UC Health reports it's one of three Ohio locations that will offer a controversial Alzheimer's disease treatment just approved by the FDA.
The UC Memory Disorders Center expects to be ready to offer the drug aducanumab - now called by the brand name Aduhelm - by sometime in August, according to Rhonna Shatz, DO, who directs the center.
"We're putting together a comprehensive safety plan," Shatz says. "We're trying to make it as safe as possible since the efficacy of this isn't firmly established."
The FDA approved the drug Monday, making it the first new treatment for Alzheimer's in nearly 20 years.
As NPR's John Hamilton reports, Aduhelm is the first drug that aims to affect the underlying disease rather than just help with symptoms.
"This drug actually affects an underlying disease process by reducing the amount of sticky amyloid plaque that builds up in the brain," Hamilton reports. "The catch is that removing this plaque may not actually help patients avoid memory loss and thinking problems. One big study showed that it did. Another showed that it didn't."
An advisory panel voted against approving the drug, but in an unusual and controversial decision, the FDA moved forward anyway. The agency is requiring further clinical studies, however.
UC's Shatz agrees more study is warranted and she'd have preferred more answers before it was approved. To that end, she says the center intends to conduct research of its own. Patients and families will be fully informed about the potential risks and benefits of the drug, she says. The center will document and study those who chose to take Aduhelm. Protocols are being prepared now.
"If you do wish to try this medication, we want you to know that we're going to be looking at a number of markers beyond what the study had an opportunity to evaluate. We'll be monitoring this, and ... we'll try to keep you as safe as possible but we're also going to try to gather more information to help everyone else know the answers to these questions."
If the drug is so controversial, why offer it all? Shatz notes it's the possibility that Aduhelm could fundamentally alter the way we treat Alzheimer's disease.
"This drug has the potential of actually reducing the death of nerve cells, not just helping the system maintain function longer," she states. "If it does end up showing that it has the signal in reducing neurodegeneration and that it manifests as clinical stabilization or clinical improvement, this is definitely a game-changer."
She says testing has shown those signals but "not with the rigor and the numbers that we all would have liked to have seen."
The drug isn't cheap. Its makers, Biogen and Eisai, say it costs $56,000 per year on top of other expenses involved in administering it. Biogen declined to say what sites in Ohio would offer the drug.
