Drug Companies & Discontinued Products

A sign that one is getting older is that retailers start to discontinue your favourite products.  The Gap no longer carries the most flattering style of jeans; the LCBO stops importing the French rosé you prefer; and the hair conditioner you once swore by is now nowhere to be found.  It can be frustrating when a familiar product is discontinued for seemingly little reason other than changing tastes.  But when the product in question is a drug that one relies upon to control a serious medical condition, “frustrating” takes on a new dimension.

According to a recent article in the Globe and Mail, more than 1,000 Canadians rely on disopyramide (trade names Norpace and Rhythmodan) to control the effects of hypertrophic cardiomyopathy.  In this condition, the muscles of the heart walls become abnormally thick, causing chest pain, shortness of breath and sometimes fainting.  About half of the patients who try the inexpensive drug find it to be so effective that they can delay or even forgo open-heart surgery.  Disopyramide is made by Sanofi Canada, and this past February the company discontinued the drug, claiming weakened demand.  Patients who rely on disopyramide are scrambling to find supplies and at least one patient quoted in the Globe article, unable to track down a reliable supply, is booked for surgery next month.

Sanofi has promised to resume production, but they haven’t said when this will happen.  They have also committed to importing the drug from Europe and offering it for free (under Health Canada’s special access program) until production starts up again.

The Globe and Mail article quotes two cardiologists (Dr. Harry Rakowski at Toronto General and Dr. Lee Benson at the Hospital for Sick Children) who both expressed frustration with Health Canada’s current regulations.  Drug companies do not require any approval to discontinue their products, even when there is no alternative drug available.  And while companies are obligated to give 30 days notice before discontinuing a drug, they are not required to provide any rationale for their decisions.

The website of Sanofi Canada describes the company’s commitment to corporate social responsibility.  (For more on this vexed but possibly useful concept, see “Two Problems with CSR” by Chris MacDonald over at “The Business Ethics Blog.”)  And Sanofi takes ethical issues seriously enough to have a vice-president of evidence, value, and access.

Businesses need the freedom to discontinue products that are no longer profitable.  However, if a financially healthy company makes a decision to discontinue a product, and that decision has serious social ramifications, then considerations besides corporate autonomy come into play.  While Sanofi seems prepared to do the right thing and resume production of disopyramide, is it right that patients who depend on the drug have to rely on the company’s willingness to consider their interests?  Should Health Canada have some role in protecting patient access to vital but perhaps unprofitable drugs?  A month’s supply of disopyramide costs about $30.  What would be the comparable cost for even one patient to have open-heart surgery instead?