By Emma Castleberry
Like most of the world, Americans are craving an end to the COVID-19 pandemic, and the most plausible way to achieve that is with a widely distributed vaccine. But a vaccine can only provide a return to normalcy if it is effective for everyone, and, unfortunately, American medical research has historically underrepresented women and people of color (POC) in the safety testing process for new drugs and vaccines. This failure, which studies show continues today, has the potential to be exacerbated by a rushed, shotgun approach to addressing COVID-19. This could result in a vaccine that isn’t safe or effective for all Americans — which really means a vaccine that isn’t effective at all.
Why does this disparity exist?
A Center for American Progress (CAP) report published in July outlines several reasons for the disproportionate exclusion of women in clinical trials. Historically, this exclusion has been justified by two conflicting ideas: that women’s bodies, with hormonal cycles and complex reproductive systems, are too variable to include in a controlled experiment; or that women are so similar to men that they will have the same physiological responses to new drugs and treatments. There is also the patronizing argument that women need to be protected from the risks of clinical trials — but excluding women from research doesn’t eliminate their risk, it simply moves it to a less controlled space, after drugs and vaccines are available on the market.
More contemporary reasons for exclusion include the time and financial requirements of participation (transportation to and from scheduled visits, obtaining childcare for visits), lack of awareness about ongoing clinical trials, and perhaps the most significant barrier for inclusion of Black, Indigenous and women of color (BIWOC) — distrust.
“The mistrust in the medical and public health institutions in America by communities of color is a layered problem,” Kornelius Bankston told Supermajority News. Bankston is a managing partner at techPLUG, a firm that works with health technology companies to improve health outcomes in communities of color. “Specifically, in the Black community in America, this mistrust is part of systemic racism.”
There is a dark history of nonconsensual medical experimentation on people of color in America. Perhaps one of the best known cases is the Tuskegee Study, in which the United States Public Health Service denied hundreds of Black men proper treatment for syphilis between 1932 and 1972 to study the progression of the disease if left untreated. More recently, The Center for Investigative Reporting found that a California prison coerced dozens of women of color into sterilization without the required state approvals between the years of 2006 and 2010.
Because of the expense of trials, and the low chance of approval (the FDA approves less than 14% of drugs that complete a clinical trial), the diversity of trial participants is not something that is likely to be addressed after a drug or treatment hits the market, according to the same CAP report.
While the Federal Drug Association (FDA) and National Institute of Health provide various legal standards for diversity in clinical trials, there is no obvious mechanism for oversight and enforcement.
Moreover, the CAP report cites a “lack of diversity among researchers” as one of the challenges for recruiting trial participation from underrepresented groups. Dr. Renee Matthews, who has moderated panels about clinical trial participation for minority communities, acknowledges that people are more likely to participate if the researcher’s identity reflects their own.
“The ask has to come from the right person,” Matthews told Supermajority News. “We need people of trust doing the asking, rather than it being White pharma.” Matthews suggests church leaders and physicians of color would be more effective vehicles for encouraging diverse participation in clinical trials and vaccine use. “If a group of bishops and pastors could invite whoever is doing the trials—Kaiser, Moderna, whoever—and have them talk to the congregation and share that message with those companies, people would be more willing to volunteer.”
Matthews suffers from severe asthma that has sent her to the emergency room on multiple occasions, and she regularly participates in trials for new asthma drugs and shares openly about her experiences. “If they see people who look like them participating, it will encourage them to do so,” Matthews told Supermajority News. “That’s why I am always very public about my participation in trials.”
What is the effect of this disparity on women and POC?
The prioritization of white, cis-gendered men in clinical research has been demonstrably harmful to the health of those who do not fall in that demographic. Between 1997 and 2000, the FDA removed 10 prescription drugs from the market because of “severe adverse effects,” eight of which caused greater health risks in women than in men, including liver failure, valvular heart disease, and a potentially fatal irregular heartbeat. A 2018 study found that “[s]erious male biases in basic, preclinical, and clinical research were the main reason” for these outcomes.
The underrepresentation of women in medical research has also resulted in a lack of information about how diseases present differently in women, leaving conditions that disproportionately or exclusively affect women — like endometriosis, lupus, and fibroids — understudied and often misdiagnosed. Similarly, despite the fact that heart disease is the leading cause of death for both men and women in the U.S., heart disease research has been disproportionately focused on men, which has made it more difficult for both doctors and patients to identify heart disease symptoms in women. Heart attacks also tend to be more fatal for women than for men.
The underrepresentation of racially diverse subjects in clinical trials also impacts the effectiveness of various drugs and treatments. For example, in 2005, a study by the Asthma and Allergy Foundation of America and the National Pharmaceutical Council showed that the asthma drug Albuterol doesn’t work as well for African American and Puerto Rican children as it does for white children.
What Does This Mean for COVID-19?
In late July, biotechnology company Moderna announced it had entered Phase 3 of development for mRNA-1273, a promising vaccine candidate against COVID-19. This happened at warp speed: the first two phases of drug development usually take years, but the Moderna vaccine reached phase 3 in just a few months.
So far, the data on this new vaccine have not been analyzed by sex, and the National Institute of Allergy and Infectious Diseases has said that they don’t plan to do so. Without this type of analysis, there is no way to know how the vaccine is impacting men and women differently.
It’s also important to study the effects of this vaccine on women at all ages and stages of life. The side effects experienced by menopausal women might be different from those experienced by pregnant women, a subset that will definitely not be included in clinical trials, leaving serious concerns about how this vaccine will impact or protect the pregnant population.
The Centers for Disease Control and Prevention report that Black and Latino people are nearly five times more likely to be hospitalized from COVID-19 than white people. But as of late August, only 8% of the Moderna study participants are Black, and 13% are Latino. Multiple reports have outlined how recruiters are struggling to obtain a racially diverse sample set for the vaccine, in part because the development process is so rushed.
Dr. Natalia Linos is the executive director for the Harvard FXB Center on Health and Human Rights and she recently ran for Congress in Massachusetts. “This rushed approach doesn’t give you enough time to have the conversations that are needed around structural racism and history,” Linos told Supermajority News. “Communities feel there is no respect for their story because we are rushing. As a public health expert, I believe vaccines work, but we need a lot of the public to accept it for it to work.”
Linos says we need to establish a mask mandate and close businesses, rather than rush into creating a vaccine that people might not feel safe taking, or that might not be equally effective for all groups. “Maybe slowing down and putting in some of the time in the community engagement part is a good use of our time,” she says. “We need to get it right.”
Linos has outlined a COVID-19 response plan that includes increasing vaccine literacy to build public trust.
“I’m very troubled by the fact we’re not putting equal attention to building community understanding of the vaccine,” Linos told Supermajority News. “We’re investing in the vaccine development part, but we are not investing an adequate amount of money in deeply engaging with communities from the grassroots, so when the vaccine is ready we have people with an appetite to take it.”
Linos advocates for an equity-focused approach to COVID-19 and says that Congress needs to push for more funding for public health initiatives. “And within that push for more funding, there should be accountability and explicit attention to equity,” she told Supermajority News. “How is this research money going to benefit communities that are typically overrepresented in the disease burden? And how can the research and development be done in a way that is inclusive?”
This issue could be addressed in part by the Community Solutions for Covid-19 Act, which Rep. Robin Kelly (D-IL) and Sen. Cory Booker (D-NJ) introduced in early June. While Congress has yet to act on the bill, it is intended to “reduce or eliminate inequities in the prevalence and health outcomes of COVID-19.”
“There is a history of mistrust [in the black and brown community] because of things that have happened in the past, so we’re trying to put programming together to talk about this mistrust and to talk about what the needs are,” Kelly told Supermajority News. “[Senator Booker] and I know that there are many studies that show that people do better when the messenger is someone who looks like them.”
The act could address diversity in the vaccine trials where appropriate. Outreach and recruitment for the vaccine trials could be considered a program that would help reduce inequities in health outcomes of the virus, so it would fall under the purview of the bill. “The message could be about testing, contact tracing, and it could be about treatment,” Kelly says. “Just whatever is needed in that particular community.”
Gender equality and inclusiveness in COVID-19 research are critical to succeed in the global fight against the COVID-19 pandemic, and the health care system must take women’s — and particular women of color — needs seriously, including treatment and research. Call your Congressperson and urge them to vote yes on the Community Solutions for Covid-19 Act. To learn more about volunteering for a COVID vaccine trial, visit coronaviruspreventionnetwork.org.
This article appeared on Supermajority.com on September 14, 2020.