Drug companies pushing to fight the coronavirus with a vaccine must overcome a legacy of suspicion, even as Black communities have been hit hard by the pandemic.
The Search for Diversity in Drug Trials
In this 1950s photo released by the National Archives, a Black man included in the Tuskegee syphilis study has blood drawn by a doctor in Tuskegee, Ala. The once-secret Tuskegee experiment has become shorthand among African Americans for a legacy of mistreatment in medicine.(NATIONAL ARCHIVES)
AMID A SEEMINGLY endless pandemic, as a spiraling number of COVID-19 deaths presage what could be a long, dark winter, the news broke through like thin rays of sunshine: Two American pharmaceutical giants racing to find a vaccine separately reported that human tests of their experimental drugs have shown highly promising results.
The potentially game-changing data from drug manufacturers Pfizer and Moderna, however, obscured what some say is anotherkey development: Both companies reported that the pools of volunteers receiving the drugs included significant numbers of Black participants.[
The inclusion of Black people in trials for a highly anticipated drug might seem like a no-brainer, particularly for a vaccine to fight COVID-19, a contagion that’s been killing Black Americans at a rate higher than whites. Indeed, PhRMA, the drug industry’s influential trade group, just announced a new set of principles that urge diversity in human trials for new drugs to boost health equity, increase participation by people of color, ensure drug effectiveness – and tackle lingering suspicion of the medical industry among some African Americans.
“Between Latinx and Black or African American populations, we’re running at about 19% or so,” Dr. Bill Gruber, Pfizer’s senior vice president of vaccine clinical research and development, told Reuters this summer, describing a trial pool of 11,000 people for a vaccine being developed with German partner BioNTech. “We’re trying to push even higher than that.”
The company appears to have improved, saying as of Monday that 30% of U.S. trial participants had “diverse” backgrounds, with Black people and those identified as either Hispanic or by the gender-neutral term Latinx accounting for approximately 10% and 13% shares, respectively. Moderna, meanwhile, said its 30,000-person phase three vaccine study included more than 11,000 people from communities of color, including more than 6,000 Hispanic or Latinx people and more than 3,000 Black or African American participants.
Yet while the industry insists it is moving with deliberate speed toward diversity and inclusion in experimental drug trials, some say it’s taking baby steps and has a long way to go toward building trust with African Americans and other minority communities.
“There are a lot of outstanding questions,” says Jonathan Jackson, a cognitive neuroscientist and director of the Community Access, Recruitment, and Engagement Research Center at Massachusetts General Hospital in Boston. The center investigates the effects of diversity and inclusion on human subject research.
“A lot of people who have been running the COVID-19 vaccine studies have been really excited because they have recruited a more diverse population, compared to what they’re used to,” Jackson says. “The bar that you’re trying to clear shouldn’t be a study that you ran last year,” but the goal should be to mirror the population most affected by the targeted disease.
“So if those are our baselines, then what we’re seeing – even though it is a significant increase in diversity – is still nowhere near representative of COVID hospitalizations or COVID deaths,” Jackson says. “It’s hard to get excited when we still have so far to go.”
Jackson and others say the lack of diversity in medical trials has roots extending deep into U.S. history.
Dr. J. Marion Sims, onetime president of the American Medical Association and an esteemed physician dubbed “the father of modern gynecology,” made groundbreaking medical strides through research he conducted on female slaves, without anesthesia. Medical journals reportedly indicate it was common to conduct medical experiments on slaves with no pain relief; procedures ranged from amputations to brain surgery.
While research on slaves gradually faded over the decades, experiments on African Americans never completely went away.
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In 1951, doctors at The Johns Hopkins Hospital in Baltimore – though segregated, one of the only leading hospitals to treat Black patients – harvested cells from Henrietta Lacks, a Black woman being treated for cancer, without her knowledge or permission. Though such harvesting reportedly was standard at Hopkins regardless of race, Lacks’ cells were abnormally reproductive and widely shared, and her “HeLa” cells are still in use for research today.
In perhaps the most egregious example, U.S. public health officials in the 1930s began a study in which syphilis was left untreated in Black men. Known colloquially as the Tuskegee experiment, the study didn’t end until 1972, and has become shorthand among African Americans for a legacy of racism and mistreatment in the medical industry.
Facing that ugly history is part of building trust and boosting participation in clinical trials by historically underrepresented communities, according to the PhRMA industry principles, which explicitly state that the Tuskegee experiment was unethical and featured serious mistakes. Still, the industry principles state that the horrible experiment became a conduit for “major changes in how clinical trials are conducted in order to protect the rights, safety, and well-being of clinical trial participants.”
Rather than lean into diversity and inclusion in medical trials, however, experts say the industry went in the other direction. For years, it wasn’t unusual for a drug to be tested on volunteers from the pharmaceutical research community, without any people of color in the pool.
In that world, “it’s not that we struggle to recruit racial and ethnic minorities; it’s that we’re really good at recruiting one type of person into clinical research,” says Jackson, the CARES director. “And that person is usually (a) white, wealthy male, and lives in an urban center, along the East or West Coast of the United States, and has some kind of advanced educational degree.”
Decades ago, “the group that was easiest to reach were poor, minority individuals that were unlikely to speak up or speak out,” he says. “Now, the group that’s easiest to reach are extremely privileged individuals” who have the means and the time to participate
Dr. Georges Benjamin, executive director of the American Public Health Association, says diversity in clinical trials is important for two reasons.
“One is that it’s just better science – you then get a better idea of how your drug or your vaccine or anything else works in a more representative population,” particularly among people dealing with issues tied to social determinants of health, Benjamin says. “And the other aspect is, it helps with trust” among African Americans and other marginalized populations.
The data underscores the need: As of August and compared with whites, Black people had a COVID-19 case rate nearly three times higher, were hospitalized at a rate nearly five times higher and had a death rate more than two times higher, according to the Centers for Disease Control and Prevention. An APM Research Lab analysis as of Nov. 10 also shows Black Americans with a death rate close to double that of whites.
Yet recent polling indicates nearly half of African Americans are either reluctant or will refuse to get a COVID-19 vaccination. That’s despite the fact that some believe the disproportionate effects the coronavirus has had on their communities should put people of color near the front of the line for inoculation.
“Having a racial preference for a COVID-19 vaccine is not only ethically permissible, but I think it’s an ethical imperative,” Lawrence Gostin, a professor of global health law at Georgetown University, told STAT. It’s justifiable, he said, because of “historic structural racism that’s resulted in grossly unequal health outcomes for all kinds of diseases, and because COVID-19 has so disproportionately impacted the lives of people of color.”
To be sure, the racial and ethnic makeup of trial participants can vary: In 2019, for example, federal data snapshot says Blacks or African Americans – who make up about 13% of the U.S. population – accounted for 4% of participants in trials that led to the approval of 11 new oncology drugs, but for 25% of participants in trials that led to the approval of six hematology drugs and 29% in trials that led to the approval of five drugs in the psychiatry and sleep disorder category. Notably, a 2018 study indicated that African Americans were overrepresented in trials that did not require informed consent but are to be aimed at life-threatening, emergency conditions.
In its vaccine pursuit, Pfizer appeared to recognize the need for diversity and inclusion: A fact sheet sent by a company representative states that COVID-19 “is an urgent health crisis that disproportionately impacts diverse communities,” a problem that requires focused action.
The drug company’s efforts include information and ad campaigns to educate the public and recruit volunteers in “diverse” communities hit hard by COVID-19, according to the fact sheet. In addition to outreach in several languages and partnerships with grassroots community organizations, Pfizer also set up a website that shows its progress in including minorities in its vaccine trials.
“We are doing everything we can to ensure that the demographics of our trial population reflect the demographics of the states and communities that have been most impacted by COVID-19,” according to the fact sheet.
Benjamin says Pfizer and other drug manufacturers are making the right moves to increase inclusion in drug trials, including by embedding representatives in the community. Still, he says, it’s a long-term process that will yield concrete results in years, not months.
“You have to make sure you have the right people at the table,” Benjamin says. Drug companies, he says, have to “make a conscious effort” to include those affected by the disease they’re trying to cure, and “actually go to the patients and take that added step to ensure that you have a representative population” for a drug trial.
Jackson, for his part, says while the diversity numbers reported by Pfizer and Moderna are sunny, “I’m probably going to be the rain cloud.”
Outstanding questions include whether the percentages equate to the number of minorities affected by the coronavirus. Moreover, “even if we had exactly the percentage in the studies that we see, there are other issues that are really problematic” and could determine how effective the drug is when accounting for social determinants of health, Jackson says.
“It actually makes a difference where your racial and ethnic minorities come from,” he says. “Do they come from areas of town that are more rural? Poorer? Have worse insurance access than the white people that are enrolling in these studies?”
Ultimately, “it really comes down to one thing, which is just the importance of community engagement, which drives more inclusive enrollment, rather than just a record of diverse enrollment,” Jackson says. When a vaccine is developed, trust has to be there in order to get the African American community to buy in and get the shot to curb the spread of disease.
“And so you need to build that trust, when the vaccine is still being tested, rather than waiting for the vaccine to be approved by the FDA,” Jackson says. “Because that’s what’s really going to drive trust, is that people understand the whole process and can attest to their involvement in it.”
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