11
Out of His Hands
In June of 1953, when Salk read in the newspaper that the NFIP was planning a field trial to begin in the fall, he was stunned. “I had no inklings of these conferences and plans,” he later complained. “Weaver and Rivers had been meeting for weeks … planning field trials of a product that did not exist and planning my duties for me as if I were a staff technician.”1 He insisted upon talking with O’Connor in person and took a train to NFIP headquarters in New York. Weaver had usurped clinical assessment of his vaccine, Salk told O’Connor, a vaccine which was not yet ready for widespread use. Added to that, a newly appointed group, the Vaccine Advisory Committee, from which he had been excluded, had been given control over the details of its testing. As much as O’Connor wanted to see a field trial go forward, he did not want to agitate his star scientist. He told Salk not to worry. “Nobody is breathing down your neck. It’s your work and nothing will be done with it that you don’t want done. You have my word on it.”2 Salk returned to Pittsburgh secure in O’Connor’s promise.
But Harry Weaver made no such promise. He was moving ahead with plans to coordinate the NFIP trial himself. “[Salk] could not be the architect, carpenter, and building inspector—or judge, jury, prosecutor, and defense attorney all at once,” he reasoned. If Salk tested his own vaccine, the results would be suspect. Weaver did understand his reaction, however. “Jonas … felt that his baby … was being torn from his arms,” he explained. “Yet it couldn’t be any other way.”3 As far as Weaver was concerned, Salk had played his part: he had prepared and tested a polio vaccine. Now he was hesitating, talking about continuing to study dose and sequence of inoculations with the tacit understanding that the NFIP supported his time schedule. Weaver and Rivers had a different agenda.
In mid-May, just three weeks after Salk had revealed his vaccine work to the public, Weaver had prepared a confidential memorandum for O’Connor, outlining plans for a field trial to be initiated on November 15, a mere six months away.4 Anticipating an outcry from the Committee on Immunization, whose members were split in their opinions regarding almost every aspect of polio prevention, Weaver and Rivers had conceived of an ingenious plan. They recommended that O’Connor bypass the group and appoint an advisory committee to determine the specifics of the poliomyelitis vaccination program. Although Weaver said publicly that this new group had been created to broaden the base of responsibility, later on he privately acknowledged, “We formed the Vaccine Advisory Committee to break a logjam.”5
For his Vaccine Advisory Committee, O’Connor had selected forward-looking men, all with extensive public health experience, who were willing to make decisions rapidly: David Price, the assistant surgeon general; Thomas Murdock, a trustee of the American Medical Association; Ernest Stebbins, director of Johns Hopkins School of Hygiene and Public Health; bacteriologist Thomas Turner, dean of Johns Hopkins Medical School; Norman Topping, vice president of medical affairs at the University of Pennsylvania; and Joseph Smadel and Tom Rivers. Notably absent were Enders, Bodian, Sabin, and Salk. All the members had one thing in common—they favored initiating a field trial before the 1954 polio season began.
On May 25, 1953, Rivers had convened the first meeting of the advisory committee.6 Although asked to report on his work, Salk had been excluded from its deliberations, so he didn’t know that one of its first recommendations concerned the field trial design. Salk had assumed the NFIP would conduct a trial in which a defined group would receive vaccine on a voluntary basis, and the incidence of polio among them would be compared with another group who received no injection—an observed control group. Weaver, Rivers, and O’Connor favored the same plan. The Vaccine Advisory Committee preferred one whereby children would be randomized to receive the vaccine or placebo, stressing its more scientifically sound design. Salk first learned about the recommendation from the press.
Salk wasn’t the only one disturbed by Weaver’s tactics; they infuriated the NFIP medical director, Hart Van Riper. A Florida pediatrician, Van Riper had moved to New York to join the NFIP when his wife became paralyzed with polio. Tall, articulate, and urbane, he represented the Foundation well at congressional hearings and medical society meetings. He had preceded Weaver at the NFIP, and Weaver supposedly reported to him. This was a mismatch from the start. Van Riper adhered to administrative protocol, whereas Weaver sought the quickest path, circumventing rules and regulations. Increasingly Weaver spoke directly to O’Connor, bypassing Van Riper. Now he appeared to be reorganizing Van Riper’s department, holding meetings without his knowledge. They regularly clashed: Van Riper accused Weaver of usurping his role; Weaver complained Van Riper was impeding his trial. “Van Riper felt that Harry Weaver was too big for his britches,” recalled NFIP regional director Charles Massey, “that Harry Weaver had not only sold O’Connor on Jonas Salk but had sold him on the idea of the field trial all without consulting with him.”7 They had reached an impasse; Weaver threatened to leave. O’Connor was torn: Weaver and Van Riper were equally valuable. So he left for Europe, telling Van Riper to settle the problem.
On August 29, Weaver resigned. “This action was taken,” he wrote to Salk, “following the realization that I could no longer discharge my responsibilities in an effective manner within the administrative framework in which I had to work. It was not easy to write this letter to you—sorry but it had to be.”8 Weaver had given Salk a major opportunity when he engaged him in the typing project. He had provided funding to build his laboratory and launched his career in the polio field. Nevertheless, once Weaver could taste victory, he had taken over, unwittingly making Salk feel like a hired hand. “I must tell you quite honestly that I was a very unhappy person for many months,” Salk wrote to O’Connor after Weaver left, “and regretted that I could not talk to you alone rather than through Dr. Weaver or in his presence.”9 O’Connor knew Jonas felt ambivalent about Weaver’s departure and sent him a telegram: “All will be much better.”10
But it wasn’t. With Weaver out of the way, Van Riper appointed Joseph Bell, chief of the NIH Epidemiology Unit, as scientific director of the field trial. A physician with a PhD in public health, Bell had substantial experience in vaccine assessment. With this expertise, however, came a tendency for inflexibility and top-down decision-making, which wouldn’t sit well with O’Connor. At the onset, Bell agreed with the Vaccine Advisory Committee: a randomized, placebo-controlled trial had become the gold standard for proving efficacy of a new vaccine. In addition, he refused to test any vaccine that contained mineral oil adjuvant; they would use an aqueous (water-based) vaccine for the field trial. And he intended to get his way.
Bell’s pronouncement sent Salk back to his laboratory to repeat his experiments with an aqueous vaccine. In monkeys, he found the best response occurred when two doses were administered a week apart followed a month later by a third dose, which he called a “booster.” Because human responses did not always parallel those in monkeys, he needed to study a new group of subjects. Salk contacted Pittsburgh’s Industrial Home for Crippled Children and the Sewickley Academy, a prep school located just north of the city. Parents readily volunteered their children as Salk set out to answer a number of questions: Could aqueous vaccine, devoid of adjuvant, produce an adequate antibody level? What were the optimal dose, number, and timing of inoculations? No matter how hard he worked, Salk worried that he couldn’t answer them in time to start a field trial in November.
The field trial design posed a bigger quandary.11 Initially O’Connor had supported Salk’s scheme: children in the second grade would receive vaccine on a voluntary basis, and the rate of polio would be compared with that of first and third graders in the same community who did not receive vaccine—an observed control group. This was the fastest, easiest, and least expensive trial to run, and parents would know whether or not their child received vaccine. O’Connor had already informed health officials in thirty-three states that this was the NFIP’s plan. The Vaccine Advisory Committee continued to resist this design, emphasizing its pitfalls. Those likely to volunteer would come from upper socioeconomic groups, the ones most susceptible to polio. Thus, children with a lower chance of contracting polio would be in the control group. The committee stressed that randomization, whereby children would be assigned by chance to inoculation with either vaccine or placebo, represented the most reliable statistical method.
Bell proposed yet a different design. He, too, favored a randomized trial, but instead of a placebo such as saline, the control group would receive influenza vaccine. He thought it was unethical to inoculate children with a solution of no value. Some committee members accused him of trying to piggyback an influenza field test onto the poliomyelitis trial. Salk was opposed to both plans, the committee’s and Bell’s. He still favored a nonrandomized trial in which second graders would be vaccinated and first and third graders would serve as observed controls. He pressed his design at every opportunity. “For arguing this as often as I did,” Salk recounted, “I earned scorn as an eccentric nuisance.”12
Additionally, Bell insisted the trial be double-blinded, such that neither the treating nurse, physician, and patient nor the NFIP would know who received which inoculate. Everyone would be coded, and the code would be broken only at the end of the trial. That way, no favoritism could be shown, and physicians, in making a diagnosis of polio, wouldn’t be biased by knowing whether or not the patient had received vaccine. Double-blind trials had the most scientific credibility. The Vaccine Advisory Committee agreed with him on this point, yet they continued to debate whether the control group would receive an influenza vaccine or placebo. Salk still resisted using a randomized trial altogether. Each felt passionate about his position, and the altercation made good copy. The Pittsburgh Press reported that the NFIP planned to inoculate more than a million children with either the new polio vaccine or a placebo. “This means they are to be given an injection of something which will look like the milky-white Pitt vaccine but actually will be only sugar water. … Dr. Salk is known to be opposed to giving any youngster ‘blanks,’ however, and may object to this proposal.”13
The dispute ran throughout September, and the start date for the trial was delayed until March of 1954. “It was never a tea party argument,” Tom Rivers recalled, “and the fur flew more than once.”14 During all this, O’Connor remained calm, trying to keep a broader perspective. Melvin Glasser, administrative director for the field trial, recalled one particular exchange when O’Connor quietly scribbled numbers on a yellow pad while the advisory committee and Bell were arguing. Suddenly he interrupted: “I have just figured out that during this coming summer thirty or forty thousand children will get polio. About fifteen thousand of them will be paralyzed and more than a thousand will die.” Caught up in their dispute over control groups and placebos, they inadvertently might delay vaccinations until after the next year’s outbreaks had begun. “Let me remind you,” he continued, “that we are supported by the people, and it is our duty to save lives.”15 With that, the debate ended. When Bell realized the Vaccine Advisory Committee would not budge from its position, he resigned.
Salk did not yield. He sent O’Connor an eleven-page letter pleading for a trial with observed controls: “I would feel that every child who is injected with a placebo and becomes paralyzed, will do so at my hands.” Those demanding a placebo-controlled trial, he argued, took that position in order to reach some statistical endpoint because of “values in which the worship of science involves the sacrifice of humanitarian principles on the altar of rigid methodology.” Such a trial would make Hippocrates “turn over in his grave.”16 But the decision had been made.
“Many Thousands to Get Polio Vaccine Next Year,” ran headlines on October 9. Starting in March of 1954, hundreds of thousands of children would be getting shots—half with a vaccine against all three known types of poliovirus, half with salt solution. “When the 1954 polio season has come and gone, scientists will count noses to see how many in each group got polio.”17 O’Connor’s public announcement provoked a groundswell of opposition among scientists, beginning with members of the Committee on Immunization who had been excluded from decision-making for the past nine months. How did they feel when news of the field trial screamed from every headline? The NFIP would soon find out. Henry Kumm, who had replaced Weaver as director of research, convened a meeting of the group on October 24 in Detroit where he intended to bring them up to date on the immunization program and invite their collaboration. The evening before the meeting, Salk told John Paul that he was concerned about how members of the committee would react when they learned how far along the NFIP had moved toward the trial.
Salk’s unease was well founded. The next day, when a committee member asked if they had a choice as to the kind of vaccine, O’Connor replied, “That’s not the function of this Committee.”18 Following the advice of the Vaccine Advisory Committee, the NFIP had already decided on the inactivated-virus vaccine. The Foundation had kept these deliberations from its own scientific advisers. “Decks had been cleared for action on a vaccine,” Paul said, “and if in the process some individuals had been hurt and some wrong decisions had been made, that was just too bad.”19 Sabin and Paul tried to convince the NFIP to postpone the trial, calling the Mahoney strain too virulent to use in the vaccine. Their concerns were brushed aside. The breach that resulted, Paul recounted, “remained for some members of the Immunization Committee an open and sore wound.”20 Since O’Connor wouldn’t listen to them, the disgruntled scientists targeted Salk. Sabin and Paul urged him to block the field trial, telling him he was being controlled by O’Connor and that it would ruin his reputation in the scientific community. Salk did not belong to the Vaccine Advisory Committee and had been ostracized by the Committee on Immunization. The former was moving too fast; the latter was suggesting he retreat. He felt like a pariah. “I’d walk down a corridor,” he said, “and people would stop talking as I approached.”21
Remarkably, the relationship between Salk and O’Connor remained as strong as ever despite this turmoil. “Jonas was the nicest, sincerest young man you ever met,” O’Connor told science reporter Victor Cohn. “There wasn’t a mean or selfish bone in his body.”22 On October 28, he sent Salk a telegram on his thirty-ninth birthday: “Twenty years from now this will be Interesting But Good History. … Best wishes from one who knows.”23 During the months that followed, as tensions rose, they grew even closer.
Although members of the Committee on Immunization had left Detroit frustrated and angry, no one resigned from the committee. Many still received considerable research funding from the NFIP and did not contest O’Connor’s decisions publicly, except Sabin. At the American Medical Association convention in New York the prior June, Sabin had informed its forty thousand members that the Mahoney strain was highly infectious and just a small amount of live virus left in the vaccine could cause paralysis. At a congressional hearing in November, he contended that Salk’s vaccine provided weak protection and that the safety of a killed-virus vaccine had not been confirmed by others. He opposed inoculating hundreds of thousands of children based on the work of one investigator. Sabin did not address the concern that waiting for him to develop a live vaccine would leave the public unprotected for several more years. “He could not suppress his own desire to be recognized,” NFIP official Charles Massey related. “He kept using the idea that Jonas was rushing too fast and that this would be risky and people might die. But, in my judgment, he was doing that to protect his own ego, rather than to be concerned about humanity.”24
The press began to portray Sabin and Salk as adversaries, racing to see who would make medical history. John Troan capitalized on this presumed contest. “Dr. Sabin,” he wrote, “is the first top-level scientist to cast a jaundiced eye on the vaccine developed at the University of Pittsburgh.”25 In this alleged rivalry, Sabin was often depicted as the villain who tried to block Salk at every turn, who repeatedly maligned him behind his back. Letters between them suggest otherwise. Following the Hershey meeting earlier that year, Sabin had written to Salk, warning him not to be pushed “to make liters of stuff for Harry Weaver’s field test.” He said he felt confident Jonas would do the best possible job, “regardless of what is said by others,” signing his note “All good wishes and affectionate regard.”26 When he wrote to a prominent pediatrician critiquing Salk’s vaccine, he sent him a copy, penciling at the top: “This is for your information so you’ll know what I am saying behind your back. … Love and kisses are being saved up. Albert.”27 No one close to Salk ever heard him make a derogatory comment about Sabin. “The race was a myth,” his research assistant Don Wegemer said.28 Each stuck firmly to his belief regarding the principles that guided immunization—live or killed virus. Thus, at that point in time, a rivalry was brewing between two scientific principles, not between two scientists.
While Sabin was campaigning against an inactivated-virus vaccine, other scientists began to question Salk’s results too. “Polio vaccine researchers got into a hassle last week,” Time magazine reported on November 23.29 Chicago physician Albert Milzer had presented a paper at the eighty-first meeting of the American Public Health Association, stating that his group had followed Salk’s published directions faithfully, and formalin had failed to kill all the poliovirus. In response, Salk sent a letter to the editor of the American Journal of Public Health. “The implication that our methods have been followed, but our findings were not repeatable, is rather serious.” Milzer seemed to lack an understanding of the formalin inactivation process. “These investigators have, without justification, impugned experiments that were carefully conducted, and they have aroused fear and doubt by their irresponsible remarks in a scientific paper in which evidence, rather than opinion, should stand out.”30 Nevertheless, the damage had been done; the Illinois state health director banned vaccine studies until they had adequate evidence of its safety.
Then, four days after the Time article, C. Henry Kempe, a junior pediatrics professor at the University of California, San Francisco, started a conflagration when he wrote to Aims McGuinness, a leader in the American Academy of Pediatrics, objecting to the Academy’s endorsement of the upcoming field trial. He and a number of others had three substantial concerns: First, they thought the formalin-inactivated vaccine had not been tested sufficiently to assure its safety. Second, Salk grew poliovirus in a monkey kidney culture, and a reaction against this foreign protein might damage a child’s kidney. Third, Salk’s published work was based on a vaccine mixed with mineral oil adjuvant, yet an aqueous vaccine was to be used in the field trial. “It seems remarkable,” Kempe wrote, “that there seems to be a general unwillingness on the part of the virologists to go on record in public against the plans of the National Foundation for Infantile Paralysis.”31 McGuinness sent Kempe’s letter to a large number of scientists, including Salk, seeking their comments.
Before Salk could compose his reply, Sabin wrote to McGuinness attacking Salk’s work as well, stating that most leading virologists held similar views.32 Thomas Francis, Jr., lambasted McGuinness, saying the statements about Salk’s vaccine appeared to be founded on “an accumulation of rumors.” He chastised him for not contacting Salk directly before spreading Kempe’s letter widely: “I count it neither valorous or virtuous to attack an individual by indirection in such a way as to cast doubt on his scientific integrity when the very doubts are neither documented nor affirmed.”33
Weeks later, Salk finally responded himself. Fully aware of the blistering letters going back and forth among leaders in the field, he wrote several long drafts, the first full of emotion, each subsequent draft less so, until he finally sent McGuinness a brief note: “I can only say that Dr. Kempe’s statement is replete with inaccuracies.”34 McGuinness sheepishly responded that in a field moving as fast as polio vaccine development, it was impossible to keep abreast of the latest information. Emboldened by the apology, Salk wrote back:
I am unaware of anything that I have done in the past that should merit the degree of distrust that is implied by the great concern that so many people have. … What right does one go forth casting aspersions and for these aspersions to parade as facts without what one might call the accused being faced by his accuser. … Science has come to a pretty pass when relationships between scientists have been so debased.35
In response to the concerns raised by Kempe and Milzer, the Vaccine Advisory Committee asked Salk to test a sufficient number of children to detect any resultant kidney damage prior to commencing the field trial. This time-consuming task would require drawing blood and collecting gallons of urine from hundreds of children. With regards to the aqueous vaccine, Salk was already testing it; Smadel insisted the number of subjects be increased to five thousand.
The NFIP had bigger problems to resolve than Kempe’s letter. Salk had prepared an effective, safe inactivated-virus vaccine in his lab; however, he couldn’t produce enough vaccine for the nation, let alone the world. That was a job for pharmaceutical manufacturers. And once it was out of his hands, Salk couldn’t attest to the vaccine’s reliability or safety. So he insisted that vaccine produced by drug companies pass safety tests not only in their own labs and the NIH Laboratory of Biologics Control but also in his laboratory. He knew this triple testing might delay the trial, yet he was firm. “While we can shorten the time between the taking of each step,” he warned those leading the field trial, “I do not think we can skip any without running the risk of tripping … [and] that would open us to criticism on the part of those who are only too ready and eager to destroy that which has been constructed thus far.”36
In early November, NFIP executives met with ten pharmaceutical companies to discuss their potential participation. Although O’Connor told them the Foundation prohibited patents for work performed under its research grants, five more companies asked to participate. By this point, Salk and his group had honed their technique for vaccine production: Monkey kidneys were minced in a blender and incubated in test tubes along with nutrient 199 for six days. Each of the three strains of live virus was added to separate tubes of kidney cells and allowed to proliferate for four days. Debris from the minced kidney was filtered out, after which the viral suspension was put into refrigerated tanks. Over the next six weeks, the fluid was tested repeatedly for possible contamination with bacteria or tuberculosis (TB). The solution was then heated to 96.8 degrees and deposited in roller tubes with formalin. At three days and again at nine it was tested for live virus. If none remained, the solution was inactivated for three more days and analyzed again for residual live virus. If negative, sodium bisulfate was added to neutralize the formalin. The viral suspensions of all three strains were then combined to form the vaccine. That was just the halfway point. Over the next twenty-eight days, Salk’s team checked and double-checked for live virus in tissue cultures, mice, and monkeys. If a lot proved clear, they bottled it. Each production cycle could take up to four months. And it was already November.
Once production left Salk’s hands, there was always the possibility for error, serious error that could result in an ineffective product or a vaccine tainted with live virus. In order to prevent this, instructions had to be spelled out in detail in a document entitled “Minimum Requirements.” For this the Vaccine Advisory Committee turned to Salk. “I was not an industrial engineer,” he said years later. “Specifications for large scale manufacture could not be my responsibility.”37 Yet only he knew all the particulars. With his many competing tasks—continuing his laboratory investigations, inoculating thousands of Pittsburgh school children, answering hundreds of calls and letters—he didn’t complete the first draft of the “Minimum Requirements” until December. Even then it had to be edited extensively. That completed, he was assigned the onerous task of reviewing the procedures of each company and answering their numerous questions.
The NFIP selected Parke, Davis and Company to lead off vaccine production. At first, its scientists could not get the vaccine to induce antibodies, and Salk was called upon to investigate the problem. He started at Connaught Laboratories, a Toronto group with which NFIP had contracted to cultivate virus for the field trial. Salk found no issues; they were sending frozen virus to Parke, Davis. Next he traveled to Parke, Davis’s lab in Detroit and discovered the problem lay in the way in which the technicians were thawing the virus. Just as that issue was solved, Parke, Davis scientists reported live virus in their inactivated vaccine. Again Salk visited their lab and found the incubator to be unreliable, varying the temperature from what Salk had specified. Although Parke, Davis blamed Salk for writing vague manufacturing directions, he was beginning to suspect they wanted to produce vaccine their own way. “The entire program is being jeopardized by the attitude that prevails,” he wrote O’Connor, “and I would urge very strongly that we waste as little time as possible attempting to bring them into line.”38 It seemed unlikely they could make enough vaccine by March. “We all believed that the Foundation had to put on a field trial in the spring of 1954,” Rivers recalled. “If it didn’t, the lid would be off and the following year everybody and his aunt would be trying out their own vaccine.”39 Swedish scientist Sven Gard was preparing a vaccine already.
It didn’t take Salk long to comprehend that drug manufacturers were entrepreneurs, not academic scientists; they occasionally ignored the “Minimum Requirements” and made cost-saving decisions. When Cutter Labs, located in Berkeley, sent Salk their production manual, he could already spot instances where some specific details of his instructions had been omitted. He sent a list of corrections, acknowledging that they would make the process more time-consuming. “Every batch of vaccine is a damned research project,” a Cutter scientist complained.40 When Salk found another company had omitted Type 2 virus and just added extra Type 3, his confidence was shaken. Reluctantly, the NFIP announced the field trial would be delayed until April 2.
O’Connor sensed Salk’s growing frustration with the pharmaceutical companies and hired G. Foard McGinnes, a former medical director of the Red Cross, to oversee vaccine procurement and distribution. O’Connor chose well. McGinnes had a strong background in product management as well as the collaborative style required to achieve teamwork between the pharmaceutical laboratories and Salk. In the end, only Parke, Davis and Eli Lilly would be ready to supply vaccine for the field trial.
Meanwhile Salk was trying to continue some much needed laboratory work. His group, now consisting of nine research professors and fellows as well as fifteen staff, worked long hours, leaving only when they completed experiments, not when the clock struck five. Many experiments ran on a twenty-four-hour basis. “Salk liked to do multiple tests on everything,” Wegemer recalled. “He duplicated, duplicated, and reduplicated to make sure everything was right.”41 When a New York Times reporter asked about his “punishing load,” Salk replied, “An investigator who develops a new vaccine assumes responsibility for its safety.”42
Initially his research group had a great deal of camaraderie. Salk had shown sensitivity and concern for every member. Now things had changed. The lab could not function like a usual academic laboratory with regular meetings, proper training of postdoctoral fellows, and seminars; they were too busy. Each morning Salk passed out slips of paper listing the tasks to be accomplished that day. He returned late at night to review the results. This angered some members of his team, in particular Julius Youngner, who considered the many daily tasks to be menial chores, not creative science. But these were extraordinary times; the lives of thousands of children were at stake. Salk held no one captive; any technician, trainee, or research professor could go elsewhere, yet no one left, not even Youngner. Although he later carped that Salk had more time for reporters than for his research team, Youngner did admit: “You had at your fingertips the prevention of a terrible disease, an epidemic disease. I can’t describe to you the kind of excitement this generated.”43
Salk was spending up to eighteen hours a day in his lab, eating most of his meals there when he wasn’t traveling to NFIP headquarters, the NIH, or the pharmaceutical labs. His grueling schedule left no time for nine-year-old Peter, six-year-old Darrell, three-year-old Jonathan, or his wife. Donna must have been amused when she read in the New York Times: “Busy as he is, Dr. Salk makes time for his three sons who range in age from three to nine. On Sundays he usually takes them out riding or walking in the country … and he tells them about the magical life processes of the plants and animals around them.”44 Donna never talked to the children about polio or their father’s work, and she never showed them pictures of Jonas, which now appeared with regularity in newspapers and magazines. While her husband was doing something with enormous global potential, she made sure her children lived ordinary lives. If Donna appeared to tolerate the situation with sangfroid, it was because she understood her husband’s aspirations. Reflecting back on their conversations the summer they met in Woods Hole, she said, “Jonas had the idea from a time when he was quite young, that he wanted to do something that would make a difference to humanity.”45 If she thought that once he had accomplished his goal of preventing polio she and the boys would recapture his attention, she was wrong.
As 1953 came to an end, the 35,968 reported polio cases marked the third-highest incidence in US history. A survey of public fears ranked polio second, just behind the atomic bomb. Everybody awaited a preventive vaccine, and their hopes were directed toward the NFIP. The field trial would be a costly endeavor, one solely supported through the March of Dimes. O’Connor set seventy-five million dollars as his fundraising goal for 1954. To accomplish this, three million volunteers from the 3,100 National Foundation chapters across America joined forces. The NFIP needed widespread publicity, and its public relations department sent the press human interest stories to encourage donations—like the “tipping from a waitress” anecdote out of Portland, Oregon.46 A group of volunteers had gathered at a local restaurant to plan their fundraising activities. At the end of dinner, as they started to leave, their waitress, Evelyn Higgenbottom, called them back and gave them their first contribution—the three dollars in tips they had left for her.
No one, however, sold magazines and newspapers as well as Salk. He had come to personify the fight against polio. In his white coat and oversized, clear-rimmed glasses, he imparted the impression of the archetypal physician-scientist; yet two things helped the press create a congenial image—his humility and his engaging smile. The public wanted to hear about this man who had risen from Harlem to free them from the fear of polio. His image was burnished by the press and the NFIP. A New York Times reporter wrote that without him “not a public health official, not a physician would move. The whole vast network of medical personnel and volunteer aids the National Foundation is erecting for the test—the largest medical test in history—would not get off the ground.”47 A friend from Syracuse wrote Salk that he had pushed the Korean conflict off the front page. “With the conquest of polio in sight,” wrote a Life reporter, “the currently lively topic in the medical world is who will get the Nobel Prize?”48 Troan, who professed to be Salk’s friend, was among the most egregious practitioners of sensationalism. “He’s the Man Who May Lick Both Polio and Flu,” Troan wrote for the World Telegram. “Don’t miss this absorbing article about a man who may be on the verge of making miracle contributions to humanity!”49
Salk remained uncomfortable with such publicity. When Life, Time, and Newsweek asked for his personal story, Salk gave them no details of his life outside the laboratory. He considered his private life irrelevant. “Why do they all want to know what I eat for breakfast?” he asked Troan.50 On the one hand, he frustrated newsmen by talking in general principles, not specifics, and answering questions with questions. On the other hand, they liked him; he was polite and well-spoken and made science accessible to the public. Limited facts didn’t keep reporters from speculating, however, based on the tidbits they had gathered. An old acquaintance sent him an article from the Jewish Daily Forward that revealed his dreams of being a rabbi. “The figment of someone’s imagination,” Salk replied.51 Interruptions by the press, many of which the NFIP had instigated, increasingly annoyed Salk. He told Tom Rivers, “I hope the intensity with which the spotlight has been focused on us will be turned off before we are burned to a crisp.”52
One of the things that embarrassed Salk most was that the press referred to his preparation as the “Salk vaccine,” an improper appellation in scientific circles. No one called Pasteur’s rabies vaccine the Pasteur vaccine or Jenner’s smallpox vaccine the Jenner vaccine. Salk knew he did not deserve such credit and feared scientific colleagues would think it a form of self-aggrandizement. Many did. He tried referring to it as the “Pitt vaccine,” but that name never stuck. When Salk asked Troan why the press insisted on calling it the “Salk vaccine,” he explained, “It fits in a headline.”53 Besides, naming it after their hero-in-waiting distinguished the vaccine. Many in the scientific community considered Salk’s protestations disingenuous. They thought he courted the press out of self-interest. When a picture of Salk vaccinating his three sons appeared in the news, some thought it another publicity stunt, lending proof to their contention that Salk was a celebrity-seeking NFIP puppet.
Ready to initiate a field trial of historic proportions, the NFIP still had not selected the person to conduct the all-important data collection and analysis after Bell resigned. Although Salk would have readily accepted the charge, the Vaccine Advisory Committee recommended the trial be analyzed by a scientist outside the NFIP. That way detractors couldn’t claim bias in the vaccine’s assessment. Van Riper, O’Connor, and Rivers concluded that Thomas Francis, Jr., had the capability, integrity, and credibility they were seeking. Van Riper contacted Francis, who was on sabbatical leave in Europe. He replied that he would not consider the task unless they agreed to his stipulations: First, the NFIP must provide him with funds to set up an evaluation center at the University of Michigan where he would have complete control over all data with no interference from the Foundation. Second, results of the trial would be released when he deemed them ready. Finally, regarding the trial design, Francis insisted that it be a randomized, double-blind trial with one group receiving vaccine and a control group receiving placebo. He understood that O’Connor had already promised some communities that they could participate in a nonrandomized study giving all second graders vaccines, with first and third graders serving as observed controls. He would honor that pledge. The primary trial, however, would be a randomized trail conducted in first, second, and third graders. Van Riper agreed to all Francis’s stipulations, and on January 25, 1954, Francis accepted his offer to evaluate what he knew would be history’s most closely watched clinical trial.
Before the field trial could commence, Salk needed to complete assessment of his aqueous vaccine, after which he would test commercially prepared vaccine in 2,500 Pittsburgh children, observing them for twenty-one days for toxicity and response. The work was proceeding at a rate that would allow the trial to begin on April 2, in advance of the summer outbreaks. It was at this point that the federal government stepped in.
Although O’Connor planned to bear the entire expense of the field trial, the NIH Laboratory of Biologics Control, under William Workman, eventually would be responsible for licensing the vaccine. Workman knew that if something went wrong during the trial, Congress would investigate why his bureau had not protected the public. So he began to get involved. He agreed that each commercial lot would be tested for potency, safety, and sterility in the pharmaceutical laboratories, in Salk’s lab, and at the Laboratory of Biologics Control. Then he mandated that the antiseptic Merthiolate be added to all vials of vaccine. He reasoned that after the vaccine was bottled, bacteria or fungus might grow and contaminate the vaccine before its use. Salk countered that he had never observed this problem, and vaccine would be used promptly. Besides, he didn’t know if Merthiolate would interfere with the vaccine’s activity, and he didn’t have much time to find out. Workman remained adamant—no Merthiolate, no trial. Salk had no option but to submit to his directive.
On March 21, Salk notified Van Riper that he had completed the inoculation of four thousand children with aqueous vaccine to address the concerns raised by Kempe. It had proved effective and produced no ill effects, including kidney damage. He was ready to assess commercially prepared vaccine in 2,500 children when Fred Stimpert called with disturbing news: at Parke, Davis, guinea pigs injected with the vaccine tested positive for TB. The NFIP dispatched a tuberculosis specialist to the Parke, Davis laboratory to examine the guinea pigs. He found no infection. Merthiolate, the antiseptic Workman had insisted be added to the vaccine to prevent contamination, had caused false positive TB tests.
While Salk was trying to meet the April deadline, enormous pressure was being exerted from all sides. The public stood by in anxious anticipation, incited by the press. Salk’s picture appeared on the cover of Time; “Polio Fighter Salk: Is This the Year?” it asked.54 Life, Collier’s, Consumer Reports, Popular Mechanics, and U.S. News and World Report all ran feature articles on the vaccine. The New York Times Magazine portrayed Salk as the star in an article entitled “A Stirring Medical Drama.”55 Time, Newsweek, and Science News Letter gave weekly updates. On the other side stood the vaccine opponents from the legitimate to the psychopathic. “Several States Balk at Tests of Polio Vaccine,” read a headline in the Chicago Daily News, with the subheading “Health Officers Call Plan Hasty, Doubt Safety of Mass Inoculation.”56 The World Health Organization issued a statement that read, “Mass immunization should not be generally adopted until such times as scientific data are available on the innocuity and efficacy of the vaccine.”57 Opening his talk before the Michigan State Medical Society in mid-March, Sabin quipped, “I felt certain that after you all had read the Life magazine story of the conquest of polio, no one would be here.” He called the field trial premature: “Let us not confuse optimism with achievement.”58 Among the most vitriolic was D. H. Miller, self-proclaimed president of Polio Prevention, Inc., in Coral Gables, Florida, who sent Salk a number of his articles, which he had circulated nationwide. One, entitled “Little White Coffins,” began, “Only God above will know how many thousands of little white coffins will be used to bury the victims of Salk’s heinous, fraudulent vaccine.”59
At the end of March, Workman approved the first batch of Parke, Davis vaccine, and O’Connor was inoculated with it. The following day, Salk had just returned from Colfax Elementary School, where he had begun vaccinating children with commercial vaccine, when he received an urgent message from Workman: safety tests performed on commercial vaccine in the Biologics Control Laboratory had revealed that Parke, Davis lots 501–506 and Eli Lilly lot E-2178 were causing polio in monkeys. Workman was calling a halt to the field trial. McGinnes asked Workman for seventy-two hours to solve the problem. He and Salk found that the companies had not followed the specifications for inactivation exactly as written. Parke, Davis had shortened the exposure time to formalin, allowing virus to survive. Eli Lilly had not filtered the viral suspension properly, leaving cellular debris that could interfere with inactivation.
On March 25, Rivers and O’Connor met with NIH Director William Sebrell and his assistant James Shannon to review the situation. Rivers pointed out that these mistakes had been caught in the safety tests, and contaminated vaccine never would have been released to the public. Shannon said their statistician had calculated that in order to validate the data, they should test samples of each lot in 350 monkeys instead of 54, the current number. O’Connor pointed out that would make the cost of vaccine prohibitive and would delay the trial to a date past polio season. “I’ve been making vaccines all my life,” Rivers told Shannon, his temper rising. “As far as I’m concerned, you can take your pencil and paper and shove them up your ass.”60 O’Connor sent Rivers back to New York to cool off. That night he called the other members of the Vaccine Advisory Committee. “This is General O’Connor speaking,” he said. “I have been attacked from all sides and need reinforcements. Can you be here tomorrow morning?”61
Over the next three days, the NIH and NFIP reached a compromise. They would continue triple testing every lot with the same number of monkeys. Each company, however, would have to produce eleven consecutive lots that tested safe before the first lot could be released. If one lot tested positive for virus, they all had to be destroyed. Someone leaked the story to the press, and on April 4 Walter Winchell in his Sunday night radio program shocked the American public when he announced: “In a few moments I will report on a new polio vaccine. It may be a killer!”62
This popular newsman for ABC, who specialized in sensationalism and scandals, threw the public into a tailspin. Some reacted with fear, others with outrage. “The public is entitled to accuracy in journalistic reporting,” a Pittsburgh judge wrote to ABC, “not tips on horse races or the stock market nor statements made in reckless disregard of their accuracy.”63 The University of Pittsburgh sent a notice to parents telling them there was no live virus in the vaccine their children had received. When Troan asked Salk if he wanted to make a statement, he said, “Winchell should stick to propaganda or rumors and not dabble in medicine.”64 Even Sabin called Winchell’s broadcast “irresponsible.”65 Nonetheless, the harm had been done. The NFIP estimated that approximately 150,000 children were kept from participating in the field trial by frightened parents.66 The state of Minnesota withdrew from the trial. Then, one week before the trial was to open, workers at the only factory that could provide the two million needles required for the trial called for a strike.67
On April 24, O’Connor and the Vaccine Advisory Committee returned to the NIH. The time had come for a decision about the field trial: it was either now or a year’s postponement. Salk reviewed his data—7,500 vaccinated with no toxicity. The commercial vaccine was now free of virus. Then, Workman told the committee that a group of mice recently inoculated with vaccine had become paralyzed. They called in David Bodian—the world’s expert on poliomyelitis in animals. It was no secret Bodian originally had not favored the inactivated vaccine. Now the decision to go forward rested on his opinion. Workman showed Bodian a tape of the mice swaggering around in their last days of life. The problem started with a subtle change in gait, followed by dragging of their hind legs, falling, and eventually death. Workman expected Bodian would need several days to determine if the mice had polio. “I don’t know,” Bodian said almost immediately. “But I know it’s not polio.”68
The Vaccine Advisory Committee met the next morning at the Hotel Carlton to vote.69 Many reported a sleepless night. A no vote guaranteed thousands would die from polio in the coming season. With a yes vote, they accepted responsibility for harm done to any child by the vaccine. Dorothy Ducas, the public relations director for the Foundation, stood by for the news release. She found Salk sitting alone on a bench outside the meeting room. When she asked why he was there, he replied he thought he might be called in for last-minute questions. Although Salk had vaccinated thousands at that point, he was not included in the proceedings. “It’s not my decision to make,” he told Ducas.70
Inside, the Vaccine Advisory Committee passed a unanimous resolution to start the polio vaccine field trial. The US Public Health Service issued a statement declaring the decision sound. At 9:35 a.m. on April 26, 1954, the biggest clinical trial in the history of medicine began when six-year-old Randy Kerr of McLean, Virginia, received the first vaccination at the Franklin Sherman Elementary School.
The period between January of 1953, when Salk first presented his work to the Committee on Immunization, and April of 1954, when the polio vaccine field trial began, was among the most trying in his life. He felt responsible for the health of the nation. Salk knew his vaccine was both effective and safe. How to demonstrate this to the satisfaction of the federal government, practicing physicians, and his scientific colleagues while answering to his own conscience, formed the crux of a major dilemma.
Salk stood by almost helplessly as the NFIP, through the actions of Weaver and Rivers, took over what he thought should have been his trial, giving him little say as to design, excluding him from the national evaluation of his vaccine. They contended that he couldn’t take responsibility for the definitive assessment of his own discovery. No large organization had wrested the smallpox vaccine from Jenner’s hands, calling it improper for him to test his own vaccine. The vaccines for yellow fever, diphtheria, and rabies had been tested by the scientists themselves, not a foundation or a government agency. And Salk and Francis had not only developed the influenza vaccine but also tested it on military recruits. The conduct of clinical trials had changed, however, and in the long run insistence on a randomized trial, evaluated by a nonbiased investigator with strict statistical oversight, would validate what was certain to be a controversial study. To make matters worse, Salk had watched his carefully prepared and tested vaccine be adulterated when the pharmaceutical companies began large-scale preparation, taking shortcuts which reduced its safety. The removal of the mineral oil adjuvant and addition of Merthiolate by the Biologics Control Laboratory added to his discontent.
In the meantime, the public, the overzealous NFIP, and Basil O’Connor, whom Salk revered, pulled at him from one side, while scientists he respected and a group of vocal physicians pulled from the other. The press stood by, reporting every move, every dispute, stretching the facts whenever necessary to make a good story and keep Jonas Salk in the headlines. Even so, his wife, Donna, maintained, “No external pressure could possibly match the internal pressure under which Jonas operated. He had decided that there ought to be a polio vaccine and that’s what he was going to do.”71 During that year Salk had heard leaders in the field, men he aspired to emulate, criticize him at every turn. When asked later in life whether that criticism had hurt his feelings, he replied, “Hurt? That’s one thing. Being deterred is another. I just plowed on.”72 Engulfed in conflict, this man who avoided confrontation reacted with equanimity. “When other people might have caved in, he didn’t,” his son Peter said. “It was just not his nature; he never caved in.”73 Some interpreted his conviction as arrogance.
While trying to complete his work with utmost speed, Salk was bombarded with hundreds of letters from parents begging for vaccine and heart-rending requests from people afflicted with polio. The sanctuary of his laboratory was invaded by researchers coming to learn his techniques and by the press hoping to get a glimpse of this man who was rapidly rising to saintly status. Always a private man, Salk had few friends in whom he could confide. He couldn’t trust colleagues in the field. His mentor, Thomas Francis, had long since distanced himself. Although he had a close relationship with O’Connor, it became clear that the NFIP was O’Connor’s favored son. And he did not seek sympathy from Donna. He rarely made it home, and when he did, it was to sleep a few hours or change his shirt. Her focus had to be her three sons, whom for the most part she was raising alone while coping with her husband’s growing celebrity.
The polio vaccine saga, one of the most controversial in medical history, was being played out on a grand scale, with the health of the public at stake. During that year Salk had to draw upon all the inner strength he had stored up since childhood when he dreamed of helping humanity, of making a difference. “I desire to so conduct the affairs of this administration,” his childhood hero, Abraham Lincoln, had said, “that if, at the end, when I come to lay down the reins of power, I have lost every other friend on earth, I shall at least have one friend left, and that friend shall be down inside of me.”74 Jonas Salk persevered because, in the end, he believed, he had to answer only to himself.