The National Health Service in the UK is facing a major criminal and ethical scandal as the true scale of the number of medical trials using infected blood products on British children in the 1970s and 80s unravels amid an inquiry into the matter, notes MedicalBrief.
Fresh details are emerging, showing how doctors placed research goals ahead of patients’ needs and treated many of them, including dozens with haemophilia, like lab rats, leaving many suffering the long-term effects of serious disease.
The trials continued for more than 15 years, involving hundreds of people, most of whom were infected with hepatitis C and HIV.
A public inquiry is under way into the scandal, with the final report expected in May, reports the BBC.
UK lawmaker Michael Shanks this week also presented a petition to Parliament on behalf of those infected and affected by the contaminated blood scandal, in particular his constituent Richard Gilmour, who was infected in 1974 through a blood transfusion. 'He has had to undergo multiple medical procedures since and says that he is lucky to still be alive. Like all those infected, he suffers chronic fatigue and other symptoms, and he deserves justice without further delay. The Government must act now,' the petition reads.
Shank called for government to urgently implement the recommendations in the Second Interim Report of the Infected Blood Inquiry without delay, saying victims and their families have waited far too long for redress.
The trials also involved children with blood clotting disorders – even though families had often not consented to them taking part – with doctors in haemophilia centres using the products despite them being widely known to be contaminated.
Most of the youngsters who were enrolled are now dead.
Imported tragedy
In the 70s and 80s in the UK, a shortage of blood products meant they were imported from the US, with high-risk donors like prisoners and drug addicts providing the plasma for the treatments that were infected with potentially fatal viruses, including hepatitis and HIV.
One blood product, known as Factor VIII, was seen to be highly effective for stopping bleeding but also known to be contaminated with viruses.
One victim, Luke O’Shea-Phillip (42), has mild haemophilia – bruising and bleeding more easily than most.
He caught the potentially lethal viral infection hepatitis C while being treated at Middlesex Hospital in central London through a blood product being administered because of a small cut to his mouth when he was three, in 1985.
Documents seen by the BBC suggest he was deliberately given the blood product – which his doctor knew might have been infected – so he could be enrolled in a clinical trial.
The doctor wanted to find out how likely patients were to catch diseases from a new version of heat-treated Factor VIII.
Though he had never been treated for his condition before, the boy was given heat-treated Factor VIII to stop his mouth bleeding.
A letter from his doctor, Samuel Machin, to another expert in haemophilia, was submitted in evidence to the public inquiry into the infected blood scandal.
Writing to Peter Kernoff at London’s Royal Free Hospital, Machin detailed the treatment of O’Shea-Phillips and another boy, saying: “I hope they will be suitable for your heat-treated trial.”
Months earlier, Kernoff had called on fellow doctors in the field to identify patients suitable for clinical trials. Specifically, he said, they had to be “previously untreated patients”, known as “PUPs” in the medical community.
They were also nicknamed “virgin haemophiliacs”, a term written on O’Shea-Phillips’ medical record by Machin.
“I was a guinea pig in clinical trials that could have killed me,” O’Shea-Phillips told the BBC. “There is no other way to explain it. My treatment was changed so I could be enrolled in the trials. This change in medication gave me a fatal disease, hepatitis C, yet my mother was never even told.”
In the following years, as the medical trial reached its conclusions, he had many blood tests. Doctors said they were monitoring him and at the time, his mother, Shelagh O’Shea, was grateful.
In their findings published in 1987, Kernoff and Machin concluded that heat treatment had “little or no effect” in reducing the risk of hepatitis C.
Both of them are now dead.
Before he died, Machin, giving evidence to the public inquiry, confirmed that O’Shea-Phillips had been recruited to Kernoff’s study, but denied this was done without the boy’s mother’s knowledge.
“This would have been discussed with his mother, although I acknowledge that standards of consent in the 1980s were different from now,” he said.
However, the boy’s mother told the inquiry she was “absolutely not” told about the trial. “I would never have considered such an action… allowed my child to be part of a trial, never,” she added.
Documents show doctors knew O’Shea-Phillips had contracted hepatitis C as early as 1993, but he was not told until 1997.
One medical record states a positive test result and says: “Have not discussed with patient or family.”
He is now clear of the infection after successful treatment.
‘Laboratory rats’
Evidence of the clinical trials has raised wider concerns.
“A patient should always be given the best possible treatment and always have given informed consent. If those two factors haven’t been achieved then a trial would be seen as very problematic,” said Professor Emma Cave, professor of Healthcare Law at Durham University.
Professor Edward Tuddenham, who was a haemophilia doctor at the Royal Free Hospital in the 1980s, confirmed these fears. When asked if he thought ethical standards had been met during clinical trials in the 1980s, he simply answered: “No.”
Machin and Kernoff were among a community of doctors with similar research ambitions.
A school for disabled children in Hampshire was attended by a large cohort of haemophiliac boys, and had an NHS haemophilia unit on site, so boys who had bleeds could be treated quickly and then return to lessons.
Their doctor, Dr Anthony Aronstam, who has also since died, used his “unique” cohort of boys for extensive clinical trials.
One series of experiments considered whether using three to four times more Factor VIII than normally required by a child would help to reduce the number of bleeds he had.
This was preventative treatment – prophylaxis – and involved repeated injections with infected Factor VIII products and follow-up blood tests. The high concentrations of infected blood products were administered to the boys without their or their parents’ consent.
Of the 122 pupils attending Treloar’s College between 1974-1987, 75 have so far died of HIV and hepatitis C infections.
“Despite knowing the product was riddled with hepatitis, they started a trial that required us to have way more of it than we needed,” said Gary Webster, who was unknowingly enrolled.
Ade Goodyear, a pupil at Treloar’s from 1980 to 1989, added: “We were treated like lab rats. There was a plethora of studies that we were all enrolled on for the decade we were at the school.”
Controversially, another trial involved placebo treatments. This meant that some boys, who thought they had been given Factor VIII to prevent bleeds, had in fact been given a saline solution.
“When you think you’ve been given a treatment, this changes your behaviour,” Webster said. “You run more, you play more rough in football. For a haemophiliac, you feel a bit invincible for a short window after a jab. But with a placebo you are just risking your life by changing your behaviour.”
He told the BBC he was punished at school if he missed injections. "It would have meant their trials would have been flawed and so we were made to toe the line.”
Kernoff’s pursuit of clinical advancement through research was rigorous, as was his hunt for suitable subjects for trials PUPs and virgin haemophiliacs – which led to those involved getting young and younger. Even a four-month-old baby was involved in a trial.
Among his studies was one that compared the infectiousness of another blood plasma product – Cryoprecipitate (Cryo) – to Factor VIII concentrates.
Cryo was used for treating mild blood clotting conditions. It contained the Factor VIII protein, but at lower concentrations and from fewer donors and was therefore thought to be less risky.
Kernoff’s search for suitable subjects led him to Mark Stewart, his brother, and his father, who all had very mild cases of Von Willebrand’s disease – another type of blood clotting disorder. Their usual treatment was cryo, but as part of his test, Kernoff gave them all Factor VIII concentrates instead.
All three contracted hepatitis C.
Stewart’s brother and father both died of liver cancer after the infection attacked the organ. Neither was told they had contracted the disease until it was too late for treatment.
A statement from Treloar’s said: “We await the publication of the infected blood inquiry, which we hope will provide our former pupils with the answers they have been waiting for.”
MPs were this week told the NHS is facing “very serious criminal and ethical issues” over the scandal, according to The Telegraph.
John Glen, Cabinet Office Minister, said reports of children being experimented on by their doctors demonstrates the “unimaginable suffering of all those impacted by this dreadful scandal”.
Labour MP Dame Diana Johnson told the Commons that more than 3 000 people have died as part of the scandal, which she called “the worst treatment disaster in the history of the NHS”.
She added: “These disturbing revelations raise very serious criminal and ethical issues for the NHS and medical profession, possible breaches of the 1947 Nuremberg Code.”
The Nuremberg Code was made in the wake of the Second World War and outlines ethical research principles for human experimentation, including stressing the importance of consent.
Treloar’s school, the Hampshire centre for disabled children, is at the centre of the human experimentation storm with more than 70 haemophiliacs at the institution dying from infected blood products.
It said in a statement at the weekend that the staff, as well as students, “placed their trust in the treatment and advice given out by the NHS clinic”.
However, survivors from the school have responded with fury to the statement and asked for it to be withdrawn.
“We take issue with the idea that effectively they too were a victim. Their apparent disregard of facts and supporting documents leaves us feeling dismissed and outraged,” four former pupils of the school, known as the Treloar’s Boys, said in a statement:
“For the school to continue to deny any responsibility, putting the blame wholly with the NHS, is not only disrespectful to the 75 dead former pupils, but is both preposterous and insulting.”
Glen replied: “I recognise the distress is widespread, it’s felt across individuals and families across the United Kingdom.
“My officials are working with prominent charities, organisations and support groups. I’m reaching out to them to share progress, to reassure the community I’ve heard their concerns, and seek their views in advance of May 20.
“I’m doing that out of deep respect for the suffering that they’ve experienced.”
The Telegraph – Infected blood scandal is ‘worst treatment disaster in history of NHS’, MPs told
See more from MedicalBrief archives:
UK’s NHS could cough up billions in infected blood scandal payments
Long-delayed inquiry into NHS contaminated blood starts at last
Contaminated blood victims given permission to sue UK government