Tensions within the FDA — Type I, Type II debate

An internecine struggle apparently exists within the FDA, according to an article in the New York Times. Those tensions between drug approval officials and drug safety officials are expected to erupt in a House hearing scheduled for June 6.

The agency is taking a lot of heat from politicians for approving drugs that have had side effects, the latest being the diabetes drug Avandia, charged with increasing the risk of heart attacks.

FDA chief Dr. Andrew von Eschenbach told reporters Wednesday that the agency shouldn’t act as a “barrier to the future.” He was quoted as saying:

The point is that we need to look at the role of the F.D.A. in being a bridge to the future, not a barrier to the future.

Representing the opposing sides within the FDA, according to the NYT, are Dr. David Graham, who authored a report stating that Avandia substantially increased the risks of heart attack; and Dr. Robert J. Meyer, an official in the drug review division who decided against the warnings.

From reports it sounds like a debate about Type I and Type II errors, with Type I being the error of rejecting something that should have been accepted, and Type II, accepting something that should have been rejected.

Government agencies are much more prone to make Type I errors. After all, they won’t get into trouble with politicians and the media if they don’t approve something. Nobody knows about it, so they’re safe from disapprobation.

A Type II error, however, is riskier for government employees. It requires a positive action to approve something that may possibly present future problems — including problems for the regulators giving the approval.

As CEI adjunct fellow Dr. Henry Miller (and other CEI staffers) has noted:

The mistaken approval of such a product is highly visible and has immediate consequences: the media pounces, the public denounces, and Congress pronounces. The developers of the product and the regulators who allowed it to be marketed are excoriated and punished in such modern-day pillories as congressional hearings, television newsmagazines, and newspaper editorials. Because a regulatory official’s career might be damaged irreparably by the good faith but mistaken approval of a high-profile product, decisions are often made defensively—in other words, to avoid Type I errors at any cost.

CEI’s “Death by Regulation” project addresses these issues directly. Sam Kazman commented on CEI’s Survey of Oncologists in January 2007 and made this point again:

In recent years FDA has been repeatedly attacked for approving allegedly defective therapies. But as this physician survey shows, the real threat to public health is that FDA’s approval process is already too long. Any attempt to make it more stringent will only worsen this problem.

We should be glad that tension exists within FDA. If the over-cautious prevail, patients could be denied life-saving drugs.