A new trial of a tuberculosis vaccine has failed to show efficacy, but an investigation into the practices of the researchers has found evidence of ethical violations. The investigation, by Deborah Cohen of the
British Medical Journal, exposes the ways researchers from Oxford University failed to disclose risks and even misled government agencies in order to obtain funding.[....]
[...] However, an analysis of the animal
research found that “the data did not provide evidence to support efficacy of MVA85A as a BCG booster. It also raised questions about the design, execution, and reporting of the studies.” In fact, this analysis showed that monkeys given the vaccine were at increased risk of death. The authors suggested that the MVA85A booster might actually
make the current vaccine less effective.
According to Cohen, parents of the babies involved in the study were told that the vaccine booster was “safe and effective”—a statement at odds with the increased risk of death and the lack of efficacy demonstrated by the animal trials.
Funders, too, only saw the positive findings. Cohen reviews a presentation to a funding agency, which did not mention the death rates of the monkeys in the trial, and left out other animal data as well. In their response, the original researchers say that the omitted data about safety and efficacy was flawed and that they left it out because it was poorly done research, not because it would have prevented them from continuing to test their dangerous, ineffective booster on humans.
