IOM Report Questions Health Claims Based on Biomarkers
The Institute of Medicine (IOM) this week published a consensus report titled Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, which urges the Food and Drug Administration (FDA) to apply “the same degree of scientific rigor for evaluating biomarker use across regulatory areas, including drugs, medical devices, biologics, foods, and dietary supplements.” IOM describes biomarkers, such as blood cholesterol levels, as “biological yardsticks” used to predict health effects when it is difficult to measure the actual incidence of disease or death. According to a May 12, 2010, press release, “FDA has been hampered in its ability to assess the proliferation of health claims being made by food and supplement manufacturers in part because it lacks a process broadly accepted across the regulatory, food, and medical communities to evaluate biomarkers as valid and appropriate measurements to substitute for clinical outcomes.”
Commissioned by FDA, the report proposes a three-part framework for “consistently and rigorously [assessing] the selection and use of biomarkers across the food, device and drug areas.” This framework apparently entails (i) “validating that a biomarker can be accurately measured”; (ii) “ensuring that it is associated with the clinical outcome of concern”; and (iii) “confirming that it is appropriate for the proposed use.” The report also evaluates several common biomarkers, including blood levels of cholesterol and beta-carotene as indicators of cardiovascular health.
IOM has since called on Congress to give FDA “the authority to conduct studies on how well consumers understand food and supplements health claims and require manufacturers to make changes if needed to promote greater clarity.” In particular, the institute notes that consumers may not realize when health claims for food ingredients are not based on actual health outcomes. As the report concludes, “ [T]here is neither rationale nor scientific grounds for basing regulatory decisions on different levels of scientific evidence for different substances—science is science.” See Reuters, May 12, 2010.
Meanwhile, the Center for Science in the Public Interest (CSPI) has welcomed the findings as a basis for establishing a regulatory framework for dietary health claims. “We support the IOM conclusion that when foods or dietary supplements claim to provide drug-like benefits, they should be held to rigorous scientific standards,” stated CSPI Legal Affairs Director Bruce Silverglade. “Right now, FDA policies are riddled with loopholes that let companies make phony promises on weak scientific evidence.” See CSPI Press Release, May 12, 2010.
