Evidence of meeting #21 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.
11:35 a.m.
Lawyer, As an Individual
Yes. I was going to speak also about adequacy of budget and staff. It's in my notes, which I have given to committee.
11:35 a.m.
Conservative
11:35 a.m.
Lawyer, As an Individual
Yes. I will not speak to that point.
Thank you very much for the opportunity to speak, and I welcome questions.
11:35 a.m.
Conservative
The Chair Conservative Joy Smith
Thank you.
Now questions are asked of you all. We'll go to our first round; there will seven minutes from each member for the questions and the answers, and we'll start with Monsieur Thibault.
11:35 a.m.
Liberal
Robert Thibault Liberal West Nova, NS
Merci, madame la présidente. Thank you all for being present.
We've been hearing a number of panels, and we hear a lot about the same thing. If you'll excuse me, Mr. Orr, I won't go into the legal matters. I think you're bringing a whole new dimension to this thing as to the regulatory issues. I'd like to stick a little bit with problems and solutions on the post-market question.
I'm glad, Mr. Morgan, that you mentioned Dr. Carleton, because that's a line of questioning I was thinking of when I was listening to Dr. Laupacis. Dr. Carleton was suggesting a network of researchers who would look at specific areas in which you have effects and adverse events, and you try to discover them so that you can predict them in the future and predict how to use....
Then we had a lot of other presenters who were telling us that at the practitioner level, they would use a reporting network if that network had value to them in their practices through two-way interaction with this website. They could get the information they needed to improve their practices or to use these treatments better in the future.
Are you suggesting somewhere between those two, or a marriage of those two types of approaches, in the network you're talking about?
11:35 a.m.
Executive Director, Li Ka Shing Knowledge Institute, St. Michael's Hospital
I didn't hear Bruce's presentation, but my knowledge is that Bruce is interested in figuring out if he can predict, on the basis of genetic susceptibility, particular people who are particularly at risk of certain adverse drug reactions. My sense is that if we could do that, it would be fantastic.
11:35 a.m.
Liberal
Robert Thibault Liberal West Nova, NS
If I could bring back my question for a minute so that you'll understand, I think the principle he was outlining goes beyond just genetic susceptibility. It's looking at areas of known problems and studying them in detail so that we understand them, and building the knowledge of a few specific cases, rather than taking a holus-bolus approach.
11:35 a.m.
Executive Director, Li Ka Shing Knowledge Institute, St. Michael's Hospital
Yes. As I said in my remarks, even if this post-marketing surveillance network were to be well funded, one would still need to make decisions about where one is going to concentrate. I would concentrate on areas that, on the basis of initial information from randomized trials, give concern over possible side effects. I think I'd concentrate on diseases for which drugs are used frequently, such as depression or heart failure. I think you really would need a group of practitioners, regulators, researchers, and policy-makers to sit down and prioritize. For sure, it can't be a holus-bolus thing; we wouldn't get anywhere.
11:35 a.m.
Liberal
Robert Thibault Liberal West Nova, NS
I studied a little bit of biology and a little bit of physics, and from my understanding from hearing everybody who comes to this committee, Newton's first law of physics applies to pharmacology also. Unless you have a pharmaceutical product that has zero effect, there has to be an equal and opposite effect. If it has a positive effect, it's also going to have some other effect that probably isn't desirable.
You can't call all side effects catastrophic; I think it's a question of the patient or the practitioner being able to reasonably predict what they will be, and you make a decision on what's right. If I have a terminal disease, I will take a risk that could cause my death if there's a better-than-even chance of having a positive effect at the end.
11:40 a.m.
Executive Director, Li Ka Shing Knowledge Institute, St. Michael's Hospital
I agree with you 100%. When my patients come in and say they want to take some homeopathic medication that has no side effects, I tell them that if there's a drug that doesn't have any side effects, I don't think it's going to be effective. I think you're absolutely right. The management of people with HIV has been transformed from people who are dead within six months to people who now live a long time--actually, they have a chronic disease. Those drugs all have significant side effects, but I think if you ask almost anybody with HIV if they want to take those drugs, they absolutely do.
11:40 a.m.
Liberal
Robert Thibault Liberal West Nova, NS
I'm using medication now to help me quit smoking. I'm on my sixth week tobacco-free.
11:40 a.m.
Executive Director, Li Ka Shing Knowledge Institute, St. Michael's Hospital
Good luck.
11:40 a.m.
A voice
We see that.
11:40 a.m.
Liberal
Robert Thibault Liberal West Nova, NS
I make my decision as a consumer as to whether I will accept the side effects of that or of tobacco in the long run, and I've chosen the ones from the medication to help me abandon....
11:40 a.m.
A voice
You made the right choice.
11:40 a.m.
Liberal
Robert Thibault Liberal West Nova, NS
As you pointed out on the question of cholesterol, you take that knowing the decision.
On the question of randomized trials--and I turn to Mr. Morgan--as I understand the progressive licensing scheme or suggestion or modifications in looking at the licensing or the enabling legislation, which I understand is supposed to be introduced today.... I'm looking forward to seeing the details. Perhaps we'll have you back at committee on those questions.
I understand it does not represent full clinical trials but maybe the uses permitted for a medication, as we get that knowledge about that medication, so that we can bring it to market faster, but just as safely, is my understanding.
What you're suggesting, though, rather than a randomized trial, is that you go by postal code area, so that some portion of the public may have access to a new treatment and others will be withheld. It sounds good to me, unless I happen to live in the postal code area that won't have access to the scientifically newest or potentially best medication. If I'm in a critical situation, I'll want that. I think that suggestion takes a bit away from the patient.
11:40 a.m.
Assistant Professor, Centre for Health Services and Policy Research, University of British Columbia
I think it's important to recognize that these notions of pragmatic trials, or what are called designed delays, are typically applied in cases when we actually don't know if the new drug is in fact superior or if the new drug will cause more harm than good.
They're also designed in such a way that is referred to as a designed delay, and all populations who would be eligible for the treatment will eventually get it. It's just--
11:40 a.m.
Assistant Professor, Centre for Health Services and Policy Research, University of British Columbia
There's a period during which some people get a medicine and some people don't. It's random. It's basically a pragmatic way of running a randomized trial in the post-market world. It is a new idea. It's been explored for years, but it hasn't been applied very often. But there are provinces now looking into using these pragmatic trials in an environment where we don't know the value and the safety of the medicine.
11:40 a.m.
Bloc
Luc Malo Bloc Verchères—Les Patriotes, QC
Thank you, Madam Chair. Thank you, gentlemen, for joining us today.
Mr. Orr, I would like to focus on a number of points that you raised in your presentation. From what you are saying, it would seem that no one knows for certain which drugs are on the market or which drugs are been sold to patients. It seems that once drugs are put on the market, it is unclear what they are exactly or what they do. I would just like you to confirm if in fact this is what you were attempting to say and implying.
You also said that once the drugs were on the market, no one was accountable or responsible for potential adverse effects. If I understand correctly, in your opinion, Health Canada washes its hands of the whole situation. Does the industry do likewise, or does it accept some responsibility, since companies need the products they sell to be effective and to meet certain needs, and need as well to keep share values high and maintain their sound reputation?
I will leave you to answer these questions.
11:45 a.m.
Conservative
The Chair Conservative Joy Smith
I'm sorry. No, it's okay. I misspoke. Go ahead.
I was trying to give you some time.