shaw@garp.mit.edu (Alan Shaw) (11/03/89)
The Treatment & Data Digest A Review of issues addressed by ACTUP's T&D committee during its past week of activities Number 18: October 30, 1989 FLUCONAZOLE -- PfUSH COMES TO SHOVE: Amphotericin-B -- otherwise known as amphoterrible -- is the only approved treatment for cryptococcal meningitis in this country. Many people cannot tolerate the drug. Possible side effects include elevated creatinine (a protein excreted by the kidneys into the urine; unusually high levels of creatinine in the urine can indicate impaired kidney function), low platelet counts (blood cells responsible for clotting, also called "thrombocytes") and nausea. Even for those who can "tolerate" the treatment, the six weeks of intravenous administration are nearly unbearable. And the six-week IV regimen must be followed up with the surgical insertion of a chest (Hickman) catheter through which weekly amphotericin treatments are administered for the duration of one's life. Fluconazole, on the other hand, is administered _orally_. Not only is it available in France, England, Denmark, Australia and other countries, but it is even being used abroad _prophylactically_ with great success. The few toxicities observed have been isolated reports of elevated liver enzymes and pancreatitis -- both of which were quickly reversed after going off the drug for some time or taking less of it. Pfizer, the company woring on fluconazole, said it submitted its NDA (New Drug Application) to the FDA last March. The NDA was submitted for two "indications:" cryptococcal meningitis and candidiasis, for both AIDS and cancer patients. But the FDA argues that Pfizer didn't submit major efficacy data until just a few months ago, not in March as Pfizer claims. On making fluconazole available through a treatment-IND program, the FDA said Pfizer wanted too many indications included. Pfizer claims the FDA feels fluconazole is already sufficiently available through the FDA's "compassionate use" program, where someone must "fail" on amphotericin-B or have a terrible reaction to it in order to get fluconazole. The FDA seems to think that since an approved treatment for cryptococcal -- terrible as it may be -- already exists, there is no rush to approve a second, more humane alternative. The FDA counters by charging that Pfizer never earnestly sought a treatment IND for fluconazole, that its entire position is a sham, and that it is forever seeking to deflect criticism. It is unclear where the real bottleneck lies. Is it the FDA or is it Pfizer? T&D has decided to pursue both possibilities. Cooper and Beininger at the FDA. And the appropriate contact at Pfizer. There is absolutely no reason for this drug to be unavailable to people with cryptococcal meningitis. And a major action is already in the works... just in case. TIME FOR ACT UP/New York TO DESIGN ITS OWN TRIALS??? At the request of a PISS AND VINEGAR representative, T&D discussed the possibility of ACT UP/ New York designing its own clinical trial or working in conjunction with the CRI (Community Research Initiative) on a drug trial. It was observed that ACT UP/New York had not lived up to its founding mission to get promising new drugs into people's bodies. Still it was not entirely clear what talent ACT UP/New York might be able to bring to the design and completion of a drug trial that groups like CRI don't already have. Wouldn't ACT UP not only be out of its area of expertise but duplicating the efforts of other groups as well? Although it was generally agreed that there is a need for change within CRI, it was difficult to see what -- if any -- role ACT UP/New York might have in that reform. A feasibility report will be presented to T&D before further discussion is pursued. DR. ANTHONY FAUCI: ARTFUL DODGER, MASTER OF EVASION. Fauci lied to ACT UP in promising us the data from trials #016 [AZT in early ARC] and #019 [AZT in asymptomatic seropositives]. And we've got to call him on it. On his visit two Wednesdays ago he promised us this data knowing full well that they were not yet available. Fauci is smooth, very smooth, but we simply must get past the fact that he's a likeable guy. A cruel twist on the Cassandra of yore, Fauci is the ever-faithful bearer of good tidings whom we enthusi- astically embrace with naive credulity. Has Fauci successfully co-opted his former activist adversaries into obedient stooges? Maybe it's time to show him that the answer is "NO." JOINT MEETING of WAC (Women's Action Committee) and T&D is on for Friday, November 3 from 6 pm to 8 pm at the Center [208 W 13 St, NYC]. Among the proposed agenda items are: 1) How to make parallel track more accessible to populations outside of the clinical trials network. 2) Drug protocols for pregnant women. 3) History of the progression of HIV disease in women. 4) Relationship between Epstein-Barr, Chronic Fatigue Syndrome, yeast infections and AIDS. 5) RU-486: access and choice. For more information, call Garance at (212) 675-5170. IMPROVING THE ODDS: Columbia University's third annual conference on treatments against HIV will be held Saturday, November 18 in the Miller Theater on 116th Street and Broadway from 9 am to 6 pm. It's a very full day but chock full of information. There is no registration or reservations; seating is available on a first come, first serve basis. Doors open at 8:30 am. The theater is wheelchair accessible. 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 outside of the official phase II trials: 800-662-7999. QUESTIONS? Call Stephen Gendin at (718) 636-9254 or Mike Barr at (212) 765-7127.