Clinical Trials For All
By Leoneda Inge | WUNC
When my youngest son Teemer was little, we’d keep a bittersweet summer tradition. We’d hop in the car and head to Stokesdale, North Carolina, where I’d drop him off at a camp designed for children living with chronic diseases. Teemer has sickle cell disease.
The camp was called Camp Carefree. I always loved the name. For a few weeks, kids like mine ages 6 to 16, could connect with each other under the Carolina sun — and enough supervision to make us doting parents feel safe.
The summer of 2017 was especially memorable because that’s when word began circulating that the FDA had approved a new drug for those living with sickle cell, called ENDARI. Sickle cell is an inherited disorder that makes it mighty damn hard for red blood cells to carry oxygen throughout the body. You see, the cells are not round, they are crescent-shaped — like a sickle — and can get all jumbled up. The result is major pain, organ damage and worse.
ENDARI was the first drug approved for sickle cell patients in 20 years. Along with the excitement and relief came a question. What took so long? One theory has to do with the fact that sickle cell affects mostly Black people, which left it low on the priority list for Big Pharma. But it’s also extremely hard to find enough African-Americans to participate in a necessary step for drug testing and approval: clinical trials.
Now that COVID-19 is another health issue disproportionately pressing on minority communities, will Black and brown people step forward to take part?
That summer of 2017, I got a chance to talk to other camp parents of kids with sickle cell disease. Some of them hadn’t even yet learned a new drug had hit the market. I asked pointedly: would you take part in a clinical trial like the one that resulted in ENDARI as an available treatment. Would you let your child take part? I was met mostly with a rousing “hell no.”
Nobody wants to be the guinea pig. And in Black communities, that fear is palpable. I’ve heard countless stories of experiences with doctors displaying biases in their diagnoses and treatment recommendations. And I have my own. Most of us can also rattle off the many times in history Black bodies have been used or misused for the sake of medical science. Does the name Henrietta Lacks ring a bell? The most famous of these medical abuses is, of course, the Tuskegee syphilis experiments going back to the 1930s when the Public Health Service withheld treatment from hundreds of Black men in Alabama who had the disease.
Feelings of deep doubt about our medical system are deserved and haven’t gone away. A recent survey by the Pew Research Center reports Black Americans are more hesitant to trust medical scientists and experimental medicine than White and Hispanic folks.
But there are those among us who counter the common narrative. Take Monica Summers. She’s the Program Director at Piedmont Health Services and Sickle Cell Agency in Greensboro, NC which runs the sickle cell program at Camp Carefree. Her teenage son has sickle cell and first participated in a clinical trial for the drug hydroxyurea, when he was one-year-old.
“Even now when we talk to people about clinical trials, the first thing that they say is, I don’t want to be a guinea pig and they are just trying things on me,” Summers reflected. “But if we don’t have the people to test the medication on we won’t know that it will ever work. We have to have clinical trials in order for the medicines to get to the next phase.”
Clinical trials are a crucial step for ending the pandemic as soon as possible, and there are many organizations joining the race to find a vaccine. The World Health Organization reports there are more than 150 vaccines in varying stages of development. How do you make sure everybody is fairly represented in trials for a COVID vaccine, especially when Black and Brown folks have historically been underrepresented in tests, but are dying from the virus at higher rates?
Kent Thoelke is the Chief Scientific Officer and Executive Vice President of PRA Health Sciences, a clinical research organization based in Raleigh. “If you take African-Americans as an example, they account for roughly 13 or 14 percent of the U.S. population. They account for somewhere around 2 to 3 percent of the clinical trial population,” he says. “So it tells you that as an industry, both healthcare and drug development, we do a really, really bad job at making sure everybody is included.”
“It is a moral imperative to me to fix this problem.”
Tholke’s organization is busy running trials for COVID treatments and potential vaccines, and is using virtual tools to reach as many participants as possible. He says the kind of diversity we need to assure efficacy of a COVID-19 vaccine “can’t be by happenstance.”
“It has to be an active decision to go out and say, ‘for this trial to be successful, we have to have at least 25 percent participation by minorities,’” says Tholke. “And until that’s achieved, we won’t close this trial.”
It’s a relief to know people like Ken Tholke and others are devoted to diversity and inclusion in medical research. It’s the only way to achieve equity and work toward eradicating the disparities that exist in our health systems.
And when I ask myself if I’m ready to be a guinea pig in the effort to create an effective COVID-19 vaccine? Well, let’s just say I never imagined I’d see a global pandemic in my lifetime and even though I’ve been thinking about this issue for years, this is the first time I’m ready to say something other than “hell no.”
This summer would have been Camp Carefree’s 37th year of operation. Unfortunately, camp was canceled this year because of COVID-19. Their plan is to be back up and running by summer 2021 — provided there is proven treatment or a vaccine to ward off the virus by that time.
Hear Leoneda discuss diversity and inclusion efforts in clinical research with Kent Thoelke, chief scientific officer and executive vice president of PRA Health Sciences on this episode of WUNC’s Tested podcast.
