Veterans Affairs Committee on Nov. 3rd, 2016

[BGen Hugh MacKay]

Yes.

[Alupa Clarke, Conservative, Beauport—Limoilou, QC]

Was it one over 1,100 that you said?

[BGen Hugh MacKay]

It's one out of 11,000.

[Alupa Clarke, Conservative, Beauport—Limoilou, QC]

Okay.

Last week I wasn't here, but I know that there were veterans who came here to talk about the mefloquine effects on their own lives. I also know that one of them said, at least to me, that he basically made a connection between the use of mefloquine and the criminal behaviour that was perpetrated by some of our military in Somalia.

Have your officers heard these kinds of connection stories often? Is this something that goes around in the circle of your commanding group?

[BGen Hugh MacKay]

It's not a common story that we hear. We hear often about the effects of our operations, whether in a conflict, in providing humanitarian assistance, or in undertaking disaster response, on mental illness. This is why it is very difficult to say that there's a causal relationship between what our military members and veterans really suffer from—and to try to care for them is the reason we're here—and saying that it is mefloquine rather than what they experienced in Somalia over and above that.

It is evident, certainly from the commission of inquiry for Somalia, that there were significant issues with respect to leadership and discipline in the unit way before they were given mefloquine, in the buildup to that operation.

[Alupa Clarke, Conservative, Beauport—Limoilou, QC]

I see. That's interesting.

[BGen Hugh MacKay]

So there are confounding factors that you have to take into consideration.

[Alupa Clarke, Conservative, Beauport—Limoilou, QC]

Thank you very much, Brigadier General.

Mr. Stewart, Madame Raymond, do you have any information that mefloquine has been related to any acts of physical violence?

[Dr. John Patrick Stewart]

We get ADR reports around neuropsychiatric behaviours that have occurred with individuals when they're taking mefloquine. These have been reported not just to Health Canada but to other jurisdictions. I can't speak to whether violence is one or not—I don't have that information in front of me—but there have been a number of different types of reports. Depression, aggression, psychoses, agitation, restlessness, and hallucinations have all been reported.

[Alupa Clarke, Conservative, Beauport—Limoilou, QC]

Are there any reports of extreme violence?

[Dr. John Patrick Stewart]

I can't answer that question; I don't know.

[The Chair, Liberal, Neil Ellis]

Thank you.

Ms. Mathyssen.

[Irene Mathyssen, NDP, London—Fanshawe, ON]

I'd like to go back to a question I asked before.

I understand what Dr. Stewart said about an individual about to deploy being given all kinds of information with respect to the drug, but what I wondered is, when CF members were given mefloquine as part of the medical trial, what were those CF members told? Were they told about the potential side effects? Were they given the information that is currently given to CF members?

Were they told?

[Dr. John Patrick Stewart]

I can't speak to what happened at the clinical trial site that DND was supervising. The information I have is that Health Canada approved the trial. The trial was submitted by the manufacturer, Hoffmann-La Roche, and as part of that trial there was a protocol, there was an informed consent document, and there was responsibility on the part of the manufacturer or sponsor of the trial to carry out the trial in the manner described in the protocol, which included informed consent.

Given the experience in Europe and in the U.S., because the product was already market-authorized there, there was already an understanding that there was potentially a problem if you had neuropsychiatric problems. The information that would have been available from those product monographs, I assume, would have been in that informed consent.

I don't have access to that document, but it was the responsibility of the clinical trial site coordinators or investigators to inform patients in the trial. I can't speak to how that may have been transmitted to the military personnel who were involved in the trial.

[Irene Mathyssen, NDP, London—Fanshawe, ON]

That's what troubles me: there's this lack of clarity. You made reference to DND's being on the ground there. I wonder whether they were recording. Were they collecting data?

Does anyone know whether they were actually watching what was happening to these individuals and collecting the data so that there could be a response to it?

Does anyone know?

[BGen Hugh MacKay]

I don't know what actually happened, personally, with respect to the clinical trial. I have read the Auditor General's report, and I have no reason to not believe what our Auditor General reported at that time with respect to the trial. That is a matter of record already, I think.

[Irene Mathyssen, NDP, London—Fanshawe, ON]

Who would know? Is there someone we should be talking to who might be able to answer that question?

[BGen Hugh MacKay]

The medical records of the day of those individual patients may show whether there was a consultation with a clinician in accordance with the clinical trial, but beyond that, I'm not sure what else you could look at.

[Irene Mathyssen, NDP, London—Fanshawe, ON]

Okay.

[Dr. John Patrick Stewart]

What I could tell you is that as a follow-up to the recommendations coming from the OAG audit, there was a recommendation to Health Canada to put in place better oversight of clinical trials. The federal government introduced Division 5, which is clinical trial regulations, in 2001, which put more responsibility on the sponsor in the oversight of clinical trials. The year after that there was a clinical trial site inspection program put in place. So as of 2002, Health Canada has a good clinical practice inspection program running. Some of the changes to Division 5 and inspections were a follow-up to some of the recommendations in that report, recommendations that were specific to Health Canada. I can't speak to the DND side.

[The Chair, Liberal, Neil Ellis]

Thank you. That ends our round of questioning.

We'll give each organization a minute or so to wrap up if you wish. We can start with Dr. Barbara Raymond from public health.

[Dr. Barbara Raymond]

I would simply thank you for your attention today and for the questions, and I would reiterate that the recommendations are undergoing a comprehensive review. We anticipate that the next iteration of the recommendations for malaria prevention and treatment will be available at some point in 2017.

Thank you.

[The Chair, Liberal, Neil Ellis]

Thank you.

Next we'll go to the Department of National Defence and Brigadier-General MacKay.

[BGen Hugh MacKay]

Again, I'd just like to reiterate my thanks for the opportunity to be here with you to speak and for your concern about the health and well-being of our veterans. We work very hard with Veterans Affairs Canada to try to make sure that those who suffer illness as a result of their work within the Canadian Armed Forces are looked after as best as we can.

We, as I said, are certainly cognizant of the work that's ongoing with respect to mefloquine and the opinions out there. We are always vigilant in trying to track what's going on, in conjunction with our regulator and the advisory committee, in order to make decisions about how we will continue to move forward with malaria chemoprophylaxis. Thank you.

[The Chair, Liberal, Neil Ellis]

Thank you.

Now from the Department of Health, Dr. John Patrick Stewart.