African babies were given a new TB vaccine even though five out of six primates involved in a trial
African babies were given a new TB vaccine even though five out of six primates involved in a trial died.
The investigation revealed last night by the British Medical Journal prompted calls for tightening of rules governing the way animal research is reported.
Jonathan Kimmelman of McGill University in Canada said the Oxford case was not an isolated one, he added: “It’s widely recognised that animal studies intended to support drug development are often riddled with flaws in design and reporting.
“Unfortunately, there are other cases where new treatments were put into human testing on animal evidence that was foreseeably flawed, incomplete, or even negative.”
An information sheet was given to parents of the babies who were handed the vaccine in 2009 which said it had been tested on animals and was “shown to be effective” – but it did not mention the dead monkeys.
Oxford researchers have been accused of “cherry-picking” their scientific evidence.
Speaking in The Daily Mail, Professor Malcolm Macleod of the University of Edinburgh said: “We need to develop better and more systematic ways to establish when a drug is ready for clinical trials in humans – and importantly, when it is not.
“Until our institutions recognise that their core purpose is to produce research of value to society they risk a slow decline in their reputation, and possibly a faster and more serious erosion of public trust in science.”
The babies from South Africa were not harmed by the jab, called MVA85A, but it also did nothing to protect them.
Oxford, who later dropped the vaccine, insists the results of the monkey study were provided to regulators in the UK, US and South Africa before the infant trial began.
It showed no safety issues in four other animal studies involving mice, guinea pigs and other monkeys.
It was also tested in 14 studies on humans, involving 400 adults, teenagers and children in the UK, Gambia and South Africa before it was given to infants.
The Oxford researchers claim the monkeys died because they were given a stronger version of TB.
But experts say this should not have stopped them making the results known to parents of the infants.
Professor Mike Turner of the Wellcome Trust, which founded the study, said clinical trials were carried out “to the highest standard”.
He added: “The decision to test this candidate vaccine was correct and based on robust, positive data from smaller trials in humans that showed that the candidate vaccine was safe and that it might be effective.
Oxford researchers have been accused of ‘cherry-picking’ their scientific evidence
“Human trials do not always generate the same results as animal testing, which is why results in animal models are typically only one of a set of considerations in determining whether to move research forward.”
A series of allegations were allegedly made about the trial by Professor Peter Beverley, a former employee, against the scientist who developed the vaccine, Professor Helen McShane.
There were three separate investigations by the university which cleared her of any wrong-doing.
The university also said it would have been unethical not to proceed with the baby trial because the vaccine proved promising in many of the previous tests.
The Oxford researchers claim the monkeys died because they were given a stronger version of TB
Registrar at the University Professor Ewan McKendrick said: “The third panel in 2016 not only cleared Professor McShane of any academic misconduct, but went so far as to add that on the basis of the vaccine’s proven safety in humans and positive phase 1 and phase 2A trials, it would have been unethical not to have proceeded with the phase 2 trials in infants.
“The time has come to stop the repeated repackaging of criticisms and allegations which independent expert analysis has demonstrated to be without foundation.”
Professor McShane said it was a “failed experiment” because “there was no difference” between the groups in the trials.