Brief # 114 – Health & Gender
The New Alzheimer Drug Controversy
By S Bhimji
June 30, 2021
For decades, there has been intense research to develop drugs that could either slow down or prevent Alzheimer Disease (AD). So far there is no such drug. A few older drugs are available but these agents only diminish early-stage symptoms in a few patients. In most people the drugs are not helpful and their adverse effects are more harmful than the benefits. For the majority of AD patients, the treatment so far has been supportive care.
Since 2003, no new drugs for AD have been introduced for clinical use. But just last week the FDA approved a new drug for AD made by Biogen. The drug, Aducanumab, is a monoclonal antibody directed towards a protein in the brain called amyloid. The drug prevents the buildup of amyloid aggregates which are found in the brains of people with AD. Amyloid is just one of the proteins believed to be playing a role in dementia and poor cognition.
The drug can only be given as an intravenous drip over a period of several hours. Weekly treatments are required. The early known adverse effects of the drug include headache, flu-like symptoms, pain and redness at the injection site, rash, sinusitis, and malaise- all these side effects are of short duration and generally do not require any special treatment. Since the announcement by the FDA last week, most hospitals have been eagerly waiting for the drug supplies.
The FDA approval of aducanumab has met with a great deal of controversy. In November 2020, both an outside and internal panel of medical experts concluded that during the initial study, the drug’s benefits were marginal at best. Investigators for the FDA further concluded that the data supporting aducanumab’s clinical efficacy was weak, and the experts also cited errors in methodology and interpretation of data.
Nevertheless, despite its own experts questioning the drug’s efficacy, the Head Honchos at the FDA went ahead with the approval and only asked Biogen to perform a follow-up study to see if the drug helps treat symptoms of AD and lowers the amyloid plaques in the brain.
Hospitals across the US have been following the drug’s development and have developed a huge list of patients that are eligible to receive the medication. Further caregivers for AD patients are more than eager to get the treatment started since the Biogen monograph clearly states that the drug can prevent the progression of the disease.
But specialists in AD care suggest that hospitals should exercise great caution before deciding to administer aducanumab to thousands of patients. The reason is that all AD patients must first undergo a PET Scan to determine if they have amyloid plaques and assess the risks. The drug may be best for individuals with early disease, mild cognitive impairment, and memory loss. Those with severe symptoms may not respond.
Amidst the FDA approval controversy, what is often not mentioned by most of the media is the cost of the drug. Aducanumab costs nearly $56,000 a year (or about $4200 a week), a princely sum for most Americans. For a drug that has weak supporting data, this is an enormous amount of money- but hospitals and physicians will do their best to seduce desperate patients with false hopes. Since the majority of AD patients are over the age of 65, it remains to be seen if Medicare will bear the financial burden, which will easily exceed $100 billion a year.
Even if Medicare does accept to pay for the aducanumab, remember Medicare only pays 80% of the bill, and patients will be stuck with the 20% copayment. Plus patients will have to pay for the imaging scans; PET scans are generally not covered by Medicare: the average cost of a PET scan is $5,000.
Finally, there are concerns of adverse effects of the drug that were noted during the clinical trials like brain bleeding and swelling. And these side effects need to be monitored with scans, which again costs money, and who will pay for these extra scans if needed? The bottom line is that everyone should not get too excited about this drug.
FDA approved controversial Alzheimer’s drug despite objections from staff. https://nypost.com/2021/06/22/fda-approved-controversial-alzheimers-drug-despite-objections-from-staff/
The FDA Has Approved A New Alzheimer’s Drug — Here’s Why That’s Controversial. https://www.npr.org/2021/06/07/1003964235/fda-approves-controversial-alzheimers-drug-aducanumab
Controversial Alzheimer’s drug could cost US $334B—nearly half of DoD budget