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FDA Approval of Aducanumab to Treat Alzheimer’s Disease Would Be a Reckless Disregard for Science, Damage Agency’s Credibility

Agency is Working with Biogen to Rush Lucrative Unproven Treatment

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should not approve aducanumab for treatment of Alzheimer’s disease due to lack of evidence of its effectiveness, Michael Carome, director of Public Citizen’s Health Research Group will say in testimony Friday before the agency’s Peripheral and Central Nervous System Drugs Advisory Committee. Carome released the following statement ahead of the hearing:

“The overall tenor of the FDA’s briefing document for this meeting reveals that the agency is actively working hand-in-hand with Biogen, the maker of aducanumab, to rush to market an unproven biologic drug to treat Alzheimer’s disease that could bankrupt our health care system.

“Two similar large studies compared aducanumab to a placebo. Both studies were stopped early because a planned interim analysis found that they were unlikely to show that the drug works. Nevertheless, Biogen subsequently pursued analyses of data from the studies that were, from a scientific standpoint, highly susceptible to bias. One study appeared to show that the drug works, but the other clearly showed the drug doesn’t work.

“FDA staff and Biogen now are trying to convince advisory committee members and the public that the negative study should be ignored and that the drug should be approved based on the one positive study. Such an approach is seriously biased and unscientific.

“Only the FDA statistician who reviewed the aducanumab study data appears to wisely recognize the recklessness of approving the drug based on the available data, noting the following in her assessment: ‘if we select only the better study, our estimate is very likely biased, and we already know not consistently repeatable in our experience. Thus, excluding data from a large trial without sufficient justification is unscientific, statistically inappropriate and misleading.’

“Approving a drug that will be used by potentially millions of desperate Alzheimer’s patients before definitive evidence of effectiveness has been established is likely to result in far more harm than good, leading to false hope for Alzheimer’s disease patients and their families and, if the drug actually is ineffective, setting back other efforts to develop truly effective treatments for many years, if not decades. And our health care system cannot afford to take a chance on such an unproven drug given Biogen’s announced exorbitant over-pricing.

“The FDA must demand another large premarket randomized, placebo-controlled trial of aducanumab. FDA approval of the drug, given the current absence of substantial evidence of effectiveness, would further damage the agency’s already diminished credibility.”