McClellan Talks Up FDA Patient Database
2 CommentsBy Ed Silverman // November 29th, 2007 // 6:25 am
The former FDA commish yesterday praised a recently enacted plan to overhaul the way drug safety is monitored in the US, citing the recently passed FDA Amendments Act, which will create a vast new database of drug patients by 2012, CNNMoney.com reports.
Such a database could prevent another debacle like Vioxx, he contended, and major health care organizations such as eHealth Initiative, Partners Healthcare and Kaiser Permanente will coordinate with insurers like Unitedhealth Group and Wellpoint, to gather and collate the data from patients. McClellan sees the info as being more complete and more objective.
“If they work together and follow the same rules (in how they define adverse events and how they use the data), then you’ve got tens of millions (of people) in the database,” McClellan told a roomful of biotech execs at Lazard Capital Markets’ 4th annual health care conference. “Most of the evidence on your products will be coming from sources other than you.”
“If you could have identified Vioxx problems in three or four months instead of five years, it would have had a huge impact,” said McClellan, a senior fellow with the Brookings Institution, adding that a much larger database from multiple sources will detect dangerous side effects sooner.
Grief
McClellan’s plan is hogwash if it does not include Medicaid. This is the treasure chest for psychotropic drugs, especially atypical antipsychotics. People with serious mental illness are often unable to work, and then we have the children who are being drugged to death - many of whom come from poor families. If this group is not included, any statistics will be sorely skewed.
Grief
The truth of drugs like Vioxx and Zyprexa was obvious on the FDA’s Medwatch system. The problem, as if often the case, is that the FDA chose to do nothing about it.