FDA Tobacco Panelists Are Challenged

The U.S. Food and Drug Administration rejected a request by cigarette giant Philip Morris USA to remove four members of a key tobacco-products advisory panel that the company said had extensive conflicts of interest.

Altria Group Inc. disclosed in a quarterly financial report with regulators Wednesday that its Philip Morris USA unit asked the FDA last month to withdraw four nominees because they had financial and other conflicts, including having served as paid expert witnesses for plaintiffs in litigation against tobacco companies. The Tobacco Products Scientific Advisory Committee was formed in the wake of the landmark law enacted last year that gave the agency broad powers to oversee the industry.

The FDA denied the request in a letter to the tobacco purveyor on March 25. According to an agency spokeswoman, the letter said the “FDA followed existing law and procedure to recruit the best scientific experts and to ensure that [the panel] has a balanced composition of expertise to handle the many complex tobacco-related issues it will face.”

Philip Morris USA, the largest U.S. cigarette maker by sales, and U.S. Smokeless Tobacco Co., another unit of Richmond, Va.-based Altria, requested that the agency remove as panelists Neal Benowitz, Gregory Connolly, Jack Henningfield and Jonathan Samet.

In a March 22 letter to the agency, the companies said the panelists have financial conflicts and “irreconcilable biases” that would undermine the credibility of the committee, which is charged with reviewing a wide range of tobacco products and making recommendations to the agency.

The four “appointees have pronounced and disqualifying conflicts and biases arising from their active and zealous participation as paid expert witnesses for plaintiffs in lawsuits” that attempt to cripple or destroy the industry, the letter said.

The four men are among nine voting members of the 12-member committee. Dr. Samet, a professor of medicine at the University of Southern California, is chairman. Dr. Samet has provided expert deposition or trial testimony for plaintiffs in at least seven cases brought against tobacco companies, Altria said, and has charged fees of $300 per hour. He also has received grants from at least one pharmaceutical company that makes and markets products that help people quit smoking.

Dr. Samet said Thursday that he did not want to comment on Altria’s request other than to say the FDA “has fully reviewed my professional career,” including any perceived or real conflicts. He said that he did not personally keep any of the money paid for his expert testimony in tobacco-industry litigation. All of it, he said, went to Johns Hopkins University, where he previously worked.

The Wall Street Journal previously reported that Messrs. Henningfield and Benowitz have ties to pharmaceutical companies that market stop-smoking medicine.

Altria said in its quarterly financial report to the Securities and Exchange Commission on Wednesday that the FDA said it had satisfied itself, after an inquiry, that the panelists “did not have disqualifying conflicts of interest.”

Altria was a key backer of the legislation signed into law by President Barack Obama last year to make the FDA the industry’s regulator. It said in its letter that “we recognize and support the important role” of the advisory panel.

The FDA has said federal law permits it to grant waivers to allow some experts with conflicts of interest to serve on advisory committees, and it has done so on certain drug-advisory panels. FDA Commissioner Margaret A. Hamburg said in an April 21 letter to staff members that it is “clearly better for the agency” when “advisors have no conflicts of interest.” However, she said, “I recognize the fact that many of the top authorities in specific areas may have conflicts of interest.”

Altria noted in its SEC filing that the FDA told the tobacco company that it would continue to screen all members of the advisory panel for potential conflicts of interest on matters taken up at panel meetings. This could lead some panel members not to participate in the discussion of certain topics.

APRIL 30, 2010

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