Women and babies in the UK are “dying needlessly” because of a lack of suitable medicines to use in pregnancy, according to a report that calls for a radical overhaul of maternal health.
A “profound” shortage of research and the widespread exclusion of pregnant and breastfeeding women from clinical trials means hardly any new drugs are approved for common medical problems in pregnancy or soon after childbirth, the report finds.
Meanwhile, scarce or contradictory information about the safety of existing medicines women may be taking for continuing conditions can make it impossible to reach a confident decision on whether or not to continue them in pregnancy, the experts add.
“While pregnancy in the UK is generally considered safe, women and babies are still dying needlessly as a direct result of preventable pregnancy complications,” the authors say. Each year, 5,000 babies in the UK are either stillborn or die shortly after birth, while about 70 women die of complications in pregnancy.
The Healthy Mum, Healthy Baby, Healthy Future report is published by a policy commission co-chaired by Eliza Manningham-Buller, the co-president of Chatham House, and Peter Brocklehurst, a professor of women’s health at the University of Birmingham.
Drawing on evidence from patient groups, clinicians, researchers, lawyers, insurance specialists and the pharmaceutical industry, it proposes “urgent” changes to transform women’s access to modern medicine.
Brocklehurst said the issue needed tackling with the same energy thrown into the early HIV crisis, when massive investment and effort went into the search for therapies. “We need to mobilise that same enthusiasm and investment towards pregnancy to develop some effective medications because we’ve simply not been touching pregnancy,” he said.
Globally, more than 800 women and nearly 7,000 newborns die each day from pregnancy-related complications, with about 5,500 babies stillborn. The vast majority of these are preventable, with pre-eclampsia, premature birth, haemorrhage, infection and birth asphyxia accounting for most of the deaths.
The report highlights a host of failures that hamper the development and approval of medicines for pregnant women. They range from the exclusion of pregnant women from clinical trials and poor information on existing medicines to woeful funding of pregnancy research and a fear of legal action if treatments on trial prove harmful.
Pregnant woman have been almost entirely excluded from clinical trials since the thalidomide tragedy in the 1950s. But while caution was understandable in the wake of the disaster, the move has led to “unintended and grave consequences” for pregnant women who are “left without safe, effective and accessible medicines”, the authors write. In the past 40 years, only two new drugs have been approved for use in pregnancy.
The problem was evident in the pandemic when pregnant women were excluded on safety grounds from all early Covid vaccine trials. This fuelled uncertainty around the safety of the vaccines for pregnant women, the authors write, contributing to Covid wards and intensive care units filling up with unvaccinated pregnant women.
The report goes on to highlight the “profound lack of research activity” and up-to-date information that leaves pregnant women and their physicians in the dark about whether to continue with certain medicines in pregnancy. Some epilepsy drugs, for example, can increase the risk of birth defects, but coming off them can put the woman at risk of severe seizures, which can also harm the baby.
Lady Manningham-Buller said the situation “urgently needs to change”, with the report setting out eight recommendations to prevent needless deaths. The authors say charities and other organisations must work together to provide robust advocacy for medicines in pregnancy, while companies should be given incentives to produce new drugs, such as extending patent licences. Meanwhile clinical trials should be open to pregnant and breastfeeding women, with tests for safety in pregnancy perhaps a compulsory requirement for many new drugs.
Other recommendations are to provide clear, updated information on the safety of existing medicines in pregnancy, and to “de-risk” clinical trials so pharmaceutical companies are not deterred by potential litigation. “If we can arrange insurance for terrorism we should be able to produce a similar scheme for pregnant women,” said Manningham-Buller, a former director general of MI5.
“The biggest killer of women and babies around the world is still pre-eclampsia for mothers and babies and preterm birth for babies. And we’ve got very little that makes a difference,” said Brocklehurst. “We could make a massive difference in a relatively short space of time if there was sufficient investment and desire to do work in this field.”
