Conflicts of Interest in the FDA

I just read the scariest sentence ever. "Recently, lawmakers have proposed loosening conflict of interest rules for FDA advisers to make it easier to find qualified experts." Wow! just wow!

Admittedly, I don't know anything about exactly what the current rules are and what the proposed changes are but I do think that with the history of rampant conflict of interest issues concerning pharmaceutical companies and FDA review boards, I think we all ought to be very very worried.

It's a pretty common practice for doctors to present their clinical opinions about drugs that are up for FDA approval, and to have been directly paid to do so by the pharma that's applying for approval. All kinds of people are paid to present evidence on behalf of the pharma's and their drugs. They would have us believe that this is standard practice and they are merely paid for their work but let's take the rose colored glasses off for the moment - are these 'experts' really going to take money from a pharma to go to the FDA and tell them they don't think the drug should be approved. And would the the pharma pay them if they knew that's what they were going to say. No. Everyone knows how this game is played.

So now the FDA is actually talking about loosening up their conflict of interest rules for their very own panels. We are not talking about approval boards where a number of outside parties come in and speak to the FDA on behalf of other interested parties, we are talking about internal FDA processes.

I read this very scary sentence in an article about an FDA review of the birth control that contain drospirenone, including Yaz and Yasmin. The FDA review board had determined that the drugs were safe and should remain the market. But, oh wait a minute, three of the 26 advisers to the board had financial ties to Bayer which makes Yaz and Yasmin. Another one of the advisers had connections to Barr Laboratories. All four of them said that the drugs benefits outweighed the risks. Are we surprised?

Yaz is a nightmare. It has been linked to serious side-effects and even to deaths in young women. Yes, every drug has its side effects but Yaz is proving to be much higher risk than other drugs. But this panel doesn't agree. a 4% higher risk of blood clots than any other birth control pill is not significant, in their opinion.

The pharmas already have much more influence over what happens at the FDA than they should, relaxing the conflict of interest rules will only make it worse. I shake my head in despair.

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