40 percent of Americans are Hispanic, Pacific Islander, African-, Asian- or Native-American, yet this entire group accounts for less than five percent of the participants in medical research. Conversely white Americans represent 60% of the population, but make up over 95% of the participants in medical research. Because of this disparity, many drugs, treatment methods, and other research developments available to patients today have been shown to be less effective on minorities. This has led to higher mortality rates, a lower quality of life, and higher healthcare costs for minority populations.
To understand how serious the problem is consider a 2011 survey by the International Journal of Health Services titled “Estimating the Economic Burden of Racial Inequality in the U.S.” which studied the racial/ethnic disparities regarding quality of life and healthcare costs. The study concluded that “eliminating health disparities for minorities would have reduced direct medical care expenditures by $203 billion, and indirect losses by more than $1 trillion.” It examined common illnesses ranging from influenza to HPV, obesity to depression, and Parkinson’s to skin disease.
It is estimated that more than 50 percent of the population will belong to a minority group by 2044. This health and economic burden threatens to balloon if researchers neglect to aggressively tackle health disparities with the diligence they should. To gain a better perspective of the problem and begin to solve it, it is important to recognize why minorities have historically been reluctant to participate in medical research, how they have been taken advantage of in the past and the effects it has caused on the population today. We also want to recognize what is being done to fix it, including one of HDP Health’s core goals: To involve more minorities in clinical research and bring medical advancements to a more diverse population.
Tuskegee University in Tuskegee, Alabama was where the horrific Tuskegee Experiment took place
Eugenics, Tuskegee & Henrietta Lacks: A Legacy of Betrayal
There is a long and winding history as to why minorities haven’t been properly involved in research and why they also tend to be very wary of participating.
In the 1880s, the “Father of Modern Statistics,” Sir Francis Galton, a cousin of Charles Darwin, popularized the pseudoscience called eugenics. The “task” of eugenics was “to encourage fit and fertile matings among those persons most richly endowed by nature” and “to devise practicable means for cutting off the inheritance lines of persons of natural meager or defective inheritance.” People considered unworthy to procreate included those with physically weak or allergic constitutions; the feeble-minded, deformed, and mentally ill; alcoholics, criminals, and paupers. What actually happened was the racist targeting of minority populations. Being born black, poor and “criminalistic,” Native American and alcoholic, or Hispanic and “feeble-minded” made them a target for forced or coerced sterilization. The practice went on for years in public hospitals, prisons, and insane asylums across the entire United States and is a major contributor to why minorities weren’t involved in early research and are wary of participating.
Another gruesome example of unscientific medical research conducted on black men was the 40-year-long Tuskegee Experiment. Started by the Public Health Service in Alabama in 1932, the doctors who ran the Tuskegee Experiment recruited poor black men that had syphilis and didn’t know it. These doctors falsely told the men that they had “bad blood”. The men were given placebos for treatment even after the disease became treatable with penicillin in the 1940s. Penicillin was never administered to the study participants, who were “compensated” with free meals, medical exams, and burial insurance. In the end researchers provided no effective care as the men died, went blind or insane, or experienced other severe health problems due to their untreated syphilis. In July 1972, the Associated Press broke the story of this terrible injustice against minorities, resulting in a class action lawsuit and compensation awarded to the remaining subjects and their families. However, the $10,000,000 settlement, free medical care, and burial expenses were a pittance compared to the lasting legacy of this collective trauma.
Minorities have been taken advantage of in research in other ways as well. Few people knew about the commercialization of Henrietta Lacks’ “immortal” cancer cells until a book about her life was published in 2010. In 1951 John Hopkins Medical Center extracted her “immortal” cancer cells, now called “HeLa” cells, during a biopsy at their “Negro ward”; the cells were kept and used for research without Lacks’ or her family’s knowledge. Lacks was a poor black tobacco farmer who died the same year she came in to the hospital, yet her extracted “HeLa” cells went on to enable cloning, gene mapping, in vitro fertilization, the polio vaccine, and many types of cancer research. For more than half a century, John Hopkins Medical Center profited from the unique, industrious, and immortal cells of Henrietta Lacks, while her family remained in poverty.
Because of all these tragedies committed against minorities, the field of bioethics was born. Bioethics is one reason that anyone can confidently enroll in drug, procedural, and device experiments in the 21st century without being fearful of mistreatment. Today’s patients must give their consent to participate in clinical trials. They receive a bill of rights, as well as written and verbal information that ensures they understand the research in which they’re agreeing to participate. At HDP Health we’re working on making this process better by presenting this information to participants at a reading level that anyone can understand. Not only does this help patients better understand the medical research they will be participating in, but it actually increases the rate at which patients enroll into clinical trials.
An Image of HeLa cells similar to Henrietta Lacks’ “Immortal Cells”
Health Is Not a Game: It’s Time to Level the Playing Field
There are numerous reasons why the U.S. lacks diversity in its medical research studies. Medical and research professionals, and the organizations that fund them, are still overwhelmingly composed of white men. (According to Data USA, the medical profession was 64 percent male and 72 percent white in 2015.) On a positive note, Asian-Americans represent 20 percent of the physician workforce versus 6 percent of the U.S. population. On the other end, only 5 percent of doctors are black versus being 13% of the population, and only 1 to 2 percent of doctors are hispanic while accounting for 17 percent of the population. Simply put, it’s easier to recruit study subjects when the recruiter looks like and shares experiences with the recruited.
Sometimes, minority patients must take matters into their own hands. The New York Times tells the story of jazz photographer K.T. Jones, a black man with an aggressive form of Hodgkin’s Lymphoma. After chemotherapy failed, Jones’ doctor told him he only had a few months to live. Jones thanked his doctor and fired him. Jones then searched for treatments—at ClinicalTrials.gov and elsewhere—on his own. Eventually, he found an immunotherapy drug trial for Nivolumab, which saved his life.
Unfortunately, many minorities never get the opportunity to join one of these potentially life saving clinical trials. Nivolumab belongs to a promising class of immunotherapy drugs called checkpoint inhibitors. According to the Times, Nivolumab’s maker Bristol-Myers Squibb recently paid for two drug trials, one focused on lung cancer, the other on kidney cancer. In the first clinical trial, 92 percent of participants were white and 3 percent each were African-American, Asian, or “Other.” In the second clinical trial, 88 percent were white, 9 percent were Asian and 1 percent were black.
Many reasons exist for the low participation of minorities in clinical trials. Individuals and families with a lower income level can’t afford to fly across the country to a hospital offering these novel treatments, or drive multiple hours each way for a regional center that might be offering such a treatment.
“Rumor is if a new drug is hot, upper class Americans with good insurance will fly to the medical center, stay at a hotel and get on the trial,” — Dr. Otis Bradley, Chief Medical Officer of the American Cancer Society
These upper class folks tend to be white.
In contrast, African-American, Latino, Pacific Islander and Native American minority groups are often left out due to a lack of insurance, the absence of a physician with knowledge of such studies, and inaccessibility to major research facilities, such as Stanford, Sloan Kettering, MD Anderson, or the Mayo Clinic. As well, the high costs of getting the word out to minority populations is another burden, due to the advertising, community outreach, and translation to Spanish or other languages that are required to reach these populations. But by not putting a focus on expanding access to clinical trials, minorities are the ones that get left behind, and their health outcomes have greatly suffered.
The National Cancer Institute finds that African-Americans, Latinos, American Indians, and Alaska Natives have the highest mortality rates from the most commonly diagnosed cancers. Black women die from breast cancer at a rate 42 percent higher than that of white women. Latina women have the highest incidence of cervical cancer, while African-American women again have the highest death rate from it. Black men appear to have a genetic variant that leads to twice the death rate from prostate cancer than white men, while Asians and Pacific Islanders contract stomach cancer at higher than average rates. And of all cancers combined, African-Americans have a death rate 25 percent higher than white Americans.
While Albuterol Inhalers are commonly prescribed for Asthma, many minorities see no benefit from it’s use
A similar problem occurs with minority children and asthma, which is the most common chronic disease youth get. Again there is a lack of medical research into the cause, detection and prevention of asthma for minorities. Only 8.2 percent of white children have the illness, while 18.4 percent of Puerto Rican and 14.6 percent of black youth struggle with it.
Not only do minorities get asthma at a higher rate, but University of California San Francisco (UCSF) pulmonologist Dr. Esteban Burchard, who leads the Asthma Collaboratory, has found that ethnicity is the most important factor in determining if a patient will respond to asthma therapy. Unfortunately, for the most most commonly prescribed asthma medication, Albuterol, 67 percent of Puerto Ricans and 47 percent of African-Americans show no improvement when taking it, yet Albuterol works therapeutically for the vast majority of Caucasian patients. For another type of asthma treatment, long-acting bronchodilators, blacks are 4 times more likely than whites to die or experience serious complications when using them. This again ties back to the issue that the original research likely didn’t involve enough minorities to identify a treatment that worked across all populations.
In addition to the less effective treatments described for cancer and asthma, a few examples of regularly prescribed pharmaceuticals that work well for whites, but not for minority ethnic groups, include the following:
- Carbamezapine, or Tegretol, requires genetic testing of Asians prior to prescription, as it can severely damage their skin.
- Clopidogrel or Plavix, a blood thinner, works like a placebo in 75 percent of Pacific Islanders; its ineffectiveness prompted a lawsuit by the State of Hawaii for false marketing.
- Warfarin causes four times the incidence of intracranial hemorrhage when prescribed to Asians for atrial fibrillation.
What’s Being Done To Fix Diversity in Research
The FDA and drug developers have acknowledged that diversity in clinical trials is a real problem affecting the industry. Recently the FDA has made a concerted effort to put in place strategies to increase participation. For example the FDA’s Office of Minority Health has developed a variety of tools and multimedia campaigns to support clinical trial participation. These materials are designed to urge those underrepresented in clinical trials to find out more information, and consider enrolling.
Other measures that have been taken include the NIH Revitalization Act of 1993 which mandated the inclusion of women and minorities in federally funded research. However, only in the past couple of years have accountability measures been added to the NIH law and we still need to see if they are being enforced. Furthermore, no such mandate exists for privately funded research that is conducted by large pharmaceutical and biotech companies which accounts for many of the treatments that have been, and currently are being, developed.
As we can see, much more work needs to be done. New clinical research studies need to be created to target improvements in diagnosis, prevention, and treatment specifically for minorities that haven’t been addressed before. While private biotech, pharmaceutical companies, and CROs have started to expand where their trials are offered, they should make a large concerted effort to offer their clinical trials in neighborhoods where minority populations live, run by doctors that look like the population that they’re treating.
How HDP Health Is Helping
From the higher costs of recruiting minority populations, to the smaller pools of highly sought after funding, and the review boards that may not prioritize diversity for their clinical trials, there are a host of barriers to improving minority participation. That’s where HDP Health aims to step in and lower the burden on hospitals, patients, researchers and pharmaceutical companies.
HDP Health was built for the purpose of advancing medical research for all by speeding up the clinical trial process and lowering the barrier of finding minority patients who are appropriate for clinical trials. Our Artificial Intelligence technology integrates with electronic medical records to analyze demographic information, coded values and extract information from doctor’s notes to help identify patients that would benefit from current and future clinical trials. We have been working with forward thinking medical institutions who have deep reach into diverse patient populations and have put our solution to work, increasing their clinical trial recruitment rates across the board, and improving the rates at which they can identify and enroll minorities for clinical trials.
If you are a healthcare provider, clinical research organization (CRO), biotechnology or pharmaceutical company committed to expanding the reach of clinical research to a broader segment of the population, HDP Health would like to hear from you and help you achieve those goals.
Contact HDP Health’s CEO Brian Clark at firstname.lastname@example.org to begin the conversation.
About our Founder
As one of a small number of African-Americans who have founded technology companies, Brian started HDP Health after being diagnosed with a degenerative knee condition and being unable to find adequate treatment options. He then made it his goal to help those who need access to the latest treatments for their conditions, and to improve healthcare outcomes for all.