The Race Gap in Clinical Trials

the safety of the world's first COVID nineteen vaccine. The country will start mass inoculation this month before clinical testing is completed. According to Russian Minister of Health Mikhail Murashko, authorities planned to start inoculating medical workers and other risk groups within two weeks on a voluntary basis. The vaccine

will be available to the wider population from October. President Vladimir Putin's announcement on Tuesday that Russia has cleared the vaccine for use was a propaganda coup for the Kremlin, but many questions remain in the West about this vaccine's safety and efficacy given the scant details about its development. New Jersey is the latest US state to retreat from plans to send kids back to classrooms. Governor Phil Murphy will now give public schools the option of all remote

teaching when classes resume in September. Earlier, Murphy had required that all districts offer some level of in person instruction with safety precautions in place. On Tuesday, the state's largest teachers union issued a joint statement with groups representing administrators saying classroom instruction quote is not safe yet. Finally, the pandemic will likely make the gender pay gap worse after the US economy recovers, but it could ultimately improve opportunities

for women. A paper from the National Bureau of Economic Research said that in a regular recession, the pay gap between men and women shrinks by two percentage points because men tend to get hit harder by job losses. But according to the report, in a pandemic recession like the one we're in now, that gap increases by five percentage points.

And now, for today's main story, in the rush to develop a vaccine or treatment for COVID, nineteen drug companies are fast tracking clinical trials, but those trials have a major diversity problem. Participants in major drug trials range from seven to eighty nine white. This is a big problem considering it's a disease that disproportionately affects people of color. Kristin V. Brown reports that failing to account for minority groups could potentially impact how well a drug eventually works

for those that the virus has harmed the most. COVID nineteen is not an equal opportunity threat. Over the past six months, black little you know, and Indigenous Americans have suffered more from the virus than anyone else. The statistics here can be shocking. For example, in cases where race is known, black lives have accounted for more than of the national death toll, even though they make up about

of the population. So I was surprised when I took a look at who has participated in clinical trials for COVID nineteen vaccines and treatments. It turns out that, at least so far, most of them have been white. You might wonder why this matters, after all, race is not biological.

It's a social construct. But the more we understand about human biology, the clearer it is that a person's individual biology can influence certain things, like whether they are more susceptible to certain diseases, or if certain drugs work for them. This can be connected to genetics or environment you grew up in, and both of those things can be connected to race. So if you know that a disease especially impacts minority populations, it's really important to make sure that

those populations are represented in clinical trials. I talked about this with John Bagel, a researcher at the National Institute of Allergy and Infectious Diseases who has worked on multiple or lea stage clinical trials for COVID nineteen. The way I would frame it is that the diversity should match

the scientific objective. If the objective is determining efficacy and understanding how the vaccine prevents disease in different populations and how effective it is in different populations, then that diversity is very critical. Uh. The last thing that you would want to do is roll out a public health intervention and not understand the impact that it had for the

different populations that you're trying to cover. Now it should be clear race is not the only variable that could be connected to why a person responds to a vaccine and another one doesn't. Age can also matter, so can other underlying medical conditions. You could also give the exact same vaccine to two different white men in their fifties, and the vaccine might work for one of them but not the other. Biology can just be mysterious. Sometimes there is still so much we don't know, but we do

have clear examples of where race is a factor. The classic examples would be for hypertensive where that in the hypertension guidelines there are clear recommendations based on race because we know that as a class, even though there is individual variation that as as a class of drugs, UH, they will have different effects on different populations. Another example

that comes to mind is asthma. Black and Latino children are known to not respond as well to abutyroll, which is the most popular medication on the market to treat asthma attacks. There's been some compelling research to suggest that a genetic variant maybe what's responsible here, and knowing someone might have that variant because save their life since abutyrol is the medication that most emergency rooms keep on hand

to treat severe attacks. But much of this we have really only started to understand over the last decade or so. It is an increasingly recognized phenomenon and the whole field of personalized medicine is revolving around this idea that there are subtle variations in our immune response, subtle variations in multiple genes that might not be a parent but but

will affect our ability to respond to different medications. Now, one thing that John mentioned is that it's important for a trial's patient population to match the scientific objectives of that trial. So he said it's less critical that early stage trials be diverse because the main objective is to test a small number of people and make sure that

drug or vaccine is safe. I looked at the data for six trials that had published results, and only one of them, elite stage trial for the drug Room Disapvere, had anything approaching diversity. But most of those trials were early stage. It's in phase three trials, which seek to test how well a drug or vaccine actually works, that diversity is absolutely critical. Congress actually passed legislation acquiring publicly

funded medical studies to include more women and minorities. The f d A also encourages the inclusion of diverse populations and its guidelines for developing COVID nineteen treatments and vaccines. Part of the problem is that can be hard to recruit minority populations to participate in a trial. There is a lot of mistrust in our healthcare system among them, but in the past drugmakers also haven't necessarily tried hard

enough to recruit them. That may be changing. Every single drugmaker I talked to for the story told me that they had plans in place to make sure that there are more diverse participants in later stage vaccine trials. Plans like working with community organizations to help recruit participants. I noticed these efforts in place when the NIH launched its

Phase three trial for a vaccine produced by Maderna. They hosted a Facebook live Q and A in which the heads of Maderna, the NIH, and the n I A I d All fielded questions from a participant in the phase one trials. That participant was a black woman named Robin, and she got right to the tough questions about race. I have to say that when I told my friends and relatives that I was going to participate, they were

absolutely adamant that it was a bad idea. They tried to discourage me because they were concerned about my health and about my safety. And the reason for that was because in the African American community, we are all familiar with the Tuskegee experiments. The Tuskegee experiments are often cited as one of the reasons there is mistrust of our

healthcare system in the black community. Beginning in the thirties, public health researchers conducted an experiment which they sought to observe untreated syphilis in black men, but lied to participants and told them they were eaving a treatment for bad blood. Even after a cure for syphilis was discovered, most of

them did not receive it. And so many people are in the African American community are familiar with it, and when you asked them about participating in clinical trials, they'll give you two words, Tuskegee and no. I was curious, though, just how Maderna had recruited Robin and others for the early stage trials. According to Maderna, of those trial participants were white. I talked with Ian Hayden, a twenty nine

year old Seattle resident who participated in the trials. He was actually one of just a few people who had a bad reaction to the vaccine. Ian is white, by the way. I first learned about the study from a co worker who posted about it in slack Um he shared a form basically where people who are interested could could express their interest. Um that was the first that I learned that the trial was taking place here in Seattle, where I live, and that they were recruiting in the

Seattle area looking for healthy people under fifty five like me. Um. So, I filled out that form really without much forethought, because I didn't expect to hear back. To be honest, I just figured I'd throw my hat in the ring and we'll see what happens. A couple of days later, I did get a call back from the clinic asking me to come in for a screening visit. Ian works in the world of vaccine development as a science communicator at the University of Washington. In other words, he heard about

the trial because it's in his field of work. He also said that he was comfortable volunteering in part because he works in this world and knows what to expect. You know, it seems clear to me that we need a coronavirus vaccine. I think that's clear to a lot of people now. It's it's how we're going to put this all behind us at the end of the day, and we're not going to get a vaccine without clinical trials,

and clinical trials need volunteer. You know, I came in, I guess with uh, I don't know on on the side of science, you could say, and of course with a lot of trust in that system, something that I was familiar with. I'm somebody who happens to know scientists. I know people who work on vaccine design, and undoubtedly that color is my thinking to this. This whole process is probably going to look very different to someone who who doesn't know a scientist, and you know, you only

hear about these things through the news. For her part in that Q and A, Robin said she decided to participate because she wanted to help her community. I felt that if those people who conducted the Tuskegee experiments were allowed to succeed, not only because of what they did, but because future generations of African Americans were still too afraid to participate in trials that would benefit us, then those people would really have one twice and I was

not going to let that happen. With so many vaccines in progress now it does seem promising that one of them will work, and eventually we will be able to put this terrible year behind us. But it will take significant effort to achieve the diversity necessary to make sure that vaccine works for everyone. That was Kristin V. Brown

and that's it for our show today. For coverage of the outbreak from one bureaus around the world, visit Bloomberg dot com slash coronavirus and if you like the show, please leave us a review and a rating on Apple Podcasts or Spotify. It's the best way to help more listeners find our global reporting. The product No sis Dale Edition is produced by Topher foreheads Jordan Gospore, Magnus Hendrickson and me Laura Carlson. Today's main story was reported by

Kristin V. Brown. Original music by Leo Sidrin. Our editors are Francesco Levi and Rick Shine. Francesco Levi is Bloomberg's head of Podcasts. Thanks for listening.