Cardiologist sued for speaking out about research findings
Here’s a story about a UK cardiologist being sued by a medical device manufacturer, over comments he made about why a clinical trial he ran didn’t end positively.
Cardiologist is sued for comments on potential migraine device
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 interview published in October 2007 by Heartwire, an online cardiology news service.
In this interview, Dr. Wilmshurst provided reasons for why he believed the trial results were negative. The premise of the trial was that closure of an (abnormal) right to left circulatory shunt in the septum of the atrium, the top chamber of the heart (a defect also called a patent foramen ovale), would reduce migraine headaches. Previous observational studies had demonstrated that, coincidentally, patients who had their right to left shunt closed also experienced a reduction in migraine headaches. In the MIST trial, Drs Wilmshurst and Dowson used the STARFlex septal repair device to close patent foramen ovales in patients and observed them for decreased migraine frequency.
The negative results, according to Dr. Wilmshurst, might have been due to either failure of the STARFlex device to properly seal open shunts or improper screening of patients enrolled in the trial. Both of these claims are very serious, and as Dr. Wilmshurst notes, in the best interests of the public to know.
I’m not a lawyer, but it’s hard to imagine a lawsuit will succeed if what Wilmshurst said was true, and, as noted, in the public interest. Most worrisome, though, is the potential chilling effect on researchers speaking out. This case, while similar to the Olivieri case has some clear differences. Dr. Wilmshurst was not stopping a trial or preventing a trial from continuing. Nor was he speaking out before having all the results in hand. Basically, he was being honest about why he thought the trial didn’t work — and either of the options he outlined as possibilities are arguably in the interest of the public to know about.
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The entire text of the BMJ article is reproduced by HealthWatch, here: Cardiologist is sued….
Research Ethics Blog 
<>The negative results, according to Dr. Wilmshurst, might have been due to either failure of the STARFlex device to properly seal open shunts or improper screening of patients enrolled in the trial.<><>Or<>, Dr. Wilmshurst, closing PFOs doesn’t cure migraines.