More than 1,000 Canadian patients are in treatment limbo – some facing complex, open-heart surgery – after a drug was abruptly discontinued with no warning to doctors.
One Toronto man is already booked for an operation, while others are scrambling to locate as much as they can get of the low-cost generic, disopyramide. 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. It affects more than 60,000 Canadians.
Sanofi Canada discontinued disopyramide in February, citing weakened demand. Although the company says it plans to resume production, it provided no firm date, revealing a troubling policy gap: Pharmaceutical companies need to give Health Canada only 30 days notice when they stop producing a drug. Much to the chagrin of physicians, Health Canada concedes it has no authority to make a company continue to manufacture a medication.
"They've really generated a huge problem for us," said cardiologist Harry Rakowski, director of the hypertrophic cardiomyopathy clinic at Toronto General Hospital. "Health Canada needs to require drug companies to get approval for discontinuing drugs for which there is no alternative."
Sanofi Canada says it is importing the drug from Europe and plans to offer it for free under Health Canada's special access program until it resumes production here.
"At this point, we have no commercial interest in this drug. It's really a question of meeting the patients' needs and that's why we're doing it," said Stan Glezer, Sanofi Canada's vice-president of evidence, value and access.
Figures show the generic was hardly a money maker: Canadian pharmacies dispensed $467,763 worth of disopyramide last year, according to figures from IMS Health Brogan, a private company that tracks prescription drug spending. The drug is taken orally three times daily and costs about $30 a month.
Those afflicted with hypertrophic cardiomyopathy experience chest pain, shortness of breath and occasional fainting. Children have a 50-per-cent chance of inheriting the disease from a parent.
Disopyramide is used with beta blockers (drugs often prescribed for high blood pressure, angina or fast heart rhythm disorders) for a number of patients, and can often delay or prevent the need for a pacemaker or an open-heart procedure called septal myectomy. That operation involves the surgical removal of a piece of heart muscle from the wall (septum) separating the right and left pumping chambers to relieve obstruction and enlarge the passageway for blood leaving the heart. The drug was recommended in the 2011 clinical guidelines published by the American College of Cardiology and the American Heart Association.
For patients, Sanofi Canada's move has caused panic and stress as they try to find pharmacies that still have a supply of the drug. Some have even considered going to the United States.
Sinnathurai Kathirgamanathan, a father of three, searched more than 50 drug stores in the Toronto area and suburbs, coming up empty-handed. "They didn't even have one pill to give me," he said.
With no guarantees he will be able to obtain the drug, he has been booked next month for a septal myectomy.
"I have no choice," said Mr. Kathirgamanathan, 44. "They have no medication. I don't want to wait for two or three months [to apply for the special program]. This is a problem of the heart."
Beth Teolis, 62, is lucky to have one month's supply, but worries what will happen if the drug is not brought back soon, adding, "I depend on it just a like a diabetic on insulin."
Lee Benson, a pediatric cardiologist at the Hospital for Sick Children, said he has a handful of patients on disopyramide. Parents are calling his office, panicked.
"I think there should be legislation from Health Canada that requires drug companies to make notification with a rationale," Dr. Benson said. "There should be some process. All of a sudden this hits you in the face and there isn't an alternative."