Standing athwart science, yelling "whoa,"* often appears to be the favorite default activity of many folks who get involved with bioethics. Today the New York Times has published an op-ed in this genre of bioethical handwringing. It's by Rebecca Skloot, author of the best-selling The Immortal Life of Henrietta Lacks. In her book, Skloot details the how cells taken in 1951 from a tumor that eventually killed Baltimore resident Henrietta Lacks became the first immortal human cell line and one of the most widely used in biomedical research. Lacks nor any of her relatives were asked for permission to use the HeLa cells derived from her cervical cancer for research.
The Lacks family first learned a bit about the HeLa cells when some were contacted in the 1970s by researchers for blood samples in an effort to figure out how to combat contamination of other cell cultures by the vigorously growing HeLa cells. After Skloot's book was published, the family sought more information and eventually negotiated an agreement in 2013 with the National Institutes of Health that essentially granted consent to continue to use the cells for research.
So what ethical violations did the Lacks family suffered as a result of the development of the HeLa cell line? Drawing blood in the 1970s from the family member participants without explanations that they would find adequate would certainly count. Otherwise? The genomic information of the HeLa cells has been published and is available. Is this an ethical violation? No. As I have long argued, genetic information about a person is not especially dangerous, occult or even interesting to most people:
While I have some sympathy for folks currently worried about their genetic privacy, I want to remind them that their genetic information is not some especially vital or dangerous kind of fact or knowledge about themselves. Such privacy regulations will needlessly reinforce unscientific notions of "genetic exceptionalism" among the public. And since the sorts of rules recommended by the commission have the habit of metastasizing into malignant bureaucracies (think here of HIPAA privacy regulations), I predict that most of us will regret adopting such a prohibition sooner rather than later.
Many years ago, I put my 23andMe genetic screening results online at SNPedia where they are regularly updated so that my friends and enemies can all find out what's genetically wrong (and right) with me. Consequences? None.
So what is Skloot advocating that has gotten me riled up? The government is proposing revisions to the Protection of Human Subjects rule that could possibly impose new and extensive consent requirements for using all sorts of biological samples derived from people. Skloot begins by asking readers if they want researchers to continue the practice of freely passing around cells derived from their bodies and the genetic information they contain? She then writes:
Tissues from millions of Americans are used in research without their knowledge. These "clinical biospecimens" are leftovers from blood tests, biopsies and surgeries. If your identity is removed, scientists don't have to ask your permission to use them. How people feel about this varies depending on everything from their relationship to their DNA to how they define life and death. Many bioethicists aren't bothered by the research being done with those samples — without it we wouldn't have some of our most important medical advances. What concerns them is that people don't know they're participating, or have a choice. This may be about to change. …
What's riding on this? Maybe the future of human health. We're in the era of precision medicine, which relies on genetic and other personal information to develop individualized treatments. Those advances depend on scientists working with vast amounts of human tissue and DNA.
So let's definitely get in the way of "the future of human health."
Back in 1990, the Calfornia Supreme Court ruled in the case of Moore v. Regents of the University of California that a patient did not own tissues and cells removed from his body as treatment for leukemia that were later used to create a lucrative cell line. In Moore's case, however, the researchers kept him coming back for blood tests over several years without telling him why. That is certainly unethical.
Since regulators must regulate (and bioethicists are generally quite enthusiastic supporters of regulation), perhaps the best we can hope for is what Skloot calls "broad consent":
When you show up to the doctor, you'd get a form saying, essentially, We want to store your tissues for future biomedical research; we can't tell you exactly what that research might involve, and you can't specify how your tissues are used. We may share your identity with other researchers, with privacy protections in place. And we may contact you for future research. Is that O.K.?
In other words, another worthless form attempting to enforce an alleged norm of genetic privacy that very few patients will bother to look at or will later care about.
So Yes. A thousand times Yes. It is O.K.!
Note: Did I mention that I wrote a book on the subject, Liberation Biology: The Scientific and Moral Case for the Biotech Revolution?
*William Buckley famously declared in National Review's 1955 mission statement that the magazine "stands athwart history, yelling Stop."