Health Canada in the Running for Hypocrisy Award

Consider these two products which are being marketed as alternatives to smoking which may help smokers quit:

Product A is a medication which binds to certain nicotine receptors and helps decrease the craving to smoke. However, it has a documented serious side effect of potentially causing serious mental disturbances and possibly even suicide. The FDA has required a black box warning which will "highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts" when taking product A.

Product B is an electronic version of a cigarette which delivers only nicotine and propylene glycol, but none of the thousands of other chemicals and carcinogens in tobacco smoke. Thousands of users testify as to its effectiveness in helping them stay off of cigarettes. It has no known serious side effects, nor has anyone postulated that there are any serious side effects.

If you were the health department in Canada, what action would you take on each of these two products?

Let's think this through. Both products are apparently useful in helping smokers to stay off of cigarettes, which we know are much more dangerous than these alternative products. So these alternative products could literally save lives by getting smokers off of cigarettes.

However, the possible saving of those lives may come at a price for product A. For product A, there is a serious risk of suicidal thoughts and even death that has been documented and led the FDA to place a black box warning on the product.

For product B, there are no known or postulated serious adverse side effects.

A rational view of the situation would suggest that the products should be treated equally, or perhaps even that product B should be favored over product A.

But how about this: a regulatory agency decides to ban product B completely, and merely to enter into discussions with the manufacturer of product A over whether or not to place a warning on the product.

The Rest of the Story

Product A is of course Chantix. Product B is electronic cigarettes. And the regulatory agency is Health Canada, which inexplicably has decided to ban the use of e-cigarettes, which have no known side effects, while allowing and encouraging the use of Chantix, which has the documented side effect of death. And the agency is apparently only considering whether to place a mere warning on Chantix, and that decision is apparently being made in discussions with the product manufacturer.

According to an article in the Ottawa Citizen: "Health Canada is still in discussions with Pfizer Inc., about whether to add safety warnings to packages containing anti-smoking drugs that may have psychiatric side effects, including suicidal thoughts."

I'm sorry, but when a product has been documented to have death as a potential psychiatric side effect, you don't enter into negotiations and discussions with the drug company to consider the possibility of putting a warning on the product. You unilaterally slap a mandatory warning on the product sooner than you can bat an eyelash.

But that action by Health Canada is not so inexplicable when viewed on its own. One could say that they just dawdled a bit. What is inexplicable to me is the juxtaposition of the way in which they handled Chantix versus e-cigarettes: another smoking cessation product that has no known side effects.

I should emphasize that I'm not arguing here that Chantix should be taken off the market. I think that Chantix should remain on the market with an appropriate warning. But if you are going to allow Chantix to be marketed, then how can you possibly argue that electronic cigarettes are too dangerous to allow smokers to use them?

This is hypocrisy at its finest:

1. We have to take e-cigs off the market because there's a hypothetical chance that they might kill you, although there's no evidence or any reason to believe that.

2. We know that Chantix is killing people, but we're leaving it on the market and we might or might not put a warning on it - let's see how the discussions go with the manufacturer.

Is it the public's health that we are truly concerned about here, or is it just the act of "smoking" that is a problem?