MMR Vaccinations and Autism
Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)
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,
"How are the substances for the study being provided, and how is the study being funded?"
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.