MMR vaccine should not have been licensed

EXCLUSIVE, By Sarah-Kate Templeton Health  Editor

Publication Date: Dec 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 licensed?" 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."