Infected blood scandal: The worst treatment disaster in NHS history

The Infected Blood Inquiry will on Monday release the results of its five-year investigation into the worst treatment disaster in the history of the NHS.

The report is expected to expose mistakes that led to thousands of people being infected with chronic and often fatal viruses, and efforts to cover up the truth.

Contaminated blood products and transfusions have caused at least 2,900 deaths since the 1970s and 80s. Up to 1,250 people with haemophilia contracted HIV after treatment with a “miracle” plasma product called Factor VIII, about 380 of whom were children. As many as 5,000 more contracted hepatitis C, along with further infections of hepatitis B and exposure to vCJD.

In a parallel disaster also investigated by the inquiry, some 26,800 people received hepatitis C from blood transfusions before testing began in 1991, hundreds of whom may have the virus and still not know. At least 79 people contracted HIV from a blood transfusion.

Haemophilia is a genetic bleeding disorder that commonly passes from mothers to sons, leaving people deficient in the protein needed to form blood clots, called Factor VIII.

In 1964, a new treatment for haemophilia was introduced called cryoprecipitate. Made with plasma from one to a few donors that had been frozen and thawed slowly to separate clotting proteins, it led to a jump in life expectancy for haemophiliacs from 20 years to 57, close to that of the general population. Cryoprecipitate took hours to defrost and transfuse in hospital.

Five years later, US pharmaceutical company Baxter created a new “wonder drug” called Factor VIII, which the UK licensed in 1973.

Factor VIII was a white powder that could be kept in a fridge then mixed with sterile distilled water and injected at home or on the go. It could be used when patients had a bleed or more regularly as a preventative treatment.

People with haemophilia were freed from the shackles of the hospital, able to live more active lives and recover from bleeds more quickly.

Before long, four US pharmaceutical companies were making Factor VIII and shipping it internationally – Baxter, Bayer, Revlon Healthcare-owned Armour, and Japanese-owned Alpha. The UK also made its own version at Blood Products Laboratory.

Warnings about hepatitis

The risks of Factor VIII transmitting blood-borne viruses were clear. It was made from human plasma donations that were collected from high-risk sources in the US, including prisons and STI clinics, and pooled together, amplifying the risk of spreading disease.

When Baxter applied for its licence, the US National Institutes for Health (the precursor to the FDA) said it was “deeply concerned over the risk of hepatitis”. The company responded that it was “highly unlikely” hepatitis could be removed and that “the product is needed in spite of its risk”. The regulator accepted the argument and Factor VIII was licensed.

Further warnings about the dangers came in the mid-1970s. The World Health Organization warned that pooling multiple plasma donations could lead to an increased spread of viruses and advised companies to limit pools to no more than 10 people.

But companies found it more efficient to pool many more donations together – at points reaching tens of thousands. The US Food and Drug Administration (FDA), which regulated blood products, ignored these warnings and set a limit at 100,000 donations per batch. Only one donor needed to have a blood-borne virus for the whole batch to be contaminated.

Understanding the risks, Factor VIII inventor Dr Edward Shanbrom became convinced Baxter should find a way to kill viruses in it, either through heat or chemicals. But his bosses disagreed and he was demoted.

Factor VIII was soon a multi-billion-dollar industry and plasma was called “liquid gold”.

Amid these warnings, the WHO said countries should stop importing blood products. But the UK didn’t invest enough money in becoming self-sufficient in Factor VIII production, and continued to rely on the US.

In 1975, a documentary from World In Action revealed US pharma companies were paying people at high risk of hepatitis in impoverished areas of cities such as Los Angeles for their plasma.

That same year, Dr Joseph Garrott Allen from Stanford University wrote to Britain’s Blood Products Laboratory advising it to stop using US Factor VIII. US plasma was “extraordinarily hazardous”, he said, and collected “100 per cent from Skid Row derelicts”. In the background a new, more virulent strand of hepatitis had been observed in patients, called non-A, non-B, which later became hepatitis C.

Lord Owen, then minister for health, announced a plan to invest in Blood Products Laboratory and become self-sufficient within two years. But he was promoted to foreign secretary and the plans fell by the wayside.

Unethical research

Doctors were “like gods” in the patrician culture of 1970s medicine: they knew best. It was down to them to balance the risks of Factor VIII with its revolutionary benefits – and they rarely gave patients a choice.

In years to come, that would prove controversial after patients realised they hadn’t been warned about hepatitis or HIV. They had also been stripped of the choice of cryoprecipitate over Factor VIII.

Patients discovered they had been participants of research without their knowledge. Doctors used unwitting patients for trials into the effectiveness of Factor VIII, preventative treatment known as prophylaxis, and the risk of viruses.

Documents later unearthed by survivors revealed doctors had referred to patients as “cheaper than chimps”. In a letter from 1983, doctors said it would be more cost effective to test the “infectivity” of different Factor VIII brands on patients rather than animals.

Across the UK, people with haemophilia were unknowingly enrolled onto a “Hepatitis Study” to monitor the infectiousness of different brands of Factor VIII for the new non-A, non-B hepatitis. Not being given a choice, patients on this study contracted hepatitis C and were often not told of the diagnoses or dangers.

Discussing the use of “virgin patients” who hadn’t been treated with Factor VIII before, doctors agreed the patients “may be safer on cryoprecipitate”. But they nevertheless planned to study adult patients and “one could then go to children”.

The results showed imported US Factor VIII was more likely to transmit hepatitis C than NHS Factor VIII made with UK plasma. Doctors decided to find out which brands were the most hazardous.

Almost every patient treated with Factor VIII contracted hepatitis C. Many didn’t find out until a test became available in 1991.

Dr William Maycock, director of Blood Products Laboratory, said if patients discovered the “close investigation”, they could conclude “they had been negligently treated and that a claim for compensation might be in order”.

Lawyers representing survivors have said these trials breached the Nuremberg code, developed after Nazi war crimes, which stated doctors should avoid actions that injure patients. The code outlines 10 principles, including giving people the choice over whether to participate in research, and giving them sufficient information of the hazards.

UK slow to react to Aids crisis

Hepatitis should have been the canary in the coalmine. In July 1982, three people with haemophilia in the US were diagnosed with Aids, a new illness affecting gay men. By January 1983, epidemiologists at the Center for Disease Control (CDC) and some researchers believed haemophilia doctors should switch patients to cryoprecipitate out of concern Aids was caused by a blood-borne virus.

In the UK, leading haemophilia doctor Professor Arthur Bloom advised the government such drastic action would cause a run on treatment and panic patients.

Signs grew that Aids could spread through Factor VIII in the summer of 1983, when two British patients developed symptoms. But the Government was sluggish in its response. Warnings from leading epidemiologists and the Council of Europe were ignored.

In September, the Government sent a leaflet about Aids to British homes with comforting words from Lord Clarke, then the health minister. It read: “It has been suggested that Aids may be transmitted in blood or blood products. There is no conclusive proof that this is so.”

In 1985, after a test became available, about 1,250 people with haemophilia tested positive.

Back then, a positive HIV test was equivalent to a death sentence and many patients were told they had two years to live.

The diagnosis came with cruel stigma – people lost jobs, were kicked out of school, had graffiti spray painted on their houses and were refused dental and hospital treatment.

Viruses tear through Hampshire school

One school in Hampshire was particularly impacted. Lord Mayor Treloar College was a specialist boarding school for children with physical disabilities, which had an onsite haemophilia centre.

Treloar’s had promised a “normal” childhood, including archery, rowing and swimming within its grounds.

But of 122 pupils with haemophilia who went to the school from the 1970s to mid-80s, 80 have died after contracting HIV and hepatitis C from infected blood products. Those still alive are plagued by survivor’s guilt, having lost so many friends.

Former pupils have come to think of themselves as “guinea pigs” and a “captive audience” for research. They report changes in their treatment, being put on trials and receiving diagnoses of HIV and hepatitis C without their parents being informed.

A group of ex-pupils is suing Treloar’s for negligence and failing in its duty of care when it was in loco-parentis.

Dangerous Factor VIII still sold after safe version

Pharmaceutical companies invested in making Factor VIII safer after German company Behringwerke released a version that had been heated to kill viruses in 1982. By February 1984, Baxter, Bayer, Armour and Alpha had made their own heat-treated Factor VIII.

The new product was more expensive and some people, including Clarke and Bloom, weren’t convinced it was actually safer. By then, the HIV, then known as HTLV-III, had been identified and isolated and it was clear Factor VIII could transmit the illness.

Doctors in the US and Scotland were told to stop using unheated Factor VIII in September 1984. But England and Wales didn’t recommend the switch until early 1985. Six months later some hospitals were still prescribing the unheated version.

In the US, pharma companies were happy to keep selling old stock and it wasn’t until the summer of 1985 that the FDA mandated they stop shipping unheated Factor VIII.

Victims given £20k settlement

The UK Government settled a lawsuit with people who had been infected with HIV via Factor VIII in 1991. It refused to accept liability and agreed to make an ex-gratia payment of £42 million.

Divided up, the money amounted to £21,500 for infected children; £23,500 for single adults; £32,000 for people who were married; and £60,500 for those who were married with children, equivalent to between £51,202 and £144,081 today.

In accepting the settlement, victims had to sign a waiver that prevented them from bringing any further action over hepatitis C infections. A test for the virus became available that year.

Survivors felt the settlement was “insulting” and that the Government had offered so little because it expected them to die.

In 2017, campaigner Jason Evans, who lost his father to Aids-related illness, and other survivors and bereaved relatives sued the Department of Health for misfeasance in public office (the case is on hold pending the results of the Inquiry).

Two failed inquiries and a cover-up

Decades of cover-up following the infections themselves compounded survivors’ trauma. The Department of Health adopted a narrative that nothing could have been done differently in the tragic infections of people with haemophilia.

Documents were shredded and two former health ministers have been scathing of the lies told when they were in government.

“I am afraid that institutions and the state close ranks around a lie sometimes – and I think that’s what happened in this case,” Jeremy Hunt told the Infected Blood Inquiry. “The totality of this was a failure by the British state. I don’t think there’s any other way to describe it.”

Andy Burnham said there is “evidence of a cover-up going right up to the top … Embedded deep within the civil service psyche, the response to this particular issue was primarily driven by fear of financial exposure”.

Two inquiries failed to get to the bottom of the scandal. The first was the Archer Inquiry, which was highly critical but had no statutory powers and was ignored by the Government.

In 2015, Lord Penrose released a report in Scotland, which – after six years and £12 million – concluded very little could have been done differently.

Lord Penrose recommended the Scottish Government should offer everyone who had received a blood transfusion before September 1991 a hepatitis C test. To date, there has been no national screening programme and there could be hundreds still who have hepatitis C but don’t know.

The Penrose report was branded a whitewash by survivors.

Theresa May announces Infected Blood Inquiry

Campaigners kept pushing for the truth and compensation. Decades of concurrent fighting eventually came to a head in 2017 and Theresa May announced the Infected Blood Inquiry.

Since hearings opened in April 2019, the inquiry has combed through 4,034 statements from survivors and bereaved relatives, heard evidence from 370 people and disclosed 75,654 pages of documents.

In an interim report released in April 2023, inquiry chair Sir Brian Langstaff said: “Wrongs were done such that infection resulted when it need not have done.”

In April last year, Sir Brian urged the Government to pay compensation without delay, saying: “My conclusion is that wrongs were done at individual, collective and systemic levels. Not only do the infections themselves and their consequences merit compensation, but so do the wrongs done by the way in which authority responded to what had happened.”

After limited response from the Government, Sir Brian took the unprecedented step in July 2023 of recalling the inquiry to grill Rishi Sunak and his ministers on why they had not responded to his recommendation.

The Government accepted the moral case for compensation and said it would announce its plans after the inquiry had released its final report. In the weeks leading up to May 20 Paymaster General John Glen held meetings with core participants across the UK.

The Poison Line: Life and Death in the Infected Blood Scandal by Cara McGoogan is out now (Penguin)

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