by Barbara Mintzes

An Ontario court case that is currently underway with very little publicity could have enormous consequences for Canada’s healthcare system and the public’s health.

Canwest MediaWorks, owner of Global TV and various newspapers across Canada, including the Vancouver Sun, Province and National Post, is suing the federal government in the Ontario Superior Court. The company claims that the Food and Drugs Act’s prohibition of direct-to-consumer advertising of prescription drugs is a breach of its freedom of expression under the Canadian Charter of Rights and Freedoms.

If Canwest is successful, we may soon find our airwaves, news media and many of our public spaces flooded with ads for prescription drugs.

Anyone who has watched US TV lately has seen the ubiquitous commercials admonishing viewers to “Ask your doctor” about this or that medicine. You thought you were healthy? That bit of heartburn could be a lurking sign of damage to your esophagus. Feeling a bit down? It may be a chemical imbalance that Prozac, Zoloft, Paxil or a host of similar pills could fix. Never mind that you just lost your job. Just pop a pill.

That Canwest is bringing this legal case forward indicates just how lucrative this advertising market really is. A media company can run any editorial content it wishes pertaining to drugs. However, under the current law, it cannot sell advertising space to drug companies to run ads featuring prescription drugs. This is the issue currently being disputed in Ontario.

A public interest coalition of non-profit health groups and unions has obtained standing in the Ontario case in support of the law. It includes CUPE, the Federation of Nurses’ Unions, Women and Health Protection and the Canadian Health Coalition, among others. The coalition is addressing concerns about the effects of skyrocketing drug costs, vis-à-vis employee health benefits, and the potential harmful effects of the drugs, especially relating to women.

Last year, drug companies spent more than $5 billion on direct-to-consumer advertising in the US. If similar advertising is allowed in Canada, the pharmaceutical industry would be expected to initially spend around $500 million, with further spending to follow.

Canada’s law is similar to that of most other countries so this case could have international repercussions if Canwest wins. Currently, only the US and New Zealand allow this type of advertising. Prescription drug advertising is generally banned as a public health measure because these medicines tend to treat serious health problems that are not easily self-diagnosed, and prescription drugs are riskier than medicines a person can buy over the counter.

The arthritis drug Vioxx (rofecoxib) is a case in point. It was one of the most heavily advertised drugs between 1999 and 2004, its length of stay on the market. In 2000, Merck spent more advertising Vioxx to the US public than Pepsi-Cola spent marketing Pepsi. That was the same year that the VIGOR trial was completed. This was the first large-scale study of Vioxx to show that it led to more than four times the rate of heart attacks than Naproxen, another arthritis drug. An estimated 88,000 to 140,000 heart attacks occurred in the US due to Vioxx use, and while not all of them can be attributed to advertising, the ads clearly helped to push sales.

Vioxx remained on the market for another four years, during which time Merck continued to advertise it heavily to the US public, in ads featuring former Olympic skater Dorothy Hamill.

Recently, Merck agreed to pay $58 million as part of a multi-state settlement against accusations that its Vioxx ads deceptively played down the drug’s health risks.

Vioxx isn’t the only widely advertised drug to be removed from the market for safety reasons. More recently, Zelnorm (tegaserod), a drug for irritable bowel syndrome in women, has also been withdrawn because it was found to lead to heart disease – in approximately one in every 1,000 users. When the FDA announced the withdrawal, it also noted that the drug was not very effective.

One of the greatest concerns about prescription drug advertising is that it blurs the boundaries between normal life circumstances and actual health problems. US researchers tested this in a study using women actors pretending to be patients. The women made unannounced visits to family doctors and were randomly assigned to either request Paxil, an advertised medicine, or not. They were also randomly assigned to have symptoms of depression or “adjustment disorder,” essentially routine life problems.If a woman asked for Paxil she was just as likely to get it whether she had clinical depression or “adjustment disorder.”

In the most recent surveys of the US public, around a third of respondents stated they had discussed an advertised medicine with their doctor. From 2000 to 2005, prescriptions for sleeping pills increased by 60% in the US. Two US brands, Lunesta and Ambien, were heavily advertised in a fierce competition for market share. The US public was caught in the middle. When used regularly, sleeping pills lead to tolerance, dependency and cause a higher rate of falls, fractures and traffic accidents. People over the age of 60, who use them for more than five days consecutively, are more likely to experience harm than benefit. In a large combined analysis of all clinical trials, this was as much the case for the newer drugs as the older ones.

Public health concerns about drug advertising include the reality that drug promotion leads to increased drug costs. This is because only the newest and most expensive drugs are advertised to the public. Advertising leads both to an overall increase in the use of medicines and to higher costs per prescription because of rapid uptake of the new, expensive medicines.

Most new medicines are no safer or effective than the existing alternatives. This is as true for the most heavily advertised medicines as for others. Take Nexium (esomeprazole), a drug for acid reflux. Astra Zeneca spent $1.2 billion advertising it to the US public, yet it’s virtually the same as the generic omeprazole, which is much cheaper.

In the Ontario case, Canwest is arguing not only that it has a right to run pharmaceutical advertising, but also that partial enforcement of the law has led to a situation of unfair competition. US cable TV targeting Canadian audiences is full of prescription drug ads. It doesn’t have to be. Technically, it’s easy to replace ads, and for marketing purposes, local ads replace US ads all the time. The federal government has not insisted that this be the case for drug ads that are illegal in Canada.

Similarly, North American editions of magazines run US ads that are illegal in Canada. Often, the same companies have a UK edition without illegal ads. Again, this is an enforcement issue.

Further, since around the year 2000, the federal government has allowed companies to run branded “reminder” ads in Canadian media, such as the “We are the champions” Viagra ads. This is possible under a new interpretation of a 1975 regulation that was brought in to allow price advertising. It is consistent neither with the spirit of the regulation – introduced to make the public aware that generics are cheaper than similar brands – nor with the way it was interpreted for 25 years.

Canwest has a valid argument that the law is not being adequately enforced. But does that mean we need to scrap the law? If the police look the other way when a corner store sells cigarettes to minors, getting rid of the age restriction is not necessarily the best solution.

Ads for medicines are dangerous because pharmaceutical companies use the same emotional branding techniques used by other companies promoting other products, with the objective of creating a connection and a desire for a drug.

When it comes to medicines, however, newer and more are not necessarily better. As the world witnessed with Vioxx, the concept of newer and more can be a very dangerous marketing technique.

For more information about the Ontario court case and copies of expert testimony, see http://www.whp-apsf.ca/en/index.html.

Dr. Barbara Mintzes is a core faculty member at UBC. She investigates drug safety and effectiveness, and provincial drug financing decisions. www.chspr.ubc.ca/about/faculty/mintzes