AIDS TREATMENT NEWS Issue #210, November 4, 1994
The protease task force was suggested by Jules Levin, an AIDS activist from Brooklyn, New York. We were not at the meeting; the following summary is from documentation he provided to us:
"We are at a crucial juncture for all of us. We are in the early stages of the development of the protease inhibitors. We need a proper plan for their orderly and effective development.
"I propose we form the Protease Task Force to plan for and guide the development of this new class of drugs. It would be a collaborative and coordinated effort to address all of the attendant issues. Some of these are:
* How best to design the overall approach for all trials, both pre-marketing and post-marketing;
* What combinations ought to be examined in which trials;
* Which controls to use;
* What markers for efficacy and safety will be utilized;
* Potential drug interactions between the protease inhibitors and other medications used by people with AIDS;
* The need for expanded access for those with more advanced HIV disease; and
* Other questions we want answered, and how best to address them.
"The participants on the Protease Task Force would represent the following groups:
* Physicians who treat large numbers of HIV patients;
* Representatives from the HIV-affected and activist community;
* Government representation from the Food and Drug Administration, and the National Institutes of Health; and
* All of the pharmaceutical companies developing protease inhibitors.
"We urgently need discussion of access for those with more advanced HIV disease. This group includes persons with T- helper counts under 50, as well as others with higher counts who have exhausted approved treatment alternatives. [Note: persons with T-helper counts under 50 have been excluded from most if not all current trials of protease inhibitors.] These people have been subjected most harshly to the mistakes of the past; and they have volunteered for the trials of nucleoside analogs and other drugs. We cannot abandon them now."
Mr. Levin told the National Task Force that "the issue burning up the wires between people with HIV is, 'When are we getting access to protease inhibitors?'"
After the presentation, Dr. Kessler said the development of protease inhibitors is the most important work the National Task Force can do now, that the time is right.
Jules Levin urged the AIDS community to rally and offer support, so that the FDA and Secretary Lee do not lose focus on this issue. If you can help, call Jules at 718/624-8541.
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