Colby Cosh: The drug that was approved on fake data

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...

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.” 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