With sequencing of the human genome completed at the turn of this century, there was the heady expectation that the summit to great cures was about to be climbed like the iconic spiral staircase of DNA.
“Having the essentially complete sequence of the human genome is similar to having all the pages of a manual needed to make the human body,” the NIH’s Human Genome Research Institute explains on its website. “[Genome-based] research will eventually enable medical science to develop highly effective diagnostic tools, to better understand the health needs of people based on their individual genetic make-ups, and to design new and highly effective treatments for disease.” (For more information, visit: https://www.genome.gov/.)
But what if this new frontier disproportionately benefits the haves over the have-nots, leading to exceptionally expensive drugs and treatments in an era when many Americans are struggling for access to basic healthcare?
That, warns Jenny Reardon, PhD, is exactly what is happening. The founder of the Science and Justice Research Center at the University of California in Santa Cruz, Reardon compares the current state of genome research to the blind that preceded the 2008 financial collapse.
“Are we sitting on top of a biomedical bubble that is about to burst?” she says. “People are going to lose trust in this system because no one understands how it works. A lot of people are making a lot of money off of it, but on the other end of the spectrum it is really aggravating the inequalities in the healthcare system.”
To meet this research inequity in genome research, Reardon urges IRBs to return to the cardinal principle of “justice.” This was one of the original core tenets in the Belmont Report outlining the ethics of human research.
In her new book, The Postgenomic Condition: Ethics, Justice, and Knowledge After the Genome, Reardon argues that issues like informed consent have overshadowed the human research principle of justice. One aspect of justice in medical research is that the gains will be realized by humanity in general, not solely to those with the wealth and healthcare access to benefit, she says.
“We’ve been really good at focusing on some of the other Belmont principles, especially looking at informed consent,” she says. “But justice has not gotten nearly enough attention, and I’m not the only person to point this out. What made me begin to think about this in the context of IRBs is the legal scholar Patricia King, who sat on the presidential blue ribbon committee that wrote the Belmont Report. In the context of Tuskegee, that seemed like a real win. They were kind of elated about that and didn’t do as much with justice, and she said later, ‘It is my major disappointment.’”2
Now a professor of law, medicine, ethics, and public policy at Georgetown, King said in a 2004 oral history of the Belmont Report that, “In my view, though we stated a principle of justice, it’s the forgotten principle.”2
Now, with the level of research underway with the human genome, Reardon argues that justice needs to be the guiding principle for IRBs and researchers.
“Who is going to access the end results of this research?” she says. “That is a core issue. In genomic medicine, we are producing these drugs that are inching toward the million-dollar-a-year category. Of course, people without health insurance won’t get access.”
Indeed, those with health insurance that have prohibitive copays and large deductibles could well be shut out from some new genomic breakthrough.
“They are just going to be priced out of their reach,” says Reardon, observing the irony of political leaders who pour billions into medical research while showing near disdain for expenditures to ensure basic healthcare.3
“You might be benefiting now from all the investment and high-end genomic research, but if no one gets access to any of this then it’s not sustainable,” she says. “I think it is a train wreck waiting to happen unless we address the underlying structural problems with the system. To me, people turn to justice when they feel the dominant institutions don’t serve them. They say this system is unjust.”
Reardon’s book calls for human genome data from more diverse populations, raising issues of informed consent, trust, and use of biological samples. Human research is certainly scarred by unethical actions toward vulnerable populations, some of whom will be reluctant to participate in research that will not benefit them.
“It’s interesting the we are living in a moment where for decades nobody cared about sickle cell,” she says. “Now, because it happens to turn out to be an ideal disease for CRISPR [Cas9 genome editing] technology because it affects a single organ — the blood — people suddenly want to pour money into sickle cell and do a clinical trial. Are they going to get enough people to participate in that trial?”
It’s a fair question, as African-Americans predisposed to the disease will be asked to participate in research even as they struggle to keep basic healthcare. Past unethical research in this community needs no introduction. Did Tuskegee poison the well?
“For too long, this field has ignored the vast majority of people who are not high-end users and are not the ones purchasing designer drugs and fancy pharmaceuticals,” Reardon says. “The elephant’s in the room — I’m just naming it.”
1. Reardon, J. The Postgenomic Condition: Ethics, Justice, and Knowledge After the Genome. University of Chicago Press, 2017.
2. HHS. Oral History of the Belmont Report and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Interview with Patricia King, JD, Sept. 9, 2004. Available at: http://bit.ly/2pdWs0t.
3. Pear, R. Medical Research? Congress Cheers. Medical Care? Congress Brawls. The New York Times Jan. 6, 2018. Available at: http://nyti.ms/2FhcugG.