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