ALZHEIMER’S GERM QUEST, INC.
To: Colleagues and Friends concerned about Alzheimer’s Disease
From: Leslie Norins, MD, PhD
Chief Executive Officer
November 10, 2020
Subject: Alzheimer’s Association should reveal possible financial conflict of interest in urging FDA to approve Biogen drug
Alzheimer’s disease (AD) is one of the most important threats to seniors. So, unbiased pharmaceutical information is critical.
Therefore, payments from a drug’s maker should be revealed when an advocacy group recommends the FDA approve their Alzheimer’s drug.
Biogen recently tried, again, to secure FDA approval to market its anti-AD drug, aducanumab, which removes amyloid. 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 then any disclosure of monies paid to the Association by the drug’s manufacturer.
The letter says their stance for immediate approval was based on a concern that “..up to a four-year delay..” for further trials, would penalize millions of patients and caregivers. I don’t think anybody would disagree that consideration should be part of the discussion.
But certainly, possible conflicts of interest should also be revealed, so these can be evaluated. The missing information at this point is the payments in cash and in-kind received by the Alzheimer’s Association from Biogen and its collaborator, Esai, during the past five years.
I urge the Association to quickly commission an independent audit to tabulate all such monies and disclose this to the FDA and public. Could it be a million dollars, or even more?
For example, 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 companies 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,”.
I also wonder if this cozy relationship with an anti-amyloid drug maker might factor into the Alzheimer’s Association’s minimal attention to other possible contributors to the disease, such as microbes.
Improved financial disclosure by the Association will help everyone interested in Alzheimer’s to assess possible conflicts of interest.