Safety problems with Vioxx could have been detected in months rather than years if the Food and Drug Administration had been able to sift through health-care information already compiled privately on one in three Americans.
Former agency chief Dr. Mark McClellan said Monday that the FDA should make more use of the pooled information contained in large health-care databases, like those run by private insurers that include information about 100 million Americans.
He said the FDA should make more use of the pooled information contained in large health-care databases, like those run by private insurers that include information about 100 million Americans.
That surveillance, for problems like the increased risk of heart attack and stroke that led to the withdrawal of the popular painkiller Vioxx in 2004, could broaden the FDA’s view of drug safety problems as they emerge while respecting patient confidentiality, he said.
McClellan spoke during an Institute of Medicine symposium on the drug safety challenges the FDA faces.
Tapping into databases
A 2006 report by the Institute, a congressionally chartered part of the National Academy of Sciences, criticized the FDA’s handling of drug safety in the wake of the withdrawal of Vioxx five years after its approval. McClellan’s claim echoed a key recommendation of the report: that the FDA step up its mining of large public and private health-care databases to detect emerging safety problems.
The FDA already has begun to tap into large private and public health-care databases, collaborating for instance with the Department of Veterans Affairs, the agency’s Dr. Gerald Dal Pan told the symposium. But the cash-strapped FDA still needs more epidemiologists and computer programmers to do the work, he added.
As a result, the FDA is still a largely passive monitor of drug-safety issues, relying on the limited numbers of safety reports that flow to the agency from drug companies, doctors and others.
“The current approach is not as systematic or comprehensive as needed,” said Andy Stergachis, a University of Washington epidemiologist and member of the Institute’s drug safety committee.
Many problems unreported
In 2006, the FDA received nearly 449,000 so-called “adverse event” reports. But the reports are just the tip of the iceberg: Experts widely believe for every one report the agency receives, perhaps nine other problems go unreported.
“It’s the 21st century and we have the potential to bring that whole iceberg out of the water — or at least see it,” said McClellan, FDA commissioner from 2002 to 2004.
Dr. Richard Platt, an epidemiologist with Harvard Medical School and Harvard Pilgrim Health Care, said a pilot study of claims data showed it could have been possible to mine large databases to detect within months at least a suggestion of potential heart problems among Vioxx users, as McClellan said.
“It would be at least a plausible signal to say, ’You need to pay more attention if there’s a real signal here,”’ Platt said.