Welcome back Careblazer!
You’ve probably heard there’s a new Alzheimer's drug that was recently approved. In this video I wanted to talk a little bit about what it is and why it’s created a lot of controversy in the medical field. I’m going to break this up into 3 segments- the good, the bad, and the ugly. Before I go through those 3 categories, let’s take a moment to talk about what this drug is.
It’s called aducanumab- that’s the generic name. The brand name is called aduhelm. It was approved by the FDA on June 7th, 2021.
A company called Biogen created the medication.
It’s given through intravenous infusion- meaning IV.
The person will get IV infusions in the arm every 4 weeks for a minimum of 52 weeks.
Real quick, before we go further, I just want to remind any new viewers that there is a free careblazer survival guide that you can download at the link here.
Okay, let’s start with the good shall we?
This is the first alzheimer’s medication that has been approved in about 18 years. That’s a sign of progress. There hasn’t been anything approved for a long time.
This is also the first medication that treats the underlying disease. So all the other medications approved for dementia treat the symptoms of dementia but don’t actually slow down the disease. This new medication actually reduces the amount of amyloid beta in the brain. Amyloid beta is also sometimes also referred to as plaques. These plaques are a hallmark feature of Alzheimer’s.
That’s about the end of my good section- it’s a new drug- it’s good to know research and progress is being done. And this actually treats underlying disease versus just the symptoms.
Now let’s go the bad.
One of the requirements to get FDA approval is you have to have at least 2 clinical studies that are done well and each have good results on their own to move forward with approval. In March 2019, the study of this medication was stopped because one of the clinical trials seemed to show some positive results for people who had mild dementia, but the other study did not show good results.
Seven months later, in October of 2019, the drug maker said they looked at the data differently. Instead of looking at cognitive test scores as a measure of success, they noticed that plaque was reduced in both studies.
So they used the same studies, no additional information, and went back to the FDA and said, "Actually if you look at it this way, both studies are promising."
And even though the drug showed zero actual benefit in terms of benefit to the patient through their ability to think better or do activities of daily living better, the FDA said that it’s “reasonable” to assume that reducing plaques could have some clinical benefit.
So basically, here is a drug that has not yet proven any significant good clinical outcomes for patients, but it’s possible it might. And even though our study had to be stopped earlier because it didn’t pass the minimum test for FDA approval, if you look at it differently, there’s a chance it could be helpful.
So on June 7, 2021, the FDA granted an accelerated approval. Meaning that the drug is approved, but they have 9 years to show that it actually works and does what they think it does.
So there is very little evidence that it does anything. Of the trials that showed some benefit, it was only with people with mild cognitive impairment or mild alzheimer’s- no one with moderate or severe dementia.
There’s also a lot of testing that has to be done if someone gets this medication. Before getting the infusions, you have to have a PET scan to show that beta amyloid is in the brain. You also need to have MRI before the 7th and 12th infusion to make sure there isn’t brain bleeding/swelling, as that is a potential side effect.
Here’s the UGLY.
This medication, that has very little evidence that it actually clinically helps people and only showed a little bit of help in one study for people with MCI/mild alzheimer’s was approved for all people with alzheimer’s. They didn’t limit it only to mild. So a medication that does absolutely nothing for people outside of the mild stage isn’t limited to only those in the mild category.
This medication- that hasn’t really proven to do anything has a $56,000 price tag. The company said that is a fair price for the value that the families would get. Yet, I will say again that there is very little evidence that this does anything at all to improve the quality of life or cognitive thinking of someone with alzheimer’s disease.
So the price tag is there, but the evidence that this drug does anything of real benefit is not. ALSO, the company has 9 years to show that it does what they think it can do. Meaning they can charge a price tag over a medication that they HOPE does something but they don’t really have proof it does anything. To me this is a crazy situation and a shame this could be done.
It’s still not clear if or how much insurance companies will cover this drug, who they will cover it for, or how much of the cost families will have to bear. There will likely be thousands of dollars in cost to families even if insurance does cover part of this treatment (that hasn’t been proven to do anything).
The American Geriatrics Society has come out and advised against using this on patients. Dr. Jason Karlawish who I interviewed on this channel and who wrote the book The Problem of Alzheimer’s says he won’t be using this medication on patients. Since the approval of the drug, three people who served on the FDA advisory panel resigned from what is considered a prestigious position because of disagreement with the decision to approve the medication. Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School wrote in his resignation letter, that approval of the drug “was probably the worst drug approval decision in recent U.S. history.”
But the shares of Biogen in the stockmarket increased 38% making a lot of people wealthy.
So my brief summary, is that this drug will make big pharma even more wealthy. This will, at best, do nothing for families/patients, but likely harm them in the way of cost/side effects/and quality of life, and my trust in the FDA is extremely low.
I wish I had better news to share about this drug. I hope I’m wrong and in 9 years there is evidence that this drug does wonders. But at this point in time, there is no evidence of that and charging $56,000 for something with no proof is a shame. I’m including links to articles and studies in the description below this post if you’d like to learn more. Several other drugs are on the horizon for fast track approval. I’ll do a video on those, or try to get someone to come in and talk about them with all of you.
In the meantime Careblazers, stay focused on healthy diets, good socialization, good exercise, good sleep, all the basics that at this point have been proven to do more than this medication. And here’s to wishing for something better to be delivered in the future.
Sending love to you all.
LINKS TO ARTICLES FOR THIS POST:
https://www.aarp.org/health/dementia/... https://www.americangeriatrics.org/si... https://www.cnbc.com/2021/06/10/third... https://www.nature.com/articles/s4158... https://jamanetwork.com/journals/jama...