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The Swine Flu Affair: Decision-Making on a Slippery Disease 10 Califano Comes In The swine flu program had not been much of an issue in the 1976 campaign. Jimmy Carter had disdained a flu shot just at the time Ford was receiving his. But this was in the ninth month after Fort Dix and without a case in sight: political marginalia. Still, for many Democrats attentive to health issues, the program had bit deeper. It had served to symbolize what they regarded as a cumulative record of deception and ineptitude on the Republican side. This evidently was the attitude of Joseph Califano, a Washington attorney who had headed President Johnson’s White House staff for domestic affairs. Given to working long hours, Califano rarely saw the television news but regularly read the New York Times, and he knew many journalists and congressmen who shared the perspective of Harry Schwartz. When Carter named Califano Secretary-designate of HEW, that perspective played a part in his approach to his new duties. The first duty was to bring in a new team. Califano set out to clean house in health. This almost automatically ruled Cooper out of office, on grounds of symbolism independent of his record, and regardless of support for him developing in Congress and in Carter’s entourage. Determined to be his own man on appointments, Califano set up his own talent search. By January 20, 1977, this had not produced a replacement for Cooper, in part because reorganization was envisaged, and Dickson became Acting Assistant Secretary. Dr. Donald Fredrickson was staying on as head of NIH, which seemed to show that a clean house need not be clean-swept. Sencer’s future was decided at the end of January after a canvass of external views. On balance it was felt that he had headed CDC too long, over ten years, that swine flu had diminished his effectiveness, and that now was a better time than most to make the change. On February 4, Hale Champion, the Undersecretary, called Sencer to Washington for a discussion of his future, told him he would be replaced in due course, offered him time to decide his next steps, and promised confidentiality. (Champion spoke under some constraint, aware that formally the Surgeon General, not the Secretary, named directors of CDC.) Sencer said he wanted to discuss the matter with a few associates and warned that HEW leaked like a sieve. They parted amicably; in retrospect each wonders if the other fully grasped what he was trying to convey. By February 4 Califano, two weeks in office, was facing his first swine flu decision; whether or not to release bivalent vaccine. The program’s suspension, December 16, had been less definitive than press obituaries made it seem. It had been for the stated purpose of examining the link between inoculation and Guillain-Barré. Hattwick’s surveillance center produced data and the ACIP reviewed it first on December 29, 1976 and again on January 14, 1977. The risk of devel-
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The Swine Flu Affair: Decision-Making on a Slippery Disease oping Guillain-Barré syndrome seemed to be eleven times greater with vaccination than without. But the risk was still remote, about 1 in 105,000, and the risk of death but 1 in 2 million. On January 14, the ACIP recommended limited resumption of the swine flu program so that the Victoria vaccine locked up in bivalent doses could be made available again to high risk groups. Sencer promptly sent this on to Cooper who responded with questions. These Sencer pursued in a telephone poll of the states. Almost all said they would make bivalent vaccine readily available for high risk groups, two-thirds said they also would make monovalent available; only a few were prepared to consider resuming an active public campaign. Short of a campaign the estimated cost of restarting the program was only $15-30,000, the cost of printing new consent forms. On January 17 Sencer reported back. Cooper now expressed his personal agreement but refused to act. The new Administration was but three days off; leave it to them. There was no hurry. Swine flu epidemic nowhere in the world, Victoria nowhere in America. Twelve days later, Victoria flu erupted in a nursing home in Miami, Florida. Califano now faced the decision Cooper had put off. There was no one else to face it. Improvising as he went, advised mainly by Fredrickson and Dr. David Hamburg, head of the Institute of Medicine, the Secretary settled on a straightforward procedure. First, Sencer's recommendation and the work behind it would be set before an ad hoc advisory group of broader character and less commitment than the ACIP, and with prestigious chairmen from outside the flu establishment. The deliberations of the group would be both covered by the press and open to the public (which in Washington means organizations) and there would be time for comment from the audience. Califano would appear himself and hear as much as he could. Then, the group would draw conclusions and present them to him for his own decision. While Fredrickson and Hamburg put together the group’s membership, Califano wrote Carter, apprised him of the problem, and explained the procedure. Members of the old ACIP would be included. But in light of the controversy surrounding the immunization program, I will ask other experts to join the special advisory group so that we will have as broad and objective a base as possible under the circumstances. The group will be led by two of our nation’s most distinguished scientists. Dr. John Knowles and Dr. Ivan Bennett.28 Knowles was President of the Rockefeller Foundation and Bennett the Dean of New York University Medical Center. Califano had recruited them himself. Thus the White House was at once informed and kept away. This was not to be a presidential decision. The new President was evidently satisfied. As for the new staff, they and Califano had divergent views on many things, but not on this. Califano’s special group met Monday, February 7, for an all-day session in the conference room on the 8th floor of HEW’s new headquarters, since named for Hubert
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The Swine Flu Affair: Decision-Making on a Slippery Disease Humphrey. When the conferees arrived they found one feature Califano had not intended, television coverage. Fearing lest it distract advisers and detract from the discussions he had ruled it out. ABC, the network pool, failed to get the word and had set up the room before the HEW press people noticed. Assistant Secretary Eileen Shanahan then sensibly let everything alone. Advisers seemed not to be much distracted, discussion proceeded, and Califano had a new element in his procedure. There was only one unhappy consequence of television coverage, this not attributable to its paraphernalia but to insufficient planning in the Secretary’s entourage. During the morning meeting which Califano attended, Ben Heineman, his Executive Assistant, got word that Sencer’s departure was being carried on one of the wire services. Sencer, of course, was also at the meeting, shepherding his people, making the presentation. Fearing that Califano might get a direct question from attending press, and in the circumstances issue a denial without knowing what was on the ticker, Heineman sent word to him about it. Califano then called Sencer aside and standing along the wall they talked for some time, out of earshot but in view of all. The press was now on to the story, so much so that at noon a one-line announcement was made by HEW. In mid-afternoon a wire service reporter finally cornered Sencer; he elaborated off-the-record. At the end of the day, with reporters pressing both of them, Califano held an impromptu press conference. After complimenting Sencer for distinguished service, he said he wanted a director of his “own choosing…. Sencer’s been at CDC for 16 years and director for 10 years. I think it’s important that institutions be rejuvenated and revitalized.”29 The universal assumption of his auditors and of the network commentators, on that night’s news shows was that the deed had been done on the spot, up against the wall, to make plain Califano’s distance from, and dislike for, the swine flu program: Sencer the human sacrifice. In professional circles this won him deserved sympathy. The CDCers present were appalled, their colleagues in Atlanta still more so. This, it seemed to many, was the government’s reward for a career in public health and for devotion to their agency. Thus Califano’s reputation there began. As a leading epidemiologist remarked to us: Sencer was canned for doing his job; it shows you Califano is nothing but a politician …. He thinks he’s a smart lawyer, but he doesn’t know the first thing about health. Three months later, Califano somewhat cooled the CDC reaction by choosing from inside Sencer’s assistant director, Foege, as the new head of the agency. Foege had not been long at Atlanta. He had come there following his own signal success in the smallpox eradication program. His ego thus was independent of the agency. Moreover, unlike Sencer, or Cooper for that matter, Foege was known for ego control. Aside from the Sencer problem, Califano’s improvised procedure, television included, was a great success with most of those attending and for HEW. At the day’s end the advisory group recommended to the Secretary that suspension of the bivalent vaccine be lifted for the sake of high-risk groups facing Victoria flu outbreaks. With no swine flu
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The Swine Flu Affair: Decision-Making on a Slippery Disease outbreaks, the monovalent vaccine should continue in suspense. The next day the Secretary announced his acceptance of those recommendations. One of the things he had sought from his procedure was an opportunity to tell the press: ‘Everything I heard, you heard if you sat through the meeting.” Now he could do just that, and did. He could also say to interest groups and critics of every sort: “You had a right to be heard, and a chance; nothing was done behind your back.” After the swine flu program, Califano thought these things great assets, and still does, elements in building (and rebuilding) credibility. Media reaction to his limited resumption strengthened that belief. Harry Schwartz wrote still another editorial for the New York Times: "… The Government stands now where it should have stood all along: focused on high-risk individuals and poised to do more, but only if necessary.”30 The Washington Post editorialized: It was not an easy decision to make, given all the unknowns and unknowables involved, and it strikes us as a sensible one that carefully balanced all the risks involved. But what struck us almost as forcefully was the wide-open way that it was made—the “sunshine” approach, if you will.31 We have heard but one caveat, procedural not substantive. Stallones, who had flown up from Texas for the meeting, found the conference room repellent—cold decor with chilly temperature—and fellow-panelists excessively Eastern: New York-Boston almost all. He commented to us: I am not very enamored of the Eastern establishment, nor do I much enjoy being practically alone in it…. Surely they could try harder on that dimension. Surely they can, but not perhaps a Fredrickson or a Hamburg in an hour’s time. The improvised procedure of February 7 worked so well that a month later, when it came time to review ACIP recommendations for the 1977-78 flu season, a comparable ad hoc group at Califano’s level was again laid on; he again received its views, again he took them as his own. Not surprisingly, the recommendations were conservative as first proposed from CDC and as approved by him: private manufacture of Victoria vaccine for high risk groups. Here was a complete reversion to 1975, no Federal programming at all. Despite an unexpected epidemic of the Texas strain (akin to the Victoria), this outcome was as well received in public as the last and carried Federal policy along until the news of Russian flu late in 1977. With these two ad hoc performances in February and March, Califano put a period to the swine flu program. What remained were doses in the refrigerator, consent forms on the shelf, and policy issues he had not yet addressed.