By Leia Rubinstein, Sci-tech Editor
The Food and Drug Administration has recently approved a new drug for treating Alzheimer’s disease. Called Aduhelm and manufactured by Biogen, this drug successfully removes beta-amyloid plaques that have been associated with the deterioration of neurons in the brains of Alzheimer’s patients. Scientists have believed that the excess buildup of proteins in the brain is the cause of memory loss in Alzheimer’s patients, which is what prompted FDA approval.
The clinical trials focused on the surrogate outcome of removing the amyloid plaque and not on a real-world outcome, such as restoring one’s memory. This is a much faster, easier, and cheaper way of getting a drug approved. While this method of approving drugs has been successful in the past, critics say that this does not guarantee that the drug can cure Alzheimer’s and does not take into account the possibility that this drug may have other damaging effects.
Aduhelm can cause painful swelling or bleeding in the brain, as seen in 30-40% of patients in the study, and is extremely expensive, costing $56,000 per year. Medicare will bear the brunt of the costs, causing the government to spend excessively over this new drug that may or may not prevent memory loss. Patients who receive the treatment are required to receive monthly infusions intravenously as well as brain scans.
Nonetheless, the FDA has taken a leap of faith and approved this drug. Around 6 million Americans suffer from this deteriorating brain disease, yet there has not been a new Alzheimer’s drug since 2003. The abundance of caution that must be taken when approving a drug as well as the bureaucratic measures and liability lawyers that are involved, prevent many potentially life-saving drugs from entering the market.
Anyone who has a family member or friend with Alzheimer’s knows the pain of watching their loved one slowly fade away through their memory loss. They may still be living and breathing, but they are no longer themselves. Any small chance that a drug can prevent brain deterioration, is a huge win and one step closer to completely eliminating the disease.
***Sources:
https://slate.com/technology/2021/06/alzheimers-drug-aduhelm-fda-outcomes-plaques.html