Health Committee on Nov. 20th, 2014

[George Da Pont]

Yes, there are actually some studies under way. Maybe I'll go back and use the example that Ms. Davies referred to.

My understanding is that the U.S. has six clinical studies under way right now looking at a derivative product that is being tested for safety and efficacy for just that type of condition. I think, at least for that specific case, as we begin to get the results of some of these clinical trials, obviously it may lead us to reconsider the approach, depending on the outcome.

We are seeing a few other applications for clinical trials, but not, as the minister said, on a widespread basis. I think everyone's aware that there may well be benefits to some drugs, but also there are significant risks. The purpose of the clinical trials is to assess whether potential benefits outweigh the risks. That's the sort of evidence that just doesn't exist at the moment. It'll hopefully begin to come in over time as we see more clinical trials.

[Wladyslaw Lizon, Conservative, Mississauga East—Cooksville, ON]

Thank you.

How much time do I have?

[The Chair, Conservative, Ben Lobb]

Thirty seconds.

[Wladyslaw Lizon, Conservative, Mississauga East—Cooksville, ON]

Well, maybe quickly, on another topic, what progress can you report following the last implementation of the health agreement with the First Nations Health Authority in B.C.?

[George Da Pont]

Again, I would say that really is a landmark tripartite agreement that has seen the responsibility for design and delivery of programs and services that previously came from Health Canada now being turned over to a newly created First Nations Health Authority. That authority has gotten off, we think, to a very good start.

One of the early things we notice is that now they have developed stronger relationships with the province, so with regional medical delivery mechanisms, and are taking a more integrated approach. They now have the ability, really, to redesign programs, get better integration and consistency with the province, and hopefully, get much better outcomes for first nations people in B.C.

Obviously, it's only been a year that it's been in place—

[The Chair, Conservative, Ben Lobb]

Mr. Da Pont, sorry, we're over time here, just to be fair.

[George Da Pont]

All right.

[The Chair, Conservative, Ben Lobb]

Mr. Young, you're next.

Then, Ms. Fry, you'll be after Mr. Young.

[Terence Young, Conservative, Oakville, ON]

Thank you, Chair.

For Dr. Beaudet, again, please, when people drop out of clinical trials early on, the researchers call that microdata. Sometimes it's because they're reacting to drugs. I call that life-saving information, and the drug industry sometimes just calls it CBI, confidential business information. This is a big problem for patient safety.

How will the requirement in Vanessa's Law to register all clinical trials change the way you enforce transparency in CIHR-funded trials?

[Dr. Alain Beaudet]

In CIHR-funded trials it's very clear. The requirement for registration and reporting of adverse effects is mandatory. It's part of the contract that we sign with the investigator when we give out the grant. Should the terms of the contract not be respected, they would be in breach of the contract, actually. They would be in breach of the TCPS's tri-council policies on ethics for trials, in which case that would come under the secretariat on ethics, which would recommend—would recommend to me, actually—a number of sanctions, the first one usually being non-eligibility for future funding at CIHR.

[Terence Young, Conservative, Oakville, ON]

You would cut them off from future trials?

[Dr. Alain Beaudet]

We'd cut them off—

[Terence Young, Conservative, Oakville, ON]

Is that your only tool of enforcement?

[Dr. Alain Beaudet]

Our only tool for enforcement is not being able to fund them in the future, indeed.

[Terence Young, Conservative, Oakville, ON]

Thank you.

Thank you, Chair.

[The Chair, Conservative, Ben Lobb]

Mr. Young, you have more time, if you like.

[Terence Young, Conservative, Oakville, ON]

Thank you.

Mr. Da Pont, could you describe what administrative changes at Health Canada will support the enforcement of Vanessa's Law, perhaps with specific reference to adverse drug reaction reporting for health care institutions? How are you going to make it work?

[George Da Pont]

Again, thank you very much for the question.

We will be putting in place a regulation and a framework to define the reporting of adverse drug reactions. We will have to, and want to, engage in discussions with provinces, local hospital authorities, and other institutions that we would be asking to report, to work out the mechanics of what exactly gets reported: the timing, the mechanism, and the frequency of reporting. Obviously we want to get any severe reaction, any serious reaction.

A lot of those discussions have started. We want to move this along as quickly as possible because obviously it's one of the critical new components of Vanessa's Law. We need to work out the nuts and bolts of how that information is going to come, when it's going to come, and in what form. That will significantly enhance our ability to make assessments and take action when we see patterns or trends.

[The Chair, Conservative, Ben Lobb]

Mr. Lunney, you have just two minutes, sir.

[James Lunney, Conservative, Nanaimo—Alberni, BC]

Thank you very much.

I asked a question earlier about the proton pump inhibitor, about CNISP, and collecting the data.

Dr. Taylor, increased risk of 40% to 275%—is that clinically significant? Compared to other things I've heard, it's over the top.

[Dr. Gregory Taylor]

Thank you for the question.

We're looking at CNISP and re-evaluating that surveillance system right now to see if we can add those kinds of questions to collect and answer that. CNISP wasn't originally created for research. It was created for surveillance, but it's nice to be able to use that network to do that.

That's a work in progress. We have to work with our partners to see if it's feasible to add those questions.

Any clinical change of 200% to 400% certainly seems clinically significant to me, but we're certainly working on that and hopefully the information will be able to address that.

[James Lunney, Conservative, Nanaimo—Alberni, BC]

Thank you for that.

I have the study here. They collected all kinds of information, including the genetic variations in the bug. That sounds like research to me. So saying that it's not set up for research.... I think it shouldn't be that hard to collect the data; it's already in the hospital records. It's costing us a lot of money—hundreds of millions of dollars. We're talking about innovation. There ought to be some way of moving forward there.

Dr. Beaudet, there was a change in the mandate of CIHR to reserve some funding for priorities, including those of the Government of Canada. Might this be a place where CIHR might be useful in doing a study to investigate not only that but what the hospital in Quebec's been doing for nine years, giving a potent probiotic 24 hours after they start antibiotic therapy and eliminating C. difficile infections with probiotics? Might that be something CIHR could help with?

[Dr. Alain Beaudet]

This is something CIHR is already helping with. We're funding some work in that area.

As you may know, DSEN, the Drug Safety and Effectiveness Network, has looked at this issue of the proton pump inhibitor and the relationship to C. difficile. We funded a number of studies looking not only at probiotics but at other approaches to treating C. difficile in the hospital.

[James Lunney, Conservative, Nanaimo—Alberni, BC]

Are you familiar with the Bio-K+ program with 50 billion CFUs?

[The Chair, Conservative, Ben Lobb]

Thank you.

Ms. Fry, you're up now for five minutes.