February 26, 2004
MMR medics challenged over child
spinal taps
By Mark Henderson, Science Correspondent
NEW questions about the ethics of the
controversial study that linked the MMR
vaccine to autism in children will be raised
in Parliament today, The Times has learnt.
Less than a week after the doctor who
pioneered the research was accused of failing
to disclose a £55,000 payment, ministers are
to be asked whether he had received proper
ethical approval. The fresh doubts centre on
whether the lumbar punctures to which
autistic children were subjected by Andrew
Wakefield’s team at the Royal Free
Hospital were clinically justified.
While The Lancet, the journal that first
published the research, cleared the
researchers of failing to secure the full
backing of the hospital’s ethics
committee, the Liberal Democrat MP Evan
Harris will today question whether it was
right to reach this verdict.
Dr Harris, a doctor and former health
spokesman, said documents indicate that the
design of Dr Wakefield’s study was
altered after it was approved by the Royal
Free’s ethics committee. The panel does
not appear to have been asked to revise its
decision in light of the changes, which
affected which children could be given lumbar
punctures — a procedure performed under
sedation in which spinal fluid is removed
with a needle.
Dr Harris has tabled a written question to
John Reid, the Health Secretary, asking
whether the Government considers that the
study was performed within ethical
guidelines. “How has he satisfied
himself that lumbar punctures carried out on
children at the Royal Free Hospital by the
inflammatory bowel disease study group since
1996 have had valid and effective ethical
approval from a properly consituted ethical
committee, on the basis of the
researchers’ relevant interests and the
full clinical context?” he asks.
The new criticisms of Dr Wakefield’s
work follow The Lancet’s announcement
last week that it would not have published
the 1998 paper had it known that the lead
authorhad been paid £55,000 as part of a
legal action against the MMR vaccine’s
manufacturers. An investigation for The
Sunday Times by Brian Deer found that Dr
Wakefield had failed to declare the payment,
even though “four or five” of the
twelve children in the study were also
involved in the litigation. Richard Horton,
the Editor of The Lancet, said non-disclosure
left the original study “fatally
flawed”.
Both the journal and the Royal Free rejected
Mr Deer’s charge that the ethical
background to the study was weak, but
documents released yesterday on the
journalist’s website have prompted Dr
Harris to raise further questions. His
concerns surround the diagnosis of the
condition of the children in the study, which
appears to have changed after it was approved
by the hospital’s ethics committee. The
original protocol suggested that Dr
Wakefield’s team intended to investigate
children with disintegrative disorder, an
extreme, late-onset form of autism known as
DD. Lumbar punctures for such patients as
they would normally be conducted anyway to
rule out other potential causes.
When the team’s findings were published
in The Lancet, however, only one of the 12
children studied had a possible diagnosis of
DD. The others had a diagnosis of either
autism, an autistic spectrum disorder or
encephalitis from vaccine or viral damage.
None of these conditions would normally
require a lumbar puncture for medical
reasons, Dr Harris said, yet the procedure
was performed anyway.
“Why, when the scientific rationale
changed and it was a different study, do they
not appear to have gone back to the ethics
committee?” he said. He urged Mr Reid to
call a public inquiry into the affair.
Independent neurologists said that it was
appropriate for scientists to seek renewed
ethical approval when a study’s terms
were altered, and that the clinical
justification for lumbar punctures was very
different for patients with DD and autism.
“If they included patients who
didn’t fulfil the original diagnostic
criteria then they should have gone
back,” Carlos de Sousa of Great Ormond
Street Hospital, said. A spokesman for Dr
Wakefield said that he did not wish to
comment. A spokeswoman for the Royal Free
Hospital said his former colleagues were
unwilling to add to statements released last
week. Last Friday, Professor Humphrey
Hodgson, Vice-Dean of Royal Free and
University College Medical School, said:
“We are entirely satisfied that the
investigations performed on the children
reported in the Lancet paper had been
subjected to appropriate and rigorous ethical
scrutiny.” The Lancet found that the
evidence did not support the allegation that
proper ethical approval was not received.
“The evidence we have seen indicates
that ethics committee approval was given for
data collection from clinically indicated
investigations in the children with an
initially undiagnosed illness and who were
described in the 1998 Lancet paper,” it
said.
A question of ethics
Research programmes at hospitals are put
before local ethics committee which decide if
they are appropriate Committee members
usually include hospital staff and lay
people. They take into account the risks
posed, the benefits to the patient and any
broader benefits Doctors and scientists must
apply for ethical review for any study
involving NHS patients The committees were
established in 1967. In 1991 the Department
of Health said that no NHS body should
support research not approved by an ethics
committee
