Remarkable in life, a stylish Black woman who loved to cook and dance, Henrietta Lacks is even more remarkable in her after-life. She is acclaimed as the progenitor of the immortalized HeLa cell line – cells that keep replicating without dying, the fodder of numerous advances in medicine. But I see her as a beacon to the importance of informed consent and privacy in medical research: Henrietta Lacks is responsible for instituting better patient controls in federally funded medical research. Yet, like in many famous families, Henrietta Lacks is not resting in peace - dissension brews, and some of it surrounds the fanfare about an impending lawsuit.
The Backstory
In 1950, Mrs. Lacks was a patient at Johns Hopkins Medical Center. While she was under anesthesia for radiation treatment, cells taken without her knowledge or permission were cultured for research and widely shared throughout the research world by the cellular biologist to whom they were entrusted – George Gey. True, Mrs. Lacks a signed consent- form before being anesthetized, but that pertained to “necessary” surgery. The cells taken from her were perhaps necessary for Gey’s research but not for her treatment.
Dubbed the “HeLa” cells, the cells are unique. They grow in a specially prepared culture medium devised by Gey, had no space limit, and were virtually immortal. Their use contributed to
- Developing the polio vaccine
- The first cloned human cell
- In vitro fertilization
- The discovery humans have 46 chromosomes
They were also the bane of many laboratories, their immortality proving a curse as well as a blessing as they contaminated other cultures.
Their use also raises complicated ethical and legal issues: disregard of patient’s rights, privacy issues, the conflict between the needs of the public and the rights of the individual, racism, informed consent for triple-use projects (treatment, research, and business), and the decision-making role of the family – especially when family voices conflict.
Initially, Mrs. Lack’s name was shielded from the public. Dr. Gey, who trained as a physician but became a cellular biologist, had no interest in either profiting from the cells or disclosing Mrs. Lacks’ name. Other scientists such as Roland Berg disagreed, advocating that humanizing the cell line by associating with a person was necessary to engage the public. In the medical community, her identity was freely known and bandied about.
In 1973, 25 years after her death, public disclosure emerged, and Mrs. Lack’s family learned about their unique ancestor and how biotech companies and biobanks were profiting handsomely from her cells. The disclosure proved divisive to the family. Daughter Deborah wanted nothing more than her mother’s contribution to medical science to be recognized; son Lawrence wanted – and still wants – compensation from medical establishments profiting from his mother’s cells.
The NIH was among those profiting from Mrs. Lack’s cells, albeit not financially. In 2013, Francis Collins, the Director, met with the family to achieve some resolution regarding how the cells would be used, agreeing that future decision-making regarding the cells’ use would include two family members.
Changing law and regulation
Another consequence of these meetings was the refinement of the Federal Policy for the Protection of Human Research Subjects (the 'Common Rule'), first promulgated in 1991. In 2014 the NIH began requiring researchers to tell study participants that their data may be broadly shared for future research, and required informed consent, not just for genomic data, but cell lines or clinical specimens such as tissue samples
In 2017 the Common Rule was further modified with the recognition, for the first time, of three possibly conflicting roles – doctor, researcher, and businessman, each with different primary functions and duties:
- to the patient
- to the integrity of the study
- to the investor [1]
The revised Common Rule required that potential research participants
- be told their specimens and information, if no longer clearly associated with them, may be used for other [unspecified] research without their permission.
- be informed whether the research has commercial intent
- notified whether participants’ results will be returned to them and under what circumstances.
But according to US federal guidelines, exceptions abound, including exempting the permission requirement and informed consent if the tissues are to be anonymized.
Perhaps most disconcerting is that the rule doesn’t assure the patient that if they refuse consent for the research element, their doctor would still provide the therapeutic aspect with the same degree of diligence or as assiduously. As it stands, the Common Rule leaves much to be desired, including how to resolve past errors.
Over the years, individuals and medical funding institutions have stepped up and contributed to the Henrietta Lacks Foundation, which awards grants to Lacks’ descendants and to family members of others whose bodies have been used without consent for research. Last October, the Howard Hughes Medical Institute made the largest, a six-figure contribution.
Money Complicates Everything
Focusing on the perceived unjust enrichment of biotech and biopharma as early as 2013, Henrietta’s son, Lawrence, was asking “about financial restitution for the use of the genome and about profits from the use of commercial products derived from the genome, [NIH director Francis] Collins insisted that this could not happen. Collins and his advisers tried to think of other ways the family could benefit, such as patenting a genetic test for cancer based on HeLa-cell mutations. They could not think of any.”
“We feel that at least Henrietta Lacks’ estate should have guardianship over her cells.”
Ron Lacks.
In 2018, Lawrence and his son Ron were contacted by a lawyer who proposed a guardianship complaint for the cells – a cute ploy presumably to overcome the statute of limitations problem. Lawrence and Ron agreed.
Attorney Christina Bostick explained, “Since the cells cannot speak for themselves, the Lacks estate would need to be named legal guardian, just as in a case involving a human who was unable to speak on his/her own behalf.” She indicated that such a claim would only require a certificate from two medical professionals verifying the individual is disabled and called on African American doctors interested in supporting the guardianship petition to submit a certification. However, even today, cells have not been granted legal personhood –and using cells to invoke a guardianship proceeding wouldn’t fly. Not surprisingly, that case went nowhere.
This hasn’t stopped Lawrence and his family from retaining new lawyers who are planning on seeking damages against a myriad of pharmaceutical companies and maybe Johns Hopkins, supposedly this week.
"This is the greatest example of corporate theft I've seen in my career and I've been pursuing pharmaceutical companies for 25 years"
Christopher Seeger, representing the Lacks family along with civil rights lawyer Benjamin Crump
Is this for real? Ask Oprah
Lawrence also reportedly once accused author Rebecca Skloot (the founder of the Henrietta Lacks Foundation and author of The Immortal Life of Henrietta Lacks), Oprah Winfrey and HBO, who produced the TV version of Skloot’s book, of profiting from his mother’s legacy without compensating the family. Oprah (who starred in the TV movie) would hear none of it, other than saying the son was offered a paid consultancy on the project and refused, and calling this "a family disagreement that I would be happy not to be in the middle of.”
Can son Lawrence and family recoup damages?
The possible suit by the Lacks Family against pharmaceutical and biotech firms should raise hackles. As I recently wrote, a civil tort suit requires violation of a duty and breach of a standard of care, statute, or rule, in addition to proving causation. The family must also show the plaintiff suffered damages - not that the defendant made money.
Since there was no relationship between the biotech companies and Mrs. Lacks – they owed her no duty, neither to safeguard her privacy nor to secure informed consent, nor any other legal duty I can think of. Yes, they made money; but that is, neither a crime nor a civil infraction. In other words, even if a duty existed, what did these potential defendants do wrong? By the time they procured her cells - the genome had already been published on the internet.
By focusing on the monetary aspect, Lawrence diverts attention from righting potential wrongs done by Johns Hopkins and the NIH – actions that could have a potent impact on issues not addressed by the current Common Rule.
It also allows Hopkins to sidestep responsibility for ethical and legal lapses by responding that “they did not sell or profit from the discovery or distribution of Hela cells.”
No, they didn’t. But perhaps Hopkins still has much to answer for? Even before a law is enacted, common law (as opposed to the Common Rule) requires adherence to the standard of care in the community – or what an ordinary prudent person would do in like circumstances.
So, what would you (a reasonable person) do? Would you take something belonging to someone else under false pretenses?
We start with the fact that as a patient, Mrs. Lacks enjoyed a doctor-patient relationship with Johns Hopkins; hence they owed her a duty of care. Next, we move to the fact that they invaded her body without telling her what they were planning to do. Even before refinements in the doctrine of privacy – that action might be considered fraud. It could also be claimed that the staff harassed her vulnerable husband for permission to collect more cells immediately after her death. Certainly, reports that he was told the cells were to be used for the good of his family but not told they would be used for other purposes could be considered a type of fraudulent concealment.
“HeLa cells pose a unique dilemma, … The donors of most other human cell lines are anonymous. But in this case, “hundreds of thousands — millions of people — know that HeLa is derived from cells from Henrietta Lacks.”
Ellen Wright Clayton, bioethicist and lawyer at Vanderbilt University
Disclosure of her name associated without her consent seems unduly intrusive. Moreover, those cells contain genetic information that relates to her descendants; such disclosure infringes on their privacy as well.
Recognition as Compensation
“I want scientists to acknowledge that HeLa cells came from an African American woman who was flesh and blood, who had a family, and who had a story.”
Jeri Lacks-Whye, Mrs. Lack’s granddaughter
The compensation sought by Lawrence, the anonymity promised by the Common Rule, the restricted usage proposed by others are not what other family members want. Several descendants are leading a new effort in her centennial year, calling for people to celebrate her life and legacy. This raises the question of whether the anonymity promised by the Common Law, suitable for most- might be an insensitive means of addressing the Henrietta Lacks situation.
The lack of transparency in the medical community that birthed the HeLa cells is not fully addressed by the latest rendition of the Common Rule. The legal and ethical abuses here were manifold, compounded by a family divided in itself. The situation raises important questions for genome research — such as whether family members have the right to override the wishes of individuals who choose to share their genetic data or provide un-anonymized tissue for research. And once having obtained genetic information from a consenting participant, are scientists obligated to disclose that genetic information to family members for whom it might impact?
Avaricious attorneys and a sordid family saga shouldn’t deflect us from real ethical and legal issues needing resolution.
[1] The revised common rule explained: “This role [as businessman] has fewer explicit ethical duties and is implicitly more self-serving. The role may also serve as a stand-in for other self-serving motives for researchers, including career advancement and recognition, both of which are more difficult to articulate than commercial gain.”
Sources: Private Bodies, Public Texts: Race, Gender, and a Cultural Bioethics Karla FC Hathaway
The Immortal Life of Henrietta Lacks, Rebecca Skloot
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