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Saturday, September 13, 2008

Drug Companies Rebuked for Withholding Clinical Trial Data Revealing Negative Results

by David Gutierrez

British officials and researchers scolded the drug industry for withholding negative drug trial results after a new study demonstrated that many antidepressants offer no significant benefit over a placebo to most patients.

The new study marked the first time that researchers in Canada, the United Kingdom and United States had used freedom of information laws to gain access to the studies that drug companies are required by law to provide to regulatory agencies like the Food and Drug Administration in the United States. Looking at the data from both published and unpublished studies, researchers found that while selective-serotonin re-uptake inhibitor (SSRI) antidepressants may be big moneymakers for drug firms, they provide little benefit for most people who take them.

"The regulatory authorities have access to everything," said Peter Littlejohns, clinical and public health director of the United Kingdom's National Institute for Health and Clinical Excellence (NICE), which is responsible for making national drug use recommendations. "Obviously we have access to the published data, and we do ask the industry for unpublished data, but it is up to the companies whether to deliver it or not. We have no power to demand it. The issue is that it relies on the good will of the industry."

Mike Clark of the UK Cochrane Center, which conducts reviews of published trials to come up with recommendations for good medical practice, echoed this sentiment.

"When we ask for details of a trial, the company might tell us nothing," Clark said. "We have even less power than NICE."

In February, the Commons Health Select Committee called for NICE to have access to all clinical trial results, published or not. But the British government responded that forcing industry to divulge these results would be illegal.

The government is advocating for a voluntary program to make a searchable database of all clinical drug trials conducted in the United Kingdom. It has also called for the European Union to make its confidential drug trial database public.

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