Evidence of meeting #17 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was drug.
A recording is available from Parliament.
March 11th, 2008 / 12:15 p.m.
Conservative
Steven Fletcher Conservative Charleswood—St. James—Assiniboia, MB
Madam Chair, I'm just going to pass my time to Patrick Brown. I'll go after him.
12:15 p.m.
Conservative
Patrick Brown Conservative Barrie, ON
Thank you, Ms. Chair. I thought that was the order, but I guess we got mixed up there for a second.
I have a few questions. I'll raise them all at the beginning, and then you can comment on them where appropriate.
I've asked previous witnesses, as they gave us their expert advice, about the use of new technology and the role you believe that could have. One thing that was mentioned before was a hand-held device where there would be real-time access to Health Canada updates. We were told by the Canadian Medical Association that sometimes notices are mailed out or faxed out, so the time period to get them can sometimes be quite lengthy. I want to see if you have any suggestions on that.
We also heard from an individual, Terence Young, who spoke on behalf of a victims' advocacy group about the need to better share international data, saying that if a pharmaceutical company does a study, it should be shared with Health Canada within 48 hours. If that pharmaceutical company is producing pharmaceutical products in Canada, they should be required to share studies they've done abroad. I want to know your thoughts on that and whether that would be helpful.
I also want to know if you could comment on the Beers list. We heard at this committee that there is information compiled about how a specific pharmaceutical drug could affect a specified category of individuals--in this case, seniors. What ability would you suggest Health Canada should have to create other lists, and is that our role? Should there be a list of drugs that could adversely affect women or children, in the same sense that we've had that Beers list that was compiled?
12:20 p.m.
Chair, Expert Advisory Committee on the Vigilance of Health Products
In my real-life world I'm a drug information pharmacist. What I do is evaluate information as it comes forward to me. We find one of the important things in terms of being able to support our clinicians is that they do get access to real-life information as quickly as possible. So any tool that can be used to provide that information to the front-line practitioner is definitely beneficial.
People who go around with their PDAs and have drug information resources that maintain and track either FDA or Health Canada alerts are very useful, and clinicians very much appreciate them.
What the ideal process would be, I'm not sure. Who would fund these? I don't know. But I believe that front-line practitioners do require this information as quickly and as succinctly as possible for it to be useful for their patients.
12:20 p.m.
Past Chair, Cancer Advocacy Coalition of Canada
If you have a question on anything in the world, you Google it and you usually find the answer. I don't see the reason why we couldn't have the same kind of mechanism to address the issues you've raised here from Health Canada, for example.
We've looked at the Health Canada website. We have had to work with it for the last three or four years in researching the effectiveness of cancer drugs and the procedures whereby they are approved, and it's a clunky site. It's not very easy to navigate. With some improvements and an eye towards user-friendliness, these kinds of issues could be addressed quite usefully, so that if a physician in his or her office encounters a question, simply tapping up the Health Canada site and getting the answer could be done.
12:20 p.m.
Associate Professor, Faculty of Pharmacy, Université de Montréal
I just want to come back with some supplementary information.
To involve pharmacists also would be a very efficient way of providing up-to-date information. For example, if they dispense a drug, it could come up on their screen that there's a new warning and they could see their patient. It's not just the prescriber or the practitioner who prescribes, but also the pharmacist would be a good channel, an efficient channel.
12:20 p.m.
Conservative
Patrick Brown Conservative Barrie, ON
Are there any comments on the creation of a specified list in terms of categories of Canadians, like there is the Beers list for seniors?
12:20 p.m.
Chair, Expert Advisory Committee on the Vigilance of Health Products
You're talking about the Beers list. There are drug information resources out there that do have disease-class drug interaction types of programs. They are available.
12:20 p.m.
Conservative
12:20 p.m.
Chair, Expert Advisory Committee on the Vigilance of Health Products
I guess I hesitate. The Beers list is one that we recognize, but we also recognize that it's not a black and white issue. Unfortunately, that's the problem with the practice of medicine. Yes, the list is there. Yes, we know that patients at risk will have greater risk with these drugs, but it doesn't mean these drugs are necessarily, absolutely contraindicated in these patients.
Is it the list you need or is it the increased awareness that patient groups are at risk?
12:20 p.m.
Conservative
The Chair Conservative Joy Smith
We are out of time now, Ms. Laughlin. Are you asking that direct question to Mr. Brown?
12:20 p.m.
Chair, Expert Advisory Committee on the Vigilance of Health Products
12:20 p.m.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Thank you, Madam Chairperson.
I want to come back to the issue of independence in decision-making, because I didn't get a chance to hear a comment from everyone and I just want to go through it again.
Everything I've read on this whole issue points to dealing first with the secrecy that surrounds the whole drug approval process. We can extend that pre-market approval process now to the post-market surveillance issue. How do we best do that? How do we ensure that all decisions relating to clinical trials and to adverse reactions are available to the academic community, so that they can address these issues and advance the concerns, and available to the public, who are looking for some wisdom as they make these difficult decisions?
12:25 p.m.
Past Chair, Cancer Advocacy Coalition of Canada
The Cancer Advocacy Coalition is struggling with just that question of transparency and accountability to the public for just exactly the reasons you have outlined.
The mechanism that seems to be working—at least it's evolving, for example, for the joint oncology drug review mechanism—is that patient representatives are on the committees, sitting there and adjudicating all of this, and they have access to the data. Those committee members, representing patients' voices—the public voices—also have connection to the non-governmental organizations of other cancer patients. They are able to deliver a consensus of opinion of those other organizations to the committee and also provide the information from the committee to these organizations. So mechanisms like that can be set up.
12:25 p.m.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
What about a website that gives people everything they need to know about drug approvals and non-approvals? Is there any problem?
12:25 p.m.
Past Chair, Cancer Advocacy Coalition of Canada
There will always be some issues that the drug companies won't want to disclose. We would hope to keep those to an absolute minimum, because that secrecy element has impeded, in our opinion, the transparency issue. The website issue is always going to be, who's going to put it on it and who's going to read it? At the end of the day, you really want somebody sitting there in the committee meeting, being able to listen and report back.
12:25 p.m.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Okay, then, let me ask this question, and I know you will want to jump in.
Right now drug regulation in Canada is completely shrouded in secrecy. What we're talking about is a very marked departure. Today even the names of drugs in the approval process are not disclosed. All the information that industry submits, including clinical trial data on safety and effectiveness, is deemed confidential, and it can only be released with the permission of the company, even when you have an access to information request. So we're talking about a complete departure from that.
I want to know if you're in agreement, because this gets to the heart of the overall issues around drug surveillance.
Yola...and maybe the others.
12:25 p.m.
Associate Professor, Faculty of Pharmacy, Université de Montréal
The problem is, when you assess the benefit-risk at the time of drug approval, the process is not transparent. What usually happens is you have a group of experts who weigh the benefits against the harms and make a decision. There's no magic formula. They don't come up with a magic number that says the drug is approved or not. This is probably the most disturbing aspect—how decisions are taken.
I can tell you, having worked on this issue, that there is at present no mechanism or system that would provide additional information. However, I am involved in some initiatives designed to define the parameters in the decision-making process and come up with explicit criteria that could be communicated either to the practitioners or the public.
It's a difficult question to answer. It's extremely relevant, but I don't have any answer at present.
12:25 p.m.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Does anyone else want to comment?
Let me ask you, Dr. Gowing. Do you see a shift from a secretive approach to one that requires full disclosure every step of the way as a problem in light of the competitive nature of the business?
12:25 p.m.
Chair of the Board, Cancer Advocacy Coalition of Canada
I think it's good to move to more transparency. We've been advocating that for a long time. In Ontario, Bill 102 was supposed to provide this transparency. I don't think it has, but all the regulations have not come through yet and we're waiting to hear.
Certainly, the secrecy about these things is wrong. I'd like to know how these expert panels come up with what they come up with. It's impossible for a prescribing practitioner to know how they made the decision that allowed him to prescribe the drug. I disagree often with the decisions of these groups. I don't have any mechanism to argue the point because I don't know how they made the decision.
12:30 p.m.
Conservative
Steven Fletcher Conservative Charleswood—St. James—Assiniboia, MB
A lot of the discussion has been at the 30,000-foot level. I want to ask some questions from right on the ground.
Twelve years ago, when I was in the hospital looking at the doctor's notes, I assumed the doctors were literate, though you'd never know it from reading their handwriting. Fast forward to the present. The doctors I've seen over the years are definitely not technically savvy. Today there are reports in the media that doctors are one of the main culprits in spreading superbugs in hospitals, because they don't have time to wash their hands.
The issue of compensation has come up. How will doctors be compensated for the time they're going to be spending filling out reports?
How would this work at the ground level? What stimuli could be provided to the doctors? It's easy to talk about cultural change, but we're talking about a massive change in the way doctors operate.
12:30 p.m.
Chair of the Board, Cancer Advocacy Coalition of Canada
We're in the electronic age, and any physician who is not in the electronic age is a dinosaur. I think this bears on a lot of the questions that have been raised here today. I have a computer on my desk. I'm using it constantly throughout the day. Not too long ago, I was computer illiterate. I think my grandchildren are still ahead of me.
The technology is there and it's very simple. This is a point we've been trying to make. You need one computer screen for reporting the data we're asking for. If you go further, the doctors will be out washing their hands and not filling in the forms.
12:30 p.m.
Conservative
Steven Fletcher Conservative Charleswood—St. James—Assiniboia, MB
Madam Chair, I think I've just been told that I should go to Jurassic Park for a medical clinic.