![](https://i.imgur.com/CLvY2jA.png")
27-09-2021, 12:53 PM
By Jeffrey Toobin, CNN
Updated 2200 GMT (0600 HKT) September 26, 2021
......
Alzheimer's is the sixth leading cause of death in the United States.
......
The public meeting, conducted as an all-day video call on November 6, 2020, concerned the application for aducanumab, a drug that would be marketed under the name Aduhelm by the company Biogen
......
As in all advisory committee meetings, this one included several representatives of the FDA and of the applying pharmaceutical company. Dr. Billy Dunn, the director of neuroscience at the FDA, spoke at length on the call, and Samantha Budd Haeberlein, a senior vice president of Biogen, led the representatives for the company. What was unusual about this meeting, though, according to Kesselheim, was the apparent relationship between the FDA and company representatives.
"There was a strange dynamic, compared to the other advisory committee meetings I've attended," Kesselheim said. "Usually there's some distance between the FDA and the company, but on this one the company and the FDA were fully in line with each other in support of the drug."
......
Most of the meeting was devoted to analysis of Biogen's own studies of the effectiveness of Aduhelm. The results were not promising in terms of clinical outcomes. Indeed, two of Biogen's major studies of people taking Aduhelm had been shut down before they were completed because they showed no significant benefit to patients.
......
In light of this, the advisory committee voted, with one member voting uncertain but no one dissenting, to recommend that the FDA reject the drug.
Seven months later, in June, the FDA gave Biogen final approval to treat patients with Aduhelm in all stages of Alzheimer's disease.
......
Kesselheim and two other members of the advisory committee promptly resigned in protest. In his letter of resignation, Kesselheim called the Aduhelm process "probably the worst drug approval decision in recent US history."
......
The financial implications are huge as well. Aduhelm will be extremely expensive, as an intravenous treatment that will cost about US$56,000 per year, plus several thousand more in related expenses. Given the number of Alzheimer's patients in the United States, the cost for widespread use of this treatment could quickly run into the many billions of dollars -- much of which would go to Biogen and its partner in the project, Eisai, a Japanese pharmaceutical company.
Super long article at: https://edition.cnn.com/2021/09/26/polit...index.html
Updated 2200 GMT (0600 HKT) September 26, 2021
......
Alzheimer's is the sixth leading cause of death in the United States.
......
The public meeting, conducted as an all-day video call on November 6, 2020, concerned the application for aducanumab, a drug that would be marketed under the name Aduhelm by the company Biogen
......
As in all advisory committee meetings, this one included several representatives of the FDA and of the applying pharmaceutical company. Dr. Billy Dunn, the director of neuroscience at the FDA, spoke at length on the call, and Samantha Budd Haeberlein, a senior vice president of Biogen, led the representatives for the company. What was unusual about this meeting, though, according to Kesselheim, was the apparent relationship between the FDA and company representatives.
"There was a strange dynamic, compared to the other advisory committee meetings I've attended," Kesselheim said. "Usually there's some distance between the FDA and the company, but on this one the company and the FDA were fully in line with each other in support of the drug."
......
Most of the meeting was devoted to analysis of Biogen's own studies of the effectiveness of Aduhelm. The results were not promising in terms of clinical outcomes. Indeed, two of Biogen's major studies of people taking Aduhelm had been shut down before they were completed because they showed no significant benefit to patients.
......
In light of this, the advisory committee voted, with one member voting uncertain but no one dissenting, to recommend that the FDA reject the drug.
Seven months later, in June, the FDA gave Biogen final approval to treat patients with Aduhelm in all stages of Alzheimer's disease.
......
Kesselheim and two other members of the advisory committee promptly resigned in protest. In his letter of resignation, Kesselheim called the Aduhelm process "probably the worst drug approval decision in recent US history."
......
The financial implications are huge as well. Aduhelm will be extremely expensive, as an intravenous treatment that will cost about US$56,000 per year, plus several thousand more in related expenses. Given the number of Alzheimer's patients in the United States, the cost for widespread use of this treatment could quickly run into the many billions of dollars -- much of which would go to Biogen and its partner in the project, Eisai, a Japanese pharmaceutical company.
Super long article at: https://edition.cnn.com/2021/09/26/polit...index.html
