At a time when medical researchers are under pressure to increase diversity in clinical trials, a Johns Hopkins study is sparking outrage among some physicians because of its large number of Black patients.
The controversy has stoked concerns that the institution infamous for its role in the Henrietta Lacks story may have once again exploited marginalized people for medical research. The university denies any wrongdoing and instead said it was simply providing a service to its local community, which has a mostly Black population.
The paper was published last fall without much notice but caused a stir on social media in recent weeks. It was a retrospective study analyzing the abilities of three specially trained nurse practitioners to perform colonoscopies, an invasive and potentially lifesaving cancer screening procedure normally done by gastroenterologists. Of the more than 1,000 patients who received screening colonoscopies from the nurse practitioners between 2010 and 2016, nearly 75% were Black.
“That is a huge red flag because that could not have happened randomly,” said Fola May, a gastroenterologist at the University of California, Los Angeles. “Did they preferentially pick Black patients to be in the study and to get the NP colonoscopies?”
African Americans make up about 63% of Baltimore’s population and 88% of the Middle East Baltimore neighborhood where Johns Hopkins Hospital is located. But Black people account for only about 25% to 31% of the patients treated in the Hopkins hospital system, according to annual reports from 2015-2016 and 2017. Johns Hopkins did not provide racial demographics of the patients who undergo colonoscopies, but said it provides the procedure to people living in the local community and outside the community.
Amid projections that demand for colonoscopies will soar as the population ages and as colorectal cancers rise among younger people, the researchers wanted to find out whether nurse practitioners who completed a yearlong gastrointestinal training fellowship could perform colonoscopies up to the same standards as doctors. For comparison, a gastroenterologist typically completes three years of internal medicine residency and three years of a gastroenterology fellowship.
Critics of the study questioned whether the patients were adequately informed that nurses don’t commonly do the procedure in the U.S., and whether they were given a choice to have their exam done by a doctor.
“When I saw the paper, my immediate concerns were around informed patient consent,” said Rachel Issaka, a gastroenterologist at the Fred Hutchinson Cancer Research Center in Seattle. “I really wanted to know, were those patients told up front that their colonoscopy was being done by a nurse practitioner, because that’s not the standard of care in the United States.”
