At 10:20 a.m., as spotlights clicked on and cameras whirred, Francis strode purposefully to a lectern. Salk’s vaccine, he announced, was “safe, effective, and potent.” He spoke for another ninety minutes—detailing the tests, describing his analyses, cautioning against over-optimism—but those three words, which had been so eagerly anticipated for so long, were all anyone needed to hear. The seeming inevitability of Francis’s announcement did nothing to temper the jubilation that swept the country: Air raid sirens were set off; traffic lights blinked red; churches’ bells rang; grown men and women wept; schoolchildren observed a moment of silence.
The rest of the day brought more of the same. The chairman of the board of trustees of the AMA said the success of Salk’s vaccine was “one of the greatest events in the history of medicine.” The New York Times devoted almost all of its front page and five full interior pages to coverage of the event. “Gone are the old helplessness, the fear of an invisible enemy, the frustration of physicians,” its editors wrote in an editorial that called for “world-wide rejoicing and thanksgiving. . . . Science has enriched mankind with one of its finest gifts.” Oveta Culp Hobby, the secretary of the Department of Health, Education, and Welfare, said, “It’s a wonderful day for the whole world. It’s a history making day.” In the second half of the twentieth century, only the assassination of John F. Kennedy, the moon landing, the resignation of Richard Nixon, and the fall of communism commanded as much of the nation’s attention. Never again would science be held in such unequivocal admiration.
At five that afternoon, Hobby and the surgeon general, Leonard Scheele, licensed six preapproved pharmaceutical companies to manufacture the vaccine, a move they said would enable production of enough vaccine to inoculate every child in the country before the polio season began in earnest. Injections were taking place by the following morning.
Over the next hours and days, no accolade would be too lofty, no honor out of reach, no prediction too optimistic. Salk would surely win a Nobel Prize. The foundation, confident that victory over polio was within its grasp, discussed where to focus its energies in the future. Questions and concerns about national vaccine programs that had been present for more than a century seemed to melt away.
It didn’t take long for that initial bout of euphoria to fade. The foundation had poured incredible effort into convincing citizens that fighting polio was their patriotic duty, but it had neglected to educate the public about the inherent limitations of its planned eradication campaign. Depending on the strain of the polio virus, the Salk vaccine failed to generate immunity anywhere from 10 to 40 percent of the time. Another factor was polio’s standard incubation period, which meant there would be people who’d been infected in the weeks immediately preceding vaccination but wouldn’t show symptoms until later. There was also a period of vulnerability between receiving the vaccine and protection taking hold. Finally, there was the inevitable reality that out of the millions of Americans who received the polio shot, some would have a negative reaction.
One illustration of the public’s overhyped expectations was the panic brought about by rumors of widespread shortages. (Partisan political jockeying didn’t help matters, as Democrats in Washington blamed any and all problems on President Dwight Eisenhower’s incompetence while Republicans spoke sotto voce of a mysterious, Democrat-fueled “black market” that was siphoning off valuable supplies.) Ten days after Francis’s celebratory press conference, Surgeon General Scheele told reporters that there would likely not be enough doses for everyone to get vaccinated before the end of the year. The day after that he retracted his forecast and promised that by August 1, there would be enough doses for all children ages one to nine.
In the midst of this frantic activity, the first reports of children who had become sick with polio after receiving the vaccine began to trickle into Washington. This was not necessarily cause for alarm, but as soon as the distribution of those cases began to be analyzed, it became clear that something had, in all probability, gone wrong. By April 26, exactly two weeks after Francis’s announcement, the Public Health Service had identified six children who’d been paralyzed after receiving doses from Berkeley, California’s, Cutter Laboratories—a significantly higher number than would have been expected to occur under normal circumstances. Before dawn the next morning, Scheele told Cutter to halt production and ordered a recall of all Cutter-produced doses that had already been distributed. Publicly, he put on a brave face. “This action does not indicate even that the vaccine was in any way faulty,” he said, stressing that the program should continue and parents should not be concerned.
Within twenty-four hours, that attitude of insouciance had evaporated. What everyone had hoped was a statistical aberration quickly became a full-blown disaster, as dozens of children who’d received Cutter-produced vaccines were paralyzed or killed. As if on cue, the parties that had been so quick to claim credit for the vaccine’s success began sniping at each other through official statements and thinly veiled, off-the-record comments: The foundation said it had “no control of the manufacturing of the vaccines” and that testing was the “sole responsibility” of the government; the same AMA officials who had so recently celebrated “one of the greatest events in the history of medicine” now announced that they had not been shown an advance copy of Francis’s report and therefore had never given their imprimatur to Salk’s vaccine; and President Eisenhower, at a loss to explain the situation, speculated at one of his weekly press conferences that the vaccine might have a “provocative effect” that activated a “latent” form of the virus already present in some people. “The actual puncture of the skin with this, to give the shot might—and they have not proven this—but it isn’t impossible that that might cause some trouble,” he said. That this conjecture went against virtually every piece of scientific evidence did not stop Eisenhower from telling reporters that perhaps it made sense to suspend the program until after the peak periods of transmission that summer.
Eisenhower’s emphasis on damage control over sound science extended to discussions occurring behind the scenes. Before continuing with the nationwide effort, his aides said, public health officials needed to promise that there would not be any more children who were diagnosed with polio after being vaccinated. That, as anyone with an elementary understanding of immunology knew, was an impossible guarantee to provide, and so, instead of trusting people to understand and accept that there are risks with every medical procedure and that correlation does not equal causation, or trying to explain that the problems appeared to be related to the specific conditions under which the infected batches had been produced and not with the safety of the vaccine generally, the government took the one step guaranteed to undermine public confidence: On May 7, Scheele announced that the polio vaccine program was being shut down so that the government, “with the help of the manufacturers,” could undertake “a reappraisal of all of their tests and procedures.”13 “The Public Health Service believes that every single step in the interest of safety must be taken,” he said. “We believe—and I am sure the American people join us in believing—that in dealing with the lives of our children, it is impossible to be too cautious.”
That was most definitely not what the “American people” wanted to hear. Did these new safety steps mean that previously the Public Health Service had not believed it had to exercise the utmost caution? Why, after insisting that the doses of the vaccine that were already at distribution centers were safe to use, did Scheele reverse course? Would the vaccinations start again in two weeks, as some officials were saying? Would it be a month, as others claimed? Or in the fall, as Eisenhower had hinted? (Both the president and members of his administration continued to be particularly inept messengers. At one point Eisenhower attributed the premature release of the vaccine to unspecified “pressure,” and said scientists had likely taken “shortcuts” on some safety tests. His appointees, meanwhile, had a habit of making baldly inaccurate statements, such as when Secretary Hobby
told a Senate committee, “No one could have foreseen the public demand for the vaccine.”) As it happened, it took only a week for the government to certify another million doses—but by then, the public’s initial elation had been transformed into mistrust and apprehension. “The nation is now badly scared,” read an article in The New York Times. “Millions of parents fear that if their children don’t get the vaccine they may get polio, but if they get the vaccine, it might give them polio.”
Before the end of the month, when the first of many investigations into what became known as the Cutter Incident had been completed, it was already obvious that the problem had been the result of a combination of inadequate safety guidelines and a lack of official oversight. The government had not required the pharmaceutical companies making the vaccine to divulge any safety issues that arose during manufacturing, turning what should have been a collaborative effort into one driven by competitive commercial interests. As a result, neither the independent scientists working on the project nor the public health officials in charge of implementing it had known that Cutter had discarded a full third of the batches it had produced because of failed safety tests.
Among those listening to officials’ conflicting and confused pronouncements with increasing horror were Robert Gottsdanker and his wife, Josephine. The couple was better acquainted than most with the ravages of the polio virus: The children of several friends of theirs had been infected with the disease, giving them a firsthand view of the suffering that it could cause. The Gottsdankers were academics with jobs at the University of California’s Santa Barbara campus—he was a psychologist, she was a counselor—and they’d always believed in the ability of science to make the world a better place. Even before the results of the Salk trials had been announced, they’d done everything possible to ensure that their two children were among the first to receive the vaccine. Within days of Thomas Francis’s April 12 press conference, the Gottsdanker family physician arrived at the family’s home to personally inject five-year-old Anne and seven-year-old Jerry.
At first, the Gottsdankers were relieved that their lobbying efforts had paid off: With a vacation planned for the week of April 18, they didn’t want to risk missing out due to the rumored nationwide shortages. It didn’t take long for them to start to question their zeal. By the time the family reached Calexico, a small border town about 120 miles east of San Diego, both children had fallen ill. Jerry soon recovered, and in later years he could barely remember being sick at all. His sister was not so lucky. By the time the family arrived back in Santa Barbara, Anne had lost the use of both of her legs. A week after being vaccinated, the Gottsdankers’ younger child had developed fullblown, paralytic polio.
By the end of the month, Anne’s parents learned that she had been among the children injected with the contaminated doses produced by Cutter Labs. (Her case was one of the ones that set off those first alarm bells in Washington.) The eagerness with which the Gottsdankers had sought out the vaccine only exacerbated the betrayal they felt after their daughter was infected, and they were one of the first of more than forty families to sue Cutter for damages. On November 22, 1957, just nineteen months after Salk’s vaccine was first made available to the public, opening arguments in Gottsdanker v. Cutter Laboratories were heard in Alameda County Superior Court. From the outset, the trial was an odd one. Each side readily conceded central aspects of its opponent’s argument: Walter Ward, Cutter’s medical director, agreed that Anne’s paralysis was in all likelihood the result of her having been injected with live virus, while Melvin Belli, the Gottsdankers’ attorney, acknowledged that the contamination had resulted from fundamental flaws in the government’s safety protocols and not from negligence on Cutter’s part.
The case, then, would hinge on whether the Gottsdankers could show that Cutter had violated what in legal terms is referred to as an “implied warranty.” If anyone was capable of convincing a jury that this was the case, it was Belli, a man who’d been dubbed the King of Torts by the press and Melvin Bellicose by his enemies.14 Belli had first achieved national prominence thirteen years earlier, when, at age thirty-five, he’d represented a waitress named Gladys Escola, who sued the Coca-Cola Bottling Co. after a glass soda bottle exploded in her hand for no reason and without warning. (The blood vessels, nerves, and muscles in Escola’s thumb were severed in the incident.) In order to win that case, Belli had successfully overturned a century’s worth of precedents regarding the doctrine of privity, which holds that there needs to be a contract between two parties in order for one of them to file suit. (In the Escola case, for example, both the waitress and Coca-Cola had agreements with the diner, but not with each other.) Belli’s victory pushed privity aside in favor of the doctrine of foreseeability, which has been the cornerstone of modern product-liability law ever since.
With Gottsdanker v. Cutter, Belli was trying to radically expand the parameters he’d set with his 1944 victory. In that case, it was clearly negligent of Coca-Cola to produce bottles that shattered willy-nilly; the debate was who (or what) had standing to sue the company for its negligence. Cutter, on the other hand, had just as clearly not been negligent: It adhered to the government-dictated safety standards every step of the way. (That the lab had faith in its work was evidenced by Cutter’s lead pathologist injecting his own children with vaccine produced by the company.) Belli, in an effort to square that circle, argued that the mechanism that caused the vaccine to be unsafe was beside the point—the bottom line was that whether the company was aware of it or not, it had abused the Gottsdankers’ trust. “There is no doubt in my mind,” Belli told the jury, “and there should be none in yours, that the process could and should be perfect.” (This abstract notion of perfection is, of course, just that: an abstraction. In its most extreme application, a strict adherence to that standard would prohibit all medical care, since there is always the possibility that a given remedy will be improved, and every treatment carries with it at least some measure of risk.)
After more than five weeks of testimony, Belli’s case remained shaky, at best, and Cutter likely would have prevailed had it not been for instructions from Judge Thomas J. Ledwich. Cutter’s compliance with government regulations, Ledwich said, had no bearing on the question of liability: “If you find that the vaccine contained infectious amounts of live virus and that the vaccine caused [Anne Gottsdanker] to become infected,” he said, “implied warranty is applicable.”
These instructions, which remain controversial to this day, threw the jurors into turmoil. On January 17, 1958, they returned the verdict they felt they’d been all but forced to deliver: Cutter was liable for Anne Gottsdanker’s paralysis. The jurors made their frustration known by including an impassioned (and highly unusual) statement with their decision, in which they wrote that “a preponderance of the evidence” had convinced them that “the defendant, Cutter Laboratories, was not negligent either directly or by inference.”
The $147,300 the Gottsdankers were awarded did not end the family’s pain, which ultimately extended far beyond Anne’s paralysis. For the remainder of their lives, the Gottsdankers seemed to simultaneously obsess over Anne and deny the realities of her condition, refusing even to install a wheelchair ramp in their home. Jerry Gottsdanker grew increasingly resentful of the attention his parents lavished on his sister; he later admitted that he had been “cruel” to Anne while growing up. Robert Gottsdanker, meanwhile, seemed to lose faith in the world. “He was a scientist,” his son said in a 2005 interview. “And he felt science had let him down.”
For the Gottsdankers and the families of the other fifty-six children who’d been paralyzed after receiving contaminated doses of the polio vaccine, the Cutter Incident was a life-altering personal tragedy. It also sullied the reputations of everyone from Salk and Scheele to the leaders of the AMA and the National Foundation for Infantile Paralysis. As a result of their obfuscation and equivocation, rumors whipped around the country: Health officials and drug makers had conspired to lie to the
public; the nation’s schoolchildren were the subject of massive experiments; the vaccine had never been safe. The outcome was as predictable as it was unnecessary: Confused and unsure about what to believe, citizens who had just weeks earlier fought to make sure they weren’t passed over began to wonder if it was such a good idea to get the vaccine after all.
If anything positive were to come from the entire affair, it would depend on future leaders’ capacity to learn from these mistakes. Instead, the precise formula that resulted in such chaos a half-century ago has been repeated time and time again. Perhaps nothing illustrates this better than a contemporaneous account that ran in the August 1955 issue of Harper’s—an account that could just as easily characterize numerous incidents in the years since:
[D]emagogy and political expediency . . . contributed to the brew. So did over-sensationalism by the press, radio, and TV, and a misguided attempt by the Department of Health, Education, and Welfare to withhold from the public for many weeks information the public was entitled to have from the beginning. Also involved were timidity and lack of leadership; a complete failure to educate the public properly on vaccines (despite all the propaganda); the constitutional unwillingness of scientists to give absolute guarantees; and many things more.
The point is, though, that the mess was unnecessary. . . . The vaccination program was perhaps not the best that could have been devised. But it was not a bad program. It could have been kept on the track. All that was necessary was a little judgment and some capacity for decisive action in the right places at the right time.
The Panic Virus Page 6