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.