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Letter urging participation in the Covid-19 vaccine trial causes violent reactions

T presidents of two historically black universities in New Orleans thought they were doing a public service by enrolling in a Covid-19 vaccine clinical trial in August, so much so they urged their campus communities to consider doing the same.

"I said we should inform our communities because I think there is something about leading by example," said Reynold Verret, a biochemist who runs Louisiana's Xavier University. "We are two black men who rolled up their sleeves."

So Verret and Walter Kimbrough of Dillard University were surprised by the fierce reaction that followed their joint letter to faculty, staff, students, and alumni. Hundreds of outraged commentators flooded their schools' Instagram, Twitter, and Facebook accounts.

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"Our children are not laboratory rats for pharmaceutical companies," said a publication. "I can't believe an HBCU does this to our people," he said in another reply. Tuskegee, Tuskegee. … Me and mine are not the first in line, "said another answer.

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<figcaption class= Dillard University in New Orleans. Emily Kask by STAT

The episode illustrates the challenges historically faced by Black colleges and universities as they seek to leverage their trusted legacies within African American communities to strengthen Black enrollment lagging behind in clinical trials of the Covid-19 vaccine. Your recruitment efforts will need to overcome the deep suspicions that many African Americans have of medical researchers, pharmaceutical companies, and the government, stemming from long-standing racial injustices perpetrated by those institutions.

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Now, as the four HBCU medical schools prepare to host COVID-19 vaccine trials on their campuses, there is hope that their efforts will be more successful.

"We've built a level of trust with communities of color that other organizations, quite frankly, just don't have," said James Hildreth, immunologist and president of Meharry College of Medicine in Nashville. "It is imperative for us as HBCU to rise to this occasion because people need us."

Meharry College plans to begin a trial of a vaccine made by Novavax in the next two weeks, with Hildreth as its first participant. The goal is to enroll 300 on the site, but Hildreth believes they can enroll 600 people, mostly African American. HBCU's other medical schools, Howard University College of Medicine in Washington DC, Morehouse School of Medicine in Atlanta, and Charles R. Drew University of Medicine and Science in Los Angeles, are planning to begin their trials in the coming weeks.

“By collaborating with the four black medical schools,” Hildreth said, “they will have people who look like them, sitting across the table, having these conversations, and we believe That is going to make a big difference. "

As the death toll passes 210,000, the Covid-19 pandemic has exposed inequalities within the US healthcare system and workforce. With a large portion of black workers employed in essential jobs putting them at risk of infection, Black Americans are three times more likely than white Americans to contract the disease, five times more likely to end up in the hospital and twice as likely to die from it, according to the CDC If black Americans had died at the same rate as white Americans, 20,800 blacks would still be alive.

rgo, vaccine clinical trials are struggling to recruit people from their communities. Moderna, one of the drug companies testing a vaccine, slowed its trial after failing to enroll enough people of color among its 30,000 participants, although as of last week it said a third of the volunteers were from "diverse communities." Pfizer and BioNTech reported that 9% of their clinical trial participants in the US are black and 13% are Latino, while 72% are white.

"All summer long, you kept seeing stories that said there weren't enough African Americans in these rehearsals," Kimbrough said. "There were people like Tony Fauci saying it would be a problem if we created this vaccine and it doesn't work for blacks."

Although people are nearly genetically identical, people of color may respond differently to a vaccine than white people, especially for a respiratory illness, due to social differences such as exposure to air pollution that disproportionately affects people. black and brown communities, or more. rates of chronic diseases such as diabetes or sickle cell anemia.

"The way we live and where we live impacts how medicine affects us," Kimbrough said. "I think it's a powerful conversation that we should have."

He signed up for a phase 3 trial of the Pfizer and BioNTech vaccine after Verret mentioned in a phone call that he had done the same through New Orleans' Ochsner Health System. The study is double-blind, so neither the participants nor the researchers know whether they received the vaccine or a placebo until the trial ends. (Because the vaccine does not contain any live virus, the participant is not at risk of developing Covid-19 from the injection.)

In their letter, Kimbrough and Verret addressed the pain caused by the Tuskegee syphilis study, in which black patients were told they would receive treatment for the disease, but were not, and how it eroded trust among the black community. and medical care. suppliers.

"We understand they're scared, we understand the story," Kimbrough said, "but we're not just telling them this, we're saying, 'Look, we're doing it.'"

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<figcaption class= Xavier University in New Orleans. Emily Kask for STAT

Nonetheless, outrage boiled over, fueled in part by a ProPublica story published the day before the presidents' letter that found Ochsner had sent black patients infected with coronavirus home to die despite the threat could transmit the disease to others.

For Tevon Blair, a 2018 Dillard graduate, part of what made the letter off-putting was the absence of predominantly white local colleges like Loyola and Tulane.

"The red flag in this vaccine trial … is that it is not a citywide partnership with other universities," Blair tweeted.

Myles Bartholomew, 22, a 2020 Xavier graduate who is pursuing his Ph.D. at Brown University in molecular biology, cell biology, and biochemistry, said that from a researcher's point of view, he understood the importance of encouraging black people to participate in clinical trials and said that the presidents were acting selflessly.

"And then from a student's perspective, there's a lot of panic and fear about anything Covid-related right now," Bartholomew said. He said that he would not enroll in a clinical trial for a Covid-19 vaccine and understands why other black people would not either because of mistrust in medical research.

"Those horror stories are something that is part of our history as African Americans, so it would be completely naive to ignore the precedents that have been set," he said.

The presidents responded to criticism on social media.

"There was some misinformation that was being exaggerated," Verret said. The suggestion that they were paying me or Dr. Kimbrough money? No. That there was money paid to Xavier. No. That Xavier required that all students be at the trial. No. "He added that any of the standard clinical trial compensation he received (participants are paid a nominal sum for their time) he would donate to his parish.

The letter from the presidents may have helped advance the recruitment process, said Julia García-Díaz, the lead investigator for the clinical trial at Ochsner.After it came out, she received an email from a woman in her 60s saying she had read the presidents note and she wanted to enroll.

"She was not only elderly and African American, but she was also a woman," García-Díaz said. "She checked all kinds of boxes because women are also underrepresented in clinical trials."

Kimbrough said that if he had to rewrite the letter, he would have addressed it to the general public rather than just his and Xavier's university communities.

"That's a good lesson in messaging terms a, "he said.

The HBCU medical schools have been working to make sure the message is correct by addressing people's skepticism. Its scope includes interacting with religious organizations and participating in virtual town halls, such as one organized in September by the Howard University radio station and The Black Coalition Against Covid-19.

“The main concern people are voicing is the question, 'Are you testing me?'” Said David Carlisle, Drew president and internist, during town hall. "I can assure people that this vaccine, when taken to combat Covid-19, is not an experiment directed against the African-American community."

He added that anyone considering enrolling should first ask their doctor if they should take this vaccine, why, and if this vaccine is safe for them.

At Morehouse, Valerie Montgomery Rice, the president and OB-GYN, is no stranger to recruiting diverse populations into clinical trials. When she helped conduct a clinical trial of a birth control pill at the University of Kansas in the 1990s, her site was praised for recruiting the largest percentage of minority women in the country. He said he is confident that between 60% and 70% of the people enrolled in the vaccine trial on his campus will be people of color, because Morehouse has long cared for the community.

“The benefit of an HBCU medical school is that we address these issues every day with our community. We are more sensitive to culture and more aware of culture, ”said Montgomery Rice. "We have the trust of the community and we have earned that trust."

Nicholas St. Fleur is a Knight-Wallace Fellow of the University of Michigan.

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