Protease Inhibitors -- Task Force Proposed

A proposal for a high-level task force on protease
inhibitors received strong support from FDA Commissioner
David A. Kessler, M.D., and from Philip R. Lee, M.D.,
Assistant Secretary for Health, U.S. Department of Health and
Human Services, at the October 27-28 meeting of the National
Task Force on AIDS Drug Development. After the proposal was
presented, Dr. Kessler suggested a special meeting of the
National Task Force in early 1995 devoted solely to protease
inhibitors.

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.