Just last week, the FDA approved a new drug for treating Alzheimer’s in the United States, Aduhelm. It is not approved in Canada yet, but there’s a storm of controversy over whether it is even effective at all, or at least in the ways intended.
This week three scientists on the FDA’s independent neurological drug advisory panel resigned however, stating that the clinical trial data was flimsy at best with one scientist telling the New York Times, “This might be the worst approval decision that the FDA has made that I can remember,” Dr. Aaron Kesselheim. The independent panel had voted to reject the drug with ten “no” votes and one “uncertain” vote.
The FDA doesn’t have to listen to the panel, they’re there for a secondary opinion only. Actual regulation of drugs and medical devices is made in-house by FDA scientists. The claim by the manufacturer is that the drug treats Alzheimers directly, rather than just the symptoms, where most treatments for Alzheimer’s deal with depression and anxiety, not the underlying cause. But adding to the controversy is that it currently costs around USD$56,000 a year. We have no idea of the costs for Canadians, should Health Canada approve the drug, but as is often the case it will be at least the same, if not more.
The concern of some scientists is that there have been a number of drugs that reduced the Azheimer’s-linked amyloid beta plaques from patient’s brains, but that this one promised it wouldn’t factor in, but it does seem to. The committee had demanded more proof that it worked in this novel way, but that was never provided. “Approval of a drug that is not effective has serious potential to impair future research into new treatments that may be effective,” Washington University School of Medicine neurologist Joel Perlmutter, the first committee member to resign, told the NYT.
“In addition, the implementation of aducanumab therapy will potentially cost billions of dollars,” he added, “and these dollars may be better spent in either developing better evidence for aducanumab or other therapeutic interventions.”
Said Dr. Caleb Alexander, one of the FDA’s advisors who recommended against the approval, “The FDA gets the respect that it does because it has regulatory standards that are based on firm evidence. In this case, I think they gave the product a pass.” Under terms of the so-called accelerated approval, the FDA is requiring the drug maker to conduct a followup study to confirm benefits for patients. If the study fails to show effectiveness, the FDA could pull the drug from the market, though it rarely does so.
The primary concern is that Aduhelm is only considered to potentially provide benefits, but doesn’t really get to the heart of treating the causes as seemed to be promoted. It is likely there will be a lot of controversy over this medication amongst healthcare professionals, patient advocacy communities and related professionals. The other concern is the added costs to the healthcare system as the drug is delivered intravenously and requires, in the United States for now at least, significant monitoring to understand any side-effects and long-term benefits. Time will tell and the impacts on the Canadian healthcare system can’t be known for now, nor whether Canada Health will follow in approving the drug, which was approved on a fast-track program to begin with.
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