New drugs need to provide more data on how they compare with existing ones: Study

By Dr. Ananya Mandal, MDMay 5 2011

According to US researchers, data on drugs that could save money and help doctors make smarter treatment decisions are often unavailable at the time new medicines hit the market. They released a study this Tuesday in Journal of the American Medical Association which 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.

Joshua Gagne, a pharmacist at Harvard Medical School in Boston said, “Even when these things are accessible, it's hugely time-consuming to go through it.” He added that this leaves insurers and healthcare providers at a loss when trying to find the best and cheapest drugs for their patients. He led the study.

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 – or placebo and not how they compare to existing treatments.

Gagne said, “There is a gap between the time the drug hits the market and the time this information is generated,” For the study his team 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. Additionally, the availability of comparative-effectiveness data varied based on treatment area, with proportions reaching up to nearly 90% for diabetes medications but only 33% for hormones and contraceptives.

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.

Dr. Alec B. O'Connor of the University of Rochester School of Medicine and Dentistry in New York differed with this saying, “A third of new drugs that are approved have no comparative data at all…I think we'd all say that is sad.” He said he believes new drugs should always be tested against those already approved to treat a given disease.

“Strategies are needed to enhance the accessibility of, and ultimately the use of, this information, particularly in the early marketing experience, when comparative-effectiveness data from other sources are scarce or nonexistent,” according to the study. The American Recovery and Reinvestment Act of 2009 allocated $1.1 billion to boost comparative-effectiveness research efforts.