by Sid Holt
On December 4, Sanofi executives held a press conference to try to calm the storm. It didn’t work.
From Sanofi’s vantage point, the growing outrage was all a big misunderstanding. The company felt the whole mess came down to one tiny mistake, really a single word in the November 29 press release: “severe.” By saying that people without previous exposure to dengue were at higher risk of getting “severe dengue” if they were given Dengvaxia, Sanofi had caused unnecessary concern.
Sanofi had taken the word “severe” straight from the language of its clinical trial design. But out of that context, it took on a different meaning.
Ng Su Peing, Sanofi Pasteur’s global medical head, had the job of fielding questions at the company’s press conference. “The general public in the Philippines thinks of severe dengue as something that’s devastating, that could lead to death,” she says. “[The announcement] was conveyed in a way that really caused alarm.”
“Severe dengue,” by the study’s definition, covered a broad category of symptoms—from fever and gum bleeding at one end of the spectrum to the sometimes fatal hemorrhaging and shock at the other. In the clinical trial, no participants died of dengue, and reported cases of “severe dengue” fell at the milder end of the spectrum. Four out of every 1,000 children vaccinated without a previous infection had a higher risk of developing such disease over a five-year period. That compared with 1.7 per every 1,000 children without a previous infection who weren’t given the vaccine.
In the spirit of transparency and scientific accuracy, Sanofi had crafted its press release carefully to adhere to the trial’s official terminology. But it had left out both the numbers and the nuance, leaving the public to interpret “severe dengue” as they would.
“If you were a lay person and you heard ‘severe,’ what else would you conclude?” says Anna Ong-Lim, a physician who is currently president of the Pediatric Disease Society in the Philippines.
Regulations prevented Sanofi from promoting Dengvaxia to the public directly, so the company stayed silent on social media. Instead, it continued to press its data-driven case with high-level stakeholders in the country. “Maybe it seemed overly scary, but actually it’s not scary at all,” says Triomphe, a former McKinsey consultant, recalling how frustrating it was to witness the public’s panic build. “It’s not changing at all the overall benefit/risk profile of the product.” He says in hindsight, the situation was more politicized than he realized: “Probably our voice was not hearable or understandable,” says Triomphe.
Nor was Sanofi the only one struggling to cut through the noise. So, too, was the Filipino health department. “Every day we were getting drowned out,” says Eric Domingo, undersecretary of health. “It was exhausting.”
In July 2019 I visited Domingo at his office at DOH’s leafy campus in central Manila. He was dressed in shirtsleeves and running late. The department was one week into a dengue alert, months into a measles outbreak, and managing occasional reports of diphtheria.
The affable Domingo speaks like a man who is trying to piece together the past two years, or maybe like one trying to peel himself off the pavement after being run down by a truck for the sixth or seventh time. Worn down, beat up, but not unable to appreciate the occasional absurdity of all that has happened.
The Dengvaxia mess began, more or less, on his first day on the job. He started December 1, the morning the government suspended the vaccination program. The timing protected him from the accusations made against others in the department, and he became the agency’s spokesperson and point man on the matter.
“It just snowballed into this gigantic thing,” says Domingo. “We were thinking we have to communicate the risk—so sit down, now that we know this, what are the risks for these children, what are we going to do, how do we mitigate that risk, how do we take care of them and how do we tell them? I guess initially everybody just expected it to go smoothly.”
What they didn’t anticipate was the spark that would ignite the furor to come: the reports of “Dengvaxia deaths” that began bubbling up almost immediately. “It was all there on social media, and then quite a few TV stations were showing autopsies—death number one, death number two, like a countdown every day,” says Domingo. Meanwhile, protests proliferated.
The country’s health workers, typically beloved figures in their communities, were chased away as “child killers.” Parents didn’t want their vaccinations or even basic medicines like deworming pills.
The Health Department itself was struggling to get information on some of the death reports. Meanwhile, the public demanded answers.
It was during this particularly toxic period of confusion, fear, and outrage, with allegations, misinformation, and unsubstantiated reports of Dengvaxia deaths flying around the internet, that the Blue Ribbon Senate Committee in the Philippines conducted a series of hearings on the vaccine debacle in late 2017 and early 2018.
Ostensibly a fact-finding operation, the hearings—hours long and televised widely—served as something between popcorn-worthy political theater and a public flogging. At their center, as master of ceremonies, was Richard Gordon, a seventy-four-year-old senator with a special gift for grandstanding.
Gordon wasn’t especially concerned with questions of risk and what, in real terms, Sanofi’s announcement meant for the Philippines—it was a given that the country had bought a vaccine that put some children in harm’s way—he was focused on how that had happened.
A news personality and litigator, Gordon presided over the hearings—and the large cast of summoned bureaucrats, politicians, scientists, and drug company representatives—with a gravitas that frequently gave way to fits of showy outrage. He grilled. He lambasted. He flashed righteous fury. When it came to discussion, he often wouldn’t have it—barking at witnesses who tried to give more than a yes or no answer or flustered scientists who refused to reduce a complicated technical matter to one word. He admonished one trembling functionary for trying to read from a piece of paper.
He mocked everything from witnesses’ accents (especially that of the Frenchman Triomphe, whom he referred to as “Mr. L’Arc de Triomphe”) to their baldness. He made insinuations and reserved special ire for Garin, the former health secretary, despite the fact that she postponed an emergency appendectomy for four days in order to testify.
But Gordon had also come prepared, ready to connect some dots for a public that was hungry for someone to blame. While the previous government pleaded that it had pursued an urgent public health good with resourceful, red-tape-shredding efficiency, Gordon alleged it was a sneaky and corrupt conspiracy that recklessly endangered hundreds of thousands of Filipino school kids. The political agenda gave the hearings a through-the-looking-glass quality at times where even basic realities seemed in dispute—like whether dengue was that much of a public health concern at all.
He homed in on Garin and Aquino’s meetings with Sanofi and raised questions about the timing—making hay of the fact that a few weeks before the Philippines approved Dengvaxia in December 2015, the president had received the drug company’s executives in Paris. (Aquino had been in town for the Paris Climate Agreement and met with many other French executives as well.) He hammered on the half-truth that the government was giving out Dengvaxia before its clinical trial had even ended. (Sanofi was conducting long-term follow-up of trial participants through 2017, but it had completed its study and registered the product in accordance with WHO guidelines.) Gordon went after Sanofi, too, pointing to the company’s long history of settlements with pharmaceutical regulators around the world.
Over the course of the hearings, the media continued to report on suspected Dengvaxia deaths, cases in which children who had gotten the vaccine later died. Some outlets—but not all of them—were careful to report that the link between the vaccine and the deaths had yet to be substantiated. The parents of those children also participated in the hearings, at one point holding their photographs up to the audience in the room.
/> Gordon’s committee ultimately produced a report on the Dengvaxia scandal calling for the prosecution of Aquino, Garin, and other officials, though some senators refused to sign it and wrote dissenting opinions. When I met Gordon in July, he was working late in his capacity as the chairman of the Red Cross in the Philippines. It was past seven p.m., and he and his staff were making arrangements to send medical tents to the regions most impacted by the ongoing dengue outbreak.
As for whether or not Dengvaxia caused the deaths of the children whose photos were displayed in his hearings, Gordon said, “I have no findings sufficient for a belief or a conclusion that it can kill. I just have the finding that [Sanofi] had been forewarned by everybody and his uncle” that Dengvaxia had problems.
The Gordon hearings were winding down when it became apparent that the Philippines had an even bigger but not totally unrelated health crisis on its hands: measles. The country recorded more than 21,800 cases in 2018, up from 4,585 the previous year. The year 2019 has been even worse: through October 19, the health department had tallied 42,612 reported cases and 566 deaths, many of them children under nine months of age.
The country’s immunization coverage rates have lagged in recent years, and the Dengvaxia scare made things far worse: a survey from the UK-based Vaccine Confidence Project found just 32 percent of Filipinos thought vaccines were important in 2018, down from 93 percent in 2015.
Despite the sobering public health situation, the health department’s Domingo says measles just opened up another round of finger-pointing over which side was more responsible. “When you have two completely polarized groups, it doesn’t quiet down,” he told me. “It just continues.”
Indeed, the blame game was in full swing when I visited the Philippines over the summer. Few were spared, but one woman in particular came up over and over again.
A Dubious Assertion
Acosta, the chief public attorney, occupies a unique role in the Philippines. As part of the nation’s Department of Justice, the Public Attorney’s Office (PAO) has a charter to serve the indigent with free legal services. Acosta has led the office since being appointed to her post in 2001.
On the July day I visited the PAO, which occupies the top floor of a government building in Manila, the tiny foyer hummed with a semieffective air-conditioning unit and was crowded with members of the public. A large photographic portrait of Acosta hung on one wall. People looked busy all around, moving with a sense of purpose among stacks of paper that were piled high on tables, chairs, and every other surface.
For parents who believe their child died or fell ill because of Dengvaxia at the hands of the government’s public immunization drive, Acosta’s advocacy has earned their loyalty. She is the rare government official they trust, their lonely crusading champion for justice.
As I waited in a small plastic chair, a security guard showed me a video on his cell phone of a man being hacked to death, his way of explaining to me the types of cases they get there. I told him I was there about Dengvaxia, and he nodded. “Oh, many cases.”
Acosta was not available to see me, but I was allowed time with two women attorneys (it was against their communications policy to give their names, they said) who had both worked for the PAO for roughly a decade. They had been leading the work on Dengvaxia cases, which at that point encompassed 144 investigations and 44 criminal cases. (PAO had filed 91 criminal and civil cases through early November.)
The two attorneys repeated to me a dubious and controversial assertion that their office had made in court filings—that it was Dengvaxia itself that had killed the children directly rather than a severe dengue infection of the kind that Sanofi had warned about.
They explained that PAO had autopsied all the bodies and in all cases found the underlying cause of death had been “viscero- and neurotropic-like disease” caused by Dengvaxia. They did not believe dengue, or vaccine-enhanced dengue, was related to the deaths (though among the deceased, one child’s death certificate had listed dengue as the cause of death).
The attorneys dismissed criticism of the PAO’s Dengvaxia work as “personal attacks” and defended the agency’s methods and forensic findings, saying they were confident they would prevail in court. They argue they have seen evidence—the autopsied bodies—that PAO’s many critics have not and rejected the idea that PAO was responsible for whipping up fear about vaccines in the country. That, they said, was caused by the launch of a drug, Dengvaxia, that hadn’t been fully tested.
The stated causes of death the PAO attorneys have cited—viscerotropism and neurotropic-like disease—critics say, come not from credible autopsy findings but rather from Sanofi’s boilerplate risk disclosures for Dengvaxia.
Many of the vaccines that protect us from terrible diseases present a small risk of adverse events. On very rare occasions, the shot for rotavirus, for example, causes a reversible tangling of the bowel called intussusception. Likewise, there’s a one in 2.4 million chance one will contract polio from the live polio vaccine. And yellow fever vaccine very, very infrequently leads to viscerotropic disease, a deadly phenomenon involving organ failure.
Because Dengvaxia is constructed with the viral backbone of the yellow fever vaccine, Sanofi listed viscerotropism and neurotropism as possible risks for Dengvaxia, and studied the vaccine for this effect in trials. (None was observed.)
Medical experts in the Philippines publicly decry PAO’s forensic investigators as unqualified and their findings as utterly wrong.
“They’re not even pathologists. They’ve not had a single day of training,” says Raymond Lo, an anatomical and clinical pathologist who is board certified in both the U.S. and the Philippines. “They were conducting autopsies in public, in full vision of television cameras, exhibiting all these bloody organs. You could spread disease. They made a mockery of the whole thing.” (As a former administrator at a hospital that procured Dengvaxia for the government immunization drive, Lo has been charged by the PAO with reckless imprudence resulting in homicide; he is fighting the charges.)
Lo has reviewed thirty-three of PAO’s forensic reports—all of which, he says, cited viscero- and neurotropic-like disease as causes of death, despite clinical notes, death certificates, and hospital pathology reports indicating the child in question died of natural causes. The Philippine Society of Pathologists has also challenged PAO’s findings, as have the Danses. Antonio Dans notes that the PAO’s forensic investigators have based their conclusions all on two basic observations—organ swelling and hemorrhaging. “Those simple things you can find in almost every child who dies,” says Dans.
The parents whose children were autopsied by the PAO offered radically different descriptions of their sicknesses and deaths. For some, the events had been sudden; in other cases, multiple hospital stays and surgical procedures were involved. Some had died weeks after vaccination, and others years. What the stories had in common was a list of general symptoms—fever, headaches, cough, dizziness, UTIs, irritability, fatigue, swollen limbs. And also a shared belief that before Dengvaxia, their child was healthy and normal—and after, he or she had died.
Many of the parents didn’t initially suspect Dengvaxia as the cause of the child’s death or illness but reached that conclusion after talking to someone—the kid’s teacher, a bystander at the funeral, a nurse at the hospital, who then connected them with the Dengvaxia Victims Facebook group. It had never made sense to these parents that their once healthy children were dead, and after hearing about other kids, it made more sense that it had been Dengvaxia than what was diagnosed or written on the death certificate: leptospirosis, rabies, leukemia, an enlarged heart, and so on.
“One Death Is One Too Many”
In March, the Filipino government indicted a wide range of individuals for their alleged roles in the so-called Dengvaxia deaths. They included former health secretary Garin and six Sanofi employees, but also a cast of more peripheral figures—Julius Lecciones, executive director of the Philippine Children’s Medical C
enter, which procured the vaccine; Rose Capeding, the researcher who investigated Sanofi’s dengue trial in the Philippines; and a handful of career employees at DOH. They were all charged with “reckless imprudence resulting in homicide,” which is punishable by up to six years in prison. All of the accused deny any guilt. Sanofi says it strongly disagrees with the DOJ’s findings and it is “vigorously defending” its employees.
When I spoke with some of the defendants in July, they were having a hard time. Many had left their jobs and were struggling to reconcile their situation with the fact that they had spent their lives serving the public. Facing a trial was expensive and stressful; it also made them public targets. One of the accused, Lyndon Lee Sy, a former Health Department spokesperson, died of a heart attack in September; his family and friends blame the weight of the case. Others noted the prosecution of researchers set a chilling precedent.
Richard Anthony Fadullon, the senior deputy state prosecutor for the Department of Justice, told Fortune that linking the deaths to the vaccine and the administration’s “rushed” implementation will be difficult. The PAO’s methods and findings, he admits, may complicate his efforts. But he says prosecuting the cases filed by the PAO is a worthy pursuit. “We cannot close our eyes to the deaths that happened,” said Fadullon. “One death is one too many. It matters a lot to the family, and it matters a lot to government.”