October 26

FDA says it Screened Panelists for Conflicts of Interest

FDA says it Screened Panelists for Conflicts of Interest

Tue, 1 Mar 2005

Bloomberg News reports that the Center for Science in the Public Interest had identified not 10, but 27 panelists on FDA’s advisory panel who had financial ties to drug manufacturers. Last week The New York Times reported that 10 out of 32 panelists had conflicts of interest.

FDA officials defended their selection of these panelists by claiming that the brief partial disclosure of conflicts of interest–in the form of a verbal announcement at the start of the meeting – met regulatory requirements. FDA’s opaque process and low bar for disclosure resemble TV drug commercials that include an incomprehensible rapid-fire recitation of possible adverse effects.

The panel’s recommendation by a close vote, to keep Vioxx, Bextra, and Celebrex on the market–despite mounting evidence that Vioxx and Bextra pose a serious risk of causing heart attacks and strokes–caught everyone by surprise.

Whatever the spin being spun by the 27 panelists whose conflicts of interest were not properly disclosed to the public – the panel’s recommendations are TAINTED by conflicts of interest – they are, therefore, invalid.

The Senate committee on Health, Education, Labor, and Labor is holding two hearings this week which the committee has not publicized:

Today at 9:30 the subject is: FDA’s Drug Approval Process: Up to the Challenge?

and Thursday at 10:00: Ensuring Drug Safety: Where Do We Go From Here?

It is most unsettling that important hearings about FDA’s performance were not widely announced – and that no agenda has been posted one hour before the start of the hearing. It would appear that the committee did not want the public in attendance.

Contact: Vera Hassner Sharav

FDA Says It Screened Merck, Pfizer Drug Panelists for Conflicts

Feb. 26 (Bloomberg) — The U.S. Food and Drug Administration said it screened doctors and scientists for conflicts of interest when the agency named a committee to rule on the safety of pain drugs made by Merck & Co. and Pfizer Inc.

A 32-member committee voted Feb. 18 that the benefits of Merck’s Vioxx and Pfizer’s Celebrex and Bextra outweighed the risk of cardiac damage for patients taking them. The New York Times reported yesterday that 10 panelists had financial ties to the two companies and a third maker of similar medicines, Novartis AG. Without their votes, the findings would have been reversed for Vioxx and Bextra, the newspaper said.

“The advisory committee members and expert consultants were screened for conflicts of interest according to the same strict ethics guidelines FDA applies to all its advisory committees,” said Sheila Dearybury Walcoff, the FDA’s associate commissioner for external relations, in an e-mailed statement yesterday.

The Center for Science in the Public Interest, a Washington consumer advocacy group, said it evaluated affiliations disclosed by the 32 committee members at the request of the Times, which didn’t name all of those identified as having ties to the companies. The analysis found 17 additional panelists with other links to drugmakers, including three to Merck or Pfizer that “were deemed to be too old to be relevant,” the center said.

In a list made available to Bloomberg, the group named the 27 advisers and their links to New York-based Pfizer, the world’s biggest drugmaker; Whitehouse Station, New Jersey-based Merck, which withdrew Vioxx Sept. 30; Basel, Switzerland-based Novartis, maker of the painkiller Prexige; and other drugmakers.

FDA Process

Inclusion of the 10 with financial ties to the makers of pain drugs “would appear to be a direct violation of the Federal Advisory Committee Act, which prohibits scientists with direct conflicts of interest from serving on panels offering advise to federal regulatory agencies,” the center said in a statement.

The FDA spokeswoman said the agency followed its rules for complying with U.S. law. As the committee meetings opened Feb. 16, 17 and 18 in Gaithersburg, Maryland, an FDA official verbally listed members with connections to health-care companies.

“This transparent process requires the agency to carefully weigh any potential financial interest with the need for essential scientific expertise,” Walcoff said.

“In our view, the FDA clearly discussed conflict issues at the start of the meeting in a very clear and forthright manner, so it was public,” Pfizer spokesman Andy McCormick said yesterday in a telephone interview. “We had no role in the selection of the FDA panel, and the membership wasn’t publicly announced until very close to the hearing.”

‘No Merck Involvement’

“The composition of the committee is a process that is left completely to the FDA with no Merck involvement,” said Tony Plohoros, a Merck spokesman, in a telephone interview.

Senator Edward M. Kennedy, a Massachusetts Democrat, said yesterday that the report of panel members’ conflicts “emphasizes the need to restore public confidence in the FDA and its ability to protect the public health and safety of the American people.”

Senate and House Committees have been probing the FDA’s monitoring of drug safety since a Merck study showed a link to heart attacks and strokes in patients taking Vioxx, leading to the biggest drug recall ever, and since antidepressants were linked to elevated suicidal behavior in children.

“The FDA needs to stop including people on its panels who have conflicts of interest, period, end of story,” said Merrill Goozner, director of the consumer group’s Integrity in Science project, yesterday in a telephone interview. “I don’t believe this country is so small the FDA can’t find unconflicted scientists who have the requisite expertise.”

Ties to Drugmakers

Those invited to sit on FDA advisory committees must disclose details of all speaking and consulting fees, contracts, grants, patents, investments and spouses’ employment, according to a 2002 guidance document on the agency’s Web site.

Among the 10 pain-drug panelists listed by the consumer group as having financial ties to Pfizer, Merck or Novartis were Robert H. Dworkin of Boston University and Richard Platt of Harvard University’s Medical School. Both said yesterday that their votes weren’t influenced by links to the companies. The eight others named by the center didn’t respond to phone or e-mail messages.

“I provided the FDA with the detailed information that they requested before the meeting, and, as was announced each morning, they granted waivers for those of us with potential conflicts of interest so that we could participate in the meeting,” Dworkin said in an e-mail. “I do not believe that the things I said at the FDA meeting last week or my votes were influenced by research grants and compensation received from Novartis or Pfizer.”

‘Very Mad at Me’

“I’m quite certain that the relationship with Pfizer didn’t make a difference to the decision I made at the meeting,” Harvard’s Platt said in a telephone interview yesterday. His Pfizer- funded research is to develop a mathematical model to detect signals of drug-related adverse events. “I voted same way for all three drugs. That’s the critical piece.”

The center’s list of 17 panelists with other links to health- care companies included Steven L. Shafer, a Stanford University anesthesiologist, and Ralph D’Agostino, a biostatistician from Boston University.

“The FDA pretty much knows everything that I do, and I suspect that’s the case for the others,” Shafer said in a telephone interview yesterday. The consumer group didn’t assess his ownership of 1.3 percent of Mountain View, California-based biotechnology company Pharsight Corp. as a conflict of interest.

“I voted to keep Vioxx and Bextra off the market,” D’Agostino said in telephone interview yesterday. The center reported he disclosed holding interests in and consulting for health-care companies that didn’t include the makers of pain drugs. “If I had industry ties, they must be very mad at me.”

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