The Vaccine Race

by Meredith Wadman

  Hayflick’s first meeting the next morning was with the NIH’s incoming permanent director, Donald Fredrickson. An NIH veteran who had directed the agency’s heart institute, Fredrickson was finishing a year’s stint as the president of the Institute of Medicine before taking the helm at the NIH, and so Hayflick met him at the institute’s home—the stately National Academy of Sciences building on the Washington Mall—and Fredrickson drove Hayflick the eleven miles to the biomedical agency in Bethesda. On the way, Hayflick remembers, Fredrickson turned to his passenger and said, “I hear you have a problem.”38

  After Fredrickson dropped off his passenger at the NIH, Hayflick proceeded through an orderly round of interviews with other senior agency figures. One of these had been hastily added to the schedule the previous afternoon. Just before lunch that Friday, Lamont-Havers, the agency’s acting director, met with Hayflick. He told Hayflick, Lamont-Havers recalled one year later, that the job offer was a firm one—“contingent upon the resolution of a possible conflict of interest in relationship to the selling of the WI-38 cells.”39

  Lamont-Havers had already decided who was going to investigate Hayflick’s activities with the WI-38 cells. It wasn’t a lawyer trained in intellectual property law. It was James W. Schriver, who headed the NIH’s internal auditing office. Called the Division of Management Survey and Review, it was charged with providing detached appraisals of the agency’s management practices and with rooting out the misuse of grant funds and conflicts of interest. In this the office worked closely with the Justice Department and the FBI.40

  • • •

  The NIH hired Schriver to head its new auditing division in 1963.41 Schriver, who died in 1999, was a native of Carlisle, Washington, an Olympic Peninsula town so small it scarcely appears on maps, even today. He earned a bachelor’s degree in business administration at the University of Oregon in 1939 and in 1945 went to work for the U.S. government, moving through internal auditing positions of increasing responsibility. When he joined the NIH, he had most recently worked in the U.S. Army Audit Agency and the Department of Agriculture investigating, among other things, food stamp fraud. Schriver would, over time, become the man sought out by whistle-blowers at the NIH and the person whom agency directors turned to with thorny, unpalatable problems. (In 1971, when Roderick Murray and the Division of Biologics Standards were under fire from Senator Abraham Ribicoff, the NIH’s then-director Robert Marston asked Schriver to investigate.)42

  In the unsmiling photos that peer out occasionally from the archived pages of the NIH’s in-house newspaper, the NIH Record, Schriver looks to be all business. He has a square face and jowls and, at the time of his 1980 retirement, silver hair. The New York Times would later report him to be “widely respected for honesty and fairness.”43 In 1972 the NIH’s parent department, the Department of Health, Education and Welfare, bestowed on him its Superior Service Honor Award, “in recognition of his high professional standards and leadership.” Richard Dugas, who worked for Schriver and flew with him to California to investigate Hayflick, recalls Schriver as “the type when he walked into the room, you knew he was the boss.”44

  Nicholas Wade, then a Science reporter, interviewed Schriver in 1976. He recalls him as being “very accountant-like. Quite a grandfatherly type, very slow and patient but very determined. . . . He presented this as just an accounting issue. These [WI-38] vials were valuable property and it was his job to find out what had happened to them.”45

  • • •

  When Hayflick’s chief lab technician, the tall, likable Nancy Pleibel, decided to follow her boss from Philadelphia to Stanford in the summer of 1968, she left behind the only life she had known, including her newly widowed father and all of her friends. But despite the big geographical leap, and the empty shell of a lab that she and her boss confronted that summer, Pleibel soon knew she had made the right decision.

  For her the Hayflick lab continued to be a fine place to work. The job was important. She was contributing to bigger things, and they kept getting bigger: Dr. Hayflick was enterprising, constantly willing to take on another grad student, apply for another grant, travel to another conference. And she and her boss had a very good working relationship. He was decent and, although he was quiet, he didn’t fail to communicate. He made his expectations very clear, right down to the correct way to take phone messages. When he was put out, he never yelled. He spelled out the problem and then spelled out how it should be fixed so that it would not happen again. She had never sensed an ounce of duplicity in him; she couldn’t imagine him playing less than straight with anyone.46

  So Pleibel wasn’t alarmed when, in late May 1975, Hayflick explained to her and the rest of the staff that some investigators from the NIH would be visiting the lab, looking into something to do with contract management. His NIH project officer, Donald Murphy, would be with them. Pleibel and the rest of the lab staff were to cooperate in every way, answer all the NIH investigators’ questions, and show them whatever they needed to see.

  When Pleibel first laid eyes on Schriver, he struck her as belonging in a corporate office. He wore a suit; he was tall; he moved and spoke like a man from that world. He had with him two colleagues who also wore suits. Richard Dugas, thirty-seven, was an easygoing former high school football player and self-described “family man” with a bachelor’s degree in economics from Providence College in his native Rhode Island, who was hired by Schriver in 1966. Chris Curtin, a bald, trim, dapper man in his early fifties who had taken a two-year accounting course at Benjamin Franklin University in Washington, DC, had a dry wit but agonized over his work—over the costs, to people’s reputations, of making mistakes. Schriver had supervised Curtin at the Department of Agriculture before hiring him away to the NIH.47

  Over the course of the next three consecutive days, Schriver, Dugas, and Curtin interviewed Hayflick at length and inspected the Hayflick lab. In a return visit the next month that lasted another three days, they searched freezers, counted ampules, and pored over Cell Associates’ invoices and bank statements.48 And Schriver asked what seemed to Hayflick’s technician, Pleibel, to be endless questions. The questions were unsettling to Pleibel for two reasons. First, they often betrayed a lack of understanding of how a lab functioned and what cell culture was all about. There was, for instance, the moment when Schriver found several ampules of WI-38 lying on the bottom of a liquid-nitrogen freezer, rather than clipped in place on the long, unwieldy canes that hung down in the freezers. (A cane is a long, straight metal rod with slots that hold ampules.)

  There was a simple explanation for how they got there. In the process of retrieving ampules from a liquid-nitrogen freezer, they occasionally got dropped and fell to the bottom of the freezer. This was no surprise: to retrieve ampules, a technician had to wear the equivalent of a welder’s mask, in case the ampule exploded, and big, gray insulated gloves, and then peer down into the freezer as the liquid nitrogen steamed up in his or her face, and then wield a pair of forceps to extract the ampule from the cane. It was no easy matter, and when the occasional ampule got dropped, it was simplest to leave it where it had fallen at the bottom and select another. The fallen ampule could be retrieved at some future point, when the freezer was drained of liquid nitrogen. Now that future point had arrived, and Schriver found ampules scattered on the bottom of a freezer. “Are these being hidden?” Pleibel, in a 2013 interview, recalled Schriver asking.49

  Schriver’s questions also became increasingly adversarial as the days went by. It seemed to Pleibel that he was looking for something that he wasn’t finding, and that he was becoming convinced that Pleibel and others on the lab staff were hiding that something. “He was trying to press like an attorney to get us to say things that we didn’t know about or didn’t have the information. And he was getting frustrated,” Pleibel recalled. “It seemed like he didn’t believe what we were saying.”

  Schriver had arrived in the lab, Pleibel decided, with a pre
conceived idea that there should be a specific number of frozen ampules of WI-38, and that he was going to account for every single one of them. Confronted with what would emerge as Hayflick’s less-than-meticulous record keeping, this accounting turned into an exercise in teeth-grinding frustration.

  At one point, Pleibel recalled, Schriver told her that if his team was not able to get the information that they wanted on this trip, there could be a Senate investigation. The lab staff would have to go back to testify in Washington. Pleibel wasn’t intimidated. She felt she had nothing to hide.

  She also thought that Schriver was disruptive, wandering around the lab, picking things up, asking a question here, a question there. The staff couldn’t plan, didn’t know when they would be interrupted, worried about maintaining sterility, grew upset. Finally Pleibel asked to meet privately with Murphy, the NIH program officer. They met in the lobby of the Holiday Inn near Stanford’s Palm Drive. (Pleibel remembers the setting vividly because the lobby looked out on the hotel pool, and as she spoke with Murphy, a man emerged from his morning swim, stark naked.) She asked Murphy to ask Schriver to tamp it down. Things improved, somewhat. And then, as suddenly as they had appeared, the NIH investigators were gone.

  After first being interviewed by Schriver in late May 1975, Hayflick got on a plane. His journey took him to the Queen Elizabeth Hotel in Montreal, Canada, for the Twenty-sixth Annual Meeting of the Tissue Culture Association. With him he carried two bottles. They contained cultures of WI-38 cells—young cells, at just the tenth population doubling level. In Montreal he handed the bottles to officials from Connaught Laboratories, Ltd., of Toronto, Canada’s major vaccine maker. The company had recently licensed Plotkin’s rubella vaccine from the Wistar and wanted to ensure that it had the WI-38 cells it would need to produce the vaccine.50 Connaught agreed to pay Hayflick $5,000 for the two cultures.51

  That Hayflick continued to sell the cells as the government investigators trolled through his lab is testament either to his naïveté or his bullheadedness—or, perhaps, to a sense of obligation to the company; it seems at least possible that the sale was arranged several weeks in advance of the meeting, before the Schriver investigation began. Whatever his motive, Hayflick never collected the $5,000 from Connaught for the cells—the last ones he would pass out in the name of Cell Associates. When officials from the Canadian company asked him several months later why he hadn’t billed them, Hayflick said he hadn’t had time.52

  On the same day that he handed off the cells in Montreal, Hayflick called Lamont-Havers, the acting director of the NIH, and told him he was withdrawing as a candidate for the directorship of the National Institute on Aging.53 Hayflick knew that he was in trouble—but not yet just how much.

  • • •

  During his first interview with Schriver in May 1975, Hayflick told Schriver, according to Schriver’s documentation of that meeting, that he hoped the investigation could be resolved without having it discussed with Stanford University officials. Schriver said he thought that would be possible.54 But by June, after consulting with senior NIH officials, he had changed his mind.55

  On June 17, 1974, Schriver met with Clayton Rich, Stanford’s vice president for medical affairs and the dean of the Stanford School of Medicine. Also present was John J. Schwartz, a Harvard Law School graduate who was assistant vice president and counsel for medical affairs. Schriver briefed the men on what he had learned of Hayflick’s activities with WI-38, and then they summoned Hayflick to Rich’s office. Schriver’s documentation of the meeting states that this was the point at which Hayflick revealed Cell Associates’ contract with Merck.56

  But what Hayflick remembers of this meeting is that, as he entered, Rich was behind his desk and Schwartz was sitting off to one side. The first words that anyone spoke came from Schwartz, who said to Hayflick: “You better get a lawyer.”57

  • • •

  Schriver, Dugas, and Curtin made several trips in the coming months, tracking down and interviewing Hayflick’s commercial customers and other key recipients of the WI-38 cells. Curtin and Dugas visited Connaught Laboratories in Toronto and Pfizer’s offices in New York City. Schriver went to the Institute of Immunology in Zagreb and visited officials at the Medical Research Council in London. He interviewed Perkins, the former MRC vaccine regulator, who was by then at the World Health Organization. He spoke with Koprowski at the Wistar Institute. And he called Donald Brooks, the Merck attorney who, according to Hayflick, had established that Hayflick owned the WI-38 cells. Brooks told Schriver that the company had entered the pricey contract with Hayflick only after Hayflick attested that he owned the cells, and that NIH concurred.58

  In between trips, back at the NIH, Schriver became deeply absorbed in the Hayflick case. He spent hours in building 1 on the NIH campus, meeting with top officials—in particular sixty-year-old Leon Jacobs, the NIH’s associate director for collaborative research.

  Jacobs, a Brooklyn native with a quick-trigger temper, was known for his work on blindness caused by the parasite Toxoplasma gondii. He had been at the NIH for most of the previous four decades. It was perhaps Hayflick’s misfortune that in the mid-1960s Jacobs had been the scientific director in the Division of Biologics Standards. Jacobs may well have been offended by Hayflick’s 1972 excoriation of the DBS at the U.S. Senate—particularly Hayflick’s description of the “undirected and subordinate role” of scientific research in the DBS, his contention that this lack of leadership was suppressing the potential of the DBS’s capable biologists, and his suggestion that DBS scientists should be allowed to move on to better opportunities “where they will enjoy a full flowering of their capabilities.”59

  Whether or not Jacobs allowed Hayflick’s humiliating Senate testimony to influence his initial attitude toward Hayflick, the senior NIH official developed an animus toward Hayflick as Schriver’s investigation continued.

  In the summer of 1975, Jacobs had been put in charge of an internal NIH committee intended to get a handle on and then supervise the ongoing use of the WI-38 cells. Jacobs was the man who, according to Merck, had one year earlier told the company that Hayflick owned the trove of young WI-38 cells at Stanford.60

  Jacobs insisted to Schriver that he had said nothing of the kind but had merely ascertained, when an employee named Fritz Miller phoned him from Merck in July 1974, that there was no agreement between the U.S. government and the Wistar that would have allowed the Wistar to own a patent on the cells, if indeed one existed. It did not, and he told the company that too.61 Later Jacobs telephoned Brooks at Merck and wrote a memo to the record: “Mr. Brooks informed me that, regarding Merck’s dealings with Dr. Hayflick, Merck relied strictly on Dr. Hayflick’s representations—and not on any information obtained during a telephone conversation with me or anyone else.”62

  Brooks was not entirely forthcoming with Jacobs. A July, 1974, memo entitled “WI-38 Human Diploid Cells” written by Fritz Miller after his consequential conversation with Jacobs and copied to Maurice Hilleman, Brooks, and other Merck executives reads in part:

  “A question was raised whether Dr. Hayflick had rights to the cells to offer them for sale. Dr. Leon Jacobs of the NIH had a search of the records made by counsel and he told me by telephone on 7/11/74 that there is no patent that the NIH knows about. . . . Accordingly, Dr. Jacobs is of the opinion that Dr. Hayflick is free to sell the cells. We should now be able to proceed with the development of a price to offer Dr. Hayflick.”63

  • • •

  In the summer of 1975 Schriver also consulted with the NIH’s legal adviser, thirty-seven-year-old Richard J. Riseberg, another Harvard Law School graduate, who would go on to positions of increasing seniority at the NIH’s parent Department of Health, Education and Welfare. Riseberg consulted the original 1962 NIH contract under which Hayflick had developed WI-38—the document which stated that, when the contract ended, the contractor agreed to transfer title to the government of any and
all materials developed under it by the contractor. He examined the minutes of the January 1968 meeting where the disposition of the cells was decided. He looked at the letter from the NIH to the Wistar following up that meeting, affirming the arrangements for the cells to be transferred to the American Type Culture Collection on March 1, 1968, and reasserting the agency’s ownership of the cells. And he concluded that the WI-38 ampules that Hayflick had taken to Stanford belonged to the NIH.64

  In July, less than two months after Schriver and his deputies first visited Hayflick’s Stanford lab, Riseberg contacted the criminal division of the Department of Justice. Lawyers there took a month looking over the facts of the case, then declined to launch a criminal probe.65 They told the NIH that the agency would be more likely to get the result it wanted—the return of all of the young WI-38 cells to the NIH, along with all of the money that Hayflick had collected—by launching a civil proceeding; the agency’s passive acquiescence in Hayflick’s possession of the cells between 1968 and 1975 would make a criminal case difficult to win.66

  In August 1975, two months into the Schriver investigation, Hayflick, Ruth, and their two eldest daughters took a trip to Israel, where Hayflick attended a scientific conference. He was miserable during the trip. When he returned, it was to a call from Schriver’s lieutenant, Dugas, informing him that NIH officials would be taking the WI-38 ampules from his lab beginning on August 19.67

  Over the next eight days those officials—who had called around to find an airline that would allow them to carry those liquid-nitrogen refrigerators that looked like bombs in the cabin (United would not; TWA would)—collected Hayflick’s entire remaining stock of low-passage WI-38 ampules and delivered it to the American Type Culture Collection in nearby Rockville, Maryland.68 The cells had at last landed at the facility where the NIH had intended them to be transferred fully seven years earlier, when Hayflick left the Wistar Institute.