Health Committee on June 6th, 2007

[John Wright]

Let us remember what the CDR does. The CDR makes recommendations to provincial and territorial governments. It's up to the province to accept that recommendation or reject it. In Saskatchewan we have an extremely good record of accepting the recommendations of the CDR, but in some cases we've said no. We've gone in a different direction for socio-economic, political reasons.

If people have a problem, it's not so much with the CDR per se; at the end of the day it's with the province or the provinces. I certainly welcome at any time any patient, any advocacy group, or even any drug company to write me a letter, come to visit, and state their objections. That's what provincial governments do, and they do it very well. Certainly there are appeal mechanisms within Saskatchewan and in most, if not all, other provinces and territories.

So please remember again that CDR simply makes recommendations to the provinces, and it's up to us to accept or reject them.

[Christiane Gagnon, Bloc, Québec, QC]

It seems that rare or orphan disease haven't been properly addressed since there is a lack of data. Some witnesses have told us that it might be a good idea to look at international data. That way, we would have a better idea of the effectiveness of a product.

Do you think it would be a good thing to increase our consideration of certain drugs? Or should we simply be more open-minded about ways to treat rare or orphan diseases?

[John Wright]

Expensive drugs for rare diseases are a unique creature. The provinces and the federal government are dealing with Fabry's disease, and that's the one that's been most public. We've come up with a made-in-Canada approach to dealing with this. In the next three to ten years we're going to see an awful lot more of what I'll simply call designer drugs, designed specifically for genetic diseases. Pompe disease is another example, and I could go on and on.

These are extremely expensive. They cost not $10,000, $20,000, or $50,000 per patient; they cost hundreds of thousands of dollars per patient per year, if not $1 million. As a consequence, all of the provinces have come together, including Quebec, to take a look at how best to approach this. As you so rightly point out, there just isn't enough evidence out there. Fabry's disease is a very good example. The drug for it hasn't been around a sufficiently long time.

We need to come up with some parameters around this that balance the interests of the taxpayers and the interests of the patients. That's why we have an awful lot of good work going on relevant to the national pharmaceutical strategy. In fact there's a subcommittee to look at this and how we should approach it.

That's the best answer I can give right at the moment. I'm certainly very open to recommendations and would love to consider recommendations on expensive drugs for rare diseases. But that doesn't really relate at this moment to the CDR itself. This is something the provinces are considering just slightly outside of the CDR process, because of the very unique qualities and nature of it.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

Mr. Fletcher.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

Thank you, Mr. Chair.

Thank you to the witnesses for presenting today.

This is not directly related to the witness testimony; it's really for the committee's information. You may recall that a couple of meetings ago we had a witness from the Best Medicines Coalition talking about their position on CDR. I asked about their funding sources, because they did not disclose that in their material. It came out that they had about a $250,000 operating budget. It was also very interesting that half their funding comes from the pharmaceutical industry and half the funding comes from Health Canada. I pointed out that when an NGO advocates for CDR to be transparent it would be helpful that the NGO be transparent as well.

Louise Binder, who was testifying on their behalf--and I'm quoting from the committee evidence here--said, “We're totally transparent about our funding.”

Well, the Monday after that meeting, in a variety of newspapers across the country, including the National Post, the Montreal Gazette, the Times Colonist, and other papers.... I'll quote what they said there: “...the Best Medicines Coalition receives 100 per cent of its funding from Canada's pharmaceutical companies--the very industry that stands to profit most from a governmental decision to approve new and expensive drugs for use and coverage in Canada.”

And then it goes on to quote an Alan Cassels from the University of Victoria saying that, “They're all conflicted. These groups are getting money from the very companies whose drugs we're talking about”. The article continues on and says: “Binder said the group actually receives all of its $250,000 operating budget from the pharmaceutical industry. ... Although it received half its funding from Health Canada last year, it was an anomaly, in the form of a grant for a research project.” The claim was hardly totally transparent about the funding.

I'd like to draw to the committee's attention that we have to be wary of some of the groups that come to committee. I'm actually quite disappointed that this individual's organization, the Best Medicines Coalition, was not totally transparent about the funding. It would have been very helpful if they had disclosed at the outset where their funding came from. We would still have listened to their point of view.

My question to the witness, maybe Mr. Wright, is whether this been an issue in the past: groups advocating that may be conflicted in a financial sense. Perhaps you can provide some guidance to this committee on how to deal with these situations.

[John Wright]

Mr. Chair, many years ago I had the great honour of being a deputy minister of finance in the Government of Saskatchewan. Indeed, I don't think it matters if you're in health care or you're running a power company, as I used to do; or an insurance company, as I used to do; or a department of finance; you'll always find situations whereby individuals and companies and lobby groups come forward who are conflicted. They will, from time to time, finance fronts, to be blunt with you.

All you can expect in this world is for people to be honest. All you can expect is for people to be transparent. That's about the best you can do. I don't think there are any guidelines. I wish there were. I wish I had pixie dust or a magic wand every time a witness or an individual came to me in any of the roles I've enjoyed in my career.... But you're not going to get it.

So it's by luck and by chance, and hopefully people are transparent, like the CDR, and hopefully people are honest, like the CDR.

[The Chair, Conservative, Rob Merrifield]

Okay. I think that's the end of the time. I hope there's no pixie dust on that.

Ms. Penny Priddy.

[Penny Priddy, NDP, Surrey North, BC]

Thank you, Mr. Chair.

I thought pixie dust came with the job, but apparently not.

Thank you to the witnesses for being here. Thank you both for your papers. They're both very good, though maybe that's just because I agree with them.

I have a couple of questions, if I might.

Dr. Sanders, you have really already spoken to this, but I just want to reaffirm that I'm understanding it correctly. I'm pretty careful about this.

I want to follow up on what Mr. Fletcher said and clarify what I understand Dr. Sander's paper to say. You're actually making the suggestion at the bottom of page 4 that patient advocacy groups and all the others involved with clinical guidelines should disclose the nature of their relationships with the pharmaceutical industry. You have made that very clear in your paper as well--just so we get that out. That is what you intended.

Second, it may sound like an odd question, but one of the criticisms we've heard--and it seems a bit odd to me--is that while the makeup of the CDR review teams is made public, whether you have an epidemiologist, hematologist, or whoever, the names of the individuals are not. I don't very often see committees made up of people whose names I don't know, so from my experience in ministries and governments and so on, I don't know how to answer the question of why people's names aren't made public.

[The Chair, Conservative, Rob Merrifield]

Does someone have the answer to that?

[Mike Tierney]

I would clarify that the members of CEDAC, our expert advisory committee, are made public, and their biographical sketches and conflict of interest disclosures are available and are on our website.

Perhaps what you're referring to are the researchers who develop the reviews for consideration by CEDAC. We do not disclose those publicly at this point.

[Penny Priddy, NDP, Surrey North, BC]

I know. Why?

[Mike Tierney]

Because, one, the reviews are not disclosed publicly; and two, some of the researchers have actually told us that they would prefer to remain anonymous because they would be subject to lobbying.

[Penny Priddy, NDP, Surrey North, BC]

I see. Okay. I'm not sure if I buy the reason, but I understand the reason.

Secondly, in previous meetings...and I think, Dr. Sanders, you have noted this. Mr. Wright, I don't know if you have or not. The CDR does look at improvement in survival and the quality of life of Canadians. I want to go to the phrase “quality of life of Canadians”, which is on page 6 of Dr. Sanders' presentation. One of the things that some of us have asked for on a fairly continuous basis...and I gather we've asked ethicists if they have time to make a submission to us. I have remained very concerned that I don't understand the way CDR is able to look at the ethics, because as Mr. Wright states, we have drugs that may cost $1 million per year per person. Is that cost-effective? Well, no, probably not; however, that doesn't mean they shouldn't have it.

When you talk about how you consider quality of life, can you tell me a bit about how you do that? You don't have an ethicist involved in those decisions, do you?

[Dr. Jill Sanders]

We're going to just talk a minute about QALYs, and that might help you, and then if you need further information I can take it further.

[Penny Priddy, NDP, Surrey North, BC]

Yes, go ahead. I've heard about QALYs.

[Mike Tierney]

In terms of the assessment of quality of life, many of the clinical trials that are done with new drugs now include measurements of quality of life that the committee will look at, and that helps in assessment of what's called the cost per quality-adjusted life, which is a frequently used standard to assess cost-effectiveness of the drug.

We don't have an ethicist on the committee per se, and as to how to incorporate an ethical framework into the decision-making process, I may turn to Mr. Wright to address that. The mandate of our process is to look at the evidence on the clinical effectiveness and safety and the cost-effectiveness, and to make a recommendation on that basis.

[Penny Priddy, NDP, Surrey North, BC]

Except that's not what this says. This says that CDR also looks at improvement in survival and quality of life of Canadians. That's more than cost-effectiveness, it's more than cost-efficiency, and it's more than whether it's safe and so on.

[Dr. Jill Sanders]

The quality of life referred to in my speech is the medical quality of life terminology, not the socio-ethical values of the society. That is a challenge to all decision-making in health care. It's a very difficult challenge.

[Penny Priddy, NDP, Surrey North, BC]

So you're talking about medical quality of life.

[Dr. Jill Sanders]

Yes, based on the scientific evidence, because CDR, as you know, is about the scientific and clinical evidence. Dealing with socio-ethical values, the willingness to take risk, the willingness to pay, and some of the things Mr. Wright just touched on, is outside of the CDR process. This is strictly clinical.

[Penny Priddy, NDP, Surrey North, BC]

I know I'm done, but it seems to me that it's hard to separate out medical quality of life from other qualities of life. I guess that would take me back—and I'll leave it at this—to when Mr. Wright referred to the cost of rare disorders.

I think it was Steve Morgan, actually, who talked about looking at international data. Even looking at medical quality of life, it's pretty hard to do with a very limited database. Yes, it was Steve Morgan from UBC who talked about looking at more international evidence for this.

That still leaves me with this niggling little concern.

[The Chair, Conservative, Rob Merrifield]

You are done, actually.

[Penny Priddy, NDP, Surrey North, BC]

I knew that!

[Some hon. members]

Oh, oh!

[The Chair, Conservative, Rob Merrifield]

Mr. Brown.