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Colby Cosh: The drug that was approved on fake data

Behind the bureaucratic bluster, bad behaviour?

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On Tuesday, Health Canada published a circular asking physicians to stop prescribing an obscure drug, Tavneos (avacopan), to new patients. We probably don’t have very many readers who are taking avacopan: it’s a drug approved recently (autumn 2021 in the U.S., spring of 2022 in Canada) for treatment of a rare and poorly understood autoimmune condition called “ANCA-associated vasculitis.” In western countries this disorder afflicts 10 or 20 persons per million a year, usually elderly ones. The symptoms, caused by out-of-control antibodies killing off interior blood vessels, range from “feeling poorly” to “choreographed and hasty organ failure.”

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Health Canada’s terse instruction mentions “significant concerns” with the main clinical trial that initially supported international approval of avacopan. That study, which reported the results of a global trial involving 331 patients enrolled from 143 hospitals around the world, appeared in the New England Journal of........

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