New NIH Ethics Rules Could Require More Disclosure from Researchers

Biomedical researchers who receive funding from the National Institutes of Health (NIH) may soon have to disclose their financial ties with <"">drug and <"">medical device makers under new ethics rules to be proposed next month.

Institutions that receive NIH funding are supposed track such financial relationships; however, recent investigations by Senator Charles Grassley, R-Iowa, indicate that there have been violations or lax enforcement of those rules.

Last July, Grassley asked 23 medical schools for information about their conflicts of interest policies and requirements for disclosure of financial relationships between faculty and the drug industry. In a letter to the schools, Grassley outlined a number of disturbing conflicts on the part of researchers at NIH funded schools, including Emory, Stanford and Harvard universities. In October, the Senator asked NIH to explain how 14 NIH-funded university researchers were able to receive payments from Merck & Co. “to promote its controversial anti-cholesterol drug Vytorin.”

During a recent interview with CSPAN’s “Newsmakers” program, NIH head Francis Collins said he was shocked at some of the conflicts Grassley had revealed. He said that next month, the NIH would propose new ethics rules for biomedical researchers that would require them to disclose their financial ties with industry.

The proposed new rules will also ban the practice of “ghostwriting”. As we’ve reported in the past, ghostwriting involves the act of a drug company producing a journal article aimed at either counteracting criticism of a drug or embellishing its benefits. Usually, a drug maker hires a professional writing company to draft the article, and recruits a physician to sign off as the author. Once the article has been published, drug sales reps often present copies of the piece to physicians as evidence that the drug covered in the article is safe and effective.

Critics of the pharmaceutical industry claim ghostwriting is a common practice. A survey published just last September in the Journal of the American Medical Association found that 7.8 percent of 900 research articles, reviews, or editorials that appeared in six general medical journals in 2008 were written by un-credited ghostwriters. So-called “Honorary Authors” were also listed in about 20.6 percent of medical journal articles the researchers reviewed. An Honorary Author is someone credited with an article, but who in reality contributed very little.

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