RESEARCHERS MISREPRESENTED THE results of animal studies to gain funding and approval to conduct human trials to test a new tuberculosis vaccine, according to an investigation by the British Medical Journal.
The writers found a “pick and mix” approach to animal research which they said raises questions around a lack of oversight and transparency in the use of animal testing before progressing onto human trials.
As a result, drug developers can be selective about what data they use to justify the use of the medicine in humans, they wrote.
Their findings on the tuberculosis vaccine are said to be just one example of “a systematic failure” in animal testing, and urgent action is needed to make it “more fit for purpose”.
MVA85A
The BMJ investigation centred on a trial vaccine for tuberculosis called MVA85A. Researchers at Oxford University had developed it to boost the effectiveness of the existing vaccine.
It was reported to have been successful in animal studies, but failed to show a benefit when tested in a large clinical trial on infants in South Africa in 2009.
Apparently, the differences between the apparent success of the animal testing vs the human trials has slowed down research in the entire field, as it led major funders of tuberculosis research to rethink their funding strategy.
An independent review of what went on in 2015 showed that the results from testing the drug on animals had been overstated.
While the clinical trial was in the late stages of preparation, a study in monkeys should have raised doubts about MVA85A’s effectiveness. The study was too small to draw firm conclusion, but it did ring alarm bells in academic circles.
The results of this trial were not included when information was submitted to the appropriate regulatory body for approval to test the vaccine on humans.
They may have publicly relied on claims from their animal tests, but privately the researchers played them down.
“Riddled with flaws”
Jonathan Kimmelman, associate professor in biomedical ethics at Canada’s McGill University, said there were numerous bad examples the researchers found.
He said: “It’s widely recognised that animal studies intended to support drug development are often riddled with flaws in design and reporting.
But it sometimes feels as if regulators and ethics committees missed the memo. Unfortunately, there are other cases where new treatments were put into human testing on animal evidence that was foreseeably flawed, incomplete, or even negative.
Malcolm Macleod, professor of neurology at the University of Edinburgh, in an accompanying editorial, said it is stories like this that erodes the public’s trust in science.
He 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. In these troubled times, that public trust is more important than ever.
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