Health Committee on May 9th, 2017

[Ramez Ayoub, Liberal, Thérèse-De Blainville, QC]

You can continue in English. That's okay by me.

[Cindy Moriarty]

I feel bad for our guests.

It was definitely one, if not the one, of the watershed moments in terms of clinical trials, and regulation of samples, distribution of drugs, and approval of drugs. For sure there have been significant changes since those days.

[Ramez Ayoub, Liberal, Thérèse-De Blainville, QC]

Do you see the link I'm trying to make when I ask whether there have been other drugs of this type or whether there have been changes in the way drugs are approved before they're made available?

I'm wondering about something. I want your opinion, as an expert at Crawford. I also want Health Canada's opinion, and maybe our external experts' opinion.

I realize that, until now, the victims have needed to provide proof of their condition. The victims must show that drugs were indeed taken, obviously by their mother in the case of thalidomide.

According to the Canadian justice system, we're innocent until proven guilty. However, in this case, the victims bear the onus of proof. Isn't there another way to support them, up to a certain point, and help them meet the criteria, as I heard Ms. Weiss say? Isn't there a way to reverse the onus of proof and put the onus back on pharmaceutical companies, and likely on Health Canada, which approved the drug initially? This would give Crawford another type of mandate, which would be issued by ministerial order, or by Health Canada.

I don't have much time left, but I want your opinion on the matter.

[Cindy Moriarty]

I'm trying to decide who will answer you.

[Theressa Bagnall, Senior Manager, Program Development, Office of Grants and Contributions Services and Innovation, Health Programs and Strategic Initiatives, Strategic Policy Branch, Department of Health]

Do you want me to respond?

[Cindy Moriarty]

Okay, go ahead.

[Theressa Bagnall]

It's a major challenge. Based on today's presentations and on our other information, we know there are different ways to provide evidence.

It would be difficult to reverse the onus of proof because we know that various conditions are very similar to the condition caused by thalidomide. Even today, birth defects occur regularly within the general population. The program was established to support thalidomide victims. The challenge is to determine the difference between the actual victims and the others.

[Ramez Ayoub, Liberal, Thérèse-De Blainville, QC]

Could the three criteria be included in the new process to ensure greater eligibility and to avoid making victims responsible for defending themselves and providing evidence?

There are 167 individuals who are left over and who don't seem to meet the criteria. However, they may still be among the victims. Today, nobody can say that none of those 167 individuals suffer from a condition related to thalidomide and that none of them are denied compensation. If nobody can say so, the system may need a review. That's what I think.

[Theressa Bagnall]

The government must make the decision.

[Ramez Ayoub, Liberal, Thérèse-De Blainville, QC]

The government receives advice. No decision is purely political. Experts help make the decisions.

[The Chair, Liberal, Bill Casey]

Your time is over. That completes our seven-minute round.

Mr. Mooney, you said you referred the file to a medical professional. I think you said that.

[Michael Mooney]

Yes. It was my colleague who said that, but yes, that's correct.

[The Chair, Liberal, Bill Casey]

Why do you do that? What is that medical professional expected to do with the file?

[Brenda Weiss]

The reason we did that is that we are not medical professionals. We wanted to make sure we had not missed anything, so we turned it over to someone who was more qualified to double-check to make sure nothing had been missed.

[The Chair, Liberal, Bill Casey]

What were they checking?

[Brenda Weiss]

If medical documentation was submitted, they would review all of the medical documents to see if any of the three criteria were met with the submission of that medical documentation.

[Michael Mooney]

Medical documentation is often replete with acronyms, codes, or language of people in the profession that, unless you are involved in that, isn't necessarily in your direct knowledge. It was done as a secondary way of making sure that medical documents that were provided were reviewed by people with the best likelihood of knowledge or understanding of interpreting the documents to determine eligibility.

[The Chair, Liberal, Bill Casey]

I just think of my own doctor. He wouldn't diagnose anything without an examination. I don't know any doctor who would.

Anyway, moving on, we'll go to Dr. Carrie.

[Colin Carrie, Conservative, Oshawa, ON]

Thank you very much, Mr. Chair.

I want to thank all the witnesses but also my colleagues around the table for allowing us to look at this, because I think that at the end of the day the purpose of this was to compensate people who were horribly damaged by this drug.

I want to talk to Health Canada first.

I understand you did your research and helped design and regulate the requirements for eligibility, the criteria for the compensation package. My understanding is that in its report in 2014, the WHO's meeting of experts on thalidomide embryopathy recommended that genetic testing and clinical genetic evaluations be done to help diagnose thalidomide embryopathy where possible.

I know the timeline. That was in 2014. You were well into your work. Did you take those recommendations into account when you were coming up with the criteria that you gave to Crawford?

[Cindy Moriarty]

I'm trying to recall the timeline, quite frankly, concerning when the actual report was published, because the event was in 2014, which is around the same time as the parliamentary motion. I wasn't personally involved in the design of the program, but I know that at the time of doing so it is typical to do as much research and international scanning as possible, and then at the end of the day a decision is made.

We have looked at that report since. I think I may not be up to date, after hearing Dr. Vargesson today—there are constantly more developments—but to my understanding there are about 13 or 14 conditions that present in similar ways to thalidomide and can't be ruled out through genetic testing.

We are keeping an eye on this as well. We have had recent discussions with the U.K.'s Thalidomide Trust—just as recently as last week, actually—and they confirmed that the algorithm hasn't been proven or verified yet. They're very hopeful. It still is just a probability, not a definitive test, but we constantly keep our eyes open for emerging science.

[Colin Carrie, Conservative, Oshawa, ON]

I'm really glad to hear that. In view of the fact that many claimants have been rejected without a medical examination that would include this genetic testing, how would you change the criteria today, considering this new medical testing that's available, such as genetic testing?

[Cindy Moriarty]

With all respect, I'm not really in a position to answer that question by speculating on changes. What I can do today is explain how the program is run and answer questions about the existing program.

[Colin Carrie, Conservative, Oshawa, ON]

I can understand that, but maybe I'll ask the same question to Crawford & Company. In your opinion, given the information that we're getting today plus the fact that in 2014 the WHO actually recommended that genetic testing and clinical genetic evaluations be done to help diagnose thalidomide embryopathy where possible, if you were going to look at the criteria, given this information, what could be done better to assess the rejected claimants?

[Michael Mooney]

With all due respect to the same caveat my friend gave, we're not really in a position to comment about how this may change. It involves expertise and understanding of the disease and of the arising science in a much more comprehensive manner than I could profess to understand and, therefore, modify a program based upon it.

Again, our role is limited to executing the program as designed and delivered to us as a third party administrator, not to sit and ask what about this and what about that, unless doing so is contemplated in the engagement from the outset.

[Colin Carrie, Conservative, Oshawa, ON]

I understand. It's a difficult question to ask, and there may have to be a political decision moving forward. Because neither of you feels you have the expertise to answer this, I'll ask Dr. Vargesson.

You have a paper titled, “Thalidomide-induced teratogenesis: history and mechanisms”. You state, “Thalidomide embryopathy is a severe condition and affects many tissues, all of which can occur independently in humans but rarely together.” Does that mean that if a patient presented with a number of such conditions, the assumption should be thalidomide?

Also, from what you've heard today concerning the Canadian system criteria, would you recommend to our colleagues down at the end of the table that perhaps the criteria could be changed?