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2010 HealthWatch student prize for the critical appraisal of clinical research
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for details.Suzanna Jefferson, Barts and the London, QMUL
Lauren Ewington, Imperial College Medical School
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He was one of two principal co-investigators in a clinical trial to test whether
using the STARFlex device to close a hole between the right and left atriums
of the heart (patent foramen ovale) would reduce the incidence of migraine,
particularly migraine with aura.
The published results of the trial were negative. Dr Wilmshurst, who supported
the idea that closing such shunts might affect migraine, later put forward several
ideas why the results were negative, with which the company disagreed. He is
now being sued in a British court. See below for the full news
story from the BMJ.
The Medical Defence Union (MDU) will not help him. They say
that whether they provide help is discretionary.
His NHS Trust will not provide any financial help for his defence.
This is despite the fact that the Trust received money from the trial. He was
contracted by his hospital to do research and this research was approved by
the Director of R&D (i.e. it was part of his job). He commented on the results
at a scientific meeting (also part of his job), but the Trust has now abandoned
him to pay for his own defence.
HealthWatch offers an Award annually to the person we think has done most to
explain why clinical trials, which are usually very valuable, may sometimes
be unreliable. One of the reasons is that the researchers may falsify their
data. Exposing this bad practice usually requires a whistle-blower who thereby
puts his own career in peril. In 2003 we honoured Peter Wilmshurst for doing
exactly that, and we hope it may have encouraged others to do likewise. He has
now done a similar service concerning the device promoted by NMT.
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Published 3 November 2008, doi:10.1136/bmj.a2412
Cite this as: BMJ 2008;337:a2412
News
Clare Dyer
A leading British interventional cardiologist who was a joint principal investigator in a clinical trial of a device made in the United States is being sued for libel and slander in the English courts by the manufacturer. The case concerns comments attributed to him about the trial that were posted on a US based news website for heart specialists.
NMT Medical, which is based in Boston, Massachusetts, makes the STARFlex septal repair implant. The company has launched the legal action against Peter Wilmshurst, a consultant cardiologist at the Royal Shrewsbury Hospital. Dr Wilmshurst and a headache specialist from King’s College London, Andrew Dowson, led the Migraine Intervention with STARFlex Technology (MIST) trial in the United Kingdom to study the effect of the device on migraine (Circulation 2008;117:1397-404).
The company is suing over an article published in October 2007 by Heartwire, an online cardiology news service (www.theheart.org). Dr Wilmshurst gave an interview to a Heartwire journalist, Shelley Wood, at the transcatheter cardiovascular therapeutics meeting in Washington, DC, in 2007.
The MIST trial was launched in early 2005 to study whether using the STARFlex device to close a hole between the right and left atriums of the heart—patent foramen ovale—would reduce the incidence of migraine, particularly migraine with aura.
Migraine is relatively common among people who have right to left shunts, which allow blood to flow from the right to the left atrium; and those who have had shunts closed for other reasons have reported a reduction in the frequency and intensity of migraines.
The published results of the trial were negative. Dr Wilmshurst, who supported the idea that closing such shunts might affect migraine, later put forward several ideas why the results were negative, with which the company disagreed. He suggested that in some cases the device might not have sealed off the shunts and that some of the patients might not have been properly screened, with the result that they were included in the trial, even though they did not actually have patent foramen ovale.
Two members of the steering committee, Dr Wilmshurst and Simon Nightingale, also of the Royal Shrewsbury Hospital, were not listed as authors of the study. They had been offered coauthorship but refused because they were not allowed access to the whole data set.
In his 90 page defence to the libel action, filed at the High Court in London, Dr Wilmshurst admits making some, though not all, of the comments attributed to him but says that his statements were true and made in the public interest.
NMT Medical’s solicitor, Robert Barry, told the BMJ that the company disagreed with Dr Wilmshurst’s statements but did not want to comment and would be producing a detailed answer by 25 November, the date fixed by the High Court. The company is also seeking an injunction to restrain Dr Wilmshurst from repeating his comments.
Dr Wilmshurst admits telling Ms Wood that some of the data he had seen were "internally inconsistent and mathematically impossible." He says he also told her that one theory for the MIST trial’s failure was the possibility that a high rate of residual shunts remained among patients who had supposedly had their patent foramen ovale closed.
He admits saying that his review of the echocardiograms suggested that the rate of residual shunts was approximately one third of the total, although Dr Dowson told the Washington conference that the residual shunt rate was only 6%. It was possible, Dr Wilmshurst alleged, that some of the patients enrolled in the trial may not have been properly screened and may not have had a patent foramen ovale.
Further investigation could have determined whether residual shunting was in fact a problem with STARFlex, he told her, but he had not been allowed access to the full data set. If it was a problem, he said, "that information needs to be in the public domain" and would have "much larger implications for STARFlex, a device already marketed in Europe for the treatment of cryptogenic stroke."
His solicitor, Mark Lewis of the law firm George Davies, argues in Dr Wilmshurst’s defence that he was "under a social, moral, and ethical duty" to make the information public and that the cardiologists and other healthcare professionals who read the Heartwire article had a legitimate interest in receiving the information.
The defence alleges that the libel action is "highly oppressive and unconscionable" and intended to "bully" him into silence.
Richard Davis, NMT Medical’s vice president and chief financial officer, said that the company did not want to comment on pending litigation. "He’s making these comments, they’re not new, and we believe they’re inaccurate and inappropriate."
Cite this as: BMJ 2008;337:a2412
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