NMT are suing Dr Wilmshurst. So how trustworthy are this company? Let’s look at their website…

Ben Goldacre, The Guardian, Saturday 11 December 2010

You will hopefully remember – from the era before Wikileaks – that US medical device company NMT are suing NHS cardiologist Peter Wilmshurst over his comments about the conduct and results of the MIST trial, which sadly for NMT found no evidence that their device prevents migraine. The MIST trial was funded by NMT, and Wilmshurst was lead investigator until problems arose.

Wilmshurst has already paid £100,000 of his own money to defend himself, risking his house, and spent every weekend and all his annual leave, unpaid, dealing with this, at great cost to his family. So what kind of a company is NMT Medical, that the British libel courts have allowed to hound one man for almost two years? And how trustworthy are their utterances?

Let’s go to their website and find out. On the front page, you will see positive quotes from patients prominently displayed, on a rotating banner (reload their page to see the full collection), accompanied by smiling studio photographs.

At this point, we should remember that the MIST Trial really was negative. It set out to see if the device permanently prevents migraine. 147 patients with migraine took part, 74 had the NMT STARFlex device implanted, 73 had a fake operation with no device implanted, and 3 people in each group stopped having migraines. The NMT STARFlex device made no difference at all. This is not a statement of opinion, and there are no complex stats involved.

This might be a good point to mention that the journal Circulation had to publish a lengthy correction for the MIST Trial because their original paper failed to mention, for example, that Wilmshurst had declined to be listed as an author over concerns over how the study was conducted, that two of the devices were lost in patients’ bodies during the procedure (one embolised to the right atrium, one to the left pulmonary artery, both worrying, both were luckily able to be retrieved), and so on.

Back to NMT’s three positive case studies with their smiling studio photographs. They were all (it explains in the 2005 NMT annual report) treated with the STARFlex device in the MIST trial. Jean Richards says “I feel so much better now. I don’t live in fear of a migraine coming on all the time”. Zoe Willows says: “people at my new job have never known me to have a migraine. I’m a totally different person.”

There are several problems here: firstly, two of them, it seems, are advertising devices they were not treated with. Jean is smiling and advertising CardioSEAL, a successor to the failed STARFlex device, although she was not treated with CardioSEAL, and Liz is advertising BioSTAR, but she was not treated with BioSTAR. I asked NMT why these patients were advertising products with which they were not treated. NMT declined to answer.

Secondly, their anecdotal experiences are entirely misleading: the MIST trial was negative (though I can find no mention of the MIST trial’s final results anywhere on the NMT site, which is odd, because it’s the only published trial I’m aware of that tests whether NMT’s device prevents migraine).

But lastly, the protocol for the MIST trial, as is standard, states that the sponsoring company are not supposed to have access to individual patients. How did NMT get hold of these patients?

I tried to contact Dr Michael Mullen, previously of the Royal Brompton Hospital, now of UCLH, cardiologist on the MIST trial, to see if he knew how these patients hit the public domain, since the RBH website has a page – hurriedly removed since I contacted them – stating that the MIST trial results were positive (these appear to be initial results from before the final paper was published), and also featuring the patient Zoe Willows saying “I’ve now been completely cured”. Dr Mullen himself appears in a smiling studio shot on the NMT website, and in 2008 declared owning shares in NMT.  I invited him to criticise NMT’s use of misleading patient anecdotes. He declined. I asked if he knew how the company got hold of the patients, or how these positive results appeared on the RBH website. He said he could not remember.

So I asked NMT. They told me that all 3 patients got in touch with the medical device company themselves, spontaneously. I asked NMT if the 3 patients whose migraines stopped after the fake operation had also got in touch to express their gratitude, because they might make useful and less misleading anecdotes. NMT declined to answer.

I could then have asked Dr Andrew Dowson, the new lead investigator on MIST, whose license to practice was restricted by the GMC at the time of the MIST trial, as he had been found guilty of research misconduct in an earlier clinical trial. To be honest, I was exhausted and not sure it was worth it.

Meanwhile NMT’s share price has fallen from $20 to 20 cents over 4 years, perhaps unsurprisingly after the negative results of the MIST trial. A judge has now insisted they put £200,000 into a UK account in case they lose, or their libel case will be struck out in January, but NMT’s solicitor argues the company’s financial situation is “dire.” This suggests that even if Dr Wilmshurst successfully defends himself, he may never get his £100,000 back. I’m not convinced that a libel law which allows a company like NMT to do this to one man is in society’s best interests.

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Diagnostic errors and their role in patient safety

by Charles A. Pilcher, MD

American Medical News published an informative essay by Kevin B. O’Reilly on December 13, 2010, about errors in diagnosis and why doctors make them.

According to Gordon Schiff, MD, associate director of the Center for Patient Safety Research and Practice at Brigham and Women’s Hospital, “The problem of diagnostic errors has gotten short shrift in the broader patient safety movement.” The article focused on “thinking mistakes” as opposed to “system errors,” and was both refreshingly honest and depressingly true.

None of us is without error. We all make mistakes. Sometimes we can blame it on some fault of the “system,” but most often we have only ourselves to blame.  So if we back up a step and ask “What happened that I made that error for which I must now accept blame?” we begin to learn something about ourselves as physicians – and maybe even as attorneys, too.

But I’ll get to that in a moment.

Another recent article in the New England Journal of Medicine by Dr. David C. Ring has garnered  a lot of press. In it Dr. Ring recounts the time when he performed the wrong operation (carpal tunnel surgery) on a patient instead of the intended trigger finger release. While the scenario leading up to the error was evaluated in detail – communications errors, personnel changes in the OR, last patient of the day, etc. – all aspects analyzed seem to be superficial excuses. The article fails to mention the over-riding fact that the surgery schedule that day was simply too busy. The department was trying to operate – literally – at more than capacity. There was no margin. There was no time to regroup, to thoughtfully consider next steps, to assure that everyone was on the same page and all was in order.

Margin is crucial. That’s why emergency departments are such a hectic, potentially high risk area in which to work. The ED doesn’t have a “surge protector.” Staff can’t be scheduled for the maximum anticipated volume, but the average. Even then there is down time, and the better staffed the department, the more down time there is. Staffing to the average means that some days, there’s simply no margin, and it’s on those days where the opportunities for diagnostic error need to be monitored most closely.

Back to the American Medical News article.

Error occurs. About 5% of autopsies find clinically significant conditions that were missed and could have affected the patient’s survival, according to O’Reilly. Also, 40% of malpractice suits are for “failure to diagnose.” These are rarely “system errors,” like mis-filing a pathology report that a tumor was malignant, but more often “thinking errors.”

There are several reasons why we make mistakes in our thought processes, when we had the knowledge and ability to think correctly. As listed in a 2003 article in Academic Medicine, these “thinking errors” include:

Anchoring bias – locking on to a diagnosis too early and failing to adjust to new information.Availability bias – thinking that a similar recent presentation is happening in the present situation.Confirmation bias – looking for evidence to support a pre-conceived opinion, rather than looking for information to prove oneself wrong.Diagnosis momentum – accepting a previous diagnosis without sufficient skepticism.Overconfidence bias – Over-reliance on one’s own ability, intuition, and judgment.Premature closure – similar to “confirmation bias” but more “jumping to a conclusion”Search-satisfying bias – The “eureka” moment that stops all further thought.

The most fascinating and most common of these is “anchoring bias.” According to Dr. Schiff, “We jump to conclusions. We always assume we’re thinking about things in the right context, and we may not be. We don’t do a broader search for other possibilities.”

As thinking errors move to the forefront of patient safety, many medical schools are beginning to teach “metacognition,” or “thinking about thinking.” The busier the OR or the ER gets, the more this becomes important. It’s second nature to work up a chest pain patient for an MI when the waiting room is full, but more important than ever to keep a broader perspective and consider a couple other killers, for example pulmonary embolism and dissecting aneurysm.

Some experts say that information technology will help us overcome our biases, broaden our perspective and avoid diagnostic errors. Perhaps. But health IT has it’s own biases. Remember GIGO – garbage in, garbage out. A simple example is an over-reliance on “template charting,” whether electronic or in paper form. Let’s say the patient tells the triage nurse “I’ve been vomiting and my chest hurts.” If one chooses too early the template for “Vomiting,” “Gastroenteritis,” or “Abdominal Pain,” one could easily lead oneself and others astray, causing them to overlook the fact that what the patient really meant to say at triage was “I started having this heavy chest pain and have been vomiting ever since.” If the template is too focused, the patient may well be discharged with an undiagnosed MI – or worse.

“Thinking problems” can be at least partially avoided by simply being aware that they exist. And “metacognition” practiced by both physicians and attorneys can lead both to make fewer “diagnostic errors.”

Charles A. Pilcher is an emergency physician who has helped both plaintiff and defense attorneys with malpractice litigation for over 25 years. He can be reached at his self-titled site, Charles A. Pilcher, MD.

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Tagged as: Malpractice, Patients

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