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Glenda Jackson: Is it not the case that, in the initial request, the criteria for investigation were that children

Is it not also the case that disintegrative disorder is a syndrome that is part of the autistic spectrum?

Dr. Harris: The selection criteria at paragraph 7 of the protocol application include "presence of disintegrative disorder"; the applicants state that the syndrome is separate, and it is established in their argument that it could be caused by something that would make a CSF test worth doing, but not by autism. Autism was not mentioned in the scientific background; had it been, I suspect that the procedure would rightly not have been permitted. When CSF tests on autistic children were required for Legal Services Commission purposes, no hospital in the UK gave ethics approval and children had to be taken to America for the tests. I hope that the hon. Lady understands the point that I making—[Interruption.] I want to continue.

It turns out that Dr. Wakefield was receiving undisclosed funding for at least four of the children from the Legal Aid Board for some of the results. A central component of the deal was genetic analysis of fluid collected from those spinal taps, with further undisclosed payments for genetic analysis of biopsy samples from the bowels, following endoscopy. The evidence strongly suggests that, from start to finish of his research, Dr. Wakefield withheld the information about his legal aid board funding interest from the REC.

The question in the protocol application under paragraph 10 was,

The reply was

There was no mention of any Legal Aid Board funding. The failure to disclose that information suggests that even the approval Dr. Wakefield received for 25 children with DD may be invalid. It also seems clear that he had no ethical approval to carry out those procedures on any child who did not have DD.

Without ethical approval, the consent that the doctors obtained from the parents may not be valid. Without a valid consent, doctors could face action for assault. I do not dispute that the parents gave consent in good faith, knowing that there was REC approval for the study—albeit apparently for a different study from the one that was carried out—but even valid parental consent does not make it lawful to conduct high-risk research procedures on children with no likely clinical benefit.

Glenda Jackson: Will the hon. Gentleman give way?

Dr. Harris: I must conclude, so that the Minister has time to reply.

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The whole affair seems dubious. It is not just that there was non-declaration of interest, nor that up to 30 children were exposed to invasive procedures under those tests, but that many more may have been thus exposed in tests agreed and funded by the Legal Services Commission with no ethical oversight at all.

The GMC—currently the Government's favoured path—cannot investigate or judge the LSC. It cannot look into the actions of non-medically qualified management. It cannot make recommendations to prevent any such practices from happening again, nor can it look for similar acts. That is why an independent inquiry is needed—not a hospital inquiry. The accused cannot investigate themselves, especially because, as the letter read out by the hon. Member for Hampstead and Highgate (Glenda Jackson) shows, they have already declared themselves not guilty.

An independent inquiry is needed and the Government must order one. After all, such activities could still be going on at the Royal Free or elsewhere. Children need protection from that sort of research behaviour. If the Government cannot guarantee that it is no longer happening at the Royal Free or anywhere else, they have no choice but to order an independent inquiry.

10.18 pm

The Parliamentary Under-Secretary of State for Health (Miss Melanie Johnson): I congratulate the hon. Member for Oxford, West and Abingdon (Dr. Harris) on securing a debate on this important subject.

Like all Members, I care greatly about the health and safety of children and I am reassured that some of the infectious diseases that used to be devastating in childhood are now seen only rarely, if at all in some cases. It is easy to forget the impact that some of those diseases had. Nowadays, parents in the UK never see their children crippled by polio. Diphtheria and tetanus are exceptionally rare in children. Since the meningitis C vaccine was introduced in the UK in the 1990s, it has cut the rate of that terrible disease by 95 per cent.

Immunisation in the UK has been greatly successful at protecting children against preventable diseases, and all those achievements have happened because of effective vaccination programmes. In particular, measles cases fell from more than 70,000 a year in 1987—before MMR was introduced—to fewer than 100 per year in 1999. Before MMR, there were between 15 and 20 deaths each year, but no child has died of acute measles for a decade.

One of the greatest achievements was the prevention of congenital rubella syndrome and the avoidance of rubella-associated terminations of pregnancy. In 2001, there was not one single case of congenital rubella syndrome in England and Wales in which a woman acquired the infection in this country. Let us not forget mumps. Before MMR, it was the commonest cause of viral meningitis and lead to around 1,200 hospital admissions a year. The MMR vaccine has dealt a hammer blow to these three serious diseases of childhood and has released children from the risk of death and disability as a consequence, which is something with which I know that the hon. Gentleman and my hon. Friend the Member for Hampstead and Highgate (Glenda Jackson) agree.

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The hon. Gentleman indicated that he is well aware of the significant media interest in MMR following the findings of an investigative journalist, Mr. Brian Deer, from The Sunday Times. Mr. Deer raised several concerns about the research carried out at the Royal Free hospital that first claimed a link between MMR and autism. The first concern was an alleged conflict of interest, and the editor of The Lancet has made it clear that the information now makes the original Lancet paper "fatally flawed". The second concern is about ethics approval for the research carried out at the Royal Free hospital, and I shall address that matter next.

As the hon. Gentleman emphasised, ethical approval, especially regarding children, is an essential part of medical research, and such medical research involving children is a matter of increasing concern. It can be an important means of promoting child health and well-being, but as the Royal College of Paediatrics and Child Health clearly recognises in its "Guidelines for the ethical conduct of medical research involving children",

The importance of evaluating the possible benefit, harm and cost of research on human beings, and the possible ways of carrying out that research, are key issues. The benefits of research can be great, especially if the condition being investigated is common or if the research has a high chance of success. Possible harm must be assessed with equal care, and possible considerations of harm include questions of how invasive the type of intervention is, how severe the risks associated with the research procedures are, and how likely damage is to occur. These are common-sense issues that are difficult to question. Any parent would expect that research carried out on their children should have addressed those issues thoroughly and carefully, but balancing the pros and cons of research is often complex, as I know that the hon. Gentleman appreciates. Research ethics committees play a vital role in considering the issues and advising on what is acceptable and what is not.

Ethics committees are faced with the paradox of trying to be both stringent assessors and an approachable forum to help researchers to resolve problems. They have to compromise between aiming for the perfect protocol in advance and encouraging researchers to respond to families' unpredictable responses, which might require changes to research design later on.

Questions have been raised about whether the lumbar punctures and colonoscopies that were carried out on children at the Royal Free were justified. Both interventions are invasive and are not undertaken lightly. Lumbar puncture—during which cerebrospinal fluid is extracted from the spinal cord for examination—is undoubtedly unpleasant and is not risk-free. Colonoscopies are unpleasant and distressing to the patient, and carry the risk of complications, such as perforation of the bowel.

Should children at the Royal Free have undergone such investigations? Professor Sir David Hull and Professor Brent Taylor raised concerns in 1998. The research team believes that the investigations were

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justified, but I cannot say what was clinically justified for each of the children in the study. However, that shows why the approval of research proposals by ethics committees is so important.

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