The Immortal Life of Henrietta Lacks (46 page)

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 analysts, scientists, philosophers, and ethicists have suggested ways to compensate tissue donors: creating a Social Securitylike system in which each donation entitles 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 institutions, 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 institution 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 institutions) 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 Nobel Prize-winning researcher who used Ted Slavin’s antibodies for hepatitis 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 institution, 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 reimbursement 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 (participate 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 assess 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 passed 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.”

T
ime 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 gratitude 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.