Drug Industry Needs More, Better Data

The pharmaceutical industry must embrace, not avoid, new ways to collect and monitor information on drug risks if it wants to continue to thrive and innovate, several U.S. health experts said.

Regulatory experts, doctors and other scientists at an Institute of Medicine (IOM) workshop on drug risks and benefits said having more clear data would not only help patients and doctors, but also allow companies to make better decisions about which drugs to develop.

They added that data collected after a drug hits the market, rather than from expensive pre-approval clinical trials, is key.

"Part of the trick is to collect it once and use it for a lot of different things," said Marc Overhage, an investigator with the Regenstrief Institute research group.

IOM, an independent scientific organization, sponsored the panel discussion to offer advice for the U.S. Food and Drug Administration, which has faced renewed controversy over its recent handling of suicide risk in youth taking antidepressants and heart risk with Merck & Co. Inc.'s withdrawn arthritis drug Vioxx.

The panel was not related to an upcoming IOM analysis of the agency's drug safety review process expected in July.

Experts were charged with discussing what criteria the FDA should use to evaluate drug risks, and whether certain methods such as cost-related analyses may help.

The panelists were mixed about the use of specific formulas, but most agreed more data overall would help tackle safety issues.

Douglas Throckmorton, deputy director for the FDA's drug center, said risk analysis should be done as soon as possible to facilitate development and help make critical decisions sooner.

"If we're able to look carefully and identify road blocks ... we could do better," he said.

Merck Vice President for Outcomes Research Marc Berger said companies, too, can benefit from knowing more about their products.

"We have a dearth of information to really know the full risks and benefits of our drugs, not just when they're approved but even years after they've been approved," he said.

Collecting more and better data "will allow us to understand the value of these drugs ... versus other cheaper alternatives," he added.

But panel co-chair Jeff Leiden said U.S. regulations focus so much on risk that some drug makers avoid potentially breakthrough medicines in favor of newer versions of drugs already on the market.

Leiden, the former president of Abbott Laboratories Inc., said a better understanding of safety issues would help boost innovation but companies need more incentives such as liability protection and greater market exclusivity.

"I'm very concerned that, if we don't, we'll cut off innovation," he said. "Right now all the attention is focused on risk."

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Reference Source 89
June 2, 2006