“Vaccines are safe,” says Narayan Nair. “That’s the message we need to get out there.”
Nair is a physician. He is also the head of the Vaccine Injury Compensation Program—the system through which the U.S. government has, over the past three decades, paid more than $4 billion to people who claim to have been harmed by vaccines.
According to its public record, from 2013 to 2017 alone, the program paid out an average of $229 million a year to patients and their families. The average payment was about $430,000.
As America enters the worst measles outbreak since the disease was declared eradicated two decades ago, it is worth examining this rarely talked about element of vaccination requirements. The Vaccine Injury Compensation Program has long percolated at the heart of misinformation and misunderstanding. It also raises questions about where large sums of tax money are flowing.
For most drugs—actually, every type of drug other than vaccines—the manufacturer can be legally liable for harm that results from a product it sells. Vaccines are produced by privately held pharmaceutical companies, but they have a unique arrangement with the U.S. government: When a person reports harm that could feasibly be related to a vaccine, a government program—not a pharmaceutical company—pays compensation.
The fact that the government pays hundreds of millions of dollars every year to people who claim they’ve been injured by vaccines could be an alarming thing to see in your Facebook News Feed, especially if you’re a parent whose pediatrician assured you that vaccination is nothing to worry about. In one case, a viral article called “Flu Vaccine Is the Most Dangerous Vaccine in the U.S. Based on Settled Cases for Injuries” points to these payments as evidence of vaccines’ danger. The post was published on a site called Health Impact News: News That Impacts Your Health That Other Media Sources May Try to Censor! and appears to have 210,000 likes on Facebook.
Subsequent Googling may only make things worse. Search for Vaccine Injury Compensation Program, and one of the first results is a site that appears to be an impartial source of information: the National Vaccine Information Center. But it is a private organization unrelated to the program, and it is a favorite of the noted conspiracy theorist Alex Jones, who described it as “the best-informed group trying to expose the dangers of vaccines.”
The head of the center, Barbara Loe Fisher, has appeared on Jones’s show several times. One time she made the case that vaccination had become a political tool to gain access to Americans’ DNA for nefarious purposes. “So they’re using the vaccine-monitoring system as the skeletal system for a total takeover of health care,” Jones surmised, blaming Barack Obama. “Then they’re using bioethicists to bring back eugenics and take over health care.”
The road from a quick question about the flu vaccine to certainty about state-sponsored genocide has never been shorter.
The “vaccine-hesitant” community is a unique ideological mix of anti-corporate liberalism and anti-government individualism. Over the years, the VICP has been criticized for paying too much and for paying too little.
The Vaccine Injury Compensation Program’s first payment was made in 1988, but its current operations can only be understood through the lens of decades prior. In the spring of 1970, after she had received a dose of oral polio vaccine, eight-month-old Anita Reyes stopped moving her legs. Paralysis spread upward to her waist, resulting in permanent incontinence, in the classic pattern of polio.
Her father filed suit against the maker of the vaccine, Wyeth Laboratories. Its polio vaccine at the time involved a live virus that was capable, in extremely rare cases, of causing the disease itself. A jury awarded the Reyes family $200,000 on the grounds that even though the risk of developing polio from the vaccine was known, the family had not been properly warned. Because the disease had, until the previous decade, paralyzed thousands of American children every year—it peaked in the United States in 1952 with some 21,000 paralytic cases—the known risk of the vaccine was heavily outweighed by the risk of going unvaccinated.
But as diseases like polio began to fade from memory, the American public began to worry instead about the specter of vaccine-related illness. Other lawsuits against vaccine manufacturers began to make news in the 1970s and 1980s. Vaccines for the disease pertussis were particularly targeted, having been tied to cases of encephalopathy. One lawsuit in 1978 increased to 73 by 1984. The average claim increased from $10 million to $47 million.
In several instances, damages were awarded “despite the absence of scientific evidence,” says Cody Meissner, the chair of pediatric infectious disease at Tufts University School of Medicine. As we spoke, his pager went off six times. “It’s impossible to prove a negative,” he emphasized to me, meaning that when an illness occurs shortly after a child receives a vaccine, it’s very easy to suggest a causal link, and not technically possible to prove that the vaccine was not the cause.
Because many cases against vaccines involve claims of permanent injury to children, they not only are difficult to argue, but can be expensive. With this in mind, the pharmaceutical companies that make vaccines began to shift their calculus. The drug-development process is costly and time-consuming, and not likely to be embarked upon without a high-likelihood payoff for a drug company’s shareholders. Developing a novel vaccine that could prevent hundreds of thousands of cases of a deadly disease—but cause a much smaller number of side effects that could lead to multimillion-dollar lawsuits—made a useful product an unappealing business proposition. During the 1970s and ’80s, some manufacturers began to withdraw from vaccine production.
In the midst of this, public-health officials grew concerned about the stability of the country’s continued supply of existing vaccines—and the dwindling business incentive for companies to invest in developing new ones. It was on these grounds that Congress passed the National Childhood Vaccine Injury Act of 1986 (also known as the Vaccine Act), indemnifying drug companies from further lawsuits.
From then on, instead of suing drug companies, people who alleged injury or illness related to a vaccine would file claims with a new entity known as the Vaccine Injury Compensation Program. When a person brings a case of reported harm, members of a team that currently includes Nair and 10 other doctors from the Department of Health and Human Services (all of whom have vaccinated their kids, Nair emphasized to me) review the person’s medical records. The team then recommends whether the case should be compensated or defended in “vaccine court,” the term for the federal claims court dedicated to hearing cases of vaccine injury.
Which brings us to the $4.1 billion.
“The creation of the VICP was a quid pro quo,” the Stanford Law School professor Nora Freeman Engstrom told me over email. People who may have been injured by vaccines would give up some ability to seek redress through the court system. In return, they would be assured swift and certain compensation. The program was charged by Congress to address claims “quickly, easily, and with certainty and generosity.”
If the government restricts individual rights for the collective good, the reasoning went, then that government should assume responsibility for the consequences. As one law review put it, the purpose was “to compensate children who had been injured while serving the public good.”
In a 2015 analysis of the program, Engstrom found that this was not the case. Only about a quarter of claims were being compensated, and often not in a timely manner. She cited the fact that the average vaccine-injury claim took longer to adjudicate than the average case alleging medical malpractice. “The VICP,” Engstrom wrote, “has simply failed to offer compensation as consistently, as quickly, as easily, or as simply as its proponents had predicted.”
Since Engstrom’s analysis was published, though, there has been a dramatic change. For most of the program’s history, the program denied a large majority of claims. But between 2015 and 2019, 77 percent of claims were compensated. In 2004, the VICP compensated just 57 cases. In 2017, it paid 706. Engstrom called the trend “a big shift.”
While this change brings the VICP closer to its initial mission, the sheer amount of money changing hands may also amplify public perception of the risk of vaccines. From a low of $54 million in 2006, total outlays steadily increased to $282 million in 2017, and are on pace to exceed that this year.
This time period has also seen rising public skepticism of the pharmaceutical industry and online conspiracies propagating more readily than ever. In January of this year, Nair and Meissner, along with the inventor of the rubella vaccine, Stanley Plotkin, addressed the growing concern that all of this money was exaggerating parents’ sense of risk. They wrote in the Journal of the American Medical Association: “Although the establishment of the VICP may support some arguments of those who question the safety of vaccines, its existence promotes wide acceptance of vaccination as a public good that is also humane to those who perceive they have been injured by this public good.”
Perception of harm is a concept that has proved trickier than the law may have predicted. The Reyes case could seem about as straightforward as possible: A child developed polio after being given an oral dose of a live polio virus. But even a case as apparently obvious as that is difficult to irrefutably prove—unless the patient had been monitored in a sealed isolation chamber to guarantee there had been no other exposure to polio virus.
In an attempt to standardize and expedite the compensation process, many of the decisions are based on a document known as the Vaccine Injury Table (the existence of which is stipulated in the 1986 law). It details myriad illnesses, disabilities, and injuries that are, as Nair put it, “presumed to be caused by a vaccine if no other cause is found.”
The key legal stipulation is that if the petitioner has experienced one of the injuries or illnesses in the table in a period after receiving a vaccination, she receives a presumption of causation. Unlike a criminal case, where a defendant is presumed innocent, the vaccine cases are to supposed to presume that vaccination was the cause—unless that can be disproved. So, as the VICP’s site states, “being awarded compensation for a petition does not necessarily mean the vaccine caused the alleged injury.”
As such, it estimates that approximately 70 percent of its payments are the result of a negotiated settlement “in which HHS has not concluded, based upon review of the evidence, that the alleged vaccine caused the alleged injury.”
With that in mind, the Vaccine Injury Table is long and regularly expanding—which could partially explain the steady increase in payouts. New additions include, for example, shoulder injuries and syncope (losing consciousness), both of which can have many causes. Another recent, better-documented addition (also described on the Centers for Disease Control and Prevention’s website) is that an influenza vaccine can, in extremely rare cases, stimulate the immune system to attack the nervous system in a pattern known as Guillain-Barré syndrome, leading to weakness or even paralysis.
Autism is notably not included in the table. In the early 2000s, the program started to receive a flood of claims about the disease. They were traced to a global conversation started the decade prior after a study of 12 people was retracted by The Lancet and widely condemned by the medical community. The reported relationship became the subject of numerous scientific investigations, none of which found any relationship. No question in the history of vaccine reactions has been so thoroughly litigated. Given the amount of available evidence, autism is one of the claims that Nair and colleagues can confidently deny, he told me. The legal precedent dates to 2010, after more than 5,000 cases had been filed claiming a link between vaccines and autism. The result was a legal review known as the Omnibus Autism Proceeding, which ultimately found no causal relationship between vaccines and autism spectrum disorder.
Officially, the table is updated by the secretary of health and human services. But these updates are based on new research, reports of adverse events, and an advisory committee that meets four times a year (Meissner is the incoming chair). In the interest of transparency and sidestepping allegations of conspiracy, the meetings are open to the public. Anyone can join, by phone or in person, and argue that something should or should not be included in the injury table. The minutes for every meeting are online. The next one will take place on June 6 and 7. The advisory committee makes a point of including among its members parents who have received payments from the fund. Meissner is insistent that he wants to hear from everyone in the process.
To that end, petitioners’ legal fees are covered by the VICP, which paid $25 million in 2017 in fees alone. Accordingly, there are attorneys and law firms that specialize in vaccine-injury claims. Some of them advertise on daytime TV. Though the sheer numbers and odds of payment could suggest some degree of financial incentive to bring claims, Meissner prefers this to a system in which bringing a claim is difficult and expensive. It would be unfair to families with insufficient means to hire a lawyer, he said.
In the same spirit of consumer advocacy, the law also requires health-care professionals to report adverse events that happen after immunization, through what’s known as the Vaccine Adverse Event Reporting System. This level of attention to side effects is unprecedented among pharmaceutical products. Though this sort of federal tracking serves as fodder for conspiracy rants by the likes of Alex Jones, the same data could reassure parents that there’s little to fear. According to the CDC, some 300 million doses of vaccines are distributed in the United States in an average year. The program reports an average of about 500 petitions, of which it compensates about two-thirds. That’s about one compensation for every 1 million vaccine doses. Working from the estimate that 70 percent of the awards are not clearly attributable to vaccines, the payments estimate a rate of injury or illness caused by vaccination at about one in 4.5 million.
“I don’t think any doctor would say, ‘Vaccines are safe,’” Meissner told me, in stark contrast to Nair’s approach. But many doctors do, depending on what level of specificity and information a patient is looking for. Some physicians want to talk about the likelihood of every possible risk and make a deeply researched, analytic decision. Others tend to dwell on worst-case scenarios and just want to top-line advice, simply put: Vaccines save lives; vaccines are safe; get vaccinated. The problem for doctors and public-health officials is not knowing exactly who’s on the receiving end of any such message.
A person might say “drinking water is safe” without meaning to downplay the cases of waterborne gastroenteritis. Vaccines are, as all things in life, not without risk. In the mid-20th century, when vaccines were rapidly adopted as common practice, incurring a small personal risk for the greater collective good may have been a more obvious tenet of life in a modern society. This was at least part of the idea behind a government program aimed at taking care of the injured and ill. While we watch as measles returns, it may have less to do with ignorance than the basic fact that this communal social fabric has been displaced by distrust, isolation, and fear.
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