Black Participants Are Sorely Absent from Medical Research
Black participants are under-represented in clinical 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."
Chicken that is grown entirely in a laboratory, without harming a single bird, could be sold in supermarkets in the coming months. But critics say the doubts about lab-grown meat have not been appropriately explored.
Last November, when the U.S. Food and Drug Administration disclosed that chicken from a California firm called UPSIDE Foods did not raise safety concerns, it drily upended how humans have obtained animal protein for thousands of generations.
“The FDA is ready to work with additional firms developing cultured animal cell food and production processes to ensure their food is safe and lawful,” the agency said in a statement at the time.
Assuming UPSIDE obtains clearances from the U.S. Department of Agriculture, its chicken – grown entirely in a laboratory without harming a single bird – could be sold in supermarkets in the coming months.
“Ultimately, we want our products to be available everywhere meat is sold, including retail and food service channels,” a company spokesperson said. The upscale French restaurant Atelier Crenn in San Francisco will have UPSIDE chicken on its menu once it is approved, she added.
Known as lab-grown or cultured meat, a product such as UPSIDE’s is created using stem cells and other tissue obtained from a chicken, cow or other livestock. Those cells are then multiplied in a nutrient-dense environment, usually in conjunction with a “scaffold” of plant-based materials or gelatin to give them a familiar form, such as a chicken breast or a ribeye steak. A Dutch company called Mosa Meat claims it can produce 80,000 hamburgers derived from a cluster of tissue the size of a sesame seed.
Critics say the doubts about lab-grown meat and the possibility it could merge “Brave New World” with “The Jungle” and “Soylent Green” have not been appropriately explored.
That’s a far cry from when it took months of work to create the first lab-grown hamburger a decade ago. That minuscule patty – which did not contain any fat and was literally plucked from a Petri dish to go into a frying pan – cost about $325,000 to produce.
Just a decade later, an Israeli company called Future Meat said it can produce lab-grown meat for about $1.70 per pound. It plans to open a production facility in the U.S. sometime in 2023 and distribute its products under the brand name “Believer.”
Costs for production have sunk so low that researchers at Carnegie Mellon University in Pittsburgh expect sometime in early 2024 to produce lab-grown Wagyu steak to showcase the viability of growing high-end cuts of beef cheaply. The Carnegie Mellon team is producing its Wagyu using a consumer 3-D printer bought secondhand on eBay and modified to print the highly marbled flesh using a method developed by the university. The device costs $200 – about the same as a pound of Wagyu in the U.S. The initiative’s modest five-figure budget was successfully crowdfunded last year.
“The big cost is going to be the cells (which are being extracted by a cow somewhere in Pennsylvania), but otherwise printing doesn’t add much to the process,” said Rosalyn Abbott, a Carnegie Mellon assistant professor of bioengineering who is co-leader on the project. “But it adds value, unlike doing this with ground meat.”
Lab-Grown Meat’s Promise
Proponents of lab-grown meat say it will cut down on traditional agriculture, which has been a leading contributor to deforestation, water shortages and contaminated waterways from animal waste, as well as climate change.
An Oxford University study from 2011 concludes lab-grown meat could have greenhouse emissions 96 percent lower compared to traditionally raised livestock. Moreover, proponents of lab-grown meat claim that the suffering of animals would decline dramatically, as they would no longer need to be warehoused and slaughtered. A recently opened 26-story high-rise in China dedicated to the raising and slaughtering of pigs illustrates the current plight of livestock in stark terms.
Scientists may even learn how to tweak lab-grown meat to make it more nutritious. Natural red meat is high in saturated fat and, if it’s eaten too often, can lead to chronic diseases. In lab versions, the saturated fat could be swapped for healthier, omega-3 fatty acids.
But critics say the doubts about lab-grown meat and the possibility it could merge “Brave New World” with “The Jungle” and “Soylent Green” have not been appropriately explored.
A Slippery Slope?
Some academics who have studied the moral and ethical issues surrounding lab-grown meat believe it will have a tough path ahead gaining acceptance by consumers. Should it actually succeed in gaining acceptance, many ethical questions must be answered.
“People might be interested” in lab-grown meat, perhaps as a curiosity, said Carlos Alvaro, an associate professor of philosophy at the New York City College of Technology, part of the City University of New York. But the allure of traditionally sourced meat has been baked – or perhaps grilled – into people’s minds for so long that they may not want to make the switch. Plant-based meat provides a recent example of the uphill battle involved in changing old food habits, with Beyond Meat’s stock prices dipping nearly 80 percent in 2022.
"There are many studies showing that people don’t really care about the environment (to that extent)," Alvaro said. "So I don’t know how you would convince people to do this because of the environment.”
“From my research, I understand that the taste (of lab-grown meat) is not quite there,” Alvaro said, noting that the amino acids, sugars and other nutrients required to grow cultivated meat do not mimic what livestock are fed. He also observed that the multiplication of cells as part of the process “really mimic cancer cells” in the way they grow, another off-putting thought for would-be consumers of the product.
Alvaro is also convinced the public will not buy into any argument that lab-grown meat is more environmentally friendly.
“If people care about the environment, they either try and consume considerably less meat and other animal products, or they go vegan or vegetarian,” he said. “But there are many studies showing that people don’t really care about the environment (to that extent). So I don’t know how you would convince people to do this because of the environment.”
Ben Bramble, a professor at Australian National University who previously held posts at Princeton and Trinity College in Ireland, takes a slightly different tack. He noted that “if lab-grown meat becomes cheaper, healthier, or tastier than regular meat, there will be a large market for it. If it becomes all of these things, it will dominate the market.”
However, Bramble has misgivings about that occurring. He believes a smooth transition from traditionally sourced meat to a lab-grown version would allow humans to elide over the decades of animal cruelty perpetrated by large-scale agriculture, without fully reckoning with and learning from this injustice.
“My fear is that if we all switch over to lab-grown meat because it has become cheaper, healthier, or tastier than regular meat, we might never come to realize what we have done, and the terrible things we are capable of,” he said. “This would be a catastrophe.”
Bramble’s writings about cultured meat also raise some serious moral conundrums. If, for example, animal meat may be cultivated without killing animals, why not create products from human protein?
Actually, that’s already happened.
It occurred in 2019, when Orkan Telhan, a professor of fine arts at the University of Pennsylvania, collaborated with two scientists to create an art exhibit at the Philadelphia Museum of Art on the future of foodstuffs.
Although the exhibit included bioengineered bread and genetically modified salmon, it was an installation called “Ouroboros Steak” that drew the most attention. That was comprised of pieces of human flesh grown in a lab from cultivated cells and expired blood products obtained from online sources.
The exhibit was presented as four tiny morsels of red meat – shaped in patterns suggesting an ouroboros, a dragon eating its own tail. They were placed in tiny individual saucers atop a larger plate and placemat with a calico pattern, suggesting an item to order in a diner. The artwork drew international headlines – as well as condemnation for Telhan’s vision.
Telhan’s artwork is intended to critique the overarching assumption that lab-grown meat will eventually replace more traditional production methods, as well as the lack of transparency surrounding many processed foodstuffs. “They think that this problem (from industrial-scale agriculture) is going be solved by this new technology,” Telhan said. “I am critical (of) that perspective.”
Unlike Bramble, Telhan is not against lab-grown meat, so long as its producers are transparent about the sourcing of materials and its cultivation. But he believes that large-scale agricultural meat production – which dates back centuries – is not going to be replaced so quickly.
“We see this again and again with different industries, like algae-based fuels. A lot of companies were excited about this, and promoted it,” Telhan said. “And years later, we know these fuels work. But to be able to displace the oil industry means building the infrastructure to scale takes billions of dollars, and nobody has the patience or money to do it.”
Alvaro concurred on this point, which he believes is already weakened because a large swath of consumers aren’t concerned about environmental degradation.
“They’re going to have to sell this big, but in order to convince people to do so, they have to convince them to eat this product instead of regular meat,” Alvaro said.
Hidden Tweaks?
Moreover, if lab-based meat does obtain a significant market share, Telhan suggested companies may do things to the product – such as to genetically modify it to become more profitable – and never notify consumers. That is a particular concern in the U.S., where regulations regarding such modifications are vastly more relaxed than in the European Union.
“I think that they have really good objectives, and they aspire to good objectives,” Telhan said. “But the system itself doesn't really allow for that much transparency.”
No matter what the future holds, sometime next year Carnegie Mellon is expected to hold a press conference announcing it has produced a cut of the world’s most expensive beef with the help of a modified piece of consumer electronics. It will likely take place at around the same time UPSIDE chicken will be available for purchase in supermarkets and restaurants, pending the USDA’s approvals.
Abbott, the Carnegie Mellon professor, suggested the future event will be both informative and celebratory.
“I think Carnegie Mellon would have someone potentially cook it for us,” she said. “Like have a really good chef in New York City do it.”
In this week's Friday Five, breathing this way may cut down on anxiety, a fasting regimen that could make you sick, this type of job makes men more virile, 3D printed hearts could save your life, and the role of metformin in preventing dementia.
The Friday Five covers five stories in research that you may have missed this week. There are plenty of controversies and troubling ethical issues in science – and we get into many of them in our online magazine – but this news roundup focuses on scientific creativity and progress to give you a therapeutic dose of inspiration headed into the weekend.
Here are the promising studies covered in this week's Friday Five, featuring interviews with Dr. David Spiegel, associate chair of psychiatry and behavioral sciences at Stanford, and Dr. Filip Swirski, professor of medicine and cardiology at the Icahn School of Medicine at Mount Sinai.
Listen on Apple | Listen on Spotify | Listen on Stitcher | Listen on Amazon | Listen on Google
Here are the promising studies covered in this week's Friday Five, featuring interviews with Dr. David Spiegel, associate chair of psychiatry and behavioral sciences at Stanford, and Dr. Filip Swirski, professor of medicine and cardiology at the Icahn School of Medicine at Mount Sinai.
- Breathing this way cuts down on anxiety*
- Could your fasting regimen make you sick?
- This type of job makes men more virile
- 3D printed hearts could save your life
- Yet another potential benefit of metformin
* This video with Dr. Andrew Huberman of Stanford shows exactly how to do the breathing practice.