Conquering Polio | The Cutter Fiasco | 3

0:28Hello, American History Teller listeners. on tickets and upcoming dates, go to AmericanHistoryLive.com. That's AmericanHistoryLive.com. Come see my Days That Made America tour live on stage. Go to AmericanHistoryLive.com.

0:56Imagine it's April 24th, 1955 in Pocatello, Idaho. You and your seven-year-old daughter Susan are sitting in an exam room at her pediatrician's office. The room smells of rubbing alcohol and floor polish. You hold your daughter next to you, her face drawn, her arm hanging uselessly by her side. And at last, the doctor enters the room, his gaze fixed on his clipboard. All right, let's see, when did this start? You take a deep breath and run your fingers through Susan's hair, trying to stay calm for her sake. Yesterday, it began with a little neck stiffness, but by nighttime she had a fever. When she woke up this morning, she couldn't move her left arm.

1:35Is this what I think it is? Does she have polio? The doctor examines her quietly, moving her head, tapping her knees, testing her grip. You try to read his face, but it stays blank. That certainly seems that way, but we'll have to do a spinal tap to confirm. But how could this happen? She was vaccinated for polio only a few days ago, just this past Monday. Was there something wrong with the vaccine? I followed last year's field trials closely. The vaccine is safe. It may not be perfect, but it's not dangerous. So what happened? Susan was probably exposed to the poliovirus just before she received her injection.

2:10I'm sorry to say, this is just a case of bad timing. The vaccine was unfortunately just too late to protect her. That doesn't make any sense. I don't know of anyone else who's sick with polio. There have been no other cases in Susan's class. It's April. I've never heard of anyone getting polio this early in the year. Polio season usually starts when it warms up in June. Yes, but viruses don't always follow the calendar, you know? let's not jump to conclusions. We can confirm the diagnosis first, and I'll keep a close eye on things and make sure that Susan receives the best care possible. The doctor makes a note on his chart and then leaves the room.

2:46You squeeze your daughter's shoulder and try to give her a reassuring smile, but deep down all you feel is dread. As her eyelids flutter closed, your gut is telling you that something has gone horribly wrong.

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4:49In April 1955, a seven-year-old girl in Idaho came down with polio just days after receiving a polio vaccine. And when similar cases surfaced, health officials began to question whether it was a coincidence or something far more troubling. One year had passed since the National Foundation of Infantile Paralysis executed an unprecedented field trial of Jonas Salk's polio vaccine. In the spring of 1954, the country held its breath as hundreds of thousands of children known as polio pioneers rolled up their sleeves to receive Salk's experimental vaccine. It was a logistical triumph, with no parallel in American history, requiring the mass production of a carefully formulated vaccine, teams of doctors, nurses, and volunteers in nearly every state, and scientists monitoring the results with painstaking precision.

5:38And it was done with no money from the federal government. The NFIP single-handedly mobilized the nation in the hopes that modern science would finally defeat the era's most terrifying disease. But then the unthinkable happened, and scientists scrambled to discover what went wrong. This is Episode 3, The Cutter Fiasco.

6:01In the spring of 1953, Jonas Salk pushed forward with his efforts to develop a polio vaccine made from a killed virus. His Pittsburgh lab now occupied 6 ,000 square feet across three floors of the city's municipal hospital. It was a bustling operation with dozens of staff members and a colony of 500 monkeys used for developing his vaccine. And it was all made possible by funding from the National Foundation of Infantile Paralysis. Salk received$400 ,000 in grants in 1953 alone. And he would need that money because his goal was to start large-scale field trials as soon as his vaccine was ready.

6:40But in the early 1950s, the federal government had almost no machinery for guiding vaccine development. apart from the rudimentary Public Health Service, the forerunner to the Centers for Disease Control. So the privately funded National Foundation for Infantile Paralysis stepped in to support Salk's research. And once Salk's vaccine was ready for field trials, it was the foundation that would control every aspect of the operation with critical support from local communities. And that spring, Salk felt confident enough with his formula to vaccinate himself and his family. He had three boys under the age of 10, and blood tests showed that after their injections, all three had elevated levels of polio antibodies, and none of them had suffered side effects.

7:21Salk's laboratory staff also received injections. But while Salk had favorable data and the steadfast support of the National Foundation on his side, he could not escape the scrutiny of his fellow scientists. In June 1953, Albert Sabin's simmering rivalry with Salk exploded into the open. At a national meeting of pediatricians, Sabin attacked Salk's vaccine and ridiculed the public's impression that a vaccine was almost ready for testing. Sabin's primary argument against Salk's killed virus vaccine was that it contained an inactivated version of an extremely potent strain of poliovirus. Sabin argued that if anything went wrong with the inactivation process, it would be a recipe for disaster.

8:03In contrast, Sabin had spent more than two years working on a live virus vaccine containing a weakened version of a live poliovirus, and he insisted his approach was the only viable option. He also condemned the NFIP, declaring that the organization was publicity-mad. But Sabin's criticism did nothing to hinder the momentum for Salk's vaccine. In November 1953, NFIP director Basil O 'Connor made the long-awaited announcement that large-scale polio vaccine trials would be held in the spring of 1954. It was a momentous decision. The Foundation would be testing an experimental vaccine on hundreds of thousands of children across America.

8:43To oversee the trials, O 'Connor enlisted leading epidemiologist Thomas Francis, who was Salk's former mentor. Not only would Francis supervise the trials, but he would also evaluate their results at his lab at the University of Michigan. And to do all this, Francis planned a double-blind study focusing on children in the first, second, and third grades. Roughly 420 ,000 children would receive the vaccine in three doses, while 200 ,000 children would receive saline placebos. Nobody involved would know who got what until the trials were over. A third group of 1.2 million children, designated as a control group, would receive nothing.

9:22And when the polio season arrived in the summer of 1954, scientists would measure the rates of polio in all three groups. The NFIP sought volunteers from a broad range of children from different races, representing urban, suburban, and rural populations. And they chose counties that had previously seen high rates of polio and seemed likely to experience outbreaks again. They also focused on counties with public health departments equipped to handle the trials. And after finishing their evaluations, they narrowed the list down to 211 counties in 44 states. The sheer size of these trials demanded extensive logistical planning, and the foundation relied on its large network of local chapters to coordinate support.

10:03Each of the 211 counties held two-day workshops to train tens of thousands of teachers, doctors, nurses, and local volunteers. Basil O 'Connor wrote letters to parents in each of the counties to request permission for their children's participation. Downplaying potential risks, he framed participation as a historic act, writing, This is one of the most important projects in medical history. We feel sure you'll want your child to take part. But he had little trouble convincing parents to give their consent. In the early 1950s, polls showed that public fear of polio ranked only second to fears of the atomic bomb.

10:39Americans were desperate for a vaccine that could finally end polio, the most dreaded childhood disease. They also had faith in the power of medical science, and they trusted the NFIP. Many had volunteered for the March of Dimes or donated their money to the organization. But finding volunteers was not the only logistical hurdle. The NFIP also had to produce enough vaccine doses for the trials. Salk's lab would not be able to handle the required volume on its own, so O 'Connor turned to commercial manufacturers. He made agreements with pharmaceutical companies Eli Lilly and Park Davis to produce the vaccine lots needed for the trials.

11:15To scale up production, government experts compiled detailed specifications based on Salk's notes, and tough quality controls were introduced. Each batch was triple-tested by the manufacturer, Salk's lab, and the Public Health Service. It was rigorous and expensive. The pharmaceutical companies needed to cover the costs of manufacturing throughout the trial period, But if the trial succeeded and the federal government approved the Salk vaccine for commercial use, these companies stood to gain substantial profits. So with the supply of vaccines secured, in February 1954, Thomas Francis opened the Vaccine Evaluation Center at the University of Michigan.

11:52He soon found himself inundated by questions from the community participants in the trials. Local health officers asked him whether he was certain there was no live virus in the vaccine, and they expressed their fears about potential contamination. Francis worked hard to assuage concerns, but just before the trials were set to begin, a popular radio broadcaster sowed new doubts.

12:16Imagine it's early April 1954 in Lansing, Michigan. You're the virologist in charge of the Salk polio vaccine trials, which are scheduled to begin at the end of the month. And with time running out, you're suddenly fighting a new wave of public uncertainty. That's why you're here at the medical practice of Dr. Baker, the president of the Michigan State Medical Society. Baker gives you a look of recognition as you sink into the wingback chair across from his desk. With a small sigh, he folds his newspaper neatly in half. May I help you, doctor? I hope so. I want to know what the hell you're thinking, recommending Michigan parents pull their children out of the vaccine trials.

12:53Well, what can I say? Walter Winchell hosts one of the most popular radio shows in the country. You can't expect people not to listen when they hear him calling the vaccine a killer. I've been fielding calls all day from spook parents. Walter Mitchell is a gossip commentator. He's trying to create sensation. I mean, he's not an epidemiologist. He doesn't know what he's talking about. The solved vaccine is triple-checked, while it seems clear that Winchell's so-called reporting isn't even checked once. Well, are you denying that problems were found with the commercially produced vaccine? I admit that a handful of batches fail to pass extremely rigid safety tests, but don't you see that's a good thing?

13:28It's proof of how well the triple-testing process is working. Oh, I don't know. I don't see why Michigan children need to be guinea pigs. I'd feel better leaving it to the other states. But we need a large sample size, Dr. Baker. I can't have an entire state pull out of the trials. I don't know what more proof you need. Dr. Salk has already inoculated hundreds of children in the Pittsburgh area, including his own three sons. Not a single mishap. And I'm glad to hear that. But I can't risk the public's trust. I expected you to know better. You shove your chair back and walk out of the office, anxiety coiling in your chest.

14:05You fear what all this means for the trials. If they're not up and running by the start of the summer polio season, they'll have to be put off for a year, wasting months of effort and putting more American children at risk.

14:20On April 4th, 1954, the famous gossip commentator Walter Winchell used his popular Sunday night radio show to attack the Salk vaccine. He claimed that the vaccine may be a killer and announced that 7 out of 10 tested batches at one facility contained live poliovirus that killed several monkeys. He also claimed that the NFIP was stockpiling little white coffins in the expectation that the trial would cause fatalities. Winchell based these claims on a tip he received from a disgruntled former NFIP associate who had learned that traces of live virus were found in four vaccine lots produced by Park Davis and Eli Lilly.

14:57But Winchell's broadcast was a gross exaggeration of the truth. The NFIP responded by confirming the tainted batches had been found and eliminated by rigorous safety testing. Thereafter, the NFIP put additional safety measures in place. Manufacturers were required to produce 11 consecutive lots of vaccine that passed safety standards before any could be approved for public use. If even one batch failed, all 10 of the other batches would be discarded. But Winchell's broadcast damaged public confidence nonetheless. Several local and state medical societies withdrew their support, and parents pulled roughly 150 ,000 children out of the field trials.

15:34Still, the vast majority of participants trusted the NFIP and planned to continue. So on April 25th, both the Vaccine Advisory Committee and the Public Health Service voted to approve the field trials on the Salk polio vaccine. The next day, April 26, 1954, a group of first graders lined up in the gymnasium of an elementary school in McLean, Virginia. Cameras flashed as a six-year-old boy named Randy rolled up his sleeve and became the first to receive an injection. He boasted, I could hardly feel it. The same procedure was repeated thousands of times over the next several weeks. Each school had a five-member volunteer vaccination team, which included a doctor, a nurse, a recorder, and two aides.

16:16Together, they oversaw identification, consent forms, preparation, injection, and disposal of syringes. But despite meticulous planning, logistical problems did arise, from children receiving extra or missed doses to doctors stealing vaccines to use on their own families. But nonetheless, by late spring, more than 600 ,000 children had received an injection, with 95 % of that number completing all three doses. This unprecedented achievement was a testament to the NFIP's careful planning and publicity and the dedicated involvement of more than 300 ,000 volunteers. The field trials amounted to the largest peacetime mobilization of volunteers in American history.

16:56But with the injections over, now all eyes turned to Thomas Francis, who faced a mammoth task of analyzing the data and determining whether Salk had finally created a safe and effective vaccine for polio, bringing an end to 40 years of fear.

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19:22In the summer of 1954, Thomas Francis and his team in Ann Arbor, Michigan, began evaluating the results of the Salk-Colio vaccine. Every day, bulging mail sacks arrived containing data in the form of letters, telegrams, laboratory reports, and health records. All of it needed to be collected and analyzed by statisticians that Francis hired from the U.S. Census Bureau, as well as dozens of Michigan graduate students. In total, 1.8 million children had participated in the trial. So now, a staff of 120 kept records on all of them, constantly updating the files as new information arrived. Much of the data entry was done by hand, but Francis also sent some of it to Detroit to be processed by early IBM computers.

20:04But despite intense interest in the outcome of the trials, Francis refused to rush his work, insisting that it would be finished when it's finished. It took a full year to process and interpret the data. Anticipation mounted in the spring of 1955 as the annual summer polio season approached, but at last, Francis told Basil O 'Connor that he was ready to release his final report. On the morning of April 12, 1955, hundreds of reporters and scientists packed a University of Michigan auditorium, eagerly awaiting advanced copies of the report. One journalist described his colleagues as hungry dogs at a garbage pail.

20:41And at 9.20 a.m., the news went nationwide when an NBC correspondent went on air and declared, the vaccine works. It is safe, effective, and potent. Shortly after, Francis stood in the auditorium and delivered a lengthy lecture confirming the vaccine's success. He said that it was roughly 60 to 90 percent effective in preventing paralytic polio, with a degree of success varying based on the type of poliovirus. Though he had some caveats about the integrity of the data, the overall conclusion was unmistakable. The Salk vaccine was a triumph. Next, Jonas Salk himself took to the stage to a standing ovation.

21:18He thanked the schoolchildren known as polio pioneers, the NFIP, and Basil O 'Connor, calling him the one person without whom all of this would not have been possible. He announced that he was already working on improvements for the vaccine, predicting the potential for 100 % protection from polio. Later that same day, Edward R. Murrow of CBS News interviewed Salk, asking him, who owns the patent on this vaccine? Salk replied, well, the people, I would say. There is no patent. Could you patent the sun? This remark came to symbolize the spirit of the polio crusade, a volunteer-driven effort made possible by millions of small donations.

21:56All across the country, Americans celebrated their shared victory. Schoolchildren cheered, church bells rang and parents wept with relief. Salk returned to Pittsburgh to a hero's welcome. He was an instant celebrity, hailed as the man who conquered polio. He explained that his vaccine had been built on ideas and techniques developed by many scientists before him, and by doing so, he acknowledged the critics who had long insisted that there was nothing novel about the science of his vaccine. But his comments did nothing to diminish his star power. The public credited him for single-handedly defeating polio.

22:29And on April 22, the White House held a ceremony in Salk's honor. President Dwight D. Eisenhower fought back tears as he declared, I have no words to thank you. I am very, very happy. Eisenhower promised to give the vaccine formula to every country that welcomed the knowledge, including the Soviet Union, and called Salk a benefactor to mankind. But though it was only hours after the release of The Francis Report, that the Eisenhower administration approved the Salk vaccine for commercial use, supplies were still limited. All across the country, pediatricians were inundated with calls from parents demanding that their child be vaccinated, and 10 million doses were released over the next two weeks.

23:08But most doses had already been promised to first - and second-graders, the age group considered most vulnerable to polio, and to children who had received placebos in the 1954 trials. This left most American children unprotected as summer approached. So Americans urged the federal government to step in. But the Eisenhower administration had made no plans to coordinate vaccine distribution. Secretary Oveta Culp-Hobby, head of the newly formed Department of Health, Education, and Welfare, admitted as much. Many Americans reacted with disbelief when she told a Senate committee, I think no one could have foreseen the public demand.

23:43Letters flooded the White House, calling her incompetent and heartless, and editorials demanded her resignation. But Secretary Hobby and her colleagues in the Eisenhower administration insisted that the government's only role was to license the vaccine, not to distribute it. In the 1950s, at the dawn of the Cold War, even limited government intervention in the health industry sparked accusations of socialism. And the pharmaceutical companies warned that government control of distribution would stifle innovation. But with supplies of the vaccine falling short of demand, price gouging became common.