STAT+: FDA advisers vote overwhelmingly against ALS treatment from BrainStorm
A panel of independent advisers to the FDA voted against a polarizing potential treatment for ALS on Wednesday, concluding that the medicine’s supporting data did not meet the standard for…
A panel of independent advisers to the Food and Drug Administration voted overwhelmingly against a polarizing potential treatment for ALS on Wednesday, concluding that the medicine’s messy supporting data did not meet the standard for approval.
After a day-long meeting that included impassioned testimony from ALS patients, the agency’s expert advisers voted 17-1 with one abstention that the case for NurOwn, a treatment from BrainStorm Cell Therapeutics, was based too heavily on convoluted clinical trial results and compelling but unreliable anecdotal evidence.
“Patients and families need hope, but providing false hope can be ethically problematic,” said panelist Lisa Lee, a bioethicist at Virginia Tech. “False hope is provided when the probability of a positive outcome is overestimated, and I think that seems to be the case here.”
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