Coerced consent is a sucker’s game

Western culture has a slightly different take on the rights of the individual versus the rights of society, compared to some of the more conservative Eastern cultures. Our culture believes that the individual’s rights may not be trampled under to serve the welfare of society. Each of us has inalienable rights that may not ignored - not unless we give our informed consent.

Aha.  That is the crucial distinction.  If you volunteer your body, your life, any part of you, because you are a generous and altruistic person looking to do something for your fellow man, that informed consent is something we can all applaud, appreciate and encourage.  But what if you got “volunteered” without your knowledge or understanding?  Do the ends justify the means?

Way back after the end of the second World War, civilized nations got together and became signatories to the Helsinki Declaration.  In brief, this important human rights declaration said clinical trials using human subjects cannot - must not - be conducted without the informed consent of the human subjects participating in them. If you are a reader of history you will readily understand the need for this declaration at that dark moment in our recent past.  Good intentions (?!) of the doctors conducting clinical trials at concentration camps was not the issue.  They had no right to do their research, not when the subjects were prisoners that did not have a say in the matter. The ends do not justify the means.

HeLa Cells: The Lady Who Saved Thousands of Lives

Ever since I took up this peculiar hobby of reading hematology and oncology journals, I have come across citations of “HeLa cell lines” thousands of times. This cell line is the work-horse in thousands of lab studies, including leukemia research. I did not know then what I know now.  “HeLa” stands for “Henrietta Lacks” - a very real cancer patient who lived and died 50 years ago under tragic circumstances. There is a fascinating article about her life and death and how her legacy lives on today in every cancer research lab in this country and elsewhere. Below is the link and several excerpts.

A Lasting Gift to Medicine That Wasn’t Really a Gift

By DENISE GRADY

New York Times

Published: February 1, 2010

Fifty years after Henrietta Lacks died of cervical cancer in the “colored” ward at Johns Hopkins Hospital, her daughter finally got a chance to see the legacy she had unknowingly left to science.

The story began in January 1951, when Mrs. Lacks was found to have cervical cancer. She was treated with radium at Johns Hopkins, the standard of care in that day, but there was no stopping the cancer. Her doctor had never seen anything like it. Within months, her body was full of tumors, and she died in excruciating pain that October. She was 31 and left five children, the youngest just a year old. She had been a devoted mother, and the children suffered terribly without her.

Neither Mrs. Lacks nor any of her relatives knew that doctors had given a sample of her tumor to Dr. George Gey, a Hopkins researcher who was trying to find cells that would live indefinitely in culture so researchers could experiment on them. Before she came along, his efforts had failed. Her cells changed everything: they multiplied like crazy and never died.

A cell line called HeLa (for Henrietta Lacks) was born. Those immortal cells soon became the workhorse of laboratories everywhere. HeLa cells were used to develop the first polio vaccine, they were launched into space for experiments in zero gravity and they helped produce drugs for numerous diseases, including Parkinson’s, leukemia and the flu. By now, literally tons of them have been produced.

Dr. Gey did not make money from the cells, but they were commercialized. Now they are bought and sold every day the world over, and they have generated millions in profits.

The Lacks family never got a dime. They were poor, with little education and no health insurance, and some had serious physical or mental ailments. But they didn’t even know that tissue had been taken or that HeLa cells even existed until more than 20 years after Mrs. Lacks’s death. And they found out only by accident.

When they learned that their mother’s cells had saved lives, the family felt proud. But they also felt confused, a bit frightened, used and abused. It had never occurred to anyone to ask permission to take their mother’s tissue, tell them that her cells had changed scientific history or even to say thank you. And certainly no one had ever suggested that they deserved a share of the profits.

Some of the Lackses later gave blood to Hopkins researchers, thinking they were being tested for cancer, when really the scientists wanted their genetic information

The bounds of fairness, respect and simple courtesy all seem to have been breached in the case of the Lacks family. The gulf between them and the scientists — race, class, education — was enormous and made communication difficult.

Patients today don’t really have any more control over removed body parts than Mrs. Lacks did. Most people just obediently sign the forms.

Which is as it should be, many scientists say, arguing that Mrs. Lacks’s immortal cells were an accident of biology, not something she created or invented, and were used to benefit countless others. Most of what is removed from people is of no value anyway, and researchers say it would be too complicated and would hinder progress if ownership of such things were assigned to patients and royalties had to be paid.

So far, the courts have sided with scientists, even in a case in the 1980s in which a leukemia patient’s spleen and other tissues turned out to be a biomedical gold mine — for his doctor. The patient, John Moore, sued his doctor after discovering that the doctor had filed for a patent on his cells and certain proteins they made, and had created a cell line called Mo with a market value estimated at $3 billion. Mr. Moore ultimately lost before the California Supreme Court.

What Say You?

This issue is not going to go away. Researchers and patient advocates like me can “sell” clinical trial volunteerism all we want.  But unless and until you decide what you want to do, the process cannot move forward.  Without your informed consent the process should not go forward. No one thought to ask Henrietta or her family for permission to use her biological samples in research. The same lack of respect for individual rights permeats much of our research culture today.  There is a severe lack of RESPECT.

How many researchers bother to thank the patients who volunteered in their clinical trials?

I raised this question with my absolute favorite top-of-the-list-good-guys at a Mayo Clinic symposium a couple of years ago. To my surprise and chagrin, I got shot down!  Thank the patients?! What a bizarre and outlandish idea!  Never been done! Researchers thank funding agencies, colleagues that participated in the work, statisticians that put the right perspective (Ahem. Dare I say ‘spin’?) on the results, the lady down the hall that did the manuscript typing.  But who stops to thank patients? Next thing you know some of the more uppity patients will be asking to have some say in their own health-care.

Thank you, Mrs Henrietta Lacks.  Please accept the belated but sincere thanks of your fellow cancer patients.