Evidence of meeting #23 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was drugs.
A recording is available from Parliament.
Liberal
Chair and Associate Professor, School of Health Policy and Management, York University
Yes, I think the group that does the studies has to be independent. Usually when Health Canada is involved, they work with industry, and the necessary arm's-length independence for the studies is missing.
I think Alan's suggestion is a good one. You need an arm's-length industry, but you also need independent research centres to conduct those studies, to analyze those results. As I mentioned, a researcher recently re-analyzed the data that were submitted to the FDA by drug companies for 12 different SSRIs, anti-depressant drugs, to treat depression, and they found that the results were positive for only half of them, whereas industry found positive results for 95% of them. There's a problem there. Those data are not being analyzed in the right way. So you really need the studies to be independently done.
Just because industry has manufactured those products doesn't mean they should be running those studies. Let the researchers do their work, independent researchers. So you'd need a system of accrediting research centres that they follow the appropriate protocols, that they have the appropriate expertise. Europe is currently going in that direction. They're going to set up a network of 60 research centres. Individual centres will determine whether they meet the accreditation standards, and then they'll determine which centres will conduct which studies.
I think that's a far better way than the risk management plan, which means negotiating with industry as to what will be done, without standards in place, and then millions and millions being spent on research that doesn't really get you to where you want to be anyway. It doesn't produce the results that you really need--those independent, rigorously designed and conducted studies.
Liberal
Conservative
James Lunney Conservative Nanaimo—Alberni, BC
It's been a fascinating discussion, and now we're down to the three minutes. Time is really limited, so I'm going to fire three questions out here as quickly as I can and hope that I can retrieve three answers.
We're discussing the effects of drugs on adolescents, and surveillance. Somebody mentioned SSRIs. The effect on adolescents can be very dramatically different, as I understand it, from what we expect in adults. Maybe somebody could comment on that.
I believe it was Mary who commented on the fourth to sixth leading cause of death in the U.S., about 100,000, with 1.5 million hospitalizations. In Canada it would be about 10% of those numbers--10,000 and 150,000, respectively. The Ross Baker study--University of Toronto--suggested 24,000 deaths a year in Canada, conservatively. That's just hospital-based. On the difference between the 10,000 and 24,000, are you referring in one instance just to drug-related, inappropriately, or even appropriately?
The third one is coming off Susan Kadis's comment about the new bill, and will it help. The new bill really eliminates the food and drug context of the Food and Drugs Act. It puts natural health products and drugs in the same category. My question really is this. As therapeutic products, should low-cost, low-risk, non-patentable, orthomolecular remedies--vitamins and minerals--be subjected to the same level of pre- and post-market surveillance as pharmaceutical drugs, which are obviously altered from a natural form?
Chair and Associate Professor, School of Health Policy and Management, York University
Let me begin with the point you mentioned about the discrepancy between the 10,000 and the 24,000 of hospitalizations. I raised the 10% just as one-tenth of the U.S. But my figure is a little different from what Ross Baker would suggest, because his figure also combines misprescribing. That means when there are actual errors, when the nurse doesn't deliver the appropriate medication that could easily double the number of problems there. I'm just looking strictly at if you take the drug as prescribed, what might happen.
Scientific Director, Clinical and Health Informatics Research, Department of Medicine, McGill University
Adverse drug-related events were estimated to be about the sixth leading cause of mortality. It's vastly underestimated by chart review studies because you're only picking up the ones you recognize and you're only doing it within the hospital. I think that's a big thing. It's like drugs and surgeries. They cure and they kill, so they're potent things.
Teens.... I have two teenagers. We now know that their brains are different. Drugs aren't tested in teens and drugs aren't tested in kids, by and large. So they are social experiments. That's why I am so supportive of progressive licensing and ongoing pharmaco-surveillance for those reasons alone.
I don't think I remember your last question.
Conservative
Scientific Director, Clinical and Health Informatics Research, Department of Medicine, McGill University
Absolutely.
One of the most interesting studies was on L-tryptophan, which was a natural food product. The ingredients it was made with, by one manufacturer, actually produced a very rare condition called eosinophilia-myalgia syndrome. In fact, a Japanese company made that product and a number of people died from that.
So, absolutely, I think that's essential.
Conservative
James Lunney Conservative Nanaimo—Alberni, BC
So a broad-spectrum vitamin D, any vitamin, should be put to the same scrutiny?
Scientific Director, Clinical and Health Informatics Research, Department of Medicine, McGill University
I think so.
Bloc
Luc Malo Bloc Verchères—Les Patriotes, QC
Thank you for your presence here today.
In earlier testimony, we heard that there are very few adverse reactions reported and that the figure varied somewhere between 5 and 10%.
I am simply wondering whether the proposed clause 20.7 in Bill C-51, compelling health establishments to advise the minister of adverse reactions to drugs, may have a positive effect on the fact that few events are reported.
At the end of the day, will this provision make the process more effective and will the drugs that are available on the market have less of a chance of causing adverse reactions?
Scientific Director, Clinical and Health Informatics Research, Department of Medicine, McGill University
It's not a good idea, mainly because there will be a false security from thinking you'll get more. You probably will get more, but we've learned something from public health. There are declarable, mandatory reportable diseases, such as tuberculosis, diphtheria, and malaria. There's a list of 16 or so. The problem of under-reporting them is so huge that public health officials have worked out fairly complicated methodological approaches to assess and inflate the under-reported figure. That's number one.
Number two, courtesy of bioterrorism in the United States they're moving to a whole new way of attempting to detect emerging epidemics. It's probably not as good as you might hope it will be. If in a declarable disease like diphtheria we can't get our act together to declare it, just imagine how it's going to be for adverse events for drugs.
I would rather put the investment in something else, like a systematic surveillance system.
Chair and Associate Professor, School of Health Policy and Management, York University
They have found that where they imposed mandatory reporting, even for health professionals like physicians in France, they didn't get any higher rates of reporting of adverse effects. As I said, it might be wasted energy.
Pharmaceutical Policy Researcher, School of Health Information Sciences, University of Victoria
The reality is that physicians have information overload. People want them to have electronic devices, and patient records at the press of a button. Putting something on top of that like mandatory reporting, in the experience in other countries, is simply not going to happen. So you need a better way.
Bloc
Luc Malo Bloc Verchères—Les Patriotes, QC
I have a small question for you, Dr. Cassels. You told us early on that cholesterol levels were over-medicated and that you carried out studies which will tend to show that.
Why would it be then that so many drugs continue to be prescribed for a problem which, in your opinion does not exist, or, if it does exist, has few long term effects on health?
Pharmaceutical Policy Researcher, School of Health Information Sciences, University of Victoria
First let me clarify that we don't study cholesterol-lowering drugs at the University of Victoria. There have been 14 major studies of the major cholesterol-lowering drugs. Why are they still being used? The answer is complex, but you might want to read the first chapter of my book about cholesterol.
The main thing is that the power of the market is so intense that it overrides anyone who raises concerns, anyone who points out lack of data, and anyone who essentially looks closely at the data and finds that those drugs aren't as effective as the manufacturers say they are.
Bloc
Pharmaceutical Policy Researcher, School of Health Information Sciences, University of Victoria
By all means, they're being manipulated.
Liberal
The Vice-Chair Liberal Lui Temelkovski
Thank you very much.
Now we'll move on to Mr. Fletcher for a three-minute round.
Conservative
Steven Fletcher Conservative Charleswood—St. James—Assiniboia, MB
I'd like to thank all the members of the panel for what has been a very interesting discussion indeed.
Mr. Cassels, you talked about disease-mongering, and that's an interesting way of putting things. I've looked at the adverts, and there are some credible organizations on the advert you passed around, like the Canadian Diabetes Association and others. So I wonder if you could comment on the relation between what you call disease-mongering and the fact that very credible organizations have put their names on that advert.
To those who discussed the issue of the pharmaceuticals' ability to advertise, I can't get into the specifics of the cases, but there are two cases where the federal government is in court trying to keep the prohibition on advertising of pharmaceutical products. I'll throw that out to Mr. Cassels.
I would also like to hear Robyn's comments on post-market surveillance and the life-cycle approach, because that is really key to the legislation the minister has brought forward.
Pharmaceutical Policy Researcher, School of Health Information Sciences, University of Victoria
That's a very good question. So the question is about the logos of the various patient organizations on this ad.
Have you ever heard of Making the Connection? Does anyone know what that is? How about the Canadian Lipid Nurse Network?
