Health Committee on June 10th, 2014

[Dr. Joel Lexchin]

First of all, Mr. Young, thank you very much for the compliment. I would like to return it to you on the basis of your long and hard fight to get this bill before the House of Commons, and unfortunately, it had to result from the tragedy around your daughter.

Let me briefly outline one example of how better transparency would improve safety for patients. We all know that antidepressants—these are the selective serotonin reuptake inhibitors, Paxil—have been used widely off label for children. This is often because people.... Doctors are desperate and there aren't enough child psychiatrists around. It's going to take a year to get a significantly disturbed child into therapy. Doctors have been reaching for these drugs on the assumption that if they help adults, they may help children.

When somebody looked at the published data around this, around the SSRIs in general, what they came up with was the conclusion that these drugs have some benefit for children and they don't pose any significant safety issues.

However, when these same researchers were able to, through the U.S., get a hold of the unpublished trials that had been done, they came up with a much different conclusion. Their conclusion was that there was no evidence of any benefit for children and that there was the potential for significant harm.

This shows the problem with relying simply on the published information. It's the unpublished information.... There have been estimates that half of all the clinical trials that are done are never published. It's that kind of information that doctors need to be able to make the best informed decisions, so that they can give patients the best therapy, and also protect patients when they're getting the medications.

[Terence Young, Conservative, Oakville, ON]

That's a terrific example.

Can you please comment on drug disasters? I wanted to ask you, if Bill C-17 had been law throughout the 1990s and clinical data had been published throughout the 1990s, how many or what drug disasters could have been avoided?

[Dr. Joel Lexchin]

There were a number of potential disasters that we might have avoided. One of them has to do with two drugs that are used to treat heart arrhythmias. These got to be widely prescribed by doctors, not for serious heart arrhythmias but for very minor heart arrhythmias. When the trials were eventually done to look at this issue, it turned out that these drugs were killing more people than they were benefiting.

Although not in the 1990s, we can look at Vioxx. Vioxx was approved in 1999 in Canada. By 2003 it was the 10th most widely prescribed drug in the country in terms of number of prescriptions, and in September 2004 it was pulled from the market because of the cardiac risks associated with it.

Finally, there is the question of the hormone replacement therapies that again were widely used by post-menopausal women. When the trial in the U.S., which had to be publicly funded because the companies were not willing to fund it on their own.... When that trial result was published it turned out that, yes, the hormone replacement did reduce fractures, but it also increased the number of cardiac problems and increased the number of strokes and it increased the number of people with breast cancer.

All of those could potentially have been avoided with better disclosure of information.

[Terence Young, Conservative, Oakville, ON]

Thank you.

I'd like to give my next question to Professor Herder.

Professor, a big issue we have in clinical research is that the drug companies, their game is to start a clinical trial and ask the researcher to sign a contract, essentially a gag order, that if they order the trial to be stopped at any given time they must never talk about it again, that it will never see the light of day. That's because many of their trials will show that their drug is not working better than a placebo or that their new drug is actually harming patients and they want to cover that up.

Your recommendations for transparency, would they address the issue of where a trial is registered and stopped? Are you insisting or asking that even the partial evidence from that trial or the partial clinical data be published as well?

[Prof. Matthew Herder]

That's a great really specific question. I think the amendments I envision would certainly capture negative results, although I think some very careful thinking would have to be done in defining what a negative result is. I'm trying to capture all results, but if you don't have a result per se because they stopped the trial, when does that become reportable?

I think there would probably need to be some kind of specific time period that would have to be surpassed for the results or whatever was done before the trial was stopped to be reported, but I think what would capture the really worrisome examples would be if there was an adverse event of some kind, even in the context of a study. If they stopped it because there were very serious safety concerns, not just for commercial reasons or strategic reasons they didn't want to pursue that particular study, that should be reportable.

I think it can be done. I'm not sure the very specific wording I gave captured it exactly, but hopefully that could be defined by regulations.

[Terence Young, Conservative, Oakville, ON]

Thank you.

[The Chair, Conservative, Ben Lobb]

Thank you very much.

For anybody that needs translation, I'd recommend getting your earpiece ready, passing it out.

If you're good to go, carry on, Mr. Morin.

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

Thank you very much, Mr. Chair.

Can you all hear me in French?

[Dr. Joel Lexchin]

I'm afraid that I don't.

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

Okay. So can we...?

[The Chair, Conservative, Ben Lobb]

Try it again.

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

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

Mr. Lexchin, can you hear me in English?

[Dr. Joel Lexchin]

I haven't heard the interpreter at this point, I'm afraid.

[The Chair, Conservative, Ben Lobb]

Okay. We're going to work on that just for a second.

I think what Mr. Morin was saying was that he thinks the Leafs are going to win the Stanley Cup next year, but I'm not quite sure. My French lessons are not quite at 100% yet.

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

I challenge the chair.

[The Chair, Conservative, Ben Lobb]

I'm pretty sure that's what he said.

Professor Graham, are you still on the line?

[Prof. Janice E. Graham]

Yes.

[The Chair, Conservative, Ben Lobb]

Could you hear the translation?

[Prof. Janice E. Graham]

No, I didn't. I didn't hear the French either.

[The Chair, Conservative, Ben Lobb]

Okay, we're going to let our technicians work on the issue.

Go ahead, Mr. Wilks, if you're ready to go, and then we'll go back to Mr. Morin afterwards, if that's okay.

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

Thank you.

Thank you, Mr. Morin.

I wanted to touch upon a couple things, and unfortunately, one of our witnesses left. One of the things that was brought up was the natural health products that were not included in Bill C-17 due to their low risk profile and the fact that they're already adequately regulated.

Ms. Hyland, do you agree with the approach, given the inherent low risk of natural health products? Perhaps I could listen to Professor Herder and Dr. Lexchin, and Janice Graham, who is online as well.

We'll start with Ms. Hyland.

[Sylvia Hyland]

I'm not sure the risks are lower. Our position is the understanding that the inclusion of natural health products in the more complex bills cause them not to move forward and be enacted. Bringing that into this bill might actually slow down the great work that's already been started. So maybe the natural health products do need to be dealt with, but in the future...to take Bill C-17 and take this first step forward. So I do think they will need to be looked at, but I'm not sure we need to bring them in right now to Bill C-17.

Does that help?

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

That does help, thank you.

Professor Herder.

[Prof. Matthew Herder]

I share the view that it's not clear to me that they are inherently less risky. For that reason, I think they should be regulated very carefully. I think it's more of a strategic consideration in some ways, as my friend just intimated, although I'm not sure it's that difficult to fix this part of the bill. As I look at the bill just quickly, it just excludes natural health products from the definition of “therapeutic product”. So, if that wording was simply removed, if the committee was motivated to hold natural health products to a higher standard, perhaps the new measures that are included in the bill could be applied against natural health products.

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

Dr. Lexchin.