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Geneticists are excited by the prospect of new research made possible by linking genetic samples in these biobanks to clinical information contained in digitized medical records. This raises new privacy concerns. Some laboratories and biobanks have procedures that strip the identifiers from specimens, so that no one knows from whom they came. But linking those samples to the information contained in medical records databases, while scientifically useful, may erode some of the privacy safeguards that depend on biospecimens being truly anonymized. Ford recalls a researcher in Arizona who did an experiment on a 1,000-person public biodatabase that included genetic and clinical data on each person. “It was said to be de-identified,” Ford says—all identifiers stripped out. “That means it did not have to be approved by a review board and anybody could access it—detective, lawyer, whatever, OK?” The researcher took 50 entries selected at random and by cross-referencing the data with other public information was able to match a person’s name to 47 out of 50.
Medical and genetic records have long lives. Henrietta Lacks’ medical records were made public again as recently as September 2009 by the authors of an article that appeared in Archives of Pathology and Laboratory Medicine. One of those authors was Grover Hutchins, a professor of pathology at the School of Medicine.
AS GENETIC MEDICINE, genomic science, and bioengineering become bigger fields, they generate more opportunities for profit by commercial enterprises. The public understands that human biospecimens may be used by scientists purely for the advancement of knowledge and the development of new medical therapies, but they’re also used by business to generate profits; through technology transfer, they have the potential to generate profits for universities as well. Few reviews of The Immortal Life of Henrietta Lacks or stories about its author have failed to mention that while Johns Hopkins has never sold, licensed, or patented HeLa cells, a number of commercial firms have sold them and continue to do so, and none of the proceeds have ever gone to Henrietta’s descendants. There seems to be no precise accounting of how much money has been made from HeLa; the near-meaningless figure of “multi-millions” has been in circulation since publication of Skloot’s book. But the amount is assumed to be substantial. In the afterword, Skloot writes, “Today, tissue-supply companies range from small private businesses to huge corporations, like Ardais, which pays the Beth Israel Deaconess Medical Center, Duke University Medical Center, and many others an undisclosed amount of money for exclusive access to tissues collected from their patients.” Meanwhile, the public asks: If a corporation used my tissue sample—a piece of my body—to develop a product that now generates profits, why am I not entitled to a share of those profits?
Ethicists speak of a “common good model” in which tissue donors are not compensated because they donated pieces of themselves not in the hope of a future payday but to further science that contributes to the common good. In this model, the payoff is not in dollars but in better medicine that someday might cure your disease or repair your injury. All well and good, but two factors complicate the situation. The first is articulated by Faden: “The hitch with this vision, which ethically has so much to commend it, is the suppressed moral premise that everyone will benefit from the advances that will result from this shared agreement to let our biospecimens be used for science,” says Faden. “This vision of the shared public good presupposes that all of us really benefit, with the emphasis on all of us. So in the absence of guaranteed access to a decent level of medical care, the moral justification for that structure breaks down.” She adds, “One of the really tragic dimensions of the Lacks story is the fact that her children still experience enormous difficulty getting access to decent medical care.” Says Skloot, “The truth is, not everyone does benefit. The people who benefit are people with money. The people it doesn’t help are people like the Lackses, people who do not have money, minorities. People who historically have been hurt most by research done without their consent tend to be the ones who do not benefit.”
Second, a biotechnology company or pharmaceutical company does not operate for the common good; it operates to enrich its investors. That suggests a different equation. If your labor as an employee contributes to the company’s success, that company owes you a salary. Why doesn’t the company owe you if it developed a lucrative product from a piece of your body? And regardless of its contributions to the common good, were a nonprofit medical center to generate revenue from selling your cells to a corporation like Ardais, wouldn’t you be entitled to a share?
Researchers and ethicists understand the sentiment behind these questions, but they point out several complications. Ethicists warn of the commodification of human tissue and the dangers of creating a market for body parts, even the tiniest of body parts. Researchers note that Henrietta Lacks’ story—a scientific breakthrough of immense importance that derived from the cells of a single person—is extraordinarily rare. Most often, advances in biomedical research involve hundreds if not tens of thousands of biospecimens, many of which may have been collected five, seven, 10 years ago. (Almost 60 years ago if they’re HeLa.) How does a research center or a for-profit company track down all of those donors to pay a royalty or fee? Says Nichols, the Hopkins vice dean for education, “You can imagine a world in which the retrospective reporting and notification requirements become so onerous that one is not able to do science at all, and the potential benefits from discovery are withheld from future patients because science is forced to grind to a halt. On the other hand, patients have rights that have to be respected, particularly if there’s commercial value.” If the alternative is to pay for tissue samples at the time they are taken, in case someone might gain commercially from them in the future, will nonprofit research centers be able to afford large-scale studies? The public wants its privacy guaranteed. How do researchers or companies know whom to pay retroactively if identifiers have been stripped from every specimen used in their research? As yet no one knows the answers to these questions. One solution, says Dang, is for consent forms to include a waiver of rights to any financial benefits.