The World Health Organisation (WHO) is spearheading a major initiative to include pregnant women in drug trials, marking what it describes as the biggest shift in policy since the Thalidomide scandal of the 1950s and 1960s. More than 90 per cent of medicines have never been tested in pregnancy, leaving millions of women worldwide with an impossible choice: go without treatment or take medication without reassurance that it is safe.
The origins of this exclusion lie in the Thalidomide tragedy, when a drug given for morning sickness caused severe birth defects. That led to the Medicines Act 1968 in the UK, which established strict drug testing rules. However, pregnant women were systematically excluded from trials, not out of malice but fear, explains Mariana Widmer, a maternal health scientist at WHO. “People have been scared to treat pregnant women since the thalidomide tragedy, and pregnant women are scared to be treated,” she says.
This exclusion has had serious consequences. After deadly bleeding, the next most common cause of maternal deaths worldwide is chronic illnesses such as heart conditions, diabetes and epilepsy. “Pregnant women are still dying from conditions that are otherwise preventable in others,” Widmer notes. The WHO team plans to work through a list of essential medicines, bringing together scientists, doctors and drug developers to change this.
Emma, a 35-year-old with Ehlers-Danlos syndrome, is one of many women affected. She relies on medications including nabilone, a synthetic THC compound, to manage severe nausea and vomiting. Without it, she requires frequent hospital visits. But she was told that data on THC-use in pregnancy is “meaningless” because it comes from recreational users who also smoke and drink. “It’s this constant weighing up of what is more dangerous, what’s not more dangerous, and it’s really, really difficult to make that judgement,” she says.
Widmer emphasises that change requires collaboration: “There’s no one single organisation or one individual that can make this change. This change is huge. This takes time. We need collaboration and we need partnerships. And this is what we at WHO would like to do.” The initiative is seen as a generational shift that could finally address the long-standing neglect of pregnant women in medical research.
