Thanks very much for inviting me to speak to you today.
The focus of my remarks is going to be on direct-to-consumer advertising of prescription drugs. In the health committee's April 2004 report, “Opening the Medicine Cabinet: First Report on Health Aspects of Prescription Drugs”, this was one of three key issues addressed.
The recommendations of that report were to maintain the prohibition on direct-to-consumer advertising in the Food and Drugs Act and that Health Canada put additional resources into enforcement and bring in active surveillance, corrective actions if there are problems, sanctions against companies that are illegally advertising drugs, and to report annually. The committee also recommended that independent information be made accessible to the public and be publicly financed.
The other thing the report highlighted was the issue of reminder advertising. These are branded ads like the Viagra ads you see on TV, which state the brand but not the indication.
The report--with which I would agree--states there is no justification from a public health perspective in allowing reminder advertising. It suggested that the 1978 price advertising clause that has been interpreted since November 2000 to allow this type of advertising be rescinded because nobody is advertising prices anyway--if I can summarize the report.
So what has happened since April 2004? I would say the recommendations made by the committee are, if anything, much more pressing today, or more pressing than they were, for three main reasons.
One reason is that following the global withdrawal of the arthritis drug Vioxx, the idea of a large-scale public health disaster coming out of a heavily advertised drug is no longer hypothetical; it has actually happened.
Second, we've seen a continued growth in reminder advertising and unbranded, disease-oriented advertising in Canada with no apparent regulatory response.
And third, we now have a charter challenge by CanWest MediaWorks, which is challenging that the Food and Drugs Act prohibition is an infringement on their freedom of expression.
I will give you a couple of examples of unsafe and unnecessary medicine use that's been stimulated by advertising. When the global withdrawal of the arthritis drug Vioxx occurred in September 2004, at that point Merck & Co., Inc. had spent more than $500 million U.S. advertising this product to the U.S. public. Vioxx is no more effective for arthritis symptoms than alternative arthritis drugs. It's costlier. In British Columbia we've probably prevented harm very effectively because we did ration access to a greater extent than other provinces.
The first study to show an increase in heart attack risk was published in late 2000. So for four additional years, Merck continued to advertise this drug heavily to the U.S. and New Zealand public, where direct-to-consumer advertising is legal, and elsewhere to health professionals.
Dr. David Graham, who is a senior official with the U.S. FDA, used drug use data in the U.S., plus the results of clinical trials, to estimate how many people had been harmed. He estimated approximately 40,000 deaths from heart attacks as a result of Vioxx use would otherwise not have occurred. One of the questions I wondered about was how many of those were stimulated by advertising. I did a bit of a back-of-the-envelope analysis of this, looking at advertising spending versus total sales and then market research data on returns on investment on direct-to-consumer advertising. If you take the blockbuster returns--which Vioxx definitely was--you have about 16,000 of those 40,000 deaths that would have occurred as a result of excess sales stimulated by advertising. That's a rough estimate, but it certainly gives you some idea that there is a cause for concern in the rapid escalation of the use of newer drugs.
The other issue that's of concern with direct-to-consumer advertising is the promotion of unnecessary medicine use for everyday life problems--the medicalization of life.
In 2005 there was a 60% increase in sleeping pill use in the U.S. Why is this? Is there suddenly an epidemic of sleeplessness in the U.S.? Well, no. What's happened is that two sleeping pill manufacturers have been vying for market share and have been very heavily advertising their products to the public. Sepracor spent $270 million U.S. advertising Lunesta to the public. Ambien was advertised to the tune of $90 million U.S.
We know that the continued use of sleeping pills can lead to a risk of dependency, an extra risk of falls and fractures in the elderly, and traffic accidents. There have also been systematic reviews of the clinical trial evidence on these drugs. There's no difference in the direction or the magnitude of effects with the newer versus the older products. You're looking at a situation where, for a person over 60, use for more than five consecutive days is more likely to lead to harm versus benefits.
As a general overview, these are a couple of examples. I could go on, but I won't.
In the U.S. the industry brought in voluntary guidelines about a year after the Vioxx disaster. The most concrete change was that they have agreed not to run any reminder advertisements anymore on television in the U.S.
What's happening in Canada? Well, we've seen an increase in advertising, and the same companies are running reminder advertisements in Canada without any kind of regulatory response. We've certainly seen no reduction in the volume of made-in-Canada ads, no change following the committee's recommendations, no change post-Vioxx, no change after the U.S. voluntary industry guidelines, and no improvement in enforcement.
If I can give you an example, I was involved in a complaint with a women's health organization, Women and Health Protection, about a televised advertising campaign for Celebrex. Celebrex is a very similar drug to Vioxx and is in the same class. There's evidence of increased heart disease risks with Celebrex as well. Health Canada has put out a safety advisory as a result, telling physicians to prescribe it with caution, at a low dose, and for a short period of time.
We submitted our complaint to the Minister of Health and to Health Canada on March 14. We saw no evidence of any kind of regulatory response, and we haven't even had the courtesy of a response to that complaint.
What's happening from a regulatory perspective?
There was a complaint in 2005 about an ad campaign for Xenical, an obesity drug. This was not a brand ad campaign, but it was being advertised to women who wanted to lose a few pounds, a use that it's never been approved for. On the complaint that we submitted to Health Canada at that point, we did get a response, which said that it was perfectly legal because the brand had not been mentioned and the company had not been mentioned. From a public health perspective, we certainly haven't seen a shift in the regulatory response to these kinds of advertising.
The other thing that has happened is that we've seen ads, for example, like the TV ads for Celebrex, which would be illegal in the U.S. on public health grounds because this is a product with what's called a “black box warning” of serious safety risks. Reminder advertising is not allowed for drugs with black box warnings in the U.S. because of safety concerns. Although our law is more strict, we have had such a lax approach to enforcement that we're actually seeing things happening in Canada that are not allowed in the U.S.
The other major change is the challenge to the Food and Drugs Act prohibition by CanWest, which I would like to briefly highlight. This is a challenge by our largest media company on the grounds that the prohibition is an infringement on their freedom of expression. Yes, I can see a grin about that.
If you think about it, as a media company, they can run any editorial content they would like to on prescription drugs and any TV program they would like to on prescription drugs. What they are prohibited from doing is selling advertising space to prescription drug manufacturers. This is really a case that has everything to do with trade, competition, and lucrative advertising contracts.
Given my concern, from the outside, and having been concerned about the shift in response to enforcement of the law, what I would like to ask is whether adequate resources are being put into defending the law against this case. That's certainly a question for the committee.
In conclusion, I would like to say that the committee's recommendations are as valid as ever, but the real question is, what can be done to implement them?
Thank you.