A new study released by the British Medical Journal has called for “urgent reforms” of the use of animal testing in trials for new drugs. It claims that researchers have “misrepresented” the results found in animal studies to secure approval and the funding they need to progress to human trials. These concerns prompted an independent review in 2015, the results of which have now been published and show that the results of animal studies have been exaggerated in some cases.
This included trials for the new tuberculosis vaccine, which was developed to boost the effectiveness of the current BCG vaccine and increase its effectiveness in protecting against the disease. Although the drug was supposedly very effective in animal studies, when taken to clinical trials in infants it was shown to have little benefit. It was also claimed that the small scale of the trial “should have raised doubts” as to their accuracy, but the human trial went still went ahead.
Deborah Cohen, who led the study noted that the report showed a “pick and mix approach” to using animal testing in clinical trials. She said they are deeply concerned about the lack of accountability and transparency in regulatory decision making, as well as in the decision making process for moving from animal studies to human trials. The BMJ also said that the results indicate that the case of MVA85A who sponsored the TB vaccination study, has slowed progress in the entire field of tuberculosis research.
Professor Ewan McKendrick, registrar of Oxford University, dismissed the claims, saying that “independent expert analysis has demonstrated [the claims] to be without foundation”. He added that the researchers involved in this study had already been “cleared of any wrong doing” and that the team “observed the highest scientific and ethical standards, aiming to improve global control of the world’s most lethal infectious disease”
However, Jonathan Kimmelman, associate professor in the biomedical ethics unit at McGill University in Canada 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 and translational neuroscience at the University of Edinburgh, added that “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.”