Prescription drug ad law notable for 'lack of teeth'

Canada is failing to enforce its law banning advertising for prescription drugs, a new review indicates.

Direct-to-consumer ads for prescription drugs are generally prohibited under Canada’s Food and Drugs Regulation. A loophole in its interpretation allows reminder ads that name a product but not its use. For example, TV ads for the erectile dysfunction drug Viagra don't name its purpose. 

Another loophole allows drugs to be advertised to mention a medical condition for "help seeking" purposes, but not a product or manufacturer's name. For example, a 2004 print ad for the cholesterol-lowering drug Lipitor depicted the corpse of a 52-year-old woman who was not obese with a toe tag that listed her cause of death as "heart attack."

University of British Columbia public health researcher Barbara Mintzes and Joel Lexchin of York University in Toronto reviewed Canadian cases of drug ads from 2000 to 2011.

"There doesn't seem to be much of an appetite for enforcement of the law on direct-to-consumer advertising," Mintzes said.

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In the current issue of the International Journal of Risk and Safety in Medicine, the researchers describe 10 cases involving drugs for acne, birth control, arthritis, cholesterol lowering, smoking cessation, obesity and shingles prevention.

The researchers gave three examples where Health Canada issued repeated warnings but the companies ignored them:

• Ads for Zyban combined the name of the product and its indication as a smoking cessation drug, a violation of the act.
• Alesse birth control ads combined the name of the product with its use in separate, related ads.
• Ads for Diane-35, an acne drug used off label for birth control, were judged to violate the law.

Mintzes is concerned about how misleading or inappropriate drug ads could be harmful. For instance, individuals could use prescription drugs when they’re not likely to be effective or when a drug with fewer side-effects would be a better choice.

Harmful use of prescription drugs is one of the most common reasons for visiting emergency departments or hospitalization, Mintzes said.

"The current approach to enforcement is notable both for its lack of teeth, and lack of accountability and transparency," the researchers concluded.

Government criticized by advisory board

During question period on Tuesday, Health Minister Rona Ambrose said new legislation known as Vanessa’s Law allows for bigger fines and jail time for company executives who violate drug advertising laws.

"Any complaints will be reviewed and we will act," Ambrose said.

Ray Chepesiuk is a commissioner with the Pharmaceutical Advertising Advisory Board. Pharmaceutical companies pay a fee to the board to have it review ads with an eye to the federal regulations. The reviews are voluntary, but Chepesiuk is obligated to forward all safety-related complaints to Health Canada.

Chepesiuk thinks Health Canada has been reluctant to go after violators because the expense of going to court isn’t worth the previous maximum fine of $5,000. Under Vanessa’s Law, the maximum fine is now $500,000 — more clout for the regulator.

"If you have the big stick behind your back, you can probably negotiate a little more effectively," Chepesiuk said.

Chepesiuk agrees with the researchers who raised the case of Celebrex reminder ads that don’t mention the need to use the anti-inflammatories with caution because of concerns about gastrointestinal bleeding and cardiovascular risks.

"Yes, it was technically within the law," he said. "Was it technically valid for societal good? Well, society should judge …If the laws aren't serving the people then the laws should be changed. I think that's something good coming out of this paper."

From his role in the middle between the companies and the regulator, Chepesiuk said he’s noticed complaints are down.

Health Canada said Thursday it takes these matters seriously.

"Health Canada achieves voluntary compliance in nearly all cases that it has assessed and strongly recommends that advertisers take advantage of the pre-clearance system in place in Canada in order to prevent contravening the legislation, such as via the Pharmaceutical Advertising Advisory Board and Advertising Standards Canada," spokesman Eric Morrissette said in an email.