◆Part 1: The Calamity
Patients received blood or blood products from the NHS from 1948. Many of those treated with them, particularly between 1970 and 1998, died or suffered miserably. This was not as a direct result of the condition that took them to the NHS. It was the treatment itself.
Sir Brian Langstaff chaired the Infected Blood Inquiry. He presented his report to Parliament on 20 May 2024 under section 26 of the Inquiries Act 2005. The report is HC 569 I. Seven volumes.
There were around 4000 to 6000 people with bleeding disorders in the UK at any one time. Around 1250 were infected with HIV. The best estimate is that this included 380 children. Almost all of those infected with HIV were also infected with Hepatitis C. Three quarters of these 1250 adults and children have died.
Between 80 and 100 people were infected with HIV after a blood transfusion. About 85 percent of those have died. Around 26800 people were infected with Hepatitis C through blood transfusions between 1970 and 1991. About 22000 were chronically infected. 2700 survived to the end of 2019.
The most accurate estimate is that more than 3000 deaths are attributable to infected blood, blood products and tissue.
Lord Winston called these events the worst treatment disaster in the history of the NHS. Langstaff reported that it could largely, though not entirely, have been avoided. He reported that it should have been.
◆Part 2: What Was Known
It was well known from at least the early 1940s that blood transfusions or the use of plasma could transmit serum hepatitis. It was known that this could be fatal. It could lead to serious long term disease, liver failure, cirrhosis and cancer.
A Scottish Home and Health Department memo in December 1964 said all blood for transfusion must be regarded as potentially contaminated. No transfusion should be undertaken unless the benefits outweigh the risk of hepatitis.
In 1975 Professor Garrott Allen wrote to Dr William d'A Maycock to try to persuade him against continued import of factor concentrates from the United States. He said one commercial product was sourced 100 percent from Skid row derelicts. A 50 to 90 percent rate of hepatitis developed from its use.
Awareness of AIDS began in 1981. It was apparent by mid 1982 that whatever was causing AIDS might be transmissible by blood and blood products. On 16 July 1982 the Centers for Disease Control reported three confirmed cases in people with haemophilia. An internal DHSS memo the same day alerted the Medicines Division that licences of certain manufacturers of imported blood products might have to be revoked.
By the end of 1982 it was known in the UK to both some clinicians and some within government that there was a real risk that blood, and blood products in particular, might transmit the cause of AIDS.
On 9 May 1983 Dr Spence Galbraith, director of the Communicable Disease Surveillance Centre, wrote to the DHSS. He had reviewed the literature. He concluded that all blood products made from blood donated in the United States after 1978 should be withdrawn from use until the risk of AIDS transmission by these products had been clarified.
Dr Diana Walford of the DHSS recorded that recommendation as premature.
The Galbraith paper was not put to ministers, not to the Chief Medical Officer, and not to the Committee on Safety of Medicines.
On 1 September 1983 Kenneth Clarke issued a press release. It said it has been suggested that AIDS may be transmitted in blood or blood products. There is no conclusive proof that this is so. On 14 November 1983 he told Parliament there is no conclusive evidence that acquired immune deficiency syndrome (AIDS) is transmitted by blood products.
◆Part 3: The Licence
The first licensing applications for Factor 8 concentrates were submitted in 1972. They were for Kryobulin and Hemofil.
In October 1972 Dr Duncan Thomas inspected Hyland Laboratories. He noted the hepatitis risk. The products were made from very large plasma pools. The donors do not inspire confidence. He recommended the grant of a licence. The Committee on Safety of Medicines recommended a product licence for Hemofil in January 1973. Kryobulin followed.
Langstaff found those decisions were wrong. Commercially manufactured blood products sourced from paid donors and manufactured in large pools were less safe than NHS concentrate or cryoprecipitate. Safety was not put first.
On 4 May 1983 Professor Arthur Bloom sent a statement to Haemophilia Society members. He said the cause of AIDS was quite unknown and it had not been proven to result from transmission of a specific infective agent in blood products. He advised no change to therapy with factor concentrates. Two weeks later his own centre in Cardiff issued treatment policy guidelines advising DDAVP, cryoprecipitate, and only NHS factor concentrates for children and those with mild haemophilia.
On 13 July 1983 the Sub Committee on Biological Products met. No action was taken in response to the risks from imported factor concentrates. The Committee on Safety of Medicines endorsed that. Langstaff found the decision not to suspend imports of commercial concentrates in July 1983 was wrong. Having made that decision, the Licensing Authority failed to keep it under review.
Collection of blood from closed prisons and borstals in England and Wales finally stopped at the end of 1984. The last open prison collection stopped in 1986.
Universal HIV screening of UK blood donations began on 14 October 1985. Universal Hepatitis C screening began on 1 September 1991. A first generation Hepatitis C test had been available from April 1989. Langstaff recorded that the UK was one of the last when it introduced that test two and a half years later.
◆Part 4: Treloar's
Treloar's treated children with haemophilia. The Inquiry understands that only around 30 of the 122 pupils with haemophilia who attended between 1970 and 1987 survive.
Dr Rosemary Biggs observed in December 1970 that the collection of 49 haemophilic patients at the Alton School makes this a unique opportunity to study the disease. Research was conducted at Treloar's to an extent which appears unparalleled elsewhere. Pupils were often regarded as objects for research.
The risks of viruses being transmitted through blood or blood products were well known to Treloar's clinicians. Those risks were not explained to parents or to pupils. Informed consent was not obtained.
Dr Anthony Aronstam, director of the haemophilia centre from 1977, used commercial concentrates heavily. By 1978 cryoprecipitate use had declined almost to nil. From as early as February 1983 individual records show that pupils were examined for any signs of the stigmata of AIDS. Treatment did not change. The prophylaxis programme continued.
Some pupils were never told by the school that they had tested positive for HIV. Others were told in groups. The staff went around the room saying YES, NO, YES, NO. Parents were not present.
A large percentage, probably about 70 percent, of those pupils with haemophilia who attended Treloar's School died in consequence of their infection. Langstaff found what occurred was not an inevitable course of events. It was not a tragic accident. It was not the result of an unknown against which steps could not be taken effectively.
◆Part 5: The Documents
Three separate sets of documents have been lost or destroyed. Files relevant to the HIV litigation. Minutes and background papers of the Advisory Committee on the Virological Safety of Blood, in particular from 1989 to 1991. The Private Office papers of Lord David Owen, Minister of State for Health from 1974 to 1976. In 1988 his files recorded a note that his papers had been destroyed by the Department of Health as normal procedure after 10 years.
Registered file GEB/1 volume 4 was destroyed on 29 September 1994, before its review date. Other GEB/1 volumes were destroyed between October 1997 and November 1998. Those files held the minutes and background papers of the committee that made central recommendations about the timing of viral screening for Hepatitis C.
Langstaff found it is more likely than not that the authorisation to destroy the files was because the documents contained material dealing with delays in the UK to the introduction of screening of blood donations for Hepatitis C. If this is right, it was a deliberate attempt to make the truth more difficult to reveal.
He could not identify who marked the files for destruction. He was clear it was not orchestrated from the top. The government had for decades repeated that patients had received the best treatment available.
◆Part 6: The Record
Responsibility for much lies with successive governments. Langstaff reported a lack of openness, transparency and candour, shown by the NHS and government, such that the truth has been hidden for decades. Repeated use of inaccurate, misleading and defensive lines to take cruelly told people that they had received the best treatment available.
Standing back, and viewing the response of the NHS and of government, Langstaff answered the question was there a cover up. There has been. Not in the sense of a handful of people plotting in an orchestrated conspiracy to mislead, but in a way that was more subtle, more pervasive and more chilling in its implications. To save face and to save expense, there has been a hiding of much of the truth.
On publication day he said this disaster was not an accident. People put their faith in doctors and in the government to keep them safe and their trust was betrayed.
The government failed, until 2017, to decide to establish a public inquiry. The Inquiry's principal recommendation on publication day was that a compensation scheme should be set up now. That recommendation had already been made in the Second Interim Report of 5 April 2023.
The documents show the knowledge existed. The report shows how little accountability followed.
Infected Blood Inquiry Final Report. Sir Brian Langstaff. Presented to Parliament pursuant to section 26 of the Inquiries Act 2005. HC 569 I. 20 May 2024.