Health Committee on May 1st, 2008

[The Chair, Conservative, Joy Smith]

Your time is up. Thank you very much, Mr. Thibault.

Madame Gagnon.

[Christiane Gagnon, Bloc, Québec, QC]

Good morning, Dr. Berthiaume. In your presentation, you said that you got additional information on risks from drugs, that the risks are becoming known, and that you often check with other agencies elsewhere because they are often tested on a larger scale. That leads me to ask you a question on Gardasil.

When you hear that, in some countries, young girls are dying—there is no proof yet, but even so—that vaccination continues on a massive scale in Canada, and that, above all, tests have not been done on girls for whom the vaccine is intended, that is, young girls from 9 to 12, what is Health Canada's reaction? I know that, at the moment, responsibility lies with the Public Health Agency. Its vaccination program is huge. But at the same time, you are also involved because Gardasil is a marketed product. It is on the market, and it is intended for children younger than those who were used to test it. There are serious complications, that, for some young girls, can mean death.

What is your link with other regulators in the countries where that has happened? What decisions do you need to make to reassure people? What do you tell mothers who give consent for their daughters to get the vaccine? I understand that children need their mother's consent to get it. How do you tell parents that the vaccine poses a risk?

[The Chair, Conservative, Joy Smith]

Ms. Law.

[Dr. Barbara Law, Interim Director, Vaccine Preventable Diseases Prevention and Vaccine Safety, Public Health Agency of Canada]

I'm with the Public Health Agency of Canada, and we actually do the post-marketing vigilance for vaccines that are used in humans to prevent disease.

With respect to the deaths in question, I think EMEA put out a press release on January 24, 2008, regarding a couple of deaths. Our action at that time was to contact them the next day, January 25, to ask specifically about their concerns in regard to these deaths. We were reassured by the EMEA officials that they felt that Gardasil was not implicated in the deaths.

Also, through the memorandum of understanding between Health Canada and us, as well as Health Canada and the European Medicines Evaluation Agency (EMEA), we were able to specifically request the reports, which we got by January 28 and distributed to Biologics and Genetic Therapies Directorate counterparts as well as ourselves, to reassure ourselves that there was nothing there that was of concern.

Every death is a concern, but there are actions undertaken. We felt that all the proper actions were taken. We communicated through proper channels with the people who knew about the deaths and we were reassured there was not an issue. Similar things had happened in the U.S., where there were nine deaths.

I think it's important to note that if you looked at the pre-licensure trials that included 10,000 women, not all 9- to 12-year-olds—and I'll come to that in a minute—but among the women who were studied in the 10,000, there was a group that got the vaccine and there was a group that got a placebo, but nobody knew who got which. There were an equal number of deaths in both groups, none of which were thought to be due to either the vaccine or the placebo.

The problem with any product like this that is used in mass programs is that deaths occur spontaneously due to other reasons. At least in a clinical trial, if it does occur, you have an opportunity to show there's no difference between the group that got immunized versus the group that got a placebo, which doesn't contain the active ingredient.

In post-marketing surveillance, you don't have that other group; you just have the report of a death, and you have to try to discern whether this would have happened because of the vaccine or some other reason. So our feeling was, in collaboration and communication with our colleagues both at Health Canada as well as internationally, that these were not due to the vaccine.

I don't know if you want me to address also the question about the children, the younger girls. In the trials that were done for the vaccine itself.... I think it was made evident earlier that any product that comes to market may have been tested, and with Gardasil, it was 10,000-plus individuals who were tested. That's a lot, but that's not enough to detect rare events, and that's why you need to have post-marketing surveillance. In rare events such as death, each one needs to be investigated and looked at.

In the pre-licensure trials that were done, they were unable to include large numbers of younger children, because of the need to do specific tests that were thought to be inappropriate to do on prepubertal girls. So the tests were only done for those 13 years of age and up. But they then tried to test whether the immune response the younger girls would have would be equivalent, and you don't need to have nearly as a big a number as that.

So from the point of view of the effectiveness of the drug, that was clearly studied. For the safety of the drug, you wouldn't have enough numbers even in the 10,000. So the smaller number, a few hundred of the 9- to 12-year-olds, clearly wasn't enough, but that's something that's followed in post-marketing surveillance.

[The Chair, Conservative, Joy Smith]

You have one minute left, Madame Gagnon.

[Christiane Gagnon, Bloc, Québec, QC]

So that would mean that the cause of death of those young girls is known and that you have been able to identify the reasons. You still had to investigate to find out why those girls died. You are telling us that the girls died for some other reason and that no link with the drug can be established.

You are telling us that there were just as many deaths among girls who got the placebo as among those who got the vaccine. So, what was the incidence of that and is the reason for the deaths known?

[The Chair, Conservative, Joy Smith]

Ms. Law.

[Dr. Barbara Law]

In some cases, yes; and in some cases, no. Regarding the clinical trials, I can't recall the specific examples right now, but we could certainly forward the results to you, if you would like. It was just that there was no difference between the people who had not received the vaccine and those who had. They were randomized.

In the U.S., where there have been reports of deaths as well, it was quite clear that one was actually due to a fatal case of influenza A. It was just a coincidental thing following immunization. There were two others due to thrombosis complications, thought possibly to be related to the oral contraceptives that were taken in those cases.

As for the deaths in Europe, no specific cause could be found. These deaths would fit the classification of sudden unexpected death syndrome, but there was nothing to pathologically link them in any way to the vaccine per se. These things happen. There are times when it could be an arrhythmia; people can drop dead, and you would like to find a cause and you don't.

All I can say is that in terms of the two deaths you were talking about specifically, the European officials indicate there was no clear cause to which they could ascribe the deaths, either from a vaccine or any other cause.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Law.

You mentioned some reports on Gardasil that you had by the end of January. I wonder if you would be so kind as to send those reports to the clerk's office, so they could be distributed to all committee members. These might be useful. Could you do that, please, Dr. Law?

[Dr. Barbara Law]

Certainly, yes.

[The Chair, Conservative, Joy Smith]

Thank you so much.

We'll now go to Ms. Wasylycia-Leis.

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

Thank you, Madam Chairperson.

Thanks to all of you.

I want to start by dealing with the issue of reporting of adverse reactions, since it has been a dominant theme here at this committee.

Bill C-51 says that a health care institution “shall” provide the minister with information about adverse reactions. My first question is that in the past, when we've tried to suggest a role for the federal government in coordinating information and strategies across the country, we have been told that the federal government can't do that because of jurisdictional issues. Why or how is this possible now? Has there been a legal interpretation of this? On what basis is this going to be possible?

[David Lee]

Certainly the committee will be visiting the discussion at the appropriate time.

We can signal that, as Dr. Berthiaume went through, there has been an evolution in how we look at the post-market. The requirement for adverse drug reaction reporting has been in the regulations for a very long time, so that has been happening. Some of the shifting is a question about who should be doing the reporting, what is the quality, what is the frequency, and which institutions should be involved. That has been the recent policy work.

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

Fair enough, but we just had the Auditor General here, who remarked on the inadequacy of provincial reporting of wait times to the federal government, and the excuse by you or the government has been that you can't force the government to do that because it's provincial jurisdiction. How can you suddenly do it here?

[David Lee]

Again, this is very important architecture to lay in, and we need to be very deliberate about what we're requiring. So we're trying to make sure that we get the burden right, that we get the quality right, and that we get the targets right. That's why we've brought on the discussion.

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

Well, I hope this is a new approach by the federal government. I hope it means there is a willingness on the part of the federal government to actually play a bigger role in terms of preserving medicare and working to enhance services across this country.

Let me ask you then, why does it say “shall” in this section? Any time it refers to the minister requiring information that has to do with a drug company not being forthcoming and misrepresenting the facts, it is “may”. Why is there a discrepancy? Why don't we have the same approach to all levels?

[David Lee]

Again, I take it that the committee will entertain a very detailed discussion on these issues as we go—

[The Chair, Conservative, Joy Smith]

I'm sorry to interrupt you, Mr. Lee. There is a point of order from Ms. Davidson.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Madam Chair, are we debating Bill C-51 today?

[The Chair, Conservative, Joy Smith]

No, we are not. We are examining post-market surveillance, and we should stick to that topic.

Thank you.

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

That is exactly what I am doing. I am asking about adverse drug reactions and mandatory reporting. It so happens that is a topic for this committee to discuss. It's also in the bill. I think we had better be clear about what is happening on all fronts, so we can do our work as a committee.

[David Lee]

We like to be helpful to the committee—

[The Chair, Conservative, Joy Smith]

Continue. That's okay.

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

I would like to know how you will define adverse reactions.

[David Lee]

Adverse reactions, again, have been in the regulations for a very long time, and there is not a proposal to change some of that. Again, it goes to who should be doing it and what other instruments we should be laying in. The very, very good work that Dr. Carleton is doing, for example—