New drugs often marketed ahead of crucial data

File photo illustration of pills. REUTERS/Jacky Naegelen

File photo illustration of pills. Credit: Reuters/Jacky Naegelen

By Frederik Joelving

NEW YORK | Wed May 4, 2011 6:43pm EDT

NEW YORK (Reuters Health) – Data that could save money and help doctors make smarter treatment decisions are often unavailable at the time new medicines hit the market, according to U.S. researchers.

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.

Dr. Robert Temple, who directs FDA’s Office of Medical Policy at the Center for Drug Evaluation and Research, said he was surprised by how many drugmakers had provided some comparative data, despite not being required to do so.

“Considering that there is absolutely no requirement, it is pretty impressive,” he said in a phone interview.

Another expert took the opposite view.

“A third of new drugs that are approved have no comparative data at all,” said Dr. Alec B. O’Connor of the University of Rochester School of Medicine and Dentistry in New York. “I think we’d all say that is sad.”

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