It was a triumph for medical science over tragedy.
The case involved a 29-year-old woman suffering an ectopic pregnancy – in which the embryo becomes embedded outside the uterus, usually in one of the fallopian tubes.
In such cases, termination of the pregnancy can be the only way to save the mother’s life.
Malcolm Pearce was an obstetrician at St George’s Hospital Medical School. He had performed a minor miracle.
After successfully extracting the embryo, he reintroduced it to the patient’s womb.
She had a healthy baby. This feat was something that many other surgeons tried, but failed to achieve.
The amazing story was published in the British Journal Of Obstetrics. It made international headlines.
It also provided hope for the thousands of women who experience such traumatic events every year.
Malcolm Pearce (pictured), was fired and found guilty of serious professional misconduct. He was also struck off the medical register for falsifying an examination.
Or, rather, it would have been if it hadn’t turned out that it was a lie.
A whistleblower from St George’s claimed that Pearce’s story was a fabrication, shortly after it was published.
Investigations subsequently revealed the surgeon had tampered with computer records and amalgamated patients’ notes – those of a woman who was dead and another who had miscarried – to create a fictitious patient.
Pearce, who was discovered to have falsified a second study into drugs to avoid miscarriage, was dismissed, found guilty in serious professional misconduct, and struck from the medical register.
We speak to experts who expose the scandalous nature of fake medical research
It’s a disturbing tale. This isn’t a one-off. According to shocking claims made by a group of highly-respected experts, research fraud is rampant in the medical industry.
Their investigations revealed that as many as one in five of the two million annual medical studies published could contain plagiarised or invented results, details about patients who never existed, and trials which didn’t take place.
The problem is ‘well known about’ in science circles, says Richard Smith, former editor-in-chief of the British Medical Journal (BMJ) – yet there is a reluctance within the establishment to accept the scale of the problem.
In a recent article, he suggested that journal editors should view all submitted studies as possible fakes until they can prove otherwise.
Speaking on The Mail on Sunday’s Medical Minefield podcast, Smith – who was involved in the investigations that exposed Malcolm Pearce – said: ‘It’s shocking, but common.
Many of these fraudulent studies have been invented. There were no patients. The trial never took place.
Research coming out of countries where doctors are commonly rewarded with pay rises for publishing their work – such as Egypt, Iran, India and China – is more likely to be faked, investigations show.
John Carlisle is an NHS anaesthetist and spends his spare time looking for fraudulent medical studies in China.
Korean pioneer Woo Suk Hwang (pictured) became a national hero when he and his research team reportedly cloned a human embryo and extracted stem cells from it – a technique that could potentially cure a wide range of diseases. These claims were bogus.
Meanwhile, Professor Lisa Bero, an expert in study fraud at Cochrane, one of the world’s foremost research organisations, warns of ‘paper mills’ – shadowy companies that operate online, churning out sham studies much like the ‘essay mills’ that profit by selling work to students.
Researchers investigating these paper mills discovered more than 1,000 cases of research fraud.
“Paper mills can create hundreds of fraudulent research studies, far more than any ‘bad egg researcher’, and saturate certain subjects, such as cardiology. Prof Bero adds that he believes we will see more of it in future.
Smith and others have voiced their concerns but argue that little has been done in the mainstream medical world to stem the tides of ‘tainted information’ over the past decades. This means that it will likely have been used for guidance to the NHS, potentially putting lives at stake.
‘I have no doubt that this is a major threat to global public health,’ warns Ian Roberts, Professor of Epidemiology at the London School of Hygiene & Tropical Medicine, who claims the regulatory systems ‘are not fit for purpose’.
Dr Werner Bezwoda, a South African oncologist, claimed that he had successfully treated late-stage breast-cancer patients with bone-marrow transplants in the mid-1990s.
His findings, published in major medical journals, were later revealed to have been invented – but not before thousands of patients had died after undergoing the ineffective treatment.
Eric Poehlman, a Canadian researcher, was the first and one of the only scientists to be jailed for research fraud after ten of his publicly funded studies – looking at weight gain in the menopause, ageing and hormone-replacement therapy – were found to be fabricated.
Then there’s Korean pioneer Woo Suk Hwang, who became a national hero when he and his research team reportedly cloned a human embryo and extracted stem cells from it – a technique that could potentially cure a wide range of diseases. These claims turned out not to be true.
Prof Bero says that research fraud has been rampant in the Covid pandemic and the worldwide rush to find treatment.
An investigation revealed that more then a third of the 26 studies on antiparasitic medication Ivermectin (which many believed could relieve Covid symptoms) had potential fraud.
Studies last year looking at whether the antimalarial hydroxychloroquine could reduce Covid severity – it was touted as a ‘wonder drug’ by President Trump – were also revealed to have grave flaws.
Prof Roberts participated in a review in 2010 that identified ‘false information’ in 90 published studies on drugs used to regulate blood sugar during surgery. The reviews were conducted by Joachim Boldt, a German anaesthesiologist (pictured).
One, which led to French health officials recommending the medication was found to contain disputed information.
Didier Raoult, a microbiologist based in Marseilles, threatened to sue one of the scientists who had flagged up ‘anomalies’ in dozens of his studies.
Raoult will now appear before an ethics committee. He is accused in the spreading of false information about the medication’s benefits.
Raoult’s lawyer said that his client would be cleared.
Two other major studies, which concluded that the drug had no effect on Covid, were also exposed as possible fakes.
These concluded that hydroxychloroquine was linked to increased deaths and heart problems – and were published in world-renowned journals The Lancet and The New England Journal Of Medicine.
These led to the World Health Organisation (WHO) and many countries stopping drug trials.
However, the ‘glaring errors” were discovered within days. Eagle-eyed readers saw that death rates did not match official records. Hospitals mentioned in the study later denied ever providing patient data.
Surgisphere, a company that provided the figures and was headed by Dr Sapan Desai (US vascular surgeon), failed to provide detailed patient records when requested.
The papers were retracted. The New England Journal Of Medicine published a statement from the study’s authors claiming they were unable to validate the data sources used in the article. They were not granted access to the raw data and apologized for any difficulties caused.
Commentators have raised questions about the inability of the respected editors and doctors who reviewed the study prior to publication to spot the problems.
Richard Horton, editor of The Lancet, called the paper that was retracted by his journal a “fabrication” and a “major fraud.”
Anaesthetists began to be suspicious about Yoshitaka Yamai’s (pictured) studies on a drug that relieves nausea and vomiting after surgery. Further investigation revealed that more than 100 trials he claimed to have done were ‘totally fabricated’.
He stated, “If you have an author who intentionally tries to mislead it’s surprisingly simple for them to do this.”
While these are eye-opening examples, far more common, says Carlisle, are ‘low-level’ fakes – studies that simply confirm what other studies say, so arouse little suspicion.
He adds: ‘You’d think people would manufacture startling results, but in my experience most studies are fairly boring – just interesting enough to get published, so they can go on the CV.’
Legally, drug manufacturers must conduct clinical trials in order to license a drug for use.
Once the approval has been granted, doctors and other researchers can then easily administer the medicine to patients in their own trials to demonstrate how it works best.
This means there can be hundreds, or even thousands of studies published on certain treatments, all producing differing results – and this creates the perfect camouflage for fabricated studies.
Experts perform systematic reviews to gather and assess all available evidence.
A review could effectively neutralize the impact of a fake study if there were enough. Fake studies could also affect the results of reviews due to the severity of research fraud.
Prof Ian Roberts became aware of research fraud during a systematic review on mannitol trials. Mannitol was a drug used to reduce brain swelling after head injuries.
Dr Werner Bezwoda, a South African oncologist (pictured), claimed that he had successfully cured late-stage breast-cancer patients by giving them bone-marrow donations in the mid-1990s. His findings were invented
He had concluded the treatment was effective – when a colleague suggested that some of the trials had been fabricated.
Prof Roberts said: “Three of these mannitol papers had been imported from Brazil, which is where this guy was from.
“He stated that it was well-known in the medical community that many of these trials had not actually taken place.
He began to investigate and found, to his horror that his colleague was correct. He contacted the names of the institutes and authors listed on the papers. They either denied knowing about the trial or could not provide further evidence.
They were fakes. He said, “I could not find any other explanation.”
When Prof Roberts then removed these ‘problematic’ studies from his review of Mannitol, the conclusion changed – it was not an effective treatment for head injuries.
He said, “These fraudulent studies could’ve meant that patients were not given the best care and put lives at risk.”
“I flagged the issue up to the research group for which I was working, and they put it down to bad fortune and moved on.”
It happened again. Prof Roberts was part of a 2010 review that highlighted ‘false data” in 90 published studies about drugs used to regulate blood pressure during surgery. All were authored by the same German Anaesthesiologist Joachim Boldt.
Prof Roberts states that these trials were published over many years in top journals, but they were never published.
“Again, the review excluded them from the treatment. It showed that the treatment was not effective. British surgical guidelines needed to be revised.
“It made it clear to me that if someone can fabricate 90 studies, then the system isn’t working.”
Before a study can be published in a medical journal it must undergo peer review.
This means that other researchers not familiar to the author can scrutinize it to spot potential errors.
Surgisphere, a company that provided figures for a possible Covid drug study, was headed by Dr Sapan Desai (pictured), but he failed to provide detailed patient records when asked.
Richard Smith, former editor of BMJ, says that it is a system “entirely based upon trust, that the actual study actually took place”.
He says it was a flawed process because 200 patients were listed in the paper. We assume that there were 200.
‘We don’t say, but we have their signatures. It doesn’t necessarily mean that something has passed peer review.
It is hard to know how widespread research fakery is.
Roughly four in every 10,000 published end up being retracted – withdrawn by the journal in question – according to an analysis by Science magazine.
This could be due to honest errors. However, in two-thirds cases there is suspicion of fraud. John Carlisle, an NHS anaesthetist, may have some additional insights.
He was first aware of bogus research 20 years ago when he and other anaesthetists became suspicious of Yoshitaka Yamai’s Japanese research into a drug to relieve nausea and vomiting after surgery.
He said that the side-effect rates of the different trails were strikingly comparable, and in some cases identical. You would expect some variation.
Further investigation revealed that he claimed to be the author of more than 100 trials, but they were completely fake.
Fujii lost his job at university, and no fewer that 183 of his papers were withdrawn or retracted by the journals which published them by 2010.
Fujii claims he did not do anything wrong, despite all of this.
Carlisle has refined his methods and conducted two major investigations into research fraud.
By looking for ‘too-good-to-be-true’ patterns in the data, he found that one study in five published by one journal, Anaesthesia, was potentially fraudulent.
Authors from five countries submitted the majority of trials – 48 per cent of Chinese trials, 62 per cent of Indian trials and 90 per cent of Egyptian trials were suspected fakes. Another possibility was that a third of the South Korean trials and a fifth were faked in Japan.
His early findings were confirmed by a similar analysis of more that 5,000 studies published in major journals such as The New England Journal Of Medicine or the Journal Of The American Medical Association. It suggested that 15% of these studies could be fraudulent.
Anaesthesia and The New England Journal now use Carlile’s methods to screen all submitted studies for publication.
It all begs the questions: why would scientists lie – particularly when there are such severe consequences, both in terms of damaging public health, and, should they be caught, on their own careers?
Eric Poehlman (pictured), a Canadian researcher, was the first and one of the only scientists to be jailed for research fraud after ten of his publicly funded studies – looking at weight gain in the menopause, ageing and hormone-replacement therapy – were found to be fabricated
Carlisle suggests that people lie because it is easier than doing a real study.
Richard Smith agrees. ‘You can’t get on the academic world if your don’t publish. And doing studies properly can take a long, difficult process.
“You need funding, skills, as well as a team. It is easier to invent something than it is to actually create it. It’s also quite easy to do it.
Prof Ian Roberts claims he warned the British health watchdog National Institute for Health and Care Excellence, the Chief Medical Officers and other concerned parties about the severity of the problem, but was ignored.
He said, “We have written to them, but they aren’t interested.” I can understand why no one wants to take it seriously – this is a difficult problem to solve and will require huge changes in the way things are done.’
When The Mail on Sunday contacted the office of the Chief Medical Officers, it claimed to have no record of Prof Roberts’s letters – despite the fact that we have seen the letter of acknowledgment from England’s Chief Medical Officer, Professor Chris Whitty.
A spokesperson for the Government said that Clinical Trials must be conducted in Good Clinical Practice.
This is a set internationally recognized ethical and scientific quality requirements that must all be followed when designing and conducting clinical trials that involve humans.
This is true. It doesn’t address the issue of studies that don’t turn out to have been conducted in the first instance.
Cochrane used procedures last year to combat fraud. Prof Bero is the coordinator of this effort. He says, “We check whether a clinical study has been registered with any governing bodies, for example. If we find a problem we will approach the institution.
“Ultimately, we may ask the journal to retract the study. Although it is a slow and tedious process, a claim of fraud could endanger scholarly careers.
Research fraud amounts to professional misconduct, yet, in most countries, including the UK, it is not a crime to fake a trial – Smith, Prof Roberts and others argue it should be treated more like financial fraud.
Smith states that “Regulators rarely have teeth so there’s very little deterrent.” First, everyone must accept that we have a problem.
“These fraudulent studies exist, and we have only discovered a small percentage.”