For decades we’ve joked about the differences between Black folks and White folks…”They” don’t season their food, “We” season everything. There are so many cultural differences, but why aren’t we asking if we’re physically or medically different?
I know you’ve seen the posts on social media saying “’Us’ Black people are genetically different” or “Black folks, ‘they’ been lying to us about our high blood pressure!” The posts go on to provide a misinformed list of medications that are said to be “poisonous” to our bodies. These posts have many of us Black folks asking…”Is this true, are we genetically different?”…” Why are they making medicines that don’t work for us?”
Let’s try to answer these questions. When it comes to being genetically different science teaches us that humans share 99.6 to 99.9 percent of their DNA. Science also indicates there are more genetic variations within races than between races. A 1997 analysis of enzyme variants found that there was only 7 percent genetic variation between Caucasoid, Negroid, and Mongoloid racial groups. Though science teaches us that there are very few genetic differences between races it also teaches us that among these are something called polymorphisms that can result in ethnic differences in drug responses.
In biology, polymorphism is defined as a genetic variation that results in multiple forms of individuals within a species or population. Differences in drug response are mainly related to racial/ethnic differences in the frequency of polymorphisms in genes encoding drug-metabolizing enzymes (DMEs) and drug transporters. These polymorphisms markedly influence how a drug is absorbed, distributed, metabolized and/or excreted from the body. This means that differences affecting the dose requirements, and the safety of drugs, do vary in different ethnic groups.
To understand why drugs that “work” for Black people are not being made, we first need to understand the process for determining whether or not medications are safe and effective in humans. Regarding all medications, numerous steps occur before the FDA grants approval. The first step is called discovery and development, which is exactly what it sounds like—discovering and developing the drug compound. Next, there is preclinical research which is where the first testing occurs in animals or on organisms in the laboratory. Once it is determined the drug is found to be acceptable in preclinical testing, it moves to the clinical research process. The clinical research step is followed by the FDA review to determine if approval will be granted.
The most important step is the clinical research step. Clinical research involves clinical trials to determine the safety and efficacy of the drug. Clinical trials are typically divided into four phases: phase I, phase II, phase III, and phase IV. The number of volunteers required depends on the phase of the trial. According to the FDA, phase I involves 20 to 100 healthy volunteers or individuals with the disease or condition, phase II involves up to several hundred people with the disease or condition, phase III involves 300 to 3,000 people with the disease or condition, and phase IV involves several thousand people with the disease or condition.
Recent statistics indicate that clinical trial volunteers are 75 percent White, 11 percent Hispanic/Latino, 8 percent Black, and 6 percent Asian. When it comes to high blood pressure 56 percent of adult Blacks have this condition, diabetes is 60 percent more common in Black Americans, Black Americans are 4 times more likely to die from strokes and Black men are 50 percent more likely than white men to get lung cancer. You may ask, why is this an issue? This is an issue because we can’t continue to stand idly by and expect pharmaceutical companies to manufacture drugs that work for us. We Black people need to understand that without our participation in the clinical research phase, there is no way to verify the safety and efficacy of the drugs the FDA approves.
It is time for us to educate ourselves about clinical research. Many of us know the atrocities of the past regarding unethical experimentation involving Blacks, Latinos, and Native Americans, however, very few of us know the laws and regulations that were implemented afterward to prevent the repeat of such events.
Myra Fonville is the Chief Editor and founder of Interim Visits, an online quarterly magazine that focuses on clinical research.
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