Former FDA Chief Champions Databases in Drug Safety
Former FDA Commissioner Mark McClellan on Monday during a speech at an Institute of Medicine symposium said the agency should increase its efforts to mine large public and private health care databases to detect emerging drug safety problems, the Washington Post reports (Washington Post, 3/13).
McClellan said increased use of the databases, which contain the pooled health information of 100 million U.S. residents, would enable FDA to broaden its surveillance of drug safety problems while maintaining patient confidentiality. McClellan noted that such oversight might have more quickly detected the increased risk of heart attack and stroke related to the painkiller Vioxx, which was withdrawn from the market in 2004.
According to the AP/Boston Herald, McClellan's comments "echoed a key recommendation" from a 2006 IOM report, which criticized FDA's drug safety oversight following the Vioxx withdrawal.
FDA's Gerald Dal Pan told the symposium that the agency already has collaborated with the Department of Veterans Affairs and others to review database information, but he added that FDA needs more epidemiologists and computer programmers to do the work.
At present, FDA often must rely on the limited numbers of adverse event reports that are given to the agency from drug companies and doctors to detect safety problems, the AP/Herald reports. In 2006, FDA received nearly 449,000 adverse event reports.
Experts believe that for each report the agency receives, another nine problems go unreported.
McClellan said, "It's the 21st century, and we have the potential to bring that whole iceberg out of the water -- or at least see it" (AP/Boston Herald, 3/12).