Industry Sector Crisis – Industry-Funded Clinical Trials Manipulations. ‘How Can Big Pharma Restore A Reputation?’ By Emily Willingham – At Forbes

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November 28, 2012 by NewsReputation

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Access to the article: ‘How Can Big Pharma Restore A Reputation?’, Forbes, 26 November 2012

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Excerpts

According to this Washington Post longread by Peter Whoriskey, the bald truth about industry-funded clinical trials for new drugs is not pretty. As Whoriskey tells it, no one’s quite sure how to give industry-funded trial results a makeover so that the good studies don’t suffer the reputation of the bad ones:

According to a survey published this fall in NEJM (New England Journal of Medicine), doctors are about half as willing to prescribe a drug described in an industry-funded trial. That’s unfortunate, doctors say, because a good portion of the industry-funded research is done well.

“On the one hand, there are a lot of important industry-funded studies that are accurate, relevant and useful,” said Jerry Avorn, a Harvard professor who has specialized in spotting adverse events from drug use. “There is also a multi-year history of abuse and distortion.”

This history of “abuse and distortion,” even if the relative number of cases is limited, leaves consumers wondering how they can tell what’s trustworthy.

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The debacles of Avandia and Vioxx suggest that greater transparency throughout the clinical trials process and designing trials that actually address side effect concerns might help keep drugs off the market whose costs outweigh their benefits. Indeed, according to the Post article, one proposed step to greater transparency is to “compel drug companies to release all of the data from trials of drugs that are on the market.” It’s a nice idea, but how will anyone know that all the data have been released and that none remain concealed or destroyed?

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For the best outcome and restoration of trust, this completely independent group of researchers would analyze data (and preferably design) from an industry-linked clinical trial. The resulting publications would then reflect the independent findings, effacing risk of bias (and possibly building up consumer trust). The expense of conducting clinical trials would stay with industry–which is one of the main reasons industry now leads the U.S. government in clinical research investment–but place analysis and interpretation in the hands of those without a dog in the hunt.

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