Veterans Affairs Committee on Nov. 3rd, 2016

[BGen Hugh MacKay]

Unfortunately, it's only been probably in the last 10 to 15 years that we've really started to track what's going on with respect to mental health outcomes. The best data we have with respect to mental illness as a result of deployment really starts around the Afghanistan time frame. I do know, though, that for our deployment to Bosnia there were no antimalarial medications, and we certainly have seen mental illness as a result of the deployment to Bosnia. Our use of antimalarials in Afghanistan was limited. We did a very strict risk assessment through the Directorate of Force Health Protection. Although the American forces were almost all on antimalarials, we gave them only to those who were going out into small regions on foot patrols in areas in which we thought they would potentially see malaria. Even given the limited use of antimalarials, which were primarily Malarone or doxycycline, we are still seeing a fairly significant amount of mental illness as a result of our efforts in Afghanistan.

[Doug Eyolfson, Liberal, Charleswood—St. James—Assiniboia—Headingley, MB]

All right. Thank you very much.

[The Chair, Liberal, Neil Ellis]

Mr. Brassard.

[John Brassard, Conservative, Barrie—Innisfil, ON]

Thank you, Mr. Chair.

I'm certainly glad that this conversation has evolved into a national conversation, because the evidence that we're hearing is that more and more of our veterans and our servicemen and servicewomen have been affected by this.

Brigadier-General MacKay, I'm trying to work out the timeline here. I know in your testimony today you spoke about the decrease in the selection of mefloquine during the last decade. In the early 2000s, mefloquine was the most often used antimalarial. This started changing in the mid-2000s. That would be about 2005, I would assume. Then you also said, in response to a question about why this is happening, that it may be more publicity about this than anything else.

This really didn't start becoming an issue until about 2013 or so, and here we are in 2016. In 2013, the issue of suicide became a little more prevalent. Mr. Dowe brought that to the forefront. We had Mr. Dowe here last week to discuss this. Why did we see such a drastic reduction in the use of mefloquine within the military in that period? It wasn't publicity, I would suggest. I would suggest it was more perhaps that the effects of the drug were starting to be known.

I'm just wondering if you can speak specifically about that reduction.

[BGen Hugh MacKay]

My initial comment about the reduction was not about the media. My initial comment was about the fact that we, in 2004, started to really sit down and educate all of our patients around the risks, benefits, and potential adverse effects of all of the choices for antimalarials, which, I believe, made a difference.

Mefloquine has been controversial since the nineties. We saw that fall out of the Somalia inquiries and the discussion around mefloquine at that time. I think that my statement with respect to media impact is not just from, I believe you said, 2013, since when there has been some discussion about it. Throughout the nineties and 2000s there has been controversy around mefloquine, which, I believe, shaped some people's decisions, in addition to, as I said, the education and discussions that we started to have seriously with patients in 2004.

[John Brassard, Conservative, Barrie—Innisfil, ON]

Thank you, Brigadier General MacKay.

Dr. Stewart, we had Dr. Remington Nevin speak on this issue last week as well. He spoke about the United States in particular and the fact that U.S. Special Operations Command issued an order acknowledging that the effects of mefloquine may confound the diagnosis of PTSD and TBI. It also directed that commanders and medical personnel address and assess the possibility and impact of mefloquine toxicity within their population.

General MacKay and Dr. Raymond, given the fact that the product monograph was changed, what type of instructions would be given to the military or for those who dispense mefloquine, for example, as a result of those changes to the product monograph? How does that work?

[Dr. John Patrick Stewart]

The product monograph is a document that provides information on the indications, the use, contraindications, warnings, precautions, and side effects. It has a part two, which has information for patients, and it has a central part, which has evidence that supports the market authorization.

As I mentioned in my opening remarks, it's a living document in the sense that as we learn more, as there is more exposure to mefloquine in broader populations, the importance of side effects becomes better understood. The document was upgraded and certain things in it were changed from the original.

A history of psychiatric or neurological problems, which was a warning, was moved to becoming a contraindication. The fact that suicidal ideation being seen was also included. The fact that these side effects could persist after the drug was stopped was added.

If you look at the history of when that was done in the U.S. and when it was done in Canada, there was a very similar progression of the product monograph.

We don't then talk to prescribers, other than to alert them that the product monograph has changed, or as I pointed out in my opening remarks, in 2005 we put out a risk communication with the manufacturers to ensure that health care providers were aware that this was changing. But the responsibility is also on the prescribers to see when things are changing, to invest in the discussion around the safety of medication, and to adjust their prescribing patterns accordingly.

[John Brassard, Conservative, Barrie—Innisfil, ON]

How would you determine there are potential effects for up to three years? Would that be based on studies that other countries have presented, which you've studied up to this point? Where would that data come from, that there could be effects three, four, and five years after a person has stopped taking the medication?

[Dr. John Patrick Stewart]

Again, as I pointed out in my opening remarks, we look at our own ADR events that are coming in, and we look at what the literature and international regulators are doing, and what the manufacturer may be telling us. We were seeing in the reports coming in—in other jurisdictions as well as in Canada—the description of the severe events, and also the point that these persisted after the drug was stopped. To sort it out ultimately and do a causality assessment to determine whether the product is causing or directly related to the symptoms the patient is describing is a very challenging type of work to do and to determine, because many different factors are involved.

For instance, depression is a diagnosis that happens in individuals who aren't on medication and for those who are on medication. If depression occurs while you're taking a medication and then continues, the medication may be playing a role. But there may be other psychosocial factors and genetic factors involved. We know that mental illness happens in the population that isn't on medication, so it's often challenging to say, when someone makes a report, that there's a direct causal relationship with the medication. But when we're seeing a number of reports, then we will look at the labelling and see whether it should be in there to alert physicians that this may have a role.

Some of the reports of adverse events with neuropsychiatric symptoms said that the symptoms persisted afterwards. It's not clear whether that's been caused by the medication, but it's there, so it's in the monograph to alert practitioners that this is something to consider when they're thinking of prescribing the drug.

[John Brassard, Conservative, Barrie—Innisfil, ON]

Thank you, Chair.

[The Chair, Liberal, Neil Ellis]

Ms. Lockhart. I believe you're splitting your time.

[Alaina Lockhart, Liberal, Fundy Royal, NB]

Yes.

Thank you all for your testimony today. It's been very helpful.

Let's assume they've gone through the briefing and made their choice. After a drug is prescribed, what type of follow-up is there in the theatre for mental health and impacts of drugs?

[BGen Hugh MacKay]

Usually when a medication is prescribed that people are taking in theatre, members of the Canadian Armed Forces are advised that if they're having some concerns with any effects they may think are attributable to the drug, they should come forward and tell us about those so that we can help to understand whether or not those are related to the medication or some other confounding factor as a result of their deployment.

We don't specifically go and do a follow-up screening for those who have received mefloquine. It's not part of our process.

With respect to mental health, it depends on the size of our deployment. In Afghanistan, at our role 3 hospital, we had a psychiatrist, a social worker, and a mental health nurse right in the hospital available to assist anybody who might have some mental health symptoms.

But when we have smaller missions, we still often have physician assistants or physicians who are also capable of helping people with mental health issues, at least in the initial phases, and of making a decision as to whether or not they need to come for more advanced care.

[Alaina Lockhart, Liberal, Fundy Royal, NB]

So there's no scheduled mental health check-ins or follow-ups? They're just on an as-needed basis? Is that correct?

[BGen Hugh MacKay]

We do have a scheduled post-deployment enhanced screening that occurs between three and six months after a six-month deployment. We don't do specific screening while they are in theatre. They are aware and have access to health care providers should they start to have some symptoms that they are concerned about, so they can come forward to see us there.

As they are leaving theatre, we start to get them ready with some briefings on the changes that they may experience as they're returning home. Some of that talks about the potential for mental health impacts. Then again, at three to six months after they're home, we go through an individual one-on-one assessment with them to see whether or not they have any follow-up mental health impacts.

We've been finding that about 50% of the people who screen positive for potential mental health effects in that post-deployment screening have already come in and sought care before that screening has occurred, so that's been a good sign for us that some of our education and messaging on mental health is working.

[Alaina Lockhart, Liberal, Fundy Royal, NB]

Thank you.

[The Chair, Liberal, Neil Ellis]

Mr. Rioux.

[Jean Rioux, Liberal, Saint-Jean, QC]

Thank you, Mr. Chair.

My thanks to the witnesses for providing us with their scientific opinions.

Dr. Stewart, you said that, in 1993, the drug was not supposed to be prescribed to patients with a past history of psychiatric disturbances or convulsions. Then, there were four reports of neuropsychiatric adverse effects. The review showed that the drug produced suicidal thoughts that could continue long after treatment was discontinued.

Last week, we heard from people, whose stories were very moving. Doctors told us that they had been diagnosed with post-traumatic stress disorder, but that the diagnosis was very different in that it was directly related to taking the drug.

Given the situation, should more research be conducted? Based on what we were told last week, the U.S. seems to be open to that.

[Dr. John Patrick Stewart]

Thank you for the question.

It's important to point out that with any medication, after it is market-authorized, there is increasing exposure to the drug as more and more patients use it. In clinical trials that were done to prove the therapy, there may have been slight signals of a concern. As you get greater exposure, you learn more, so the neuropsychiatric side effects associated with mefloquine became better defined and better described as use persisted.

We see that globally in the labelling of the product in many countries increasing from a warning of “don't prescribe it to people with neuropsychiatric problems”. We started to see that a small number of people who, before starting the drug, did not apparently have neuropsychiatric problems developed these while on the drug. Not only should it not be given to people who have pre-existing problems, but in a very small number of individuals without a history, we were getting reports that it actually induced neuropsychiatric problems, some of them severe. That's why the labelling got tighter and tighter.

I agree that there should be research. It's a very important area to explore. The question is who is best positioned to do that? The role of Health Canada is to monitor each drug and the information we have on it, and to make sure it's labelled. If it reaches a point where the benefit-risk profile is not positive, then we will take affirmative action. At this point, as signalled by its still being listed as one of the choices to treat falciparum malaria in chloroquine-resistant areas, the profile is not that severe. But we would support and encourage additional research into this area, absolutely.

[The Chair, Liberal, Neil Ellis]

Thank you.

Mr. Clarke, go ahead.

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

Thank you, Mr. Chair.

It's a great honour to be here today.

Good afternoon, everyone.

Brigadier-General, my first question is for you. I imagine that the Canadian Forces Health Services group includes psychologists and psychiatrists. Is that the case?

Yes, great.

The officers under your command who are psychologists and psychiatrists provide diagnoses, meet soldiers and produce reports, which are confidential, of course. As commander, do you receive statistical reports? For instance, a report said that 31% of members who came last year had post-traumatic stress disorder or that 15% of members were depressed. Do you receive statistical reports from the medical staff under your command?

[BGen Hugh MacKay]

The approach we've taken to get a good understanding of the mental health burden in the Canadian Armed Forces is that we had a very significant survey done through Statistics Canada in which members of the Canadian Armed Forces were interviewed to identify those who had symptom complexes that were representative of mental illness. Through that, we were able to see that the 12-month prevalence of post-traumatic stress disorder had changed from 2.7% in 2002 to 5.4% in 2013. We did see, though, that there was no real change in the percentage of Canadian Armed Forces personnel suffering from depression—which is still our number one cause of mental illness in the military—which was around 8% in 2002 and still the same in 2013. I don't get an annual report on the statistics.

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

On page 2, for example, you talk about the neuropsychiatric effects of mefloquine, and you say that those are rare. What numbers does the word “rare” correspond to? Would it be possible for us to know the statistics?

[BGen Hugh MacKay]

I'm using the information we have, not just from within the Canadian Armed Forces. I believe what we have, writ large, for those who have received mefloquine is that one in 11,000 or one in 13,000 persons may experience a severe reaction to mefloquine.

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

So that's where the word “rare” comes from, one out of 11,000.