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  When it was over, the hepatitis A virus outbreak at Chi-Chi’s had infected about seven hundred people and killed four. Although this was the largest outbreak of hepatitis A in the United States, it wasn’t the largest outbreak in the world. In 1989 in Shanghai, hepatitis A virus in uncooked polluted clams from the East China Sea had infected more than three hundred thousand people and killed forty-seven. Clams, like mussels and oysters, can filter as much as ten gallons of water an hour, concentrating the virus a hundredfold relative to its concentration in the ocean.

  At the time of the outbreak at Chi-Chi’s, a vaccine that could have prevented the tragedy had been available for eight years. Critical to the development of the first hepatitis A vaccine was Friedrich “Fritz” Deinhardt.

  In the mid-1960s, Fritz Deinhardt was an unknown researcher. Born in Gütersloh, Germany, he attended the University of Göttingen and received his medical degree from the University of Hamburg. After completing both an internship and a residency in Hamburg, Deinhardt came to the United States, where he met his wife, Jean, and later became the chairman of microbiology at the Presbyterian St. Luke’s Hospital in Chicago. In 1965, while working at St. Luke’s, Deinhardt sampled the blood of a thirty-four-year-old surgeon whose initials were G. B. The surgeon had been ill with hepatitis for three days, his skin and eyes had turned yellow, he couldn’t eat without vomiting, and he was tired and listless, unable to work. To capture the surgeon’s virus, Deinhardt took the blood and injected it into the veins of white-lipped, hairy-faced marmosets—small, squirrel-like monkeys found in South America. Within a few years, marmosets would become an endangered species. But before the United States government prohibited research on marmosets, Deinhardt imported them, bred them, and, with the help of his wife—who fed milk to the babies—raised them. A few weeks after Deinhardt had injected marmosets with the surgeon’s blood, all of the animals fell ill with hepatitis.

  Despite his apparent success at isolating a hepatitis A virus, the American military, which funded Deinhardt’s studies, was skeptical of his results. They asked Hilleman what he thought of Deinhardt’s work. Although Deinhardt could be difficult to deal with—aggressive and argumentative—Hilleman stood by his friend, recalling that “[Fritz] took samples of blood from a surgeon with the initials G. B. and isolated a virus from that. He reportedly had hepatitis A. [Deinhardt] showed he had transmitted the virus to marmosets. All the time that the military was funding that, they would ask me, ‘Do you think that he’s doing anything? Do you think he’s right?’ I said ‘Fritz Deinhardt is very bright. And who in the hell are you going to get to do the hepatitis A work if Fritz doesn’t do it? You’ve got to fund him.’ I had no reason to believe at the time that he hadn’t isolated hepatitis A virus.”

  On April 30, 1992, at the age of sixty-six, Fritz Deinhardt died of cancer. One of Deinhardt’s obituaries, in reference to his work on marmosets, stated, “It was here that the first roots of meaningful specific studies of hepatitis A were begun. This breakthrough discovery was the epicenter of all hepatitis A investigations, opening a window to that which followed, and initiating a trail to the reality of [a] vaccine. Were it not for these seminal marmoset findings, we might still be struggling with the mysteries of hepatitis A.” But Fritz Deinhardt had never studied hepatitis A virus. He had isolated a very rare virus now called hepatitis G virus, an uncommon cause of disease in humans. Although he was unknowingly studying a different virus, Deinhardt was right about the marmosets; they were an excellent model for the study of hepatitis A.

  Following Deinhardt’s lead, Hilleman injected blood from a nine-year-old Costa Rican boy with hepatitis into the vein of a marmoset. Several weeks later he detected hepatitis A virus in the marmoset’s liver. But marmosets were becoming increasingly harder to find. He needed other cells in which to grow his virus. And Hayflick’s cells were the only ones that worked.

  During the next thirteen years Maurice Hilleman became the first person to detect hepatitis A virus and hepatitis A antibodies, the first to grow the virus in fetal cells, the first to weaken it (as an added margin of safety), and the first to kill it with formaldehyde. Then he became the first to show that his weakened-then-killed hepatitis A vaccine worked in animals. Confident, he was ready to test it in people. When he tested his measles, mumps, and rubella vaccines, Hilleman had needed people at high risk for those diseases, so he had chosen institutionalized, mentally retarded children. Now he needed people at high risk for hepatitis A infection. Fortuitously, at around the time that Hilleman was looking for a place to do his studies, Alan Werzberger visited Merck. Werzberger was a physician at the Kiryas Joel Institute of Medicine.

  In 1974, to accommodate their growing population in the Williamsburg section of Brooklyn, a group of Hasidic Jews moved to the Hudson Valley, fifty miles northwest of New York City. The village that they established, Kiryas Joel, transformed a quiet rural setting into a bustling urban center, with bearded men wearing black coats on hot summer days and women in head scarves pushing baby carriages past signs written in Hebrew. They brought a unique way of life from Brooklyn. Inhabitants of Kiryas Joel married at eighteen and had large families. By the early 1990s, about eight thousand people lived there.

  The village of Kiryas Joel stood out for yet another reason: it had unusually high rates of hepatitis A. Typically, when infants and young children are infected with hepatitis A virus, they don’t suffer any symptoms of the infection. But when older children, teenagers, and adults are infected, they often suffer severe disease. At Kiryas Joel, the living conditions allowed for easy transmission of the virus from younger children to older children. “The high birth rate, large family size, [and] day care center–like school atmosphere permitted close contact between younger and older children,” said Werzberger. “[We had] difficulty maintaining constant control over what the [younger] children did with their hands, from peremptory hand washing to surreptitious dips into communal school food.” “They all bathed together in these community pools,” recalled Phil Provost, Hilleman’s co-worker on the hepatitis A vaccine at Merck. “It was a traditional practice in the community. But there was a lot of hepatitis A virus contamination in those pools. That’s how they were spreading it.” From 1985 to 1991 local physicians cared for three hundred children infected with hepatitis A virus at Kiryas Joel. The virus infected 70 percent of all residents.

  Hasidic boy living at Kiryas Joel receives an experimental hepatitis A vaccine while Alan Werzberger (left), who conducted the clinical trials, looks on, 1991.

  The task of testing Hilleman’s weakened-then-killed hepatitis A vaccine fell to Alan Werzberger. First, Werzberger found a thousand children who had never been infected with the virus. Then he divided them in half; one half received a shot of vaccine, the other a shot of placebo. Three months later he found that hepatitis A virus had infected thirty-four children in the study, all of whom had received placebo. In a paper published in the New England Journal of Medicine, Werzberger concluded that Hilleman’s hepatitis A vaccine was 100 percent effective.

  Since 1995, when Merck licensed its hepatitis A vaccine, the incidence of the disease in the United States has declined about 75 percent.

  WHEN STANLEY PLOTKIN, TAD WIKTOR, MICHIAKI TAKAHASHI, AND Maurice Hilleman made their vaccines using Hayflick’s cells, they didn’t consider their actions to be immoral. Fetal cells were attractive because they were free of contaminating animal viruses, easy to grow in the laboratory, and highly susceptible to every known human virus. They were, in many ways, ideal cells in which to make vaccines. At the time they were being made, no one complained: not the media, the public, religious groups, the FDA, the NIH, or the WHO. Also, the woman who had provided her fetus to Leonard Hayflick for use in vaccines had requested the abortion. But times have changed. Now some groups—like those headed by Debi Vinnedge—see vaccines made from fetal cells as immoral.

  Vinnedge sees a simple solution. Now that we have more sophisticated methods to detect contaminating viruses,
we can remake these vaccines in animal cells. It wouldn’t be easy. First, companies would have to find the right animal cells in which to grow these viruses. Then they would have to effectively weaken or kill the viruses, test these new vaccines in progressively larger trials (including tens of thousands of children), construct or refit buildings in which to make the vaccines, solicit FDA approval in the United States, and solicit approval from other regulatory agencies throughout the world. Because these diseases are now uncommon, it would be difficult or impossible to conduct trials large enough to prove that they worked. And because these new vaccines might not work as well, these trials could be considered unethical. Furthermore, from the point of view of regulatory agencies, these companies would be making new products that would have to be subjected to the standard scrutiny of a new product. Regulatory burdens would be immense; each new vaccine would cost at least $800 million to make. These new vaccines wouldn’t increase sales, just costs. And these costs would have to be absorbed by taxpayers, medical insurance premiums, and international health agencies.

  It’s unlikely that vaccine makers are going to remake routine children’s vaccines—such as those for rubella, hepatitis A, and chickenpox—at great cost for no financial benefit. And inflammatory, incorrect statements regarding vaccines in current use don’t help. “The widespread use of these vaccines makes it very likely [that] additional cell lines will be created from other aborted babies,” says Vinnedge. “As opposed to the Nazi Holocaust, the abortion Holocaust is ongoing.” But the truth is that no new abortions are performed to make any of these vaccines. The cells frozen from the abortion performed in 1961, periodically thawed and grown in laboratory flasks, constitute all that is necessary to make them for generations.

  LEONARD HAYFLICK, THE MAN WHO HAD GIVEN FETAL CELLS TO PLOTKIN, Wiktor, Hilleman, and Takahashi to make their vaccines, became a pariah. In 1968 Hayflick left the Wistar Institute to become a professor of medical microbiology at Stanford University School of Medicine. He took his fetal cells with him. Hayflick had already set up a company called Cell Associates, with him and his wife as sole proprietors, which sold fetal cells to hundreds of researchers throughout the world. Hayflick charged researchers his costs for preparing and shipping the cells, never profiting from the sales; the total proceeds were only about $15,000. But some saw Hayflick as profiting from his work. “In those days, in that environment,” recalled a Wistar co-worker, “when you did research with government support, it was in the public domain. When it came out that Len was selling these cells, a lot of people were appalled.”

  Well funded by the NIH, in the midst of making important discoveries about how and why we age, and well respected by many of his fellow scientists, Hayflick was at the top of his game. But two years later Leonard Hayflick was standing in an unemployment line in Palo Alto.

  On January 30, 1976, James W. Schriver, a management accountant at the NIH, filed a report claiming that Hayflick was selling something that wasn’t his to sell. Schriver claimed that because Hayflick’s research was funded by the NIH, money made from the sale of fetal cells should be paid to NIH, not Hayflick. Stanford’s School of Medicine, alarmed by the growing scandal, concluded that Hayflick had acted unethically. On February 27, 1976, Leonard Hayflick resigned. “In 1975 I took the first initiative and asked the director of NIH to make a definitive determination about [who owned my fetal] cells,” recalled Hayflick. “Instead of sending a lawyer or a scientist, who might understand my claim, they sent an accountant, who went to Clayton Rich [Stanford’s dean] and said ‘Do you know that you have a thief in the microbiology department?’ [The dean was] advised by the bookkeeper that his cooperation was expected because 90 percent of [Stanford’s] budget came from NIH. Stanford University called the campus police and asked them to call the district attorney. Public servants from the NIH [then] entered my laboratory, confiscated [my fetal cells], and claimed them for themselves. The NIH maintained that it was perfectly fair for commercial organizations, the Russians, and themselves to sell [my fetal cells] for tens of millions of dollars, but they viewed as theft the inventor or his institution profiting.” In the eyes of his fellow scientists, Hayflick was ruined. “I went from full professor at Stanford to the unemployment line in one week,” he recalled. “My wife and I lived on $104 a week for the next year.” Plotkin remembered the controversy: “I think that in the really classical Greek sense it was a tragedy because here was a man who at the height of his powers brought about his own downfall.”

  Hayflick sued the federal government, which in turn countersued. “I felt, and I think I was justified in feeling, that these cells were like my children,” he said. Hilleman, who was asked to testify against Hayflick, recalled, “I was asked to be a principal witness against him. And I said that if there was an attempt to convict him, I would make a campaign on my part that two top-level government officials would spend time in jail with him. He should have been celebrated as a scientific hero instead of being persecuted.” In September 1982, after six years of wrangling, the case was settled out of court—in Hayflick’s favor. Hayflick was awarded the principal plus interest of the $15,000 that had been held in escrow, and the government allowed him to keep his cells. Hayflick never kept the settlement award, using it to pay his lawyers. Colleagues rallied to his support. A letter signed by eighty-five scientists was published in the journal Science: “This happy outcome of Dr. Hayflick’s courageous, sometimes lonely, emotionally damaging, and professionally destructive ordeal provides several important object lessons for the future. In light of the settlement terms and other government actions, few will disagree that the original allegation against him was entirely unjustified.” Hayflick’s battle changed the law. Now scientists receiving federal money can own and sell their discoveries. This single ruling allowed for the boom in private-sector biotechnology in the 1980s and 1990s. “I was a pioneer,” recalled Hayflick. “And it’s the pioneers that have the arrows in their backs.”

  ALTHOUGH THE USE OF FETAL CELLS TO MAKE VACCINES REMAINS CONTROVERSIAL for some, the vaccines made from them are safe. Fetal cells allowed Hilleman and others to avoid contaminating viruses like chicken leukemia virus and SV40. But Maurice Hilleman was about to use a material to make his next vaccine that few thought was safe, even after the vaccine had been licensed and sold: human blood. Hilleman obtained blood from drug abusers and homosexual men living in New York City in the late 1970s, when HIV first entered the United States. It was arguably the most dangerous starting material ever used to make a medical product.

  CHAPTER 8

  Blood

  “We had a process that would destroy all life forms.”

  MAURICE HILLEMAN

  In 1984 researchers at the CDC published a paper titled “Cluster of Cases of the Acquired Immune Deficiency Syndrome (AIDS): Patients Linked by Sexual Contact.” AIDS, a syndrome that included unusual infections and cancers, was sweeping across the country. Thousands had been infected.

  Victims of AIDS died of many different diseases. For example, they died of pneumonia. Before AIDS entered the United States, pneumonia caused by pneumococcal bacteria killed tens of thousands of people every year. But AIDS patients were different; they were killed by Pneumocystis, an organism previously found to cause pneumonia only in cancer patients. They also died of meningitis—but again, not from typical bacteria, such as meningococci, but from unusual fungi such as Cryptococcus. Or they died of Kaposi’s sarcoma, a previously rare form of cancer that caused hideous dark purple spots under the skin.

  The CDC researchers found several groups of people at high risk for AIDS: Haitians living in the United States, intravenous drug users, and people who required frequent blood transfusions. But no group was at greater risk than homosexual men. The first forty people diagnosed in the United States with AIDS were gay men living in California, Florida, Georgia, New Jersey, Pennsylvania, and Texas. To figure out how the AIDS virus—soon to be called human immunodeficiency virus (HIV)—spread, investigators const
ructed a diagram showing who had had sex with whom. In the center of the diagram was one man. All forty AIDS victims had had sex with this man or with someone who had had sex with him. They called him Patient Zero. His name was Gaetan Dugas.

  Born and raised in Quebec, Dugas, a steward for Air Canada, traveled extensively throughout the United States, frequenting many gay bars and bathhouses. When he walked into bars, he would stand in the entrance, scan the room, look carefully at each patron, and declare, “I am the prettiest one.” And he was. Randy Shilts in And the Band Played On described Dugas as having “sandy hair that fell boyishly over his forehead, an inviting smile, and a laugh that could flood color into a room of black and white.” His sexual escapades were legendary. “In San Francisco,” wrote Shilts, “Gaetan returned from every stroll down Castro Street [the center of the gay community] with a pocketful of matchbook covers and napkins that were crowded with addresses and phone numbers. At times [he] would stare at his address book with genuine curiosity, trying to recall who this or that person was.”

  Dugas was twenty-eight years old when a biopsy of an enlarging purple spot below his right ear revealed Kaposi’s sarcoma—“gay cancer.” At the time, Dugas estimated that he had slept with two hundred and fifty men a year for ten years—twenty-five hundred sexual partners in all. Knowing that AIDS was contagious didn’t stop Dugas from continuing to satisfy his sexual appetite. “Rumors began on Castro Street about a strange guy at the Eighth and Howard bathhouse, a blond with a French accent,” noted Shilts. “He would have sex with you, turn up the lights in the cubicle, and point out his Kaposi’s sarcoma lesions. ‘I’ve got cancer,’ he said. ‘I’m going to die. [And now] so are you.’”

  A FEW YEARS BEFORE HIV FIRST ENTERED THE UNITED STATES, MAUrice Hilleman began working on a new vaccine—not for HIV, which was still unknown, but for hepatitis. Because of the method he chose for making it, fear of AIDS would soon spread to fear of Hilleman’s vaccine. For almost two hundred years, researchers had used cells from monkeys, chickens, mice, rabbits, and ducks to make their vaccines. Hilleman was about to break new ground. He would be the first (and last) to use human blood to make a vaccine. He didn’t know until later that the blood was heavily contaminated with HIV.