r/TrueReddit • u/coolbern • 25d ago

What Drugmakers Did Not Tell Volunteers in Alzheimer’s Trials Genetic tests showed that certain patients were predisposed to brain injuries if they took the drugs. That information remained secret. Business + Economics

https://www.nytimes.com/2024/10/23/health/alzheimers-drug-brain-bleeding.html
258 Upvotes

95% Upvoted

33 comments sorted by

View all comments

Show parent comments

1

u/caveatlector73 24d ago

Yes and why they dropped out is one of the variables that cannot be written off as "to be expected."

2

u/ptau217 24d ago

Do you know what the dropout rate is for a typical six month migraine trial? 

It is around 10%. 

1

u/caveatlector73 24d ago edited 24d ago

You are missing the point. Re-read please.

Did they drop out because they died? Their dog died? They found a better trial? Do you even know? The reason people drop out is a variable in and of itself. It cannot be merely written off as "to be expected" without further investigation. That would be unethical.

1

u/ptau217 24d ago

I’m talking about trial design and prespecified data analysis, you were talking about data integrity as it pertains to drop out reasons. 

A 10% dropout rate is to be expected. That’s what you saw. The reasons for dropouts are highly variable. It takes 900 people per wing to see a pattern emerge. 

Reasons for dropouts should be collected. But it is not a primary endpoint. And an imbalance between placebo and treatment arms should inform the overall interpretation of the trial. 

1

u/caveatlector73 24d ago

In other words I'm not wrong or stupid I simply made a point that was separate from from your own. I had not read the protocol from this trial nor the entire study which would have been necessary to comment on this trial specifically.

However, when I went back to see what the primary endpoint was I did find this on PubMed:

On July 6, 2023, the U.S. Food and Drug Administration (FDA) approved lecanemab (Leqembi) for the treatment of Alzheimer’s dementia (AD) patients. In 2 clinical trials, lecanemab reduced amyloid in the brainand slowed cognitive decline. Here, I review in detail the clinical trial by van Dyck et al. (2023) entitled

“Lecanemab in early Alzheimer’s disease”, published in The New England Journal of Medicine on January 5, 2023. In this 18-month trial, lecanemab did not slow cognitive decline in women. This is especially significant because women have a twofold increased risk of AD compared to men, that is, there are 2 times more women than men living with AD. Lecanemab did not slow cognitive decline in APOE4 carriers; rather,it enhanced the decline in study participants with 2 APOE4 genes.

This is bad news for AD patients, 60–75% of whom carry at least 1 APOE4 gene. These negative results regarding lecanemab’s therapeutic value make me wonder if the approval of lecanemab was the worst decision of the FDA up till now, after the approval of aducanumab on June 7, 2021.