Dementia expert says evidence “was not enough” for approval
Dementia expert Dr Jason Karlawich told CNBC he was skeptical of the Food and Drug Administration Approval of BiogenAlzheimer’s disease drug Aduhelm said “the evidence to approve the drug was not sufficient.”
“Another study is needed to establish whether this drug, in fact, is 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 of the ‘University of Pennsylvania. said Monday after the agency’s formal agreement.
FDA approval marks the first new treatment for Alzheimer’s disease in nearly two decades. Alzheimer’s disease is a progressive neurodegenerative disease that slowly destroys memory and thinking skills. More than 6 million Americans are living with the disease, according to Alzheimer’s Association estimates.
Karlaoui said “The News with Shepard Smith” that there are a lot of promising Alzheimer’s drugs in the pipeline.
“I am optimistic about the future coming here, so I have hope. I just think this is not the medicine on which to base our hopes,” he said. “Desperation should lead to funding for Alzheimer’s disease research, it should not lead to the interpretation of scientific evidence.”
Clinical trials have shown that some patients who received the approved dose of Aduhelm developed painful swelling of the brain.
“What you’re asking someone to do is take a chance with uncertain benefit, but known risk,” Karlawich said of prescribing the drug to patients.
The FDA has said it will continue to monitor the drug when it hits the US market. The agency granted approval on the condition that Biogen conduct another clinical trial.
Karlawich told host Shepard Smith that Biogen would face a challenge of “how to do this study when the drug is also available for clinical prescription.”
Representatives for Biogen and the FDA did not immediately return requests for comment on Karlawich’s statements.