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NIH To Propose Rules Banning Ghostwriting, Require More Disclosure From Researchers

Dec 22, 2009 | Parker Waichman LLP

New ethics rules to be proposed by the National Institutes of Health (NIH) next month could require medical researchers to disclose their financial relationships with drug and device makers if they receive funding from the agency.  The new rules could 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.

One example of such a ghostwriting program was the  so-called CASPPER program uncovered earlier this year by attorneys representing plaintiffs in Paxil lawsuits. According to an Associated Press report on the program, one memo instructed Glaxo salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing Paxil. 

Glaxo is far from the only drug company to use such a program.  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. 

Institutions that receive NIH funding are supposed to keep track of the industry money their researchers receive.  However, recent investigations by Senator Charles Grassley, R-Iowa,  indicate that there have been violations or lax enforcement of those rules.   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."

Last July, Grassley asked 23 medical schools  information about 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.

The plan for the new ethics rules were announced earlier this week by NIH head Francis Collins during an interview with CSPAN's Newsmakers program.  During the interview, Collins said he was shocked at some of the conflicts Grassley had revealed.  

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