Dr. Pegg's testimony hasn't gotten enough attention. Dr. Pegg was the chairman of the Ethics Committee at the Royal Free Hospital from 1995.
Jim Moody, the US attorney for a number of vaccines cause autism groups who supported Wakefield wrote a complaint to the UK medical authority, the GMC, making accusations against five doctors who gave testimony against Wakefield. He did not understand why he
shouldn't mention Dr. Pegg. Because it was through his ridiculous complaint against Dr. Pegg that the fanciful two studies theory really comes apart.
Moody first sets out Wakefield's defense:
"...[Dr.Pegg] falsely claimed that the investigation of the 12 children reported in the Paper did not have the approval of the Ethics Committee. In fact, the children were investigated according to their clinical need and not as part of a follow-on program of scientific and clinical investigation approved by the Committee on December 18, 1996. The one “research” aspect relevant to these children (collection of additional biopsies during colonoscopy and biopsy analysis for research purposes) had, in fact, been granted routine generic approval by the Committee on September 5, 1995 (project 162-95)."
. I've discussed that before.
Much of the hearing was decided when Dr. Pegg finished testified. The key to understanding the GMC decision are a few words by Dr. Pegg, reported, probably by accident, by Martin Walker.
Walker wrote the following:
A second key matter on which the defence was eager for commitment from Dr Pegg was whether a ‘case study’ - that is a clinical report of one or more similar cases – did or did not need ethical committee approval. On this matter, Pegg was hardly helpful to anyone. If the doctor concerned knew from the beginning of a case that he was going to write it up, then he needed ethical approval. If he did not initially intend writing up the case but did anyway, then he didn’t.[emphasis added] This was a ridiculous explanation and one suspects it was made up on the hoof. What he probably meant to say, was that if individual children were examined for the sake of a scientific study then the doctor concerned needed ethical committee approval. If, however, all the children were seen on the basis of clinical need and at some point a number of the cases were written up, no ethical committee approval was needed.
Actually, Dr. Pegg said exactly what he meant to say. The standard way of determining if it is research is to look to the intent.
Brian Deer, no surprise, has a great reference:
6.4. The distinction between medical research and innovative medical practice derives from the intent. In medical practice the sole intention is to benefit the individual patient consulting the clinician, not to gain knowledge of general benefit, though such knowledge may emerge from the clinical experience gained. In medical research the primary intention is to advance knowledge so that patients in general may benefit: the individual patient may or may not benefit directly."
Guidelines on the practice of ethics committees in medical research involving human subjects, The Royal College of Physicians of London, August 1996.
Here is one that really zeroes in on why they were toast.
Research is a systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalisable knowledge. Any such investigation raises ethical issues. The issues themselves may be small, but because studies may involve subordination of at least the immediate interest of the individual participant to the objective of the advancement of knowledge, they must be subject to ethics review...
2.1.3 Clinical practice and research
The distinction between clinical practice and research is often less clear than is suggested above, because both may be practised simultaneously on the same person. Any activity aimed at obtaining knowledge affecting a person in any way, and which is additional to ordinary clinical practice, is to be regarded as research (see also 7). A useful rule of thumb is that if this new knowledge is generalised or transferred to others, or presented at a scientific meeting, or submitted for publication or for a higher qualification, it is research.[emphasis added ] Clinical audits through examination of patient records; observation of activities of individuals; health systems research to improve efficiency, cost-effectiveness and equity in health care, all are recognised as valid research.
I even emailed an expert, who confirmed, contrary to every word spoken by Wakefield and his supporters that clinically indicated procedures can be research.
Apply this to the situation at hand, The first child, Child 1, is admitted to the Royal Free on July 21, 1996. In June 1996, Wakefield writes up and submits a proposal to Legal Aid that will be written up....DING, DING, DING...GAME OVER FOR WAKEFIELD.
On July 15, 1996, Walker-Smith sends a letter to the Ethics Committee regarding the proposal that will become 172-96. ...DING, DING, DING...GAME OVER FOR WALKER-SMITH AND MURCH.
There was just no way to undo what happened. Whether you call it a case-study or not, whether you say it never started or not, it is clear that what was going to happen to those children had a possible end point leading to publication before they saw a single child. The way the panel expressed it was to say that all the children were seen under proposal 172-96, which is perfectly reasonable.
The rest of the hearing was to establish the details of how 172-96 ended up in The Lancet and separately determine if the children were assaulted by the doctors.
Martin Walker criticizes the 'prosecutor', Sally Smith QC, over and over again. Based on his ignorance of the procedure and his bias in every word, there's no way of knowing if any of the criticism was valid. However, those who understood what the prosecutors needed to prove, knew that despite all the slogging to come, much of the case was over after Dr. Pegg finished testifying.