Health Watch: Fairbanks doctor expresses concerns over newly FDA approved Alzheimer’s drug
FAIRBANKS, Alaska (KTVF) - For the first time in nearly 20 years, the U.S. Food and drug administration has approved a new drug designed for the treatment of Alzheimer’s disease. Developed by Biogen, this drug called Abucanumab is designed to cleanse a form of plaque build up in the brain called amyloids.
Dr. Daniel McCully, geriatrician at the Tanana Vally Clinic and Denali Center explained, “This new medication is an antibody that attaches to amyloid in the brain which is part of Alzheimer’s. It helps remove that amyloid from the brain. So the hope is that this would be an effective treatment to help prevent the decline that can come about from Alzheimer’s disease and help keep people functional longer.”
There has already been some controversy regarding the FDA approval process for the drug, including independent studies that raised concerns about whether or not the drug is actually effective. According to Dr. McCully, “A big group of outside experts from places like Harvard, and Johns Hopkins, and Mayo Clinic actually reviewed all the data eight months ago, and unanimously they recommended this medication not be approved. The FDA decided to approve it anyways in the hope that since there’s not much else for Alzheimer’s, maybe it would be helpful.”
Of two studies testing the efficacy of Abucanumab, one produced negative results while the other saw marginal success. Usually in this situation the FDA would require two positive studies to approve a new medication. Dr. McCully continued, “The American geriatric society, which is the biggest group of geriatricians and other specialists who take care of people with Alzheimer’s and other kinds of memory issues recommended against approval for this medication. So I think a lot of the geriatricians like me will be pretty reluctant to use it at this point until more evidence comes out that it is effective, especially since there are significant side effects that were seen in the studies.”
According to Dr. McCully side effects included swelling and bleeding in the brains of several patients. “In the studies they had to do monitoring with MRIs fairly often because people had bleeding in the brain and swelling in the brain. About 30 percent of people had swelling in the brain. Only a quarter of that caused symptoms but it’s still a cause for concern. About 20 percent of people on the medication had at least small bleeds in the brain, and some of those were serious and lead to people not being able to finish the study. So I think we have very strong evidence that there are some side effects with this medication. It’s also incredibly expensive. You have to go to an infusion center every 4 weeks, it’s more than $50,000 a year for this medication, and there’s really not strong evidence that it helps.”
Due to these factors, Dr. McCully stated he would not advise a prescription of Abucanumab to patients at this time. “I’ll have, I’m sure, many long complicated conversations with patients about this issue. I’m very disappointed the FDA approved it with the limited level of evidence and the side effects we see. I think if a family member asked me if they should be on this medication, I’d say ‘not at this point.’ We need more evidence to see exactly how safe it is and if it is even effective at all.”
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