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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.
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“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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