When Sinead Hayes was 13 weeks pregnant, she became feverish with what turned out to be swine flu and pneumonia. Hayes, who was 30 years old at the time, was advised by her midwife to drink honey and lemon and avoid taking any medication. "I was basically told to suck it up and that anything I took would be bad for the baby," she says. "I ended up in hospital and being put into an induced coma."
Her coma lasted for seven weeks, she suffered two collapsed lungs and spent three months in hospital. At 38 weeks, she gave birth to Esme, who will be three in June. Esme has a number of health issues, including deafness, delayed mobility and potential epilepsy. Hayes is adamant that Esme would not have these conditions if she had been allowed to take medication in the first place. Her midwife's advice, though, is standard, and reflects the views of many. "Women are too quick to take the easy option. Personally, I would rather suffer," one mother told me.
The bottom line, however, is that pregnant women get sick. Sick women get pregnant. Coming off medication or avoiding new treatment is not always an option and, as the average age of motherhood creeps up, chronic health conditions in pregnant women will become more common. Yet a blackout in knowledge exists – mothers with serious health conditions are given conflicting advice by health professionals during their pregnancy, while many others find that pharmacists refuse to sell them over-the-counter medicines that their doctor has deemed safe.
There is history, and politics, behind this knowledge vacuum. Women – and not just pregnant women – are still underrepresented in medical trials. Historically, they have been completely absent: the thalidomide scandal of the early 1960s resulted in women of childbearing age being excluded from trials. Even when the ban was lifted, this absence continued. Women's bodies, with their monthly cycles, were considered complicated; adding another costly variable and affecting the bottom line.
The European Medicines Agency (EMA) admits that there is still a problem. "Increasingly, marketing authorisation applicants are expected to include women in trials but still, more than I would like, women are only included if they are post-menopausal or if they're using contraception," says Corinne de Vries, head of risk management review at the EMA.
The Pregnancy and Medicine Initiative is calling for more research on the topic, and bringing together medics and researchers with an interest in treating pregnant women. Dr Anne Lyerly is part of the coalition and a cofounder of the Second Wave Initiative, geared towards advancing the evidence base for medical treatment during pregnancy.
"There's a problematic conception that it's unethical to do research on pregnant women," Lyerly says. "We've been taught that the ethical thing to do is check the box 'no pregnant women were included'. Actually, this is a very unethical state of affairs. There's a notion that it's never justified to trade off risks and benefits between the woman and her unborn child."
This challenge to the idea of "zero risk" is key. Dr Frédéric Amant is at the forefront of cancer and pregnancy research and is on the board of the Pregnancy and Medicine Initiative. His work has shown that there is no increased risk of congenital defects in children who are exposed to chemotherapy during pregnancy.
"The guidelines we use are that the risk should be not zero – even a normal pregnancy has a risk – but should be as close as possible to that of the general population," he says. "Many patients will accept a certain risk."
Amant is regularly contacted by pregnant women across Europe who have discovered that they have cancer. Often, they have been told that their only options are a termination or the postponement of treatment. This will only change if more data is gathered, shared and made publicly available, says Amant.
Caroline Swain discovered she was pregnant when she did a precautionary test, just days after being diagnosed with breast cancer, aged 35. Unwilling to choose between her own life and her unborn child, and under the care of forward-thinking consultants at Southend Hospital, Caroline underwent chemotherapy. Both Caroline and the baby survived. Her son is now 11.
"It was a scary time," says Swain. "When you're pregnant you don't smoke or drink so I thought, 'How will it be possible to have chemo?'".
A decade ago, information was even harder to come by and Swain's consultants took a risk on the basis of positive results from cases in the US. Today, Swain works with Amant to raise awareness, passionate that other women will be offered the right advice.
"There's potential harm caused either way – failing to take medication or not being prescribed needed medication for an acute condition can be fatal." says Martha Nolan, vice president of the Society for Women's Health Research (SWHR). "We must provide the research community with the ability to study pregnant women and demand a well-balanced and rigorous informed-consent process. Women can make decisions themselves and should be given the opportunity to participate in research if that is what they need to get the best health care."
Doing so, however, will not be easy. "A strange myopia happens when a women gets pregnant," says Lyerly. "All the attention turns to the foetus. She becomes a vessel." Untangling thorny questions of medical ethics from deep-rooted beliefs is essential. Value judgments around medication not only hold back research but could cost lives.
• This article was amended on 27 May 2014 to correct some personal details.
