Corrected February 24, 2010
Out of the mouth of Professor Walker-Smith, comes proof that Andy Wakefield isn't the paragon of virtue of http://www.wesupportandywakefield.com/ and that he, Walker-Smith and Murch are all guilty of professional misconduct.
Since at least August 2008, anyone closely falling the proceedings before the GMC knew that Professor Walker-Smith gave sufficient evidence that he, Wakefield and Murch were guilty of performing research procedures on children without the approval of the ethics committee of the hospital where the procedures were carrired out.
Before and after November 1996, despite a written assurance in November 1996 by Walker-Smith to the ethics committee that all procedures were clinically indicated, research procedures were carried out.
A clinically indicated procedure is one that is carried out in the course of looking after a patient and is intended for the individual benefit of the patient. For our purposes, a research procedure is one that is intended for the general benefit of patients. The distinction may not always be clear. Where there is a research protocol or other documents in writing, it is much easier to make the distinction.
Correction: A clinically indicated procedure can be medical research requiring Ethcs Committee approval. That was the case at the Royal Free. That is why at the end of Dr. Pegg's testimony to the GMC hearing, the defendants were pretty much done.
Wakefield, Walker-Smith and Murch have claimed that there were multiple studies, research processes or just plain data gathering and analysis of information gained through clinically indicated procedures of patients. They submitted a proposal to the ethics committee dated August 6, 1996 that matches very closely the week long timetable for procedures carried out on the children. The August 6th document specifies that the procedures are clinically indicated.
Whether there were zero studies, one study or a million studies, by September 4, 1996 when he was sent a letter by the hospital Chief Executive, Wakefield knew that he needed written ethics committee approval for any procedures on the children which were not clinically indicated.
By this time, some of the children used for the 1998 Lancet study had already had research procedures done on them. The most obvious being lumbar punctures done on children without any indication of infection.
Despite the August 6th document stating that all procedures were clinically indicated, the ethics committee was concerned that procedures were being done for research as opposed to clinically indicated reasons. So Walker-Smith sent them a letter dated November 11, 1996 which stated, "I can confirm that children would have these investigations even if there were no trial."
The three had to lie because otherwise the ethics committee would have shut them down until this was looked at in great detail. The committee might have expressly forbidden the research. They may have already told the committee what was in Walker-Smith's November 1996 letter, that they had already investigated 5 children.
The Wakefield theory was that there was a difference in the GI tracts of autistic children through which autistic causing elements escaped the GI tract and reached the brain. So the three needed to examine, invasively, by endoscopies a lumbar punctures and other procedures any differences of these children who did not have classic Crohn's.
As well as looking for physical differences through GI tract biopsies, they would look for measles virus in the intestinal biopsies and the spinal fluid.
So Walker-Smith lied. He lied again in his November 1996 letter to the ethics committee, with copies to Wakefield and Murch. He repeated the lie in 2004.
In August 2008, while denying all wrong doing to the GMC (see http://briandeer.com/solved/story-highlights.htm for this and a great explanation of the whole sorry mess) Walker-Smith tells a different story. It sinks all three of them.
I don't have a transcript. But according to this newspaper report, Walker-Smith explained the lumbar punctures as being "in the children's best interests to perform the controversial lumbar punctures - also known as spinal taps. He told the panel he thought he was doing the parents of these children (referred to by number rather than name in the proceedings) a service so they could rule out neurological disorders in the future."
Whether you think this is a good idea or not --- this concern doesn't meet the clinically indicated test. Especially when you realize that the conspirators are all gastroenterologists, not the type of doctor who would judge the clinical value of a lumbar puncture. So that's cooked their goose.
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