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BLOG biotech : Mar 2, 2010
Informed Consent or Not, Tissue Donors Do Not Have Commercial Rights
A poor African-American tobacco farmer from Virginia, named Henrietta Lacks, is the subject of Rebecca Skloot's new book, The Immortal Life of Henrietta Lacks (Crown, February 2010). Lacks died in 1951 from cervical cancer at the age of 30, leaving behind five children and her husband. Without her knowledge or her families’ knowledge, Lacks' doctor had removed tissue from her tumor for the purpose of his scientific research on maintaining human cells in culture. At that time, no one had successfully grown human cells in the laboratory.
Lacks’ cancer cells surprisingly had the ability to grow in culture in the lab, and over time an immortal cell line named HeLa for Henrietta Lacks was generated. Prior to the HeLa cell line no human cells had ever been cultured for any meaningful period of time in the lab. Today, there are many cell lines from many organisms available for scientific research (e.g., from humans, monkeys, mice, etc.). HeLa cells have been used during some key discoveries in the 20th century, for example, they were used to test the polio vaccine and over the years have been used to screen for potential cancer drugs and many other medical technologies and therapies.
According to Skloot, the company Microbiological Associates, which became a part of Life Technologies and BioWhittaker, was the initial supplier of HeLa cells to the scientific research community. However, it appears that until the 1970s, the Lacks family had no knowledge that their mother/wife/sister’s cells were being used for research and commercial purposes.
While it is human nature to view the issue of whether taking Lacks’ cells and using them for scientific endeavors was proper with the benefit of current knowledge and legal principles on the issue, it is improper to apply modern-day ethical standards to an event that occurred 60 years ago. Since that time period (early 1950s) both the U.S. and international medical communities have put guidelines in place to protect people who take part in clinical research.
Certain key events occurred in the 1940s through to the 1960s that led to informed consent guidelines that exist today. In 1947, in response to the Nuremberg Trials of Nazi doctors who performed unthinkable experiments on prisoners of war in concentration camps, the Nuremberg Code was developed to provide a code of ethics for clinical research.
In the 1940s, black males, many of whom were incarcerated, became part of a study on syphilis in what was referred to as the Tuskegee Syphilis Study. Many of the subjects were unaware of their disease and denied treatment even though treatment was available by 1947. Over the next 20 years research practices and policies were put in place to create fair and ethical medical procedures worldwide, which included a requirement that individuals be informed of the risks of procedures and require that they give their consent.
Patients’ tissues are typically considered medical waste after they are removed in a hospital setting (e.g., after surgery). Cells and cell lines including the HeLa cells can be considered research tools, however, the value of such cells is actually downstream in the final products produced as a result of using the cells. Does the donor of cells have a right to these downstream products that are made using the cellular starting material? Isn’t the value created by using the cells as “factories” to produce a final product that has commercial and therapeutic importance (e.g., insulin, growth hormone)?
This issue of who “owns” the cells or has rights to products produced by donated cells was decided in 1990 when cells from a leukemia patient named John Moore were grown and developed into a cell line. Moore v. Regents of the University of California was a landmark Supreme Court of California decision that dealt with the issue of property rights in one's own body parts. John Moore underwent treatment for hairy cell leukemia at the UCLA Medical Center under the supervision of Dr. David W. Golde. Moore's cancer cells were developed into a cell line that was later commercialized. The California Supreme Court ruled that Moore had no right to any profits gained from the commercialization of his cancer cells.
Skloot makes a point of noting that the fact that the Lacks family never knew what scientists were doing with Henrietta's cells is a critical part of the story. She explains that science and medicine must be open and honest with patients. However, it appears that Skloot and others are imposing modern-day thinking on bioethics and scientific research to events that occurred in the 1950s when researchers were desperately trying to find human cells that could be grown in culture. Skloot repeats several times that the Lacks family not only did not know about the valuable products that had been produced as a result of research using HeLa cells, but they never received any revenues from such products, and, in fact, many of them had no way to afford health insurance.
There is no doubt that growing human cells in culture was a significant step forward in scientific research, and Mrs. Lacks’ cells afforded researchers the first opportunity to study the requirements for cell culture in the laboratory. However, providing a portion of any profits gained based on the use of such cells to her family would be analogous to “reach-through” rights, which have been the subject of several legal cases in the past decade. Companies that sell cell lines today do not require the purchaser to pay them back a royalty or portion of revenues on any product derived from use of the cell line—this would be considered a reach-through right, which is prohibited. The cell line is considered a tool, or a means to obtaining a useful end product, but a supplier of the cells has not created or invented the final commercially viable product. It is important to understand that even if Mrs. Lacks had given consent to use her cells for scientific discovery, it is unlikely that she or her heirs would have benefited from profits realized on products discovered using her cells years later.
Lisa A. Haile, J.D., Ph.D. (firstname.lastname@example.org) is a partner at DLA Piper LLP U.S. and co-chair of the firm’s Global Life Sciences Sector Group. Web: www.dlapiper.com/lisa_haile. Twitter: @dnajd.
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