Some Doctors Say They Won’t Give Their Patients Controversial New Alzheimer’s Drug

Parts of the medical community continue to rebel against Aduhelm, the controversial treatment developed by Biogen and recently approved for Alzheimer’s disease by the Food and Drug Administration. This week, two major medical centers in the United States said they would not treat their patients with the drug.

The Cleveland Clinic, as the first reported by The New York Times yesterday, convened a formal panel of experts to examine the evidence behind aducanumab, the active ingredient in Aduhelm, before making their decision.

“Based on the current data regarding its safety and efficacy, we have decided not to offer aducanumab at this time. However, we support further research in this area, and when more data becomes available, we will re-evaluate this drug for use in our patients, ”the clinic said in a statement sent to Gizmodo. Doctors working there can still prescribe the drug, given once a month by IV infusion, to patients, but patients should receive it elsewhere.

In a subsequent update to the NYT article, Sam Gandy, director of the Mount Sinai Center for Cognitive Health, said the center would not give the drug to its patients, at least not until the Office of the Inspector General. , a government watchdog agency, has its say.

“The FDA approval of Aduhelm has raised serious concerns and questions from clinicians, patients and caregivers and a cautious approach is required. The Mount Sinai health system will not administer Aduhelm until the results of the Inspector General’s investigation into Biogen are completed, ”a Mount Sinai representative confirmed in a statement sent to Gizmodo.

Calls for the Inspector General to investigate the approval have intensified in recent weeks, following Stat News report of a close relationship between Biogen and some FDA officials during the process. Days After House Representative Katie Porter sent a formal request for an investigation last week, acting FDA chief Janet Woodcock issued her own open letter to the inspector general asking for the same. At this point, however, no investigation has been announced.

The crux of the controversy surroundings Aduhelm comes down to the mixed data on its effectiveness, as well as the unusual steps the FDA has taken to approve the drug, using a process known as expedited approval. Rather than saying that the drug has been shown to at least slow the progression of Alzheimer’s disease in clinical trials, the FDA instead argued that it would likely work, given other surrogate parameters (in in this case, the reduction of amyloid plaque in the brain of patients). Under the current rules, Biogen will have up to nine years to conduct additional research that can actually demonstrate real benefit to patients.

While FDA officials Carry on to defend the approval, the agency backed down somewhat. Last Thursday, the FDA made formal changes to its labeling of the drug, now recommending that doctors only prescribe it to people with early-onset Alzheimer’s disease, rather than all Alzheimer’s patients.

The change is expected to limit medical coverage and availability of the drug, but that will likely cost healthcare systems a pretty penny, given its list price of $ 56,000 per year. A recent analysis by the Kaiser Family Foundation has estimated that Medicaid alone can spend between $ 720 and over $ 2 billion a year on Aduhelm, depending on the number of eligible patients who start using it. Medicare’s financial burden, which covers most seniors, may be even greater, although the exact fate of its coverage status for the drug is not yet clear.

This week, the Centers for Medicare and Medicaid Services ad he would conduct a formal assessment of whether and how Medicare would cover Aduhelm, an assessment that might not end until the start of next year (in the meantime, coverage will be determined on an individual basis)