Health Committee on May 11th, 2017

[The Chair, Liberal, Bill Casey]

I call our meeting to order. This is meeting number 54, and we are studying the thalidomide survivors contribution program.

I welcome our guests.

Members, I want to say initially that we've passed around the list of witnesses who we invited to appear, because there was some question about why they didn't appear. There were several who were not able to. We've provided that list to members so you would understand why they're not here.

We do have excellent witnesses today. First I want to introduce them, and then we'll ask them to make an initial presentation.

We'll start with Canada's Still Forgotten Thalidomide Survivors, represented by Terry Bolton, the founding member. We also have with us Mr. Douglas Levesque, appearing as an individual. Joining us by video conference from Sweden is Mr. Ralph Edwards, professor in medicine.

We're going to start with the two witnesses here at the table. Then we'll invite Mr. Edwards to make a presentation. Each presenter has a maximum of 10 minutes for an opening statement. Then we will move to questions.

Mr. Bolton, would you like to make an opening statement?

[Terry Bolton, Founding Member, Canada's Still Forgotten Thalidomide Survivors]

Thank you, Mr. Casey and ladies and gentlemen.

I would like to start by thanking the Canada's Still Forgotten Thalidomide Survivors group for appointing me spokesperson for our group today and thanking the health committee for allowing me to appear as a witness.

In 2012 I was informed by a heart specialist that I had a unique condition with the organs in my heart. I was born with an extra valve, which branched off the right side of the main aorta, causing my heart to make an extra beat every time it cycled. This syndrome is known as Wolff-Parkinson-White syndrome. I remember my mom telling me that I had been born with a murmur. I was also born with phocomelia, affecting my left arm, and with an extra digit on my right hand, which was surgically removed at birth.

I had other problems at birth as well. I was and still am missing internal organs in my left eardrum, which has caused complete tone deafness from birth. The hearing in both ears has now deteriorated to the point that, as recently as 2012, I am considered legally deaf in both ears.

As an eight-year-old, I also had surgery to remove what is called Meckel's diverticulum from my intestines. This condition is known to occur in only 3% of the human population, while Wolff-Parkinson-White syndrome is known to occur only in only 2% of the population.

I started researching and found that thalidomide side effects included almost everything I have had happen to me. I went to my mother's sister, my aunt Eileen, to ask whether there was a family secret. I knew enough then to know that I wasn't just a gift from God. I needed the truth. That's when she broke down and admitted to me that my mom had taken a morning sickness drug pretty well all through her pregnancy.

I tried diligently to obtain my birth records and medical records, as requested by Crawford. As a child of eight or nine, I remember my orthopedic surgeon, Dr. John Hazlett, telling me, “We have enough X-rays of you to make six complete skeletons.” According to my birth hospital, which is Kingston's Hotel Dieu Hospital, all records and X-rays have been destroyed due to their retention policy.

I did further research and found out that there was a fire in the records building in the mid-seventies. I believe it was in April 1977, because I remember being in the hospital at that time for my 14th birthday. We were locked into our rooms because there was a fire in the basement. There were also two fires in my hometown of Gananoque, one that destroyed the pharmacy my parents used and the other at my family doctor's office.

I believe other survivors in our group have similar stories to tell.

It would really seem as though there is something more to this, but history cannot be brought back. Records can't be recovered. Most of our mothers' doctors are dead or, as I've heard in some cases in our group, fail to remember. As for prescriptions, a pharmacist with over 25 years' working experience told me that no one keeps these records after 10 years.

This now leaves me with the number three criterion: you must already be registered on a government list. After calling the number we were provided by Crawford to see if by some miracle I was on this list, I was told no.

In 1991 I was still under the belief that my problems had “just happened”, so I never sought recognition or compensation. I worked at many jobs, including jobs in factories, from the time I was 17 until eight years ago when my back gave out. I could no longer do the job I had with the Town of Gananoque.

I returned to school and obtained my AZ licence, but no one would hire me—I suspect because of my age and because they believed I could not do the job. I then went to St. Lawrence College and obtained my solar photovoltaic systems installer certificate. Basically, I can set up a solar farm and service it. Again I had the same problem. I was passed by for each and every job I applied for.

In 2003, with my mom still alive, I left her and went overseas to Afghanistan to work for the Department of National Defence. I was a civilian. I served my country that I love so much.

All I am asking here today is that the health committee see to it that the proper qualified professionals examine our medical records that we have managed to obtain and physically interview each one of us so they can make an educated decision as to whether we qualify for the compensation package that we justly deserve.

Finally, it's time to right a very big wrong.

Thank you.

[The Chair, Liberal, Bill Casey]

Thank you very much.

Now we'll go to an opening statement from Mr. Levesque.

[Douglas Levesque, As an Individual]

Good morning. Thank you very much for taking the time to hear our stories.

I was born on September 27, 1963, with seven fingers on each hand. The extra ones were surgically removed when I was 18 months old. I have pronounced webbing on both hands and feet, and I have extra-short feet with a 6E-plus width. My right leg is more than an inch shorter than my left leg. I've also had 13 spinal cord tumours, which were dermoid cysts or ganglions. These were referred to by Dr. McCredie on page 11 of a WHO report from the Geneva World Health Organization summit of 2014, when she talked about ganglions being evident in the spine.

I have back spasms three or four times a week—sometimes daily—and they're only controlled by medication that is not covered under our health plan. I've had two surgeries on my right ankle. I have poor circulation in both legs; arthritis and inflammation throughout my body; bowel and bladder problems; sleep apnea; hypoxia; and, ongoing intestinal problems. I have a right knee replacement scheduled for early July. I've been denied by WSIB in terms of repetitive strain in both my wrists; they refer to it as a “previous injury” because I was born with the extra fingers on both hands.

I've seen many doctors, naturopaths, acupuncturists, chiropractors, and reflexologists in my relentless search to find out what is the cause of my pain. As the years go on, it's not getting any better. I have two older siblings who are in perfect health, and there is no evidence in my parents' lineage, on either side, of anybody with extra fingers or any extra digits.

I believe that in the government's extraordinary assistance plan for thalidomide, which was brought out in 1991, all the discussion was on three criteria, but in actual fact, there were four criteria.

One of the criteria was a mother's statement, preferably sworn, that she took thalidomide at the relevant time, with an indication of its source, which was not necessarily a prescription. I am a sample baby. My mother received the thalidomide pill on two occasions, once at the Copper Cliff clinic in Sudbury, and one other time, a week later, at a hospital. Even though the drug was stopped in 1962, the doctors in the rural Sudbury area continued to use it. I have spoken to one doctor who received samples in 1964, when he took his practice to Sudbury.

I've had some of my genetic testing done through CARE for RARE here in Ottawa, out of CHEO. I don't have any results yet, because it was a research study. We will receive those results at the end of this month.

Crawford informed us, in their wording, that this is deemed final. They didn't inform us that we could appeal or anything along those lines. I really don't agree with their statement, which says that there are 167 people, because my file number was 138, and I know people whose file numbers are in the 300s and others whose numbers are in the 400s. I don't know how they do their filing system, but I think there are some inconsistencies there that we have to look at.

Also, when I called Crawford, I received no help from them. They just kept harping away on the three criteria. That was it. That was final. When I called the TVAC, it was the same situation. There was no help at all from them either.

It's interesting to find out how many people at Crawford had affidavits from a parent and were still denied. Crawford had a list of applicants whose medical records were destroyed either by flood or by fire. My records and my mother's records were both destroyed in a flood. When you talk to all the people who were undocumented, it's common how many people's files have disappeared by way of either fire or flood.

Thank you very much.

[The Chair, Liberal, Bill Casey]

Thank you very much for your testimony.

We're going to move to Professor Edwards now, by video conference.

We very much appreciate your time, Professor.

Professor Edwards is the past president of International Society of Pharmacovigilance and a frequent expert witness in legal actions relating to adverse drug effects. He was previously the director of the Uppsala Monitoring Centre, which monitors drug safety worldwide.

Professor Edwards, you have the floor for 10 minutes.

[Dr. Ivor Ralph Edwards, Professor in Medicine, As an Individual]

Thank you very much.

Thank you for asking me to be part of this important meeting.

My main interest started when I was about to become a medical student and heard, of course, of the Distillers action in the U.K. when the story of the thalidomide problem first broke. Thalidomide was in fact the start of the discipline that I've worked in since 1980, namely pharmacovigilance.

Pharmacovigilance is a discipline that looks for problems with medicines and tries to establish a causal link between a medicine and the harm. The difficulty is how to establish causation. That was the difficulty that faced the investigators in the early days in Germany and in the U.K. It's a real problem because, given the extreme disability caused or thought to be caused by thalidomide, what they were tasked with was, how do you decide on what is caused by thalidomide?

They were actually seeing individuals and trying to work out what was the causative link between thalidomide and a variety of defects. They put together what we would call a “syndrome of defects”, which they were sure—or pretty sure—followed the exposure to thalidomide. Knowledge of the exposure was a critical factor. The first point I must make is that it isn't just being exposed to thalidomide: it's being exposed at a critical time, during the first three months while the baby is forming essential organs. That is a critical factor in the cause-and-effect situation: to know exactly when the drug was taken by the mother.

The second thing is that the thalidomide syndrome was rare. Therefore, each expert at the time would see perhaps a maximum of 200 patients. Indeed, in the research I'll talk about shortly, we have been able to have only around about 200 people who we're sure took thalidomide during those early three months of pregnancy, so therefore we could be as sure as we possibly could be that there was a cause-and-effect relationship.

That work was done a long time ago. Things have moved on since then. It's important to note that there's a kind of gap. We do know that thalidomide is still being used for inflammatory diseases and cancer, but that usually means that it's not given to women of child-bearing age.

It is used in the treatment of leprosy to counteract the negative effects of Dapsone, and therefore it is given to some young people. In Brazil, for example, we know there are about 400 women who have had children with the obvious features of thalidomide exposure. The trouble is that we haven't been able to look at them closely because they're in rural areas and the facilities haven't been made available for us to update our knowledge.

I was asked by The Thalidomide Trust in the U.K. if I would help them bring together a meeting of experts within the WHO umbrella to see what we could firmly state about the cause-and-effect relationship between thalidomide and congenital defects. The short answer is that we were only really able to confirm for sure what was thought all those years ago.

There is research, and it was actually all presented at a meeting, about the way in which the thalidomide-type drugs might affect a growing embryo, and it's in all sorts of ways. Unfortunately, that is only experimental work, and we're left with a feeling that there might be more. There is some excellent work going on, but as I say, we don't have anything that goes from the experimental work in animals and other models to what happens in human beings who are exposed now.

There is a final thing I want to say by way of introduction. When the thalidomide embryopathy was first discovered, it was thought that it was going to be unique because it was so rare. People were saying that it only occurs with thalidomide, that it doesn't occur naturally. Since then, we've found that unfortunately there are genetic reasons that similar limb reduction and other defects can occur because of a family history of genetic problems. That makes it very difficult.

I think I would prefer to answer questions, but I want to mention one thing. We have worked out a “decision tree” way of making a diagnosis of the conditions that might be caused by thalidomide in a human being, based on this historic evidence and based on Europeans. It really only confirms the very limited views that we have about the effects that are well known to be caused by thalidomide.

We haven't been able to say any more. Indeed, what we have been able to say is that some of the conditions where thalidomide has been a possible cause have in fact been explained by other genetic problems. Genetic testing is a key issue.

As I say, I think I would prefer to answer questions.

[The Chair, Liberal, Bill Casey]

Thank you for your initial remarks. We appreciate them very much.

Now we're going to seven-minute rounds of questions.

Mr. Oliver.

[John Oliver, Liberal, Oakville, ON]

Thank you.

Thank you for your testimony today and for coming in and talking to the committee and sharing very personal health stories and health conditions with us.

Also, thank you, Doctor, for your testimony.

As an opening statement from me personally, as a member of the committee, I'd sooner see the Canadian compensation plan err on the side of compensating people who perhaps weren't necessarily thalidomide victims rather than err on the other side of denying compensation to thalidomide victims. I'd sooner see the error happen in that positive way.

Nevertheless, both in 1991 and in 2015, the criteria in Canada were limited to the knowledge of exposure and proof of exposure to the drug. We have heard from other witnesses that other countries have used more of a mixed model.

Both of you began with testimony about your health factors and conditions. Can I conclude from this that you both would present those birth conditions as being in the cluster of thalidomide-like birth defects that would fall into these medical evaluation criteria?

[Terry Bolton]

Yes. I believe that for the conditions that we both show or whatever, if you were to look into the research that TVAC has done, all these things are listed.

[John Oliver, Liberal, Oakville, ON]

TVAC is the Thalidomide Victims Association of Canada. Unfortunately, I don't think we've had testimony from the association, but can I conclude, then, that there is a list of the cluster of symptoms—

[Terry Bolton]

Yes.

[John Oliver, Liberal, Oakville, ON]

—that the Thalidomide Victims Association has identified as being likely consequences of thalidomide exposure?

[Terry Bolton]

Yes.

[John Oliver, Liberal, Oakville, ON]

Okay.

Dr. Edwards, I have in my notes here that in 2014 the World Health Organization held a meeting of experts on thalidomide embryopathy to try to develop diagnostic criteria for thalidomide embryopathy. Were you part of that group? Do I understand that you were the convenor?

[Dr. Ivor Ralph Edwards]

Yes. I convened it and chaired it.

[John Oliver, Liberal, Oakville, ON]

I thought I heard you say the outcome of that was there were limited conditions that you felt would be verifiable as thalidomide exposure conditions. Did I understand that correctly?

[Dr. Ivor Ralph Edwards]

Yes. They, of course, are the well-known ones: limb reductions, hearing problems, some cardiac problems, small jaw, and all of these things.

The problem we all have is that it's a catch-22. Those things that were recognized by the experts were the things that stood out. Other things that were included didn't happen very often and didn't happen with all of the victims, so we're left with a group of conditions that could easily be caused by something else, something more common than the exposure to thalidomide. That is the scientific difficulty.

[John Oliver, Liberal, Oakville, ON]

One of the other witnesses talked about genetic screening. Genetic screening isn't necessarily saying “yes, thalidomide”. It's saying no, that it's probably related to another cause. If you bring in genetic screening, will that winnow down the population we're unsure about?

[Dr. Ivor Ralph Edwards]

In our research subsequent to the meeting, where we tried to devise a diagnostic algorithm to help us, we certainly conclude that genetic screening is a very important tool.

[John Oliver, Liberal, Oakville, ON]

Looking forward, then, if we were to re-engage with a program here in Canada that added an element of clinical evaluation and screening on top of the eligibility criteria we have, there certainly would be a body of some limited conditions that would be reasonably strong indicators of thalidomide exposure. If you coupled that with genetic screening to ensure that it wasn't related to other underlying causes, would you recommend that as a way to make our program a bit more robust?

[Dr. Ivor Ralph Edwards]

I think so, yes. That's exactly what we did. It's our main finding, the genetic screening and of course the family history, which obviously is linked with the genetics. Yes, I think it's important.

[John Oliver, Liberal, Oakville, ON]

Mr. Bolton, you indicated that you felt that for those who had been denied, there should be a review by proper qualified professionals. Has the Thalidomide Victims Association identified that pool? Are there Canadian experts on this that you have identified who would be able to review clinical conditions where the proof of exposure is no longer available?

[Terry Bolton]

The only experts I've come across are the three we've had here so far. I don't know if there's anybody in Canada.

[John Oliver, Liberal, Oakville, ON]

Okay.

Mr. Levesque.

[Douglas Levesque]

The geneticist who comes up twice a year from Toronto to Sudbury said there was one in B.C., but we're talking over 50 years ago now, since this became evident. Most of these people who did have any knowledge about it are all retired now, so I'm not aware of anybody.