Sat, 9 December 2023

Newsletter sign-up

Subscribe now
The House Live All
Seeking Safety for the Most Vulnerable – Escalating Action Against E-Bike Battery Fires Partner content
By Electrical Safety First
New report highlights how a holistic approach to pharmacy can transform healthcare delivery Partner content
Early diagnosis and timely treatment: Why both are key to improving cancer survival Partner content
London’s super sewer is nearly here – but we must keep making progress Partner content
By Andy Mitchell CBE, Tideway CEO
Press releases

The infected blood scandal – how a key warning was ignored

Tom Sasse

Tom Sasse

13 min read

With the Infected Blood Inquiry nearing its conclusion, The House has heard that the then-department of health ignored and downplayed calls in the early 1980s to mitigate risks and warn patients. Tom Sasse reports.

In June 1983 the Council of Europe, the continent’s leading human rights body, issued a warning. With the AIDS epidemic spreading rapidly, it alerted governments that this “new and severe health hazard” was “transmissible by blood products” and urged them to “take all necessary steps”.

It was concerned about Factor VIII, a product developed by American pharmaceutical companies in the 1970s and marketed as a “wonder drug” for people with haemophilia, an inherited bleeding disorder which prevents blood from clotting.

The letter recommended health authorities “avoid wherever possible the use of factor products prepared from large plasma pools”, especially when imported, and “inform attending physicians and selected recipients, such as haemophiliacs of the potential health hazards”.

But The House can reveal that in the United Kingdom, these warnings were downplayed and subsequently ignored by the then-department of health.

A department of health official mischaracterised the letter’s seriousness, suggesting it only required that “appropriate precautions are taken in preparation of certain blood products” and “groups of recipients such as haemophiliacs are accordingly reassured”.

Steven Snowdon QC, a barrister acting for victims, said documents showed a civil servant “inaccurately summarised the [Council of Europe] recommendations”, entirely ignoring the need to avoid the use of factor products or inform patients of the risks.

While other countries acted quickly, the Inquiry has heard that changes in the UK took years: the department of health did not issue a public statement about the link between HIV and blood products until December 1984, while British haemophiliacs went on being given imported Factor VIII until at least 1985.

Campaigners argue that hundreds of British haemophiliacs died as a result of the department’s inaction, most with little idea of the risks they faced.

Jason Evans, a campaigner whose father died in 1993, said: “Had untreated Factor VIII been withdrawn from use in June 1983 or earlier, hundreds of lives would have been saved. My father would probably still be alive today.”

Jason Evans, then aged 4, with his father
Jason Evans, then aged 4, with his father

Philippa Whitford, an MP and former doctor, said: “This looks to be one in a string of egregious decisions in the 1980s that saw the health department pulling the wool over patients’ eyes.

We have to remember clotting factors were being used quite liberally at the time, even in minor cases when it wasn’t essential.”

“To choose to deliberately change a warning to a reassurance...they should have been doing everything to warn clinicians not to use this product unless they absolutely had to,” she added.

The June 1983 memo constituted the starkest warning the UK government had received, but it came on the back of growing evidence of risks in the early 1980s.

AIDS had been first been identified by doctors in 1981. Terrence Higgins, a Hansard reporter and DJ, died a year later – thought at the time to be the first British victim. In April 1983, the BBC broadcast Killer in the Village, a documentary tracing the rapid spread of the disease across America, which asked whether it was already being transmitted in London.

Since the 1960s, most haemophiliacs – who can suffer from bleeding spontaneously as well as after knocks and scrapes – had been treated with another product, called Cryoprecipitate (Cryo). Derived from single donor units, Cryo was relatively safe and had greatly improved haemophiliacs’ lives. As Snowden told the Inquiry: “the game changer, if I may use that expression, for life expectancy was not factor concentrates, it was cryoprecipitate”.

Factor VIII, however, was sold by manufacturers and promoted by doctors on the promise of convenience. While Cryo was a raw plasma product that had to be kept frozen, Factor VIII was a freeze-dried powder that could be stored in the fridge and dissolved in water. Both products contained the clotting protein deficient in people with haemophilia, but Factor VIII could be produced in bulk by pooling blood from thousands of donors.

The UK had always been self-sufficient in Cryo, which tended to be produced at local centres. But the government decided to phase it out from the mid-1970s in favour of Factor VIII, according to evidence heard at the Inquiry. This meant becoming increasingly reliant on imports because, along with several other European countries, the UK had fallen behind demand and repeatedly missed targets for boosting domestic production.

There was a large paid-for blood plasma industry in America, but United States companies bought plasma from those in need of quick money – often prisoners and vagrants. Countries were importing blood products made in the crucible of a new blood-borne disease – and a single infected donation among tens of thousands could contaminate an entire batch.

Concerns about contaminated blood were not new; there had been warnings about Hepatitis, a liver infection, in pooled blood since the 1940s – and outbreaks recorded in UK hospitals in the 1970s. But by 1982, patients were also contracting AIDS. The US Centre for Disease Control (CDC) reported three American haemophiliacs had contracted the disease. One infant died after receiving a transfusion.

At an emergency meeting in January 1983, US experts warned that thousands of patients could have been exposed and questioned why Factor VIII was not being “heat-treated” – a process used to prevent infections. Don Francis, a CDC official, asked: “How many dead haemophiliacs do you need?” By March, growing frustrated, the agency issued another warning that “blood products appear responsible for AIDS among haemophiliacs”.

In May 1983, the first infections of UK haemophiliacs were reported, in Bristol and Cardiff. Later that month, Dr Spence Galbraith, director of the UK Communicable Disease Surveillance Centre, wrote to ministers urging the withdrawal of all products made from blood donated in the US after 1978. By this point, there were 14 cases. Weeks later, the Council of Europe’s letter arrived.

Some countries had already taken precautions. In Finland, Factor VIII was banned from the beginning due to the risk of Hepatitis, and Finnish doctors used only Cryo to treat their haemophiliacs throughout the 1970s and 1980s. As a result, only two haemophiliacs are known to have been infected with HIV in Finland.the memo

Others heeded the warnings. In the US itself, non heat-treated products were rapidly withdrawn from use – even as American companies continued to sell them abroad. In Germany, authorities alerted doctors in 1982 and then banned non heat-treated products in early 1983. By mid-1983, France had halted all imports of clotting concentrates.

The UK did not. None of the Council of Europe’s recommendations were implemented. Warnings from the US were ignored. British haemophiliacs went on being given non-heat treated Factor VIII throughout 1983, 1984 and into 1985 – years after it was banned elsewhere.

In October 1985, a study found that 1,130 UK haemophiliacs – 44 per cent of those tested – had been infected with HIV, the virus that leads to AIDS. By August 2022, the latest estimate available, 2,400 people had died in the UK from blood contaminated with HIV and Hepatitis – by far the biggest death toll of any failure of government in modern British history.

The department of health memo raises questions about the process of decision making at the heart of government that led to these failures.

In testimony provided to the Infected Blood Inquiry – which is set to report in the middle of this year –  Lord Glenarthur, health minister responsible for blood products at the time, said that he had never seen the full Council of Europe warning.

He subsequently agreed that the department “didn’t do anything to act” on the Council’s key recommendations and said: “If a submission had been made through me or directly to other ministers making such recommendation, that would have been considered but it didn’t happen.”

In final submissions to the Inquiry, lawyers have described ministers in the 1980s as poorly informed and overly dependent on officials – and accused both of demonstrating a mixture of ignorance and arrogance in relation to decisions about public health.

Des Collins, a solicitor representing victims, said the Inquiry had shown “ministers were overly deferential to civil servants who stubbornly and persistently refused to admit that mistakes had been made, fearing the legal and financial costs”.

Concern about the size of settlements appeared to make ministers increasingly resistant to reopening what had happened, too. Lord Norman Fowler, who was health secretary from 1981-1987, told the Inquiry:

“The Treasury was against it, the prime minister [Margaret Thatcher] would have been against it because she would have been told that it would have other effects. It was a hopeless case I’m afraid because they took the view that, if agreed to, the floodgates would have been opened.”

Unpicking decisions made in the early 1980s remains challenging, with many key witnesses having died, vital documents missing and the Department of Health and Social Care remaining tight-lipped.

Such foot-dragging did not characterise the response elsewhere. In Germany, the scandal led to a huge inquiry in the early 1990s, led by then-health minister Horst Seehofer. He apologised to victims, established a large compensation scheme and dissolved the responsible government agency after evidence emerged of a cover-up.

In France, following an investigation by a leading journalist in the 1990s, the then-prime minister Edouard Balladur backed a legal investigation. Three former ministers, including Balladur’s predecessor Lauren Fabius, were charged with manslaughter. The heads of the National Blood Bank and the Blood Transfusion Service went to prison.

No such reckoning has taken place in the UK. For four decades, ministers of various political persuasions held firm to a line that what had happened was a tragedy, but one that could not have been prevented.

In the early years, ministers repeated one phrase again and again: “there was no conclusive proof”. Lord Clarke, who served as minister of state for health from 1982 to 1985, told the Inquiry: “somebody, somewhere, decided that that was the most accurate line to take… it was repeatedly used by every minister”.

The reality was more complicated. The “mainstream view” in the department – according to testimony from Dr Diana Walford, former chief medical officer – was that blood products were a likely cause of AIDS transmission.

We were told this was really not any of our business and it was not going to be a problem and go away and stop rocking the boat.

But departmental documents suggest influential officials and scientists still harboured doubts, and were concerned about their capacity to source alternative supplies. With twisted logic, the documents show ministers and officials fretted that a scandal getting out would harm public trust in the NHS – and instead chose to reject warning signs and hoped the crisis would go away.

Dr Richard Tedder, from Middlesex, one of a small number of British doctors who identified the risks and chose to continue giving his patients Cryo, has described how his attempts to warn the department were “dismissed”: “We were told this was really not any of our business and it was not going to be a problem and go away and stop rocking the boat”.

Throughout, patients seemed to be the last who needed to know – despite the fact that many did not require urgent treatment, safer products like Cryo were available, and AIDS at the time carried a near-certain death sentence. Whitford told The House it was clear that “there was no such thing as informed consent”.

There is also evidence of tracks being covered. In the early 1990s, an entire set of papers from the Advisory Council on the Virological Safety of Blood (ACVSB) – the key expert body that would have advised ministers on Factor VIII – went missing, according to witnesses to the inquiry.

A government legal official has alleged that a secretary in the department destroyed them in the aftermath of the BSE Inquiry, which had poured over documents and caused consternation within Whitehall. The secretary told the inquiry that she “certainly would not destroy documents for this reason”.

Lord Owen – a Labour health minister from 1974 to 1976 who argued for national self-sufficiency in blood products, and later campaigned for infected blood victims – has also questioned why his private office papers were “for some inexplicable reason pulped”.

Even now, many details have to be pieced together from individual testimonies and leaked documents, with lawyers and campaigners arguing that the present Department of Health has remained reluctant to properly reflect on its role.

The department has admitted that “wrong has been done”. But presenting its final submission to the Inquiry on 18 January – after four years of public hearings – the department’s barrister Eleanor Grey QC did not expand on this.

Pressed by the Inquiry chair, Sir Brian Langstaff, to explain “what wrong”, she said the government “did not have a position on what wrong” and argued it would be “fairer not to pre-empt” the Inquiry’s findings.

Mr Collins said: “right the way through the inquiry process the Department of Health has failed to engage on any of the substance”.

The department itself has yet to demonstrate the candour of a more recent generation of ministers, who in hearings last summer began to criticise the government’s decades-long position towards the scandal – and the accuracy of what they were told by officials.

Current Chancellor Jeremy Hunt, who served as health secretary from 2012 to 2018, told the Inquiry that the briefing he received – that what happened in the UK was “unavoidable” – was “simply wrong”.

Andy Burnham, who was health secretary between 2009 and 2010, said the department of health had been “grossly negligent… over five decades” and suggested officials had provided “inaccurate lines” to ministers. He said that he believed there could be a case for corporate manslaughter.

Some will ask why ministers did not ask more probing questions at the time. It cannot have helped that reckoning with the legacy of the scandal has been left to junior ministers – while, in office, health secretaries (as well as prime ministers and chancellors) have tended to have other priorities.

Yet, however the weight of responsibility is finally allocated, the episode will remain a bracing case study of how, as Hunt put it, “institutions close ranks around a lie”. It must be hoped that the legacy of the Inquiry’s final report – due this summer, some 40 years on from the ignored warnings of June 1983 – is that such a generational failure should never be repeated.

A Department of Health and Social Care spokesperson said: “The infected blood tragedy should never have happened and the ongoing public inquiry was set up to get to the truth and give families the answers they deserve.

The Inquiry chair has invited core participants to make submissions before the report is concluded. This is an important stage of the process and we continue to await the final judgement and report on these matters.”

PoliticsHome Newsletters

Get the inside track on what MPs and Peers are talking about. Sign up to The House's morning email for the latest insight and reaction from Parliamentarians, policy-makers and organisations.

Read the most recent article written by Tom Sasse - The Parent Trap: Cost of childcare