Alan Cassels

Last month, Alan Cassels presented a brief to the House of Commons Standing Committee on Health in Ottawa, which is examining the issue of “post-market surveillance” of prescription drugs. Surveillance is the term given to gathering reports on the adverse effects of pharmaceuticals; an activity Health Canada has been under increasing criticism for not properly monitoring. Issues such as the dangerous side effects caused by the arthritis drug Vioxx, the use of antipsychotics by the elderly, and the safety and efficacy of antidepressants have all called into question the role of the government in monitoring drug safety in Canada. The following is an abridged version of his presentation to the committee:

When I told my family I was coming to Ottawa, my 11-year-old daughter –who is a budding environmentalist – asked me: “Dad, why are you going to increase greenhouse gases to travel all the way to Ottawa for a 10 minute speech?”

I had to explain to her that every day in this country people are harmed or die because they are taking perfectly legal prescribed drugs. I told her I didn’t want her or her brother, or anyone for that matter, to die because they or their doctors didn’t learn of the potential dangers of their drugs. I told her the story of Terence Young, a former member of the Ontario legislature, who lost his own daughter because she took a drug they thought would help her. She said: “OK Dad, you can go to Ottawa.” So here I am.

I have been doing drug policy research for 14 years in British Columbia. My research at the University of Victoria is funded by the Canadian taxpayer, mostly through federal and provincial research grants. I have never held any stocks or shares in pharmaceutical companies, nor have I done any work that has been funded by the pharmaceutical industry. I mention this specifically because it’s important. As a researcher, I like to base my assertions on data and my reading of the data tells me that most of the time when patient groups—many of whom do important and vital work—have ties to pharmaceutical companies, they will push for policies that improve the profits of the companies that fund them.

My reading of the data also tells me that those people you have heard from who demand better transparency of drug information, better regulation, more careful safety screening of drugs and better warnings issued to the public are not receiving funding by corporations whose interests are profits. Those who have gone before me, specifically Michelle Brille-Edwards, Terence Young and those from the Canadian Women’s Health Network, have made very good suggestions and I hope that this committee acts on them.

This drug I’m holding in my hand is the most prescribed drug in the history of the world. It’s a drug to lower cholesterol called Atorvastatin and is also known by the trade name Lipitor. Globally, the manufacturer sold $14 billion worth of Lipitor last year of which about 14 million scripts went into the mouths of Canadians. In total, more than 20 million prescriptions for cholesterol lowering drugs – or statins – at a cost of over $1.5 billion every year get consumed in Canada. That’s an awful lot of money for one class of drugs.

Let me tell you three things about high cholesterol.

1. High cholesterol is not a disease. It is a risk factor for a disease but it is often treated as a disease in and of itself.
2. Taking a drug to lower your cholesterol may save your life. If you are a man and have had a heart attack, it can help prevent another one. The benefit of the drug for these high-risk men is about three percent. Which is to say, even in high risk men, over 90% of men who swallow these drugs every day over five years will see no benefit in terms of living longer. There is evidence that the drug will not provide any benefits for women and these drugs provide no benefit to the elderly.
3. Taking a drug to lower your cholesterol may kill you.

While many people won’t have any problem taking statins, others will experience terrible – sometimes intolerable – adverse effects, the most well known of which is a condition called rhabdomyolysis. It’s a muscle weakening disease that can cause kidney failure and death. Cerivastatin (Baycol) was very good at lowering cholesterol but it also killed people and was removed from the Canadian market on August 8, 2001.

Four years after Baycol went off the market, Health Canada issued a public advisory about the risk of rhabdomyolysis (July 12, 2005). Did Canadian doctors read this warning? Did they even see it? Did consumers become concerned and stopped taking statin drugs? Not the way I read it. Canadians swallowed 22 million scripts for statins last year, a number that has risen steadily throughout the last decade.

Yesterday, I searched the Canada Vigilance Online Database and found 1,173 reports for which Atorvastatin was associated with a ‘suspected’ adverse event.

How many people are really being hurt by this and other statins? The answer is: “we don’t know.” Those 1,173 reports (remember they are sent in by volunteers) could represent between one and 10 percent of the people injured by atorvastatin – which means to say there could be between 11,000 and 111,000 Canadians injured by this one drug alone. There are currently seven other statins on the market.

How many of the 22 million scripts for statins in Canada this year are prescribed for men at high-risk? Probably three quarters of those drugs are taken by women, the elderly and other low-risk men who would not see any benefit.

The point that I want to make is that in Canada we don’t control the advertising and promotion of diseases, what I call “disease mongering.” We don’t control the definitions of disease and we don’t provide adequate, impartial health or drug information to Canadians or to our physicians. We allow conflicted experts to sit on committees deciding the definitions of disease and we allow our physicians to be educated by the pharmaceutical industry – an industry which currently spends in excess of $3 billion per year marketing its products directly to Canadian physicians.

Where does the poor patient end up? In my estimation Canadians are naked in the pharmaceutical marketplace.

My recommendations for post-market surveillance revolve around stopping bad and misleading information from getting to patients or physicians and ensuring that we have adequate data before drugs are released to the wider population. I believe we need the following:

1. A policy on disease mongering. We need to maintain our current ban on direct-to-consumer advertising of pharmaceuticals but we need to go further and ask Health Canada some hard questions such as: What is your policy around disease mongering? Can you collect data to see if disease mongering is driving the inappropriate use of pharmaceuticals?
2. Better information for patients. There is a dire need for Canadians to receive approved and regulated information about diseases and drugs provided by an independent, objective source that is free from profit-driven industries that sell drugs or other treatments.
3. More objective information for physicians. It’s not just patients who need independent information. It’s time we recognized that leaving the education of our physicians to the pharmaceutical industry has some downsides. We need better physician education on prescribing and that education has to come from an objective source, preferably one with stable public funding.
4. Learn from other industries. I think that post-market surveillance needs to be done and it needs to be done better, but it seems to me it’s largely an ‘after the fact’ proposition. Could you imagine another industry, say the nuclear or the airline industries, where we allow the manufacturers to rely on post-market surveillance for the safety of their plants or their planes? Nobody would accept the proposition that the job of the regulator is to count the bodies afterwards and then decide if something is good enough to expose to the wider population. Both the nuclear and airline industries are required to take a zero-risk approach to their products, so why do we accept a lesser standard for products that people consume everyday? I don’t know where new efforts to modernize the drug regulatory environment are heading, but I know no one has told me how a more modern drug-licensing regime will prevent thousands of Canadians from being injured by statin drugs.

If you think you have been injured by a prescription drug, you should call the Canada Vigilance Program at 1-866-234-2345. You can also submit an adverse reaction report on the Med Effect Canada website (www.hc-sc.gc.ca/dhp-mps/medeff/index_e.html).