Consequences of the FDA Decision on Aducanumab for Patient Care and Research

Abstract

The recent accelerated approval of Aducanumab has been the most mixed-consequence and historical decision that has taken place in the public health arena during my professional career. When I search for earlier comparisons of similar moment, the National Cancer Act of 1971 comes to mind, based upon what I have learned about it from Siddhartha Muckherjee’s “biography of cancer (1).” That, too, evidently involved passionate scientists with widely differing opinions, politics, and the loud voices of influential advocacy groups. There was a large outcry protesting the interference of politics and social concerns into the integrity of the scientific process. The approval of the National Cancer Act enabled many diverse efforts to treat a host of cancers, often treatments that would have been considered too high risk before the Act, resulting in some treatments that devastated patients, and some treatments and innovative approaches (e.g. combinations) that eventually worked.