We’re presenting a Q&A session with Peter Wilmshurst, now a part-time consultant cardiologist who has spent decades embroiled in misconduct investigations as a whistleblower.
Retraction Watch: A UK judge recently upheld two findings of dishonesty by the Medical Practitioners Tribunal Service against Andrew Dowson, director of headache services at King’s College Hospital and your former co-investigator. Were you pleased with the verdict? (Last week, Dowson also began a four-month suspension from practicing medicine in the UK.)
Peter Wilmshurst: In part, because I was pleased that he was shown to be dishonest, because I knew that he was, which was why I reported him. But I wasn’t pleased in the sense that I don’t think the investigation dealt with all the issues involved in the Migraine Intervention with STARflex Technology (MIST) Trial.
RW: What additional issues did you hope to see addressed?
PW: The case centered on a trial of an implantable device to repair a type of hole in the heart of people with migraine with aura, who have a disproportionately high prevalence of such holes. Preliminary evidence had suggested that the procedure might reduce attacks of migraines with auras but the mechanism is not known.
As a cardiologist, I was involved in the early stages of the trial. But I started to have concerns about the data when I saw that the U.S. manufacturer of the device — NMT Medical – was getting involved in writing up the results, making significant changes to the presentation and interpretation of the data, and refused to disclose all the data to the steering committee. And what I saw included numerical claims that I knew couldn’t be correct.
The paper was ultimately published in 2008 in Circulation, and reported “no significant effect” on the primary end-point, migraine incidence. But it also omitted mention of problems with the device, which I knew had occurred, such as devices coming loose in the heart and causing potentially life-threatening problems. The following year, the journal published a major correction addressing this and some other issues, as well as additional data.
The Court judgment confirms the earlier findings, including that Dowson had failed to disclose to the ethics committee that approved the MIST trial that he had been removed from a previous trial because he had falsified patient data. He also failed to disclose that he was paid £200 per hour by NMT Medical while working on the MIST trial.
RW: This certainly isn’t the first misconduct case you’ve been involved in and some have involved you in legal disputes. What are some of the others?
PW: Unfortunately not. So far, I’ve been sued three times for libel and slander, including by NMT Medical. Fortunately, the company went bankrupt in 2011, which ended that case..
My first brush with research misconduct came in the 1980s, when I was researching a drug to treat heart failure, amrinone. I discovered that the drug wasn’t effective and had serious side effects, which I reported to the manufacturer, Sterling-Winthrop. The company asked me to omit data from some of the patients, but the effect of that would have been that reanalysis of the remaining data would have suggested that the drug had a beneficial effect. When I refused, the company offered me money not to publish the data at all. I published a few papers on the drug anyway, even though they threatened me with legal action.
I was eventually contacted by a representative of the committee that at the time regulated medicines in The Netherlands, who said the side effects I had reported weren’t listed on the forms submitted by the company for a product license and which the company said were the clinical record forms from my research. It was easy to show that the forms had been falsified, and The Netherlands refused a license for the drug, and got other European countries to do the same. In 1984, Sterling-Winthrop told the FDA that it had withdrawn the drug worldwide because of concerns about safety, but two years later I realized it was still being marketed in parts of Africa and Asia, where it could even be purchased over the counter. At this point, we knew the drug could increase mortality by 30%. So I asked a representative of Oxfam to arrange purchase of the drug in developing countries. We took proof of purchase to the World Health Organization, which forced the company to truly withdraw the drug worldwide. (Sterling-Winthrop was sold in the 1990s.)
RW: You wrote in 1997 in The Lancet about the need for new mechanisms to pursue misconduct in the UK. Have things improved since then?
PW: No, not really, not as far as research misconduct is concerned. I think regulators often don’t understand research misconduct. Dealing with it can be difficult because often there are conflicting arguments over what the truth is. But in many cases, there are undeniable facts about a researcher’s wrongdoing, and often these aren’t dealt with properly by the appropriate authorities.
RW: How would you like to see misconduct dealt with in the UK?
PW: First, we need to have the will to do something about it. I would like to see a public body that investigates research, and has the legal powers to demand access to data. We need to institute random checks of data submitted to journals by experts who can verify whether it shows what the authors claim. We also need people with the power to inspect research institutions, which are often more interested in getting money from sponsors than getting scientifically valid data.
RW: Do you think you’ve simply had the bad luck to find yourself in the middle of major cases of misconduct, or is this something you believe most researchers encounter, but don’t make public in the way you have?
PW: I suspect the latter. Whenever I talk to colleagues or other scientists about my experiences with fraud, most give me examples they’ve come across – involving people in their labs, or colleagues. But nothing is done about it. Misconduct is very much more common than academics would have you believe. We know it must be, given that so many therapies appear wonderful in their early reports but then turn out to be useless and the data from early reports proves to be unreproducible. You’d expect that to happen occasionally, but not as often as it does.
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