Process not Persecution

  • by: |
  • 07/24/2006

I’ll bet all those pols and pundits who naively call for a “conflict-free code” for FDA advisory committee members don’t realize that such a zero-tolerance policy would lead to the destruction of the most open, transparent — and successful programs of clinical review in the world.

Consider Canada and Europe where advisory committees meet in secret, deliberating behind closed doors, commenting publicly only after they have reached a decision.

During my tenure at the FDA I was the senior official in charge of advisory committees. I recollect a meeting with officials from Health Canada — the FDA’s equivalent in Ottawa — who were aghast that our adcomm meetings were regularly attended by members of the media, financial analysts, patient groups, politicians — and that the meetings were recorded for public consumption.

I explained that such transparency was what made the meetings so valuable. At an FDA adcomm the agency is put to the test, to explain and defend its scientific thinking in public, before a panel of experts with the breadth and depth of experience to dissect the results, to challenge conclusions, and to make sure that no clinical stone goes unturned.

And the cornerstones of every adcomm are the clinical experts who serve on them. The best and the brightest our nation has to offer.

But Dr. Scott Gottlieb (the FDA’s Deputy Commissioner for Medical and Scientific Affairs) is worried (and rightfully so) that the value of these committee meetings could be eroded, “if current legislative proposals become law, and FDA is hampered in its ability to put experience and expertise as the paramount criteria when recruiting members to serve on these committees.” Gottlieb is concerned “by some who want appearance to trump acumen — who want the lack of private sector work to trump a plethora of scientific experience as a criterion when we are selecting who to put on our committees.”

In order to increase public confidence in the integrity of the advisory committee process, the FDA plans to take the following steps to help ensure advisory committees continue to be scientifically expert and independent and that the advisory committee process is transparent:

* Issue a guidance identifying more clearly the conditions under which conflict of interest waivers are granted. Currently, for example, waivers can be granted to committee members under certain circumstances for participation in scientific endeavors related to the work of the committee, as well as for certain unrelated activities.

* Issue a guidance specifying when waivers of conflict of interest will be disclosed to the public and what information will be made available.

* Issue a guidance specifying when briefing materials used at advisory committee meetings will be made publicly available.

* Provide greater public dissemination of advisory committee schedules through increased mailings to public groups, and providing electronic notifications through an FDA advisory committee list serve and posting on the FDA web site.

* Implementation of a more streamlined approach to the appointment of members to the agency’s drug-related advisory committees.

At a panel discussion today on government-sponsored advisory committees organized by the Center for Science in the Public Interest (a group whose regular criticism of the agency makes Charles Grassley’s aureate prattle look meek by comparison), Gottlieb is expected to say that it “would be a significant step backwards if our primary criterion for selecting members to our committees becomes their lack of private sector work, if we exclude people for deep experience rather than embrace them for it. The public health will not be served if we’re no longer able to attract the kind of very active medical practitioners and clinical trialists who are able to inform our meetings with some very unique medical insights that only comes from years of experience both seeing patients and developing and looking at clinical data, sometimes in some very narrow fields or for specific indications.”

Yet pols and pundits continue to ask simplistic questiones, phrased more as accusations than inquiries. For example — “Why can’t the FDA just appoint panels with experts who don’t have conflicts and, therefore, won’t need waivers?”

It sounds good as a soundbite, but even a little homework shows the ignorance inherent in the question. FDA doesn’t appoint adcomm members meeting-by-meeting, case-by-case, action-by-action. FDA adcomms are standing committees, with members recruited and appointed sometimes years in advance, and who serve for defined terms of up to four years. And, according to Gottlieb, “This serves us well, since there is a value from having people who have institutional experience from serving on these committees. It is similar to the way the Senate works, where you don’t want all the members being brand new each year, or appointed just to vote on each individual issue.”

Gottlieb continues, “And this leads me to the heart of the problem: When we appoint these committee members, it is impossible to tell who is going to have relationships that could present the potential for an appearance of a conflict around a specific issue, and therefore require them to get a waiver, since we don’t know what issues are going to come up a year or two in advance. If we err on the side of caution, and only appoint members who have had absolutely no associations of any kind with any regulated products or industries, then we’re going to be hard pressed to find people that have also been engaged in relevant and unique scientific endeavors, since a lot of medical product research is done in collaboration, at least in part, with sponsors.”

“If we were prevented from being able to grant waivers in the first place, we’d have to recruit people who had no such associations, and were unlikely to develop them for the length of their tenure on our committees. I’m not only worried that such people would be very hard for us to find, especially since it’s sometimes not obvious to researchers themselves that their institution might have received a grant for research they had no involvement in, or a clinical trial they are working on might have received partial funding from a private source.”

Might we really pass legislation that bans the best and the brightest from serving the public health by disallowing their service on advisory committees because their preeminent expertise has also been viewed as valuable by the pharmaceutical industry?

Well, maybe not outright ban, but a codicil tucked in at the very end of the Enzi/Kennedy bill (page 98 for you really dedicated drugwonks out there) would make the process seem like persecution. The bill calls for the HHS Inspector General to review “on an on-going basis” the financial interests of a representative sample of individuals who have served on an FDA advisory committee.

I can attest, as a former senior FDA official, that it is very difficult to recruit the best and the brightest. This would make it almost impossible. After all, who would want to serve on an advisory committee when you’re viewed as a potential criminal before the ink on your appointment is even dry? Independent-thinking adcomm members will feel threatened and suffocated by the unspoken threat of federal investigators knocking at their clinic doors. Such legislation amounts to adcomm Lettres de Caches for folks like CSPI, posturing pols and Page One hungry reporters.

Ad captandum vulgus.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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