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Are FDA Changes Really a Step in the Right Direction?

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August 12 2006 | 2,283 views

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The U.S. FDA has announced plans to make its conflict of interest rules more stringent. This announcement comes in the wake of criticism that many of its advisory board members have undisclosed financial ties to the drug industry.

Advisory committees guide the FDA on issues of drug safety and effectiveness, and their recommendations carry considerable weight. A recent study found that 28 percent of committee members have industry ties.

Currently, the FDA can waive its own conflict of interest rules for these committees. Congress is considering legislation that would prevent the FDA from doing so.

The FDA, however, has argued that it is difficult to find qualified panel members without industry connections, and has proposed instead enacting rules that would help identify when committee members have a conflict of interest, and address when conflict of interest waivers should be granted.

Critics of this move contend that these reforms would not stop many researchers with financial conflicts from serving on the panels.

Dr. Mercola's Comments:

The FDA monitors some 50 advisory panels that allegedly offer impartial advice. Yet, more than a quarter of members serving on those panels are paid by the very same companies they're expected to oversee, the multinational drug companies.

I am dubious that these new rules will actually do much good, especially considering that such conflicts of interest are so numerous and common.

The current set-up is not too surprising, since the drug companies have the largest number of lobbyists in Congress. However, there have been so many FDA-related scandals recently that even a heavily-lobbied congress is beginning to find it too much to ignore.

I suspect the FDA hopes their pledge will be enough to hold off a Congressional bill that would force the agency to bar outside consultants from serving on advisory panels with any financial ties to a company's product under consideration.

The FDA's proposed new policies may help superficially, but it'll take far more than that to fix the FDA, considering the Vioxx debacle and the growing concerns surrounding the bone-rotting drug Fosamax.

The FDA at this point has such a corrupt history that you should not put your life in their hands.

They are, for the most part, a compromised and crippled federal entity more interested in helping their real "partners" -- the multinational drug companies -- than their "true" responsibility -- the American taxpayers. We have got to put an end to this nonsense and start the process of ensuring responsible leadership at the FDA.

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