By Barbara Mintzes and Joel Lexchin
A handsome man struts over to the office water cooler with a smirk on his face. When his colleagues ask about his weekend, he replies enthusiastically, with the audio muted. A large blue pill appears with the tagline, "Viagra, Ask Your Doctor." Vibrant, energetic older people are shown swimming, bowling and having a good time. With a twinkle in their eye, they suggest the viewer "ask your doctor" about Celebrex.
These are 'made-in-Canada' television commercials for prescription medicines. Although advertising of prescription medicines to the public is generally banned in Canada on public health grounds, shifts in administrative policy have allowed two types of ads since late 2000: "reminder" ads that mention a brand name, but make no health claims; and "help-seeking" ads that mention a condition, but do not state a brand or company name.
In a new study, published this month in the International Journal of Risk and Safety in Medicine, we examine how these ads are regulated in practice, through a review of a set of complaints over a 10-year period, from 2000 to 2011, and Health Canada's response to these complaints. The results show a consistent lack of effective action to protect public health.
We have identified six main weaknesses in how Health Canada regulates this advertising -- four related to the content of the ads, and two related to how regulation is carried out.
First, Health Canada fails to prevent advertising for "off-label" or unapproved uses. When a medicine is approved for marketing, the company provides evidence to show that it is effective and safe enough for specific approved uses. Companies are not allowed to promote their drugs for unapproved uses, as there is no guarantee of safety or effectiveness.
The drug Xenical (orlistat) is approved for obese patients or very overweight patients with heart disease risks. However, when Hoffman-LaRoche ran the "I am Julie" ad campaign, with a slim woman pictured in a bikini and the tag line, "What would you do with a few pounds less?" Health Canada did nothing to stop this off-label advertising campaign and imposed no fines or sanctions. When Abbott ran ads for its testosterone product, Androgel, with symptoms that included "low sex drive" and "falling asleep after dinner," again Health Canada did nothing to stop the campaign. Testosterone is approved to treat hypogonadism, not getting older.
Letting companies use fear of death to sell a product should not be allowed. But when Pfizer advertised its cholesterol-lowering drug Lipitor (atorvastatin) with a toe-tagged corpse, Health Canada did nothing to stop the campaign or levy sanctions. The image and headline suggested treatment prevents death in women without heart disease -- an unsubstantiated claim.
When Safeway Pharmacy offered 100 Air Miles for patients getting a shingles vaccine, Health Canada did nothing because it said this was an issue of the practice of pharmacy, although this is a financial inducement.
Health Canada also failed to act when products with serious safety concerns were heavily advertised, including ads for drugs subjected to repeated safety warnings and boxed warnings of life-threatening harm. Health Canada warned doctors to prescribe Celebrex with caution, at the lowest possible dose and duration, because of risks of heart disease and gastrointestinal bleeding, yet turned a blind eye to television ads with exaggerated promises of effectiveness and no hint of harm.
Complaint letters repeatedly raised concerns about harm. Health Canada's reply was that the ads were legal citing technicalities such as lack of mention of a brand or company name.
When Health Canada did judge ads to be illegal, the agency failed to take effective action. In the case of the acne drug Diane-35, testimony in a court case indicated that the agency repeatedly judged advertising to be illegal, yet did nothing to stop the ads beyond negotiating with the company. There were no fines, sanctions or attempts to prosecute despite Health Canada's claim that prosecution is the next step if compliance cannot be achieved.
This series of complaints and Health Canada's responses is admittedly incomplete. We amassed all the examples we could find. Health Canada does not keep any publicly available list of advertising complaints, list of its decisions and enforcement actions.
What should happen? The administrative policies allowing 'reminder' and 'help-seeking' ads should be reversed. These loopholes are inconsistent with protection of public health. They were a "compromise too far" in the face of industry pressure to allow advertising of prescription medicines, introduced without public or parliamentary debate. Second, regulation should be adequately resourced, open and transparent, with fines, other sanctions, and prosecution if needed, to prevent repeat violations.
Prescription medicines can lead to important health benefits and to serious harm. They are too important to allow misinformation that promotes unsafe and ineffective use. Canadians deserve better health protection.
Barbara Mintzes teaches in the School of Population and Public Health at UBC and works with the research group the Therapeutics Initiative.
Joel Lexchin is an advisor with EvidenceNetwork.ca, teaches health policy at York University and works in the emergency department at the University Health Network.