Health Committee on June 10th, 2014

[Dr. Joel Lexchin]

I certainly think we need more information about natural health products. I work in an emergency department. When people come in and they say they're taking various natural health products, I really have no idea of, one, the inherent risks associated with those products, and two, how those products interact with any prescription drugs that those people may be taking.

I'm not alone. I think most of my colleagues are in the same position. We definitely need more information about the safety of these products. But I think one of the things that killed Bill C-51 was the opposition from the natural health products community. I would hate to see Bill C-17 killed because of that same kind of opposition. I think we need to move forward with better regulation of natural health products. But I agree that I think it can be done at a later date.

[David Wilks, Conservative, Kootenay—Columbia, BC]

Thank you.

Professor Graham.

[Prof. Janice E. Graham]

Thank you. It's a very good question, Mr. Wilks. Thank you for asking it.

I was researching at Health Canada when the natural health products directorate was brought into being. At that point in time, Canada was a world leader, and it remains a world leader in having a natural health products directorate. Unfortunately, and I will say it here, they caved to industry pressure—and I'm talking about the natural health products industry—and removed issues of efficacy from approvals. So unlike biologics and pharmaceuticals, NHPs or natural health products don't actually need to have the stamp of showing that they are an efficacious agent.

Mostly people were worried about safety, and I share all of my colleagues' concern that many of the natural health products aren't all that safe. This is something that is recognized everywhere in the world.

I was in West Africa last month and watched a little boy writhing on the ground after he had to have a terrible abscess removed without painkillers, because the nurse in this tiny clinic without electricity recognized that these kids were coming in and.... People first go to what in Canada is the medicine cabinet or to what anywhere else is the local herbalist and pick up whatever they have. When they finally go as a last effort to the emergency ward, the emergency people can't treat them, because they don't know what they've taken.

I think the issue of natural health products would very easily derail all of our interests in getting the amended Bill C-17 forward, but I would like to leave it off for now, because we want to see Bill C-17 amended and approved.

[The Chair, Conservative, Ben Lobb]

Thank you very much.

Thank you, Mr. Wilks.

[Terence Young, Conservative, Oakville, ON]

Mr. Chair, I have a point of order.

Professor Gibson made a really brief remark on natural health products, and I could tell she wanted to say more. I wonder if we could ask the clerk to write to Professor Gibson to ask her if she wouldn't mind submitting further remarks in addition to her brief comments on the record about natural health products and Bill C-17.

[The Chair, Conservative, Ben Lobb]

We can certainly ask her to do that and will make sure that the analyst gets it in her hands, too.

Okay, Mr. Morin.

We'll give it another go here, ladies and gentlemen.

Dr. Lexchin and Ms.Graham, would you give us an indication once Mr. Morin starts whether you're getting it in English or not?

[Dany Morin, NDP, Chicoutimi—Le Fjord, QC]

Can you now hear me in English when you use the earphones?

[Prof. Janice E. Graham]

Yes, I do.

[Dr. Joel Lexchin]

There were only a few words from Mr. Morin. I didn't hear any English associated with it. Perhaps if he says a little more, I can tell.

[Dany Morin, NDP, Chicoutimi—Le Fjord, QC]

That is not a problem. If you wish, I can speak in French longer.

Can you now hear the simultaneous interpretation?

[Dr. Joel Lexchin]

That's fine. I can now hear in English. Thank you.

[Dany Morin, NDP, Chicoutimi—Le Fjord, QC]

I am very happy about that.

Thank you for giving me the opportunity to speak my native language.

My first question is for Mr. Lexchin and Mr. Herder. Other witnesses may also make comments on this.

Earlier, we spoke about a contraceptive pill which, according to the old definition which is not included in Bill C-17, meant that a pregnancy was considered to be the consequence of a life choice. So, according to the new definition we find in the bill before us, are there other concrete examples of medications which were mistakenly classified?

In other words, will the new definition solve other situations we may have seen in Canada, aside from the contraceptive pill which was used as an example previously?

[Prof. Matthew Herder]

Perhaps I can speak first.

I think the point Professor Gibson was making was around restrictive interpretation of harm or injury. Her point was that without clear guidance, harm or injury encompassed products that had been mislabelled or mispackaged and that therefore wouldn't work as a result, as was the case in a contraceptive pill, which they may not include in the definition of “harm”.

With the definitions that are in Bill C-17 and with the additional wording that she proposed for circumstances in which they may not work because of mislabelling or mispackaging, the bill would capture other things as well as adverse drug reactions—the more traditional kinds of harm.

I'm not sure that I have squarely addressed your question, but I think we're there in terms of what has been offered.

[Dany Morin, NDP, Chicoutimi—Le Fjord, QC]

In the history of Canada, do you know of any other concrete cases of this type of problem, or was this type of decision only made for one medication?

[Prof. Matthew Herder]

I think there have been other examples where there hasn't been quick action by the regulator because there's been a dispute or a discussion about whether the harm is clearly owing. Diane-35 was another medication that's commonly used to treat acne that has received some attention in the last year or so. Really the delay that people were concerned about stems from a lack of a power to issue a recall without the permission of the manufacturer. That's what's in this bill.

That's one example. I don't know if Dr. Lexchin can offer others.

[Dr. Joel Lexchin]

I don't know of any concrete examples, but one of the problems with getting concrete examples is that it's very difficult to get information from what Health Canada publishes about drugs that it has withdrawn from the market for safety reasons. In fact, Health Canada does not currently have such a list. If you want to know what drugs or how many Health Canada has withdrawn from the market because of safety problems, say in the past 20 years, you have to go into and search through 20 years of reports from Health Canada to compile such a list. Health Canada doesn't maintain that on its own.

[Dany Morin, NDP, Chicoutimi—Le Fjord, QC]

Thank you.

Doctor Herder, you spoke earlier about post-marketing trials.

In Canada, how important is it to crack down on pharmaceutical companies by forcing them to release the results of other trials once the medication is on the market?

[Prof. Matthew Herder]

I think it's essential to do a couple of things. One is to ensure that any such conditions placed on a licence to market a drug and to keep doing post-market studies be made publicly known so that others can both hold the company to account and the regulator to account to be following up on those particular conditions.

Then, if those studies are done but not necessarily published, that information should be communicated to Health Canada. If Health Canada has the ability to disclose that information because it's making ongoing decisions perhaps to transition a conditional licence to a licence without any more conditions because this post-market study has been fulfilled, then it would have to disclose that at that point. So the specific recommendation I made about making sure that Health Canada's decisions are transparent would hopefully enable the regulator to put up any post-market studies that are done. Even if the company doesn't take it upon itself to publish those on its own, the regulator could do that on its behalf.

[The Chair, Conservative, Ben Lobb]

Thank you.

Mr. Gravelle, you're up next, sir.

[Claude Gravelle, NDP, Nickel Belt, ON]

Thank you, Mr. Chair.

Could you let me know when there's only one minute left, please?

Mr. Lexchin, I'm not sure if I heard you correctly so I'm going to ask you to maybe repeat it. I think I heard you say that Health Canada allows Canadians to take drugs that health care knows nothing about. Did I hear you correctly?

[Dr. Joel Lexchin]

No. For any new prescription or in fact non-prescription drug to reach the market, Health Canada has to evaluate the information that the companies submit about those drugs.

The problem is that the trials that are done before a drug is on the market are relatively restricted kinds of trials. They tend to be for short periods of time. They tend to be done on very limited populations, typically middle-aged men and women who are not taking any other drugs and who don't have any other conditions that may interfere with detecting whether or not the drug works.

So when these drugs come on the market, we actually know very little, especially about their safety or about how they're going to work in a wide range of people. For instance, if the drug has only been studied in middle-aged people, what's it going to do to your 85-year-old grandmother who's already taking five or six other medications, or what's it going to do with your eight-year-old daughter? We don't know those kinds of things.

That's one of the reasons why we definitely need these post-market studies to acquire this additional information to be able to be sure that the drugs are used in the most effective and safest way possible.

[Claude Gravelle, NDP, Nickel Belt, ON]

Thank you.

You also talked about trials that are funded by drug companies as compared to trials that are funded independently. So what's best for Canadians, trials that are funded by drug companies, or by independent companies?

[Dr. Joel Lexchin]

Well, right now the money to do the trials is primarily with the drug companies. A trial can cost in the range of $150 million. The total CIHR budget, I think, the last time I looked, is about $900 million, and that's for all of the research that it funds, not just drug trials.

So, the drug companies have the money to do the trials, but the drug companies also have a dilemma. One, they have a duty to their shareholders to make sure the company's value increases, and two, they have a duty to doctors and the public to make sure information is reported accurately and completely.

Sometimes, based on what we've seen in the United States, as a result of the lawsuits brought against companies by the justice department, those conflicts are resolved in favour of keeping information secret. The drug companies can continue to fund the trials. But as I said earlier, what we need is a barrier put up between paying for the trials and selecting who designs, carries out, and analyzes the trials. So that's why I was suggesting that the drug companies would give the money to an independent organization, like CIHR, which would then use a peer-reviewed process to decide who should conduct them.

[Claude Gravelle, NDP, Nickel Belt, ON]

Thank you very much.

I only have one minute left, so I'd like to ask each witness here today, starting with Ms. Hyland, if the suggested amendments would make this bill better.

[Sylvia Hyland]

I believe that—