Healthy Skepticism Library item: 15172
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Publication type: news
Burne B.
Anger at bid to silence heart op whistleblower
The Daily Mail 2009 Feb 26
http://www.dailymail.co.uk/health/article-1156382/Anger-bid-silence-heart-op-whistleblower.html
Full text:
A senior heart specialist is being sued for libel. Not for making damaging allegations about a colleague, but because he questioned the benefits of a surgical device used to close holes in the heart.
Around 25,000 people have had the device inserted, and the sorts of question Dr Peter Wilmshurst has been asking are the ones you’d want answers to: Does it work well? Is it being used on the right patients?
Yet the American company, NMT Medical, which makes the device claims that by talking about his concerns, Dr Wilmshurst has breached a confidentiality agreement. The company has demanded that he apologises and pays damages.
Dr Wilmshurst is not claiming that the heart device is dangerous, just that it is ineffective.
Dr Wilmshurst’s relationship with NMT Medical began cordially. The consultant cardiologist at the Royal Shrewsbury Hospital was commissioned to be joint principal investigator on a big trial, known as MIST, designed to test the theory that closing a hole in patients’ hearts with a device called Starflex could reduce migraines.
Surprisingly, 20 per cent of adults have a such a hole, known as a PFO. This is different from the life-threatening hole that occasionally has to be closed in the heart of newborn babies.
If you have a PFO, it means some of your blood goes the wrong way – directly to the brain rather than through the lungs, putting you at risk of conditions such as stroke.
The one thing everyone agrees on is that the device didn’t help people with migraine: of the 70 patients who had the operation, only three had any improvement in their migraine.
The controversy is over whether the device actually closed the PFOs. That’s because even if it didn’t work as a migraine treatment, it might still be ‘sold’ as a way of closing PFOs.
As part of the trial, each patient had echocardiograms – ultrasound videos of the heart at work, known to specialists simply as ‘echoes’. One before the operation, the other, six months later.
‘It had been agreed that all the records of the echoes would come to me to assess whether the PFOs had been successfully closed,’ says Dr Wilmshurst.
Although the surgeons doing the operations reported that 94 per cent had been successful, that wasn’t what Dr Wilmshurst saw. ‘Around 30 per cent had signs that some blood was going the wrong way,’ he says.
When Dr Wilmshurst reported this, plans for him to review echoes in a follow-up trial were dropped and another researcher was called in.
The new review found the Starflex had successfully closed more than 90 per cent of the PFOs – but also found that 30 per cent of patients still had blood going the wrong way via a different route.
There was no mention of these findings during the presentation of the results of the trial at a major cardiology conference in the U.S. in October 2007.
Instead, the company said that although the procedure had done nothing to help with migraine, Starflex had successfully closed 94 per cent of PFOs.
The evidence that the device might not be as effective as had been claimed was simply ignored.
Wilmshurst talked to a journalist about what appeared to be a missing discussion of the evidence from echoes, and added that he had not been able to see the trial’s full data.
The manufacturer denied there had been any reviews of echocardiograms. What’s more, it said, Dr Wilmshurst had breached a confidentiality agreement by raising these issues and had been dropped from the trial as a result.
The dispute was reported on an academic website specialising in cardiology – heart.org. It was this that triggered the libel suit.
NMT vice-president Richard Davis suggests Dr Wilmshurst’s objections were sour grapes. ‘It is his long-held belief that closing the PFO would help with migraine,’ he says.
‘This is why he is trying to make out the device is not effective – to protect his theory.’
Dr Wilmhurst was not the only expert concerned about the trial. Professor Sir John Lilleyman, head of the National Research Ethics Service which oversaw the MIST trial, is concerned about the conflicting results of echocardiogram reviews.
‘The company assured me the results would be published and the issues dealt with,’ he says. ‘I’ve seen no sign of that.’
Professor Lilleyman is also worried some patients in the trial may believe their PFO was closed when it wasn’t: ‘I believe we may have a duty of care to those patients.’
Dr Wilmhurst won’t be intimidated by the libel action and has a history of standing up for what he believes in.
More than 25 years ago, he was threatened with the courts if he didn’t keep quiet about unfavourable findings about a drug used for heart failure.
He also fended off legal threats that followed an article he wrote for the BMJ some years later, which revealed how senior doctors had concealed serious professional misconduct and research fraud for a decade.
Dr Richard Smith, a former editor of the British Medical Journal, describes Dr Wilmshurst as ‘perhaps British medicine’s champion whistleblower’.
NMT Medical says Dr Wilmshurst’s allegations have all been raised privately in a multitude of discussions. ‘We’d prefer not to resort to litigation,’ says vice-president Richard Davis. ‘But we cannot allow the company to be libelled.’
Dr Wilmshurst doesn’t intend to back down. He says: ‘I’m prepared to stick my head above the parapet because I think these things are important.’
If you have had an operation to close a PFO and you are worried about whether it has worked, talk to your GP or the cardiologist who performed the operation.
‘If they think it’s necessary, they will run another echocardiogram to check all is well,’ says Dr Vaikom Mahadevan, consultant cardiologist at Manchester Royal Infirmary.
