FDA Approves Alzheimer’s Drug that Research Shows Does Not Workby Amylee Amos MS, RDN, IFMCPNews
In November of 2020, we wrote about the FDA’s rejection of Biogen’s Alzheimer’s drug, Aducanumab. Now we’re back on that same subject, but with a very different breaking headline: today the FDA approved aducanumab. You might think that there must have been some new research performed that changed the minds of FDA advisory committee members since their initial decision last November, but unfortunately, that would be giving them too much credit. This drug, which will be called by its brand name Aduhelm, does not work in slowing or stopping the progression of Alzheimer’s disease.
You might wonder why the FDA would make a decision like this. Aducanumab is now the first Alzheimer’s drug that has been approved for use in the last 18 years. So for nearly two decades, the billions of dollars spent on Alzheimer’s pharmaceutical treatments have failed. This leaves pharmaceutical companies feeling the financial pressure, and it leaves the millions of people with Alzheimer’s disease or risk of Alzheimer’s disease feeling desperate. Yet one would hope that the FDA requires substantial proof that a drug actually works (and is safe to use) prior to allowing it to be prescribed and taken by patients. However in addition to the lack of research showing benefit, the side effects of aducanumab aren’t minimal. 40% of Phase 3 trial participants receiving the high dose experienced side effects including brain swelling and bleeding (1).
It seems crazy that a drug can be approved despite a lack of evidence demonstrating its efficacy. The process by which this happened is through the FDA’s Accelerated Approval Pathway, which they state is “a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit” (2). In other words, we haven’t been successful in finding an Alzheimer’s drug in 18 years, so even though this one doesn’t work either according to all of our research, we’re going to sell it to you anyways because Alzheimer’s disease is really serious. Wow.
So if patients won’t benefit from this drug, who benefits from it being on the market? You guessed it, Biogen stands to make billions of dollars off of aducanumab. According to the New York Times, Biogen “has yet to announce a price, but it could be in the range of $10,000 to $50,000 per patient per year, Wall Street analysts project” (3). In our years of working with Alzheimer’s patients and their families, we have seen the desperation this disease induces first hand. Alzheimer’s patients and their loved ones are willing to try anything, make any accommodation necessary to try to fight this disease. This left me wondering, when a doctor writes a prescription for a $10,000 to $50,000 pharmaceutical, will they discuss the results of the clinical trials with the patient and their family? Will they be transparent about the Accelerated Approval and the fact that so far the research shows that the drug actually does not work? Will the doctor writing the prescription even know all of that?
The FDA is requiring that Biogen conduct a post-market trial, called a Phase 4 Clinical Trial. This trial will take years to complete and in the meantime, aducanumab will be available to the public. If the results of the Phase 4 trial mirror the Phase 3 clinical trials and show that the drug does not work, the FDA can- but does not have to- rescind its approval for the drug. That means that even if this additional clinical trial fails, now that the FDA has approved it, it could stay on the market indefinitely and doctors can continue to prescribe it to patients.
I often talk about the fact that I founded the Amos Institute in honor of my Nana who died from Alzheimer’s disease. When she was diagnosed, we immediately filled the prescriptions she was given. We would have done anything the doctors recommended, finding ways as a family to cover every cost incurred. At the time, it wouldn’t have crossed my mind to ask about the efficacy of the drugs prescribed, despite the hefty price tags- and they certainly were not as high as the projected cost of aducanumab. I worry that so many people will be left with false hope, thinking that anything that expensive surely must work. That’s just one of many reasons why our team believes so passionately in the Amos Institute Cognitive Health Program. We know this approach works- and it doesn't just help cognition. Not only does our Cognitive Health Program improve markers of cognitive function including memory, attention, and alertness, but our clients also experience improvements in inflammatory status, reduced oxidative stress, improved glycemic control, and reduced total toxic load. Sign up today for a safe and effective way to improve your health.
- Haeberlein, S.B. et al. EMERGE and ENGAGE Topline Results: Two Phase 3 Studies to Evaluate Aducanumab in Patients With Early Alzheimer’s Disease. https://investors.biogen.com/static-files/8e58afa4-ba37-4250-9a78-2ecfb63b1dcb#_blank
- Cavazzoni, P. (June 7, 2021). FDA’s Decision to Approve New Treatment for Alzheimer’s Disease. US Food & Drug Administration. https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease
- Belluck, P. & Robbins, R. (June 7, 2021). F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works. New York Times. https://www.nytimes.com/2021/06/07/health/fda-approves-alzheimers-drug.html