On the 24 March 2021, the Inquiry heard evidence from Professor Howard Thomas, Director of Skipton Fund (SF) 2011-18 and Trustee of the Caxton Foundation (CF) 2011-18.
Before becoming the first medical Director of the Skipton Fund, Professor Thomas had been involved in the initial stage of setting up of the Fund. He explained he had been brought in to provide medical input in the Stage 2 application process.
Inquiry Counsel questioned Professor Thomas about the ‘trigger point’ to qualify for the higher level of Stage 2 payments and how qualification was determined. Professor Thomas explained how the Appeal Panel of Directors would decide whether an applicant had provided sufficient evidence of cirrhosis/liver disease to qualify for Stage 2 payments. He also explained the problems that they came up against when applicants were unable to provide sufficient evidence because their medical records had been destroyed.
Professor Thomas explained the alternative methods that were used to determine on the balance of probability, whether the applicant had developed cirrhosis/liver disease. He explained that Nick Fish the Scheme Administrator was able to sign off on the majority of cases, if they were straightforward and had sufficient evidence, but more difficult cases were referred to him to consider and investigate further.
Inquiry Counsel questioned Professor Thomas in relation to spontaneous ‘natural clearers’ and the exclusion of these cases from the Scheme. He explained that the understanding at that time was that the majority of cases, would clear the infection within 3 to 6 months and return to normality, although he believed some of these cases moved on to chronic infection with approximately 1% developing cirrhosis/liver cancer. These types of cases were treated with Interferon which caused continuing symptoms. However, the psychological effect on individuals had never been taken into consideration in the qualifying process. Professor Thomas said it was for this reason that he had suggested a ‘special category mechanism’. He said he had been involved in the development of the rules for the scheme but that it was the DoH who decided who made the final decision as to who got the ex-gratia payments.
Professor Thomas explained the Stage 1 application process was more problematic because of the difficulty in obtaining proof of source of infection if an individual’s medical records had been destroyed or were incomplete or maybe did not show administration of blood. Individuals were often asked to produce evidence such as photographs of operation scars as proof. Professor Thomas explained to the Inquiry how he would liaise with other experts but often used the Internet as a tool to research the balance of probabilities of infection by such operations reported by applicants. Investigation also included genotypes which Professor Thomas considered was an advantage in helping the individual’s case. He explained that if a case was turned down, then the applicant had the opportunity to appeal the decision through the Appeals Panel. He explained it was a difficult stage of assessment and was highly subjective.
Professor Thomas spoke about the automatic rejection of individuals if there was evidence of intravenous drug abuse.
Inquiry Counsel referred Professor Thomas to Minutes of various meetings he had attended where discussions had included the possible inclusion of dependents in the scheme; discussion concerning borderline claims and the use of Fibroscans in the assessment for Stage 2 payments. He explained some of the cases could be complicated and so sought the help of Dr. Dusheiko, who later also became a Director of the SF.
Professor Thomas explained to the Inquiry the system of Fibroscan scoring used by the SF. He commented that qualification was always a contentious issue.
Inquiry Counsel posed questions to Professor Thomas concerning the provision of evidence of infection for deceased individuals and he explained what had been required by the SF.
Inquiry Council questioned Professor Thomas on his role at the Caxton Foundation and how individuals got to hear about the CF. He explained that he had sat on the Audit Committee and attended meetings to discuss policy. He explained that haemophilia patients would have probably heard about CF from the hepatology nurses who were very good at providing information to patients and who often helped patients by completing the application forms for them.
Inquiry Counsel questioned Professor Thomas on access to new treatments, and referenced a letter Professor Thomas had written to the Minister in November 2014 in which he informs the Minister of 90 patients receiving ex-gratia payments from the SF who will go on to develop irreversible cirrhosis. He informs the Minister that the curable antiviral drugs could prevent the progression of disease in these patients and asks that the Minister consider fast track access to these ‘expensive’ drugs. Professor Thomas explained that the response to his letter was that the government could not give to one group and not another and that the consideration of these drugs was under the control of NICE.
Inquiry Counsel posed questions to Professor Thomas on his involvement in discussions with the DoH regarding the Special Category Mechanism (SCM). He explained at length the effects of hepatitis C variants on the brain and how it caused depression and cognitive problems (brain fog) in people with both hepatitis C and hepatitis B. He said that nearly everybody had claimed for this as it had been difficult to differentiate. Over £300 million was spent in this regard.
Inquiry Counsel asked Professor Thomas about the exclusion of hepatitis B at the Caxton Foundation and Skipton Fund. He said it had been an anomaly why hepatitis B had not been taken into account. He went on to explain how there was no differentiation between hepatitis B and hepatitis C. He explained most of those individuals with hepatitis B seemed to be of Asian ethnicity who had got it from their mothers at birth. He described patients being ‘sheepish’ about their infection because of the association with drug abuse. He said these people were left out as it was considered that there was an 80-90% chance of them getting an acute episode which would lead to full recovery, particularly once the hepatitis vaccine was introduced.
Inquiry Counsel then turned to Professor Thomas’ involvement in NANB and hepatitis C research and Professor Thomas spoke about his concerns when it became evident to him that the disease was progressive and would lead to young people suffering with cirrhosis and liver disease in the future. He said he could foresee this becoming an enormous problem.
Professor Thomas made reference to his involvement in a controlled blind study on three patient groups where biopsies were examined for markers and diagnosis including hepatitis B. His aim was to get a histological basis to work from.
Professor Thomas informed the Inquiry how he had been involved in the development of radioimmunoassay testing for NANB hepatitis and had written a paper on it. He explained at length how serum was used to develop radioimmunoassay and new assays. He gave a concise explanation as to what monoclonal antibodies were and how these were a leap forward in hepatitis testing.
Professor Thomas referred to the use of surrogate testing to pick up NANB which had been used in the US and Germany. His view was that screening should have been introduced in the UK. He spoke about his involvement in discussions with the DoH concerning screening and had written the arguments for and against for the DoH. Professor Thomas said the DoH’s decision was not to use the first generation assay but to wait for the second.
Professor Thomas was questioned on a patient study that he took part in with Dr. Kernoff which involved 30 patients treated with commercial and NHS concentrates, some of these patients not having been treated previously. Professor Thomas provided information on Dr. Kernoff’s methods of treating these patients, ensuring they were treated with the same batch of concentrate for each bleed. Inquiry Counsel questioned whether these patients should have been informed of the NANB risk and should have been told about the two preparations. Professor Thomas considered it had been ethical to continue with the trial and considered the trial had been a success in the non haemophiliac community.
For a full transcript of the evidence of Professor Thomas please visit https://www.infectedbloodinquiry.org.uk/evidence where you can read the transcript or watch the evidence via YouTube video.