Before 100 million Americans got the polio vaccine starting in 1962, there were about fifteen thousand annual cases of polio, mostly in children. By the time the vaccination program finished three years later, there were fewer than five hundred new cases annually. That had fallen to only ten a year by the 1970s. Except for a single traveler who arrived in the U.S. in 1993 with polio, there has not been a case of the virus in North America since 1979.1 I 2 The World Health Organization has long had the global eradication of the crippling disease as one of its primary goals. But polio has been difficult to eliminate in some developing countries.3 The disease is endemic in Afghanistan and Pakistan where the Taliban ban aid workers, believing that Western countries conduct espionage under the guise of the health programs and that the vaccines are part of a covert CIA program to sterilize Muslim women.4 In Central African countries, particularly Nigeria, there are fears fed by rumors that the injections caused AIDS and include cancer-inducing agents.5 Health workers who have nevertheless tried administering vaccines have been attacked and killed.
While polio might be a distant memory in America, other contagious, and potentially deadly, diseases—measles, mumps, and rubella—have reappeared after medical science declared them eliminated. Doctors blame a modern-day anti-vaccine movement that was sparked by a 1998 study published in Britain’s prestigious Lancet medical journal. Twelve physician coauthors reviewed the cases of a dozen children hospitalized in London for inflamed digestive tracts and “regressive developmental disorder” (autism). Nine children lost their language skills after getting a combined vaccination for the three diseases. That was enough for the authors to conclude that “possible environmental triggers” (the vaccine) were connected somehow to the “developmental regression.”6
Much of the media reported the results by converting a “possible” trigger into “vaccines cause autism.” The study’s lead author, Dr. Andrew Wakefield, reinforced the most sensational coverage. In public appearances and lectures he was far more provocative and confident about a vaccine-autism link than he and his colleagues were in their peer-reviewed Lancet article. It was not long before some prominent Hollywood celebrities and alternative medicine advocates embraced the anti-vaccine movement.7 Lost in the tsunami of fear-mongering was that a year after the Lancet story, the U.K.’s Committee on Safety of Medicines completed a reappraisal of the evidence and concluded there was no link between the vaccines and autism.8 It took another four years before a different British medical council discovered that the dozen children directed to the study, and some of the funding for it, came from “lawyers acting for parents who were involved in lawsuits against vaccine manufacturers.”9 That prompted ten of Wakefield’s original coauthors to print a retraction in the Lancet, in which they stated, “No causal link was established between MMR vaccine and autism as the data were insufficient.”10 In 2010, the Lancet published a small, anonymous paragraph attributed only “on behalf of the editors.”11 It was extraordinary. The journal retracted the original paper and admitted it contained serious errors. Britain’s General Medical Council concluded that Wakefield was guilty of scientific misrepresentation and ethical violations regarding the study’s dozen children.12
The British Medical Journal delivered the coup de grâce with the disclosure that Wakefield and his coauthors falsified some of the supporting data and selectively chose results that only buttressed their conclusion.13 Since then, dozens of other clinical research studies have failed to demonstrate any causal link between vaccines and autism or other mental disorders. Wakefield was struck off the medical register in the U.K.14 Still, the anti-vaccine movement remains strong, with many parents hesitant to inoculate their children.II15
Although the modern-day anti-vaccine movement might have been sparked by a fraudulent 1998 scientific paper, the beginning of the public’s loss of faith in vaccines happened more than twenty years earlier. It was February 4, 1976, when an eighteen-year-old Army recruit, David Lewis, collapsed unconscious during a five-mile hike with his Fort Dix–based platoon. Lewis and some of his fellow soldiers had been battling respiratory problems. He had gone on the midwinter march against the advice of the platoon’s medical officer. His sergeant revived him with mouth-to-mouth resuscitation, but within a day Lewis was dead of pneumonia.16
An Army doctor sent samples of throat cultures from Lewis and eighteen sick soldiers to New Jersey’s Department of Health. Most turned out to be a common influenza virus.17 They could not, however, identify five cultures (that included the one from Lewis).18 Researchers knew that the influenza virus mutated, and they then believed (incorrectly) that a severe influenza was likely about every decade. More than twenty thousand had died in 1957 in the U.S. from the Asian swine flu. It had been eight years since 1968’s virulent Hong Kong bird flu killed forty thousand Americans.19
Worried that they might have stumbled across a new virulent influenza strain, the New Jersey Department of Health sent the mystery viruses to the Centers for Disease Control in Atlanta. There, alarmed researchers tested the sample positive for swine flu virus. Although swine virus was not isolated in a lab until the 1930s, most researchers thought it was responsible for the infamous Spanish flu that had killed upward of 100 million people in history’s greatest pandemic in 1918.20 The Spanish flu had killed between 500,000 and 700,000 Americans, more than ten times the number who died in World War I.21III
If a close variant of the Spanish flu had returned after such a long absence, it would mean that no one under the age of fifty had any natural antibodies. What was most important was to determine if it was transmissible from person to person. There had been two cases of swine flu in 1974 and 1975 but both patients had worked in farms where they were in close contact with pigs. None of their friends, fellow workers, or family got sick and the two who were ill recovered fully.22 More data was needed. Hospitals were put on notice to test all patients arriving at the emergency rooms for swine flu antibodies.
In several thousand blood tests taken at Fort Dix, close to five hundred tested positive for swine flu antibodies, including the sergeant who had done mouth-to-mouth resuscitation on Private Lewis. None had gotten sick yet. As for the four who had been ill with swine flu at the same time as Lewis, they had recovered. Lewis was so far the only fatality.23 Still, CDC epidemiologists concluded that hundreds of exposures meant the bug they had isolated was almost certainly transmissible between people.
The first the public heard about it was in a February 19 press conference. The CDC’s assistant director, Dr. H. Bruce Dull, read a prepared statement disclosing that the swine virus had been identified in a few patients at Fort Dix. There was little danger the virus would spark a “wildfire” epidemic, he said.24 The statement avoided any reference to the 1918 pandemic. No one wanted to pass along “doom and gloom” and get ahead of the known facts.25 Responding to a reporter’s question, Dull did admit the CDC had confirmed that the Fort Dix cases were quite like the 1918 flu virus.
That opened the media floodgates. The next day’s New York Times front-page headline was “U.S. Calls Flu Alert on Possible Return of Epidemic’s Virus.” The article, by the health and science reporter Harold Schmeck, started, “The possibility was raised today that the virus that caused the greatest world epidemic of influenza in modern history—the pandemic of 1918–19 may have returned.”26
When the CDC’s Advisory Committee on Immunizations met on March 10, there had not been a single case of swine flu reported anywhere in the world outside of Fort Dix. January and February are the peak months for influenza. New cases taper off starting in March. While it appeared there would not be any widespread outbreak for the current season, what about the next one? All agreed it was impossible to calculate precisely the odds for a swine flu pandemic. They decided the only “responsible approach” was to assume that “a pandemic was possible.”
The CDC Advisory Committee concluded that the foolproof way of guarding against a catastrophic epidemic was a mass immunization program. It would take months, however, before such a plan might get the necessary approvals. Completing safety testing and then manufacturing tens of millions of vaccine doses would be a massive undertaking.27 The public would have to be inoculated at the very latest several weeks before flu season kicked into high gear in mid-December (any vaccine needed two to three weeks to activate each person’s immunity against swine flu).28
David Sencer, the CDC director, distributed a memo warning that an untreated national swine pandemic would be devastating. The World Health Organization had adopted a “wait and see” attitude.29 Although a pandemic was certainly not inevitable, Sencer believed the government had to err on the side of public safety.30 His bottom line was a “Combined Approach.” Pharmaceutical companies would manufacture the vaccine from the swine virus isolated by the CDC. The Bureau of Biologics would handle all safety and efficacy testing, and the National Institute of Allergy and Infectious Disease would be responsible for oversight of the field trials. When vaccine production finished, the federal government would buy 200 million doses from the drug companies. At least 80 percent of Americans would get vaccinated at a network of assorted federal, state, local, and private medical facilities and clinics. It was an ambitious and complicated plan with an equally grand price estimate, $135 million.31
The HEW secretary forwarded Sencer’s recommendation to the White House where President Gerald Ford hastily convened an advisory panel of esteemed infectious disease experts, including the inventors of the two competing polio vaccines, Jonas Salk and Albert Sabin.32 They agreed that a swine epidemic was “possible” for the next flu season. They could not quantify if the chances were one in five or one in a million. A few suggested to start manufacturing the vaccine but waiting for more data before immunizing Americans. There was no time, unfortunately, for the more cautious approach. To produce the vaccine, pharma firms had to inject the CDC-isolated virus into millions of hen’s eggs, where it was replicated, harvested, and purified. According to the CDC’s Sencer, there were at most a couple of weeks to decide “go or no go.”33
Faced with such a short window, the scientists voted to proceed with mass immunization. They had reached the same conclusion as the politicians: it was better to err on the side of safety given the catastrophic consequences from a pandemic.34 Some of the scientists advising Ford later told the journal Science they felt the president was leaning to say yes before they even offered their advice.35
Ford had some reasons, totally separate from public medical and health considerations, to embrace bold action. The country was only four months from the two hundredth anniversary of the signing of the Declaration of Independence. The administration had planned grand celebrations for the Bicentennial and Ford hoped it might help reverse his abysmal approval ratings. They were the lowest of any president since World War II; he was the only one in Gallup history who did not top their “most admired man” list while in the White House.36 Americans were desperate for some good news. It had been less than a year since the ignominious end to the country’s military intervention in Vietnam. The images of civilians hanging on to the helicopter gunships that took off for the last time from the U.S. embassy, while North Vietnamese troops closed in on the capital, was a humiliating finish to the unpopular nineteen-year war. The previous year Ford had issued a controversial pardon to Richard Nixon for any crimes he may have committed while president. California governor Ronald Reagan thought that Ford was politically vulnerable and had challenged him for the nomination. Ford had started out strong, however, winning the first six primaries.37
On March 23, Reagan beat Ford in North Carolina. That panicked the president’s political team. The following day, Ford addressed the nation from the White House: “I have been advised that there is a very real possibility that unless we take effective counteractions, there could be an epidemic of this dangerous disease [swine flu] next fall and winter here in the United States.” He asked Congress “to appropriate $135 million, prior to the April recess, for the production of sufficient vaccine to inoculate every man, woman, and child in the United States.”38
Ford correctly calculated that Congress would not stand in the bill’s way. Without any dissenting debate, it authorized $135 million for “Preventive Health Services… for a comprehensive influenza immunization program” on April 15. Ford signed it in an Oval Office ceremony that same day.39 Although the money was appropriated, none of the details had been worked out. The CDC submitted an ambitious timetable to start vaccine production by June and average 24 to 30 million doses monthly.40 The FDA’s Bureau of Biologics began selecting thousands of volunteers for what it called the “largest pre-certification field trials ever performed.”41
The drug firms began “cultivating seed stock,” the first step in growing millions of copies of the CDC-supplied virus in hen eggs.42 After a few days, inspectors found that Parke-Davis had incorrectly recombined some of the virus’s genetic elements. The equivalent of 2.6 million doses were useless. That caused a several-week delay as the CDC double-checked the technical procedures in place at each company.43
While that review was under way, an unexpected and more serious challenge came from the four pharmaceutical firms chosen to make the vaccines.44 The executives from Merck’s Sharp & Dohme subdivision, Merrell, Wyeth, and Parke-Davis, and the Pharmaceutical Manufacturers Association, were concerned about liability for adverse reactions to the swine flu vaccinations. The government had agreed to be fully responsible for a “duty to warn” all those who got the vaccine about its risks. However, eighteen months earlier, a federal appeals court sent chills through the pharma industry when it upheld a $200,000 verdict against Wyeth for partial paralysis in a Texas infant after she received an oral polio vaccine Wyeth had manufactured. The Texas Department of Public Health had bought the vaccine from Wyeth. Texas law required parents to vaccinate their children. A registered nurse at the Hidalgo County Department of Health Clinic had administered the vaccine to the child and the infant’s mother had signed a liability release. When the child later developed poliolike symptoms, the mother sued, claiming that her primary language was Spanish and she had only a seventh-grade education.
Wyeth said it had satisfied its “duty to warn” as a manufacturer by including a large, detailed circular warning of possible side effects with every ten-dose batch. The nurse who administered the vaccine had not warned the plaintiff about the potential risks. Wyeth experts testified at the trial that the odds the infant’s illness was from the vaccine was one in 5.88 million. Still, the court ruled that Wyeth’s “duty to warn” extended past the date it sold the vaccine to any private or government agencies. It did not matter, concluded the court, whether the Texas mother would have changed her mind if she had gotten such a warning. What mattered was that Wyeth had not provided some means for that mother to have had easy access to the side effect printout.45
Little wonder that pharma firms believed that no matter how broadly the government assumed the “duty to warn,” plaintiffs’ lawyers would find a creative way to sue them. Major insurance underwriters agreed. They informed the drug firms they would not issue any liability coverage for the swine flu vaccinations. Given the huge size of the program and the expedited schedule, the insurers did not have time to calculate and price the potential risk.46 Without insurance, the drug companies insisted on full indemnification from the government for defending lawsuits and settling cases that arose from side effects.47
Congress’s $135 million emergency appropriations covered the costs for testing, manufacturing, and administrating the inoculations, but nothing for liability claims. Getting politicians to sign a blank check for the pharmaceutical industry in an election year was not easy. As a sign of good faith, the four pharma firms began producing bulk amounts of the swine flu vaccine. They would not sell any of it to the government, however, until there was an indemnity agreement. Drug company attorneys did not budge in more than thirty summer meetings with federal health officials.48
The government finally capitulated, drafting legislation under which it assumed responsibility for all claims other than those resulting from the negligence of the drug firms. There was little support though for that in Congress, much to the anger of the drug firms.
By July 31, the pharma manufacturers had produced enough vaccine for 100 million doses. They still refused to sell any to the government.49 HEW secretary F. David Mathews wrote to Ford: “Without a resolution of the liability issue, manufacturers are expected to stop vaccine production within a matter of days.” Merrell and Parke-Davis had stopped buying eggs to make more vaccine.50 Merrell announced it would soon withdraw from the program.51
Ford and CDC officials worried that the earlier sense of urgency had faded in Congress as the odds for a pending health crisis seemed more remote. Besides Private Lewis and the four Fort Dix soldiers who had gotten ill six months earlier, there had not been a single case of swine flu reported anywhere. Some health officials thought Congress might use pharma’s indemnification demand as the excuse to scuttle the program. The public mostly blamed the delay on generalized bureaucratic inefficiency. Few realized the drug companies were the obstacle.
But as the thalidomide scare in 1962 had broken the impasse over the Kefauver Amendments, fear over an unrelated infectious outbreak in midsummer changed the dynamics in the swine flu stalemate. On August 2, Pennsylvania health authorities announced that dozens of military veterans who had attended a July American Legion convention in Philadelphia had become ill with high fevers, severe muscle aches, and in many cases pneumonia. The sicknesses were confined to one of the four hotels that hosted thousands of the veterans. Within a week of the convention, 221 veterans were seriously ill and 34 had died.52 The lethal illness stumped state health officials. The press dubbed it “Legionnaire’s Disease.”
The news raised the prospect that the feared swine flu epidemic had started as those in charge were stuck debating who might pay for any injuries from adverse reactions. The CDC dispatched twenty epidemiologists to Philadelphia. The New York Times called it “the largest squad of medical detectives to investigate an outbreak in the federal agency’s history.”53
The news shook Congress from its torpor. No politician wanted to look as if they were risking the lives of Americans because of a money dispute over side effects that might affect a few people. Ford picked up his behind-the-scenes lobbying. In an August 4 letter he urged congressional leaders to “delay no longer,” arguing “there is no excuse now… clinical tests show that the vaccine is safe and effective” and “the lives of many, many Americans” are at stake.54 Only seventy-two hours after the first reports about Legionnaire’s Disease, Congress appeared ready to approve the vaccine liability provisions. Just before the vote, the CDC director tried allaying public fears by announcing preliminary lab tests that showed it was “very unlikely” that swine influenza had caused the Philadelphia deaths. Congress postponed the vote.
Ford’s advisors told him there was only a week left in which it was possible to restart vaccine production.55 On August 6, only a few days before Congress’s summer recess, Ford took his case to the public. He had considered charging that the drug companies were responsible for the impasse. Ford’s advisors felt liability indemnity was too complex an issue to explain to the public. Congress was a much easier culprit. Ford, who had served in the House for twenty-four years before Nixon tapped him to become vice president in 1973, had good political instincts.
“I am frankly dumbfounded that Congress, which took the time and effort to enact ill-advised legislation to exempt its own members from certain State income taxes, has failed to act to protect 215 million Americans from the threat of swine flu.… There is no excuse… for any further delay.”56
Ford’s national address sparked public outrage that Congress had found the time recently to pass preferential tax treatment for its members while doing nothing about protecting citizens from a possible pandemic. The New York Times and a minority of newspaper editorial boards cited some dissident doctors and urged “a real public debate… on the few known facts instead of the bloodcurdling predictions being used to frighten the nation.” It was too late for that. The public outcry meant there was little opposition in Congress.57 The National Swine Influenza Immunization Program Act passed overwhelmingly the evening before the summer recess began and only a day before the Republican presidential convention. Ford signed it on live television.58
The bill put the federal government into the middle of the vaccine business for the first time. It alone assumed responsibility for all damages from personal injuries or deaths caused by the vaccinations. The attorney general was charged with defending any legal claims.
To reduce the likelihood of lawsuits, all patients had to sign informed consent forms that listed in detail the vaccine’s benefits and risks.59 Those forms, devised by the CDC, stated that swine flu had been tested extensively. Only a handful of people knew that the vaccine tested by the Bureau of Biologics and the National Institute of Allergy and Infectious Diseases had failed to develop any antibodies that would provide some immunity in children. As a result, the vaccine to be dispensed to the entire country—dubbed the X53a—had been reformulated to nearly twice the strength as the one in the clinical trials. X-53a had never been tested.60
While pharmaceutical companies were pleased that the government assumed all liability responsibility, they were irked by a clause that “eliminated any profit” from their production of the vaccine. What they got in exchange was authorization to earn “a reasonable profit” from the most commonly used version in annual influenza shots (the failure to define “reasonable” later led to considerable bickering between pharma and government officials).61
A Gallup poll showed that while a remarkable 94 percent of adult Americans were familiar with swine flu, only half were likely to be vaccinated.62 Many worried about unknown side effects. Even more feared was the still-mysterious Legionnaire’s. The CDC investigators had followed thousands of leads and conducted every possible test but were still stumped about what had caused it (in another four months, January 1977, the CDC determined the microbial culprit in the veterans’ outbreak was from a bacterium found in dirty or sitting water; it spread through the invisible mist emitted by the hotel’s air-conditioning units).63
The swine flu vaccinations got under way on October 1 even though there still had not been any more cases outside the small Fort Dix cluster.64 Those most at risk, the elderly, children, and anyone with a suppressed immune system, were the priorities. Ten days after it had begun, the Pittsburgh Post-Gazette had a front-page story in its evening edition about three elderly people who had died shortly after getting their swine flu vaccinations at the Allegheny County Health Department. That story line—that the swine flu vaccine might have killed more people than the swine flu virus itself had nine months earlier at Fort Dix—took off.65 Twenty-two additional deaths across the country were soon reported. The CDC’s answer—they were “statistical anomalies” and the average age of “those who died was 72.1, and all but one had a history of heart disease”—was not reassuring to an already skittish public.66 President Ford and his wife, Betty, tried tamping down the anxiety by getting their vaccine shots during a widely publicized photo opportunity.67
Forty million people, just under a fifth of the country, had been vaccinated by mid-October. Although it seemed an impressive number, health officials knew that if a pandemic was coming, it was too few people. They needed to double that and still allow enough time for the antibodies to develop to provide protection against an epidemic.68
Events worked against them. On November 2 Georgia governor Jimmy Carter defeated Ford in the presidential race. Four days later, Albert Sabin, one of Ford’s highest-profile members of his blue-ribbon vaccine panel, wrote an op-ed for The New York Times. He said that “federal health agencies need public trust… but they are destroying it.” According to Sabin, the government was “irresponsible to use scare tactics” by comparing the swine influenza to the Spanish pandemic of 1918. And he questioned the effectiveness of the vaccine with certain age groups. He concluded that it was “now highly probable” that “the epidemic does not come this winter,” meaning that the vaccine would be “largely ineffective” if one should come the following year.69
Cities across the country had reported few cases of any strain of influenza during the first half of November. It was not because of the swine vaccine but because by chance, very few influenza viruses had developed that year in the U.S. Influenza-related deaths and pneumonia were at their lowest in years. Americans were increasingly skeptical as fears about a looming pandemic receded.
Fewer than five million people got the shot after November 1. For those still undecided, something that started during the third week of November helped them make up their minds. A Minnesota man who got the vaccine returned to his doctor complaining of weakness in his legs and arms. Initially, his feet and hands tingled but had since gone numb. His reflexes were poor. The physician recognized the symptoms: Guillain-Barré syndrome, a rare but serious disorder in which the immune system assaults healthy nerve cells. Most people recover but others have permanent nerve damage and paralysis. In some cases it is deadly.70
Although the CDC was aware that a mass immunization would result in adverse reactions for some, the government’s epidemiologists had not expected to see much of Guillain-Barré.71 Even those who suspected a link believed the risk was one or two cases for every million doses. The CDC-designed consent form everyone signed before getting the vaccination did not mention anything about neurological adverse effects. CDC director David Sencer later claimed that the omission was because he had not been told about the risk. A memo in July from Dr. Michael Hattwick, who ran the CDC’s vaccine surveillance team, had raised that “neurological complications” were possible from any influenza vaccine. Somehow it had not been put into the consent form since some officials thought it would scare away too many people.72
Sencer issued an urged order to hospitals, doctors, and clinics to be on the lookout for Guillain-Barré. The problem was that there were no tests to detect the disease and doctors disagreed as to what symptoms confirmed a diagnosis.73 It was not until December 14 that Sencer issued a press release disclosing that fifty-four vaccinated people were ill with Guillain-Barré. There were many calls to halt the program. Sencer suspended it for a month.
The CDC meanwhile kept investigating if there was a link between the vaccine and the unusual neurological disorder.74 Efforts to explain away the infections as an “expected and normal rate” given the millions vaccinated, did little to allay public alarm.75 Four days after the mass vaccinations were suspended, a New York Times editorial titled “Swine Flu Fiasco” concluded the entire effort had been a “sorry debacle” based “on the flimsiest of evidence.” The CDC had exploited “Washington’s panic” to “increase the size of its empire and multiply its budget.”76
On January 20, 1977, Jimmy Carter was inaugurated as the thirty-ninth president of the United States. Guillain-Barré cases topped 1,100, with the swine flu vaccine responsible for most of them. More than one hundred patients were on respirators. Fifty-eight had died.77 Carter wasted no time in selecting his own team to run the country’s medical regulatory agencies. He appointed Joseph A. Califano Jr., Lyndon Johnson’s top domestic advisor, as the HEW secretary. Two weeks later Califano dismissed David Sencer as the CDC’s chief.
The first lawsuits on behalf of people claiming debilitating side effects were filed the same month the Carter administration took charge. There would ultimately be 4,181 claims asking for $3.2 billion in damages. The Justice Department, obligated by the National Swine Influenza Immunization Program Act, put ten lawyers full-time on defending the government. The White House Office of Management and Budget approved a multimillion-dollar emergency appropriation for the legal defense. The shortcomings in the legislation’s indemnity clauses became clear. Liability was to be determined under the law of the state where the vaccine was dispensed, making it impossible to consolidate the cases into a single class action (they were merged for pretrial discovery only).78 Instead, Justice Department attorneys had to juggle fifty different malpractice standards and product liability statutes.
The government paid $38 million to settle several hundred cases. More than 1,600 proceeded. The litigation lasted sixteen years, during which the government lost 109 cases. Taxpayer-funded judgments topped $100 million.79
The swine flu trials cost more than time and money. A lead attorney for the plaintiffs later commented that “permitting the government to step into the private world of the [pharmaceutical] manufacturers and defend the swine flu suits” meant that “the government has become the adversary of the citizens it originally acted to protect.”80 That tsunami of litigation also had a chilling effect on Congress, which steered far away for many years from approving any federal immunization programs. It also opened a Pandora’s box. Some swine flu attorneys subsequently filed complaints for clients for all types of vaccines.81
The scientists involved in developing vaccines in the 1950s had hoped that mass immunization might not only prevent another influenza pandemic like the one that infected one third of the planet in 1918, but also eliminate typhus, polio, diphtheria, and whooping cough. Until swine flu, the U.S. produced about 80 percent of the world’s annual supply of vaccine.82 “Insurance carriers, politicians, drug companies, and the judicial system,” writes science writer Laurie Garrett, “adhered to the basic principle that the rights of an immunized society superseded those of small numbers of individuals.”83
The swine flu litigation, however, ended that cooperation. Federal courts became ground zero in an expanding controversy over individual rights versus the public health. District courts have at times issued orders overruling family objections and mandating vaccines for public school children or elderly relatives in nursing homes. In early 2019, the question of vaccines and immunizations reached a public crisis in several states due to an outbreak of measles. Officials in a hard-hit upstate New York county (Rockland) banned unvaccinated children from public places.84 Washington and Oregon state legislators weighed overturning previous laws that allowed individuals to opt out of vaccines for “personal, religious or philosophical reasons.”85 (As of December 5, 2019, there were 1,276 reported infections in thirty-one states, the second highest on record since 2000, when the CDC had declared it eliminated.)86
The ghost of the swine flu debacle scared pharmaceutical companies and their liability insurers. In the coming years, more than a dozen drug firms that were in vaccine research and production abandoned the field. By 1993, there were only four American pharma companies left. Most are relieved to be out of the business. They were reminded of the perils of producing vaccines recently when major health problems were reported among three million children in the Philippines who had received the first ever vaccine against dengue fever. The three-dose shots made by French-based Sanofi had been under way since 2015. They resulted in adverse effects that often mimicked the disease it was supposed to prevent. For those who eventually contracted dengue, having had the vaccine made it a more virulent infection. The first lawsuits, charging that Sanofi’s vaccine was responsible for a “runaway immune reaction,” were filed in 2019. 87 IV 88
When Califano took charge at HEW, he ordered an outside investigation to determine what had gone wrong. It turned out there was no single error or miscalculation. There was, undoubtedly, a rush to judgment about the likelihood of a pandemic, based on too little data: five infections and a single death. Instead of methodically assessing the worst-case scenario, policymakers focused on the devastating outcome if they underestimated the possibility of a pandemic.
Adding to the sense of urgency was the fear that the time in which to deploy a vaccine was short. When the discussion turned to vaccine production and inoculation scheduling, policymakers had closed the door on debating the odds for a pandemic. Keiji Fukuda, a leading influenza epidemiologist, expressed a widely held consensus that the biggest error was the failure to realize the importance of no swine flu cases after the first ones at Fort Dix.
“If a new virus gets identified or reappears, you don’t want to jump the gun and assume a pandemic is happening.”89 Many infectious disease physicians and researchers echoed that. Government health officials at the CDC acknowledged that swine flu had been a difficult lesson but one from which they learned. Unfortunately, it was a lesson learned at the wrong time. Within a decade, the mantra of “don’t jump the gun and assume a pandemic is happening” would be one of the reasons for the slow and hesitant response to the emergence of a sexually transmitted lethal virus, HIV/AIDS.
I. A poliolike disease, acute flaccid myelitis (AFM), began to break out in 2014. Mostly children under the age of ten were infected. The CDC is still working to discover the cause of the breakout, but suspects three enteroviruses (A-16, A-71, and E-68) typically responsible for hand, foot, and mouth disease. As of December 2019, there is no treatment or vaccine and the CDC has confirmed 601 cases in all fifty states. Ninety percent of the infections have occurred in children.
II. When in March 2019 health officials in northern Kentucky banned unvaccinated students from school after an outbreak of more than thirty cases of chicken pox, one family sued on behalf of their son who refused the vaccine on religious grounds. The family, devout Catholics, said the vaccine “is derived from aborted fetuses and it goes against our Catholic faith.” In fact, the chicken pox vaccine relies on cell lines from two fetuses aborted in 1964 and 1970, and no further abortions were done to keep those cell lines intact. The Vatican has grudgingly given its approval to the rubella vaccine, saying that the most important consideration of parents should be “to put the health of their children and of the population as a whole at risk.” Still, legal experts believe the case is potentially precedent-setting since a religious exemption to vaccines could be claimed by many people without the ability of local governments or school districts to verify the truthfulness of such claims.
III. The most deadly influenza year in the U.S. since the 1918 pandemic was 2018. An estimated eighty thousand Americans died, most of them elderly and with compromised immune systems. The problem, in part, was that the vaccination was not targeted for the strain that developed that year and provided little protection.
IV. A subsequent example of the effect of litigation on the vaccine industry is Lyme disease, the bacterial infection that can cause debilitating arthritic conditions and was first spotted in 1976 in a cluster of children in Connecticut. Smith Kline got FDA approval for its LYMErix vaccine in 1998. In clinical trials it was 78 percent effective in preventing Lyme transmitted from infected ticks to humans. In the ten states that then accounted for 90 percent of the annual twenty thousand infections, Smith Kline dispensed 1.5 million vaccinations over eighteen months. The follow-up safety reports were good except for several dozen patients reporting either developing arthritis or that their existing arthritic condition worsened. Those claims caught the attention of the media. “Lyme Vaccine May Cause Problems”; “Concerns Grow over Reactions to Lyme Shots”; “Lyme Disease Vaccine’s Safety Is Questioned.” Anti–Lyme vaccine advocacy groups launched. Although no subsequent trial established a direct link from the vaccine to inducing arthritis, a class action lawsuit was filed in 2002. Smith Kline responded by withdrawing the vaccine. There have been 369,000 new infections of Lyme since then. The annual costs of treatment and lost productivity from disability in chronic cases is an estimated $75 billion annually. After Smith Kline canceled its product, Austrian-based Baxter Pharma abandoned its development of a Lyme vaccine that was in a combined Phase I/II trial. A French drug firm, Valneva, announced in 2018 it will start early trials of a vaccine like the one Smith Kline marketed twenty years ago. Until its expected approval in a few years, there is no Lyme vaccine.