Despite women making up nearly half of the global population, medical research has historically treated women's bodies as atypical, with men's bodies considered the norm. This bias has led to significant underrepresentation of women in clinical trials, impacting the diagnosis and treatment of conditions that predominantly affect women. Conditions like endometriosis, menopause, breast cancer, and other female cancers often receive disproportionately less funding compared to male-dominated conditions, leading to delayed diagnosis and inadequate treatment options.

Historical Exclusion from Clinical Trials

Historically, women were excluded from clinical trials due to concerns about hormonal fluctuations and potential risks during pregnancy. The FDA's 1977 policy to exclude women of reproductive potential from early-phase clinical trials was a major setback, effectively excluding most women of childbearing age from medical research. It wasn't until 1993 that the FDA reversed this policy, mandating the inclusion of women in research unless there was a justification for exclusion.

It's hard to believe, but the official publication acknowledging that sex differences influence biology and should be studied as a variable in clinical research was only announced 24 years ago, in 2001 by the Institute of Medicine.

Funding Disparities

Research funding for women's health conditions is often not aligned with the burden of disease. For instance, endometriosis affects about 10% of women worldwide but receives significantly less funding than diabetes, which has a similar prevalence. This disparity contributes to health care disparities, as biological sex can play a role in physiological, metabolic, hormonal, and even cellular differences that influence how diseases present and the effectiveness of treatments.

An analysis of cancer funding, using data from the US National Cancer Institute over the 11 years from 2007 to 2017, showed that gynaecological cancers receive much less support than do other cancers when accounting for lethality (years of life lost for each new diagnosis). In a selection of 19 cancers, ovarian cancer ranks 5th for lethality, but 12th in terms of its funding-to-lethality ratio. Cervical cancer followed a similar pattern. For many gynaecological cancers, the ratio of funding to mortality dropped during the 11-year period.

Autoimmune Diseases: A Case Study

Autoimmune diseases, such as lupus, rheumatoid arthritis, and multiple sclerosis, disproportionately affect women. Approximately 80% of those diagnosed with autoimmune diseases are women, with conditions like lupus and Sjogren's syndrome showing female-to-male ratios as high as 9:1 and 19:1, respectively Stanford Medicine. 

Despite this, women remain underrepresented in clinical trials for these conditions. For example, Alzheimer's disease, which affects twice as many women as men, has clinical trials that include eight times more male participants than female participants.

Impact of Underrepresentation

The underrepresentation of women in clinical trials has significant consequences, including health care disparities and increased adverse effects from medications. Women experience adverse effects from medications at twice the rate of men, partly due to inadequate testing in women. For instance, women with metal hip replacements were found to be 29% more likely than men to experience implant failure, possibly due to anatomical differences and inadequate testing.

Recent Breakthroughs in Women's Health Research

The lack of representation in clinical trials and the underinvestment in women's health research are interconnected issues. The underrepresentation of women in trials leads to inadequate data on how treatments affect them, which in turn can result in less effective treatments and reduced investment in women's health research. Conversely, increased funding and research focus can drive more inclusive clinical trials, ultimately improving health outcomes for women.

Despite these challenges, recent years have seen significant advancements in women's health research. Innovative treatments and diagnostic tools have emerged for conditions like endometriosis, breast cancer, menopause, and other female cancers, offering new hope for improved health outcomes.

1.    Endometriosis:

• Non-Invasive Diagnostic Tests: Recent advancements include the development of non-invasive blood tests to improve early detection and reduce diagnostic delays. Companies like Proteomics International are leading this effort.
• Dichloroacetate Treatment: Researchers have explored using dichloroacetate to manage endometriosis symptoms without hormonal side effects.

2.    Breast Cancer:

• HER2-Targeted Therapies: Research has focused on overcoming resistance to HER2-targeted therapies, with discoveries like blocking the ERK5 molecule to prevent resistance in HER2-positive breast cancer. Pfizer and AstraZeneca are among the companies driving these advancements.
• PROTAC Drugs: Pfizer and Arvinas have reported mixed results from late-stage trials of a PROTAC drug, offering potential new treatment options for breast cancer patients.

3.    Menopause:

• Hormone Replacement Therapy (HRT) Innovations: Recent studies have explored safer and more effective HRT options to manage menopausal symptoms, addressing concerns about cardiovascular risks associated with traditional HRT. Novartis and Merck are investing in these areas.

4.    Other Female Cancers:

• Ovarian Cancer: Advances in genetic testing and targeted therapies have improved early detection and treatment outcomes for ovarian cancer. Roche and GSK are among the key companies driving innovation in this area.
• Cervical Cancer: Efforts to increase HPV vaccination rates and improve screening methods have reduced cervical cancer incidence in many regions. Merck and GSK are key players in HPV vaccine development.

Companies Investing in Women's Health Research

In the US, UK, and Europe, several pharmaceutical and biotech companies are leading investments in women's health research:

1.    Pfizer: Known for its extensive research in breast cancer and menopause treatments.

2.    Merck: Invests heavily in HPV vaccines and cervical cancer prevention.

3.    Novartis: Focuses on innovative treatments for menopause and endometriosis.

4.    Roche: Leads in ovarian cancer research and targeted therapies.

5.    GSK: Invests in cervical cancer vaccines and treatments.

The underinvestment in women's health research and clinical trials is a critical issue that affects not only women's health outcomes but also the broader economy. At Warman O'Brien, our mission is to support pioneering biotech and pharma companies by connecting them with the brightest minds, thereby fuelling future clinical trials globally.

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