On June 7th, 2021, the U. S. Food and Drug Administration (FDA) came to the rescue of many of the 6.2 million Americans who struggle with Alzheimer's by approving Aduhelm.
The drug gave families and patients hope, but some of that optimism seems to be waning with the Cleveland Clinic and New York's Mount Sinai's recent decision not to administer it.
Interestingly, the FDA approved Aduhelm using the accelerated approval pathway as a faster way to approve drugs for serious conditions. Back in 2012, Congress approved the Food and Drug Administration Safety Innovations Act. This Act amended the Federal Food, Drug, and Cosmetic Act allowing the FDA to base accelerated approval for drugs for serious conditions that fill an unmet medical need on whether the drug has an effect on a surrogate or an intermediate clinical endpoint. Simply put, utilizing the surrogate endpoint allowed the FDA to approve these drugs quicker.
When studying a new drug, it can sometimes take many years to know the results of how a patient feels, responds, or survives. Those patients who endure the dreadful Alzheimer's disease daily are grateful for the Accelerated Approval regulation that the FDA approved. Time is certainly of the essence to all of them.
In FDA's July news release, the words by one of their leading medical experts could not have been clearer. "Alzheimer's disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones," said Patrizia Cavassoni, M.D., director of the FDA's Center for Drug Evaluation and Research. "Currently available therapies only treat symptoms of the disease: this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer's. As we learned in the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation." This victory appeared to be a major win for patients.
It is gut-wrenching to many older adults to hear the recent news that two significant American health systems have decided not to administer this treatment to patients. What is even more disappointing is what Mount Sinai's director of Cognitive Health, Dr. Gandy said about the process in a New York Times piece. Dr. Gandy said the decision was driven that there have been calls for a federal investigation to look into the FDA decision and the agency's relationship with Biogen, the drug manufacturer. Sadly, Dr. Gandy seems to be putting his political interests ahead of patients.
Our older adults are grateful to live in America, home of the greatest health care system in the world. Thanks to the outstanding work by the hospitals, physicians, nurses, and pharmaceutical manufacturers across the country, many of our older Americans are living long healthy lives. The data continues to show that hospitals, manufacturers and businesses invest millions of dollars to deliver the results we want and expect. Hopefully, that will continue.
Thankfully, Biogen took a monumental risk investing years of effort and resources into developing their treatment. That risk finally paid off when the FDA granted its approval making Aduhelm the first new Alzheimer's drug in almost two decades and the first to attack the disease.
Instead of making political statements, maybe Mount Sinai and the Cleveland Clinic should listen to their patients and families.