Part II of a likely-ongoing series of posts regarding Direct-to-Consumer Advertising of prescription drugs (DTCA), here is some discussion from a librarian’s standpoint regarding CanWest’s claim that Canada’s ban on DTCA infringes on the media company’s Charter-granted “Freedom of Expression.”
Freedom of corporate expression vs. human rights of people?
There is certainly a legitimate debate regarding whether the ability to sell ads is truly “free expression.” This case, after all, is not even looking at the question of pharmaceutical companies’ right to communicate their advertising content, but at CanWest’s right to make money off of this advertising content.
Canadian Supreme Court precedent is to interpret expression broadly, to include pretty much any attempt to convey meaning. The library community has generally supported this broad interpretation, even when applied to paid advertisements, as in the multiple challenges to the queer newspaper Xtra! West based on allegedly explicit advertising content (See BCLA’s “Censorship in British Columbia” timeline for details of some of these challenges)
I’m not 100% sold, personally, on the argument that paid ads in Media X are Media X’s own expression. However, if you do accept that CanWest has a charter-given right to freely express itself by way of selling ad space to ads that contain content that may be detrimental to Canadians’ health, then the second question we must ask is, of course, whether CanWest’s right to sell ads is in conflict with Canadians’ human rights (e.g., health). If so, does this right to free expression outweigh the negative impact on health as a human right.
Is there precedent?
There certainly is! And it swings in both directions. (Whee!)
The Supreme Course has upheld at least three similar restrictions on free expression:
- Advertising aimed at children (A-G Quebec v Irwin Toy Ltd.)
- Hate speech (R v Keegstra)
- Obscenity (R v Butler)
Frankly, as a civil libertarian and advocate of intellectual freedom, I think the latter two of those three are bad decisions. But, saving that for another post on another day, there clearly is precedent for limiting free expression, even expression by corporate interests.
Tobacco and alcohol are the clearest analogues to prescription drugs, seeing as they are also regulated substances that have been allowed limited advertising. Unfortunately the stories are messy and neither is a perfect analogue. Prescription drugs, when used correctly, can actually improve health and save lives, which cannot be argued at all by tobacco which will eventually kill almost anyone (thus faces the strictest restrictions of the three classes of substances) and hardly by alcohol (which is allowed to advertise to adults in many media).
The Tobacco Example
The tobacco advertising history is especially complex, but – because of that complexity – may be instructive as we watch the DTCA case play out.
In 1995, the Supreme Court narrowly struck down the Tobacco Products Control Act that prohibited tobacco advertising. RJR-MacDonald argued in 1995 that the act infringed on their freedom of expression on under Sec 2(b) of the Charter, similar to what CanWest is arguing about the DTCA restrictions. The majority opinion of the court was that there were not grounds to invoke the limiting clause (Sec 1 of the Charter) in the case of tobacco advertising. The minority opinion was, of course, that there was cause to limit tobacco advertising, because the product is harmful and often fatal, and advertising targeted young people.
Of course, in 1997 a new tobacco ad regulation law was passed, the Tobacco Act, which limits, rather than completely prohibiting tobacco ads. (There has been speculation that the government’s inflexibility to considering anything but complete prohibition on advertising angered the court; this more moderate approach of regulation has seemed to succeed.)
How does that compare with the case of DTCA?
Prescription drugs can be harmful or fatal, but should not be when used properly. The advertising increasingly does target young people – and women, another “vulnerable” population according to previous court decisions such as Butler. But there are, in theory at least, professionals to mediate people’s access to the products.
The current prohibition on DTCA is not absolute, and in fact more closely resembles the latter Tobacco Act restrictions on promotion than the earlier absolute prohibition (although again it must be noted that enforcement of the restrictions is pretty toothless).
So it would seem to me (in my unequivocally not-a-lawyer mind) that the question is one of how tightly we need to regulate/limit DTCA. Which hinges on the question of how harmful it can be (i.e., how much “limiting” can we reasonably invoke upon this type of expression).
All of which more or less brings us to Vioxx…
Ah, yes, Vioxx (rofecoxib), perhaps the ENRON of pharmaceutical regulation?
According to the New York Times’ handy Vioxx timeline, the FDA approved Vioxx on May 20, 1999. In June 2000 the VIGOR study final data was submitted to the FDA. This was the study that showed a 4x higher rate of heart attacks among patients using Vioxx than those using naproxin (a NSAID, standard osteoarthritis pain treatment). On Sept. 28, 2004, more than 4 years later, the FDA met with Merck about the cardiovascular adverse effects and Merck agreed to “voluntarily” withdraw Vioxx.
The FDA estimates that between 1999 and 2003, Vioxx may have contributed to almost 28,000 heart attacks and sudden cardiac deaths. Some other estimates range much higher.
During that same time period, 1999-2004, Merck spent $550 million on DTCA for Vioxx to the US public. Vioxx was pulling in about $2.5 billion (yes, billion with a B) annually for Merck during this time.
It seems pretty clear that Vioxx was approved on limited safety data, yes, but that even after data showing harm was submitted it took years (and another still more damning study, APPROVe, in 2004) before action was taken to withdraw this drug from the market.
Years during which people sickened and died needlessly.
Years during which the drug which was sickening and killing them was being heavily promoted both to doctors and the public, to the tune of record ad spending *and* record profits.
How much less uptake might there have been of Vioxx without all the Direct-to-Consumer Advertising? It’s hard to say definitively.
Does this example of Vioxx, a product with huge DTCA and huge sales, demonstrate enough risk or harm inherent in DTCA to justify limiting this type of expression?
To be continued…
See here for DTCA part I – the CanWest legal challenge