With 5.8 million Americans living with Alzheimers, and a disease that doubles every 5 years for people over age 65, it is no wonder that we are clamoring for treatment and cure. On June 7, Biogen's Aduhelm (aducanumab) was approved through the FDA accelerated approval process for treatment of Alzheimers.
The approval doubled the company's stock price, but there is increasing anger from clinicians and even the Alzheimer's Association about the process and pricing ("simply unacceptable") of this drug. In the dementia medical community, 87% think the drug's approval was political and 68% say they would not use the drug themselves due to lack of evidence. So what is going on here?
Biogen tried to get this drug approved between 2015-2018 after two large trials could not show effectiveness. In March 2019, the FDA told the company that the results were "inconclusive". The company then launched "Project Onyx" to get the failed drug approved through the backdoor. A key insider, Billy Dunn, Director of FDA Neuroscience, worked with Biogen to get approval, despite there being no new evidence that it was effective. It was so irregular that a number of statisticians and scientists resigned from Biogen's advisory board after the FDA proposed the drug get approved through the accelerated approval designation (put in place for Covid drugs). Despite objections from its outside scientific advisory committee which voted 8-1 against approval with 2 abstaining, the FDA has approved this drug for use to halt the "plaques" of Alzheimers. There is considerable dissent within the scientific community that this is even the right research and approach to be taking. "There were dozens of red flags in the data in front of the room", according to Caleb Alexander, an epidemiologist from Johns Hopkins University and an advisory member.
The company now has until 2030 to complete a study that shows if it even slows mental decline. The infusions of Aduhelm cost $56,000.year, not including doctors, brain scans and infusion centers. At that rate, for the next nine years the company can make billions of dollars for a drug that may be ineffective.
If you think proving efficacy of a drug doesn't matter, consider that hospital drug costs increased almost 38% in the past 3 years. Many hospital drugs (chemo anesthetics, IV solutions) increased 80%. Hospitals cannot absorb those increases without increasing prices or reducing staff (and that means nurses and techs). Drug like Aduhelm will be demanded by Medicare patients. Desperate people will try anything, especially if they aren't responsible for the cost.
No laws were broken. Biogen is just doing what the stock market wants. But our tax dollars support the FDA and we should demand more of them. Many of us are losing confidence in how the system works.