Press release | GENDRO

Press release: GENDRO Raises Alarm Over Rollback of Diversity and Equity Initiatives in U.S. Research

by admin | Jan 28, 2025 | Press release

27 January 2025 | GENDRO and 22 civil society and academic partners

GENEVA, SWITZERLAND (27 January 2025) The recent decisions by the U.S. Food and Drug Administration (FDA) to eliminate resources promoting diversity in clinical trials¹, and the removal of information on NOH website about the NIH Sexual & Gender Minority Research Office (SGMRO)², which coordinates sexual and gender minority (SGM)-related research, represent significant setbacks in addressing gender and other biases in medical research. These actions threaten to undermine decades of progress aimed at ensuring medical studies and health research accurately reflect the diverse populations they are intended to serve. Diverse representation in clinical trials is not merely a matter of equity; it is essential for scientific validity. The exclusion or underrepresentation of certain groups can lead to findings that are not generalisable, potentially compromising patient care and outcomes. Without efforts to address gender and other biases in health research, health disparities will deepen, and social inequities will persist.

Women’s underrepresentation in clinical trials and inadequate attention to sex and gender dimensions in clinical studies have already been shown to cause risks to women’s health. For instance, a 2001 report by the U.S. Government Accountability Office found that eight out of ten prescription drugs withdrawn from the U.S. market since 1997 posed greater health risks for women than for men.³ In addition, in 2013, the FDA issued a safety notice recognising sex differences in the metabolism of the drug zolpidem and lowered the recommended dose for women to mitigate next-morning impairment risks.⁴ These examples showcase how neglecting sex and gender aspects can undermine the generalisability of medical research and underscore the importance of considering sex and gender factors in drug trials before drug approvals.

Likewise, the risk of removal of initiatives such as the SGMRO further marginalises populations already underrepresented in research, leaving their unique health needs at risk of being neglected. This action deepens the disparities faced by people of diverse sexual orientation and gender identities and expression and sex characteristics, further excluding them from the evidence base that informs diagnostics, treatments, and policies, and ultimately limiting advancements in equitable healthcare.

We call upon the European Medicines Agency and other regulatory and research bodies worldwide to intensify their commitment to ensuring that medical and health research reflects the diversity of the populations it serves. It is imperative that considerations of sex and gender, and their intersections with other variables, are integrated into study designs, data collection and analysis, and reporting, as recommended by the SAGER guidelines⁵. Such diligence can ensure that medical interventions are safe and effective across all segments of the population, improving diagnostic accuracy, treatment efficacy, and effectiveness of policy interventions.

GENDRO remains steadfast in its dedication to promoting gender equity and diversity in scientific research. We will continue to advocate for policies and practices that uphold the principles of gender equality, diversity, and inclusivity, recognising that such an approach is fundamental to scientific rigour and integrity, and to advancing health equity, leaving no one behind.

References

1.FDA purges clinical trial diversity pages | STAT. https://www.statnews.com/2025/01/23/fda-purges-pages-clinical-trial-diversity-after-trump-dei-ban/ (accessed Jan 26, 2025).

2. https://dpcpsi.nih.gov/sgmro (accessed Jan 26, 2025) 404 Error page.

3. Drug Safety: Most Drugs Withdrawn in Recent Years Had Greater Health Risks for Women. GAO-01-286R Drugs Withdrawn From Market. United States General Accounting Office, 2001.

4. U.S. Food and Drug administration. Risk of next‐morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist). FDA, 2013.

5. Heidari S, Babor TF, De Castro P, Tort S, Curno M. Sex and Gender Equity in Research: rationale for the SAGER guidelines and recommended use. Research Integrity and Peer Review 2016; 1: 2.

About GENDRO

GENDRO is a non-for-profit, non-governmental, independent association registered as a charity in Geneva, Switzerland with the mission to advance equity through the integration of sex and gender dimensions in research across disciplines. Our vision is to work collaboratively with partners, identify gaps, strengthen capacity, generate evidence, and advocate for academic research and any forms of knowledge production to create more equitable solutions to the societal challenges of our time. To learn more about GENDRO please visit our website.

Contact

For questions relating to this press release, please contact: [email protected]

Press release : Building back better – towards a gender-responsive international instrument for pandemic prevention, preparedness, and response

by admin | Jun 13, 2022 | Press release

13 June 2022 | GENDRO and 22 civil society and academic partners

Civil society and academic institutions urge governments to ensure gender equality, equity and human rights figure in the new International Instrument for pandemic prevention, preparedness and response.

GENEVA, SWITZERLAND (13 June 2022) – A coalition of 22 civil society and academic partners, convened by GENDRO, issued a Consensus Statement on 9 June, urging Member States to ensure a gender responsive international instrument for an effective and equitable prevention, preparedness and response to future pandemics.

The COVID-19 pandemic has transformed the global health landscape and has shown the necessity of revisiting response mechanisms to global health crises. It has also created an opportunity to build on momentum to critically reflect on persistent gender biases and inequalities that continue to exacerbate inequities and injustices.

As an International Negotiating Body (INB) is guiding the multilateral negotiations of a new international binding instrument to optimize a coordinated response to future global health emergencies, GENDRO and partners are appealing to INB and Member States to ensure an equitable and gender responsive pandemic response that leaves no one behind. They further call for key aspects pertinent to diverse women’s health, uninterrupted and non-discriminatory access to sexual and reproductive health services, timely prevention and response to gender-based violence and accountability mechanisms for zero tolerance against sexual harassments and abuse, to be explicitly articulated in the new instrument.

“At times of crisis, gender inequalities and social inequities are exacerbated and vulnerable populations are pushed further down margins. The gendered implications of the COVID-19 pandemic on women and girls and other marginalized groups are still palpable and are likely to be long lasting. We need to ensure that a gender, equity, and human rights lens is at the heart of the negotiations and ultimately embedded as an integral and cross-cutting theme in the new instrument” said Dr Shirin Heidari, founding president of GENDRO, at a civil society and Member State dialogue, co-hosted by GENDRO and the Permanent Mission of Canada to UN in Geneva on Thursday, 9 June 2022.

“Constructive dialogue about how to ensure gender, equity and human rights needs to start now as the INB begins its important work. In preparing for the next pandemic, we need to make sure no one is left behind” reiterated Tamara Mawhinney, Minister Counsellor at the Permanent Mission of Canada to the UN.

The Consensus Statement is currently endorsed by 22 organizations and a growing number of individuals are signing on. The key recommendations of the Consensus Statement were presented to the Member States at the event. Recommendations include the critical role of gender-sensitive data and evidence as basis for equitable policies and effective response that leaves no one behind. The group call on countries to strengthen their health information systems and invest in quantitative and qualitative research on diagnostics, therapeutics, prevention and protective measures, as well as social and economic implications to generate evidence that includesintersectional gender dimensions. The Consensus Statement further draws attention to specific elements, such as the need for ensuring uninterrupted access to sexual and reproductive health services, timely prevention and response to gender-based violence and due attention to the health and wellbeing of health workers.

Public health responses, including emergency measures must be legal, proportionate, necessary, and non-discriminatory and the gender implications must be considered prior to the imposition of any rights limitations in public health or emergency measures. Finally, meaningful participation of diverse groups of voices, including from organizations focusing on feminist approaches and gender equality from around the globe, through a transparent and inclusive process, must be guaranteed and it is imperative for an effective, acceptable, and successful pandemic preparedness.

GENDRO is welcoming other individuals and organizations to join as signatories to its statement.