Correction: The version of this story that aired on KPBS Evening Edition and radio incorrectly stated the All of Us study is a clinical trial. The All of Us study is multi-year collection of participants' biomedical data that can be used by researchers in clinical trials and other scientific research.
In 2009, when Los Angeles resident Estela Mata was 35 years old, her sister, Juana Mata, was diagnosed with lupus.
“And we didn't know what lupus was back then. It wasn't really talked about a lot. And she literally almost died,” Estela Mata said.
The Mata family moved to the U.S. when she was just a child. And her mother, who didn’t speak English well, had to learn quickly about the disease. But, treatments for lupus were hard to find. The rare genetic disease still doesn’t have a cure.
“When we found out that lupus was genetic, we're like, oh, my gosh, like we need to get more involved into clinical trials,” she said.
Estela Mata and her sister found a National Institutes of Health (NIH) study called the All of Us Research Program and enrolled in Los Angeles. She now works for the program with Scripps Research Institute in San Diego.
The 10-year $1.5 billion tax-payer funded program started enrolling patients in 2018, with the goal of collecting genetic and other biomedical information of 1 million people across the United States. Specifically, the program collects information from electronic health records, physical measures, and participant-provided survey questions in a massive biomedical dataset.
Half of that genetic information will come from "racial or ethnic minorities." The objective is to rectify a decades-long problem: most clinical trials have only collected data on white men, and not Latinas like the Matas.
“We're talking about precision medicine, right? So, if you have this illness, take this medication or this treatment plan. It's not customized to the individual … especially in the Hispanic community, we wanted to make sure that we were included,” Estela Mata said. She consented to giving her genetic information because she believes it will be used to help low-income people of color receive treatments that could help them.
Colonized Science Means People Of Color Are Often Left Behind
But, some genetics experts say, the All of Us program is not really for all of us.
“You can't really talk about science in America without talking about colonialism. We use bodies to derive data,” said Keolu Fox, an anthropologist at UC San Diego.
“In terms of underrepresented people being ... validated or recognized in science, that's kind of unfortunate because there aren't enough Ph.D. carrying brown, Black, indigenous people to represent our interests.”
Fox, who grew up in Hawaii, got into genetics because he wanted to study why people with his indigenous heritage are more prone to develop certain diseases. But throughout his career, he says he found that people of color are often exploited in science.
And he says that exploitation will happen with the All of Us study. The data is open to everyone.
“Is it actually going to benefit indigenous, Black and brown communities in the same way that it's going to benefit a handful of people that work for Pfizer, Merck, GSK, et cetera? I don't think so,” he said.
Fox says big data, including digital and genetic data from humans, has become one of the most valuable commodities on Earth. One report from Global Market Insights found that the global digital genome market value is expected to cross $50.4 billion by 2025, a doubling from its value in 2018.
“What key genetic mutations have allowed humans to subsist in the harshest, most remote environments on planet Earth? And can those signatures of natural selection lead to therapeutic value?” he said. “We're talking about deriving genetic information from populations that have been in sync with their land and characteristics that they earned through their diaspora, through natural selection.”
Joseph Yracheta, a genetics researcher of indigenous Mexican descent, agrees with Fox.
Yracheta, who's at consulting group Indigenomics and has a background in pharmaceuticals, says large scale data research and the technology associated with it has become so advanced and powerful that big data not only has potential to cure disease. It also has potential to be highly destructive.
"They're basically saying that genomics is going to make everything equal, but that's not what makes things equal. Legislation, social movements, civil rights, limiting corporate power, those are what makes things equal," Yracheta said.
"This is going to create a huge honeypots, a huge treasure chest of information for the people who have the power to turn that information into products to simply turn them into products."
Yracheta says precision medicine is a good way to start equalizing medicine, but achieving that outcome is not as easy as one research program.
"It's a hope. It's a beautiful castle on a hill. And many of us, including scientists of color, we believe in that castle on the hill. That's what we've been working our whole lives for," he said.
"But they don't tell you about all the barbed wire, all the buried mines, all the problems getting up that hill to that castle."
Precedent For Expensive Treatments
Arizona State University biomedical historian Ben Hurlbut says exploitation of people of color and underserved communities happened before in medicine. In the 1990s, a lot of academic researchers started teaming up with rare disease groups to identity genes causing disease.
“The academic researchers would patent the gene and control diagnostics and drug development without the involvement of the rare disease group who brought them the resources to do the research in the first place,” said Hurlbut.
In fact, after scientists discovered the gene causing cystic fibrosis in 1989, a rare disease group and NIH funded researchers partnered to study the condition. Vertex Pharmaceuticals used the decades of research to create a therapy that could help 90% of patients.
But the treatment costs around $300,000 a year.
“When that drug came out, one of my daughter’s best friend had cystic fibrosis and was a candidate for that drug. His mom took on a full-time job in order to pay for the drug like that was the sole purpose of her job was to pay the copay,” said Hurlbut.
The solution to unequal health-care access isn’t easy, he says that doesn’t mean it can be ignored. Especially when to date, more than 270,000 people have gone through All of Us.
“We as a society and a public put in place the regulatory structures, the public research investment, the market structures that produce the dynamics that we have,” Hurlbut said.
“We could change those tomorrow if there was the political will to do so.”
Solutions Aren't Easy
Pharmaceutical companies are working on the All of US study. Alyssa Cotler, a spokeswoman for the program, says participants get information before they consent. And she says private-public partnerships are productive. They’ve led to life saving therapies.
“It really is important to bring together all of these different voices and resources to make sure that we're building a resource that will really be available to answer this very ambitious call,” Cotler said.
She says the data has been made anonymous and there’s a code of conduct that researchers have to follow in order to get the data. She says the NIH is aware future treatments from the program may be unaffordable. But, she said the NIH doesn’t have an answer to that problem yet.
“We think that the goal of our program is really to ensure that we can accelerate these breakthroughs so that everybody has access to the outcomes. And it's important to us that we have diverse representation, that we have people who have not been included in research in the past so that the findings will be relevant to everybody,” Cotler said.
“We want to ensure that they have access to those treatments. So, it's an area of ongoing conversation that I think is not very simple to answer in an easy way. There have been a lot of conversations with different communities to really help us think this through,” Cotler said.
As for All of Us participant Estela Mata, she says she’s OK with the idea of her data going to a pharmaceutical company, if people like her sister, who need the therapies, will be able to afford them.
