Scientists: MMR Vaccine Should Not Have Been Licensed

       ["EXCLUSIVE", by Sarah-Kate Templeton, Sunday Herald, London,
December 10, 2000.]

       The controversial vaccine for measles, mumps and rubella (MMR) should
never have been licensed, according to a shocking new report to be published
next month.
      Senior clinicians, including a former medicines regulator at the
department of health, argue that the MMR should not have been licensed in
1988 because there was insufficient evidence of its safety and the decision
to license it was "premature."
      The leading authorities in the regulation of medicine are writing in
the next issue of the journal of Adverse Drug Reactions. They review a paper
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, on the process which led up to the introduction of
the vaccine which has been linked to autism in children. Both are critical
of the level of evidence supporting the introduction of the jab.
      Dr Peter Fletcher, who was a senior professional medical officer for
the department of health in the early 1980s, also criticises the decision
taken by his successors. In his review, which will also be published in the
journal, he says: "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 licence 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 programme set up with a computerised primary
care database.
      The granting of a product licence 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," he said.
"Interaction between vaccines had not been considered adequately in children
with multiple vaccinations and potentially ill-developed immune systems. He
adds: "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."
      A note on the paper, which has been seen by the Sunday Herald, says:
"In view of the serious implications of this paper by Wakefield and
Montgomery, [it] was sent to a number of referees who have agreed to the
comments they made on this paper being published.
      "These referees include the former chair of the medicines commission,
a former member of the Committee on the Safety of Medicines, and a former
principal medical officer in medicines division - now the Medicines Control
Agency - of the department of health who served as medical assessor to the
Committee on the Safety of Medicines."
      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
      Nobody from the journal of Adverse Drug Reactions can officially
comment on the paper ahead of its publication next month, but a source from
the journal 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."