Kate Womersley

The UK’s annual medical research funding pot has grown to £5bn, giving it transformative power, but how it spends that money has just been tempered by a revolutionary equality and diversity commitment.

Major funders, who operate across a dynamic sector, are now pledging to ensure that sex and gender is integrated into their research programmes.

Remarkably, UK research funders – representing more than 150 charities and organisations – had no policy in place until the MESSAGE (Medical Science Sex And Gender Equality) project – a joint initiative between The George Institute for Global Health and Imperial College, London – highlighted the failing and starting working on a programme for change.

Until now, the UK has been an outlier, as the European Commission – through the Horizon programme – insists that proposals must include intersectional sex and gender analysis as a default, and the US National Institutes of Health has had stipulations in place since the 1990s.

“This support for change is long overdue but very welcome, as women have been disadvantaged for decades,” says Dr Kate Womersley, Research Fellow at The George Institute for Global Health and Imperial College, London and the project’s principal investigator.

The MESSAGE project, funded by the Wellcome Trust, has worked with research funders, regulators, researchers, patient and public groups, academic publishers and the UK government to co-design a sex and gender policy framework that will recalibrate a sizeable portion of the UK medical research sector.

“Research has mainly been done on male cells, male animals and male participants. More than five times the number of male cells and animals than female cells and animals are used in preclinical research in animals and more than 70% of participants in early stage clinical trials are white men,” adds Dr Womersley. “That means we know less about women, about their health, how they experience disease and treatments, what doses will be effective and what side effects they will experience.”

The challenge is tailoring a framework that is flexible for major governmental and charities to organisations concentrating on a single disease with limited permanent staff.

“We are providing educational materials for researchers so they can gain skills in understanding why sex and gender inclusivity is important, along with quantitative skills to be able to do the data analysis and carry out research that is rigorous,” says Dr Womersley.

Alice Witt, a Research and Policy Fellow at The George Institute UK working on the two-year MESSAGE project, adds: “Bringing about any kind of cultural change will require investing in upskilling and supporting researchers through this process, and embedding skills for accounting for sex and gender across postgraduate curricula.

‘Major funders, who operate across a dynamic sector, are now pledging to ensure that sex and gender is integrated into their research programmes’

“Proper accounting for sex and gender dimensions is necessary for researchers to produce rigorous, reproducible, accurate and safe science – we can’t be fully aware of the risks and benefits that people might experience from medical treatments if they haven’t been tested on representative groups. It also makes financial sense to avoid harm, so there are lots of reasons why this is a good idea, as well as it being the right thing to do.”

Research has shown that women can encounter sub-standard treatment at all points of their medical journey; from clinicians not recognising symptoms and delayed diagnoses to inappropriate medication plans that are influenced by historic male bias.

“For example, type 2 diabetes is more common in men than in women yet women are more likely to suffer complications like stroke and heart disease, and they’re more likely to die from diabetes than men,” observes Dr Womersley. “Some of that may be due to biological differences between males and females, but I think a considerable portion of it is to do with the standard of care that women receive, compared to men.

“The UK is lagging behind other nations and there are huge gaps to close, but this is an important moment to improve the opportunities for women to live healthy lives and not be disadvantaged.”

Dr Babu-Narayan, a consultant cardiologist at the Royal Brompton Hospital, London, adds: “More men die of heart disease, and at a younger age, but if we only understand it as a man’s disease that presents with a Hollywood heart attack, it doesn’t help women.

“This is one of the embedded biases in society, not just in medicine or science, that has mediated women dismissing their symptoms in the first place and or seeking help too late.”

Professor Neena Modi, a former president of the British Medical Association and Professor of Neonatal Medicine at Imperial College London and Consultant in Neonatal Medicine at Chelsea and Westminster NHS Foundation Trust, confirms that inequalities exist across a woman’s experience of pregnancy and childbirth.

She highlights the lack of new medicines for use in pregnancy – only one in the last 30 years – and that pregnant women were excluded from initial COVID-19 vaccine trials.

“It was the most graphic and telling example of the way in which women have been and continue to be disadvantaged. The COVID-19 vaccine story is quite rightly hailed as a huge success but hidden within that is the terrible way in which pregnant and breastfeeding women were treated,” she says.

“There was absolutely no biological or scientific reason to exclude pregnant and breastfeeding women from the first wave of vaccine trials.

‘The MESSAGE project has worked to co-design a sex and gender policy framework that will recalibrate a sizeable portion of the UK medical research sector’

“In consequence, pregnant and breastfeeding women were given a wide range of advice and were put in the absolutely terrible position of having to decide to stop breastfeeding, which is really detrimental to the baby, and have the vaccine or to continue breastfeeding and not have the vaccine, which is detrimental to their own health. It’s not surprising that vaccine reluctance and vaccine hesitancy rates among the female population rose drastically.”

The UK government has launched a Women’s Health Strategy to address a range of disparities, including the male default that it accepts taints research and clinical trials, healthcare education and training and health policies and services.

Professor Modi adds: “We are moving in the right direction and it is great that the government has a strategy, but it needs to be held to account for implementing it. These disparities have well recognised life or death consequences and there is no excuse not to tackle them.”

The clinical clamour for change has been met by huge strides within industry and EDIS (Equality Diversity and Inclusion in Science and Health) – an organisation founded by The Francis Crick Institute, the Wellcome Trust and GSK – has drawn together organisations across the sector to improve health equity and share best practice.

The Medical Research Council has developed inclusivity policies and the Association of the British Pharmaceutical Industry has a programme of events and resources designed to improve health equity. Its Equality, Diversity and Inclusion strategy states: To address these inequalities, clinical research should reflect and include the diversity of the population as a default, unless there is good scientific rationale to exclude particular groups.

Dr Womersley, an NHS doctor in psychiatry, says: “The MESSAGE project itself is a clear indication that change is happening and momentum is building towards the goal of the UK moving from performing poorly and [being] very behind Europe, the US and Canada to doing well and producing something that is as good, if not better, and really contributing to improving sex and gender equity internationally.

“There’s a huge positive from science that can be derived from more complete studies and preventing people from having the wrong medicine, which results in higher costs and poorer outcomes.

“It is the right thing to do and it makes sense ethically and economically.”

Caroline Criado Perez, in her landmark book, Invisible Women, that exposed disturbing differences in how men and women are diagnosed and treated, called for a revolution in the research and practice of medicine, stating: “It is time to stop dismissing women and start saving them.”

Find out more at www.messageproject.co.uk

Danny Buckland is a freelance journalist specialising in the healthcare industry