The Vaccine Race

by Meredith Wadman

  Should Mrs. X be paid, even at this late date, for the use of her fetus? Some ethicists argue that paying people like Mrs. X is not warranted, because she wasn’t put to any extra inconvenience—she was going to have the abortion anyway—and because she, unlike Hayflick, Plotkin, Koprowski, and others, didn’t do any of the work that turned the cells of the fetus into lasting tools for improving human health.36 Others, like Alta Charo, a lawyer and bioethicist at the University of Wisconsin, point out that an abortion so long ago and so far away leaves Mrs. X with virtually no legal route to claim compensation, even if she was motivated to pursue it. That doesn’t mean, Charo adds, that compensating Mrs. X might not be the moral thing to do.37

  Going forward, there is still a live debate about whether tissue donors should be compensated when their contributions are not a by-product of routine medical care but are specifically collected, with their consent, for research—and are later turned into lucrative research tools or therapies. Some experts argue that sorting out who is owed what would be a legal nightmare that would bring science to a standstill.38 Others say that the prospect of profiting would be an incentive to people to donate and would speed research.39

  What about research tools or medicines developed from the hundreds of millions of tissue samples that are already stored in biobanks all over the United States—samples, from pancreas to placenta, that are left over from surgeries and medical procedures?40 They will never financially benefit their donors; researchers can use these samples—as long as they have been stripped of information that could lead a scientist back to the person they came from—freely, without the consent or knowledge of the donor. In the spring of 2016, the U.S. government was finalizing rules that would change that. They would generally require patients to give a one-time informed consent for the use of their surgical leftovers for future research.41 As this book went to press, the proposed change was generating a wave of protest from medical researchers who argued, backed by a new report from the National Academy of Sciences, that the new consent requirement would create an expensive bureaucratic morass without benefiting the people it is supposed to protect.42 Ironically in the context of this book, the rule change, if it does go through, would not apply to fetal tissue, which is governed by a different part of U.S. regulations. This part says that fetal tissue can be used without consent as long as it does not have identifying information attached to it that would allow it to be traced back to a living human being—and as long as using it without consent would not break state or local laws.*43 In fact, in most places, doing so would indeed break state laws: At least thirty-seven states and the District of Columbia have enacted laws that require a woman’s informed consent for the use of tissue from her fetus in research.44

  • • •

  The unregulated, exploitative experiments on orphans, prisoners, newborns, and intellectually disabled children that populate these pages are no longer permitted in the United States. In 1966, after the publication of Henry Beecher’s New England Journal of Medicine report documenting two decades of appalling abuses of human subjects, the U.S. surgeon general told government-funded medical researchers that they would have to obtain the informed consent of research participants, and that an independent “committee of associates” at their hospital or university would have to preapprove human studies. Those committees were instructed to scrutinize the risks and benefits to the people participating and just how the informed consent was going to be obtained. Their charge was to protect the participants’ rights and welfare.45

  Then, in 1972, journalist Jean Heller of the Associated Press revealed the particulars of the Tuskegee Syphilis Study.46 Her story appeared in national newspapers, reporting that since 1932 U.S. government researchers had been studying the effects of untreated syphilis in 399 poor, illiterate African American men. Even after penicillin became available in the 1940s and was widely and successfully used to treat the slowly progressive, devastating venereal disease, the researchers lied to the men, saying they were getting treatment while withholding the drug.47

  In 1974, responding in part to an avalanche of protest that followed the Tuskegee revelations, Congress enshrined in law the 1966 requirements that until then had simply been a policy.48 The Department of Health, Education and Welfare issued new regulations interpreting the law. They required that laypeople—lawyers, bioethicists, religious figures, community members—be included on the committees that preapprove human studies before they go ahead. (A 1968 survey had revealed that 73 percent of medical research institutions had constituted their committees entirely of scientists and physicians.)49 The regulations also laid out very specifically what constituted informed consent.50 Those 1974 regulations have since been added to with extra protections for pregnant women, newborns, fetuses in the womb, prisoners, and children—including institutionalized children.*

  Today independent ethics committees typically meet for several hours to scrutinize proposed human trials—like the committee that met in 2015 to assess a study of a new Ebola vaccine being put forward by scientists at the National Institutes of Health. (The vaccine contains not the Ebola virus but a snippet of its DNA that cannot cause the disease.) The committee grilled the trial’s leaders on points of safety and told them to make the informed-consent form less long and complicated. An eighth grader should be able to read and understand it, one of the committee members insisted.

  After the form was revised, the trial participants—140 healthy volunteers who would be among the first human beings injected with the vaccine—were given days to scour both the study plan and the informed-consent form. They asked the researchers as many questions as they wanted to and were given tutorials on the trial. They were told repeatedly, by various members of the research team, that they could withdraw from the trial at any time for any reason. They were closely watched on site for hours after their injections and commanded to call a 24-7 hotline to the trial investigators if they were experiencing any serious symptoms. They returned for a next-day follow-up and then at intervals of weeks and finally months for blood draws so that their anti-Ebola antibody levels could be measured. They were compensated modestly for their time and inconvenience.

  One of the volunteers, Grant, a twenty-six-year-old apartment manager, says that he began volunteering for vaccine trials as a way to earn some extra cash but has come to consider it something of a civic duty. “It’s not this weird, cold, archaic process anymore,” he says when prompted to compare the trial with experiments on prisoners and orphans fifty and sixty years ago. “Why not donate my body and my time?”

  • • •

  For some, the use of cells from Mrs. X’s fetus will continue to be an abomination, no matter how long ago the abortion was and no matter that it would have happened anyway. Antiabortion activists recently took their fight beyond the use of fetal cells in vaccine-making, to attack any use of fetal tissue in research. In the summer of 2015 David Daleiden, an antiabortion activist who founded an organization that he calls the Center for Medical Progress, released covertly filmed, heavily edited videos in which he and a colleague posed as biotechnology company executives. They showed senior physicians from the women’s health provider Planned Parenthood discussing how they performed abortions and provided fetal tissue for medical research.

  Fetal tissue research is legal in the United States. The NIH spent $80 million in 2015 on scores of projects that use fetal tissue. The research is increasing scientists’ understanding of HIV/AIDS, hepatitis, blinding diseases, and what happens when things go wrong during fetal development.51 Separately, companies have used fetal cells to create medicines like the arthritis drug, Enbrel, which was developed using the WI-26 cells that Hayflick derived before he launched WI-38; Pulmozyme, which helps children with cystic fibrosis clear the thick mucus that clogs their lungs; and Nuwiq, an improved treatment for hemophilia, a life-threatening bleeding disorder that occurs in boys and men.

  The law stipulates that abort
ion clinics can be reimbursed only for costs when they provide fetal tissue for research. Daleiden’s videos purported to show Planned Parenthood trafficking illegally, for profit, in fetal body parts. More than a dozen investigations were launched by outraged conservative lawmakers on Capitol Hill and in the states. None of the investigations have found evidence that Planned Parenthood profited by providing fetal tissue for research—although Daleiden was indicted by a Texas grand jury on a felony charge of tampering with a government record, for creating a false driver’s license to mask his real identity. Nonetheless, in the spring of 2016, a specially-convened panel of the House of Representatives, the House Committee on Infant Lives, subpoenaed scientists across the country who work with fetal tissue, asking for voluminous amounts of information.52 The episode has cast a chill on fetal tissue research in the United States. One institution posted a guard outside a lab where the research was being conducted.53 Fetal tissue has become harder for scientists to procure.54

  In other countries, the research proceeds apace. In one recent paper, Chinese scientists reported the launch of a new cell line, derived specifically to give the Chinese people their own normal, WI-38-like cells for vaccine-making. The new human fetal cell strain is called walvax-2, after the biotechnology company in Yunnan where the cells were derived. They came from the lungs of a female fetus aborted at three months of pregnancy because the mother, a healthy twenty-seven-year-old, had scar tissue from a previous Caesarian section affecting her uterus. The scientists reported that they dissected nine electively aborted fetuses, with the consent of the women who had the abortions, before choosing the lungs that they did.55 When Debi Vinnedge at Children of God for Life learned of the paper, she published an article on a website called LifeNews.com with the headline “Scientists in China Create New Vaccines Using Body Parts From Nine Aborted Babies.”56

  • • •

  Later on the same cold November day that I visited Merck, I attended a special event at the American Philosophical Society’s Benjamin Franklin Hall, a grand, Italianate building with a white marble facade in old, historic Philadelphia. Hayflick and his colleague Moorhead, who coauthored the 1961 paper asserting that normal cells aged in their lab dishes, were there to receive an award. The John Scott Award was endowed by a Scottish druggist who was reportedly an admirer of Benjamin Franklin and thus chose the city of Philadelphia to administer the prize. It recognizes “ingenious men or women who make useful inventions” for the “comfort, welfare and happiness” of mankind. Since 1822 inventors of a door lock, a wheelbarrow, and a tooth extractor have been honored. But there have also been scientific and engineering superstars among the recipients: Thomas Edison; Marie Curie; the Wright brothers; Frederick Banting, the codiscoverer of insulin; and Saul Perlmutter, who won the Nobel Prize in physics in 2011. The award was the latest in a long list of honors that have been bestowed on Hayflick, who was eighty-eight years old as this book went to press.

  The crowd that night was exceedingly gray haired, and the event was something of a reunion for those who were still standing among Hayflick’s former colleagues. Plotkin was not there; he was in Germany, presenting a paper on the development of vaccines against cytomegalovirus, today the most common cause in the United States of viral-induced injury to fetuses in the womb. Robert Roosa, the Wistar administrator who had been called back from Toronto when Koprowski discovered the missing WI-38 cells, was there, in a wheelchair, clearly happy to be among old friends; he would pass away a few months later. Also present was Anthony Girardi, the scientist then at Merck who tested Hayflick’s first fetal cell strains on hamsters to see if cancers sprouted in their cheek pouches. Eero Saksela, the visiting Finnish scientist who worked with Moorhead in 1962 and 1963 to study whether WI-38 cells turned cancerous late in their lives, had traveled from Helsinki to be there. And Moorhead himself attended, albeit in poor health. It was doubtless the last time that many of those assembled would see one another.

  When Hayflick’s turn at the podium came, he outlined his many accomplishments, from the discovery of the Hayflick limit, to the identification of the microbe that causes walking pneumonia, to the launch of WI-38 and its widespread use to make vaccines. He exaggerated, telling his elderly audience that if they had ever received a viral vaccine of any kind, “it’s almost a certainty that it was produced in WI-38.” He claimed that the cells had been used to make vaccines that have immunized more than two billion people. (Merck’s rubella vaccine is by far the largest product made with WI-38 cells, and the company says that as of March, 2016, it has shipped some 677 million doses.)57 And he ended his talk by saying that he felt his greatest achievement was “having reversed the universal belief and the laws that biologists have no intellectual property rights.”

  Hayflick didn’t need to exaggerate. His accomplishments were remarkable enough unadorned.

  • • •

  As Hayflick spoke that night, it had been seven years since he was in possession of any WI-38 cells. The six ampules of original eighth-passage cells that he received under the 1981 settlement with the NIH he first kept in his lab at Oakland Children’s Hospital. When he moved to the University of Florida in Gainesville, they went with him in his car, in a portable liquid nitrogen freezer. In 1988, when he moved back to California, the cells drove cross-country with him again. Back in the Bay Area they lived in the portable freezer at his home in San Carlos and then at another home in Hillsborough. At last, in 1991, he deposited the cells in his garage overlooking the Pacific on the beautiful bluffs at the Sea Ranch.58

  For the next sixteen years, every month or so, Hayflick drove 130 miles round-trip to Santa Rosa, the nearest city of any size, to buy liquid nitrogen to top up the freezer. In 2006 he at last had had enough. He donated the cells to the Coriell Institute for Medical Research in Camden, New Jersey, where they reside to this day.

  “It was about time,” he told Nature in 2013, “that my ‘children’—now adults—should leave home.”59

  Epilogue: Where They Are Now

  Studying history, my friend, is no joke and no irresponsible game.

  —Hermann Hesse, The Glass Bead Game1

  Margareta Böttiger, the young physician and scientist who in 1962 was dispatched by her boss, Sven Gard, to find the medical history of Mrs. X, played a key role in Sweden’s successful polio eradication effort, and continued follow-up studies on vaccinated people for forty years. In 1976 she became the Swedish government’s top epidemiologist. In that position, she was deeply involved in responding to the HIV/AIDS epidemic in its earliest days and worked to improve vaccine coverage against several other infectious diseases. Now eighty-nine years old, she lives part of the year in a historic seaside mansion near Stockholm that was once a favorite escape for close friends of the Böttiger family: Sweden’s Crown Princess Margaret and Crown Prince Gustav Adolf—later king Gustav VI Adolf.

  • • •

  Bernice Eddy, the NIH microbiologist who was demoted for discovering a cancer-causing “substance” in the monkey kidney cells used to make polio vaccine, worked at the agency’s Division of Biologics Standards until she retired in 1973 at age seventy. She continued to publish papers on the tumor viruses until her retirement. She passed away in 1989.

  The question of whether Eddy’s “substance,” the silent monkey virus SV40, has caused cancers in Americans who were vaccinated against adenovirus and polio between 1955 and 1963, when vaccine makers were obligated to switch to using a species of monkey that does not naturally harbor SV40, has become, and remains, a contentious one.

  The most authoritative statement to date on the matter comes from the Institute of Medicine, a branch of the National Academy of Sciences. The Institute concluded in 2002 that although studies that followed vaccine recipients over the decades provide no evidence of increased cancer risk, these studies were “sufficiently flawed” that the question of whether or not contaminated polio vaccine caused cancer couldn’t be answered. It re
commended continued analysis and research on the question.2

  In 2013 a fact sheet on the Web site of the Centers for Disease Control and Prevention stated that “more than 98 million Americans received one or more doses of polio vaccine from 1955 to 1963 when a proportion of vaccine was contaminated with SV40; it has been estimated that 10–30 million Americans could have received an SV40 contaminated dose of vaccine.”

  The CDC fact sheet also stated, “The majority of scientific evidence suggests that SV40-contaminated vaccine did not cause cancer; however, some research results are conflicting and more studies are needed.”3

  In July 2015 a CDC official said that the fact sheet had been removed for updating. The agency has not posted a new one.

  • • •

  Eva Ernholm, who performed the WI-38 abortion, practiced gynecology in Sweden until 1992. She also taught sex education in high schools and vocally cautioned young women against approaching abortion casually. When she moved away from her first private practice in the town of Kristinehamn, patients there continued to seek her out, driving the four hours to Ernholm’s private practice in Falkenberg. She died in 2011 at age eighty-six.

  • • •

  After leaving the University of Florida in 1988, Leonard Hayflick became an unpaid adjunct professor of anatomy at the University of California at San Francisco. He no longer had a lab but spent a portion of his time consulting for nearby Genentech, the first big biotechnology company, advising labs there on cell-culture techniques. “I was involved essentially in research by proxy, but it still gave me the joy of doing research,” he said in a 2013 interview.4 He was elected a fellow of the American Association for the Advancement of Science in 1986 and served as editor in chief of the journal Experimental Gerontology for thirteen years, until 1998. He served as a scientific adviser to several companies, including Geron, the firm that was founded in 1990 to exploit telomeres and telomerase. He won many awards. His 1994 book How and Why We Age has been translated into nine languages. Today he is eighty-eight years old and lives in Sea Ranch, California. His wife, Ruth, passed away in March 2016.