Vital (T)issues

In The Immortal Life of Henrietta Lacks journalist Rebecca Skloot tells the story of a poor Southern tobacco farmer who passed away in 1951, but lives on through her “immortal” cells. These HeLa cells have allowed countless medical advances and spawned multimillion-dollar industries, but have also raised troubling ethical questions, seen in the anguish inflicted upon Lacks’ family, who, having only learned about her unknowing contributions to science 20 years after her death, were forced to grapple with the ethical and emotional fallout. Though Lacks’ is the most famous of cases illustrating the need for tissue ownership regulations, others also have unwittingly donated cells. As Skloot explains in the book’s afterword, creating guidelines for tissue use is not ethically straightforward—and in the meantime the next Henrietta Lacks could be you.

Today most Americans have their tissue on file somewhere. When you go to the doctor for a routine blood test or to have a mole removed, when you have an appendectomy, tonsillectomy, or any other kind of ectomy, the stuff you leave behind doesn’t always get thrown out. Doctors, hospitals, and laboratories keep it. Often indefinitely.

In 1999 the RAND Corporation published a report (the first and, so far, last of its kind) with a “conservative estimate” that more than 307 million tissue samples from more than 178 million people were stored in the United States alone. This number, the report said, was increasing by more than 20 million samples each year.

[. . .] Scientists use these samples to develop everything from flu vaccines to penis-enlargement products. They put cells in culture dishes and expose them to radiation, drugs, cosmetics, viruses, household chemicals, and biological weapons, and then study their responses. Without those tissues, we would have no tests for diseases like hepatitis and HIV; no vaccines for rabies, smallpox, measles; none of the promising new drugs for leukemia, breast cancer, colon cancer. And developers of the products that rely on human biological materials would be out billions of dollars.

How you should feel about all this isn’t obvious. It’s not as if scientists are stealing your arm or some vital organ. They’re using tissue scraps you parted with voluntarily. Still, that often involves someone taking part of you. And people often have a strong sense of ownership when it comes to their bodies. Even tiny scraps of them. Especially when they hear that someone else might be making money off those scraps, or using them to uncover potentially damaging information about their genes and medical histories. But a feeling of ownership doesn’t hold up in court. And at this point no case law has fully clarified whether you own or have the right to control your tissues. When they’re part of your body, they’re clearly yours. Once they’re excised, your rights get murky.

[. . .] There are, essentially, two issues to deal with: consent and money. For most people, knowing if and how their tissues are being used in research is a far bigger issue than profiting from them. [. . .] The Federal Policy for the Protection of Human Subjects, also known as the Common Rule, requires informed consent for all human- subject research. But in practice, most tissue research isn’t covered because: (1) it’s not federally funded, or (2) the researcher never learns the identity of the “donors” or has firsthand contact with them, in which case it’s not considered research on humans. So in the end, the Common Rule doesn’t actually govern most tissue research.

[. . .] According to Judith Greenburg, director of the Division of Genetics and Developmental Biology at the National Institute of General Medical Science, the NIH [National Institutes of Health] now has “very stringent guidelines” requiring consent for any tissues collected for their banks. “It’s very important for donors to understand what the consequences of tissue research might be,” she says. But their guidelines apply only to NIH research, and they’re not legally binding.

Supporters of the status quo argue that passing new, tissue-specific legislation is unnecessary, and that the current oversight practices are enough. They point to institutional review boards; the many professional guidelines, like the American Medical Association’s Code of Ethics, (which requires doctors to inform patients if their tissue samples will be used in research or lead to profits); and several post-Nuremberg codes, including the Declaration of Helsinki and the Belmont Report, all of which list consent as a requirement. But guidelines and ethical codes aren’t laws, and many tissue-rights supporters say internal review doesn’t work.

Beyond simply knowing their tissues are being used in research, some tissue-rights activists believe donors should have the right to say, for example, that they don’t want their tissues used for research on nuclear weapons, abortion, racial differences, intelligence, or anything else that might run contrary to their beliefs. They also believe it’s important for donors to be able to control who has access to their tissues, because they worry that information gathered from tissue samples might be used against them.

[. . .][A] growing number of activists—ethicists, lawyers, doctors, and patients—are arguing cases and pushing for new regulations that would grant people the right to control their tissues. And a growing number of tissue “donors” are suing for control of their samples and the DNA inside them.

[. . .] David Korn, vice provost for research at Harvard University, argues that giving patients control over their tissues is shortsighted. “Sure,” he says, “consent feels nice. Letting people decide what’s going to happen with their tissue seems like the right thing to do. But consent diminishes the value of tissue.” To illustrate this, Korn points to the Spanish flu pandemic. In the 1990s, scientists used stored tissue samples from a soldier who died in 1918 to re-create the virus’s genome and study why it was so deadly, with hopes of uncovering information about the current avian flu. In 1918, asking that soldier’s permission to take tissues for this kind of future research would have been impossible, Korn says.

[. . .] For Korn, the consent issue is overshadowed by a public responsibility to science. “I think people are morally obligated to allow their bits and pieces to be used to advance knowledge to help others. Since everybody benefits, everybody can accept the small risks of having their tissue scraps used in research.” The only exception he would make is for people whose religious beliefs prohibit tissue donation. [. . .] But he acknowledges that people can’t raise those objections if they don’t understand their tissues are being used in the first place.

[. . .] If the issue of consent isn’t addressed, Robert Weir, founder of the biomedical ethics center at the University of Iowa, sees only one outcome: “Patients turns to law as a last resort when they don’t see their participation being acknowledged.” Weir favors fewer lawsuits and more disclosure. “Let’s get these things on the table and come up with legal guidelines we can all live with,” he says. “Because going to court is the only other option.”

Rebecca Skloot is a science writer whose work has appeared in The New York Times Magazine; O, The Oprah Magazine; Discover; and many other publications. She is the guest editor of The Best American Science Writing 2011, a contributing editor at Popular Science magazine, and has worked as a correspondent for WNYC’s Radiolab and PBS’s Nova ScienceNOW. The Immortal Life of Henrietta Lacks was published in February 2010 by Crown Books, a subsidiary of Random House. This article is a condensed version of the book’s afterword.