Aya Allam, M.D., Steven Lippmann, M.D.

Now in our second year of a coronavirus pandemic, the Food and Drug Administration (FDA) is approving COVID-19 vaccines. They are well researched, proven safe, currently effective, and already utilized by millions of people. Trust in the FDA as a medical authority enhances their recommendations for getting immunized.

Similarly, distrust in their judgment can result in lower than medically indicated vaccination acceptance. History always reveals some degree of vaccination refusal, based on a variety of religious, medical, historical, social, and political reasons. Immunization refusals and/or vaccine hesitancies began initially with political and social movements. Skepticism about the FDA’s coronavirus vaccine recommendations nowadays is widely known. Our population, with too many unvaccinated persons, allowed COVID-19 infection rates to rise with coverage below herd immunity levels.

What about aducanumab? It is a new monoclonal antibody medication designed for the treatment of patients with Alzheimer’s disease. Some affected individuals evidence deposition of beta-amyloid in their brains, and aducanumab pharmacotherapy may diminish amyloid plaques. Perhaps, less amyloid in the brain might restore some cognitive abilities or at least retard further clinical declines. However, the pathophysiology of beta-amyloid at causing Alzheimer’s disease or a result of it is unclear and diminishing plaques is not widely accepted as a means of attenuating intellectual loss.

Research about aducanumab began years ago and was terminated in 2019 because of questionable outcomes. Somehow, the investigation continued and data recalculation later was said to reveal effectiveness at increased dosage quantities. Another study evidenced no benefit beyond placebo. Significant side effects were noted to include brain edema and/or hemorrhage with potential superficial siderosis via hemosiderin deposits.

Something new has happened that is harming confidence in FDA guidelines. That was the FDA’s June 2021, approval of aducanumab. Initially the news was received with enthusiasm, but the process was tainted and yielded distrust. This anxiety might also extend to coronavirus vaccination hesitancy. What happened?

In late 2020, the FDA’s advisory committee recommended not to approve this drug by 10 votes against approval and one vote in favor. Despite that, in June, the FDA surprisingly granted an Accelerated Approval to aducanumab. Now available for use, the Accelerated Approval requires the manufacturer to continue study of the medication to definitively define the safety and efficacy for patients with Alzheimer’s disease.

Many dementia experts are reluctant to prescribe it. Some aducanumab-induced adversities are rather frequent and dangerous. The drug is astronomically expensive and for now not universally covered by insurance. Administration requires monthly intravenous infusions under clinical and some magnetic resonance brain scan monitoring. In addition, its application does not require proof that the patient exhibits beta-amyloid plaque deposits, and it is indicated only for those with early, less overt cognitive decline. Is it wise to prescribe this medicine to people with a relatively moderate mental handicap, at huge expense, with inconclusive effectiveness, and with potentially dangerous consequences?

These worries cause distrust at the FDA’s decisional processes. This is tragic as it harms the FDA’s reputation. Distrust might worsen the pandemic by less acceptance of the FDA, including COVID-19 immunization and new monoclonal antibody medication coronavirus treatment recommendations. Beyond more coronavirus infections, this process hampers global confidence, and also for those with Alzheimer’s disease or other dementing illness concerns. A sad situation.