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Journal editorials this week: the magic asterisk and transparency in clinical trials

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Two journal editorials touching on different health care reform issues caught our eye.

Harold DeMonaco, MS, one of our story reviewers on HealthNewsReview.org, thought that an editorial in the New England Journal of Medicine by editor Jeffrey Drazen, MD, deserves some news attention.  DeMonaco wrote me:

“Over the past five years or so, there has been a gradual increase in the registration of clinical trials into a single database.  Although it would be nice to believe that the pharmaceutical industry has embraced the concept of transparency, it is more likely that the FDA Amendments Act of 2007 forced their hand.  Without registration of the clinical trial and reporting of the results, the FDA would not consider the data for submission for a New Drug Application.

As Dr. Drazen notes, there are some holes in the existing legislation.  Not all studies need be registered.  A newly introduced bill into the US House of Representatives would close the loopholes and provide ‘real transparency.’  There are always two sides to every story and the pharmaceutical industry has legitimate proprietary concerns that no doubt will be voiced loudly to members of the House and to the media.  It seems to me that this issue represents a wonderful opportunity for the media to inform and educate the public on this important piece of legislation for both sides on the issue.”

 

And in the JAMA Forum, David Cutler, PhD, of Harvard and the Institute of Medicine suggests that journalists and the public pay more attention to “the magic asterisk” in health policy discussions.

 

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Greg Pawelski

August 30, 2012 at 11:26 am

In regards to the “magic asterisk” in health policy discussions, what is frustrating is this Administration cannot explain all of this stuff to voters in a readily understandable way.