Can Big Pharma be trusted not to "mess with" the publication of clinical trials they sponsor?
Er, probably not.
JAMA editors Phil Fontanarosa and Catherine DeAngelis have listed some "situations" from recent industry-funded studies:
1. The key Celebrex trial published in the British Medical Journal included only six months of data, even though the company had 12 months of data that showed no benefit in reducing gastrointestinal side effects.
2. The key Vioxx trial downplayed that drug’s cardiovascular risk in favor of an erroneous interpretation that the comparison drug naproxen had cardioprotective effects.
3. Trials showing Paxil increased the risk of teenage suicide or lacked efficacy were suppressed.
4. The manufacturer of a new HIV-AIDS drug tried to stop researchers at the from publishing negative results from its clinical trial.
5. The maker of an implantable cardioverter-defibrillator failed to report a potentially fatal design defect for more than three years.
“We will continue to require an independent statistical analysis for studies in which the analysis was conducted only by statisticians employed by the sponsor,” the editors wrote.
Good, says Insider. Big Pharma should be judged by its actions and the above list is pretty damning.
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.
Hat tip: http://www.Gooznews.com/
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