Researchers say FDA increases public risks by delaying safety data release
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. Such legal wrangling is a time-consuming process that comes at the expense of public health, said the lead author of a commentary published this morning in the March/April issue of the journal Health Affairs.
"It’s just a long process," said 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 an 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 Kesselheim and Michelle M. Mello, a Harvard School of Public Health associate professor of health policy and law, to take 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 filed by such consumer activists as Public Citizen.
"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," wrote Kesselheim and Mello.
The FDA did not immediately respond to a request for comment.
According to the authors, the FDA often knows about troubling safety data well in advance of informing the public or doctors.
FDA reform legislation being considered in Congress 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."
Projan said the proposal could imperil public health by dooming valuable drugs whose early safety picture was muddy. For instance, he said, in early trials of aminoglycosides -- a class of antibiotics that includes gentamicin and tobramycin -- patients took lower doses more than once a day and suffered kidney toxicity. Switching to a single high dose daily raised concentrations sufficiently for the antibiotics to work, but also gave the patients' kidneys more time to rest between doses.
Releasing raw data from the early stage trials, before the drug dosing was finessed, "might have killed that class of drugs," Projan said.
