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
