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Dementia professional says proof for approval was “inadequate”

Dementia expert Dr. Jason Karlawish told CNBC he was skeptical about the Food and Drug Administration’s approval of Biogen’s Alzheimer’s drug Aduhelm.

“Another study is needed to see if this drug is actually effective. Unfortunately, the FDA has approved the drug for marketing, although they also want another study,” said the co-director of the Penn Memory Center at the University of Pennsylvania on Monday after the agency’s formal OK.

FDA approval marks the first new treatment for Alzheimer’s in nearly two decades. Alzheimer’s is a progressive neurodegenerative disease that slowly destroys memory and thinking skills. The Alzheimer’s Association estimates that more than 6 million Americans are living with the disease.

Karlawish told The News with Shepard Smith that there are many promising Alzheimer’s drugs in the pipeline.

“I’m optimistic about the future here so I have hope. I just think this is not the drug we can put our hopes on,” he said. “Desperation should drive funding for Alzheimer’s research; it should not drive interpretation of scientific evidence.”

Clinical studies have found that some patients who received the approved dose of Aduhelm had painful brain swelling.

“What you are asking someone to do is risk an uncertain benefit but a known risk,” Karlawish said of prescribing the drug to patients.

The FDA said it would continue to monitor the drug once it hits the US market. The agency granted approval on the condition that Biogen conduct another clinical study.

Karlawish told host Shepard Smith that Biogen would face a challenge “how to conduct this study when the drug is also available for clinical prescription.”

Representatives from Biogen and the FDA did not immediately respond to requests for comment on Karlawish’s statements.

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