Health Committee on Jan. 31st, 2008

[Christiane Gagnon, Bloc, Québec, QC]

Let me tell you about a rather worrisome case. I would like to know what kind of decisions you make when you learn, for instance, that some people have died after taking a drug or a vaccine.

In Europe, two people died after taking a vaccine against cancer of the cervix. Now we had a sizeable vaccination campaign here. Many people reacted because apparently, certain stages of the process had been skipped because they were in a hurry to put this drug on the market. In Europe, young adolescents died after being injected with this drug.

Your answers lead me to believe that you are never proactive and that you wait for serious or extremely serious situations to come up before reacting. In the example I cited, the stages preceding the marketing of the product were followed too hastily. In certain provinces, the stages which consist in detecting the undesirable side effects of the drug had not been completed. And then, two people died. Was that the cause? It raises some questions.

When people die and when, within a very short period of time, we succeed in connecting the deaths to the injection of the vaccine, don't you think that we should impose a moratorium? Right now, we are running a huge vaccination campaign with this vaccine, and it has been widely criticized. People feared the very things that happened.

How do you analyze the situation?

[Meena Ballantyne]

It's quite true we are reactive. We are trying to move toward a much more proactive approach. There's no question about it. So if we did get an indication of two deaths due to this vaccine, we would have to make sure we knew the cause and effect in this case, because--

[Christiane Gagnon, Bloc, Québec, QC]

Are you aware of that?

[Meena Ballantyne]

We would hope so.

[Christiane Gagnon, Bloc, Québec, QC]

Are you aware of that?

[Dr. Chris Turner]

Vaccine surveillance is done by the Public Health Agency of Canada, but they then liaise, in this situation, with the biologics and genetic therapies directorate in our branch, so they're--

[Christiane Gagnon, Bloc, Québec, QC]

Are you aware of the fact that two cases of mortality were reported by the European Agency for the Evaluation of Medicinal Products? It was on January 25.

[Dr. Chris Turner]

No, as I said, the monitoring activity my directorate does is not responsible for vaccines. That's monitored by the Public Health Agency. So I can't speak to whether or not they're aware of this at this point, but I would suggest--

[Christiane Gagnon, Bloc, Québec, QC]

It is really unbelievable that you are not in touch with... I was opposed to the Public Health Agency of Canada precisely because that makes two entities that do not seem to be communicating. Each one is working in isolation from the other. You are involved in post-market surveillance, and it is a public health issue. I can hardly imagine why there is no contact. I was opposed to this separation between Health Canada and the Public Health Agency of Canada.

[Meena Ballantyne]

I'd like to say that we might not be aware here, but we have a whole team of people who are scanning this, who are probably aware of this, and we can check into whether we know about it.

[Christiane Gagnon, Bloc, Québec, QC]

Many of the mothers who read the newspapers must be worried about this now. Some tests on young women aged from 15 to 25 had not been carried out.

[Meena Ballantyne]

But as you can.... If I may, Madam Chair--

[The Chair, Conservative, Joy Smith]

You were trying to answer.

[Dr. Chris Turner]

One of my directors from our area who is monitoring pharmaceuticals has just advised me the EMEA in Europe has issued a risk communication on this issue, so there is an awareness of it. But as I said, we're not primarily responsible for the monitoring of adverse effects for vaccines, so we wouldn't be responsible for that. But just as an aside, we are aware of it, if that gives you any confidence.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Turner.

Thank you, Madam Gagnon.

Mr. Tilson, go ahead.

[David Tilson, Conservative, Dufferin—Caledon, ON]

Madam Clerk, is the Canadian Medical Association coming as a witness in the future on this topic? I'm going to talk about them.

[The Chair, Conservative, Joy Smith]

The clerk informs me that they are on the witness list.

[David Tilson, Conservative, Dufferin—Caledon, ON]

A representative from the Canadian Medical Association sent me--I don't know what it is--a paper, purportedly by them, in which they talk about a number of topics, one of them being strengthening post-marketing surveillance. I have no idea the date of this. It was faxed to me on January 23, 2008. This is what they say:

Currently post-marketing surveillance of drugs in Canada is inadequate, relying on reporting which is often erratic and inconsistent, and for which reporters are not compensated. Canada needs a coordinated post-marketing surveillance system to monitor the ongoing safety of marketed drugs. Surveillance should include medication incidents and adverse drug reactions, and should document and consider the effect of the “systems factors” contributing to these events.

Of course, I don't want you to repeat what you've spent the last two hours talking about, but have you got anything to add to this? I assume they're going to come. I assume this is a reliable piece of paper I have and that it's accurate, so if they're going to come, they're going to say this.

[The Chair, Conservative, Joy Smith]

Mr. Tilson, they are invited for February 26. They have not confirmed yet, but that invitation is there.

[David Tilson, Conservative, Dufferin—Caledon, ON]

Well, if this is correct, if this is their statement, could one of you comment on that? It's like an opposition statement.

[The Chair, Conservative, Joy Smith]

Yes, go ahead.

[Michael Vandergrift]

I'd say that's precisely what we're striving to do, to have a more coordinated approach to post-market surveillance activity, and as Dr. Turner was mentioning, that's a combination of increasing reporting of serious adverse drug reactions, but also doing things like working with data sets that exist at provincial and territorial levels, data sets that the Canadian Patient Safety Institute is developing, and data sets that CADTH, the drug and health technology assessment agency, has. So it's a combination of recording and data coming in, but also proactively mining data sources that exist. That's how you can get a better and more complete picture of what's taking place out there.

[David Tilson, Conservative, Dufferin—Caledon, ON]

The answer that was just passed to you there, what does that say?

[David Lee]

I'd just add that ongoing surveillance of this nature is really very key to our life cycle management. I mean, this is why we're asking for these tools, to be able to coordinate.

[David Tilson, Conservative, Dufferin—Caledon, ON]

Yes. In other words, you're acknowledging some of these things and you're saying you're trying to improve on them.