Mis-investigating alleged research misconduct can cause widespread, unpredictable damage.

Abstract

Twelve years ago, Deborah and Carl Henshall, whose prematurely born daughter Sofie had received respiratory support using continuous negative extrathoracic pressure (CNEP), alleged research misconduct by the clinicians responsible for the randomized comparison of CNEP with intra-tracheal positive pressure ventilation being undertaken in Stoke on Trent.1 These allegations were very widely publicized, and separate overlapping investigations were mounted by the local NHS Trust, the NHS Executive, and the General Medical Council (GMC), causing hospital staff and their families stress severe enough to end a few careers. More generally, the allegations led to the introduction of a national Research Governance Framework, and much of the UK's current hyper-regulation of clinical research. It took 11 years for the GMC to conclude that there was no case for the defendants to answer, and that one of the study's principal critics (and the main expert called in to support the Henshalls' case) was neither an expert nor independent.2,3 Our involvement with this affair began when we were asked by a medical defence society to assess a Government report that had raised serious questions about the conduct of the CNEP study. We agreed to do this, and do it unpaid, on the understanding that: (1) our work would be confined to the report's critique of the CNEP trial; (2) we could have access to all the relevant documents to which the defence society had access; and (3) we would be free to publish our findings – whatever they were. Four months after the government report was released, the BMJ published our assessment. We concluded that ‘The statements relating to the CNEP trial … contain so many errors of fact … that the whole report stands discredited’.4 Not only did we find no evidence of the alleged research misconduct, we noted that the trial had, in many ways, been ahead of its time. The protocol had been alpha-rated by the Medical Research Council; it had twice been ethically approved; it had, exceptionally, been registered publicly at inception; an information leaflet had been provided for parents; a sequential design had been used to monitor accumulating results during an era before data monitoring committees had become common; post-trial questionnaires were used to elicit parental views; the trial report was co-authored by doctors, nurses and a statistician; and it was published in a prestigious paediatric journal. Our BMJ article concluded that, since the whole edifice of administrative reform called for in the government report rested on the implied conclusion that the CNEP trial was conducted in a flawed and irresponsible way, the NHS Executive needed to retract its report and reassess the appropriateness of its recommendations.4 The Government, however, has never publicly admitted that its review was flawed. On 10 October 2000, Lord Walton of Detchant asked Lord Hunt of Kings Heath, the Parliamentary Under-Secretary of State at the Department of Health, ‘whether they support the findings and conclusions of the Griffiths report … in the light of the criticisms published in the British Medical Journal’. This led to the following exchange: Lord Turnberg: My Lords, will the Minister agree that the Griffiths report appears to have given rise to a number of injustices, despite the Ministers' comments about the value of some elements of it, not least of those being the apparent denial of human rights to the doctors being criticised in that they were not allowed to see the report before it was produced in order to be able to answer some of the criticisms. Lord Hunt of King Heath: My Lord, I have no reason to believe the review was not conducted appropriately … Lord Campbell of Alloway: My Lords, I have listened to a plethora of words but I want to ask the Minister a simple question. Is he prepared to consider giving the apology sought by the noble Lord, Lord Walton of Detchant, or is he not? Can I have a straight answer to a straight question? Lord Hunt of Kings Heath: My Lords, I always think that ‘yes’, ‘no’ answers are best avoided. Seldom has the British public been told something that was so blatantly untrue, so consistently, and for so many years, as the story that first broke in 1997. At that time a quality newspaper came out with the headline: Parents say ‘guinea-pig’ trial killed their babies and claimed that ‘Forty three premature babies, many only a few hours old, died or suffered permanent brain damage after being used as “guinea-pigs” in a radical hospital experiment’.5 When no rebuttal seemed to appear even after the story had been repeated many times, people naturally began to believe that it must be true. And when, after three years, a Government enquiry offered tacit support for the story, this strengthened the public's belief that the press reports must be true.