Biogen recently tried again to secure FDA approval to market its anti-AD drug, aducanumab. But, the FDA’s own advisory committee of 11 experts delivered only one vote in favor of the move at its meeting on November 6.

The FDA also received a letter urging the drug’s approval from the Alzheimer’s Association, the main advocacy group against the disease. The three-page document, dated October 23, devoted just one sentence to the validity of the company’s application itself, saying only “…the publicly released data justifies approval… .” No details were provided as to how the group reached this conclusion. Nor was there any disclosure of monies paid the Association by the drug’s manufacturer.

The letter says their stance for immediate approval was based on concern that “…up to a four-year delay…” for further trials, would penalize millions of patients and caregivers. “Nobody would disagree that consideration should be part of the discussion,” said Dr. Norins.

But, he continued, possible conflicts of interest should also be revealed, so these can be evaluated.

“The Alzheimer’s Association should quickly commission an independent audit to tabulate all monies paid to it by Biogen and its collaborator, Esai, in the past five years, and disclose this to the FDA and public,” says Dr. Norins. “It could be a million dollars or more,” he speculates.   

For example, he says both firms were “Platinum Sponsors” of the association’s 2020 convention, and Biogen is a Gold Sponsor of this month’s Neuroscience Next convention. The two are also “Sustainers.” at $25,000 each, of the affiliated Alzheimer’s Impact Movement political action group.

“For those levels of financial support, a company certainly wouldn’t expect an association to knock its drug,” he says.

Alzheimer’s Germ Quest, Inc is privately held and independent, and does not accept outside donations. Its mission is encouraging deeper investigation of the role of microbes in causation of AD.

SOURCE Alzheimer’s Germ Quest, Inc.

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