WEBVTT - The Race Gap in Clinical Trials 0:00:04.440 --> 0:00:09.800 Welcome to Prognosis. I'm Laura Carlson. It's day one and 0:00:09.920 --> 0:00:15.600 fifty four since coronavirus was declared a global pandemic. Today's 0:00:15.640 --> 0:00:20.880 main story. Despite the fact that COVID nineteen has disproportionately 0:00:20.880 --> 0:00:27.040 affected black, Latino and Indigenous Americans in major drug trials, 0:00:27.520 --> 0:00:34.919 the participants are overwhelmingly white. But first, here's what happened 0:00:34.960 --> 0:00:51.960 in virus news today. Russia rushed aside international concerns about 0:00:51.960 --> 0:00:57.040 the safety of the world's first COVID nineteen vaccine. The 0:00:57.120 --> 0:01:02.160 country will start mass inoculation this month before clinical testing 0:01:02.440 --> 0:01:07.360 is completed. According to Russian Minister of Health Mikhail Murashko, 0:01:07.760 --> 0:01:11.759 authorities planned to start inoculating medical workers and other risk 0:01:11.800 --> 0:01:16.240 groups within two weeks on a voluntary basis. The vaccine 0:01:16.280 --> 0:01:21.360 will be available to the wider population from October. President 0:01:21.480 --> 0:01:25.440 Vladimir Putin's announcement on Tuesday that Russia has cleared the 0:01:25.520 --> 0:01:29.160 vaccine for use was a propaganda coup for the Kremlin, 0:01:30.200 --> 0:01:33.679 but many questions remain in the West about this vaccine's 0:01:33.880 --> 0:01:39.039 safety and efficacy given the scant details about its development. 0:01:41.720 --> 0:01:45.160 New Jersey is the latest US state to retreat from 0:01:45.200 --> 0:01:50.120 plans to send kids back to classrooms. Governor Phil Murphy 0:01:50.120 --> 0:01:53.240 will now give public schools the option of all remote 0:01:53.280 --> 0:01:59.919 teaching when classes resume in September. Earlier, Murphy had required 0:02:00.160 --> 0:02:04.000 that all districts offer some level of in person instruction 0:02:04.520 --> 0:02:09.640 with safety precautions in place. On Tuesday, the state's largest 0:02:09.680 --> 0:02:14.240 teachers union issued a joint statement with groups representing administrators 0:02:14.880 --> 0:02:21.320 saying classroom instruction quote is not safe yet. Finally, the 0:02:21.320 --> 0:02:25.600 pandemic will likely make the gender pay gap worse after 0:02:25.680 --> 0:02:31.559 the US economy recovers, but it could ultimately improve opportunities 0:02:31.560 --> 0:02:35.200 for women. A paper from the National Bureau of Economic 0:02:35.280 --> 0:02:39.000 Research said that in a regular recession, the pay gap 0:02:39.080 --> 0:02:43.640 between men and women shrinks by two percentage points because 0:02:43.680 --> 0:02:48.079 men tend to get hit harder by job losses. But 0:02:48.280 --> 0:02:51.920 according to the report, in a pandemic recession like the 0:02:51.960 --> 0:02:57.960 one we're in now, that gap increases by five percentage points. 0:03:04.760 --> 0:03:08.480 And now, for today's main story, in the rush to 0:03:08.560 --> 0:03:13.000 develop a vaccine or treatment for COVID, nineteen drug companies 0:03:13.040 --> 0:03:17.640 are fast tracking clinical trials, but those trials have a 0:03:17.760 --> 0:03:22.680 major diversity problem. Participants in major drug trials range from 0:03:22.720 --> 0:03:29.200 seven to eighty nine white. This is a big problem 0:03:29.240 --> 0:03:33.880 considering it's a disease that disproportionately affects people of color. 0:03:35.280 --> 0:03:38.800 Kristin V. Brown reports that failing to account for minority 0:03:38.840 --> 0:03:43.280 groups could potentially impact how well a drug eventually works 0:03:43.640 --> 0:03:52.800 for those that the virus has harmed the most. COVID 0:03:52.880 --> 0:03:58.120 nineteen is not an equal opportunity threat. Over the past 0:03:58.160 --> 0:04:02.080 six months, black little you know, and Indigenous Americans have 0:04:02.160 --> 0:04:06.640 suffered more from the virus than anyone else. The statistics 0:04:06.720 --> 0:04:11.120 here can be shocking. For example, in cases where race 0:04:11.200 --> 0:04:15.000 is known, black lives have accounted for more than of 0:04:15.040 --> 0:04:18.160 the national death toll, even though they make up about 0:04:18.680 --> 0:04:22.599 of the population. So I was surprised when I took 0:04:22.600 --> 0:04:25.719 a look at who has participated in clinical trials for 0:04:25.800 --> 0:04:30.000 COVID nineteen vaccines and treatments. It turns out that, at 0:04:30.080 --> 0:04:34.800 least so far, most of them have been white. You 0:04:34.880 --> 0:04:39.680 might wonder why this matters, after all, race is not biological. 0:04:40.320 --> 0:04:44.599 It's a social construct. But the more we understand about 0:04:44.640 --> 0:04:48.520 human biology, the clearer it is that a person's individual 0:04:48.560 --> 0:04:52.640 biology can influence certain things, like whether they are more 0:04:52.680 --> 0:04:57.520 susceptible to certain diseases, or if certain drugs work for them. 0:04:57.560 --> 0:05:00.720 This can be connected to genetics or environment you grew 0:05:00.800 --> 0:05:03.359 up in, and both of those things can be connected 0:05:03.400 --> 0:05:07.400 to race. So if you know that a disease especially 0:05:07.440 --> 0:05:12.320 impacts minority populations, it's really important to make sure that 0:05:12.360 --> 0:05:19.960 those populations are represented in clinical trials. I talked about 0:05:20.000 --> 0:05:23.479 this with John Bagel, a researcher at the National Institute 0:05:23.560 --> 0:05:27.560 of Allergy and Infectious Diseases who has worked on multiple 0:05:27.640 --> 0:05:31.040 or lea stage clinical trials for COVID nineteen. The way 0:05:31.040 --> 0:05:34.800 I would frame it is that the diversity should match 0:05:34.880 --> 0:05:42.200 the scientific objective. If the objective is determining efficacy and 0:05:42.800 --> 0:05:48.680 understanding how the vaccine prevents disease in different populations and 0:05:48.720 --> 0:05:53.479 how effective it is in different populations, then that diversity 0:05:53.880 --> 0:05:59.080 is very critical. Uh. The last thing that you would 0:05:59.080 --> 0:06:02.280 want to do is roll out a public health intervention 0:06:02.320 --> 0:06:05.880 and not understand the impact that it had for the 0:06:05.960 --> 0:06:10.039 different populations that you're trying to cover. Now it should 0:06:10.040 --> 0:06:13.560 be clear race is not the only variable that could 0:06:13.560 --> 0:06:16.360 be connected to why a person responds to a vaccine 0:06:16.600 --> 0:06:20.840 and another one doesn't. Age can also matter, so can 0:06:20.839 --> 0:06:24.599 other underlying medical conditions. You could also give the exact 0:06:24.720 --> 0:06:27.680 same vaccine to two different white men in their fifties, 0:06:27.800 --> 0:06:29.680 and the vaccine might work for one of them but 0:06:29.839 --> 0:06:33.880 not the other. Biology can just be mysterious. Sometimes there 0:06:34.000 --> 0:06:37.120 is still so much we don't know, but we do 0:06:37.360 --> 0:06:41.200 have clear examples of where race is a factor. The 0:06:41.320 --> 0:06:45.720 classic examples would be for hypertensive where that in the 0:06:45.800 --> 0:06:49.880 hypertension guidelines there are clear recommendations based on race because 0:06:49.920 --> 0:06:52.720 we know that as a class, even though there is 0:06:52.800 --> 0:06:57.480 individual variation that as as a class of drugs, UH, 0:06:57.760 --> 0:07:02.160 they will have different effects on different populations. Another example 0:07:02.200 --> 0:07:05.960 that comes to mind is asthma. Black and Latino children 0:07:06.000 --> 0:07:09.279 are known to not respond as well to abutyroll, which 0:07:09.320 --> 0:07:11.960 is the most popular medication on the market to treat 0:07:11.960 --> 0:07:15.800 asthma attacks. There's been some compelling research to suggest that 0:07:15.840 --> 0:07:20.080 a genetic variant maybe what's responsible here, and knowing someone 0:07:20.160 --> 0:07:23.240 might have that variant because save their life since abutyrol 0:07:23.280 --> 0:07:26.160 is the medication that most emergency rooms keep on hand 0:07:26.200 --> 0:07:29.560 to treat severe attacks. But much of this we have 0:07:29.760 --> 0:07:33.360 really only started to understand over the last decade or so. 0:07:34.480 --> 0:07:40.920 It is an increasingly recognized phenomenon and the whole field 0:07:41.040 --> 0:07:47.760 of personalized medicine is revolving around this idea that there 0:07:47.800 --> 0:07:55.160 are subtle variations in our immune response, subtle variations in 0:07:55.400 --> 0:08:00.160 multiple genes that might not be a parent but but 0:08:00.880 --> 0:08:05.080 will affect our ability to respond to different medications. Now, 0:08:05.360 --> 0:08:08.040 one thing that John mentioned is that it's important for 0:08:08.080 --> 0:08:12.400 a trial's patient population to match the scientific objectives of 0:08:12.400 --> 0:08:16.640 that trial. So he said it's less critical that early 0:08:16.680 --> 0:08:20.160 stage trials be diverse because the main objective is to 0:08:20.240 --> 0:08:22.960 test a small number of people and make sure that 0:08:23.040 --> 0:08:26.640 drug or vaccine is safe. I looked at the data 0:08:26.720 --> 0:08:30.160 for six trials that had published results, and only one 0:08:30.200 --> 0:08:33.480 of them, elite stage trial for the drug Room Disapvere, 0:08:34.200 --> 0:08:38.560 had anything approaching diversity. But most of those trials were 0:08:38.600 --> 0:08:42.360 early stage. It's in phase three trials, which seek to 0:08:42.360 --> 0:08:45.600 test how well a drug or vaccine actually works, that 0:08:45.720 --> 0:09:01.199 diversity is absolutely critical. Congress actually passed legislation acquiring publicly 0:09:01.280 --> 0:09:05.800 funded medical studies to include more women and minorities. The 0:09:05.880 --> 0:09:10.160 f d A also encourages the inclusion of diverse populations 0:09:10.559 --> 0:09:14.520 and its guidelines for developing COVID nineteen treatments and vaccines. 0:09:15.520 --> 0:09:17.560 Part of the problem is that can be hard to 0:09:17.600 --> 0:09:21.319 recruit minority populations to participate in a trial. There is 0:09:21.360 --> 0:09:25.080 a lot of mistrust in our healthcare system among them, 0:09:25.160 --> 0:09:29.240 but in the past drugmakers also haven't necessarily tried hard 0:09:29.440 --> 0:09:35.680 enough to recruit them. That may be changing. Every single 0:09:35.760 --> 0:09:38.240 drugmaker I talked to for the story told me that 0:09:38.280 --> 0:09:40.640 they had plans in place to make sure that there 0:09:40.679 --> 0:09:45.360 are more diverse participants in later stage vaccine trials. Plans 0:09:45.520 --> 0:09:50.440 like working with community organizations to help recruit participants. I 0:09:50.559 --> 0:09:53.440 noticed these efforts in place when the NIH launched its 0:09:53.440 --> 0:09:57.600 Phase three trial for a vaccine produced by Maderna. They 0:09:57.600 --> 0:09:59.719 hosted a Facebook live Q and A in which the 0:09:59.760 --> 0:10:03.040 heads of Maderna, the NIH, and the n I A 0:10:03.160 --> 0:10:06.319 I d All fielded questions from a participant in the 0:10:06.360 --> 0:10:10.679 phase one trials. That participant was a black woman named Robin, 0:10:11.320 --> 0:10:14.080 and she got right to the tough questions about race. 0:10:14.400 --> 0:10:16.520 I have to say that when I told my friends 0:10:16.520 --> 0:10:20.240 and relatives that I was going to participate, they were 0:10:20.320 --> 0:10:24.760 absolutely adamant that it was a bad idea. They tried 0:10:24.800 --> 0:10:28.480 to discourage me because they were concerned about my health 0:10:29.120 --> 0:10:32.200 and about my safety. And the reason for that was 0:10:32.360 --> 0:10:36.200 because in the African American community, we are all familiar 0:10:36.679 --> 0:10:43.280 with the Tuskegee experiments. The Tuskegee experiments are often cited 0:10:43.320 --> 0:10:45.640 as one of the reasons there is mistrust of our 0:10:45.679 --> 0:10:49.840 healthcare system in the black community. Beginning in the thirties, 0:10:50.000 --> 0:10:54.120 public health researchers conducted an experiment which they sought to 0:10:54.160 --> 0:10:58.839 observe untreated syphilis in black men, but lied to participants 0:10:58.960 --> 0:11:01.760 and told them they were eaving a treatment for bad blood. 0:11:02.760 --> 0:11:06.160 Even after a cure for syphilis was discovered, most of 0:11:06.200 --> 0:11:10.520 them did not receive it. And so many people are 0:11:10.840 --> 0:11:14.480 in the African American community are familiar with it, and 0:11:14.679 --> 0:11:18.600 when you asked them about participating in clinical trials, they'll 0:11:18.640 --> 0:11:26.360 give you two words, Tuskegee and no. I was curious, though, 0:11:26.559 --> 0:11:29.320 just how Maderna had recruited Robin and others for the 0:11:29.360 --> 0:11:35.040 early stage trials. According to Maderna, of those trial participants 0:11:35.040 --> 0:11:38.760 were white. I talked with Ian Hayden, a twenty nine 0:11:38.840 --> 0:11:42.520 year old Seattle resident who participated in the trials. He 0:11:42.600 --> 0:11:44.600 was actually one of just a few people who had 0:11:44.600 --> 0:11:48.360 a bad reaction to the vaccine. Ian is white, by 0:11:48.400 --> 0:11:51.000 the way. I first learned about the study from a 0:11:51.080 --> 0:11:54.320 co worker who posted about it in slack Um he 0:11:54.400 --> 0:11:57.920 shared a form basically where people who are interested could 0:11:57.960 --> 0:12:01.960 could express their interest. Um that was the first that 0:12:02.040 --> 0:12:04.520 I learned that the trial was taking place here in Seattle, 0:12:04.559 --> 0:12:06.760 where I live, and that they were recruiting in the 0:12:06.840 --> 0:12:12.320 Seattle area looking for healthy people under fifty five like me. Um. So, 0:12:12.360 --> 0:12:16.439 I filled out that form really without much forethought, because 0:12:16.480 --> 0:12:18.840 I didn't expect to hear back. To be honest, I 0:12:18.920 --> 0:12:20.800 just figured I'd throw my hat in the ring and 0:12:21.160 --> 0:12:23.600 we'll see what happens. A couple of days later, I 0:12:23.600 --> 0:12:25.400 did get a call back from the clinic asking me 0:12:25.440 --> 0:12:28.560 to come in for a screening visit. Ian works in 0:12:28.600 --> 0:12:31.760 the world of vaccine development as a science communicator at 0:12:31.800 --> 0:12:35.520 the University of Washington. In other words, he heard about 0:12:35.559 --> 0:12:38.160 the trial because it's in his field of work. He 0:12:38.280 --> 0:12:41.320 also said that he was comfortable volunteering in part because 0:12:41.320 --> 0:12:43.960 he works in this world and knows what to expect. 0:12:45.440 --> 0:12:47.280 You know, it seems clear to me that we need 0:12:47.320 --> 0:12:50.080 a coronavirus vaccine. I think that's clear to a lot 0:12:50.120 --> 0:12:52.240 of people now. It's it's how we're going to put 0:12:52.240 --> 0:12:54.520 this all behind us at the end of the day, 0:12:54.760 --> 0:12:58.360 and we're not going to get a vaccine without clinical trials, 0:12:58.400 --> 0:13:01.480 and clinical trials need volunteer. You know, I came in, 0:13:01.559 --> 0:13:04.320 I guess with uh, I don't know on on the 0:13:04.360 --> 0:13:06.880 side of science, you could say, and of course with 0:13:06.960 --> 0:13:09.040 a lot of trust in that system, something that I 0:13:09.080 --> 0:13:13.280 was familiar with. I'm somebody who happens to know scientists. 0:13:13.360 --> 0:13:16.360 I know people who work on vaccine design, and undoubtedly 0:13:17.040 --> 0:13:19.559 that color is my thinking to this. This whole process 0:13:19.640 --> 0:13:22.160 is probably going to look very different to someone who 0:13:22.400 --> 0:13:24.520 who doesn't know a scientist, and you know, you only 0:13:24.600 --> 0:13:27.560 hear about these things through the news. For her part 0:13:28.000 --> 0:13:30.960 in that Q and A, Robin said she decided to 0:13:31.000 --> 0:13:34.640 participate because she wanted to help her community. I felt 0:13:34.800 --> 0:13:40.320 that if those people who conducted the Tuskegee experiments were 0:13:40.360 --> 0:13:43.640 allowed to succeed, not only because of what they did, 0:13:44.240 --> 0:13:48.400 but because future generations of African Americans were still too 0:13:48.440 --> 0:13:53.880 afraid to participate in trials that would benefit us, then 0:13:53.920 --> 0:13:57.480 those people would really have one twice and I was 0:13:57.520 --> 0:14:03.480 not going to let that happen. With so many vaccines 0:14:03.520 --> 0:14:07.000 in progress now it does seem promising that one of 0:14:07.040 --> 0:14:10.080 them will work, and eventually we will be able to 0:14:10.080 --> 0:14:14.800 put this terrible year behind us. But it will take 0:14:14.880 --> 0:14:19.520 significant effort to achieve the diversity necessary to make sure 0:14:19.640 --> 0:14:37.520 that vaccine works for everyone. That was Kristin V. Brown 0:14:38.080 --> 0:14:40.720 and that's it for our show today. For coverage of 0:14:40.720 --> 0:14:44.680 the outbreak from one bureaus around the world, visit Bloomberg 0:14:44.840 --> 0:14:49.160 dot com slash coronavirus and if you like the show, 0:14:49.600 --> 0:14:52.320 please leave us a review and a rating on Apple 0:14:52.400 --> 0:14:56.080 Podcasts or Spotify. It's the best way to help more 0:14:56.160 --> 0:15:00.560 listeners find our global reporting. The product No sis Dale 0:15:00.760 --> 0:15:05.640 Edition is produced by Topher foreheads Jordan Gospore, Magnus Hendrickson 0:15:05.800 --> 0:15:10.400 and me Laura Carlson. Today's main story was reported by 0:15:10.480 --> 0:15:16.000 Kristin V. Brown. Original music by Leo Sidrin. Our editors 0:15:16.040 --> 0:15:20.960 are Francesco Levi and Rick Shine. Francesco Levi is Bloomberg's 0:15:20.960 --> 0:15:23.440 head of Podcasts. Thanks for listening.