Drugmakers, Black Women's Health Imperative press for diversity in the healthcare system.
According to FDA data, in 2020 more than 32,000 people took part in drug trials and 75% were white, 11% were Hispanic, 8% were Black, and 6% were Asian. The aftermath of COVID-19 shed light on glaring health disparities in the system, as access to vaccines and care impacted ethnic minority groups unequally.
In reaction to this spotlight, several pharma companies have pledged to increase their efforts in narrowing the gap in health equity. Pfizer, Johnson & Johnson, Moderna, and Novartis have all been vocal about their efforts, according to a report by media analytics company Commetric. Bristol Myers Squibb, Genentech, AbbVie and Gilead Sciences are also reported to be funding similar initiatives.
For example, Johnson & Johnson and nonprofit Stand Up to Cancer have joined in a $5 million partnership to increase diversity in early-phase clinical trials. In 2020, J&J also launched Our Race to Health Equity, a five-year, $100 million commitment to address the inequities and systemic racism that contribute to poorer health outcomes in communities of color in the United States.
Another example of pharma contributing to the health equity solution is the partnering of Pfizer and clinical research site organization Headlands Research. The two companies plan to launch new research sites in regions with vastly diverse populations to boost diversity in clinical trials. Last year, Pfizer ran a TV ad campaign aimed at increasing clinical trial participation in the black community, called 'Black Community Health Concerns.'
Additionally, the Pharmaceutical Research and Manufacturers of America (PhRMA) is funding a clinical trial initiative, Equitable Breakthroughs in Medicine Development, to enhance diversity with a $10 million grant which will source an 18-month pilot at 10 community sites located in the southern United States. This includes collaborating with three medical schools: the Yale School of Medicine, Morehouse School of Medicine, the Research Centers in Minority Institutions Coordinating Center at Morehouse School of Medicine and Vanderbilt University Medical Center.
The nonprofit Black Women's Health Imperative (BWHI), which strives to improve the health and wellness of Black women and girls, has several pharmaceutical companies as partners. Its core mission is advancing health equity and social justice for Black women, across their lifespan, through policy, advocacy, education, research, and leadership development. BWHI lists Gilead, bluebird bio, Novo Nordisk, Pfizer, Merck, Amgen and many more as partners working towards improving health equity in patients of color.
Linda Blount, MPH, President, CEO of BWHI spoke with Health Leaders about the possible solutions and initiatives that address the health disparities facing women of color.
Black women are vastly underrepresented in clinical research and trials, BWHI reports. An analysis of data from the FDA indicates that in trials for 24 of the 31 cancer drugs approved since 2015, fewer than 5% of study patients were Black. Without more diverse participation, research cannot be confident that new precision treatments will be effective for all patients.
To narrow the seemingly immovable gap (ratio of blacks to whites in clinical trials have stayed steady since 1985), there are several changes in the system that need to be made, according to Blount.
"In 1985, the Heckler report outlined the difference in health indicators between white and people of color, and honestly, things are worse now than they were in 1985. So, it's hard to talk about progress," Blount says.
Change clinical trial infrastructure
Blount suggests that one solution to addressing health disparities is to change the clinical trial infrastructure.
"Against the backdrop of last 40 years or so, more than $200 billion has been invested in research and community-based programs and philanthropy and all manner of ideas and efforts to achieve health equity, but we haven't gotten there yet," she says.
From the informed consent process to the location of clinical trials, the system is built against where and how black and brown people typically live. "Fundamentally, we've got a structure that doesn't comport itself to equity being accomplished," Blount says. "The way the systems of care are organized and delivered are not set up for black people, people of color or low-income people."
The number one reason people of color don't participate in clinical trials is not medical mistrust but that no doctor ever asks them, because doctors make assumptions about what black patients and Latino patients will and will not do, she adds. To participate in a clinical trial, you need to be near an academic medical center, you need to have time, money, childcare and transportation. That is not necessarily how patients are living.
Increasing the use of real-world studies can increase the enrollment of patients of color in clinical trials. These trials tend to accept nonmodel patients who are dealing with their condition in a very real life. "Real world studies are happening to a tiny degree now, but we need to conduct more so that we understand how these therapeutics work in the real lived experiences of people," Blount says.
Consequences need to be in place
Although the FDA has implemented the Enhance Equity Initiative to support efforts to advance diversity in clinical trials, there is no enforcement to encourage the practice. Some sort of consequences or incentives are needed in order to get researchers to try harder at achieving appropriate diversity in a clinical trial. Blount says this needs to be addressed through policy and enforcement. "The FDA says, 'we should have diversity in clinical trials,' but it doesn't enforce it," she says. "There are no repercussions for any researcher anywhere for not having appropriate diversity in a clinical trial. This needs to change because unfortunately, we just can't count on people to do things because it's the right thing to do."
Initiatives at the BWHI
The BWHI is doing its part with numerous initiatives, one of which is the Rare Disease Diversity Coalition (RDDC).
In May of 2020, BWHI launched the RDDC, to support rare disease patients of color facing racial disparities that created a serious health crisis for them. The RDDC was formed to identify and advocate for evidence-based solutions to alleviate the disproportionate burden a rare disease places on communities of color. The coalition brings together rare disease experts, health, and diversity advocates, and industry leaders to identify and advocate for evidenced-based solutions to alleviate the disproportionate burden of rare diseases on communities of color. Blount says this initiative has been successful because companies working in rare disease are usually smaller and more flexible and they were not afraid to have a conversation about medical bias and strive to be transparent about what they are doing to be inclusive in their trials. "We know black patients with a rare disease are waiting, on average, another five to six years longer to get a diagnosis than white patients," she says. "We've been able to fund groups to do proof of concept of the ideas that have come out of this coalition to see how they work so that we can then share that with hopefully, bigger Big Pharma, and researchers across the country.
Despite the slow movement in improving outcomes for patients of color, Blount says she believes achieving health equity for people of color is possible, but it will require change in behaviors, systems, policies and quality measures.
“In 1985, the Heckler report outlined the difference in health indicators between white and people of color, and honestly, things are worse now than they were in 1985. So, it's hard to talk about progress.”
Linda Blount, MPH, president / CEO, BWHI.
Robin Robinson is a contributing writer for HealthLeaders.
Pharmaceutical companies are partnering to increase participation in clinical trials.
The solution to health equity lies in changing health infrastructures.
Without consequences or incentives, health stakeholders will not transform their behavior toward patients of color.