Infected blood study: study that deemed the risk ‘acceptable’ omitted patient death

A study cited by the Infected Blood Inquiry as evidence that the devastating effects of hepatitis-contaminated blood products could not have been anticipated misrepresented the results of a trial in its advocacy, the Guardian can reveal.

Up to 6,520 people are believed to have been infected with hepatitis C through imported factor VIII blood products in the 1970s and 1980s, while an additional 26,800 people are estimated to have been infected with the virus through blood transfusions. It is estimated that approximately 2,000 people died as a result.

The inquiry, which will publish its final report on May 20, heard that the medical profession considered non-A and non-B hepatitis (later known as hepatitis C) to be “relatively benign” at the time, with Pier Mannuccio Mannucci’s 2003 article , AIDS, hepatitis and hemophilia in the 1980s: memoirs of an insiderquoted in support of this proposal.

Mannucci’s 2003 article argued that the view of “the vast majority of hemophilia practitioners was that the problem of hepatitis was tolerable because the benefits of concentrates appeared to outweigh the risks.”

In making his argument, Mannucci cited his own work, writing: “I conducted a prospective biopsy study…in 10 hemophiliacs with non-A, non-B chronic hepatitis, followed for more than six years. The study, published in 1982, showed no case of progression toward cirrhosis or hematocellular carcinoma.”

however, the original report from 1982 says that there were actually 11 – not 10 – people involved in the study and that “one patient with active cirrhosis died of liver failure during the follow-up period.”

Who knew what about the risks and when is an important part of the investigation.

Jason Evans, who was four years old when his father died after receiving blood contaminated with HIV and hepatitis C, and who founded the organization Factor 8 campaign, said: “It is a calculated cover-up, removing uncomfortable truths about the deadly risks of hepatitis to justify the decision to give patients dangerous Factor VIII blood products. We’re starting to see the details of how the cover-up of the tainted blood scandal took place, and the scale of it is truly incredible.

“This evidence sets a dangerous precedent in medical research, where data could so easily be manipulated to fit a narrative about defending past decisions.

“The audacity to omit the death of a patient to distort the results of a study is a direct attack on the scientific method and an abuse of the public’s trust in researchers. What happened here was not merely a mistake or bad judgment; it was clearly a deliberate act to deceive.

“The victims of this scandal deserve justice, and the medical community and the state must take the investigation’s findings seriously to understand how it has so deeply failed so many.”

Mannucci’s 2003 study, published in the Journal of Thrombosis and Haemostasis, stated: “The view and arguments presented here are certainly not exciting for the media, which prefers stories about avoidable disasters with associated blame on the medical community.”

Prof. Christine Lee, who worked at the Haemophilia Center at the Royal Free Hospital in North London in the 1980s and 1990s, testified at the Infected Blood Inquiry in October 2020 and quoted from the report saying that “it was only the mid-1980s “In the 1980s it turned out that the disease (hepatitis) was progressive and serious in one sixth of patients.”

Lee told the inquiry that she didn’t like the idea of ​​compensation for the victims of the tainted blood scandal because “it suggests liability” and people at the time were “killing what they thought was best.”

Evans said that given the 2003 study had misrepresented the data, it was “anathema to the victims of the infected blood scandal” that Lee cited it.

When asked by The Guardian whether there was a cover-up, Mannucci, professor emeritus of internal medicine at the University of Milan, said: “What happened to the eleventh patient who developed severe liver disease and died of decompensated liver disease, frankly, I don’t know anymore. The majority of patients had no liver disease, at least not at biopsy, and these results were also confirmed by a much larger study conducted in the United States.

“Hepatitis C was not yet known. It was only when hepatitis C was discovered much later that it became clear that it could progress to chronic liver disease and cirrhosis.”