Health Committee on Feb. 5th, 2008

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

I'll just let the members respond. I'm done with my questioning.

[Dr. Philip Schwab]

I'd like to respond to that briefly. Our members have been very actively involved in discussions with Health Canada around the progressive licensing framework and the life-cycle approach.

Regarding your specific question around marketing approvals with conditions, we are examining that quite closely as well. We would just add the caveat that discussions around that type of framework need to also occur with the provinces, because our members who manufacture biologic products are somewhat concerned that anything less than a full market approval by Health Canada will inhibit the ability of provinces to make positive decisions regarding reimbursement of those products. We encourage very careful collaboration, so that provinces definitely understand what those notices of compliance with conditions actually mean.

[The Chair, Conservative, Joy Smith]

Thank you so much, Mr. Schwab.

Mr. Skinner, did you have a couple of comments?

[David Skinner]

I'll add very quickly, because it goes to something I raised earlier, that the life cycle changes, and having attachments to that.... I'll give you a good example.

Vitamin K, until recently, was a prescription drug. There's a lot of history behind that. Some of the attachments to how it's sold depend on its final use. As a prescription drug, it has certain aspects with respect to post-market surveillance. If you expose that to a larger audience without the intervention of a health professional, then you can attach other kinds of post-market requirements to give you feedback. Then, as you discover that there's no increased ADR as a result of it, you can remove some of those encumbrances. So it does have a good, positive life-cycle approach when applied appropriately for the kind of product you're thinking of.

[The Chair, Conservative, Joy Smith]

Thank you, Mr. Skinner.

Mrs. Wasylycia-Leis.

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

Thank you, Madam Chairperson.

Well, as usual, my good friend Steven Fletcher has distorted and taken out of context my remarks. Let me try to get back to what I think is the issue of the day, which is recognizing that drug companies, both brand name and generic, have a responsibility for their products.

It's also recognized that you can't have the fox in charge of the henhouse, so our job today is to try to find a way to make sure that there is good oversight from the government of those companies producing the products in which you obviously have an interest in terms of your profit margins.

My question is, given an issue such as the one involving Vioxx, where drugs on the market doubled the risk of heart attacks and stroke and three million prescriptions a year were being written when it was taken off the market, have we learned anything from it? And what changes do you think government should put in place to protect Canadians from that kind of situation?

Does anybody want to answer that?

[Dr. Pier-Giorgio Fontana]

I can certainly comment on the fact that some of these instances have shown that adverse events can occur after a number of years. And the post-marketing effort that Health Canada is trying to regulate in a more structured manner takes care of the recognition that side effects sometimes can happen after so many thousands of patients have been exposed.

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

But I don't think we're seeing that from Health Canada. Whichever incident we're looking at, there's usually a history of all kinds of evidence and all kinds of reports of problems. Canada is very slow to react before getting involved in trying to get more stringent warnings, and it never gets involved in withdrawals. There is no process. It doesn't engineer a process afterwards to see whether the drug was withdrawn soon enough. There's never any analysis.

We have a situation.... I'll go back to Ortho Evra, the patch for birth control. It's on the market. The drug company is basically saying that it's safe but might not be safe for a certain high-risk group of women. But there's no withdrawal. There are all kinds of lawsuits in the States. There are settlements by the drug company. We're sitting in Canada. We're going to wait. We have 93 incidents already in the one year, of which 17 were serious. There were two deaths. So when does something kick in when we have enough information to protect Canadians and tell them that there is a serious risk if they take that drug? We don't have that now. So what do you suggest ?

[Dr. Pier-Giorgio Fontana]

There have been recent cases of market withdrawal when the information, for example, originated in Australia, and that information was communicated by the manufacturer to Health Canada, and there was an agreement between the manufacturer and Health Canada to withdraw the product.

We have to realize that sometimes, as in these cases, some patients benefit from the drug. Also, when you withdraw that product from the market, you have to address issues. What are you going to do with people who really benefit from that drug because--

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

Okay, fine. Then put on a label that says clearly, “This product could cause blood clots or heart attacks”.

[Dr. Pier-Giorgio Fontana]

We are doing that.

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

Well, it's still not clearly on the label with respect to Evra.

[Dr. Pier-Giorgio Fontana]

I cannot comment.

The only thing is that “Dear health care professional” letters are accompanied as well by public advisories on the Health Canada website. So again, in terms of transparency, we are not just communicating this information through Health Canada. Health Canada will then decide whether there is a benefit to changing or altering to the point where substantial steps have to be taken to restrict the product. But the patient is also advised, so there is a way of communicating now.

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

Well, in the case of, say, Evra, the patients weren't advised. So lawsuits were entered into, because serious harm and death happened, because there wasn't that information.

So why wouldn't we then, if we're going to enter into this risk management model, err on the side of telling all? Say there are problems with this drug in certain circumstances. Be up front about it from your end, from Health Canada's end, and from the doctor's end, as opposed to waiting and seeing what the science is. Why don't we accept the science and practise the “do no harm” principle?

[Dr. Pier-Giorgio Fontana]

When those risks are well established and there is consensus about those risks, the labelling goes on to the extent that you even have what is called a framed warning. So it's very clear in the labelling what the major risks are.

If you look at the labelling of some drugs, especially drugs for critical care medicine, you will see that these drugs are very frequently accompanied by very clear, bold.... The problem is that sometimes people do not take these warnings seriously. The manufacturer is really doing everything possible to communicate that information. Doctors have, of course, the responsibility to prescribe appropriately, and the patients have to have a dialogue with the physicians to report how they feel, and they have to read the patient leaflet.

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

Sometimes doctors don't know, as in the case of Vanessa Young, who died because she had a drug for the wrong--

[Dr. Pier-Giorgio Fontana]

But the labelling was correct. The labelling was correct.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Fontana. Our time has run out now. Thank you, Ms. Wasylycia-Leis.

I just want to say that Mr. Tilson is next for questioning. But we are running out of time. There is a new committee coming in at one o'clock, and this committee does have two pieces of business that have to be completed before one o'clock. So there is no time for further questions.

Go ahead, Dr. Bennett.

[Carolyn Bennett, Liberal, St. Paul's, ON]

On a point of order, I have a suggestion.

I've never done this before, but I think the questions the Library of Parliament prepared for this hearing are so exceptional. Because this is so complex, I wonder if we could agree as a committee to put those questions into a letter to these witnesses and have them answer in writing. I don't think we're going to be able to figure out exactly what the concerns have been in a complete way without getting answers to questions such as their participation in the blueprint and a number of other things.

I suggest that might give more information to the researchers and to us, as parliamentarians, with which to write the report.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Bennett.

Mr. Fletcher.

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

My concern is that we had the opportunity to ask those questions. Also, I don't know how much time or how many resources that would take for the witnesses. We may be asking them to do an excessive amount of work. Do they know what they're getting into?

[The Chair, Conservative, Joy Smith]

Ms. Wasylycia-Leis.

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

I think Carolyn's suggestion is an excellent one. It's a matter of sending all the questions to the witnesses and asking them to answer to the best of their ability. If there are problems, they'll let us know. I think it would be very helpful.

[The Chair, Conservative, Joy Smith]

Could we have a consensus? Who agrees that we should send the questions in? Can I have a show of hands, please?

[Christiane Gagnon, Bloc, Québec, QC]

Does that mean questions that we are asking here today, or questions that we ask in writing?