The Immortal Life of Henrietta Lacks and biomedical research ethics
John M. Garrison
First prize winner - Grossmont College Essay Contest on the book by Rebecca Skloot.
Henrietta Lacks died from cervical cancer long ago,(1) but cells grown from her tumor have sparked tremendous advances in biomedical research, giving Henrietta Lacks a sort of immortality and placing her and her descendants in the midst of important legal and ethical questions involving sociology and medicine.(1)(2)(3) Cells called HeLa, derived from her cancer, have been used in research ranging from the development of the polio vaccine(4)(5) to the safety of cosmetics.(4) By 2010, her cells have played a role in nearly 11,000 patents(4) and they have been mentioned in more than 60,000 scientific papers.(1) Henrietta Lacks herself died in 1951 in the “colored” ward of Johns Hopkins University, a charity ward providing care for poor African-Americans.(1) Henrietta’s children, too poor to afford health-care themselves, have not received money from the worldwide use of HeLa.(1) Neither she nor her family gave permission for the cell sample to taken or grown into an immortal cell-culture line, and the family did not even learn HeLa cells existed until 1973. The Lacks’ situation is hardly unique. In fact, most any patient in any modern hospital or doctor’s office could find themselves in a similar situation with no control over their medical samples. Sixty-years after Henrietta Lacks’ death, United States jurisprudence still has no clear answer to what seems a basic question: “Do we own our own bodies?”(6)
The use of human tissues in commercial biomedical research raises ethical questions on several fronts:
- Informed consent – How much should the patient be told about how their tissues may be used, and who may come to benefit from those uses?
- Control – What rights does the patient have to control the fate of their bodily tissues and fluids, and what control do they have over their medical information?
- Profit – Should a patient have a financial stake in the sale of their body parts, or in licensing technologies derived from their bodies?
Today, we assume patients must give their “informed consent” for medical procedures conducted on them. Medical experimentation on unwilling human subjects is the subject both of fictional horror stories and of the real-world horrors of Nazi medicine that led to declarations such as the Nuremberg Code.(7) It is an interesting coincidence that at the same time Henrietta Lacks’ cells were being produced in industrial quantities at the Tuskegee Institute, 600 impoverished, African-American sharecroppers were the being subjected to the notorious Tuskegee syphilis experiment.(1)(3) The legacy of Tuskegee led to changes in laws governing medical consent.
Even so, requirements for informed consent do not necessarily cover procedures that happen once part of a patient has been removed. It is assumed that medical consent informs a patient of risk from a medical procedure. But if the research is happening on something that is no longer a part of the patient it may be asserted there is no risk to the patient. But the question of risk is not so clear-cut. Genetic research has led scientists to understand a large amount of information about a person, including their predisposition to certain diseases, from their genetic makeup. Since this information is inherited, information about one person may indirectly reveal information about their close relatives. The genotype of HeLa cells has been well-studied, meaning that her children do not have complete genetic anonymity. A federal law to mandate confidentiality of patient records did not come about until the passage of HIPPA in 1996.(8) HIPPA gives a patient has a degree of control over their medical information that they have over their own excised tissues.
Aversions to inhumane treatment may be behind people not having rights to their own tissue. It has been suggested that society’s reluctance to attach property rights to the human body stem from “society’s moral abhorrence towards any form of slavery.”(9) At times, some of Henrietta Lacks’ descendents have felt that they were due a share of the worldwide commercial sale of HeLa cells. They felt that people worldwide were profiting from the sale of their mother as “property” and they felt they deserved a share of those profits. At other times, they have said they weren’t interested in financial reward, but merely to share in the knowledge of what happened with their mother. At times they have said they only wanted to see their mother recognized: for the beauty of her humanity and for the “immortal” contributions they felt she had made to science.(1)
In 2011, as in 1951, there is no law granting a person right of determination or a fiduciary stake in the use or sale of their bodily tissues ex vivo. There are court precedents where patients have tried unsuccessfully to reap a share of the profits earned from parts of their bodies but the law has never established clear ownership rights in donated human tissues.(10) In Moore v. Regents of the University of California the California Supreme Court held that the patient did not have a financial stake in his severed tissues.(11) In Greenberg v. Miami Children’s Hospital Research Institute, a Florida District Court held that patients could not control who ended up with their excised tissues nor could they place restrictions on whether the tissues were used commercially.(11) If a patient wishes to dictate how their cells or organs can be used after they are removed, they must negotiate this ahead of time. As the dean of the Stanford Medical School remarked after the Moore ruling, “I guess you could sit there with your ruptured appendix and negotiate.”(1)
However, there is case law suggesting that patients do preserve certain rights. In Washington University v. Catalona, the courts determined that the patients did not have a right to determine the course of research on their tissues, but the courts agreed that a provision of the consent form allowed the patients to decide if they wanted the samples to simply be destroyed.(6) Some other court decisions concerning the donation of cadaveric corneas, management of frozen embryos, and postmortem control of stored semen, “suggested that donors might have some property rights in their tissues.”(6)
In 2006, Forbes reported that worldwide spending on prescription drugs topped $600 billion for the first time.(12) It is impossible to say for sure how much of that industry rests upon research conducted on HeLa cells. Today, numerous other human cell lines exist, such as HEK-293 and LNCAP.(13) It is impossible to say how many lives have been saved, or enhanced, by research utilizing HeLa or any other human cell-line. Before a new pharmaceutical is approved for sale, it must be tested on many different living patients in clinical trials. Prior to that, it will typically have been tested in many different tissue cultures that may have come from many different persons. Should they all receive some compensation? If so, should the compensation be somehow based upon the size of their contribution? Who has contributed more to a new disease cure: the singular patient whose cancer cells were transformed into a new cell culture line, or the dozens of patients who are given multiple doses of a new cancer fighting agent in a Phase I clinical trial?Note-1 It may be impossible to fairly apportion a direct financial benefit; so perhaps it is best to let the benefit accrue to society.
Stakeholders in modern medicine include prominent pharmaceutical and biotechnology companies, some of which earn over a billion dollars a year from a single drug. Also important to the industry are government labs and research institutions, such as Johns Hopkins. Though Johns Hopkins never patented or charged for distribution of HeLa cells, it is common today for universities and hospitals to maintain a portfolio of intellectual property rights and to receive royalties. Some of the money from those license fees is invested into new research, or into treating indigent patients. Smaller businesses are stakeholders as well; although the family doctor may not be engaged in any form of research, she has a stake in seeing new medicines developed. And of course we all have a stake in seeing new discoveries created that may benefit us, or our loved ones, when we need it most. Any limits on research could be a setback to medical progress.
Perhaps we are better served by donating our unneeded tissues to this overall societal cause than attempting to receive a direct payment each time the doctor removes a suspicious wart or a lump from our breast. Perhaps that way we all can join in a share of Henrietta Lacks’ immortality as well as her humanity.
Note 1: Typically people participating in clinical trials may receive payment of a “convenience fee” to cover expenses such as parking and meals, but they are not allowed to receive a payment that would be substantial enough to constitute inducement to participate for monetary gain.(15)
