Health Committee on April 8th, 2008

[The Chair, Conservative, Joy Smith]

You only have 10 seconds left.

[Ève-Mary Thaï Thi Lac, Bloc, Saint-Hyacinthe—Bagot, QC]

Do I have time for one last question?

[The Chair, Conservative, Joy Smith]

We're running out of time. We have just a few seconds left.

[Ève-Mary Thaï Thi Lac, Bloc, Saint-Hyacinthe—Bagot, QC]

The briefing notes prepared by the Library of Parliament for the committee contain a section on Health Canada drug notices and warnings. Health Canada has issued warnings about three drugs. I was astounded to read this, because I use one of these drugs and as a consumer, I was unaware that any warning had been issued. Even after the warning had been issued, my doctor renewed my prescription.

Is there not a simple way of advising consumers when they go to the pharmacy that a warning has been issued about a certain drug? We know that...

[The Chair, Conservative, Joy Smith]

Very briefly now, please.

[Ève-Mary Thaï Thi Lac, Bloc, Saint-Hyacinthe—Bagot, QC]

When the automobile industry announces a recall or issues a warning, consumers are notified. I would like to be informed in this case as well.

[The Chair, Conservative, Joy Smith]

I'll go to the next person.

Mr. Fletcher.

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

Thank you, Madam Chair.

Today we have talked a lot about post-market surveillance of the consumption of drugs. I want to take a bit of a different angle. Today the Canadian Medical Association Journal released a study described as the first to document a wide range of unintended health consequences from a major drug warning.

It describes how Health Canada issued a warning on a variety of antidepressants for children, and as a result, there was a 10% decrease to visits to doctors but a 25% increase in the suicide rate. I read that first in the Winnipeg Free Press this morning. I'm looking at the Leader Post from Regina.

Could you comment on the unintended consequences? If you're too cautious, you could have unintended consequences the other way, by denying people the drugs they would need. If you deny the drugs or reduce the availability of drugs that people may need, that would be an unintended consequence in itself.

[Patrick Orr]

Thank you.

I'm not aware of the study, but I'm aware of the original problem with the drug. I sympathize with the issue. If you alarm people, they'll swing in an opposite direction, and they may do things that are adverse to their health interests.

In my view, the problem is a lack of trust in the system. When the public hears there's this great drug, the advertising hypes it, and then they tell you there are all these unintended consequences; people lose faith in the approval process and the drug company representations. So it's partly an expectation of the public. They're told there's faster access to miracle drugs and so on, but then they get disappointed and might swing in the opposite direction.

We need public awareness that drugs are quite imperfect and they cause lots of problems.

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

But this is the problem for government--coming up with a balance.

This is the first study of its kind. I'm concerned. The government is trying to do this progressive licensing to allow people to have access, and we'll keep an eye on the negative consequences and so on, but if we don't do that, there could be a lot more people potentially adversely affected, but it would be a lot more difficult to figure out.

[The Chair, Conservative, Joy Smith]

Dr. Laupacis, I think you wanted to comment on the other question. Would you like to speak on this as well?

[Dr. Andreas Laupacis]

Yes. I don't know the details of this study, but I think it's a perfect example of how one needs to balance the benefits and harms of medications in a rational way.

To address your question about whether there are any other downsides to some of the post-marketing surveillance, the fact of the matter is that analyzing these databases that Steven and I have talked about is relatively cheap, because they exist. It's not like a random trial where you have to randomize hundreds of patients.

We need to be careful. There is a tendency, for example, for the pharmaceutical industry to want to mine these databases until they find the result that makes their drug look terrific, publish that, and not tell you that they did 25 studies before they found the one they really wanted. Similarly, some people who might have an axe to grind with the pharmaceutical industry might search these databases 25 times and only report the one that shows harm.

I think it is absolutely crucial that we have a network of these researchers, and that we not make any major decisions such as pulling a drug off the market on the basis of one of these post-marketing studies, but rather on consistent and reproducible evidence from different jurisdictions.

[The Chair, Conservative, Joy Smith]

Thank you, Doctor.

Ms. Wasylycia-Leis is next. She'll be here momentarily.

We'll go to Mr. Tilson.

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

Thank you, Madam Chair.

I have a question for Mr. Orr. You indicated that you've represented people in class action lawsuits. Did I hear you say that?

[Patrick Orr]

Yes, that's correct.

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

This may contradict a little of what you said, but my understanding is that there is no obligation on health professionals--nurses, doctors, pharmacists, people in hospitals--to report, as you described, the serious problems. I may have misinterpreted what you said. It is my understanding that there is an obligation on the pharmaceutical companies to report serious issues--serious complaints.

If someone gets something as a result of taking a drug, they don't know what's serious and what's not. I don't even know if I know what serious problems are, although I've asked the question of a number of witnesses.

We're probably down to three minutes by this time, but can you give us a short summary of the case law with respect to the liability of professionals who do not have an obligation to make reports to Health Canada, if any?

[Patrick Orr]

It's a difficult question for me to answer. It's not an area of my particular expertise.

If you're speaking of the responsibility of physicians to a patient and not industry or Health Canada, my understanding is that their obligation is to take reasonable care to protect the health of their patients. That standard is judged by what's normal in the profession. Reporting by them to industry or Health Canada, I think, is not necessarily part of their standard of care.

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

Well, I guess, then, getting to the point, they prescribe something, and it turns out that maybe they shouldn't have, so the patient comes and says, “What in the world is going on here?” and the doc tries to protect himself or herself by saying something.... Well, they may be liable.

I guess I'm getting to the issue of reporting, the obligation to report. Someone has indicated here—at least I thought so, and maybe it was you—that there is no obligation to report, and I don't think there is with these people. But my goodness, if a doc prescribes something and it turns out that there's a serious problem, he'd better report. And if he doesn't, I would suspect he's liable.

[Patrick Orr]

That I would perhaps defer to a physician and their code of conduct.

I would speak to mandatory reporting from industry, because there is at least some obligation on industry to report now, although I believe it's only in a very serious event. But I believe the physician should inform the patient that there might be a problem with this drug and deal with it, and they should probably have to report to their professional association, and if it's aware of this drug causing problems, they should report to Health Canada as well.

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

Yes. Well, I guess we'll have to watch what's going on.

You made some comments about adverse reactions. Am I to understand you to have said that what are now serious adverse reactions need to be reported? Are you saying that, really, all adverse reactions should be reported?

[Patrick Orr]

Yes.

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

I'd like others to comment on that.

[Dr. Andreas Laupacis]

As a physician, if I prescribe a drug thinner like Warfarin, which has a clear risk of major bleeding, and I tell my patient that's the risk and we agree that he or she wants to take the risk and then the patient has a bleed, to my knowledge I don't have an obligation to report it. I have an obligation to discuss it with the patient, and I'll feel terrible that it happened, but that's a well-known side-effect of the drug. Frankly, reporting it to Health Canada, with 30 million people taking drugs, would just paralyze the system.

[The Chair, Conservative, Joy Smith]

The time is over now, Dr. Laupacis.

Madam Wasylycia-Leis, you have five minutes.

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

Thank you, Madam Chair, and thank you for your indulgence, since I had to slip out of the room.

I want to try to get back to the essential ingredients of any kind of proper post-market surveillance system. One we've talked about is progressive licensing, as long as it doesn't reduce or move away from any attempt to follow a precautionary principle at the front end. I just want to check that this is what you're saying, and what it means, when the ADM comes to our committee and says they want to implement a lifestyle approach to regulating health products that shifts the focus from a pre-market review to that one that continuously assesses a product's risks and benefits. Is that not a problem?

Secondly, related to that, I know we have to talk about risks and benefits and that there are some drugs that come on the market that have some safety problems but it might be better than dying, etc. Don't we have now an “exceptional circumstances” drug release program to do just that? Why do we need to be less stringent at the front end and put more Canadians at risk in order to accomplish something that's already on the books now?

That's the first question. I'll try to fit in some more if there's time.