The Problem With Colorblind Clinical Trials
WHY YOU SHOULD CARE
A dearth of Black patients in drug trials results in subpar health care outcomes.
By Kate Bartlett
Professor Kelly Chibale has an easygoing manner and a big laugh that belies the fact that he’s one of Africa’s preeminent scientists, and among the world’s top Black leaders in biotech. Speaking over Zoom from Cape Town, South Africa, he’s quick to tease me that his home country, Zambia, is superior to mine, neighboring Zimbabwe. But Chibale’s start in life was anything but easy and is in fact perfectly captured by the name of the impoverished township he grew up in: Kabulanda, which literally translates as “sadness” in a local language.
Living with his entire family in a one-room home with no running water or electricity as a child, the young Chibale studied at night by the light of a kerosene lamp and against all odds made it into Cambridge, where he studied chemistry.
An illustrious career followed, with Chibale living in both the U.K. and U.S. doing academic fellowships and lecturing, but he always felt a pull to return to the continent of his birth. Then, 11 years ago, Chibale set up H3D, the only integrated drug research and development platform in Africa, at the University of Cape Town, where he’s made it his mission to develop drugs that improve treatment outcomes for Black patients, who, he says, are woefully underrepresented in clinical trials.
I spoke to Chibale about his work and learned why he’s passionate about combating what he calls “Afro-pessimism.” The interview has been edited for clarity and length.
Why do you think it’s important that more drug trials enroll African patients?
Africa makes up about 15 to 20% of the world’s population. When it comes to clinical trials, less than 2% actually happen on the continent. This is the implication: The volunteers in clinical trials … are largely from the global north, and because the majority of the clinical trials happen outside of Africa, irrespective of the disease area, it means that the dosages and the dosing regimens, whether it’s a drug or a therapeutic or a vaccine … are then brought into Africa. What it then means is the African perspective in those clinical trials is not considered … our genetics. Africa as a continent is the most genetically diverse on planet Earth. African governments do not demand local clinical trial data. In other countries, like China or Japan, before [companies] can license a product, [those governments] will demand that you generate data, you do the clinical trial on Japanese people so you can understand what the data looks like on Japanese people. In Africa, governments don’t demand that. We’re desperate because we don’t innovate ourselves, so we’re at the mercy of those who innovate. COVID-19 has brought this to the fore.
What does the lack of data involving Africans and people of African descent mean for health care outcomes?
When you do a clinical trial, there are three categories you think about: normal and fast metabolizers and then slow metabolizers. One of these ARV drugs [antiretrovirals used to treat HIV/AIDS] is called Efavirenz. If you do a clinical trial on Caucasians, which is what happened, you identify normal metabolizers, but in people of African descent, including African Americans, you find that they are slow metabolizers because of genetic polymorphism. Guess what? If you give this to the slow metabolizers, it will be toxic, because it’s an overdose. So people can die from [drug] toxicity and not the HIV virus. If you do a clinical trial on Africans you can see this. … The reason for the health inequities is because we don’t have enough clinical trials; we need to test across Africa. There’s a direct correlation between the genetics of the population, the social or physical environment in which they live and treatment outcome.
What are some of the barriers to drug and health care innovation in Africa?
Disinformation. People think clinical trials want to eliminate Black people … colonialism, apartheid, in the U.S. there was the Tuskegee incident — so people have a basis for fear.
[One of the reasons for establishing H3D] is what I call confronting “Afro-pessimism.” That term has got two sides to it. One side to Afro-pessimism is how — rightly or wrongly — people outside of the continent view Africa: corruption, civil wars. The second side of Afro-pessimism is that African people ourselves don’t think we can do something like this unless it first comes from Silicon Valley, then it’s good; if it comes from Zimbabwe, then you’ve got to be suspicious. African people need to have confidence that you can do something world-class.
You’re working on something you call “the Liver Project.” What is that about?
There’s a culture of organ donation in the Western world. These liver fractions that we use in studies come from Caucasians, because we buy them from companies in America, because that’s where the donors are. That means there are no African livers. Enzymes in the liver, some of them are different in people of African descent, including African Americans. [With this project] we want to create a repository of well-characterized human liver tissues derived from diverse African populations. Then the next stage is to take any drug, whether it’s already used in Africa or not, generate data to see how this drug is metabolized and how long it survives when it’s in the African liver. When we determine the rate of metabolism and compare with what is known, we can begin to see differences, and then we use that data to build mathematical models which help us to predict what the right dose will be in Africans.
What else are you working on?
Four infectious diseases: malaria, TB, antibiotic-resistant microbes and COVID-19. We are using artificial intelligence to fast-track the identification of COVID-19 therapeutics.
How did your difficult background drive you to excel?
That disadvantage to me was an advantage. You know why? Because then I have a drive to say these conditions are unacceptable. The point is, I moved from here and I went to Cambridge. I can inspire people that it’s possible [to grow up poor and succeed]; you don’t have to feel condemned. We need more role models whether it’s in politics or leadership. So when a Black kid from a township sees me, knowing that I also came from a township, there’s hope that if that can happen for me, it can happen for them as well.
Africa is ripe and ready for innovation. I’ll tell you why. This is untapped … Africa is the next growth market for the pharmaceutical industry, this is not in dispute. Secondly, Africa genetically is the most diverse continent. Thirdly, Africa is a continent of a billion people. This is the place to make incredible discoveries.
- Kate Bartlett, OZY Author Contact Kate Bartlett