Controversy erupts over new Alzheimer’s drug

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ROCHESTER, N.Y. (WHEC) — Just a month ago, the Food and Drug Administration approved the first new drug for Alzheimer’s disease in nearly 20 years. However, several weeks later amid major confusion, the FDA changed the prescription instructions, which is a rare occurrence for the governing agency.

“When the medication was approved the FDA approved it for anybody with Alzheimer’s disease at any severity and it didn’t make a comment about whether a test had to show whether there was amyloid in the brain,” said David Gill, MD, co-director of the Memory Unity Center.

In a major turn of events, the FDA and drugmaker Biogen now clarifies that the Alzheimer’s drug is only recommended for those in the mild to early stages of Alzheimer’s, adding more heat to the ongoing debate about the drug.
“Many of us felt like the FDA had put us in a somewhat awkward position when we had to deny patients access to the medication because we wanted to follow the research studies,” Dr. Gill said.

Biogen addressed the change in a release Thursday clarifying the patient group studied in the company trials were only those with mild to early-stage Alzheimer’s. Doctors say this is just one of the issues with the drug.

“I think the implications of these new recommendations are going to be most clearly be seen when the insurance payers are making their guidelines for what they will and won’t pay for in their insurance policies,” said Marla Bruns, MD, co-director of the Memory Unity Center.

At nearly $56,000 for a full dose of the drug, advocacy groups like the Alzheimer’s Association are fully aware of the hefty price tag and are trying to help those impacted by the disease.

“Our position is that the price is absolutely unacceptable, so we have already begun advocating with the Centers for Medicare and Medicaid services for payment mechanisms or this type of treatment,” said Teresa Galbier, chapter executive at the Alzheimer’s Association Rochester and Finger Lakes Chapter.

Adding more to the controversy, also Friday, FDA Acting Commissioner Dr. Janet Woodcock requested an investigation by the Department of Health and Human Services Office of Inspector General into the approval of Biogen’s drug. Woodcock says an independent review and assessment should look at the interactions between the drug manufacturing company and the FDA during the approval process.

The Alzheimer’s Association is ramping up its public policy efforts with agencies and other stakeholders to ensure that this becomes a treatment that is available to those who need it most. For more information about the association, click here.