alan@garp.mit.edu (Alan Shaw) (10/06/89)
[A reader of sci.med.aids asked about back issues of the Digest. The T&D Digest is a publication of the Treatment and Data Committee of ACT UP New York. I began posting the Digest with issue number 13. Earlier issues exist only in printed form so far. They should be available from the committee. Call Stephen Gendin at (718) 636-9254 or Mike Barr at (212) 765-7127. --ais] The Treatment & Data Digest A Review of issues addressed by ACTUP's T&D committee during its past week of activities Number 15: October 2, 1989 ERRATUM: Last week's _Digest_ erroneously labeled crypto (cryptosporidiosis), toxo (toxoplasmosis gondii) and MAI (mycobacterium avium intracellulare) as _preventable_ infections. That is not yet true. While the drug pyrimethamine is being used as both prophylaxis (prevention) and treatment for toxo, there is not yet any prophylaxis for MAI or crypto. A combination of tuberculosis drugs (ciprofloxacin, clofazamine, rifampin, ethambutol, amikacin) is used to treat MAI. Two drugs, diclazuril and spiramycin, are being used to treat crypto. Spiramycin has already proven effective against crypto in some people. Diclazuril, while promising, is still in early stages of testing and its efficacy has yet to be officially determined. ddI DISCUSSION: As part of its monthly _HIV_ _Discussion_ _Forum_, New York University (NYU) will host an evening discussion about the beginning of phase II trials and the parallel track treatment IND for ddI. Speakers are to include Dr. Bernard Bihari, Dr. Charles Farthing and Dr. Alvin Friedman-Kien. All are welcome. Wednesday, October 4, 6:30 p.m. Tishman Auditorium in Vanderbilt Hall of the NYU Law School. 40 Washington Square South. "Q" FUROR: After hours and hours and hours of emotional discussion, T&D has drawn up a statement regarding Compound Q (trichosanthin) and unofficial treatment protocols which it will present Monday night 10/2. The statement reaffirms ACTUP's belief in a person's freedom of choice so long as that choice is based on fully-informed consent. (It is important to note that _not_ _one_ of the three deaths which occurred during the unofficial trichosanthin protocol has yet been shown to be a direct result of the drug itself.) The _Project_ Inform_ data is being analyzed by an independent research firm and is scheduled to be released October 6. HYPERICIN/ST. JOHN'S WORT: Hypericin is a chemical substance found in the herb St. John's wort. Both hypericin and its synthetically produced twin "pseudohypericin" have shown potent anti-viral activity both in the test tube as well as in retrovirus infected mice. Pseudohypericin is NYU's synthetic version of hypericin which a Stamford-based pharmaceutical company (VIMRX) is working to develop. VIMRX has recently submitted its IND (Investigational New Drug) application for its "pseudohypericin" to FDA. Once FDA gives VIMRX the go-ahead, Phase I trials will begin. Executives at VIMRX said they expect to hear from FDA by mid-October. All in all, a promising substance. But as we well know, a Phase I trial can take years! Hypericin has been used successfully as an antidepressant in Europe with virtually no toxicity. So why fart away a year or two trying to establish a maximum tolerated dose (MTD) when the drug has already shown low cytotoxic (cell- killing) activity at concentrations sufficient to produce dramatic antiviral effects in tissue cultures? Many people living with HIV have taken it upon themselves to investigate the anti-retroviral properties of hypericin first-hand. Since various forms of hypericin are available inexpensively at health food stores (and through the PWA Health Group: (212) 532-0280), quite a pool of anecdotal evidence is already available. John James, author of the biweekly newsletter _AIDS_ _Treatment_ _News_ (ATN), has spent the past several months assembling responses from his survey of hypericin users. His conclusions are to appear in the next issue of ATN and are rumored to be quite encouraging. NAC (N-acetylcysteine), an inexpensive, non-toxic drug widely available throughout Europe to treat bronchitis appears to inhibit the HIV-stimulating effects of the tumor-necrosis factor (TNF) and perhaps to halt the production of HIV itself. TNF is believed to activate HIV and to cause the _cachexia_ or "wasting" that is associated with AIDS. NAC's action against TNF has only been observed in the test tube thus far. It is yet unclear if the results can be reproduced in humans. NAC was tested in a simulation that combined kidney cells and HIV genes. In the U.S., NAC is used as an antidote for overdoses of acetaminophen (_Tylenol_) and is available by prescription. In Europe, _Fluimucil_, the over-the-counter drug which contains NAC, has shown to be so safe that doctors routinely prescribe daily doses for months on end. The drug is slated for a community-based trial, but the developers declined to identify who the trial organizers would be. PEPTIDE T: Ken sat in for Jon at the Peptide T meeting in Boston last Wednesday. Although he's still sifting through reams of information that came out of the meeting, his overall mood might be described as exuberant. Peptide T trials have been under way for some time now in Los Angeles and Boston. There are 22 people in the LA study; 37 in Boston. Results do far suggest improvements in weight, mood, diarrhea, neuropsychological performance and HIV dermatitis. And Peptide T has been found to be completely non-toxic. Unfortunately, drug politics between NIMH (National Institutes of Mental Health) and NIH (National Institutes of Health) complicated by disagreement over useful surrogate markers has given Peptide T short shrift. Bristol- Meyers, the original sponsor of Peptide T trial, dropped the drug unexpectedly -- perhaps due to pressure from NCI (National Cancer Institute) which has a great stake in CD4. It's a complicated -- and fascinating -- story. The NIMH researcher who discovered the peptide, Candice Pert, seems to have some unconventional ideas about HIV and an even more unorthodox method of presenting them. We'll keep you posted. MORE ON ddI: Bristol-Myers was to meet with FDA last Thursday to work out one remaining bug holding up the parallel track distribution of ddI. Bristol is said to be working at a furious pace to make sure the program is ready to fly by 9/30. After Thursday's meeting, Bristol will have 5-7 days to put the revised protocol in writing and get the appropriate materials printed up. Every doctor across the country who has called the toll-free number (1-800-662-7999) will receive a packet explaining the program. As of last Wednesday, talk was that Bristol would offer a Treatment IND for the AZT intolerant and an "open-label" protocol for what they're calling "AZT failures;" that is, people who have been on AZT for 6 months or more and for whom the drug is not working. As we go to press, the exact criteria used to determine if AZT is working or not are still being negotiated. Bristol is having a meeting later this week to discuss how it will tackle the issue of paying for medical costs (e.g. bloodwork) associated with the protocol. AZT IN KIDS: Despite the success with AZT, the FDA has continued to demonstrate a conservative approach to drug testing with children. The FDA has taken the position that AIDS drugs must be tested and toxicity defined in adults before it will allow testing in children with AIDS to proceed. This policy has delayed the development of effective therapy for children with AIDS, and it denies access to those for whom experimental drugs may provide the only therapeutic option. Establishment of a safe dose in adult patients should not be a prerequisite for conducting clinical trials in children, since different spectrums of toxicity -- as well as benefits -- may be seen in the two populations. Such delays will surely cause deaths in the end. Drug companies such as Burroughs-Wellcome refuse to invest the time and money required for FDA approval of AZT for children because the market is not yet sufficiently lucrative; that is, there are not yet enough children infected with HIV -- or worse, not enough children whose parents can pay. IMPORTANT NUMBERS: AIDS Treatment Registry: information about trials in the New York area: 212-268-4196. Project Inform: information on different experimental treatments: 800-822-7422. National Trial Hotline: information on trials throughout the United States: 800-TRIALSA. Bristol Myers ddI Hotline: information on how to get ddI through the parallel track: 800-662-7999.