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Dark Side of Medical Research: Widespread Bias and Omissions

Much of that problem arises from financial conflicts of interest when pharmaceutical or medical device companies fund the studies, according to Wieseler and her colleagues. They pointed to past research showing an association between industry sponsorship and positive outcomes or conclusions in studies.

One of the most well-known examples of bias involves the selective serotonin reuptake inhibitor (SSRI) paroxetine (Paxil), an anti-anxiety medicine. The pharmaceutical company GlaxoSmithKline suppressed results from four trials that not only failed to show treatment effectiveness for off-label use of its SSRI among children and teens, but also showed possible increased risk of suicidal tendencies in this age group. (Off-label means the drug, while approved by the FDA for some uses, isn’t approved for that particular usage.)

As part of a legal settlement with New York State, GlaxoSmithKline agreed to establish an online clinical trials registry for the result summaries of all its sponsored studies conducted after a certain date.

But that’s just one company. For the rest, physicians and patients must rely upon either journal publications or whatever shows up in the online registry of the U.S. Food and Drug Administration. The FDA currently does not disclose much of the information it receives from companies when deciding what drugs or devices to approve for market.

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