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

December 11th, 2010 by Ben Goldacre in bad science, big pharma, legal chill, libel | 30 Comments »

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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30 Responses



  1. nickuk72 said,

    December 11, 2010 at 6:35 am

    Another case of greed over professional integrity. This one with a particularly nasty outcome for an individual who has shown strength and true integrity. I hope they manage to extract some cash for Dr Wilmshurst before the collapse of this horrible company.

  2. le canard noir said,

    December 11, 2010 at 9:39 am

    Their Q3 Results for 2010 make interesting reading,

    www.snl.com/irweblinkx/file.aspx?IID=4148066&FID=10340484

    Plummeting sales. And huge losses. The investors are going to have to keep shovelling huge quantities of cash to keep this one afloat. One might glimpse the reasons why bad news on trials might not be in their best interest.

  3. T.J. Crowder said,

    December 11, 2010 at 11:18 am

    “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”

    Let’s not be disingenuous. It’s not odd at all. NMT is in the business of selling their products. The trial doesn’t help them do that, so they don’t mention it. Unethical? Sure. Odd? Surprising? Not so much (more’s the pity).

    It’s too bad the device doesn’t work. It could have helped a lot of people if it did. But if the company behind it is run by people stupid enough to continually publicize their failures by suing people for standing up and being ethical, it deserves to collapse. I hope Dr. Wilmshurst sees some of his money.

    Perhaps we need a “science defense fund” that people like Dr. Wilmshurst and Simon Singh and your own good self can tap into when wingnuts, fish-oil salesmen, and multinationals sue you for libel under the current idiotic system. (Although in regard to Singh — and I’m glad that action was finally dropped — “happily promotes bogus treatments” *does* sound a lot like accusing the BCA of knowingly acting in a dishonest way.)

  4. osipacmeist said,

    December 11, 2010 at 11:46 am

    I am a bit shocked: is it really the case that someone is willing to carry out major surgery (or even minor surgery) on the basis of the kind of tests described here. To hell with self regulated malpractise restrictions, isn’t that assault?

  5. truthygum said,

    December 11, 2010 at 1:42 pm

    It would be insane if the law allows the individuals who have done this to hide behind their company NMT without fully recompensing Dr. Wilmshurst.

  6. paulatthehug said,

    December 11, 2010 at 5:15 pm

    What I find sad in all of this is that a friend on mine who is a chronic migraine sufferer made their decision to have their heart hole plugged (not sure if it was by this device or another similar device) at least partially because of the stories that were coming out in the press at that time about how this could help cure migraines. It didn’t.

  7. alexandraengland said,

    December 11, 2010 at 6:21 pm

    T.J. Crowder suggested:

    ‘Perhaps we need a “science defense fund” that people like Dr. Wilmshurst and Simon Singh and your own good self can tap into when wingnuts, fish-oil salesmen, and multinationals sue you for libel under the current idiotic system.’

    I think that’s an idea that requires someone to follow up on it. There are a lot of interested people who would like scientists to take an ethical stand on behalf of all of us who don’t understand the details well enough to make informed judgements much of the time, know that that’s the case, and would like to support ethical science financially, given the means. Just hope Visa, Mastercard and PayPal don’t close down on you when you speak up.

  8. msjhaffey said,

    December 11, 2010 at 8:02 pm

    It would seem to me that libel law needs a provision along the lines of the following:

    If, in the opinion of the judge, a company filed a suit with mischievous intent, then the directors of that company at the time of filing the suit will be jointly and severally liable for costs awarded should the company cease trading or be unable to pay.

  9. Munin said,

    December 11, 2010 at 10:44 pm

    What a bunch of utter Culture Secretaries.

  10. SimonW said,

    December 11, 2010 at 11:22 pm

    I suspect the judge could ask for the Directors to guarantee the 200,000. Director guarantees are nothing new, not sure if they’ve ever been asked for by a judge, but I don’t see why they couldn’t.

  11. felicityflix said,

    December 12, 2010 at 9:27 am

    What I find strange is how this trial could be presented as positive one day so that people like me considered getting checked out and considered having this operation only to find out that the trial was actually negative and the treatment doesn’t work at all. I was intrigued by this so did a bit of research and was suprised to find that the original presentation was by Wilmshurst and Dowson. Now I am just confused….

  12. tialaramex said,

    December 12, 2010 at 11:23 am

    The directors are presumably Americans. They are thus outside the court’s legal and physical jurisdiction and even if on paper they owed a pile of money, they can’t be made to pay it.

    If a court finds a foreign citizen guilty of a crime in their absence, it can order them locked up if they ever enter its jurisdiction. But this isn’t a criminal matter, probably their names wouldn’t even be flagged on arrival at our airports.

    So you’d have to hire bailiffs to watch for indications they were travelling here (which they might never do) and then seek to serve them with papers demanding the money. They will then get back on a plane to the US and you still won’t get a dime. Only if they tried to settle here, or bought property, would you have much chance at getting the money owed.

    Thus, the directors, while a useful target in a local company, are no help for an international lawsuit.

    However the general principle that the full cost of losing such a lawsuit must be put into escrow by the plaintiff at the start of the case could be worth establishing. If “Let’s sue this guy” meant “Let’s put hundreds of thousands of dollars of our precious working capital into a foreign escrow account” I think you’d see less such lawsuits.

  13. MrNick said,

    December 12, 2010 at 2:58 pm

    “What a bunch of utter Culture Secretaries.” Indeed.

    What happened on June 17th this year? The share price fell off a cliff and lost about 80% of its remaining “value” in one day.

    It looks to me that unless they have lots of backing or a miracle happens they don’t have much of a future (the loss per share being so big in comparison to the share price).

    Nick

  14. blah said,

    December 12, 2010 at 5:28 pm

    Munin, that is gold.

  15. sgp said,

    December 12, 2010 at 7:07 pm

    Back to the subject of money. I’d prefer to donate to a general fund. But if not, has Wilmshurst set up any campaign fund of his own we can donate to?

    If enough of us little guys make small donations, the result can be very significant.

  16. nickyb said,

    December 13, 2010 at 2:32 am

    Has this article been removed from the Grauniad website? I can’t find it anywhere…

  17. David Cruise said,

    December 13, 2010 at 4:02 am

    Believe it or not, it’s surprisingly difficult to commit libel properly. The problem is, it’s very easy to accuse and harass somebody for it. A company with a case, especially in ‘dire straits’ would have cleaned up long ago.

    I’d certainly chip into a communal libel fund, though with the condition that we insist no money changes hands until after the case. Sabre rattling is bloody expensive by the looks of it.

  18. stinkychemist said,

    December 13, 2010 at 10:05 am

    What is there to guarantee that NMT will be able to pay their soilicitor, who clearly knows that their finances are “dire”? If I was that solicitor I’d be asking for money up front, too.

    Maybe Dr. Wilmshurst could team up with them…..

  19. heavens said,

    December 13, 2010 at 4:31 pm

    One problem with holding “the directors” liable for the costs is that the individual directors may not unanimously and wholeheartedly support the lawsuit.

    “The directors” could include the guy who was pounding on the table and yelling that this loser of a lawsuit was a stupid waste of the company’s resources. Do you want him to be on the hook for the cash, just because the majority voted against him?

    What about the director who wasn’t able to attend the meeting at which the decision was taken? Or the director that joined the board later? Shall we dun him, but let the person who set it all in motion, but who resigned just before the critical moment, completely off the hook?

    I don’t think that’s a good solution. A far more practical solution would be to require the company to post bond for the respondent’s legal costs.

  20. wizman said,

    December 14, 2010 at 12:29 pm

    I had a PFO closure back in 2005 (I think) to prevent headaches, vomiting and visual disturbances when Scuba diving caused by shunting of bubbles across the PFO when diving.

    It completely cured my symptoms. I’ve done 500 dives since the operation with not a single incident – I was suffering this with on around 25% of my dives prior to the operation.

    I’ve also never had any other migraine since then – although my non diving induced migraines were not massively severe or frequent. Probably once a month visual disturbance and once every three months with reasonably severe headache.

    I wasn’t part of any study that I’m aware of and I’m not suggesting that the manufacturers are correct to make their claims. I’m just holding myself up as a positive case study for migraine relief via PFO closure as you seem to be questioning the validity of the previous case studies. Feel free to email me if you want more details.

    As for the whole libel issue – this is out of order regardless of my experience and I fully support libel reform.

  21. MatthewT said,

    December 14, 2010 at 12:38 pm

    @MrNick – NMT announced on 16 June that a new product trial had not achieved its ‘primary endpoint’, a lovely phrase which I think we can all translate. The markets would appear to agree – the share price nosedived the next day and hasn’t recovered.

    NMT trial press release: www.snl.com/irweblinkx/file.aspx?IID=4148066&FID=9712903

    As someone else has already said, given bad trial news like this is bad for business, why pursue a libel action with its inherent negative publicity?

  22. howler said,

    December 14, 2010 at 5:41 pm

    @Ben

    Do you have the URL for the now-removed page on the Brompton website? We could check it on way-back machine – would be interesting to see the content.

  23. Ben Goldacre said,

    December 14, 2010 at 5:49 pm

    hi
    here’s the text of the original RBH page, before it was taken down. i told them on the phone last week that i’d probably be posting it so ppl could see it for debate, and they didnt raise any objection.

    RESEARCH SUCCESSES:

    Heart trial offers relief for migraine sufferers

    Our researchers investigated the relationship between migraine headaches and holes in the heart. Their study indicated as many as 40 per cent of patients could have their migraine symptoms significantly relieved through intervention to close the holes in their hearts.

    The MIST I (Migraine Intervention with STARflex Technology) study brought together a significant number of partners, with Royal Brompton & Harefield acting as a key cardiology centre. The study was the first to specifically focus on migraine sufferers with holes in their hearts, known as a Patent Foreman Ovale or PFO, and to examine whether closing this hole could effectively treat the migraine.

    Relief from life-long symptoms

    A total of 147 patients with a PFO were enrolled in the trial, with over a third of patients being treated by one of the lead investigators, Dr Mike Mullen at Royal Brompton Hospital.

    Commenting on the launch of the trial, Dr Mike Mullen said, “This is significant news for migraine sufferers. For the first time this study has shown that closing a PFO can have a substantial effect in reducing the symptoms for patients with severe migraine. The challenge now for headache doctors and cardiologist is to identify the characteristics of patients who can benefit from this treatment.”

    Trust patient Zoe Willows

    Zoe Willows, a patient involved in the trial, suffered migraines with acute aura symptoms for over 22 years. “My doctors just kept on prescribing different pills and medication but nothing ever worked,” she said.

    “I’ve now been completely cured and can live my life as a normal person.”

    Click to watch the BBC video report on our research.

    “I encourage other migraine sufferers like me to go to their GPs and insist they refer them to a specialist to test whether they too have a hole in their heart.”

    Closure of a hole in the heart may not be suitable to all migraine sufferers. Patients with severe migraine should go to their GP who will assess whether it is appropriate for them to be referred to a specialist for initial tests.

    Read more about the study on the MIST website.

  24. wizman said,

    December 14, 2010 at 9:02 pm

    For the record I should point out that my PFO was closed using an Amplatzer PFO Occluder manufactured by AGA Medical Corporation and not anything made by NMT.

    However since google tells me that AGA had to settle a patent case with NMT for this device I assume it’s pretty much the same thing.

  25. CliveHill said,

    December 15, 2010 at 12:55 pm

    Reading this I became curios about what Dr. Wilmhurst actually said, and I found this: scientific-misconduct.blogspot.com/2007/11/more-quack-medical-research-in-uk-nmt.html
    As an uninformed observer, it seems to me like it is a real accusation of fraud, and while I support libel reform I would support NMT having a right to defend against such an accusation.
    I strongly suspect the accusation is valid, and the use of libel law to silence Dr. Wilhurst is indeed wrong, but still, if you publicly accuse a company of fraud you must expect to have to back it up.
    I only wonder now why it’s taking so much time and effort to do that.

  26. Guy said,

    December 16, 2010 at 9:11 am

    clive, we obviously interpret that link very differently. To me it reads as a fairly forensic dissection of the time line for Wilmshurst and the trial. No accusations simply a lot of questions that have not been given a satisfactory answer.

  27. MrNick said,

    December 17, 2010 at 10:14 am

    @MatthewT Thanks. I thought that it must be something like that.

    Perhaps they are changing their focus so that what they produce is litigation not medical devices.

    Nick

  28. lucifee said,

    December 30, 2010 at 4:08 pm

    But Ben, surely the order requiring NMT to pay £200k into court demonstrates that the system is working, rather than the other way around? That order requires NMT to pay actual cash into a court bank account, and if (a) they fail to pay, then their claim is struck out and if (b) they pay and fight on and then lose (as seems likely), Dr Wilmshurst gets his legal costs paid.

    There has to be a defamation law which protects people against being libelled or slandered. The need for this is recognised in (among other major statements of human rights) Article 10 of the European Convention on Human Rights. It is a very sad fact that where you have a completely proper and appropriate law, you will find entities that abuse it. (For example, the law says that if you drive negligently and cause injury you must compensate the injured person. Obviously this law is correct and necessary. It is also constantly abused by false or exaggerated claims. The fault is not in the law, but the abusers of it).

    I absolutely recognise that being the defendant in litigation is a nightmare, and I am not surprised at the extent of the financial and time commitment that poor Dr Wilmshurst has had to put in. I also agree that NMT are trying to bully him into silence.

    The blame for the cost and the trauma to Dr Wilmshurst however belongs with NMT, not UK libel law.

    I have stopped coming to the libel campaign meetings because it is apparent to me that although everyone running the campaign is well aware of this fact, they prefer to concentrate on a target for which it is easier to drum up public sympathy (law and lawyers!). This is v depressing given your (and others running the campaign) longstanding commitment in the field of science to not dumbing down, to explaining properly, to getting it right.

    By all means show NMT up as wrong, stupid and bullying. But don’t confuse that with a problem in the law itself.

  29. flyingbanana said,

    March 17, 2011 at 2:10 pm

    It seems like the case is still going on, so NMT may have put up the £200,000.
    www.lawgazette.co.uk/opinion/comment/does-threat-cfas-mean-libel-redress-will-be-only-rich

  30. SonaMason3 said,

    July 29, 2012 at 7:04 am

    I was implanted with a Starfelx device in 2001 for TIAs. Within a month of the device being implanted I started getting sever migraines. Sometimes my migraines last 1-2 weeks and have to be broken in the ER. I also have auras which include loss of eyesight and loss of feeling/tingling in my arms, face, tongue, and sometimes torso. I get these migraines at least 2-3 times a week and cannot wake up without at least a mild migraine every day. I never had an issue with these until after the device was implanted. I was 14 when it was put in… im 25 now and Im still dealing with the effects of the Starflex device. I have also since had 2 more TIAs since 2001… so this device not only made new symptoms, it never helped the existing ones to begin with. Im appalled at how this company is acting when their false information has severely impacted and hurt peoples lives as Im sure Im not the only one who faces such complications today.