Aducanumab: A Call to Action

This is the third time this month that we have written about the FDA’s shocking approval of Biogen’s Alzheimer’s drug aducanumab, which will be sold under the brand name Aduhelm. We first wrote about the outrageous approval of this drug by the FDA despite its rejection by the FDA Advisory Committee.  Aducanumab does not work. It does not stop or reverse the course of Alzheimer’s disease. It comes with dangerous, life threatening side effects. And its astronomical cost may bankrupt millions and take an unbearable toll on our healthcare system. Aducanumab is estimated to cost $56,000 per patient per year. And because aducanumab is an infusion drug that will be administered in doctors’ offices as opposed to a pill taken at home, it will be covered by Medicare Part B—not Part D. Under Part B, beneficiaries pay 20 percent of the costs of their care, and for a single year of aducanumab treatment, that will be at least $11,200. States will also bear a major brunt of the cost. Some experts have predicted that states may have to pull from their education budget in order to pay for aducanumab. The downstream effects of approving this drug are catastrophic. 

We then wrote about the backlash this caused, which included the resignation of three members of FDA Advisory Committee members. These committee members are appalled by the total disregard of the science and research. I spoke earlier this week with a well known neurologist who said his office line is ringing off the hook with requests from patients and their families for a prescription for aducanumab. He is refusing to write these prescriptions because he has followed this story, read the research from the clinical trials, and thus knows that aducanumab does not work. Sadly, he mentioned the many colleagues he knows who are only too willing to prescribe aducanumab, and who are planning on increasing costs further to serve their own bottom lines. The controversy and discussion surrounding aducanumab has only continued in the last week. 

This is the first time at the Amos Institute that we have spent this much time on one story. We have never written three consecutive articles on the same topic. But that is because until this point, no story has warranted such attention. What has and is happening with regard to aducanumab is of unbelievable importance.  At the Amos Institute we believe in being proactive about both your health and the laws and policies that affect your health. We believe the approval of aducanumab is outrageous and is a danger to both our healthcare system and families who are fighting Alzheimer’s disease. We are encouraging our community to educate themselves on this important issue, and to speak out about this catastrophe. In that regard, we encourage you to:

Email your congressperson: https://www.house.gov/representatives/find-your-representative

Send a letter to the Secretary of Health and Human Services (see below).

For a comprehensive analysis of this issue, we refer you to the letter sent by Public Citizen this week which you can find here: https://www.citizen.org/wp-content/uploads/2590.pdf

Below we have provided the letter that we sent to Xavier Becerra, the Secretary of Health and Human Services. Feel free to copy and paste parts of our letter into your own. We urge you to take this call to action. 

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June 21, 2021

The Honorable Xavier Becerra

Secretary of Health and Human Services

U.S. Department of Health and Human Services

200 Independence Ave. SW

Washington, D.C. 20201

RE: Stop the FDA’s Approval of Aducanumab

Dear Secretary Becerra:

The Amos Institute is an online nutritional platform that specializes in helping individuals prevent and reverse Alzheimer’s disease and cognitive decline utilizing a functional medicine approach. We believe our Cognitive Health Program is the most affordable and efficient program of its kind. It is used throughout the United States and in 12 countries.

As founder of the Amos Institute, I am writing to express my dismay of the unprecedented collaboration between the Food and Drug Administration (FDA) and Biogen which occurred both before and after the submission of Biogen’s biologics license application (BLA) for the new biologic drug aducanumab for treatment of Alzheimer’s disease.

New research shows Alzheimer’s disease is the third leading cause of death and affects millions of people daily. Worldwide, 50 million people are living with Alzheimer’s and other dementias. This is without a doubt a healthcare crisis, but the recent action by the FDA has made it worse.  

In November 2020, Biogen’s drug, aducanumab, was overwhelmingly rejected by an FDA Advisory Committee for failing to meet efficacy standards. At that time 10 out of 11 committee members fully rejected it. The 11th member was uncertain. Then, without explanation or further evidence or testing, the drug was suddenly approved! We are asking you to investigate this and to put a stop to this dangerous course of action.

The clinical trials demonstrated that aducanumab DOES NOT stop cognitive decline. Even worse, the drug comes with the very serious potential side effects including swelling of the brain and brain hemorrhage (in about 40% of patients, and in about 50% of ApoE4 patients).

This is a drug that is going to do more harm than good.

Biogen has announced that the drug will cost $56,000 per year- and that’s just for the infusions of the drug itself. That does not include the PET scans needed to diagnose the patient or the follow up MRIs to ensure that the patient doesn’t die of the side effects. 

As a result of this action, healthcare spending may increase by over $100 billion annually- even if only a fraction of Alzheimer’s patients decide to take the drug. Most people with Alzheimer’s qualify for Medicare and Medicare’s bill for this single drug might exceed the total cost of all other drugs combined. And because aducanumab is an infusion drug that will be administered in doctors’ offices as opposed to taken at home, it will be covered by Medicare Part B—not Part D. Under Part B, beneficiaries pay 20 percent of the costs of their care, and for a single year of aducanumab treatment, that will be at least $11,200.

 Recent reports have indicated that states will also bear a major brunt of the cost of this dangerous drug- and some experts have predicted that states may have to pull from their education budgets in order to pay for aducanumab. While Biogen stands to make billions of dollars from this drug, patients, their families, our school children, and the American taxpayers will bear the burden of their excessive profiteering.

As the Secretary of Health and Human Services, and on behalf of our wellness community, I am urging you to take immediate action to mitigate the damage caused by the FDA’s approval of aducanumab. We believe the agency’s approval of Biogen’s BLA for aducanumab should be withdrawn.

Thank you for your attention to this urgent public health issue. I welcome an opportunity to meet with you and/or your senior staff to discuss these issues.

With warm regards,

Amylee Amos MS, RDN, IFMCP

The Amos Institute