Health Committee on March 13th, 2008

[Colleen Fuller]

From our perspective, the biggest problem with the vaccine is its promotion. This is a new vaccine. The clinical trial history could have been more complete and longer, from our perspective. But there is no clinical trial that will ever be able to detect all of the potential risks associated with a drug or a vaccine or a medical device. It's just not possible.

Our concern with this particular vaccine was that it was being promoted for a mass vaccination, that all girls were being targeted for a vaccination with Gardasil. We felt that was just inappropriate because the deaths due to cervical cancer in Canada are quite low, and because there has been significant progress as a result of the Pap smear screening program. There wasn't the need for this type of mass vaccination program.

That may be different with different population groups as well. People who are not in large urban centres don't have access to regular cervical cancer screening, and so on. So there are these differences even among the Canadian people. And internationally, that's even more so.

With this particular vaccine, I haven't seen a plan for the post-market monitoring of the use of the vaccine and I'm not even sure if there is one. Perhaps there is and I haven't seen it. I don't know. But with this type of heavy promotion and what we already know about the adverse side effects, which have been reported internationally, I think Health Canada should be proposing some very systematic collection of data and monitoring of adverse side effects. And I haven't seen that.

[Carol Kushner]

I would only add that I think fewer than a hundred girls in the 12- to 13-year-old age category were actually subjected to clinical trials.

There have been some assumptions made in the clinical testing: first of all, that younger girls would be similar to older girls and young women; and secondly, that it was important they vaccinate girls who had not yet become sexually active because their risk of having been infected already with HPV was so high, and that would have rendered the vaccine absolutely useless. So it was important to demonstrate efficacy by testing it on girls who were not yet exposed.

The other thing is that the groups that are most at risk tend to be immigrants, Innu women, and people in remote locations. Apparently, at least for some subpopulations, the virus causing HPV among some of those populations is not the one targeted by Gardasil, so we have a problem there as well.

I think this program was just launched a little too hastily.

[Dr. Durhane Wong-Rieger]

Can I make one additional comment on that? I think it's a perfect question and it's a perfect example of the disconnect between what happens in terms of Health Canada and their approval for marketing and what actually happens in terms of the availability and marketing.

It goes back to the federal-provincial divide. At the federal level they approve it for safety, approve it for efficacy. I think when Health Canada does that approval it means something, and it means something significant. The problem is that then when we talk about making it available, that information is not necessarily carried over in the right way, but as other people have said, the availability becomes totally disconnected. And it's almost impossible to call it post-market surveillance anymore, because as we're talking about progressive licensing and continuous licensing renewals, we have to be talking about ongoing surveillance.

So this is a perfect opportunity to ask, based on the uncertainty of the information—there is always some uncertainty—based on, as you say, the patient populations it's been tested on, what else do we need to do in order to be assured that if we're going to roll out the program, we're going to collect, in a continuous way, the information that is going to feed back into that decision?

And again, Health Canada, in their progressive licensing framework, has set it up perfectly to say that as we get more information, we can re-evaluate where we are. So as this program rolls out, as we collect not only safety information but efficacy information, we should be able to feed it back into the approval process to ask, where are we, and do we agree? And that should also feed back into the accessibility or the marketing process to ask, is it still being marketed in the right populations?

So it's an ideal opportunity to set up that integrated framework, and this is really where we do have to have that close cooperation between all of the stakeholders, including the patients and the clinicians, but also between the various levels of government.

As we're looking at it, it's an example where we can really take advantage of what we're trying to do in terms of setting up a much more robust, continuing surveillance of both efficacy and safety, but also the appropriate patient populations. And I would agree that I don't think it has been done.

[The Chair, Conservative, Joy Smith]

Thank you, Ms. Wong-Rieger.

Ms. Wasylycia-Leis is next.

[Christiane Gagnon, Bloc, Québec, QC]

I just would like to make a comment.

[The Chair, Conservative, Joy Smith]

Madame Gagnon, your time is up.

Please go ahead, Ms. Wasylycia-Leis.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Thank you, Madam Chairperson.

And thanks to all of you for being here today.

I want to start by asking each of you if you have any money for your organizations from pharmaceutical companies. Do you, Durhane?

[Dr. Durhane Wong-Rieger]

Yes, we do.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Can you give us more detail? For example, which companies are involved?

[Dr. Durhane Wong-Rieger]

We have it in terms of any time there's a conflict of interest.... We work with a number of organizations, including organizations that deal with us on anemia. We deal with organizations that deal with us in terms of blood. I also get some funding from--

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

But do you get some money from pharmaceutical companies?

[Dr. Durhane Wong-Rieger]

I get money from pharmaceutical companies.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Mel?

[Mel Fruitman]

No. We get no money at all, actually.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Does PharmaWatch get any money from big pharma?

[Colleen Fuller]

No, we don't get any money from big or small pharma.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

I ask that question because we've had a number of presentations over the course of the study, and we're not always informed about what's behind some of the groups' recommendations. I always get a bit suspicious when I hear a very unequivocal support for the government's present system by those groups that don't seem to have connections to big pharma. It seems to be very worrisome.

To start with, Colleen and Carol, you've clearly raised some concerns and you have no funding from big pharma. What is your sense of the government's plans with respect to post-market surveillance?

Even though we're involved in the study, a parallel approach is being carried out by the government. According to the department officials themselves, it will shift the focus from pre-market review to this continuous assessment of risks and benefits. This has been tried before by previous administrations. It's always been defeated because of concerns about products getting onto the market without necessarily being safe, without the precautionary principle having been practised.

I want to know what you think about that plan, because in fact it gets at the heart of our discussions.

[Colleen Fuller]

We are a critical voice. We criticize Health Canada. We criticize the pharmaceutical industry for policies that result in harm. That's what our role is. We have been, and continue to be, critical of Health Canada because we feel that their orientation is focused on creating a friendly business environment for the pharmaceutical industry and ensuring pharmaceutical investments in Canada.

We think that approach often subordinates the public interest. I'll tell you, as somebody who has been involved in this area because of a very serious adverse drug reaction, that my impression of Health Canada was that they wanted to convince me, and I think they want to convince the public, that the industry is doing the right thing. They want the public to have confidence in the industry and believe that the industry is able to place the public's interests above the interests of their own investors, and I don't believe.... I think Health Canada does think that they are charged with that responsibility—to balance the public interest with the interests of pharmaceutical investors—and I don't agree with that, so I'm concerned about the direction.

My concern about post-market surveillance right now involves a number of things. One is that there's discussion about applying a cost-recovery model to post-market surveillance, which we are completely opposed to. We also feel that post-market surveillance should not take the place of a rigorous system that is put in place before drugs ever get to the market. That is the most important thing: post-market surveillance is obviously very crucial, but nothing can take the place of a good system to ensure we are getting safe and effective drugs on the market in Canada.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Carol, I'd like you to comment in that context. We already have, as you know, an imperfect system in terms of pre-market approvals. It must worry you, then, to hear department officials say they're going to shift the emphasis from that to post-market. Talk about some of the problems.

[Carol Kushner]

It's very worrying. We've already seen Canadians suffering significant harm from drugs that went through the old system—even the old, old system, before we speeded up approvals to the point where they are today, because approval times have come down significantly. One of the problems is that the department itself, the directorate, is penalized if they take longer with a drug. So there's a cost to their budget if they're slower.

The idea that we should actually speed up approvals even more, to my mind, would only expose Canadians to further potential harms and, in a sense, deceive the public into thinking this was perfectly safe, just as it was before. It's not.

We have to take a step back and look at these issues again. We have to be sure that when we approve a new drug, we're as sure as we can be that it's safe and efficacious. And even then, because of the nature of clinical trial evidence, we still have to do good post-market follow-up to make sure that when it's exposed...because a drug that is tested on a thousand people may be used by a million people or more.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Carol, could you talk a bit about some of the problems we need to watch out for as we go through these hearings? You're an expert, I think, from reading in the media, on astroturf groups—

[Carol Kushner]

Yes.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

I'd like to know what we should watch for as people come before us with connections to drug companies, how we can identify them, and what we're likely to hear from them and how we should treat the evidence from these groups.

While you're at it, could both of you address the fact that there are a number of expert advisory committees to Health Canada with representatives of industry on them? What does this do to the work of these committees?

[The Chair, Conservative, Joy Smith]

We're just about out of time, Ms. Kushner, and that's a big question. So I'd just ask you to summarize it, because you'll have other questions coming at you as well.

[Carol Kushner]

Okay, I'll be very brief.

The issue around industry-funded groups is that in general—and this is a generalization—they tend to emphasize faster access to new products and they under-emphasize safety concerns. Almost always they are talking about needing access. That seems partly to be a defence of a patient group that might need access to that drug, but it also reflects what is very much in the pharmaceutical company's interests.