The almighty FDA? I think not…

I just realised it has been ages since I’ve posted. So good to return on a wave of cynicism I think.

The almighty FDA (U.S. Food and Drug Administration) is responsible for protecting and promoting public health through the regulation/ supervision of food safety, tobacco products, dietary supplements, medications, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed, and veterinary products. According to their website they are all about “Protecting and Promoting Your Health”.

So it was interesting/ disappointing/ and not really surprising to read a recent article about how experts who serve on FDA advisory panels (and who make recommendations about medical devices) frequently have undisclosed ties to device makers.

The WSJ found that of the 122 FDA advisers who evaluated cardiac, orthopaedic, and gynaecologic devices from 2012–2014, ONE THIRD had received compensation from device companies (eg. money, research grants, food, travel), and that nearly 10% had been compensated by companies whose device they were assessing.

The FDA disclosed none of these relationships (it only publishes such ties when an expert needs a waiver to serve on a panel… But whether a waiver is needed is left up to the FDA). Ooh, tricky.

One example: a doctor serving on a panel evaluating laparoscopic power morcellators (used for removing fibroids) stated that the risks weren’t as severe as the data suggested. OOPSIE, that physician previously received over USD 150,000 in compensation from morcellator companies.

Another cardiologist was compensated over USD 100,000 for ‘advising’ on cardiac devices. Yah and I bet his opinion was TOTALLY unbiased.

Why on earth is someone not paying me in food for my opinion? It’s a sad world….

REFERENCES
www.wsj.com/articles/fda-advisers-financial-ties-not-disclosed-1418095981
www.fda.gov

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