HeLa Cells: History, Lawsuit, and Settlements

The story of HeLa cells is deeply intertwined with the life of Henrietta Lacks, a woman whose cervical cancer cells were the source of the first immortal human cell line. The cells were obtained by researchers at Johns Hopkins Hospital during her treatment in 1951, without her knowledge or consent, marking a significant yet controversial milestone in medical research. This narrative has been compellingly captured in the book "The Immortal Life of Henrietta Lacks," which explores the impact of HeLa cells on science and the ethical issues surrounding the lack of consent. The story of HeLa cells and Henrietta Lacks sheds light on the invaluable contributions of these cells to numerous scientific breakthroughs while highlighting important ethical considerations in medical research.

Timeline of Events

The Personal History of Henrietta Lacks

Henrietta Lacks, originally named Loretta Pleasant, was born on August 1, 1920. In her early years, she worked as a tobacco farmer and cared for animals and a garden. She left school in the sixth grade to support her family.

After her mother passed away, Henrietta moved to live with her paternal grandfather. In 1941, she married David "Day" Lacks and relocated to Turner Station, Maryland, where they had five children. Several months after giving birth to her fifth child, Henrietta experienced distressing symptoms, including a painful cervical knot and vaginal bleeding. She sought medical help at Johns Hopkins Hospital, which, at the time, treated Black patients only in segregated wards.

Discovery and Treatment

Dr Richard Wesley TeLinde, the gynaecology chair at the hospital, was criticized for his extensive surgical removal of tissues in patients with early-stage cervical cancer to study the disease's behaviour. Dr. George Gey, head of tissue research, used these tissues to develop the lab's first immortal human cell line, aligning with his interest in cell survival under laboratory conditions. Meanwhile, Henrietta Lacks underwent a biopsy on February 5, 1951, revealing a large, malignant cervical tumour. Her treatment with radium tubes led to infertility, a side effect she was not informed about and would have likely refused. Despite the treatment, her cancer progressed, and she died on October 4, 1951.

Unbeknownst to Lacks, tissue samples taken during her treatment without her consent led to the discovery of HeLa cells, the first human cells to grow indefinitely in culture.

Informed Consent

In the 1950s, it was common, especially at Johns Hopkins, to collect tissue samples from patients, including those with cervical cancer, without their consent or knowledge, as there were no established protocols requiring patient consent for such practices. Today, informed consent procedures are much more rigorous, involving various methods like electronic, verbal, or written consent, and must include detailed information about the use, storage, and potential future research applications of human tissue. Legal requirements for informed consent in clinical research are specified in 21 C.F.R. § 50.20 for FDA-regulated research, and broader protections are provided under 45 C.F.R. Part 46 by the U.S. Department of Health and Human Services. The collection of Henrietta Lacks' cells occurred before these regulations were established, highlighting an ethical issue primarily involving Johns Hopkins and the involved doctors, as companies like Thermo Fisher Scientific, which later profited from HeLa cells, were not yet in existence.

In response to the HeLa controversy, ethical guidelines and regulations governing the use of human tissues in research have been significantly strengthened. Informed consent is now a cornerstone of medical research, ensuring that individuals understand how their tissues will be used and granting them the autonomy to make informed decisions.

Henriette Lacks Cells, Lawsuits and Settlements

The lawsuits involving Henrietta Lacks's HeLa cells, including the notable case against Thermo Fisher Scientific, center on the unauthorized use of Lacks's cells, taken without consent in 1951, which later became crucial in medical advancements such as vaccine development and cancer research. Despite their significant scientific contribution, the Lacks family was not compensated or acknowledged for decades. The legal actions, particularly against Thermo Fisher Scientific, focused on the ethical and legal issues surrounding the rights to profits from biological specimens obtained without consent, raising questions about informed consent and the commercial use of human biological materials. Although the settlement details with Thermo Fisher were not disclosed, these developments, alongside agreements with the NIH regarding the use of HeLa cells' genomic data, mark progress in recognizing the contributions of Henrietta Lacks and her family, as well as the importance of ethical considerations in biomedical research.

Further legal challenges continued with a lawsuit against Ultragenyx Pharmaceutical, Inc., filed on August 10, 2023, for unjust enrichment from the commercial use of HeLa cells, highlighting the ongoing concerns within the biopharmaceutical industry about the use of biological materials obtained without proper consent. The case against Ultragenyx, like the one against Thermo Fisher, underscores the broader implications for the industry, suggesting that other companies might also face similar claims due to the widespread use of HeLa cells and other biological materials acquired decades ago under outdated consent standards. These cases emphasize the evolving landscape of legal and ethical standards in biomedical research and the need for the industry to address the issues of consent, ownership, and compensation for biological materials.

Henrietta Lacks Story in Film and Media

In both the book "The Immortal Life of Henrietta Lacks" by Rebecca Skloot and its film adaptation, the story of Henrietta Lacks is brought to life, chronicling the journey of her cells, which became the first immortal human cell line, known as HeLa cells. These adaptations explore the groundbreaking contributions of HeLa cells to medical science alongside Lacks and her family's ethical dilemmas and personal narrative, emphasizing the intersection of scientific progress with individual rights and ethics.

The Ongoing Legacy

The controversy surrounding HeLa cells is a reminder of the ethical complexities that can arise at the intersection of scientific progress and human rights. While HeLa cells have left an indelible mark on medical science, Henrietta Lacks' story serves as a poignant reminder of the importance of ethical safeguards and respect for individuals in pursuing scientific knowledge. The legacy of HeLa cells continues to challenge us to navigate this delicate balance between progress and ethics.

HeLa cells quickly became a scientific sensation due to their remarkable ability to divide indefinitely. They were distributed to labs worldwide, leading to numerous scientific breakthroughs. However, the fact that these cells were derived from a human being without her consent raises profound ethical questions.