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?

“Just War” and Targeted Assassinations (Part Two)

In my previous post I wrote about the U.S. program of targeted assassinations against terrorists and the “just war” tradition.  I focused on jus ad bellum.  These are the conditions that must be met before a country has a moral case to declare war.  In this post, I’ll discuss jus in bello – moral restraints on the way war is fought.

First, a war must not be fought in such a way that it is a greater evil than the evil it is intended to remedy.  (Remember that a “just war” is one that is fought in order to promote good or avoid evil.)  So the harm inflicted by military operations must be both necessary and proportionate to the ends sought.  There is a moral difference between targeting a daycare centre and targeting a munitions factory.  It would be difficult to make a case that demolishing a daycare centre was necessary for victory in war, while demolishing a munitions factory might well help bring a quicker end to an armed conflict.

Second, non-combatants should not be intentionally attacked.

One complication arises right away:  How to draw the line between “combatant” and “non-combatant”?  According to a New York Times article about the U.S. targeted assassination program, when calculating civilian deaths caused by the program, all military-age males in a strike zone are counted as “combatants.” The reasoning is that, “people in an area of known terrorist activity, or found with a top Qaeda operative, are probably up to no good.”

There is a further complication:  If  non-combatants are harmed as a foreseeable but unavoidable “side effect” of some proportionate and necessary military action, then, according to the “just war” tradition, the harm is morally permissible.  Philosophers in the “just war” tradition call this the “doctrine of double effect.”

For example, a leader decides that bombing a munitions factory is both a necessary and proportionate step towards military victory.  However the munitions factory is next to a daycare centre, and there is a risk that the bombs will strike the daycare centre as well as (or instead of) the factory.  The leader does not intend to harm anyone at the daycare centre, yet he forsees that this might be a possibility.  Although the leader must try to minimize the risk of harm to non-combatants (say, by bombing the factory at night when the daycare centre is likely to be empty), he is not morally obligated to spare the factory because of the risk to the daycare centre.

The “doctrine of double effect” is controversial.  Philosophers have argued whether the distinction between “intended” and “unintended, but foreseeable” actions really makes much sense.

The “just war” tradition does not provide a “formula” for getting clear answers on the morality of armed conflict.  It is best approached as a set of considerations for thinking through the morality of particular decisions and strategies.  Again, I leave it to readers to decide whether the U.S. program of targeted assassinations meets the criteria for “just war,” and even whether the criteria are themselves morally defensible.