Family members of Henrietta Lacks, the African American woman whose cancer cells are the source of an immortal cell line known as HeLa, which spurred the discovery of the polio vaccine and many other medical advances, spoke at Yale’s Innovation and Diversity Summit on October 5 in the Harkness Auditorium. The story of the HeLa cells, which were taken from Lacks without consent, exemplify the treatment that has sown a historic mistrust between minority communities and the medical establishment over the past century. The one-day summit, convened by the Yale Center for Clinical Investigation (YCCI), focused on the source of this mistrust, and on the search for solutions on how to reestablish that trust and foster necessary minority participation in clinical research.
“This is about changing the narrative of negative implications of medical research history,” said Tesheia Johnson, MBA, MHS, deputy director and chief operating officer of YCCI. Minority participation in clinical trials is essential, said Johnson, in order that these groups be represented in the understanding of diseases as well as the therapies that arise from research.
Henrietta Lacks’ cancer cells were taken from her when she died of cervical cancer at Johns Hopkins Hospital in Baltimore in 1951. Speaking at the summit, Lacks’ daughter-in-law, Shirley Lacks, said that Lacks’ family only learned the story of the HeLa cell line years later during research by author Rebecca Skloot for what became a milestone book, The Immortal Life of Henrietta Lacks.
That story inspired Victoria Baptiste, Lacks’ great granddaughter, to become a registered nurse. Baptiste seeks to “advocate for my patients, and make sure they give consent and understand their treatments.” Both women, in their remarks, underlined the importance of consent in reestablishing trust among minorities in medical research. “I believe that had she been asked and informed about the process, she would have been willing to donate her tissue sample to science,” said Shirley Lacks.
The summit also highlighted a new partnership between the U.S. Food and Drug Administration (FDA), and YCCI, that seeks to correct this historic skepticism by encouraging minorities to participate medical research, and pursue careers in the health professions. “This partnership with the FDA began with Henrietta Lacks,” said RADM Denise Hinton, MS, chief scientist at the FDA. The partnership is focused on raising awareness about the need of minority populations to participate in clinical trials; patient-centered approaches to care and research, and the role technology plays in achieving these goals. To that point, Allen Hsiao, MD, associate professor of pediatrics (emergency medicine) and of emergency medicine, and chief medical information Officer for Yale School of Medicine and Yale New Haven Health, described how electronic health records can be used to engage minority populations in clinical trials in a culturally competent fashion.
Information acquired from a voiceless individual, when we take their voice away, we take away their humanity.
Quincy Birdsong
“We are always trying to work with those who have achieved success in advancing minority participation in clinical trials,” said CAPT Richardae Araojo, PharmD, the FDA’s associate commissioner for minority health. The partnership will cultivate YCCI’s successful Cultural Ambassadors Program, which partners with members of minority communities to provide feedback on clinical trial communications and protocols, in order to make them more culturally competent. Jovonni Spinner, MPH, senior public health advisor at the FDA Office of Minority Health, moderated a panel discussion that included representatives from AME Zion Church and Junta for Progressive Action who act as Cultural Ambassadors, as well as representatives from industry and academia, including Pfizer and University College London, which are at work on these issues.
Quincy Birdsong, EdD, Executive Director for Research Administration for the WellStar Research Institute, presented an overview of the history of involuntary participation of minorities in research, reaching beyond Henrietta Lacks to the Tuskegee syphilis experiment that began in 1932, the root of much of the African-American community’s mistrust of medical research. “Information acquired from a voiceless individual, when we take their voice away, we take away their humanity,” he noted.
Changing the narrative on Tuskegee and Henrietta Lacks also means changing the protocols of clinical research. Linda Coleman, director of Yale’s Human Research Protection Program, outlined the federal regulatory efforts toward optimizing human participation in research, including policies that seek to ensure that women and minorities are adequately represented in research protocols. The summit closed with Eric J. Velazquez, MD, professor of medicine and chief of cardiovascular medicine at Yale, who discussed how pragmatic principles in clinical trials can potentially help the enrollment of typically underrepresented populations, citing a case study in which he is examining how loop diuretics are used in the treatment of heart failure. He is working toward 40 percent African American enrollment in the study, and will collaborate with Yale’s Cultural Ambassadors to critique and improve the study protocol. “[There has] never been a more exciting time do to this kind of work,” said Velazquez.