[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.
|