In 1890 a man sold the rights to his body after death to the Royal Caroline Institute in Sweden for research purposes. Later, he tried to return the money and cancel the contract. In the subsequent lawsuit, the court held that he must turn his body over to the Institute and also ordered him to pay damages for diminishing the worth of his body by having two teeth removed.
Today, it would be an anathema for a person’s body to be used against his wishes or for a research subject not to be allowed to withdraw from a study. In fact, the Uniform Anatomical Gift Act allows people to change their minds and withdraw a previous agreement to donate organs and tissue after their death and the Federal research regulations allow people to withdraw from studies without penalty or loss of benefits. Yet the law is murky regarding research on a person’s tissue outside of his body and some modern doctors and researchers emulate the Royal Carolina Institute and stake their claims on materials from people’s bodies.
In 1951, a 31-year-old African-American woman, Henrietta Lacks, died of ovarian cancer. Without the knowledge or consent of Lacks or her family, her tissue was taken and made into a cell line that has been extremely valuable for research and is still sold today. In an interview in 1994, her husband said, “As far as them selling my wife’s cells without my knowledge and making a profit — I do not like that at all. They are exploiting both of us.”
Dorothy Nelkin and I wrote about Henrietta in our 2000 book, Body Bazaar: The Market for Human Tissue in the Biotechnology Age. Over the past decade, journalist Rebecca Skloot probed more deeply. In The Immortal Life of Henrietta Lacks, Skloot tells a moving story of how the unauthorized use of Henrietta’s cells (known to scientists as HeLa cells) provided the foundation for most modern medical discoveries. I caught up with Rebecca Skloot on her whirlwind book tour when she spoke at the Northwestern Medical School.
She described how Henrietta’s cells formed the basis for much of the scientific enterprise across the world in the decades since her death. Virtually every high school biology student, every medical student, and every vaccine maker has manipulated her cells. While fortunes have been made on the foundation of the HeLa cells, her own children lacked access to education and basic health care. In fact, when her children were contacted decades after her death by researchers wanting their tissue, they completely misunderstood what scientists meant by research on their mother’s cells. They visualized their mother as still alive, in a cell, being researched upon.
But they are not the only people kept in the dark about tissue research. How many people realize that their tissue is being used today without their knowledge and consent? Over 282 million archived and identifiable pathological specimens from more than 176 million individuals are being stored in United States repositories. Some specimens are anonymized or coded and not identified with specific individuals; others carry patient names or codes that allow personal identification. Virtually everyone has his or her tissue “on file.”
Expanding markets have increased the value of this tissue, and institutions — hospitals, research laboratories, and the state and federal repositories that store tissue samples — find they possess a capital resource. Medical centers have deals in place with biotech companies to do genetic research on their hospital patients’ tissue without the patients’ permission.
This lackadaisical approach to consent has recently been called in question. A Native American group, the Havasupai, gave tissue to a scientist for research on diabetes. Instead, the scientist undertook research about schizophrenia and in-breeding, which stigmatized the Havasupai, and research about geographical origins, which conflicted with the Havasupai’s religious beliefs.
When the researcher was challenged in federal court, the judge found that the Havasupai had asserted valid claims for intentional infliction of emotional distress, negligent infliction of emotional distress, civil rights violations, negligence and gross negligence. In April 2010, the researcher’s university settled with the Havasupai, paying $700,000 to 41 members of the tribe for using their tissue without appropriate informed consent.
The attention being paid to Skloot’s excellent book and the good news of a settlement in the Havasupai case are spurring societal discussion about the use of tissue samples. Clear laws and regulations are needed to assure that no one’s tissue is used without specific informed consent.
The specifics of Henrietta Lacks saga will soon be made into a movie, with Oprah as an executive producer. But her story affects us all. Hospitals, universities, research centers, and private depositories retain pathology samples and genetic data collected in the course of surgical procedures or research projects — a fact unknown to most patients. New laws are needed to make sure we are not a nation of guinea pigs.