HeLa Cases Prompt More Thinking on Ethics

The descendants of Henrietta Lacks, an African American woman whose cells have been used by researchers for more than 70 years and have spurred countless advances in science and medicine, recently settled their lawsuit against Thermo Fisher Scientific for using and profiting from the cells without consent. The Lacks family's attorneys issued a statement saying that both “parties are pleased that they were able to find a way to resolve this matter outside of court.” The details of the settlement are confidential, but part of its legacy may be its impact on how researchers and biopharmaceutical companies view their own ethics.

“They now have to ask the question, ‘How will my actions be viewed decades from now? Have I really acted in the best interests of patients and research subjects with obscure informed consent forms and attempts to commercialize tissue and the knowledge derived from it?’” says Lori Andrews, director emerita of the Chicago-Kent College of Law's Institute for Science, Law and Technology in Illinois.

In 1951, Lacks underwent a biopsy for cervical cancer at The Johns Hopkins Hospital in Baltimore, MD; she died of the disease later that year at age 31. Scientists cultured her tumor cells without her consent, which was legal at the time, and created the immortalized HeLa cell line. Johns Hopkins has said it never made money from the cells, but many companies have, and the Lacks family did not learn about any of this until 1975.

The Thermo Fisher suit alleged unjust enrichment, meaning that the company profited at the expense of another—in this case that the company knowingly continued to use the cells for commercial purposes without compensating the family.

Following the Thermo Fisher settlement in early August, the family filed a similar lawsuit against the biopharmaceutical company Ultragenyx regarding its use of, and profits from, the HeLa cells since its founding in 2010.

“I think that, for years, either people knew nothing about this opportunistic behavior or were shocked when they heard about it, but also assumed that the family had been taken care of somehow,” says Caprice Roberts, associate dean of the Louisiana State University's Paul M. Hebert Law Center in Baton Rouge.

The Lacks case is not the only instance in which people's tissue or cells were taken without their consent. For example, The Washington Post recently reported that the Smithsonian Institution acquired more than 250 brains, with the majority being gathered from individuals without their families’ consent, in the early to mid 1900s.

A modern example involved Seattle, WA, businessman John Moore. He frequently traveled to the University of California, Los Angeles, where an oncologist monitored his hairy cell leukemia. But the doctor also patented viral antibodies from Moore's blood. Moore sued, and the California Supreme Court ruled in 1990 that the doctor violated informed consent, but that Moore had no property rights to his discarded cells and that the profits belonged to the doctor and any biotechnology company developing a drug using the antibodies. Without a property right, Moore could not prove unlawful conversion. Moore's case did not include an unjust enrichment claim.

Andrews says that the Lacks and Moore cases stand out in history because they had unique properties that could be patented, but that many Americans have likely had their tissue or cells used in research.

The American Medical Association's Code of Medical Ethics requires doctors to inform patients if they are going to use patients’ tissue in research or commercially, but that language may be buried in stacks of legal documents.

“Probably all of us who have had blood testing or surgery at a research hospital have had our tissue used in research and possibly commercialized, generally without our knowledge or consent,” Andrews says.

Both Andrews and Roberts think the Lacks's settlement should also be a call to biopharmaceutical companies to be mindful of how they have acquired such materials, as they may face unjust enrichment lawsuits at some point.

“The unseemly ethics and possibility of unjust enrichment litigation should get them thinking about the profits they're making and where they come from,” says Roberts. –Aaron Tallent

For more news on cancer research, visit Cancer Discovery online at http://cancerdiscovery.aacrjournals.org/CDNews.