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Treatment Activists Meet With the FDA

November 2003

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

HIV treatment activists met with officials and staff of the Federal Food and Drug Administration (FDA) on November 14, 2003 in Rockville, Maryland. The FDA hosted the meeting to update the community on several recent drug approvals and to address several questions that activists had been asking about the future of drug approval for HIV in the U.S. The event was a field trip for staff of the Center for Drug Evaluation and Research (CDER), with at least 30 scientific and clinical staff in attendance. The activist community was represented by 25 members of the AIDS Treatment Activist Coalition (ATAC).

Mark Harrington opened the forum by recapping the history of HIV drug development from the community perspective. Some FDA staffers may have been surprised to learn that fifteen years ago, on October 11, 1988, over a thousand AIDS activists had surrounded their headquarters and shut down the agency for a day in protest of slow drug approvals and unethical study demands. Harrington recounted how relations improved dramatically after that, and that cooperation between the community and the FDA during the term of Commissioner David Kessler in the 1990s helped speed the approval of an unprecedented number of new drugs that altered the course of the U.S. epidemic. He also noted the leadership role the agency has played by holding hearings about emerging challenges in HIV drug development before they become widely recognized, and for makeing the industry informed about what is expected of them early in the approval process.

Harrington then summarized the community’s requests:

  • More data on pharmacokinetics of drugs in more diverse populations.

  • More drug-drug interaction studies completed at the time of approval, including studies with methadone, birth control hormones, and TB drugs such as rifampin.

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  • Drug-drug interaction studies with the most commonly used protease inhibitors and NNRTIs should also be performed.

  • Industry should be consistently prodded to assure that study populations reflect the makeup of the epidemic by adequately representing women and people of color. The composition of study populations is usually set at the time the study sites are selected and it will be important to build new relationships with clinics capable of enrolling more diverse groups of individuals.

  • After drugs have been approved, promises made by companies to continue post-marketing research should not be allowed to languish. Currently the agency has no effective way to compel completion of these Phase IV commitments, and pressure on Congress to give the FDA more leverage may be needed.

  • The community is also asking that better systems be implemented to monitor long-term side effects after drugs are approved. The current adverse events reporting system is voluntary and may miss early signals of toxicity. A network of "sentinel practices" that would report unusual symptoms might be a viable enhancement to our early detection system. The need for a better system to detect and track side effects such as lipodystrophy syndrome after drugs are approved is a top concern for ATAC.

In addition to these drug development issues, ATAC members expressed concern about reports that ideologically biased individuals had been inappropriately appointed to sit on FDA advisory committee panels that review drugs concerned with reproductive health. There was also concern that radical deregulationists who view the FDA as a roadblock to free and unfettered business would seek to dismantle the Agency.

Current commissioner Mark McClellan joined the meeting, thanked the community for its important contributions and responded to the issues raised by ATAC. In particular he outlined a prototype adverse events surveillance system being developed in association with the National Cancer Institute. McClellan has made better safety reporting a priority for the agency and the pilot model for cancer should be implemented for HIV as soon as possible.

The commissioner also addressed activist concerns about politicization of the agency, radical deregulation and reimportation of prescription drugs from Canada and Europe. He denied that politicization was occurring or that the agency was in jeopardy from Congressional cutbacks. On the drug importation issue, he defaulted to reciting familiar arguments about counterfeiting and improper storage. While these are serious potential problems, in the current political conversation these issues seem intended to deflect discussion about ways to cope with out-of-control drug prices. Recent news articles about the diversion of HIV drugs from Florida to Texas via a string of small, shady pharmaceutical wholesalers makes it difficult to understand where the risk is in importing pharmaceuticals from state regulated distribution networks in Europe. Between the ill-regulated domestic drug channels and the hourly email offers I get for vicodin and valium, it seems disingenuous to suggest that the greater risk to consumers comes from abroad.

Debra Birkrant, director of the division of antivrial drug products, reviewed the various paths that drug approval can take. Accelerated approval for important new drugs to treat HIV will always be considered, she said, despite the demands placed on the agency to assure a thorough evaluation within the six-month window given to fast-tracked agents. She also had a request for the activists: instead of delivering a position paper outlining community concerns and unanswered questions at the end of the process, the agency would find it helpful to hear the activist analysis earlier on, so that it could help guide the agency’s priorities.

After the meeting broke up, activist and FDA staffers mingled and exchanged ideas about how each could help the other assure that future HIV drugs were approved with fewer gaps in knowledge and better data on safety and effectiveness. It's clear that the people of the FDA are keenly interested in understanding everything about the world of AIDS and how the drugs they regulate are used in the real people's lives. In particular, it was gratifying to learn that several senior staffers who are physicians volunteer their time in local HIV clinics every week, helping them to keep in touch with the realities of HIV care.

The FDA workers we met clearly take their duties seriously; they should feel fortunate to work for an agency that exemplifies the highest ideals of what government can do. In proactively reaching out to the community for this meeting, the FDA and CDER went beyond what was expected and set a welcome tone for future cooperation. A follow up meeting with CDER’s sister center, the Center for Biologics Evaluation and Research (CBER) is being planned. CBER will play an important role in the development of HIV vaccines as those candidates begin to enter clinical trials.


Guidelines Panel Responds

ATAC received another demonstration of the power of activist intervention in the recent revision of the HHS HIV/AIDS Treatment Guidelines. ATAC had sent a letter to John Bartlett and members of the guidelines panel asking that ambiguous links between d4T (stavudine, Zerit) and lipoatrophy in denoted Table 12a be strengthened.

The revisions also now clarify that the "preferred" classification attached to certain regimens is a general designation, and that one of the "alternative" regimens may actually be the preferred regimen for a selected patient depending on circumstances. This addresses activist concerns that the guidelines are sometimes mistaken as a "cookbook" for HIV care. Also, two recently approved drugs are now included in the guidelines. Atazanavir has been added as an alternative PI and FTC has been added as an alternative NRTI. Fosamprenavir was approved too recently to make it into this round of revisions.

The recent spectacular failure of tenofovir + abacavir + 3TC updates a section on regimens that should never be offered at any time. Another triple NRTI regimen, tenofovir + ddI + 3TC, also joins the "do not use" list, as does the combination of ddI and d4T in all cases; formerly the combo was only proscribed during pregnancy. Atazanavir plus indinavir are also now contraindicated due to their potential for worsening elevated bilirubin levels, and mixing 3TC and FTC is not recommended because they have such similar resistance profiles.

Finally, new data on using Fuzeon in patients with virologic failure has been added.

The guidelines are neccesarily a work in progress and the logistics of keeping up with changing treatment practices and new drug data is daunting. With these more frequent updates and the willingness to respond to community input, the guidelines are more than ever before becoming a "living document."

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!



  
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This article was provided by Gay Men's Health Crisis. It is a part of the publication GMHC Treatment Issues. Visit GMHC's website to find out more about their activities, publications and services.
 
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