The end of week four of the autumn hearings concluded with the evidence of Professor Tuddenham MBBS MD FRCP FRCPath F Med Sci.
He began his evidence by providing an overview of his career, stating that he had been a Director of the Medical Research Council, a member of the advisory panel of the Haemophilia Society and member of the UKHCDO in the late 70s early 80s.
Professor Tuddenham spoke about his time as a Lecturer at the University Hospital of Wales in the early 1970s where he trained under his main mentor, Professor Arthur Bloom. His main focus being research into haemophilia A and Von Willebrands disease. He spoke about how Professor Bloom stored blood samples at Cardiff and he had used these in the preparation of assays. In 1978 Professor Tuddenham and Dr. Peter Kernoff became Co-Directors at the Royal Free Hospital in place of Dr. Dormandy and set up the Haemophilia Centre there. Dr. Kernoff managed the clinical aspect of the Centre and Professor Tuddenham managed research.
Professor Tuddenham was questioned on the use of Cryoprecipitate treatment in the 1970s and the transitional phase to home therapy. He spoke about the preference of NHS concentrates for the treatment of children. He agreed they were aware of the risks of this treatment but had no undue concern about transferring patients on to commercial concentrates because they had already been exposed.
Mild haemophilic patients were also treated with concentrates and patients with inhibitors given large doses of Factor VIII. It was later found that treatment with ‘pig’ Factor VIII (Porcine) was more beneficial for treating inhibitors. The use of NHS Factor IX was found to be an effective treatment for haemophilia B. This development resulted from an error by a clinician who had administered the wrong treatment only to find that it had had a positive effect. Professor Tuddenham spoke about how initially NANB had seemed a mild virus compared to hepatitis B, as patients seemed to get better. He later agreed that he and Dr. Kernoff had become aware in the mid-1970s that NANB was in fact a serious illness with long term consequences which had been evidenced by liver biopsies. He said he had been unaware of the poor screening processes in the US and that US donors were high risk.
Professor Tuddenham was questioned on the supply and allocation of commercial and NHS blood products to patients and whether patients were aware their data was being stored on a central database. Ms Richards queried the description of a ‘low’ hepatitis product. Professor Tuddenham was not aware of this. Ms Richards said the Inquiry would try to find out more information about this product.
The focus then turned to the subject of the responsibility of the Haemophilia Centre Directors when purchasing blood products from commercial pharmaceutical companies, the influence on their decisions when purchasing blood products and profit making. Professor Tuddenham said he thought commercial incentive had overwhelmed safety issues and that safety should always be at the forefront.
Ms Richards questioned Professor Tuddenham on the developing knowledge of HIV and the risks of treating haemophiliac patients, referring to various documents from medical journals and Minutes of Reference Centre Directors. Ms Richards highlighted the prolonged delay by the Reference Centre Directors in producing firm recommendations to transfer patients on to alternative treatments. Professor Tuddenham said in 1984 the risks of treatment were well known, and referred to ‘commercial secrecy’ amongst the commercial product companies when trying to inactivate the viruses. He said they took a long time to do this, and it should have done much earlier. Professor Tuddenham was questioned about his involvement in sourcing NHS/commercial heat-treated concentrate at the Royal Free in 1984 when it was decided that this should be phased in. He said he had not been involved in this and it had been handled by Dr. Kernoff. However, he recalled there had been a supply issue and subsequently, patients on home treatment were told to continue to use up their supply and not change immediately. Some patients reverted to the use of Cryoprecipitate. Professor Tuddenham agreed that patients should have had the opportunity to decide on what treatment they received.
Professor Tuddenham was questioned further on the role of the UKHCDO in the AIDS crisis and how the UKHCDO responded to this. He explained that the role of the UKHCDO was limited to making recommendations and representations to Government. He explained how anxious and puzzled they were about this new virus but that no recommendation had been made for a change in treatment. The Directors’ recommendations were to continue with present policies. Ms Richards referred to a letter dated June 1983 where Dr. Spence Galbraith writes to the Department of Health recommending that all blood processed after 1978 should not be used. Professor Tuddenham said he had no knowledge of such a letter and agreed the information should have been shared and there should have been more collaboration amongst clinicians.
Ms Richards questioned Professor Tuddenham about informing patients of their positive HIV test results. He agreed patients should have been informed of their results, but the opinion of clinicians at the time was that patients should only be informed if they ask for their results. Professor Tuddenham agreed that the advice to patients was vague. He was questioned on the ethics of clinical research on patients and ‘implied consent’ for research projects and clinical trials.He was also questioned on the use of stored blood samples at the Royal Free without the patient’s knowledge, to which he said he had used samples to check for seroconversion and in some cases of litigation. Professor Tuddenham then provided information in relation to testing for vCJD and the use of blood products.
Ms. Richards put to Professor Tuddenham questions from Core Participants and in conclusion of the hearing, Sir Brian Langstaff asked Professor Tuddenham’s opinion on what should happen going forwards to stop this kind of thing happening again. Professor Tuddenham expressed his regret at past events and replied that there should be careful, intense surveillance on products and people, and ways should be found to replace human products with safe synthetic ones.