The charges against Dr. Wakefield and his two co-defendants: subjecting vulnerable children to research under the guise of clinical care. The key charges & verdicts were as follows:
(1) “The children described in the Lancet paper were admitted for research purposes under Project 172-96; the purpose of the project was to investigate the postulated new syndrome following vaccination. The Lancet paper failed to state that this was the case, and the Panel concluded that this was dishonest, intentional and irresponsible.” [quoted in High Court Decision, Par. 149]
(2) Children were subjected to invasive tests “that were not clinically indicated” – e.g., spinal taps and endoscopic procedures such as colonoscopies and biopsies – for research purposes under 172-96;
(3) The study lacked ethics committee approval;
(4) “Some of the children were not routine referrals to the gastroenterology department, in that they lacked a history of reported gastrointestinal symptoms and had been referred for investigation of the role played by the measles vaccination or the MMR vaccination in their developmental disorders.”
(5) The description of the children’s diagnosis in the Lancet paper [Table 1] and the description of the referral process as “consecutively referred” was “inaccurate,” and “irresponsible”.
(6) The GMC justification for its verdicts: “The Panel has heard that ethical approval had been sought and granted for other trials and it has been specifically suggested that Project 172-96 was never undertaken and that in fact, the Lancet 12 children’s investigations were clinically indicated and the research parts of those clinically justified investigations were covered by Project 162-95. In the light of all the available evidence, the Panel rejected this proposition.”
- The pivotal allegations against Dr. Wakefield, from which all the others stemmed, was that the study described in the Lancet paper was commissioned by the Legal Aid Board; that the children were subjected to medically unjustifiable, therefore unethical, invasive diagnostic tests, to substantiate a diagnosis made-up for legal purposes.
- When the case was subjected to genuine judicial review, the allegations collapsed. After a thorough assessment of all the evidence and testimonies, the High Court determined that there was no evidence to support any of these allegations. The six GMC verdicts were overturned. The deliberative judgment of the High Court was unconditional.
- Additionally, the GMC panel found Dr. Wakefield guilty of “dishonesty in regard to his writing of a scientific paper that had major implications for public health”, and failure to disclose a conflict of interest, involving funding from the Legal Aid Board (LAB), a government agency which holds the purse strings that enable ordinary citizens to obtain legal assistance for a judicial determination. And he was charged with “callous disregard”, for having caused:
“blood to be taken from a group of children for research purposes at a birthday party, which the Panel found to be an inappropriate social setting. He behaved unethically in failing to seek Ethics Committee approval; he showed callous disregard for any distress or pain the children might suffer, and he paid the children £5 reward for giving their blood. He then described the episode in humorous terms at a public presentation.”
One blood sample was taken from these developmentally normal, healthy children for research purposes, to serve as controls, for comparison with autistic children with bowel disease. Each of the parents had been contacted prior to the party; they were fully informed, and each gave permission (some of the parents were medical doctors). The children had agreed to give blood – including two of Dr. Wakefield’s own children. For the children the setting, a private side room within a familiar sports center, was not strange or intimidating.
The blood was taken by a qualified, experienced medical professional, not Dr. Wakefield; the equipment used was appropriate, sterile and the type commonly used. The children were not put in harm’s way, nor were they exploited. According to testimony, they did not suffer any pain, nor did any child become distressed. The children were likely proud to be contributing to medical science. At the end of the party the children were surprised to receive £5 as a thank you gesture. [Of note: most healthy research volunteers receive monetary compensation for their participation.]
As for Dr. Wakefield’s failure to obtain approval from the Research Ethics Committee (REC) for the taking of blood from these children: first, according to the National Research Ethics Service, “Not all research conducted within the UK requires approval from an NHS REC”. Dr. Wakefield testified that it was his “understanding at that time was that such approval was not necessary unless the subjects of the research were National Health Service patients. Accordingly, as he put it, the question of Ethics Committee approval never crossed his mind”.51 The issue was confounded, however, by Dr. Wakefield’s videotaped satiric presentation at a conference of parents and professionals. The GMC panel took his fictional parody to be an accurate description of the actual event. Had anything like his simulated portrayal occurred, parents would surely have complained; none complained.
- Whereas the GMC panel placed much credence to this trivial incident, the GMC avoided touching upon the issues of paramount importance; namely, the scientific merit of the study, and whether the MMR might have contributed to autism.
[Conflict of interest charges against Dr. Wakefield are discussed in section 25.]
On Day 197, GMC issued this statement: “The Panel wish to make it clear that this case is not concerned with whether there is or might be any link between the MMR vaccination and autism.”[GMC Transcript]