The Immortal Life of Henrietta Lacks (19 page)

Informed consent focused on what doctors were required to tell their patients; there was little mention of how it might apply to research like Southam’s, in which subjects weren’t the researcher’s patients. And it would be decades before anyone thought to ask whether informed consent should apply in cases like Henrietta’s, where scientists conduct research on tissues no longer attached to a person’s body.

But to the three doctors who refused to help with Southam’s research, injecting cancer cells into a person without consent was a clear violation of basic human rights and the Nuremberg Code. Mandel didn’t see it that way. He had a resident give the injections in their place, and on August 27, 1963, the three doctors wrote a resignation letter citing unethical research practices. They sent it to Mandel and at least one reporter. When Mandel got the letter, he called a meeting with one of the doctors, and accused them of being overly sensitive because of their Jewish ancestry.

One member of the hospital’s board of directors, a lawyer named William Hyman, didn’t think they were being overly sensitive. When he heard about the doctors’ resignation, he asked to see the records of patients in the study. But his request was denied. Meanwhile, just days
after the doctors resigned, the
New York Times
ran a tiny news item deep in the paper under the headline SWEDEN PENALIZES CANCER SPECIALIST, about a cancer researcher named Bertil Björklund. He’d been giving himself and patients intravenous injections of vaccines made from HeLa cells, which he’d gotten from George Gey’s lab in such enormous quantities, they joked that instead of injecting them, Björklund could just fill a pool with HeLa—or maybe even a lake—and swim around in it for immunity. Björklund’s HeLa injections got him expelled from his laboratory, and Hyman hoped for similar results with Southam. So, in December 1963 he sued the hospital for access to medical records related to the study.

Hyman compared Southam’s study to Nazi research and got affidavits from the three doctors who’d resigned—they described Southam’s research using words like
illegal, immoral
, and
deplorable
. Hyman also got an affidavit from a fourth doctor explaining that the patients in the study wouldn’t have been capable of giving informed consent even if Southam had asked: one had advanced Parkinson’s disease and couldn’t talk, others spoke only Yiddish, one had multiple sclerosis and “depressive psychosis.” Regardless, Hyman wrote, “I was informed that consent was not necessary … that it was unlikely that Jewish patients would agree to live cancer cell injections.”

That caught the media’s attention. The hospital called the suit “mis leading and fallacious.” But newspapers and magazines ran headlines saying:

They said the Nuremberg Code didn’t seem to apply in the United States, and that there were no laws protecting research subjects.
Science
magazine called it “the hottest public debate on medical ethics since the Nuremberg trials,” and said, “The situation at present appears rather perilous for everyone.” A reporter from
Science
asked
Southam why, if the injections were as safe as he swore they were, he didn’t inject himself.

“Let’s face it,” Southam responded, “there are relatively few skilled cancer researchers, and it seemed stupid to take even the little risk.”

Patients who’d unknowingly been injected with cancer cells by Southam read the articles and began contacting reporters. New York State Attorney General Louis Lefkowitz learned about Southam’s research through the media as well, and immediately launched his own investigation. In a scathing five-page document filled with exclamation points, he accused Southam and Mandel of fraud and unprofessional conduct, and demanded that the Board of Regents of the University of the State of New York revoke their medical licenses. Lefkowitz wrote, “Every human being has an inalienable right to determine what shall be done with his own body. These patients then had a right to know … the contents of the syringe: and if this knowledge was to cause fear and anxiety or make them frightened, they had a right to be fearful and frightened and thus say NO to the experiment.”

Many doctors testified before the Board of Regents and in the media on Southam’s behalf, saying they’d been conducting similar research for decades. They argued that it was unnecessary to disclose all information to research subjects or get consent in all cases, and that Southam’s behavior was considered ethical in the field. Southam’s lawyers argued, “If the whole profession is doing it, how can you call it ‘unprofessional conduct’?”

This rattled the Board of Regents. On June 10, 1965, its Medical Grievance Committee found Southam and Mandel guilty of “fraud or deceit and unprofessional conduct in the practice of medicine” and recommended that their medical licenses be suspended for one year. The Board wrote, “There is evidenced in the record in this proceeding an attitude on the part of some physicians that they can go ahead and do anything … and that the patient’s consent is an empty formality. With this we cannot agree.”

Their decision called for more specific guidelines in clinical research,
saying, “We trust that this measure of discipline will serve as a stern warning that zeal for research must not be carried to the point where it violates the basic rights and immunities of a human person.”

The suspensions of Southam’s and Mandel’s licenses were stayed, leaving them both on one-year probation instead. And the case seemed to have little impact on Southam’s professional standing: soon after the end of his probationary period, Southam was elected president of the American Association for Cancer Research. But his case brought about one of the largest research oversight changes in the history of experimentation on humans.

Before the Board of Regents announced its decision, the negative press about Southam’s work had gotten the attention of the NIH, which funded his research and required its investigators to get consent for all studies involving humans. In response to the Southam situation, the NIH investigated all their grantee institutions and found that only nine out of fifty-two had any policy in place to protect the rights of research subjects. Only sixteen used consent forms. The NIH concluded: “In the setting in which the patient is involved in an experimental effort, the judgment of the investigator is not sufficient as a basis for reaching a conclusion concerning the ethical and moral set of questions in that relationship.”

As a result of its investigation, the NIH said that to qualify for funding, all proposals for research on human subjects had to be approved by review boards—independent bodies made up of professionals and laypeople of diverse races, classes, and backgrounds—to ensure that they met the NIH’s ethics requirements, including detailed informed consent.

Scientists said medical research was doomed. In a letter to the editor of
Science
, one of them warned, “When we are prevented from attempting seemingly innocuous studies of cancer behavior in humans … we may mark 1966 as the year in which all medical progress ceased.”

Later that year, a Harvard anesthesiologist named Henry Beecher
published a study in the
New England Journal of Medicine
showing that Southam’s research was only one of hundreds of similarly unethical studies. Beecher published a detailed list of the twenty-two worst offenders, including researchers who’d injected children with hepatitis and others who’d poisoned patients under anesthesia using carbon dioxide. Southam’s study was included as example number 17.

Despite scientists’ fears, the ethical crackdown didn’t slow scientific progress. In fact, research flourished. And much of it involved HeLa.

B
y the 1960s, scientists joked that HeLa cells were so robust that they could probably survive in sink drains or on doorknobs. They were everywhere. The general public could grow HeLa at home using instructions from a
Scientific American
do-it-yourself article, and both Russian and American scientists had managed to grow HeLa in space.

Henrietta’s cells went up in the second satellite ever in orbit, which was launched by the Russian space program in 1960, and almost immediately afterward, NASA shot several vials of HeLa into space in the
Discoverer XVIII
satellite. Researchers knew from simulated zero-gravity studies using animals that space travel could cause cardiovascular changes, degradation of bone and muscle, and a loss of red blood cells. They also knew radiation levels were higher beyond the ozone layer. But they didn’t know what effects any of this would have on humans: Would it cause cellular changes, or even cell death?

When the first humans went into orbit, Henrietta’s cells went with them so researchers could study the effects of space travel, as well as the nutritional needs of cells in space, and how cancerous and
noncancerous cells responded differently to zero gravity. What they found was disturbing: in mission after mission, noncancerous cells grew normally in orbit, but HeLa became more powerful, dividing faster with each trip.

And HeLa cells weren’t the only ones behaving strangely. Since the start of the decade, researchers had been noticing two new things about all cultured cells. First, it seemed that all normal cells growing in culture eventually died or underwent spontaneous transformation and became cancerous. This phenomenon was exciting for researchers trying to understand the mechanisms of cancer, because it suggested that they might be able to study the moment a normal cell becomes malignant. But it was disturbing for those trying to use cell culture to develop medical therapies.

George Hyatt, a Navy doctor working with the National Cancer Institute, had experienced this phenomenon firsthand. He’d cultured human skin cells for treating badly burned soldiers, then created a wound on a young volunteer officer’s arm and smeared the cells across it, hoping they’d grow to form a new layer of skin. If it worked, it might mean doctors could use skin-cell transplants to treat wounds in the field. The cells did grow, but when Hyatt biopsied them a few weeks later, they were all cancerous. He panicked, removed the cells, and hadn’t tried transplanting skin cells since.

The other unusual thing scientists had noticed about cells growing in culture was that once they transformed and became cancerous, they all behaved alike—dividing identically and producing exactly the same proteins and enzymes, even though they’d all produced different ones before becoming malignant. Lewis Coriell, a renowned cell culturist, thought he might have an explanation. He published a paper suggesting that perhaps “transformed” cells behaved the same not because they’d become cancerous, but because they’d been contaminated by something—most likely a virus or bacterium—that made them behave similarly. Almost as an aside, he pointed out one possibility that other researchers hadn’t considered: all transformed cells seemed to behave
identically to HeLa, he wrote, which could mean that HeLa was the contaminant.

Soon after his paper was published, Coriell and a few other top tissue culturists called an urgent meeting to talk about the state of their field, which they worried was becoming a disaster. They’d mastered the techniques of cell culture and simplified them to such a degree that, as one researcher put it, they’d “made it possible for even the rank amateur to grow a few cultures.”

In recent years, using tissue samples from themselves, their families, and their patients, scientists had grown cells of all kinds—prostate cancer, appendix, foreskin, even bits of human cornea—often with surprising ease. Researchers were using that growing library of cells to make historic discoveries: that cigarettes caused lung cancer; how X-rays and certain chemicals transformed normal cells into malignant ones; why normal cells stopped growing and cancer cells didn’t. And the National Cancer Institute was using various cells, including HeLa, to screen more than thirty thousand chemicals and plant extracts, which would yield several of today’s most widely used and effective chemotherapy drugs, including Vincristine and Taxol.

Despite the importance of this research, many scientists seemed cavalier about their cultures. Few kept clear records of which cells grew from which donors, and many mislabeled their cultures, if they labeled them at all. For scientists doing research that
wasn’t
cell-specific, like investigating the effects of radiation on DNA, not knowing what kind of cell they were working on might not affect the outcome of their research. But if cells were contaminated or mislabeled in research that
was
cell-specific—as much research was—the results would be worthless. Regardless, the culturists who called the meeting said, precision was essential in science, and researchers should know what cells they were using, and whether they were contaminated.

According to Robert Stevenson, one of the scientists involved in the meeting, their goal was to keep the field from “degenerating into complete chaos.” The group encouraged researchers to use protective
measures, like working under hoods with suction that pulled air and potential contaminants into a filtration system. And they recommended that the NIH establish a reference collection of cells: a central bank where all cultures would be tested, cataloged, and stored under maximum security, using state-of-the-art sterile techniques. The NIH agreed, and formed a Cell Culture Collection Committee made up of tissue culturists, including William Scherer, Lew Coriell, and Robert Stevenson. Their mission was to establish a nonprofit federal cell bank at the American Type Culture Collection (ATCC), which had been distributing and monitoring the purity of bacteria, fungi, yeast, and viruses since 1925, but never cultured cells.