By Dominic Wilkinson, @Neonatalethics
Earlier this year, the Lancet published a trial (the ‘ACT’ trial) involving 100,000 babies at risk of being born prematurely in developing countries. Half of the mothers in the ACT trial did not receive a simple cheap medicine that has been previously shown in multiple trials and meta-analysis to reduce the risk of death for premature babies. From the ACT trial results, it appears that 89 additional babies died as a result of their mothers taking part in the trial.
Surely this is an egregious example of unethical research? It appears to be in breach of the World Medical Association Declaration of Helsinki standards. Why did ethics committees allow the research? Why did a major journal like the Lancet publish it? Why aren’t bioethicists and activist and advocacy groups like Public Citizen jumping up and down in outrage?
The Declaration of Helsinki appears to be clear: “The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s)”. In this case, the intervention involves giving mothers at risk of delivering a baby prematurely an injection of steroids. This steroid injection is widely regarded as one of the most effective interventions in perinatal care. It is standard of care to give mothers this injection in developed countries. Meta-analysis (the statistical tool for combining the results of many different studies) shows very clear benefit. There have been strong campaigns to increase the use of this simple intervention, particularly in developing countries. Before the trial was published, Professor Joy Lawn, perinatal epidemiologist, noted that
“it is extremely unlikely, statistically, that antenatal corticosteroids would be shown not to work in African or Asian babies.”
There is no doubt that it would be regarded as unethical to perform a placebo controlled (or no-treatment controlled) trial of antenatal steroids in a country like the UK or the US.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.