Opinion: Listen: A doctor with ALS laments the slow pace for drug approval

During his long career as a pediatric oncologist and cancer researcher, William Woods thought highly of the FDA’s work evaluating and approving new cancer drugs. Since the 1960s, the cure rate of all childhood cancers rose from from 25% to 80%.

But his opinion of the agency changed when he was diagnosed with amyotrophic lateral sclerosis (ALS), a progressive disease that damages nerves in the brain and spinal cord. The FDA’s Office of Neuroscience, which oversees the development of new ALS drugs in the U.S., “has repeatedly failed to take aggressive steps to greenlight these experimental therapies,” Woods wrote in his First Opinion essay, “As a pediatric cancer researcher, I admired the FDA. Then I got ALS.”

This week on the “First Opinion Podcast,” Woods talks about living with ALS, and watching what he sees as the glacial pace of approving an experimental ALS drug called AMX0035. On Wednesday, Woods is scheduled to testify before an FDA advisory committee about the new drug that slowed the loss of muscle function compared to placebo — a result published by the New England Journal of Medicine — and in a follow-up study improved survival by 10 to 18 months.


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Source: STAT