Every day, the world of medicine moves one step forward. Compared to half a century ago, a decade ago, even a year ago, doctors have never been better informed, have more answers, and a wider range of drugs to turn to and help patients. But this pace of change hasn’t been equal for everyone. Particularly when it comes to testing new drugs on pregnant patients.
The ethical question of including pregnant women in clinical trials has no clear answer. There’s a sense of caution. Traditionally, drug regulatory bodies have been, reluctant to include pregnant women in research – the FDA, for example, only advocates clinical trials in pregnant women when investigating a life-threatening condition. But there are voices calling for inclusion, on ethical (and logical) grounds. There are even professionals asking whether or not this exclusion is actually discrimination.
There’s certainly a strong case for inclusion. The 2010 outbreak of bird flu – which had a disproportionate impact on pregnant women – is one such example. While public health officials called for mothers-to-be to ask doctors for a vaccination, many were too scared to do so because no one could reassure them of its safety profile for their unborn child.
HIV and AIDS have helped shake up the medical community in this respect. In the 1990s, doctors were quick to realize that excluding pregnant women from trials for potential treatment would cause more harm than good. But this is one response to one disease. And it hasn’t been replicated elsewhere.
Of course, simply letting pregnant women into all clinical trials isn’t going to happen overnight. It’s going to take time, with some healthcare professionals advocating a gradual approach that takes extra steps to maximize the well-being of two, not one, trial candidates. But this extra knowledge brings multiple benefits. And greater choice for doctors and pregnant women.
What are your thoughts on excluding pregnant women from clinical trials?