Peter Wilmshurst

In 1986, Wilmshurst, a cardiologist then working at St. Thomas' Hospital, London, approached The Guardian newspaper with a substantial dossier detailing alleged misconduct in the development of amrinone, a cardiac drug manufactured by Sterling-Winthrop. The drug was supported by a study at Harvard Medical School and published in the New England Journal of Medicine, whose lead author was Eugene Braunwald, a professor of cardiology in Harvard University and a leader in his field. Wilmshurst's group ran a series of experiments on the promising new drug but found no effect on contractility and frequent life-threatening side effects. Wilmshurst reported these findings to Sterling-Winthrop, who asked him to suppress the data. He refused, and they retaliated by threatening litigation. He continued the research and published his adverse findings in abstracts and conference presentations, until Sterling-Winthrop staff removed all stocks of the drug from the hospital pharmacy. A review by the Netherlands Committee for the Evaluation of Medicines found substantial discrepancies between the record cards of Wilmshurst's group and those submitted by Sterling-Winthrop. Wilmshurst showed that they had falsified the records, suppressing the adverse events he had reported. He then contacted the UK's Committee on Safety of Medicines (CSM) and discovered that Sterling-Winthrop had also failed to report the adverse events to the UK; they had also threatened the UK Government with closure of a large manufacturing plant in the UK. Sterling-Winthrop subsequently reported over 1,400 adverse events to the US Federal Food and Drug Administration and terminated research and marketing in the USA, while continuing to market the drug in the developing world. Finally, after a substantial Guardian feature, they withdrew the oral drug entirely in 1986.^[1][3] In 2003 Wilmshurst was given the Health Watch Award for this work.^[4]

In 2000, Wilmshurst published a paper linking migraine to patent foramen ovale, a common cardiac condition affecting up to one in four people. This led NMT Medical to develop a PFO closure device branded STARflex. Wilmshurst was recruited as part of the "Migraine Intervention with STARflex Technology" (MIST) trial. The number of patients and potential value of the market (estimated in excess of $15bn) drove NMT's stock price to $25/share. A substantial discrepancy emerged between interpretations of echocardiogram results by the implanting cardiologists and Wilmshurst's review. Wilmshurst reported a significantly higher proportion (one in three versus four in sixty-five) with residual cardiac shunts. An independent review backed Wilmshurst's figures.^[1] Less than a fortnight after returning from a conference in Washington, where he discussed his results, Wilmshurst was contacted by lawyers for NMT making accusations of "seriously defamatory allegations". The first NMT libel suit was lodged in 2007, and drew media attention.^[5] NMT served four separate writs on Wilmshurst. The courts demanded that they lodge £200,000, owing to their parlous financial state and the likelihood of failing in the action.^[6] NMT declared bankruptcy after pursuing Wilmshurst for over three years.^[7]

In light of the Hadiza Bawa-Garba case, Dr Peter Wilmshurst has referred himself to the GMC and asked the regulatory body to both remove himself from the register and scrutinise his medical practice. This is because of concerns felt by British medical practitioners with the GMC's outcome and appeal (successfully won) against Bawa-Garba. Multiple parties have been concerned about the outcome of this hearing, as well as the repercussions on current medical practice.^[8]

Wilmshurst's experience, along with British Chiropractic Association v Singh, have been cited as catalysts for the UK's libel reform campaign, leading to the Defamation Act 2013.^[9][10][11]