Cautionary Flags Raised by Aduhelm Approval
The FDA recently approved aducanumab, branded as Aduhelm, to treat Alzheimer’s disease. How this was done raises flags of caution, and reveals troublesome features of healthcare marketing in the USA. Recurrent neglect of these factors will compound the chronic problem of expensive treatments that are not infrequently futile.
This does not mean that the approval was unjustifiable. The burden of Alzheimer’s disease is crushing. Over 6 million USAmericans suffer from the disease, and this number can be expected to increase as the proportion of older adults increases. Since the natural history of each case lasts for years and because the cognitive loss produces extreme behavioral demands, it is easy to see how the manufacturers could argue for more lenient standards to approve this new treatment.
The first cautionary flag is raised by over-reliance on biomarkers to approve this medication. Another, separate and commercial concern, is how physicians will be incentivized to administer it. Both are instructive because the dynamics aren’t unique to Alzheimer’s disease- even if the stakes are arguably higher in this instance.
The biomarker here is amyloid plaques. These protein deposits in the brain are pathognomic of Alzheimer’s disease. Evidence of their presence is used to establish a diagnosis. Relying on a physical manifestation is, of course, not unusual in medicine. Critics assert that the decision did not adequately weigh clinical markers too. In this instance, the evidence that aducanumab removes amyloid plaques was not so much in question. Evidence that it produces clinical improvements, or slower loss of cognitive abilities, was slimmer. That made this approval contentious. Read more…