FDA advisers vote against experimental ALS treatment pushed by patients

[BumRushDaShow]

Source: AP

Updated 6:15 PM EDT, September 27, 2023


WASHINGTON (AP) — Federal health advisers voted overwhelmingly against an experimental treatment for Lou Gehrig’s disease at a Wednesday meeting prompted by years of patient efforts seeking access to the unproven therapy.

The panel of Food and Drug Administration experts voted 17-1 that drugmaker Brainstorm’s stem cell-based treatment has not been shown effective for patients with the fatal, muscle-wasting disease known as ALS, or amyotrophic lateral sclerosis. One panel member abstained from voting.

While the FDA is not bound by the vote, it largely aligns with the agency’s own strikingly negative review released earlier this week, in which staff scientists described Brainstorm’s application as “scientifically incomplete” and “grossly deficient.”

“Creating false hope can be considered a moral injury and the use of statistical magic or manipulation to provide false hope is problematic,” said Lisa Lee, a bioethics and research integrity expert from Virginia Tech, who voted against the treatment. The lone positive vote came from a panel member representing patients.

Read more: https://apnews.com/article/als-nurown-fda-lou-gehrigs-disease-1884a8704d5f5d251f42301dd5eda696

[PSPS]

1. Social media and other disinformation efforts will bring a lot of these Ivermectin-type situations.

[Fresh Water Falling]

2. "Social Media" is a Contradiction in Terms

But I suspect you already knew that.

[carpetbagger]

3. It's a bit more organic with the ALS community.

At my last job, I was the attending physician for several dozen ALS patients. It's a close-knit, very knowledgeable community. Also desperate. We were really proud that our patients were living an average of 5 years instead of 3, that pretty much tells the story. I've got a lot more sympathy for people who are convinced that they've gotten a cure for a fatal disease than I do for people who get butthurt over advice to get a vaccine, wear a mask, and stay out of Applebees when everybody's getting sick.

To their credit, the ALS Association, which funded the brainstorm trials, took no position.

And fun fact: ivermectin's been studied as a medication for ALS. Same results as Covid... in vitro effect that didn't pan out in early trials.