The Consent Conundrum
Decades after a woman's cervical cancer cells were taken without her permission, we're still trying to determine what rights researchers have to your body.
In February1951, Henrietta Lacks lay unconscious, her feet in stirrups, at Johns Hopkins Hospital as doctors examined the particularly aggressive cervical cancer that would soon kill her. The 31-year-old had traveled 20 miles to Hopkins, the nearest major hospital that would treat black patients. She may have been a regular patient, but she was about to achieve an odd form of immortality in the medical world.
At the time, Hopkins' head of tissue culture research, George Gey, was refining the art of sustaining cells in stews of placental blood, chicken plasma, and other savory ingredients. After her surgery, Lacks' surgeon passed a thin disc of her cancerous cells to Gey's lab. Those cells became the first human tissue to replicate indefinitely in test tubes, launching a series of revolutions in medicine. The value of the so-called HeLa cell line that sprung from Lacks' tumor is incalculable: Its resilience and rapid growth made it ideal for testing Jonas Salk's polio vaccine, developing numerous cancer drugs, studying basic cellular processes, and honing experimental methods now standard in biology. Over the years, Lacks' cells have been sold for $10 to as much as $10,000 a vial—and her chronically impoverished family has received nothing.
Her story has been floating around for decades now: A 1976 Rolling Stone article was among the earliest to link HeLa to Henrietta Lacks and her family; Ebony and Jet covered the story soon after, as have a few other magazines. Michael Gold wrote the first book on HeLa, A Conspiracy of Cells: One Woman's Immortal Legacy and the Medical Scandal It Caused, in 1985. But now, in The Immortal Life of Henrietta Lacks, Rebecca Skloot tells the most detailed account yet of Henrietta and her family. The glaring incongruity between Lacks' contribution to medicine—which her family was unaware of until the 1970s—and her descendants' lack of health care could be resolved by a more equitable health care system. But the prevailing theme of Skloot's book is not on the question of how much Lacks and her family are owed; rather, it's that Lacks' doctors experimented on and distributed her cells without asking, or telling, her or her family.
At the time, researchers considered consent-free "donations" and experimentation a fair trade for free health care in the public wards. They said requiring consent encumbered scientific progress through bureaucracy and feared that patients would decline en mass. So researchers preferred not to give the patients a choice—or to acknowledge that the patients had any choice at all.
It's tempting to assume that such cowardice is an artifact, like lobotomy or twilight sleep, of midcentury medicine. In part, this is true. Myriad committees and regulations have since been erected to make informed consent a mainstream practice. Yet even today, Henrietta Lacks would not have had to be informed about the research done on her cells: Tissue research is among the fields with the fewest regulations about consent, and the sample was initially taken for diagnostic purposes.
Disregard for something so basic as consent is still disturbingly common. Take, for instance, accusations that a prominent Northwestern University surgeon implanted a modified heart-valve device, rather than the standard version, in more than 150 patients without notifying them of the changes. In defending himself to the Wall Street Journal in December 2009, the doctor pointed to the frequency of such unannounced device-tweaking. "Asked whether he thought he should have asked for a review board, he said: 'Not even remotely.' " Or see the much-criticized practice in Canada of having medical students practice pelvic examinations on unconscious women who have just been through surgery—without the patients' consent.
Less shocking yet far more common are the lack of consent requirements for in vitro research. From 2002 until last year, the Texas state health department obtained blood samples from every infant and stored them indefinitely for potential medical research, without parental consent. Every state in the nation collects dried blood spots from newborns to screen for birth defects. How they are handled and how long they are kept varies greatly, but the vast majority of states don't require informed consent. As with Lacks' case, the samples were initially used for diagnosis and so could be legally repurposed for any type of research thereafter. Few Texans outside the health department knew about the practice until the Austin American-Statesman published details of the program last February.
In March, the Texas Civil Rights Project sued the state on behalf of four parents and an expecting mother. They argued that storing the samples without consent constituted a violation of privacy and "an unlawful search and seizure." Though the Texas samples were stripped of the infants' names, plaintiffs said the DNA embedded in each cell quashed those privacy measures. In May, the Texas Legislature passed a law requiring the state to notify parents of the blood-collection program and allow them to opt out by sending a letter to the health department after the birth of a child, in which case the samples are destroyed after being tested for birth defects.
Months later, the state agreed to destroy all 5.3 million blood samples stored without consent since the program began. Texas had spent untold millions of dollars collecting blood now headed for the biohazard bin—and it had squandered incalculable sums of moral and persuasive capital. In the roughly five months after the law was passed, during which about 240,000 new Texans were born, fewer than 7,000 were opted out of the storage program. Even with a large margin for twins and triplets, that's less than 5 percent, but that number could have a large effect on blood spot research. Collections such as Texas' were prized for their lack of selection bias, since all children born in the state—regardless of their parents' income level, ethnicity, or distrust of science—were represented. Each withdrawal makes the collection disproportionately less valuable.
Other recent examples demonstrate problems with getting the right kind of consent. In the early 1990s, members of the Havasupai Tribe donated blood to Arizona State University researchers for studies on diabetes, which was becoming increasingly common within the tribe. But the blood samples were soon used for research on schizophrenia, inbreeding, and evolutionary genetics—uses to which the tribe objected and had not consented. They learned about this nondiabetes research only a decade later. In 2004, the tribe sued the university for $50 million, a case that continues to bounce around the courts.
Trust of Johns Hopkins and other hospitals in the 1950s was so low among the African-American community that there's a decent chance Henrietta Lacks would have declined to donate her cells had she been asked. Myth and fact blended in stories of body-snatching and dodgy human experimentation. When Lacks died, six months after her initial biopsy, Hopkins was legally required to request permission for an autopsy or tissue removal. "I told them they could do a topsy. Nothin else," Lacks' husband told Skloot many years later. "Them doctors never said nuthin about keeping her alive in no tubes or growin no cells."
You could accuse the Texas plaintiffs of scaremongering, looting science of 5 million chances to cure childhood cancer. And you could argue that, had Johns Hopkins required Lacks' consent and had she said no, the polio vaccine or early cancer drugs would have arrived later, causing unnecessary suffering. Though Lacks' cells were the first to achieve "immortality," cell-culturing techniques were steadily improving and paved the way for infinitely replicating lines to supplement HeLa. But at the time, George Gey and cell culturists had had such poor luck in their craft that the assistant who first prepared HeLa had nearly given up. Aren't we "morally obligated," as Skloot quotes David Korn, Harvard's vice provost for research, "to allow [our] bits and pieces to be used to advance knowledge to help others"?
But it's shortsighted to pit consent against scientific progress in this way. Consent ultimately speeds us toward discovery and cures by boosting scientific trust within the communities that those researchers not only serve but also depend upon. The trend since Henrietta Lacks first arrived at Johns Hopkins' public ward has been toward research requiring consent more, not less, frequently. Patients have embraced their role in medical decision-making, and institutions have elevated the importance of ethics and public trust. If researchers (and the scientific community at large) want a steady flow of willing subjects, they have to resist the mirage of such shortcuts.