The need for innovation in Women’s Health
Women’s Health Week (14-20 May 2024) provides an opportunity to reflect on the changing landscape for the access, treatment, and representation of women across healthcare.
We’re proud that many of the clients we are partnering with are part of driving much needed change and reform within Women’s Health, lending our experience and expertise to the innovation that is required.
Historic perspective of women’s healthcare
Women’s health covers both sex-specific conditions (for example, endometriosis and menopause) and general health conditions that may affect women differently (higher disease burden) or disproportionately (higher prevalence).
Despite clear gender differences, the medical approach to research and treatment has historically been centred around patriarchal investigation into the human body, focusing on data collection exclusively from male trials and studies. As late as 1977 the Food and Drug Administration created a policy to exclude women of reproductive potential from Phase 1 and 2 clinical trials unless they had a life-threatening condition.
In fact, including female participants in clinical studies only started in the late 1980s and was only made mandatory in the US in 1993, per National Institutes of Health guidelines.
The impact of historical lack of studies in women or trials including women continues to this day.
In 2019, women accounted for only around 40% of participants in clinical trials for three of the diseases that most affect women — cancer, cardiovascular disease, and psychiatric disorders — despite representing 51% of the U.S. population. WHO data from 2019 showed Alzheimer’s disease and other forms of dementia ranked as the 7th leading cause of death globally and that women are disproportionately affected. Globally, 65% of deaths from Alzheimer’s and other forms of dementia are women.
A study published in the Lancet Public Health journal in 2021 suggested that the biggest contributors in disadvantaging women are low back pain, depressive disorders, headache disorders, anxiety disorders, bone and muscle disorders, Alzheimer’s disease and other dementias, HIV and AIDS.
The report went on to say that “Conditions that disproportionately impact females in all world regions, such as depressive disorders, are significantly underfunded compared with the massive burden they exert, with only a small proportion of government health expenditure globally earmarked for mental health conditions.”
It is hard putting a value on what that burden would translate to in fiscal terms but a report by McKinsey estimated that, “investments addressing the women’s health gap could add years to life and life to years—and potentially boost the global economy by $1 trillion annually by 2040.”
And yet, women’s health has historically lacked investment in research and development. Just 1% of the roughly $200 billion spent on health-care research and development focuses on women’s health.
There have been steps in the right direction and millions of women have already benefitted from access to HRT, increased cervical screening, and awareness around previously misunderstood reproductive health conditions. The UK Government recently published its plans and priorities for women’s health in 2024 including improved maternity care and one-stop women’s health hubs .
However, the reality is we are still behind where we need to be in the UK let alone globally.
Conditions such as endometriosis affects approximately 1 in 10 women and while there is a better understanding of the condition in recent years and new research being conducted, no new treatments has been made available to patients for 40 years.
Pregnant and nursing women are still greatly underrepresented in clinical trials, as are Black, Hispanic, Asian, and Indigenous women.
So, while there have been significant strides forward towards equality, there is still more to be done and a significant unmet need remain when it comes to women’s healthcare.
For the gender gap to be truly addressed change needs to be implemented much further down the supply chain starting with improved research and drug development.
In the US, President Biden in March 2024, signed an Executive Bill to start addressing the underlying causes for the inequity seen in women’s healthcare and research. He laid out his vision for transforming women’s health research and improving women’s lives across America, calling on Congress to make a bold, transformative investment of $12 billion in new funding for women’s health research.
Addressing the gender health inequality in the future will require a combination of large national and international policies and legislation which proactively address the underlying causes of the gender inequality whilst also tackling institutionalised bias across the board.
How to truly turn the tide in Women’s Health
– the Deallus perspective:
Attracting and retaining a diverse group of women in leadership roles for medical and clinical research
Celina Yong, MD, the director of Interventional Cardiology at the Palo Alto VA Medical Center and an associate professor at Stanford University, conducted a study analysing the sex of principal investigators for cardiovascular clinical trials and found that just 18% of the trials were led by women, but those led by women enrolled more female participants. Apprciating the field of cardiology has long been male dominated we should continue to encourage women entering this field and in return shift the pipeline for future leadership in otherwise male dominated medical fields.
Improve medical education to ensure it is truly inclusive
According to Patient Engagement Hit, “inadequate medical education and training can keep clinicians from understanding the best way to treat the unique health needs women face. Training largely does not address gender, although gender plays a key role in disease progression.”
Often male biology is still taught as the “default,” and learning about how female biology is different — from organ systems to hormones to cellular differences — is considered “special interest”.
This needs to shift to a holistic medical teaching, embracing the fact medical treatment approaches needs to be differentiated and aligned according to gender.
Appreciate and address the limitations of AI
AI is, for many, hailed as a critical driver of innovation in future healthcare research – from disease target identification to the optimisation of clinical trial programmes. However, the risk with AI is the internal bias that historic data will have (and which AI will leverage) is all male dominated.
In addition, there are fewer women working in AI, occupying only 26% of roles, meaning their experiences and perspectives are less likely to be considered in the development of machine learning algorithms.
The risk of bias and further perpetuation of the gender gap needs to be acknowledged and addressed as we see AI increasingly support outputs considered for medical research and drug development.
Give women a voice -then listen
At the World Economic Forum in Davos earlier this year the women’s health gap was highlighted. As well as the health conditions highlighted where diagnosis and treatment were vastly different for women then for men, one of the other challenges was around the voices of women being heard. India’s Minister of Women and Child Development states: “Women have no problem speaking up,” said India’s Minister of Women and Child Development, in the session Closing the Gender Gap in Health. “The problem is, how much are they heard? And I think that articulates the gap.” [12]
Wider investment in FemTech
FemTech – technologies that enhance women’s health – are now driving a change to improve this.
The 2022 Women’s Health Strategy for England, a policy imperative seeking to address the imbalance in women’s health experiences and outcomes, highlights the need to harness the potential of FemTech to “empower women to have fair access to clinically safe technologies – whether diagnostic, therapeutic or preventive – to ultimately improve health outcomes for women”
When speaking to Erica Kantor, Sector Manager, Medical at Sagentia Innovation, a leading voice in this sector, she reflected: “Women’s health startups still face roadblocks in securing investment. This is largely due to the lack of historic data on women’s health conditions, making it challenging to quantify the business opportunity for novel technologies and solutions. However, with emerging government initiatives, growing VC attention, and women’s health companies driving education and advocacy, we have every reason to feel hopeful.”
There remains an opportunity to prioritise which unmet needs should be a focus and drive the required alignment with those using and developing healthcare technologies to ensure devices don’t exacerbate or create further health inequalities.
At Deallus equality is paramount -across race, gender, class, and sexual orientation. As an organisation we celebrate that more than 40% of our senior leaders are women and we take pride in playing a small but critical part in supporting our clients identifying and closing the gender gap across a range of TAs including oncology, rare diseases, vaccines, and neuroscience. Together we are challenging the status quo and will continue to support innovation and insights into what’s needed for a medical world that truly embraces and enhances gender equality.
Author – Julie Munch Khan, Chief Commercial Officer
May 2024
1. https://www.aamc.org/news/why-we-know-so-little-about-women-s-health#:~:text=Women%20were%20already%20poorly%20represented,2%20clinical%20trials%20unless%20they
2. https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death)
3. Differences across the lifespan between females and males in the top 20 causes of disease burden globally: a systematic analysis of the Global Burden of Disease Study 2021 – The Lancet Public Health
4. https://www.mckinsey.com/mhi/our-insights/closing-the-womens-health-gap-a-1-trillion-dollar-opportunity-to-improve-lives-and-economies
5. https://www.bloomberg.com/news/newsletters/2022-07-21/getting-drug-companies-and-investors-focused-on-women-s-health?embedded-checkout=true
6. https://www.thewomensorganisation.org.uk/what-are-the-governments-plans-for-womens-health-in-2024/#:~:text=Millions%20of%20women%20have%20already,previously%20misunderstood%20reproductive%20health%20conditions.
7. https://www.theguardian.com/society/2023/mar/08/endometriosis-new-treatment-non-hormonal-drug-dichloroacetate
8. https://www.theguardian.com/science/2023/nov/20/women-health-research-jill-biden-white-house
9. https://www.whitehouse.gov/briefing-room/presidential-actions/2024/03/18/executive-order-on-advancing-womens-health-research-and-innovation/
10. https://med.stanford.edu/cvi/mission/news_center/articles_announcements/2023/why-more-women-should-lead-clinical-trials.html
11. https://bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-023-02778-2 Anon. Women’s health strategy for England. London: GOV.UK; 2022. p. 54.
12. https://www.weforum.org/publications/closing-the-women-s-health-gap-a-1-trillion-opportunity-to-improve-lives-and-economies/
13. https://www.gov.uk/government/publications/womens-health-strategy-for-england/womens-health-strategy-for-england