A British doctor faked test results during clinical trials for an asthma drug in which one person died and others contracted cancer and pneumonia, The Independent has learnt.
The medical trial began in 2003, when a dozen researchers at Imperial College London began trialling a new drug on 38 asthma sufferers at St Mary’s Hospital, London, where Dr Edward Erin worked as a consultant.
Erin denies fabricating data but an Imperial College Committee of Inquiry concluded that he was the person ‘most likely to be responsible for the inaccuracies’ established by its investigation. As a consequence of the Committee’s findings, a number of papers reporting trial findings were formally withdrawn. In an extraordinary coincidence, by the time serious concerns about Erin’s research were raised, he had been arrested in relation to an entirely different matter – an attempt to cause his girlfriend to miscarry her unborn child by poisoning her. He was subsequently jailed for six years.
His sentence was later extended by two years after it emerged that he had tried to persuade a formal cellmate to steal the woman’s mobile phone and send a text message which ‘confessed’ to having set Erin up. The cellmate also alleged in court that Erin had wanted him to kill the woman and her son. That claim was not established.
The drug trials began with good intentions, but turned into the medical experiment from hell: a search for a wonder cure for asthma attacks which left one man dead, 20 seriously ill with pneumonia and eight with cancer. But for Britain’s leading heart and lung scientists at Imperial College, London, it was to get even worse: a doctor on their 12-strong team had faked his research results.
Only two of the scientists involved in the study were willing to talk to The Independent: Professor Peter Barnes, who for three decades has been the world’s most respected specialist in his field, and the US asthma specialist Dr Sally Wenzel.
The medical trials began in 2003, when researchers started testing 38 asthma sufferers at St Mary’s Hospital, London. They were trying to discover whether a new drug could prevent airways of asthma sufferers from becoming life-threateningly inflamed.
In Barnes, a professor of thoracic medicine and head of airway disease at the National Heart and Lung Institute, it had at its head a renowned name in respiratory medicine. Working alongside him was Professor Andrew Bush, Imperial College’s professor of paediatrics and professor of paediatric respirology, Dr Trevor Hansel, medical director of the Imperial Clinical Respiratory Research Unit, and Dr Onn Min Kon, consultant respiratory physician and lead clinician for tuberculosis services at St Mary’s and Hammersmith Hospitals.
The costs of the trial were part-funded by the American drugs company, Centocor, which manufactured the drug being tested. Success would mean that it owned a multibillion dollar medicine.
The UK team’s results of their clinical study of 38 modestly ill asthmatics were found to be promising. Meanwhile, an international experiment almost eight times as big, and using severely ill patients, was launched in parallel.
The results had been partly based on data by Erin, a consultant at St Mary’s hospital, whose job was to analyse the sputum taken from patients’ lungs, enabling the scientific team as a whole to assess what the drug might achieve. At the time it was first published, his data was believed to be correct.
From 2004 to 2006, three-quarters of 309 patients with severe and uncontrolled asthma who had volunteered to take part in the international trial were given the drug, known as Golimumab, in three different strengths; the rest were on placebos. Dr Sally Wenzel, professor of medicine and director of the Asthma Institute at Pittsburgh’s Montefiore Hospital, was put in charge of the new clinical trials in the US and several European countries, including the UK.
The scientists running the study were deliberately not allowed to see the results as they were compiled, so their judgements were not compromised until all the data had been collated up to the 24th week. It was not until 25 February 2007, when the data was unlocked, that the awful consequences of the drug were discovered.
“There were serious side effects,” Professor Barnes said. “Pneumonia and cancer.” Dr Wenzel added: “It is potentially one of the big finds if it works, but Golimumab had substantial side effects.”
The next day the US Food and Drug Administration ordered an immediate shut-down of the trials. But it was too late. “One death occurred in the 200mg group,” the American Journal of Respiratory and Clinical Care (AJRCC) dispassionately reported. “This patient was hospitalised in an unresponsive state one week after receiving the fourth Golimumab dose. The patient’s respiratory status declined, requiring ventilatory support, and the patient died from septic shock following diagnosis of small-bowel pneumatosis.”
It continued: “Eight malignancies were reported in Golimumab-treated patients: breast cancer in the 50mg group; B-cell lymphoma and malignant melanoma in the 100mg group; and cervical carcinoma, renal cell carcinoma, colon cancer (stage 0), and two basal cell carcinomas in the 200mg group.” One female test subject had to have her breast removed, while another man had a fast-growing polyps.
What was not then known was that an analysis of one set of tests, which looked at the build up of mucus developing in the lungs of patients, was bogus. Those findings were the result of work done by Erin, whose name appeared first among all the study authors in four AJRCC reports monitoring its progress. Just as questions were starting to be asked about his work, he was suddenly arrested in February 2008 on charges of having laced his lover’s drink with drugs to try to make her miscarry and was suspended from practising as a doctor. Checks carried out by another member of the research team discovered that a lot of Erin’s data had indeed been fabricated. Some statistics had been inflated to several times their real value.
In 2009, Erin was given six years in jail for two counts of attempting to administer poison and ordered to pay £30,000 costs. Judge Richard Hone, QC, described him as an “egocentric” who had delusions of grandeur. “The trial process has exposed you,” he added, “stripped of your flummery, as a liar, a cheat and a predator.”
“Erin did not seem different to any to any other research fellow,” Professor Barnes said. “He worked there. Was always in and working.” He discovered that Erin had consistently changed results for about three years. “The judge was absolutely right about Erin,” he said. “He was a liar and a cheat. But psychopaths are very convincing. It could happen to anyone.”
He continued: “Before he was arrested, we had no suspicions. We only had concerns about Erin because he was arrested and convicted of a crime. The person in a related area was not getting similar results. We obtained the notebook which contained the original data that Erin had taken. He had systematically changed figures.”
Professor Barnes acknowledges that Erin, a 44-year-old father of two with a 20-year unblemished medical record, may have been driven by a desire to enhance his career. “It is very difficult to see why he would he did it. It is as if he had a compulsion to change things. These people lie about things they don’t need to lie about. We have never had anything like it in my 30 years.”
In September 2010 a letter, signed by Professor Barnes, Professor Andrew Bush, Dr Trevor Hansel and Dr Onn Min Kon was sent to AMJCC retracting the research. It cited, among other things, an example of the way Erin had altered his data. One figure had been changed from 3.81 to 23.81.
The plot: A deception that continued in jail
On the surface, Dr Edward Erin was a respected doctor and family man. But the 47-year-old father of two was leading a double life. Dubbed “Dr Poison”, he was jailed in 2009 for trying to poison his secretary, Bella Prowse, when she became pregnant after an affair that began at a Christmas party.
He tried to lace two drinks – a coffee and an orange juice – with drugs that he hoped would induce a miscarriage. Noticing her drinks had been tampered with, Ms Prowse went to the police. A former consultant at St Mary’s Hospital in west London, Erin’s subsequent trial revealed a man described by Old Bailey judge Richard Hone, QC, as “a liar, a cheat and a predator” who exploited his position and his wealth to seduce women.
Even in prison, Erin continued to plot a web of deception that he hoped would clear his name. He convinced a fellow inmate, Joe Mallia, to steal Ms Prowse’s phone and to send a text from it “confessing” that she had made the whole thing up. But Mallia took his story to The Sun, who then secretly filmed Erin going over the plot with Mallia.
The video was used as evidence against the disgraced doctor and he was found guilty of perverting the course of justice.
The retraction: an extract from the letter
In September 2010, a letter was sent to the AMJCC, signed by Dr Hansel, Prof Bush, Dr Kon and Prof Barnes:
“In January 2008 we were presented with some individual immunoassay points provided by Dr Edward M. Erin. On 16th February 2008 another member of our research team highlighted serious concerns. This matter was immediately reported to the relevant authorities. Having reviewed all immunoassay data from relevant studies, the Committee confirmed there was an overwhelming case to answer.
In their report, the Committee stated that Dr Erin, the first author in these publications, is the most likely person to have been responsible for the inaccuracies in the date. The Committee noted Dr Erin has not provided a satisfactory explanation for any of the several hundred unambiguously detailed numerical faults identified, despite being given a chance to provide an explanation.
Dr Erin has denied any wrongdoing on his part in relation to the above clinical research matters, but we authors feel the strong need for withdrawal of the above paper due to the factual inaccuracies.
This article has been amended to clarify that Dr Erin’s fraudulent test results in the UK study were not the direct cause of a patient’s death in the subsequent international trial. The article also previously stated that Dr Erin tried to persuade a former cellmate to kill Bella Prowse and her child. This was an allegation made in court but was not the basis for his conviction for perverting the course of justice.