Black Participants Are Sorely Absent from Medical Research
After years of suffering from mysterious symptoms, my mother Janice Thomas finally found a doctor who correctly diagnosed her with two autoimmune diseases, Lupus and Sjogren's. Both diseases are more prevalent in the black population than in other races and are often misdiagnosed.
The National Institutes of Health has found that minorities make up less than 10 percent of trial participants.
Like many chronic health conditions, a lack of understanding persists about their causes, individual manifestations, and best treatment strategies.
On the search for relief from chronic pain, my mother started researching options and decided to participate in clinical trials as a way to gain much-needed insights. In return, she received discounted medical testing and has played an active role in finding answers for all.
"When my doctor told me I could get financial or medical benefits from participating in clinical trials for the same test I was already doing, I figured it would be an easy way to get some answers at little to no cost," she says.
As a person of color, her presence in clinical studies is rare. The National Institutes of Health has found that minorities make up less than 10 percent of trial participants.
Without trial participation that is reflective of the general population, pharmaceutical companies and medical professionals are left guessing how various drugs work across racial lines. For example, albuterol, a widely used asthma treatment, was found to have decreased effectiveness for black American and Puerto Rican children. Many high mortality conditions, like cancer, also show different outcomes based on race.
Over the last decade, the pervasive lack of representation has left communities of color demanding higher levels of involvement in the research process. However, no consensus yet exists on how best to achieve this.
But experts suggest that before we can improve black participation in medical studies, key misconceptions must be addressed, such as the false assumption that such patients are unwilling to participate because they distrust scientists.
Jill A. Fisher, a professor in the Center for Bioethics at the University of North Carolina at Chapel Hill, learned in one study that mistrust wasn't the main barrier for black Americans. "There is a lot of evidence that researchers' recruitment of black Americans is generally poorly done, with many black patients simply not asked," Fisher says. "Moreover, the underrepresentation of black Americans is primarily true for efficacy trials - those testing whether an investigational drug might therapeutically benefit patients with specific illnesses."
Without increased minority participation, research will not accurately reflect the diversity of the general population.
Dr. Joyce Balls-Berry, a psychiatric epidemiologist and health educator, agrees that black Americans are often overlooked in the process. One study she conducted found that "enrollment of minorities in clinical trials meant using a variety of culturally appropriate strategies to engage participants," she explained.
To overcome this hurdle, The National Black Church Initiative (NBCI), a faith-based organization made up of 34,000 churches and over 15.7 million African Americans, last year urged the Food and Drug Administration to mandate diversity in all clinical trials before approving a drug or device. However, the FDA declined to implement the mandate, declaring that they don't have the authority to regulate diversity in clinical trials.
"African Americans have not been successfully incorporated into the advancement of medicine and research technologies as legitimate and natural born citizens of this country," admonishes NBCI's president Rev. Anthony Evans.
His words conjure a reminder of the medical system's insidious history for people of color. The most infamous incident is the Tuskegee syphilis scandal, in which white government doctors perpetrated harmful experiments on hundreds of unsuspecting black men for forty years, until the research was shut down in the early 1970s.
Today, in the second decade of twenty-first century, the pernicious narrative that blacks are outsiders in science and medicine must be challenged, says Dr. Danielle N. Lee, assistant professor of biological sciences at Southern Illinois University. And having majority white participants in clinical trials only furthers the notion that "whiteness" is the default.
According to Lee, black individuals often see themselves disconnected from scientific and medical processes. "One of the critiques with science and medical research is that communities of color, and black communities in particular, regard ourselves as outsiders of science," Lee says. "We are othered."
Without increased minority participation, research will not accurately reflect the diversity of the general population.
"We are all human, but we are different, and yes, even different populations of people require modified medical responses," she points out.
Another obstacle is that many trials have health requirements that exclude black Americans, like not wanting individuals who have high blood pressure or a history of stroke. Considering that this group faces health disparities at a higher rate than whites, this eliminates eligibility for millions of potential participants.
One way to increase the diversity in sample participation without an FDA mandate is to include more black Americans in both volunteer and clinical roles during the research process to increase accountability in treatment, education, and advocacy.
"When more of us participate in clinical trials, we help build out the basic data sets that account for health disparities from the start, not after the fact," Lee says. She also suggests that researchers involve black patient representatives throughout the clinical trial process, from the study design to the interpretation of results.
"This allows for the black community to give insight on how to increase trial enrollment and help reduce stigma," she explains.
Thankfully, partnerships are popping up like the one between The Howard University's Cancer Center and Driver, a platform that connects cancer patients to treatment and trials. These sorts of targeted and culturally tailored efforts allow black patients to receive assistance from well-respected organizations.
Some observers suggest that the federal government and pharmaceutical industries must step up to address the gap.
However, some experts say that the black community should not be held solely responsible for solving a problem it did not cause. Instead, some observers suggest that the federal government and pharmaceutical industries must step up to address the gap.
According to Balls-Berry, socioeconomic barriers like transportation, time off work, and childcare related to trial participation must be removed. "These are real-world issues and yet many times researchers have not included these things in their budgets."
When asked to comment, a spokesperson for BIO, the world's largest biotech trade association, emailed the following statement:
"BIO believes that that our members' products and services should address the needs of a diverse population, and enhancing participation in clinical trials by a diverse patient population is a priority for BIO and our member companies. By investing in patient education to improve awareness of clinical trial opportunities, we can reduce disparities in clinical research to better reflect the country's changing demographics."
For my mother, the patient suffering from autoimmune disease, the need for broad participation in medical research is clear. "Without clinical trials, we would have less diagnosis and solutions to diseases," she says. "I think it's an underutilized resource."
DNA- and RNA-based electronic implants may revolutionize healthcare
Implantable electronic devices can significantly improve patients’ quality of life. A pacemaker can encourage the heart to beat more regularly. A neural implant, usually placed at the back of the skull, can help brain function and encourage higher neural activity. Current research on neural implants finds them helpful to patients with Parkinson’s disease, vision loss, hearing loss, and other nerve damage problems. Several of these implants, such as Elon Musk’s Neuralink, have already been approved by the FDA for human use.
Yet, pacemakers, neural implants, and other such electronic devices are not without problems. They require constant electricity, limited through batteries that need replacements. They also cause scarring. “The problem with doing this with electronics is that scar tissue forms,” explains Kate Adamala, an assistant professor of cell biology at the University of Minnesota Twin Cities. “Anytime you have something hard interacting with something soft [like muscle, skin, or tissue], the soft thing will scar. That's why there are no long-term neural implants right now.” To overcome these challenges, scientists are turning to biocomputing processes that use organic materials like DNA and RNA. Other promised benefits include “diagnostics and possibly therapeutic action, operating as nanorobots in living organisms,” writes Evgeny Katz, a professor of bioelectronics at Clarkson University, in his book DNA- And RNA-Based Computing Systems.
While a computer gives these inputs in binary code or "bits," such as a 0 or 1, biocomputing uses DNA strands as inputs, whether double or single-stranded, and often uses fluorescent RNA as an output.
Adamala’s research focuses on developing such biocomputing systems using DNA, RNA, proteins, and lipids. Using these molecules in the biocomputing systems allows the latter to be biocompatible with the human body, resulting in a natural healing process. In a recent Nature Communications study, Adamala and her team created a new biocomputing platform called TRUMPET (Transcriptional RNA Universal Multi-Purpose GatE PlaTform) which acts like a DNA-powered computer chip. “These biological systems can heal if you design them correctly,” adds Adamala. “So you can imagine a computer that will eventually heal itself.”
The basics of biocomputing
Biocomputing and regular computing have many similarities. Like regular computing, biocomputing works by running information through a series of gates, usually logic gates. A logic gate works as a fork in the road for an electronic circuit. The input will travel one way or another, giving two different outputs. An example logic gate is the AND gate, which has two inputs (A and B) and two different results. If both A and B are 1, the AND gate output will be 1. If only A is 1 and B is 0, the output will be 0 and vice versa. If both A and B are 0, the result will be 0. While a computer gives these inputs in binary code or "bits," such as a 0 or 1, biocomputing uses DNA strands as inputs, whether double or single-stranded, and often uses fluorescent RNA as an output. In this case, the DNA enters the logic gate as a single or double strand.
If the DNA is double-stranded, the system “digests” the DNA or destroys it, which results in non-fluorescence or “0” output. Conversely, if the DNA is single-stranded, it won’t be digested and instead will be copied by several enzymes in the biocomputing system, resulting in fluorescent RNA or a “1” output. And the output for this type of binary system can be expanded beyond fluorescence or not. For example, a “1” output might be the production of the enzyme insulin, while a “0” may be that no insulin is produced. “This kind of synergy between biology and computation is the essence of biocomputing,” says Stephanie Forrest, a professor and the director of the Biodesign Center for Biocomputing, Security and Society at Arizona State University.
Biocomputing circles are made of DNA, RNA, proteins and even bacteria.
Evgeny Katz
The TRUMPET’s promise
Depending on whether the biocomputing system is placed directly inside a cell within the human body, or run in a test-tube, different environmental factors play a role. When an output is produced inside a cell, the cell's natural processes can amplify this output (for example, a specific protein or DNA strand), creating a solid signal. However, these cells can also be very leaky. “You want the cells to do the thing you ask them to do before they finish whatever their businesses, which is to grow, replicate, metabolize,” Adamala explains. “However, often the gate may be triggered without the right inputs, creating a false positive signal. So that's why natural logic gates are often leaky." While biocomputing outside a cell in a test tube can allow for tighter control over the logic gates, the outputs or signals cannot be amplified by a cell and are less potent.
TRUMPET, which is smaller than a cell, taps into both cellular and non-cellular biocomputing benefits. “At its core, it is a nonliving logic gate system,” Adamala states, “It's a DNA-based logic gate system. But because we use enzymes, and the readout is enzymatic [where an enzyme replicates the fluorescent RNA], we end up with signal amplification." This readout means that the output from the TRUMPET system, a fluorescent RNA strand, can be replicated by nearby enzymes in the platform, making the light signal stronger. "So it combines the best of both worlds,” Adamala adds.
These organic-based systems could detect cancer cells or low insulin levels inside a patient’s body.
The TRUMPET biocomputing process is relatively straightforward. “If the DNA [input] shows up as single-stranded, it will not be digested [by the logic gate], and you get this nice fluorescent output as the RNA is made from the single-stranded DNA, and that's a 1,” Adamala explains. "And if the DNA input is double-stranded, it gets digested by the enzymes in the logic gate, and there is no RNA created from the DNA, so there is no fluorescence, and the output is 0." On the story's leading image above, if the tube is "lit" with a purple color, that is a binary 1 signal for computing. If it's "off" it is a 0.
While still in research, TRUMPET and other biocomputing systems promise significant benefits to personalized healthcare and medicine. These organic-based systems could detect cancer cells or low insulin levels inside a patient’s body. The study’s lead author and graduate student Judee Sharon is already beginning to research TRUMPET's ability for earlier cancer diagnoses. Because the inputs for TRUMPET are single or double-stranded DNA, any mutated or cancerous DNA could theoretically be detected from the platform through the biocomputing process. Theoretically, devices like TRUMPET could be used to detect cancer and other diseases earlier.
Adamala sees TRUMPET not only as a detection system but also as a potential cancer drug delivery system. “Ideally, you would like the drug only to turn on when it senses the presence of a cancer cell. And that's how we use the logic gates, which work in response to inputs like cancerous DNA. Then the output can be the production of a small molecule or the release of a small molecule that can then go and kill what needs killing, in this case, a cancer cell. So we would like to develop applications that use this technology to control the logic gate response of a drug’s delivery to a cell.”
Although platforms like TRUMPET are making progress, a lot more work must be done before they can be used commercially. “The process of translating mechanisms and architecture from biology to computing and vice versa is still an art rather than a science,” says Forrest. “It requires deep computer science and biology knowledge,” she adds. “Some people have compared interdisciplinary science to fusion restaurants—not all combinations are successful, but when they are, the results are remarkable.”
In today’s podcast episode, Leaps.org Deputy Editor Lina Zeldovich speaks about the health and ecological benefits of farming crickets for human consumption with Bicky Nguyen, who joins Lina from Vietnam. Bicky and her business partner Nam Dang operate an insect farm named CricketOne. Motivated by the idea of sustainable and healthy protein production, they started their unconventional endeavor a few years ago, despite numerous naysayers who didn’t believe that humans would ever consider munching on bugs.
Yet, making creepy crawlers part of our diet offers many health and planetary advantages. Food production needs to match the rise in global population, estimated to reach 10 billion by 2050. One challenge is that some of our current practices are inefficient, polluting and wasteful. According to nonprofit EarthSave.org, it takes 2,500 gallons of water, 12 pounds of grain, 35 pounds of topsoil and the energy equivalent of one gallon of gasoline to produce one pound of feedlot beef, although exact statistics vary between sources.
Meanwhile, insects are easy to grow, high on protein and low on fat. When roasted with salt, they make crunchy snacks. When chopped up, they transform into delicious pâtes, says Bicky, who invents her own cricket recipes and serves them at industry and public events. Maybe that’s why some research predicts that edible insects market may grow to almost $10 billion by 2030. Tune in for a delectable chat on this alternative and sustainable protein.
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Further reading:
More info on Bicky Nguyen
https://yseali.fulbright.edu.vn/en/faculty/bicky-n...
The environmental footprint of beef production
https://www.earthsave.org/environment.htm
https://www.watercalculator.org/news/articles/beef-king-big-water-footprints/
https://www.frontiersin.org/articles/10.3389/fsufs.2019.00005/full
https://ourworldindata.org/carbon-footprint-food-methane
Insect farming as a source of sustainable protein
https://www.insectgourmet.com/insect-farming-growing-bugs-for-protein/
https://www.sciencedirect.com/topics/agricultural-and-biological-sciences/insect-farming
Cricket flour is taking the world by storm
https://www.cricketflours.com/
https://talk-commerce.com/blog/what-brands-use-cricket-flour-and-why/
Lina Zeldovich has written about science, medicine and technology for Popular Science, Smithsonian, National Geographic, Scientific American, Reader’s Digest, the New York Times and other major national and international publications. A Columbia J-School alumna, she has won several awards for her stories, including the ASJA Crisis Coverage Award for Covid reporting, and has been a contributing editor at Nautilus Magazine. In 2021, Zeldovich released her first book, The Other Dark Matter, published by the University of Chicago Press, about the science and business of turning waste into wealth and health. You can find her on http://linazeldovich.com/ and @linazeldovich.