A controversial new drug to treat Alzheimer’s has been released. It goes by the name ‘Aduhelm’ and is creating something of a civil war among doctors as they hold discussions with patients about whether they should take the drug.
Controversial Drug to Treat Alzheimer’s Receives FDA Approval
Multiple doctors are of the opinion that the FDA has jumped the gun in providing approval for Aduhelm and they are refraining from recommending the use of the medication.
Dr. Ken Lin said that a lot of physicians look to be reluctant to prescribe the drug as they don’t believe the data is convincing yet.
A medical professional who was involved in Aduhelm’s clinical trials believes that the FDA’s approval was required to stimulate Alzheimer’s research which has been at a standstill after repeated failure of treatments.
The Cleveland Clinic, along with Mount Sinai in New York, announced that they will not be prescribing the drug to patients. A lot of major medical centers and insurance companies are actively reviewing the usage of the drug.
The effectiveness of the medicine is highly disputed and its enormous price tag is also a key player in the debate. The list price set by the manufacturers is $56,000 per year.
The government might burn a hole in their pockets if just a quarter of the patients under Medicare-covered treatments for Alzheimer’s are recommended to take the drug. The figure stands at around $29 billion a year.
To put that number into perspective, NASA’s budget this year is only $23 billion and this includes missions to the moon and even Mars. The total amount spent on all Medicare-covered prescriptions was $37 billion in 2019.
The FDA approved the drug even after an expert advisory panel voted against it.
Not a single member of the panel voted for the approval of the drug. 10 voted against while one was uncertain.
Clinical trials that were held in 2019 were shut down due to conclusions by monitors that the drug was not helping patients. What’s alarming is that the panel’s decision and the FDA approval were based on the exact same data.
The trials showed that the drug was effective in removing beta-amyloid, which is a protein that collects together in the brain and is considered a hallmark of Alzheimer’s.
Out of the two trials in question, in one trial, clearing amyloid didn’t make any difference in the patients’ brain function. In the other trial, there was a slowdown of cognitive decline in the patients.
The FDA approved Aduhelm based on its ability to get rid of amyloid.
Many prior experiments have shown that many drugs can clear amyloid, but did not attain approval as they were not able to exhibit clinical benefit.
It is really surprising that the FDA gave the approval to the drug as a presentation from a year ago talking about the benefits of this drug seemed to leave doctors questioning the side effects of the drug.
Despite skepticism about the drug from medical professionals, it is expected that there will be a huge push from patients and families of patients to try Aduhelm.
Alzheimer’s is a horrible disorder. If something gives people even the tiniest sliver of hope, they’re going to grasp at it.
The drug is not for everyone and patients must be warned against using it. It’s effective for people who have mild cognitive impairment where getting rid of amyloid may help.
Doctors remain hopeful that this approval will help spur the stagnating field of research for treatments for Alzheimer’s. This would ultimately provide patients with multiple options.
Several drugs in the same league as Aduhelm will now be tested and receive FDA reviews.
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