Recent analysis by the British Medical Journal (BMJ) cited a “systematic failure” to faithfully report the results of animal tests in order to secure funding and permission for human trials.
The report, by Dr Deborah Cohen (doi:10.1136/bmj.j5845), suggested that preclinical trials using animals can produce unreliable results, negatively impacting on human health.
The article focused on the testing of a new vaccine, MVA85A, designed as a booster to the BCG vaccine to improve the prevention of tuberculosis.
The experiments were carried out by senior scientists at Oxford University who tested the booster vaccine on monkeys at the Porton Down Government laboratory in Wiltshire in 2006 ahead of a trial involving nearly 2,800 South African babies.
The animals inoculated with MVA85A died at roughly the same rate as those exposed to TB without it. But this was not reported until after funding and permission for the wider infant clinical trial had been sought.
Instead, the Oxford team reported that MVA85A had been successful in animal trials overall and human trials on the African babies went ahead in 2009.
Dr Cohen said the case highlights the “pick and mix” approach some researchers take to reporting the result of animal testing, which is far less stringently regulated than human trials.
She said that the failure of Oxford’s animal tests to predict the outcome in South African human trials had prompted investors to rethink their funding, which may have slowed progress across the entire field of TB research.
An inquiry by Oxford found the actions of Professor Helen McShane had not broken the law, adding that it would have been good practice for the “potentially adverse reaction” observed in the monkey trial to have been disclosed.
The university went on to set up a vaccines oversight committee in 2012, and in 2015 an independent review suggested the efficacy of MVA85A had been overstated.
Dr Andrew Bennett, director of the FRAME Alternatives Laboratory, said: “The “systematic failure” to accurately report the results of animal tests is aptly illustrated in the case of the MVA85A vaccine, as reported in the BMJ.
“Currently, new drug development is underpinned by animal research, but FRAME contends that animal evidence is often unreliable and of poor design and statistical analysis, is therefore needs urgent reform in it applicability.“This is because animal models can not accurately predict the response of the human body. Also, many pre-clinical [animal] studies are plagued by poor design and reporting practices, potentially exposing human patients to ineffective and sometimes harmful medicines.”
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