蜜桃导航

Updated: 5:08 p.m., Thursday, July 15, 2021 

The Alzheimer鈥檚 Association, a national organization focused on Alzheimer鈥檚 and dementia care and research, is criticizing Cleveland Clinic鈥檚 decision not to offer a controversial new Alzheimer鈥檚 drug to its patients.

The treatment, Aduhelm, was granted  accelerated approval by the Food and Drug Administration (FDA) in June, but some  . Aduhelm, also known by its generic name aducanumab, is the first Alzheimer鈥檚 therapy approved for use in nearly 20 years. 

Cleveland Clinic announced on Thursday it agrees with that assessment and that it will not offer the drug to patients.

鈥淏ased on the current data regarding its safety and efficacy, we have decided not to carry Aducanumab at this time,鈥� Cleveland Clinic officials said in a statement.  

The hospital system will re-evaluate its decision if additional data become available after continued research of the drug, according to the statement. 

鈥淲e were surprised and disappointed by the hesitancy of Cleveland Clinic to provide patients that access to treatment,鈥� said Kristen Clifford, chief program officer at the Alzheimer鈥檚 Association. 

Cleveland Clinic officials told 蜜桃导航 that physicians can still prescribe the drug, but patients would have to receive the treatment at a different facility. Clifford disagrees with that decision. 

鈥淣ot being able to receive treatment at the institution does create a potential access barrier,鈥� Clifford said. 鈥淲e want to try to address and eliminate those barriers as much as possible so those who could benefit from the treatment have the opportunity to do so.鈥�  

Aduhelm removes plaque buildup on an Alzheimer鈥檚 patient鈥檚 brain, which is thought to help slow down the memory loss process. However, experts have not concluded the treatment is effective, and two different studies had conflicting findings.  

An advisory panel did not recommend authorization of the drug for that reason, but the FDA still approved it. 

One month later, the FDA then issued updated guidance, clarifying that Aduhelm should only be prescribed in patients in the disease stage studied in the clinical trials: people who have mild cognitive impairment (MCI) or mild dementia. 

The national Alzheimer鈥檚 Association applauded this clarification, Clifford said. 

鈥淲e appreciate the FDA鈥檚 thoughtful consideration and response to the Alzheimer鈥檚 Association and others in the community including physicians, researchers and patients to ensure this treatment is prescribed only to those who may see benefit," Maria C. Carrillo, Alzheimer鈥檚 Association chief science officer, said in a statement.  

Scientists within the Alzheimer鈥檚 Association have reviewed the clinical trial data, Clifford added, and support the authorization of the drug because it could be effective for some patients. There is currently no other treatment that addresses the underlying biology of the disease, she said. 

鈥淭here is a dire and drastic need for this community for relief and support,鈥� Clifford said. 鈥淲e believe based on the totality of the science that it should have been approved, also given that unmet need and the devastating toll of the disease.鈥�  

Clifford added that she supports additional research into the drug, and her organization is also lobbying the drug鈥檚 maker, Biogen, to decrease the price of the drug, which has been set at $56,000 a year. 

鈥淲e remain outraged. We think the price is simply unacceptable,鈥� she said. 

As part of the FDA's accelerated approval, Biogen must conduct another trial, even though the drug is already on the market. 

Read the full statement from Cleveland Clinic below: 

鈥淎 multidisciplinary panel of Cleveland Clinic experts have reviewed all available scientific evidence on this medication. Based on the current data regarding its safety and efficacy, we have decided not to carry Aducanumab at this time. However, we support continued research in this area, and when additional data become available, we will re-evaluate this medication for use in our patients.鈥�