Did the FDA Suffer a Memory Loss on Due Process?

Humankind has reached a turning point in biomedical innovations; from mind control prosthetics to developing a vaccine in under 12 months. Drugs and technologies are being invented and are improving at a rate faster than ever. On June 7th, 2021, the FDA approved an Alzheimer’s Drug, called Adulehm (aducanumab), produced by Biogen, a biotechnology company focused on the development and treatment of neurological diseases. This expedited approval stirred debate amongst the medical and ethics community as none of the medical advisory panelists had agreed to approve the drug, yet the FDA still did – a very unprecedented case. 

What is Alzheimer’s?

Since the first identification of Alzheimer’s in 1906, neuroscientists have been discovering and modifying their approach to helping those diagnosed with it. As it is a neurodegenerative disorder — physical damage to the brain — damage besides memory loss is common, affecting the patient and their loved ones deeply. One of the main difficulties with treating Alzheimer’s patients is age and source of funding of treatment. The typical US patient is 65 years old, retired  and relying on Medicare for treatment expenses. This creates a significant amount of stress on patients and their families. Also, having a caregiver is crucial for dementia patients as they are unable to do any basic tasks, without ensuring no harm is caused upon themselves or others. The stress piles up rapidly for Alzheimer’s patients and with a longer average life span, total costs have exponentially increased as well. 

In 1984, researchers George Glenner and Cai’ne Wong identified a plaque that causes memory loss, a beta-amyloid, which triggers nerve cell damage. The approved drug, Adulehm, reduces the amount of sticky amyloid plaque that builds up in the brain; however there are many controversies and considerations that have risen since the approval. 

Why the Controversy?

To start, the data itself collected by Biogen and presented to the FDA does not confirm that the drug actually works to preserve the memory and stop the plaque. Studies with results showing it working and it not working have been collected, yet the FDA, in their explanation of their thinking, focus on what the drug is supposed to do: remove the plaque, even though studies have not proved it yet. This itself was a major reason why three of the FDA’s medical panelists resigned after they repeatedly rejected the approval of the drug. Dr. Aaron Kesselheim of Harvard Medical School who resigned claims, “This might be the worst approval decision that the FDA has made that I can remember”.

The panelists had found that, besides the drug showing no evidence of its effectiveness, one clinical trial showed that about 40 percent of patients had some serious side effects such as brain swelling and brain bleeding. Of the 11 panelists, 10 immediately voted against the drug’s approval, and one was uncertain! This dissent by FDA’s medical panelists is rare and historic.

Ethical Considerations for Doctors

However, this situation puts the doctors in an ethical quandary.  Should they prescribe the drug on patient’s insistence, or should they withhold recommending the treatment as the risk-benefit analysis hasn’t been fully established. The medical community is in strong opposition to the drug’s approval, yet they are the ones who will have to prescribe it to their patients. 

Since this is the first major drug for Alzheimer’s in nearly two decades, which would impact nearly 6 million patients, the FDA’s enthusiasm for an accelerated approval is worth noting. The need for any sort of hope for a cure, for both patients and families, is in high demand. However, Biogen has set the drug treatment price at $56,000 per year! Most Alzhiemer’s patients are Medicare beneficiaries, which can cost roughly $11,500 per patient, per year. Senior citizens and Medicare will have to pay for the drug. Analysts predict that Medicare will be paying from $6 billion to $29 billion, per year solely for Alzheimer’s treatment. Yes, there are other medications that have an even higher cost, but Adulhem was approved by the FDA for any patient with Alzheimer’s, a much larger group of people, and the drug is expected to be taken for multiple years. 

Even without the drug, Alzheimer’s is one of the most expensive illnesses to treat. With the need for a caregiver, frequent MRI scans, numerous procedures and tests, it is projected to cost the United States over $355 billion in 2021, says Dr. PH. Joanne Pike, Chief Strategy Officer of the Alzheimer’s Association. However, Biogen Executive Vice President, Churfi Guindo states, “So we consider this to be a really responsible price, we consider this to be a price that is sustainable for the system.”

As groundbreaking as Adulehm is for the Alzheimer’s and medical community, it is important for public policy makers to make decisions based on scientifically proven data and not just based on patient’s sentiments.

References 

Belluck, P., & Robbins, R. (2021, June 10). Three F.D.A. Advisers Resign Over Agency’s Approval of Alzheimer’s Drug. The New York Times. https://www.nytimes.com/2021/06/10/health/aduhelm-fda-resign-alzheimers.html. 

Caplan, A. (2015, November 11). Ethicist: Why a New Alzheimer’s Drug Isn’t A No-Brainer. NBCNews.com. https://www.nbcnews.com/health/aging/ethicist-why-new-alzheimers-drug-isnt-no-brainer-n329581. 

Emory, T. N. P. @. (2020, August 11). Alzheimer’s Disease and the FDA: Two Things To Watch. The Neuroethics Blog. http://www.theneuroethicsblog.com/2020/08/alzheimers-disease-and-fda-two-things.html.  

Hamilton, J. (2021, June 8). FDA Approves A Controversial Drug To Treat Alzheimer’s Disease. NPR. https://www.npr.org/2021/06/08/1004269864/fda-approves-a-controversial-drug-to-treat-alzheimers-disease.  

Milestones. Alzheimer’s Disease and Dementia. (n.d.). https://www.alz.org/alzheimers-dementia/research_progress/milestones. 

Pagliarulo, N. (2021, May 27). ‘A hugely consequential decision:’ How Biogen’s Alzheimer’s drug came to face the FDA. BioPharma Dive. https://www.biopharmadive.com/news/biogen-aducanumab-alzheimers-fda-drug-review/600897/. 

Simons, P. (2021, May 11). Ethical Issues Raised Over FDA Collaboration with Biogen on Failed Drug. Mad In America. https://www.madinamerica.com/2021/05/ethical-issues-raised-fda-collaboration-biogen-re-review-failed-drug/.  

Watt, A. D., Jenkins, N. L., McColl, G., Collins, S., & Desmond, P. M. (2019). Ethical Issues in the Treatment of Late-Stage Alzheimer’s Disease. Journal of Alzheimer’s disease : JAD. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6484269/.