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Scientists hit FDA on drug data

WASHINGTON -- Heart problems that pushed the painkillers Bextra and Vioxx off the market could have come to light earlier had federal regulators given outside researchers speedier access to raw safety data, according to a commentary written by Boston researchers.

Instead, the Food and Drug Administration shrouds clinical trial data in secrecy, releasing it only when forced to do so, critics say . Such legal wrangling is a time-consuming process that comes at the expense of public health, said the lead author of a commentary published yesterday in the March/April issue of the journal Health Affairs .

"It's just a long process," Aaron S. Kesselheim , a clinical fellow in medicine at Brigham and Women's Hospital in Boston , said of the legal route to data release. "What we envision is a way that the FDA would more routinely release full safety data about drugs that it approves, so that independent analysts can look at the data and help physicians in their prescription decision making."

The FDA should publish such safety data on its website, Kesselheim said. But other information that provides the manufacturer with a competitive advantage over rivals -- such as chemical data about the drug's composition and efficacy -- would remain confidential because the public health implications are "less compelling," he said.

The opinion piece comes amid the latest allegation of a drug company concealing drug-safety data thought to jeopardize FDA approval of its product.

Federal authorities are seeking more information about a Danish study of Amgen Inc.'s drug Aranesp . The drug is part of a class of anemia treatments that raised safety concerns when used in ways not specifically approved by the FDA.

Such high-profile drug withdrawals as Merck & Co.'s decision to pull Vioxx and Pfizer Inc.'s market withdrawal of Bextra triggered a closer look at how the FDA handles the volumes of data it receives when it approves a drug.

Drug manufacturers are required to submit full clinical trial data to federal regulators. But they and the FDA consider those details to be confidential commercial information, so only a summary written by the manufacturer is made public.

Often, more details are released in response to Freedom of Information Act requests.

"Balanced against the need to protect companies' investments in drug development, however, is the risk that withholding this information can frustrate evaluation of drug safety," the authors wrote.

An FDA spokeswoman said the law precludes the agency from disclosing information contained in a drug application prior to approval. "After approval, the regulation permits FDA to make a summary of safety and effectiveness information available, and we do that," said Susan Cruzan.

Proposed FDA reform legislation would force publication of more early-stage clinical trials.

But a scientist who works in Cambridge for Wyeth Research worries most that plaintiffs attorneys will "make mischief" with such data. Wyeth Pharmaceuticals, a global leader, spends billions on research and development in support of new drugs, vaccines, and biotechnology treatments.

"Remember what the Miranda rights are: Whatever you say can and will be used against you in a court of law," said Steven J. Projan , Wyeth Research vice president and head of biological technologies . "This data will not be used by the plaintiffs attorneys to say, 'These are such nice guys; they got the data out early.' That's irrelevant to someone who makes their living by saying we hurt people."

Diedtra Henderson can be reached at