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Is Big Pharma Paying to Play with FDA?


Just how deeply has Big Pharma infiltrated the U.S. Food and Drug Administration (FDA), especially when it comes to blockbuster drugs?

On a regular basis the agency convenes experts to listen to the latest evidence and make decisions whether a drug should be pulled from the market or if it needs a more strongly-worded label.

Hundreds of e-mails, obtained in a public records request, show that a panel convened on painkillers and how to weigh evidence from clinical trials, invited representatives from pharmaceutical companies who paid as much as $25,000 for a seat at the table. FDA officials who regulate painkillers later co-wrote papers along with the Big Pharma employees.

The gathering of FDA officials included about 14 from pharmaceutical companies as well as National Institutes of Health (NIH) representatives and the academics, upward of 40 people in all. It was only the pharma reps who were singled out to pay fees to the organizers.

The two academics, Robert Dworkin and Dennis Turk, created the review panels known as IMMPACT which gathers the players to discuss what clinical trials say about the safety and effectiveness of painkillers. Imagine the schooling the pharmaceutical companies can get in return on how the FDA thinks and makes decisions as well as meeting opinion leaders.

For that education $25,000 is a small price to pay.

These are the same regulators who sit on panels and make decision to affect Americans about drug safety.

The funds raised, about $50,000, went to their academic research organizations, in this case the University of Rochester and the University of Washington. The two academics discussed whether they should take $5,000 each for arranging the four-hour meeting, the e-mails disclose.

In defense of the gathering, a deputy director of the FDA made a distinction – this was a private partnership, not a public-private meeting, so the rules of transparency and conflict-of-interest did not apply. That appears to be a distinction without a difference.

In a true example of the Washington D.C. revolving door, the e-mails reveal that two former FDA officials later decided to become consultants to the same pharmaceutical industry they had previously regulated.

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Posted By: Bud Wilder