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FDA Drug Approval Conflicts of Interest

Here in America, the medications which your doctor prescribes, and which your pharmacist dispenses are carefully studied: going through not one, not two, but three phases of clinical trials usually at multiple medical centers.

The process involves typically thousands of patients over a course of years.

The food and drug administration often decides to approve a medication based on the recommendation of an advisory committee composed of outside scientific experts.

But according to new research in the Journal of the American Medical Association, after all the careful data collection, that near-final step of approval is frequently put into the hands of those with close ties or a financial investment in the company making the drug, and in the opinion of some, de-legitimizing the entire drug approval process.

Out of 221 meetings, in 73% there was at least one member who disclosed a conflict.

Perhaps they had been paid a consulting fee by the company, or had received a grant. Or maybe, he or she had a financial investment in it.

Dr. Peter Lurie of the public citizen’s health research group found led the study. He says, “Conflict of interest at advisory committee meetings are common, they’re size is large, and we found a small but important relationship between those conflicts and the voting behavior of the members.”

In 36 percent--in greater than one in every three advisory committee meetings-- more than half of the committee members had a financial conflict of interest. And as long as the amount was less than 100,000 dollars, the member could vote for the drug.

“You get to talk and convince other members of the committee and then you get to vote. What we have is significant large conflicts of interests,” says Dr. Lurie.

We contacted the FDA for an interview, but they would only give us this written response:
The FDA is committed to a strict code of ethics and transparent process for selecting Advisory Committee members and expert consultants. This process requires any voting committee member or consultant invited by the FDA to disclose financial interests they have or are currently negotiating. The Agency reports any conflicts for the public record at the beginning of the advisory committee meeting in a statement read aloud by the committee executive secretary. FDA also posts the nature and basis for conflict of members 15 days before the meeting. The Agency carefully weighs any potential financial interest with the need for essential scientific expertise. Only in this way can the Agency protect and advance the highest standards of public health.
There have been questions surrounding the approval of medications like Vioxx, and the recommendation of approval of the diabetes drug muraglitazar, which was at the last minute shown to cause cardiac deaths. So, Dr. Lurie says this final step of taking medications to market--the recommendation of approval-- should come from those with little or ideally, no conflict of interest at all.

“Until such time these advisory committees will be seen at least by some in the general community and by some in the medical communities as contaminated by conflict of interest and their recommendations will hold less credibility,” Lurie states.

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