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Less ads, more data urged for drug safety

By Susan Heavey, Reuters, June 1, 2006

WASHINGTON (Reuters) - When it comes to drug safety, U.S. patients and doctors need less advertising hype and more data to help decide whether to use prescription medicines, health researchers said on Tuesday.

A panel of behavior experts, statisticians and other scientists said the Food and Drug Administration should consider simpler information on risks and benefits, such as a chart listing basic facts and how new drugs compare to older ones.

Drug advertisements in particular should be toned down so patients can make rational choices, several experts said. Often they make broad claims without proper data, they said.

"People get unrealistic expectations about what the product is going to do for them," said Peter Ubel, head of the University of Michigan's behavioral sciences center.

The panelists' comments came at the start of a two-day workshop held by the Institute of Medicine (IOM) to discuss the risks and benefits of medicines.

The independent scientific organization convened the meeting to help guide the FDA, which has faced renewed controversy in recent years following its handling of suicide risk in youth taking antidepressants and heart risk with Merck & Co. Inc.'s withdrawn arthritis drug Vioxx.

Steven Galson, director of the FDA's drug center, said the agency would consider the advice. While he acknowledged the recent controversy, he said current safety issues are not as serious as historic crises that established and later overhauled the FDA.

"The questions we're looking at now ... are much more subtle benefit-risk issues to detect," he told the audience of government scientists, industry representatives and patient advocates.

The panel was unrelated to an upcoming IOM analysis of agency's drug safety review process expected in July.

At the meeting, researchers said deciding whether to use a medicine is complex and both patients and doctors can be confused by too many numbers. Graphics and charts could help.

Steven Woloshin, a professor of medicine at Dartmouth Medical School in New Hampshire, welcomed the FDA's recent effort to redesign drug labels but said more could be done with advertisements.

Studies show patients benefit from including a simple table with basic numbers on side effects and how well a therapy works, he said.

Last year, the drug industry adopted voluntary guidelines to make its ads more balanced. It also spent more than $11 billion on consumer ads and doctor promotions, according to research from IMS Health.

Still, University of Pennsylvania epidemiologist Brian Strom said people cannot rely on the marketplace or regulators to moderate medicine use.

"When a drug is released there is immediate pressure to have large sales," he said. "We need the most data possible."