Bay Area Reporter - October 12, 2000
Jeff Gustavson, Survive AIDS Writers Pool

This meeting, which has been delayed several times, will be modeled on last year's meeting on resistance testing. Survive AIDS spoke with Sheryl Lard, Ph.D., who is the FDA's Center for Biologics Evaluation and Research ombudsman, about the issues surrounding this meeting. Lard also is the director of quality assurance who recently moved from drugs to biologics.

"Oversight for immune-based therapies for HIV is currently focused in the Center for Biologics because of the types of products now under development. The antiviral committee, which brings a tremendous wealth of knowledge of HIV therapeutics based on its long history with conventional antiviral agents, will be introduced to the topic in a formal way: where we are and what do we need to start doing to properly evaluate IBTs? This hearing will address agents in phase I and phase II [toxicity and dose-ranging, efficacy is done in phase III], opening the initial discussions of what the FDA should accept when considering these agents.

The hearing will not consider any specific products. We plan to look at the big picture in very general terms," Lard said.

By law, the FDA is limited in its number of committees to 26. These committees are broken down by organ systems or in some cases product characteristics and tend to be more dispersed in terms of disease processes they are evaluating. Organizing review of both biologic agents and antiviral drugs under a committee that is focused around a single disease is something new for the FDA. Moving oversight to the committee that understands HIV can only facilitate more rapid evaluation by more knowledgeable people.

Lard continued: "Sponsors [IBT manufacturers] are unclear what to measure [to prove efficacy]. In the past, under biologics, IBTs have not gone to a single HIV-specific committee. The antiviral committee is a cohesive, disease-specific group which follows a well-planned process. It is composed of a core group of virologists, clinicians, and community representatives which can be augmented each time with the addition of specific expertise to address the type of product being considered."

The community representative for Monday's hearing is Project Inform's Brenda Lein.

The meeting will have a review of the current paradigm of current standards for product approval by agency speakers. Dr. Dan Kuritzkes, from the University of Colorado Health Sciences, will talk on the usefulness of CD4 count and viral load in measuring bioactivity of IBTs. Dr. Michael Lederman, from Case Western Reserve University in Cleveland, Ohio, will present on lab and in vivo measures of immune function. The only measure not lab-based (besides clinical end points) is the skin test measure of delayed-type hypersensitivity (DTH). A DTH test is where they inject a small amount of antigen beneath the skin and look for the immune system to react to it, like the routinely administered TB tests.

Aland Landay, Ph.D., from Rush Medical Center and vice chair of the immunology research agenda committee of the ACTG, will present an overview of the immune response to viruses and tools to measure specific functions, of which there are many. Dr. Donna Mildvan, chief of infectious diseases from Beth Israel Medical Center in New York City, who once said "a surrogate marker is in the eye of the beholder," will talk about where we are and where to go from here with respect to IBTs (see Survive AIDS column from May 11, 2000 "Immune-based therapies").

Following this, there is a period for public comment and this writer intends to testify. It is with concern that Survive AIDS has observed claims being made in the press by manufacturers of IBTs regarding their utility and efficacy, confusing the public into believing a great effect has been seen in the absence of data. We would like to see a more clearly defined benefit to IBTs rather than press releases. We also are concerned that press releases are distorting the informed consent process.

Nevertheless, we are pleased that the FDA is finally giving IBTs the attention these promising therapies deserve.

After the period for public testimony, the panel will discuss all the issues presented for two and one half hours. A future Survive AIDS column will report back on the meeting.

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