&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& J O H N J A M E S writes on A I D S &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& Copyright 1993 by John S. James; permission granted for non-commercial use. AIDS TREATMENT NEWS Issue #174, May 7, 1993 phone 800/TREAT-1-2, or 415/255-0588 CONTENTS: [items are separated by "*****" for this display] New Kind of HIV Antiviral: Food Spice, Cancer Drug Show Activity Urgent, Federal AIDS Funding: Kentucky, California, Connecticut, Florida, Illinois, Iowa, Maryland, New York, Ohio, Texas, and Wisconsin Tat Drug: Parallel Track Negotiations Status Alternative Medicine Grant Program Not Easily Accessible Announcements: Children: NIH Begins First Pediatric Trial of Therapeutic Vaccine KS: DaunoXome Study Recruiting, Compassionate Use Also Available AIDS Health Fraud Congressional Hearings Set Quietly -- Postponed to May? San Francisco: ACT UP/Golden Gate Treatment Issues Committee Benefit, May 11 Alternative Medicine and Health-Care Reform Conference, Washington, May 20-23 ***** New Kind of HIV Antiviral: Food Spice, Cancer Drug Show Activity by John S. James Researchers at Harvard Medical School, using laboratory tests, have developed a new class of anti-HIV compounds -- substances which inhibit the LTR (long terminal repeat) sequence of HIV. Three substances which might have potential were reported in the March 1993 Proceedings of the National Academy of Sciences, USA. One, curcumin, is the main active ingredient in turmeric, a spice used in curry and other foods; another, topotecan, is being tested in humans as a possible cancer treatment; the third, beta-lapachone, has not been tested in humans, but laboratory and animal data suggest that it might be possible to find a useful dose. HIV is often inactive, even after it has entered a cell and has become integrated in that cell's genetic machinery. (This does not contradict the recent report that HIV is active even early in the disease while there are no symptoms; the virus is active in some cells but not in others. For background information, see "AIDS Pathogenesis" in AIDS TREATMENT NEWS #172, April 2, 1993.) The LTR of HIV appears to be critically important in "turning on" the virus (causing it to produce the proteins which are assembled into new viruses, and which cause other harmful effects). The LTR also maintains viral activity after it has started, suggesting that inhibiting the LTR could slow or stop virus which has already been activated. Normally, many substances in the cells seem to be affecting the LTR -- either to inhibit it and keep the virus inactive, or to activate the LTR and promote HIV growth and activity. Much is unknown about how this process works and what substances may affect it. But a drug which effectively inhibited the LTR might keep the virus inactive indefinitely -- not only in acutely infected cells, but also in chronically infected cells, where AZT, ddI, etc. are largely ineffective. Certain experimental treatments already in use in the community -- pentoxifylline, NAC, and antioxidant nutrients such as beta carotene, vitamin C or vitamin E -- may already be having some inhibitory effect on the HIV LTR. The Harvard work is new in that it demonstrates a way to systematically search for potential drugs which work through this particular viral target. The Laboratory Experiments The recent report described two kinds of experiments. One did not use any HIV or other virus; instead it used a genetically engineered human cell, which included a copy of the HIV LTR and also a "reporter" gene, controlled by that LTR, which creates an enzyme which could easily be detected in the laboratory. Scientists can grow this cell, and then add certain chemicals known to activate the LTR, and verify that the enzyme was indeed produced, as expected. Then they can add potential drugs, in various concentrations; if one of the drugs stops the enzyme from being produced, that drug is probably inhibiting the LTR. [Incidentally, the cells for this experiment were developed in the laboratory of Leonard Herzenberg, Ph.D., a Stanford researcher studying NAC, whose group uses the cells in their studies of HIV activation and repression.] The other experiments used cells infected with HIV, to verify that the substances which showed anti-LTR activity did indeed show anti-HIV activity in the laboratory. Both acutely infected and chronically infected cells were used. Results The most powerful of the three substances found may be topotecan, which was active against HIV in very small concentrations, and is reasonably well tolerated in cancer patients, according to published research. These patients tolerated 200 times the blood level of topotecan required to reduce p24 antigen production (a measure of HIV activity) by 80 percent in chronically infected cells. Curcumin, found in the spice turmeric, was less active than topotecan. But it may be particularly important because, as one of the study's authors, Bruce J. Dezube, M. D., points out, "it is a food additive, readily available, non-toxic, and a potential benefit for developing countries." The paper notes that curcumin has been eaten for thousands of years [it is used especially in India, where turmeric is a major ingredient of curry]. It has also been tested for potential pharmaceutical uses, and it has been used for various purposes in traditional Indian, Chinese, and Western herbal medicine. The third substance, beta-lapachone, had no human toxicity data available, but is well tolerated in mice. It was tested 20 years ago for other purposes, and abandoned. Its patent has now expired, so it may be hard to find a pharmaceutical company to develop it. The research which found these three potential treatments is also important because it demonstrated a method which could be used to screen thousands of potential drugs to look for LTR inhibitors. Because of limited resources, this project did not screen many candidates; instead, the researchers were selective, trying to pick substances they considered likely to work. About fifteen potential compounds were tested to find the three listed above. The Next Step The next step in the development of this approach is unclear, because these three potential treatments have reached the point at which new AIDS drugs usually stop. Potential treatments developed in laboratories by well-respected scientists usually do get into scientific journals, but in most cases nothing further happens, because usually there is no drug company which has or can acquire the rights, and also has an interest in the drug, and the money and other resources available to develop it. (The government does little drug-development work, and most of that is on drugs which companies are already testing.) Even those drugs which are ultimately successful often float around at this stage for several years, with progress largely stopped, before enough momentum develops to take them further. Of the three LTR inhibitors described above, two may be unpatentable, and the third is being developed by a company which, as far as we know, is not testing drugs for AIDS. We cannot rely on business as usual to get these substances tested. The problem is that there is still no institution to examine potential treatments which have reached this stage, select which ones are promising enough to begin human testing, and then quickly get that testing to happen. When an "AIDS czar" is appointed, that office may be a place to go to get this long- standing omission addressed. But this official will have a small staff and will probably focus mainly on non-technical issues; in addition, it will be hard to start anything new because of budget constraints. Community-based research groups might be able to help. Topotecan has already been tested in people as a cancer treatment, so basic dosage and safety information is known. Various permissions would be required to test it for HIV; these permissions might or might not be an obstacle. The company developing topotecan, SmithKline Beecham, is testing it for cancer but not for AIDS. Curcumin, at least in turmeric, would certainly be accessible. However, one German paper reported that it was poorly absorbed when given orally to animals, and more active when given by intraperitoneal injection. But a study in India found protection against cancer-causing chemicals in cigarette smoke when turmeric was given orally to people. (Most of the traditional uses have been topical; one study in India, for example, reported a 97 percent cure rate for scabies with a preparation of turmeric mixed with another herb.) A community- based research organization could relatively easily review the available literature, review traditional medicinal uses, and test turmeric or curcumin in a few patients to see if it reduced viral activity. The inexpensive, commercially available acid- dissociated p24 antigen test could be used to look for an antiviral effect. Or it might be possible to use more sophisticated virological tests, through collaboration with the researchers who are developing them. If little or no effect is found, then it might be worth investigating whether curcumin could be prepared in an injectable form. In past years, the only way the AIDS community could move a drug forward in the face of institutional neglect was to develop it as an "alternative" treatment -- i.e., let it go into widespread use -- in the hope that if there were any substantial value it would be noticed, and if not, the substance would be retired through the usual "drug of the month" process. Maybe we can do better today. References Li CJ, Zhang LJ, Dezube BJ, Crumpacker CS, and Pardee AB. Three inhibitors of type 1 human immunodeficiency virus long terminal repeat-directed gene expression and virus replication. PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES, USA. March 1993; volume 90, pages 1839-1842. ***** Urgent, Federal AIDS Funding: Kentucky, California, Connecticut, Florida, Illinois, Iowa, Maryland, New York, Ohio, Texas, and Wisconsin Residents, People with AIDS Need You by John S. James If you live in one of these states or know anyone who does, now is the time to contact Congress to support AIDS funding, and medical research funding overall to find treatments and cures not only for AIDS but for other diseases as well. Decisions being made over the next few weeks will set patterns for national commitment to AIDS and other medical research for the next several years. The big problem is that most members of Congress (outside of a few big cities and others areas) have seldom or never heard from their voters that AIDS and medical research are important to them. We have to change that. Right now the most important people in Washington are 13 members of Congress -- those on the Labor, Health and Human Services, and Education Subcommittee of the House Appropriations Committee, representing the 11 states above -- especially William H. Natcher, Democrat, Kentucky, the Subcommittee (and also full Appropriations Committee) chairman. Congress has already supported the broad outlines of President Clinton's budget for fiscal 1994 (which begins October 1, 1993); the budget includes important increases for a few areas including breast cancer and AIDS research, but otherwise is disappointing for medical research. The real decisions are still to be made in the appropriations process, now beginning, where competing priorities are traded off; much of the budget will not be fully funded. There will almost certainly be efforts to take money away from AIDS and use it for other purposes. Aside from research, Clinton's budget includes a significant increase for AIDS care ($310 million for the Ryan White Care Act programs), and a modest ($45 million) increase for AIDS prevention. The research funding is probably the most vulnerable, however, because of the level funding or even decreases proposed for some of the institutes at the U. S. National Institutes of Health. Terry Beswick, AIDS treatment specialist for the Human Rights Campaign Fund, a Washington organization which lobbies on gay rights and AIDS issues, told AIDS TREATMENT NEWS, "People need to pick up the phone and call their representative, or write them a note, immediately upon reading this. It could mean a difference of hundreds of millions of dollars this year. "While the Subcommittee is generally supportive of AIDS research, and biomedical research overall, we don't need them to simply be supportive this year. When they sit down at the table with their colleagues to carve up the pie, we need them to be leaders advocating with a vengeance for medical research as a top national priority. This is the year of the deficit -- no one is going to speak up without some serious prodding. "People with HIV or AIDS and their families in the districts and states of the Subcommittee members have more than a responsibility to call or write their representatives -- they have a duty. Their voice represents thousands of people with HIV or AIDS who do not live in those districts and states and have greatly diminished representation when it comes to allocating money for AIDS and research." If you live anywhere in the above states (and especially in the Congressional districts indicated below) please call your state's representative(s) on the Subcommittee, and tell their office that you want more funding for AIDS, and more for medical research on all diseases. You can either call their local office or their Washington office, at the phone numbers below. Whenever you can speak from your personal experience, do so. And if you can write a letter to your state's representative, that's even better than a phone call. Address it to The Honorable ________, U. S. House of Representatives, Washington, D. C. 20515. Kentucky (West Central -- Owensboro): William Natcher (Chair), Democrat, 502/842-7376, 202/225-3501 California (San Francisco): Nancy Pelosi, Democrat, 415/556- 4862, 202/225-4965 Connecticut (South -- New Haven): Rosa DeLauro, Democrat, 203/562-3718, 202/225-3661 Florida (West -- Southern Pinellas County, St. Petersburg): C. W. Bill Young, Republican, 813/893-3191, 202/225-5961 Illinois (North and Northwest Chicago suburbs, Waukegan): John Porter, Republican, 708/940-0202, 202/225-4835 Iowa (Southwest -- Des Moines, Council Bluffs): Neal Smith, Democrat, 515/284-4634, 202/225-4426 Maryland (Baltimore, Harford counties): Helen Delich Bentley, Republican, 410/337-7222, 202/225-3061 Maryland (Outer Prince George's County, Southern Maryland): Steny H. Hoyer, Democrat, 301/464-6440, 202/225-4131 New York (Southern Westchester, White Plains, parts of Bronx, Queens): Nita M. Lowey, Democrat, 914/428-1707, 202/225-6506 New York (South Bronx): Jose E. Serrano, Democrat, 718/538- 5400, 202/225-4361 Ohio (Cleveland East Side and suburbs): Louis Stokes, Democrat, 216/522-4900, 202/225-7032 Texas (Laredo, San Antonio suburbs): Henry Bonilla, Republican, 210/697-9055, 202/225-4511 Wisconsin (Northwest -- Wausau, Superior, Stevens Point): David R. Obey, Democrat, 715/842-5606, 202/225-3365 ***** Tat Drug: Parallel-Track Negotiations Status by David Peck [Editor's note: there is intense scientific and community interest in drugs to inhibit the HIV tat gene and the tat protein it produces (for background, see AIDS TREATMENT NEWS #166, January 1, 1993, and #153, June 19, 1992). Only one company, Hoffmann-La Roche Inc., now has a tat-inhibitor drug in human trials. Information about how well it is working should be available by this summer.] Meanwhile, ACT UP/Boston has taken the lead in negotiating with Hoffmann-La Roche to get the company to develop a parallel- track program (to go into effect if the trial results are promising), to allow some patients to get the drug before it is approved for marketing. AIDS activists have found it difficult to work with this company. David Peck of ACT UP/Boston, who has been most closely involved in negotiating with Hoffmann-La Roche, has professional experience as a management consultant and brings these skills to his activist work. Two years ago he negotiated successfully with Burroughs-Wellcome to set up a program for early access to their experimental pneumocystis drug, 566C80, for patients who had exhausted other options. (The drug, re-named Mepron, has since been approved.) Two weeks ago, David Peck wrote the following description of the current status of parallel-track negotiations with Hoffmann- La Roche.] During the last five months ACT UP/Boston has been working with Hoffmann-La Roche to arrange pre-FDA-approval access to its novel drug, RO 24-7429 (tat inhibitor). During this time, ACT UP/Boston has sought access to the drug via parallel track for HIV, and compassionate access for KS for people who have exhausted all treatment options. During this time Hoffmann-La Roche has negotiated positively, despite intense pressure from community organizations nationwide. Although they acknowledge the tremendous need for access to the tat drug, on April 16 Hoffmann-La Roche stated that parallel track cannot be implemented until fall 1993 at the earliest, even though the interim safety monitoring from the current trial showed "no undue safety problems." In addition to the current human trial which is gathering safety and efficacy data (ACTG 213), Hoffmann-La Roche believes a purely phase II trial (in addition to ACTG 213, which is "phase I/II") must be underway before parallel track can begin. Each new trial takes a great deal of time and coordination, and is subject to a large number of potential unexpected delays, both sides agree. As a result, the promise of fall 1993 could easily become mid-1994. In addition Hoffmann-La Roche has said "No" to compassionate access for those with severe, immediately life-threatening KS who have exhausted all existing therapies, including chemotherapy. Compassionate use is a humane, patient-by- patient program intended to make promising, theoretically helpful drugs available to immediately life-threatened people whose only choice is to die, or to take a chance on a new drug. In a letter dated April 16, 1993, Gail Levinson of Hoffmann-La Roche addressed the KS issue to ACT UP/Boston: "Currently, there are no data available which show the tat antagonist to be effective against Kaposi's sarcoma. As you know, we will shortly be initiating a KS protocol which will evaluate the drug's effectiveness against this disease. The prospect of making the drug available on a compassionate plea basis is unwise at this time given the lack of data on the drug." ACT UP/Boston responds: There is theoretical evidence to suggest this drug may be of use against KS. Compassionate use is a de facto industry standard in the AIDS crisis, often in the absence of controlled activity or efficacy data. Many lives have been saved by such programs, which offer those with no hope a new option. This potential for control of one's options alone can mean the difference between life and death. Ms. Levinson's letter also addressed the parallel-track issue: "As we reviewed in detail, the interim analysis of ACTG 213 showed no undue safety problems. However, we will not know activity nor dosage information until this stage of the study is complete and the data analyzed. We anticipate this activity to be completed during the summer months. At that time, assuming the data are favorable, drug will be formulated at the required dosage strengths for availability to patients on an expanded access basis during the fall months. Activity data and a recommended dose are essential information before the raw compound can be converted into final form. However, to manufacture a dosage form that may not be effective is not a responsible way to respond to the needs of the patient population. Therefore, after carefully reviewing this situation, we have determined that we will be unable to compress the time line for initiating the expanded access program." ACT UP/Boston responds: Activity data will be available in June -- why wait until the fall? While ACT UP/Boston and its consensus signer organizations agree that parallel-track guidelines do not require activity data, we were willing to concede on this point as long as Hoffmann-La Roche agreed to implement parallel track in July -- immediately following the review. Hoffmann-La Roche refused, citing the dosage form as the primary rationale, and the need for a second efficacy trial to be underway as a secondary reason. [Note: In early May, ACT UP/Boston learned that ACTG 213 added a higher dosage arm, 200 mg three times a day, to that trial. The previous highest dose had been 100 mg. This increase confirms that no major safety problems have been found.] In the short term, the parallel-track dose is unlikely to be vastly different from the study dose, which Hoffmann-La Roche is fully capable of making in its "final form." ACT UP/Boston believes that even now Hoffmann-la Roche has enough data to select an appropriate starting dose (i.e., the lowest ACTG 213 dose) for parallel track (as opposed to a proven "effective" dose), which meets the requirements of parallel track. Hoffmann-La Roche disagrees, believing that an effective dose is required. History has shown that identification and manufacture of the effective dose form is often a revisionist (and responsible) process; if a better dose is discovered during the trials, patients can, for example, be told to take two pills as opposed to one. ACT UP/Boston feels that Hoffmann-La Roche has not presented a valid reason to delay access to tat. Underground production of tat on a large scale is now underway, at great risk and expense to the community. This should show Hoffmann-La Roche the overwhelming need of those who have exhausted all their treatment options. These people would rather try something than do nothing -- and there are thousands! Hoffmann-La Roche's acknowledgment of this fact, coupled with their refusal to take immediate steps to address it, is incomprehensible. We acknowledge Hoffmann-La Roche's willingness to carry on a dialog on these issues. We believe they view these delays as critical steps that must be taken before the drug can be made available. But what Hoffmann-La Roche misses, despite numerous conversations and even a video presentation by people who have no options left, is this: It is not Hoffmann- La Roche's responsibility to protect people from a drug that may save them. That's what the federal guidelines say, that's what other companies are doing, and that's why the community is making the drug for themselves -- we just can't wait any longer. Questions? Comments? Contact: David Peck of ACT UP/Boston, 617/776-2534. ***** Alternative Medicine Grant Program Not Easily Accessible by Dave Gilden The new Office of Alternative Medicine in the National Institutes of Health has finally issued guidelines for its 1993 grant cycle. The Office has been the subject of tremendous interest and press attention (see AIDS TREATMENT NEWS #172) despite its small size and minuscule budget by NIH (U. S. National Institutes of Health) standards. There are only four professional staff members and one secretary in the Office, and the annual budget is $2 million. Six hundred thousand of that amount will be divided into about 20 grants. No grant may exceed $30,000. The OAM is putting the best face it can on the grants' minimal size by calling them "exploratory grants" intended to fund small scale studies for obtaining preliminary data on particular therapeutic techniques -- sort of phase I studies for practices that the NIH has ignored up to now. To help inexperienced grant writers, the OAM in the week of April 19 held grant-writing workshops in four cities, Atlanta, Albuquerque, St. Louis and San Francisco. An earlier workshop was held in Washington, D. C., at the end of March. Attendance was quite high. In Washington, over 200 people took part, and in San Francisco, the figure was over 100. The size of the competition might seem daunting to anyone interested in obtaining funding, but several factors will weed out many potential applicants -- including the deadlines. The OAM was created by Congress in October, 1991 and stumbled along through its first year without any permanent staff. Now, all of a sudden, the Office is in a great hurry and advancing at an unusually rapid pace for the NIH. Applicants had to have a letter, stating their intent to apply, in the OAM's hands by April 30, only a month after the Office issued its grant guidelines and too soon for most people to react. The completed grant applications are due June 8, and award announcements will be made three months later. Many people at the San Francisco workshop, meanwhile, seemed just beginning to define what they wanted to investigate. The requirement that created the greatest concern in the San Francisco workshop was the need for each grant to represent a collaboration between practitioners of alternative medicine and conventional researchers. In fact, developing such collaborations is one of the Office's main stated purposes in issuing the grants. The OAM's assistant director, Daniel Eskinazi, Ph.D., defended the forced collaboration as a protection for nonstandard researchers, who would stand little chance of getting any money on their own when competing against the grant writing experience and scientific resources available at universities. But the whole process at this point seems geared to groups with on-going research efforts and prior connections with mainstream institutions. Eskinazi did speak of a "non-funded alternative track" and, in a few years, a funded program that would give less experienced groups technical support in meeting NIH requirements, designing protocols, checking subjects' safety and the like. These two programs are just tentative proposals at this point, however. The NIH already funds significant research in some fields considered part of alternative medicine, e.g. nutrition and acupuncture for AIDS-related conditions. The OAM seems to be establishing a routine that merely incorporates more unconventional therapies into a conventionally functioning research apparatus. As Eskinazi remarked, "We are part of the NIH, and we have to go with that." Comment The most intriguing kinds of alternative medicine do not just offer alternative therapies but look at ways to systematically support the normal, healthy functioning of the body. Fields like psychoneuroimmunology and Chinese medicine, for example, have developed promising approaches to AIDS therapy from theories based on the interaction between various organ systems. Such holistic medicine does not easily lend itself to be taken apart in standard clinical trials. It is also generally non toxic and may not require all the bureaucratic regulations in place to ensure the safest possible testing of normal experimental medicines. Last September, the OAM convened 150 experts in alternative medicine to study these sorts of issues and make recommendations on ways to proceed. It is unfortunate that the Office did not wait for this panel's report before moving forward. That report will review a wide range of alternative medical practices and theories, including different ways to evaluate innovative therapies. It could lay the basis for a much needed comprehensive program to evaluate therapeutic strategies outside the mainstream. For now, Eskinazi can only say, "I think there are much better ways to do things than randomized double blind studies, but I don't know what the grant review committee will think." The grant review committee for the OAM program is being set up by the NIH Division of Research Grants, which reviews all the grants applications sent to the NIH, some 30,000 in the course of a year. The ad hoc alternative medicine grant review committee is therefore emerging as a critical point for determining how the OAM grant program operates this year. The NIH is now seeking expert individuals for that committee. Those interested should contact Dr. Eskinazi at the OAM (301/402-2466) for further information. In talking with several officials at the NIH, we were impressed by how much budget-cutting pressure exists in Washington these days. The OAM claims to be "under the gun," with a great need to justify its continued existence through a serious research program. But the Office exists as a result of popular pressure exerted on Congress. To survive, the OAM will have to maintain the support of this alternative medicine activist constituency over the years. This will be difficult to do if that constituency lacks access to the Office, and this year's grant procedures indicate that such access is not easily forthcoming. ***** Announcements ** Children: NIH Begins First Pediatric Trial of Therapeutic Vaccine The U. S. National Institutes of Health is now running the first trial of an HIV treatment vaccine for children. The ultimate goal of this research is to find out if an HIV vaccine can prevent children already infected with HIV from getting sick. The study will enroll children between the age of one month and 12 years. They must have well-documented HIV infection (many infants who test HIV positive are not actually infected), but no symptoms of HIV disease (or nothing other than swollen lymph glands or a mildly swollen liver or spleen). Three different vaccines are being studied: a gp160 vaccine by MicroGeneSys, a gp120 vaccine by Genentech, and another gp120 vaccine (with a different adjuvant) by Biocine, a joint venture of Chiron and CIBA-Geigy. An adjuvant is a substance added to a vaccine to make it work better. In each group of 15 children, 12 will be randomly assigned to receive vaccine and three will receive a placebo (the adjuvant only). If the vaccine is well tolerated, a higher dose will be given to the next group of 15 children. This trial is looking mostly for safety and immunological information; it is too small to tell if one vaccine is more effective than another. The trial will be conducted at 12 sites in the U.S. A total of 90 children will be enrolled. Each child will receive six immunizations -- one a month for six months -- and will then be followed up for 24 months after the last shot. For the site locations or other information about this trial, call the AIDS Clinical Trials Information Service, 800/TRIALS-A, on weekdays from 9 a.m. to 7 p.m. Eastern time. Spanish-speaking information specialists are available. *** KS: DaunoXome Study Recruiting, Compassionate Use Also Available A phase III trial of liposomal daunorubicin (brand name DaunoXome, being developed by Vestar, Inc., of San Dimas, California), an experimental treatment for Kaposi's sarcoma (KS), is now recruiting at nine cities in the U.S. This trial will randomize patients to receive either liposomal daunorubicin, or the conventional treatment ABV (adriamycin, bleomycin, and vincristine). In addition, a compassionate-use protocol is being started in four cities. Ordinary daunorubicin is an approved drug used in chemotherapy for cancer. Its use is limited because of serious toxicity, especially damage to the heart. Liposomal daunorubicin (brand name DaunoXome) is daunorubicin enclosed in liposomes, which are microscopic balls of fat. Liposomes are used for targeted drug delivery, because they can be designed to be differently absorbed by different tissues. In trials so far, liposomal daunorubicin has been able to deliver a higher concentration of the drug to tumors or to KS lesions than free daunorubicin (not in liposomes), with less toxicity, especially to the heart. Terrence Chew, M. D., of HIVCare at St. Francis Memorial Hospital, is running one of the two trial sites in San Francisco, and the only compassionate-use site in that city. He has used liposomal daunorubicin to treat patients for two years in early, small studies, and has seen no evidence of cardiac toxicity. However, hematologic toxicity is much like that of free drug, or only slightly less. He has seen about 70 percent of patients respond well to the drug -- about the same as with the conventional treatment, ABV -- but feels that because there is less toxicity with liposomal daunorubicin, the quality of life is better. The phase III comparative trial is actively enrolling patients with five or more untreated KS lesions, who have never had systemic chemotherapy. There are 200 slots in the trial. Persons must have primary care before enrolling. There is no charge for the trial, except that patients randomized to the ABV arm of the study may need to pay for that drug, as Vestar does not cover all of this cost. Persons interested in volunteering can check with the site nearest them for further information. The clinical trial is being conducted in: Chicago, Houston, Los Angeles, New York, Palm Springs, Portland, San Francisco, Tucson, and Washington The compassionate use program for advanced KS is for persons who have failed conventional therapy. They must usually have 25 or more lesions (or ten new ones in a single month). As with most compassionate-use protocols, patients are responsible for the cost of laboratory and other tests, and drug administration; only the drug is free. Each infusion visit (every two weeks) costs about $250 at the site we checked, including a required physical and drug preparation. This price may vary at different sites. The compassionate-use program is available in: Boston, Los Angeles, New York, and San Francisco. For more information about the DaunoXome phase III trial, call Jeanni Brenning at Vestar, 714/394-4000. For more information about the compassionate-use protocol, call Michelle Sample at PACT, 800/247-3303. PACT is administering this program for Vestar. ** AIDS Health Fraud Congressional Hearing Set Quietly -- Postponed to May? A hearing on AIDS health fraud, originally set for April 15, has been postponed and may take place in May. As of May 3, however, the date had not been set. The hearing will be before the House Judiciary Committee Subcommittee on Crime and Criminal Justice, chaired by Congressman Charles Schumer (Democrat, Brooklyn). AIDS TREATMENT NEWS learned about this hearing only by chance on April 15, the date it was supposed to have occurred, when our editor was on a panel with an FDA spokesperson who happened to mention that an AIDS health fraud hearing had been scheduled for that day but was being postponed. We called about 10 AIDS treatment activists across the country, and none of them had heard of the hearing -- not even the policy department of the Gay Men's Health Crisis, the leading AIDS organization in Congressman Schumer's district. We do not know who has been invited to testify, since the witness list is being kept confidential until a few days before the hearing takes place. And the new date remains uncertain because the Subcommittee has been busy with the World Trade Center bombing in New York, the events near Waco, Texas, and an upcoming national summit on drug control. We recently heard that the Subcommittee has been in contact with two AIDS activist organizations. But neither of them had known about the hearing until we told them -- after the date on which it was supposed to have occurred. These circumstances raise suspicion that there may be an effort to create an unbalanced hearing, possibly to lay the groundwork for future crackdowns against treatment options and access -- the kinds of crackdown that could limit legitimate treatment choices, as well as fraudulent, deceptive, or dangerous ones. It may be important for AIDS organizations to attend the hearing and make contact with any reporters who show up, to make sure they know that there are well-informed, legitimate viewpoints, and sources of well-documented information, which may not otherwise be represented there. This press outreach will not affect the record of the hearing, however; therefore, if the content does turn out to be unbalanced, it will be necessary to include a continuing effort to inform Congress and other parties of that fact. Since AIDS TREATMENT NEWS probably cannot get to Washington to attend the hearing, we hope that others will. Meanwhile, outright AIDS treatment scams do exist (although they seem considerably less common than we would have expected at this stage of the epidemic). The Subcommittee may indeed have enough horror stories of completely baseless, grossly overpriced, or deceptively promoted treatments that it can stay well away from legitimate unproven choices. In any case, persons who want to tell the Subcommittee about cases of health fraud, AIDS- related or otherwise, can write to: Charles E. Schumer, Chairman, Subcommittee on Crime and Criminal Justice, 362 Ford House Office Bldg., Washington, D. C. 20515. ** San Francisco: ACT UP/Golden Gate Treatment Issues Committee Benefit, May 11 The American Association of Physicians for Human Rights, its San Francisco area affiliate, and several dozen physicians, dentists, and other health professionals are sponsoring a $100+ benefit reception for the ACT UP/Golden Gate Treatment Issues Committee, to raise money for AIDS treatment activists to attend medical conferences. The reception will be Tuesday May 11, 6 to 8 p.m., at the Cafe Majestic, 1500 Sutter Street in San Francisco. For many months the Treatment Issues Committee has been doing excellent work which is complex and largely unknown to the larger AIDS community. It has negotiated on many different issues with pharmaceutical companies, public officials, researchers, and others, to speed the most important initiatives in AIDS research, make clinical trials more workable for patients and physicians, ease the conditions for access to new treatment options, and bring pressure to lower excessive prices. Regardless of whether you can afford $100, or whether you see this notice before the date has passed, you can come to the Treatment Issues meeting every Thursday at 7:30 p.m., at the ACT UP/Golden Gate workspace, 592 Castro Street (at the corner of 19th Street), on the 2nd floor. [This address may change because there are often too many people to fit in the room; call the ACT UP/Golden Gate voicemail announcement line, 415/241-8800, to confirm the location.] Working with this group is a good way to learn the latest news about treatments. Newcomers are sometimes intimidated because they cannot follow much of the discussion at first. The key is to realize that, of the dozen or more projects that may be ongoing at any one time, you only need to find one which interests you; it is not hard to learn enough about that one area to be able to start contributing to the work of the group. ** Alternative Medicine and Health-Care Reform Conference, Washington, May 20-23 A four-day conference, "Alternative Medicine, Wellness, and Health Care Reform: Preparing for a Sustainable Future," will take place May 20-23 at the National Museum of Health and Medicine and the Dirksen Senate Office Building in Washington, D. C. It is sponsored by the NIH Office of Alternative Medicine (see article in this issue), the National Museum of Health and Medicine, the National Wellness Coalition, and the U.S. Botanic Garden; co-sponsors are the Taoist Health Institute and the Center for Natural and Traditional Medicine. Topics include the future of alternative medicine in the U.S. ; improving health- care access, delivery, and research; and over two dozen lectures and panels on specific medical systems and other topics (examples: "Homeopathy: The Art and Science"; "Attitudinal Healing"; "Nutritional Approaches to the Treatment of Chronic Disease"; "Traditional Chinese Pharmacopeia"; "Herbs, Nutritional Supplements, and Government Regulations"; and "Holistic Treatments for AIDS"). This is not an AIDS conference, but AIDS is one area to be discussed. Registration is $75 per day, $275 for four days (slightly less if postmarked before May 14); discounts are available for senior citizens, volunteers, and full-time students. For more information, call EEI Conferences, Attn: Alison Malone, 703/684-2116. ***** 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 and Business: David Keith Thom Fontaine 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. If you cannot afford a subscription, please write or call. Outside North, Central, or South America, add air mail postage: $20/year, $10 for six months. Back issues available. Fax subscriptions, bulk rates, and multiple subscriptions are available; contact our office for details. Please send U. S. funds: personal check or bank draft, international postal money order, or travelers checks. VISA, Mastercard, and purchase orders also accepted. ISSN # 1052-4207 Copyright 1993 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used. &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& End of display - - - - - - - - - - - - AIDS Info BBS 415-626-1246 (free) From: Ben Gardiner Return address: ben@maggadu.Queernet.ORG -- ben@maggadu.QueerNet.ORG AIDS Info BBS 415)_626-1246 free since July 25, 1985