&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& J O H N J A M E S writes on AIDS &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& Copyright 1992 by John James; permission granted for non-commercial use. AIDS TREATMENT NEWS Issue #154, July 3, 1992 phone 800/TREAT-1-2, or 415/255-0588 CONTENTS: [items are separated by "*****" for display] DDC Approved for AZT Combination Three-Drug Study Begins: AZT Plus DDC Plus Alpha Interferon, Eight U. S. Cities Current Clinical Trials, New Computerized Journal, Starts July 1 Burroughs Wellcome Donates $1,000,000 to Community-Based Research Mother-Infant Trial Suspended Due to Liability Issue; Year's Delay Expected National Commission on AIDS Cites "Tragic Insufficiency of Administration's AIDS Efforts". Women and HIV on Agenda for Eighth International Conference Amsterdam Conference Notes: Conference Preview; Standard of Care Pain Control Access at Stake in Congressional Bill ***** DDC Approved for AZT Combination Late Friday, June 19, the U. S. Food and Drug Administration approved ddC (brand name HIVID) for marketing to certain patients for combination use with AZT. The approval was announced the following Monday. Developer Hoffmann-La Roche distributed supplies of the drug very rapidly, following plans for quick distribution developed since late 1991. According to the company, ddC was distributed to wholesalers in 12 areas with large numbers of AIDS patients by the day approval was announced, and nationwide the following day. Patients now receiving free drug through the expanded-access program for combination therapy can continue to receive supplies for two months, to give them time to make arrangements with insurance companies or other third-party payers. The ongoing expanded-access program for ddC monotherapy, for patients with AZT intolerance or failure, will continue, but will not add any new patients. Hoffmann-La Roche has started a program, called ASSIST(, for physicians and other health care providers to obtain reimbursement information to help patients pay for ddC plus AZT combination therapy. Health care providers can call the ASSIST Hotline, 800/285-4484, 9 a.m. to 8 p. m. Eastern time Monday through Friday, for information about insurance companies and HMOs in all states, and about Federal reimbursement programs. The company also has the Roche Indigent Patient Program, started in 1963, which, according to the company, "provides all Roche prescription drugs to patients who have been identified by their physician as unable to pay for treatment." According to a Roche spokesperson quoted in a June 22 press release, "No one in need of a Roche medication will go without it because of their inability to pay." DDC was approved in Austria on April 7, 1992. Roche has also applied for marketing approval to the 12 European Community members, and to 11 other European countries. Approved Indications for ddC The official "labeling" for ddC, approved by the FDA, emphasizes caution since less is known about this drug (the first drug officially marketed under the FDA's new "accelerated approval" policy) than about most drugs when they are approved. While the drug's safety and toxicity are fairly well known, due to the expanded-access programs which have enrolled over 10,000 patients, there is no definitive proof that the drug is beneficial to patients. Instead, there are two small studies, both of which showed substantially greater T-helper count improvements with the drug combination than would be expected from AZT alone. The following is the first paragraph of the "indications and usage" section of the labeling for ddC: "Combination Therapy with Zidovudine in Advanced HIV Infection: HIVID (zalcitabine) in combination with zidovudine is indicated for the treatment of adult patients with advanced HIV infection (CD4 cell count <= 300 cells/mm3) who have demonstrated significant clinical or immunologic deterioration. This indication is based on limited data from two small studies in which zidovudine-naive patients with a CD4 cell count <= 300 cells/mm3 who were treated with HIVID plus zidovudine had a greater CD4 response than patients treated with zidovudine alone (see "Description of Studies"). Neither study included a concurrent control group taking the currently recommended zidovudine dose of 100 mg q4h, and these studies were not designed to measure the clinical efficacy of the combination. No data are currently available on the combined use of HIVID and zidovudine in patients who have previously received zidovudine monotherapy, although controlled studies are ongoing. At present there are no data available from controlled or uncontrolled studies addressing whether an effect on CD4 cell count would be observed by the addition of HIVID to patients who are currently receiving zidovudine or who had previously been exposed to antiretroviral therapy. Because zidovudine has been shown to prolong survival and decrease the incidence of opportunistic infections in patients with advanced HIV disease, zidovudine monotherapy should be considered as initial therapy for adult patients with HIV infection who have evidence of impaired immunity (CD4 cell counts of <=500 cells/mm3)." [Note on terminology: Drugs sometimes have three names because a generic drug name different from the familiar chemical name is used; there is also at least one proprietary brand name. Thus ddC (chemical name) is zalcitabine (generic drug name) and HIVID (brand name); until exclusive rights to the drug expire, however, there will only be one brand. Similarly AZT has the generic name zidovudine, and the brand name Retrovir. For any drug, AIDS TREATMENT NEWS prefers the name which is most familiar to our readers.] *** Three-Drug Study Begins: AZT Plus DDC Plus Alpha Interferon, Eight U. S. Cities by John S. James Burroughs Wellcome Co is now beginning a major study of a three-drug combination -- AZT plus ddC plus alpha interferon -- in eight U. S. cities: Houston, Manhasset (New York), Nashville, Salt Lake City, San Francisco, Tampa, Washington, and Wichita. It will compare this three-drug treatment with the two-drug combination AZT plus ddC (which was recently approved by the FDA). The goal of this 76-week study is to see if either regimen can restore T-helper counts to normal (over 800) for at least six months, in volunteers with starting T-helper counts between 300 and 500 -- and to see if the three-drug combination works better than the two-drug one. The standard doses of AZT and ddC will be used; the alpha interferon dose will be fairly low, 3MU per day. Everyone in the study will get at least AZT and ddC, and there will be no placebo. A total of 250 volunteers will be enrolled, with 125 assigned randomly to each of the two treatment regimens. This study is important because laboratory tests have shown that the three-drug combination works particularly well against both laboratory strains of HIV, and "wild" strains taken from patients. The graph below (page 3) shows some of these laboratory results. The combination of AZT and ddC worked substantially better than AZT alone, and better than the other two-drug combinations tried (AZT plus alpha interferon, and AZT plus foscarnet; foscarnet, while best known for its anti-CMV use, also has some anti-HIV activity). But the three-drug combination of AZT, ddC, and alpha interferon worked far better than any other regimen tested. What is being measured in all these cases is cytopathic effect, meaning the damage to cells in the laboratory when they are infected by HIV and then treated with antivirals. The alpha interferon used is Burroughs Wellcome's Wellferon, which is different from most of the alpha interferon approved in the United States. Wellferon, approved in some European countries for treating hepatitis B but not approved in the U. S., is a "natural" alpha interferon, produced by transformed human cells; it contains at least 16 varieties of human alpha interferon. Many brands of alpha interferon, by contrast, are made by genetically engineered non-human cells; they contain only a single variety of the interferon. No one knows if this difference matters when alpha interferon is used as an HIV treatment. But Wellferon was used in the laboratory tests of the three-drug combination, and it will be used in the trial. (Recombinant alpha interferon has, however, often been used in AIDS treatment.) This study is only open to volunteers with T-helper counts between 300 and 500, who do not have AIDS, and who have had no more than three months of any antiretroviral treatment (such as AZT, ddI, or ddC). The reason for these eligibility criteria is that the drugs may work best if the virus has not already developed resistance to them. This is why patients must not have received AZT, etc. before -- or received only a little of it. The reason for requiring that volunteers have a relatively early stage of disease is that alpha interferon is normally present in the body -- and when AIDS develops, this level often becomes abnormally high. Therefore the patient's virus may already have become partly resistant to alpha interferon, which could cause the drug would work less well in the trial. The selection criteria were designed to find patients who are unlikely to be resistant to any of the three study drugs when they begin the combination treatment. This does not mean that the combination would not work at later stages of HIV disease, in some patients at least. But for purposes of this trial, the entry criteria were designed to give the treatment the best possible chance to show a successful result. And since AZT, ddC, and alpha interferon are all approved, any U. S. physician can prescribe them; patients who are not in the trial could try the same three- drug combination now, no matter what their T-helper count. The reason for the entry requirement of a T-helper count no greater than 500 is, presumably, because no antiretroviral treatment is officially recommended at this time for persons with counts greater than 500. Also, it would be hard to know what improvement to look for if T-helper counts started in or near the normal range -- especially since there has been little experience so far with anti-HIV drugs in this patient group. Comment This study is well designed. It asks an important question, it could answer that question, and the answer could improve medical practice. And there is an excellent scientific rationale, based on (1) especially good results in laboratory tests for this three-drug combination, (2) the fact that three or more drugs in combination have been needed historically for successful treatment of difficult diseases like tuberculosis and cancer, and (3) the fact that HIV can develop drug resistance very rapidly -- which further increases the rationale for combination therapy, since it is unlikely that an organism will develop three or more different kinds of drug resistance simultaneously. One question which has often been asked is why the two-drug combination AZT plus ddC works as well as it seems to, in the two small studies which have provided all the results we have so far on this regimen. Those studies were in persons with fairly advanced disease; in the most important trial, called ACTG 106, the median T-helper count before patients began the treatment was about 70. One possibility -- just a speculation at this time -- is that the treatment worked as well as it did because the two-drug combination was really a three-drug combination, since the level of alpha interferon in the patients already at that stage of the disease would be likely to be high. If this is true, then the two-drug combination might not work as well in early disease -- unless interferon were added to the regimen. All this is guesswork, however, until the three-way combination trial is done. Theories and laboratory tests cannot prove that a treatment works in people. The only way to know with confidence is to run a well-designed trial. This trial is important because, while waiting for better drugs to treat AIDS or HIV, we need to learn how to make the best use of the drugs already available. This three-way combination study is at the leading edge of that effort. For More Information Potential volunteers for this trial should call the study coordinator at a site convenient for them. Volunteers must be at least 13 years old, have T-helper counts between 300 and 500, and not have AIDS; they must not have used AZT or other antiretrovirals for more than three months. There are several other exclusion criteria, mostly for medical conditions (such as anemia) which could increase the risk of using one of the drugs. Note that over 20 visits, for blood work, etc., are required during the course of the 76-week study. The alpha interferon is given once per day by subcutaneous injection, which can be done by the patients themselves at home. As this article went to press, we learned that institutional review boards have approved the trial at all the study sites (listed below), and that the first two patients have been enrolled and are now receiving the drugs. The study coordinators for the Burroughs Wellcome three-drug combination trial can be reached at: Houston: Baylor College of Medicine, 713/798-4720. Manhasset, New York: North Shore University Hospital, Division of Infectious Diseases, 516/562-1527. Nashville: Vanderbilt University School of Medicine, 615/343- 6693. Salt Lake City: University of Utah School of Medicine, 801/581-4878. San Francisco: ViRx, Inc., 415/474-4440. Tampa: University of South Florida, Div. of Infectious Diseases, 813/974-3163. Washington: Georgetown University Medical Center, 202/687- 5378. Wichita: University of Kansas School of Medicine, 316/261- 2655. ***** Current Clinical Trials, New Computerized Journal, Starts July 1 by John S. James The world's first peer-reviewed journal delivered online by computer will be available to subscribers starting July 1. The Online Journal of Current Clinical Trials, published by the American Association for the Advancement of Science (AAAS, which publishes Science) and the Online Computer Library Center, Inc., will completely avoid the mechanical printing and mailing delays, (as well as the wait for the next available publication date), which have seriously delayed information flow to scientists and to the public. Subscriptions will be priced at about $100 per year, competitive with print journals, which will allow any amount of online reading time. (There is an additional telecommunications charge of about $8 to $10 per hour.) Subscribers can also print the articles with typeset quality, or have printed copies sent to them. Advantages of this online journal include: * Speed of access to new results. Current Clinical Trials plans to release articles to the press and the public within 24 to 48 hours after acceptance. There will be no press "embargo"; all of the public, subscribers and the press, will have access to new articles at the same time. * Ease of use. We have seen the system demonstrated, and noted that it can be learned almost immediately; then it is as easy to find one's way around in the online journal as in a print journal. * Ability to search for articles containing any words or combinations of words. The whole articles can be searched, or only particular sections (such as the "Results" section). Searches by author, subject, title, and date are also provided. * Readers are automatically notified about related letters, rebuttals, or retractions -- or anything else that the journal editors think is important about the article. When there is such information, an "alert" button flashes until the reader clicks to read it. (Since these items occur after the article is published, there is no easy way to find them in print journals.) * When the text refers to a figure or table, readers can "click" to see the illustration displayed immediately, in high-quality graphics on the screen. (Equally important, readers can click to go back to the point in the text which referred to the graphic.) Alternatively, readers can pull up an instant index of all the tables or figures in the article, and select which they want to view. And they can see a list of all "open windows" (representing points they have already viewed in the article), and return to continue reading at any of them. * When readers encounter a reference number in the text, they can click to see the reference immediately. More importantly, they can also immediately see the abstract of the published article, if it appeared in Medline (the large database of medical articles, provided by the National Library of Medicine) from 1986 on. (These abstracts are copied from Medline into the Current Clinical Trials database, when the article which references them is published; the system does not need to enter Medline directly.) * Text size can be enlarged for ease of reading, or reduced for convenience. * Articles can be "downloaded" to disk (at extra charge) for printing or later use. Alternatively, copies can be mailed or faxed, if a typeset-quality printer is not available locally. * The journal will include a news section, with clinical alerts and meeting notices. It is negotiating to include the text of MMWR (Morbidity and Mortality Weekly Report, published by the U. S. Centers for Disease Control). * Because there has never been a journal like Current Clinical Trials before, each article includes a recommended citation for use by scientists who need to refer to it in articles published in other journals. For example, there is no issue numbers in Current Clinical Trials, since articles can be published online at any time; a "document number" is used instead. Similarly, there are no page numbers, so paragraph numbers are used. But for consistency with other bibliographic formats, a "volume number" will be used; it will be the year of publication. * Readers can sign up for automatic fax or mail notification about articles in fields of interest to them. How to Subscribe To use the full features including graphics, you need a computer running Windows 3.0. A 9600-bps modem is recommended; 2400-bps will work. (Apple Macintosh software is expected to be ready in 1993.) An alternative is to use text-only access, from any computer (including Macintosh) running software emulating a VT100 terminal. Subscriptions are by calendar year; the 1992 subscription is $95. To order a subscription, send your name, title, address, and telephone number to: Current Clinical Trials, Subscription Dept., OJC, PO Box 3000, Denville, NY 07834-9653. They will send an invoice and subscriber agreement, which must be signed and returned. For information about subscribing, call 202/326-6446. Note: Potential authors should obtain a copy of Information for Authors, and of Guidelines for Reporting Clinical Trials. Authors should contact Maria L. Lebron, Managing Editor, Current Clinical Trials, 1333 H Street, NW, Washington DC 20005, phone 202/326-6735 or 202/842-2868 (fax). All material, including letters, will be peer reviewed before publication. ***** Burroughs Wellcome Donates $1,000,000 to Community-Based Research On June 30, Burroughs Wellcome Co. announced a $1,000,000 gift to support community-based research. The company acknowledged that the gift "was prompted by an initiative spearheaded by individuals within ACT UP/New York." This gift represents the first in a campaign, developed by Peter Staley of ACT UP/New York, to raise $5,000,000 from pharmaceutical companies to support community-based research. "We have asked the pharmaceutical industry to invest in the concept of community-based research as an important alternative to our government's clinical research program," said Staley. "With their donations, the industry will help build an invaluable network of research sites through which promising AIDS treatments can be tested. ACT UP looks forward to working with the pharmaceutical industry towards this common goal." The grant will be administered by the American Foundation for AIDS Research (AmFAR). Since 1985, AmFAR has provided over $45 million in funding to 730 research projects, with money contributed entirely by the private sector. Comment There has been some concern among activists at the choice of AmFAR to administer these grants from pharmaceutical companies to community-based research. The concern has been that AmFAR has been unwilling to break with the thinking of the research mainstream when necessary, in its choice of treatments to study and in study design. For example, a January 1992 listing of trials by the Community-Based Clinical Trials Network, consisting of over 40 community- based organizations which have been heavily funded and influenced by AmFAR, shows almost no research on natural products. AmFAR was necessary for the current fundraising project, because pharmaceutical companies need an established fiscal sponsor in order to donate money. And the fact that Peter Staley recently became one of the directors of AmFAR has relieved some of the concern. ***** Mother-Infant Trial Suspended Due to Liability Issue; Year's Delay Expected By Nancy Solomon Abbott Laboratories is refusing to provide HIV Hyperimmune Globulin (HIVIG), a blood product containing antibodies to HIV, for a clinical trial to stop pregnant women from passing HIV to their babies, according to the medical officer for the study. The decision by Abbott is expected to delay the AIDS Clinical Trials Group (ACTG) 185 for another year; it had already been delayed since April due to contract negotiations with the pharmaceutical company. Abbott spokeswoman Cathy Babington said the company would still like to provide HIVIG for the trial, but only if the National Institutes for Health agree to waive any product liability. She said negotiations are continuing. "It's a business decision of Abbott Labs," Babington said. "We had sought assurances that the NIH would waive product liability." The delay has angered activists. "They"re a profiteering company and they don"t want it to affect the bottom line," said Vince Maloney of ACT UP/Golden Gate. But Abbott's delay could pose a public relations nightmare because the company is the largest producer of infant formula in the United States. "They"re selling formula for infants but they won"t do anything to save infant lives," Maloney said. The activists' anger appears to be supported by doctors associated with the trial who want to see the therapy tested as soon as possible. The trial would provide a combination of AZT and HIVIG to pregnant women with HIV and then the combination therapy would be given to the babies for six months after birth. "It's a sad statement that promising therapies will be held up because of monetary concerns," said Lynn Mofenson, M. D., the medical director of ACTG 185. "Abbott is insisting the NIH provide 100 percent indemnification but none of the other companies have that." The phase III trial is designed to enroll 400 HIV-positive pregnant women at 12 ACTG sites around the country. All the women would be given AZT while half receive HIVIG and the other half receive Intravenous Immune Globulin (IVIG), a blood product similar to HIVIG but without any HIV antibodies. HIVIG is produced by concentrating several liters of blood plasma taken from asymptomatic people with HIV. The blood donors are selected because they have shown a strong immune response to HIV, meaning they are unusually healthy and have a high amount of antibodies. When the concentrated plasma is injected into patients it is expected to boost the immune response against HIV. The plasma is screened for HIV so it is safe and unable to infect healthy cells, according to the research protocol. [Note: As we went to press, ACT UP/Golden Gate announced a demonstration against Abbott Laboratories, Wednesday, July 8, at noon, at the Pacific Stock Exchange, 301 Pine Street (near Sansome), in San Francisco. The demand is that people should sell stock in Abbott. For more information, call Vince Maloney, 415/922-5480.] ***** National Commission on AIDS Cites "Tragic Insufficiency of Administration's AIDS Efforts" by John S. James After a 90-minute meeting on June 24 with U. S. Health and Human Services Secretary Louis M. Sullivan, M. D., and other top officials, the National Commission on AIDS broke openly with the Bush Administration and "reluctantly concluded that the Administration is not prepared to undertake any significant new actions against the HIV/AIDS epidemic, and that current efforts fall tragically short of what is needed." The Commission is an independent, bipartisan body; five of its 12 voting members were appointed by the Senate, five by the House of Representatives, and two by President Bush. David E. Rogers, M. D., Vice Chairman of the Commission, said, "We need very forceful leadership and we need clear articulation that we have a crisis. We"re not getting either. From all that flows the need for a genuine national plan to combat this epidemic, better care, drug treatment programs, research and prevention efforts untainted by politics. Little of that is coming, and sadly the problem starts at the top." Chairman June E. Osborn, M. D., said, "It is hard to attack a whole Administration when there are so many health professionals and researchers who have been working flat out. Nevertheless, the sad fact is this is an epidemic of historic proportions which has not been met by appropriately historic measures." A five-page summary by the Commission, "Statement on the Meeting Between the National Commission on AIDS and the Secretary of Health and Human Services," outlined five critical areas of failure: "Leadership, a national plan, prevention, provision of health care, and the interrelationship of HIV and substance use." Comment The result of the lack of national leadership on AIDS is illustrated by an article elsewhere in this issue on yet another major delay in the clinical trial of a drug which may prevent transmission of HIV from pregnant women to their babies -- a delay caused purely by a business dispute. This trial had already been seriously delayed by a different business dispute -- but largely outside of public view, as the strategy had been to quietly seek a solution. Any major delay in learning how to reduce transmission to infants is likely to result in thousands of additional cases of AIDS in children. If this country had the political will to deal properly with AIDS, such a delay would be an unthinkable scandal which would never be allowed to happen. Any manager knows that the best way to solve this kind of problem is leadership from the top. Once it is known that the top executives of a company, for example, care about an issue, then people are mobilized throughout the organization, and problems which seemed insurmountable before can suddenly be solved. Why has President Bush not provided this kind of leadership on AIDS? It seems clear to us that the reason Bush cannot act effectively on AIDS, and on other health issues as well, is that he is afraid of offending part of his coalition -- the right-wing groups whose major interest in AIDS is hatred of gays and of other groups associated with the disease. The Republican economic program, widely perceived as unduly favoring the rich, could not win a national election by itself; it must ally with non-economic votes to do so. During the last two decades, thinly disguised hatred and divisiveness have been used to provide those missing votes. This situation is unlikely to change soon. Therefore, while we are usually nonpartisan in order to work with all political camps, we cannot avoid concluding that one of the best things that could happen for people with AIDS would be the election of a president other that George Bush in November. Neither of the other major candidates is likely to be paralyzed on health policy, as neither is captive of hate groups the way Bush is. In the last major poll on this subject, conducted over a year ago by the Boston Globe, almost one person in five reported that they personally knew somebody affected by AIDS or HIV. Today, the election is volatile because voters have trouble finding a reason to vote for any candidate, to vote for president at all. If word goes out that this election could have a life or death impact on people known personally to a fifth of the country, then the issue of AIDS could influence the election considerably. Some day all this will be widely known, considered obvious to almost everybody. But then it will be too late to bring back those who died as a result. That is why we can save lives by letting people know what is happening now. ***** Women and HIV on Agenda for International Conference By Nancy Solomon If researchers leave the Eighth International Conference on AIDS with more questions about women and HIV than when they arrived, some women organizers will be happy. "Maybe at the end of this conference -- round about July 25 -- we will have a list of questions that have yet to be answered," said Holly Ladd, executive director of the Boston AIDS Consortium, reflecting widespread concern at how much has not been studied. "That's the only way we"ll get women's issues on the agenda." The conference will be held from July 19-24 in Amsterdam, The Netherlands. Ladd is a community liaison for the conference and organized much of the schedule specific to women and HIV. In past years, the conference has been dominated by issues facing researchers in North America who considered gay men and male drug users to be the core groups affected by HIV, she said. This year, a considerable effort was made to address issues specific to women. Nineteen sessions will deal with women's issues specifically and many other panels will include presenters who submitted abstracts specific to women. A minicourse will held on three nights about HIV/AIDS and the commercial sex industry. Ladd said women fought hard to get panels on epidemiology and clinical manifestations for women with HIV, two areas in which activists have been pushing for change. Little is known about sexual transmission of HIV and women. For example, how much virus is in vaginal secretions or menstrual blood? And women continue to go undiagnosed because their first symptoms and illnesses associated with AIDS, such as Pelvic Inflammatory Disease or persistent vaginitis, are not on the lists published by the Centers for Disease Control. Of the 19 sessions specific to women, only three are oral abstract sessions, which means that researchers present the results of specific studies or clinical trials. Nine are round table discussions, in which political and social issues are debated by "experts" holding diverse points of view. Four are "State-of-the-Art" sessions which are designed to make complex subjects accessible to the largest possible audience. And three are poster discussions, in which a moderator evaluates several papers on a related topic that are posted during the conference. Conference Schedule A list of sessions specific to women was published in the Bulletin of Experimental Treatments for AIDS (BETA) in May 1992 by the San Francisco AIDS Foundation. Here is that list, slightly updated : * Gender, Power, and HIV, State-of-the-Art, Mon., July 20, 8:30 a.m. * Gender-Related Variations in Natural History, Oral Abstract, Monday, July 20, 9:45 a.m. * Impact of HIV on Family Systems, Oral Abstract, Monday, July 20, 2:30 p. m. * Pathogenesis of Pelvic Inflammatory Disease, Round Table, Monday, July 21, 2:30 p. m. * Epidemiology of HIV in Women, State-of-the-Art, Tuesday, July 21, 8:30 a.m. * Human Sexuality, State-of-the-Art, Tuesday, July 21, 8:30 a.m. * AIDS Programs and Family Planning, Round Table, Tuesday, July 21, 8:30 a.m. * Definitions of AIDS, Round Table, Tuesday, July 21, 9:45 a.m. * AIDS and Breast Cancer: Lessons Shared, Round Table, Tuesday, July 21, 9:45 a.m. * Female Drug Injectors, Poster Discussion, Tuesday, July 21, 1 p. m. * Clinical Manifestations of HIV in Women, Oral Abstract, Tuesday, July 21, 2:30 p. m. * Economic Impact on Households, Round Table, Tuesday, July 21, 4:15 p. m. * Variations in Clinical Manifestations by Population, State- of-the-Art, Wednesday, July 22, 8:30 a.m. * Prevention Programs for Women, Round Table, Wednesday, July 22, 9:45 a.m. * Decreasing Sexual Transmission in Women, Poster Discussion, Wednesday, July 22, 1 p. m. * Women with HIV; Reproductive Choices, Round Table, Wednesday, July 22, 4:15 p. m. * Empowering Heterosexual Women, Poster Discussion, Thursday, July 23, 1 p. m. * HIV/STD Prevention Technology Controlled by Women, Round Table, Thursday, July 23, 2:30 p. m. * Women's Access to Prevention & Care, Round Table, Thursday, July 23, 4:15 p. m. Under the heading of Pediatrics HIV/AIDS, BETA published a list including several other sessions specific to women: * Vertical Transmission, Oral Abstract, Wednesday, July 22, 9:45 a.m. * Maternal-Fetal Transmission, State-of-the-Art, Thursday, July 23, 8:30 a.m. * The role of Breast Feeding in HIV Transmission, Oral Abstract, Thursday, July 23, 9:45 a.m. * Maternal-Infant Transmission by Population, Poster Discussion, Thursday, July 23, lunch break. ***** Amsterdam Conference Notes: Conference Preview, Standard of Care * The May 1992 issue of the Bulletin of Experimental Treatments for AIDS (BETA), published by the San Francisco AIDS Foundation, includes a major preview of the International Conference. It includes, for example, a "road map" listing some of the sessions relevant to those interested in a number of areas: General therapy issues, Treatment of opportunistic infections, Women and HIV/AIDS (see article above), Gay men and HIV/AIDS, Youth and HIV/AIDS, Pediatric HIV/AIDS, Prevention, and HIV/AIDS in developing countries. To obtain a copy of the May 1992 issue of BETA, or to subscribe, call the San Francisco AIDS Foundation's subscription office, 800/327-9893. * On July 25 in Amsterdam, one day after the Eighth International Conference on AIDS, the Physicians Association for AIDS Care (PAAC) is sponsoring a one-day conference as part of its initiative to establish standards of care for the management of HIV disease. Thirty-two physicians are scheduled to speak; 16 physicians will summarize data from the conference relating to clinical management decisions. These talks will be videotaped for later broadcast on PAAC's AIDS Television Network. For more information, call Gordon Nary at PAAC, 312/222-1326. ***** Pain Control Access at Stake in Congressional Bill by Dave Gilden Stepping into ambiguous terrain, Rep. Pete Stark (D-CA) is introducing a bill to monitor prescriptions of all potentially addictive medications. The impact of Stark's proposal on the treatment of HIV and AIDS could be either positive or negative. It may help alert AIDS specialists to the proper use of tranquilizers and opioid pain killers, or it could impose stifling legal restraints on efforts to alleviate suffering among those affected psychologically and physically by the disease. HR 5051, or the Prescription Accountability Act, would create ten model computer networks managed by state health departments. The states' computers would record all sales of controlled substances, flagging those that appear to be violations of the law. Limitations on the system mean that the grounds for detecting abnormally large or frequent prescriptions are rather crude: Unusual sales will be spotted largely on the basis of patient age and physicians' specialty. Addiction medicine expert Westley Clark, M. D. fears the outcome: "The issue is what happens when the law and the individual patient don"t fit, and a third party is monitoring and contends the matter." In contrast, Alex Stalcup, M. D., an HIV specialist and pioneer in measures for relieving chemical dependencies, lauds the physician education portions of the bill. The bill contains provisions for a national commission to develop informational programs concerning the treatment of chronic pain. A national telephone hotline also is to be established. On the state level, HR 5051 mandates "practice parameter" and patient care panels, which would include physician and patient representation, to address the undertreatment of pain and establish what is legally acceptable. "Doctors are hungry for knowledge about pain management and especially desire education from someone outside the drug companies," Stalcup said. Stalcup noted, however, "Guidelines apply to the mean, but in HIV we haven"t established that mean. There is a great need for individualized treatment plans." Painful Complexities The issues involved in prescribing psychoactive drugs to people with HIV can become very complex. One illustration is Stalcup's patient Karen, a one-time heroin addict. Karen came to Stalcup for medical assistance in breaking her Valium dependency. She had been taking the Valium under a doctor's supervision to ease the side effects of the antidepressant Elavil. And she was taking Elavil to reduce the pain from her AIDS-related peripheral neuropathy. Stalcup prescribed Dilaudid rectal suppositories for her pain and proceeded to help her stop the Valium. Dilaudid is a morphine derivative, and Stalcup was in a legal gray area when he prescribed it to an ex-addict, even though such suppositories are not easily abused. The doctor thinks the use of Elavil is fine for dealing with neuropathy. "It helps make pain matter less," he said, "Patients can distance themselves from the sensation and then use less opiates." Valium is not a good idea, though. According to Stalcup, tranquilizers are greatly overprescribed. He commented, "They"re good for the acute anxieties that arise during HIV, when terror is palpable, but we should be very cautious with them. Detoxification after long-term use creates free-falling anxiety, confusion, shakes and concentration problems for up to a year." Cost-Cutting Medicine An aide to Rep. Stark said that the Congressman's primary motivation is curbing Medicaid fraud. "Illegal diversions of drugs for street sales or personal use cost the government a lot of money. They keep benefits from law-abiding patients," said the aide, who does not want to be identified. Stark himself said on the floor of the House, "In short, this effort is nothing more than an expansion of existing federal law for Drug Utilization Review beyond the Medicaid population to the population as a whole." The individual states' DUR Boards, set up to find ways to cut Medicaid costs, will lay out the basic guidelines for controlled substance prescriptions under the proposed law. HR 5051 also suggests that the prescription tracking database be stored within the state-operated Medicaid Management Information System computers used to monitor Medicaid reimbursement. Economy is the basic watchword for the whole prescription recording process. That process relies on pharmacists' pre- existing computers, and Stark argues it imposes no burden at all on doctors. The economic implications upset Dr. Clark. He observed that undertreatment is much harder to catch than overtreatment, especially when the supervising body has a financial interest in cutting medical costs. Comment The Stark bill does mandate a very cumbersome secret encryption system to meet privacy concerns. The code will be known only to a special commission directing the program. But the privacy safeguards may not make much difference since much of the same prescription information is available elsewhere on Medicaid and insurance company computers. HR 5051 does not confront the growing stockpile of accessible personal information, nor does it challenge the tendency to limit freedom of medical care in the name of cost-cutting or the "war on drugs." It just tries to smooth the rougher edges. Stark's aide is in a hurry, though. He said, "Computerization of medical records already exists. Do you want the systems run by the district attorney or the health care administration? We say health care, and let's not wait while the health people study the issue. The police kick down doors." Of course, the police could still kick down doors once they are notified by the board overseeing the prescription monitoring system. Or a licensing board could invade a doctor's practice in an equivalent manner. "Doctors are very paranoid about the state looking over their shoulder and getting hauled in," noted Stalcup. As long as the government maintains its present rigid position regarding psychoactive drugs, it may be impossible to rationalize prescription policies for addictive drugs. AIDS TREATMENT NEWS Published twice monthly Subscription and Editorial Office: P. O. Box 411256 San Francisco, CA 94141 800/TREAT-1-2 toll-free U. S. and Canada 415/255-0588 regular office number 415/255-4659 fax Editor and Publisher: John S. James Medical Reporters: Jason Heyman John S. James Nancy Solomon Reader Services, Business, and Marketing: David Keith Thom Fontaine Jason Heyman Nancy Solomon Laura Thomas Tadd Tobias Rae Trewartha Statement of Purpose: AIDS TREATMENT NEWS reports on experimental and standard treatments, especially those available now. We interview physicians, scientists, other health professionals, and persons with AIDS or HIV; we also collect information from meetings and conferences, medical journals, and computer databases. Long-term survivors have usually tried many different treatments, and found combinations which work for them. AIDS Treatment News does not recommend particular therapies, but seeks to increase the options available. Subscription Information: Call 800/TREAT-1-2 Businesses, Institutions, Professionals: $230/year. Nonprofit organizations: $115/year. Individuals: $100/year, or $60 for six months. Special discount for persons with financial difficulties: $45/year, or $24 for six months. 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