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Oct. 18, 2020, 9:09 a.m. EDT

People of color shouldn’t be treated equally in COVID-19 vaccine trials, ER doctor says: They should be over-represented

Ensuring that there’s a diverse group of participants is ‘a bottom line issue’ for investors, the emergency room physician says

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By Jaimy Lee

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Choo: Doctors Without Borders got called in for humanitarian aid for our Indigenous population. It should have been a major news story. We had to call in humanitarian aid for our own population, because we so neglect the Indigenous peoples in our country. [Doctors Without Borders said it has also worked with the Pueblos, at-risk New Yorkers, and migrant farm workers in Florida, among other U.S. groups, during the pandemic.] The United States government should have made a major push to Congress, to release special aid to ramp up these efforts. It really got lost in the chaos of the whole nation this year, in addition to the fact that we haven’t mobilized much of anything effectively for anybody in the country. Our Indigenous people got left behind, and I don’t think we’ll understand the extent of it until later.

Data certainly will help but we can’t wait for data. We’ll look back at the data and feel terrible about it. That’s my fear for the vaccine, which is the last thing in our power to do well. We’re in disaster mitigation mode for most everything. We’ve gotten testing so fundamentally wrong. With vaccines, there’s at least conversations happening around what vaccine equity development and distribution equity look like. We have time to get this right.

MarketWatch: How does the U.S. ensure that people of color feel safe about getting a vaccine or even participating in a trial?

Choo: The way that we’ve traditionally done clinical studies is that we get a bunch of white people from pharmaceutical companies to work with white people in the ivory tower of academia, to develop this thing and then we try to disseminate it. And we ask why communities of color have not embraced that therapy, as we sit in this historical context of not only the Tuskegee [syphilis study] and Henrietta Lacks but so many violations of autonomy and respect that are the fundamentals of research ethics. [The Tuskegee syphilis study , in which 400 Black men with syphilis were not informed of their diagnoses but were tracked by researchers, and the use of Henrietta Lacks’ cells in research without her permission or that of her family are both commonly cited examples of how medical researchers in the U.S. have taken advantage of Black Americans.] If you just pull up the big pharmaceutical companies that are developing the vaccines, just look at their senior leadership teams and the board of directors. It doesn’t evoke trust for communities of color.

People reach out to me to talk about, how do we bring equity into our research practices? Part of it is: Diversify up your damn team, and have targets for enrollment that you live up to.

When the [National Institutes of Health] awards a grant, they ask you for your enrollment table, broken down by race, ethnicity, and gender. Nobody ever asks you again about it. I can put in that table, and then I can enroll 100% white people, publish my paper, and nobody will ask me about it. It’s one thing to ask upfront, it’s another thing to hold people accountable.

The NIH and the [Centers for Disease Control and Prevention] and any funders of research need to have mechanisms where your funding is dependent on your ability to recruit. And if you can’t recruit at the ratios that you promised to recruit, then you need a good explanation why and a corrective plan moving forward. That includes [medical] journals. If journals are accepting a paper related to COVID, they need to ask for a demographic table, and they need to say a huge limitation of the study is that it was conducted in 95% not people of color. In this pandemic, and the way it’s played out in the United States, it is not acceptable to have those demographics, because you didn’t study populations who are actually experiencing the disease. Every time I see a major COVID paper, I pull up the demographic table, and we have not done a good job. When we do a good job, it almost always demonstrates inequities.

As we do these vaccine trials and try to disseminate vaccines, if we don’t have teams that look like America, and the affected population, if we don’t have advisory boards on those teams, if we don’t have outreach to communities, including multilingual recruitment strategies, and engagement of trusted leaders in those communities in paid roles — they have to be paid roles, because we don’t take million dollar grants and then put volunteers in charge of recruitment — they also have to be supported by grants...

MarketWatch: Do you think this is something investors should be asking of the companies developing therapies or vaccines?

Choo: Absolutely. There’s a bottom line issue for them, too, because if 25% to 50% of an entire significant head count population in the United States is refusing to take your product, those are potential customers. Why would you leave that on the table? Investors should be really asking them, what are your plans so that this is as widely disseminated as possible.

In the real world, you need to know in aggregate how the vaccine uptake and behavior will be across populations. There’s so many reasons, whether it’s differences in chronic disease, the medications that you’re on, how adherent you are to the two regimens. If you told me we gave a vaccine to white populations and black populations, and the black populations didn’t have good outcomes, that tells me that there continue to be differences in exposure to high viral inoculum and it’s going to affect vaccine effectiveness as well. It will tell us how much the vaccine mitigates those factors in that population.

This Q&A has been edited for clarity and length.

Read more A Word from the Experts interviews:

Trump’s vaccine czar says the first vaccine should be submitted for emergency authorization around Thanksgiving

Abbott exec: Why better COVID-19 tests may help the U.S. get back to normal

Philadelphia pediatrician Paul Offit: Prepare to wear masks and socially distance even after getting COVID-19 vaccine

Jaimy Lee is a health-care reporter for MarketWatch. She is based in New York.

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