About 1,000 Canadian heart patients and their physicians learned through pharmacists and the media this summer that the low-cost generic drug disopyramide had been abruptly discontinued for business reasons, with no alternative on the market. Health Canada was informed by the drug-maker at the beginning of the year, but did not pass this fact along to patients. The drug is as important to these heart patients as insulin is to a diabetic, and the discontinuation with no warning highlights a serious flaw in public health policy.
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One patient, Gary Piniach, a 57-year-old father of two in Regina, began rationing his limited supply. Others scrambled to locate as much as they could, and some faced complex open-heart surgery. The drug is used to treat hypertrophic cardiomyopathy, a condition in which the heart muscle becomes abnormally thick and narrows the passageway through which blood leaves the heart.
Health Canada cannot compel a pharmaceutical company to manufacture a drug. But many doctors argue that Ottawa has an obligation to warn patients of a drug stoppage as early as possible, especially when the medication is life-sustaining, as in this particular instance. At it stands now, pharmaceutical companies need to give Health Canada only 30 days’ notice when they stop producing a drug.
Luckily for patients using disopyramide, Sanofi Canada bowed to public pressure and plans to resume production sometime next year. Until then, it is offering the drug for free under Health Canada’s special-access program (SAP).
But this is bound to repeat itself with another drug, at another time, unless public policy is strengthened. Health Canada is in the process of considering a report by the House of Commons standing committee on health that would require pharmaceutical companies to provide it with six months’ notice, up from the current 30 days, when they discontinue a drug. That would be the same as the notice given to the U.S. Food and Drug Administration.
As importantly, Health Canada needs to warn patients and their doctors as soon as it receives word that a drug is being discontinued, and do its utmost to help them find alternative therapies. That way, fewer patients such as Mr. Piniach would be caught off guard.