INQUIRY FIASCO LEAVES CHILD PROTECTION IN THE COLD
(Published in Hospital Doctor, February 9, 2006)
When paediatric research was thwarted in the wake of the Griffiths inquiry, it was sick children who suffered. Yet results of a research trial ordered by Griffiths, which have only just come to light, cast doubt on whether the inquiry was necessary in the first place. Jonathan Gornall reports
REMEMBER CNEP? It was the hospital 'baby experiment scandal' that straddled the millennium, unleashing a tide of misinformed comment in the media, triggering a broadside of complaints to every possible authority from the police to the GMC and threatening to end the career of one of the country's leading paediatricians and child-protection experts.
It even led to a DoH inquiry and, when Prof Rod Griffiths delivered his damning report in 2000, CNEP and the man behind it appeared to be on the ropes.
And yet, barely noticed in the hue and cry that greeted the Griffiths report, there was one recommendation that had the potential to change everything. When Prof Griffiths ordered a study into the long-term effects of the four-year research trial in North Staffordshire of CNEP - an experimental ventilator to help premature babies with severe breathing problems - he was in effect telling the press, the protestors and the medical community that the jury was out on CNEP.
Now, unnoticed by almost everyone, including Prof Griffiths, the jury is back. And its verdict appears to change everything.
Hospital Doctor has learnt that the forgotten study ordered by Prof Griffiths into the long-term effects of continuous negative extrathoracic pressure (CNEP) was finished 18 months ago and, although it remains unpublished, a leaked abstract seems to end a decade of controversy by vindicating both the controversial trial and Prof David Southall.
Not only did the CNEP trial not cause harm - many parents and campaigners have long claimed it did - but in some respects babies who underwent the treatment appear to have fared better in the longer term than those in the control group, who received the standard treatment.
One effect of the Griffiths report was to paralyse paediatric research, especially in Stoke. In an ironic development, the DoH has published on its own website all the submissions to last year's consultation paper Best research for best health, as part of the launch of its new research strategy for the NHS - and among them is the serious allegation that Prof Griffiths confessed to having been pressured by ministers into producing 'named scalps' in his report on CNEP.
The Griffiths inquiry was set up in 1999 following allegations by parents that they had been duped into taking part in the trial, that consent signatures had been forged and, most seriously, that CNEP had caused death or brain damage.
Although Prof Griffiths found no evidence of harm, he concluded that the trial had lacked proper safeguards to ensure that the parents knew what was happening, and that Prof Southall was 'an enthusiastic and assertive lead researcher' who had not taken sufficient care over the management of his trial.
This provoked a fierce response from doctors, as did Prof Griffiths' remark at a press conference that it was 'very important for the public to feel they are not being used as guinea pigs'.
Many doctors saw the attack on CNEP as an extension of the guerrilla campaign against Prof Southall's child-protection work. His use in the 1990s of covert video surveillance to catch mothers suspected of harming their own children had provoked a storm of protest, despite the fact that the surveillance of 39 babies and young children had exposed recurrent intentional suffocation and other serious abuse by mothers.
In November 1999, following accusations by an advocate for parents accused of abuse, Prof Southall was suspended by North Staffordshire Hospital. The trust appointed two separate external teams to examine the many and varied charges against them. It took almost two years and close to £1m to complete the inquiries and, in October 2001, the trust announced that Prof Southall had been exonerated of all allegations of professional and personal misconduct or incompetence.
At the time, many doctors felt that Prof Griffiths - by broadening his original terms of reference to consider the research governance framework in the trust, and by entertaining unrelated evidence from mothers who claimed they had been falsely accused - had played into the hands of a group of protestors sworn to the goal of having the paediatrician struck off.
Dr Edmund Hey, a retired paediatrician, and Sir Iain Chalmers, a former director of the National Perinatal Epidemiology Unit in Oxford, were commissioned by the Medical Defence Union to examine the Griffiths conclusions. In September 2000, they wrote in the BMJ that 'almost every statement made about the design, conduct, and reporting of the CNEP trial in the Griffiths report was ill-informed, misguided, or factually wrong'.
It is Sir Iain who has now reopened the controversy with his response to the consultation paper, ‘Best research for best health’, which was published by the DoH along with all the other submissions on 25 January, the day it launched the NHS research strategy, complete with 'bureaucracy-busting' measures.
In his submission, Sir Iain blames Prof Griffiths for what many doctors now see as the impossibly bureaucratic task of gaining ethical approval for trials. He says that 'the generally defensive judgements of research ethics committees' are due in part to the 'grossly misleading government inquiry into research in Stoke on Trent'.
Sir Iain adds: 'The chairman of the inquiry has made clear to me that ministers required the inquiry team to produce "named scalps", and that he felt under pressure to comply. If true, this is disgraceful.'
Sir Iain, also a former director of the UK Cochrane Centre, set up by the NHS to monitor the effects of healthcare, told Hospital Doctor that Prof Griffiths made the admission to him during a tea-break at a seminar on public health on 12 October 2004. In an email sent to Prof Griffiths the week before his submission was published, Sir Iain wrote: 'I am sorry that you haven't yet followed up on your expressed intention . . . to meet and explore how to mitigate some of the damage done by unsubstantiated allegations of research misconduct in Stoke on Trent. I was encouraged by your expression of regret about aspects of what had happened, and probably should not have been shocked that politicians had put you under pressure to "deliver scalps" for them.
'My responsibilities [with the Medical Research Council] require me to foster public and professional discussions about clinical trials. My task isn't made easier by the fact that North Staffordshire keeps on being alluded to as a scandal.'
Prof Griffiths, now president of the Faculty of Public Health, denied that he had been ordered to deliver scalps. 'If Iain wishes to give his versions of private conversations that we have had, I can't stop him, but I don't wish to reiterate the comment or comments,' he says. 'I can tell you this: those words were never used. No minister ever spoke to me and said "You have to do this", but at the same time we were under pressure from lots of directions, especially from certain parents' groups. Our problem was to stick to blaming the system rather than individuals.'
The long-term study of the effects of CNEP, recommended by Griffiths 'to see if claims of significant benefit or damage can be substantiated', was carried out by a team at Queen's Medical Centre, Nottingham, headed by Neil Marlow, professor of neonatal medicine. It was completed 18 months ago, but it is understood that the resulting paper, ‘Outcome following neonatal continuous negative pressure ventilation’, was rejected for publication by the BMJ. Another leading journal is now said to be considering it.
Hospital Doctor has, however, seen a copy of an abstract, presented last September in Belfast to the annual meeting of the British Association of Perinatal Medicine. Prof Marlow says: 'I was hoping that this wouldn't come out piecemeal, as you do have to read the whole paper to understand that the negative - there was no evidence of disadvantage resulting from CNEP - is the correct conclusion. If you have the abstract, you will see that we didn't examine the whole cohort, only those who came forward - hence the positive findings have to be tempered with some degree of caution. It is a pity that the same caution was not applied to the interpretation of the original study.'
For the original trial of CNEP, conducted by Prof Southall and colleagues between 1989 and 1993, a total of 244 newborn babies, dangerously premature and suffering respiratory failure, were recruited. Half received conventional treatment, which consisted of intubation and air being pumped into their lungs, while the other half were placed in the CNEP ventilator, which aided their breathing by reducing the external pressure around the chest.
Of the 122 receiving CNEP, 28 died and 15 showed brain damage, compared with the 22 who died and 10 who showed brain damage in the control group. Statistically, these differences were not significant and the rate of death and brain damage in both groups was within the range expected nationally for this critically ill group of babies. However, the trial has been consistently misrepresented in the media as an experiment that went wrong and had to be stopped because it was killing and brain-damaging babies.
For Prof Marlow's long-term study, 65 complete pairs of children from the original Stoke trial, now aged between ten and 15, were assessed. The researchers found the 'primary outcome' (death or severe disability) was equally distributed between the children who had been treated with CNEP and those who hadn't, and that there was 'no evidence of poorer long-term outcome following neonatal CNEP performance'.
Moreover, IQ was higher in the CNEP group, which also saw significantly higher scores on language and spatial skills. The most frequent area of disability in premature babies born with the respiratory problems that had necessitated treatment in the first place was in learning skills and, found the researchers, 'there was a trend towards better cognitive scores in the CNEP group'.
Prof Southall says: 'I am really pleased that the follow-up study confirms that CNEP is not a cause of brain damage and that the outcome for the newborn babies receiving CNEP was significantly better in some respects than for those receiving standard treatment. But I am distressed that so many babies with respiratory failure from bronchiolitis who could have benefited from CNEP over the past five years have been deprived of this because of flawed reviews and propaganda.'
In the face of vocal opposition by parents and other campaigners, the use of CNEP was halted in 1999 and has not been developed or used in Stoke since, even though the original study had found improved lung function in premature babies. At that time, CNEP was also being used to treat bronchiolitis, a common and dangerous viral infection of the lungs in babies, and had been found to help them breathe and to reduce the need for intensive care.
Shown the abstract, Prof Griffiths welcomed the news. 'On the basis of what I have seen, which is not the complete report, it seems that children have not been damaged any more by CNEP than by the condition they had, and that the clinical work must have been of a reasonable order,' he says. 'The notion that children in the CNEP trial were exposed to something untried and dangerous has now to be kicked out. It looks as though CNEP may, if anything, have been better for them in the cognitive area than the original treatment.'
Prof Griffiths says that it was 'over-interpreting' to suggest, as Sir Iain had, that his report 'had had that much influence on the system. I know a lot of work had been done on research governance in the DoH before we reported and, in fact, all that section of our report was essentially written by people working for the director of research and development in the DoH, so I think it is hanging a lot on it to suggest that we were that influential.'
However, he adds that he was 'absolutely at one with Iain' over the excessive bureaucracy that had crept into research governance within the NHS. 'The object of the exercise was to be able to facilitate good, safe research that would benefit patients and make it easier for researchers to have careers in which they weren't unjustifiably attacked,' he says. 'It seems to me what has happened since is that the system has become over-bureaucratic and burdensome, and I said to Iain that I regretted the way that it had turned out and that we ought to be able to do better than that.
'The whole process could be made simpler and better - and ought to be. Being slightly cruel about it, I think individual bureaucrats within the trusts, for the best of intentions, want to cover their backs. The easiest way is to have people write down everything you can possibly imagine - but that doesn't produce good governance, it just produces lots of paper.'
Meanwhile, the campaign against Prof Southall goes on. On 14 December, one of the CNEP families won the right at the Court of Appeal to have the GMC re-examine complaints it has already twice rejected.
Prof Southall was also told last month that he now faces five fresh complaints against him to be heard by the GMC's Fitness to Practise panel. It is believed the allegations, which refer to events which took place several years ago, concern the professor's child protection work, and that at least one of the accusations dates back 17 years.