The regulations need reform

With no made-in-Canada solution, consumers are vulnerable to spill-over

By Anne Kothawala and John Hinds

Try this simple test to find out if Canada’s legislation on prescription drug advertising is working. Can you name the conditions treated by the following medications: Viagra? Prozac? Vioxx?

If you answered erectile difficulties, depression and arthritis, then you are in possession of information the Canadian government doesn’t want you to have. This is why the current law on pharmaceutical advertising needs to be changed.

Any ad for a prescription medication that Canadians see or read that mentions a disease or condition, and the name of a medication, is an American ad targeting an American audience. These ads are not subject to Canadian regulatory review, as they air on U.S. networks. But we still see them, and such spill-over ads often promote medications that are not even available in Canada.

In contrast, Canada’s legislation on pharmaceutical advertising, which dates from 1953, only allows an ad to provide information about a disease or condition or give the name of a product – an ad cannot do both. This has resulted in vague campaigns that provide no information about the product, who should be taking it, or what the major side effects are.

A current example of the Canadian approach in action is the recent TV spot for Viagra which depicts a man dancing his way to work in the morning. The tagline at the end is simply ‘Viagra. Talk to your doctor.’

If Viagra hadn’t received so much popular press coverage, this latest ad could be confused for an advertisement for any number of products. More troubling is that there is no information about the product, no indication of who should be taking it and no mention of the side effects.

Canadians are getting information about prescription medications. The question is whether they are getting the comprehensive Canadian-sourced information that they need to make informed decisions about their health.

Patient and medical groups want Canadians to be properly informed about prescription drugs. We couldn’t agree with them more. That’s why Canada’s newspapers, broadcasters, magazines and advertising agencies – through a coalition called the Alliance for Access to Medical Information (AAMI) – have been calling on the federal government to modernize the legislation.

Canadians have the right to balanced advertising made in Canada by and for Canadians. The current legislation is also unconstitutional, violating Canadians’ fundamental rights to freedom of speech.

We are not suggesting that we adopt the American model here in Canada. In fact, over the last two years, as we consulted with governments, academics, doctors, pharmacists, nurses, and patients across the country, we met very few who supported importing the U.S. guidelines unchanged. Many find that the stateside approach is too sales oriented and simply doesn’t offer the consumer protection that Canadians have come to expect from their government and regulatory authorities.

Instead, in response to our consultations, we developed a six-point made-in-Canada solution that provides the protection and the balanced information that Canadians demand and deserve:

* Each ad will have to show (in the body of the ad) that it has been reviewed and approved by an independent regulatory authority appointed by the federal government

* Advertising for new drugs will not begin until after a six-month waiting period following Health Canada approval, to allow physicians time to learn about the new medication

* Ads will point consumers to further sources of reliable and unbiased information on treatment options and medical conditions (Health Canada or association Web sites such as The Heart and Stroke Foundation)

* As in the U.S., all ads will clearly state who the product is for, who it isn’t for, and the major side effects

* Ads will note prominently that this is a medication approved in Canada

* Ads will provide questions to ask physicians

A national survey conducted by Ipsos-Reid shows that Canadians support pharmaceutical direct-to-consumer advertising and are ready to embrace AAMI’s made-in-Canada solution. The survey also reveals that fully 53% of Canadians believe that prescription medicines can already be advertised directly to consumers. Such is the confusion spawned by U.S. spill-over advertising.

As well, 42% of Canadians view the current restrictions on pharmaceutical advertising as unfavourable, and nearly seven in 10 Canadians support direct-to-consumer advertising of prescription medicines. When AAMI’s made-in-Canada solution, as outlined above, is described, it earns 85% agreement. Clearly Canadians are ready for reform.

Do we as the media have a vested interest in changing the rules to allow DTCA of prescription medicines? Yes. But that doesn’t weaken the sound public policy rationale on which this solution is built. Canadians are searching for, and have a right to, balanced, regulated, clear information on prescription medicines, so that they can participate in decisions that affect their health.

In 2002, any law that inhibits access to such information is an anachronism that serves no useful purpose.

Anne Kothawala is president and John Hinds is VP public affairs at the Toronto-based Canadian Newspaper Association. The CNA can be reached at: (416) 923-3567.

Leave the laws alone

DTC advertising isn’t ‘information’ – it’s a pitch to sell more drugs

By Dr. Henry Haddad

If you ask a doctor whether patients are asking more frequently about prescription drugs they’ve seen advertised on TV, you’ll probably get an emphatic ‘yes.’ Most Canadians have seen direct-to-consumer advertising (DTCA) of prescription drugs, usually in American television commercials or print ads. DTCA is big business in the U.S., where pharmaceutical manufacturers spend over $2 billion per year to promote their products to the general public.

This advertising is having an effect, at least on drug sales. A U.S. study found that the 25 best-selling prescription drugs advertised directly to consumers accounted for nearly half the increase in overall drug spending in 1999. Whether this growth in sales represents appropriate prescribing, or whether it will lead to improved health outcomes, remains to be studied.

Many viewers are not aware that DTCA, except for notification of price, quantity and the name of the drug, is prohibited in Canada under the Food and Drugs Act. Nevertheless, you can now see ads on Canadian television and billboards for prescription medications such as Zyban and Viagra.

While these advertisements have been crafted so as not to contravene the letter of this legislation (i.e. the Viagra TV ads only mention the name of the drug, not its indications) the Canadian Medical Association (CMA) believes that they flout the spirit of the law. Certainly they are pushing the envelope to a worrying degree.

Proponents of legalizing DTCA in Canada claim that patients have a right to information about the drugs they are taking. CMA agrees. Patients should be properly informed about their medications. Is brand-specific advertising the proper way to provide this information? CMA doesn’t think so.

There are many reasons to be concerned:

* DTCA does not provide enough information to allow consumers to make appropriate drug choices. Studies show that though DTCA has produced greater awareness about certain prescription drugs, patients still lack detailed knowledge about these drugs, their indications and risks, who should take them and who should not.

* DTCA may lead to a drug-dependent health care system, in which consumers prefer quick-fix pills to lifestyle changes and other non-pharmacologic solutions that may have more long-run benefit.

* DTCA imposes additional costs on the health care system, both for the drugs themselves and for visits to physicians. For example, it has led to the tendency to choose heavily-publicized brand-name drugs over less expensive but equally effective generics.

* DTCA strains the patient/physician relationship because the doctor may feel pressured to prescribe a drug contrary to his or her best clinical judgment.

In short, we don’t think brand-specific direct-to-consumer product advertising is information, but rather marketing, intended not so much to inform the patient as to maximize profits for the drug manufacturer.

Obviously, Canadians have the right to information about prescription drugs. However, we believe this information should not be related to a specific brand-name product. It should be evidence-based, providing details about side effects and risks as well as benefits. A regulatory body should be established to develop standards for consumer information on prescription drugs, to monitor compliance to those standards and to act as a surveillance system for all drug information directed at consumers.

Federal Minister of Health Anne McLellan has stated she has no intention of loosening restrictions on DTCA in Canada. I congratulate the minister on her position and call on the government to not only retain the current ban, but to ensure that the regulations restricting DTCA are enforced so that both the law and the spirit of the law are respected.

The issue is of great importance to CMA, and we will continue to work with Health Canada, our members, health professional associations and other stakeholders to ensure that the drug information Canadians receive is accurate, balanced and fair.

Henry Haddad, MD, FRCPC, is president of the Canadian Medical Association. The CMA can be reached at: (613) 731-8610.