Committee member Aaron S. Kesselheim, associate professor at Harvard Medical School, said “the studies provided by [Sarepta] were not adequate and well controlled.” But he acknowledged that it remains an “open question” whether Eteplirsen produces a clinical benefit to patients who take it.
A national conversation about the evidence behind health care and health policy options is an “ethical imperative,” but values conflicts are likely to arise. Dr. Mille Solomon and scholars from the Hastings Center propose a way forward in an article in Health Affairs.
Center faculty members Dr. Spencer Hey and Dr. Aaron Kesselheim examined a lawsuit filed by Amarin Pharmaceutical in May 2015 that sought permission to distribute "truthful and non-misleading" statements relating to an off-label use of its product Vascepa, a pill derived from fish oil. The authors conclude that "informativeness," understood as asserting scientific facts--beyond mere logical truth--"ought to be the standard for regulating commercial speech about pharmaceuticals".