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.
Monkeypox produces more telltale signs than COVID-19. Scientists think that a “ring” vaccination strategy can be used when these signs appear to help with squelching the current outbreak of this disease.
A new virus has emerged and stoked fears of another pandemic: monkeypox. Since May 2022, it has been detected in 29 U.S. states, the District of Columbia, and Puerto Rico among international travelers and their close contacts. On a worldwide scale, as of June 30, there have been 5,323 cases in 52 countries.
The good news: An existing vaccine can go a long way toward preventing a catastrophic outbreak. Because monkeypox is a close relative of smallpox, the same vaccine can be used—and it is about 85 percent effective against the virus, according to the World Health Organization (WHO).
Also on the plus side, monkeypox is less contagious with milder illness than smallpox and, compared to COVID-19, produces more telltale signs. Scientists think that a “ring” vaccination strategy can be used when these signs appear to help with squelching this alarming outbreak.
How it’s transmitted
Monkeypox spreads between people primarily through direct contact with infectious sores, scabs, or bodily fluids. People also can catch it through respiratory secretions during prolonged, face-to-face contact, according to the Centers for Disease Control and Prevention (CDC).
As of June 30, there have been 396 documented monkeypox cases in the U.S., and the CDC has activated its Emergency Operations Center to mobilize additional personnel and resources. The U.S. Department of Health and Human Services is aiming to boost testing capacity and accessibility. No Americans have died from monkeypox during this outbreak but, during the COVID-19 pandemic (February 2020 to date), Africa has documented 12,141 cases and 363 deaths from monkeypox.
Ring vaccination proved effective in curbing the smallpox and Ebola outbreaks. As the monkeypox threat continues to loom, scientists view this as the best vaccine approach.
A person infected with monkeypox typically has symptoms—for instance, fever and chills—in a contagious state, so knowing when to avoid close contact with others makes it easier to curtail than COVID-19.
Advantages of ring vaccination
For this reason, it’s feasible to vaccinate a “ring” of people around the infected individual rather than inoculating large swaths of the population. Ring vaccination proved effective in curbing the smallpox and Ebola outbreaks. As the monkeypox threat continues to loom, scientists view this as the best vaccine approach.
With many infections, “it normally would make sense to everyone to vaccinate more widely,” says Wesley C. Van Voorhis, a professor and director of the Center for Emerging and Re-emerging Infectious Diseases at the University of Washington School of Medicine in Seattle. However, “in this case, ring vaccination may be sufficient to contain the outbreak and also minimize the rare, but potentially serious side effects of the smallpox/monkeypox vaccine.”
There are two licensed smallpox vaccines in the United States: ACAM2000 (live Vaccina virus) and JYNNEOS (live virus non-replicating). The ACAM 2000, Van Voorhis says, is the old smallpox vaccine that, in rare instances, could spread diffusely within the body and cause heart problems, as well as severe rash in people with eczema or serious infection in immunocompromised patients.
To prevent organ damage, the current recommendation would be to use the JYNNEOS vaccine, says Phyllis Kanki, a professor of health sciences in the division of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health. However, according to a report on the CDC’s website, people with immunocompromising conditions could have a higher risk of getting a severe case of monkeypox, despite being vaccinated, and “might be less likely to mount an effective response after any vaccination, including after JYNNEOS.”
In the late 1960s, the ring vaccination strategy became part of the WHO’s mission to globally eradicate smallpox, with the last known natural case described in Somalia in 1977. Ring vaccination can also refer to how a clinical trial is designed, as was the case in 2015, when this approach was used for researching the benefits of an investigational Ebola vaccine in Guinea, Kanki says.
“Since Monkeypox spreads by close contact and we have an effective vaccine, vaccinating high-risk individuals and their contacts may be a good strategy to limit transmission,” she says, adding that privacy is an important ethical principle that comes into play, as people with monkeypox would need to disclose their close contacts so that they could benefit from ring vaccination.
Rapid identification of cases and contacts—along with their cooperation—is essential for ring vaccination to be effective. Although mass vaccination also may work, the risk of infection to most of the population remains low while supply of the JYNNEOS vaccine is limited, says Stanley Deresinski, a clinical professor of medicine in the Infectious Disease Clinic at Stanford University School of Medicine.
Other strategies for preventing transmission
Ideally, the vaccine should be administered within four days of an exposure, but it’s recommended for up to 14 days. The WHO also advocates more widespread vaccination campaigns in the population segment with the most cases so far: men who engage in sex with other men.
The virus appears to be spreading in sexual networks, which differs from what was seen in previously reported outbreaks of monkeypox (outside of Africa), where risk was associated with travel to central or west Africa or various types of contact with individuals or animals from those locales. There is no evidence of transmission by food, but contaminated articles in the environment such as bedding are potential sources of the virus, Deresinski says.
Severe cases of monkeypox can occur, but “transmission of the virus requires close contact,” he says. “There is no evidence of aerosol transmission, as occurs with SARS-CoV-2, although it must be remembered that the smallpox virus, a close relative of monkeypox, was transmitted by aerosol.”
Deresinski points to the fact that in 2003, monkeypox was introduced into the U.S. through imports from Ghana of infected small mammals, such as Gambian giant rats, as pets. They infected prairie dogs, which also were sold as pets and, ultimately, this resulted in 37 confirmed transmissions to humans and 10 probable cases. A CDC investigation identified no cases of human-to-human transmission. Then, in 2021, a traveler flew from Nigeria to Dallas through Atlanta, developing skin lesions several days after arrival. Another CDC investigation yielded 223 contacts, although 85 percent were deemed to be at only minimal risk and the remainder at intermediate risk. No new cases were identified.
How much should we be worried
But how serious of a threat is monkeypox this time around? “Right now, the risk to the general public is very low,” says Scott Roberts, an assistant professor and associate medical director of infection prevention at Yale School of Medicine. “Monkeypox is spread through direct contact with infected skin lesions or through close contact for a prolonged period of time with an infected person. It is much less transmissible than COVID-19.”
The monkeypox incubation period—the time from infection until the onset of symptoms—is typically seven to 14 days but can range from five to 21 days, compared with only three days for the Omicron variant of COVID-19. With such a long incubation, there is a larger window to conduct contact tracing and vaccinate people before symptoms appear, which can prevent infection or lessen the severity.
But symptoms may present atypically or recognition may be delayed. “Ring vaccination works best with 100 percent adherence, and in the absence of a mandate, this is not achievable,” Roberts says.
At the outset of infection, symptoms include fever, chills, and fatigue. Several days later, a rash becomes noticeable, usually beginning on the face and spreading to other parts of the body, he says. The rash starts as flat lesions that raise and develop fluid, similar to manifestations of chickenpox. Once the rash scabs and falls off, a person is no longer contagious.
“It's an uncomfortable infection,” says Van Voorhis, the University of Washington School of Medicine professor. There may be swollen lymph nodes. Sores and rash are often limited to the genitals and areas around the mouth or rectum, suggesting intimate contact as the source of spread.
Symptoms of monkeypox usually last from two to four weeks. The WHO estimated that fatalities range from 3 to 6 percent. Although it’s believed to infect various animal species, including rodents and monkeys in west and central Africa, “the animal reservoir for the virus is unknown,” says Kanki, the Harvard T.H. Chan School of Public Health professor.
Too often, viruses originate in parts of the world that are too poor to grapple with them and may lack the resources to invest in vaccines and treatments. “This disease is endemic in central and west Africa, and it has basically been ignored until it jumped to the north and infected Europeans, Americans, and Canadians,” Van Voorhis says. “We have to do a better job in health care and prevention all over the world. This is the kind of thing that comes back to bite us.”
Interventions in health and safety often yield results that are the opposite of what policymakers were hoping for. Officials can take a science-based approach by measuring what really works instead of relying on gut intuitions.
nudgesYou are driving along the highway and see an electronic sign that reads: “3,238 traffic deaths this year.” Do you think this reminder of roadside mortality would change how you drive? According to a recent, peer-reviewed study in Science, seeing that sign would make you more likely to crash. That’s ironic, given that the sign’s creators assumed it would make you safer.
The study, led by a pair of economists at the University of Toronto and University of Minnesota, examined seven years of traffic accident data from 880 electric highway sign locations in Texas, which experienced 4,480 fatalities in 2021. For one week of each month, the Texas Department of Transportation posts the latest fatality messages on signs along select traffic corridors as part of a safety campaign. Their logic is simple: Tell people to drive with care by reminding them of the dangers on the road.
But when the researchers looked at the data, they found that the number of crashes increased by 1.52 percent within three miles of these signs when compared with the same locations during the same month in previous years when signs did not show fatality information. That impact is similar to raising the speed limit by four miles or decreasing the number of highway troopers by 10 percent.
The scientists calculated that these messages contributed to 2,600 additional crashes and 16 deaths annually. They also found a social cost, meaning the financial expense borne by society as a whole due to these crashes, of $377 million per year, in Texas alone.
The cause, they argue, is distracted driving. Much like incoming texts or phone calls, these “in-your-face” messages grab your attention and undermine your focus on the road. The signs are particularly distracting and dangerous because, in communicating that many people died doing exactly what you are doing, they cause anxiety. Supporting this hypothesis, the scientists discovered that crashes increase when the signs report higher numbers of deaths. Thus, later in the year, as that total mortality figure goes up, so do the percentage of crashes.
Boomerang effects happen when those with authority, in government or business, fail to pay attention to the science. These leaders rely on armchair psychology and gut intuitions on what should work, rather than measuring what does work.
That change over time is not simply a function of changing weather, the study’s authors observed. They also found that the increase in car crashes is greatest in more complex road segments, which require greater focus to navigate.
The overall findings represent what behavioral scientists like myself call a “boomerang effect,” meaning an intervention that produces consequences opposite to those intended. Unfortunately, these effects are all too common. Between 1998 and 2004, Congress funded the $1 billion National Youth Anti-Drug Media Campaign, which famously boomeranged. Using professional advertising and public relations firms, the campaign bombarded kids aged 9 to 18 with anti-drug messaging, focused on marijuana, on TV, radio, magazines, and websites. A 2008 study funded by the National Institutes of Health found that children and teens saw these ads two to three times per week. However, more exposure to this advertising increased the likelihood that youth used marijuana. Why? Surveys and interviews suggested that young people who saw the ads got the impression that many of their peers used marijuana. As a result, they became more likely to use the drug themselves.
Boomerang effects happen when those with authority, in government or business, fail to pay attention to the science. These leaders rely on armchair psychology and gut intuitions on what should work, rather than measuring what does work.
To be clear, message campaigns—whether on electronic signs or through advertisements—can have a substantial effect on behavior. Extensive research reveals that people can be influenced by “nudges,” which shape the environment to influence their behavior in a predictable manner. For example, a successful campaign to reduce car accidents involved sending smartphone notifications that helped drivers evaluate their performance after each trip. These messages informed drivers of their personal average and best performance, as measured by accelerometers and gyroscopes. The campaign, which ran over 21 months, significantly reduced accident frequency.
Nudges work best when rigorously tested with small-scale experiments that evaluate their impact. Because behavioral scientists are infrequently consulted in creating these policies, some studies suggest that only 62 percent have a statistically significant effect. Other research reveals that up to 15 percent of desired interventions may backfire.
In the case of roadside mortality signage, the data are damning. The new research based on the Texas signs aligns with several past studies. For instance, research has shown that increasing people’s anxiety causes them to drive worse. Another, a Virginia Tech study in a laboratory setting, found that showing drivers fatality messages increased what psychologists call “cognitive load,” or the amount of information your brain is processing, with emotionally-salient information being especially burdensome and preoccupying, thus causing more distraction.
Nonetheless, Texas, along with at least 28 other states, has pursued mortality messaging campaigns since 2012, without testing them effectively. Behavioral science is critical here: when road signs are tested by people without expertise in how minds work, the results are often counterproductive. For example, the Virginia Tech research looked at road signs that used humor, popular culture, sports, and other nontraditional themes with the goal of provoking an emotional response. When they measured how participants responded to these signs, they noticed greater cognitive activation and attention in the brain. Thus, the researchers decided, the signs worked. But a behavioral scientist would note that increased attention likely contributes to the signs’ failure. As the just-published study in Science makes clear, distracting, emotionally-loaded signs are dangerous to drivers.
But there is good news. First, in most cases, it’s very doable to run an effective small-scale study testing an intervention. States could set up a safety campaign with a few electric signs in a diversity of settings and evaluate the impact over three months on driver crashes after seeing the signs. Policymakers could ask researchers to track the data as they run ads for a few months in a variety of nationally representative markets for a few months and assess their effectiveness. They could also ask behavioral scientists whether their proposals are well designed, whether similar policies have been tried previously in other places, and how these policies have worked in practice.
Everyday citizens can write to and call their elected officials to ask them to make this kind of research a priority before embracing an untested safety campaign. More broadly, you can encourage them to avoid relying on armchair psychology and to test their intuitions before deploying initiatives that might place the public under threat.