Everyone has their risk threshold, and obviously, circumstances will contribute to the decision-making process. The circumstances surrounding the Food and Drug Administration’s approval of Aducanumab manufactured by Biogen made national news. It is exciting to many because the drug is the first new Alzheimer’s drug approved by the FDA in nearly 20 years.
How it works
The drug is supposed to slow down the progression of Alzheimer’s because it has reportedly proved highly effective in reducing plaques called beta-amyloid. These plaques build up in the brains of those who have Alzheimer’s. Typically, this would be great news.
Some troubling details
There are several red flags to be aware of:
- A panel of expert advisors to the FDA recommended not approving the drug back in November of 2020.
- Two large studies offered conflicting results regarding the effectiveness of the drug.
- The FDA required Biogen to conduct a new study to see if it reduces the plaques, which then leads to patient improvement. This study was a condition for the drug’s fast-track approval by the FDA.
- The FDA’s shaky approval may prompt some to avoid using the drug, thus limiting the study pool. Conversely, some may not want to risk getting the placebo as part of the study and avoid the study.
- It could be several years before clinical trials end for the drug.
- An impartial third party think-take also analyzed the studies and found no evidence that the drug’s benefits outweighed the harm.
- The controversial drug treatment costs $56,000 per year.
Critics question use
A doctor of medicine and medical ethics spoke for some when he criticized the drug, citing the expense, lack of clear benefits and the risks of bleeding on the brain caused by treatment. Families of loved ones with Alzheimer’s should also be cautious about this drug. Depending upon the drug’s impact on the patient, families may need to file a drug injury lawsuit.