Ad Ban Probably Saved Canadians $150 Million in 2006 for Cholesterol Drug

By Helen Branswell, THE CANADIAN PRESS

TORONTO – Canada’s ban on direct-to-consumer drug advertising probably saved Canadians with high cholesterol and their drug plans $150 million in 2006 alone, suggests a new study comparing sales patterns of a controversial cholesterol lowering drug in the United States and Canada.

Canadian sales of the drug Ezetrol – the generic name is ezetimibe – were four times lower than those rung up south of the border, where the drugs’ manufacturers spent US$200 million advertising the drug to consumers in 2007.

Sales of ezetimibe, which is sold solo in the U.S. as Zetia or combined with a statin drug as Vytorin, are expected to drop after Sunday’s release of trial results showing the drug failed to slow atherosclerosis, the clogging of the arteries with fatty deposits.

“It basically shows that the approach in Canada to this whole drug was much more appropriate and evidence-based compared to the U.S. approach where basically it’s been marketed very aggressively,” said Dr. Jack Tu, one of the authors of the study comparing usage trends in the two countries.

“It’s sort of a textbook example of the potential downsides if you have direct-to-consumer advertising where the manufacturer potentially can promote new and expensive drugs that don’t have a huge amount of evidence behind them and get them to be first-line therapy as opposed to older, cheaper medications with a lot more evidence.”

Canada’s ban on direct-to-consumer drug advertising is currently being challenged in the courts by media giant CanWest Global Communications.

The study was conducted by researchers from Western University of Health Sciences, in Pomona, Calif., the Institute for Clinical Evaluative Sciences (ICES) in Toronto and Yale University. Tu, a senior scientist at ICES, is also a cardiologist and epidemiologist at Toronto’s Sunnybrook Health Sciences Centre.

It will be published in a future issue of the New England Journal of Medicine, but was released Sunday to coincide with the presentation of the findings of the Enhance trial at a scientific meeting of the American College of Cardiology in Chicago. That long-awaited trial tested whether Vytorin (ezetimibe plus simvastatin) was better at slowing atherosclerosis than simvastatin alone.

Ezetimibe (as Zetia) was brought to market in the United States in October 2002 and in Canada (as Ezetrol) in May 2003. Vytorin hit the U.S. market in July of 2004 but was never licensed for sale in Canada.

The manufacturers, Merck and Co. and Schering-Plough Corp., aggressively pushed the drugs through ubiquitous TV commercials in the United States, one of only two countries in the world that allows direct-to-consumer advertising. The other is New Zealand.

In Canada, where the Ezetrol is sold by Canadian subsidiary Merck Frosst, drugmakers face constraints when they want to promote drugs to consumers.

Health Canada allows pharmaceutical companies to advertise either the name of a drug – useful only if the public already knows what the drug is for – or a health condition with a reminder that people who suffer from it should talk to a doctor about potential treatments.

Worldwide sales of ezetimibe alone or in combination took off, recently crossing the US$5 billion threshold – despite the fact there was yet no evidence the drug was better at slowing the clogging of the arteries than widely prescribed statin drugs. (Ezetimibe had been shown to lower bad cholesterol levels; it was assumed that would slow atherosclerosis.)

In the U.S., the drug captured 15 per cent of the market for cholesterol lowering drugs by 2006, whereas in Canada it made up only 3.4 per cent of such sales.

In fact, figures suggest some U.S. doctors were prescribing it as a first-line treatment for high cholesterol, instead of a statin. In Canada, several provincial drug plans stipulated that Ezetrol should only be used in patients who couldn’t tolerate statins or those who couldn’t get their cholesterol counts to safe levels with a statin alone.

Tu and his co-authors suggest this prudence on the part of the provincial formularies also played a part in slowing sales growth in Canada.

“No one should be surprised by this,” Arthur Schafer, director of the Centre for Professional and Applied Ethics at the University of Manitoba, said of the findings of the study. Schafer was not involved in the study.

“There’s lot’s of evidence that if you advertise directly to consumers and … induce the patients to mention a particular drug to their doctors, their doctors are likely to prescribe it regardless of the medical evidence for that drug.”

“We knew that beforehand and this is a powerful illustration of what will happen in Canada if and when the government of Canada lifts its restriction on direct-to-consumer advertising within Canada.”

In fact, a study published in 2003 by Barbara Mintzes, a University of British Columbia health policy expert, showed that patients were 17 times more likely to get a prescription for a drug if they asked their doctor for it by name compared to patients who didn’t ask for new medication.

Strikingly, 50 per cent of the doctors who wrote those prescriptions later admitted they were not convinced that medication was the best course of treatment for those patients.

“It’s easy to dupe consumers. It’s actually not that difficult to dupe physicians. And when the consumers are asking for the drugs by name, then of course we know that they are much more likely to get them,” Schafer said.