1. Lack of Representation & Inclusiveness in Biomedical Research & Clinical Trials

Women of Color in Peace, Security and Conflict Transformation The Race Across the Pond Initiative: Women of Color in the Healthcare System Series

PART II - PRINCIPLE OF HEALTH CARE QUALITY

Authors: Yasmine El Addouli*, Saara Bouhouche

“The discrimination to which people, who are perceived as of non-European origin, are exposed, through their referrals, are supported by official data and research: Differences in treatment based on origin are a large-scale phenomenon. Deploying in all spheres of social life, these practices, sometimes openly discriminatory, constitute --for immigrants, descendants of immigrants, or people who are simply perceived as such-- daily pressures with lasting and deleterious effects on the life course and the social relations of a large part of the population residing in France” (France’s Defender of Rights, 2020).

1. LACK OF REPRESENTATION AND INCLUSIVENESS IN BIOMEDICAL RESEARCH AND CLINICAL TRIALS

In general, RMGs, including women, are underrepresented in biomedical research. A large majority of clinical study participants do not include RMGs.This situation has direct and indirect consequences on the population’s health since some therapies and medical devices, used in a standardized way, are not suitable for everyone. This oversight impacts the therapeutic support provided to RMG populations even today.

Although France is very largely affected by intersectional discrimination and structural inequities in health care, notably with a lack of representation of RMGs in biomedical research, questioning the discriminatory effects of racialization in health is rarely discussed or documented in France. Unlike in the United States and Great Britain, the topic is still considered taboo. As a consequence, additionally to the French resources, documentations and research, when comparisons were relevant and possible, this paper relied on the assistance of foreign scientific and empirical literature as illustrations. This document is an invitation to further reflect and understand how inequity is produced in public health.

In order to remedy the lack of representation of RMGs in biomedical research, researchers such as Steven Epstein argue in favor of oversampling racialized groups and women. Along the efforts of many social movements to fight for decolonization, equal civil rights, social justice, and anti-discriminations, biomedical research began to focus, at the end of the 80s in North America and in the beginning of the 90s in France, on the lack of representativeness of women and “ethnic groups” in clinical trials.

Women of Color in Peace, Security and Conflict Transformation The Race Across the Pond Initiative: Women of Color in the Healthcare System Series

However, structural transformation in the field is still a major priority and the needs remain important.

In the United States for example, The National Institutes of Health (NIH) published in 1993 a plea - The Revitalization Act - in favor of the women and “ethnic groups” inclusion in clinical trials. It even went further to make their inclusion a criterion for funding research.5 Despite these efforts, Risch. et al. posit that ten years later, most studies conducted through a random sample in the United States obtain, on average, a sample population of 75% Caucasian (who are non-Hispanic).

Other researchers reached similar conclusions, which led to reviewing the NIH Revitalization Act in 2009 and requiring all clinical trials to report the ethnicity of their participants. Despite this decision, to this day, the literature continues to warn that medical research still has major difficulties in pursuing the goals of the NIH.

Furthermore, a literature review (Burchard and Al, 2015) of articles on the pulmonary illnesses covering the period from 1993 to 2013 shows that, in the studies not financed by the NIH, the proportion of participants from “ethnic groups” increased only by 1.9% in the 20-year period.

CAUSES AND CONSEQUENCES

It is important to stress that RMGs and women, especially non-white women, have been excluded from biomedical research. In many cases, excuses and stereotypes were used to justify their exclusion from samples and research. For women in particular, the main argument was (and often continues to be) biological (hormonal fluctuation, menopause, and pregnancy chances during the study), and the related stereotyping of women as less “stable” subjects than men in the eyes of researchers.

The under-representation of RMGs in biomedical research is the result of a multi-causal process, which is not studied in an intersectional and exhaustive manner. Furthermore, penalty are not imposed for missing out on the fundamental and combinatorial factors of discrimination, inequalities, and inequity on these populations.

Racism and discriminating discourses are pervasive in French society and are found in all spheres (structural, institutional, collective, and individual). They are also expressed in a conscious and assertive manners (discriminatory policies, discourses, and acts that are racist and supremacist, sexist, islamophobic, and homophobic). Alternatively, they are more common to be expressed insidiously and unconsciously through collective

5 NIH Revitalization Act .Subtitle B:§131-133; 1993.

Women of Color in Peace, Security and Conflict Transformation The Race Across the Pond Initiative: Women of Color in the Healthcare System Series

behaviors, individual practices, and popular beliefs. Finally, they proliferate with reproducing biases, and stereotypical and discriminating patterns.

The health system as a whole is no exception; discrimination, ethnic and racial inequities in the health sector are prevalent in France but still remain considered anecdotal. Alternatively, systemic racism has become a proven cause and target of remedial action in the United States or Great Britain. This lag is due to the lack of understanding in France of the role of social determinants, socio-economic disparities, the colonial heritage in the French society and the impact of colonization in countries of origin of a large part of RMGs. The production mechanisms, and dissemination and establishment of social norms are based on a racialization that is derived from a culture of whiteness in healthcare.

The under-representation of RMGs also comes from the lack of unanimity in the scientific community regarding the use of ethnic data in biomedical clinical trials. Some researchers believe that the inclusion of ethno-racial data could be a great way to reduce health inequities. Others believe emphasizing individualized care is more important. However, the inclusion of such data would allow, according to proponents, to explore whether individuals sharing common ethnic or geographical characteristics are indeed more vulnerable to certain diseases compared with individuals with different affiliations. Indeed, the use of such data can facilitate the identification of the most vulnerable groups to certain health issues, and be able to protect them adequately.

For example, the use of ethnoracial data, in North America, has made it possible to better understand the disparities in the treatments of women with uterine fibroids. A 2010 article (Jacoby et al.,) on Americans and a recent article (Murji et al.,) on Canadians, show that black and East Asian women are exposed to severe uterine fibroids at higher rates and younger ages than the rest of the female population, especially white women. The extent and risk of the disease on these women necessitate close monitoring of these groups compared with other women.

However, unlike the United States or Great Britain, the collection of ethnoracial data in France is not common. Limitations are associated with contravening Article 1 of the Constitution which stipulates “equality before the law of all citizens without distinction of origin, race or religion.” Consequently, there is a strong legal limitation on the use of ethno-racial statistics. As mentioned before, certain exceptions for statistical and research purposes are possible under certain well-defined conditions. However, this legal context prevents the inclusion of such data in the french medical research field.