FDA advisers vote against experimental ALS treatment pushed by patients [View all]

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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