Over-Caution Bias and the Invisible Graveyard

"Well, Baby-O, it's not exactly Mai-Thais and Yahtzee out here, but let's do it!"
--Cameron Poe (Con Air)

Prof Williams discusses over-caution bias in the context of the FDA. Policymakers in general and FDA officials in particular can make two types of errors. In the context of the drug approval process, a type I error involves delaying approval of a medicine that is safe and effective (i.e., over-caution, or not acting when one should). A type II error is approving a medicine that subsequently exhibits unanticipated side effects (i.e., under-caution, or acting when one shouldn't).

In the case of FDA officials, incentives favor erring to the side of over-caution. If the FDA approved a drug that had unanticipated side effects, then the victims of the agency's mistake would be readily visible. Political uproar would ensue and heads would likely roll.

On the other hand, if the FDA delayed approval of a safe and effective drug, then the victims are all of those who suffered and died because they were denied access to medicine that would have otherwise been available on the market. Because these victims stem from 'errors of omission' and are not readily visible not connectable to the FDA process, the associated type II errors do not attract anywhere close to the political fallout that type I errors do.

To minimize political fallout, FDA officials will clearly prefer making type II mistakes.

Consequently, the over-caution bias embedded in the FDA's regulatory process sends victims to what Prof Williams calls 'the invisible graveyard' on a routine basis.