I call the meeting to order. This is our very first meeting on thalidomide.
We welcome our guests. We apologize for being late, especially to our guests on teleconference. You're looking very bright. We are glad you're with us. I'm sure we'll learn a lot about this issue today.
From Crawford, our guests today are Mr. Michael Mooney, vice-president, Class Action Services, and Brenda Weiss, project manager, thalidomide survivor compensation program.
From the Department of Health, we have Cindy Moriarty, executive director of health programs and strategic initiatives, and Theressa Bagnall, senior manager of program development at the office of grants and contributions services and innovation.
As individuals, by video conference, we have Dr. Martin Johnson, former director of the United Kingdom Thalidomide Trust, and Dr. Neil Vargesson, senior lecturer at the school of medicine, medical sciences and nutrition, in the institute of medical sciences, University of Aberdeen.
We're going to open with 10-minute remarks by each witness: Crawford, then the Department of Health, and then the individuals.
Mr. Mooney, you have 10 minutes.
I am happy to speak briefly on behalf of Crawford Class Action Services.
First of all, I would like to say thank you for the opportunity to appear. We are always pleased to be involved and to participate in the process, especially when the work we are doing involves providing important benefits and consideration to people who are entitled to receive them pursuant to either a litigation settlement, or in this instance, a program.
Crawford Class Action Services has been operating since about 1999. We've conducted somewhere between 90 and 100 legal settlements pursuant to class-proceeding litigation, or government subsidy or other benefit programs where a third party administrator was desired to be engaged.
We've had the pleasure of being involved in such important cases as the Indian residential school settlement, the hepatitis C tainted blood transfusion cases, the Walkerton water crisis in Ontario, and numerous other cases involving medical devices, food-borne illnesses, fraud against the markets, anti-trust or anti-combines settlements—pretty much anything—and of course institutional duty-of-care cases for situations where unfortunate incidents of abuse or interference with people's rights have taken place.
We are pleased to be involved working with Health Canada on the thalidomide compensation program. We began our work in October 2015. We are in place as a third party administrator to execute the program as designed by Health Canada and delivered to us. Within that capacity, we've worked to follow the process that was outlined and to provide service to the survivors and to potential new members of the class who are seeking to be considered in the program as well.
I think that's the extent of our opening comments. I don't really have a lot to add beyond that, except that we are happy to do our very best to answer any questions that may be put our way about our involvement in the administration of the program.
We look forward to the mutually shared learning opportunity that all of us will have from being involved in this process today.
Good morning. Thank you for the opportunity to provide information on the government's support for Canadian thalidomide survivors. Most of my remarks will be in English.
I can also respond in French.
I would be happy to take questions in either language.
In my current position at Health Canada, I am responsible for the oversight of a number of funding programs, including the thalidomide survivors contribution program.
I'd like to provide you with a brief history leading up to the establishment of the program, as well as some information about the program's design and implementation. Some of this you may have already received from a letter from the .
I'll start with the history. In the late 1950s and early 1960s, thalidomide was used as a sedative. It was also found to be effective in treating symptoms associated with morning sickness. Thalidomide became available in sample tablet form on July 17, 1959, and was licensed for prescription use by the Department of National Health and Welfare, now Health Canada, on April 1, 1961. It remained legally available until March 2, 1962, when it was removed from the market. Thus, the earliest full-term births to be affected by thalidomide would have been after April 1960.
In 1991, the Government of Canada created the $8.5 million extraordinary assistance plan for people born with disabilities caused by thalidomide. The funds were distributed in the early 1990s, then the program ended.
To date, 97 known Canadian survivors have received compensation through the plan. Many years later, on December 1, 2014, the House of Commons unanimously passed a motion to provide support for Canadian survivors. In spring 2015, the government announced a set of federal support measures for survivors. These measures are provided by the Thalidomide Survivors Contribution Program.
The purpose of the program is to contribute to meeting the needs of thalidomide survivors for the remainder of their lives so that they can age with dignity. The program also provided an opportunity and a process to assess individuals who had not already been identified in 1991 to determine if they were Canadian thalidomide survivors.
Each year a certain number of children are born with spontaneous or otherwise unaccountable malformations. In the absence of any definitive scientific test, it is difficult to distinguish between conditions caused by thalidomide and those caused by other factors.
It was, therefore, important to ensure the program was founded on objective and verifiable criteria. Thus it was decided and subsequently announced on May 22, 2015, that the program eligibility criteria would be determined based on the 1991 criteria, as follows: that there be verifiable information of the receipt of a settlement from a drug company; documentary proof, for example medical or pharmacy records, of the maternal use of thalidomide—brand names known to be Kevadon and Talimol—in Canada during the first trimester of pregnancy; and listing on an existing government registry of thalidomide victims.
This approach provided an objective process to assess unconfirmed individuals to determine if they were thalidomide survivors. It also provided consistency between the 1991 extraordinary assistance plan criteria and the criteria used to assess new applicants.
I'd like to note that the absence of time parameters in the eligibility criteria allows for the possibility that a person might submit proof from outside the time period of thalidomide distribution in Canada. The criteria also did not preclude the person whose mother ingested thalidomide after its withdrawal from the market.
Next, a few words about program implementation.
Following a competitive process, Health Canada selected Crawford & Company (Canada) Inc., an experienced and well-established provider of claims services, to act as the independent third party administrator of the thalidomide survivors contribution program. In addition to administering the ongoing support payments and the extraordinary medical assistance fund, Crawford is responsible for assessing the eligibility of all new claimants.
The administrator's discretion in implementing the program was intentionally limited. Crawford was to strictly adhere to the program parameters, including the eligibility criteria.
Crawford has confirmed 25 new survivors, in addition to the 97 survivors who had been identified in the early 1990s. This brings the total number of confirmed living survivors to 122. Of the 25 new individuals confirmed, 16 submitted documentary proof of maternal ingestion. That is the second of the three criteria that I just listed.
Four individuals have filed requests for judicial review of the administrator's decision. Last week, on May 2, a decision was rendered in the first of these cases. The decision reflected that the court does not have jurisdiction to review the crown's prerogative power nor to reformulate or add eligibility criteria, and it found that the administrator's decision was procedurally fair.
In closing, thank you for your time today. As Michael said, I think we all have something to learn from today's exchange in going forward. I hope the information has been helpful to you.
I'm happy to answer your questions.
The background is that I was the director of Thalidomide Trust from July 2000 to May 2014. Up until the end the 2006, we accepted as new beneficiaries to the trust only those individuals who had achieved a settlement in respect of their thalidomide damage with Diageo plc, as the heirs and successors to Distillers Co. (Biochemicals) Ltd.
The process they employed involved two U.K. experts, Professor Richard Smithells and Dr. Claus Newman, who had separately specialized in the care of thalidomide children in the 1960s and were co-authors of the paper “Recognition of Thalidomide Defects” in the Journal of Medical Genetics, October 1992.
This was a normal adversarial process. Following the death of Professor Smithells in 2002, the lawyers acting for Diageo were left with about 12 unresolved claims where Professor Smithells and Dr. Newman had been in disagreement over diagnosis. I assisted them in finding experts they had not used before, namely Dr. Hans-Georg Willert from Göttingen University and Dr. Janet McCredie of Sydney.
As a result, they were able to resolve these remaining cases. It was largely a result of this experience that led Diageo to announce they were going to discontinue their ex gratia scheme from the end of 2006, with 12 months' warning given by advertisements in the national press.
Dr. Willert died in September 2006, and the only other remaining thalidomide diagnostic experts in Europe other than Dr. Newman were Professor Marquardt of Heidelberg, who was very frail and elderly; Dr. Jürgen Graf of Nuremberg, whom Marquardt had trained; and Dr. Peter Kohler in Stockholm, who also retired not long afterwards.
Against this background, the trustees of the Thalidomide Trust decided they had to be able to consider applications to the trust directly from potential thalidomide victims affected by the Distillers' product.
From the beginning of January 2007 until my retirement at the end of May 2014, we were contacted by more than 600 applicants, of whom fewer than 30 met our criteria. Only three of these were able to produce documentary evidence of their mothers having been prescribed the drug.
We were aware that probably 50% of the original cases in the 1968 and 1973 settlements, where thalidomide exposure was agreed a virtual certainty, had no documentary evidence. This was because of the very widespread and casual distribution of the drug from hospitals to dental surgeries and as free samples to general practitioners. I heard there had been one case where the mother had been given the tablets by her veterinarian surgeon.
From the outset, it was known that this standard of evidence could not be insisted on in every case. We were also aware from epidemiological studies that the number of people born with non-thalidomide dysmelic conditions during the years 1959 to 1962 was likely to exceed the number of thalidomide survivors by between two and three to one, so we expected to see several cases not conforming to the typical thalidomide damage patterns.
My role was first to screen out those applicants who were born either before the availability thalidomide or after its withdrawal, allowing for the appropriate gestational timings. People born after the withdrawal date were advised that the case could only be considered if contemporary documentary evidence of late ingestion of the drug by their mother could be produced.
Second, we checked the location of the mother at the appropriate time to assess whether or not she was in a territory where we had known Distillers' thalidomide to be available. We were aware that thalidomide had travelled with medical practitioners to some unexpected places, but if a claim was made concerning a territory where we had no record of distribution, then we would require documentary evidence showing that the Distillers version of the drug had actually been present in that location before taking the case further. This was not produced in any case I know of.
The third stage of screening was for atypical conditions, specifically unilateral and transverse reductions. People with such conditions were also informed that we could only proceed if contemporary documentary evidence was produced that their mother had received the drug. I had been trained by most of the experts mentioned above in this subject, and by 2007 had met several hundred thalidomiders in various countries, so my trustees considered my knowledge adequate for this purpose.
People who passed these three stages of screening then had their cases presented to a committee of our trustees, which always included medical and legal experts. The decision almost invariably was then to commission an expert medical report from Dr. Newman. I can think of no subsequent case where Dr. Newman's recommendation was not followed. We did have one case of a person who'd moved to Australia as a child, and we arranged for that person to be examined by Dr. McCredie. Then her report, including X-rays, was reviewed by Dr. Newman for the trustees.
The trustee chair of our claims committee, as we called it, was always a very experienced High Court judge, and the standard of proof required for a decision was on the balance of probabilities.
In parallel with this, we began work to transfer and update Dr. Newman's knowledge, particularly to encompass what had been learned over the years about various genetic conditions. This was the background to the WHO meeting in Geneva, where the work of the genetics teams was considered by a gathering of global experts on the subject. It was hoped that an algorithm could be developed to facilitate screening. I do not know how far this has developed, but it should be easy to find out. I've been making efforts on this topic since Friday afternoon, when I was contacted about this, but I don't have an answer. I do know that the algorithm is not in use yet.
While our medical experts would always say that there was no aspect of thalidomide damage that had not been reported prior to the arrival of thalidomide, there were distinct patterns to typical thalidomide damage, and phocomelia was foremost among these. In a paper in the 1960s, one German doctor, reporting on many cases he'd dealt with, wrote that before thalidomide he had seen more babies with two heads than with phocomelia. All the work by Smithells, Newman, McCredie, Willert, Marquardt, etc., was based on extensive reporting from Germany of cases where there was no doubt that thalidomide had been involved.
The WHO meeting, in essence, endorsed the results of all the German early research that had been studied and acquired around the world in subsequent years. Theories have been advanced, such as that thalidomide operated primarily by restricting the growth of blood vessels. That theory was rejected on the basis of the known damage timeline, which mostly fell before the development of the circulatory system, and the abundant contemporary evidence showing that ingestion of the drug by mothers after the sensitive period, 20 to 42 days from conception, caused no detectable damage to the baby.
We did deal with a few claims pushed by law firms in the U.K. that were mainly concerning atypical cases, but the whole point, as seen by our board, was that atypical cases required a higher burden of proof in the form of contemporary documentation before they could be accepted. To my knowledge, this was produced in only one instance, and that was an exceptionally rare disorder called RBS. Typical cases presented no problem for acceptance.
From the notes that I was sent on Friday, I understand that you are trying to find out whether there are ways to assess thalidomide damage. The answer has to be yes because we did it. It is possible to assess thalidomide damage with a high degree of confidence. It's a medical-legal issue. I gather that Dr. Newman, in his middle eighties, is still performing this function for the Thalidomide Trust, but he's now being supported by Professor Sahar Mansour of St. George's University Hospitals, London. I note also that Professor Schuler-Faccini of Brazil is still in the saddle and operating in this role. She reported at Geneva that she'd been studying cases born as late as 2010.
I recommend that you read the Geneva report. It refers to an appendix 3, which is a technical appendix and which has still not been appended to it. I think it is probably available if you are able to make contact with the St. George's University team, or possibly the Thalidomide Trust. The WHO report says that theories of mechanism of causation are not actually of help with the diagnostic problem, but they're very keen that research is continued into these subjects, because one day it might add an awful lot to the sum of human knowledge.
In summary, no, we don't know how the drug does what it does to the babies, but we do know what it does and we know the times in the gestation pattern when it happens. On that basis, we were confident to take the decisions that we did.
I hope this is of service to you.
I'm a developmental biologist. I'm a scientist, not a clinician. I've been studying how thalidomide acts on the embryo for the last 15 years.
The drug itself is quite complicated. It exists as enantiomer, which means it can exist in two different forms in the body. One form is believed to be positive. That's what gives us its good benefits, its anti-inflammatory actions. The other side is supposed to be its teratogenic side effects, and that's damage to the embryo.
I've been interested in how the drug works. I got interested in this some time ago. Janet McCredie's work from the 1970s suggested that the nerves were targeted by the drug to cause the various birth defects. I've always been interested in that work and interested in how a drug like thalidomide could cause such massive damage. This drug, in just a short time period, affects almost every tissue in the body apart from the brain and the central nervous system. How it can do that is just amazing.
As Dr. Johnson just alluded, in the report from Smithells and Newman in 1992, they talk about just one tablet being enough to cause damage to an embryo. If you took more than one tablet, you would get lots more damage.
We took apart the drug. We made different versions of it, broke it down, and asked the question, what does the drug do in an embryo? We used chicken embryos and zebra fish embryos because they develop in very similar ways to early humans. They have similar genetic and molecular makeups to us. They're simple to use. You can put drops on them and see what they do. We found that, if you make versions of the drug, you can change the molecular structure. You can find versions of the drug that affect blood vessels. You can find versions of the drug that affect the inflammatory system and the immune system.
This is what the drug does normally. If you take a tablet of the drug, it's useful to treat cancers because it destroys blood vessels. It's useful to treat conditions like leprosy and multiple myeloma because it's anti-inflammatory.
We found that the drug's anti-angiogenic actions are what causes its effects on the embryo, and the anti-inflammatory actions don't seem to do much to it. We're now looking at molecular targets of that action, and if we can understand molecular targets, you could perhaps, possibly, identify or have a tool to identify who might be at risk.
We're also now looking at drug safety. Dr. Johnson also mentioned that there is a new generation of thalidomide babies in Brazil, and I would strongly recommend that you contact Lavinia Schuler-Faccini in Brazil because she is leading all the diagnostics there. In Brazil they have a leprosy problem, and thalidomide is very useful to treat leprosy. It's very effective, but the side effect is that they have a new population of babies with thalidomide-like damage.
We've been trying to make forms of thalidomide that don't cause birth defects. We're looking for versions that are not anti-angiogenic—that is, don't affect the blood vessels—and that are purely anti-inflammatory. We have identified some of those, and we're now trying to use those in other inflammatory conditions to see if we can use them as an alternative to thalidomide.
That's my expertise. I'm not a clinician, but I would say that, from the animal evidence from the 1960s through to recent years, if you look at particularly the primate studies—that's the studies in monkeys—this drug causes an amazing range of damage. If you look at monkeys, you have four or five embryos per litter, and each embryo is different. Each embryo is affected differently by the drug. You can have some that have phocomelia, as Dr. Johnson mentioned, where they have the digits sticking out of the top of the shoulders, and some that have almost no damage at all.
How the drug can do that, how the drug can affect one pregnancy and affect each embryo in such a different way, we still don't understand, but the fact is that in animal evidence the drug affects each embryo differently.
I think Dr. Johnson can confirm this or disagree, but I think each individual thalidomide survivor has a different range of damage as well. This is one of the reasons it's been so difficult to understand how the drug acts and how it causes its problems, because each person seems to have a different amount of damage. This is one of the problems we have in science, trying to understand how the drug acts.
Thank you for your time. I hope that was helpful.
I'm replacing my colleague Don Davies here. I'm very pleased to do so, because I narrowly avoided the illness, in the sense that I'm exactly the same age as the people affected. I was quite well acquainted with two people affected. You should have seen the emotion expressed by these people when, after my colleague Libby Davies tabled the motion, the House acknowledged them. The NDP has been working on this case for a long time. We must acknowledge the work of Libby Davies, who was a health critic for this topic in particular, and of Don Davies, who took over. Coincidentally, they have the same last name.
I'm not an expert in the field, so I'm pleased to see English experts among us. When a problem seems unsolvable, we usually look at what has happened and at the expertise acquired elsewhere.
How do the developments in the thalidomide victims' cases in Canada compare with the developments in other countries? My question is for the two British experts, who are speaking today by videoconference.
Ms. Moriarty, since you are the one asking the people from Crawford to administer the program, I'll also ask you the question. What are the best practices?
As my colleague Mr. Brown said, the people affected by this drug face unspeakable difficulties in life that any normal person wouldn't have to endure. The compensation for these people doesn't involve huge amounts for a government, especially since, in this case, everyone clearly failed at their job. This includes the pharmaceutical company and the various governments that approved the drug.
Ms. Moriarty, what expertise has been acquired worldwide on how to manage this situation and compensate victims over the long term? A few years ago, when we tabled our motion, we argued that, although the people affected had been compensated and had received support, their disabilities or defects had resulted in wear and tear and premature aging. This was specific to each case.
From this perspective, what are the best practices worldwide?
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.