What is the contaminated blood scandal?
The Factor 8 Scandal, Contaminated Blood Scandal or Infected Blood Scandal is the event of thousands of people in the UK (mostly Haemophiliacs) being infected with Hepatitis C (HCV) or HCV & HIV (co-infected) by a pharmaceutical product known as Factor VIII Concentrate. Some people with a less common form of Haemophilia, Haemophilia B, were infected via Factor IX concentrate.
“Around 1,250 were infected with HIV. The best estimate is that this included 380 children. Almost all infected with HIV were also infected with Hepatitis C and some with Hepatitis B and Hepatitis D as well. Three quarters of these 1,250 adults and children have died. A larger number still (between 2,400 and 5,000 people with bleeding disorders) who were not infected by HIV received blood products infected with one or more hepatitis viruses, and developed chronic Hepatitis C.”
Findings of the Infected Blood Inquiry
The Infected Blood Inquiry Report concluded that: Infections, leading to deaths, illness and suffering were caused needlessly to people with bleeding disorders by:
• Failures in the licensing regime – in particular (but not only) by allowing the importation and distribution from 1973 of blood products (Factor 8 concentrates) made in the US or Austria which carried a high risk of causing hepatitis, and were understood to be less safe than current domestic treatments for bleeding disorders.
• A failure to ensure a sufficient supply of Factor 8 concentrates from the plasma of UK donors to meet reasonable foreseeable demand without the need to import any products from abroad (ie failure to achieve “self-sufficiency”). In part this arose from the inept, fragmented system by which the blood services of England and Wales operated; and in larger part because (a) the fractionation facilities in England (“BPL”) were in great need of redevelopment, but this was badly delayed; and (b) new fractionation facilities in Scotland (“PFC”) which had been designed and funded to produce blood products for the North of England as well as Scotland were not utilised for that purpose.
• Increasing the size of the pools used to manufacture factor concentrates (both 8 and 9) in the UK, although it was well known that this would markedly increase the risks of viral transmission.
• Whilst presiding over this increase, failing to encourage and finance research into methods of viral inactivation of factor concentrates (both 8 and 9).
• By failing to do so, failing to achieve the total or at least partial viral inactivation of hepatitis viruses (in domestic production) by around 1980/1981 which would probably have resulted from such research if it had been pursued earlier (no new technology was needed). Viral inactivation could have prevented many infections (hepatitis and later HIV) and deaths.
• Also, by failing to do so, failing to provide factor concentrates which would with rare exceptions have been free of active HIV virus.
• Failing to ensure sufficiently careful and rigorous donor selection and screening (and allowing continued collection of blood from prisons).
• Adopting an attitude of denial towards the risks of treatment with factor concentrates.
• Treating people with ever increasing volumes of concentrates despite the increased risks of viral transmission.
• Failing to respond to serious risks of infection by making adjustments to treatment regimes to make them safer: such adjustments might have included greater use of cryoprecipitate (and, on a temporary basis, fresh frozen plasma) and of DDAVP, taking a more conservative approach to treatment, reducing the amount of home treatment, avoiding prophylactic treatment, adopting batch dedication policies, and deferring elective or non-urgent surgery.
• Treating children at Treloar’s with multiple, riskier, commercial concentrates, prophylactically and as objects for research.
• Treating children unnecessarily with concentrates (especially commercial ones) rather than choosing safer treatments.
• Failing to provide advice, guidance and information to clinicians to ensure that safer treatment practices were adopted.
• Adopting the wrong approach by looking for conclusive proof of what was the cause of AIDS rather than asking if there was a real risk that blood might transmit it.
• Falsely reassuring the public and patients – that blood did not carry AIDS; that the risk of AIDS for people with bleeding disorders was small; and that non-A non-B Hepatitis (Hepatitis C) was relatively mild and inconsequential.
• Taking a decision in July 1983 not to suspend the continued importation of commercially produced blood products.
• Having made that decision, failing to keep it under review.
• Failing to tell people of the risks of treatment and of available alternative treatments, thus treating them without their informed consent.
• Conducting research on people without, in many cases, telling them (or in the case of children, their parents) beforehand, or informing them of the risks and whether the research would enhance their treatment or primarily benefit others, and without obtaining properly informed consent. • In some cases, failing to tell people that they were infected and thereby denying them the opportunity to control the progression of their own illness more effectively and to prevent the spread of infection to others close to them.
• Being complacent about the risks of non-A non-B Hepatitis (Hepatitis C) and being slow to respond to the risks of AIDS.
• Being too slow to establish an expert advisory committee on AIDS and too slow to establish an overarching body with responsibility for blood safety.
• Failing to tell people of the risks of treatment or transfusions, and failing to seek their consent on a properly informed basis. • Failing to offer people reasonable alternatives to treatment or transfusions.
• In far too many cases, using insensitive and inappropriate means to tell people of their infections.
• Testing samples (which in most cases patients did not know were to be retained for the purpose) without their knowledge or consent.
• Delaying informing people of their infections by weeks, months and sometimes years.
• Too often compromising patient confidentiality and adding to stigma by prominent indications that these patients were a high risk to others.
• Failures of record-keeping, such that many people’s medical records have been destroyed or lost or are materially incomplete.
The Infected Blood Inquiry Report also concluded that harms were compounded by…
• Repeated and ongoing failures to acknowledge that they should not have been infected.
• The absence of any meaningful apology and redress.
• Repeated use of inaccurate, misleading and defensive lines to take which cruelly told people that they had received the best treatment available.
• A lack of openness, transparency and candour, shown by the NHS and government, such that the truth has been hidden for decades.
• Deliberate destruction of some documents and the loss of others.
• Failing to provide psychological support and counselling to people who had been infected and their families.
• Difficulties and delays in accessing appropriate specialist treatment and monitoring for Hepatitis C.
• Failures of palliative care for those dying in consequence of infection with HIV or hepatitis.
• Refusal to provide compensation (on the ground there had been no fault).
• Long delays in agreeing to provide even ex gratia financial support.
• Establishing ex gratia payment schemes which were underfunded and did not function in the best interests of those infected and affected.
• Failing to reform those ex gratia schemes promptly and failing to ensure that the national schemes which replaced them offered parity of support across the UK.
• Responding to calls for a public inquiry by producing flawed, incomplete and unfair internal reports.
• Failing, until 2017, to decide to establish a public inquiry.