Ethics 2 : Issues in research on human tissues!

The times are hot for the area of ethics! What is ethics? This I discussed in an earlier post – but today I bring it up in another context! “The Immortal Life of Henrietta Lacks”  by Rebecca Skoot is about the life of the woman from whom the HeLa cell line was generated. She was an uneducated, poor black American woman who lived in the pre-segregation era and who would never have dreamed that she would become a household word in the world of biology.

Cell lines are immortalized cells, all of them identical, which can be grown ad noseum in the laboratory.  HeLa has the distinction of being the first cell line to be ever developed, in the early 1950s. Henrietta was in her mid-twenties and the mother of 4 children, the youngest only a year old, when she had her cervix biopsied at John Hopkins for suspected cancer. A piece of  this tissue was  sent to the research laboratory, where George Gey was trying to generate immortalized cell lines, without much success.  No one bothered to ask her for her permission or inform her that her tissues would be used for research. Henrietta underwent the radium implantation and the primitive radiation therapy, that was the standard of the time. She died in a few months after much suffering. Her husband was asked to give consent for an autopsy  and another piece of her tumor was taken for the research lab, again with no consent. And this was at one of the leading medical centres of the world and only a few years after the war. In 1947, the War Tribunal in Germany, had sentenced to death Nazi physicians who had conducted abominable experiments on Jews without consent. As a fall out, a Code of Ethics (The Nuremberg Code) for conduct of research on human subjects was put forth of which the first line was “The voluntary consent of the human subject is absolutely essential”. This was later adopted in 1948 as the Declaration of Geneva. However, these were recommendations without legal teeth and the Code continued to be violated for many years after. It was common practice in the US to use blacks and prisoners for all kinds of human experimentation well into the 60s.

The cells from Henrietta’s cancer tissue  grew and kept on growing and growing and are still growing in the millions in hundreds of labs across the world. There was only sporadic interest in the source of these cells, and for two decades the source was attributed to a Helen Lane – which was a deduction, as Hopkins did not reveal the identity. However, this too was violated and in the early 70’s  the real identity of the cell source became public, violating another principle of ethics. And it was around this time that the family became aware of the existence of the cell line. Victor McKusick, a pioneering world renowned human geneticist, went to collect blood samples of the family, in order to isolate their DNA and study the genetics of HeLa. Again, no one bothered to take any form of consent from any of them, although in 1966 National Institute of Health, which was funding McKusick’s study, had made it necessary for all researchers to do so.

Research using HeLa, and the many cell lines generated after, have helped us to understand how cells become cancerous, to develop vaccines and anti-cancer drugs and advance medical knowledge in innumerable ways. In the process it has created wealth for the companies that have grown and sold it.

In the years since then, a lot has changed regarding the use of humans for research. Independent “Institutional Review Boards” to oversee clinical research have become mandatory by law in most countries, as has the use of informed consent. However, the use of human tissue taken in the course of diagnosis or  treatment is more controversial. There is a strong lobby that claims that patients should have right to the tissues and that they should not be used for anything beyond the originally intended use without consent.  The scientist/pharmaceutical lobby feels that without access to human samples, scientific progress  will be stalled and drug development will suffer. US courts have dismissed many cases in which claimants wanted the right to their tissues. If there is indeed a drug discovered, do the tissue donors deserve a share of the profits? Since many tissues may be used, how will the profits be distributed?  This is a topic of heated debate and the  current status is that residual tissues/samples can be used for research if they are completely anonymized (that is totally delinked from the the donor).

Henrieta’s children grew up in poverty, with little education and as adults led difficult, marginal  lives with little or no access to health care. One does feel a sense of unfairness about the whole story, and the author is sympathetic to their cause throughout the book. She has set up a trust fund from proceeds from the book to educate the next generation of Lacks children. However, this cannot compensate for what the world owes to Henrietta Lacks!!

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