Dr. Diana Zuckerman, President of National Center for Health Research: June 8, 2021
Everyone agrees that there is an urgent need for an effective treatment for Alzheimer’s Disease, but the key word is “effective.” Many experts, including FDA’s own statisticians and advisors, made it clear that Aduhelm is not proven to work – of the company’s 2 studies, one study showed it would harm memory rather than help it, and the other study showed it might slightly benefit memory. FDA’s obvious wise choice would have been to require the company to conduct a well-designed 3rd study, to see if any patients benefit in a meaningful way, and if so, which patients are most likely to benefit and which patients are likely to be harmed. Instead, FDA has made a decision based on wishful thinking and politics, not on science.
A new treatment for Alzheimer’s Disease should be cause for rejoicing, but the FDA’s approval of Aduhelm on June 7 is one of the worst FDA decisions we’ve ever seen. Since the results of the 2 studies of memories conflicted with each other, the FDA decided to ignore those results and just focus on the “biomarker” of a substance in the brain called amyloid beta. Unfortunately, although previous studies have shown amyloid beta to be associated with Alzheimer’s, reducing the substance has never been shown to improve memory, as we showed in our article in BMJ several years ago.
What about safety? Aduhelm often causes brain swelling, which can cause headaches, falling, diarrhea, confusion and delirium/altered mental status. In other words, there are no proven benefits, but there are proven risks. The FDA is requiring Biogen to continue to study their drug, but the company reports that the FDA gave them 9 years to complete and report that study. How many patients will be harmed in the meantime?
Despite all these concerns, the FDA put even more patients at risk when they approved Aduhelm for all Alzheimer’s patients, even though it was only studied on patients with mild Alzheimer’s disease.
Meanwhile, Biogen has announced they will charge $56,000 per patient, and PET scans will add to the price because they are needed to diagnose Alzheimer’s disease. Almost all people who suffer from dementia are thought of as having Alzheimer’s Disease, but some dementia has other causes and the drug has even less benefit for them if they don’t have amyloid beta in their brain. Repeated PET scans and MRIs will add to the cost to help reduce harm from the drug.
The FDA’s decision sets a very dangerous precedent that could harm patients’ health and will also be financially devastating. Since Medicare is already due to run out of money in 2022 or 2023, this will obviously speed up that disaster. If FDA’s decision bankrupts Medicare, FDA’s leadership will be to blame. And, it is expected that the co-pay for patients will be $11,000/year for the drug alone – even more when PET scans and MRIs are added.
See our analysis of the company’s worrisome data here.