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Amid firestorm of criticism, FDA narrows use of $56,000 Alzheimer's drug:
Less than five weeks after granting a highly controversial approval for the Alzheimer's drug Aduhelm, the Food and Drug Administration has updated its recommendation for who should receive the drug. The update narrows the recommended patient pool from all those with Alzheimer's disease to only those with mild forms of the disease.
The FDA's initial sweeping recommendation was a highly contentious aspect of the drug's approval, because it wasn't backed by any data. Aduhelm's developer, Biogen, had only included people with mild disease in its clinical trials. The numerous critics of the approval raised immediate questions as to why the drug would be open to all.
[...] Critics quickly called the approval "disgraceful" and "dangerous." Three members of the agency's advisory panel resigned in protest. Watchdog group Public Citizen called for the ouster of three top FDA officials.
Adding fuel to the fiery criticism is Biogen's decision to price Aduhelm at $56,000 for a year's supply. One analysis estimated that if the country's 5.8 million Medicare-eligible adults with Alzheimer's began taking Aduhelm, it could cost the federal insurance program $334.5 billion a year. In 2019, Medicare spent a total $37 billion for all drugs in the same category as Aduhelm, which is a doctor-administered drug. And the eye-popping cost estimate does not include additional, pricy brain scans and safety monitoring that taking the drug would require. While Aduhelm's efficacy is uncertain, the drug's known side effects include dangerous brain swelling and bleeding.
The FDA's update to narrow the potential patient pool will bring down those cost estimates. But perhaps not by much. A recent study led by researchers at Boston University estimated that half of people living with Alzheimer's could be categorized as having mild disease. And, even if just 500,000 Medicare beneficiaries end up taking Aduhelm, it could still cost the federal government $29 billion a year.
Previously:
Three F.D.A. Advisers Resign Over Agency's Approval of Alzheimer's Drug
Member of FDA's Expert Panel Resigns Over Controversial Alzheimer's Therapy Approval
(Score: 0) by Anonymous Coward on Sunday July 11 2021, @06:21AM (5 children)
That paper says:
> Although the vast majority of patients develop clinical symptoms at age older than 65 years (late-onset AD), 2–10% of patients have an earlier onset of disease (early-onset AD)....Together, mutations in APP, PSEN1, and PSEN2 explain 5–10% of the occurrence of early-onset AD.
Even if you assume all those mutations only affect amyloid beta levels and nothing else, that would be 0.1% to 1% of cases
Does a correlation with > 1% pass as strong evidence now?
(Score: 0) by Anonymous Coward on Sunday July 11 2021, @07:29AM (4 children)
The extremely high penetrance for certain mutations and EOAD (complete penetrance in some mutations), their mechanism of action, and the protective mutations shows that amyloid beta is, at worse, indirectly causative of AD in those cases. In addition, the other genes that affect amyloid beta in different ways also have high predictive power for AD and comprise the majority of its heritability.
(Score: 0) by Anonymous Coward on Sunday July 11 2021, @07:47AM (3 children)
There is a very low correlation between amyloids and alzheimers, so your premise is wrong. But even if it was high that would still be wrong.
Amyloids are the lowest energy conformations peptides can form. If anything starts malfunctioning you get accumulation of amyloids, starting with whichever ones are most prone to do it in that tissue. Look up any disease + amyloid and 100% of the time you will see they either accumulate or no one checked.
It is the same as being too sick to take out the trash, accumulated trash could then also cause more problems but removing it does not address the root problem.
(Score: 0) by Anonymous Coward on Sunday July 11 2021, @08:31AM (2 children)
They aren't correlating amyloids with Alzheimer's. Its a subtle distinction, no worries.
(Score: 0) by Anonymous Coward on Sunday July 11 2021, @02:22PM (1 child)
Yes, they are correlating mutations that correlate with increased amyloid beta in 0.1-1% of cases.
It is a research programme that has never generated anything useful. An entire generation of researchers and funding has been wasted on misinterpreting this extremely tenuous correlation.
(Score: 0) by Anonymous Coward on Sunday July 11 2021, @09:36PM
No, they are not. Genetic studies can be difficult when you don't understand population differentiation, conditional subpopulations from segmentation, and heterologous analysis of non-homogeneous populations. No worries.