Health Committee on Feb. 5th, 2008

[Christiane Gagnon, Bloc, Québec, QC]

Thank you for being with us today and trying to provide us with more insight on your various mandates and on how to interpret your initiatives.

These days, the average citizen feels that he or she may or may not be safe, given the horror stories we read in the paper about deaths, about products that are harmful to the health and about medications that ought not to be on the market. The impression is that we do not have all the information that we would like about the seriousness of the post-market process and about clinical trials.

Mr. Fontana, you say that public posting of information on clinical trials is intended to increase the transparency of the information posted. I understand your objectives. You continue by saying that the International Federation of Pharmaceutical Manufacturers and Associations has to post the results of all clinical trials and that these should be publicly accessible.

But we are not aware of the adverse events. The public has no access to those. That information seems somehow to be shrouded in mystery.

Research protocols are not published. At very least, these protocols are important in assessing the validity of the trials. Do you not think that they should be submitted to an independent body? This point has often been raised by some observers of the pharmaceutical industry.

Could there be a publication on research that leads to adverse events and on all research protocols?

[Dr. Pier-Giorgio Fontana]

Merci pour votre question.

The clinical database is now available through international websites and registries.

We in Canada are in agreement with the recommendation of the International Federation of Pharmaceutical Manufacturers and Associations in publishing in these registries all the clinical trials that are conducted. This is also inclusive of studies that are not started, so that from the outset the protocol or the description of that study is also publicly available.

The fact that some of the studies might not appear in the literature does not mean they escape regulatory scrutiny, because all clinical trials, including the ones that are under way, are part of the new drug submission. So there is scrutiny of all clinical trials, and post-marketing as well—phase 4 trials—will be part of this database.

There can be access, as I mentioned, through portals such as the portal of the IFPMA, and also by Rx&D, but there are other international databases, such as that of NIH or those of the other international organizations. So there is that level of access and transparency.

[Christiane Gagnon, Bloc, Québec, QC]

From the variety of evidence that we have heard this morning, one gets the impression...You know that pharmaceutical companies must give reasonable information about follow-up both on the trials process and on post-market safety. But healthcare professionals are the ones who have to provide the most information to Health Canada, and they do it voluntarily.

Why is the pharmaceutical industry not proactive? How is it that healthcare professionals have to do it? I will not list all the products that have been re-examined from an ethical standpoint and, at very least, whose negative effects and dangers should be made known. In some cases, even deaths have occurred.

BIOTECanada also comes to mind, and GARDASIL, the human papilloma virus vaccine. It is administered very widely in Canada now, even though we know that there have been five deaths in Europe. You are aware of this, of course. You said you are very proactive in providing information and making sure that products do no harm.

What does a company like BIOTECanada do? I asked Health Canada what its responsibility is and I was told that responsibility lies with the Public Health Agency. The vaccine comes from a company like your own. Now we are told that the Public Health Agency is responsible for it. I was not talking to the right person. I was under the impression that it was Health Canada, because that is the department that you have to report to. Things seem to be at an impasse.

I would like you to answer my questions.

[Dr. Philip Schwab]

Thank you for your question.

[The Chair, Conservative, Joy Smith]

Excuse me, Dr. Schwab. You have one more minute, just to let you know.

[Dr. Philip Schwab]

On your last point, the Public Health Agency of Canada is responsible for the administration of vaccines through the public health offices in the various provinces. So reporting on adverse events from vaccines often comes through the public health system, but then the ultimate responsibility for informing manufacturers rests with Health Canada in the marketed health products directorate. Because the vaccines are distributed through the public health system, they have a role in reporting, but the repository of the reports rests with Health Canada. I don't know what specific product you are speaking about, but I can say that when manufacturers of--

[Christiane Gagnon, Bloc, Québec, QC]

You mentioned papilloma. You know that there have been five deaths in Europe. Are you going to take it off the market for the time being?

[The Chair, Conservative, Joy Smith]

Your time is up now. I hate to interrupt you, but we'll go on to Mrs. Wasylycia-Leis.

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

Thank you, Madam Chairperson, and thanks to all of you for your input today. Clearly there are some very divergent views on the question we're tackling as members of the health committee.

It seems to me that when we're talking about post-market surveillance, we're really trying to get from you the best advice for how government, i.e., Health Canada, can ensure that the drugs you put on the market are safe beyond a reasonable doubt and that there are checks and balances in place by government, not by those with vested interests to do that.

I'm very concerned, Dr. Fontana, that you're suggesting, in fact, more collaboration between government and the drug industry on this front, and you have made no recommendations for how you think you need to have proper oversight to ensure that Canadians' health and safety is put ahead of your right to make profits, and that's why you're in the business.

I'm very concerned that you seem to be going along with this risk management model of Health Canada, which of course will aid and abet your bottom line but will do nothing to help Canadians. Why are you not supporting the idea of an independent board to evaluate drug safety, as I understand the representatives from the Generic Pharmaceutical Association are? I'd like to hear from both of you about your views in terms of government's role vis-à-vis safety of drugs and who is in the best position to do that.

[Dr. Pier-Giorgio Fontana]

Our industry is very clearly regulated as to our responsibility with respect to developing the appropriate labelling that describes the risk-benefit profile of the drug when it goes to market.

As you know, once the drug reaches the market, obviously there could be the occurrence of rare events, which could be serious, so there is an evolution of the labelling based on this post-marketing surveillance. The safety of a product is subject to scientific scrutiny. I believe that good science should be open and there should be checks and balances. I do not believe that safety can be in a repository in isolation, without the manufacturer, the clinical experts, the regulatory agencies, and academia. Science has to be a public forum for challenge and scrutiny. When you refer to the post-marketing diligence program that Health Canada is following now, especially with the last draft guidance that was issued last month, we see that they encourage, or they are favourable to, the use of standards that have been developed through ICH, such as E2E.

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

Let me stop you there, because in fact I'm not asking about standards. That's part of the problem, as I see it. We've moved to a paper process in which industry regulates itself based on a set of standards.

I'm talking about active oversight pre and post drugs entering the market. I'm talking about preventing things like Vioxx, which clearly was a problem of improper oversight by an independent body, because the drug company didn't do it. I'm talking about things like Evra, the birth control patch that is now on the market, for which the drug company refuses to put out warnings about the risk of blood clots and heart attacks. I'm talking about the fact that we need something to put a check on you. There's nothing wrong with that. Your job is to market and make profits. The job of government is to protect Canadians.

I want to hear from the generic organization on this front.

[Dr. Colin D'Cunha]

To answer the honourable member's question, our perspective is that the government has the role in regulating. Very clearly, manufacturers that have marketed health products in Canada have a legal obligation to report all adverse reactions known to them. The gap that the previous member got into was what can be done to encourage other people to report. From the perspective of the organization I work for, we receive reports from consumers, health professionals--namely pharmacists, nurses, physicians--other regulatory bodies, and the literature, to name but a few. I think the issue of whether the data should be analyzed within Health Canada or by a third party is something that should be subjected to a policy scrutiny analysis from a perception and reality perspective.

I'd like to close my comment with just one perspective. Even a glass of water is not necessarily safe because drinking too much water for someone who is not in a position to tolerate it may not be a good thing. Forget about the bacterial quality of the water.

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

I'd like to follow up with all of you on the idea that this whole matter should be out in the public in an open way for dialogue and discussion and transparency. Unfortunately, now it's not. It's very hard for ordinary Canadians to get information about what stages various drugs are at, what's being taken into consideration, what have been the adverse reactions, what's the best advice. The two incidents I mentioned, Vioxx being one, are worthwhile to look at just in terms of the problems with our whole process and the problem with progressive licensing, because in fact what we're seeing is the possibility of a drug on the market for one use, but it has adverse reactions in the case of another usage. It starts to open the door to the use of our drug approval process, without going through all the hoops again, for getting drugs on the market for other purposes. I think that's probably a shoddy way of doing public protection.

I'd like to know if you have an objection to full transparency about the whole drug approval process. Do you have an objection to an independent board scrutinizing both pre- and post-drug market surveillance?

[The Chair, Conservative, Joy Smith]

Dr. Fontana, the time is just about up, so please give a short answer.

[Dr. Pier-Giorgio Fontana]

We do not object. The only thing is that, again, we believe in a transparent system, in a way that the manufacturer, the regulatory agency, the prescribing physician, and the patient are part of a partnership of communication. The information is available and is becoming more and more available through the registries I mentioned. The off-label use that you referred to is something that we, the manufacturer, obviously cannot be responsible for. We know that sometimes doctors do that, but that's medical practice. We have a product monograph that clearly defines what indication, what is the target population, what are the risks.

If you look at the product monograph of a drug, you will see that there is a list of adverse events by frequency of event. As I mentioned, though, these are data coming from controlled clinical trials and a controlled environment. Once the drug goes on the market, we have to monitor. If the risk-benefit profile evolves in a negative manner, then there are means for Health Canada to remove the product or restrict the product in terms of usage.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Fontana.

Mr. Tilson.

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

Good morning.

My question is to all the groups. I'll start with Mr. Schwab.

What is a serious adverse reaction? I know that sounds like a dumb question, but obviously complaints are made and someone has to decide whether it's serious or it's not serious. That decision has to be made, so I assume that somewhere in the bowels of regulation there's a definition as to what that is.

[Dr. Philip Schwab]

Absolutely, and I believe a physician or a public health professional makes a decision about when an adverse event needs to be reported, and then those—

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

I understand that. I want to know what it is. I'm just a simple guy. I don't know what it is.

[Dr. Pier-Giorgio Fontana]

A serious adverse event is a noxious or toxic side effect of a drug that causes potential injury, or hospitalization, or cancer--there are five or six criteria, which doctors know about, because it's also part of that reporting form I mentioned.

The serious adverse events are reported, again, in the product monograph, and again, they are defined as causing a serious injury, hospitalization, or impairment of some sort. So they are well defined.

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

Dr. Skinner, are you okay with that? Is that too loosey-goosey?

[David Skinner]

Actually, I was going to define it more broadly. It's any reaction that would require some medical intervention. I'll give you an illustrative example of what would be and would not be--say, a poisoning incident--because this is more commonly part of the entire database of adverse events, as well as a risk profile.

A poison control centre may indeed get a phone call from a mother worried that her child had ingested something from underneath the kitchen counter. That gets logged as a poison statistic. There may never have been an ingestion, just simply that there was a suspicion on the mother's behalf, she made the phone call, and so on. But had there been one that required the child to go to the hospital and have an intervention, that would have been logged as an actual event versus a report. So at a very simple level it requires an intervention, and it also really reinforces the need for good clarity on definition.

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

Does Health Canada have a definition?

[David Skinner]

Yes, they do.

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

This is a question to anyone. Let's move to Mr. D'Cunha.

Health Canada has said that less than 10% of adverse reactions to products are reported to Health Canada. That's not very good, if that fact is true.