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According to The London Sunday Herald, many prominent
British researchers are now convinced that the controversial MMR shot
should never have been licensed in the UK.
This shocking assertion is to be made in an upcoming
report to be published in the journal Adverse Drug Reactions, the paper
reports. This is of course assuming that UK health officials are not successful
at preventing the publisher from printing the article, as they have reportedly
attempted to do.
Several senior clinicians, including a former senior
professional medical officer at the UK Department of Health, argue that
the MMR should not have been licensed back in 1988 because there was insufficient
evidence of its safety and the decision to license it was "premature."
These accusations come as they review a paper in
the same publication by Dr Andrew Wakefield, a consultant gastroenterologist
at the Royal Free Hospital in London, and Dr Scott Montgomery an epidemiologist
at Karolinska Hospital in Stockholm, entitled "Measles, mumps, rubella
vaccine:
Through a glass, darkly" that criticizes the
process which led up to the introduction of MMR vaccine. In the November
2000 issue of Adverse Drug Reactions, Wakefield and Montgomery are both
critical of the level of evidence supporting the introduction of the vaccine.
Dr. Wakefield is largely responsible for the current
controversy regarding a possible MMR vaccine link to
autism, after having several papers published on the subject.
Ever since these potential risks emerged, the British government has been
accused of refusing to acknowledge evidence.
According to a report in the Sunday Herald, Dr.
Wakefield has warned that government failure to face up to the danger
will lead to a catastrophe on the scale of the BSE (Mad Cow disease) crisis.
Support From Others
While previously, detractors of Dr. Wakefield and
others questioning MMR safety tried to discredit and ostracize them, newly
published support from others prominent in the vaccine research community
is showing that there is indeed reason to be concerned.
Dr Peter Fletcher, who was a senior professional
medical officer for the UK Department of Health in the early 1980s, concurs
with much of the criticism in his review of the approval decision taken
by his successors. According to Dr. Fletcher:
"Being extremely generous,
evidence on safety was very thin, being realistic there were too few
patients followed-up for sufficient time.
Three weeks is not enough, neither is four weeks.On
the basis that effective monovalent vaccines were available, the Committee
on the Safety of Medicines could be confident that delay in granting
a license would not result in a catastrophic epidemic of measles, mumps
and rubella.
Caution should have ruled the
day, answers to some important questions should have been demanded and
encouragement should have been given to conduct a 12-month observational
study on 10-15,000 patients and a prospective monitoring program set
up with a computerized primary care database.
The granting
of a product license was definitely premature."
Another of the reviewers, Professor Duncan Vere,
a clinical pharmacologist and former member of the Committee on the Safety
of Medicines, agrees that the observation periods for the tests of MMR
were too short.
"In almost every case,
observation periods were too short to include the time of onset of delayed
neurological or other adverse events.
Interaction
between vaccines had not been considered adequately in children with
multiple vaccinations and potentially ill-developed immune systems.
It
is possible that a group of children exists who are developing a disorder
with gastroenteritis, abnormal reactions to measles virus and neurological
disease.
In the present condition they are highly likely
to be vaccinated. The existing data throws no light on the question
and new comparative studies are needed to seek an answer to it."
Dr Montgomery, who formerly worked with Dr Wakefield
at the Royal Free Hospital in London, said that the opinions of the reviewers
were particularly interesting due to their background in the licensing
of medicines. He said: "The people who reviewed this paper used to
be in charge of drug safety and what they are saying is: "Should
this vaccine have been licensed?"
The Sunday Herald reports that someone from the
journal of Adverse Drug Reactions said:
"All the reviewers conclude
that something needs to be done about MMR and that there is a case to
answer against the vaccine. The first thing this paper says is that
the MMR vaccine should not have been licensed. There was not enough
evidence of the safety to license it.
The view
is that the evidence was inadequate."
Pressure Not to Publish
Dr John Griffin, editor of the journal is irate
over a letter he received from a government health official, which he
says tried to put him under pressure not to publish the potentially damaging
paper and he states:
"I think this is an attempt to put
pressure on me not to publish the article and I resent that. We are
going to publish the article. We are not going to be deterred by threats.
I think putting pressure on us not to publish is despicable."
Adverse Drug Reactions,
November 2000; Volume 19, Issue 4 and
The Sunday Herald (London), December 10 and 17, 2000
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