Evidence of meeting #16 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was patients.
A recording is available from Parliament.
12:15 p.m.
Conservative
12:15 p.m.
Board Member, Canadian Health Coalition
You're talking about what goes out to doctors.
12:15 p.m.
Board Member, Canadian Health Coalition
Yes, there is a huge deficit on Health Canada's part in the manner in which they communicate with physicians. There has been a long-standing attitude within the department that the system doesn't work because the doctors don't send them reports, so what obligation does Health Canada have to speak to them?
12:15 p.m.
Board Member, Canadian Health Coalition
The recommended solution is to have transparency in the system. It is to demand that the ways in which the department is assessing the information and the reasons behind their communications are transparent, so doctors can judge whether they agree with what's been done and said within the department and can evaluate the validity of the advice that's coming out.
The second thing that could easily be done today is to have every physician who is linked to the Internet—and that is, in today's world, in the practising world, about 95%—aware that they have the opportunity to have immediate e-mail alerts from Health Canada. That is as real time as you can get.
It demonstrates the passivity of Health Canada. They have this system operating, but they don't make any effort or have any outreach to the physician and pharmacy community to say, “Please help us. Please give us your e-mail address. Let us send you these reports.”
12:15 p.m.
Conservative
Patrick Brown Conservative Barrie, ON
Another comment you made that I was interested in, Mr. Young, was that international studies should be shared with Health Canada within 48 hours, not within the current six to twelve months. What are those timelines based on?
12:15 p.m.
Chair, Drug Safety Canada
The medical community calls them signals. A patient falls dead, and they think it might be due to a prescription drug. That could be in the U.K., South America, the United States, or somewhere else. The medical community calls that a signal. They start counting them, and when they get enough of them, they call it noise. When they get enough noise, somebody actually starts to look into it.
If the signals--the information the drug company got when it was reported to them that it was potentially a cause--were immediately sent to the regulators, the regulators could start to open their own files and start to investigate the drug themselves. You could have patients doing their own adverse reaction reports too. So they would get information earlier, and they could act sooner, instead of it taking months and months and months, while the body count rises.
12:15 p.m.
Liberal
The Vice-Chair Liberal Lui Temelkovski
Thank you very much.
Now we're moving to the second round. In the second round we'll keep it to three minutes, so we can finish. It is the same for everyone.
Mr. Thibault.
12:15 p.m.
Liberal
Robert Thibault Liberal West Nova, NS
I want to thank you all for your discussion and for bringing that forward. It's a very difficult area. I want to see drugs available. If there's a chance of somebody being saved by a pharmaceutical or product, I want them to have access to it. At the same time, I agree that they should have all the information.
We had one practitioner telling us that when you read that compendium everything that could possibly be in there is included. You really don't know what is significant and what isn't, so that's one of the reasons it gets to be in disuse.
The other thing we heard from Dr. Brill-Edwards, and that we have heard from others, is about interaction between practitioners and the system on adverse drug reaction so you could have that benefit. Technology gives us that chance. As we do the Drug InfoNet and health InfoAid, hopefully that will be part of it.
We see that the pharmacists have quite a good system, and our MDs and practitioners don't.
12:15 p.m.
A voice
The vets and the dentists have it.
12:15 p.m.
Liberal
Robert Thibault Liberal West Nova, NS
The vets and the dentists do, and the pharmacists, so that possibility is there.
As for health care contacting practitioners, I don't know about every province, but every practitioner in Nova Scotia does his or her billing by way of technology. With the MSI system, they are online, so why couldn't that system feed the health advisory or an advisory on drugs?
I do want to be careful, and I'll give you as much as I can to answer, but in your consideration I'd want to be careful. I like the idea of progressive licensing. I understand why off-label use is done with drugs. I understand these things are necessary.
But I'm also scared when I hear Mr. Young talk about Gardasil. Until I heard you say that, I saw it as something that held great promise. If I'm the father of a young daughter, I would be very happy that it's available for her and it's is going to protect her. But then you raise these points that there is a lot of risk. That scares me, frankly. You're telling me something could be prescribed to all young women in Canada that would be licensed and encouraged by our government, that would even make it into a budget speech; it would make it through our system, and it carries that risk.
Could you elaborate?
12:20 p.m.
Chair, Drug Safety Canada
I think Gardasil does hold promise, but when they don't know whether it will last beyond five years and it hasn't been tested with other vaccines.... The most important word in drug safety is contraindication. If it hasn't been tested with these 16 other vaccines, say, that little girls might have had before, they could run into contraindications. I'm saying it's unproven. I'm saying there are too many unknowns about it to ask every little 9- or 10-year-old girl to take these three painful needles.
There's another one coming out, by the way, following Gardasil, which will apparently protect against the other 30% of cancer-causing HPV. Who knows how they will react?
There are always questions, and you want the questions answered. You want to monitor patients very closely. You don't want a million little girls taking something when it's brand new. It's better to start it slowly with patients who are more willing, in this case--I was going to say patients who have the condition, but there is no condition yet--and build it up slowly, so that if it has a deadly side effect you can catch it before a million patients are exposed to it.
12:20 p.m.
Liberal
The Vice-Chair Liberal Lui Temelkovski
Thank you.
We'll move on to Mr. Tilson, for three minutes, question and answer.
March 6th, 2008 / 12:20 p.m.
Conservative
David Tilson Conservative Dufferin—Caledon, ON
Thank you very much for coming.
All of your testimony is most compelling. In fact I find it alarming. It makes me never want to take a drug again.
I'm not going to summarize what you said. I made notes, as we all have. We all have that information. It's most useful for the committee to consider as to what recommendations we'll make to Parliament.
I'm still not clear on this. As I understand it, the only people who can make a report to Health Canada are the pharmaceutical companies. That's what I understand, although I think now we're talking about hospitals.
My question is for anyone. If an individual has a reaction and they're not too sure whether it's serious or not, because you only report serious reactions, what happens? What does that person do? They don't know where the drug company is. You talked about a friendly form. You talked about doctors trying to talk you out of filling it out. I think you mentioned that. You said a lot of alarming things.
So I've had a reaction. I think it's a serious reaction. What do I do today?
12:20 p.m.
Vice-Chair, Operations Committee, Best Medicines Coalition
That's why we need to empower the Canadian patient to be able to report. It's not up to the patient to decide what is serious. I actually think all adverse reactions should be reported, and let Health Canada figure out what's serious and what's not serious, what's significant and what's not significant.
Drugs have helped a lot of people, and I'm walking testimony. I wouldn't be here today if it wasn't for a biologic to treat the rheumatoid arthritis that I've lived with for 25 years. There is always a risk-benefit. But there has to be more of a dialogue, and Canadian patients have to realize that just because a drug is there doesn't mean it's safe. There always has to be a dialogue with their position: is the benefit of this drug going to outweigh the risks of this medication?
Natural health products, over-the-counter medication, everything you do has a risk to it. It's up to patients to be informed and educated, and we're not doing a good job of that.
12:20 p.m.
Conservative
David Tilson Conservative Dufferin—Caledon, ON
Let's assume it's a serious reaction. My question is to anyone.
What do I do? I clearly have a serious reaction and I'm almost dying. I'm trying to think of a serious reaction, and I don't even know what one is—I think I do. Let's say I'm convinced I have one. What do I do? I go and fill out a form somewhere, but who gives me the form?
12:25 p.m.
Member, Steering Committee, Best Medicines Coalition
Presumably you would go to the hospital if you had a really serious problem, and then the hospital would take care of that.
But I think you raised a really important thing in that we don't know what to do. The public doesn't know what to do.
There are many times that things are going on that we don't even know about. All of you here have probably taken ibuprofen. Do you know that after one dose of ibuprofen your stomach bleeds? One dose. You don't see that, so you don't even know that it's going on. Some people think, “I can just get this medicine over the counter, therefore I can take a couple more, and I'll give it to my kids.” We're not even aware of things that are going on inside of us, what it's doing to our cardiovascular system and all those things.
We don't know when we take a medicine whether it's taking it or whether it's interaction. If we had a public education awareness campaign to tell people what they can do and the infrastructure to manage that, I think that's the biggest challenge that we have here and this committee has. Where is the infrastructure going to come from that's going to manage all those reports?
12:25 p.m.
Bloc
Luc Malo Bloc Verchères—Les Patriotes, QC
Good day and thank you for joining us. I have a few questions that I will put to you in quick succession, after which you can respond.
Earlier, you stated that several drugs were administered to people who were not members of the group targeted by these studies. I was wondering how many people taking this drug fell into this category and how serious the problem actually was?
You also suggested that an independent evaluation bureau be set up. What type of funding should this bureau receive and what advantage would this present over the system currently in place?
Thank you.
12:25 p.m.
Board Member, Canadian Health Coalition
Regarding the first question on off-label usage, Health Canada and other regulatory bodies—not Health Canada alone—leave practitioners in the lurch, because we have a system in which the manufacturer asks for the drug to go to market for particular uses, the so-called indications, for which evidence has to be produced. And when evidence is available, the drug goes to market for that use in that general population—let's say adults—but if the same drug is useful for other purposes, and research has been done on it by universities or medical groups and has been published in the literature, and it is well accepted that the drug has a bona fide other use, that is not then reflected in the approval of use by Health Canada. So this forces doctors to use drugs in an off-label fashion, with the result that the industry can always say, oh well, it was used for a non-approved use. It gives them an out; it reduces their liability. But in fact it's a very dangerous process that forces doctors to use drugs for indications where there isn't any official authority saying yes, this is how the drug should be used.
I'm a pediatrician, as well as a clinical pharmacologist, with extensive regulatory experience in years past. I am now working part-time in the emergency department at CHEO, the Children's Hospital of Eastern Ontario in Ottawa. We see patients day in and day out, and we are using drugs that do not have a pediatric indication but are used worldwide and accepted as appropriate for use in those indications.
So this whole notion of off-label is very misleading in that it allows the drug companies to get off the hook by saying, oh, it was an unapproved use. And it leaves doctors and patients with no federal body having said yes, this is appropriate.
12:25 p.m.
Liberal
The Vice-Chair Liberal Lui Temelkovski
Thank you very much.
I'd like to thank the witnesses for all of their testimony and information.
We will be breaking—