AdCom-ical If It Weren't True

  • by: |
  • 04/11/2007
This from Biocentury which I thought was a send up or parody of the extremes to which the FDA would have to go or bottoms of the barrels to which they would have to scrape -- you can choose your image -- in a search for untainted members or at least bias balance rather than just finding the best scientific minds to determine the risks and benefits of a medicine:

Arcoxia COI disclosures
The FDA advisory panel committee to review Arcoxia etoricoxib from Merck (MRK) this week has been granted three conflict of interest waivers to academics with commercial ties. The panel also will include two consumer advocates as voting members who have taken public stances against COX-2 drugs but do not require COI waivers under the agency's rules.

"Diane Aronson, the Arthritis Advisory Committee's voting consumer representative, is president of the Road Back Foundation, an organization dedicated solely to advocating the use of antibiotics to treat arthritis, an indication that has not been approved by FDA.

Arthur Levin, a temporary voting member, is director of the Center for Medical Consumers. The center is a participant in the Prescription Access Litigation Project (PAL), which has lawsuits pending against MRK alleging deceptive advertising of Vioxx and a similar suit against Pfizer (PFE) related to Celebrex.

The COI waiver participants include temporary voting member Robert Levine of the State University of New York, who reported ownership of $25,000-$50,000 in MRK stock.

A permanent member, Kenneth Saag of the University of Alabama at Birmingham, received $10,000-$50,000 in the last year as a member of MRK's speaker's bureau for topics unrelated to the meeting and received less than $10,000 from each of two competing companies for consulting unrelated to the meeting.

The University of Washington's Dennis Turk, who will chair Thursday's meeting, received less than $10,000 over the last year for participating on the advisory board of a company that competes with MRK.

According to Levin, the Center for Medical Consumers does not have a financial interest in PAL's litigation against MRK or PFE. "Everyone comes to the meeting with some kind of bias. The best way to deal with it is make sure that any one bias isn't over-represented," he told BioCentury. Nevertheless, Levin said, FDA should not have issued the Arcoxia waivers given controversy over a February 2005 meeting on COX-2 safety.

The three academics would be precluded from voting under new COI guidelines recently proposed by FDA. But Levin and Aronson would not need waivers under either scheme."

So let me get this straight: someone who is suing drug companies regarding the very safety issues that the Adcom will present and a patient who pushing a very different approach to an entirely different disease (RA as opposed to OA) are entitled to weigh in but not everyone else?

We have lost our moral compass on the issue of drug safety. By Levin's definition no one who receives money from companies for any reason can be trusted to engage in scientific enterprises or make a professional judgment that impacts individual or societal health while people who do not take money for companies but who nonetheless are biased in their own ways are therefore entitled to do so?

The Adcom composition is a glimpse of what will be left of the scientific enterprise and decisors if we keep going down this road. The litigators and junk scientists on the one hand and the scientific Stalinists like Marcia Angell, Jerry Avorn, Relman and the rest on the other.... All funded by George Soros and trial attorneys.

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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