The Story of Henrietta Lacks: Bioethics of Handling Human Tissues

Bioethics is anchored on ethics, which is the philosophical disciple relating to notions of right and wrong, as well as good and bad. Ethics is the basis of a community’s moral life. Bioethics, on the other hand, is the application of ethics in healthcare and medicine ( Beauchamp & Childress, 2001 ). It is thus multidisciplinary, incorporating such areas as medicine, philosophy, medical humanities, theology, health policy, law, nursing and history (Center for Practical Bioethics, n.d.). First coined in 1971, the term bioethics initially signified the integration of bioscience and biology into a humanistic experience. However, the term has since grown to cover such aspects as the private decisions made by individuals in clinical settings, controversies around stem cell research, and the impacts of reproductive technologies. The term also covers such concerns as international human subject research, allocation of resources, and public policy in healthcare ( Nisbet & Fahy, 2013 ). The four critical domains of bioethics are clinical and organizational ethics; aging and end of life; disparities of health and healthcare, and life sciences (Center for Practical Bioethics, n.d.). The field has also evolved to become a key aspect of legislation and public policy, as well as in the practical applications of other theoretical principles. Currently, bioethics is conceptualized as the intersection of philosophy and medicine, law and theology, and practitioner and his or her patient. It entails such issues as life and death, pain and suffering and rights and responsibilities. Others include social justice, advocacy for fair access to healthcare, improved patient-centered outcomes, innovative ways of delivering care, research, and pushing boundaries of science and technology. Bioethics also covers inclusion, policy, advanced care planning, innovation, environment, education, and patient care ( Nisbet & Fahy, 2013 ). One important and crucial application of bioethics and health law is in the handling of human tissues. This paper seeks to explore the bioethical implications of the use of HeLa cells that were obtained from Henrietta Lacks. In this case, the legal and ethical beliefs of the time will be explored. 

In 1951, a 31-year old African American woman named Henrietta Lacks presented to The John Hopkins Hospital in Baltimore, Maryland, for irregular vaginal bleeding (The John Hopkins University, 2018). During the time of Henrietta Lacks, John Hopkins Hospital was one of the few hospitals that provided health care to African Americans. The gynecologist at John Hopkins who saw Mrs. Lacks, Dr. Jones, found a large and malignant tumor on her cervix upon examination. A biopsy of her cervical cells was taken without her consent and sent to Dr. Gey’s pathology lab, which was common practice at the time. Dr. Gey was a well-known cancer and virus researcher at the time and had been collecting cells from patients who were diagnosed with cervical cancer that presented to The Johns Hopkins Hospital. Each of the samples he collected had all died off except for Mrs. Lack’s cells. Her cells, unlike any other cervical cells Dr. Gey had been collecting, began to replicate and double every 20 to 24 hours (The John Hopkins University, 2018). Today, the immortal cells from Henrietta Lacks, nicknamed ‘HeLa’ cells, have been used and continue to be used in numerous studies and aiding in the creation of vaccines for polio and flu viruses, in-vitro fertilization, AIDS, and more recently how viruses can fight off the proliferation of cancer cells, all without requiring experimentation on human subjects (The John Hopkins University, 2018). However, the story of Henrietta Lacks has raised many bioethical and moral questions regarding informed consent, confidentiality, and the use of specimens collected from patients. The purpose of this paper is to discuss the implications behind the use of Henrietta Lack’s cells without her permission since 19 5 1, research on human subjects, the introduction of informed consent and policies and laws that have been enacted and changed since that time in terms of how specimens are handled and whether or not patients are fully informed about what happens to specimens that are collected from their bodies . Lastly, the paper will highlight how HeLa cells have been used in the advancement of science and research. In a bid to protect the parties involved, and as exemplified by Henrietta’s case, the importance of health law and bioethics in the handling of human tissues cannot be overstated. 

The Story of Henrietta L acks 

Death and Autopsy 

The story of Henrietta Lacks goes back to 1 st February 1951 when the 31-year old woman presented to the Gynaecology clinic at John Hopkins Hospital in Baltimore, Maryland. Lacks showed symptoms of spotting in between her menstrual periods. For instance, her previous menstrual period was on 4 th January 1951. On undergoing a general examination, results indicated that she was healthy. However, an examination of her cervix showed that there was a glistening, raised, purple and smooth lesion sized less than 2.54 cm ( Lucey et al., 2009). This lesion was restricted to the cervix and was seen to differ from the carcinomas of the cervix that the treating physician had seen before. Following the discovery, Lacks was treated using radium and deep x-ray for several months. This treatment did not stop the cancer from spreading, in which case it extended rapidly to cover Lacks’ both parametria. On 8 th August the same year, Lacks developed extensive abdominal pain and was subsequently admitted to the hospital. Following her admission, the pain became more intractable and severe. Ureteral catheterization was carried owing to a failure to void urine, but the attempt was unsuccessful. The nonprotein nitrogen serum level rose significantly. Next, the medical team administered diathermy therapy, but this was also not successful. Eventually, Lacks succumbed to the cancer on 4 th October 1951 at 12.15 am ( Lucey et al., 2009). One year before her death, Lacks had given birth to a normal infant, and her cervix was declared as normal six weeks later. It is three months after this that Lacks presented herself to the clinic bearing the cervical tumor. 

An autopsy was conducted on Lacks’ body was conducted on the day she died. The exercise revealed that her well-developed body was characterized by deeply pigmented skin around her lower abdomen. This attribute was consistent with what would be seen following an x-ray treatment. A small quantity of yellowish fluid was found in the peritoneal cavity while the pleural cavity had more fluid. The pericardium did not have any fluid. The victim's lungs had bibasilar lobar pneumonia, and the bronchi were covered with cheese-like material. There were blood stains on the bronchi's mucosa. The most telling observation was that the abdominal and thoracic cavities had white, small and firm nodules ( Lucey et al., 2009). These nodules were also present on the surface of the intestines, peritoneum, and liver. Further, the pleural and superior surfaces of the diaphragm had the nodules. The nodules were also found on the liver parenchyma, pericardium, and lung. The nodules were varied in size and exhibited minimal necrosis. The superior pole of Lacks' right kidney had a large sub-capsular hematoma, and a tumor nodule had embedded itself into the capsule. The calyces, pelves, and ureters were dilated which was attributed to severe hydronephrosis. A mass of tumor was found on the left ureter just inside the pelvis’ brim. The right ureter was entangled by a mass of tumor close to the bladder’s posterior wall. More small nodules were found on the bladder mucosa with the external surface boasting a solid mass of tumor. 

The autopsy also revealed that the right ureter was dilated about 4 cm of the bladder, but the dilation stopped abruptly. The ureter’s circumference was about 14mm. This right ureter was also left intact but a probe passing down the patient’s bladder with difficulty. While both ureteral openings were patent from within the bladder, it was difficult to pass the probe through the left ureter and to the bladder. The left ureter was dilated up to the bladder wall, and at this point, an obstruction was caused by a mass of tumor located on the external surface. The nodular masses of tumor partially surrounded the bladder and also penetrated the bladder wall ( Lucey et al., 2009). Tumors had also infiltrated the vagina wall with the cervix being replaced by friable masses of tumor. While Lack’s uterus was of approximate normal size, it was covered by tumor nodules. The victim’s ovaries and fallopian tubes were destroyed by clusters of tumor nodules. Further, the iliac veins were surrounded by a mass of tumor while the right iliac vein had a tumor that seemed to enter the lumen. The autopsy also noted the presence of focal uremic diphtheritic colitis. Overall, the autopsy revealed that without any doubt that Lacks' cause of death was cancerous. 

HeLa Cells and their Use at Johns Hopkins Hospital 

Lacks' cervical biopsy was used as a source of tissue by the pathology department for use in carrying out a clinical evaluation. The tissue was also used for research purposes by Johns Hopkins hospital in the Department of Surgery, Tissue Culture Laboratory. One of the most prominent persons at the hospital was Dr. George Gey, who was the director of the hospital’s laboratory. In collaboration with his wife, Dr. Gey had a long history at the hospital and had researched on tissue culture for many years. His range of work included in vitro research pertaining to cancer, endocrinology, virology, and intracellular and membrane cytology. Despite efforts in these areas, Dr. Gey’s most important scientific contribution was attributed to Henrietta Lacks. While Lacks was undergoing treatment at the Johns Hopkins Hospital, Dr. Grey was fixated on fulfilling his ambitious goals at the Tissue Culture Laboratory. Specifically, Dr. Gey was working on the isolation and maintenance of normal as well as malignant or diseased tissues either as stable or temporary organoids or in the form of derived cell strains ( Lucey et al., 2009). 

To fulfill this purpose, Dr. Gey and his team were collecting tissue from all surgical procedures in the hospital. By the time Lacks presented to Johns Hopkins hospital gynecology clinic, about 30 cervical cancer specimens had already been sent to Dr. Grey. The cells obtained from Lacks' biopsy specimen were placed into the culture by use of the roller-tube technique. Contrary to results obtained from the previous specimens, the growth of these cells was robust ( Agarwal & Rimm, 2012) . Consequently, these cells became the first human cancer cell line to be immortalized in tissue culture ( Lucey et al., 2009). The cells were subsequently named ‘HeLa’ by using the initial two letters of the victim’s first and last names. Despite this discovery, Lacks was not credited as the source of the cell line for years. For instance, for years, the cells were misinterpreted to have been obtained from a Helen Lane or Harriet Lane. The previous attempts to grow cervical carcinoma or normal cervical epithelium in culture had been unsuccessful. However, growing cells from the adenocarcinoma of the cervix from which Lacks had succumbed was highly successful. The histopathology slides from Lacks’ surgical autopsy and biopsy were re-examined twenty years later. The re-examination resulted in a revision of the victim’s initial diagnosis. It was established that Lacks had adenocarcinoma of the cervix that was extremely aggressive. 

Henrietta Lacks’ cervical carcinoma was undoubtedly malignant leading to the patients’ noted rapid clinical deterioration. While the idea of rapidly progressing cervical carcinoma had been questioned, Lacks' case suggested otherwise. For instance, in recent times, the HeLa cells have been proven to contain the human papillomavirus (HPV) 18 DNA while HPV 18-positive HeLa cells have been associated with changes in microRNA expression. The association of HPV18 with aggressive adenocarcinomas is the reason the inexhaustible growth of HeLa cells when put in culture was unprecedented. Carrying out Papanicolaou smear screening routinely is not likely to detect the rapid progressive cervical carcinomas. However, the HP vaccine is envisaged to prevent the tumors. Data with HeLa cells was first published in 1952 by Gey and his team. In their study, these scholars sought to evaluate in-vitro, the potential for growth of normal and early intra-epithelial as well as carcinoma from various cases of cervical carcinoma. Following the use of continuous roller-tube cultures that were conducted for one year, only one strain of cervical carcinoma cells was obtained. This strain grew in a medium of bovine embryo extract, chicken plasma, and human placental cord serum. This strain came to be referred to as ‘HeLa’ ( Lucey et al., 2009). This discovery led to the successful propagation of poliomyelitis virus using HeLa cell culture. 

Social Justice, Ethics and the Discovery of HeLa 

Following Lacks' death, Dr. Gey declared to the world via national television that based on the results of a study he had conducted, it was now possible for those in the medical field to learn how to eradicate cancer. While making this announcement, he was holding a vial of Henrietta Lacks' cells. The scientific importance of Dr. Gey's discovery cannot be overstated. The discovery of HeLa cells and their subsequent use in the medical field resulted in an unprecedented examination of the field of medical science and presented such queries as the need to balance rights and responsibilities. The resultant rapid growth of medical research and development of modern-day biomedical industry led to the clashing of consent and the rights of privacy for individuals ( Nisbet & Fahy, 2013 ; Rothstein, 2005 ). Lacks' was not available to understand and benefit from her contributions. However, the most unfortunate aspect is that it took more than three decades for her family to realize their rights for their kin's contribution to the medical field. This process is ongoing to date. Thus, the discovery of HeLa cells at Johns Hopkin hospital and their subsequent use led to the emergence of the field of biomedical ethics ( Nisbet & Fahy, 2013 ). The same discovery gave rise to regulations pertaining to informed consent. Henrietta Lacks’ cells were taken from her without her consent. In doing this, Dr. Gey and his medical team violated Lacks’ rights. This was made possible by the fact that there were no adequate laws to protect Lacks as well as other patients from ongoing unauthorized tissue research even if this research was conducted for the common good. Thus, the HeLa cells brought to the fore the responsibilities of medical practitioners and this transformed how researchers collect samples and gather information from human subjects ( Nisbet & Fahy, 2013 ; Rothstein, 2005 ). Likewise, the discovery influenced the regulation of modern-day tissue research. 

During Lacks’ time, the Johns Hopkins Hospital was the only facility that offered free medical care for the poor African American patients in the Baltimore, Maryland area. However, this care was not only free but also segregated ( Chafe et al., 2011; Faden & Powers, 2011 ). Likewise, the treatment was disguised as free, but in actual sense, research would be carried out simultaneously on the African Americans ( Dean & Wolfe, 2017 ) . Thus, while undergoing treatment at the hospital, Lacks was also available for use by Dr. Gey’s medical team. Dr. Gey was not keen on the patients’ rights or the responsibilities he owed to them but rather was fixated on finding a cure for cancer. For instance, the team harvested HeLa cells from cancer tumors on Lacks’ body while her autopsy was being conducted ( Rothstein, 2005 ). It was common for medical practitioners in the 1950s to research patients without their consent and knowledge ( Spigner, 2017 ; Faden & Powers, 2011 ). Since current protections did not exist then, no laws were broken. However, it is undeniable that by doing so, both informed consent and the right to privacy were violated in the process. Going by current standards, the researchers at Johns Hopkins failed to honor their patients as individuals who had inviolate rights of dignity and privacy. On discovering the HeLa cells, Dr. Gey disguised Lacks’ identity by purporting that these cells were associated with a fictional individual by the name of ‘Helen Lane.’ However, Lacks’ identity was revealed accidentally leading to her re-identification. The HeLa cells were correctly identified with, and renamed after Henrietta Lacks in the 1970s, more than twenty years after their discovery ( Nisbet & Fahy, 2013 ; Hepworth, 2011 ). Still, zero efforts were made in informing as well as obtaining consent from Lacks’ family ( Dean & Wolfe, 2017 ) . At a bare minimum, it would have been appropriate for the medical team to contact the family on discovering how important Henrietta's cells were to the field of medicine. HeLa, as opposed to Henrietta, became the focus for science. The cells were also freely shared with various cancer researchers all over the world. These actions were made possible by Lacks' African American background and social-economic status. As opposed to focussing on Lacks as a person with rights, the science community focussed on Dr. Gey and how vital the HeLa cell line was to the future of medicine. 

The Use of HeLa Cells in Medical Research: Balancing E thics, Science, and Privacy 

Since its separation from Henrietta Lacks, the HeLa cell line has been at the forefront of revolutionizing medical research and science. The HeLa cells became the first human cell line ever to survive outside of a human body, and thus was a breakthrough for the medical science field ( Ncayiyana, 2011 ). These cells assured the medical science field of a constant supply of one of the most crucial and precious resources. As opposed to other cells, the HeLa cells could regenerate every 24 hours and thus were used to stock labs all over the world ( Ncayiyana, 2011 ). The discovery of HeLa cells solved one of medical sciences mysteries, which was the ability to mimic the functions of a human body outside the live body. This feat combined biological research with medical practice for the first time. The fact that HeLa cells were similar to normal human cells made it possible for scientists to use them in tests that involved human diseases. The cells could also be used in experimental circumstances that were deemed unusual. Notable among the latter was the use of HeLa cells to study the influence of zero gravity on human cells ( Ncayiyana, 2011 ). To achieve this, the cells were taken to space aboard the Vostok 4. These cells became a vital component of the efforts in search of a polio vaccine. They also became critical to the study of virology. In this case, HeLa cells played a crucial role in growing the polio virus which aided in developing a vaccine. Owing to their importance, an industry was borne out of HeLa with tons of HeLa cells being produced in mass for scientific uses ( Ncayiyana, 2011 ). The HeLa factory was subsequently set up at Tuskegee Institute by the National Foundation for Infantile Paralysis (NFIP) scientists. 

The location of HeLa factory at the Tuskegee Institute was found to be ironical. This was owed to the institute’s reputation for carrying out an unethical study on syphilis while using African Americans as test objects. Since its establishment, the HeLa factory has grown more than 50 metric tonnes of HeLa cells ( Nisbet & Fahy, 2013 ; Ncayiyana, 2011 ). More than 11,000 patents related to HeLa cells have been registered while trillions of these cells can be found in biological companies and laboratories globally. Thus, HeLa cells have been beneficial to hundreds of millions of individuals due to their widespread use in medical research. Specifically, the cells have been used in developing polio vaccines; carrying out genetics research; manufacturing drugs for influenza, herpes, and other numerous diseases; carrying out in-vitro fertilization; and understanding and studying various cancers ( Nisbet & Fahy, 2013 ; Agarwal & Rimm, 2012; Zhang et al., 2012). In recent times, the interface of the Human Genome Project and HeLa has proven that disconnecting research from consent and privacy is bound to be a challenge when viewed in the context of balancing responsibilities and rights. To maintain this balance, there is a need for a continuous conversation between bioethicists, doctors, patients, and nurses. 

On tracking down Lacks’ family in the year 1973, geneticists went ahead and asked for blood samples from her kin. These samples were aimed at studying the family's genetics. It is after this encounter that Lacks' family learned that the HeLa cells had been distributed globally. Studying the genetic makeup of the HeLa cells put Lacks and her descendants at the forefront of a clash between ethics, science, and privacy ( Nisbet & Fahy, 2013 ). Mapping of HeLa’s exact genetic code was made possible by the exponential growth experienced in the field of genomics. This genetic code was subsequently published on the internet for use by anyone. In doing publishing and mapping HeLa’s genetic code, the geneticists were once again infringing on Lacks family privacy rights ( Spigner, 2017). The publication of the genetic code on the internet ignited debate on the risks of ignoring the principles of medical ethics, consent, and privacy. In this regard, an emphasis has been placed on the responsibilities of scientific research as well as science in advancing medicine. While the genetic code has significantly enriched the medical industry and researchers, the people that have contributed towards this were paid nothing ( Truog et al., 2012). In a bid to protect themselves, Lacks descendants were forced to learn about their rights. The family members sought to find out why geneticists were interested in obtaining tissue samples from them. The ensuing scrutiny brought attention to the right of individual donors, particularly uninformed ones like Henrietta. 

The posting of Lacks’ genetic code on the internet by German scientists violated the rights of her family. The family also felt highly disrespected by this action. Henrietta’s story gave rise to a system of checks and balances in which case science is permitted to advance while at the same time protecting donors’ rights. Following the publishing of Lacks’ genetic code on the internet, an agreement was reached between the family and the U.S National Institutes of Health (NIH). In the deal, two members of the Lacks family were nominated to the board that would oversee the use of HeLa in various research efforts ( Nisbet & Fahy, 2013 ). This board is expected to approve all studies involving HeLa that are federally funded. This way, it is clear that HeLa revolutionized the concepts of responsibilities and rights in research. While the agreement does not cover the private industry, the NIH expects all researchers to ask for permission from the board before embarking on any research on HeLa cells. Currently, the question of the beneficiary of human tissues and bodies has emerged. This is mainly driven by the ubiquity of tissue specimen and advent of genomics, which are both by-products of modern medicine. Thus, while the family was the last to become aware of the HeLa cells, it now has to grant permission to the research use of the cells. 

The Po licies and L aws E nacted to Guide Collection and Use of H uman T issues and S pecimens 

Mishandling of Lacks' rights forced the United States (U.S) government to act in a bid to offer comprehensive protection to all research subjects. These efforts informed the Belmont Report. The National Commission wrote this report for the Protection of Human Subject of Biomedical and Behavioral Research in 1979 ( Beauchamp, 2003 ; Cassell, 2000 ) . The report led to the establishment of the Common Rule which plays a crucial role in all research that is funded by the federal government. Initially published in 1991, the Common Rule refers to the Federal Policy for the Protection of Human Subjects and was aimed at protecting all vulnerable categories of research test subjects. The regulations implementing the Common Rule were enacted by the Department of Health and Human Services and resulted in the process of Institutional Review Board (IRB). This process is aimed at promoting robustness in medical research and advancement and at the same time protecting individual patients' rights ( Claudot et al., 2009) . This is especially the case for the persons deemed most vulnerable. Examples include children, pregnant women, prisoners, the destitute, and fetuses. 

The Office for Human Research Protection (OHRP) is charged with the responsibility of overseeing the IRBs. These IRBs offer leadership in protecting the welfare, rights, and wellbeing of all the subjects involved in research that is supported or conducted by the Department of Health and Human Services. The OHRP aids in ensuring this through the provision of guidance and clarifications, development of educational materials and programs, maintenance of regulatory oversight, and provision of advice on regulatory and ethical issues in behavioral and biomedical research. The Health Insurance Portability and Accountability Act (HIPAA) was passed by Congress in 1996. This act was aimed at protecting the privacy of patients (Hash et al., 2005). Nevertheless, as exemplified by the challenges faced by Lacks' family, HIPAA does not protect genetic information. In a bid to fill this gap, the Genetic Information Non-discrimination Act (GINA) was passed by Congress in 2008. This was followed by the creation of the Presidential Commission for the Study of Bioethical Issues by President Obama. The commission comprises of experts from the fields of genetics, ethics, medicine, engineering, political science, and advocacy. 

The basic tenets of medical ethics have evolved due to the experiences of Henrietta ( Nisbet & Fahy, 2013 ) . Currently, ethical requirements cover non-maleficence which entails the principle of not harming and acts as the basis of all medical decisions. The other aspect is beneficence which pertains to doing or benefitting from good. Autonomy, on the other hand, is anchored on the narrative that a patient has the right to refuse or decide medical treatment. Lastly, justice is a core aspect of medical ethics and requires that all patients are treated impartially and without bias as a result of race, wealth, gender, and sexuality. While the progress achieved is commendable, the experiences of Lacks' family with regard to extraction and use of HeLa cells should act as a source of caution with regard to the future of research on human tissue and its associated technical advancement. It is vital for this field to continue enhancing the rights of individual patients. In an age where re-growing of organs is possible, the questions of ownership, as well as beneficiaries of human tissue, will continue to plague the field of medicine with increased achievements and advancements. This question has both economic and medical implications. Thus, as society pushes the current boundaries of medicine and science, it is critical for all stakeholders to remember Henrietta Lacks’ story. 

Conclusion 

Bioethics is the application of ethics in healthcare and medicine and is multidisciplinary. The field incorporates such areas as medicine, philosophy, medical humanities, theology, health policy, law, nursing, and history. The term has grown to cover such aspects as the private decisions made by individuals in clinical settings, controversies around stem cell research, and the impacts of reproductive technologies. It also includes such concerns as international human subject research, allocation of resources, and public policy in healthcare. The four critical domains of bioethics are clinical and organizational ethics; aging and end of life; disparities of health and healthcare, and life sciences. One notable application of bioethics and health law is in the handling of human tissues. A case that highlights the importance of bioethics and health law is that of an African American woman called Henrietta Lacks. Lacks succumbed to cervical cancer on 4 th October 1951. A biopsy of her cervical cells was taken without her consent and sent to Johns Hopkins pathology lab oratory. Unlike others that had been to the laboratory, replicate d and doubled every 20 to 24 hours . T he immortal cells from Henrietta Lacks were subsequently named nicknamed ‘HeLa’ cells . The cells have been used and continue to be used in numerous studies . They have also been used in the creation of vaccines for polio and flu viruses, in-vitro fertilization, AIDS, among other diseases. R ecently HeLa cells have been used to show how viruses can fight off the proliferation of cancer cells without requiring experimentation on human subjects . Henrietta Lacks ’ story has raised many bioethical and moral questions over the years. These regard informed consent, confidentiality, and the use of specimens collected from patients. Consequently, the debate has resulted in various changes to the field of medicine and bioethics. It has also given rise to various legislation and policies. Notable among the latter include Federal Policy for the Protection of Human, the IRB process, HIPAA, GINA, and most recently, the Presidential Commission for the Study of Bioethical Issues. Despite these developments, in an age where re-growing of organs is possible, the questions of ownership, as well as beneficiaries of human tissue, will continue to plague the field of medicine. As society pushes the current boundaries of medicine and science, it is critical for all stakeholders to remember Henrietta Lacks’ story. Overall, the importance of health law and bioethics in the handling of human tissues as exemplified by Henrietta’s case cannot be overemphasized. 

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