Doctor’s Tip: Worried about Alzheimer’s? Don’t count on recently approved Aduhelm
Six percent of Americans suffer from Alzheimer’s dementia. Aging Americans fear getting this memory-robbing disease more than any other age-related condition.
Alzheimer’s is associated with amyloid plaque in the brain, which is different than the atherosclerotic plaque that occurs in arteries and is the cause of heart attacks and strokes. However, association is not the same as causation. Most of the information in this column was obtained from The Prudent Prescriber, an email newsletter that is sent out monthly to Colorado physicians by Rocky Mountain Health Plans, based in Grand Junction.
It would seem logical that removal of brain plaque would improve Alzheimer’s symptoms. However, as is so often the case in medical science, when studies are done, what seemed logical is proven to be false. Over the last few decades, several drugs have been developed that decreased brain plaque, but all of them were rejected by the FDA because they failed to improve Alzheimer’s symptoms.
The latest such drug is Aduhelm (aducanumab), developed by Biogen. This drug reduces Alzheimer’s-associated brain plaque, but whether it improves the disease is controversial at best. Aduhelm was approved by the Federal Drug Administration on June 7, under an accelerated approval pathway. Almost all experts feel that the approval was premature, rushed and not based on science.
The FDA is a governmental agency under the Department of Health and Human Services. It was established in 1906, with its mission being protecting public health through overseeing food safety; regulating prescription and over-the-counter drugs; and regulating vaccines — among other things. The FDA has done a good job for the most part, although in the past they have sometimes been criticized for being too cautious and slow in approving new drugs; and at times for being influenced by Big Pharma and politics.
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Biogen did two clinical trials on Aduhelm, both of which have been criticized for their quality. They stopped the studies in 2019 because although plaque burden improved, patients’ symptoms did not. Biogen later claimed that on further analysis, one of the studies did suggest mild clinical improvement (the other clearly didn’t) and resubmitted their application to the FDA for approval. Obviously, a third study was needed. The 11-member FDA expert advisory committee voted 10 to 0 to recommend denial of approval (the 11th member abstained), but the FDA took the unusual step of ignoring their advice. Furthermore, the FDA approved Aduhelm for all Alzheimer’s patients, no matter the severity of their disease, even though the participants in the two trials were limited to those with mild disease. Three members of the advisory committee quit in disgust, one of them saying “the FDA’s decision was probably the worst drug approval decision in recent U.S. history.”
This is not a cheap drug. A year of monthly infusions of Aduhelm costs $56,000, with an additional $30,000 for required MRIs and PET scans. There are also safety concerns, with side effects including headaches (27 percent of patients), brain swelling (35 percent), brain bleeds (19 percent) and death.
There will be other negative fallout from the premature release of this drug. Patients and families are desperate for a cure, and there will be pressure on physicians to prescribe it against their better judgment. There will be pressure on Medicare and private insurance companies to approve use of this unproven drug, which will result in a huge financial burden. In addition, the FDA’s action will cause the public to lose trust in the agency.
Hopefully, some day there will be a drug to prevent and reverse Alzheimer’s, but it doesn’t appear that Aduhelm is it (although it’s possible that further studies will paint a more positive picture). If you’re concerned about Alzheimer’s, stick with what we know helps: 1) Engage in intellectual and social activity as you age. 2) Eat a diet rich in vegetables, fruit, whole grains, nuts and seeds. 3) Engage in regular aerobic exercise. 4) Control cardiovascular risk factors, which are the same as the risk factors for Alzheimer’s: obesity, hypertension, high cholesterol, diabetes, inflammation, smoking and stress. (There are cases of people with normal brain function who have brain plaque but healthy brain arteries, and it’s possible that Alzheimer’s will prove to be a vascular disease). 6) Get seven to eight hours of sound sleep a night. 7) Consider daily turmeric. In a study group of 40 patients with mild to moderate Alzheimer’s symptoms, all 40 returned to normal after taking a teaspoon a day of powdered turmeric. (Search turmeric and Alzheimer’s on nutritionfacts.org).
Greg Feinsinger, M.D., is a retired family physician with a special interest in heart disease and diabetes prevention and reversal, ideally through lifestyle changes. He’s available for free, one-hour consultations — call 970-379-5718.
Dr. Feinsinger is offering 1½ hour grocery store shopping sessions where he shows how to make healthy food choices. By appointment; call 379-5718.
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