[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.
|