The Battle Over an Alzheimer's Treatment

The U.S. Food and Drug Administration (FDA) is under fire from doctors saying it is approving too many high-priced drugs — with Biogen's Alzheimer's drug aducanumab among such medications, reports the Wall Street Journal . Aducanumab is the first disease-modifying drug to show effectiveness. A late-stage trial indicated that a high-dose treatment eliminated 71 percent of amyloid plaque accumulation after 18 months, and significantly affected disease progression. However, the long history of failed Alzheimer's medicines has prompted skeptics to dismiss this result as a false positive, and cite a second concurrent trial that lacked a statistically significant impact on symptoms. Yet a post-hoc review apparently explained the discrepancies, and the FDA said in June 2019 that the evidence from the positive trial could be "considered exceptionally persuasive." But an outside panel of scientist advisers that the FDA convened in November 2020 claimed Biogen massaged the data, and urged the FDA to undertake another trial — which could take at least five years. Three panelists wrote in the Journal of the American Medical Association that the FDA's "unusual degree of collaboration" with Biogen could have "potentially compromised" its objectivity. However, such interaction is one reason for the rapid development of COVID vaccines, and if the agency accedes to the panel's recommendations, Alzheimer's drug development could be set back by years.