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Cleveland efforts to recruit black, minority patients for COVID-19 vaccine trials an uphill battle

Cleveland efforts to recruit black, minority patients for COVID-19 vaccine trials an uphill battle

by Brie Zeltner

   (Plain Press, November 2020) Dr. Carla Harwell, an internist who is the medical director of the University Hospitals Otis Moss Jr. Health Center is Black. So are almost all of her patients, and nearly everyone who lives in the city’s Fairfax neighborhood, where the center is located. 

   In early September, Harwell agreed to help recruit patients for one of the many clinical trials testing a vaccine for COVID-19.

   Currently, 11 vaccines are being tested worldwide in large-scale trials, often with 20,000 people or more, to determine if they protect people from the coronavirus and are safe for wide use. 

   Harwell knows how important it is to include more Black people and other minorities in clinical trials, particularly for a disease that has sickened and killed them more than any other racial or ethnic group. 

   “You know, we’re the ones that are dying,” she said. “This is our community that’s dying at a higher rate than we even represent in the U.S. population.”

   Black and Latinx residents in the United States have been three times as likely to be infected by the coronavirus and twice as likely to die from the virus than their white neighbors, according to data from the Centers for Disease Control and Prevention analyzed by the New York Times this summer. 

   In Cleveland, 60% of the deaths reported from COVID-19 have been Black residents, though Blacks make up only about half of the city’s population. 

   Recruitment in the Black community to test a vaccine that could protect against the virus has been an uphill battle, Harwell said. She’s handed out brochures about the trial for the vaccine being developed by Pfizer and BioNTech and talked with about 75 patients. Only five have expressed even tepid interest in participating, she said. 

   There’s no way to track minority participation across all vaccine trials, though many of the biotechnology companies have ramped up recruitment through social media, such as Pfizer’s “Undo Underrepresented”campaign. Some have slowed down study timelines, like Moderna did in September, to do more targeted enrollment of Black and Latinx participants. 

   As of Oct. 9, Moderna reported 34% of volunteers enrolled from “diverse communities.” About 28% of participants in a final-stage Pfizer and BioNTech trial are minorities.

   Harwell never expected her patients to jump at the chance to join a clinical trial testing a COVID-19 vaccine, she said, despite her two decades of building trust and credibility in the community. Most have given a flat-out, “No.”

   Their reasons reflect the mistrust, abuse and exploitation that riddle the history of clinical trials in the Black community, as well as pandemic-era confusion stemming from politically driven mixed messages about the virus and its severity, and even conspiracy theories about its existence.

   They’re also an indication that the decades-long trust-building battle to boost minority enrollment in clinical trials is far from won.

Skepticism born of history

   Harwell’s patients tell her they’re afraid of being “guinea pigs” in the COVID-19 vaccine trials, and that because they’re Black, they’ll probably be given something harmful instead of a vaccine. 

   “They’ll probably give me something different in the syringe than what they’re supposed to,” is what they’ve told her. 

   Patients often bring up the Tuskegee Syphilis Study, she said, as a reason to doubt the motives of researchers. In that 40-year-long experiment, researchers never informed the Black men, who participated, about the intent of the research, and did not offer them treatment for the disease even when treatment became available.

   “There’s a history in this country of medical and research abuse of African Americans before and well beyond Tuskegee,” Harwell said. “But what I reassure them of is that we have mechanisms in place to make sure that that doesn’t happen anymore.”

   One of these mechanisms is the institutional review board, or IRB, a group that independently reviews and monitors human research trials. Patients often don’t know about it, she said.

   Harwell has discovered “there’s still a lot of patient education that still needs to be done, probably in general about clinical trials,” she said.

   In addition, information about the illness has been inconsistent and marred by partisan politics, Harwell and other Cleveland-area experts said. 

   “The messaging has clearly been a less-than-optimal incentive for … potential participants who you would like to recruit into these trials,” said Dr. Jackson Wright, director of UH’s William T. Dahms Clinical Research Unit. 

   The mixed messages about the virus from political leaders are creating a “real sour taste” for Black people, Harwell said. 

   Even knowing someone with COVID-19 doesn’t seem to encourage participation in trials, Harwell said, in part because of the newness and mysteriousness of the illness, and the lack of a consistent message about it.

   Of all the responses Harwell’s heard when she talks about the vaccine trials, the oddest, she said, was from a woman who said that there was no such thing as COVID-19, and that the pandemic was “just one big conspiracy to shut stuff down.” 

   “Wow, now I’ve heard a lot of different things,” she said. “But that was a first.”  

Reason for hope

   Despite the numerous obstacles to recruitment, Harwell sees some reason for hope. 

   Several of her patients have asked her for her thoughts about the vaccine trials, displaying the trust she has built over years in caring for them.

   “That makes me feel good on several levels that they … truly trust my opinion and that at least they’re being a little open-minded about it,” she said. 

   And some of the trepidation about the vaccine trials is not unique to the Black community, she said. Many people across the country are concerned about the pace at which the trials are moving and worry that corners are being cut when it comes to safety.

   “So, what I’ll hear is … ‘Now, I don’t want to be the first person to try this out. I want to wait and see.’ I don’t think that’s just an African American thing,” Harwell said.  

   Some of that is fueled by disinformation that spreads like wildfire on social media, like the false claim that those vaccinated would be secretly “microchipped.” 

   The stakes right now, though, are high, reminding Harwell of an oft-repeated adage: Sometimes if you’re not at the table, you’ll be on the menu. 

   “We want to make sure that we’re represented so that we know that the vaccine will be safe and that it works for us,” she said.

Editor’s Note: This article is the fourth in a series. The series is a partnership between the Northeast Ohio Solutions Journalism Collaborative and The Cleveland Observer. It is presented as part of ideastream’s Coping With COVID-19 project, which is funded by the Third Federal Foundation and University Settlement.

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