Updated: 5:08 p.m., Thursday, July 15, 2021
The Alzheimer’s Association, a national organization focused on the care and research of Alzheimer’s and dementia, has criticized the Cleveland Clinic’s decision not to offer its patients a controversial new Alzheimer’s drug.
Treatment, Aduhelm, was granted accelerated admission by the Food and Drug Administration (FDA) in June, but some Health experts claimed there wasn’t enough clinical evidence that the drug was effective. Aduhelm, also known under the generic name Aducanumab, is the first approved Alzheimer’s therapy in almost 20 years.
The Cleveland Clinic announced Thursday that it agrees with this assessment and will not offer the drug to patients.
“Based on current data on its safety and effectiveness, we have decided not to use aducanumab for now,” Cleveland Clinic officials said in a statement.
The hospital system will reassess its decision if additional data becomes available after further research into the drug, the statement said.
“We were surprised and disappointed at the Cleveland Clinic’s reluctance to give patients this access to treatment,” said Kristen Clifford, chief program officer for the Alzheimer’s Association.
Cleveland Clinic officials told Ideastream Public Media that doctors can still prescribe the drug, but patients would need to be treated in a different facility. Clifford disagrees with this decision.
“Not being able to receive treatment at the facility creates a potential barrier to entry,” said Clifford. “We want to try to address these barriers as much as possible and remove them so that those who might benefit from the treatment have the opportunity.”
Aduhelm removes plaque buildup in an Alzheimer’s patient’s brain that is believed to slow the memory loss process. However, experts have not concluded the treatment is effective, and two different studies had conflicting results.
An advisory panel did not recommend approval of the drug for this reason, but the FDA approved it anyway.
Then, a month later, the FDA released updated guidelines clarifying that Aduhelm should only be prescribed to patients in the disease stage studied in the clinical trials: people with mild cognitive impairment (MCI) or mild dementia.
The National Alzheimer’s Association welcomed this clarification, Clifford said.
“We appreciate the FDA’s careful consideration and response to the Alzheimer’s Association and others in the community, including doctors, researchers, and patients, to ensure that this treatment is only prescribed to those who may see benefit,” said Maria C. Carrillo , Chief Science Officer of the Alzheimer’s Association said in a statement.
Alzheimer’s Association scientists have reviewed the clinical trial data, Clifford added, and are backing the drug’s approval as it could be effective for some patients. There is currently no other treatment that addresses the underlying biology of the disease, she said.
“This community is in dire need of help and support,” said Clifford. “We believe, given the body of science, that it should have been approved, given the unmet needs and the devastating toll of the disease.”
Clifford added that she is supporting additional research on the drug and that her organization is also using the drug’s maker, Biogen, to lower the drug’s price, which has been set at $ 56,000 a year.
“We remain indignant. We think the price is just unacceptable, ”she said.
As part of the FDA’s accelerated approval, Biogen has to conduct another study even though the drug is already on the market.
Read the full Cleveland Clinic statement below:
“A multidisciplinary panel of experts from the Cleveland Clinic reviewed all of the available scientific evidence on this drug. Based on the current data on safety and effectiveness, we have decided not to use aducanumab at this time. However, we support further research in this area and will re-evaluate this drug for use in our patients as additional data become available. ”
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