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UCSF study questions drug trial results
Key Excerpts from Article on Website of San Francisco Chronicle (San Francisco's leading newspaper)


San Francisco Chronicle (San Francisco's leading newspaper), June 5, 2007
Posted: June 8th, 2007
http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2007/06/05/...

Money talks -- and very loudly -- when a drug company is funding a clinical trial involving one of its products. UCSF researchers looked at nearly 200 head-to-head studies of widely prescribed cholesterol-lowering medications, or statins, and found that results were 20 times more likely to favor the drug made by the company that sponsored the trial. "We have to be really, really skeptical of these drug-company-sponsored studies," said Lisa Bero, the study's author and professor of clinical pharmacy and health policy studies. The trials typically involved comparing the effectiveness of a drug to one or two other statins. UCSF researchers also found that a study's conclusions -- not the actual research results but the trial investigators' impressions -- are more than 35 times more likely to favor the test drug when that trial is sponsored by the drug's maker. Bero said drug companies fund up to 90 percent of drug-to-drug clinical trials for certain classes of medication. The researchers found other factors that could affect trial results. For example, pharmaceutical companies could choose not to publish results of studies that fail to favor their drugs, or they could be designed in ways to skew results. The study found the most important weakness of trials was lack of true clinical outcome measures. In the case of statins, some trials focused on less-direct results such as lipid levels but failed to connect the results with key outcomes such as heart attacks or mortality. "None of us really care what our cholesterol level is. We care about having a heart attack," Gibson said. "For the drug to be worthwhile taking, it has to be directly related to prevent a heart attack."

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