Professor A C Grayling has written about the recent, well publicised victory of Simon Singh in the appeal court (BMJ 2010;340:c1910). As almost everyone now knows, in a previous sitting with Mr Justice Eady, Dr Singh was set the nearly impossible task of proving that chiropractors were knowingly making false claims for the efficacy of their treatment of children with conditions such as asthma and colic. The victory is that the distinguished judges in the appeal court decided that Justice Eady (not for the first time) had “erred.” They ruled that the criticism made by Singh was not a statement of fact, but an opinion, so he was now set the much easier task of showing that some claims for chiropody were not supported by good clinical evidence. That is indeed a matter for celebration, and credit deserves to go to Sense about Science, and other charities, who organised a great popular uprising about the gross defects of the English libel laws. However, as Grayling observes, the Singh saga has not finished yet.
The Wilmshurst saga is less well known than the Singh one, but is, in my opinion, of even greater importance concerning patient protection from non-evidence based medicine. Peter Wilmshurst is a consultant physician and cardiologist at the Royal Shrewsbury Hospital, and well known internationally for his research on the physiology of divers.
He was recruited to be a chief investigator for a trial of a device made by NMT Medical, a company based in Boston, USA. The trial was to test the hypothesis that using a patch to close a patent foramen in patients with migraine would improve the migraine. The results did not support this hypothesis: there was no significant difference between the migraine in patched or control patients. Wilmshurst was at a cardiological meeting in the US at which these results were reported. After the presentation he was approached by a Canadian reporter who worked for an on-line journal: she asked him why the trial had failed to produce the expected benefit. He replied that he could not be sure, since he had been unable to examine the raw data from all the units who had contributed to the multicentre trial. Possible explanations were that some volunteers had been wrongly recruited because they did not have a patent ductus, or in some cases the patch had failed completely to cover the hole in the atrial wall. This conversation was later published in the online journal.
To his surprise and dismay Wilmshurst then received a threat from NMT Medical that he must withdraw his criticisms, since they were untrue and defamatory. If he did not do so the company would sue him for libel. There followed a great deal of attacks by NMT, which portrayed Wilmshurst as professionally incompetent and untruthful. This went on for years, but Wilmshurst would not withdraw his criticisms.
He considered it was unethical for him to agree not to talk to the media about the results of the study, since future potential users of the patch should be warned of these possible disadvantages.
Further information about the events during this period are set out by Clare Dyer (BMJ 2008;337:a2412), but my objective is to compare the similarities and differences between the libel cases of Singh and Wilmshurst.
The similarities are that both men are highly intelligent academics who are being sued under English libel law for making defamatory comments about organisations that are involved in health care. Both claim (correctly) that it is in the public interest that their complaints are widely known, in order to protect patents from treatments that are potentially harmful. However there are important differences between the reasons for the defendants making these criticisms, and the balance of power between defendant and complainant.
Singh describes himself as a “particle physicist,” and indeed that was the topic of his PhD thesis. But he is famous (and affluent) as the author of several bestselling books on scientific subjects, and as a journalist who exposes therapies that have no good evidence of efficacy. His contributions to the public understanding of science have been recognised by the award of an MBE. The cause of the libel action is an article he wrote in the Guardian as described by Grayling.
Wilmshurst is a full time NHS consultant physician at the Royal Shrewsbury Hospital, and has written more than a hundred papers in peer reviewed medical journals, and many chapters in textbooks on cardiology and respiratory medicine. This literary activity is commendable, but certainly does not bring affluence. Indeed the activity for which he is most famous has done nothing for his income, and has had a very negative effect on his relationship with some very senior medical academics. When working as a junior doctor in one of our great London teaching hospitals he noticed that there were sometimes contradictions between what had actually been done in the laboratory and the report that was sent for publication. He raised the problem of this unacceptable behaviour with the people in charge, and far from getting support from them he was warned not to damage the reputation of the institution. He did not follow this advice, and reported some offenders to the GMC. It has certainly damaged his professional advancement ever since. He received no recognition for his whistle-blowing apart from an award from HealthWatch that was of no significant monetary value (see www.healthwatch-uk.org).
So the important difference between the two defendants is that Singh made his criticism as a public criticism of the claims of efficacy made by the British Chiropractic Association. He must have been aware that this might provoke a legal counter-attack, but he was willing and able to raise an effective defence.
Peter Wilmshurst did not make his criticism in public, but answered the questions of a reporter (Shelley Wood) who reported the conversation in her online journal. Wilmshurst has no written account of what he said, but accepts that her report is substantially accurate. NMT is now suing Wilmshurst in a libel action – not Shelley Wood, not her online journal, but the person who did the work for the trial sponsored by NMT. Unlike Singh, Peter Wilmshurst does not have the finances to pay for a full legal defence, so I have no doubt that NMT was confident that he would agree to retract his criticism rather than face bankruptcy. However, he believes he has a moral duty to protect future patients who might be offered the patch.
There is now agreement among all political parties that the libel laws must be changed, but the changes designed for the type of problems that Singh has encountered are not necessarily the changes that Wilmshurst’s case would call for. The one point that is obvious to me is that if sponsors of clinical trials are able to gag any adverse comment from scientists, then the whole structure of evidence based medicine is undermined. EBM is built on what trials are believed to show, both in the efficacy and safety of the therapy. If the report of the trial is distorted to conceal any defects in the therapy we have a terrible consequence: we will have to rely on the heroism of people who are prepared to risk bankruptcy and blow a whistle. Such heroes are rare.
John Garrow says: “I am now 81, but I am sure that will change. I ran an obesity clinic at Barts. Since they pensioned me off I do some work for HealthWatch and try to look after the garden.”