Universities carry out ‘unethical’ drug trials

Universities have been accused of carrying out 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 cited a “systematic failure” to faithfully report the results of animal tests in order to secure funding and permission for human trials. The BMJ said the Oxford case highlighted the “pick and mix” approach of some researchers.

UNIVERSITIES have been accused of carrying out 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 could potentially harm patients and risked stalling scientific progress by putting off investors, the BMJ said.

The investigation focuses on senior scientists at Oxford University who tested a tuberculosis booster vaccine on monkeys at the Porton Down government laboratory in Wiltshire in 2006 ahead of a trial involving nearly 2,800 babies in South Africa.

After they were exposed to TB, the animals inoculated with the drug, MVA85A, died at roughly the same rate as those without it. However, this was not disclosed until after funding and permission for the infant trials 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 in the report. 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 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 field of TB research.

An initial inquiry by Oxford found the actions of Professor Helen Mcshane had not broken the law.

Prof Mcshane has previously told The Telegraph she did not believe families in South Africa were exploited and that the monkey trial only included a “limited” number of animals.

South African Medicines Control Council, which was one of the regulators which approved the trial, said a “large body of data” – which included human trials, not the monkey experiment – were considered as part of the approval process.

They also said that the monkey experiment was “not a trial of the vaccine in monkeys” and that “there was no suggestion that the vaccine was unsafe in the monkeys or that it had caused disease or death”.