Health Committee on March 13th, 2008

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you very much, Madam Chair.

We all share the same common interest, the participation of patients in adverse side effects reporting. I only would like to know if patients should also play a role in the reporting of positive effects of drugs. I am thinking of cases where a medication would result in more benefits than expected.

[Colleen Fuller]

When patients contact us, they tell us about the positive effects of.... Most of the patients we talk to are taking more than one drug. They have both positive and negative experiences; it's not only negative experiences.

Yes, patients do have a role in communicating the effectiveness of the drugs they're using. When patients are talking about medicine, there are a number of different things that they want to tell you, and there is also information that they want to get. Reporting adverse drug reactions or reporting about the effectiveness of a drug also is part and parcel of a quest for information about other people's experiences and so on. It's all of a piece, if you want to put it that way.

So yes, patients have a role in communicating information about the effectiveness and efficacy of drugs as well as about adverse side effects.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

In our meetings with witnesses like yourselves, we realize that there is a lot of information available. Several organizations are collecting that information. I think that the problem is more on the level of communicating, processing and storing that information. I am talking about the process by which, after analysis, the information is communicated to physicians and pharmacists. I wonder if we will improve the efficiency of the system by adding the patient to the list of persons who collect data. I think that we already have a lot of information, but that we don't really know what to do with it.

[Carol Kushner]

I think you're quite right that there is a huge responsibility on Health Canada to become more effective as communicators of this information. Right now, the ways in which doctors are advised about problems with drugs don't appear to be that effective, necessarily. They are probably more likely, frankly, to react to a front page news story than to an official report from Health Canada. That's a problem.

One thing that will happen, I can assure you, is that when patients read that the drug they are taking is on the front page of their newspaper, they will then inquire about what else they could be taking, what the alternatives are, whether this bad thing is likely to happen to them too.

So I take issue a little bit with the gentleman from the Consumers' Association of Canada, with all respect, because I think that no one has a greater interest in the safety of drug products than the person who is taking them. Especially if it can be easy for them to make a phoned-in report, they have a perfect interest to do so.

The question is, what then is the response? Is it going into a black hole, or is there going to be some reporting back of how their information was used? I think there needs to be more of a quid pro quo.

In other words, if I tell you my story, you have to tell me how it helped fill in the history of this particular product; you have to tell me what steps are going to be taken to advise the larger community about this problem.

Or if my story is a one-off and really wasn't very relevant, I'd like to know that too. I don't mind negative results, but I'd like to know something was done with that report.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

How can we judge if the information reported by the patient is relevant an d needed?

[The Chair, Conservative, Joy Smith]

I just want to say that we have somebody else, Mr. Fruitman, who also wants to say something, and we only have 50 seconds.

Mr. Fruitman.

[Mel Fruitman]

Quickly, in terms of individuals, they're not interested in reporting; they're interested in finding out what it means to them.

Going back to the question about reporting positive results, I'd be quite concerned about that. If you're reporting negative results, it indicates that further testing is required. Reporting of positive results becomes anecdotal type of information, and I see potential for great misuse of that anecdotal type of information. I'd approach that extremely cautiously.

[The Chair, Conservative, Joy Smith]

Thank you very much.

Mr. Tilson, it's your turn, and we just have five minutes. Thank you.

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

I'm going to refer to a report of this committee in 2004, in which all of your organizations participated. In fact, I think Mr. Fruitman gave testimony. Page 5 of that report was on post-market surveillance. The report dealt with a number of things, advertising as well, and that may have been why you were there.

It says this: “In 2002, the department received more than 8,500 domestic adverse reaction reports and more than 106,600 foreign adverse reaction reports. There were 169 recalls of drugs for human use for the same year.” And this is the sentence I'm concerned with: “Health Canada estimated that half of newly approved therapeutic health products have serious side effects identified only after approval and marketing, due to exposure with the larger population.”

My question is this. We're looking at post-market surveillance, but what about the approval system? I find that sentence rather shocking, actually. This is after approval. Have any of you put your thoughts to whether we're looking at the wrong thing, whether the approval system should be improved? I don't even know how that could be.

[Carol Kushner]

Yes, we should be using comparators other than placebo, in addition to placebo. We should be using the best drug to treat a given condition against a new drug to see whether in fact the new drug that's coming out actually performs as well.

[Dr. Durhane Wong-Rieger]

That's not going to tell you. I think the heart of your question is that most studies are not powered to find adverse events, because they're very, very rare in the grand scheme of things. Most studies are powered to find out whether or not they work and whether or not there are some known side effects. I think that's a good question.

I would suggest that it is in fact the right role for post-market and not the role for pre-market. We are looking for a balance. I go back to many of our patients who have severe, life-threatening diseases, who are looking for some treatments here, and they will make those trade-offs between saying they don't know what all the risks are, they do know what some of the benefits are, and they are willing to move into this. We need to continue to collect that information post-market. Having a robust and early-warning kind of post-market system would help address what you need.

The question is this. If we have continual surveillance and we think about it as I think Health Canada has now, where do we draw the line in terms of saying it can now be made available and we'll continue to collect that information? It is a bit of a moving target, and I don't think that's wrong. Most of us are now looking internationally at life cycle of products, and it means ongoing collection.

I hear what you're saying, but I think it becomes a matter, then, of those kinds of judgments. I don't think we have it wrong yet, right now, in terms of where we give the approvals. I don't think we have it right in terms of how much ongoing surveillance we do and what we do with that information.

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

I think you were the one who said a lot depends on how great the risk is. Before you proceed, you try to minimize the risk as much as possible. There's always going to be risk; I think that's what you're saying.

[Dr. Durhane Wong-Rieger]

That's right.

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

Madam Chair, I have a quick question with respect to cost. All of you have ideas as to where we're going to go on this, who's going to do it, how long it is going to take, and how much it is going to cost. I don't know whether anyone's ever estimated what the costs of some of your theories are.

The population's getting older. We have a shortage of doctors. We have increased medical education. We have problems in emergency departments. Everybody wants more money.

In Ontario, at least, 46¢ on the tax dollar was for health care. I assume now it's close to 50¢. I don't know. All of us have to watch that; otherwise we won't be able to spend any money on roads. I hate to put it like that.

[Dr. Durhane Wong-Rieger]

I'll make a quick comment.

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

So does someone have a comment on the issue of costs for all of your theories?

[Dr. Durhane Wong-Rieger]

If I go with Carol's proposal of, say, $20 million—and I don't know what it is because we haven't costed it out—I will say we allocated $2 billion in compensation for people infected with hepatitis C. I think the cost of not investing up front is going to be much greater, and there's also the costs of the patients who are involved. So I say put the money up front.

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

The problem is that everybody uses that argument. The doctors say, if you don't put in some more doctors, we're going to have more problems in emergency departments.

[The Chair, Conservative, Joy Smith]

Thank you.

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

They all use that argument.

[The Chair, Conservative, Joy Smith]

Thank you, Mrs. Rieger and Mr. Tilson.

Ms. Wasylycia-Leis, very quickly. Thank you.

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

I have two quick questions to Carol and Colleen.

What would be your opinion of Canadians when it comes to drug safety? Do you think they accept Durhane's proposal, which is, having checked for safety precautions as much as possible, letting products on even if they're not safe? Or do you think Canadians expect to see products on the market that are safe beyond a reasonable doubt, as much as it's possible given the science and our whole approach?

Secondly, with respect to progressive licensing, could you tell us what we've learned from Vioxx that raises concerns about progressive licensing and how it might lead to a focus on approval of already approved drugs for new medications?

[The Chair, Conservative, Joy Smith]

We need to do this quickly, I'd just remind you, because we are adjourning at 12:30.

[Carol Kushner]

With respect to Vioxx first, the information about Vioxx only came to light because the manufacturer was trying to expand the indications for which it was approved. They thought it would help to prevent colon cancer. The researchers had to twist themselves into knots to hide the fact that this drug in fact was more dangerous, not safer. They had to suggest that naproxen was protective for heart attacks, not the opposite.

In effect, by allowing drugs on even faster, we are really risking not just one more Vioxx story, but many Vioxx stories, and we're going to repeat them again and again. So I would say let's err on the side of safety, let's use the precautionary principle, let's use good science, and let's beef up both pre-approval and post-marketing.

[Colleen Fuller]

I would just add that most Canadians have an expectation that when a drug is approved and sold on the market in Canada, it has been shown to be safe. That is the precautionary principle, that during clinical trials a drug is shown to be safe. The risk management approach is that if the drug shows no harm during clinical trials, it's approved, rather than demanding that it be proven to be safe. It sounds like a subtle difference, but it's not that subtle. Canadians have a right to expect that the drugs that are proven on the market are safe.