I see that Nathan Schachtman has had many interesting posts during the time I was away. His recent post endorses the idea of “a hierarchy of evidence”–but philosophers of “evidence-based” medicine generally question or oppose it, at least partly because of disagreement as to where to place RCTs in the hierarchy. What do people think?
Litigation arising from the FDA’s refusal to approval “health claims” for foods and dietary supplements is a fertile area for disputes over the interpretation of statistical evidence. A ‘‘health claim’’ is ‘‘any claim made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication … characterizes the relationship of any substance to a disease or health-related condition.’’ 21 C.F.R. § 101.14(a)(1); see also 21 U.S.C. § 343(r)(1)(A)-(B).
Unlike the federal courts exercising their gatekeeping responsibility, the FDA has committed to pre-specified principles of interpretation and evaluation. By regulation, the FDA gives notice of standards for evaluating complex evidentiary displays for the ‘‘significant scientific agreement’’ required for approving a food or dietary supplement health claim. 21 C.F.R. § 101.14. SeeFDA – Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims – Final (2009).
If the FDA’s refusal to approve a health claim requires pre-specified criteria of evaluation, then we should be asking ourselves why have the federal courts failed to develop a set of criteria for evaluating health effects claims as part of its Rule 702 (“Daubert“) gatekeeping responsibilities. Why, after close to 20 years after the Supreme Court decided Daubert, can lawyers make “health claims” without having to satisfy evidence-based criteria?