The Immortal Life of Henrietta Lacks (45 page)

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. The samples come from routine medical procedures, tests, operations, clinical trials, and research donations. They sit in lab freezers, on shelves, or in industrial vats of liquid nitrogen. They’re stored at military facilities,
the FBI, and the National Institutes of Health. They’re in biotech company labs and most hospitals. Biobanks store appendixes, ovaries, skin, sphincters, testicles, fat, even foreskins from most circumcisions. They also house blood samples taken from most infants born in the United States since the late sixties, when states started mandating the screening of all newborns for genetic diseases.

And the scale of tissue research is only getting bigger. “It used to be, some researcher in Florida had sixty samples in his freezer, then another guy in Utah had some in his,” says Kathy Hudson, a molecular biologist who founded the Genetics and Public Policy Center at Johns Hopkins University and is now chief of staff at NIH. “Now we’re talking about a massive, massive scale.” In 2009 the NIH invested $13.5 million to develop a bank for the samples taken from new borns nationwide. A few years ago the National Cancer Institute started gathering what it expects will be millions of tissue samples for mapping cancer genes; the Genographic Project began doing the same to map human migration patterns, as did the NIH to track disease genes. And for several years the public has been sending samples by the millions to personalized DNA testing companies like 23andMe, which only provide customers with their personal medical or genealogical information if they first sign a form granting permission for their samples to be stored for future research.

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.

Kathy Hudson, who has conducted focus groups about the public’s feelings on the tissue issue, says she believes that tissue rights have the potential to become a bona fide movement.

“I could see people starting to say, ‘No, you can’t take my tissues,’ “ she told me. “All I can say is, we better deal with the problems now instead of waiting until that happens.”

     
T
here 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. Yet when this book went to press, storing blood and tissues for research did not legally require informed consent, because the law governing such things doesn’t generally apply to tissue research.

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: (i) 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.

Today, if doctors want to gather tissues from patients strictly for research purposes—as in Henrietta’s case—they are required to get
informed consent. But storing tissues from diagnostic procedures like, say, mole biopsies, and using them in future research doesn’t require such consent. Most institutions still choose to get permission, but there’s no uniformity in the way that’s done. A few hand out enough information to fill a small book, explaining exactly what will be done with all patient tissues. But most just include a short line in an admission form saying that any tissues removed may be used for education or research.

According to Judith Greenburg, director of the Division of Genetics and Developmental Biology at the National Institute of General Medical Science, the NIH 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.

In 2005, members of the Native American Havasupai Tribe sued
Arizona State University after scientists took tissue samples the tribe donated for diabetes research and used them without consent to study schizophrenia and inbreeding. Their case is still pending. In 2006, some seven hundred new mothers found out that doctors had taken their placentas without consent to test for abnormalities that might help the hospital defend itself against future lawsuits over birth defects. And in a handful of cases, genetic tests performed on people without their consent have been used to deny workers’ compensation or health insurance claims (something now protected against by the Genetic Information Nondiscrimination Act of 2008).

Because of cases like these, 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. In 2005, six thousand patients demanded that Washington University remove their tissue samples from its prostate-cancer bank. The university refused, and the samples were tied up in litigation for years. So far, two courts have ruled against the patients, relying on the same logic used in the Moore case (that giving patients those rights would inhibit research, etc). In 2008 the patients appealed to the Supreme Court, which refused to hear their case. When this book went to press, they were contemplating class action. Most recently, in July 2009, parents in Minnesota and Texas sued to stop the nationwide practice of storing and conducting research—without consent—on fetal blood samples, many of which can be traced back to the infants they came from. They argue that research on those samples is an invasion of their children’s privacy.

Because of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, there is now clear federal law in place to prevent the kind of privacy violation that happened to the Lacks family when doctors at Hopkins released Henrietta’s name and her medical records. Since tissues connected to their donors’ names are subject to strict regulation under the Common Rule, samples are no longer named using donor initials as Henrietta’s cells were; today they’re usually identified
by code numbers. But, as Judith Greenburg of the NIH says, “It’s never possible to one-hundred-percent guarantee anonymity, because in theory we can now sequence genes and find out who anyone is from their cells. So the consent process has to be more about laying out the risks of tissue research so people can decide whether they want to participate.”

Ellen Wright Clayton, a physician and lawyer who is director of the Center for Biomedical Ethics and Society at Vanderbilt University, says there needs to be a “very public conversation” about all of this. She says, “If someone presented a bill in Congress that said, ‘As of today, when you go to the doctor for health care, your medical records and tissue samples can be used for research and nobody has to ask you’—if the issue were stated that bluntly so people could really understand what’s happening and say they’re okay with it, that would make me more comfortable with what we’re currently doing. Because what’s happening now is not what people think is going on.”

Lori Andrews, director of the Institute for Science, Law and Technology at the Illinois Institute of Technology, wants something more drastic: she has called for people to get policymakers’ attention by becoming “conscientious objectors in the DNA draft” and refusing to give tissue samples.

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. “It was an inconceivable question—no one even knew what DNA was!”

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. “If somebody says being buried without all their pieces will condemn them to wandering forever because they can’t get salvation, that’s legitimate, and people should respect it,” Korn says. But he acknowledges that people can’t raise those objections if they don’t understand their tissues are being used in the first place.

“Science is not the highest value in society,” Andrews says, pointing instead to things like autonomy and personal freedom. “Think about it,” she says. “I decide who gets my money after I die. It wouldn’t harm
me
if I died and you gave all my money to someone else. But there’s something psychologically beneficial to me as a living person to know I can give my money to whoever I want. No one can say, ‘She shouldn’t be allowed to do
that
with her money because
that
might not be most beneficial to society’ But replace the word
money
in that sentence with
tissue
, and you’ve got precisely the logic many people use to argue against giving donors any control over their tissues.”

Wayne Grody, director of the Diagnostic Molecular Pathology Lab oratory at the University of California, Los Angeles, was once a fierce opponent of consent for tissue research. But after years of debating people like Andrews and Clayton, he’s become more moderate. “I’m pretty convinced that we should go the extra mile to have a good and complex consent process,” he told me. Still, he can’t imagine how it would work. “These tissues enter a pipeline of millions of other samples,” he said. “How are you going to distinguish, well, this patient said we can study colon cancer; the next one said we can do anything we want, but we can’t commercialize it. I mean, do they all have to be color-coded?” Regardless, Grody stresses that questions of consent should apply only to the collection of future samples, not the millions already stored, including HeLa. “What are we going to do,” he says, “throw them all out?”

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 turn 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.” And court is where these cases often end up, particularly when they involve money.

     
W
hen it comes to money, the question isn’t
whether
human tissues and tissue research will be commercialized. They are and will continue to be; without commercialization, companies wouldn’t make the drugs and diagnostic tests so many of us depend on. The question is how to deal with this commercialization—whether scientists should be required to tell people their tissues may be used for profit, and where the people who donate those raw materials fit into that marketplace.