How a ‘wonder drug’ ruined thousands of lives in infected blood scandal
A “wonder drug” that turned out to be a deadly poison should never have been used on NHS patients, a report into the infected blood scandal has found.
Thousands of people were infected with chronic and often fatal viruses which were covered up over a period of four decades, the report, released on Monday, said.
Sir Brian Langstaff, the chairman of the Infected Blood Inquiry, said: “This disaster was not an accident. The infections happened because those in authority – doctors, the blood services, and successive governments did not put patients first. The response by those in authority served to compound people’s suffering.”
Sir Brian described a “catalogue of failures” in a report that runs to more than 2,500 pages and covers over five years of investigation. He said those failings amount to “a calamity” and were “systemic, collective and individual”.
Contaminated blood products and transfusions have caused at least 3,000 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, often known as mad cow disease.
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. Up to 100 people contracted HIV from a blood transfusion.
Sir Brian urged the government to pay compensation now, said that a memorial to the victims should be built at public expense and suggested that the NHS and Civil Service should undergo cultural change to fix “a culture of defensiveness”.
‘Wonder drug’ Factor VIII should never have been licensed
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, Baxter, a US pharmaceutical company, 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, Armour, and Japanese-owned Alpha. The UK also made its own version at Blood Products Laboratory.
Sir Brian has concluded that the decision to license the US Factor VIII product was wrong, because once it had been approved for use clinicians could treat it as “safe”.
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.
“There was evidence of a lack of safety,” said the report. “The risk was a serious one. Though safety is a balance, and not an absolute, there is no material now available which shows what it was that may have tipped the scales in favour or licensing. I have concluded that the decisions were wrong.”
Warnings about hepatitis ignored
When Baxter applied for its first licence for Factor VIII, 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” that 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 suggested 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, 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.
The report condemned the use of large pools and high-risk donors. It said: “The price of having more factor concentrates which were from large pools and paid donors was the taking in of products manufactured in a way which significantly increased the risk to recipients that they would incur serious, and sometimes fatal, disease.”
Understanding the risks, Dr Edward Shanbrom, the Factor VIII inventor, became convinced that Baxter should find a way to kill viruses in it, either through heat or chemicals. But his bosses disagreed and he was demoted.
Sir Brian found that the risks of hepatitis C and B were well known by the 1970s and should have been taken seriously.
Factor VIII was soon a multi-billion-dollar industry and plasma was called “liquid gold”.
After these warnings, the WHO said countries should stop importing blood products. However, the UK did not invest enough money in becoming self-sufficient in Factor VIII and so relied on the US.
In 1975, a documentary from World In Action revealed that US pharmaceutical companies were paying people at high-risk of hepatitis for their plasma, in impoverished areas of cities like Los Angeles.
That same year, Dr Joseph Garrott Allen, of Stanford University, wrote to Britain’s Blood Products Laboratory advising it to stop using US Factor VIII. American 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 David Owen, then the 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.
Sir Brian found the UK had failed to become self-sufficient in plasma because of a lack of funding and coordination. “In part this arose from the inept, fragmented system by which blood services of England and Wales operated,” said the report. The service “was in great need of redevelopment but this was badly delayed”.
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 that haemophilia doctors should switch patients to cryoprecipitate out of concern AIDS was caused by a blood-borne virus.
Sir Brian discovered pharma companies were monitoring the development of AIDS from even before those cases in early 1982, but that little action had been taken.
“There was a lack of any sense of urgency,” said the report.
In the UK, leading haemophilia doctor Prof Arthur Bloom advised the government that 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.
But, Sir Brian said, it should have been accepted there was a risk of AIDS in Factor VIII by the beginning of 1983.
In September, the government sent a leaflet about AIDS to British homes with comforting words from health minister, then Ken Clarke, now Lord Clarke: “It has been suggested that AIDS may be transmitted in blood or blood products. There is no conclusive proof that this is so.”
Sir Brian described the continued use of this line as “indefensible”. “It did not spell out the real risk,” said the report. “It gave false reassurance. It lacked candour, and by not telling the whole truth it was misleading.”
He added that it was a “deliberate choice” by the Department for Health to imply an absence of proof rather than the likely risk to patients.
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 a school in Hampshire
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.
Sir Brian described the experiences of children at Treloar’s as a “nightmare of tragic proportions”. He said children were treated “unnecessarily” with more risky treatment and were objects of research without their knowledge.
Former pupils have come to think of themselves as “guinea pigs” and a “captive audience” for research that was conducted at the school. They report changes in their treatment, being put on trials and receiving diagnoses of HIV and hepatitis C without their parents being informed.
“Children were often regarded as the objects of research rather than first and foremost children,” said the report, in a damning conclusion.
A group of ex-pupils is suing Treloar’s for negligence and failing in its duty of care when it was in loco-parentis.
Sir Brian said the school was a “microcosm of what happened across the UK.
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.
“Falsely reassuring the public and patients that blood did not carry AIDS,” was a further failure that removed choice from people, the report said.
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.
The report was critical of research on people with haemophilia, saying, “retrospectivity is not an explanation for what happened”.
Added to that, some patients weren’t told of their HIV diagnoses for years, which Sir Brian described as “unconscionable”.
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 that 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 did not 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.
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, were not 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 did not 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 was not until the summer of 1985 that the FDA mandated they stop shipping unheated Factor VIII.
Sir Brian concluded that it was “obvious that to impose no restriction on the continued imports of products made [from high-risk plasma before March 1983] put the British public at some additional risk”.
Baxter said: “We sympathise with anyone impacted by infected blood in the 1970s and 1980s. Baxter is committed to providing the highest quality products to its patients and customers, and to conducting its business ethically and compliantly.”
Bayer said it “expresses deep sympathy for people who contracted HIV or Hepatitis infection through use of blood therapies in the 1970s and 1980s and for the family members of those that were infected”.
It continued: “Bayer is truly sorry that this tragic situation occurred and that therapies that were developed by Bayer Group companies, and were prescribed by doctors to save and improve lives, in fact ended up causing so much suffering to so many.”
Sanofi, which owns the remains of Armour, said: “We would like to express our condolences to those who have lost loved ones and those who continue to suffer the impact of HIV and hepatitis. We have no comment to make whilst the Infected Blood Inquiry is ongoing.”
Victims given £20,000 settlement
Sir Brian concluded that the UK government had overseen a “litany of failures”. And yet for more than 30 years, it maintained that patients had been given “the best possible treatment”.
Sir Brian described this as “inappropriate, ill-considered and demonstrated a lack of curiosity about what actually happened”. In his report, he outlined how this had set the tone for government response, which amounted to a cover-up.
In 1991, the government settled a lawsuit with people who had been infected with HIV via Factor VIII. It refused to accept liability and agreed to make an ex-gratia payment of £42 million.
“The government had no plans to offer compensation,” said the report. “It had already decided at the start that no one could or should be held responsible – no one was at fault.”
Sir Brian described the settlement as “derisory”. 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.
Survivors felt the government had offered so little because it expected them to die.
Meanwhile, victims found themselves living a double life, lying to the outside world about being HIV positive while also experiencing horrific physical and mental suffering.
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.
In 2017, campaigner Jason Evans, who lost his father to AIDS-related illness, and other survivors and bereaved relatives sued the Department for 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.
In February 1985, Ken Clarke, then the health minister, said the infections were “the unavoidable adverse effects which can unhappily arise from many medical procedures”.
In his report, Sir Brian accused the government of “blindness” in parroting this line, “which was wrong from the very outset, then became entrenched for around 20 years: a dogma that became a mantra”.
He said no one had every stopped to question the evidence. The added that the government became “so fixated on holding that line, maintaining that ring fence, that it lost sight of desperate circumstances of those whose lives had been and were continuing to be devastated as a result of their treatment by the NHS”.
Documents were shredded and two former health ministers have been scathing of the lies told when they were in government.
Jeremy Hunt, now the Chancellor, told the Infected Blood Inquiry: “I am afraid that institutions and the state close ranks around a lie sometimes – and I think that’s what happened in this case. 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, now the mayor of Greater Manchester, 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”.
Sir Brian agreed with Mr Hunt and Mr Burnham and said the government had not only covered up the mistakes of the past but also hidden the truth.
“Hiding the truth includes not only deliberate concealment… but also a lack of candour; the retelling of half-truths,” said the report. “The not telling people what they had a right to know… the use of less informative rather than more revealing words on documents such as death certificates, and the use of inaccurate and misleading lines to take.”
The report said doctors, the civil service and politicians had all hidden the truth.
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 George Penrose released a report in Scotland, which – after six years and £12 million – concluded that 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 program and there could be hundreds still who have hepatitis C but don’t know.
The Penrose report was branded a whitewash by survivors.
The 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, then the prime minister, 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.
Sir Brian concluded: “Patients were knowingly exposed to unacceptable risks of infection.”
Then, after having been given chronic viruses that were unavoidable, his report said: “Many of those infected and affected by this disaster, in addition to dealing with the consequences of the original infection, have been forced into a decades long battle for the truth… The damage caused has been compounded.”
In an interim report released in April 2023, Sir Brian said: “Wrongs were done such that infection resulted when it need not have done… 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.”
He urged the Government to pay compensation without delay in that report but a year later victims are still waiting.
The Government accepted the moral case for compensation and said it would announce its plans after the inquiry had released its final report.
Following limited response from the Government, Sir Brian took the unprecedented step in July 2023 of recalling the inquiry to grill Rishi Sunak, the Prime Minister, and his ministers on why they had not responded to his recommendation.
Sir Brian repeated the call for compensation in his final report. “The Government is right to accept that compensation must be paid,” he said. “Now is the time for national recognition of this disaster and for proper compensation to all who have been wronged.”
In the weeks leading up to May 20, John Glen, the paymaster general, held meetings with core participants across the UK and said they could be due “life-changing sums”.
