Abbreviation | ACVSB |
---|---|
Successor | Microbiological Safety of Blood and Tissues (MSBT) [1] |
Formation | 8 March 1989 [2] |
Founder | Dr H. H. Gunson, and DHSS [3] |
Defunct | February 1993 [1] [4] |
Type | Advisory |
Focus | Blood safety, maintaining adequate blood supplies, testing and screening of blood donors [5] |
Location |
|
Key people | Dr E L Harris (chair); [6] Dr J Metters (chair from August 1989) [7] |
The Advisory Committee on the Virological Safety of Blood, often abbreviated to ACVSB, [8] was a committee formed in March 1989 [2] in the United Kingdom to devise policy [9] and advise ministers [10] and the Department of Health on the safety of blood with respect to viral infections. [11] The scope of the ACVSB concerned areas of significant policy for the whole of the United Kingdom and operated under the terms of reference: "To advise the Health Departments of the UK on measures to ensure the virological safety of blood, whilst maintaining adequate supplies of appropriate quality for both immediate use and for plasma processing." [5] Of particular emphasis to the remit was the testing of blood donors using surrogate markers for Non-A Non-B hepatitis (NANBH) [12] and later on, HCV-screening of blood donors. [11]
The first meeting took place on 4 April 1989 and was chaired by the (then) Deputy Chief Medical Officer (DCMO), Dr E L Harris. [6] [13] From August 1989, Dr J Metters, also DCMO, sat as chair. [7] The advice to be given by the committee extended to blood products and donor organs as well as blood, and the viral agents to be considered by the group were HIV1 and HIV2, HTLV-I, Non A Non B Hepatitis, CMV, parvovirus and the prion disease Creutzfeldt–Jakob disease (CJD). [9]
After the inaugural meeting of 4 April 1989, the advisory committee met a further 13 times, with the fourteenth meeting being held on 29 September 1992. The files and minutes of the committee do not continue beyond February 1993 by which time the ACVSB was considered defunct. [4] Following a memorandum from NHS Management Executive dated 8 February 1993, the ACVSB was replaced by the committee on the Microbiological Safety of Blood and Tissues (MSBT). [14]
Meeting | Date | Topics discussed |
---|---|---|
First meeting | 4 April 1989 [13] | Creutzfeldt-Jakob Disease, the EC directive on blood products, HTLV-I testing. [10] |
Second meeting | 22 May 1989 [15] | HTLV-I, Non A Non B hepatitis, Human Growth Hormone, EC directive on blood products, overview on hepatitis, hepatitis B, Non A Non B hepatitis. [16] |
Third meeting | 3 July 1989 [17] | EC directive on blood products, HGH, HTLV-I, Non A Non B hepatitis, action in response to reports of blood/blood product infectivity, effect of gamma irradiation on the Human Immunodeficiency Virus and human coagulation proteins. [18] |
Fourth meeting | 6 November 1989 [19] | Human Growth Hormone, EC directive on blood products, HTLV-I screening, Non A Non B hepatitis, report on UKBTS survey of surrogate testing and Chiron screening. [19] |
Fifth meeting | 17 January 1990 [20] | Human Growth Hormone, EC directive on blood products, HTLV-I screening, Non A Non B hepatitis, combined HIV 1 and HIV2 testing. [20] |
Sixth meeting | 24 April 1990 [21] | EC directive on blood products, HIV 1 and 2 testing, Hepatitis C, anti HCV testing. [21] |
Seventh meeting | 2 July 1990 [22] | Hepatitis C testing, anti-HCV ELISA tests, chimpanzee study of Anti-HCV tested source plasma. [22] |
Eighth meeting | 21 November 1990 [23] | Hepatitis C testing, counselling of HCV positive donors, anti-HBc testing, reinstatement of donors found to be reactive in previously-used HIV screening tests, HCV in the community. [23] |
Ninth meeting | 25 February 1991 [24] | Hepatitis C: UKBTS pilot study, NIBSC meeting on Hepatitis C, protocol for HCV Screening and supplementary testing, EC directive on viral safety, EC directive on blood products, hepatitis C: Community transmission, anti-HBc testing of blood donors, hepatitis BsAg confirmatory testing, chronic fatigue syndrome (ME) and blood transfusion, [24] CJD agent/prions in blood donors. [25] |
Tenth meeting | 21 May 1991 [26] | Protocol for hepatitis C screening and supplementary testing, anti-HCV tests on blood donations. [26] |
Eleventh meeting | 29 October 1991 [27] | Hepatitis C, screening of non UK plasma in blood products, results of first HCV testing trials, ALT testing, use of plasma from anti-HBc positive donors with a history of jaundice, re-admittance of donors not confirmed HIV antibody positive, HTLV-I BTS study, [27] possible look-back study. [28] |
Twelfth meeting | 21 February 1992 [29] | Funding anti-HCV screening, chronology of HCV testing, preliminary analysis of HCV testing, evaluation of in-vitro diagnostics by PHLS, non HCV-tested plasma, EC directive on blood products, ALT testing of blood and plasma, HTLV-I testing of blood donations, non-viral infections of blood transfusions including Yersinia, hepatitis A, virally inactivated fresh frozen plasma. [29] |
Thirteenth meeting | 2 July 1992 | Anti-HTLV testing/screening, virus inactivated plasma (VIP), initial screening and alternatives to PCR/RIPA confirmatory tests.[ citation needed ] |
Fourteenth meeting | 29 September 1992 | Detection of parvovirus B19 in blood products. [30] [ better source needed ] |
It came to light in 2004 that documentation that fell within the scope of NHS contaminated blood products had gone missing from within the Department of Health and was thought to have been destroyed in the early 1990s. [31] It was claimed by the (then) Minister of State, Lord Warner, that the files in question had been identified by the Department of Health as minutes and background papers of the ACVSB spanning May 1989 to February 1992 and that they were "unfortunately destroyed" having not been properly archived. [32] In May 2006, it was recorded in Hansard that officials became aware of the destruction of the files as early as April 2000, at which point the Department of Health undertook an internal audit. [33] According to a report in The Times of 13 May 2019, there were 17 volumes of papers generated by the advisory committee during the course of its operation. [4] The investigation by the Department's internal auditors conducted in April 2000 found that of the 17 volumes, 14 had been destroyed and only volumes 1-3 survived. [34] A court disclosure list from the Hepatitis C Litigation dated 9 May 2000 also confirms that ACVSB volumes 4-17 of file series "GEB1" were destroyed at various stages between July 1994 and March 1998. [35]
A significant decision made by the committee in November 1990 was to recommend to Ministers that routine anti-HCV screening of blood be introduced. However, the ACVSB decision was not implemented until September 1991 which came under criticism in the Final Report of the Penrose Inquiry for having been delayed by 10 months. [36] [37] In 2001, the role of the ACVSB was referred to in the judgment of A and Others v National Blood Authority in that ministerial approval had been given on 21 January 1991, yet the second generation tests were not introduced in England and Wales until 1 September 1991. [38]
During the HIV Haemophilia Litigation, the ACVSB recommended the use of a waiver, or deed of undertaking, aimed at ensuring that the claimants would not be able to litigate against the government if they were found to have contracted any further viruses. [39] [40] It was recorded in Hansard in 2007 that a number of these deeds of undertaking from 1989 were inadvertently destroyed. [41]
Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV) that primarily affects the liver; it is a type of viral hepatitis. During the initial infection period, people often have mild or no symptoms. Early symptoms can include fever, dark urine, abdominal pain, and yellow tinged skin. The virus persists in the liver, becoming chronic, in about 70% of those initially infected. Early on, chronic infection typically has no symptoms. Over many years however, it often leads to liver disease and occasionally cirrhosis. In some cases, those with cirrhosis will develop serious complications such as liver failure, liver cancer, or dilated blood vessels in the esophagus and stomach.
A blood-borne disease is a disease that can be spread through contamination by blood and other body fluids. Blood can contain pathogens of various types, chief among which are microorganisms, like bacteria and parasites, and non-living infectious agents such as viruses. Three blood-borne pathogens in particular, all viruses, are cited as of primary concern to health workers by the CDC-NIOSH: HIV, hepatitis B (HVB), & hepatitis C (HVC).
The tainted blood disaster, or the tainted blood scandal, was a Canadian public health crisis in the 1980s in which thousands of people were exposed to HIV and hepatitis C through contaminated blood products. It became apparent that inadequately-screened blood, often coming from high-risk populations, was entering the system through blood transfusions. It is now considered to be the largest single (preventable) public health disaster in the history of Canada.
Murine coronavirus (M-CoV) is a virus in the genus Betacoronavirus that infects mice. Belonging to the subgenus Embecovirus, murine coronavirus strains are enterotropic or polytropic. Enterotropic strains include mouse hepatitis virus (MHV) strains D, Y, RI, and DVIM, whereas polytropic strains, such as JHM and A59, primarily cause hepatitis, enteritis, and encephalitis. Murine coronavirus is an important pathogen in the laboratory mouse and the laboratory rat. It is the most studied coronavirus in animals other than humans, and has been used as an animal disease model for many virological and clinical studies.
The Joint Committee on Vaccination and Immunisation (JCVI) is an independent expert advisory committee that advises United Kingdom health departments on immunisation, making recommendations concerning vaccination schedules and vaccine safety. It has a statutory role in England and Wales, and health departments in Scotland and Northern Ireland may choose to accept its advice.
Hepatitis B vaccine is a vaccine that prevents hepatitis B. The first dose is recommended within 24 hours of birth with either two or three more doses given after that. This includes those with poor immune function such as from HIV/AIDS and those born premature. It is also recommended that health-care workers be vaccinated. In healthy people, routine immunization results in more than 95% of people being protected.
Hepatitis B virus (HBV) is a partially double-stranded DNA virus, a species of the genus Orthohepadnavirus and a member of the Hepadnaviridae family of viruses. This virus causes the disease hepatitis B.
Hon. Richard Tedder FRCP is an English virologist and microbiologist, was head of the Department of Virology at the University College London Medical School, and worked as virologist at Public Health England
In the 1970s and 1980s, a large number of people – most of whom had haemophilia – were infected with hepatitis C and HIV, the virus that leads to acquired immune deficiency syndrome (AIDS), as a result of receiving contaminated clotting factor products. In the United Kingdom, these were supplied by the National Health Service (NHS) and many of the products were imported from the US.
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The Penrose Inquiry was the public inquiry into hepatitis C and HIV infections from NHS Scotland treatment with blood and blood products such as factor VIII, often used by people with haemophilia. The event is often called the Tainted Blood Scandal or Contaminated Blood Scandal.
Arthur Leslie Bloom FCRP, FRCPath (1930–1992) was a Welsh physician focused on the field of Haemophilia.
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A and Others v National Blood Authority and Another, also known as the Hepatitis C Litigation, was a landmark product liability case of 2001 primarily concerning blood transfusions but also blood products or transplanted organs, all of which were infected with hepatitis C, where liability was established under the Consumer Protection Act 1987 and the Product Liability Directive (85/374/EEC) even in the absence of the ability to test to ascertain which blood transfusions were defective. The claimants were 114 individuals, six of whom were considered lead plaintiffs and given close consideration by the judge, Mr Justice Burton. Several of the claimants were minors who had become infected with Hepatitis C in the course of their treatment for leukaemia. The defendants were the National Blood Authority (NBA) and in respect of Wales, the Velindre NHS Trust, Cardiff. The court found that the UK government should have implemented measures to screen donated blood for HCV by March 1990, rather than September 1991, and that surrogate testing should have been introduced within the United Kingdom no later than 1 March 1988.
The HIV Haemophilia Litigation [1990] 41 BMLR 171, [1990] 140 NLJR 1349 (CA), [1989] E N. 2111, also known as AMcG002, and HHL, was a legal claim by 962 plaintiffs, mainly haemophiliacs, who were infected with HIV as a result of having been treated with blood products in the late 1970s and early 1980s. The first central defendants were the then Department of Health, with other defendants being the Licensing Authority of the time, (MCA), the CSM, the CBLA, and the regional health authorities of England and Wales. In total, there were 220 defendants in the action.
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Prior to the formation of SaBTO advice was provided at UK Government level by the Committee for the Microbiological Safety of Blood, Tissues and Organs (MSBTO) and its predecessor, the Committee for the Microbiological Safety of Blood and Tissues (MSBT) (1993 -2007). Prior to that we understand that advice was provided on a national level by a body called the Advisory Committee on the Virological Safety of Blood (ACVSB).
Dr Gunson had recommended to the DHSS that a group should be established and this had been agreed.
The committee produced 17 volumes of documents and the files were closed in February 1993.
I have also been Chairman of the Advisory Committee of the Virological Society of Blood (ACVSB) since August 1989.
The task of the Advisory Committee was to devise policy...
He explained that the Committee had been set up to give advice to the UK Health Ministers.
The ACVSB advised the UK government, among other things, on surrogate testing of blood donors for NANB Hepatitis and screening of donors for Hepatitis C.
Surrogate testing of blood donations in relation to Non A Non B hepatitis formed an important part of its business.
The ACVSB first met on 4 April 1989.
Each group met in May 1989: the ACTTD had its second meeting on 19 May and the ACVSB its second meeting on 22 May.
The report was given to the third meeting of the ACVSB on 3 July 1989...
Below is the agenda for the 4th meeting of the ACVSB, to be held at 1030hrs Monday 6 November 1989...
...and then we have in October of 1991 an 11th meeting of that committee, the Advisory Committee on the Virological Safety of Blood considering recommendations in relation to HCV testing and the results of the first HCV test trials and the possibility of look-back study although no decision then taken....
"Dry heat treatment of 8O°C for 72 hours reduced but did not always eliminate detectable B19 from factor VIII concentrates, consistent with recent observations that current methods of viral inactivation during blood product manufacture are insufficient to entirely eliminate B19 infectivity.
...although volumes 14-17 were destroyed, volumes 1-3 survive...
Penrose ruled that, overall, little could have been done differently by the authorities to prevent the contamination, but that mistakes were made. He criticised a 10-month delay in 1990 by the advisory committee on the virological safety of blood to recommend that screening start...
The Inquiry has endeavoured to assess why there was a delay of almost 10 months between the decision by the ACVSB on 21 November 1990 to recommend the introduction of screening as soon as practicable and 1 September 1991...
Recommendations to proceed with the introduction of the anti-Hep C testing were made by the relevant UK Committee, the ACVSB, in July and November 1990, subject to the holding of various trials. Ministerial approval was given on 21 January 1991 and a programme of implementation was then commenced for all RTCs. The tests (by now second generation tests, and with a supplementary test available for confirmatory purposes in place) were introduced throughout England and Wales on 1 September 1991.
The ACVSB had advised ministers to require victims to sign a waiver agreeing not to pursue the Government over hepatitis infections when applying for compensation.
It is also believed that the committee was responsible for suggesting that those who had been infected with HIV and wanted compensation should sign a waiver agreeing not to sue if they were later found to have contracted other viruses.
A number of signed waivers, going back to 1989, were inadvertently destroyed with the files in which they were held.