The best thing about the recent exposé of research fraud in the UK around the vaccination-causes-autism debacle is that everyone now knows about scientific misconduct. People comment to each other on the bus, “Did you hear that study linking autism to vaccination was fraudulent?” In a day when published studies convince people to start taking vitamin D, stop taking vitamin E, get their children vaccinated, don’t get their children vaccinated, eat broccoli, drink a glass of wine a day, do crossword puzzles to prevent dementia, take ibuprofen every day… and so on… research fraud is now immensely important.
And more so for the patients enrolled in scientific studies. Imagine being subjected to difficult, painful, even potentially harmful tests or treatments without sufficient reasons. Imagine getting a diagnosis or following a treatment to fit someone’s pet theory, instead of for good, rational, objective purposes.
That’s what happened to the toddlers in the study of measles-mumps-rubella vaccine and subsequent behavioural and bowel problems.
As outlined in the recent series of journalistic articles by Brian Deer, published in the British Medical Journal, this fraud was not prevented by good ethical oversight, it was not uncovered by peers or the medical journal editors but by a journalist, and, when it was finally investigated by the General Medical Council, it resulted only in a loss of license for two physicians involved. (Fortunately, they had been dismissed from their hospital posts earlier, after complaints from colleagues.)
There is a contrast with a case in the US 4 years ago. Dr. Eric Poehlmann, a respected researcher, was found to have fabricated data over 10 years to support his hypotheses about menopause and metabolism. His many papers had to be retracted because they were based on fraudulent data. The US Office of Research Integrity got involved because he had benefited from US$1.7 million in research funding from the US National Institutes of Health – taxpayers’ money. Because he misused public funds, Poehlmann was charged, convicted, and sentenced to a year of prison time or two years’ probation.
What was the difference? Poehlmann’s patients were protected by approvals from institutional review boards at the various hospitals, which approved the protocols. A coworker uncovered the fraud, and he was listened to. Poehlmann’s university conducted an objective, thorough but swift investigation. This is key: in the US, institutions must investigate allegations and submit a report to the ORI, which reviews the report and takes a series of administrative sanctions against perpetrators. The matter landed in court. Poehlmann was ordered to write letters to the journals where he had published his papers, retracting them. And there was a real sanction.
What would have happened to the perpetrator of the vaccination-autism fraud (Andrew Wakefield) and Eric Poehlmann if they had worked in Canada? (As a footnote, Poehlmann actually did work in Canada for a while, but other researchers maintained oversight of studies he was involved with, and they were not fraudulent.)
Dr. Paul Pencharz of the University of Toronto says the classic Canadian response is, “Deny, deny, deny. Sweep it under the carpet.” He was called in to investigate a serious case of research fraud at Memorial University of Newfoundland two years ago. And he concluded that Canada is dragging its feet in coming to terms with research misconduct.
According to an article in the Canadian Medical Association Journal, Pencharz suggested a national regulatory agency on research integrity. But this response did not meet with a positive reception from an existing Canadian Research Integrity Committee, bringing together several research and academic organizations, including the three granting agencies.
Most recently, an expert panel convened by the Council of Canadian Academies has suggested a system to address prevention, investigation, and sanction. Its broad report, published in October 2010, rejected creating a new legislated body, or giving the job of prevention and education to the three granting councils (Tri-Council). Instead, it proposed an independent, non-adversarial body called the Canadian Council on Research Integrity. The proposed CCRI would fill some of the gaps: prevention, promotion, independent advice to institutions (universities), requiring reporting on practices and policies of universities, and such-like. It therefore falls far short of the mandate of the ORI in the US.
Investigation would rest with the institution, with the knowledge and request of the funding agency. Investigations could result in job loss for perpetrators, and provide the evidence to allow the publishers to retract previous papers. Sanction would still rest with the Tri-Council, whose purview is limited to cutting off funding to the offending party. Physician-researchers would be subject to sanctions up to loss of license from their professional regulatory bodies.
But no one would go to jail.
This approach is obviously a step in the right direction, but does it go far enough? Are the investigation (institution) and sanction (Tri-Council) too diffuse? Are there too many holes through which a fraud artist could escape?
One of the things that really struck me when reading Brian Deer’s series was that the Lancet editors’ approach to investigating the allegations about the vaccination-autism article was fairly standard in cases of alleged fraud published in a scientific journal, but Deer – and probably most of his readers – found it too close-knit, too subjective, too “inside.” Fraud investigations need to be handled like an audit – objectively, by an outside body or investigator, with strict avoidance of conflict of interest or personal involvement. It should be clear who has responsibility for such investigations, and how they should be carried out. As the ORI points out, such investigations are rare for universities, and they may have little experience or knowledge to know how to approach them.
And if, at the end of the day, patients have not been treated ethically, or public funds have been misused, the perpetrators should be fully accountable and responsible. Not only to their funders, but also to society.