NEWS ON THE FIGHT FOR BETTER TREATMENT, A VACCINE, AND A CURE FOR AIDS
Position Paper on Accelerated Approval for INVIRASE Brand Saquinavir
by Mark Harrington
by Mark Harrington and Michael Marco with Spencer Cox and Tim Horn
The 35th ICAAC was a more interesting conference than usual, with results from many important AIDS clinical trials being reported. Partly ICAAC benefitted from the lack of an international AIDS meeting in 1995, and partly perhaps from its location in San Francisco, a favorite junket site for physicians and activists alike. Spencer Cox, Mark Harrington, Tim Horn and Michael Marco attended the 35th ICAAC on behalf of TAG and we here summarize some of the more interesting new data reported there. Any errors of data transcription or interpretation are entirely ours and not to be blamed on the presenting investigator. ICAAC presentations have only the most pro forma of peer review, and hence some assertions made there may not end up being substantiated when data are recorded in the medical literature. As always, everything needs to be taken with a grain of salt.
FDA Regulation of Anti-HIV Drugs: A Historical Perspective
By Spencer Cox
Over the period in which FDA has reviewed and regulated anti-HIV therapies, there has been a substantial decline in the quality and quantity of available information regarding the clinical utility of those drugs at the time of their approval. While the experience with accelerated approval remains limited, it seems that the decline in information rapidly increased following the implementation of those regulations. While on the surface this often seems to represent problems in basic trial design methodologies — such as improper controls, early termination, inadequate sample size and post-hoc adjustment and analysis — FDA's willingness to accept fundamentally flawed studies as providing sufficient confirmatory evidence to validate approval may be reducing incentives to properly design and implement post-marketing studies.
by Michael Marco
Lymphomas are not new. They pre-date AIDS for many many years. We have known for some time that organ transplant patients and others from the general population develop lymphomas -- both non-Hodgkin's lymphoma (NHL) and Hodgkin's disease. Never the less, in 1982 patients with HIV disease were reported to be developing NHL at an alarming rate. This is evident by the Lancet's headline for an article which read, "Outbreak of Burkitt's-like Lymphoma in Homosexual Men" (Ziegler 1982). It wasn't until 1985 that the CDC caught on and added NHL to the list of AIDS-defining illnesses.
Problems With Protease Inhibitor Development Plans
By David Barr, Spencer Cox, Gregg Gonsalves, Mark Harrington, Derek Link, Michael Ravitch & Theo Smart
Edited by Mark Harrington for the National Task Force on AIDS Drug Development
The development of protease inhibitors offers the National Task Force on AIDS Drug Development the opportunity to best fulfill its promise of shepherding a coordinated effort to develop new drugs for HIV disease. If it rises to this opportunity, the Task Force could help coordinate the development of a new and possibly exciting class of drugs that may lengthen and improve the quality of life of millions of HIV-infected people. By articulating the significant problems we face in developing the protease inhibitors and then implementing a coordinated strategy towards addressing these problems, the Task Force could present an approach to drug development heretofore unseen, an approach that would place quality research and concern for public health above all other concerns. If the Task Force fails to take this opportunity today, then it has failed in its overall mission, has wasted precious resources and time, and most importantly, has lied to those of us so desperately looking for leadership in the fight against AIDS.