A very public break-upBMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c110 (Published 18 January 2010) Cite this as: BMJ 2010;340:c110
- Jonathan Gornall, freelance journalist
With hindsight, it is easy to see the email sent by NMT Medical’s Geoff Fournie in August 2004 as a prophetic moment in the story of the highly public collapse of the relationship between the Boston medical devices company and British cardiologist Peter Wilmshurst.
Mr Fournie, vice president of clinical development for Europe, was writing to Len Doyal, the ethical adviser of NMT’s then embryonic trial, Migraine Intervention with STARFlex Technology (MIST), investigating whether closure of patent foramen ovales with the company’s septal repair implant might cure migraine. Not only was Dr Wilmshurst “the ‘seminal thinker’ in this area,” he wrote, he was also “recognized as an ‘ethical physician.’”
Conceived as a randomised, double blind, placebo controlled study in which control patients would have a general anaesthetic and sham procedure, the trial was ethically pioneering, and Mr Fournie was keen to stress Dr Wilmshurst’s credentials as a member of its steering committee. The previous year, the Shrewsbury cardiologist had won the HealthWatch Award, “in recognition of his dogged and selfless pursuit of the truth”; he had “spent the last two decades trying to expose research misconduct and has reported more than twenty doctors to the General Medical Council.”1
But three years later, before the trial’s findings had been published, Dr Wilmshurst had raised concerns that triggered three investigations into its conduct of the trial, including one that led to a complaint to the GMC against his co-principal investigator, Andrew Dowson, the director of headache services at King’s College Hospital.
Investigations by the US Food and Drug Administration, the General Medical Council, and …