Henrietta Lacks: Ethics at the Intersection of Health Care and Biomedical Science

Dr. Ruth Faden

Dr. Ruth Faden

The 2011 Charles W. Bodemer Lecture was given by Dr. Ruth Faden, PhD, MPH, of the Johns Hopkins Berman Institute of Bioethics. Several NWABR staff attended and offer this account of the lecture, “Henrietta Lacks: Ethics at the Intersection of Health Care and Biomedical Science.”

Dr. Faden lectured in three segments:

  1. Relating the experience of Mrs. Henrietta Lacks and her children as chronicled in The Immortal Life of Henrietta Lacks by Rebecca Skloot. Faden is friends with Skloot, as she disclosed. Included in this segment: how HeLa cells came to be.
  2. Ethical considerations of consent and compensation raised by the story.
  3. Examination of the story through a social justice lens.

Note: We’ve bolded ethical questions below, for emphasis.

1. About Henrietta Lacks

A poor black woman, undereducated and living in Baltimore in the 1940s, Lacks had been living with her husband, Day (David) and her 5 children while hiding a great deal of abdominal pain. Finally in 1950 she asked Day to bring her to Johns Hopkins Hospital, the only regional hospital where African Americans could receive treatment. Diagnosed with cervical cancer in February 1951, she received cervical radiation, which was the gold standard treatment of the day, under general anesthesia.

The Immortal Life of Henrietta LacksOngoing research at Johns Hopkins by two doctors played a large part in the story: Dr. Richard TeLinde, head of gynecology and a cervical cancer expert, was researching whether different types of cervical cancer were interrelated. Dr. George Gey, head of tissue culture, had been trying for decades to grow an immortal cell line which could be used as a standard research tool. In their respective research pursuits, both Dr. TeLinde and Dr. Gey routinely used tissue samples which had been removed from patients who came to Hopkins for treatment. Henrietta Lacks was one of these patients.

Faden points out that the cervical tissue samples were not part of Mrs. Lacks cancer treatment and that in keeping with the practices of the time, Mrs. Lacks was never asked for permission. Dr. Gey was offered some of the tissue to contribute to efforts to grow the first human cells outside of the body (called tissue culture).

After just 3 weeks of trying to grow Mrs. Lacks’ cells in culture, it was clear to Dr. Gey that these cells would be the very first immortal human cells. In keeping with his system of using the first two letters of a patient’s first and last name, Dr. Gey labeled the cells “HeLa.”

Since that time these cells have made remarkable contributions to medicine including development of the polio, smallpox, and HPV vaccines, and cancer treatments, and over 80,000 medical publications. On October 4, 1951 Henrietta died without ever knowing the breakthroughs she helped provide.

Mrs. Lacks’ children and husband didn’t know that her cells were taken, bought, sold, and used — until 20 years later when her actual name was made public, without notifying her family, in the 1970’s.

Click here to view a slideshow from Skloot’s website, with photos from Lacks’ life.

Neither Johns Hopkins nor the doctors profited directly. In fact, Dr. Gey gave the cells internationally to anyone who wanted them. That isn’t to say that they did not benefit in recognition and professional reputation.

Other people have made money on HeLa cells. You can purchase them today from cell culture companies. The Lacks family never received compensation for the commercialization of HeLa cells. The family has remained poor and to this day has inconsistent health care insurance.

2. Ethical considerations still relevant today

Tissue donation is not hypothetical or a thing of the past. Anytime someone has an “opsy”—as in biopsy—or an “ectomy”—as in tonsillectomy, tissue is being removed from their body. What happens to that tissue once it has served its medical purpose of diagnosis or treatment? It can be discarded as medical waste or it can be used for research.

The 2011 Bodemer Lecture

Creation of biobanks or biorepositories — see our previous blog posts from the event, “Do You Know Where Your DNA Is?” on biobanks — from huge sets of human tissue samples, is creating great expectations of what scientists will be able to accomplish toward predicting, preventing, and personalizing medical breakthroughs. Breakthrough hopefuls include diagnostic tests and individualized treatments for chronic disease like diabetes and heart disease.

Should patient consent be obtained for research purposes if 1) once utilized for medical purposes, the tissue would be sent to medical waste anyway? if 2) extra tissue is taken solely for research purposes, as in the case of Mrs. Lacks?

Should patients re-consent every time their tissue is used for a different study? How can patients with tissues in biobanks consent to future research that has not yet been conceived?

Should people be compensated if anyone benefits from marketable products derived from the human body? How should people be informed about discoveries resulting from the use of their tissues?

Dr. Faden quickly moved to her passion — how to examine these ethical questions through the lens of social justice.

3. Social Justice is an important lens through which to examine the ethics of science

The Twin Aims Theory of social justice is 1) “improvement of human well being” and 2) “combating densely woven patterns that compromise multiple core elements of well being.” Faden listed the core components of well being and what she calls the Essential Elements of Well Being:

  1. Personal security
  2. Reasoning capacities with which to think about the world
  3. Respect of others as moral agents
  4. Health
  5. Affection and attachment
  6. Self-determination (the ability to exert some control over the path of one’s own life, free from the tyranny of other people or conditions)

Dr. Faden next introduced ‘counterfactuals’ otherwise known as “What If” statements:

What if 1) the Lacks family had received compensation? What if 2) Mrs. Lacks was an affluent white person with great health insurance? Would the story still raise questions about social justice? Dr. Faden argues YES.

Of course monetary compensation would have made a difference for the Lacks family; however, it would have done little to adjust for the systemic injustices of being poor and black. (Note from Faden: Cases where someone’s body is a source of commercial value are extremely rare. More often, medical discovery is the result of hundreds of thousands of specimens and data.)

If Henrietta Lacks had been white and wealthy, Faden feels that the systematic injustice of being “disrespected by biomedical research” likely would not have been different. Mrs. Lacks’ family was in the dark; in keeping with the practice at the time, Dr. Gey and Johns Hopkins did not tell them anything about the HeLa cells for twenty years (if you read the book, you’ll note that they only told her family because they accidently learned about it from a young Hopkins researcher who happened to be a distant cousin and was using the cells in his research. He put two and two together and realized the connection when he was visiting his family).

And this is what Faden means by lack of respect. Deborah, one of the Lacks children who is featured in the story, describes her worry about her mother’s cells and her inability to learn about what happened to the cells—and by association to her mother. This worry and insecurity is what causes disconnect, disrespect, and ultimately injustice.

Dr. Ruth Faden wrapped up her presentation with what may have been the most interesting examination — The Collective Action Problem of the current profit model that drives scientific discovery. Also called the Reciprocity Model, it acknowledges that even though I may not directly benefit my contribution and you may not directly benefit your contribution, our communal contributions may benefit each other.

researchmatch logoWithout communal action toward a common goal, the goal will not be realized. Advancing medical progress faces this problem. In medical research and biorepositories in particular there is need for a critical mass of people to donate tissue, blood, and health data. Not just any people—all people from all ethnic and racial backgrounds. Without access to many samples there will not be benefit for anyone. This was her call to public participation, the 4th “P” of P4 Medicine, as coined by Seattle’s Leroy Hood of the Institute for Systems Biology.

Do you want to participate in research? Sign up as a volunteer with ResearchMatch.org, an anonymous volunteer matching service funded by the National Center for Research Resources, part of the National Institutes of Health. Explore opportunities to donate blood and tissue for research. Participate in public dialogue about medical research and ethics.

Faden envisions a society in the near future without the expectation of monetary compensation for research participation, because we understand that medical progress will benefit everyone. Do you?

Charles W. Bodemer

Charles W. Bodemer

Who was Charles Bodemer and why have an annual lecture series?

Bodemer was the founder of the University of Washington School of Medicine, Department of Bioethics & Humanities, serving as chair from 1967 to 1985.

Bodemer “had a distinguished career as a research scientist before dedicating his energies to his other love: the history of medicine.”

For more, please see http://depts.washington.edu/bhdept/conedu/Bodemer.html.

A guide to “Do You Know Where Your DNA Is?”

Welcome to the event blog for “Do You Know Where Your DNA Is?” — a public forum on biomedical ethics hosted by the Northwest Association for Biomedical Research and CityClub Seattle on October 25, 2010.

The forum addressed issues of public trust and professional ethics in “biobanks” — large collections of biological samples and personal health information, also called “biorepositories.”

How should we govern biobanks? Can we trust them with our health information? How should donors provide consent? Will biobanks lead to medical progress?

These questions and others from the general public were addressed by our moderator, Gretchen Sorensen of Sorensen Ideas and three expert panelists:

Listen to or download recordings of the event (MP3): Part 1 | Part 2 or, see and read about the event below.

The most recent posts are listed at the top of this blog, so you might prefer to read up from the bottom:

This blog was written by Brian Glanz for NWABR with photos by Jeffrey Luke for CityClub Seattle.

Experts answer bioethics questions from the public

Sorensen asks for questions from the general public, and the first is from a CityClub charter member, Maryel Duzan. She asks about “the white coat problem” — described generally as biases and problems introduced by personal interaction with a doctor or scientist. Examples of the problem cited by Duzan are that some people don’t remember what they’ve been told, or feel personally compelled toward consent by this interaction.

Photo by Jeffrey Luke for CityClub Seattle

Duzan’s question, then is: As a potential solution to the white coat problem, has anyone considered using videos to establish understanding and consent in place of a one on one interaction?

Sewards notes that “We think of consent as an on-going process.” That is, they ensure participants have an on-going understanding and that forms stay updated.

Russell, for GAPPS describes that their study coordinators know the women across a long period of time, so there are a lot of questions back and forth.

Photo by Jeffrey Luke for CityClub Seattle

For GAPPS donors then, there is a lot of time to think about consent.

Edwards adds there are new consent forms with more options, with which you can opt into or out of different parts of the research.

Photo by Jeffrey Luke for CityClub Seattle

Still better, some of Edwards’ bioinformatics colleagues are working on a software interface with a question and answer experience on a computer. This is to lead you through the choices and help identify what you really want in terms of consent.

Next, writer Sally James from the Northwest Science Writers Association (@jamesian on Twitter) begins: “I find the definition of ‘informed’ to be really tricky right now. For those of us familiar with proteomics (the large-scale study of proteins, particularly their structures and functions) we can imagine: can anyone right now know the ramification of giving a DNA sample?

Photo by Jeffrey Luke for CityClub Seattle

We are on the cusp of learning so much more information, and things are changing so quickly, James summarizes: “Can anyone know what we’re consenting to?”

Edwards replies: “This is exactly why I wonder whether we’ve out grown the usefulness of classic consent. I think we’ve outrun the term ‘informed consent’. We don’t know all the risks and benefits with respect to genetic information. We’ve had a number of conferences with experts in the room … and we still cannot anticipate all the risks.”

Photo by Jeffrey Luke for CityClub Seattle

Edwards continues: “We should shift to consenting to a process … [such as] I agree to be a part of this bank, I understand there is a governing process, and if things change you will contact me again,” rather than committing to everything in the future at this one time.

Renee Delong, Regulatory Affairs Project Coordinator at Fred Hutchinson Cancer Research Center asked “What steps do you recommend to build public trust around biorepositories?”

Photo by Jeffrey Luke for CityClub Seattle

Delong added, “I believe in the promise of biorepositories,” while mentioning a recent New York Times article about use of the Internet as a sort of repository for patients with rare genetic disorders. These patients openly share symptoms and diaries online which researchers can then, also access.

Edwards replied that communication and being transparent, having accountability, and having systems in place to know where the data are are all essential to building trust. She also stressed that biobank experts don’t yet know all the answers and they are open to suggestions.

Edwards agreed that people are absolutely owed some results back, but noted that not everyone wants to known their own personal results. Many people just want to know how the research is going in general. Individual results may not be conclusive or relevant, but scientists can give back more in terms of general results.

To another question from Delong, Russell replies that GAPPS participant-donors can change their minds up until that specimen has been sent out for research. Samples left behind or not yet used can be destroyed, and donors can be given confirmation that it’s been done.

Sewards adds: Every consent form has the phone number of the reviewing IRB, and they would love to hear from more people! — http://www.washington.edu/research/hsd/

Wendy, a member of CityClub and not a scientist says: “I would donate blood for science. What is the parade of horribles?” i.e. what are people’s objections to doing the same? She continues, “I don’t understand what all the issues are. If data are anonymous what are people worried about?”

Sewards outlines: “We are concerned if someone’s genetic information is out there without enough safeguards. Say an employer or someone else may find data related to health test results, like a test for HIV, and that data could come back to hurt you.”

Photo by Jeffrey Luke for CityClub Seattle

Sewards particularly notes again that right now, DNA is seen as only identifiable with related and associated information, but what about five years from now?

Edwards adds: If you are a part of a clearly identifiable community such as by your ethnicity, there is also concern about research which could stigmatize your community. An example: whether a particular ethnicity is more inclined to commit crime. Perhaps you gave your blood to fight disease and it ends up being used in unintended ways, which are not personally, but socially disagreeable to you.

Ryan Luce, co-founder of Corengi asked whether there is a public health consideration which answers the privacy concerns of individuals.

Photo by Jeffrey Luke for CityClub Seattle

Edwards replied that some patient groups, especially want more data shared and publicly. Open data and more open access to data and research might bypass even institutions themselves. Some want the data available to anyone who might use it and make a breakthrough.

Russell noted that many of the women in GAPPS have no problem with data sharing but that GAPPS still feels the responsibility of that trust being placed in them. “We don’t want people to ever feel bad about what they did.”

Sorensen, our moderator offers one closing question: “We have an enormous opportunity to move research forward and transform medicine but must ensure the public trust. If engaging the public is the way to do it, how can the people here today get more involved?”

Edwards answers: Continue conversations like this one, join book groups, bring all of this up during dinner with friends.

Raise these issues and get people thinking about them. This is not straightforward, so we need more people thinking about it and we need more and different ideas. Jen Wroblewski and NWABR can help put book groups or other conversations together and Edwards and her colleagues at UW would love to have more public conversations — so get in touch, http://www.nwabr.org/about/contact.html and http://depts.washington.edu/bhdept/facres/kfe_bio.html.

Russell points to The Immortal Life of Henrietta Lacks by Rebecca Skloot, which tackles some of the ethical issues involved. NWABR has prepared a discussion guide which can be used personally or by anyone wanting to facilitate discussions — download it in PDF format, here.

Russell also mentions a recent article in Newsweek, “The Prematurity Puzzle – Research on early births could hold clues to disorders like autism and cerebral palsy.” Her advice is to read and engage in all of this.

Sewards concludes: contact your local representatives if you have any concerns. The rights of research subjects are codified by the federal government and we want to make sure you are aware of your rights!

Photo by Jeffrey Luke for CityClub Seattle

Read on below for the moderated panel discussion before public questions and answers, and see a guide to all posts on this blog, here. — Brian Glanz for NWABR

How are biorepositories best governed?

Sorensen asks the panel: “How are biorepositories best governed?”

Sewards answers first, describing that there are federal regulations which it is their job to implement. “We look at ‘gatekeeping’ in IRB-speak. Who is the researcher approaching, what are they collecting, where is it being placed, what are the security measures? What is the purpose of the repository? Who will have access and how do you keep track?”

In other words, they look from the beginning to the end of the process. They especially have many regulations related to whether data are stored and released with due respect to privacy.

Edwards answers that “It depends on the purpose of the biobank.” They often advocate for dynamic governing because research and our understanding is changing a lot, and because we are just starting into these areas historically speaking.

Edwards continues: some old tools like consent forms may now be outdated. You can tell people up front a certain amount or number of things, but you may need to get back in touch later when the research changes or more researchers want to be involved or do different things with the data or specimens. We need new and more flexible strategies for communications and data management, including personal interactions of participants with their own data and with the research in general.

Russell notes: “We have two IRBs plus a utilization committee looking at scientific validity. We are looking at ways of harmonizing across sites and forming some standard operating procedures, but we are also talking about the bioethics of all of it.” They are actively addressing these questions and do not feel they have it all figured out, yet.

Sorensen asks Sewards: “Who is on these IRBs?” and her answer: UW faculty, people from the community, students, lawyers — the full gamut of who makes up our society — as required by federal regulation. Scientific expertise is important but so is the general public component.

Photo by Jeffrey Luke for CityClub Seattle

Data collection and privacy

Edwards describes that there are a variety of decisions being made about how specimens are collected, how much information to keep, and on what are minimum standards of privacy and security in various areas.

She asks everyone in the room — do you know that you have, or do you think that you have, your own specimens or data in a biobank? About half the room raises a hand, many tentatively. Edwards then explains there are many ways our tissues or data are collected that we may not be aware of, even being collected at birth.

There are two trends in biobank privacy. In one, greater anonymization has led to stripping more personal identifiers from samples and data.

Another trend is in the opposite direction, though: in some repositories, a tight link is being kept between personal identifiers and a person’s samples and other data. Advocacy-based biobanks tend toward this trend.

The reasons include that people can manage and access their own data and larger medical and/or research profiles. In some cases, people can track the use of their data in research.

This latter trend is more complicated, ethically and practically, but it may also lead to greater benefits in science and in public understanding.

Russell notes that GAPPS enrolls women at their first pre-natal visit, not knowing who may end up with a pre-term birth or other relevant circumstance. This is a very expensive operation, but even so they spend a lot of time in education and in verifying that strict rules have been followed to collect enough and valid data.

Sewards then describes the issues in greater detail — when do you ask for consent? What does the consent form look like? A concern of hers is adding greater context to consent.

The public as a full partner in science

Russell advocates: “Get the public involved as a full partner in science.”

Then, they will push the science and the scientists faster and more directly toward practical solutions. There are times a scientist may want to focus on understanding how every part of a process works, but the public may be more interested in working directly on the solution, especially in biomedicine.

Russell says generally that there needs to be more open dialogue and interaction between scientists and the public for the greater good. “I think that’s the promise of biobanks” she says, noting simply that biobanks don’t exist without samples from the general public.

Photo by Jeffrey Luke for CityClub Seattle

Will large biobanks lead to breakthroughs?

Sorensen asks the panel: “Experts are claiming that large scale biobanks are going to lead to [scientific] breakthroughs. Is that true?”

Sewards replies first: Having different varieties of specimens and data together is very powerful, as is having one place researchers can go to get data. Greater variability and generalizability are the wins.

Edwards adds: For a while it seemed like everybody was starting their own repository, whether governments or institutions. Scaling up has benefits but do we really need to scale up in this way, or are we doing it in the best way over all, is there too much redundancy?

Edwards continues: Operating biobanks at larger scales creates larger scale ethical questions as well. Quality suffers with samples and data from repositories, in some cases, and even ethics quality can suffer. In one significant case, the State of Texas was required to destroy 5 million samples in a biobank due to a parents’ group lawsuit. The details of the case aside, its result was a scientific loss for everyone involved.

The biggest breakthrough we’ve seen is in cancer research — such as determining which chemo will work for which person. A lot of the biobanks forming now are specific to a single disease, such as autism.

Photo by Jeffrey Luke for CityClub Seattle

Introducing our panelists

Moderator Gretchen Sorensen introduces our panelists:

Kelly Edwards, PhD is Associate Professor, Department of Bioethics and Humanities at the University of Washington School of Medicine. Edwards is core faculty for the Institute for Public Health Genetics and the Critical Medical Humanities Research Cluster. For more, see her bio in the Department of Bioethics and Humanities.

Edwards describes the questions she helps others consider in her work as a bioethics consultant, often regarding biorepositories. Questions are sometimes  about recruitment and communications to potential recruits, such as “How should we handle consent?” Other questions surround data access, i.e. who has or should have access to data from the repository?

Shannon Sewards is Assistant Director for Operations, Human Subjects Division at the University of Washington. “What is ‘the human subjects division’ all about?” muses Sorensen, noting the intriguing name, before answering simply that it’s “anything that involves research on a person.” For further clarification we offer the following, from the division’s home page:

“Research involving human subjects must be reviewed and approved by an Institutional Review Board (IRB). At the UW, several IRB committees serve this function. The Human Subjects Division (HSD) provides administrative support and facilitates IRB review; assisting researchers throughout the process.”

Sewards describes that the role of IRBs is to be protective for the general public, while they can be a hindrance, relatively speaking for researchers.

Donna Russell, MHA is Director of Research Development and GAPPS at Seattle Children’s. GAPPS is the Global Alliance to Prevent Prematurity and Stillbirth, whose expanded mission includes maternal, newborn, and child health with a global scope.

Russell notes that GAPPS began because of the magnitude of the problem of pre-term birth, here in the U.S. and globally. 13 million pre-term births happen annually around the world, and 1 million of those are fatal. There are also 3 million still births.

That means there are more than ten times the number of still births as there are “SIDS” deaths. SIDS is relatively well publicized while still birth is not.

We still, fundamentally do not know what causes many of these deaths. The best strategy for solving the mystery is to link high quality specimens to descriptive data.

Therefore a cornerstone of GAPPS is their biorepository. They just started collecting data in the last year, after two years of preparation and addressing many of the issues we will discuss today.

A fundamental ethical question for GAPPS is that pregnant woman are a vulnerable population.

Photo by Jeffrey Luke for CityClub Seattle

Edwards, Russell, and Sewards are introduced by Sorensen

From reactive to proactive health

Our moderator is Gretchen Sorensen of Sorensen Ideas. Sorensen opens with a brief introduction: “There’s a revolution going on right now in biology and medicine, and Seattle is at the forefront of it,” citing examples not only in global health but in biomedicine generally.

The revolution is a shift from reactive to proactive in health and biomedical research. We are looking at genetics, the environment, and interactions between them and changing medicine for the future. Medicine is becoming more personal with increased understanding and accessibility of genomics. Patients and consumers are playing a key role, participating more in determining their own medical future.

Biobanks are more than libraries of flesh,” Sorensen declared, in response to some popular media descriptions of repositories. (CityClub blogger Sara Neppl clarified that Sorensen was quoting this Wired magazine article from June 2010 that referred to biobanks as “libraries of flesh.”)

Biobanks combine biological specimens of organs, blood, and so on with data about health and lifestyle. Combining all of this is very powerful but also requires that we proactively and comprehensively address issues of public trust and ethics in research. Today’s panel discussion is one more step in that effort.

Moderator Gretchen Sorensen introduces our topic:

Photo by Jeffrey Luke for CityClub Seattle