May 5th, 2011

New drugs often marketed ahead of crucial data


In a study out Tuesday, they found nearly a third of new drug approvals from the Food and Drug Administration included no data on how well the medications compare with existing alternatives.

“Even when these things are accessible, it’s hugely time-consuming to go through it,” said Joshua Gagne, a pharmacist at Harvard Medical School in Boston.

That leaves insurers and healthcare providers at a loss when trying to find the best and cheapest drugs for their patients, Gagne, who led the new work, told Reuters Health.

In 2009, Congress earmarked $1.1 billion to support drug comparison research, which would help doctors choose between various drugs.

But that information is unlikely to appear until years after new medicines reach the market, because drugmakers only need to show their products work better than a sugar pill—not how they compare to existing treatments.

“There is a gap between the time the drug hits the market and the time this information is generated,” Gagne said.

With his colleagues, he went through public FDA data for 197 drugs approved between 2000 and 2010.

After excluding medications for diseases with no alternative treatments, 70 percent of the FDA approval packages contained some data on how the new products compared to existing ones.

Experts who spoke with Reuters Health were split in their reaction to the new study, published in the Journal of the American Medical Association.

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