- FRESH
DOUBTS CAST ON MMR STUDY DATA
The
Sunday Times (London) April 25 2004
Brian
Deer
SERIOUS concerns have been raised about a key study
cited by Dr Andrew Wakefield and campaigners as
crucial evidence that the MMR vaccine causes autism
in children.
The High Court in London has requested that the Irish
courts order Professor John O’Leary, the Dublin
pathologist who carried out the study, to hand over
all the raw data so it can be re-examined by experts.
It follows claims made in the High Court of anomalies
in O’Leary’s laboratory reports on samples
from hundreds of autistic children who are allegedly
victims of the MMR vaccine. Along with earlier
research by Wakefield, which was discredited in
February after a Sunday Times investigation,
O’Leary’s tests have been seen as critical
to the claim linking the vaccine with autism.
Unigenetics, O’Leary’s private company,
found that 80% of the 91 autistic children it tested
had traces of measles in their bodies, presumably as
a result of being given MMR. This data is being
relied on by parents who believe MMR caused autism in
their children and are suing three manufacturers of
the vaccine — GlaxoSmithKline, Merck and Aventis
Pasteur.
Experts for the three companies, who have had access
to some of O’Leary’s raw data, have claimed
in court that the samples could have been
contaminated and were incorrectly reported. If this
is so, it would be a big blow to the families’
case and to Wakefield’s campaign for single jabs
to replace the MMR triple inoculation.
O’Leary’s data provided Wakefield with the
linchpin evidence that was central to his
theory,” said Dr Stanley Plotkin, of the Wistar
Institute in Philadelphia, who is a world expert on
vaccines. “If that falls away, all you have is a
hypothesis unsubstantiated by anything . . . the
whole thing falls into the water.”
Wakefield first sparked controversy over a possible
link between MMR and autism six years ago with the
publication of a study in The Lancet. The
paper’s key finding was withdrawn last month
following a Sunday Times investigation that revealed
Wakefield’s involvement in the vaccine lawsuit.
The O’Leary study, co- authored by Wakefield,
was published in the journal Molecular Pathology in
April 2002. They claimed to have found fragments of
the measles virus in samples from the intestines of
children with autism. This research and further tests
by O’Leary were described by the judge presiding
over the MMR litigation as “pivotal” to the
case.
However, questions were raised over the research when
two other laboratories, testing samples from the same
children, apparently failed to confirm
O’Leary’s findings. One, at Edinburgh
University, had been commissioned by the drug
companies, and the other, at Queen Mary medical
school, London, by the children’s lawyers.
O’Leary’s results were generated from a
machine called TaqMan PCR, which amplifies molecular
DNA sequences.Since 2000, Unigenetics has been paid
£800,000 for this work by the UK legal aid fund.
Further experts were asked to investigate
O’Leary’s methodology and results. Led by
Dr Stephen Bustin, of Queen Mary, they visited
O’Leary’s laboratory last year and were
given 20% of the raw data recorded by the PCR
machine.
But after comparing this data with
O’Leary’s reports, Bustin’s team
claims it found instances of different results.
“These findings are raising very serious
concerns,” Charles Gibson QC, counsel for one of
the MMR manufacturers, told a court hearing this
month.
Bustin claims the PCR machine used by O’Leary
found traces of measles in control samples —
such as those containing distilled water — that
should have been negative. He also claims some of the
controls were wrongly reported as negative when the
machine had found positive traces of the virus.
“Bustin is beginning to find a mismatch between
the raw data which he is examining and the
experimental reports that relate to that,”
claimed Gibson.
Measles is among the most infectious agents known. In
tests such as O’Leary’s, some materials are
intentionally infected — acting as positive
controls to be sure the machine is working — and
it is thought that this may have been a cause of the
contamination.
In a statement issued on Friday, O’Leary
strongly disputed the claim that contamination might
have occurred and said that positive controls used in
the research were “prepared in a separate
building”. He said that had contamination
occurred “all the samples would have tested
positive, and that clearly was not the case”.
O’Leary claimed that any differences between the
reports and raw data were because of “the use of
different software” by those checking his data.
The lawyers in the MMR litigation had agreed
informally last July that O’Leary should allow
Bustin to collect the remaining 80% of data from the
machine. Bustin says the exercise is as simple as
copying a home computer disk.
But Bustin, a specialist in PCR technology, and a
fellow expert claim they have met a number of
obstacles and Unigenetics put forward numerous
reasons why the data could not be produced.
O’Leary insists he has gone to
“considerable lengths” to help Bustin
retrieve the data.
Yesterday Dr Richard Smith, editor of the British
Medical Journal, which publishes Molecular Pathology,
said: “If it turned out to be true that the
results were contaminated, then I imagine that
O’Leary himself would want us to retract that
paper, because clearly it would be delivering a false
message.”
Copyright,
Brian Deer. All rights reserved. No portion of this
article on MMR, the Lancet and Andrew Wakefield may
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