On June 7, 2021 the FDA approved a drug called Aducabanumab which is manufactured by Biogen. It will be sold under the name Aduhelm. It is a monthly intravenous infusion intended to slow cognitive decline in people with mild memory and thinking problems. It is the first approved treatment to attack the disease process of Alzheimer’s instead of just addressing dementia symptoms. As many of you know I have been praying for a cure, or something will slow down the disease. I don’t think this is it and I don’t think it should have been approved by the FDA.
I know three people who have been involved in the trial of this drug and they have been praying for approval. I am happy for them that they got their wish. I on the other hand feel this is a setback for the Alzheimer’s movement. This drug has significant issues during the trials that they conducted. I was invited to attend two different international Alzheimer’s research conferences in the last year where Aducabanumab was discussed at length by the researchers. They felt that there were too many concerns about the efficacy of the drug and more importantly the side effects ( ex: brain bleeds especially for people with the APOE4 gene (I have two) were too concerning to ignore. Also, Biogen skilled Phase 2 of the trial which is the “learn and confirm phase”. You can learn more about how the trials were conducted here.
I then met with my neurologist at the Alzheimers Institute where I receive my treatment for her opinion. She said that there is a huge amount of pressure to approve something and bring it to market and that she does not feel this drug has been fully vetted nor is it safe. There is plenty of evidence to support her comments. At the November 6, 2020 meeting of the FDA advisory committee voted overwhelmingly against approval. Then in January of 2021, Biogen submitted more data to try to refute the November 6 findings, and the Alzheimer’s Association and Biogen went into high gear touting the benefits of this drug. On June 7, 2021 the FDA approved it recognizing that clinical trials of the drug had provided incomplete evidence to demonstrate effectiveness, the F.D.A. granted approval for the drug to be used but required Biogen to conduct a new clinical trial.If the new trial, called a Phase 4 trial, fails to show the drug is effective, the F.D.A. can — but is not required to — rescind its approval. This New York Times article summarizes the situation very well.
The cost of this drug is $56,000 annually, and also requires tens of thousands of dollars for diagnostic testing and brain imaging. The average person does not have this kind of money and to put their eggs in one basket for a drug that has such mediocre results is ludicrous. I want something to slow down the progression of my Alzheimer’s more than anyone but I am nobody’s fool. I do not trust the FDA as far as I can throw them. How many other drugs and products have they approved that have proved dangerous for us. Just look at all the.ads on TV and the warnings about all their side effects.
At this point, I am disappointed in the FDA for approving it thus far. I know they can change their mind after this last trial, but they are giving false hope to those of us with Alzheimer’s. I am also disappointed in the Alzheimer’s Association which I have spent 10 year supporting and fundraising for. A lot of money went into lobbying the FDA and advertising for support of this drug. That is money that could have been invested in continuing to focus on finding a cure that works. It seems like the Alzheimer’s Association needed a “win” in their column, but it seems like they have taken their eye off the prize.
Even if I wanted to take this drug, I can’t because I have a pacemaker that is not MRI compatible and it requires regular MRIs. Also, with two APOE4 genes I don’t think it would be prudent for me to do so. For those of you who have dementia or Alzheimer’s who do take it I pray that it is effective for you and does not cause you any problems.
Not today, Alzheimer’s not today!