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 healthcare information already compiled privately on one in three Americans.
Former agency chief Mark McClellan said Monday during an Institute of Medicine symposium that the FDA should make more use of the pooled information contained in large healthcare databases, such as those run by private insurers that include information about 100 million Americans.
That surveillance, for problems such as 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.
The FDA already has begun to tap into large private and public healthcare databases, collaborating for instance with the Veterans Affairs Department, the agency's Gerald Dal Pan told the symposium. But the cash-strapped FDA still needs more epidemiologists and computer programmers to do the work, he added.