Years of polarizing scientific discourse and bruising online debate will come to a head next week when advisers to the Food and Drug Administration weigh in on NurOwn, a potential treatment to slow the progression of ALS that has bitterly divided physicians and patient advocates.
On Sept. 27, a panel of experts will consider the convoluted data supporting the potential approval of NurOwn, a stem-cell therapy the FDA previously refused to even consider. To some physicians, the drug’s failure to show significant benefits in clinical studies leaves approval out of the question. Others, including the influential ALS Association, say NurOwn’s manufacturer, a small biotech firm called BrainStorm Cell Therapeutics, hasn’t disclosed enough information to properly determine the medicine’s value.
Another group of patients and doctors argue that NurOwn’s supporting evidence, while problematic, justifies making it available to the roughly 30,000 ALS patients in the U.S., people for whom there is currently no hope of arresting an incurable disease that gradually erodes motor function and leads to death within about five years of diagnosis.