Highly recommended weekend reading: in his Bad Science column in the UK’s Guardian, Ben Goldacre, the physician and best-selling author and columnist, brutally dissects NMT Medical, the troubled medical company that makes closure devices that have had a poor record in the clinical trial arena. CardioBrief readers will likely recall the company’s vicious assault on Peter Wilmshurst, the cardiologist who was the PI of the company’s (in)famous MIST trial until he was unceremoniously dumped by the company after he objected to the company’s dubious tactics in running the trial. When Wilmshurst told his story to TheHeart.Org (where I was then the editor) the company sued him for libel.
Goldacre asks a simple question: since NMT has questioned the trustworthiness of Wilmshurst, just how trustworthy is NMT? And then he finds immediate evidence of the company’s untrustowrthiness right at the company’s front door, on the home page of their website:
On the front page, you will see positive quotes from patients prominently displayed, on a rotating banner, accompanied by 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.
Goldacre points out, correctly of course, that MIST was a negative trial. It seems strange to use examples from a failed trial to demonstrate the virtues of your products. But then Goldacre raises an even more troubling ethical issue:
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.
There’s more where that came from. Go read Goldacre’s column.
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