Dispatch: IOM Tells FDA What It Wants to Hear

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The Institute of Medicine (IOM) yesterday released a report on biomarkers, which are characteristics that indicate biological processes; e.g., high cholesterol as an indicator of the development of heart disease. According to the IOM, “[T]he Food and Drug Administration (FDA) asked the IOM to conduct a study on the evaluation process for biomark¬ers, focusing on biomarkers and surrogate endpoints in chronic disease. The FDA’s Center for Food Safety and Applied Nutrition initiated this study at a time when it was faced with hundreds of applications for review of food health claims based on stated effects on biomarkers.”

“The main point of the IOM report is that we should standardize the use of biomarkers across all consumer products,” says ACSH’s Jeff Stier. “For example, if you sell oatmeal and you claim, ‘Oatmeal can reduce the risk of heart disease,’ the basis for that is not actually a study that says oatmeal reduces the risk of heart disease, but a study that says oatmeal can reduce cholesterol, which is a biomarker for heart disease. The IOM says we should be careful when making those claims because there is a degree of uncertainty to them. Fair enough.

“In the middle of all this, the IOM says that we need to reform the Dietary Supplement Health and Education Act (DSHEA). Basically, they argue that supplements should be treated like pharmaceuticals in terms of which health claims they are allowed to make. We agree with that. However, the IOM acknowledges that their report was sponsored by the FDA. In other words, the FDA paid for a study calling for greater regulatory authority for the FDA. I’ve read coverage of this report in Reuters, The Wall Street Journal, the L.A. Times, lots of different blogs, etc., and nowhere did any of them point out this conflict of interest. Reporters are always looking for examples of industry conflict of interest, but when the conflict comes from a government agency, it is ignored.”

“There is a double standard since the government agencies are not making a profit,” says ACSH’s Dr. Elizabeth Whelan. “But it’s true that no one in the press seems to associate government authority and funding with government interest.”

ACSH’s Dr. Gilbert Ross notes, “Our own Jeff Stier, head honcho of ACSH's Tweet-Central, was the first person to alert the blogosphere to this blatant lapse of journalistic insight about the apparent IOM-FDA conflict of interest.”