CEI has just published a new OnPoint, which I co-wrote with West Virginia physician Jerry Arnett. The paper, “FDA’s Bad Medicine: How the Dispersed Knowledge Problem Affects Drug Safety Analysis,” argues that in a world of increasing knowledge about the subtle but important genetic differences among individuals, clinical physicians are able to make increasingly fine distinctions among their patients’ physiology and ability to benefit from and tolerate certain medicines. And that, in turn, is making FDA’s role as pharmaceutical gatekeeper less, not more, important.
“FDA scientists may know a lot about the drugs they evaluate and their average effects on thousands of users, but they know nothing about the individualized physiology of each patient. On the other hand, intensively trained clinical physicians, who do have knowledge of individual patients, are best able to advise them if a drug is appropriate. … This dispersed-knowledge problem makes FDA ill-equipped to choose which risks are worth taking to achieve which benefits for which patients.”