Universities accused of unethical ‘pick and mix’ reporting of drug trial results

Universities have been accused of undertaking widespread unethical drug trials after The Daily Telegraph revealed Oxford researchers allowed a vaccine to be tested on babies despite doubts about its effectiveness.

An 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 alleged practice potentially harms patients and risks stalling scientific progress by putting off investors, the BMJ said.

The investigation focuses on senior scientists at Oxford University who tested a candidate tuberculosis 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 the drug, MVA85A, died at roughly the same rate as those exposed to TB without it, however this was not disclosed 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.

The Porton Down monkey study was one of several, but its results were not included

Human trials on the African infants went ahead in 2009.

Writing in the BMJ, Dr Deborah 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 are human trials.

She said that the failure of Oxford’s animal tests to predict the outcome in South African human trials had prompted investers to rethink their funding, which may have slowed progress across the entire field of TB research.