Category Where Have We Been
Henrietta Lacks circa 1945
For those of you who have experience with in vitro (cellular based) research, you are very likely familiar with the first immortal cell line called HeLa cells. The immortality of these cells, or ability of the cell line to continue be cultured and grown over and over again without dying, has been the cornerstone of research in multiple disciplines, but particularly in oncology (cancer biology) and vaccine research. Understanding how these cancer cells are able to stay alive and are able to replicate has been a pivotal query of scientific discovery for the last sixty years. For example, HeLa cells, a cell line that was derived from the cervical tumor cells of Henrietta Lacks, have been utilized to understand the disease process of Human Papilloma Virus (HPV) and subsequently lead to the development of a HPV vaccine which holds the promise of reducing young women’s risk to cervical cancers. However, the contribution of HeLA cells to research and development did not come without the cost of bioethical concerns.
Much of these issues are tackled in the comprehensive narrative by Rebecca Skloot entitled ‘The Immortal Life of Henrietta Lacks.’ Skloot’s book brings a biographical view to the life of Henrietta Lacks, including how the cells were originally harvested from this poor Black woman and introduced to the scientific community without her or her family’s permission or notification. In addition, the volume explores the past and present impact that this significant medical discovery has had on science, but also on past and present generations of the Lacks family. Skloot’s research also reminds us of some common bioethical issues in biomedical research that still plague the African-American community. The bioethical issues seen in the case of Lacks (sometimes misidentified as Helen Lane in the literature) during the middle of the 20th century are not new and include themes such as mistrust of physicians, lack of informed consent, and the ethics of ownership and compensation in biomedical research.
As discussed in a previous posting, we identified Johns Hopkins Hospital (JHH) as one of the first large institutional facilities that provided both care for the African-American community with a “colored” ward and served as a research training ground for emerging physicians. Johns Hopkins also serves as the backdrop to this story. With the founding of the hospital at the end of the 19th century, it quickly gained a reputation within the African-American community where black people went to die, instead of being healed. This is in direct contradiction to the mission outlined by the hospital’s founder, Johns Hopkins, who wanted to insure that the indigent population of Baltimore, especially poor black children, had access to medical care they ordinarily could not afford. However, the community justifiably believed that the quality of the care in the colored ward was inferior to the main hospital and that the patients were treated as medical experiments and exhibits for physician training. This was further exacerbated by the idea of “night doctors” where physicians played a role in procuring black cadavers from the surrounding community either by allowing patients to die, facilitating grave robbing or worse, participation in schemes to snatch people from the streets for research purposes. In the case of Henrietta Lacks, when treatments began for her advanced stage cervical cancer, she was given standard of care radium treatment, a ghastly treatment which while known for its ability to kill cancer cells, also was known to have a poor safety profile and Henrietta suffered excruciating pain until her untimely death at the age of 31. David “Day” Lacks, Henrietta’s husband, was distraught following his wife’s death, as he already held significant mistrust for the doctors at Johns Hopkins. He and his family members knew of the history of JHH for human experimentation and body snatching, so the questionable treatment of Henrietta’s cancer without consultation with the family was not unexpected. In addition, the subsequent revelation that the scientific bounty derived from HeLa cells stemmed from an unauthorized biopsy by Henrietta’s physician, Dr. George Gey, was no surprise. Unfortunately, this manner of protocol (or lack thereof) was consistent with the Lacks family’s view of perceived unethical, if not deadly, practices at JHH. The history of these events still plagues the reputation of JHH in the African-American community and provides validity to feelings of mistrusts for medical treatment at JHH and at similar types of facilities.
According to the ICH Guidance for Industry on Good Clinical Practice, Informed Consent is defined as, “A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate.” Although this guidance was fully adopted in 1996, the ICH guidance represents the amalgamation of codes, doctrines and decrees from the international community on minimum requirements for biomedical research, since the Nuremburg Code was ratified in 1947. As Dr. Gey was engaged in oncology research before he treated Henrietta, it was commonly understood that he would take a biopsy sample of both the tumor and surrounding health tissue for comparison. What was uncommon in the practice was notification to patients or their families of the biopsy process, including notification that the samples had been taken and how the biological material would be used. Henrietta and her family had no idea that her cells had been biopsied and were being studied in culture. It was only made clear through a chance meeting with a family member, where a researcher who had used HeLa cells made the correlation. Even worse, other investigators, such as Dr. Susan Hsu made attempts to take additional biological samples from the Lacks family under false pretenses. The family was told that they were being screened as a preventative measure to see if they shared the deadly cancer with Henrietta. In reality, Dr. Hsu was looking for surrogate markers in the family members that would help explain the immortality of the HeLa cell line. These are clear examples where the pursuit of science overshadowed the use of basic bioethical considerations and violated individual rights to be informed. These violations are particularly egregious, as they occurred after the ratification of the Nuremburg Code. Given this period of time in American history, these unethical practices were overlooked or even justified in the minds of those who participated in institutional racism and the reinforcement of second-class status of African-Americans during this time.
Finally, because the introduction of the HeLa immortalized cell line was one of the most significant scientific discoveries of that time (and of all time), Gey’s lab was inundated with requests to share the cells. As the potential for replicating cells in culture without them dying or reaching an expansion limit, the implications and use of these cells were infinite. Their resulting commercialization was not only necessary to meet the global demand for the cells, but also seen as an appropriate way to support research and innovation in biomedical research. Ironically, Tuskegee University played an early role in the commercial process, as they served as a HeLa factory for supplying cells to researchers and laboratories globally. It was not long before the demands exceeded their capacity and vast commercialization was picked up by a startup company called Microbiological Associates. With customers such as government agencies (i.e. National Institutes of Health), universities and global researchers, soon Microbiological (now Invitrogen) was selling thousands of lots of HeLa cells around the world. This served as the impetus for the creation of a multi-billion dollar industry exchanging biological supplies. Although difficult to quantify the total revenue generated from HeLa cells through the years, it is estimated to be in the hundreds of millions of dollars. Even today, genetically modified lots are being sold for as much as $10,000 USD.
The HeLa cell line has gone on to be sold by other biological supply companies, but in itself raises several questions, many of which have been appealed up to the Supreme Court Level. Who owns tissues/samples after they are have been harvested from the body? Can scientific discoveries derived from biological samples be patented and commercialized? Are donors, whether voluntary or involuntary, due compensation for discoveries made from their biological specimen? Although many of these questions have been adjudicated in courts, mostly in the favor of scientists and organizations, unresolved accounting still remains regarding the impact on the affected families and the responsibility of the scientific community. Incredibly, the Lacks family was only formally notified of the commercialization of her cells in 1975, some twenty-four years after her death. Although it is clear that the excision of the tumor cells from Henrietta Lacks’ cervix served as the origin of the parental line of HeLa cells, the Lacks family themselves have received little to no compensation for the contribution.
Although it has been more than sixty years since Henrietta Lacks created this scientific legacy, the impact that she has had on science has been indelible. Significant credit should be given to Skloot for investigative reporting efforts in bringing forth this important story. Unfortunately, it highlights another dark chapter in American history. We must hold fast to the highest ethical considerations, never again allowing the pursuit of science and those in vulnerable positions, i.e. illiterate, lower socioeconomic status, or poor to be exploited or taken advantage of. Empowered with the knowledge of our past, patient protections are now enforced by law, and steps have been taken to avoid similar situations and ensure that patients are treated with respect and as a full, informed, partner in the process.