Newswise — The advocacy group Us Against Alzheimer’s (UsA2) did not reveal in its January 19 letter to the FDA urging approval of aducanumab for Alzheimer’s disease it had received monies from the drug’s maker, Biogen, says Leslie Norins, MD, PhD, CEO of Alzheimer’s Germ Quest.
For example, Biogen and its co-venturer, Esai, were both listed as “Premier” sponsors of the virtual Alzheimer’s symposium presented by UsA2 in November 2020. The “premier” designation was ranked even higher than “platinum”, but its cost was not given.
This is similar veiling to that of the Alzheimer’s Association letter supporting approval of the same drug; significant contributions—possibly millions of dollars--to the association from Biogen and Esai were not disclosed, says Dr. Norins.
Although aducanumab is controversial, and an FDA expert panel voted nine to one against it, UsA2’s letter did not supply any new scientific evidence, or a re-analysis of existing data.
Instead, Dr. Norins says, it restated the well-known fact that Alzheimer’s is a serious health problem, and said its survey of citizens showed they favored approval of a vague "drug”. Specifics such as chemical name, efficacy, and side effects were not presented. Moreover, he feels the survey questions were slanted toward affirmative answers. "Only an ignorant person would have answered 'No'".
These hidden financial conflicts of interest taint the value of the advocacy groups’ recommendation for approval, says Dr. Norins in his February 16 letter to the FDA.
He stresses financial disclosure is not required when the advocacy group is conducting charitable or service activities. But, whenever an advocacy group "plays scientist", and urges FDA approval of a drug, it is incumbent on them to follow the same strict disclosure of conflicts as is required by medical journals , he asserts.
“For example, Alzheimer’s and Dementia journal, owned by the Alzheimer’s Association, requires doctors who wish to publish a paper to disclose even a few hundred dollars received from a drug company. Thus, when that very association requests the FDA approve a medication, shouldn’t it have to reveal it received millions of dollars from the same drug firm? There seems to be a double standard,” says Dr. Norins.
He concludes that the credibility of the two advocacy groups is jeopardized by their failure to reveal these financial conflicts of interest to the FDA, and he urges more transparency in the future.
Alzheimer’s Germ Quest is an independent group not affiliated with or endorsed by any other organization. It encourages research on microbes in Alzheimer’s. It is self-funded, does not sell anything, and neither seeks nor accepts outside donations.