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Health disparities brought on by racial bias remain quite prevalent in areas such as drug access, use of diagnostics, and representation in clinical trials, but society-jarring events in recent years have sparked renewed efforts by industry to tackle these issues with tangible and hopeful gains.
It is no secret that there are racial—and gender—biases within the pharmaceutical and healthcare industries. This is apparent through the types of treatments that are researched and developed as well as through the people and communities who have historically had access to and been included in clinical trials. There is, of course, other evidence of these biases in present times, such as diagnostic tools created for white individuals and patients with lighter skin (i.e., pulse oximeters). But in recent years, there has been a renewed push for diversity, equity, and inclusion (DE&I) and to better address racial inequity specifically.
“The pharmaceutical/biotechnology/life sciences industry is very focused on racial bias as a driver of health inequity, including how it can undermine the inclusion of underrepresented populations in clinical trials as a function of improved health outcomes,” says Rose Blackburne, MD, vice president, global head, general medicine, PPD Clinical Research, part of Thermo Fisher Scientific. “While addressing racial bias is not a new interest for the industry, there has been [a] much renewed focus on this issue as a result of recent societal events, like the severe racial and ethnic disparities in COVID-19 outcomes seen early in the pandemic and the racial unrest stemming from the murder of George Floyd in 2020, as well as similar racially motivated violence prior to the pandemic that brought a wider recognition that racism has a structural basis and is embedded in long-standing social policy.”
Patrice Matchaba, MD, head of US corporate responsibility at Novartis and president of the Novartis US Foundation, also emphasizes changes that have transpired due to the pandemic.
“COVID tells us everything. COVID tells us that we should and can be doing much more,” says Matchaba. “[W]hen COVID struck, people saw two things: the lack of participation of communities of color in the clinical trials initially, and then the impact of COVID on the Black and Brown communities in terms of hospitalization and deaths. Then the whole discussion was—is this a genetic thing, or is it a social deterrent? And the basic answer is this: there has been no inclusion of Black and Brown communities and women in the R&D ecosystem.”
When it comes to R&D, Matchaba describes how there are countless therapeutic areas that heavily impact—or specifically impact—Black and Brown individuals as well as therapeutic areas specific to people assigned female at birth, and there are currently no or few treatments. Those therapeutic areas include:
Historically researched and developed treatments target therapeutic areas that typically impact white individuals, specifically white people assigned male at birth. Other diseases, such as leprosy, heavily impact Black and Brown communities in some countries due to a lack of access to diagnostics as well as proper treatments.
Another example of racial disparity was hospitalizations and mortality rates during the COVID-19 pandemic, which showed that Black and Hispanic/Latinx patients were disproportionately impacted, Jamie Freedman, PhD, MD, senior vice president, head of US medical affairs, Genentech, explains. But beyond the pandemic, Freedman also points to how patients living in rural areas are often excluded from clinical trials (usually at large academic medical centers) due to travel limitations.
Unfortunately, there are more underserved communities in medicine, which include Native Americans, Alaska Natives, and the First Nation.
“American Indian and Alaska Native (AI/AN) make up approximately 3% of the US population and face significant disease burden across disease areas and specifically higher cancer mortality rates compared to the general population,” says Freedman. “Health disparities and inequities in this population are attributed to poverty, lack of access to preventive and screening services through Indian Health Services, [and] distance to health facilities as many live in remote tribal and rural areas (54%).”1
Nan Gu, associate principal of patient health and equity, ZS, a management consulting and technology firm, describes additional racial bias in medicine, specifically how Native Americans and Alaska Natives have the lowest rate of private insurance coverage of anyone.2
One glaring example of racial bias is pulse oximeters. It has been discovered that, during COVID-19, pulse oximeters measured the oxygen levels of Black and Brown patients incorrectly, saying the patients were fine when they were not.3 As a direct result of this, Black and Brown patients were refused hospital admission and not given an ICU bed or access to ventilators—leading to increased levels of mortality rates. FDA met in 2022 to discuss pulse oximeters and this very issue.
While this example is geared toward diagnostics and devices, it is a glaring example of health inequities that are being brought to the surface, and Matchaba believes this is only the beginning.
“Look at the discussion from the FDA on the pulse oximeters. It is going to create an avalanche because it’s not just the pulse oximeters,” says Matchaba. “What about every other diagnostic that has come before us that has not included women or people of color? And I bet you, it’s all of it.”
Fundamentally, many things need to be changed to truly address racial bias in medicine, and it’s a long road ahead. But what can the industry do to combat bias and inequities today? Some of the first things to address in Black and Brown communities, according to Matchaba, are to:
Efforts are currently underway. According to Judith Kulich, principal, patient health and equity lead, ZS, the industry is targeting health inequities in the following ways:
Both Kulich and Matchaba talk of the Beacon of Hope as an example of what is being done in the clinical development space. It’s an initiative between Novartis, Merck, and Sanofi to address systemic health disparities through working with historically Black medical schools to enable the next generations of leaders, increase clinical trial diversity, and support research to reduce racial health disparities. Those schools include Morehouse School of Medicine, Howard University College of Medicine, Charles Drew University College of Medicine, and Meharry Medical College.
While there are many areas and sectors that require improvement in addressing health inequity, clinical trials are a current focus of the industry. Blackburne discusses the need to offer decentralized clinical trials (DCTs) and take advantage of digital and decentralized tools, which could increase patient access in Black and Brown communities.
“There is a huge opportunity for continued innovations that bring research closer to patients, leveraging real-world data and bringing the voice of the patient more fully into the drug development process,” Blackburne tells Pharm Exec.
Freedman also adds: “[DCTs] are an important approach, creating greater access for patients from remote or underserved communities. Patients are provided wearable devices that are used to interact with study investigators and have their labs and vitals monitored remotely.”
However, it is important to note that some marginalized communities have socioeconomic limits and may not have access to the internet or WiFi. Sometimes, even great technology can prevent people from having access to care.
Another way to support underserved communities in accessing clinical trials, according to Freedman, includes offering transportation vouchers or free rideshare options. Freedman also emphasizes the importance of having staff members at clinical trials who speak the language of the patient population, which is important for discussing consent forms as well as for patient advocacy.
Where to next? Matchaba stresses the importance of data as a way to address racial disparities.
“To me, [utilizing] data and race is our greatest [opportunity] to right the wrongs and improve medicine and healthcare for everybody, not just in the US,” says Matchaba.
Freedman sums up a few action steps:
While there is much work to be done that will span across decades, many in the industry are hopeful for changes in the coming years.
“This is highly speculative, but I see the possibility for numerous changes in the next five to 10 years that will greatly impact pharma’s ability to reduce health disparities,” says Kulich. “Even just focusing on the US, within five to 10 years FDA’s guidance on clinical trial representation will have been firmly established, and pharma will, I hope, have built capabilities to reach underserved populations through [DCTs and] expanded diversity among trial investigators, digital tools, and other means. The federal anti-kickback statute may have been revised, aimed at enabling pharma to more freely engage in partnerships and programs specifically targeted at improving health equity and patient outcomes. At the same time, we may have additional legislation designed to improve healthcare coverage for vulnerable Americans such that financial burden alone becomes less of a driver of inequity in care.”
Meg Rivers is Pharm Exec’s managing editor and can be reached at email@example.com.