Jenni Richards QC firstly focused on the use of BPL and American concentrates during the late 70s to early 80s. Dr Winter provided background on the use of these treatments. He explained about the poor supply and great demand of BPL Factor VIII at the Centre at Guys Hospital during the 1970s and 80s.
He explained that children were prioritised for the BPL product but when supplies were low, they were ‘topped-up’ with American commercial Factor VIII. However, it was acknowledged by clinicians at this time that there was an element of risk with both products. He explained how ‘liberating’ home treatment was, allowing patients to live their lives with some kind of ‘normality’. Mild haemophiliacs and people with von Willebrand’s disease were mostly treated with DDAVP around this time but were also incorrectly treated with commercial Factor VIII.
In the 1970s the risk of American Factor VIII was acknowledged and a third agent, other than hepatitis A and B, was suspected. It was unknown whether it was one virus or many, however clinicians considered it to be harmless, and decided to monitor its development. Then liver biopsies taken in the late 1970s showed that it was in fact, a serious evolving problem, which caused liver disease and cirrhosis. Dr Winter acknowledged patients should have been informed and made aware of this development, but clinicians were reluctant to inform patients of the ‘agent’ as the home treatment was working so well, and patients were not showing signs of illness.
Ms Richards then questioned Dr Winter on his knowledge of the AIDS virus and HIV in the 1980s and the response to this virus by clinicians. Dr Winter was critical of the Department of Health for not providing clear guidance to clinicians. He felt the Department of Health should have had a stronger role in the process and there should have been a more co-ordinated approach led by the Department of Health. He felt that Elstree and the Transfusion Service should also have been more politically active. He considered there were too many mixed opinions at the UKHCDO and that guidelines for clinicians should have been more structured as they were left ‘too open’ for misinterpretation by clinicians. He considers a document on best practice with recommendations for clinicians should have been available. There was no recommendation not to use American concentrates until about 1983, when changes were recommended by the UKHCDO not to give concentrate unless it was absolutely necessary. Dr Winter agreed that they should have been informing patients of the risk of AIDS at this time. He described how he personally informed his own patients of their infection of AIDS/HIV, but how other clinicians were known to have informed their patients in such an insensitive and inhumane way e.g. in hospital corridors, by letter or just in a matter of fact manner.
Ms Richards referred to a letter written in May 1985 by Professor Bloom giving advice to the Haemophilia Society in which he states the cause of HIV is unknown. Dr Winter stated this was obviously untrue as it was on this day that a Cardiff patient under Professor Bloom’s care tested positive. Dr Winter spoke about the AIDS stigma and problems arising from the description of cause of death on death certificates, the problems with undertakers and the distress caused to families when a Coroner insisted on an Inquest.
Dr Winter was asked about PuP studies and provided an insight into the lengthy and complicated procedure of seeking approval for such a study. When HCV testing began in 1991, patients under the care of Dr Winter were not told immediately but informed of their test results at routine appointments. Dr Winter explained how patients were informed of their infections and then referred to a liver specialist.
Ms Richards then focused on heat treated Factor VIII. Dr Winter explained how he and Dr Savage decided in 1984 that although heat treated Factor VIII was more expensive, it was the safest option and so transferred their patients onto this treatment. Dr Winter said this was “the hardest decision he had to make as a doctor” and referred to widespread disagreement with other clinicians in regard to this decision.
Dr Winter was asked about pharmaceutical companies and their role. He explained how they provided the funds for the extra “frills” for people with haemophilia e.g. residential weekends, home treatment kits, physiotherapy etc all things the Department of Health would not pay for, but said this did not influence his decision as to where he purchased the Factor VIII.
Dr Winter had an active role as a Trustee of the Macfarlane Trust and Eileen Trust and was involved in the assessment of registrants for payments. He explained how registrants did not want to be ‘passive’ recipients but wanted help with retraining, rebuilding their lives and getting back to work. He spoke of widows and the lack of support for them and the lobbying of the Department of Health on their behalf. Some Trustees, however, thought this counter-productive and political activity should not be undertaken. Comparison was made between what registrants were receiving in England to what they were receiving in Ireland which was much more. Dr Winter referred to some really sick people not making any applications, whereas there were others whose applications he described as “over the top”.
On Day 2 Ms Richards began by asking questions on the previous day’s evidence put by Core Participants and others. These involved questions regarding heat treatment and the inactivation of HIV. Also, on patients’ consent when changing treatment, whether patients were informed of their infection with hepatitis C and HIV and how they were informed. Dr Winter explained about the approach of more elderly Expert Haematologists and their insensitivity to patients when informing them of sensitive information.
At the conclusion of his evidence Dr Winter expressed his opinion that Lord Owen was so close to achieving self-sufficiency in the UK and it would have made a huge difference if his initiative had gone ahead. He questioned the sensibility of taking blood from paid blood donors in the US?