Anand Kumar writes: “We are ill-served by overinterpreting statistical significance, heralding the false dawn and expediting the approval of ineffective, inadequately tested drugs under the umbrella of “cutting-edge science.
U.S. Food and Drug Administration offices in Silver Spring, Maryland, on Dec. 10, 2020. The FDA recently approved a new drug for the treatment of Alzheimer’s disease.
An image provided by Eisai in January 2023 shows vials and packaging for the medication Leqembi. On Jan. 6, 2023, U.S. health officials approved Leqembi, a new Alzheimer’s drug that modestly slows the progression of the disease. Today, more than 115 years later, Alzheimer’s is a major health problem globally, and the amyloid hypothesis — that amyloid accumulation causes dementia — dominates the research community. This hypothesis has guided drug development, and pharmaceutical companies saw a huge opportunity. Lecanemab is the first drug that lowers brain amyloid levels and ostensibly slows progression. That being said, that proof of principle is tenuous in this case.
While there is considerable pressure from advocacy groups, Big Pharma and elected officials to approve new drugs, the premature approval of expensive drugs with modest clinical impact does not serve the community well. It has the additional risk of setting a dangerous precedent and opening the floodgates for similar expensive compounds that do not discernibly affect the course of the disease.
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