‘War of scientists’ on TB vaccine

‘Safe’ for children but tests on monkeys failed

THE controversy over the deaths of monkeys in TB research is nothing but a war between Oxford University scientists hoping for global recognition in the discovery of a vaccine, says Health Minister Dr Aaron Motsoaledi.

He was reacting to reports that Oxford University academics had given South African babies a new TB vaccine which had been linked to the deaths of monkeys in tests.

Nearly 1 400 infants were given the experimental jab even though five of six primates involved in a trial died.

An information sheet given to the parents of the babies in the Western Cape in 2009 said the vaccine had been tested on animals and was “shown to be safe and effective”. But it did not mention the failed monkey trial.

The babies, from South Africa, were not harmed by the jab – called MVA85A – but it did nothing to protect them against TB.

The details, published last week after an investigation by the BMJ (formerly known as the British Medical Journal), prompted calls for a tightening of rules governing the way animal research is reported. Oxford researchers were accused of “cherry- picking” their scientific evidence.

“The question is: why there’s this war? The only answer we got is that it’s war between some group of scientists in Oxford because scientists also fight for recognition if they think they can get a Nobel prize. The whole issue about monkeys is a war of Oxford academics,” said Motsoaledi, who is also the chairperson of the Global Stop TB Partnership.

Oxford, which later dropped the vaccine, insists it provided the results of the monkey study to regulators in the UK, the US and South Africa before the infant trial began. Research had shown no safety issues in four other animal studies – in mice, guinea pigs and other monkeys.

And the vaccine had also been 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 say the monkeys died in one particular study because it involved a stronger version of TB. The animals had become “very unwell” and had to be put down. But experts say that should not have stopped Oxford from making the results known to the South African parents – and accused scientists of using a “pick and mix” approach to their findings.

Motsoaledi said there was nothing wrong with the research.

“Our own scientists and universities were involved in this and South African scientists have a very high standard of ethics in terms of research.

“This is part of the South African TB initiative and it was done by some of the most eminent scientists from SA, working with their counterparts from Oxford. The first thing is that they obtained approval from the UCT ethics committee as well as the Medicine Control Council,” he explained.

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.

“Jonathan Kimmelman, of McGill University in Canada, said the Oxford case was not an isolated one. ‘ It’s widely recognised that animal studies intended to support drug development are often riddled with flaws in design and reporting,’ he said.

“Unfortunately, there are other cases where new treatments were put into human testing on animal evidence that was foreseeably flawed, incomplete, or even negative.”

Oxford said it would have been unethical not to proceed with the baby trial, given that the vaccine had proved promising in so many previous tests.

A series of allegations are said to have been made by a former employee, Professor Peter Beverley, against the scientist who developed the vaccine, Professor Helen McShane.

Three separate investigations by the university cleared her of any wrong-doing.

Motsoaledi called for further research, saying the discovery of a TB vaccine would be a game changer. “(The outcome of the research) simply means it did not produce the desired results, but the research must go on. TB has become such a problem globally that in September this year, it must go to the UN General Assembly to be debated by heads of states.

“One of the things we are going to push for is to try and accelerate TB vaccine research. If we can find a vaccine in TB, it will be a game changer.”

PICTURE: JACQUES NAUDE Minister of Health Dr Aaron Motsoaledi has reacted to reports that Oxford University academics gave South African babies a new TB vaccine which had been linked to the deaths of monkeys in tests.