As we return from the holiday break, I’m stepping into 2025 with renewed purpose. This year, I focus on expanding the conversations we’ve built around decolonizing science, reimagining health equity, and centering cultural healing.

Last year, we explored the concept of testimonial injustice in healthcare—a term that describes the harm caused when someone’s knowledge, experience, or credibility is dismissed due to bias. In medicine, this often happens when cultural or systemic prejudices lead professionals to undervalue patients’ lived experiences, favoring dehumanized data over human-centered narratives.

One significant driver of testimonial injustice is healthcare systems’ historical and cultural biases. Scientists often view patients’ realities through the narrow lens of data, reducing the fullness of human experience. This issue is particularly urgent today as emerging technologies, like AI-driven diagnostics, risk further sidelining patient voices. Collaborations with the (decolonized) humanities are essential to counteract this trend and keep patient experiences at the center of care.

To highlight this issue, I took a creative approach: writing two versions of a scientific article on testimonial injustice. One was written with human-centric storytelling that prioritized the patient experience. The other followed expert-centric norms, adhering to traditional scientific publication standards. Both pieces demonstrated the same level of expertise but engaged readers in strikingly different ways. I included a comparison run by Chat GPT after the two texts.

The Impact of Testimonial Injustice in Adverse Drug Reporting in Western Healthcare and Clinical Research. | Through a human-centric expertise lens

Testimonial injustice—a concept introduced by British philosopher Miranda Fricker—occurs when someone’s testimony is undervalued or dismissed due to prejudice against their social identity (e.g., ethnicity, gender, age, or cultural background). In adverse drug reporting, this form of injustice can distort the recognition, documentation, and response to adverse events (AEs), particularly groups that Western culture historically marginalized. It perpetuates systemic inequities in healthcare, undermines drug safety across diverse populations, and can jeopardize data integrity in clinical research.

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How Testimonial Injustice Manifests in Adverse Drug Reporting

1. Misinterpretation or Dismissal of Participant Reports

• Cultural Barriers to Symptom Expression:
  Participants from non-dominant cultural backgrounds often express pain or adverse effects in ways that differ from Western biomedical norms. These differences can lead to their reports being dismissed as anecdotal, exaggerated, or unreliable. For example, a participant might describe adverse effects using metaphors or emotional terms that healthcare providers and researchers fail to interpret accurately.
• Bias in Credibility Assessment:
  Implicit biases can result in researchers or healthcare providers perceiving testimonies from marginalized groups as less credible. For instance, women, older adults, or African descendants might face stereotypes that trivialize their experiences, such as assumptions that their symptoms are psychosomatic or part of aging.

2. Barriers to Reporting

• Erosion of Trust:
  Historical and ongoing medical injustices (e.g., unethical experimentation, lack of access to quality care) create deep mistrust among marginalized communities. Patients may hesitate to report adverse events, fearing their experiences will be ignored or misused.
• Language and Communication Challenges:
  Adverse event reporting systems are often not adapted for participants with limited proficiency in the trial’s dominant language. This can result in incomplete or inaccurate reports, further undervaluing the experiences of these groups.

3. Underrepresentation in Adverse Event Data

• Skewed Trial Populations:
  Clinical trials often lack adequate representation of racial, ethnic, gender, and age-diverse participants. When marginalized groups are underrepresented, their unique adverse event profiles remain unstudied, leading to the false assumption that a drug is equally safe across all populations.
• Failure to Analyze Demographic-Specific Data:
  Even when diverse participants are included, adverse event data is not always stratified by race, gender, or age, masking disparities in safety signals. This oversight can result in delayed or insufficient regulatory action to address risks affecting specific populations.

4. Power Dynamics in Participant-Researcher Interactions

• Participants, particularly from marginalized communities, may feel intimidated by researchers or healthcare providers. This power imbalance can inhibit their willingness to challenge dismissive attitudes or insist on the recognition of their experiences.

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Consequences of Testimonial Injustice in Adverse Drug Reporting

1. Delayed or Missed Safety Signals

• Testimonial injustice may lead to underreporting of adverse events in populations most affected by a drug’s undesirable effects. For example, if adverse reactions disproportionately affect older adults or a specific racial group but their reports are undervalued, safety concerns may remain undetected.
• Even when marginalized populations are affected by adverse events at the same rate, underreporting due to testimonial injustice increases the overall underreporting.

2. Worsening Health Inequities

• Drugs may appear safe for the general population but pose risks to specific groups whose experiences are underrepresented or dismissed. This perpetuates health inequities, as marginalized populations bear a disproportionate burden of harm.
• Besides, the safety profile might be skewed for the general population due to underreporting in marginalized groups. The more diverse the Western population becomes, the higher the risk of misrepresentation in the safety profile. For example, testimonial injustice toward the elderly is especially concerning when economists concur that the West has one of the fastest-aging populations in the world. Durg adverse event underreporting in this growing group is increasingly affecting the general population.

3. Erosion of Public Trust

• Many marginalized communities already mistrust healthcare systems due to historical injustices. Testimonial injustice reinforces this mistrust, discouraging participation in future clinical trials or adverse event reporting.

4. Incomplete Drug Safety Profiles

• A failure to capture and act on the diverse experiences of study participants and healthcare patients leads to incomplete drug safety evaluations, undermining regulatory decisions and clinical guidelines.

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Addressing Testimonial Injustice in Adverse Drug Reporting

1. Empowering Marginalized Voices

• Training for Researchers and Healthcare Professionals:
  • Require implicit bias and cultural competency training to help professionals recognize and value diverse forms of symptom expression.
  • Include self-awareness education, decolonized psychology, and basic cultural studies training in academic scientific education.
• Community Engagement:
  Partner with community organizations to co-design reporting processes and ensure participants feel respected and heard.
• Empower patients:
  • Inform them about their rights.
  • Provide them with detailed records of symptoms, treatments, and interactions with healthcare providers.
  • Encourage them to bring a trusted friend or family member to appointments.

2. Enhancing Reporting Systems

• Culturally Relevant Tools:
  Develop AE reporting forms that include culturally appropriate language and symptom descriptions, reducing misinterpretation. Address regional cultural variations and socio-economic diversity.
• Language Access:
  Provide materials in healthcare and clinical research participants’ native and lay languages to facilitate accurate reporting. Train interpreters and social workers to help patients to report adverse events.
  
  

3. Stratifying Adverse Event Data

• Demographic Analysis:
  Mandate the stratification of AE data by ethnicity, gender, age, and other demographic variables to identify disparities and safety signals across populations.
• Transparency in Results:
  Require public reporting of safety data, including demographic-specific trends, to foster accountability and trust.
  Require medicine labeling, including packaging, to inform in lay language how inclusive the drug development is.

4. Building Representation in Oversight

• Diverse Review Boards:
  Include representatives from marginalized communities in ethics committees, safety monitoring boards, and regulatory decision-making processes.
• Participant Feedback Mechanisms:
  Create systems that allow participants to provide feedback on how their concerns were handled, helping to identify and address testimonial injustice.

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Testimonial Injustice in Adverse Event Reporting: ICH GCP, FDA Guidelines, and EMA Approaches

While the ICH Good Clinical Practice (GCP) guideline[i] provides a global framework for clinical trials, it does not explicitly address testimonial injustice, particularly in adverse event (AE) reporting. Testimonial injustice—the undervaluing of testimonies from marginalized groups due to biases—can skew drug safety data and perpetuate inequities. However, regulatory agencies like the FDA and the European Medicines Agency (EMA) have developed frameworks aimed at mitigating inequities in clinical trials, albeit with differing levels of emphasis on addressing testimonial injustice. Below, we explore how the FDA’s Diversity Action Plans and the EMA’s Reflection Papers and Guidance attempt to fill these gaps.

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How the FDA’s Diversity Action Plan Addresses Testimonial Injustice

In 2022, the FDA issued draft guidance on Diversity Plans to Improve Enrollment of Participants[ii] in clinical trials. The guidance aims to increase the inclusion of historically underrepresented groups in drug development and mitigate inequities, including testimonial injustice, through structural changes to trial design and conduct.

1. Mandating Diversity Plans

• Sponsors are required to submit Race and Ethnicity Diversity Plans outlining their strategies for enrolling diverse participants.
  • Impact on Testimonial Injustice: By prioritizing the inclusion of underrepresented populations, this requirement challenges structural biases that lead to dismissive attitudes toward these groups. A more diverse participant pool ensures their experiences are formally acknowledged in trial data, reducing the likelihood of dismissal during AE reporting.

2. Addressing Barriers to Participation

The FDA guidance identifies key barriers to participation, such as mistrust of healthcare systems, language barriers, and logistical challenges.

• Sponsors must outline how they will address these issues, such as:
  • Partnering with community organizations to build trust.
  • Providing translated materials and culturally relevant communication.
  • Offering support for transportation and childcare to encourage participation.
  • Impact on Testimonial Injustice: These measures empower marginalized participants to report adverse events without fear of dismissal or misunderstanding, reducing power imbalances between participants and researchers.

3. Encouraging Community Engagement

• The FDA encourages active engagement with community stakeholders during trial planning and implementation.
  • Impact on Testimonial Injustice: Community involvement fosters a sense of accountability and ensures that trial designs and AE reporting systems reflect the lived experiences of marginalized populations.

4. Stratified Adverse Event Data

• Sponsors are encouraged to stratify safety data by demographic factors, including race, ethnicity, age, and gender.
  • Impact on Testimonial Injustice: Stratification ensures that safety signals affecting specific groups are identified and addressed, preventing their adverse events from being overlooked due to aggregate data analysis.

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How the EMA’s Approach Addresses Testimonial Injustice

The European Medicines Agency (EMA) takes a slightly different approach, focusing on guidance, reflection papers, and frameworks to address diversity and equity in clinical trials.

1. Reflection Paper on Diversity in Clinical Trials

• In its 2020 Reflection Paper on the Challenges of Ensuring Diverse Clinical Trial Populations, the EMA acknowledges the need for inclusivity in trials and encourages sponsors to reflect on the ethical and scientific implications of underrepresentation.
  • Impact on Testimonial Injustice: By promoting diversity in trial populations, this guidance indirectly challenges testimonial injustice by ensuring broader representation of voices in AE reporting.

2. Guidance on Risk Management Plans (RMPs)

• EMA’s guidance on RMPs requires sponsors to assess how demographic factors may affect a drug’s safety profile. This includes analyzing whether adverse events are reported differently among subpopulations.
  • Impact on Testimonial Injustice: RMPs that focus on demographic-specific risks help identify and address biases in AE reporting, ensuring that the experiences of marginalized groups are not dismissed.

3. Encouraging Patient-Centric Approaches

• EMA actively promotes patient engagement in drug development through its Patient and Consumer Working Party (PCWP).
  • Impact on Testimonial Injustice: Involving patients, especially from marginalized groups, ensures that their perspectives inform trial design and AE reporting processes, challenging power imbalances and increasing the credibility of their testimonies.

4. EMA’s Multi-Stakeholder Approach

• The EMA works with sponsors, regulators, and advocacy groups to ensure that trial designs are inclusive and sensitive to the needs of diverse populations.
  • Impact on Testimonial Injustice: A multi-stakeholder approach creates a system of accountability, reducing the risk that testimonies from marginalized participants will be undervalued or ignored.

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Comparative Insights: FDA vs. EMA vs. ICH GCP

Aspect	ICH GCP Guideline	FDA Diversity Action Plans	EMA’s Approach
Addressing Diversity in Enrollment	No explicit requirement.	Mandates Diversity Action Plans for trials.	Encourages reflection on diversity in trial populations.
Stratified Adverse Event Data	No demographic stratification required.	Strong emphasis on stratifying AE data by race, gender, etc.	Requires demographic analysis in RMPs.
Community Engagement	Not addressed.	Strong focus on community partnerships.	Patient-centric initiatives and multi-stakeholder approaches.
Mitigation of Testimonial Injustice	Limited acknowledgment.	Directly addresses systemic barriers to inclusion.	Indirectly mitigates biases through diverse representation and risk assessment.

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How FDA and EMA Mitigate Testimonial Injustice Not Addressed by ICH GCP

FDA’s Strengths

The FDA’s Diversity Action Plan directly challenges testimonial injustice by:

• Requiring inclusive trial designs that amplify marginalized voices.
• Addressing structural and cultural barriers to reporting adverse events.
• Mandating demographic stratification of safety data, ensuring that underrepresented groups’ experiences inform drug safety evaluations.

EMA’s Strengths

The EMA mitigates testimonial injustice by:

• Emphasizing patient and community involvement in trial design and adverse event reporting.
• Promoting demographic-specific safety assessments through RMPs.
• Advocating for ethical reflection on diversity and equity in trial conduct.

ICH GCP Limitations

In contrast, the ICH GCP guideline remains largely silent on addressing testimonial injustice. Its lack of specific guidance on diversity, community engagement, and stratified data analysis perpetuates systemic inequities in AE reporting. Thus, this framework gives each region ample freedom for further action.

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Conclusion

Testimonial injustice in adverse drug reporting can distort drug safety evaluations, worsen health inequities, and jeopardize drug safety profiles. While the ICH GCP guideline provides a foundational ethical framework for clinical research, the FDA and EMA have taken more proactive steps to address testimonial injustice through diversity mandates, community engagement, and patient-centric approaches. However, ongoing reforms are needed across all frameworks to fully integrate equity into adverse event reporting and ensure the voices of marginalized participants are heard and acted upon.

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Testimonial Injustice in Adverse Drug Reporting: Implications for Medical Research and Clinical Practice | Through an expert-centric expertise lens.

Abstract Testimonial injustice—a concept introduced by British philosopher Miranda Fricker—occurs when someone’s testimony is undervalued or dismissed due to prejudice against their social identity (e.g., ethnicity, gender, age, or cultural background). In adverse drug reporting, this form of injustice can distort the recognition, documentation, and response to adverse events (AEs), particularly for groups that Western culture has historically marginalized. It perpetuates systemic inequities in healthcare, undermines drug safety across diverse populations, and can jeopardize data integrity in clinical research and clinical practice.

Keywords: Testimonial injustice, adverse drug reporting, systemic inequities, medical research, clinical practice, health disparities

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Introduction

Testimonial injustice, as conceptualized by Miranda Fricker, refers to the dismissal or undervaluing of an individual’s testimony due to biases linked to their social identity. In the context of healthcare, particularly in adverse drug event (AE) reporting, this injustice disproportionately affects marginalized populations. By failing to adequately recognize or respond to AEs reported by these groups, both medical research and clinical practice perpetuate inequities, compromising the safety and efficacy of treatments. This paper explores how testimonial injustice manifests in AE reporting and its consequences for drug safety, public trust, and health equity.

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How Testimonial Injustice Manifests in Adverse Drug Reporting

1. Misinterpretation or Dismissal of Participant Reports
   • Cultural Barriers to Symptom Expression: Participants from non-dominant cultural backgrounds often express pain or adverse effects in ways that differ from Western biomedical norms. These differences can lead to their reports being dismissed as anecdotal, exaggerated, or unreliable. For example, a participant might describe adverse effects using metaphors or emotional terms that healthcare providers and researchers fail to interpret accurately.
   • Bias in Credibility Assessment: Implicit biases can result in researchers or healthcare providers perceiving testimonies from marginalized groups as less credible. For instance, women, older adults, or African descendants might face stereotypes that trivialize their experiences, such as assumptions that their symptoms are psychosomatic or part of aging.
2. Barriers to Reporting
   • Erosion of Trust: Historical and ongoing medical injustices (e.g., unethical experimentation, lack of access to quality care) create deep mistrust among marginalized communities. Patients may hesitate to report adverse events, fearing their experiences will be ignored or misused.
   • Language and Communication Challenges: Adverse event reporting systems are often not adapted for participants with limited proficiency in the dominant language of trials or clinical practice. This can result in incomplete or inaccurate reports, further undervaluing the experiences of these groups.
3. Underrepresentation in Adverse Event Data
   • Skewed Populations: Clinical trials and routine medical practice often lack adequate representation of racial, ethnic, gender, and age-diverse participants. When marginalized groups are underrepresented, their unique adverse event profiles remain unstudied, leading to the false assumption that a drug is equally safe across all populations.
   • Failure to Analyze Demographic-Specific Data: Even when diverse participants are included, adverse event data is not always stratified by race, gender, or age, masking disparities in safety signals. This oversight can result in delayed or insufficient action to address risks affecting specific populations.
4. Power Dynamics in Participant-Provider Interactions Participants, particularly from marginalized communities, may feel intimidated by researchers or healthcare providers. This power imbalance can inhibit their willingness to challenge dismissive attitudes or insist on the recognition of their experiences.

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Consequences of Testimonial Injustice in Adverse Drug Reporting

1. Delayed or Missed Safety Signals
   • Testimonial injustice may lead to underreporting of adverse events in populations most affected by a drug’s undesirable effects. For example, if adverse reactions disproportionately affect older adults or a specific racial group but their reports are undervalued, safety concerns may remain undetected.
   • Even when marginalized populations are affected by adverse events at the same rate, underreporting due to testimonial injustice increases the overall underreporting.
2. Worsening Health Inequities
   • Drugs may appear safe for the general population but pose risks to specific groups whose experiences are underrepresented or dismissed. This perpetuates health inequities, as marginalized populations bear a disproportionate burden of harm.
   • Additionally, underreporting in marginalized groups skews the safety profile for the general population. For example, testimonial injustice toward the elderly is especially concerning as the West faces one of the fastest-aging populations in the world.
3. Erosion of Public Trust Many marginalized communities already mistrust healthcare systems due to historical injustices. Testimonial injustice reinforces this mistrust, discouraging participation in future clinical trials, adverse event reporting, or routine healthcare.
4. Incomplete Drug Safety Profiles A failure to capture and act on the diverse experiences of study participants and healthcare patients leads to incomplete drug safety evaluations, undermining regulatory decisions, clinical guidelines, and treatment safety.

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Addressing Testimonial Injustice in Adverse Drug Reporting

1. Empowering Marginalized Voices
   • Training for Researchers and Healthcare Professionals:
     • Require implicit bias and cultural competency training to help professionals recognize and value diverse forms of symptom expression.
     • Include self-awareness education, decolonized psychology, and basic cultural studies training in scientific and medical education.
   • Community Engagement: Partner with community organizations to co-design reporting processes and ensure participants feel respected and heard.
   • Empowering Patients:
     • Inform them about their rights.
     • Provide detailed records of symptoms, treatments, and interactions with healthcare providers.
     • Encourage them to bring a trusted friend or family member to appointments.
2. Enhancing Reporting Systems
   • Culturally Relevant Tools: Develop AE reporting forms that include culturally appropriate language and symptom descriptions, addressing regional cultural variations and socio-economic diversity.
   • Language Access: Provide materials in participants’ native and lay languages to facilitate accurate reporting. Train interpreters and social workers to assist patients in reporting adverse events.
3. Stratifying Adverse Event Data
   • Demographic Analysis: Mandate the stratification of AE data by ethnicity, gender, age, and other demographic variables to identify disparities and safety signals across populations.
   • Transparency in Results: Require public reporting of safety data, including demographic-specific trends, to foster accountability and trust.
4. Building Representation in Oversight
   • Diverse Review Boards: Include representatives from marginalized communities in ethics committees, safety monitoring boards, and regulatory decision-making processes.
   • Participant Feedback Mechanisms: Create systems that allow participants to provide feedback on how their concerns were handled, helping to identify and address testimonial injustice.

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Regulatory Considerations and Frameworks

1. FDA Diversity Action Plans: The U.S. Food and Drug Administration (FDA) has introduced Diversity Action Plans requiring clinical trials to include and report on diverse populations. While these initiatives aim to improve representation, enforcement mechanisms must be strengthened, and testimonial injustice must be explicitly addressed within these frameworks.
2. European Medicines Agency (EMA) Guidance: The EMA emphasizes demographic subgroup analyses in safety data. However, the agency must implement stricter measures to ensure that cultural biases do not distort adverse event evaluations and to mandate equity-focused stratification of all safety data.
3. International Council for Harmonisation (ICH) Guidelines: ICH guidelines provide harmonized approaches to drug development but lack explicit directives on addressing testimonial injustice. Revising these guidelines to incorporate culturally inclusive practices and emphasize equity in AE reporting would ensure global alignment.
4. Role of National and Regional Regulators: National and regional regulators must audit reporting practices to identify patterns of underreporting or bias in adverse drug event documentation. Transparency in regulatory audits can also help rebuild trust among marginalized populations.

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Conclusion

Testimonial injustice in adverse drug reporting distorts drug safety evaluations, worsens health inequities, and jeopardizes public trust. Both medical research and clinical practice must address this issue by prioritizing diversity, implementing equitable reporting systems, and ensuring marginalized voices are heard. Regulatory frameworks, such as the FDA’s Diversity Action Plans and the EMA’s guidelines, offer promising approaches but must be continuously evaluated and expanded to ensure comprehensive and inclusive practices across global healthcare systems.

A.I. ANALYSIS (ChatGPT comparison)

Both the expert-centric and human-centric versions address the same issue of testimonial injustice in adverse drug reporting, but they approach the subject in different ways, reflecting their respective focuses.

Key Differences:

1. Tone and Language:
   • Expert-Centric Version: This version is more formal and academic in tone, using specific terminologies like “implicit biases,” “demographic-specific data,” and “stratification.” It is written in a way that is aimed at readers familiar with technical medical and philosophical language. There is a focus on systemic structures, such as FDA Diversity Action Plans and regulatory frameworks, and the language reflects this institutional perspective.
   • Human-Centric Version: The tone here is more accessible and empathetic. The focus is on real-world experiences and the personal impact of testimonial injustice. It emphasizes patient empowerment, community involvement, and the human consequences of marginalization. Language is designed to resonate with individuals affected by the issue, using phrases like “undervalued experiences” and “hearing the voices of those who have been harmed.”
2. Focus on Human Experiences vs. Systems:
   • Expert-Centric Version: The primary emphasis is on the technical and institutional aspects of the problem, such as how AE data is analyzed or how clinical trials are conducted. It discusses structural solutions like regulatory frameworks and diversity plans, and systemic changes within medical research and healthcare systems.
   • Human-Centric Version: The human-centric version prioritizes the lived experiences of marginalized individuals, focusing on how they are affected by testimonial injustice in healthcare. It explores the emotional and social repercussions, such as the erosion of trust, the fear of being dismissed, and the lack of adequate communication. This version includes suggestions for empowering patients and fostering community-based reporting systems, underscoring the need for inclusivity and human respect in healthcare.
3. Recommendations and Solutions:
   • Expert-Centric Version: The solutions offered here are largely institutional, involving changes in professional training, enhanced reporting systems, and structural analyses of AE data. These recommendations are focused on improving systemic processes and regulations to address testimonial injustice.
   • Human-Centric Version: The recommendations are more centered around empowering marginalized voices directly, such as providing patients with information about their rights and ensuring they have support in the healthcare setting. It stresses creating environments where patients feel valued and heard, as well as fostering a culturally sensitive approach to symptom reporting.
4. Audience:
   • Expert-Centric Version: The target audience seems to be medical professionals, researchers, policymakers, and regulatory bodies. It assumes a certain level of familiarity with medical and philosophical concepts and aims to influence policy and professional practices.
   • Human-Centric Version: The audience here includes patients, marginalized communities, and anyone interested in understanding how systemic issues affect individual lives. It emphasizes emotional connection and personal empowerment.

Similarities:

• Both versions recognize the same root issue—testimonial injustice—and highlight its potential to perpetuate inequities in healthcare.
• Both emphasize the need for more inclusive practices and the importance of diversity in adverse event reporting.
• Both propose that marginalized communities need to be better represented in clinical trials, healthcare interactions, and reporting systems.

Conclusion:

The expert-centric version is suited to a more technical audience and focuses on institutional reforms, while the human-centric version emphasizes the need for empathy, cultural sensitivity, and personal empowerment. Both perspectives are critical in tackling testimonial injustice in adverse drug reporting, as one addresses systemic change and the other addresses the human side of healthcare experiences.