The Vaccine Race

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The Vaccine Race Page 44

by Meredith Wadman


  In an appeal to the Securities and Exchange Commission, Merck tried but failed to prevent the resolution from appearing on the proxy statement on which shareholders would vote at the company’s annual general meeting in 2003.6 The SEC did agree to remove the language stating that the company was materially benefiting from the destruction of human life. The resolution that went before shareholders instead read that “Merck has violated its basic Statement on Values because of our company’s use of cell culture lines from aborted humans.” The resolution received 4.96 percent of the vote, above the 3 percent threshold that would allow Vinnedge to return with the resolution the following year.7 (Such resolutions are not binding on companies; they are simply requests.)

  Vinnedge attended the 2003 meeting in Rahway, New Jersey. At a break she approached the stage and presented Merck’s then-CEO, Ray Gilmartin, with a book of some 375,000 signatures, names, and addresses she had gathered, asking the company to provide what the signatories described as moral alternatives to the company’s rubella vaccine, and to the hepatitis A and chicken pox injections that it also produced using fetal cells.

  The company did not do the bidding of the book’s signatories or respond to the shareholder resolution. At the company’s next annual general meeting, in 2004, the resolution failed to gain the requisite votes—5 percent on a second attempt—that would have allowed it to be put before stockholders again in 2005.

  • • •

  In June 2003, not long after the first Merck meeting she attended, Vinnedge took her campaign to an authority more likely to receive her warmly: the Vatican. There a group of cardinals and bishops is charged with promoting and defending Catholic doctrine; they are known as the Sacred Congregation for the Doctrine of the Faith, or, informally, the Holy Office. When Vinnedge wrote to them, their chief, or prefect, was Cardinal Joseph Ratzinger, the conservative German prelate who two years later would be inaugurated Pope Benedict XVI. Vinnedge asked the congregation to restate the church’s teaching that Catholics shouldn’t be forced to act contrary to their conscience.8 She noted that some parents who opposed fetal cell–produced vaccines were challenged by state courts, health officials, and school administrators when they sought religious exemptions. “The permission to abstain from medical treatments and vaccines cultivated on aborted fetal cell lines needs to be addressed,” she wrote. The congregation sent the question to another Vatican body, the Pontifical Academy for Life, launched by Pope John Paul II less than a decade earlier, for “the promotion and the defense of human life.” Its roughly seventy members included medical scientists and its mandate was to study and pronounce on bioethics questions. (It also helped develop the church’s response to sexual abuse allegations.) The academy began a study that would take two years to complete. In Florida, Vinnedge waited patiently for an answer.

  • • •

  In the early summer of 2000, as Vinnedge was becoming absorbed in her work launching Children of God for Life, Adam Wood, a previously healthy twenty-one-year-old recruit in boot camp at Naval Station Great Lakes in Illinois, appeared at the base infirmary complaining of a cold. He went back to the infirmary the next day, and the next. He was prescribed an antibiotic but couldn’t seem to shake the illness. On the fourth morning he couldn’t get out of bed. He lost vision, and then consciousness. He was taken to the hospital in an ambulance. A chest X-ray of the comatose young man showed that one of his lungs was infected, and a CT scan revealed the same of his sinuses, the bony spaces behind the forehead and cheeks. Two weeks after he first fell ill, Wood’s parents, who had rushed to his bedside from a Colorado vacation, told staff to remove the respirator that was keeping their son alive.9,10

  The pathologist who conducted an autopsy found that Wood’s brain was severely inflamed—a condition called encephalitis. Researchers from the CDC and the military tested pieces of his lungs and brain and found the DNA of a respiratory virus that had very likely caused the encephalitis. It was adenovirus.

  Death is a rare outcome of infection with adenovirus, a common virus that typically causes fevers, runny noses, sneezing, coughing, and pink eye where stressed people live in cramped quarters—think boot-camp trainees in military barracks. But it visited another formerly healthy recruit at the Great Lakes base later that same summer. He was nineteen-year-old Jess Duden, who died of respiratory collapse one month after developing symptoms of a garden-variety nose and throat infection that were initially treated with Tylenol and decongestants. Scientists found the DNA of adenovirus in his ravaged lungs, and concluded that his death was probably associated with the virus.11

  Duden and Wood were, to an extent, victims of the success of the adenovirus vaccine. Six years earlier, in 1994, Wyeth, which made the vaccine for the military, had told the Pentagon that it was stopping production. The company had used WI-38 cells to make enough vaccine for every incoming recruit—some 7.5 million people—since 1971. It was administered within hours of their arrival at boot camp, as two oral tablets, coated to keep stomach acid from destroying the virus. (There is one pill for each of the two most common strains of adenovirus, types 4 and 7.) But by 1994 the firm had been pleading with the Pentagon for a decade for cash for a new facility; in 1984 FDA inspectors had warned that its dated existing plant in Marietta, Pennsylvania, needed upgrades. The military had answered the company’s request for $3 million to $5 million with inaction. In 1995 Wyeth told the Pentagon that it had ceased production and that its existing vaccine stores would be depleted within several years. The supply ran out in 1999. Still nothing was done. Senior military leaders had become complacent.

  Within a short time the rate of adenovirus infections in boot-camp barracks returned to what it had been in the 1950s, prior to mass vaccination, when physicians estimated that 10 percent of all new enlistees were infected and that the virus caused 90 percent of the pneumonia in military infirmaries.12

  “When the vaccine was in use, a busy [basic-training] camp might see as many as 200 cases of respiratory infection a week, fewer than 10% of which were caused by adenovirus,” the Wall Street Journal reported in 2001. “Without the vaccine, the same camp sees as many as 800 cases a week, with 90% caused by adenovirus.”13

  It would take the Pentagon another decade and about $100 million to restart the adenovirus vaccination program, after Israel-based Teva Pharmaceuticals finally agreed to manufacture the vaccine for the military.14 (Barr Laboratories, part of Teva, packs the weakened, freeze-dried virus into pills at a plant in Forest, Virginia.) Since October 2011 every incoming recruit—more than a million of them through late 2016—has once again upon arriving at boot camp received the WI-38–propagated vaccine. Within two months of the program restarting, the rate of new adenovirus infections at the military’s basic-training centers fell sevenfold and remained there.15

  • • •

  In August of 2000, as Jess Duden sickened and died, another life was beginning.

  In Cleveland, Ohio, a thirty-one-year-old woman named Elizabeth Graham was singing the role of the Countess in The Marriage of Figaro at the Lyric Opera Cleveland, winning plaudits from the local press for the passion of her arias and looking stunning onstage, her red lips encircling the perfect O of her mouth.

  At postperformance receptions Graham—everyone calls her Betsy—met many admirers, shook many hands, and kissed many cheeks. She felt fine except for something that seemed like allergies that mildly bothered her nose and throat for a few days. They were gone by the time her husband, Chip MacConnell, a physician assistant, traveled from the couple’s home in Dayton to take in some performances. After the run the pair enjoyed a vacation in the Smoky Mountains of Tennessee. A month or so later Graham was pretty sure that she was pregnant. She was excited; she and Chip were ready to start a family.16

  Betsy MacConnell (she uses the name Graham only professionally) saw her family physician in early October 2000. He ran routine pregnancy blood tests, including one for antirubella antibodies
. The lab reported that she was immune. This computed; MacConnell had been vaccinated against rubella as a three-year-old in 1972 with one of the vaccines that pediatricians were using then: Merck’s HPV-77 duck-embryo injection or the Cendehill vaccine.

  On May 7, 2001, at Miami Valley Hospital in Dayton, after a marathon labor, Betsy gave birth to a girl with pink cheeks and a full head of dark hair. She was crying lustily. She weighed five pounds, twelve ounces—about the 5th percentile for newborn girls. They named her Anna Gabrielle.

  Within a day the MacConnells learned that Anna had the four-part heart defect known as tetralogy of Fallot. Over the next few weeks it emerged that she was also profoundly deaf and blinded by cataracts. Tests of Anna’s blood not long after her birth showed antirubella antibodies of a kind that do not cross the placenta, meaning that Anna had made them herself, in the womb, in response to exposure to the virus. Later, virologists at the CDC isolated rubella virus from the cataract material that surgeons removed from Anna’s eyes.

  Anna underwent corrective heart surgery at eleven weeks of age. Several years later she would require another heart surgery to replace one of her heart valves. Postoperative complications after the first surgery led to a tracheostomy—a hole cut into her windpipe, on the front of her neck, through which she breathed for the first three years of her life. She had cataract surgeries at three and five months of age and later multiple eye surgeries to extract scar tissue and to reattach a detached retina. She was also put under anesthesia several times so that doctors could take pressure measurements for glaucoma, raised pressure inside the eye. Glaucoma affected both of Anna’s eyes, as it had those of Stephen Wenzler, the boy born with congenital rubella in Toms River, New Jersey, in 1964.

  Anna benefited from one medical advance that was not available to Wenzler. At the age of two she received a cochlear implant that gave her a degree of hearing. Her father remembers how his heart leaped the first time that she reached up and turned her “ear” off when he scolded her—it meant that she was hearing him.

  Anna’s cataract surgery provided her with what is called navigational vision—in Chip MacConnell’s definition, she could see a wall just before she ran into it. As she grew—and was joined by a healthy baby sister, Danielle, in 2004—she attended her local elementary school in Centerville, Ohio, where the family had since moved. There she became something of a rock star; the whole school learned to sing the school song in sign language.

  Anna took great pleasure in life. She gleefully slid along a backyard zip line and loved to lie under the kitchen window, watching the play of the sun on translucent toys she held up to the light. She played soccer with her service dog, a goldendoodle named Cadi, at her side. She fought with her sister from time to time; there was pinching and pulling of hair. She identified people she knew by feeling their thumbs. She had a radiant smile and an extraordinary bullshit detector.

  In the autumn of 2011, when she was ten years old, Anna began flagging on the soccer field and having a hard time staying awake at school. When walking, she leaned on Cadi heavily in a way she hadn’t done before. It became clear that her heart was failing. She was turned down for a heart transplant, in part because of the uncertainty inherent in putting a new heart in someone with congenital rubella; it had never been done, and there was a question as to whether lurking rubella in Anna’s system would infect and damage a new heart.

  In September 2012, a few months after her eleventh birthday, Anna died. Her last hours, in her hospital bed, were peaceful. Cadi was curled in a ball in the corner of the room. Her family was around her, and the ceaselessly beeping machines had been turned off. Anna repeatedly rotated her hands so that her palms faced out, and then in, and then out, and then in. She was signing the word “finished.”

  • • •

  Betsy MacConnell’s positive blood test for antirubella antibodies in October 2000 seems likely to have resulted from an infection when she first became pregnant two months earlier, not from her 1972 vaccination. Either she had not produced antibodies in response to that long-ago injection or they had waned over time or they were simply ineffective—precisely the outcome that the Yale pediatrician Dorothy Horstmann had worried about all those decades earlier as she harangued Merck’s Maurice Hilleman to switch to Plotkin’s rubella vaccine.

  • • •

  Debi Vinnedge at Children of God for Life received a reply from the Vatican in June 2005. The Pontifical Academy for Life had produced a study documenting the use of cells from aborted fetuses in vaccine making and addressing whether it was sinful for Catholics to have their children immunized with such vaccines.17 The powerful Congregation for the Doctrine of the Faith had signed off on the study, and it had been translated from the original Italian for transmission to Vinnedge.

  The report was carefully argued, using arcane concepts from moral philosophy. But it began by noting that, among the vaccines made using human fetal cells, the rubella vaccine was “perhaps the most important due to its vast distribution and its use on an almost universal level”—and because of the particular risk at which rubella put fetuses.

  The report’s bottom line was this: so long as no alternative vaccines existed, it was “lawful” for Catholic parents to have their children immunized with vaccines made in fetal cells, “in order to avoid a serious risk not only for one’s own children but also . . . for the health conditions of the population as a whole—especially for pregnant women.”

  The Academy admonished the companies for producing vaccines that forced parents to choose between acting against their conscience and putting the health of their children, and others, at risk. And it urged Catholics to fight for alternatives and to do their all “to make life difficult for the pharmaceutical industries which act unscrupulously and unethically.” But it did not call for Catholics to refuse all vaccinations with fetal-cell–produced vaccines.

  In 2009 Vinnedge and her constituents were dealt a blow when Merck said it would no longer make the measles, mumps, and rubella vaccines as separate injections. The company said that making the vaccines, which accounted for just 2 percent of its measles, mumps, and rubella vaccine output, was not in the best interests of public health.18 It pointed to recommendations from the CDC’s Advisory Committee on Immunization Practices and from the American Academy of Pediatrics, which preferred the combined MMR vaccine on the grounds that it meant fewer shots and better vaccine coverage.19 Asking parents to make two or three doctor visits for two or three different vaccines presents a greater risk of missed injections, the reasoning goes, and during the protracted process, children are at risk for the diseases that they haven’t yet been vaccinated against. (The CDC advisers also endorsed a four-in-one vaccine called ProQuad, in which Merck added its chicken pox vaccine to MMR.)20

  Merck had initially indicated to a parent affiliated with Children of God for Life that it would continue production of monovalent vaccines.21 When it stopped, Vinnedge and her group felt betrayed. In 2015, when there was an outbreak of measles that began at Disneyland, Children of God for Life issued a press release under the headline “Blame Merck—Not the Parents!” The company’s “rash” decision, the group wrote, “left families who cannot use the aborted fetal MMR in good conscience, unprotected.”22

  CHAPTER TWENTY-SEVEN

  The Afterlife of a Cell

  Philadelphia, 2014

  Bethesda, 2016

  Developing vaccines is probably one of the most productive things you can do, simply because if you succeed in getting one made, you watch a disease disappear.

  —Alan Shaw, former executive director of vaccine research at Merck1

  In his laboratory at the Wistar Institute on a spring day not long ago, Rugang Zhang was waxing enthusiastic about some cells luxuriating in what looks like an overgrown fridge but is in fact a tissue incubator. The cells are an important, familiar tool for Zhang, a Chinese-born scientist who studies how cells age and how ordinary c
ells transform into cancerous ones. “Cancer cells have so many alterations they are hard to track, but WI-38 is essentially normal. Which is why it’s a very important biological system, even in our days,” Zhang explains.

  Look at a photo of Zhang’s WI-38 cells on this late April day, and you might be underwhelmed: it shows a motley assortment of purple-stained, spindly bodies; they are typical fibroblasts, pumping out the ingredients of the extracellular matrix—the noncellular scaffolding that holds tissues together. Turn to a second photo, and those same skinny cells are hardly recognizable. Their once-streamlined bodies are bloated and bright turquoise, their shapes various, their neat uniformity gone. They look unruly. And they are. These are elderly cells, their powers waning, their interiors increasingly decrepit and disorganized.

  It hasn’t always been so easy to identify aging cells. The turquoise is a dye that Zhang added because it stains an enzyme that accumulates when cells have hit the Hayflick limit and stopped dividing. How do scientists know that this enzyme reliably marks a cell’s old age? They learned this in part by studying WI-38.2 This is one of the many ways that WI-38 cells have pushed aging research forward, because they so reliably age in the lab, allowing scientists to study how that process unfolds. The importance of this work across the spectrum of human health is enormous; it can also be heartbreakingly compelling. Robert Goldman, the chairman of molecular and cell biology at Northwestern University’s Feinberg School of Medicine in Chicago, Illinois, is using WI-38 cells to try to understand why cells age prematurely in patients with progeria, a rare, inevitably fatal disease that ages children so rapidly that they look like they’re eighty years old before they’re ten.3

 

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