Health Committee on March 13th, 2008

[The Chair, Conservative, Joy Smith]

Thank you, Ms. Kushner.

Mr. Brown.

[Patrick Brown, Conservative, Barrie, ON]

Thank you, Ms. Smith.

Thank you for your presentations here today.

Certainly this committee has been fortunate to have heard many distinguished presenters as we've studied post-market surveillance, and one thing I heard suggested early on in the testimony thus far was mobile devices, electronic devices, as a way to have real-time exchanges of Health Canada updates. I heard from the Canadian Medical Association that sometimes their notices to physicians are mailed out or faxed out, and that there is a block of time involved there that could be hazardous when prescriptions are made.

Secondly, we heard from Terence Young on behalf of some victims, including his own daughter, who suffered, unfortunately, from an adverse drug reaction. One thing he suggested, which I wanted to get your comments on, was better pooling of international information. He said there was a timeline—and I forget what it was, but I think he said it was six or eight months—within which studies by a pharmaceutical company had to be shared if their products were being used in Canada. He thought that if study results were found, they should be shared within 48 hours with Health Canada.

I wanted to get your impressions, one, on how mobile devices would be useful, and two, what we could do to better exchange internationally the studies done on pharmaceutical products. They may be sold in Canada, and the study may have been done outside of Canada, but there should be a requirement on that pharmaceutical company to share that information in Canada.

[Dr. Durhane Wong-Rieger]

For the most part, we see that a lot of the studies are in fact international. I go back also to some of our work with new and innovative therapies for rare disorders. Certainly for many of our patients, having no access to medicine is a much greater harm than not. And many patients do recognize that there are risks and benefits and trade-offs. I think what's important is to inform patients of that so they can make good, informed decisions.

Obviously the data have to be, as you say, internationally pooled. In many cases, you're only going to be able to pick up an adverse event, for instance, if you have access to the international database.

What I caution against, though, is what we consider to be some of these knee-jerk reactions. Every study can come out with a different set of outcomes. You have to have in place, the same as you have for an application for approval, a continuous-surveillance or post-market scientific framework. If in fact a physician were to receive a new alert every single time a new study came out and we had these rolling alerts coming out.... We're seeing that happening in some cases, in part because governments have tended to become very reactionary. So people are much more concerned about accusations of not being proactive or accusations of not being up to date with the information, and they end up with these rolling comments. I think that becomes as dangerous, in fact, as not providing the information.

What we need is a systematic framework: how much information, how do we collect it, when should it be made available, how is it analyzed, how is it communicated? Right now, all we're doing is working within very much an ad hoc kind of framework. I don't think we have a framework that really has been put together.

[Patrick Brown, Conservative, Barrie, ON]

Could we get a comment from PharmaWatch as well?

[Carol Kushner]

The important thing here is transparency and access. Right now, an awful lot of data that comes forward to Health Canada the public never sees and the doctors never see. Negative trials are usually not published. One of the issues related to finding out that, for example, SSRIs don't work better than placebos is that the negative trial data was never published. The trial data that said this product wasn't helping never made it into a publication. Now, that might have been because it was actively suppressed or because the study wasn't of high enough quality to merit inclusion, but for whatever reason.... Also, a good proportion of those negative studies were reinterpreted as positive. This is the sleight of hand in science known as creative writing.

[Patrick Brown, Conservative, Barrie, ON]

I know my time is limited, so I have a quick question for Durhane Wong-Rieger.

You said in your presentation that we need to avoid politically biased reporting in the use of post-market data. Could you expand upon that a little bit? Is there currently politically biased reporting on post-market surveillance?

[Dr. Durhane Wong-Rieger]

I go back to saying that everybody has a bias. When we look at Health Canada, at the government, at the drug review agencies, at the provincial governments, and at industry, everybody comes with a bias. I think the challenge is to put that bias out there and to be very clear. Unfortunately, there is no such thing as an unbiased report. What you need is a combination of all the stakeholders and to go back to the opportunity for all stakeholders to have access to information. But there's no such thing as being totally unbiased.

I go back to my example of the government reaction to tainted blood. All the decisions can be looked at in terms of the political biases that went into them, both before the inquiry and after the inquiry. None of them were based on pure science. None of them, one can say, carry no bias of the agency, whether it be reactionary or whether it be protective.

[Patrick Brown, Conservative, Barrie, ON]

Mr. Fruitman, do you have any comments?

[Mel Fruitman]

Yes. I'm certainly in favour of having more information sooner rather than less. I'm not familiar with the exact process, but if they wait until it's published somewhere to have the information, I think that's too long. There should be some mechanism by which the appropriate agencies internationally exchange this information, perhaps even at the early stages. Unfortunately, if they wait until it is published, even if it's in professional publications, then it takes a long time. Then, too, we run into the situation of the media picking up on these things and incorrectly reporting so much of this information, because they aren't equipped to interpret it or they don't read through to the end, where it says something quite different from what the heading seemed to say. None of that serves the public well at all.

Also, perhaps there should be some requirement for researchers, if they stumble across something that should be known.... I think of the Nancy Olivieri case several years ago, in which she basically broke the terms of her contract but felt that she had to do so in the public interest. There needs to be some mechanism by which somebody like that would in fact be required to submit that information and not be penalized or vilified for it. She was subsequently, at least, exonerated.

[The Chair, Conservative, Joy Smith]

Thank you, Mr. Fruitman. I appreciate your insightful comments.

We'll now go into the second round, which is five minutes.

Mr. Temelkovski.

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

Thank you very much. I'll share my time with my colleague Susan.

Consumer reporting is the law. I think we all agree on that. What would make the consumer report? And how would that happen? How do you see that happening—from the consumer to the stakeholder, such as the pharmacist? Right now one pharmacist working for the same company—Shoppers Drug Mart—on this corner does not communicate with the pharmacist down the street on the other corner. Communication is very important.

On Tuesday, we heard from one panellist. He said that if the report is larger than one screen on the computer, it's too big for any professional to fill out. So how would we encourage somebody to report? What are some of the carrots and sticks that we should use?

[Dr. Durhane Wong-Rieger]

I think one has to talk about the different patient populations. When we're talking about very small patient populations—hemophiliacs, or people who have other kinds of conditions—patient registries become really important. Again, you're dealing with very small databases, you're dealing with a lot of uncertainty in terms of outcomes. You get down to, in many cases, very individualized responses to drugs and treatments.

So having a comprehensive patient registry in which ongoing information is collected.... For instance, every month hemophiliacs load their information, talk on electronic mikes, and send it off to the clinic, the database. So all that information is constantly collected.

That's different from, as you say, a large-scale public drug in which people may be taking it who are not necessarily part of a specific patient population.

I think the most important thing in order to encourage people to report is actually to give them good feedback. If in fact I get feedback in terms of what my report is relative to what others have done, if I get examples in terms of what other kinds of reactions or what evidence of efficacy there is, and if we get the good information back that can summarize this, that is probably the best encouragement in terms of reporting.

I'm really willing to do some very onerous reporting. Especially, I will go back to some of our rare disease patient populations, where there are a lot of adverse reactions that we have no clue to.

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

So what you're saying is that we really don't know which came first, the chicken or the egg. Do we tell professionals that we will give them reports and outline the kinds of reports that we'll give them before we ask them to report? We have to ask them to report first, before we tell them how we're going to report it.

Maybe we can hear from the other panellists.

[The Chair, Conservative, Joy Smith]

Ms. Fuller seems to want in on this. I just want you to keep in mind, if you're sharing your time with Ms. Kadis, that she's going to have to have an opportunity. We're just about out of time.

Ms. Fuller.

[Colleen Fuller]

We have enough information to have an idea about who is reporting amongst consumers. For example, both in Canada and internationally, it's known that women are more likely to report than men. They report on their own behalf and they report on behalf of family members and so on.

An obvious strategy would be to focus on women--where women get information, organizations that women belong to and so on--to raise awareness about ADR reporting and about their opportunity to do so.

We also think that community health centres are a venue through which information about ADR reporting should be placed and that patients who walk into a community health centre should basically be approached about adverse side effects.

The MedEffect website that Health Canada established is very, very good for people who are able to use the Internet, but the reporting form is atrocious. It's horrible. It is not consumer friendly. Even if people are prepared to report online, they are so unlikely to use that reporting form.

Most people, in fact, will not use the Internet to report. They're more likely to report on the telephone.

The last thing I want to say is that PharmaWatch has adverse drug reaction reports from consumers that we are unable to give to Health Canada because of the privacy legislation. If we're collecting information from consumers, this is where it stops. It's because Health Canada will not accept information that is anonymous. They have to have a patient identifier. This is a discouragement to a lot of consumers who don't want their personal information known.

[The Chair, Conservative, Joy Smith]

I'm sorry, Ms. Fuller, but we're way over time.

My apologies, Ms. Kadis. We have to go to Mrs. Davidson.

Mrs. Davidson.

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

Thank you very much, Madam Chair.

I want to continue on the same line. Right now when we're looking at reporting, it's not mandatory. The onus, though, is on the manufacturer to do the reporting.

To whoever wants to answer, who do you think should be doing the reporting? And should it be mandatory?

I'll start with you, Mr. Fruitman, because I think you had some other comments to make.

[Mel Fruitman]

I think we get ourselves into a bit of a bind here when we talk about professional reporting systems. Of course, it is a different situation when you have specified groups who are involved with the medical profession in a much more active way than, say, 98% or 99% of the population out there. I think the reaction of most people, when they take a drug that does something they don't expect it to, is to either call their pharmacist and say, “Hey, this happened, do I need to worry about it?”, or call their doctor, whichever one they can get hold of.

I think that needs to be the starting point. I don't think you need to stimulate that. People do that naturally. It becomes a means, then, of how to set up a simple reporting system—for pharmacists, for doctors, or for anybody else who may be the appropriate point of contact there—that allows them to determine, simply, is that report significant? Should it be carried out? Should I fill out a form and forward it to whoever the appropriate body is to collect and analyze that data? You have to have a reporting mechanism right down at that level.

In effect, it becomes mandatory. I don't think you have to legislate—i.e., if you don't report, we'll take away your licence. Instead, set up a system that allows it to be done simply, so that all this data can be collected. Indeed, sometimes it can be refined over time if it turns out you're getting a lot of reports, or maybe these things are inconsequential, or maybe they indeed do indicate something that needs to be made much clearer and apparent to all the practitioners and the general public.

[Carol Kushner]

I think we ought to actually spend a little bit of time looking at the research in this area, because it suggests that patient or consumer reporting directly is a far richer resource than when the report is reduced, through coding, to a few words. I think there will be a real loss if we do anything that would discourage consumers from reporting directly.

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

Do you mean directly to Health Canada?

[Carol Kushner]

Yes, I do.

Now, at the moment we don't have a formal position on our board about mandatory reporting. Our board is somewhat divided. Some people, especially physicians, are saying, “I would spend all of my time making these reports. You have no idea how many people are experiencing these adverse side effects. I wouldn't have time to see patients. All I'd be doing is filling out reports.”

On the other hand, when a patient reports to a doctor or a pharmacist that they're experiencing a problem, maybe it should be mandatory for the doctor or the pharmacist to say, “Aha, here's a way for you to report”--either to PharmaWatch or to Health Canada.

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

Mr. Fruitman, you disagree with that?

[Mel Fruitman]

I think it just won't happen. By putting that kind of obligation on the consumer.... We're all so time-pressed as it is, we don't get to do the things we want to do now. I think the natural reaction is to query, should this be happening, and is it of concern to me? Once they get an answer to that question, they're not going to go beyond that. Even if they're told that perhaps they'd better stop taking something right away because it has a very harmful side effect, they're not going to go back, sit down at their computer, and report to somebody. It's over and done with, as far as they're concerned.

[Dr. Durhane Wong-Rieger]

I think part of it, though, comes back to the level of uncertainty. The more uncertain the data, the more innovative the product, the more you have to put in a robust surveillance system. In some cases, as a condition to having that drug approved, you have to set up a very robust surveillance system. The only way the clinicians are actually going to be able to prescribe that medication is in fact if they agree to do the monitoring and the surveillance. On the other hand, if you have something that has in fact been around for a long time, I think that requires a lesser level of surveillance.

So it really depends, I think, on the product we're talking about. As we've said before, when you're talking about very specific patient populations, in many cases you want to put in a very rigorous ongoing monitoring system in order to make sure you have a product that works and is also safe.

[The Chair, Conservative, Joy Smith]

Thank you, Ms. Rieger.

Monsieur Malo.