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MMR scare study published in the Lancet wasn't approved by an ethics committee

This page is material from the award-winning investigation by Brian Deer for The Sunday Times of London, the UK’s Channel 4 TV network and BMJ, the British Medical Journal, which exposed vaccine research fraudster Andrew Wakefield | Investigation summary

In February 1998, a worldwide vaccine scare was launched by Andrew Wakefield at the Royal Free hospital, London, spearheaded by an "early report" paper in the Lancet medical journal. Among Brian Deer's revelations was that a claim in the paper that the research investigations were approved by the hospital's ethics committee was misleading. In response to Deer's findings, Wakefield later maintained through lawyers that he didn't need ethical approval. He said in 2005: "In contrast to a clinical research study requiring ethical approval, the Early Report was a report of clinical findings of tests which had been performed solely on the basis of clinical need"

This surprising argument raises the question of the intent behind a protocol, a proforma, dated August 6 1996, a patient information sheet and an "expert review", for a research project approved by the committee on December 18 1996. And also behind a legal contract, bid for in June 1996. The table below contrasts this project with the paper later published in the Lancet.



 
Wakefield study authorised
[18.12.96]


Wakefield study published
[28.2.98]

Title
[notes 1 & 2]
"A new paediatric syndrome: enteritis and disintegrative disorder following measles/
rubella vaccination"


"Ileal-lymphoid nodular hyper-
plasia, non-specific colitis, and pervasive developmental disorder in children"

Inclusion criterion
[notes 3 & 4]
Disintegrative disorder/
Heller's Disease

Pervasive developmental
disorder/autism

Number enrolled
[note 5]

25

12

Subjects included
[note 6]
Only children enrolled after
ethical approval, 18.12.96

At least six children
admitted before 18.12.96, with
an "autistic child study" shown
on
lab test forms weeks before
any ethical approval

Controls
[note 7]
None 14 age- and sex-matched for
methylmalonic acid tests

Reason given for
lumbar punctures
[note 8]

Test for MV antibody and
cytokine profiles in CSF

Test for lactic acid in CSF
Virological analysis
[note 9]

RT-PCR and NASBA

Results not reported
Ethics committee
approval claim
[note 10]
Challenged investigations claimed to be "clinically-
indicated", and so not
approved by committee
"Investigations were approved
by the Ethical Practices Committee of the Royal Free Hospital"


Vaccine hypoth-
esised as suspect
[note 11]

Measles,rubella (MR) Measles, mumps, rubella (MMR}


[note 1]
The title submitted to the ethics committee in a protocol Q&A proforma dated August 6 1996 - two months after a contract was sought by Wakefield and lawyer Richard Barr from the UK's Legal Aid Board - implies that the researchers may have concluded that such a syndrome existed before they allegedly discovered it in the course of the research. A clinical and scientific study document, setting out the protocol, was also supplied to the committee.

[note 2] Ileal-lymphoid nodular hyperplasia had long been reported in medical literature as a "benign" finding in children without developmental disorders, including in earlier reports by Lancet study investigators. A later study involving Wakefield found it almost universally in non-autistic constipated controls. Despite its inclusion in the title of the paper, oddly, there is no discussion, or references to previous literature.

[note 3] The distinction between autism and disintegrative disorder is well documented in medical literature, and was understood by Wakefield et al. It was set out in part 5, "scientific background", of the protocol pro-forma he submitted to the ethics committee, copied word-for-word from "Child and Adolescent Psychiatry", eds Michael Rutter, Eric Taylor and Lionel Hersov, third edition, page 581. All but possibly one of the 12 children in the Lancet paper fail to meet the inclusion criterion approved by the ethics committee.

[note 4] The committee granted approval for "high risk" investigations into patients with disintegrative disorder, after being told of the children's hopeless prognosis. A competent doctor acting professionally could not propose such a prognosis for young children diagnosed with autism, whether as a group or individually - especially without specialist assessment.

[note 5] Actually, at least 30 children were reported to be investigated under this regime. An abstract was published in the journal Gut (vol 42, supplement 1, TF340), apparently reporting on an extended consecutive series. Why results on only 12 were included in the Lancet paper has never been explained. But comparison between that paper and the abstract shows a marked decline, after the first 12 children admitted to the Royal Free, in the numbers of parents allegedly blaming MMR. According to Wakefield in the Lancet, in 8 of the first 12 consecutive cases the parents blamed the vaccine for their child's autism. But comparison with the abstract shows that only 3 of the next 18 do so. See a chart illustrating this situation.

[note 6] A list of children shows that the seventh was admitted to the Royal Free hospital on Sunday 1 December 1996, with lab tests looking for measles virus already performed on samples in an "autistic child study". The ethics committee approval letter stated: "Only patients enrolled after the date of the December meeting will be considered to be in the trial."

[note 7] Wakefield told an Institute of Medicine conference in Washington on March 8 2001: "In the first set of children we did lumbar punctures. We looked for viral antibody titers. We did MRI scans, EEGs. We could find no evidence of active inflammation, or local IGG synthesis in the brain. After that, it became too expensive and too invasive to continue doing that."

[note 8] Methylmalonic acid tests were attempts to show B12 deficiencies. In addition to lawyer's clients, some children and financial sponsorship were obtained from the residue of a B12/autism project at the Chelsea and Westminster hospital, London, which had been shut down in 1995 following what the hospital believed to be ethical and publication anomalies.

[note 9] Planned virological studies notified to the ethics committee included tests for measles and rubella viruses by Nick Chadwick, named in the full study protocol. He didn't find any. This vital information wasn't included in the Lancet paper, and different results from a Japanese physician, later retracted by Wakefield, were reported to the ethics committee.

[note 10] Both the chair of the committee and the dean of the medical school stated that investigations were not approved by the ethics committee. Claims that the committee approved "data collection", but not the project, were made after the Lancet paper was challenged in 1998 by Sir David Hull, an expert on vaccines, child health and medical ethics. No document making such a claim has been found by Brian Deer from the period of ethical review in 1996.

[note 11] In November 1994, a UK government campaign saw 7.1 million school-age children vaccinated with MR - 11 times the annual take-up of MMR. MR was used at no other time in the UK. This is an age group in which disintegrative disorder/Heller's Disease manifests. MMR is normally given at around 13 months, an age at which, the vastly more common, autism often manifests.

Brian Deer's investigation revealed that the MMR element of the research was funded by lawyers, with this involvement concealed through a Wakefield scheme.



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