Study claims MMR vaccine trials were inadequate

By Louise Jury

                                 21 January 2001

                                 The MMR "triple" vaccine for children,
which has been controversially linked to autism and bowel disease, was
introduced without adequate trials according to new research, published

                                 Dr Andrew Wakefield, who caused a storm
when he first questioned the jab in 1998, concludes that even 20 years ago
there were warning signs that combining three live viruses in one vaccine
could be dangerous. There was not "adequate evidence of safety" for the
measles, mumps and rubella vaccine, which is now boycotted by many parents
who are demanding three separate vaccinations for their children, one for
each disease.

                                 Dr Wakefield's conclusions have been hotly
contested by ministers and the medical establishment. His latest research,
published in the medical journal, Adverse Drug Reactions, comes as the
Government is struggling to encourage parents to take up the MMR vaccine
amid fears of a possible measles epidemic if figures do not improve.

                                 Immunisation needs to be at least 92 per
cent to protect the whole population, but rates have fallen as low as 75
per cent in some parts of the country because of concerns about the
consequences. Around 500 families are taking legal action, claiming their
children have developed autism or inflammatory bowel disease.

                                 Dr Wakefield, a consultant
gastroenterologist at the Royal Free Hospital, London, said parents should
be offered a choice of either the MMR, which is given in a combined jab at
around 15 months with a booster at the age of three, or single vaccines
until safety fears are allayed. The Government has so far refused to make
single vaccines available.

                                 His report concentrates on the trials
before the vaccine was introduced, which happened in 1975 in the United
States and 13 years later in Britain. Studies on several hundred children
in America showed that significant numbers of youngsters developed stomach
bugs throughout the trial, but researchers took no long-term data. A study
in 1969 showed that combining live viruses could have an effect on the
body's immune response.

                                 "Two dose MMR vaccine schedules appear to
be unsatisfactorily tested for safety," said Dr Wakefield.

                                 He added: "I am a firm believer in the
protection of children against serious infectious diseases and their
consequences. This paper advocates vaccination against measles, but issues
of vaccine safety are vitally important and must be of paramount concern."

                                 Four other experts were asked by the
medical journal to review Dr Wakefield's controversial paper. Two supported
his criticisms, while the others did not dismiss them.

                                 Dr Peter Fletcher, a former principal
medical officer at the Department of Health, said the evidence on MMR was
"thin" and that the granting of the licence had been "premature". He said a
year-long trial on 15,000 patients should have been carried out before it
was introduced in Britain, instead of the three-week study involving 10,000

                                 Jackie Fletcher, of the anti-MMR pressure
group JABS, said the report showed a huge question mark remained over the
vaccine's safety. "We want the MMR to be suspended and parents to have the
right to choose single vaccines so that children can still be protected
against the diseases."

                                 But a British Medical Association
spokesman dismissed the study. Dr Simon Fradd said: "There is no new
evidence in this paper, other than a review of previously published papers
relating to the triple vaccine. MMR is a safe and effective vaccine and we
strongly recommend that children are protected with it."

                                 A Finnish study of 1.8 million children
published earlier this month found no cases of autism or bowel disease
linked with the vaccine. Nearly half of 173 adverse reactions were probably
caused by something else, the study concluded.

                                 A spokesman for the Department of Health
said: "we are not aware of any country in the world that recommends that
MMR be given as three separate vaccines. In Japan, where they do not have a
suitable MMR vaccine licensed for use, there have been 79 measles deaths
between 1992 and 1997. In the same period in the UK there were no deaths
from measles. Dr Wakefield does not produce any new data and his review of
published articles is highly selective."