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FDA Relationship with Drug Makers Continues to Raise Questions

Oct 21, 2013

After pharmaceutical firms were recently found to have paid to sit in at meetings with a scientific panel that advised the U.S. Food and Drug Administration (FDA), one United States senator is accusing the agency of being engaged in an “improper relationship” with the industry and is seeking a Congressional probe, according to American News Report.

Drug companies paid up to $25,000 to attend the Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT) meetings, according to The Washington Post. The meetings, wrote American News Report, are “a quasi-government panel set up by two academics to give advice to the FDA on clinical drug trials, many of them involving prescription painkillers.” Medical professors Robert Dworkin of the University of Rochester and Dennis Turk of the University of Washington organized the meetings.

“These allegations clearly demonstrate a conflict of interest by allowing pharmaceutical companies to have undue influence over the FDA’s decision-making process,” wrote Senator Joe Manchin (D-West Virginia) to FDA commissioner Margaret Hamburg, according to American News Report. “These recent reports raise serious doubts about the FDA’s ability to make objective and scientifically based decisions regarding the proper treatment of prescription painkillers. Even worse, when challenged by another federal agency, the National Institutes of Health, on the stigma of this ‘pay to play process,’ the FDA balked and continued with the arrangement,” the senator added.

According to a prior report by the Post, an FDA official described the group as “an essential collaborative effort.” Consumer advocates say the FDA was becoming too comfortable with drug makers seeking to become players in the $9 billion U.S. painkiller market.

FDA officials met privately and co-wrote papers with drug companies. According to the FDA, its officials received no financial benefit from their participation in the meetings, the Post reported. Meanwhile, two officials later secured positions as pharmaceutical consultants. The FDA issued a statement that “we take these concerns very seriously,” adding that “we are unaware of any improprieties” tied to the group.

Dworkin and Turk received about $50,000 each per meeting, which they have said went to their academic research accounts, research assistant costs, expenses, “or to cover a small percentage of faculty effort,” according to the Post. Based on emails reviewed, the academics issued a proposal for honoraria of $5,000 each for a four-hour hotel meeting near the FDA’s offices, the Post reported.

Michael Carome, director of health research for the watchdog group Public Citizen, said that the emails raise concerns about the “pay-for-play arrangement” involving drug makers purchasing access to invitation-only meetings with FDA officials where they could impact FDA pain drug policy, the Milwaukee-Wisconsin Journal Sentinel reported. “The whole picture is a troubling one and it warrants an independent investigation,” said Carome, who has seen the emails.

A 2003 email authored by Raymond Dionne, a National Institutes of Health (NIH) official, discussed the closed meetings, suggesting that attendees should meet publicly instead, at the NIH, the Sentinel wrote. “The major advantage of having the meeting on the NIH campus would be the ability to open the meeting to all interested parties and avoid the stigma that this initiative is a ‘pay to play’ process,” Dionne wrote. The meetings were “paid for by a few large pharmaceutical firms who are assumed to be influencing the outcomes” and ”if they play by the book should not accept dinners for meetings at the Four Seasons Hotel. I may even bring a brown bag,” wrote Dionne. In a glib response, Dworkin said that the organization could order “inexpensive sandwiches for lunch for the government folks…. The rest of us undoubtedly will feel guilty, but we will probably resist the temptation to have tuna fish in respect for your plight,” the Sentinel reported.

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