Beyond Henrietta Lacks: How the Law Has Denied Every American Ownership Rights to Their Own Cells
A 2017 portrait of Henrietta Lacks.
The common perception is that Henrietta Lacks was a victim of poverty and racism when in 1951 doctors took samples of her cervical cancer without her knowledge or permission and turned them into the world's first immortalized cell line, which they called HeLa. The cell line became a workhorse of biomedical research and facilitated the creation of medical treatments and cures worth untold billions of dollars. Neither Lacks nor her family ever received a penny of those riches.
But racism and poverty is not to blame for Lacks' exploitation—the reality is even worse. In fact all patients, then and now, regardless of social or economic status, have absolutely no right to cells that are taken from their bodies. Some have called this biological slavery.
How We Got Here
The case that established this legal precedent is Moore v. Regents of the University of California.
John Moore was diagnosed with hairy-cell leukemia in 1976 and his spleen was removed as part of standard treatment at the UCLA Medical Center. On initial examination his physician, David W. Golde, had discovered some unusual qualities to Moore's cells and made plans prior to the surgery to have the tissue saved for research rather than discarded as waste. That research began almost immediately.
"On both sides of the case, legal experts and cultural observers cautioned that ownership of a human body was the first step on the slippery slope to 'bioslavery.'"
Even after Moore moved to Seattle, Golde kept bringing him back to Los Angeles to collect additional samples of blood and tissue, saying it was part of his treatment. When Moore asked if the work could be done in Seattle, he was told no. Golde's charade even went so far as claiming to find a low-income subsidy to pay for Moore's flights and put him up in a ritzy hotel to get him to return to Los Angeles, while paying for those out of his own pocket.
Moore became suspicious when he was asked to sign new consent forms giving up all rights to his biological samples and he hired an attorney to look into the matter. It turned out that Golde had been lying to his patient all along; he had been collecting samples unnecessary to Moore's treatment and had turned them into a cell line that he and UCLA had patented and already collected millions of dollars in compensation. The market for the cell lines was estimated at $3 billion by 1990.
Moore felt he had been taken advantage of and filed suit to claim a share of the money that had been made off of his body. "On both sides of the case, legal experts and cultural observers cautioned that ownership of a human body was the first step on the slippery slope to 'bioslavery,'" wrote Priscilla Wald, a professor at Duke University whose career has focused on issues of medicine and culture. "Moore could be viewed as asking to commodify his own body part or be seen as the victim of the theft of his most private and inalienable information."
The case bounced around different levels of the court system with conflicting verdicts for nearly six years until the California Supreme Court ruled on July 9, 1990 that Moore had no legal rights to cells and tissue once they were removed from his body.
The court made a utilitarian argument that the cells had no value until scientists manipulated them in the lab. And it would be too burdensome for researchers to track individual donations and subsequent cell lines to assure that they had been ethically gathered and used. It would impinge on the free sharing of materials between scientists, slow research, and harm the public good that arose from such research.
"In effect, what Moore is asking us to do is impose a tort duty on scientists to investigate the consensual pedigree of each human cell sample used in research," the majority wrote. In other words, researchers don't need to ask any questions about the materials they are using.
One member of the court did not see it that way. In his dissent, Stanley Mosk raised the specter of slavery that "arises wherever scientists or industrialists claim, as defendants have here, the right to appropriate and exploit a patient's tissue for their sole economic benefit—the right, in other words, to freely mine or harvest valuable physical properties of the patient's body. … This is particularly true when, as here, the parties are not in equal bargaining positions."
Mosk also cited the appeals court decision that the majority overturned: "If this science has become for profit, then we fail to see any justification for excluding the patient from participation in those profits."
But the majority bought the arguments that Golde, UCLA, and the nascent biotechnology industry in California had made in amici briefs filed throughout the legal proceedings. The road was now cleared for them to develop products worth billions without having to worry about or share with the persons who provided the raw materials upon which their research was based.
Critical Views
Biomedical research requires a continuous and ever-growing supply of human materials for the foundation of its ongoing work. If an increasing number of patients come to feel as John Moore did, that the system is ripping them off, then they become much less likely to consent to use of their materials in future research.
Some legal and ethical scholars say that donors should be able to limit the types of research allowed for their tissues and researchers should be monitored to assure compliance with those agreements. For example, today it is commonplace for companies to certify that their clothing is not made by child labor, their coffee is grown under fair trade conditions, that food labeled kosher is properly handled. Should we ask any less of our pharmaceuticals than that the donors whose cells made such products possible have been treated honestly and fairly, and share in the financial bounty that comes from such drugs?
Protection of individual rights is a hallmark of the American legal system, says Lisa Ikemoto, a law professor at the University of California Davis. "Putting the needs of a generalized public over the interests of a few often rests on devaluation of the humanity of the few," she writes in a reimagined version of the Moore decision that upholds Moore's property claims to his excised cells. The commentary is in a chapter of a forthcoming book in the Feminist Judgment series, where authors may only use legal precedent in effect at the time of the original decision.
"Why is the law willing to confer property rights upon some while denying the same rights to others?" asks Radhika Rao, a professor at the University of California, Hastings College of the Law. "The researchers who invest intellectual capital and the companies and universities that invest financial capital are permitted to reap profits from human research, so why not those who provide the human capital in the form of their own bodies?" It might be seen as a kind of sweat equity where cash strapped patients make a valuable in kind contribution to the enterprise.
The Moore court also made a big deal about inhibiting the free exchange of samples between scientists. That has become much less the situation over the more than three decades since the decision was handed down. Ironically, this decision, as well as other laws and regulations, have since strengthened the power of patents in biomedicine and by doing so have increased secrecy and limited sharing.
"Although the research community theoretically endorses the sharing of research, in reality sharing is commonly compromised by the aggressive pursuit and defense of patents and by the use of licensing fees that hinder collaboration and development," Robert D. Truog, Harvard Medical School ethicist and colleagues wrote in 2012 in the journal Science. "We believe that measures are required to ensure that patients not bear all of the altruistic burden of promoting medical research."
Additionally, the increased complexity of research and the need for exacting standardization of materials has given rise to an industry that supplies certified chemical reagents, cell lines, and whole animals bred to have specific genetic traits to meet research needs. This has been more efficient for research and has helped to ensure that results from one lab can be reproduced in another.
The Court's rationale of fostering collaboration and free exchange of materials between researchers also has been undercut by the changing structure of that research. Big pharma has shrunk the size of its own research labs and over the last decade has worked out cooperative agreements with major research universities where the companies contribute to the research budget and in return have first dibs on any findings (and sometimes a share of patent rights) that come out of those university labs. It has had a chilling effect on the exchange of materials between universities.
Perhaps tracking cell line donors and use restrictions on those donations might have been burdensome to researchers when Moore was being litigated. Some labs probably still kept their cell line records on 3x5 index cards, computers were primarily expensive room-size behemoths with limited capacity, the internet barely existed, and there was no cloud storage.
But that was the dawn of a new technological age and standards have changed. Now cell lines are kept in state-of-the-art sub zero storage units, tagged with the source, type of tissue, date gathered and often other information. Adding a few more data fields and contacting the donor if and when appropriate does not seem likely to disrupt the research process, as the court asserted.
Forging the Future
"U.S. universities are awarded almost 3,000 patents each year. They earn more than $2 billion each year from patent royalties. Sharing a modest portion of these profits is a novel method for creating a greater sense of fairness in research relationships that we think is worth exploring," wrote Mark Yarborough, a bioethicist at the University of California Davis Medical School, and colleagues. That was penned nearly a decade ago and those numbers have only grown.
The Michigan BioTrust for Health might serve as a useful model in tackling some of these issues. Dried blood spots have been collected from all newborns for half a century to be tested for certain genetic diseases, but controversy arose when the huge archive of dried spots was used for other research projects. As a result, the state created a nonprofit organization to in essence become a biobank and manage access to these spots only for specific purposes, and also to share any revenue that might arise from that research.
"If there can be no property in a whole living person, does it stand to reason that there can be no property in any part of a living person? If there were, can it be said that this could equate to some sort of 'biological slavery'?" Irish ethicist Asim A. Sheikh wrote several years ago. "Any amount of effort spent pondering the issue of 'ownership' in human biological materials with existing law leaves more questions than answers."
Perhaps the biggest question will arise when -- not if but when -- it becomes possible to clone a human being. Would a human clone be a legal person or the property of those who created it? Current legal precedent points to it being the latter.
Today, October 4, is the 70th anniversary of Henrietta Lacks' death from cancer. Over those decades her immortalized cells have helped make possible miraculous advances in medicine and have had a role in generating billions of dollars in profits. Surviving family members have spoken many times about seeking a share of those profits in the name of social justice; they intend to file lawsuits today. Such cases will succeed or fail on their own merits. But regardless of their specific outcomes, one can hope that they spark a larger public discussion of the role of patients in the biomedical research enterprise and lead to establishing a legal and financial claim for their contributions toward the next generation of biomedical research.
The Next 100 Years of Scientific Progress Could Look Like This
From nanobots that kill cancer to carbon-neutral biofuels, we envisioned what the next century could bring.
In just 100 years, scientific breakthroughs could completely transform humanity and our planet for the better. Here's a glimpse at what our future may hold.
The Next 100 Years of Scientific Progress
Kira Peikoff was the editor-in-chief of Leaps.org from 2017 to 2021. As a journalist, her work has appeared in The New York Times, Newsweek, Nautilus, Popular Mechanics, The New York Academy of Sciences, and other outlets. She is also the author of four suspense novels that explore controversial issues arising from scientific innovation: Living Proof, No Time to Die, Die Again Tomorrow, and Mother Knows Best. Peikoff holds a B.A. in Journalism from New York University and an M.S. in Bioethics from Columbia University. She lives in New Jersey with her husband and two young sons. Follow her on Twitter @KiraPeikoff.
George Papanicolaou (1883-1962), Greek-born American physician developed a simple cytological test for cervical cancer in 1928.
For decades, women around the world have made the annual pilgrimage to their doctor for the dreaded but potentially life-saving Papanicolaou test, a gynecological exam to screen for cervical cancer named for Georgios Papanicolaou, the Greek immigrant who developed it.
The Pap smear, as it is commonly known, is credited for reducing cervical cancer mortality by 70% since the 1960s; the American Cancer Society (ACS) still ranks the Pap as the most successful screening test for preventing serious malignancies. Nonetheless, the agency, as well as other medical panels, including the US Preventive Services Task Force and the American College of Obstetrics and Gynecology are making a strong push to replace the Pap with the more sensitive high-risk HPV screening test for the human papillomavirus virus, which causes nearly all cases of cervical cancer.
So, how was the Pap developed and how did it become the gold standard of cervical cancer detection for more than 60 years?
Born on May 13, 1883, on the island of Euboea, Greece, Georgios Papanicolaou attended the University of Athens where he majored in music and the humanities before earning his medical degree in 1904 and PhD from the University of Munich six years later. In Europe, Papanicolaou was an assistant military surgeon during the Balkan War, a psychologist for an expedition of the Oceanographic Institute of Monaco and a caregiver for leprosy patients.
When he and his wife, Andromache Mavroyenous (Mary), arrived at Ellis Island on October 19, 1913, the young couple had scarcely more than the $250 minimum required to immigrate, spoke no English and had no job prospects. They worked a series of menial jobs--department store sales clerk, rug salesman, newspaper clerk, restaurant violinist--before Papanicolaou landed a position as an anatomy assistant at Cornell University and Mary was hired as his lab assistant, an arrangement that would last for the next 50 years.
Papanikolaou would later say the discovery "was one of the greatest thrills I ever experienced during my scientific career."
In his early research, Papanikolaou used guinea pigs to prove that gender is determined by the X and Y chromosomes. Using a pediatric nasal speculum, he collected and microscopically examined vaginal secretions of guinea pigs, which revealed distinct cell changes connected to the menstrual cycle. He moved on to study reproductive patterns in humans, beginning with his faithful wife, Mary, who not only endured his almost-daily cervical exams for decades, but also recruited friends as early research participants.
Writing in the medical journal Growth in 1920, the scientist outlined his theory that a microscopic smear of vaginal fluid could detect the presence of cancer cells in the uterus. Papanikolaou would later say the discovery "was one of the greatest thrills I ever experienced during my scientific career."
At this time, cervical cancer was the number one cancer killer of American women but physicians were skeptical of these new findings. They continued to rely on biopsy and curettage to diagnose and treat the disease until Papanicolaou's discovery was published in American Journal of Obstetrics and Gynecology. An inexpensive, easy-to-perform test that could detect cervical cancer, precancerous dysplasia and other cytological diseases was a sea change. Between 1975 and 2001, the cervical cancer rate was cut in half.
Papanicolaou became Emeritus Professor at Cornell University Medical College and received numerous awards, including the Albert Lasker Award for Clinical Medical Research and the Medal of Honor from the American Cancer Society. His image was featured on the Greek currency and the US Post Office issued a commemorative stamp in his honor. But international acclaim didn't lead to a more relaxed schedule. The researcher continued to work seven days a week and refused to take vacations.
After nearly 50 years, Papanicolaou left Cornell to head and develop the Cancer Institute of Miami. He died of a heart attack on February 19, 1962, just three months after his arrival. Mary continued to work in the renamed Papanicolaou Cancer Research Institute until her death 20 years later.
The annual pap smear was originally tied to renewing a birth control prescription. Canada began recommending Pap exams every three years in 1978. The United States followed suit in 2012, noting that it takes many years for cervical cancer to develop. In September 2020, the American Cancer Society recommended delaying the first gynecological pelvic exam until age 25 and replacing the Pap test completely with the more accurate human papillomavirus (HPV) test every five years as the technology becomes more widely available.
Not everyone agrees that it's time to do away with this proven screening method, though. The incidence rate of cervical cancer among Hispanic women is 28% higher than for white women, and Black women are more likely to die of cervical cancer than any other racial or ethnicities.
Whether the Pap is administered every year, every three years or not at all, Papanicolaou will always be known as the medical hero who saved countless women who would otherwise have succumbed to cervical cancer.