The Institute of Medicine (IOM) has taken a critical stance on epidemiologic methods and systems for determining the value of study evidence. This recently published report highlights the methods and criteria used by various reputable scientific organizations (e.g., International Agency for Research on Cancer and the American Institute for Cancer Research) and how these organizations go about collecting, assessing and weighing evidence when making causal judgments.

A short commentary written by David Oliver (Partner at VORYS LLP) calls out two important ideas: (1) criteria should be explicit regarding the weight or relative importance, given to studies in humans, animals, or other experimental systems; and (2) strong and consistent epidemiological evidence in rigorously conducted studies is prima facie (self-evident from the facts) evidence.

The Food and Drug Administration has completed its safety review and concluded that Multaq increases the risk of death and serious cardiovascular events in persons with permanent atrial fibrillation. The agency issued a statement on December 19^th stating that they still believe Multaq has benefits for patients with non-permanent AF and that the use of Multaq should be limited to only the approved indication. Multaq, approved in 2009 for cardiac arrhythmia, was seen as a blockbuster product for Sanofi until encountering a recent series of setbacks related to adverse events.

Sanofi halted a late stage trial in July 2011 when the company saw a significant risk in cardiovascular disorders including heart attack and stroke. The FDA announced the beginning of their safety review following the termination of this study. Following the results of the safety review, the labeling for Multaq has been revised to advise health care providers from prescribing Multaq in patients with AF “who will not or cannot be converted into normal sinus rhythm” because “it doubles the rate of cardiovascular death, stroke, and heart failure in such patients.”

Two vitamin-related studies have recently made a splash in the media. Both studies reported that taking extra doses of vitamins can do more harm than good.

Let’s take a closer look at the studies.