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The Best American Magazine Writing 2020

Page 8

by Sid Holt


  I knew I was seeing only a small slice of these women’s lives, but Laumer and her friends didn’t seem quite as miserable as the women I saw in so many other corrections facilities. “Don’t count your days,” they say, riffing on a quote usually attributed to Muhammad Ali. “Make your days count.” No one said that when I did time. Maybe it was just a show or a fleeting, out-of-character moment. But as I watched them howl an out-of-key rendition of “We Are the Champions,” I hoped so much that it was all real.

  Erika Fry

  Epidemic of Fear

  Fortune

  FINALIST—REPORTING

  The vaccine Dengvaxia had been expected to be a public health triumph and a financial bonanza for its manufacturer, the French pharmaceutical giant Sanofi—until the drug was blamed, perhaps mistakenly, for the deaths of 148 children in the Philippines. “What happened to Dengvaxia could happen to any imperfect medical innovation in the age of social media,” writes Erika Fry in “Epidemic of Fear, “for here, in the emotional gyre of politics, anxiety, and misinformation, the rational questions and doubts of science can quickly be branded as crimes and conspiracies.” Fry, said the judges, “deftly explains both complex science and social contagion, unpacking an issue—fear of vaccines—that is one of the most pressing of our day.” A graduate of Dartmouth College and the Columbia School of Journalism, Fry worked as an investigative reporter at the Bangkok Post before joining Fortune in 2012. She is now a senior writer at the magazine.

  The scene is quiet, eerily so. A camera moves over a motionless child—dressed in church clothes, laid out on a metal table—and then pans over a huddle of grieving family members. There is another video just like it, and another, and another—an entire series that, collectively, offers a startling amount of footage showing children lying dead in a morgue in the Philippines.

  Two stoic-looking women figure prominently in the videos. One of them, Annie Gabito, has a stern and commanding presence. The other, Persida Acosta, is typically at the center of the scene. Acosta, the chief public attorney of the Philippines, offers a word or hand to the grief-stricken family and, in one instance, with a look of serious inquiry prods the child’s lifeless body.

  Broadcast live on Facebook over the past two years, the videos have together been viewed millions of times. They were filmed after a forensic team assembled by the public attorney’s office—rather than by the government’s regular medical examiners—conducted autopsies of the children as part of its investigation into the deaths of 148 children.

  Citing these autopsy results, Acosta and the family members all point to the same culprit for the children’s deaths: Dengvaxia, made by French pharmaceutical giant Sanofi, the first and only vaccine approved to protect against the dengue virus, which infects an estimated 390 million people around the world each year.

  I met the parents of eighteen of these children this July. They had come from all over the chaotic, gridlocked megacity of Manila one Saturday to the modest two-story home of Gabito, who works unpaid for a Filipino nonprofit called Volunteers Against Crime and Corruption and who now spends much of her time focusing on the families of the 148 dead children she calls the “Dengvaxia Victims.”

  While Gabito made lunch, I sat at a table in the upstairs kitchen as parents filed up, one by one, to share their stories. They each wore a T-shirt with a picture of their deceased child framed by name and the Dengvaxia Victim number assigned to them by Gabito’s organization. Many of them came with their child’s Dengvaxia card, documenting the dates of vaccination and a sleeve or two of photographs, before-and-after-inoculation pictures that showed their kids healthy (fourth-grade graduation, family photos, a selfie with a pet cat) and sick (swollen body parts or tethered to a hospital bed and an IV drip). A few volunteered photos from their child’s autopsy, an image of a brain or internal organs, which they said showed the telltale signs of Dengvaxia’s horrific effects.

  Sumachen Dominguez, a lead organizer of the group, told me, “Nobody is listening to our anguish.”

  And there is some truth to that now. Last year, the story of the Dengvaxia Victims was the stuff of government hearings and wall-to-wall TV coverage—a made-for-the-movies narrative about dozens upon dozens of schoolkids dying, like sacrificial guinea pigs, as the Philippine government prematurely pushed its dengue immunization drive. There was even a fitting corporate villain—a foreign pharmaceutical giant, with $42 billion in annual revenue, that appeared to confess that its vaccine had a serious flaw.

  But while the Philippine news media and most of the politicians involved have moved on, the Dengvaxia controversy continues to have a profound and lasting impact. A handful of Sanofi executives and employees have been charged with “reckless imprudence resulting in homicide,” as have numerous Filipino government health officers and a couple of scientific researchers, for their alleged roles in the Dengvaxia immunization program. Those trials are planned for next year.

  For Sanofi, it has been devastating financially as well. Right up through Dengvaxia’s 2016 launch, the Paris-based company, one of the premier vaccine makers in the world, had projected booming sales and a major win in terms of global goodwill. It is struggling to sell Dengvaxia anywhere now—despite its regulatory approval in the United States, the EU, and an additional twenty countries—and the vaccine’s inclusion on the World Health Organization’s Essential Medicines List. (Sanofi took a $186 million write-down on Dengvaxia in 2017, but the total loss—counting everything the company spent on development and infrastructure, plus vanishing sales and damage to its reputation—is likely several times that.)

  Much worse is the damage that has been done to public confidence in vaccines: In the Philippines, where immunization coverage was already dangerously low, the Dengvaxia scare caused vaccination rates to fall even further, opening the door to infectious diseases once believed to be on the wane. Over the past two years, there have been new outbreaks of measles and polio. When it comes to combating dengue itself—a scourge that can be bone-crushingly painful for some and deadly for others, and which in recent decades has emerged as the world’s fastest-spreading and most common mosquito-borne illness—the opportunity cost has been grave as well.

  Which brings up the first of this tale’s tragic, even Shakespearean twists: the fact that the Dengvaxia controversy may well bury forever a vaccine that actually works—not for everyone but for huge swaths of populations in countries where dengue is an urgent and growing public health problem. Indeed, if the vaccine were an active part of global health campaigns, it would likely save many lives annually. That’s plain to see, given that devastating dengue outbreaks have tested governments this year from Pakistan to Honduras to, yes, the Philippines.

  Twist number two is this: there is a good chance that Dengvaxia didn’t cause the tragic deaths of those 148 children in the Facebook videos.

  A Fiasco Foretold

  Innocuously titled “Sanofi updates information on dengue vaccine,” the press release went out to the world, in both French and English, at 11:36 a.m. Eastern Time on November 29, 2017. In the Philippines, the country where the most doses of the world’s first dengue vaccine, Dengvaxia, had been administered, it was just after midnight on November 30.

  Twenty months earlier, the Philippines had proudly been the first country to launch a public immunization program involving Sanofi’s vaccine, boldly taking aim at a disease that perennially caused agony for its citizens and taxed its overburdened health care system.

  Dengvaxia, which the Filipino government gave to roughly 890,000 children, had been feted globally as a public health triumph. The development of Sanofi’s vaccine was as complicated and technically challenging as they come. And it was the culmination of a broader effort that spanned decades and took billions of public and private dollars. Plus, in an admirably altruistic inversion of the Big Pharma playbook, the vaccine was being delivered first not to the rich Western countries that could pay the most but to a poorer one that needed it more. It was a story to cel
ebrate.

  But here in Sanofi’s press release, buried in the middle of a dense paragraph of highly technical language, was a sentence that would surely give anyone in the Philippines pause:

  “For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection.” In other words, there were some people who wouldn’t be protected from dengue by Dengvaxia. In fact, the opposite: It put them at risk for getting sicker.

  The statement, which Sanofi had sweated over and planned around for days, lacked context, local or otherwise. It didn’t offer probabilities or degrees of risk; it didn’t explain what “severe dengue” meant or give people in the Philippines or Brazil, where another mass immunization drive was underway, or in any of the other fifteen countries where Dengvaxia was licensed, any clue how worried they should be. It just recommended that people who had never previously had dengue not get the vaccine.

  That was the moment the Dengvaxia fiasco began. It was also a fiasco foretold. While the vaccine had many boosters, a handful of scientists saw problems ahead. The most vocal of the critics was one of Sanofi’s own consultants, who warned the world that the vaccine would work—but only with a critical asterisk that health officials and the public needed to understand. Which meant the news that jolted the Philippines into a spiraling calamity on November 30 was, among researchers, the subject of ongoing study and a much-discussed possibility.

  “It seemed like a surprise, though it wasn’t a surprise,” says In-Kyu Yoon, a senior adviser for the International Vaccine Institute.

  “The communication around this was difficult,” says Gundo Weiler, a director with the World Health Organization (WHO) based in Manila. The intricacies of vaccine science and dengue, especially in an environment of fear, he adds, “are not so easy to understand—that was the problem of the whole situation.”

  Eric Domingo, who serves as undersecretary for the Department of Health of the Philippines, sums up the Dengvaxia tale best of all: “It just turned into this gigantic monster,” he tells Fortune. But what’s truly frightening is how quickly this monster formed and how easily. What happened to Dengvaxia could happen to any imperfect medical innovation in the age of social media—for here, in the emotional gyre of politics, anxiety, and misinformation, the rational questions and doubts of science can quickly be branded as crimes and conspiracies.

  Nothing about the development or administration of Dengvaxia was intentionally reckless, it should be said—though its story does contain elements of hubris, blind optimism, and questionable haste.

  That was clear from the start, when Chris Viehbacher became CEO of Sanofi in December 2008. Almost right away, he green-lit the building of a $398 million plant to produce Dengvaxia outside Lyon, France. The company was more than a decade into its dengue clinical development program, but this was a next-level, we’re-in-it-to-win-it commitment. Or gamble, perhaps. At the time, the vaccine candidate was still in clinical trials and years from reaching the market. There was a decent chance it could fail outright—but then, the potential was enormous. On an earnings call in 2010, Viehbacher told analysts that the drug “promises to be potentially the biggest vaccine we’ve ever sold.”

  Preventing dengue, which epidemiologists call a “neglected tropical disease,” was an enormous unmet need. There was no drug to prevent, treat, or cure the illness. And in the past half-century, as the virus swept from Southeast Asia to 128 countries, or roughly half the globe, cases had increased thirty-fold.

  Dengue is carried by the female Aedes aegypti mosquito, a resilient, disease-spreading pest—it also efficiently transmits yellow fever, chikungunya, and Zika, among other viruses—that has thrived in the modern, globalized world. The flying menace moves around on cargo ships and breeds in water that collects in, say, plastic waste and used tires. “It’s beautifully adapted to densely populated urban environments,” says Jeremy Farrar, director of the Wellcome Trust, a UK-based charity focused on global health.

  Sanofi executives expected that with a warming climate, the dengue-carrying mosquito’s reach would expand, too, spreading the miserable disease.

  Once commonly called breakbone fever, dengue is painful to endure. (The origin of the name “dengue” is not certain but is thought by some to come from the Swahili phrase ka-dinga pepo, meaning a cramplike seizure caused by an evil spirit.) Patients suffer debilitating spells of headaches, fever, and severe joint pain that can send them to the hospital with symptoms that can linger for two weeks. In the worst cases, patients experience “plasma leakage,” a life-threatening process in which the protein-rich fluid of the blood seeps out of vessels and into surrounding tissues.

  Most cases of dengue are not so severe (the majority are asymptomatic), but up to 5 percent of them are—resulting in patients who may in frighteningly abrupt fashion go into shock or suffer hemorrhagic fever that can lead to death.

  Experts contend no one should die of dengue. There’s a way to manage cases so that even the most severely ill recover, but that requires early detection and involves close monitoring and maintenance of a patient’s fluid levels over a period of days. That’s not easy for resource-strapped health systems, especially during outbreaks when dengue patients pile up in hospital wards. For that reason, dengue kills about 20,000 people a year.

  Given all that, Sanofi expected governments, not to mention donors like the Gates Foundation and GAVI, an international vaccine alliance, to happily shell out dollars to prevent the disease. But the potential market was even bigger than that. Viehbacher envisioned that Dengvaxia could one day be a vaccine for everyone—not just for the people who live in dengue-endemic countries but also for those in rich, Western countries who travel to them.

  That was exactly the sort of game-changing product Sanofi’s new CEO needed in order to transform the storied but doddering French pharmaceutical firm. Three of Sanofi’s top-selling drugs were soon to lose patent protection—and with them, a good chunk of the company’s revenues.

  Viehbacher himself symbolized change. The German-born Canadian was the first non-Frenchman to helm the company (which this year ranked number 288 on the Fortune Global 500), and many hoped he’d rev up Sanofi’s slow-moving and rigidly hierarchical culture. (Viehbacher, who did not respond to requests for comment on this story, was ousted in 2014.)

  Sanofi had grown into one of the world’s largest pharmaceutical firms through acquisitions. But it traces its history back to the days of Louis Pasteur, the renowned French scientist who, among other things, invented the rabies and anthrax vaccines. He founded the Pasteur Institute, the respected biomedical research institute—part of which became Sanofi Pasteur, Sanofi’s $6-billion-in-revenue Lyon-based vaccine business. Today Sanofi Pasteur produces much of the world’s supply of inoculations against flu, polio, and meningitis. Viehbacher saw huge potential in the business.

  Backed by Viehbacher, the dengue vaccine became a marquee project for the company, one that earned ink in Sanofi’s annual reports and regular mentions on earnings calls as the sort of innovative, globally relevant product that could power the company’s growth.

  Sanofi had to move quickly though. A number of other organizations had their own dengue vaccines in the works.

  Being first and fast to this potentially multibillion dollar market would be critical, and Sanofi tried to establish an edge by wringing excess time from the clinical and commercial development processes. Its trials ran on a compressed schedule, with Dengvaxia’s expensive Phase III studies beginning before Phase IIb had ended. The company also ramped up manufacturing years in advance so that it would have a ready supply when the vaccine was eventually approved.

  Determined to do everything possible to ensure the vaccine would become a commercial success, Sanofi created a new internal structure, the Lyon-based Dengue Company, that was designed to be an agile and all-encompassing “team of teams.” Every function—regulatory, ma
rketing, distribution—was represented in the unit to more quickly coordinate work.

  In May 2013, Viehbacher painted a rosy picture: “We’ve got ourselves a robust dengue vaccine,” he told analysts. He predicted the company would be producing 100 million doses annually by 2015. “This is a major not only public health issue but I think a commercial opportunity,” he said. “This affects half the world’s population.”

  Sanofi’s optimism, though, wasn’t fully supported by the drug’s test results: The company had already begun its two Phase III trials when the results from the Phase IIb trial came in. They were disappointing: Tested on 4,000 children in Thailand, the vaccine had reduced dengue infections in kids by just 30 percent in the two-year follow-up period. In short, the vaccine had fallen far short of expectations.

  But the Phase III results—based on two studies of 31,000 children in ten countries—were more promising. Dengvaxia didn’t work perfectly. But Sanofi and the scientific community believed they had a vaccine that could make a difference against dengue.

  Tackling a Year-Round Killer

  “Dengue is really, really difficult,” says Stephen J. Thomas, a professor at SUNY Upstate Medical University who started studying the virus as a doctor with the U.S. Army a couple of decades ago. Questions that were raised about the virus in the early 1950s remain unanswered today. “Half of the world lives at daily risk of being infected with dengue,” says Thomas, “but we don’t know why some people get sick and some people don’t. We don’t know why some people get very sick and some don’t. A lot of the questions that have plagued dengue researchers are the exact questions that have been so problematic to vaccine developers.” There’s not an animal model that comprehensively mimics the disease in humans, explains Thomas, who has been a paid adviser to numerous dengue vaccine developers, including Sanofi.

 

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