suffice in creating and sustaining behavioral change. 
> Nevertheless, when testing is accompanied by supportive pre- and post-test
> counseling, knowledge of HIV antibody status can help some individuals make
> the changes necessary to prevent the further spread of HIV.  Beyond its
> function as an adjunct to behavioral change, HIV antibody testing now has a
> role to play in the context of early intervention.  Discovery that one is HIV
> positive early in the course of HIV disease can provide hope of a longer life
> of better quality when diagnosis, monitoring, and treatment begin early in
> the course of HIV disease.  Individuals at risk of HIV infection need ready
> access to voluntary testing and counseling services in order to find out
> their HIV status.  For many impoverished individuals, gaining entry into a
> health care and social services system by means of a passport stamped "HIV
> antibody positive" is a cruel hoax.  Many still experience long delays
> between the time they test positive and the time they have their first
> medical evaluation.  Too many people with HIV disease first enter the health
> care system via the hospital emergency room with an episode of Pneumocystis
> carinii pneumonia, a largely preventable illness;  too many women first find
> out they are HIV positive after giving birth to an infected child.
> Increasingly, public health providers are being asked to provide primary
> health care, including the monitoring of health status in the initial stages
> of HIV disease.  HIV antibody testing has expanded from the alternative test
> sites created in the mid-1980s to a variety of settings, such as:  methadone
> maintenance clinics; sexually transmitted disease clinics; hospital
> outpatient programs; tuberculosis clinics; family planning centers; and
> private physicians' offices.  HIV antibody testing that is voluntary and
> accompanied by counseling continues to be essential.  Both anonymous and
> confidential testing contribute in different ways and both options should be
> available.   
> 
>       It is unrealistic to attempt to rely solely on physicians to provide
> HIV-related behavioral counseling.  Although physicians need more training
> and experience in taking sexual histories and in dealing with sensitive
> topics related to drug use or sexual behavior, there also must be greater
> emphasis on recruiting and training other health and social service
> professionals to provide the psychological and social support that is
> necessary to cope with a diagnosis of HIV disease and to make necessary
> behavioral changes.  Although many new HIV testing programs have been put
> into place, the training of counselors has lagged behind.  The Commission
> believes that HIV education as well as testing services with trained
> counselors should be available where individuals are likely to seek services. 
> Programs for HIV antibody testing and counseling should be evaluated in part
> on their record of facilitating referrals and providing ongoing health care
> interventions.     
> 
>       Expanding Access to Investigational Therapies 
> 
>       Investigational new therapies are a critical aspect of HIV care.  A
> later chapter discusses policy and regulatory questions related to the
> development of drugs to treat HIV disease, beginning with the proposition
> that investigational therapies are in many instances the only hope for people
> with HIV disease.  Hence, it is wrong not to offer drugs under study to
> women, people of color, substance users, prisoners, adolescents, and
> children_all of whom have experienced difficulty in gaining such access.
> Frequently individuals enroll in clinical trials because it is their only
> means of access to primary care.  Primary care providers are increasingly
> being called upon to help people with HIV disease choose among potential
> investigational therapies and monitor the administration of such drugs.   
> 
>       Information about drugs under study and eligibility requirements for
> clinical trials must be made widely available for care providers and patients
> alike.  News about the latest results of clinical trials also must be rapidly
> communicated to health care providers who may not be directly involved in
> conducting clinical research studies.  In some cases, it may be appropriate
> for federal agencies to conduct widely targeted mailings concerning
> breakthroughs in HIV care to supplement information available in medical
> journals and through professional associations.  Access to a growing number
> of therapies is also currently available through the parallel track or
> expanded access programs administered by pharmaceutical companies.  This can
> make medications available to a great many individuals for whom there are no
> alternatives.  However, the process of gathering data to monitor patients'
> reactions to drugs under study is extremely time-consuming and may differ
> from drug to drug (even though individual patients may need a number of such
> drugs over the course of their illness).  The time and paperwork involved is
> daunting for individual care providers who lack the resources of clinical
> investigators.  Some of these problems could be obviated by the development
> of uniform guidelines for data collection for drugs dispensed in expanded
> access programs, including data for individuals simultaneously taking
> multiple investigational drugs.  Ways must be found to assist health care
> providers in the administration of such efforts.   
> 
>       Integrating Treatment _for Drug Use _with Primary Care 
> 
>       The percentage of AIDS cases related to injection drug use has
> increased sharply, from 18 percent before 1985 to nearly 33 percent in
> 1990_1991.  There are an estimated 500,000 to 1.5 million injection drug
> users in the United States, and only 15 to 20 percent are estimated to be
> receiving treatment for their drug dependency.  Drugs other than injected
> ones, particularly alcohol and crack cocaine, are also strongly implicated in
> increased risk of HIV infection because of the role they play in impairing
> judgment about sexual risk taking. 
> 
>       Health care workers in primary care roles must be able to recognize
> substance use problems and provide care in a compassionate and
> nondiscriminatory manner.  Substance users have often been "unwelcome guests"
> in the health care system and may have problems attaining care.  Providers
> fear that they may leave the hospital against medical advice and may seek or
> use drugs while hospitalized.  Intravenous drug users often have no private
> insurance or even public medical assistance.  In addition, medical problems
> related to their substance use may be difficult to treat, e.g., collapsed
> veins, cirrhosis, or other liver diseases.  The failure to obtain
> compassionate and needed care may in turn foster negative attitudes among
> substance users about the health care system, which in turn may result in a
> reluctance on the part of substance users to seek care in the future.   
> Attention to how to care for drug users and deal with substance use issues
> has been a major gap in both medical and nursing education.  Physicians
> should be able to take a drug use history and to understand the care needs of
> substance users.  Primary care providers do not necessarily have to become
> chemical dependency treatment experts, but they should be familiar with
> treatment options and know how to make appropriate diagnoses and referrals. 
> Most drug treatment, including methadone maintenance, detoxification,
> twelve-step programs, and therapeutic communities, takes place outside of
> traditional health care settings.  The AIDS epidemic underscores the
> importance of integrating such services with primary care.  Such integration
> should be a top priority.   
> 
>       Supporting the Contributions of Volunteers, Friends, _and Family One of
> the most remarkable features of the HIV epidemic has been the extent to which
> services needed by people living with HIV disease have been provided by
> volunteers.  Many people with HIV disease need assistance in activities of
> daily living_help with cooking, cleaning, and other household chores and with
> transportation to appointments.  At times the assistance involves helping
> with the administration of medications or providing medical services that can
> be accomplished by lay people with minimal training.  These services are
> either provided informally or through community-based organizations that
> utilize volunteer services.  Much unpaid work on behalf of people living with
> AIDS is not thought of as "volunteering," because it happens in the context
> of kinship relationships.   
> 
>       Volunteer labor is not equally available in all regions of the country
> or to all people.  As the epidemic continues, the supply of volunteers may
> prove inadequate.  It may prove more difficult to enlist volunteers on behalf
> of people who use drugs or to find people who can afford to  volunteer in
> communities ravaged by poverty.  The gay community is losing many volunteers
> to burnout and to sickness and death, and others are choosing to funnel their
> energies into spurring governmental action to provide needed services.  
> 
>       Community-based organizations are struggling to keep pace with
> increased caseloads.  Many such groups are finding that the skills and
> energies necessary to get them off the ground are different from those needed
> to sustain them.  Many community-based organizations are struggling to
> diversify and solidify sources of funding, as they run out of funds from
> sources of seed money and demonstration grants. Federal, state, and local
> entities must provide support for training, technical assistance, supervisory
> staff, and program coordination to acknowledge and support the
> community-based organizations, family members, friends, and volunteers who
> are an integral part of the HIV care system.  Applications for funding are
> frequently too complex and bureaucratic requirements too burdensome to allow
> programs to flourish in communities of greatest need.  Community-based
> organizations must be given greater lattitude to experiment with programs to
> address the needs of particular communities.   
> 
>       Small investments of funds in supporting and training volunteers will
> yield enormous returns of invaluable services.   Funders should support newer
> programs while resisting the temptation to pay for such support by trimming
> viable existing programs.  Community-based organizations formed in
> communities of color and in cities where there are large numbers of
> intravenous drug users with HIV disease have special needs.  Inadequate and
> unstable funding sources contribute to unnecessary competition among local
> groups, when coalition building is essential.          
> 
>       In the second decade of the AIDS epidemic, care will have to be
> provided to many thousands of people.  It will have to include social and
> mental health services alongside medical care.  It will require trained
> providers at locations across the country where people come for care.  And it
> will require the commitment of the nation to make care accessible and
> affordable.   
> 
>       Recommendations  
> 
>       1. Government should assure access to a system of health care for all
> people with HIV disease. 
> 
>          At a minimum, a system of care for all people with HIV disease
> should include a package of continuous and comprehensive medical and social
> services designed to enhance quality of life and minimize hospital-based
> care.  States, counties, and municipalities should assure that such services
> are available for individuals with HIV disease.  Case management programs
> should be available to coordinate such care.  These services must include: 
> 
>          y  HIV antibody testing that is voluntary and must be accompanied by
>             counseling_both anonymous and confidential testing   contribute
>             in different ways and both options should be available; 
> 
>          y  education and counseling to help foster and maintain behavioral
>             changes to reduce transmission of the virus; 
> 
>          y  medical care, including drug therapy and frequent diagnostic
>             monitoring, ongoing primary care, coordination of inpatient and 
>             outpatient care, access to investigational new therapies, and
>             adequate options for long-term care; 
> 
>          y  psychological care, including mental health counseling and
>             spiritual support, that is helpful in coping with a frightening
>             and sometimes overwhelming condition; 
> 
>          y  drug treatment to help individuals stop using or injecting drugs
>             or adopt safer drug use practices; and 
> 
>          y  social services, including a range of housing options and income
>             maintenance, without which medical advances may be beyond the
>             grasp of those who could most benefit from them.  
> 
>       2.  HIV-related services should be expanded to facilities where
> underserved populations receive health care and human services, in part to
> ensure their increased participation in trials of investigational new
> therapies.  
> 
>       3.  HIV education and training programs for health care providers
> should be improved and expanded, and better methods should be developed to
> disseminate state-of-the-art clinical information about HIV disease, as well
> as drug and alcohol use, to the full range of health care providers. 
> 
>           The Commission believes all health care providers have an ethical
> responsibility to care for people with HIV disease.  In order to equip
> providers to better counsel and care for people with HIV disease, government
> at all levels and local agencies and institutions must develop more effective
> education programs and methods for getting the information to all providers,
> particularly primary care providers. 
> 
>           Programs to train health care providers to recognize and manage
> drug and alcohol use must be expanded, and programs that integrate treatment
> of drug use with primary care must be created and supported.  The Commission
> believes more federal funds are needed for these efforts.  
> 
>       4.  Federal, state, and local entities should provide support for
> training, technical assistance, supervisory staff, and program coordination
> to acknowledge and support the family members, friends, and volunteers who
> are an integral part of the care system of a person with HIV disease._  
> 
>       Selected Bibliography  
> 
>       American Medical Association, Council on Ethical and Judicial Affairs. 
> 1987.  Ethical issues involved in the growing AIDS crisis.  Journal of the
> American Medical Association 259:1360_1361.  
> 
>       Andrulis, D.P.  1989.  Crisis at the Front Line: The Effects of AIDS on
> Public Hospitals.  New York:  Twentieth Century Fund.  
> 
>       Arno, P.S.  1986.  The non-profit sector's response to the AIDS
> epidemic:  Community-based services in San Francisco.  American Journal of
> Public Health 76:1325_1330.  
> 
>       Arno, P.S., D. Shenson, N.F. Siegel, P. Franks, and P.R. Lee. 1989. 
> Economic and policy implications of early intervention in HIV disease. 
> Journal of the American Medical Association 262:1493_1498.  
> 
>       Arnow, P.M., L.A. Pottenger, C.B. Stocking, M. Siegler, and H.W.
> DeLeeuw.  1989.  Orthopedic surgeons' attitudes and practices concerning
> treatment of patients with HIV infection.  Public Health Reports 104:121_129.
> 
>       Arras, J.D.  1988.  The fragile web of responsibility:  AIDS and the
> duty to treat.  Hastings Center Report 18(2):10_20.  
> 
>       Association of American Medical Colleges, Committee on AIDS and the
> Academic Medical Center.  1989.  The HIV Epidemic and Medical Education.  New
> York:  American Association of Medical Colleges.  
> 
>       Barnes, M., N.A. Rango, G.R. Burke, and L. Chiarello.  1991.  The
> HIV-infected health care professional:  Employment policies and public
> health.  Law, Medicine & Health Care 18:311_330.  
> 
>       Bartlett, J.G.  1988.  Who will take care of patients with AIDS?
> Washington Post.  Health supplement.  April 5:10_11.  
> 
>       Becker, C.E., J.E. Cone, and J. Gerberding.  1989.  Occupational
> infection with human immunodeficiency virus.  Annals of Internal Medicine
> 110:653_656.  
> 
>       Benjamin, A.E.  1988.  Long-term care and AIDS:  Perspectives from
> experience with the elderly.  Milbank Quarterly 66:415_443.  
> 
>       Bennett, C.L., J.B. Garfinkle, S. Greenfield, D. Draper, and W. Rogers. 
> 1989.  The relation between hospital experience and in-hospital mortality for
> patients with AIDS-related PCP.  Journal of the American Medical Association
> 261:2975_2979.  
> 
>       Bosk, C.L., and J.E. Frader.  1990.  AIDS and its impact on medical
> work:  The culture and politics of the shop floor.  Milbank Quarterly
> 68(Suppl. 2):257_279.  
> 
>       Brennan, T.A.  1987.  The acquired immunodeficiency syndrome (AIDS) as
> an occupational disease.  Annals of Internal Medicine 107:581_583.  
> 
>       Centers for Disease Control.  1991.  Recommendations for preventing
> transmission of human immunodeficiency virus and hepatitis B virus to
> patients during exposure-prone invasive procedures.  Morbidity and Mortality
> Weekly Report 40.  
> 
>       Cooke, M., and M.A. Sande.  1989.  The HIV epidemic and training in
> internal medicine:  Challenges and recommendations.  New England Journal of
> Medicine 321:1334_1338.  
> 
>       Cotton, D.J.  1988.  The impact of AIDS on the medical care system. 
> Journal of the American Medical Association 260:519_523.  
>       Cotton, D.J.  1989.  Improving survival in acquired immunodeficiency
> syndrome:  Is experience everything?  Journal of the American Medical
> Association 261:3016_3017.  
> 
>       Currey, C.J., M. Johnson, and B. Ogden.  1990.  Willingness of
> health-professions students to treat patients with AIDS.  Academic Medicine
> 65:472_474.  
> 
>       Daniels, N.  1991.  Duty to treat or right to refuse?  Hastings Center
> Report  21:36_46.   
> 
>       Doebbeling, B.N., and R.P. Wenzel.  1990.  The direct costs of
> universal precautions in a teaching hospital.  Journal of the American
> Medical Association 264:2038_2087.  
> 
>       Finck, B.K., M.H. Katz, and S.R. Hernandez.  1989.  The care of
> asymptomatic HIV-infected patients.  Western Journal of Medicine 151:464_466. 
> 
> 
>       Fox, R.C., L.H. Aiken, and C.M. Messikomer.  1990.  The culture of
> caring:  AIDS and the nursing profession.  The Milbank Quarterly 68(Suppl.
> 2):226_256.  
> 
>       Freedman, B.  1989.  Health professions, codes, and the right to refuse
> to treat HIV-infectious patients.  Hastings Center Report 18:20_25.  
> 
>       Gellin, B.G., and D.E. Rogers.  1991.  Branding doctors with HIV.  New
> York Times.  January 2:A13.  
> 
>       Gerberding, J.L., and W.P. Schecter.  1991.  Surgery and AIDS: 
> Reducing the risk.  Journal of American Medical Association 265:1572_1573.  
> 
>       Gerbert, B., B.T. Maguire, and T.J. Coates.  1990.  Are patients
> talking to their physicians about AIDS?  American Journal of Public Health
> 80:467_469.  
> 
>       Gerbert, B., B.T. Maguire, S.B. Hulley, and T.J. Coates.  1989. 
> Physicians and acquired immunodeficiency syndrome:  What patients think about
> human immunodeficiency virus in medical practice. Journal of the American
> Medical Association 262:1969_1972.    
> 
>       Gostin, L.  1989.  HIV-infected physicians and the practice of
> seriously invasive procedures.  Hastings Center Report 19(1):32_39. Gostin,
> L.  1989.  Hospitals, health care professionals, and AIDS:  The "right to
> know" the health status of professionals and patients.  Maryland Law Review
> 48:12_54.  
> 
>       Gostin, L.O., ed.  1990.  AIDS and the Health Care System.  New Haven,
> Conn.:  Yale University Press.  
> 
>       Green, J., and P.S. Arno.  1990.  The "Medicaidization" of AIDS: Trends
> in the financing of HIV-related medical care.  Journal of the American
> Medical Association 264:1261_1266.  
> 
>       Hauptman, P.J., and M.B. Feinberg.  1990.  Occupational exposure to HIV
> among house staff.  New England Journal of Medicine 323:1356.  
> 
>       Hayward, R.A., and M.F. Shapiro. 1991.  A national study of AIDS and
> residency training:  Experiences, concerns, and consequences.  Annals of
> Internal Medicine 114:23_32.  
> 
>       Henderson, D.K.  1990.  HIV-1 in the health care setting.  In G.F.
> Mandell, R.G. Gordon, Jr., and J.E. Bennett, eds., Principles and Practices
> of Infectious Diseases.  3rd edition.  New York: John Wiley.  
> 
>       Henderson, D.K., B.J. Fahey, M. Willy, J.M. Schmitt, and K. Carey. 
> 1990.  Risk for occupational transmission of human immunodeficiency virus
> type 1 (HIV-1) associated with clinical exposures:  A prospective evaluation. 
> Annals of Internal Medicine 113:740_746.  
> 
>       Imperato, P.J., J.G. Feldman, K. Nayeri, and J.A. DeHovitz.  1988. 
> Medical students' attitudes towards caring for patients with AIDS in a high
> incidence area.  New York State Journal of Medicine 88:223_228.  
> 
>       Jacobson, P.D., P.A. Lindsey, and A.H. Pascal.  1989.  AIDS-Specific
> Home and Community-Based Waivers for the Medicaid Population.  Santa Monica,
> Calif.:  RAND Corporation.  
> 
>       Jellinek, P.S.  1988.  Case managing AIDS. Issues in Science and
> Technology 4:59_63.  
> 
>       Jonsen, A.R.  1990.  The duty to treat patients with AIDS and HIV
> infection.  In L.O. Gostin, ed.,  AIDS and the Health Care System. New Haven,
> Conn.:  Yale University Press.  
> 
>       Kerr, P.  1991.  Medical society urges that all New Jersey hospital
> patients be tested for AIDS.  New York Times.  May 2:A11.  
> 
>       Lambert, B.  1989.  Flaws in the health care system emerge as  epidemic
> rages.  New York Times.  February 8:A1.  
> 
>       Lambert, B.  1990.  AIDS war shunned by many doctors:  Patients are
> said to miss out on life-prolonging drugs.  New York Times. April 23:A1.  
> 
>       Levine, C.  1990.  In and out of the hospital. In L.O. Gostin, ed., 
> AIDS and the Health Care System.  New Haven, Conn.: Yale University Press.  
> 
> 
>       Lewis, C.E., and K. Montgomery.  1990.  The HIV-testing policies of
> U.S. hospitals.  Journal of the American Medical Association 264:2764_2767. 
> 
>       Makadon, H.J.  1991.  Assessing HIV infection in primary care practice. 
> Journal of General Internal Medicine 6(Suppl. 1):S2_S7.  
> 
>       Makadon, H.J., S.F. Delbanco, and T.L. Delbanco.  1990.  Caring for
> people with AIDS and HIV infection in hospital-based primary care practice. 
> Journal of General Internal Medicine 5:446_450.  
> 
>       Northfelt, D.W., R.A. Hayward, and M.F. Shapiro.  1988.  The acquired
> immunodeficiency syndrome is a primary care disease. Annals of Internal
> Medicine 109:773_775.  
> 
>       Nunn, P., D. Kibuga, A. Elliott, and S. Gathua.  1990.  Impact of human
> immunodefiency virus on transmission and severity of tuberculosis. 
> Transactions of the Royal Society of Tropical Medicine and Hygiene 84(Suppl.
> 1):9_13.  
> 
>       Oleske, J.M.  1989.  Who cares for the human immunodeficiency
> virus-infected child?  Pediatrics 84:727.  
> 
>       Peterson, L.M.  1989.  AIDS:  The ethical dilemma for surgeons. Law,
> Medicine, and Health Care 17:139_144.  
> 
>       Rogers, D.E., and E. Ginzberg, eds.  1989.  Public and Professional
> Attitudes Toward AIDS Patients:  A National Dilemma. Boulder, Colo.: 
> Westview Press.  
> 
>       Rosenthal, E.  1990.  Practice of medicine is changing under specter of
> the AIDS virus.  New York Times.  November 11:A1.  
> 
>       Rothman, D.J., E.A. Tynan, and the New York City Task Force on
> Single-Disease Hospitals.  1990.  Advantages and disadvantages of special
> hospitals for patients with HIV infection:  A report by the New York City
> Task Force on Single-Disease Hospitals.  New England Journal of Medicine
> 323:764_768.   
> 
>       Smith, M.D.  1990.  An integrated primary care system for HIV disease. 
> Maryland Medical Journal 39:173_176.  
> 
>       Smith, M.D.  1991.  Primary care and HIV disease.  Journal of General
> Internal Medicine 6(Suppl. 1):S56_S62.  
> 
>       Steinbrook, R., B. Lo, J. Tirpack, J.W. Dilley, and P.A. Volberding. 
> 1985.  Ethical dilemmas of caring for patients with AIDS.  Annals of Internal
> Medicine 103:787_790.  
> 
>       Turner, B.  1990.  Models of ambulatory care:  Opportunities for SGIM. 
> SGIM (Society for General Internal Medicine) News 13:2,4_5.  
> 
>       Volberding, P.  1989.  Supporting the health care team in caring for
> patients with AIDS.  Journal of the American Medical Association 261:747_748. 
> 
> 
>       Wong, E.S., J.L. Stotka, V.M. Chinchilli, S. Williams, and C.G. Stuart. 
> 1991.  Are universal precautions effective in reducing the number of
> occupational exposures among health care workers?  A prospective study of
> physicians on a medical service.  Journal of the American Medical Association
> 265:1123_1128.  
> 
>       Wofsy, C.  1988.  AIDS care: Providing care for the HIV infected. 
> Journal of Acquired Immune Deficiency Syndromes  1:274_283.  
> 
>       Zuger, A., and S.H. Miles.  1987.  Physicians, AIDS and occupational
> risk:  Historic traditions and ethical obligations. Journal of the American
> Medical Association 258:1924_1928.    
> 
>       Caring for People with HIV Disease 
> 
>       Side bar pull out information   
> 
>       I feel I am quite fortunate because I know how to access the system. 
> I know all the "right" people.  I know how it operates.  I know what my
> rights are.  And I know where to go for assistance, because I am a part of
> the system professionally.  But I can tell you it is still never easy.  It is
> particularly difficult when I have to run all over town to see the
> ophthalmologist, internist, dermatologist, nutritionist, et cetera, and am
> not feeling well and trying to hold down a full-time job  at the same time. 
> 
> 
>       But what about the people who don't have the ability to access the
> system due to social, economic  or educational barriers?  How do they access
> a hostile system, a system designed to discourage their use and
> participation?   
> 
>       Andrew Ziegler, M.H.S.A. 
>       September 1990   
> 
>       Yesterday in our office, a young woman came who had spent an hour and
> a half on a bus with a temperature of 102, a hematocrit of 25, and a very
> active six-year-old in tow.  She refused hospital admission because she has
> the sole responsibility of this child,  and would not come in until better
> arrangements could be made.  We basically babysat her child and let her sleep
> in the office until she could regain her strength.  This is not an uncommon
> problem.  Women are often subrogating their care to the care of children or,
> in some cases, other infected spouses.  
> 
>       Mary Young, M.D.  
>       June 1991   
> 
>       Neither dentist would see me, due to HIV infection.  One dentist told
> me that his office was carpeted and he would not be able to sterilize the
> room after my visit. A second dentist told me she had plants and could not
> take the risk of my infecting her plants and then infecting her other
> patients.  
> 
>       Ronald Jerrell 
>       July 1990   
> 
>       We need the same range of housing options for people living with AIDS
> as we do for any group of people who may experience deteriorating health: 
> apartments that can accommodate walkers and wheelchairs, congregate living,
> group homes.  And it needs  to be subsidized because of our limited incomes. 
> We need home care and personal care attendant services to help people stay in
> their homes.  And we need flexibility so that people can move back and forth
> between those arrangements  as their needs change.  
> 
>       Rebecca Lomax, M.S.W., M.P.H. 
>       July 1990   
> 
>       There is a real risk of burnout on the part of the physicians and their
> nursing staffs. . . . We have a major problem as treaters regarding how to
> take care of our own psyches as well as to maintain the psyches of our
> patients and their families.   In addition to that, new physicians are not
> going into AIDS treatment. They are avoiding hemophiliac care.  They are
> avoiding  anything that has to do with AIDS care.  
> 
>       Craig Kessler, M.D.   
>       November 1989     
> 
>       We know that there are too few laboratories in this country to do CD-4
> testing and that we don't know what kind of quality we will get in the
> testing that is done.  We know that many hospitals even today  do not provide
> aerosolized pentamidine for their patients, including, I might point out,
> some of the major academic hospitals in this country.  We know that some of
> those hospitals actually avoid AIDS care altogether.  And perhaps most
> disturbingly, we know that the majority of American physicians do not yet
> know  about these advances and  in fact have no access to programs that could
> teach them about these advances.  
> 
>       Deborah Cotton, M.D., M.P.H. 
>       November 1989  
> 
>       The loss of my mother, the loss of my three children, the lack of
> services have left me with  a wish for death.  But then I think I want to
> live.  And I want to stop using drugs, but I need someone to care  for me. 
> Right now I have known for two years that I am HIV positive.  Fortunately, 
> I have not gotten sick.                                                
> 
>       Yvette  
>       January 1991   
> 
>       The percentage of AIDS cases related to injection drug use has
> increased sharply, from 18 percent before 1985 to nearly 33 percent in
> 1990_1991.   
> 
>       I polled a bunch of volunteer managers at other agencies and said,
> "Here's your chance to say something.  What would you want me to pass on for
> you?"  And one man just sighed on the phone, this man at the San Francisco
> AIDS Foundation, and he said, "Just tell them that without the huge volunteer
> work force in our organizations this epidemic would have crippled the country
> a long time ago.  Just make sure they know that."  
> 
>       Laurie Sherman 
>       July 1990   
> 
>       Chapter 4  
> 
>       Health Care Financing    
> 
>       Gaps in the United States health care financing system have been made
> increasingly evident by the HIV epidemic.  Millions of Americans are without
> health insurance and thus face significant barriers to needed care.  The
> first decade of AIDS coincided with a period of great ferment in health care
> financing, during which numerous proposals emerged for improving access and
> quality of care and limiting rising costs.  Although health care access is
> not a problem unique to people with HIV disease, the HIV epidemic does pose
> some unique challenges for the health care system.  It adds to a problem that
> has grown beyond the scale that can be solved by piecemeal tinkering. 
> Fundamental reforms are needed, and it will clearly require political courage
> to propose and implement them. Part of the Commission's mandate from Congress
> is to "evaluate the adequacy of, and make recommendations regarding, the
> financing of health care . . . relating to AIDS."  This chapter does so in
> considerable detail.  By necessity, however, the discussion goes beyond the
> mandate, for a financing reform proposal addressed solely to HIV disease
> would provide selectively and perhaps only temporarily for that population
> while ignoring the larger, more systemic problem.   
> 
>       The Commission urges the President and Congress to address the health
> care problems of all people living in the United States by supporting
> universal health care coverage.  This coverage should be comprehensive and
> include prescription drugs.  No person living in the United States should be
> denied health care because of an inability to pay, nor should people be
> forced into poverty or left without dignity because they are unfortunate
> enough to have a major health problem.  Our nation must do what virtually
> every other major industrialized nation has done_adopt a universal health
> plan that ensures access to health care for all its citizens. 
> 
>       Unless action is taken, the ranks of the uninsured and underinsured
> will continue to grow, opportunities for HIV education, prevention,
> counseling, and early intervention will continue to be missed, and
> individuals whose HIV disease requires acute care will turn increasingly to
> the already overburdened public hospital system.*  
> 
>       The Particular Challenges of HIV Disease 
> 
>       Original estimates of the costs of caring for people with AIDS were
> quite high.  The first and most widely cited estimate, made in the mid-1980s,
> was $147,000 for each patient for the direct medical costs of AIDS care from
> AIDS diagnosis to death.  This figure has been revised substantially downward
> in several subsequent studies, as ambulatory care has supplanted expensive
> hospitalizations and as costs for many of the drugs needed to treat
> manifestations of AIDS have declined.  Although caring for people with HIV
> disease is still quite expensive, in the aggregate, costs for HIV care
> presently and in the foreseeable future probably total no more than 2 percent
> of total U.S. health expenditures.  In this context, therefore, it is
> probably more accurate to think of HIV disease as posing "financing," rather
> than "cost" problems.   
> 
>       The financing problems are severe.  They arise in part because much of
> the need for HIV care is concentrated in particular cities and among people
> whose care is not covered by private insurers.  Moreover, both private and
> public third-party payers often fail to cover the full range of services
> needed. 
> 
>       Exclusion from private coverage has resulted from a combination of
> factors such as the clinical nature of HIV disease, the demographic
> characteristics of people with AIDS, and the employer-centered nature of
> health insurance.  HIV disease is disproportionately represented among the
> poor and people of color, who are at greater risk of being uninsured.  Even
> those with HIV disease who have private health insurance often find coverage
> wanting.  Employment-based private health insurance frequently fails to
> provide comprehensive coverage of preventive care, outpatient care, long-term
> care, and prescription drugs, all of which are key elements of care for HIV
> disease.   
> 
>       A substantial portion of the costs of caring for people with HIV
> disease is being shifted from private insurers to public-sector programs. 
> State, county, and municipal governments are experiencing enormous financial
> and political difficulties as they are pressed into service as providers of
> last resort in rendering uncompensated care.  Those who are impoverished by
> the disease and "spend down" to meet eligibility for public programs will
> find that Medicaid coverage varies widely from state to state, often leaving
> people with HIV disease without effective entitlement to care.  For example,
> some states did not cover the cost of AZT under their Medicaid program even
> after the drug became licensed.  Now all states cover AZT, but in some cases
> it took well over a year before the only available treatment for people with
> AIDS was covered under Medicaid. 
> 
>       The Scope of the Problem 
> 
>       It is currently estimated that at least one million individuals in the
> United States are HIV infected.  The Centers for Disease Control (CDC)
> estimated that in 1990 there were between 111,000 and 122,000 people with
> AIDS living in the United States, and the projection for 1993 is between
> 151,000 and 225,000 people.  These alarming figures necessitate immediate
> action.  The primary recommendation of the Commission is that universal
> health care coverage should be provided for all persons living in the United
> States.  However, in the interim, the Commission recommends a series of
> immediate short-term steps to address the urgent problem of inadequate
> coverage for people with HIV disease.  These steps should build on existing
> programs such as Medicare, Medicaid, and the Ryan White Comprehensive AIDS
> Resources Emergency (CARE) Act, which already provides limited assistance. 
> Such steps are well within the nation's economic and administrative
> capability and should be a top priority for policy attention.   
> 
>       Similarly, the Commission encourages long-term reform of the private
> health insurance industry.  However, in this report the Commission has
> focused primarily on recommendations that can result in immediate changes in
> publicly funded programs.  These changes will provide prompt assistance to
> those who are poor and seriously disabled and who are therefore in most
> urgent need. 
> 
>       This chapter provides a summary of the current health care financing
> system and highlights gaps in health care financing as experienced by
> individuals with HIV disease.  The recommendations in this report are set
> forth with the objective of extending current health care financing coverage
> to more people and improving the benefits provided.  In view of the charge to
> this Commission, our recommendations apply specifically to people living with
> HIV disease, but they could reasonably be implemented incrementally for all
> people with serious chronic illnesses requiring expensive, recurring care.  
> 
>       Current Estimates of the Cost of Caring for a Person with HIV Disease
> There have been a number of efforts to delineate the costs of caring for
> people with AIDS.  Most such studies have reviewed costs and charges for
> cohorts of gay male patients from the time of an initial AIDS diagnosis until
> death.  The most recent and realistic estimate of the annual direct medical
> care cost for treating an individual with AIDS is $32,000 in 1990 (Hellinger,
> 1991).*  However, because the proportion of intravenous drug users in the
> AIDS patient population is rising, this estimate may have to be adjusted
> upward in the future.  Intravenous drug users with HIV disease tend to incur
> higher than average annual costs than gay men with HIV disease as a result of
> their generally poorer state of health and inability to obtain outpatient and
> preventive care.  Future cost estimates will also have to be adjusted to
> reflect changing treatment modalities, but the direction of change could be
> either up or down.  New drugs may be more or less costly, depending on their
> cost of manufacture, their effectiveness, and the manner in which they are
> administered.  Even if more costly, better drugs may still lead to fewer
> hospitalizations and shorter lengths of stay.  There may well be other cost
> factors to be considered, particularly in rural settings where the cost of
> transportation is a factor and where already tenuous resources for general
> health care may be disastrously affected by the unexpected expense of AIDS
> care.   Much of the estimated cost of care for AIDS and for earlier stages of
> HIV disease, especially early intervention care, reflects high drug prices. 
> Medications are key to improvements in the functional status of patients and
> to the prevention of Pneumocystis carinii pneumonia, a leading cause of
> hospitalization and death for people with HIV disease.  The average cost of
> providing early intervention to individuals with HIV disease was recently
> estimated to be $5,904 per year in 1990 (Arno and Shenson, 1990).  This cost
> is somewhat lower than in earlier years, but it still poses a considerable
> financial burden to those who have moderate or low incomes or are uninsured. 
> It may even be a burden for insured people, as prescription drugs are not
> covered by all private insurers, nor does Medicare cover them.  Even with
> Medicaid, coverage of drugs is selective and varies from state to state.  
> 
>       The Current System 
> 
>       The United States provides health care through a patchwork system
> centered on employer-sponsored private health insurance.  This is
> supplemented, at least in part, by government entitlement programs, most
> notably Medicare and Medicaid, covering primarily the elderly, the disabled,
> and the poor.  Recent estimates indicate that private health insurance covers
> approximately 29 percent of individuals with AIDS, Medicaid covers
> approximately 40 percent, Medicare covers 2 percent, and the remaining 29
> percent are uninsured.  Some of the uninsured individuals may be eligible for
> direct care from such sources as the Department of Veterans Affairs, prisons,
> public hospitals, or other programs.  
> 
>       Private Insurance 
> 
>       As it is currently structured, private health insurance is not well
> suited to respond to HIV disease because of limitations in the range of
> services covered and the eligibility for coverage.  The vast majority of
> individuals with private health insurance secure such coverage through their
> workplace or that of a spouse or parent.  When health insurance is secured
> through large employer-sponsored group plans, there are few initial
> restrictions on obtaining coverage. 
> 
>       Federal law requires employers with 20 or more employees to permit
> continued coverage for a period of time following termination of employment
> if the insured are able to pay the full premium and additional costs.  Health
> plans for fewer than 20 employees are likely to exclude people with AIDS or
> HIV infection or charge higher premiums.  Eight states and the District of
> Columbia have taken steps to implement premium-paying programs for
> individuals with chronic health conditions who are unable to continue paying
> their private individual or group insurance premiums.  The Commission
> believes that all states and/or the federal government should adopt some form
> of premium-paying policy. Even good faith employers, fully committed to
> keeping people with HIV disease on their payroll and covered by
> employer-based insurance, find it difficult to do so.  When just one person
> is diagnosed with HIV disease on an employer-based insurance program,
> insurance premiums are often raised.  For many employers, such a raise in
> insurance premiums can make the insurance plan virtually unaffordable.  The
> cost of insurance could, in fact, force an employer to reduce or eliminate
> the health insurance program.  In some cases, it may force an employer out of
> business.  This is particularly true for small employers who may have a
> number of employees who need HIV-related services.  The significant increase
> in premiums that can result when an insurance company discovers that one or
> more employees need HIV-related services must be addressed.   
> 
>       The linking of health insurance to employment is problematic for people
> living with HIV disease.  People with HIV disease may become too debilitated
> to work.  Even when they are able to work on a reduced schedule, employers
> may not be willing to accommodate their needs for time off to cope with
> intercurrent illnesses or to keep various medical appointments.  In addition,
> many with HIV disease have faced discrimination in the workplace.  They have
> been fired or laid off because of their HIV status, without regard to their
> ability to continue working.  One study of work loss among individuals with
> HIV disease found that in a sample of 193 individuals, 50 percent who worked
> prior to the onset of symptoms stopped working within two years.  The authors
> noted that improved treatments would help slow the rate of work loss (Yelin
> et al., 1991).   
> 
>       Individually purchased health insurance is not commonly held by people
> with HIV disease because most insurance companies screen out people who are
> already HIV infected and even those believed to be at risk. There are other
> problems with private insurance, even when it is available.  For instance,
> the range of health care benefits provided under private insurance varies
> considerably and may not include coverage for costly prescription drugs.  In
> rare instances, insurers or self-insured groups have attempted to impose
> restrictive caps on payments for AIDS-related treatments, caps that have not
> been used for any other life-threatening diseases. Another fundamental
> limitation of private insurance that is particularly relevant for people with
> HIV disease is the traditional restrictions on coverage of experimental drugs
> and procedures.  Treatments that are technically experimental may be the
> standard of care for HIV disease.  To exclude coverage of experimental
> treatments may be to exclude the sole choice  available to someone with HIV
> disease.       
> 
>       Medicaid 
> 
>       Medicaid is currently the most important source of financing for AIDS
> and HIV-related health care benefits (HCFA, 1990).  Forty percent of people
> with AIDS are covered by Medicaid, and ninety percent of children with AIDS
> are covered by Medicaid.  Recent studies reveal a strong trend that has been
> dubbed the "Medicaidization" of AIDS, that is, a shift in the distribution of
> individuals with third-party financing from private insurance to Medicaid
> (Green and Arno, 1990; Merlis, 1990).  It is unclear whether this can be
> explained better by the increase in the number of low-income individuals
> contracting the disease or by the reduction in coverage of the disease by
> private insurance; probably both factors contribute to this dramatic trend. 
> 
>       Evidence of such "Medicaidization" is abundant.  Whereas Medicaid pays
> for approximately 11 percent of total health care costs in the United States,
> it funds approximately 25 percent of AIDS care.  There is an unfortunate side
> to this trend, for although Medicaid is designed to cover low-income people,
> it falls short of serving the needs of many poor individuals because of the
> stringent criteria defining "low-income" and the prerequisite that assets be
> below a certain minimum.  In addition to poverty restrictions, an individual
> must meet one of the categorical eligibility criteria by being over 65, a
> member of a family with dependent children, or totally disabled.  For most
> people with HIV disease, eligibility for Medicaid is through disability,
> which requires a clinical diagnosis of AIDS.  As a result, Medicaid is
> generally available only to very poor individuals and during the later stages
> of HIV disease. 
> 
>       Eligibility criteria and types of benefits covered vary considerably
> from state to state, and coverage is almost nonexistent in the Commonwealth
> of Puerto Rico and the U.S. territories.  While some states provide coverage
> for the complete range of benefits needed, others provide a more restricted
> range of benefits including only partial and selective coverage of costly
> prescription drugs.  The low provider-payment rates under Medicaid raise
> other concerns, specifically the reluctance of physicians to serve Medicaid
> patients and the financial burden placed on hospitals serving Medicaid
> patients.  Green and Arno found that "physicians are reimbursed by Medicaid
> an average of 33 percent of the rates paid by private insurance in San
> Francisco and 15 percent in New York.  In New York, an intermediate care
> office visit is compensated at $84 by private insurance compared with $11 by
> Medicaid."  They also found a "disproportionate number of hospitalizations of
> AIDS patients with Medicaid beginning in an emergency room, unmediated by a
> physician responsible for continuing care."  Clearly, this situation does not
> serve anyone well.  Patients are poorly served because of late intervention
> and limited services.  The health care system is poorly served because of
> high overhead costs and the use of expensive inpatient services when early
> intervention might have prevented the need for them.    
> 
>       Medicare 
> 
>       Medicare provides coverage for approximately 2 percent of people with
> AIDS (HCFA, 1990).  This is largely as a result of the limiting effect of
> eligibility criteria.  Before qualifying for Medicare, individuals who are
> not elderly must qualify for Social Security Disability Insurance (SSDI). 
> Before obtaining Medicare they must wait five months from diagnosis of a
> disabling condition to receive SSDI payments and then survive a two-year
> waiting period_a total of 29 months.  It is also important to note that
> eligibility for Medicare requires a history of employment.  The Commission
> believes SSDI beneficiaries who are disabled and have HIV disease or another
> serious chronic health condition should have the option of purchasing
> Medicare during the current two-year waiting period.  
> 
>       Also, while there are obstacles to becoming eligible for Medicare,
> there are also drawbacks to Medicare coverage once one receives it.  The lack
> of prescription drug benefits and limited long-term care benefits poses real
> problems for people with HIV disease.  Out-of-pocket costs can be prohibitive
> for a beneficiary as a result of limitations such as deductibles,
> coinsurance, the Part B premium for physician services, and uncovered
> services.    
> 
>       Additional Problems of Access to Care 
> 
>       A variety of factors may cause delays or serve as barriers to early
> treatment and care of individuals with HIV disease.  Some of these factors
> are highlighted in the preceding chapter, which discusses limitations in the
> organization and delivery of HIV care.  The preceding chapter also looks at
> ways in which fear of HIV transmission in the health care setting imperils
> access to care by driving a wedge between patients and their caregivers.  The
> following section discusses some additional barriers to HIV care that relate
> to financing issues.  
> 
>       Prevention and Early Intervention 
> 
>       CDC estimates that approximately 60 percent of individuals with HIV
> infection could benefit from early intervention.  This means that even if
> there were no further spread of the virus, 480,000 to 720,000 people should
> receive such care right now.  However, individuals such as intravenous drug
> users, the homeless, and those who live in rural areas and who lack access to
> care in general, may have limited or no access to counseling and testing and
> diagnostic resources and may not receive care until it is an emergency.  Many
> others who do not have a primary care provider do not have access to
> appropriate testing and counseling services and have no access to the early
> intervention services they may have been told are now available for people
> with HIV disease.  Others are afraid to be tested for a variety of reasons,
> not the least of which is the very real fear that they will be discriminated
> against if they test positive, perhaps losing their health insurance.  CDC
> estimates that only 12 percent of people who are infected know of their HIV
> serostatus, and fewer than that are receiving treatment.  Equally alarming,
> when counseling is unavailable or inadequate, HIV-infected individuals do not
> have sufficient information upon which to base decisions regarding treatment
> and risk behavior changes.  
> 
>       Drug Treatments 
> 
>       It has been estimated that 90 percent of the early intervention costs
> for HIV infection are for prescription drugs, principally AZT and aerosolized
> pentamidine (Arno, 1990).  CDC estimates that approximately 60 percent of
> HIV-infected individuals would benefit from immediate treatment with these
> drugs.  In addition, the majority of people currently living with AIDS
> require expensive drug therapies.   
> 
>       Later in this chapter, the Commission discusses the impact of the
> Orphan Drug Act on the high cost of AIDS drugs and recommends amending the
> law to address this concern.  The Commission also believes the Department of
> Health and Human Services should negotiate reasonable and accessible prices
> for drugs developed through NIH-funded research.  This would reflect the
> federal government's contribution to the research and development costs
> normally undertaken by the private sector.  
> 
>       Provider Reimbursement 
> 
>       Public and teaching hospitals are an important source of care for
> low-income individuals who are uninsured or who have qualified for Medicaid. 
> Owing to uncompensated care provided to the uninsured and low reimbursement
> rates under Medicaid, public hospitals have been experiencing significant
> economic losses when they provide care to AIDS patients.  Private hospitals
> are treating more AIDS patients, but even they are experiencing financial
> strains.   
> 
>       As noted above, physicians have financial disincentives to provide care
> to individuals on Medicaid.  Physician reimbursement rates under Medicaid are
> much lower than those from other third-party payers, and in the final
> analysis much care for HIV disease is entirely uncompensated.  In this
> climate, not only may patients be forced to wait for care until serious
> symptoms develop, but they then are likely to be driven for lack of
> alternatives to seek care in the more expensive hospital emergency room or
> inpatient setting.  
> 
>       Inefficiency in Current Care Patterns 
> 
>       There are marked inefficiencies in current patterns of care for people
> with HIV disease.  One of the primary reasons inefficiency exists is the
> unfamiliarity of some providers with cost-saving regimens.  Outpatient
> management of AIDS in the San Francisco area has been proven to have
> substantial cost savings (Hiatt et al., 1990).  The use of AZT also has the
> potential for reducing annual costs while extending productive lives
> (Scitovsky et al., 1990). 
> 
>       Improving Health Care Financing for People _with HIV Disease The
> Commission believes that universal health care coverage is a necessary step
> toward addressing these obstacles and ensuring access to quality health care
> for all people living in the United States.  This coverage should be
> comprehensive and should include prescription drugs.  In the interim, the
> Commission recommends a series of immediate short-term steps to close the
> gaps in health care financing for those with HIV disease.  In developing
> these recommendations, the Commission has sought to make incremental steps
> consistent with longer-term comprehensive reform.  It has placed primary
> emphasis upon: 
> 
>          y  encouraging greater access to health care, especially through
>             early intervention and outpatient primary care;  
> 
>          y  providing financing for a sufficiently broad range of health care
>             benefits to avoid distortions and inefficiencies in patterns of
>             patient care; 
> 
>          y  assuring provider participation by setting payment rates at
>             adequate levels, while avoiding large profits and open-ended
>             escalating health care costs; and 
> 
>          y  promoting equity and fairness by giving the greatest assistance
>             to those most in need_the poor and those with catastrophically
>             expensive illnesses. 
> 
>       These incremental recommendations focus primarily on the expansion of
> existing public health care financing programs rather than the expansion of
> employer-provided private insurance coverage.  The Commission does not
> believe that an employer-based approach will be successful in meeting the
> needs of all people living with HIV disease.  In part this is because many
> affected persons are outside the work force or are unable to continue working
> once the disease reaches an advanced stage.  Furthermore, private insurers
> have been reluctant to shoulder a greater proportion of the financing burden,
> and regulatory attempts to force this burden on employers and insurers in the
> absence of more comprehensive reforms are likely to be circumvented.  
> 
>       Medicaid Expansion 
> 
>       The Commission recommends that legislation be enacted to expand
> Medicaid eligibility for low-income people with HIV disease.  Currently, many
> people with HIV disease are not eligible for Medicaid even if they are poor. 
> In addition to its poverty requirement, Medicaid is further limited to people
> who are (1) over 65;  (2) members of families with dependent children;  or
> (3) totally disabled.  With HIV disease, this requirement generally limits
> Medicaid coverage to only those individuals who have a clinical diagnosis of
> AIDS.  People who have tested HIV positive but have not advanced to a
> diagnosis of AIDS do not qualify, even if they meet the low-income
> eligibility requirements.  This restriction renders poor people with HIV
> disease who do not have a clinical diagnosis of AIDS virtually ineligible for
> the early intervention treatments and services that can delay progression of
> HIV disease, prevent opportunistic infections, and limit numerous (and
> expensive) hospital visits.  The disability requirement for Medicaid should
> be eliminated for people with HIV disease.  Although the Commission has made
> this recommendation specific to people with HIV disease, it can and should
> lead to further changes that will include people with other serious chronic
> illnesses. 
> 
>       The Commission also recommends that the income eligibility requirement
> for Medicaid be increased for people with HIV disease.  Currently, an
> individual must actually be, or in some states be at risk of becoming,
> extremely poor to meet the income eligibility requirements for Medicaid. 
> Many people with HIV disease are not impoverished but nevertheless do not
> have the health insurance or independent means to pay for the health care
> treatments and services they need.  Therefore, either they are forced to rely
> on the already overburdened public hospital system for expensive inpatient
> care or they must spend themselves into poverty to qualify for Medicaid. 
> Once impoverished and eligible for Medicaid, they become dependent on many
> other welfare programs for such basic needs as food, clothing, and shelter. 
>  
>       Eliminating the disability requirement at various income levels
> (including, in some instances, eliminating the asset test) would expand the
> number of people with HIV disease who would be eligible for Medicaid.  
> Eliminating the disability requirement for people with HIV disease and
> raising the current income eligibility to 100 percent of the federal poverty
> level would expand Medicaid coverage to include an estimated additional 6,800
> low-income people with AIDS and 63,700 additional low-income people with HIV
> infection.  This option would increase the total number of Medicaid
> recipients by less than half of one percent.   
> 
>       The overall estimated Medicaid cost of this option would be $345
> million in FY 1991, and would be split between the federal government ($176
> million) and state governments ($169 million). This option would result in an
> increase in total Medicaid expenditures of less than one percent. If the
> income requirement were raised to 185 percent of the federal poverty level,
> with applicable asset tests, Medicaid would cover 91,000 people with HIV
> infection and 21,000 people with AIDS.  The total cost for Medicaid would be
> $660 million and would be split between the federal government ($337 million)
> and state governments ($323 million). If the income requirement were raised
> to 200 percent of the federal poverty level, with no asset test, Medicaid
> would cover 103,200 people with HIV infection and 22,100 with AIDS.  The
> total cost to Medicaid would be $727 million and would be split between the
> federal government ($371 million) and state governments ($356 million).   
> 
>       Another incremental step would be to allow persons whose Social
> Security disability benefits render them ineligible for Supplemental Security
> Insurance (SSI) (because their disability payments are larger than the SSI
> income level permits) to keep their Medicaid coverage.  In some cases, once
> a person becomes eligible for SSDI, they lose their eligibility for SSI and
> Medicaid and along with it, many of the health care services they need,
> particularly prescription drug coverage.  Some states have opted to allow
> low-income SSDI recipients to keep their Medicaid coverage in order to expand
> Medicaid to the medically indigent.  The Commission believes all states
> should exercise this option.   
> 
>       Medicaid payment rates for providers should also be increased
> sufficiently to ensure adequate participation in the Medicaid program. 
> Unrealistically low reimbursement rates under the Medicaid program are
> serious disincentives for health care providers to care for people who rely
> on Medicaid.  Medicaid payment rates for physicians, which currently average
> only 64 percent of Medicare rates, should be raised to Medicare levels. 
> 
>       Low reimbursement rates to hospitals may also contribute to an
> inequitable distribution of the HIV patient caseload.  States should ensure
> that payment rates are adequate to cover the cost of efficiently caring for
> people with HIV disease.   
> 
>       To expand primary care to Medicaid beneficiaries with HIV disease, all
> community health centers and community clinics receiving Ryan White CARE Act
> funding, or similar sites meeting minimal federal standards, should be
> entitled to Federally Qualified Health Centers status.  As a Federally
> Qualified Health Center, a provider would be eligible for reimbursement at
> 100 percent of reasonable cost under Medicaid.  This would increase the
> availability of primary care in areas with large concentrations of people in
> need of care.  
> 
>       Special attention should be given to the concerns of the Commonwealth
> of Puerto Rico, where the HIV epidemic is intense and yet where there is a
> cap on total Medicaid expenditures, regardless of the growing needs of the
> population dependent on Medicaid.  Because of the existing cap on Medicaid
> funds allocated to Puerto Rico, none of the Medicaid recommendations the
> Commission has put forward to expand benefits for people with HIV disease
> would include individuals living in this part of the United States.  Congress
> and the Administration should work together to raise the Medicaid cap on
> funds directed to the Government of Puerto Rico to ensure equal access to
> care and treatment.  
> 
>       COBRA Premiums 
> 
>       States and/or the federal government should pay the employer-based
> health insurance premiums for people with HIV disease who have left their
> jobs and cannot afford to pay their premiums.  The Consolidated Omnibus
> Budget Reconciliation Act (COBRA) includes a provision to require employers
> with 20 or more employees to permit continued coverage if the insured are
> able to pay the premium.  If the employee is disabled when he or she leaves
> a job, continued coverage must be allowed for 29 months.  For people not
> disabled at the time they leave their jobs, continued coverage is for 18
> months.  This provision is designed to ensure health care coverage during the
> time a person would be waiting to become eligible for other health insurance
> or, if disabled, for Medicare.  Many people with HIV disease cannot afford to
> pay the health insurance premiums (referred to as COBRA premiums) during the
> waiting period and are forced instead to spend themselves into poverty in
> order to become eligible for Medicaid.   
> 
>       Eight states and the District of Columbia have implemented some form of
> premium-paying program to cover the private individual or group health
> insurance premiums for individuals with chronic illnesses.  The Commission
> believes all states and/or the federal government should pay the COBRA
> premiums for low-income people with HIV disease who have left their jobs and
> cannot afford to pay the health insurance premium. If this option is limited
> to people with HIV disease who have incomes below the federal poverty level,
> it would extend employer-sponsored insurance to an estimated 2,000 people
> with AIDS and 8,000 people with HIV infection.  Of the 2,000 people with AIDS
> receiving coverage under this option, 1,600 would have previously been
> eligible for Medicaid.  (It is assumed that the low-income population cannot
> afford the COBRA premiums and would apply for Medicaid.)  If the Medicaid
> income eligibility level is increased, that increased level should apply to
> this COBRA recommendation as well.   
> 
>       This option has the advantage of buying beneficiaries into private
> coverage, which is generally much more attractive than Medicare or Medicaid
> in terms of benefits covered and reimbursement rates.  In addition, a
> comprehensive package of benefits is provided through many employer-sponsored
> group plans, which would include early intervention treatments.   
> 
>       The more generous reimbursement rates would be attractive to providers
> and people with HIV disease, who would not be required to change their source
> of care, as they would if they were covered under Medicaid and their
> physicians or hospitals did not participate in Medicaid.  This option might
> take some of the burden of providing care away from the teaching and public
> hospitals and away also from those physicians who accept Medicaid patients. 
> 
>       This option results in a net savings to Medicaid because costs are
> shifted from the Medicaid program to employers through continuing coverage
> under employer-sponsored insurance plans.  Overall FY 1991 savings to
> Medicaid would be $4 million for both people with HIV infection and people
> with AIDS.  Of this, $28 million is saved for those with AIDS, whom otherwise
> Medicaid would have had to pay for, while the net cost is $24 million for
> people with HIV infection.  
> 
>       Medicare Expansion 
> 
>       SSDI beneficiaries who are disabled and have HIV disease or another
> serious chronic health condition should have the option of purchasing
> Medicare during the current two-year waiting period.  Medicaid would be
> required to purchase Medicare coverage for low-income SSDI beneficiaries.  
> 
>       This option would allow an estimated 10,500 SSDI beneficiaries with
> AIDS to purchase Medicare coverage.  An estimated 4,900 would have their
> Medicare coverage purchased and supplemented by Medicaid; 5,600 would
> purchase Medicare on their own.  Once eligible for SSDI, an individual would
> immediately be allowed to purchase Medicare coverage without having to wait
> out the 24-month waiting period.  The annual cost to the beneficiary would be
> $3,559_the full actuarial cost for Part A (Hospital Insurance) and Part B
> (Supplemental Medical Insurance) premiums.  In addition, beneficiaries would
> be liable for Medicare cost sharing and noncovered services such as
> prescription drugs.  The cost to beneficiaries is therefore estimated to be
> $9,600 annually.  Individuals with incomes above the federal poverty level
> would be expected to make these payments.  Owing to the potentially large
> out-of-pocket cost to the individual, it is estimated that only 35 percent of
> the SSDI beneficiaries would take advantage of this option.   
> 
>       Private supplemental insurance policies (called Medi-gap policies)
> should also be opened up to people with HIV disease who can afford to
> purchase them.  These policies are often the only way to cover the cost of
> prescription drugs and long-term care for Medicare beneficiaries.   There are
> significant gaps and cost sharing in the coverage provided by Medicare, which
> would put a heavy financial burden on many individuals purchasing Medicare
> under this option.  Specifically, out-of-pocket costs for Part A include a
> deductible of $628 per episode of illness.  
> 
>       Out-of-pocket costs for Part B, the coverage for physician and related
> services, include a deductible of $100 per year and coinsurance of 20 percent
> of the allowable Medicare charge.  In addition, beneficiaries would be
> assessed a combined Part A and Part B premium of $3,559 per year.  Figures
> are effective as of January 1, 1991. 
> 
>       Under Medicare Part A, individuals would be covered for inpatient
> hospital care, some inpatient skilled nursing facility care, home health
> care, and hospice care.  Under Part B, they would be covered for physician
> services, outpatient hospital services, durable medical equipment, and other
> medical services and supplies.  However, individuals would not be covered for
> prescription drugs, dental care, and a variety of long-term care services. 
> The lack of prescription drug coverage would be particularly significant for
> some individuals because the annual cost of prescription drugs for people
> with AIDS averaged $4,400 in 1990 (Hellinger, 1991). 
> 
>       Despite these limitations in benefits, Medicare coverage will be
> attractive to many SSDI beneficiaries.  Many are uninsured and unable to
> obtain private health insurance.  Without Medicare they will be quickly
> driven into poverty or will do without needed care.  A further benefit of
> Medicare coverage is that reimbursement rates higher than Medicaid's would
> act as an incentive for physicians to provide ambulatory care to individuals
> with HIV disease. 
> 
>       The cost of this option to the Medicare program is $220 million, in
> addition to payments paid by beneficiaries through premiums, deductibles, and
> coinsurance.   
> 
>       Such a change would result in a net savings to Medicaid of $78 million,
> since Medicaid would be used to purchase Medicare premiums for those
> individuals with incomes below the federal poverty level.  Medicaid would
> continue to be used for paying coinsurance, deductibles, and for items not
> covered by Medicare, such as drugs for those currently eligible for Medicaid. 
> Of the $69 million savings, approximately $35 million would be federal
> dollars and $34 million would be state dollars. 
> 
>       The Commission supports extending this option to SSDI beneficiaries
> with other serious chronic health conditions.  Since all SSDI beneficiaries
> are by definition seriously disabled, they should be permitted the option of
> purchasing Medicare by paying the full actuarial cost of coverage during the
> two-year waiting period.  This would extend coverage to an estimated 335,000
> persons at an annual cost to Medicare of $1.2 billion and to Medicaid of $900
> million.  
> 
>       The Ryan White Comprehensive AIDS Resources Emergency _(CARE) Act The
> federal government should fund the Ryan White CARE Act at the fully
> authorized level.  Creating the authority for federal programs to respond to
> the crisis of the HIV epidemic is one thing_actually providing the dollars to
> pay for them is another.  While the Commission commends the Congress for
> establishing the Ryan White CARE Act programs, the Commission is very
> concerned about the small amount of money actually appropriated to implement
> the programs.  Full funding is required to assure the availability and
> success of these desperately needed programs.  The funds for the Ryan White
> CARE Act should be new money and not money shifted from other federal health
> and human services programs.   
> 
>       Full funding of the Ryan White CARE Act would encourage the provision
> of ambulatory care services to people with HIV disease by increasing
> compensation for outpatient care in hospitals, migrant and community health
> centers, community clinics, and other entities.  This would increase support
> for hospitals in areas serving a disproportionate share of individuals with
> HIV disease, but it would also bolster migrant and community health centers
> and community-based organizations, which currently provide a substantial
> share of outpatient care for individuals with HIV disease.  Financial relief
> for these institutions will enable them to care better for underserved and
> indigent patients.  They are an important last resort for many uninsured
> people and for Medicaid patients who have difficulty finding providers
> willing to accept the Medicaid reimbursement rates.   This funding is
> earmarked for outpatient preventive services and clinical care.  These
> alternative care strategies have been designed to reduce the number of
> unnecessary hospital admissions involving essentially preventable conditions
> such as Pneumocystis carinii pneumonia.  Such outpatient care, if integrated
> into a larger network of services including mental health care, housing,
> family services, clinical care, and hospice care will ensure that patients
> receive services appropriate to their needs as their HIV disease progresses. 
> 
>       Interim Steps to Improve Access to Expensive Drugs 
> 
>       There is a precedent for federal assistance with the cost of expensive
> HIV-related drugs.  Prior to the Ryan White CARE Act,  the federal government
> provided discretionary dollars, through the AIDS Drug Reimbursement Program,
> to each state to help pay for AIDS-related drugs.  This program was expanded
> by some states and now, under the Ryan White CARE Act, all states and other
> eligible jurisdictions may use grant funds for this purpose.   
> 
>       The following interim steps should also be taken to improve access to
> expensive HIV-related drugs: (1) adequately reimburse patients for the
> purchase of drugs required in the prevention and treatment of HIV disease,
> including clotting factor for hemophilia;  (2) undertake, through the
> Department of Health and Human Services, a program for the consolidated
> purchase and distribution of drugs used in the prevention and treatment of
> HIV disease;  (3) amend the Orphan Drug Act to set a maximum sales cap for
> covered drugs.  
> 
>       Adequate Reimbursement _for HIV-related Drugs 
> 
>       While advances in treatments and technology have made more HIV-related
> drugs available, they are for many unaffordable.  Many people lack health
> insurance and others have selective insurance policies that do not cover the
> cost of drugs (or at least the cost of certain kinds of drugs).  In addition,
> state-funded programs operate on very limited budgets.  Adequate 
> reimbursements and improved payment mechanisms must be explored.  
> 
>       For example, advances in technology have made clotting factor for
> people with hemophilia free from HIV but at a tremendous economic cost. 
> Virally attenuated clotting factor now costs $60,000 to $100,000 per year
> simply to meet the basic needs of one person with severe classical
> hemophilia.  Three years ago the Presidential Commission on the HIV Epidemic
> recommended that the Health Care Financing Administration and Health
> Resources and Services Administration "develop alternative payment mechanisms
> to make clotting factor treatment affordable for patients."   Notwithstanding
> this recommendation, nothing has been done.  Meanwhile, insurers have become
> more selective, many patients have reached their lifetime caps on insurance,
> and state-funded programs to provide supplemental assistance are running into
> the same budget difficulties that are affecting every other state and local
> assistance program.    
> 
>       Consolidated Purchase_of HIV-related Drugs 
> 
>       A consolidated purchase of HIV-related drugs would enable the federal
> government to negotiate reduced costs for HIV drugs by offering
> pharmaceutical manufacturers volume sales.  This could be done through a new
> mechanism involving a federal agency or through the Medicaid program.  There
> are a number of precedents for this type of approach.  One example is the
> federal purchase of childhood vaccines.  The federal government, through CDC,
> buys childhood vaccines through negotiated open-ended contracts with large
> guaranteed minimum purchases.  CDC offers this consolidated purchase option
> to the states on a voluntary basis.  All fifty states have opted to
> participate in this program.  By purchasing in bulk, the cost of a complete
> vaccination series is reduced by approximately 40 percent per child over the
> private-sector cost. Medicaid programs in states that pay for prescription
> drugs currently pay the full retail price for HIV drugs.  With consolidated
> purchase, state Medicaid programs could opt to supply medications to Medicaid
> recipients at a negotiated reduced rate.  The Medicaid program could be
> expected to save considerable sums on drug costs for Medicaid recipients. 
> Lack of access to early intervention because of inability to pay for
> medication remains a significant barrier to care for the uninsured, whose
> care would therefore be particularly enhanced by this program. The
> consolidated purchase approach is attractive for two reasons.  First, there
> are precedents, such as the federal childhood vaccine program.  Second,
> consolidated purchase could actually increase sales of AIDS drugs.  The
> administrative cost would depend on the structure of a consolidated purchase
> program, but experience with the consolidated purchase of vaccines suggests
> that savings could be considerable.  
> 
>       Amendment of the _Orphan Drug Act 
> 
>       The high cost of drugs used in HIV treatment is explained in part by
> their patent protection and "orphan drug" status.  The Orphan Drug Act of
> 1983 was intended to encourage development of drugs for treating small
> numbers of people with rare diseases (Asbury, 1991).  It provides financial
> incentives, tax breaks, and a seven-year exclusive right to the drug's
> market. 
> 
>       Although drug companies' expectation of recouping investments in
> research and development and realizing a profit is legitimate, it is also
> legitimate for the public to expect a reasonable price for lifesaving drugs. 
> Frequently cited examples of drugs granted orphan drug status that have
> subsequently generated considerable sales and profits include AZT,
> aerosolized pentamidine, recombinant human growth hormone, and recombinant
> erythropoietin (EPO) (Thoene, 1991).  EPO, although principally used for
> patients who are suffering from renal disease, is also used to treat
> HIV-related anemia.  Of the aforementioned drugs, only pentamadine (with 1990
> sales estimated at $480 million) would be clearly affected by reform of the
> orphan drug law, since the others are currently protected by patent law
> beyond the seven-year exclusivity of orphan status (Asbury, 1991).  Reform of
> the Orphan Drug Act, however, could affect other drugs still under research,
> as well as orphan drugs used in other diseases. 
> 
>       Reform of the Orphan Drug Act through a cap on sales or profits has a
> number of implications.  It would deny orphan status to a drug once it had
> proved very profitable, while retaining orphan status for small market or
> unprofitable drugs.  Thus, one result would be to return the application of
> the law to its original intent.  Further, by preserving orphan status until
> a drug has achieved high profitability, manufacturers could still recover the
> cost of research and development phases of a new drug for a rare disease;
> thus, research incentives would not be lost.  For a previously approved drug
> granted orphan status for a new indication (as was the case for pentamidine),
> the loss of orphan status once high profitability was established would mean
> the loss of exclusivity for that drug and for that indication.  Market forces
> would then be expected to lower costs. 
> 
>       This proposed approach has an advantage over a population limit for
> orphan drugs in that it is based on a demonstrable end point (profits or
> sales), whereas population targets are likely to be based on figures (such as
> the number of HIV-infected individuals) subject to considerable debate.  A
> sales cap of $150 million dollars has been suggested by the National
> Organization of Rare Disorders.  This option attempts to return the Orphan
> Drug Law to its original intent, and would not affect drugs with low sales or
> profits. 
> 
>       This proposal could result in considerable savings for all payers of
> drugs for treatment of HIV disease.  Savings on pentamidine alone could
> amount to $900 per patient per year;  administrative costs would be minimal. 
> Such a policy would not be AIDS-specific and would be expected to benefit any
> patient group requiring an expensive orphan drug whose price was affected by
> the amendment. 
> 
>       The Commission firmly believes that total systemic reform will be
> necessary to genuinely achieve appropriate access to health care for all
> people living in the United States.  In the interim, the Commission
> recommends a series of immediate short-term steps to address the urgent
> problem of inadequate coverage for people with HIV disease.   
> 
>       Recommendations  
> 
>       1.  Universal health care coverage should be provided for all persons
> living in the United States to ensure access to quality health care services.
> 
> 
>           The Commission believes universal health care coverage is a
> necessary step to ensuring access to quality health care.   This coverage
> should be comprehensive and should include prescription drugs.  In the
> interim, the Commission recommends a series of immediate short-term steps to
> address the urgent problem of inadequate coverage for people with HIV
> disease.     
> 
>       2.  Medicaid should cover all low-income people with HIV disease. 
> 
>           The Commission recommends eliminating the disability requirement
> and raising the income level for Medicaid eligibility for people with HIV
> disease.  By eliminating the disability requirement, low-income people with
> HIV infection who have not had a clinical diagnosis of AIDS could be covered
> by Medicaid and receive the early intervention treatments and services they
> need.  Increasing the income eligibility requirement would prevent many
> people with HIV infection from having to impoverish themselves in order to
> qualify for basic health care services.  At the same time it would relieve
> some of the reliance on public hospitals by the uninsured.   
> 
>           The Commission strongly believes these changes should be mandated;
> however, at the very least, states should be given the option of making these
> changes.  In addition, the Commission believes these changes can and should
> lead to further changes that will include people with serious chronic
> conditions other than HIV disease.  
> 
>       3.  Medicaid payment rates for providers should be increased
> sufficiently to ensure adequate participation in the Medicaid program. 
> 
>           Unrealistically low reimbursement rates under the Medicaid program
> serve as a serious disincentive for health care providers to care for people
> who rely on Medicaid.  Medicaid rates should be raised to Medicare levels.  
>  
> 
>       4.  Congress and the Administration should work together to adequately
> raise the Medicaid cap on funds directed to the Commonwealth of Puerto Rico
> to ensure equal access to care and treatment.  
> 
>           Because of the existing cap on Medicaid funds allocated to the
> Commonwealth of Puerto Rico, none of the Medicaid recommendations the
> Commission has put forward to expand benefits for people with HIV disease
> would include individuals living in this part of the United States.  
> 
>       5.  States and/or the federal government should pay the COBRA premiums
> for low-income people with HIV disease who have left their jobs and cannot
> afford to pay the health insurance premium.  
> 
>       6.  Social Security Disability Insurance (SSDI) beneficiaries who are
> disabled and have HIV disease or another serious chronic health condition
> should have the option of purchasing Medicare during the current two-year
> waiting period.   
> 
>           Medicaid should be required to purchase Medicare coverage for
> low-income SSDI beneficiaries.    
> 
>       7.  The federal government should fund the Ryan White CARE Act at the
> fully authorized level.      
> 
>       8.  The following interim steps to improve access to expensive
> HIV-related drugs should be taken: 
> 
>       (a) adequately reimburse for the purchase of drugs required in the
> prevention and treatment of HIV disease, including clotting factor for
> hemophilia;   
> 
>       (b) undertake, through the Department of Health and Human Services, a
> consolidated purchase and distribution of drugs used in the prevention and
> treatment of HIV disease;   
> 
>       (c) amend the Orphan Drug Act to set a maximum sales cap for covered
> drugs.   
> 
>       Selected Bibliography  
> 
>       Andrulis, D.P., V.B. Weslowski, and L.S. Gage.  1989.  The 1987 U.S.
> hospital AIDS survey.  Journal of the American Medical Association
> 262:784_794.  
> 
>       Antman, K., L.E. Schnipper, and E. Frei.  1988.  The crisis in clinical
> cancer research, third party insurance and investigational therapy.  New
> England Journal of Medicine 319:46_48.  
> 
>       Arno, P.S., and D. Shenson.  1990.  "From AIDS to HIV Disease: 
> Transformation of an Epidemic."  In Community_Based Care of Persons with
> AIDS:  Developing a Research Agenda.  Washington, D.C.:  U.S. Government
> Printing Office.    
> 
>       Arno, P.S., D. Shenson, N.F. Siegel, P. Franks, and P.R. Lee. 1989. 
> Economic and policy implications of early intervention in HIV disease. 
> Journal of the American Medical Association 262:1493_1498.  
> 
>       Asbury, Carolyn.  1991.  "The Orphan Drug Act:  The first 7 years." 
> Journal of the American Medical Association 265(7):893_897.    
> 
>       Benjamin, A.E.  1988.  Long-term care and AIDS:  Perspectives from
> experience with the elderly.  Milbank Quarterly 66:415_443.  Bloom, D., and
> G. Carliner.  1988.  The economic impact of AIDS in the United States. 
> Science 239:604_610.  
> 
>       Centers for Disease Control.  1990.  HIV prevalence estimates and AIDS
> case projections for the United States:  Report based upon  a workshop. 
> Morbidity and Mortality Weekly Report 39(RR-16):1_31.  
> 
>       Centers for Disease Control.  1991.  Mortality attributable to HIV
> infection/AIDS_United States, 1981_1990.  Morbidity and Mortality Weekly
> Report 40:41_55.  
> 
>       Davis, K., R. Bialek, C. Beyrer, P. Chaulk, P. Cowley, and J. Harlow. 
> 1991.  Financing Health Care for Persons with HIV Disease:  Policy Options. 
> A Technical Report Prepared for the National Commission on AIDS.  Baltimore,
> Md.:  Johns Hopkins School of Hygiene and Public Health, August 26.  
> 
>       Fox, D.M.  1990.  Chronic disease and disadvantage:  The new politics
> of HIV infection.  Journal of Health Politics, Policy and Law 15:341_355.  
> 
>       Fox, D.M., and E.H. Thomas.  1990.  The cost of AIDS:  Exaggeration,
> entitlement, and economics.  In L.O. Gostin, ed., AIDS and the Health Care
> System.  New Haven, Conn.:  Yale University Press.  
> 
>       Gage, L.S., V.B. Weslowski, D.P. Andrulis, E. Hintz, and A.B. Camper. 
> 1991.  America's Safety Net Hospitals: The Foundation of Our Nation's Health
> System.  Washington, D.C.: National Association of Public Hospitals.  
> 
>       Gail, M.H., and R. Brookmeyer.  1988.  Methods for projecting course of
> Acquired Immunodeficiency Syndrome epidemic.  Journal of the National Cancer
> Institute 80:900_911.  
> 
>       Green, J., and P.S. Arno.  1990.  The "Medicaidization" of AIDS: 
> Trends in the financing of HIV-related medical care.  Journal of the American
> Medical Association 264:1261_1266.  
> 
>       Griggs, J., ed.  1989.  Simple Acts of Kindness, Volunteering in the
> Age of AIDS.  New York:  United Hospital Fund of New York.  
> 
>       Health Care Financing Administration, Office of the Actuary. 1990. 
> Financing Health Care for People with AIDS:  The Role of the Health Care
> Financing Administration.   Washington, D.C.:  U.S. Government Printing
> Office.  
> 
>       Hellinger, F.J.  1990.  Forecasting the medical care cost of AIDS. 
> Paper presented at the Sixth International Conference on AIDS, San Francisco,
> Calif., June 20_24.  
> 
>       Hellinger, F.J.  1990.  Updated forecasts of the costs of medical care
> for persons with AIDS, 1989-93.  Public Health Reports 105:1_12.  
> 
>       Hellinger, F.J.  1991.  Forecasting the medical care costs of the HIV
> epidemic in the United States:  1991-1994.  Paper presented at the Seventh
> International Conference on AIDS, Florence, Italy, June.  
> 
>       Hiatt, R.A., C.P. Queensberry, J. Selby, B. Fireman, and A. Knight. 
> 1990.  The cost of acquired immunodeficiency syndrome in Northern California: 
> The experience of a large prepaid health plan.  Archives of Internal Medicine
> 150:833_838.  
> 
>       Iglehart, J.  1987.  Financing the struggle against AIDS.  New England
> Journal of Medicine 317:180_184.  
> 
>       Intergovernmental Health Policy Project.  1990.  State financing for
> AIDS:  Options and trends.  Intergovernmental AIDS Reports 3:1_8,12.  
> 
>       Lambert, B.  1989.  Insurance limits growing to curb AIDS coverage. 
> New York Times.  August 7:A1,A10.  
> 
>       Makadon, H.J., G.R. Seage, K.E. Thorpe, and H.V. Fineberg.  1990. 
> Paying the medical cost of the HIV epidemic:  A review of policy options. 
> Journal of Acquired Immune Deficiency Syndrome 3:123_133.  
> 
>       Merlis, M.  1990.  Acquired Immune Deficiency Syndrome (AIDS):  Health
> Care Financing and Services.  Issue Brief 87219.  Washington, D.C.: 
> Congressional Research Service.  
> 
>       Oppenheimer, G.M., and R.A. Padgug.  1991.  AIDS and the crisis of
> health insurance.  In F. Reamer, ed., AIDS and Ethics.  New York:  Columbia
> University Press.  
> 
>       Padgug, R.A., and G.M. Oppenheimer.  1990.  AIDS, health insurance, and
> the crisis of community.  Notre Dame Journal of Law, Ethics and Public Policy
> 5:35_51.  
> 
>       Rango, N., I. Feldman, G. Burke, E. Anderson, and S. Anderman.  1990. 
> Enhanced Medicaid rates for the treatment of HIV.  Paper presented at the
> Sixth International Conference on AIDS, San Francisco, Calif., June 20_24.  
> 
>       Roper, W.L., and W. Winkenwerder.  1988.  Making fair decisions about
> financing care for persons with AIDS.  Public Health Reports 103:305_308.  
> 
>       Rowe, M., and R. Keintz.  1989.  National survey of state spending for
> AIDS.  Intergovernmental AIDS Reports 2:1_10.  
> 
>       Scitovsky, A.  1988.  The economic impact of AIDS in the United States. 
> Health Affairs 7:32_45.  
> 
>       Scitovsky, A.A.  1989.  Studying the cost of HIV-related illnesses: 
> Reflections on the moving target.  Milbank Quarterly 67:318_344.  
> 
>       Scitovsky, A.A., M.W. Cline, and D.I. Abrams.  1990.  Effects of the
> use of AZT on the medical care costs of persons with AIDS in first 12 months. 
> Journal of Acquired Immune Deficiency Syndrome 3:904_912.  Sisk, J.  1987. 
> The costs of AIDS:  A review of the estimates.  Health Affairs 6:5_21.  
> 
>       Stone, D.A.  1990.  AIDS and the moral economy of insurance.  American
> Prospect Spring:62_73.  
> 
>       Thoene, J.G.  1991.  Curing the orphan drug.  Science 251:1158_59.  
> 
>       Yelin, E.H., R.M. Greenblatt, H. Hollander, and J.R. McMaster. 1991. 
> The impact of HIV-related illness on employment.  American Journal of Public
> Health 81:79_84.  
> 
>       Health Care Financing 
> 
>       Side bar pull out information  
> 
>       We can't go any longer in trying to provide care without addressing the
> underlying failures of our health care system.  It's a national shame that we
> do not guarantee health care to all of our people.  We are struggling now
> against enormous odds, both for the acute care needs of people with HIV
> infection as well as the long-term needs of people with HIV infection.  We're
> not going to improve longevity if people can't get into care.   
> 
>       We need to improve our education efforts.  I cannot believe that we
> have not put more resources into education at the community level so that
> both women and men will recognize that they are at some risk for HIV
> infection and can make some kind of informed choice about whether to access
> health care, if it exists, in their community.    
> 
>       Kathryn Anastos, M.D.  
>       June 1991  
> 
>       Footnote 
>       * Material in this chapter is drawn from a technical report prepared
> for the National Commission on AIDS (Davis et al., 1991).  All cost estimates
> and projected savings cited in this chapter are based on information
> submitted by consultants from The Johns Hopkins University School of Hygiene
> and Public Health and The Actuarial Research Corporation to the National
> Commission on AIDS.  Further information regarding these calculations is
> available from the Commission.     
> 
>       I'd like just to make one comment and that's my late realization in my
> career that health care is not a constitutional right.   Health care is a
> business, and that's why we don't have access to health care for everyone.  
> 
>       Carmen Zorilla, M.D. 
>       June 1991  
> 
>       Footnote 
> 
>       * Of course, direct medical care costs are not the only costs of AIDS. 
> As noted by Yelin and colleagues in 1991: ". . . the largest component of
> cost of human immunodeficiency virus (HIV)-related illness is due to lost
> work rather than to direct expenditures for medical care, reflecting the
> onset of this condition among persons in the first half of their careers. .
> . ." Other indirect costs of HIV disease include prevention and education
> programs, screening of the blood and tissue supply, and training of health
> care workers.   
> 
>       Our state department of health currently provides AZT to persons with
> HIV infection providing they have an absolute CD4 cell count of five hundred
> or less.  The department currently has twenty-three PWAs receiving AZT now
> and thirty-six on the list.  
> 
>       Donna Antoine-Perkins 
>       July 1990   
> 
>       The problem is that insurance companies single out these men because
> they do not want the financial burden of taking care of  what they have
> entered into a contract to provide.  Insurance companies cut back on  ways of
> providing health care of these individuals afflicted with HIV by cutting back
> on benefits which keep them alive.  This is a terrible disgrace.  They make
> insurance premiums rise astronomically, forcing people with limited incomes,
> even with employment, to drop their insurance and then receive benefits as
> near as they are from the public sector.  
> 
>       Paul Rothman, M.D.  
>       January 1990             
> 
>       The sobering reality is that health care is indeed rationed in this
> country.  Only the rich can afford it.  Only the employed can attain it. 
> Only the educated can exploit it.  And those who need it are left without it.
> Subsequently, they die faster. We have put a price on living longer.   
> 
>       William Waybourn 
>       July 1990  
> 
>       Our state department of health currently provides AZT to persons with
> HIV infection providing they have an absolute CD4 cell count of five hundred
> or less.  The department currently has twenty-three PWAs receiving AZT now
> and thirty-six on the list.  
> 
>       Last week, we received word that continued additions to the waiting
> list may no longer be possible.   I don't know what's worse; to tell someone
> they are number twenty-seven on a waiting  list of thirty-six or to tell them
> we are no longer accepting names for the waiting list.  
> 
>       Donna Antoine-Perkins 
>       July 1990  
> 
>       The first thing that immediately comes to mind is that what we have is
> a crisis of national health care.   I mean, we have a health care system that
> is just not dealing with the health care needs of people who don't have
> private insurance.  
> 
>       Jim Graham, J.D., L.L.M. 
>       July 1990  
> 
>       I keep getting reoccurring infections, but I can't get Medicaid since
> I get $800 a month from my job.  I have no health insurance.  I can't get
> any.  I had to deny health benefits in order to get my job.  
> 
>       Lorelei Estrada  
>       June 1991      
> 
>                  We have had to face the AIDS epidemic with our limited
> resources since the major financial subsidy for the indigent, Medicaid, has
> an island-wide annual cap of $79 million.  This has restricted substantially
> the use of AZT, much needed by our AIDS patients.  
> 
>       Pedro Borras, M.D. 
>       November 1990  
> 
>       Once I went to a hospital in New York City.  They asked me if I had
> Medicaid.  When they found out I didn't have any Medicaid they didn't want to
> help me.  The nurse said, "Oh, your sores don't look that bad, I've seen
> worse."  My legs hurt so bad I couldn't walk without the crutches I had
> stolen.  They didn't even clean my sores, they just gave me antibiotics and
> put me out on the street to clean them myself.  Now, how am I going to keep
> my sores clean when I was living in the subway ditch?  You know how they are
> going to stay?  Dirty.  
> 
>       Ralph Hernandez 
>       November 1989  
> 
>       Chapter 5  
> 
>       Clinical Trials and Treatment-Related Research    
> 
>       The following chapter deals exclusively with clinical trials and
> related issues of drug development.  Such focus should not be construed as an
> indirect statement about the relative importance of various other research
> endeavors.  In fact, the Commission recognizes and appreciates the importance
> of the larger biomedical research enterprise and the enormous contributions
> it has made to all diseases, particularly HIV disease.  This chapter focuses
> particularly on the extensive attention and input on clinical trials and drug
> development that occurred during months of Commission hearings and
> discussions with people living with HIV disease and their caregivers. 
> Clearly, other areas of research are of critical importance (particularly
> vaccine studies and behavioral and social science research), and the
> Commission will be focusing attention on these areas in the coming year.  
> 
>       Overview 
> 
>       The lack of primary health care services for many people with HIV
> disease has forced them to look to clinical trials for basic primary care, as
> well as for access to experimental treatments.  Although the Commission
> firmly believes access to experimental treatments is an essential component
> of health care services for all people with HIV disease, the Commission also
> believes that obstacles to receiving primary care outside the clinical trial
> setting must be addressed so that the research setting is not the only place
> of access for experimental treatments.  The Secretary of Health and Human
> Services should direct the National Institutes of Health (NIH), the Health
> Care Financing Administration (HCFA), and the Health Resources and Services
> Administration (HRSA) to work together to develop a series of recommendations
> to address the obstacles that keep many people from participating in
> HIV-related clinical trials, as well as the variables that force some people
> to seek participation in trials because they have no other health care
> options.   
> 
>       For people with HIV disease, access to experimental treatments is an
> essential component of their basic health care needs.  The fast pace of
> HIV-related research often results in experimental therapies becoming the
> standard of care for people with HIV disease.  Experimental drugs are the
> only option for many.  Access to these drugs through traditional clinical
> trial programs and the community-based clinical trials program, as well as
> new expanded access programs, is imperative.   
> 
>       New safe and effective drugs to treat HIV disease are urgently needed. 
> Although there are some drugs currently available that either attack the
> human immunodeficiency virus (HIV) or treat or prevent the many opportunistic
> infections that characterize HIV disease, these drugs are, at best, half-way
> measures.  They may extend life and minimize suffering of people with HIV
> disease, but they are far from a cure.  Currently available HIV treatment
> drugs are expensive and the means of delivering them may be cumbersome,
> involving aerosolizers or intravenous infusions.  All of these factors may
> present barriers to those who could benefit from their use.  HIV treatments
> may also be toxic; some patients are unable to tolerate certain drugs. 
> Without new safe and effective drugs, many thousands of people living with
> HIV disease face suffering and death. 
> 
>       In this chapter the Commission looks at how HIV-related clinical trials
> have been conducted, highlights ways in which access to these trials can and
> should be improved, and explores ways in which the drug development and
> approval process can make experimental drugs more accessible to people with
> HIV disease.    
> 
>       Clinical Trials 
> 
>       Typically it takes many years to get drugs from the laboratory bench to
> the pharmacy.  This process includes extensive laboratory testing, animal
> testing for safety, and early human testing.  This sequence of carefully
> designed scientific methods also includes a regulatory process to ensure the
> safety and efficacy of drugs.  These methods and processes have long been in
> place to ensure that information is accurate and that drugs are safe.  For
> many in need of these potentially lifesaving therapies, this process can be
> lengthy, laborious, and frustrating.   
> 
>       Examples abound of drugs, widely believed to be effective, that were
> proved ineffective or even harmful when subjected to rigorous scientific
> study.  In fact, the brief history of the HIV epidemic includes several
> examples of such drugs, such as suramin, which actually hastened the death of
> people with AIDS, and dextran sulfate, which was used widely before it was
> learned that it was not absorbed into the body when taken orally. 
> 
>       The double-blind, placebo-controlled, randomized clinical trial has
> long been considered the most reliable method for evaluating new medical
> interventions.  It has often been regarded as the "gold standard" for the
> establishment of efficacy of proposed new medical treatments.  In ideal
> circumstances, efficacy protocols would include strict entry criteria
> defining a subject's stage of disease, age, and health status, and would be
> designed to minimize the number of confounding variables posed by other
> disease conditions or drug interactions.  Many scientists believe such study
> designs offer the most rapid answers to the question of how well a therapy
> works.   
> 
>       The HIV epidemic, however, has prompted a reassessment of the methods
> of clinical research and the use of placebo controls.  It has brought a new
> sense of urgency and concern about the appropriate balance between the need
> to bring new, safe, and effective drugs to market for treating
> life-threatening illnesses and the need to protect the welfare of
> experimental subjects, many of whom see access to these unproven therapies as
> their only hope.  Some consider this access to experimental therapies a
> right.  The HIV epidemic has also brought a recognition that the validity of
> the scientific process itself depends upon the ability to translate
> scientific findings to the real world.   
> 
>       The strict entry criteria traditionally associated with the controlled
> clinical trial have excluded many who wish to participate in HIV-related
> trials.  
> 
>       Women, drug users, people with hemophilia, and children, among others,
> were initially excluded from HIV-related trials because they did not meet the
> strict entry criteria for participation.  Such criteria made access to
> experimental therapies virtually impossible for whole communities of people
> with HIV disease.  (Later in this chapter the Commission identifies obstacles
> to participation in trials that still exist for people of color, women,
> children, drug users, people with hemophilia, and prisoners.)  The
> appropriate medical management of people with HIV disease often involves the
> use of many different drugs at one time.  Each new complication of HIV
> disease and its prevention or treatment makes entry into a classically
> designed clinical trial difficult since the classically designed protocol
> would attempt to minimize the number of variables posed by other disease
> conditions or drug interactions. 
> 
>       Efforts have been made to address the concerns expressed by many about
> the strict entry criteria for participation in controlled clinical trials. 
> The Commission believes these efforts should continue and be expanded, since
> greater participation by traditionally excluded groups will not only provide
> increased access to experimental therapies for many people with HIV disease
> but will also contribute to a better understanding of how certain
> experimental drugs will actually work outside a scientifically controlled
> environment.   
> 
>       The Commission believes controlled clinical trials are an essential
> part of any comprehensive clinical research program.   Placebo controls are
> warranted in clinical research when no other effective therapy exists, but
> where effective therapies do exist, comparison of new therapies to those
> proven effective are considered appropriate.  The realities of HIV disease
> demand that creativity and flexibility in designing and implementing the 
> trials are equally essential.  Input from representatives of affected
> communities at the earliest stage of study design can minimize
> misunderstandings and improve participation in trials.  The importance of
> autonomy and patient choice, long a central theme of discourse about the
> ethics of human subjects research, should be underscored.  People with HIV
> disease have sought and disseminated information in order to make informed
> choices about whether they wish to assume the risk of participation in
> research.  People with HIV disease have also sought greater involvement on
> research-related advisory councils.  This involvement is now reflected by the
> participation of people with HIV disease on many decisionmaking councils of
> the National Institutes of Health, the Food and Drug Administration, the
> Institute of Medicine, Institutional Review Boards, and other such bodies. 
> The Commission believes the involvement of people with HIV disease on all of
> these councils and advisory bodies has and will continue to enhance
> HIV-related research programs.  The Commission particularly encourages the
> involvement of people of color on these bodies and advisory councils.     
> 
>       The National Institutes of Health, in particular the National Institute
> on Allergy and Infectious Diseases (NIAID), sponsors most of the clinical
> research on HIV.  The AIDS Clinical Trials Group (ACTG) is a national program
> administered by NIAID which sponsors HIV-related clinical trials in academic
> institutions around the country.  Included in this national program is an
> "ACTG-without-walls concept" that specifically conducts clinical studies for
> people with hemophilia.     
> 
>       The ACTG Program has received considerable scrutiny and criticism over
> the past few years from a number of individuals and organizations including
> ACT-UP, the People with AIDS Coalition, members of Congress, the Institute of
> Medicine, and advocates for women, children, and prisoners, among others.  In
> its Third Interim Report to the President and the Congress, the National
> Commission on AIDS also expressed a great deal of concern about the ACTG
> program.  The Commission was particularly concerned about the
> underrepresentation of people of color and women in HIV-related clinical
> trials.  The Commission is pleased to note that NIH has increased the
> participation of people of color and women in their ACTG trials, and strongly
> recommends that these current efforts be continued and increased. 
> 
>       NIAID also sponsors the Community Programs for Clinical Research on
> AIDS (CPCRA).  These programs are designed to encourage the participation of
> persons currently underrepresented in the ACTG Program in well-designed
> trials.  It is important to note that this program should serve as an
> additional research opportunity for underrepresented communities and not as
> a substitute for their participation in ACTG trials.  The program is also
> designed to utilize the considerable expertise and energy of community-based
> physicians and organizations for the conduct of sound research.  The
> Commission continues to consider this to be an imaginative and effective
> program that should be continued and expanded in parallel with steps
> necessary to strengthen the ACTG Program.  The Commission also strongly
> supports CPCRA's emphasis on the prevention and treatment of opportunistic
> infections as the highest scientific priority of the program. 
> 
>       The appropriate balance between research on antiviral drugs (aimed at
> HIV, the underlying cause of AIDS) and drugs targeted for treatment and
> prevention of the many opportunistic infections associated with HIV disease
> has also been a topic of much discussion and concern for many people with HIV
> disease, for members of the research community, and for the National
> Commission on AIDS.  The Commission continues to believe that both areas of
> research are vitally needed and that the dollars to ensure both are
> essential.  Congress should provide sufficient funding to enable NIH to give
> greater priority to research related to opportunistic infections without
> undermining research on antiviral drugs.   Sufficient funding is essential
> for all HIV-related research activities to protect against shifting funds
> from one vital area of research to pay for another.  The development of an
> NIH plan, as recommended by the Institute of Medicine in its study of the
> AIDS Research Program of NIH, would go a long way toward helping to identify
> and plan for HIV-related research priorities and funding needs.  
> 
>       Drug Development _and Approval 
> 
>       The Food and Drug Administration (FDA) is the federal government agency
> with the responsibility to ensure that drugs meet standards of safety and
> efficacy before they are marketed.  FDA does not initiate drug development,
> but rather its regulatory decisions can determine which drugs (developed by
> the pharmaceutical industry, or the government, or both) reach the
> marketplace. 
> 
>       During much of the HIV epidemic FDA has been criticized for not acting
> quickly enough to approve drugs for use in treating HIV disease.  Much of
> this criticism has come from people with HIV disease.  However, there has
> long been criticism of FDA for the length of the drug approval process by
> proponents of deregulation who consider the drug lag to be evidence of
> excessive red tape.  In fact, recently the National Committee to Review
> Current Procedures for Approval of New Drugs for Cancer and AIDS (referred to
> as the "Lasagna Committee" after its Chairman Louis Lasagna, M.D.) reviewed
> FDA activities.  In its August 1990 report, the Committee called for less
> stringent criteria of effectiveness and recommended that FDA "be more
> flexible and permit the use of treatment earlier in the [regulatory] process
> where alternative therapies are unavailable." 
> 
>       There is a great deal of debate over how much and what kind of data
> must be required before FDA will approve a drug for marketing;  but not all
> of the roadblocks to getting drugs to the marketplace involve philosophical
> or scientific disagreements with FDA.  FDA has been grossly underfunded and
> as a result has been hampered by a lack of trained scientists, as well as by
> insufficient facilities and equipment needed to review quickly the data
> submitted by clinical researchers.  Clearly, FDA needs funds and personnel
> commensurate with its important mission to safeguard the public health, and
> in the context of HIV disease, to speed up the pace of drug approval. The
> Commission strongly urges the Congress and the Administration to review FDA's
> budget and provide the funding increases needed to meet the demands placed on
> the agency.  
> 
>       Expanded Access Strategies  
> 
>       From the beginning of the modern era of drug development regulation in
> the early 1960s, there have been provisions for distributing potentially
> lifesaving drugs, not yet licensed for use, to seriously ill individuals. 
> Since that time, it has been possible for physicians to gain access to drugs
> under study through investigational new drug (IND) applications
> ("compassionate use" INDs or investigator INDs).  The rules governing such
> access were never completely codified; the result was an informal process
> that relied heavily on the ingenuity and energy of individual physicians. In
> 1987 the IND regulations for drug trials in serious illnesses were updated. 
> The regulations allowed patients with serious or life-threatening conditions
> to receive drugs under any phase of investigation if there was evidence that
> they "may be effective."  There was much debate about the interpretation of
> these regulations in practice as they applied to HIV disease.  These problems
> led to the search for a mechanism that would allow for widespread
> distribution of promising drugs while they are still under study.  This
> alternative mechanism was dubbed the "parallel track" because it facilitated
> early access to experimental therapies for people who did not qualify for
> inclusion in protocols, in parallel with ongoing, traditional clinical
> trials. 
> 
>       The parallel track permits the use of a drug as early as the end of a
> phase one clinical trial for all patients who are not eligible for
> conventional clinical trials or treatment INDs, and for whom no alternative
> treatments exist.  In May 1990, the parallel track proposal was published in
> the Federal Register for public comment.  These comments were reviewed by the
> Public Health Service in September 1990; the Commission awaits the
> promulgation of a formal policy.   
> 
>       The expanded access arm of the parallel track system was not designed
> to yield reliable information about the efficacy of drugs under treatment.
> There are no control groups and the use of historical controls (retrospective
> comparisons to untreated populations, matched by clinically relevant
> characteristics) is made difficult by the complex nature of HIV disease and
> the rapidly changing treatments that strongly influence the "natural history"
> of the disease.  However, data from the expanded access arm may, if collected
> properly, be useful in monitoring safety and in providing information about
> drug interactions and resistance.  The downside of this potential is that
> data collection requirements continue to be a concern for beleaguered primary
> care physicians and a stumbling block to greater access. 
> 
>       Furthermore, once a drug is widely available, it may be difficult to
> rebut intuitive but poorly substantiated belief in its effectiveness.  Drugs
> introduced for narrowly defined patient groups often gain adherents for
> broader usage that may not be warranted. 
> 
>       Two questions concerning the success of expanded access programs should
> be posed:  (1) Are promising drugs getting to the widest possible group of
> those in need? and (2) Is sufficient information being gathered to allow
> researchers to determine whether drugs are truly effective?  The experience
> with expanded access programs for dideoxyinosine (ddI) and dideoxycytidine
> (ddC) may partially answer these questions. There are also a number of other
> proposals to expand access to experimental drugs, ranging from broadening the
> range of treatment INDs to conditional approval.  FDA should aggressively
> pursue all options for permitting the early use of promising new therapies
> for conditions for which there is no standard therapy or for patients who
> have failed or are intolerant of standard therapy.    
> 
>       Disseminating Information Concerning Research 
> 
>       A repeated concern of people with HIV disease about AIDS drug trials
> has been delay in getting information about promising new drugs to physicians
> and their patients in need.  There are a number of possible venues for the
> release of information about potential breakthroughs in treating HIV disease. 
> Peer-reviewed journal articles have a major advantage over most of the
> alternative means of distributing information, especially the "science by
> press release" process.  Side effects, numbers of subjects, study design, and
> potentially important caveats are usually overlooked when "breakthroughs" are
> announced.  However, some researchers have  withheld critical data while
> awaiting acceptance for publication in peer-reviewed medical journals.  A
> number of journals follow the "Ingelfinger rule" (named after a former editor
> of the prestigious New England Journal of Medicine) enforcing a news embargo
> during consideration of articles and prior to publication of research
> results.  However, in the context of the HIV epidemic many journals have
> amended that policy and now recognize exceptions for information of urgent
> importance to the public health.     
> 
>       The main problem with journal publication of important findings about
> treatment for HIV disease, including zidovudine (AZT), aerosolized
> pentamidine, and corticosteroids, is that publication has lagged as many as
> nine months behind less conventional communications such as press
> conferences, press releases, or abstracts presented at scientific
> conferences.   This delay is difficult to understand for people whose
> survival may be measured in months or a few years.   
> 
>       A number of solutions have been proposed, including: revising the
> timelines for submitting, reviewing, and accepting articles in peer-reviewed
> publications; making articles available on-line as soon as they are accepted
> (even prior to actual publication); and encouraging a standard format for
> release of information to the press. 
> 
>       There is a significant role for federal agencies to play in
> disseminating information about promising new treatments for HIV disease. 
> Each of the following groups has an important role to play:  the National
> Cancer Institute (which administers the Physician Data Query Service), FDA
> (which publishes the FDA Drug Bulletin and places columns in a number of
> leading medical journals), the National Library of Medicine, the Health
> Resources and Services Administration (which funds the AIDS Education and
> Training Centers' program to educate health care providers about AIDS), and
> the Agency for Health Care Policy and Research.  These avenues deserve
> exploration, since the merits of peer review per se are substantial and
> minimizing delay thus becomes the strategy of choice. The Commission
> recognizes that efforts have been made at NIH to facilitate and accelerate
> the dissemination of new information concerning therapeutic interventions and
> alternatives for people living with HIV disease, including the AIDS Clinical
> Trials Information System and Clinical Trials Alerts.  In addition, the
> January 1991 workshop on expedited dissemination of information and the July
> 1991 meeting of a panel convened to develop guidelines on distributing
> information are clearly steps in the right direction.  The Commission urges,
> however, that the worthy objectives of these panels be imbued with the sense
> of urgency appropriate to the status of people progressing through stages of
> HIV disease and in need of intervention.  
> 
>       Access to Clinical Trials for Populations in Need  
> 
>       Some individuals and communities affected by HIV disease have
> experienced considerable obstacles to participation in trials, and the
> Commission wishes to highlight them specifically. 
> 
>       Intravenous drug users are often wrongly assumed to be unwilling or
> unable to comply with research protocols.  In addition, they often have other
> health problems that complicate studies.  Many lack access to primary care
> and, therefore, the information and opportunity to participate in a trial. 
> 
>       People of color have concerns about exploitation that has taken place
> in the research context in the past.  The Commission heard powerful testimony
> about the shadow of the Tuskeegee syphilis study and the significant impact
> the remembrance of this disturbing incident has had on views of many
> African-Americans regarding clinical research.  Much must be done about the
> antipathy for research felt by many people of color.  Increasing the number
> of racial and ethnic minority health professionals would be an important step
> toward addressing this concern.  Every effort must be made to identify,
> nurture, and support researchers indigenous to the communities they serve.  
>   
>       As mentioned earlier in this chapter, women, particularly women of
> color, have traditionally experienced difficulty in qualifying for clinical
> trials.  Obstacles to their participation, including the need for
> transportation and daycare, should be carefully examined and addressed. While
> the Commission recognizes that lack of access to health care seriously
> hampers efforts to recruit underrepresented people into clinical trials, this
> does not mean it is impossible to do so.  Current efforts at NIH to expand
> the recruitment of underrepresented populations in the ACTG have enjoyed
> initial success and should be continued and increased.   Children with HIV
> disease also have many problems with access to experimental treatments;
> again, some problems are unique to HIV and others are not.  The vulnerability
> of children raises special concerns about placing them at risk in
> experimentation, even when there are potential therapeutic benefits for the
> individual children involved or for similarly situated children.  However, as
> the Commission pointed out in its Third Interim Report, science has moved
> forward to the point where the inclusion of children in experimental HIV
> therapies is clearly possible.   
> 
>       Pediatric pharmacology can differ substantially from that of mature
> adults.  Put succinctly, children are not miniature adults in regard to the
> types and dosages of drugs needed for treatment of HIV disease.  As with all
> research involving children, their limited understanding and capacity to
> consent means that proxy decision makers, such as parents or other guardians,
> must speak on their behalf.  In some cases, this raises further concerns
> because of the fragile family and social settings in which children with HIV
> disease are likely to be found.  Aside from a small fraction of
> transfusion-related cases, virtually all HIV-positive children have mothers
> who are themselves infected with HIV and may be sick and dying.  These
> mothers, with limited means and waning energy, are hard-pressed to find
> health care for both themselves and their children and may have serious
> difficulty in conforming to diverse research protocols.  Many young children
> with HIV disease are cared for by relatives other than their parents or are
> placed in foster care.  It may be difficult to secure the necessary consents
> for experimental HIV care; parents who relinquish custody do not necessarily
> give up decisionmaking rights regarding health care. 
> 
>       Concerns about scientific issues and the vulnerability of children as
> research subjects must be carefully balanced with children's need for, and
> right to participate in, research into promising new drugs.  The Commission
> encourages efforts to address the special needs of the growing number of
> children with HIV disease.  
> 
>       People with hemophilia who live far from any ACTG or who are perceived
> of as having co-morbidities of bleeding and liver disease are also often
> excluded from trials.  Such exclusions should be carefully examined and the
> judgment of the person's physician should be respected. Prisoners'
> participation in clinical trials has been hampered by a serious confusion
> about the applicability of federal regulations designed to protect prisoners
> from experimentation abuses.  Many have assumed that human subject
> regulations and prior ethical analysis all but preclude prisoners'
> participation as clinical trial participants; commentators have interpreted
> these regulations to preclude only prisoners' participation on the placebo
> arm of clinical trials.  Practical considerations also pose formidable
> barriers for prisoners.  It is difficult to ensure voluntariness and informed
> consent in the prison setting.  Clinical researchers in academic and
> community settings may find the regulatory, ethical, and logistical stumbling
> blocks too daunting even to attempt enrolling prisoners in trials.  
> 
>       Concerns about research in correctional facilities, discussed in the
> Commission's Fourth Interim Report, warrant close attention because of the
> increasing number of people living with HIV in correctional settings.  The
> Commission reiterates its recommendation that the Department of Health and
> Human Services should issue a statement clarifying the federal policies on
> prisoners' access to clinical trials and investigational new drugs.  In
> addition, FDA, in conjunction with HRSA and NIH, should initiate an
> educational program directed toward informing inmates and health care
> professionals working in correctional facilities of the availability of
> investigational new drugs, expanded access programs, and applicable criteria
> for eligibility of prisoners in prophylactic and therapeutic research
> protocols.   
> 
>       Who Should Pay? 
> 
>       The question of who pays or who should pay for experimental drugs and
> treatments is still a topic of considerable debate.  Many people with HIV
> disease have significant limitations on their private and public health
> insurance coverage, if they have insurance at all.  These limitations are
> typically more severe in the coverage of experimental drugs.  As new
> proposals to expand access to experimental drugs are developed, the debate
> over who should pay is sure to continue to force the government and private
> sector to answer this question. 
> 
>       Traditionally, third-party payers have required evidence of a drug's
> safety and efficacy before routinely providing coverage, often explicitly
> denying coverage for experimental treatments.  Such an approach has a
> profound impact on people with HIV disease, for whom experimental treatments
> are frequently the only recourse.   
> 
>       Third-party payers rely on a few specific sources for coverage
> decisions:  FDA approval for drugs under treatment INDs, National Cancer
> Institute approval of Group C cancer drugs, or a few authoritative medical
> compendia (three are specifically cited in the Medicare Catastrophic Coverage
> Act of 1988).  Relying only on such sources will greatly restrict the
> coverage of many potentially useful drugs, as specific approvals are
> sometimes not sought by the manufacturer; for some drugs and some uses
> approval may never be sought.   
> 
>       In most cases thus far, expanded access drugs for treating HIV disease
> have been provided by pharmaceutical companies free of charge to eligible
> patients, but only if patients are participating in protocols in which
> physicians report on the drug's effectiveness and provide the results of
> laboratory tests.  It should be noted that, even in these special
> circumstances, neither the physician's time nor laboratory services are
> covered by the drug company.   
> 
>       In addition, third-party payers have often been reluctant to reimburse
> for so-called "off label" use of drugs, that is, use for other than
> indications specifically covered on the FDA-approved labeling.  As treatments
> for HIV disease move quickly through the drug approval process, in some cases
> bypassing some traditional phases, the benchmarks usually relied upon by
> third-party payers (public and private) will have to be reconsidered.  The
> Health Insurance Association of America, Blue Cross and Blue Shield, and HCFA
> are all reexamining processes for determining which experimental drugs are
> eligible for coverage and looking at new technology assessment procedures. 
> This reexamination is essential for many HIV-related drugs. 
> 
>       The difficulties in deciding who pays for health care associated with
> research vividly reveals the discontinuity in federal health programs. 
> NIH-based researchers claim no jurisdiction over health care provision, and
> the federal agencies responsible for the reimbursement and delivery of health
> care, HCFA and HRSA, are not designing program strategies that would take
> these research-related issues into account.  As discussed above in this
> chapter, the Secretary of Health and Human Services should direct NIH, HCFA,
> and HRSA to work together to address the health care needs of clinical trial
> participants.  This effort should include the full support and participation
> of the NIH Director of AIDS Research, the Administrator of HCFA, and the
> Administrator of HRSA.   
> 
>       It is important to note that the issue of who should pay the associated
> hospital costs when patients are taking combinations of licensed and
> experimental drugs is another serious problem.  The NIH Reauthorization Bill
> that passed the House of Representatives on July 25, 1991 calls for the
> Department of Health and Human Services to conduct a study to determine the
> policies of third-party payers regarding the payments of certain health
> service costs that are provided as part of an individual's participation in
> clinical trials conducted in the development of HIV-related drugs.  The
> Commission supports this provision and urges its swift implementation.   
> 
>       Access to clinical trials and experimental drugs is essential for all
> people with HIV disease.  Access should be available equally to people in
> need without reference to race, ethnicity, gender, or ability to pay.  The
> following recommendations are made with this priority in mind.  
> 
>       Recommendations  
> 
>       1.  Current efforts at the National Institutes of Health (NIH) to
> expand the recruitment of underrepresented populations in the AIDS Clinical
> Trials Group should be continued and increased. 
> 
>           While the Commission recognizes that lack of access to health care
> seriously hampers efforts to recruit underrepresented people into clinical
> trials, this does not mean it is impossible to do so.  NIH has begun to
> increase participation and should aggressively pursue the participation of
> women and people of color in their clinical trials.    
> 
>       2.  The Secretary of Health and Human Services should direct the
> National Institutes of Health, the Health Care Financing Administration, and
> the Health Resources and Services Administration to work together to develop
> a series of recommendations to address the obstacles that keep many people
> from participating in HIV-related clinical trials, as well as the variables
> that force some people to seek participation in trials because they have no
> other health care options.  
> 
>       3.  The Food and Drug Administration should aggressively pursue all
> options for permitting the early use of promising new therapies for
> conditions for which there is no standard therapy or for patients who have
> failed or are intolerant of standard therapy.    
> 
>       4.  The National Institutes of Health should develop a formal mechanism
> for disseminating state-of-the-art treatment information in an expeditious
> and far-reaching manner. 
> 
>           While the Commission is aware of the efforts at NIH to disseminate
> information about state-of-the-art HIV treatment, the Commission is also
> aware that many health care providers are still not getting the information
> they need to responsibly care for their patients with HIV disease.  The
> Commission believes NIH needs to develop a more formalized mechanism for
> disseminating information in a timely and ongoing fashion and should work
> with the federally funded AIDS Education and Training Centers, as well as
> professional medical societies, to reach as many people as possible.    
> 
>       5.  The Department of Health and Human Services should conduct a study
> to determine the policies of third-party payers regarding the payments of
> certain health service costs that are provided as part of an individual's
> participation in clinical trials conducted in the development of HIV-related
> drugs.   
> 
>       Selected Bibliography  
> 
>       AIDS Coalition to Unleash Power (ACT-UP).  1989.  A National AIDS
> Treatment Research Agenda.  Distributed at the Fifth Annual International
> Conference on AIDS, Montreal, June 4_9.  
> 
>       AIDS Coalition to Unleash Power (ACT-UP).  1990.  A Capsule History of
> ACT-UP.  New York:  ACT-UP.  AIDS Treatment Registry.  1989.  Deciding to
> Enter an AIDS/HIV Drug Trial.  New York:  AIDS Treatment Registry, Inc.  
> 
>       Arras, J.D.  1990.  Noncompliance in AIDS research.  Hastings Center
> Report 20:24_32.  
> 
>       Bayer, R.  1990.  Beyond the burdens of protection:  AIDS and the
> ethics of research.  Evaluation Review 14:443_446.  
> 
>       Breo, D.  1991.  Tired of taking the blame, AIDS drug regulator Ellen
> Cooper quits.  Journal of the American Medical Association 265:1027_1028.   
> 
>       Byar, D.P., D.A. Schoenfeld, S.B. Green, D.A. Amato, and R. Davis. 
> 1990.  Design considerations for AIDS trials.  New England Journal of
> Medicine 323:1343_1347.  
> 
>       Cooper, E.C.  1989.  Controlled clinical trials of AIDS drugs: The best
> hope.  Journal of the American Medical Association 261:2445.  
> 
>       Cotton, P.  1990.  Is there still too much extrapolation from data on
> middle-aged white men?  Journal of the American Medical Association
> 263:1049_1050.  
> 
>       Delaney, M.  1989.  The case for patient access to experimental
> therapy.  The Journal of Infectious Diseases 159:416_419.  
> 
>       Eckholm, E.  1986.  Should the rules be bent in an epidemic?  New York
> Times.  July 13:E30.  
> 
>       Edgar, H., and D.J. Rothman.  1990.  New rules for new drugs:  The
> challenge of AIDS to the regulatory process.  The Milbank Quarterly 68(Supp.
> 1):111_142.  
> 
>       Erdman, K.  1989.  AIDS drugs:  Is the government research program a
> helping hand for patients, or a handout for the pharmaceutical industry? 
> Public Citizen May/June:10_13,16_17.  
> 
>       Freedman, B., and the McGill/Boston Research Group.  1989. Nonvalidated
> therapies and HIV disease.  Hastings Center Report 19(3):14_20.  
> 
>       Green, S.B., S.S. Ellenberg, D. Finkelstein, A.B. Forsythe, and L.S.
> Freedman.  1990.  Issues in the design of drug trials for AIDS.  Controlled
> Clinical Trials 11:80_87.  
> 
>       Gross, J.  1991.  Turning disease into a cause:  Breast cancer follows
> AIDS.  New York Times.  January 7:A1.  
> 
>       Harrington, M., K. Fornataro and J. Eigo.  1990.  A Critique of the
> AIDS Clinical Trials Group.  New York:  ACT-UP.  
> 
>       Henninger, D.  1990.  Will the FDA revert to type?  Wall Street
> Journal.  December 12:A16.  
> 
>       Institute of Medicine.  1987.  An Agenda for AIDS Drug Development. 
> Washington, D.C.:  National Academy Press.  
> 
>       Institute of Medicine.  1991.  The AIDS Research Program of the
> National Institutes of Health.  Washington, D.C.:  National Academy Press.  
> 
>       Institute of Medicine.  1991.  Expanding Access to Investigational
> Therapies for HIV Infection and AIDS.  Washington, D.C.:  National Academy
> Press.  
> 
>       James, J.S.  1989.  AIDS Treatment News.  Berkeley, Calif.: Celestial
> Arts.  
> 
>       Kessler, D.  1989.  The regulation of investigational drugs.  New
> England Journal of Medicine 320:281_288.  
> 
>       Kolata, G.  1988.  Odd alliance would speed new drugs.  New York Times. 
> November 26:A9.  
> 
>       Lasagna, L.  1989.  Congress, the FDA and new drug development:  Before
> and after 1962.  Perspectives in Biology and Medicine  32:322_343.  
> 
>       Levine, C.  1988.  Has AIDS changed the ethics of human subjects
> research?  Law, Medicine & Health Care 16:167_173.  
> 
>       Levine, C.  1990.  Women and HIV/AIDS research:  The barriers to
> equity.  Evaluation Review 14:447_463.  
> 
>       Levine, R.  1988.  Ethics and Regulation of Clinical Research. 2nd
> edition.  New Haven, Conn.:  Yale University Press.   
> 
>       Martin, J.M., and H.S. Sacks.  1990.  Do HIV-infected children in
> foster care have access to clinical trials of new treatments? AIDS & Public
> Policy Journal 5:3_8.  
> 
>       Merigan, T.C.  1990.  You can teach an old dog new tricks:  How AIDS
> trials are pioneering new strategies.  New England Journal of Medicine
> 323:1341_1343.  
> 
>       Merton, V.  1990.  Community-based AIDS research.  Evaluation Review
> 14:502_537.  
> 
>       National Committee to Review Current Procedures for Approval of New
> Drugs for Cancer and AIDS, President's Cancer Panel.  1990. Final Report. 
> Bethesda, Md.:  National Cancer Institute.  
> 
>       National Institute of Allergy and Infectious Diseases (NIAID). 1990. 
> NIAID Responds to ACT-UP Allegations and Demands.  Washington, D.C.:  NIAID
> Office of Communications, National Institutes of Health.  
> 
>       National Institutes of Health. 1990.  AIDS: 1989 Research
> Accomplishments.  Bethesda, Md.: National Institutes of Health.  
> 
>       Nolan, K.  1990.  AIDS and pediatric research.  Evaluation Review
> 14:464_481.  Novick, A.  1989.  Clinical trials with vulnerable or
> disrespected subjects.  AIDS and Public Policy Journal 4:125_130.  
> 
>       Palca, J.  1991.  Conflict over release of clinical research data. 
> Science 251:374_375.  
> 
>       Richman, D.  1989.  Public access to experimental drug therapy:  AIDS
> raises yet another conflict between freedom of the individual and welfare of
> the individual and public.  Journal of Infectious Diseases 159:412_415.  
> 
>       Rothman, D.J.  1987.  Ethical and social issues in the development of
> new drugs and vaccines.  Bulletin of the New York Academy of Medicine
> 63:557_568.  
> 
>       Rothman, D.J.  1987.  Ethics and human experimentation:  Henry Beecher
> revisited.  New England Journal of Medicine 317:1195_1199.  
> 
>       Silverman, W.A.  1986.  Human Experimentation:  A Guided Step into the
> Unknown.  New York: Oxford University Press.  
> 
>       Steinbrook, R., and B. Lo.  1990.  Informing physicians about promising
> new treatments for severe illnesses.  Journal of the American Medical
> Association 263:2078_2082.  
> 
>       U.S. Congress.  House.  1988.  100th Congress, 2d Session.  House
> Committee on Government Operations.  AIDS Drugs:  Where Are They?  Report
> 100-1092.  
> 
>       Valdiserri, R.O., G.M. Tama, and M. Ho.  1988.  The role of community
> advisory committees in clinical trials of anti-HIV agents.  IRB: A Review of
> Human Subjects Research 10(4):5_7.  
> 
>       Vogel, D.  1989.  AIDS and the politics of drug lag.  The Public
> Interest 96:73_85.  
> 
>       Weiss, R., and L. Mazade.  1990.  Surrogate Endpoints in Evaluating the
> Effectiveness of Drugs Against HIV Infection and AIDS.  Washington, D.C.: 
> National Academy Press.   
> 
>       Clinical Trials and Treatment/Related Research 
> 
>       Side bar pull out information:   
> 
>       I have a son who is infected with HIV. . . . He was doing very well, up
> until a couple of months ago.   
> 
>       He had to have his tonsils removed.  And since then, he's been very
> tired and just_he's worn out.  And he's just tired of fighting this whole
> thing.  But he'll hear these little things from people, from school, from the
> media.  "I heard about a miracle cure."  He came home saying,  "Mom, I heard
> about this cure.  You know, can we check on it?  Can we go somewhere in
> France or something?  It comes from some snake's head or something_you know." 
> And he gets his hopes up so much.  
> 
>       And just today when I called to see how he was, he said, "Did you
> testify yet?  Did you tell them?"   
> 
>       He said, "Did you tell them to hurry up and find a cure?"  What do I
> tell him?  What do I tell him now?  I mean he knows ddI is helping  him but
> now what do I tell him when he hears there's something going on in France
> that is definitely a cure?  "It's a real cure, Mom.   It is. That's what
> they're saying."  
> 
>       How do I explain to him that it's maybe not?  What do I tell him?  What
> happens after ddI?  I don't know.  I don't have the answers.  I know what I
> need to tell him, but I don't.  I can't.  He wants to have hope.  I want to
> have hope, but I don't see any hope on the horizon as far as a vaccine goes. 
> He was so excited about a vaccine and I said, well, that wouldn't really help
> you.  It would help other people like us_like your brothers and myself who
> aren't infected.  And he said, "So it wouldn't do a damn thing for me, huh?" 
> 
>       I mean, he deals with it very, very well.  But he's starting to see the
> injustice and the prejudices and I know it's got to hurt.  It's got to hurt,
> but he handles it so well.  I don't know,  I don't know how he does it.  I
> just think he's a remarkable child.  
> 
>       Sheila Swain 
>       March 1991     
> 
>       Recently I met a woman physician who agreed with me that I may be
> experiencing symptoms indigenous to women.   
> 
>       Read my lipstick_women do not have the same symptoms as men.  
> 
>       Sonia Singleton  
>       May 1990   
> 
>       The strategy for treatment is threefold: treating the complications of
> HIV, be they opportunistic infections or neoplasms; direct antiviral therapy;
> and ultimately, if we are successful, to reconstitute the diminished immune
> response, which,  as you could imagine, is something that is really quite
> complex.  
> 
>       Anthony Fauci, M.D. 
>       May 1990     
> 
>       Some of you will tell me that, in the world of drug research and
> approval, it's never gone so quickly as  it has with AIDS; I will tell you
> that in some neighborhoods of this country people have never died so often so
> young  of diseases so ugly as cryptosporidiosis, of MAI, or of a peripheral
> neuropathy. . . . Give us this day our daily death and forgive me  if I
> sometimes sound bitter.  But I have a face in my mind for every AIDS-related
> condition I can describe to you, and sometimes several faces, every one the
> face of a friend either living or dead. . . .  When the process by which we
> test and approve therapies  is so suffocatingly slow, I can see little quick
> relief from the cycle of sickness and death that for a decade now has drained
> my community and rendered our culture incalculably poorer.  
> 
>       Jim Eigo, M.F.A. 
>       May 1990    
> 
>       During the recent NIAID conference on HIV infection and women, some
> observers criticized health officials and researchers for seeing women with
> AIDS mainly as vectors for the transmission of the disease to their male
> partners or children, rather than as a center of attention in their own
> right.  In a way, this same question hovers, unasked, around many discussions
> of AIDS in the African-American community.  Many in the African-American
> community wonder about expressions of distress over AIDS among Black
> Americans in the face of such  remarkable inattention to and disregard for
> the health status of the Black community in general:  "Are they interested in
> the spread of AIDS  because they are concerned about us, or are they
> interested in us only because they are concerned about the spread  of AIDS?" 
> 
> 
>       Mark Smith, M.D., M.B.A. 
>       December 1990    
> 
>       Our medical systems, of course, are going to have to address ways of
> trying to keep pace with this disease, not only in terms of providing care,
> but equally importantly in training individuals who will be able to lead the
> research effort as well as the clinical care demands of the future.  We will
> have to bear the financial burdens for this treatment  and research.  In
> addition the pediatric population also faces potential discrimination, which
> may increase in the future.  
> 
>       Philip Pizzo, M.D.  
>       May 1990   
> 
>       Chapter 6  
> 
>       Government Responsibilities  
> 
>       The lack of a clear definition of government roles and inter-
> governmental partnerships has seriously hampered the nation's response to the
> HIV epidemic.  A comprehensive national HIV plan should be developed with
> full participation of involved federal agencies and with input from national
> organizations representing various levels of government to identify
> priorities and resources necessary for preventing and treating HIV disease. 
> The lack of a national plan seriously impairs efforts to end discrimination,
> to finance health care, to organize and deliver health and social services,
> to recruit and train health care workers, to provide housing for the sick, to
> provide effective AIDS education and prevention programs, and to provide
> substance use treatment.  This chapter identifies government functions that
> are key to controlling the HIV epidemic, considers the extent to which these
> functions are actually fulfilled, and recommends a series of measures for
> improving the response of all levels of government to the HIV epidemic. 
> 
>       Leadership and Partnership 
> 
>       The single most important role for government at all levels in the HIV
> epidemic is leadership:  the ability to inspire citizens, to mobilize
> resources to provide for those in need, and to do so with foresight,
> compassion, and competence.   
> 
>       Appropriate government response to AIDS is a subject of enduring
> controversy.  Elected officials at all levels of government have the
> responsibility to be leaders in this time of health care crisis and should
> exercise leadership based on sound science and informed public health
> practice.  The Commission recognizes that many issues raised by the HIV
> epidemic place pressures on elected officials to pass laws intended to
> respond to constituent fears and concerns.  The Commission, however, is very
> concerned that policies are being enacted into law that are better left to
> scientists and public health experts.  Legislative action should focus on
> full funding of programs that provide necessary research, prevention, and
> treatment programs, and that protect those with HIV disease from
> discrimination. 
> 
>       The social ferment occasioned by AIDS has been great.  It has risen to
> the top of legislative agendas;  nearly one thousand bills related to AIDS
> were proposed in state legislatures in the first decade of the epidemic.  It
> is the most litigated disease in American history.  AIDS is also a persistent
> topic of headline news, although often the news centers on controversies on
> the periphery of the crisis_Should gay bathhouses be closed?  Should children
> with HIV disease be excluded from school?  Should health care workers be
> tested for HIV?_obscuring more central issues, such as the lack of access to
> health care and the lack of treatment opportunities for substance users. 
> 
>       All of this is a predictable consequence of the absence of a strong
> guiding voice.  Committed and informed leadership is necessary to help the
> nation focus on the central issues that must be addressed in order to alter
> the course of the HIV epidemic.  The waning national interest in AIDS has, on
> occasion, been accompanied by a backlash against sustaining levels of or
> commitment to funding for AIDS prevention and education, health care, and
> research.  Some have decried what they perceive to be the privileged status
> of funding for AIDS research and care.  But in contrast to many other
> diseases in society, the upsurge in AIDS deaths and illnesses is ongoing,
> uncontrolled, and in urgent need of further attention.  The word "privileged"
> is especially and poignantly misused in the context of HIV disease.  A
> diagnosis of AIDS confers no privileges; it is a frightening occurrence that
> severely tests physical, emotional, and economic resources. 
> 
>       Leadership is also essential to keeping AIDS at the top of the list of
> urgent national problems. The HIV epidemic will expand, demanding ever
> greater efforts in the years to come.  It should not be allowed to fall off
> the list of national priorities because it seems like old news.  Nor can the
> nation afford to indulge in exasperation or in a misapprehension that the job
> of prevention, care, and research is already done. 
> 
>       Leaders will surely have to take unpopular stands to meet the
> challenges posed by HIV, at least until their efforts begin to bear fruit in
> enhanced public understanding.  Irrational fears must be allayed in order to
> prevent discrimination and to implement the advice of medical and public
> health officials.  Leaders must be willing to speak on behalf of those at
> greatest risk of HIV disease, many of whose voices cannot be heard because
> they live on the margins of society. 
> 
>       It is important to acknowledge the differences among state, county, and
> municipal governments.  In the case of the HIV epidemic, variations in
> government structure and function are complicated by major disparities in the
> prevalence of HIV infection.  Geographic concentration of diagnosed AIDS
> cases was so striking a feature of the earliest phase of the epidemic that a
> few municipalities, counties, and states dominated both development of policy
> responses and consumption of resources.  While the incidence of new infection
> has expanded far beyond these initial epicenters, the relative concentration
> of the epidemic in certain localities has persisted.  Debates continue about
> how to respond to a disease that is unevenly spread throughout the country. 
>  
>       Government_at all levels_must do more to respond to the AIDS epidemic. 
> The lack of government leadership in the epidemic is everywhere evident. 
> Nevertheless, among all the tasks that must be accomplished, only some can be
> done by government.   Even where government is not in a position to respond
> directly, it must still be sufficiently attentive and aggressive in assuring
> that a response is in place.  It is imperative that government play a greater
> leadership role in helping to delineate responsibilities and to create
> effective partnerships among the various levels of government as well as with
> the private sector, especially insurers, foundations, corporations, and
> community-based organizations. 
> 
>       The Persistence of Stigma and Discrimination 
> 
>       In some areas of the country the sheer number of people with HIV
> disease has forced a greater awareness and understanding of the disease and
> of the people living with the disease.  Unfortunately HIV-related
> discrimination is not disappearing as more becomes known about the disease. 
> Surveys of court cases and complaints to human rights commissions show that
> rather than disappearing, AIDS discrimination is changing.  Subtle prejudices
> involving denial of basic health care services are replacing overt forms of
> bias. 
> 
>       The landmark Americans with Disabilities Act (ADA) is a significant
> step toward protecting the rights of all disabled Americans, including people
> with HIV disease.  The passage of the ADA with the inclusion of protections
> for people with HIV disease is a victory worth celebrating.  Nevertheless, it
> would be naive to think that such a law, in and of itself, will eliminate
> discrimination and injustice, any more than the civil rights legislation of
> 1964 has abolished discrimination based on race.  Much will depend upon how
> assiduously the ADA is implemented and enforced.  Implementation of the ADA
> should be carefully monitored, and states and localities should evaluate the
> adequacy of existing state and local antidiscrimination laws and ordinances
> for people with disabilities, including people living with HIV disease. 
> 
>       Discrimination against people with HIV disease continues to be the
> greatest obstacle to effectively and compassionately responding to the HIV
> epidemic.  Even the ADA excludes active drug users, a significant portion of
> the people infected with HIV, from protections against discrimination.  As a
> nation we must look carefully at all of our antidiscrimination laws and
> ordinances (federal, state, and local), work toward the development of
> additional protections where they are needed, aggressively pursue enforcement
> programs, and actively work to educate public and private employers,
> proprietors, and service providers about their lawful requirement to adhere
> to these laws. 
> 
>       Federal Government 
> 
>       While a general lack of leadership has been evident at the federal
> level, there have been a number of important exceptions.  The early and
> pivotal work of the Centers for Disease Control (CDC) in epidemiologic
> studies to determine the modes of transmission of HIV infection was a major
> factor in alerting and informing the world about the epidemic.  The primary
> role played by the National Institutes of Health (NIH) in supporting both
> intramural and extramural biomedical and clinical research is another example
> of federal leadership.  NIH efforts contributed enormously to the rapid
> identification of the causative agent of HIV disease, the development of the
> HIV antibody test, and the development of drugs for treatment of HIV disease. 
> The federal government has also played a leadership role in improving the
> protection of the blood and tissue supply, by accelerating procedures for
> testing licensure, and by production of drugs, vaccines, diagnostic reagents,
> and medical devices. 
> 
>       While these successes are dramatic and noteworthy, the Commission
> believes that serious and substantive problems persist in the coordination of
> planning, policy, and program development among federal agencies.  Within the
> Department of Health and Human Services (HHS), there is still a lack of
> effective coordination between the Public Health Service (PHS) and other
> agencies within HHS.  This is particularly true between PHS, the Health Care
> Financing Administration, and the Social Security Administration. 
> Reimbursement and disability issues are all crucial to the care for many
> people with HIV disease and should be closely linked to research, prevention,
> and care programs.   An even greater potential for gaps exists between HHS
> programs and other non-health-related federal agencies.  This coordination
> could be significantly enhanced by the adoption of a national plan for HIV
> including a mechanism for interdepartmental coordination within the federal
> government. 
> 
>       Although the National AIDS Program Office is designated as the
> coordinating agency for HIV within PHS and reports to the Assistant Secretary
> for Health, there is no cabinet-level coordinating group to deal with HIV,
> nor has a single agency been designated with the responsibility for AIDS
> programs.  One glaring example of the absence of coordination serves to
> illustrate the need for improved cabinet-level communication and
> cooperation_the longstanding impasse over policy regarding restrictions on
> the travel and immigration of HIV-infected individuals.  This impasse arose
> because of an infrequently used relationship between HHS and the Department
> of Justice, and in particular, because of the unwillingness of the Department
> of Justice to defer to HHS officials on matters of public health. 
> 
>       The Commission is aware that there are a number of federal HIV
> coordinating groups at this time and that PHS is currently finishing a
> strategic plan for HIV policies and programs.  There is a leadership group
> within PHS to resolve HIV-related policy issues; there is a PHS Executive
> Task Force on AIDS;  and there is a federal coordinating committee that
> includes federal agency heads. 
> 
>       Unfortunately, the coordinating groups as constituted do not have the
> breadth or the authority needed to meet the challenge of HIV disease.  When
> coordination does take place it is most likely to occur among health-related
> agencies (especially within PHS).  Yet non-health-related HIV issues arise
> with sufficient frequency to warrant more inclusive coordinating bodies. 
> Such issues include housing, immigration, criminal justice, and corrections. 
> Some mechanism is needed that would support ongoing consultations among all
> federal departments, such as the Department of Housing and Urban Development,
> the Department of Justice, the Department of State, and other departments and
> agencies that deal with AIDS-related policy issues.  This coordination must
> also take place at the highest level of each department.  Although it is
> important for agency staff members to meet regularly to cement working
> relationships, it is also critical that cabinet secretaries themselves forge
> the broad policy outlines.  
> 
>       Technical Assistance _and Evaluation 
> 
>       State and local governments need a much broader form of technical
> assistance from the federal government than is currently envisioned or
> provided by any one agency.  Usually, assistance does not extend through the
> life of a program;  it is narrowly confined to the particular program and is
> primarily attuned to the needs of the granting agency. To some extent, a
> model for a broader form of technical assistance or capacity building existed
> during the 1970s in the CDC regional centers for training and technical
> assistance in the areas of sexually transmitted diseases and tuberculosis. 
> Although HIV technical assistance would have to span an even broader range of
> programs and agencies, the defining characteristics of such centers could be
> usefully applied.  Staff at these centers were permanently assigned to
> fostering state and local competence and were able to assist state and local
> governments in evaluating and developing policies and programs, in training
> staff, and in planning for future needs.  Support of this kind would require
> a substantial change in the way federal agencies do business_in effect, it
> would require the creation of field technical assistance teams not tied to
> specific federal programs or funding streams. 
> 
>       A related but separate need exists for technical assistance and
> capacity building for community-based organizations.  Such assistance would
> include financial management, personnel recruitment and management, program
> planning, and evaluation systems, as well as program and policy issues more
> directly related to HIV prevention and treatment. A fundamental and
> persistent problem in the development of policies and programs at all levels
> of government has been the lack of adequate evaluation.  Even now, a decade
> into the epidemic, new programs continue to be introduced with inadequate
> evaluation designs and processes.  Without such evaluations the ability to
> discern useful strategies is lost, and continued funding of effective public
> programs may well be jeopardized through lack of supporting data and
> documentation. One critical factor contributing to the failure to evaluate
> public programs has been a marked degree of confusion about which level of
> government, and which agency at each level, is responsible for evaluation. 
> Clear decisions are needed concerning which agency requires the evaluation,
> which provides technical assistance, who funds it, and who ensures that it is
> done and renders the results both accessible and understandable.  Outside
> observers often criticize program administrators for failing to evaluate
> their own programs when in fact operating agencies rarely have the funds or
> technical assistance required to make such analyses.  This could be addressed
> by increased funding for evaluation and by a concentrated federal effort to
> develop and provide technical assistance in the specific area of evaluation. 
>  
>       Often funds for technical assistance and evaluation are included in
> administrative budgets for public programs.  This almost invariably results
> in inadequate support, both in absolute terms and as a proportion of program
> funds.  Reasons given for this include legislative concern over the propriety
> of large administrative budgets and limited support for appropriating money
> to state and local government for evaluation and technical assistance.  This
> has been the case particularly when federal dollars have been limited and
> when a choice had to be made between putting the money into the actual
> delivery of services or into administration.    State and local governments
> have a substantial need for technical assistance, evaluation, and program
> dollars.  These activities should not be forced to compete with each other. 
> For example, full funding of the Ryan White CARE Act is required to meet both
> the operational and administrative needs of CARE Act programs.  There is a
> critical need for more broad-based technical assistance and capacity building
> in all HIV-related programs.  In addition, ways must be found to ensure that
> new programs are responsive to local needs. 
> 
>       There is also a notable lack of agencywide guidance for program
> evaluation within CDC, the Health Resources and Services Administration
> (HRSA), the National Institute on Drug Abuse, and other PHS agencies.  Such
> leadership should emphasize the short-term development of information that
> will be useful in further policy planning and in program design and
> implementation.  Evaluation plans are most objective and useful when they are
> developed before programs are implemented; but unfortunately at present they
> are almost exclusively designed and instituted after programs have been
> implemented.  This results in unnecessary complexity, undue delay, and
> greater costs than the information produced would warrant.  Finally, to
> warrant investment in them, evaluations must be synthesized and disseminated
> in a manner useful to state and local agencies. 
> 
>       Coordination   
> 
>       As noted above, federal HIV-related programs are housed in a number of
> federal agencies, without a coordinating body or lead agency to track and
> resolve contradictory and overlapping program elements.  States and
> localities are left to cope with funding and administrative requirements that
> expand their own bureaucracies and limit their flexibility.     With the
> implementation of the CARE Act have come some improvements in interagency
> coordination within PHS, particularly between HRSA and CDC.  Neither Congress
> nor federal agencies are preparing adequately, however, for the growing
> discrepancy between available re-sources and caseloads of HIV-infected
> persons.  Plans should be undertaken with a sense of urgency to make changes
> in policies, structures, functions, and uses of public monies to cope with
> dramatic expansion of needs.  Plans must also be made to cope with shifts and
> evolutions in relationships between government and private partners.  
> 
>       The necessity of planning cannot be overemphasized.  It is all the more
> pressing in light of the critical budget deficits at federal, state, and
> local levels (which are at their worst in some of the states with the highest
> prevalence of HIV disease).  Research on the cost-effectiveness of
> alternative policies and programs should be a key component of this planning
> process.    
> 
>       Limitations of Research _and Demonstration Programs 
> 
>       Federal, state, and local agencies have frequently found themselves
> resorting, de facto, to the use of research funds to pay for outreach and
> health care delivery services.  This occurs because of a high level of need
> for direct services and insufficient funds to meet that need.  Sometimes
> programs begin as demonstration projects for services and are "retrofitted"
> as re-search studies.  Under such circumstances services are in serious
> jeopardy if and when the demonstration has been judged successful and the
> research is concluded.  Often the research agencies that funded the projects
> initially argue that they are not authorized to continue service delivery
> beyond the specific demonstration programs.  Thus there may be an abrupt
> cessation of care for desperately ill people.  Further, the services
> themselves are "cadillac models" developed with research funds and are
> sometimes too expensive to implement on a larger scale.  Yet dependent
> populations and political constituencies understandably may protest the
> significant curtailment of care. 
> 
>       State Government 
> 
>       Many states have organized comprehensive planning processes or have
> worked extensively with health care providers, employers, volunteer groups,
> and others in the development of policies for HIV prevention and treatment. 
> Nevertheless, problems of coordination among state agencies are common. 
> These problems have been exacerbated by the rapid growth of HIV programs and
> by the fact that staff in agencies other than public health departments are
> often unfamiliar with HIV-related issues.  These problems become even more
> critical in light of state deficits, as states may be forced into
> uncoordinated and even contradictory policies in response to federal funding
> streams. 
> 
>       These difficulties have existed since the onset of the epidemic.  As
> noted above, recent budget deficits have developed in many areas with
> moderate-to-high HIV prevalence rates.  The pressures of these deficits are
> likely to erode existing programs and to leave states, counties, and
> municipalities unable to meet the rising tide of need for HIV services.  The
> same financial crises may also make it all but impossible for these
> localities to comply with or fulfill the intent of federal programs when
> maintenance of level-of-effort or matching funds are required. 
> 
>       Local Government _(County and Municipal) 
> 
>       A number of examples of extraordinary leadership on the local level
> have emerged in recent years.  Many county and municipal governments have
> established comprehensive planning processes that involve not only health
> care providers and public health leaders, but also a much broader base of
> citizens, HIV-infected individuals, and representatives of impacted
> communities.  Also, many counties and municipalities have worked successfully
> with employers to sponsor policies against discrimination and          to
> educate employers, health care providers, community and religious
> organizations, and other public sector agencies including police, emergency
> services, and schools. 
> 
>       The capacities of some county and municipal governments are strained,
> however, by jurisdictions too small to support adequate county and municipal
> health departments.  These small counties and cities operate without the
> public health programs and competence necessary to organize effective
> HIV-related (or other) public health and medical programs. County and
> municipal governments are increasingly overwhelmed by the demands of
> providing access to medical care services (HIV-related and non-HIV-related). 
> Although local government is the provider of last resort for a growing
> population of medically indigent people, tax revenues are diminishing in
> proportion to the programs now delegated to local government, and access to
> care must compete with many other important social programs including
> education, public safety, and general assistance. Lack of information and
> technical assistance is as critical a problem at the local level as it is for
> state agencies.  State and federal agencies provide no systematic information
> or technical assistance regarding HIV program design, management, and
> effectiveness.   
> 
>       All levels of government must exhibit strong leadership and improve
> their response to the HIV epidemic.  The following recommendations should be
> adopted immediately.    
> 
>       Recommendations  
> 
>       1.  A comprehensive national HIV plan should be developed with the full
> participation of involved federal agencies and with input from national
> organizations representing various levels of government to identify
> priorities and resources necessary for preventing and treating HIV disease. 
>  
> 
>           To develop the comprehensive national HIV plan, the Commission
> calls upon the President of the United States to designate an individual or
> lead agency with the authority and responsibility for instituting a
> cabinet-level process to articulate the federal component of an HIV plan,
> develop a mechanism for interagency as well as state and local participation
> and coordination, and establish a timeline for completion of key tasks.  
> 
>       2.  All levels of government should develop comprehensive HIV plans
> that establish priorities, ensure consistent and comprehensive policies, and
> allocate resources. 
> 
>           These plans should build on the national HIV plan and be developed
> at the state level with clear direction and support from each governor and at
> the appropriate local level (city or county) with clear direction and support
> from the appropriate locally elected official body.  Each level of government
> should have an HIV Advisory Committee that is composed of representatives of
> diverse community-based organizations; the private sector; religious
> organizations; public safety officials; people living with AIDS; housing,
> health, and social service agencies; and other appropriate  representatives. 
>   
>           The Commission recognizes that most states and many local
> governments may have an HIV plan.  However, these existing plans should be
> carefully reviewed to ensure that they are up to date and comprehensive, and
> that they coordinate the entire spectrum of prevention and treatment
> services.  
> 
>       3.  Implementation of the Americans with Disabilities Act should be
> carefully monitored, and states and localities should evaluate the adequacy
> of existing state and local antidiscrimination laws and ordinances for people
> with disabilities, including people living with HIV disease.  
> 
>       4.  Elected officials at all levels of government have the
> responsibility to be leaders in this time of health care crisis and should
> exercise leadership in the HIV epidemic based on sound science and informed
> public health practices.   
> 
>           The Commission recognizes that many issues raised by the HIV
> epidemic place pressures on elected officials to pass laws intended to
> respond to constituent fears and concerns.  The Commission, however, is very
> concerned that policies may be enacted into law that are better left to
> scientists and public health experts.  Legislative focus should be on full
> funding of HIV-related research, prevention, and treatment programs and on
> protecting those with HIV disease from discrimination.  
> 
>       5.  The federal government should develop an evaluation and technical
> assistance component for all federally funded HIV-related programs. 
> 
>           Understanding what works and why is essential to the development of
> effective prevention and care services for people living with HIV disease. 
> It is essential that all HIV-related prevention and treatment efforts be
> evaluated and that the information be integrated into all planning,
> prevention, and health care delivery programs.  
> 
>       Selected Bibliography  
> 
>       Abt, C.C., and K.M. Hardy, eds.  1990.  AIDS and the Courts. Cambridge,
> Mass.:  Abt Books Inc.  
> 
>       American Bar Association (ABA).  1989.  Policy on AIDS and the Criminal
> Justice System.  Resolution Adopted by the House of Delegates.  Chicago,
> Ill.:  American Bar Association.   
> 
>       American Bar Association (ABA).  1990.  Policy on AIDS.  Chicago, Ill.: 
> American Bar Association.  
> 
>       Annas, G.J.  1991.  Back to the future:  The IOM report reconsidered. 
> American Journal of Public Health 81:835_837.  
> 
>       Association of State and Territorial Health Officials (ASTHO). 1987. 
> Guide to Public Health Practice:  AIDS Confidentiality and
> Anti-Discrimination Principles:  Interim Report.  Washington, DC.: 
> Association of State and Territorial Health Officials.      
> 
>       Brandt, A.  1985.  No Magic Bullet:  A Social History of Venereal
> Disease in the United States Since 1880.  New York:  Oxford University Press. 
> 
> 
>       Cunningham, I.  1989.  The public controversies of AIDS in Puerto Rico. 
> Social Science and Medicine 29:545_553.  
> 
>       Dalton H.L., S. Burris, and the Yale AIDS Law Project, eds.  1987. AIDS
> and the Law.  New Haven, Conn.:  Yale University Press.   
> 
>       Gostin, H.O.  1989.  The politics of AIDS:  Compulsory state powers,
> public health, and civil liberties.  Ohio State Law Journal 49:1017_1058.  
> 
>       Gostin, L.O. L. Porter, and H. Sandomire, 1990.  U.S. AIDS Litigation
> Project:  Objective Description of Trends in AIDS Litigation.   Volume II. 
> Contracct with the Office of the Assistant Secretary of Health, Department of
> Health and Human Services.  Washington, D.C.:  U.S. Government Printing
> Office.   
> 
>       Gostin, L.O., ed.  1990.  AIDS and the Health Care System.  New Haven,
> Conn.:  Yale University Press.   
> 
>       Gostin, L.O.  1990.  The AIDS litigation project:  A national review of
> court and human rights commission decisions.  Part II. Discrimination in
> education, employment, housing, insurance and health care.  Journal of the
> American Medical Association 263:2086_2093.  
> 
>       Gostin, L.O., L. Porter, and H. Sandomire.  1990.  U.S. AIDS Litigation
> Project:  A National Survey of Federal, State and Local Cases Before Courts
> & Human Rights Commissions.  Volume I.  Contract with the Office of the
> Assistant Secretary of Health, Department of Health and Human Services. 
> Washington, D.C.:  U.S. Government Printing Office.   
> 
>       Gostin, L.O., L. Porter, and H. Sandomire.  1990.  U.S. AIDS Litigation
> Project:  Objective Description of Trends in AIDS Litigation.  Volume II. 
> Contract with the Office of the Assistant Secretary of Health, Department of
> Health and Human Services.  Washington, D.C.:  U.S. Government Printing
> Office.     
> 
>       Hunter, N.  1990.  Epidemic of Fear_A Survey of AIDS Discrimination in
> the 1980's and Policy Recommendations for the 1990's.  New York:  American
> Civil Liberties Union AIDS Project.  
> 
>       Institute of Medicine.  1988.  Confronting AIDS:  Directions for Public
> Health and Research.  Washington, D.C.:  National Academy Press.   
> 
>       Institute of Medicine.  1989.  The Future of Public Health. 
> Washington, D.C.:  National Academy Press.  
> 
>       Intergovernmental Health Policy Project AIDS Policy Center.  1989. 
> Policy Maker's Guide on AIDS.  Washington, D.C.:  Intergovernmental Health
> Policy Project.    
> 
>       Intergovernmental Health Policy Project AIDS Policy Center.  1989. 
> State AIDS Legislation Related to Worker Notification and Exposure: 1983_88. 
> Washington, D.C.:  Intergovernmental Health Policy Project.    
> 
>       Intergovernmental Health Policy Project AIDS Policy Center.  1989. 
> State Laws Governing Confidentiality of HIV-Related Information.  Washington,
> D.C.:  Intergovernmental Health Policy Project.    
> 
>       Intergovernmental Health Policy Project AIDS Policy Center.  1991.  A
> Summary of HIV/AIDS Laws From the 1990 State Legislative Sessions. 
> Washington, D.C.:  Intergovernmental Health Policy Project.    
> 
>       National Association of Counties Task Force on HIV Infection and AIDS. 
> 1989.  County Government and HIV Infection.  Washington, D.C.:  National
> Association of Counties.    
> 
>       Panem, S.  1988.  The AIDS Bureaucracy.  Cambridge, Mass.:  Harvard
> University Press.    
> 
>       Parmet, W.  1990.  Discrimination and disability:  The challenges of
> the ADA.  Law, Medicine & Health Care 18:331_344.  
> 
>       Rowe, M., and C. Ryan.  1989.  A Governor's Policy Guide on AIDS. 
> Washington, D.C.:  National Governor's Association.    
> 
>       Stoddard, T.B., and W. Rieman.  1990.  AIDS and the rights of the
> individual:  Toward a more sophisticated understanding of discrimination. 
> Milbank Quarterly 68:143_174.    
> 
>       United States Conference of Mayors.  1991.  The Impact of AIDS on
> America's Cities. Washington, D.C.:  United States Conference of Mayors.  
> 
>       Government Responsiblities 
> 
>       Side bar pull out information:  
> 
>       From my travels and involvement with the National Association of People
> with AIDS,  it has become painfully obvious that most of the country, if not
> the entire nation, does not have coordinated, collaborative, and consistent 
> social and health care services.  The tens of thousands of those of us who
> are infected with the human immunodeficiency virus are crying out for local,
> state, and national leadership.  The majority of the time we feel that no one
> is listening, that we have been abandoned by our government and our society. 
>              
>       The HIV epidemic is much too large for national, state, and local
> organizations and governments  to address separately or without some vehicle
> for coordination and direction.  Our attempts during the last eight years
> have been incomplete, results spotty, and victories few and far between. 
> Innovative solutions are required if our institutions are not to be  brought
> any closer to the brink of disaster or chaos.   
> 
>       James Smith   
>       January 1990  
> 
>       Timidity at the top creates tremendous burdens for the troops at the
> bottom.  
> 
>       Tim Wolfred 
>       January 1990    
> 
>       Nearly one thousand bills related to AIDS were proposed in state
> legislatures in the first decade of the epidemic.  It is the most litigated
> disease in American history.  
> 
>       I urge you as a Commission to insist that the President and Congress
> break the silence of denial and speak out candidly about ways to curb the
> spread of the HIV virus and why those who are infected deserve our love and
> compassion.  
> 
>       Brian Coyle 
>       January 1990    
> 
>       Too often we are denied services or cannot find services that
> adequately address the real needs in  our lives because of gender issues,
> economic issues, politics, racism, sexism, and because we do not yet have  a
> single strong voice of advocacy.  We are so preoccupied with meeting the
> needs of others that there is never enough attention  focused on our own
> needs.  Many of us are poor and must improvise and compromise ourselves or
> simply do without much needed support, basic services, love and attention,
> and all of the simple things in life which help people develop whole and
> wholesome attitudes about themselves.  
> 
>       Janice Jireau 
>       June 1991       
> 
>       Most of the key transactions that affect the health of people take
> place in households, in neighborhoods, in communities.  So finally, those of
> us at the federal level are two steps removed, and even state health
> officials are one step removed from  where things really happen at the
> community level.  I believe that the most important  thing I can do as a
> federal official is to work to strengthen local public health agencies across
> the country.  
> 
>       William Roper, M.D., M.P.H. 
>       September 1990    
> 
>       What I'd like to do is try to bring to you the perspective of the local
> health officer and the local health department as we have responded to the
> HIV epidemic.  It is not an easy task because the response has been very
> diverse locally.   It has been diverse due to different resources, due to
> different attitudes in the communities, and certainly due to different
> traditions in the communities and different support among the political
> leadership of the local communities.  
> 
>       William Myers, M.S. 
>       September 1990    
> 
>       Conclusion    
> 
>       Over the past two years the National Commission on AIDS has called for
> federal leadership in the HIV epidemic and for the  creation of partnerships
> at all levels of government and in the  private sector.  We have also
> emphasized the need to develop and assure access to a system of health care
> for all people with HIV disease.  The fundamental right of all people with
> HIV disease to be protected against discrimination has guided all of our
> work.  We have conducted numerous hearings and site visits, heard from nearly
> one thousand people across the country, and have issued a series of interim
> reports designed to focus on topics that we thought were particularly
> important and urgent to bring to the  attention of the President and
> Congress.  This report is intended to underscore the importance of all of
> these efforts, as well as linking HIV prevention, care, treatment, and
> research, and improving the coordination of all of the mechanisms designed to
> pay for these programs. 
> 
>       In the coming year, the National Commission on AIDS will continue to
> bring urgent matters to the attention of the President and the Congress; to
> monitor the adoption and implementation of the recommendations contained in
> this report; to seek to build a broad public understanding on the magnitude,
> scope, and urgency of the HIV epidemic; to provide and inspire leadership at
> all levels of both public and private sectors; and to advocate for effective,
> cooperative, and nondiscriminatory systems and resources required for the
> prevention, comprehensive care and treatment, and research necessary to halt
> the epidemic. There is still much to do. The National Commission on AIDS
> calls on all of our nation's leaders to enter into partnership with us to
> work with the individuals and  communities throughout the United States who
> have for too long felt forgotten or abandoned by their government.  
> 
>       CUMULATIVE RECOMMENDATIONS  
> 
>       PREVENTION AND EDUCATION  
> 
>       1.  The federal government should establish a comprehensive national
> HIV prevention initiative.  
> 
>           This initiative should be authorized by Congress and developed by
> the Department of Health and Human Services.  It should provide flexible
> resources to state and local government and other public or private nonprofit
> entities for communitywide HIV prevention efforts.  It must also include
> input from individuals who have expertise through experience, education, or
> training.  The prevention initiative is an essential component of a national
> HIV plan.  
> 
>       2.  Greater priority and funding should be given to behavioral, social
> science, and health services research. 
> 
>           Behavioral, social science, and health services research are
> currently grossly underfunded.  The Commission believes there must be a more
> appropriate balance of funding between these areas of study and biomedical
> research.  
> 
>       3.  Congress should remove the government restrictions that have been
> imposed on the use of funds for certain kinds of HIV education, services, and
> research. 
> 
>           Government restrictions on certain HIV programs and on behavior-
> oriented research studies impede the fight against HIV disease.  HIV
> prevention programs and research into sexual and drug using behaviors must be
> conducted and evaluated.  Results from these and other health promotion and
> disease prevention efforts must be shared and rapidly incorporated into HIV
> prevention and education strategies.  
> 
>       4.  The U.S. Public Health Service should expand and promote
> comprehensive programs for technical assistance and capacity building for
> effective long-term prevention efforts.  
> 
>       5.  Federal, state, and local governments should join forces with the
> private sector in providing long-term support to community-based
> organizations. 
> 
>           Community-based efforts are now and will continue to be an integral
> part of any HIV prevention strategy.  The role of people with HIV disease
> must be recognized, encouraged, and supported.  In designing services,
> community-based organizations and their programs must be accountable, yet
> they must be afforded sufficient flexibility to implement programs that will
> best serve communities in need.  
> 
>       6.  Policies should be developed now to address future plans for the
> distribution of AIDS vaccines and the ethical and liability issues that will
> arise when vaccines become available.  
> 
>       7.  The federal government should expand drug abuse treatment so that
> all who apply for treatment can be accepted into treatment programs.  The
> federal government should also continually work to improve the quality and
> effectiveness of drug abuse treatment.  
> 
>       8.  Legal barriers to the purchase and possession of injection
> equipment should be removed. 
> 
>           Legal barriers do not reduce illicit drug injection.  They do,
> however, limit the availability of new, clean injection equipment, thereby
> encouraging the sharing of injection equipment, and the increase in HIV
> transmission.  
> 
>       Caring for people with hiv disease  
> 
>       1.  Government should assure access to a system of health care for all
> people with HIV disease. 
> 
>           At a minimum, a system of care for all people with HIV disease
> should include a package of continuous and comprehensive medical and social
> services designed to enhance quality of life and minimize hospital-based
> care.  States, counties, and municipalities should assure that such services
> are available for individuals with HIV disease.  Case management programs
> should be available to coordinate such care.  These services must include: 
> 
>          y  IV antibody testing that is voluntary and must be accompanied by
>             counseling_both anonymous and confidential testing contribute in
>             different ways and both options should be available; 
> 
>          y  education and counseling to help foster and maintain behavioral
>             changes to reduce transmission of the virus; 
> 
>          y  medical care, including drug therapy and frequent diagnostic
>             monitoring, ongoing primary care, coordination of inpatient and
>             outpatient care, access to investigational new therapies, and
>             adequate options for long-term care; 
> 
>          y  psychological care, including mental health counseling and
>             spiritual support, that is helpful in coping with a frightening
>             and sometimes overwhelming condition; 
> 
>          y  drug treatment to help individuals stop using or injecting drugs
>             or adopt safer drug use practices; and 
> 
>          y  social services, including a range of housing options and income
>             maintenance, without which medical advances may be beyond the
>             grasp of those who could most benefit from them.  
> 
>       2. HIV-related services should be expanded to facilities where
> underserved populations receive health care and human services, in part to
> ensure their increased participation in trials of investigational new
> therapies.  
> 
>       3. HIV education and training programs for health care providers should
> be improved and expanded, and better methods should be developed to
> disseminate state-of-the-art clinical information about HIV disease, as well
> as drug and alcohol use, to the full range of health care providers. 
> 
>          The Commission believes all health care providers have an ethical
> responsibility to care for people with HIV disease.  In order to equip
> providers to better counsel and care for people with HIV disease, government
> at all levels and local agencies and institutions must develop more effective
> education programs and methods for getting the information to all providers,
> particularly primary care providers. 
> 
>          Programs to train health care providers to recognize and manage drug
> and alcohol use must be expanded, and programs that integrate treatment of
> drug use with primary care must be created and supported.  The Commission
> believes more federal funds are needed for these efforts.  
> 
>       4. Federal, state, and local entities should provide support for
> training, technical assistance, supervisory staff, and program coordination
> to acknowledge and support the family members, friends, and volunteers who
> are an integral part of the care system of a person with HIV disease.  
> 
>       HEALTH CARE FINANCING  
> 
>       1. Universal health care coverage should be provided for all persons
> living in the United States to ensure access to quality health care services.
> 
> 
>          The Commission believes universal health care coverage is a
> necessary step to ensuring access to quality health care.   This coverage
> should be comprehensive and should include prescription drugs.  In the
> interim, the Commission recommends a series of immediate short-term steps to
> address the urgent problem of inadequate coverage for people with HIV
> disease.     
> 
>       2. Medicaid should cover all low-income people with HIV disease. 
> 
>          The Commission recommends eliminating the disability requirement and
> raising the income level for Medicaid eligibility for people with HIV
> disease.  By eliminating the disability requirement, low-income people with
> HIV infection who have not had a clinical diagnosis of AIDS could be covered
> by Medicaid and receive the early intervention treatments and services they
> need.  Increasing the income eligibility requirement would prevent many
> people with HIV infection from having to impoverish themselves in order to
> qualify for basic health care services.  At the same time it would relieve
> some of the reliance on public hospitals by the uninsured.   
> 
>          The Commission strongly believes these changes should be mandated;
> however, at the very least, states should be given the option of making these
> changes.  In addition, the Commission believes these changes can and should
> lead to further changes that will include people with serious chronic
> conditions other than HIV disease.  
> 
>       3. Medicaid payment rates for providers should be increased
> sufficiently to ensure adequate participation in the Medicaid program. 
> 
>          Unrealistically low reimbursement rates under the Medicaid program
> serve as a serious disincentive for health care providers to care for people
> who rely on Medicaid.  Medicaid rates should be raised to Medicare levels.  
>  
> 
>       4. Congress and the Administration should work together to adequately
> raise the Medicaid cap on funds directed to the Commonwealth of Puerto Rico
> to ensure equal access to care and treatment.  
> 
>          Because of the existing cap on Medicaid funds allocated to the
> Commonwealth of Puerto Rico, none of the Medicaid recommendations the
> Commission has put forward to expand benefits for people with HIV disease
> would include individuals living in this part of the United States.  
> 
>       5. States and/or the federal government should pay the COBRA premiums
> for low-income people with HIV disease who have left their jobs and cannot
> afford to pay the health insurance premium.  
> 
>       6. Social Security Disability Insurance (SSDI) beneficiaries who are
> disabled and have HIV disease or another serious chronic health condition
> should have the option of purchasing Medicare during the current two-year
> waiting period.   
> 
>          Medicaid should be required to purchase Medicare coverage for
> low-income SSDI beneficiaries.    
> 
>       7. The federal government should fund the Ryan White CARE Act at the
> fully authorized level.    
> 
>       8. The following interim steps to improve access to expensive
> HIV-related drugs should be taken: 
> 
>             (a) adequately reimburse for the purchase of drugs required in
>       the prevention and treatment of HIV disease, including clotting factor
>       for hemophilia;   
> 
>             (b) undertake, through the Department of Health and Human
>       Services, a consolidated purchase and distribution of drugs used in the
>       prevention and treatment of HIV disease;   
> 
>             (c) amend the Orphan Drug Act to set a maximum sales cap for
>       covered drugs.  
> 
>       Clinical Trials and Treatment-related Research  
> 
>       1.  Current efforts at the National Institutes of Health (NIH) to
> expand the recruitment of underrepresented populations in the AIDS Clinical
> Trials Group should be continued and increased. 
> 
>           While the Commission recognizes that lack of access to health care
> seriously hampers efforts to recruit underrepresented people into clinical
> trials, this does not mean it is impossible to do so.  NIH has begun to
> increase participation and should aggressively pursue the participation of
> women and people of color in their clinical trials.    
> 
>       2.  The Secretary of Health and Human Services should direct the
> National Institutes of Health, the Health Care Financing Administration, and
> the Health Resources and Services Administration to work together to develop
> a series of recommendations to address the obstacles that keep many people
> from participating in HIV-related clinical trials, as well as the variables
> that force some people to seek participation in trials because they have no
> other health care options.  
> 
>       3.  The Food and Drug Administration should aggressively pursue all
> options for permitting the early use of promising new therapies for
> conditions for which there is no standard therapy or for patients who have
> failed or are intolerant of standard therapy.    
> 
>       4.  The National Institutes of Health should develop a formal mechanism
> for disseminating state-of-the-art treatment information in an expeditious
> and far-reaching manner. 
> 
>           While the Commission is aware of the efforts at NIH to disseminate
> information about state-of-the-art HIV treatment, the Commission is also
> aware that many health care providers are still not getting the information
> they need to responsibly care for their patients with HIV disease.  The
> Commission believes NIH needs to develop a more formalized mechanism for
> disseminating information in a timely and ongoing fashion and should work
> with the federally funded AIDS Education and Training Centers, as well as
> professional medical societies, to reach as many people as possible.  
> 
>       5.  The Department of Health and Human Services should conduct a study
> to determine the policies of third-party payers regarding the payments of
> certain health service costs that are provided as part of an individual's
> participation in clinical trials conducted in the development of HIV-related
> drugs.   
> 
>       GOVERNMENT RESPONSIBILITIES  
> 
>       1.  A comprehensive national HIV plan should be developed with the full
> participation of involved federal agencies and with input from national
> organizations representing various levels of government to identify
> priorities and resources necessary for preventing and treating HIV disease. 
>  
> 
>           To develop the comprehensive national HIV plan, the Commission
> calls upon the President of the United States to designate an individual or
> lead agency with the authority and responsibility for instituting a
> cabinet-level process to articulate the federal component of an HIV plan,
> develop a mechanism for interagency as well as state and local participation
> and coordination, and establish a timeline for completion of key tasks.  
> 
>       2.  All levels of government should develop comprehensive HIV plans
> that establish priorities, ensure consistent and comprehensive policies, and
> allocate resources. 
> 
>           These plans should build on the national HIV plan and be developed
> at the state level with clear direction and support from each governor and at
> the appropriate local level (city or county) with clear direction and support
> from the appropriate locally elected official body.  Each level of government
> should have an HIV Advisory Committee that is composed of representatives of
> diverse community-based organizations; the private sector; religious
> organizations; public safety officials; people living with AIDS; housing,
> health, and social service agencies; and other appropriate  representatives. 
>   
>           The Commission recognizes that most states and many local
> governments may have an HIV plan.  However, these existing plans should be
> carefully reviewed to ensure that they are up to date and comprehensive, and
> that they coordinate the entire spectrum of prevention and treatment
> services.  
> 
>       3.  Implementation of the Americans with Disabilities Act should be
> carefully monitored, and states and localities should evaluate the adequacy
> of existing state and local antidiscrimination laws and ordinances for people
> with disabilities, including people living with HIV disease.  
> 
>       4.  Elected officials at all levels of government have the
> responsibility to be leaders in this time of health care crisis and should
> exercise leadership in the HIV epidemic based on sound science and informed
> public health practices.   
> 
>           The Commission recognizes that many issues raised by the HIV
> epidemic place pressures on elected officials to pass laws intended to
> respond to constituent fears and concerns.  The Commission, however, is very
> concerned that policies may be enacted into law that are better left to
> scientists and public health experts.  Legislative focus should be on full
> funding of HIV-related research, prevention, and treatment programs and on
> protecting those with HIV disease from discrimination.  
> 
>       5.  The federal government should develop an evaluation and technical
> assistance component for all federally funded HIV-related programs. 
> 
>           Understanding what works and why is essential to the development of
> effective prevention and care services for people living with HIV disease. 
> It is essential that all HIV-related prevention and treatment efforts be
> evaluated and that the information be integrated into all planning,
> prevention, and health care delivery programs.    
> 
>       APPENDICES  
> 
>       Appendix A 
> 
>       Commission Chronology 1989_1991  
> 
>       1989  
> 
>       August 3   
>       Meeting to select Chairman and discuss future direction of Commission.
>       Washington, D.C.  
> 
>       August 17              
>       Meeting to select Executive Director.  Washington, D.C.  
> 
>       September 6            
>       Statement in support of passage of the Americans with Disabilities Act. 
> 
>       September 18_19        
>       Hearings to gain an overview of the HIV epidemic.  Washington, D.C.  
> 
>       September 19           
>       Statement in support of increase in AIDS funding in the FY'90
>       Appropriations Bill.  
> 
>       September 26           
>       Statement in support of the goal of treatment on demand for drug users. 
>        
>       November 2_3           
>       Hearings on health care, treatment, finance, and international aspects
>       of the HIV epidemic.  Washington, D.C.  
> 
>       November 7             
>       Statement in support of continued funding of research on the
>       effectiveness of bleach distribution.  
> 
>       December 5             
>       First interim report to President Bush and the Congress:  "Failure of
>       U.S. Health Care System to Deal with HIV Epidemic."  
> 
>       December 12            
>       Press conference in which a Commission resolution calls for an end to
>       dis-criminatory visa and immigration practices and a review of
>       immigration policies regarding communicable diseases, particularly HIV
>       infection.  Washington, D.C.
> 
>       1990  
> 
>       January 4_5            
>       Hearing of the Working Group on Federal, State, and Local
>       Responsibilities.  Purpose was to examine the roles and
>       responsibilities of different levels of government in responding to the
>       AIDS/HIV epidemic.  St. Paul, Minnesota.  
> 
>       January 24_26          
>       Hearing and site visits to assess regional aspects of the HIV epidemic
>       in Southern California.  Visits were made to Los Angeles Area
>       community-based organizations, clinics, a hospice, and a public
>       hospital.  Los Angeles, California.  
> 
>       February 15_16         
>       Hearing of the Working Group on Social and Human Issues.  Purpose was
>       to examine the relationship of early intervention, HIV testing, and
>       psychosocial issues to HIV.  Boston, Massachusetts.  
> 
>       February 26_27         
>       Site visits to study issues of HIV and AIDS among the homeless, drug
>       users, and hemophiliacs.  New York City, Newark, and Jersey City.  
> 
>       March 6    
>       Testimony of Chairman June E. Osborn, M.D., on meeting the health care
>       needs of people living with HIV and AIDS before the Task Force on Human
>       Resources of the Committee of the Budget of the United States House of
>       Representatives.  
> 
>       March 6    
>       Statement endorsing principles and objectives of the Ryan White
>       Comprehensive AIDS Resources Emergency (CARE) Act of 1990.  
> 
>       March 9    
>       Letter to President Bush urging him to resolve visa controversy before
>       international conferences to be held in the United States in June and
>       August of 1990.    
> 
>       March 15   
>       Statement that despite debate among epidemiologists, HIV epidemic will
>       have a greater impact in the 1990s than in the 1980s.  
> 
>       March 15   
>       Summary Report of the Working Group on Federal, State, and Local
>       Responsibilities, including recommendations from January meeting in St.
>       Paul, Minnesota, on the roles and responsibilites of different levels
>       of government.  
> 
>       March 15_16            
>       Hearings to review executive and legislative branch initiatives,
>       including the National Drug Control Strategy and the Report of the U.S.
>       Bipartisan Commission on Comprehensive Health Care.  Washington, D.C. 
>       
> 
>       April 16_17            
>       Site visits to examine issues surrounding AIDS in rural communities. 
>       Waycross, Albany, and Macon, Georgia.  
> 
>       April 24   
>       Second interim report to President Bush and the Congress:  "Leadership,
>       Legislation, and Regulation."  
> 
>       May 7      
>       Letters to Senate Majority Leader Mitchell and Senate Minority Leader
>       Dole urging Senate consideration of the Ryan White CARE Act of 1990.  
>        
> 
>       May 7_8    
>       Hearings to review current research activities, particularly clinical
>       trials.  Washington, D.C.  
> 
>       May 11     
>       Statement endorsing principles and objectives of AIDS Prevention Act
>       (H.R. 4470) and Medicaid AIDS and HIV Amendments Act of 1990 (H.R.
>       4080).  
> 
>       May 24     
>       Letters to Senators Kennedy and Hatch underscoring support for the
>       Americans with Disabilities Act and declaring the amendment concerning
>       food handlers bad public health policy.  
> 
>       June 6     
>       Letters to Speaker of the House Foley and House Minority Leader Michel
>       urging Congress to resist attempts to impose a federal mandate on
>       states for name reporting.   
> 
>       June 27    
>       Testimony of Commissioner Donald S. Goldman before the Subcommittee on
>       Health and the Environment of the Committee on Energy and Commerce of
>       the United States House of Representatives regarding immigration and
>       visa policies and the Rowland Bill (H.R. 4506).  
> 
>       July 9_10  
>       Hearing by the Working Group on Social and Human Issues to examine
>       early intervention and HIV testing from the public health perspective,
>       as well as the range of social and human services needed by people
>       affected by the HIV/AIDS epidemic.  Dallas, Texas.  
> 
>       July 17_19             
>       Hearings to review current health care personnel and work force issues. 
>       Washington, D.C.  
> 
>       July 30_31             
>       Working Group on Social and Human Issues hearing and site visits to
>       examine the range of services needed by people affected by the HIV/AIDS
>       epidemic, the partnerships and coalitions necessary to provide these
>       services, and the social and human services programs established in the
>       Seattle-King County Region.  Seattle, Washington.  
> 
>       August 16_17           
>       Hearings and site visits to examine HIV infection and AIDS in
>       correctional facilities.  New York State.  
> 
>       August 21              
>       Third interim report to President Bush and the Congress:  "Research,
>       the Work Force, and the HIV Epidemic in Rural America."  
> 
>       August     
>       First Annual Report to the President and the Congress documenting and
>       describing the work of the Commission over the past year.  
> 
>       September 17_18        
>       Hearings on public health and the HIV epidemic.  Washington, D.C.  
> 
>       September 18           
>       Letter to President Bush and Members of Congress calling for full
>       funding of the Ryan White CARE Act.  
> 
>       November 27_28         
>       Hearings and site visits to assess the impact of the HIV epidemic in
>       the Commonwealth of Puerto Rico.  San Juan, Puerto Rico.  
> 
>       December 17_18         
>       Hearings on HIV disease in African-American communities.  Baltimore,
>       Maryland.  
> 
>       1991  
> 
>       January 16_17          
>       Hearings on HIV disease and substance use.  Washington, D.C.  
> 
>       February 6_7           
>       Site visits to examine regional response to the HIV epidemic.  Belle
>       Glade and Miami, Florida.  
> 
>       February 15            
>       Letter to Charles McCance, Director of Quarantine, Centers for Disease
>       Control, regarding the immigration issue.   
> 
>       February 25_28         
>       Site visits to study HIV disease in Native American communities. 
>       Oklahoma, Minnesota, South Dakota, Arizona, and New Mexico.  
> 
>       March 6    
>       Statement endorsing the principles and objectives of the Ryan White
>       CARE Act.  
> 
>       March 11_13            
>       Hearings and site visits to assess pediatric and adolescent HIV disease
>       and AIDS/HIV in Hispanic communities.  Chicago, Illinois.  
> 
>       March 15   
>       Fourth interim report to President Bush and the Congress:  "HIV Disease
>       in Correctional Facilities."  
> 
>       March 21   
>       Testimony of Chairman June E. Osborn, M.D., before the Senate
>       Appropriations Committee.  
> 
>       April      
>       Report of the Working Group on Social and Human Issues.  
> 
>       April 22_23            
>       Hearings and meeting on financing, the federal structure, and
>       consultants' reports for the Second Annual Commission Report. 
>       Washington, D.C.  
> 
>       April 30   
>       Testimony of Chairman June E. Osborn, M.D., before the House
>       Appropriations Committee.  
> 
>       May 16_17              
>       Hearings on the HIV epidemic in the lesbian, gay, and bisexual
>       communities and on HIV disease among Asians, Asian-Americans, and
>       Pacific Islanders.  San Francisco, California.  
> 
>       June 5     
>       Letter to Members of Congress regarding funding of the Ryan White CARE
>       Act.  
> 
>       June 5_7   
>       Hearings and meeting on women and HIV disease, civil rights and HIV
>       disease, and the Second Annual Commission Report.  Denver, Colorado.  
>        
> 
>       June 10_11             
>       Meeting to discuss the Second Annual Commission Report.  Alexandria,
>       Virginia.  
> 
>       June 13    
>       Letter to Attorney General Richard Thornburgh with accompanying letter
>       to Secretary Louis Sullivan regarding current immigration policy.  
> 
>       July 11    
>       Statement of the Commission's stand on HIV testing in the health care
>       workplace.  
> 
>       July 11    
>       Statement of the Commission's stand on immigration.    
> 
>       July 24    
>       Letter to congressional leadership regarding support for funding of
>       behaviorial and social research.  
> 
>       August 6   
>       Fifth interim report to President Bush and the Congress:  "The Twin
>       Epidemics of Substance Use and HIV."  
> 
>       September 25           
>       Second annual report to the President and the Congress:  "America
>       Living With AIDS."  
> 
>       Appendix B  
> 
>       Recommendations from Previous Reports   
> 
>       Report Number One: 
> 
>       Failure of U.S. Health Care System to Deal with HIV Epidemic December
> 1989  
> 
>       What is Needed? 
> 
>       FIRST, frank recognition that a crisis situation exists in many cities
> that will require extraordinary measures to overcome.  Significant changes
> must be made not only in our health care system but in how we think about the
> system and the people it is designed to serve.  As one witness told the
> Commission, it can no longer be "business as usual."  
> 
>       SECOND, the creation of a flexible, patient-oriented, comprehensive
> system of care, closely linking hospital, ambulatory, residential, and home
> care.  Primary care physicians must be central to such a system.  But if
> primary care doctors are to care for patients with HIV infection and AIDS,
> they need the financial, social and institutional support to assist them in
> managing complicated patients.    
> 
>       THIRD, consideration of the creation of regional centers of networks of
> care, perhaps using the already existing regionalized hemophilia treatment
> program as a model.  These centers would not serve as a replacement for the
> care provided by primary care physicians but would provide backup and
> consultation to help strengthen community based primary care. 
> 
>       It is essential that everyone be afforded early intervention and access
> to care.  In addition, the availability of backup and consultation from
> appropriate specialists is required to provide the assistance and
> encouragement primary care doctors need to see more people with HIV infection
> and AIDS.  Regional centers should also provide the appropriate link with the
> hospital when hospital services are needed.    
> 
>       FOURTH, create units which can treat patients who have both HIV
> infection and drug addiction.  The availability of drug treatment on request
> is essential for responding to the combined HIV and drug epidemic that
> imperils not only drug users but also their sexual partners and children.
> Given the massive link between drug use and HIV infection, and the fact that
> there is an alarming increase in the number of new infections among
> intravenous drug users, the Commission wishes to go on record in expressing
> its surprise and disappointment that the White House National Drug Control
> Strategy mentions AIDS only four times in its ninety pages of text and not at
> all in its recommendations or discussions of how to allocate resources.  The
> President's drug strategy simply must acknowledge and include HIV infection
> and AIDS.  
> 
>       FIFTH, provide comprehensive health care services under one roof. 
> Fragmented services create additional barriers to needed health care.  Often
> mothers will seek health care services needed for their babies but are not
> able to then gain access to care for themselves.  Health care services for
> women and children need to be provided in one place.  For the homeless,
> housing and health care need to go hand-in-hand.  This is true not only for
> those who are homeless today but for those who will become homeless tomorrow
> because of the HIV epidemic.      
> 
>       Report Number Two: 
> 
>       Leadership, Legislation and Regulation 
> 
>       April 1990  
> 
>       1.  The National Commission on AIDS will continue to recommend policy
> goals for a national plan.  However, the Commission believes it is essential
> that a federal interagency mechanism be in place to coordinate a national
> plan.  In this way, those who are ultimately responsible for the
> implementation will have an active role in its development.  
> 
>       2.  Federal disaster relief or direct emergency relief is urgently
> needed to help states and localities most seriously impacted to provide the
> HIV prevention, treatment, care and support services now in short supply. 
> The Commission strongly supports the efforts in Congress, now embodied in
> S.2240, to address this need.  The resources simply must be provided now or
> we will pay dearly later.  
> 
>       3.  Housing is an absolutely vital component of any comprehensive
> effort to address the multiple problems posed by HIV infection and AIDS. 
> While the Commission recognizes that coordination between the state and local
> government, with input from community based organizations, is essential to
> effectively respond to the homeless crisis, we also believe the federal
> government must take the lead in providing the dollars needed to respond to
> this overwhelming, indeed catastrophic, problem.  
> 
>       4.  Government restrictions imposed on the use of education and
> prevention funds are seriously impeding HIV control.  They are clearly
> serving to prolong the HIV epidemic and should be removed.  
> 
>       5.  Because the Americans with Disabilities Act (ADA) guarantees
> protection against discrimination for people with HIV infections and AIDS,
> the National Commission on AIDS strongly urges the U.S. House of
> Representatives to pass the ADA in a swift and timely manner.  State and
> local governments should pass laws forbidding discrimination in areas not
> covered by the ADA or other federal statutes.        
> 
>       Report Number Three: Research, the Workforce and the HIV Epidemic in
> Rural America August 1990  
> 
>       1.  A comprehensive community-based primary health care system,
> supported by adequate funding and reimbursement rates, is essential for the
> care and treatment of all people, including people living with HIV infection
> and AIDS.  The Commission highlighted this need in its first report and
> continues to believe that lack of access to primary care services provided by
> adequately trained primary care providers is undermining current efforts in
> HIV/AIDS research, prevention and treatment.  The development of a
> comprehensive system with linkages to research protocols, existing
> community-based services, hospitals, drug treatment programs, local health
> departments, and long-term care facilities, based on a foundation of adequate
> support, is long overdue and should be a top priority for the federal
> government.  
> 
>       2.  AIDS education and outreach services in rural communities should be
> expanded and designed to provide clear and direct messages about how HIV is
> and is not transmitted, and the kinds of behaviors that may place an
> individual at risk for HIV and other sexually transmitted diseases. 
> Expansion of programs, resources and health care providers is also needed to
> respond to rural America's need for prevention and treatment programs that
> address the three epidemics of HIV infection, drug addiction and sexually
> transmitted diseases.  
> 
>       3.  The NIH clinical trials program is in serious trouble.  The limited
> number of enrollees in trials and the lack of demographic and geographic
> diversity of the participants threatens the success of the program and denies
> many people living with HIV infection and AIDS the opportunity to participate
> in experimental drug therapies.  The academic health centers involved have
> not been as vigorous as one would hope in advancing these trials, nor has the
> NIH been vigorous in monitoring their performance.  Aggressive efforts must
> be made to overcome the obstacles to participation of many who are
> under-represented.  Success in this area can only be measured by increased
> participation in trials.  
> 
>       4.  There is a desperate need for more research on the management of
> opportunistic infections, usually the cause of death for people with AIDS. 
> The NIH simply must expand the level of research in this area.  This
> expansion must not come at the expense of other research efforts and should
> be an integral part of a comprehensive AIDS research plan.  This plan should
> outline the AIDS research priorities and goals for the entire NIH, and the
> resources needed to achieve them.  The plan should be widely disseminated and
> should incorporate the views of persons living with HIV infection and AIDS. 
> 
>       5.  There is a shortage of crisis proportions of health care providers
> capable and willing to care for people living with HIV infection and AIDS. 
> This crisis will only get worse as the HIV epidemic continues into the
> 1990's.  Action must be taken now to increase and improve the effectiveness
> of all programs designed to educate and retain practicing health care
> professionals, and to create incentives for providers to care for people in
> underserved areas.  Existing programs such as the National Health Service
> Corps should be expanded.  New programs such as those outlined in the
> Disadvantaged Minority Health Improvement Act (H.R. 3240) should be created. 
> And, specific HIV/AIDS fellowships and training programs should be
> established and supported to prevent a crisis of greater magnitude.  
> 
>       6.  Volunteers should be publicly recognized not only for the
> invaluable contribution they have made to people living with HIV infection
> and AIDS, but also for the way in which they fight fear and bigotry by
> fostering compassion and caring.  The cost effective dollars needed to
> recruit, train, support and manage volunteers must be provided by the
> government and the private sector, and recognized as essential to our
> national response to the HIV epidemic. 
> 
>       Report Number Four: 
> 
>       HIV Disease in Correctional Facilities 
> 
>       March 1991  
> 
>       1.  The U.S. Public Health Service should develop guidelines for the
> prevention and treatment of HIV disease in all federal, state and local
> correctional facilities.  Immediate steps should be taken to control the
> subsidiary epidemics of tuberculosis and sexually transmitted diseases. 
> Particular attention should be given to the specific needs of women and youth
> within all policies.  
> 
>       2.  Given the dearth of anecdotal and research information on
> incarcerated women, incarcerated youth and children born in custody, federal
> and state correctional officials should immediately assess and address
> conditions of confinement, adequacy of health care delivery systems, HIV
> education programs, and the availability of HIV testing and counseling, for
> these populations.   
> 
>       3.  To combat the overwhelming effects which drug addiction,
> overcrowding and HIV disease are having on the already severely inadequate
> health care services of correctional systems nationwide, a program such as
> the National Health Service Corps should be created to attract health care
> providers to work in correctional systems.   
> 
>       4.  The Department of Health and Human Services should issue a
> statement clarifying the federal policies on prisoners' access to clinical
> trials and investigational new drugs.  In addition, the Food and Drug
> Administration, in conjunction with the Health Resources and Services
> Administration and the National Institutes of Health, should initiate an
> educational program directed toward informing inmates and health care
> professionals working in correctional facilities of the availability of
> investigational new drugs, expanded access programs, and applicable criteria
> for eligibility of prisoners in prophylactic and therapeutic research
> protocols.   
> 
>       5.  Meaningful drug treatment must be made available on demand inside
> and outside correctional facilities.  Access to family social services and
> nondirective reproductive counseling should also be made available with
> special emphasis on the populations of incarcerated women, youth and children
> born in custody.  
> 
>       6.  Prison officials should ensure that both inmates and correctional
> staff have access to comprehensive HIV education and prevention programs. 
> Particular attention should be paid to staff training on confidentiality and
> educating inmates about the resources available in the prison setting that
> may be employed to reduce the risk of infection.  
> 
>       7.  The burden of determining and assuring standards of care has
> largely fallen to the courts, due, in part, to the failure of the public
> health authorities to take a leadership role in assuring appropriate
> standards of health care and disease prevention for our incarcerated
> populations.  Bar associations and entities such as the Federal Judicial
> Center must, therefore, establish programs to educate judges, judicial
> clerks, and court officers about HIV disease.    
> 
>       Report Number Five: 
> 
>       The Twin Epidemics of Substance Use and HIV 
> 
>       July 1991  
> 
>       1.  Expand drug abuse treatment so that all who apply for treatment can
> be accepted into treatment programs.  Continually work to improve the quality
> and effectiveness of drug abuse treatment.    
> 
>       2.  Remove legal barriers to the purchase and possession of injection
> equipment.  Such legal barriers do not reduce illicit drug injection.  They
> do, however, limit the availability of new/clean injection equipment and
> therefore encourage the sharing of injection equipment, and the increase in
> HIV transmission.   
> 
>       3.  The federal government must take the lead in developing and
> maintaining programs to prevent HIV transmission related to licit and illicit
> drug use.  
> 
>       4.  Research and epidemiologic studies on the relationships between
> licit and illicit drug use and HIV transmission should be greatly expanded
> and funding should be increased, not reduced or merely held constant.    
> 
>       5.         All levels of government and the private sector need to
> mount a serious and sustained attack on the social problems that promote
> licit and illicit drug use in American society.    
> 
>       Report of The Working Group on Social/Human Issues  
> 
>       April 1991  
> 
>       Early Intervention and a Continuum of Care 
> 
>       Increased efforts must be made to reach those who have historically
> been denied access to health care.  These efforts must include the
> development and enhancement of health care and social service providers
> within and by minority communities. 
> 
>       Meaningful early intervention is more than the provision of AZT or
> other drugs to those with HIV disease before they develop symptoms.  Early
> intervention also entails psychological support, education and counseling,
> substance use treatment and social services. People living with HIV disease
> should be provided a continuum of care so that at every stage of illness they
> are cared for in the least restrictive setting possible, preserving the
> greatest degree of independence.  A responsive continuum of care will depend
> upon complex and intricate relationships among public health agencies,
> community-based and voluntary organizations, hospitals, nursing homes, and
> hospices. 
> 
>       Comprehensive models of medical and psychosocial care for asymptomatic
> and mildly symptomatic individuals must be developed to ensure prevention and
> appropriate treatment.  Stronger links are needed among the HIV testing
> enterprise, the public health system, health care delivery systems, and
> social services.  In particular, case management programs should be
> supported, and evaluated on an on-going basis. 
> 
>       Spiritual counseling can be a critical component of care.  Spiritual
> counseling should be encouraged, not only in the hospital setting, but also
> in the outpatient and home care environment.  Professional pastoral training
> programs, whether based in hospitals or graduate schools, should include
> curricula designed to prepare trainees to care for people living with HIV
> disease. 
> 
>       Housing tailored to a range of medical and social needs is a critical
> part of the continuum of care for persons living with HIV disease.  Congress
> should fund fully the AIDS Housing Opportunity Act of 1990. There is a need
> for a consistent commitment to provision and expansion of drug treatment. 
> Attention must be given to the development of care relevant to HIV disease. 
> High quality HIV education needs to be an integral part of all drug treatment
> programs.  States should consider making this an explicit requirement of
> licensure for drug treatment programs.  
> 
>       Delivering, Coordinating and Paying for Services 
> 
>       Planning is key to developing a coordinated and effective response to
> HIV disease and people living with HIV disease must be included in planning
> activities.  The planning process should be vigorously directed by the
> governmental agencies responsible for planning the communities' HIV response. 
> Such planning should include the private sector and members of affected
> communities.  The receipt of government funding should be conditional upon
> the establishment of relationships between service providers and affected
> communities. 
> 
>       Leadership is essential.  Leadership entails developing a vision of the
> response needed to meet the challenge of the HIV epidemic in a community,
> developing a plan to realize it, and accepting responsibility for its
> fulfillment. 
> 
>       Continued and increased government and private support of voluntary and
> community-based organizations is critical.  Fledgling organizations
> established more recently to meet the needs of minority communities may
> require special technical assistance and financial support. Where the
> appropriate governmental entity is unable or unwilling to assume
> responsibility for planning and coordination, voluntary and community-based
> organizations should coordinate local efforts to avoid needless duplication
> and support the creation of mechanisms to provide national volunteer
> leadership, technical assistance, and resource sharing.  Volunteer efforts
> are too important to be fragmentary and competitive. Cooperation and
> accountability is necessary in coordinating the resources of a panoply of
> service providers and interest groups.  Government leaders, elected and
> appointed, must vigorously support the coordination effort. 
> 
>       The HIV disease caseload will continue to skyrocket, even if HIV
> disease loses its salience as a matter of public attention.  Because of the
> disproportionate impact of HIV and its enormous impact on already suffering
> communities, the federal government has the ultimate responsibility of
> assuring that a continuum of medical, psychological, and social services are
> available to people living with HIV disease.  
> 
>       Testing and Counseling 
> 
>       It is inappropriate to create HIV antibody testing programs to identify
> asymptomatic individuals for therapeutic interventions unless they include
> plans to deliver and pay for appropriate follow-up services for a substantial
> majority of those screened. 
> 
>       Presently available or foreseeable therapeutic benefits cannot justify
> mandatory testing programs.  The prospect of therapeutic benefits is not a
> sufficient reason for abandoning long-standing principles of informed
> consent. 
> 
>       Long-standing principles of confidentiality of medical information
> should not be abandoned, especially in light of the history of discrimination
> against persons with HIV disease. HIV antibody testing must be accompanied by
> pre- and post-test counseling.  People with both positive and negative
> results should receive counseling.  For those engaging in high-risk
> behaviors, whether infected or not, counseling must be viewed as a sustained
> process.  More comprehensive standards are necessary to ensure consistently
> high quality counseling in a wide range of settings.  More trained counselors
> are needed. 
> 
>       Despite the potential therapeutic benefit of HIV antibody testing,
> there exists an array of educational and counseling interventions that can
> proceed independent of testing.  Much more needs to be done about education
> and prevention for women and people of color. 
> 
>       Those who design and implement education and prevention programs must
> have the freedom to use explicit communication acceptable to the particular
> culture or group being addressed.  Sound principles of health education
> demand that messages which encourage behavior change be in language people
> understand and consistent with values that they accept. Legal protections
> against discrimination and unwarranted disclosures of HIV status are even
> more critical as more at risk individuals are encouraged to undergo HIV
> antibody testing for early intervention.  Mechanisms for the enforcement of
> the Americans with Disabilities Act and other anti-discrimination provisions
> must be put into place.  In particular, state and local laws against
> discrimination must be rigorously enforced.  Where such laws do not exist, or
> where they are weak, they need to be established and strengthened.       
> 
>       Working Group on Federal, State and Local Responsibilities 
> 
>       January 1990  
> 
>       1. Efforts in the public sector at all levels of government should be
> guided by broad policy goals. The Working Group suggested that the policy
> goals identified by the National Association of Counties Task Force on HIV
> Infection and AIDS could serve as a model for all levels of government. 
> These goals are: 
> 
>          1. to end the HIV epidemic through prevention, education and
> research; 
> 
>          2. to assure access to treatment, care and support services for all
> persons with HIV infection; 
> 
>          3. to protect the civil rights of all citizens; and 
> 
>          4. to assure adequate funding for a continuum of HIV prevention,
> treatment, care and support services and HIV research through effective
> public sector-federal, state, and local government and private sector
> leadership and partnership.            
> 
>       2. Federal, state and local governments should develop comprehensive
> plans for implementing identified goals.  These plans should be developed in
> response to the policy recommendations of the National Commission on AIDS
> with interagency government representation and private sector involvement,
> including community-based organizations and persons with HIV disease. 
> 
>          The Working Group strongly recommended that the federal government
> should immediately develop a forceful comprehensive national HIV plan
> addressing prevention, education, treatment, care, support services, civil
> rights, research, and funding for these activities.  The President should
> designate the Secretary of Health and Human Services to chair a cabinet-level
> Task Force to develop the national implementation plan.  While the National
> Commission on AIDS fully intends to recommend policy goals for a national
> plan, the Commission believes it is essential that a Task Force be in place
> to enhance government-wide implementation of such a plan.  In this way, those
> who are ultimately responsible for the implementation will have had an active
> role in its development, thus enhancing the likelihood of implementation. 
> The Task Force should include each Department in the federal government and
> should solicit input from state and local governments and the private sector,
> including community-based organizations and persons with HIV disease.  
> 
>       3. The U.S. House of Representatives should, like the United States
> Senate, pass the Americans with Disabilities Act and state and local
> governments should pass laws forbidding discrimination in areas not covered
> by the Americans with Disabilities Act or other federal statutes.  
> 
>       4. Immediate action is necessary at the federal level to assist states,
> counties, and cities disproportionately impacted by the HIV epidemic.  
> 
>       "Impact Aid"_disaster relief or direct emergency relief_is needed to
> assist states and localities in developing a continuum of HIV prevention,
> treatment, care, and support services.  
> 
>       5. The issues of Health Care Financing and Health Care and Social
> Service Organization and Delivery require a level of expertise and commitment
> of time that was not provided for in this working group session.  The Working
> Group believes these issues would be best addressed by the full Commission. 
> 
>       6. Incentives at the federal, state and local level need to be created
> to recruit, retain and train human services personnel.  The Working Group
> recommends that the federal government should support a National Health
> Service Corps approach to involving more primary care providers in the care
> of persons with HIV.  Medicaid reimbursement rates for outpatient care should
> be augmented and all universities (public and private) should include HIV
> education in health professional education and training.  
> 
>       7. Federal, state and local government should have in place policies to
> encourage the development of housing programs that meet emergency, short-term
> and long-term needs of persons with HIV.  Congress should support legislation
> to establish housing programs that provide short-term and long-term housing
> with necessary support services.  State legislation should encourage
> flexibility in developing alternative housing and residential settings. 
> Localities need to address the "not-in-my-backyard" syndrome related to
> shelters and residencies, and work closely with neighborhood groups.  
> 
>       8. Federal, state and local governments and community-based agencies
> need to develop more effective partnerships in HIV prevention, education and
> information.  The Working Group believes that federal restrictions on the use
> of education and prevention funds is counterproductive and prolongs the HIV
> epidemic.  Restrictive legislative language appears to hinder states and
> localities and community-based agencies in providing the prevention message
> in ways that would reduce individual risk and limit the spread of HIV
> infection.  Therefore, while states and localities should be accountable for
> the federal funds they receive, the use of these dollars for education and
> prevention programs should be flexible.  Evaluation of these programs to
> determine what approaches work best is essential and these programs should be
> innovative, creative, and culturally respectful.  Finally, since
> community-based organizations are at the heart of HIV education efforts,
> these agencies should be supported by all levels of government, including the
> provision of support for education and training of agency staff and
> organizational development assistance.  
> 
>       9. The Working Group identified substance abuse prevention and
> treatment as a priority area but time did not permit specific recommendations
> to be made.  The Working Group recommends that the full Commission address
> this issue.   
> 
>       Appendix C 
> 
>       Implementation of Presidential Commission Recommendations  
> 
>       In its enabling legislation, the National Commission on AIDS was called
> upon to "[m]onitor the implementation of the recommendations of the
> Presidential Commission on the HIV Epidemic, modifying those recommendations
> as the Commission considers appropriate."1  Monitoring the implementation of
> those recommendations has been a useful task for the National Commission,
> providing the National Commission with a number of insights into the federal
> response to the epidemic.   
> 
>       First, the recommendations were never used as the basis for a "national
> strategy" as was originally intended by the Presidential Commission.  As
> Chairman Watkins expressed in his letter of transmittal to the President, "It
> is our hope, Mr. President, that you will . . . use our report as your
> national strategy. . . . "2  Our failure as a nation to adopt the
> recommendations and to mobilize the necessary resources to respond to the
> recommendations indicates a glaring need for a national plan to coordinate
> the federal response to the HIV epidemic.   
> 
>       Second, the process of monitoring the recommendations highlighted how
> fragmented and decentralized the response to the epidemic has been on the
> part of the federal government.  While some federal agencies have
> incorporated Presidential Commission recommendations into initiatives, these
> actions have taken place separate from other agencies within their Department
> and separate from other federal Departments.   Third, there is a need for
> evaluation of initiatives on the federal level.  No clear evaluation tool was
> developed to gather useful information to monitor the response to the
> Presidential Commission recommendations.             
> 
>       Historical Overview 
> 
>       In 1987 President Reagan established the Presidential Commission on the
> HIV Epidemic.  After one year of hearings, the Presidential Commission
> produced a comprehensive report, which included 597 recommendations, and
> presented it to the President on June 27, 1988.   The Institute of Medicine
> Committee for the Oversight of AIDS Activities, in a 1988 update of its book
> Confronting AIDS, stated that ". . . the commission has made major
> contributions to the public's understanding of HIV infection and AIDS and to
> the development of a compassionate and informed response to the epidemic. 
> Guided by Admiral James D. Watkins' strong leadership and open-minded
> approach, the commission's focused attention has been effective in bringing
> diverse public and private resources to bear on a national problem."3    
> 
>       Within the 597 recommendations, the Presidential Commission identified
> a number of recommendations for immediate consideration by the federal
> government.  Among these were: (1) passage of federal, state, and local
> antidiscrimination laws dealing with HIV as a disability in both the public
> and private sectors, (2) substance use treatment on demand, (3) federal
> protections for confidentiality, (4) health care worker recruitment and
> retention initiatives, (5) HIV education and prevention targeted to distinct
> populations as well as to the general public, (6) expansion of experimental
> drug trials, (7) health care financing reform, (8) ensuring the safety of the
> blood supply, and (9) support for international education and prevention
> efforts.   
> 
>       The Presidential Commission presented the recommendations to President
> Reagan, who then submitted them to his staff for evaluation.4  In July of
> 1988 four staff members from the Department of Health and Human Services
> (HHS) were detailed to the White House to assist the Director of the Drug
> Abuse Policy Office to prepare a response to the Presidential Commission
> recommendations.  The staff created a form to standardize the response
> information and sent the report to all executive branch agencies, asking them
> to respond to recommendations that fell under their purview.   As a result of
> their review, the staff determined that "40 percent of the commission's
> recommendations with a federal component have already been completed, are
> underway or are planned.  Another 30 percent are under consideration as part
> of the FY 1990 agency budget plans."5 
> 
>       On August 2, 1988, President Reagan announced the adoption of a
> "10-point plan of action to advance the battle against AIDS and HIV
> consistent with the recommendations of the Presidential Commission on AIDS."6 
> Of the 10 points included in the plan, 9 were rephrased Presidential
> Commission recommendations, including 6 of the top 20 recommendations.  The
> 9 points were:  (1) concern about substance abuse and its relation to HIV,
> (2) increase in community-based education and prevention, (3) acceleration of
> development, approval, and distribution of AIDS-related therapeutics, (4)
> support for international education and prevention efforts, (5) ensuring the
> safety of the blood supply, (6) health care financing reform, (7) adoption of
> "HIV in the workplace" guidelines, (8) creation of a special HIV emergency
> fund, and (9) review of Public Health Service plan for combating HIV and
> designation of a mechanism to follow up on the recommendations.  The
> remaining point in the President's plan was a rephrased sentence from the
> introduction to the Commission report, affirming the President's commitment
> to allocation of adequate resources to combat the epidemic.  The President
> also requested that the Attorney General identify the best way for the
> "federal government to provide direction and leadership to encourage
> non-discrimination for HIV infected individuals."7   
> 
>       The Office of the Director of Drug Abuse Policy was asked to update the
> recommendations again in September and December of 1988.  In July of 1989,
> the Public Health Service's National AIDS Program Office (NAPO) updated the
> responses in a selected number of the report chapters in preparation for
> congressional hearings on AIDS treatment and health care.   
> 
>       At the time that the National Commission on AIDS was created HHS had
> taken responsibility for monitoring the response to the recommendations.  The
> first involvement of the National Commission in the monitoring process came
> in working with NAPO to select a limited number of the recommendations to
> make the monitoring process more efficient.  National Commission staff, with
> the assistance of NAPO staff, eliminated from consideration those
> recommendations that had been completed since the release of the report and
> selected those recommendations that highlighted gaps in the federal, state,
> and local responsibility, as well as those recommendations that the National
> Commission held to be priorities, including those that addressed prevention,
> treatment, research, and discrimination.  The National Commission also
> eliminated those recommendations that were identified as statements of
> guidance rather than calls for specific action.  Once the number of
> recommendations had been narrowed down, the National Commission asked NAPO to
> continue to serve as the liaison between the National Commission and the
> agencies responsible for action on the recommendations and to provide the
> National Commission with updates on progress being made on the
> recommendations.  NAPO currently provides the National Commission with
> regular updates on those recommendations directed at HHS (a total of 113).  
> 
>       Quality of Responses 
> 
>       On the standardized response forms developed by the White House staff,
> agencies are asked to determine whether or not the recommendations are the
> responsibility of the federal government, indicate whether they agree or
> disagree with the recommendations, and indicate whether their agency has
> taken any action as a result of the recommendations.  According to the
> updated responses by HHS, the Administration agreed with the intent of 7 and
> has taken action on 8 of the 75 recommendations identified as the
> responsibility of the federal government.  The 7 recommendations that the
> Administration agreed with and initiated action on included: (1) the signing
> of the Americans with Disabilities Act (ADA), (2) new initiatives on behalf
> of the National Institutes of Health to expand drug trials to include
> underrepresented groups, (3) a grant to the Network of Runaway and Youth
> Services to provide HIV education and prevention to homeless and runaway
> youth, (4) new demonstration projects to link primary care and drug treatment
> for HIV-infected individuals and their families, (5) implementation of
> Diagnostic Related Groups (DRGs) for Medicare-eligible HIV-infected patients,
> (6) state medical laboratory regulatory requirements proposed by the Health
> Care Financing Administration to be used as state model law, and (7) the
> extension of COBRA from 18 to 29 months to continue employer health
> insurance.  
> 
>       The Administration disagreed with the intent of the eighth
> recommendation, that funds be appropriated to support home health care
> programs for underinsured people with HIV.  The Administration took action on
> the eighth recommendation when Congress passed the HOPE Act (P.L. 100-607),
> which was signed into law by the President on November 4, 1988, and which
> authorized funds for the Health Resources and Services Administration to
> provide home health care to underinsured people with HIV.   
> 
>       It is unclear how much influence the Presidential Commission
> recommendations had on the implementation of these initiatives.  It is
> probably safe to say that the recommendations played a role in identifying
> these issues as important and that individual agencies incorporated the
> recommendations of the Presidential Commission, along with those of other
> external and internal groups, into their own priority setting.   The
> remaining 67 responses to the recommendations identified as the
> responsibility of the federal government cite the continuation of ongoing
> federally sponsored projects as fully or partially addressing the
> recommendations.    
> 
>       Within the recommendations identified as not the reponsiblity of the
> federal government, there were three different categories of agency response: 
>  
> 
>       1.  The recommendation cited is not the responsibility of the federal
> government, rather the federal government is setting an example for state and
> local government and the private sector by incorporating the recommendation
> into federally based programs.   
> 
>       2.  The recommendation is not the responsibility of the federal
> government, but the federal government has acknowledged the importance of the
> recommendation by including it as an incentive for state and local
> governments and the private sector to take the recommended action.  Action on
> the recommendation becomes an incentive either by having the federal agencies
> include the recommendation as criteria for funding, or by providing funding
> and/or technical assistance specific to the recommendation.   
> 
>       3.  The recommendation is not the responsibility of the federal
> government and the federal agencies are leaving it to state and local
> governments and the private sector to address the recommendation in their own
> projects.    
> 
>       More Effective Process Needed for Evaluation   
> 
>       Unfortunately, the gathering of agency responses to the recommendations
> (even given the limited number of recommendations that the National
> Commission identified as priorities) has become a paper-driven rather that an
> evaluation-driven process.  The most recent updates provided by the agencies
> cite "no change" as their response to the majority of the recommendations. 
> Without comprehensive responses, the National Commission is unable to
> distinguish between those recommendations that have been successfully
> completed and those that warrant additional action.  Additionally, the agency
> responses currently collected provide no information to the National
> Commission as to why those recommendations that have been planned or under
> consideration for three years have never been implemented.    
> 
>       Action on Additional Presidential Commission Recommendations  
> 
>       A number of recommendations that the federal government acted on were
> not among the 113 identified by the National Commission.  For example,
> federal agencies have taken action on Presidential Commission recommendations
> concerning workplace discrimination, housing discrimination, and immigration
> policy.  The Presidential Commission asked that "[a]ll federal agencies
> should serve as a role model for the private sector by immediately adopting
> and implementing the employment policies for HIV infected workers described
> in the Office of Personnel Management guidelines."  When President Reagan
> announced the adoption of his "10-point plan of action" against AIDS and HIV
> he echoed the Presidential Commission's recommendation by directing that
> "every federal agency adopt a policy based on the Office of Personnel
> guidelines on how to treat HIV infected persons in the workplace."8 
> According to the Office of Personnel Management's evaluation of federal "AIDS
> in the workplace" policies, entitled "Implementation of AIDS policy at the
> Installation Level," only five federal agencies had not yet implemented "AIDS
> in the workplace" policies, and these five all reported having drafts
> currently in the approval process.9 
> 
>       The second recommendation stated that "federal antidiscrimination
> protection for persons with disabilities, including persons with HIV
> infection, should be expanded to cover housing that does not receive federal
> funds."10  The Fair Housing Amendments Act of 1988 revised the Fair Housing
> Act to protect handicapped persons.  The law itself does not contain specific
> language regarding HIV infection, but the Department of Housing and Urban
> Development, in its final rule implementing the law, included HIV in the
> listing of diseases that constitute a handicap."11 There has also been
> considerable federal action on issues pertaining to HIV and immigration
> policies.  The Presidential Commission concurred with the World Health
> Organization's statement that "screening of international travelers for HIV
> would require an unjustified, immense diversion of resources from other
> critical programs of education, protection of the blood supply and care."12 
>  Prior to 1987, HHS had the power to designate the diseases to be included on
> the list of "dangerous contagious diseases" that served as warrants for the
> exclusion of persons wishing to enter the United States.  In 1987 Congress
> added an amendment to the Supplemental Appropriations Act of 1987 (P.L.
> 100-71) that directed the President to add HIV infection to the "dangerous
> contagious diseases" list.   
> 
>       In 1989 a number of scientific, medical, and humanitarian organizations
> criticized the current U.S. visa practices.13  In protest to these practices,
> expected participants to both the 6th International Conference on AIDS
> scheduled for San Francisco in June of 1990, and the 19th International
> Congress on Hemophilia scheduled for Washington, D.C. in August of 1990,
> announced their intention to boycott those meetings unless visa restrictions
> were changed.  In December of 1989, the National Commission on AIDS released
> a background paper on AIDS and immigration and called upon the Department of
> State, the Department of Justice, and the Department of Health and Human
> Services to "conduct a comprehensive review of immigration policies as they
> regard communicable diseases, particularly HIV infection, focusing on public
> health needs."14   In response to the National Commission, as well as other
> concerned constituencies, Congress passed an immigration law that directed
> HHS to evaluate the list of "dangerous contagious diseases," renamed as the
> list of "communicable diseases of public health significance" as it relates
> to those entering the United States in late 1990.15   In congressional
> testimony in 1990, Dr. William Roper, Director of the Centers for Disease
> Control, testified concerning the removal of HIV/AIDS and other sexually
> transmitted diseases (STDs) from the list of dangerous contagious diseases,
> and stated that  "[a]liens with these diseases can no longer be considered a
> significant public health threat to the United States.  The sexually
> transmitted diseases proposed for deletion, as well as HIV infection, are not
> transmitted by casual contact, through the air, or from common vehicles_such
> as fomites, food, or water.  Therefore an infected person in a common or
> public setting does not place another individual inadvertently or unwillingly
> at risk.  Rather these diseases are primarily spread through voluntary
> exposure."16    
>       In January of 1991, HHS revised the list, deleting a number of STDs,
> including HIV infection, leaving "infectious tuberculosis" as the only
> "communicable disease of public health significance" for which aliens,
> including refugees, can be excluded from the United States.    As the June 1,
> 1991 deadline neared for decision about what list of diseases constituted
> grounds for exclusion, a new debate apparently arose within the
> Administration around the proposition that travelers should be dealt with
> separately from immigrants.  One view in this discussion was that the costs
> of medical care for people with HIV infection or AIDS made this disease a
> communicable disease of public health significance that should result in
> exclusion of immigrants.  The Commission has reviewed that issue and found
> that present immigration law deals extensively and in detail with such
> economic concerns in the exclusion of persons who wish to immigrate if they
> are likely at any time to become a public charge.  To single out HIV disease
> in this economic context seems irrelevant and highly discriminatory. 
> 
>       The issuance on May 31, 1991 of an interim rule that extends the same
> travel and immigration restrictions as "communicable diseases of public
> health significance" that previously were classified as "dangerous contagious
> diseases" defies public health knowledge.  This action perpetuates the
> misleading and discriminatory effects of prior HIV inclusion on an outdated
> list of diseases.  This has had the additional, serious side effect of
> jeopardizing further important scientific meetings that are crucial to the
> efficient exchange of scientific information and progress in the midst of
> this accelerating pandemic.    
> 
>       Conclusions 
> 
>       Over the course of the past two years, the National Commission on AIDS
> has submitted a series of recommendations to the President and Congress in
> addition to those included in this comprehensive report.  Given the lack of
> federal response to the Presidential Commission recommendations, the National
> Commission has had to re-recommend a number of initiatives that were
> highlighted by the Presidential Commission.  National Commission
> recommendations that overlap with the Presidential Commission recommendations
> include: (1) passage of antidiscrimination legislation,  (2) intravenous drug
> use treatment on demand, (3) expansion of health care provider recruitment
> initiatives including the National Health Service Corps, (4) expansion of
> clinical trials to include underrepresented groups traditionally excluded
> from clinical research, such as people of color, (5) development of
> comprehensive care programs, (6) creation of a federal interagency mechanism
> to coordinate a national plan, and (7) funds for housing projects for people
> with HIV.  The Congress and/or the President have taken some action to
> address all but two of these recommendations_treatment on demand and the
> creation of a federal interagency mechanism to coordinate a national plan. 
> The National Commission will continue to monitor the response to its own
> recommendations in its third year and identify those areas of the national
> response that need additional initiatives.   
> 
>       The National Commission on AIDS has attempted to monitor the response
> to the Presidential Commission recommendations and in the process has brought
> attention to a number of deficiencies in the national response to the AIDS
> epidemic: lack of a comprehensive national plan, absence of federal
> leadership, and insufficient methods for evaluating HIV-related programs.  As
> the successor to the Presidential Commission, the National Commission will
> continue to monitor the national response to the HIV epidemic and call for
> action from the federal as well as the state and local government and the
> private sector.  
> 
>       References 
> 
>       1.  National Commission on AIDS, Enabling Legislation, PL 100-607,
> November 4, 1988. 
> 
>       2.  Report of the Presidential Commission on the Human Immunodeficiency
> Virus Epidemic, June 24, 1988, p. vii. 
> 
>       3.  Institute of Medicine.  1988.  Confronting AIDS: Update 1988.
> Washington, D.C.: National Academy Press. 
> 
>       4.  "AIDS Drugs, Where are They?" 73rd Report of the Committee on
> Government Operations.  Washington, D.C.: U.S. Government Printing Office. 
> 
>       5.  White House, Office of the Press Secretary.  1988.  Press release,
> August 2. 
> 
>       6.  Ibid. 
> 
>       7.  Report of the Presidential Commission on the Human Immunodeficiency
> Virus Epidemic, June 24, 1988, p. 112.   
> 
>       8.  White House, Office of the Press Secretary.  1988.  Press Release,
> August 2. 
> 
>       9.  Communication with John Rogers, Employee Labor Relations, Office of
> Personnel Management; correspondence from Constance Newman, Director, Office
> of Personnel Management. 
> 
>       10. Report of the Presidential Commission on the Human Immunodeficiency
> Virus Epidemic, June 24, 1988, p. 107. 
> 
>       11. Congressional Research Service.  AIDS Discrimination Issues:
> Legislative and Executive Actions, IB89125, February 28, 1991. 
> 
>       12. Report of the Presidential Commission on the Human Immunodeficiency
> Virus Epidemic, June 24, 1988, p. 156. 
> 
>       13. National Commission on AIDS.  1990.  Press release, "Commission
> Calls for Changes in U.S. Visa and Immigration Policies."  National
> Commission on AIDS Annual Report, p. 37. 
> 
>       14. National Commission on AIDS.  1990.  "Resolution on U.S. Visa and
> Immigration Policy."  National Commission on AIDS Annual Report, pp. 39_40. 
> 
>       15. National Commission on AIDS.  1990.  Background paper "AIDS and
> Immigration: An Overview of United States Policy."  National Commission on
> AIDS Annual Report, pp. 41_57. 
> 
>       16. Correspondence from Peter West, Senior Medical Advisor, Department
> of State, July 24, 1990.   
> 
>       Appendix D  
> 
>       Public Law 100_607, November 4, 1988____  
> 
>       Appendix E 
> 
>       Commissioner Biographies             
> 
>       Chairman June E. Osborn, M.D., is Professor of Epidemiology and Dean of
> the School of Public Health at the University of Michigan;  she is also
> Professor of Pediatrics and Communicable Diseases at the University of
> Michigan Medical School.  She has served on numerous federal and nonfederal
> committees, currently including the Global Commission on AIDS for the World
> Health Organization and the Robert Wood Johnson Foundation National Advisory
> Committee for the AIDS Health Services Project (Chair).  Dr. Osborn has
> published extensively in the fields of virology, public health, and public
> policy.  She earned her M.D. at Case Western Reserve University School of
> Medicine and did her pediatric residency at Harvard Hospitals.  She is a
> member of both the American Academy of Pediatrics and the American Academy of
> Microbiology.  In 1986 she was elected to membership in the Institute of
> Medicine of the National Academy of Sciences.   
> 
>       Vice Chairman David E. Rogers, M.D., completed his M.D. in 1948 at
> Cornell University and served an internship and residency at Johns Hopkins. 
> Among his important appointments are those of Dean of Medicine and Vice
> President for Medical Affairs at Johns Hopkins University and Medical
> Director of the Johns Hopkins Hospital.  Dr. Rogers was appointed the first
> Walsh McDermott University Professor of Medicine at the New York
> Hospital-Cornell University Medical Center in November 1986.  For the 15
> years preceding this appointment, Dr. Rogers was President of the Robert Wood
> Johnson Foundation in Princeton, New Jersey, the largest philanthropy
> devoting its resources to alleviating problems in the health care of
> Americans.  Dr. Rogers has been very involved in the problems of AIDS,
> holding appointments as Chairman of the Advisory Council of the AIDS
> Institute of New York State, member of the Citizens Commission on AIDS of New
> York and New Jersey, Chair of the National Community AIDS Partnership, and
> Chair of the New York City Mayoral Task Force on AIDS.              
> 
>       Diane Ahrens is presently serving her 17th year as Commissioner of
> Ramsey County, Minne-sota.  She chaired the Human Services Steering Committee
> of the National Association of Counties (NACO) from 1986_1988 and in 1988 was
> appointed chair of NACO's task force on HIV/AIDS, which formulated
> recommendations for all counties regarding their role in addressing the HIV
> epidemic.  She earned her Masters degree in Religion and Higher Education at
> Yale University.   
> 
>       Scott Allen, of Dallas, Texas, serves as a consultant for Homeward,
> Inc., and specializes in transitional care.  He has conducted extensive
> research on the spiritual, ethical, and psychological dimensions of AIDS.  He
> also provides direct pastoral care for people with AIDS, and is often called
> upon to act as a liaison between people with AIDS and their religious
> community and/or family.  In addition, Reverend Allen is the founder and
> Co-Coordinator of the AIDS Interfaith Network of Dallas, Chairperson of the
> Subcommittee on State Responsibility of the Special Texas Legislative Task
> Force on AIDS, and Board Member of AIDS ARMS, a program to meet the special
> human needs of people with AIDS.  Reverend Allen earned his Masters in
> Divinity from the Golden Gate Theological Seminary and served as pastor of
> the Pacific Baptist Church in California and as Minister of Education and
> Youth for the First Christian Church in Colorado Springs before joining the
> Christian Life Commission in 1985.   
> 
>       Harlon L. Dalton is a Professor at Yale Law School and a leading
> authority on legal issues generated by the AIDS epidemic.  His AIDS-related
> publications include AIDS and the Law:  A Guide for the Public, and "AIDS in
> Blackface."   Mr. Dalton serves on the AIDS Interfaith Network in New Haven
> (chairperson), the Advisory Board of the Connecticut Consortium of AIDS, the
> Editorial Board of the AIDS Alert, and the New Haven Mayor's Task Force on
> AIDS.  He earned his J.D. from Yale Law School.  
> 
>       Don C. Des Jarlais is currently the Director of Research for the
> Chemical Dependency Institute of Beth Israel Medical Center, Deputy Director
> for AIDS Research with Narcotic and Drug Research, Inc., and Professor of
> Community Medicine at Mount Sinai School of Medicine.  He is an international
> leader in the fields of AIDS and intravenous drug use and during the past
> seven years has published over 100 scientific articles on the topics.  He was
> the plenary speaker on intravenous drug use and AIDS at the 3rd, 4th, and 7th
> International Conferences on AIDS.  He also serves as a consultant to various
> institutions, including the Centers for Disease Control, the National
> Institute on Drug Abuse, the National Academy of Sciences, and the World
> Health Organization.  He is a Guest Investigator at Rockefeller University
> and a Visiting Professor of Psychology at Columbia University.  Dr. Des
> Jarlais earned his Doctorate of Philosophy in Social Psychology from the
> University of Michigan.    
> 
>       Eunice Diaz, M.S., M.P.H., a private health consultant, is a nationally
> known expert and speaker on the subject of AIDS in the Hispanic community,
> and a former board member of AIDS Project Los Angeles.  In addition, Ms. Diaz
> has served on numerous AIDS-related committees and panels, including the Los
> Angeles County Commission on AIDS, the Planning Committee for the Surgeon
> General's Conference on Pediatric AIDS, and most recently, the Task Force on
> AIDS of the Society for Hospital Marketing and Public Relations, American
> Hospital Association.  Ms. Diaz earned her Master of Science and Master of
> Public Health at the Loma Linda University.  She has received an honorary
> doctorate degree in humanities.  
> 
>       Donald S. Goldman is an attorney in private practice as a partner in
> the West Orange, New Jersey, law firm of Harkavy, Goldman, Goldman & Caprio. 
> Active in The National Hemophilia Foundation and its chapters for over 25
> years, he served as its Chairman from 1983 to 1984 and its President from
> 1984 to 1986.  Mr. Goldman coordinated The National Hemophilia Foundation's
> efforts to improve the safety of the nation's blood supply, began many of its
> efforts in HIV risk reduction, and introduced initiatives to improve
> hemophilia and HIV service delivery to minorities.  Currently he is also Vice
> President of the National Health Council, Inc.  Mr. Goldman earned his J.D.
> from Rutgers University and has published and lectured widely on legal
> aspects of hemophilia, HIV infection, and other medical and ethical issues. 
> He is a member of the Bar of New Jersey, the United States Court of Appeals
> for the Third Circuit, and the United States Supreme Court.   
> 
>       Larry Kessler is a founding member and Executive Director of the AIDS
> ACTION Committee of Massachusetts, New England's largest AIDS service
> organization.  Beginning in 1983 as its only paid staff member, Kessler
> organized a corps of volunteers to combat the AIDS epidemic through
> education, service, advocacy, and outreach.  He now oversees a staff of 75
> full-time employees and more than 2,000 volunteers who provide support
> services to more than 1,400 men and women living with AIDS and HIV, and
> educational programs for health care providers, the public, and communities
> at risk of HIV infection.  Kessler continues to play a leading role in
> advocating on the federal, state, and local levels for fair and effective
> AIDS policy and funding.  He was an original member of the Massachusetts
> Governor's Task Force on AIDS and the Boston Mayor's Task Force on AIDS,
> under appointments by Governor Michael S. Dukakis and Mayor Raymond Flynn,
> respectively.  Kessler is a founding board member of the former National AIDS
> Network and the AIDS ACTION Council in Washington, on whose board he
> continues to serve.  Most recently, he was named to the Advisory Boards of
> the Harvard AIDS Institute and the National Leadership Coalition on AIDS.  In
> 1987, Simmons College in Boston awarded him an Honorary Degree of Doctor of
> Human Services.    
> 
>       Charles Konigsberg, M.D., M.P.H., is a public health physician.  He
> most recently served as Director of the Division of Health of the Kansas
> Department of Health and the Environment from October 1988 to August 1991. 
> Previously he was the District Health Program Supervisor and Broward County
> Public Health Unit Director for the Department of Health and Rehabilitative
> Services in Fort Lauderdale.  In Florida Dr. Konigsberg represented the
> county health official perspective on the Governor's AIDS Advisory Task
> Force.  Dr. Konigsberg has also served as a consultant to the Centers for
> Disease Control and the U.S. Public Health Service in the development of HIV
> prevention and control strategies.  He earned his M.D. from the University of
> Tennessee Center for the Health Sciences and his Master of Public Health in
> Community Health Administration from the University of North Carolina School
> of Public Health.   
> 
>       Belinda Ann Mason is a journalist and fiction writer who lives in rural
> Kentucky.  In 1987 she was diagnosed with HIV and thereafter with AIDS.  In
> 1988 she founded the Kentuckiana People With AIDS Coalition, the first
> organization of its kind in either Kentucky or Indiana.  From 1989 to 1990
> she served as President of the National Association of People With AIDS, and
> continues as its Chair Emeritus.  Since 1990 she has served on the board of
> the AIDS Action Council in Washington, D.C.  She is the recipient of numerous
> honors and awards including a distinguished leadership award from the
> Kentucky legislature.       
> 
>       J. Roy Rowland, M.D., is now serving his fourth term in the U.S. House
> of Representatives (Democrat, Georgia's Eighth Congressional District).  As
> the only physician in Congress from 1985 to 1988, Congressman Rowland has
> provided leadership and insight on a number of health issues, such as infant
> mortality, rural health, the veterans' health system, and AIDS.  His efforts
> on behalf of the AIDS community include sponsoring the legislation that
> authorized creation of the National Commission on AIDS and introducing a bill
> mandating study of AIDS among college students_an idea that was adopted
> administratively by the Centers for Disease Control.  Congressman Rowland
> earned his M.D. from the Medical College of Georgia and maintained a family
> practice in central Georgia for three decades before pursuing a political
> career.  
> 
>       Ex Officio Richard B. Cheney was nominated by President Bush to be
> Secretary of Defense on March 10, 1989, was confirmed by the United States
> Senate on March 17, 1989, and took the oath of office on March 21, 1989.  In
> August 1974, when Gerald R. Ford assumed the presidency, Mr. Cheney served on
> the Ford transition team, beginning in September 1974 as a Deputy Assistant
> to the President.  In November 1975, he was named Assistant to the President
> and White House Chief of Staff, a position he held through the remainder of
> the Ford Administration, until January 1977.  He returned to his home state
> of Wyoming in May 1977 to resume private life.  Mr. Cheney was elected to
> Congress in November 1978.  He was reelected in 1980, 1982, 1984, 1986, and
> 1988.  
> 
>       Edward J. Derwinski, President Bush's choice to become the first
> Secretary of the newly created cabinet-level Department of Veterans Affairs,
> was confirmed by the Senate on March 2, 1989 and sworn in on March 15, 1989. 
> Secretary Derwinski directs the activities of the federal government's second
> largest department, responsible for a nationwide system of health care
> services and benefits programs for America's 27.3 million veterans.  A member
> of the U.S. House of Representatives from 1959 to 1983, representing
> Illinois' Fourth Congressional District, he was the senior minority member of
> the House Foreign Affairs Committee, Post Office Committee, and Civil Service
> Committee.  He played a major role in the passage of landmark civil service
> reform, postal service reorganization, and foreign service reform
> legislation.  
> 
>       Louis W. Sullivan, M.D., was sworn in as Secretary of Health and Human
> Services on March 10, 1989.  As head of the Department of Health and Human
> Services, Dr. Sullivan oversees the federal agency responsible for the major
> health, welfare, food and drug safety, medical research, and income security
> programs serving the American people.  Dr. Sullivan came to HHS from the
> Morehouse School of Medicine in Atlanta, Georgia.  In July 1975, Dr. Sullivan
> became founding dean and director of the medical education program at
> Morehouse College.  In July 1, 1981 when the School of Medicine became
> independent from Morehouse College he served as its first dean and president. 
> In April 1985, the Morehouse School of Medicine was fully accredited and on
> May 17, 1985, the school awarded the M.D. degree to its first 16 graduates. 
> 
> 
>       Appendix F 
> 
>       Commission Documents  
> 
>       For any of the following information please contact:   
> 
>       The National Commission on Acquired Immune Deficiency Syndrome  
>       1730 K Street, N.W., Suite 815 
>       Washington, D.C.  20006  
>       (202) 254-5125.    
> 
>       Records are kept of all Commission proceedings and are available for 
> public inspection at this address.   
> 
>       Reports  
> 
>       First Interim Report to the President and the Congress:  "Failure of
> U.S. Health Care  System to Deal with HIV Epidemic."  December 1989.  
> 
>       Working Group Summary Report on Federal, State, and Local
> Responsibilities.  March 1990.  
> 
>       Second Interim Report to the President and the Congress:  "Leadership,
> Legislation, and  Regulation."  April 1990.  
> 
>       Third Interim Report to the President and Congress:  "Research, the
> Work Force, and the  HIV Epidemic in Rural America."  August 1990.  
> 
>       Annual Report to the President and the Congress.  August 1990.  Fourth
> Interim Report to the President and the Congress:  "HIV Disease in
> Correctional  Facilities."  March 1991.  
> 
>       Report of the Working Group on Social and Human Issues to the National
> Commission on AIDS.  April 1991.  
> 
>       Fifth Interim Report to the President and the Congress:  "The Twin
> Epidemics of Substance  Use and HIV."  August 1991.   
> 
>       Statements  
> 
>       Support for Passage of the Americans with Disabilities Act. September
> 6, 1989.  
> 
>       Support for Increase in AIDS Funding in the FY '90 Appropriations Bill. 
> September 19, 1989.  
> 
>       Support for the Goal of Treatment on Demand for Drug Users. September
> 26, 1989.  
> 
>       Support for Continued Funding of Research on Effectiveness of Bleach
> Distribution.   November 7, 1989.  
> 
>       Endorsement of Principles and Objectives of Comprehensive AIDS
> Resources Emergency  (CARE) Act of 1990.  March 6, 1990.  
> 
>       Despite Debate Among Epidemiologist, HIV Epidemic Will Have Greater
> Impact in 1990s  than 1980s.  March 15, 1990.  
> 
>       Endorsement of Principles and Objectives of AIDS Prevention Act (H.R.
> 4470) and Medicaid  AIDS and HIV Amendments Act of 1990 (H.R. 4080).  May 11,
> 1990.  
> 
>       Endorsement of Principles and Objectives of the Ryan White CARE Act of
> 1990.  March 6, 1991.     
> 
>       Information on the Commission  
> 
>       Commission Fact Sheet  
> 
>       Individual Commissioner Biographies  
> 
>       Public Law 100-607 (Creation of the National Commission on AIDS)      
>  
>       America Living With AIDS 
> 
>  
>