The Immortal Life Of Henrietta Lacks Part 40

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. 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 ident.i.ty 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 inst.i.tutions 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 Inst.i.tute 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 pa.s.sing new, tissue-specific legislation is unnecessary, and that the current oversight practices are enough. They point to inst.i.tutional review boards; the many professional guidelines, like the American Medical a.s.sociation'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 cla.s.s 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 partic.i.p.ate."

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 n.o.body 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 Inst.i.tute for Science, Law and Technology at the Illinois Inst.i.tute 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 ill.u.s.trate 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 sc.r.a.ps 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 Laboratory 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 partic.i.p.ation 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.

When 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.

It's illegal to sell human organs and tissues for transplants or medical treatments, but it's perfectly legal to give them away while charging fees for collecting and processing them. Industry-specific figures don't exist, but estimates say one human body can bring in anywhere from $10,000 to nearly $150,000. But it's extremely rare for individual cells from one person to be worth millions like John Moore's. In fact, just as one mouse or one fruit fly isn't terribly useful for research, most individual cell lines and tissue samples aren't worth anything on their own. Their value for science comes from being part of a larger collection.

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.

"You can't ignore this issue of who gets the money and what the money is used for," says Clayton. "I'm not sure what to do about it, but I'm pretty sure it's weird to say everybody gets money except the people providing the raw material."

Various policy a.n.a.lysts, scientists, philosophers, and ethicists have suggested ways to compensate tissue donors: creating a Social Securitylike system in which each donation ent.i.tles a person to increasing levels of compensation; giving donors tax write-offs; developing a royalty system like the one used for compensating musicians when their songs are played on the radio; requiring that a percentage of profits from tissue research go to scientific or medical charities, or that all of it be funneled back into research.

Experts on both sides of the debate worry that compensating patients would lead to profit-seekers inhibiting science by insisting on unrealistic financial agreements or demanding money for tissues used in noncommercial or nonprofit research. But in the majority of cases, tissue donors haven't gone after profits at all. They, like most tissue-rights activists, are less concerned about personal profits than about making sure the knowledge scientists gain by studying tissues is available to the public, and to other researchers. In fact, several patient groups have created their own tissue banks so they can control the use of their tissues and the patenting of discoveries related to them, and one woman became a patent holder on the disease gene discovered in her children's tissues, which lets her determine what research is done on it and how it's licensed.

Gene patents are the point of greatest concern in the debate over ownership of human biological materials, and how that ownership might interfere with science. As of 2005-the most recent year figures were available-the U.S. government had issued patents relating to the use of about 20 percent of known human genes, including genes for Alzheimer's, asthma, colon cancer, and, most famously, breast cancer. This means pharmaceutical companies, scientists, and universities control what research can be done on those genes, and how much resulting therapies and diagnostic tests will cost. And some enforce their patents aggressively: Myriad Genetics, which holds the patents on the BRCA1 and BRCA2 genes responsible for most cases of hereditary breast and ovarian cancer, charges $3,000 to test for the genes. Myriad has been accused of creating a monopoly, since no one else can offer the test, and researchers can't develop cheaper tests or new therapies without getting permission from Myriad and paying steep licensing fees. Scientists who've gone ahead with research involving the breast-cancer genes without Myriad's permission have found themselves on the receiving end of cease-and-desist letters and threats of litigation.

In May 2009 the American Civil Liberties Union, several breast-cancer survivors, and professional groups representing more than 150,000 scientists sued Myriad Genetics over its breast-cancer gene patents. Among other things, scientists involved in the case claim that the practice of gene patenting has inhibited their research, and they aim to stop it. The presence of so many scientists in the suit, many of them from top inst.i.tutions, challenges the standard argument that ruling against biological patents would interfere with scientific progress.

Lori Andrews, who has worked pro bono on all of the most important biological ownership cases to date, including the current breast cancer gene suit, says that many scientists have interfered with science in precisely the way courts always worried tissue donors might do. "It's ironic," she told me. "The Moore court's concern was, if you give a person property rights in their tissues, it would slow down research because people might withhold access for money. But the Moore decision backfired-it just handed that commercial value to researchers." According to Andrews and a dissenting California Supreme Court judge, the ruling didn't prevent commercialization; it just took patients out of the equation and emboldened scientists to commodify tissues in increasing numbers. Andrews and many others have argued that this makes scientists less likely to share samples and results, which slows research; they also worry that it interferes with health-care delivery.

There is some evidence to support their claim. One survey found that 53 percent of laboratories had stopped offering or developing at least one genetic test because of patent enforcement, and 67 percent felt patents interfered with medical research. Because of patent licensing fees, it costs $25,000 for an academic inst.i.tution to license the gene for researching a common blood disorder, hereditary haemochromatosis, and up to $250,000 to license the same gene for commercial testing. At that rate, it would cost anywhere from $46.4 million (for academic inst.i.tutions) to $464 million (for commercial labs) to test one person for all known genetic diseases.

The debate over the commercialization of human biological materials always comes back to one fundamental point: like it or not, we live in a market-driven society, and science is part of that market. Baruch Blumberg, the n.o.bel Prize-winning researcher who used Ted Slavin's antibodies for hepat.i.tis B research, told me, "Whether you think the commercialization of medical research is good or bad depends on how into capitalism you are." On the whole, Blumberg said, commercialization is good; how else would we get the drugs and diagnostic tests we need? Still, he sees a downside. "I think it's fair to say it's interfered with science," he said. "It's changed the spirit." Now there are patents and proprietary information where there once was free information flow. "Researchers have become entrepreneurs. That's boomed our economy and created incentives to do research. But it's also brought problems, like secrecy and arguments over who owns what."

Slavin and Blumberg never used consent forms or ownership-transfer agreements; Slavin just held up his arm and gave samples. "We lived in a different ethical and commercial age," Blumberg said. He imagines patients might be less likely to donate now: "They probably want to maximize their commercial possibilities just like everyone else."

All the important science Blumberg has done over the years depended on free and unlimited access to tissues. But Blumberg says he doesn't think keeping patients in the dark is the way to get that access: "For somebody like Ted who really needed that money to survive, it would have been wrong to say scientists could commercialize those antibodies, but he couldn't. You know, if someone was going to make money off his antibodies, why shouldn't he have a say in that?"

Many scientists I've talked to about this issue agree. "This is a capitalist society," says Wayne Grody "People like Ted Slavin took advantage of that. You know, the way I see it is, if you think of doing that on the front end, more power to you."

The thing is, people can't "think of doing that on the front end" unless they know their tissues might be valuable to researchers in the first place. The difference between Ted Slavin, John Moore, and Henrietta Lacks was that someone told Slavin his tissues were special and that scientists would want to use them in research, so he was able to control his tissues by establishing his terms before anything left his body. In other words, he was informed, and he gave consent. In the end, the question is how much science should be obligated (ethically and legally) to put people in the position to do the same as Slavin. Which brings us back to the complicated issue of consent.

Just as there is no law requiring informed consent for storing tissues for research, there is no clear requirement for telling donors when their tissues might result in profits. In 2006 an NIH researcher gave thousands of tissue samples to the pharmaceutical company Pfizer in exchange for about half a million dollars. He was charged with violating a federal conflict of interest law, not because he failed to disclose his financial interest or the value of those tissues to the donors, but because federal researchers aren't allowed to take money from pharmaceutical companies. His case resulted in a congressional investigation and later a hearing; the possible interests of the patients, and their lack of knowledge of the value of their samples, wasn't mentioned at any point in the process.

Though the judge in the John Moore case said patients must be told if their tissues have commercial potential, there was no law enacted to enforce that ruling, so it remains only case law. Today the decision to disclose this information is up to the inst.i.tution, and many choose not to tell patients. Some consent forms don't mention money at all; others come right out and say, "We may give or sell the specimen and certain medical information about you." Others simply say, "You will receive no reimburs.e.m.e.nt for donating tissue." Still others embrace confusion: "Your sample will be owned by [the university]. ... It is unknown whether you will be able to gain (partic.i.p.ate in) any financial compensation (payment) from any benefits gained from this research."

Tissue-rights activists argue that it's essential to disclose any potential financial gain that might come from people's tissues. "This isn't about trying to get patients a cut of the financial action," says Lori Andrews. "It's about allowing people to express their desires." Clayton agrees, but says, "The fundamental problem here isn't the money; it's the notion that the people these tissues come from don't matter."

After the Moore case, Congress held hearings and commissioned reports that uncovered the millions of dollars being made from human tissue research, and it formed a special committee to a.s.sess the situation and recommend how to proceed. Its findings: the use of human cells and tissues in biotechnology holds "great promise" for improving human health, but raises extensive ethical and legal questions that "have not been answered" and to which "no single body of law, policy or ethics applies." This, they said, must be clarified.

In 1999, President Clinton's National Bioethics Advisory Commission (NBAC) issued a report saying that federal oversight of tissue research was "inadequate" and "ambiguous." It recommended specific changes that would ensure patients' rights to control how their tissues were used. It skirted the issue of who should profit from the human body, saying simply that the issue "raises a number of concerns," and should be investigated further. But little happened.

Years later, I asked Wayne Grody, who was in the thick of the debate in the nineties, why the congressional recommendations and NBAC report seemed to have vanished.

"It's weird, but I have no idea," he said. "If you can figure that out, I'd like to know. We all just wanted to forget about it, like if we ignored it, maybe it would just go away." But it didn't. And given the steady flow of court cases related to tissues, the issue isn't going away anytime soon.

Despite all the other cases and the press they've received, the Lacks family has never actually tried to sue anyone over the HeLa cells. Several lawyers and ethicists have suggested to me that since there is no way to anonymize HeLa cells at this point, research on them should be covered by the Common Rule. And since some of the DNA present in Henrietta's cells is also present in her children, it's possible to argue that by doing research on HeLa, scientists are also doing research on the Lacks children. Since the Common Rule says that research subjects must be allowed to withdraw from research at any time, these experts have told me that, in theory, the Lacks family might be able to withdraw HeLa cells from all research worldwide. And in fact, there are precedents for such a case, including one in which a woman successfully had her father's DNA removed from a database in Iceland. Every researcher I've mentioned that idea to shudders at the thought of it. Vincent Racaniello, a professor of microbiology and immunology at Columbia University, who once calculated that he's grown about 800 billion HeLa cells for his own research, says that restricting HeLa cell use would be disastrous. "The impact that would have on science is inconceivable," he said.

As for the Lackses, they have few legal options. They couldn't sue over the cells being taken in the first place for several reasons, including the fact that the statute of limitations pa.s.sed decades ago. They could attempt to stop HeLa research through a lawsuit, arguing that it's impossible to anonymize Henrietta's cells, which contain their DNA. But many legal experts I've talked with doubt such a case would succeed. Regardless, the Lackses aren't interested in stopping all HeLa research. "I don't want to cause problems for science," Sonny told me as this book went to press. "Dale wouldn't want that. And besides, I'm proud of my mother and what she done for science. I just hope Hopkins and some of the other folks who benefited off her cells will do something to honor her and make right with the family."

Acknowledgments

Time and time again, I saw people energized by the story of Henrietta and her cells-energized, and filled with the desire to do something to show their thanks for her contribution to science, and make amends to her family. Many of those people put that energy into helping me with this book. My grat.i.tude goes out to everyone who devoted time, knowledge, money, and heart to this project. I do not have room to name all of you here, but I could not have written this book without you.

First and foremost, I owe endless thanks to Henrietta Lacks's family.

Deborah was the soul of this book-her spirit, her laughter, her pain, her determination, and her unbelievable strength were an inspiration that helped keep me working all these years. I feel deeply honored to have been part of her life.

I thank Lawrence and Zakariyya for their trust and their stories, and Sonny, for seeing the value of this project and being its backbone within the family. I thank him for his honesty, his never-ending optimism, and for believing I could and would write this book.

Deborah's grandsons, Davon and Alfred, were incredibly supportive of Deborah's quest to learn about her mother and her sister. I thank them for keeping us laughing and for answering my many questions. Bobbette Lacks, a strong woman who has helped hold the Lacks family together for decades, put up with hours of interviews and many requests for doc.u.ments, and she never held back when it came to sharing her stories. I'm grateful to Sonny's ever-reliable daughter, Jeri Lacks-Whye, who tracked down facts and photos, and often wrangled her big extended family on my behalf. I thank her and her mother, Shirley Lacks, as well as Lawrence's granddaughters Erika Johnson and Court-nee Simone Lacks, and Deborah's son, Alfred Carter Jr., for their openness and enthusiasm. James Pullum's support was unwavering; I thank him for his stories, his laughter, and his prayers. The same is true for Gary Lacks, who sang beautiful hymns into my telephone voice mail, and never failed to serenade me on my birthday.