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.