Royal Free hospital child investigations "weren't authorised by ethics committee"

MMR: the Royal Free hospital scandal:

In February 2004, research by Dr Andrew Wakefield and other doctors at the 1000-bed Royal Free hospital, Hampstead, north London (pictured above), purporting to show a link between the MMR vaccine and autism in children, was exposed as a sham.

But overlooked in a media storm that greeted the revelations was the care, or possibly lack of it, accorded to first 30, then at least 170, autistic children who were used in the research.

This page indexes materials that go some way to getting to the bottom of the question of whether these children were properly cared for, or whether they were subjected to a battery of invasive and risky tests without either ethical approval or legitimate clinical justification: in short, whether or not they were used by Wakefield and his colleagues as guinea pigs in an effort to stand up the now discredited MMR-autism theory.

Through lawyers, Wakefield claims to have "at all times had proper ethical approval for his research to the extent the same was required."

The children's treatment - and claims made about it since the sham research finding was exposed - are expected to be important issues for a UK General Medical Council inquiry into
Wakefield's conduct. Evan Harris, LibDem MP for Oxford West and Abingdon, is also pressing for a statutory inquiry.

It was announced in The Sunday Times of December 12 2004 that the GMC had agreed to hold a
public inquiry into Wakefield's conduct. The hearing is expected in late 2005.

Brian Deer would be interested to hear from anyone with information, insights or ideas about MMR, the Wakefield affair, including its pursuance in the United States, the publishing standards at the Lancet, or the events at the Royal Free hospital and its medical school.

You can contact Brian Deer via this website, which updates in the light of developments. Please check back.

A further index of documents - on Andrew Wakefield issues - is available to view at this website

In February 1998, research by Dr Andrew Wakefield and 12 other doctors from the Royal Free hospital, London, was published in the Lancet medical journal, linking the triple measles, mumps and rubella vaccine - MMR - with autism. This triggered a worldwide scare, and falls in children's immunizations. Six years later, Brian Deer investigated for The Sunday Times and Channel 4 TV, and exposed the truth | Go to part I: The Lancet scandal | Go to part II: The Wakefield factor |

Brian Deer obtained documents relating to a battery of potentially hazardous investigations on autistic children - including ileocolonoscopies and lumbar punctures - questioning whether the study described had the required ethical approval. To analyse this issue, go to the comparison table at this website, which contrasts the committee's approval with what was published in the Lancet

This page updates - please check back Page last modified: December 17, 2010

The David Hull papers - after the Lancet publication - on research ethics concerns
01: July 06 1998: Sir David Hull inquires over ethics approval
02: July 09 1998: Dean expresses "concern" to Prof Brent Taylor
03: July 15 1998: Walker-Smith requests "research analysis" permission
04: July 20 1998: Dr Michael Pegg says committee to discuss matter
05: July 23 1998: Brent Taylor expresses "concerns about the ethics"
06: July 24 1998: Pegg says "we did not approve the investigations"
07: July 27 1998: Dean replies: "investigations" not approved
08: July 15 1998: Dean says legal money rejected after ethical talks

From original study documents - for MR and Heller's disease, not MMR and autism
08: Undated: Expert review is one undated paragraph
09: November 11 1996: Walker-Smith letter admits "high" risk
10: January 7 1997: Inclusion ruling and accceptance
11: August 6 1996: Protocol says study not of autism
12: September 16 1996: Informed consent has no goals for participants

Suffer the children? The medical background to what went on at the Royal Free

Doctors' extra! Take the Royal Free hospital ethics quiz
Comparison: Approved study quite different to Lancet publication
Litigants listed: Seven admitted before ethics committee approves
Introducing encopresis: No mystery in children's bowel condition
Ileal lymphoid nodular hyperplasia: Things they didn't tell us
Medical opinion: Indications for gastrointestinal endoscopy
BMJ study: Bowel problems not reported as peculiar to autism
BMJ study: No "new variant" autism - and parents change stories
Lab document: Study under way before ethical approval
Royal College of Physicians: Definition of medical research
Case note: Royal Free had "Wakefield clinic"
BMJ legal discussion: "Protecting children from forced altruism"
CSM/MHRA report: Lawyer's clients showed no new distinctive problems

Formal statements issued by Lancet - not endorsed by Brian Deer as accurate
February 20 2004: Statement by Dr Simon Murch
February 20 2004: Statement by Professor John Walker-Smith
February 20 2004: Statement by Dr Andrew Wakefield
February 20 2004: Statement by Professor Humphrey Hodgson
February 20 2004: Statement by Dr Richard Horton

The Royal Free hospital and medical school's move that helped create MMR scare

May 23 1997: Hospital knew Lancet research was legal contract
September 1 1997: Roy Pounder's influence brokered Lancet publication
January 16 1998: Roy Pounder warned of damage to MMR planned
February 27 1998: Hospital video news release extract

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