There’s a new Alzheimer’s drug. Should we get excited about it?

I thought that when the day finally arrived, it would be greeted with streamers and balloons. And a parade. Surely, it would deserve a parade.

Instead, it was accompanied by controversy.

Experienced advisors quit.

Long-time allies found themselves on opposite sides of a battle they had been fighting together.

Both sides had loads to say. News articles were written. Podcast episodes were aired. Experts and pundits galore.

I’m talking about aducanumab (Aduhelm) and last month’s highly controversial FDA approval of the drug for Alzheimer’s disease.

What’s the fanfare about:

Although there are a handful of drugs available today for Alzheimer’s patients, aducanumab is the first drug purported to slow down the disease.

Which is huge because none of the others do that.

The other drugs treat the symptoms. Aducanumab targets the underlying issue — the so-called beta-amyloid plaques.

Aducanumab instead binds to and removes the beta-amyloid plaques – and slows down this process that would eventually lead to widespread destruction of brain cells.

Worth noting that this is the first drug approved by the FDA for Alzheimer’s disease in 18 years! Which just tells us how difficult the road has been to find a cure for a disease that afflicts around 50 million people worldwide. Source.

By the way, that number is expected to go up naturally due to the longevity revolution and the projected global aging population (i.e., By 2050, 1 in 6 people in the world will be over the age of 65. Source).

So, there are even bigger legit reasons for drug companies and the medical profession to want to find a cure.

So, what’s the problem?

There are four areas of contention, as I understand it:

1. Efficacy of the drug is in question. The FDA’s provisional approval appears to have been based on two studies that produced opposing results. One was positive, the other negative.🤦🏻‍♀️ Several of the FDA’s own advisors quit over the decision citing a lack of evidence of the drug’s effectiveness.

2. The drug is based on a hypothesis that’s in dispute. The amyloid hypothesis posits that plaque in the brain is in part responsible for the disease and that therefore removing plaque could help relieve the symptoms. But scientists have raised questions about whether this prevailing dominant hypothesis is correct. They say the medical community’s singular focus on this hypothesis has been the reason why so little progress has been made on finding a cure.

3. There’s concern that the rushed FDA decision will result in less innovation. What if the hypothesis turns out to be wrong and that there are other causes of the disease? Meanwhile, drug companies have rushed in to invest following the footsteps of Biogen and aducanumab???

4. At an estimated cost of $60K a year per patient, some worry that this expensive drug will send Medicare and private insurance costs through the roof. (As in, more “through the roof” than it already is.)

Clearly, there isn’t going to be a parade with streamers and balloons. (sigh)

Following all the hullabaloo, the FDA has revised its guidance on the use of the drug emphasizing that the drug should only be used in patients with the earliest stages of the disease, which was the only group studied in the clinical trials.

BOTTOM LINE

Many worry about dementia and specifically, Alzheimer’s disease, as we get older. Personally, this is my biggest fear, along with cognitive decline.

I’m not an expert, OBVIOUSLY. Just someone following the developments closely out of personal interest. I think this drug is a step forward but not the end-all-be-all. And we need research and development to continue.

In the meantime, let’s focus on doing what we can to take care of ourselves and keep our brains healthy.

ADDITIONAL SUGGESTED READING

• Let’s focus on keeping our brains healthy. Lifestyle has a profound impact on our brain’s health. Here are the 6 pillars of a healthy brain according to the Cleveland Clinic. There’s an interesting test that attempts to measure your brain’s health score. I took it and man, do I need to do some work, stat!

• And for my female reader friends… here’s what’s recommended we eat to maintain a healthy brain, according to neuroscientist and nutritionist Lisa Mosconi. “Although it’s best to optimize your diet for brain health well before you experience any cognitive decline, making these changes whenever you can will put you at an advantage. Regardless of your age, genetics, or medical predispositions, your quality of life can be enhanced.”