November 23, 2005
Although it appears that JAMA is taking steps to address this problem, finally:
Industry-Funded Drug Studies Once Again Under the Microscope
...Last July, JAMA adopted new author guidelines that made it more difficult for industry to exert control over research and publication. The key new elements required the principal investigator in a clinical trial to certify the accuracy of the data in the study and insure he or she had access to all of it. The guidelines also distinguished between purely academic and industry funded studies. In the latter case, JAMA added a requirement that the certification of data come from someone not employed by the company sponsoring the study.
The new guidelines drew a heated response from the drug industry, which appeared in this week's Journal. Dr. Caroline Loew, science and regulatory affairs vice president at the Pharmaceutical Research and Manufacturers of America, claimed drawing a distinction between academic and industry studies “has no basis in experience.” The group resented the implication that industry-sponsored studies were somehow “at higher risk of bias and fraud than other types of studies and thus require special scrutiny.” Peer review would ferret out any flaws, she claimed.
...A few years ago, then editor of the New England Journal of Medicine Marcia Angell decided to stop publishing editorials, reviews and commentaries from authors with financial ties to companies whose products were under discussion. She was roundly criticized within the medical profession. Shortly after assuming the reins in 2002, new editor Jeffrey Drazen repealed the rule. He thought merely disclosing those ties would be enough.
...Editors and regulators need to recognize that the best way to eliminate bias from interpreting clinical trial results is to put the conduct of those trials into the hands of an entirely independent body, perhaps a new institute at the National Institutes of Health. The entire purpose and ethic of this new institute would be to generate validated medical evidence -- not sales for a sponsor's product.
Posted by gooznews at November 23, 2005 11:11 AM
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