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Before I talk about the COVID-19 vaccine, I want to share my own experience around taking medication as a minority. If you're new to this blog, you'll come to know I believe in the importance of sharing our experiences (as valuable raw data) so we can learn from them. And if you're also a person of color, maybe you can relate to my story. It's a story about representation and skepticism, something I expect many of us are familiar with. If you're looking for a quick conclusion, you can skip to the next section and still get the gist, but my experience provides a little context for the rest of the post.
When I was hospitalized and diagnosed with my mental illness, I was hesitant to take pills and was interested in exploring other treatment options. However, once my psychiatrist explained to me that medication is the only real treatment for people with bipolar, I was on board. Why was I hesitant? A few reasons. I didn't want to grow dependent on a drug that might change my brain. I didn't want to have my cognitive processes or emotions dulled in some way. I didn't want to have an unexpected reaction, like becoming suicidal or violent. Basically, I didn't want any harm to come to me. And even as the nurses and social workers assured me not to worry, and that the side effects of these medications are well-studied and "usually not bad," I shook my head: just because these drugs were approved for use, does not mean that I know how they will affect me, an Asian-American woman. That requires extra work on my part. I said I'm sorry, but I'm going to need to take a look at the clinical trial reports before I take anything. You say it's well-researched....well, I'm going to confirm if that applies to me and not just white people. Yeah, I was a really annoying patient.
It's because I was manic, but it's also because I work in the field of precision health, where the idea is that we need to start taking into account more of the differences that make us individuals. So not only your demographics, family history, and measures like your height and weight, but also your genes, lifestyle, and environment. Each of us is unique, and it's time to account for as many of those differences as we can and find the optimal solution for each person's health. The concept of precision health is hugely powerful and foreshadows a world-changing shift in healthcare practices. If you didn't know about it, it's time to get excited.
Well, okay, maybe don't get too excited just yet. The problem is, the concept of precision health is so new that there's not much concrete, usable research in this area yet. Researchers have essentially just started working on this and will be doing so for the next several decades at least. New research questions are emerging more rapidly than we have the data or computing resources to analyze, and this combined with other obstacles means we have a long way to go. The research is not there yet and I don't expect it to be, but I still want a certain level of assurance that I've been represented in the study as best as possible. Your study population informs the extent to which you can generalize your results[efn_note]Glen, S. 2016 May 23. "Generalizability and Transferability in Statistics and Research." Statistics How To (Blog). Retrieved from https://www.statisticshowto.com/generalizability-transferability/[/efn_note]. So while it's great if your drug is approved in a sample of white Americans, how can I say how it is going to affect me? Where is your data on multiethnic Asian women with my genetic profile? This is a tall ask in today's world, but it's how I've started thinking.
In my daily 15 allotted minutes for internet use at the psych ward, I looked up the clinical trial reports for each of the bipolar drugs I was considering. I was disappointed that first off, demographic information for clinical trials is not straightforward to find, and isn't always available (unless it's just that hard to find). Secondly, for those that did have this data available, they had low numbers of minority samples, as I expected. I should note that it's typical for clinical trial sample sizes to be small, because there are ethics concerns with enrolling more people than needed — where "need" is defined by how much power your statistical test has to detect the effect of the drug. Larger sample sizes are often not necessary and in some cases, not possible[efn_note]Sakpal, TV. 2010 Apr. "Sample Size Estimation in Clinical Trial." Perspectives in Clinical Research. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3148614/[/efn_note]. But the thing is, when you start off with a small sample size, you end up with an embarrassingly small number of minority samples, and possibly not much variation among them. Larger numbers (and mindful sampling) increase the expectation that you'll include people with different environmental and lifestyle exposures and a wider range of demographic and genetic variation. It covers your bases a little better, so to speak.
As an example, one drug I looked up contained a sample of 85% white (of which 72% were Non-Hispanic white), which is an overrepresentation above the expected 76% and 60% respectively. So when the sample is only 200 people total and 10% East Asian, as this one was, that means they only tested this drug on 20 East Asian people, of which probably 10 got the drug. That's a pretty small number to me, and I'm not sure I'm comfortable with that. Out of those 10 Asians, how many are multiethnic? How many have a similar lifestyle to me in terms of diet, exercise, sleep and stress? We don't know and with only 10 of them, the expected value of that number is low. There were even fewer Black people, comprising around 4% and less than 10 people total. There were no South Asians included in the study, so as a South Asian person this was concerning to me. Maybe there were more minority samples included in Phase I and II clinical trials, but I don't have a way to know that. Remember, my concern was that the drug might have unintended consequences and nasty side effects for someone like me. Looking at the reports, I have no evidence either way because "someone like me" probably wasn't included in the study. As a statistician, I don't love that lack of data. I decided I wasn't comfortable taking that particular drug.
If you're interested, after some research I did eventually choose a bipolar drug because I saw that it had also been approved in an East Asian country and South Asian country. I figured if horrible side effects were common in East/South Asian people with that medication, it wouldn't have been approved in those countries. Maybe it's weak evidence, but it was the best I had. That drug has been working for me pretty well. Not to say that the others definitely wouldn't have worked — it's just that there wasn't enough data for me to comfortably make that decision. Because of a lack of representation, I had to weigh certain risks and make the decision that I thought was the least risky.
wait, so should i take the vaccine or not?
There are plenty of great reasons to get a coronavirus vaccine[efn_note]2020 Nov 24. "Benefits of Getting a COVID-19 Vaccine." CDC. Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html[/efn_note], and there are some bad reasons not to. But there are also good reasons not to: like concerns about representation in research, or if you come from a population that has a valid reason to distrust science, because you or people like you have been harmed by these institutions in the past. There have been plenty of flagrant ethics and human rights violations in our history, and those violations tend to disproportionately harm marginalized populations, including people of color[efn_note]Brandt, AM. 1978. "Racism and research: The case of the Tuskegee Syphilis study." The Hastings Center Report. Retrieved from https://dash.harvard.edu/handle/1/3372911[/efn_note] [efn_note]Barnett, A. 2004 Apr 4. "UK firm tried HIV drug on orphans." The Guardian. Retrieved from https://www.theguardian.com/world/2004/apr/04/usa.highereducation[/efn_note] [efn_note]Washington, HA. 2006. "Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present." Doubleday Publishing. ISBN 978-0-385-50993-0[/efn_note], women[efn_note]2020 Sep 1. "Henrietta Lacks: science must right a historical wrong." Nature. Retrieved from https://www.nature.com/articles/d41586-020-02494-z[/efn_note], people with mental illnesses[efn_note]Wessely, S. 2009 Oct 1. "Surgery for the treatment of psychiatric illness: the need to test untested theories." Journal of the Royal Society of Medicine. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2755332/[/efn_note] [efn_note]Hickey, P. 2020 Aug 27. "Deep Sleep “Therapy” in Australia in the 1960’s and 70’s. Could Something Like This Happen Today?." Behaviorism and Mental Health (Blog). Retrieved from https://www.behaviorismandmentalhealth.com/2020/08/27/deep-sleep-therapy-in-australia-in-the-1960s-and-70s-could-something-like-this-happen-today/[/efn_note], people who are homeless[efn_note]Aronowitz, R. 2014 Jan. "“Screening” for Prostate Cancer in New York’s Skid Row: History and Implications." American Journal of Public Health. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3910041/[/efn_note], and more. So as a half-Brown Asian woman with bipolar, I understand if that's your hesitation. I'm not here to tell you what decision to make (I don't believe in that), but what I can say is that I will definitely be taking the COVID-19 vaccine as soon as I'm able, and here's why.
The clinical trials for the Moderna COVID-19 vaccine have enrolled over 30,000 participants, of which 37% come from racial and ethnic minorities[efn_note]2020 Nov 16. "Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine." NIH. Retrieved from https://www.nih.gov/news-events/news-releases/promising-interim-results-clinical-trial-nih-moderna-covid-19-vaccine[/efn_note]. Pfizer's trials enrolled over 44,000 participants, of which 42% come from racial and ethnic minorities[efn_note]2020 Nov 18. "PFIZER AND BIONTECH CONCLUDE PHASE 3 STUDY OF COVID-19 VACCINE CANDIDATE, MEETING ALL PRIMARY EFFICACY ENDPOINTS." Pfizer.Retrieved from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine[/efn_note]. The COVID-19 vaccine trials have officially become among the largest vaccine trials ever undertaken in the United States[efn_note]Brown, A. 2020 Nov 11. "It’s official: Covid-19 vaccine trials rank among the largest." Evaluate Vantage. Retrieved from https://www.evaluate.com/vantage/articles/news/snippets/its-official-covid-19-vaccine-trials-rank-among-largest[/efn_note]. Pfizer reports 5% Asian in their trial, so that's roughly 2200 Asian people who risked their health to make things safer for me, which is over 10 times more than the total sample size for the clinical trial example I shared earlier. They report 10% Black, so that's 4400 Black people. Hopefully more than 0 South Asians, though they don't distinguish between East Asian and South Asian. 🙃 Those numbers sit a little better with me, because there is likely to be a greater amount of diversity among those participants in terms of age, gender, socioeconomic status, lifestyle, and other factors as opposed to when you have a sample of 10 Black people or 20 Asian people. Both companies reported no severe safety concerns overall[efn_note]Pfizer and BioNTech. 2020 Dec 10. "FDA Briefing Document: Pfizer-BioNTech COVID-19 Vaccine." FDA. Retrieved from https://www.fda.gov/media/144245/download[/efn_note] [efn_note]ModernaTX. 2020 Dec 17. "FDA Briefing Document: Moderna COVID-19 Vaccine." FDA. Retrieved from https://www.fda.gov/media/144434/download[/efn_note], so that must mean that there were no severe adverse events caused by the vaccine observed across the >1000 Asians who got the drug, which puts me at ease. (Side note: I want to mention that in general, the check for adverse events should be done within specific racial and ethnic groups too, not just overall, to see if severe side effects are disproportionately common in minorities. I'm assuming this check is already done, but I wasn't able to find information on that in the FDA reports. In this case it doesn't matter because overall, things looked good.)
When it comes down to it, even if they had enrolled fewer Asian people in the vaccine clinical trials, I would still take it because I view the benefits of receiving the vaccine to be worth the risks it may bring me. I'm one of those people who's seen friends and family in person less than 10 times in 9 months. Like many, I'm sick of COVID-19 and sick of staying inside. I want the vaccine as soon as possible so I can start going back to my pre-pandemic activities and see my loved ones without the fear of getting the virus and possibly suffering long-term consequences for months after I recover[efn_note]2020 Nov 13. "Long-term Effects of COVID-19." CDC. Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects.html[/efn_note]. Having that sense of normalcy back and peace of mind, to me, is worth the low risk of a negative outcome. The vaccine has also been shown to prevent serious cases of COVID-19 in the rare event that it is contracted, which would be a huge ease off my mind because yeah, I don't want to die. I don't think there's any concrete evidence yet that getting vaccinated will prevent you from spreading the disease to others (I will update if that changes), but it's certainly possible. The bottom line is that scientists have a very credible theory that the more people that get vaccinated, the more lives will be saved, and I want to be included in that effort and investigation. Seeing that over 2000 Asian people were included in the study, and that likely 1000 of those Asian people got the vaccine and didn't have a severe adverse event is good enough for me. You need to decide for yourself what you are comfortable with, and what your reasons are for getting the vaccine. But remember that nothing is completely without risk because you are unique, and there will never be an identical you in a clinical trial unless you yourself have volunteered to pave the way for others (in which case, thank you).
If you don't believe that the vaccine is safe for you to take as a minority, I honestly don't blame you. The reason there's poor representation of minorities in clinical trials and other studies is because of that same lack of trust. It's inarguable that the road to scientific progress has been marked with the bodies and blood of marginalized populations, but just like we're all fighting for change and starting to revolutionize, the scientific community has its own fight and revolution too. For years, I have seen the genetics and precision health fields continue to push for more diversity in research and better protections for participants, and I can only imagine this is happening in other fields too. Just recently, Warren et al. published a thoughtful piece in the New England Journal of Medicine discussing the lack of minority participation in clinical trials and how the scientific community can remedy that[efn_note]Warren, RC et al. 2020 Nov 26. "Trustworthiness before Trust — Covid-19 Vaccine Trials and the Black Community." New England Journal of Medicine. Retrieved from https://www.nejm.org/doi/full/10.1056/NEJMp2030033[/efn_note]. It's an accessible and highly worthwhile read. I especially appreciate that their solution places the burden on the scientific community to be worthy of trust, not on Black or minority populations to place their trust in researchers. That is, it is the responsibility of the researchers to first build trustworthiness by providing better conditions to participate, such as clearer consent and adequate resources and protection. We cannot ask minority populations to trust us blindly. Based on past evidence, they have little reason to do so, and such a request would be fundamentally wrong.
As a minority, I can understand the fear and hesitation; the thought that we are not a priority for the white world we live in, and that we may be ignored or exploited. But as a scientist, I've been in conversations where it's clear that's changing. Diversity and representation are starting to matter a lot more, and the commitment to including non-white populations in the COVID-19 vaccine trials is proof. I know that might still sound like an empty statement, and certainly too little too late applies here as well, but I'm hopeful and I believe that things can change if we work on it. I agree that scientists are not owed trust; we need to earn it. We're trying to earn it now but we're running out of time. We want as many people to take the vaccine as possible because we trust the science behind it, but it's your decision to trust us or not. I hope you do because I really believe it could save your life, but if you'd like to discuss more, feel free to reach out. And if you're unhappy with the current climate of science and research, consider joining us, whether that's as a scientist or research participant.
what if i'm white?
Based on the evidence, there is very, very little cause for worry for white people. If you do have a concern, please drop them in the comments so we can discuss. Honestly, I'm very jealous of how well-represented white people are in this and other clinical trials, and research in general. Here I am justifying that 1000 Asian people makes me comfortable while you have over 10 times that number. As a white person, you can still weigh valid concerns about representation (pregnant people, minors, people with drug allergies, etc.) but you have much less to worry about than a person of color. Both vaccines have been well-studied and tested on literally tens of thousands of white people, and experts have deemed it to be very safe. When experts deem something safe, minorities may take that with a grain of salt but white people, you have the ability and freedom to trust. You're the overwhelming majority in these studies, and consequently the conclusions apply to you. Those tens of thousands of clinical trial participants risked their own health to protect yours. Their commitment allows you to have confidence. So please, read up on the science, do your part, and take the vaccine.
The vaccine is well-researched and a true testament to how much can be accomplished with ample funding, adequate resources, and reduced red tape. I believe in it because it's backed by data — data that actually applies to me. If you'd like to discuss something but don't feel comfortable leaving a comment, please feel free to reach out to me directly through Instagram or Twitter.
Also, a big thank you to my friend and colleague Brooke Wolford for reading these thoughts and providing feedback before I made them public. I'm sure we're all familiar with imposter syndrome and general insecurity, and I'm not immune. It helps to get feedback from those you trust and value, so I really appreciate that and am lucky to have supportive friends.
© if you know you grow 2023.