FDA-Pain Killer Manufacturer Meetings Raise Questions

improper_conduct_pain_killer_manufacturersIt seems that some pain killer manufacturers were paying to attend meetings with a scientific advisory panel to the U.S. Food and Drug Administration (FDA). Now, a United States senator is accusing the FDA of engaging in an “improper relationship” with industry and seeks a Congressional investigation, according to American News Report.

Drug makers paid up to $25,000 to attend the Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT) meetings, The Washington Post reported. The meeting 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, American News Report wrote. 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 (Democrat-West Virginia Democrat) 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.

A FDA official described the group as “an essential collaborative effort,” according to the Post; however, consumer advocates say the agency was becoming too cozy with drug makers that were seeking to become a part of the $9 billion pain killer market in the United States, the Post reported. FDA officials met privately and co-authored papers with drug companies; the FDA states that its officials received no financial benefit from their participation in the meetings, according to the Post. Yet, 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.

Meanwhile, the professors received about $50,000 each per meeting, which they have said goes to their academic research accounts, research assistant costs, expenses, “or to cover a small percentage of faculty effort.” Emails written on the matter indicate that the academics issued a proposal for honoraria of $5,000 each for a four-hour hotel meeting near FDA offices, according to the Post.

Michael Carome, director of health research for the watchdog group Public Citizen said that the emails raise concerns over the so-called “pay-for-play arrangement” that involves drug makers purchasing access to invitation-only meetings with FDA officials and which 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, an official with the National Institutes of Health (NIH), discussed the closed, invitation-only meetings, suggesting that instead of closed meetings, that the attendees meet publicly 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 in his email. Dionne also later wrote that the meetings were “paid for by a few large pharmaceutical firms who are assumed to be influencing the outcomes” and that ”if they play by the book should not accept dinners for meetings at the Four Seasons Hotel. I may even bring a brown bag.” In response, Dworkin wrote 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,” according to the Sentinel.

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