There was a second way to run the swine flu programme, and it was proposed four times between March and June 1976 by people inside the circle that made the decision. Make the vaccine, they said, and then wait: put it into people only if the virus showed itself again, in the southern hemisphere’s winter or in America’s autumn. The proposal was never adopted, never formally rejected, and never answered on its merits in any document Neustadt and Fineberg could find except one staff study of May. This piece gathers what the record holds of it.
10 March: the committee
The Advisory Committee on Immunization Practices met in Atlanta on 10 March with the Fort Dix findings in front of it. Russell Alexander of the University of Washington’s public health school was, in the historians’ words, “the principal proponent of a pause for further evidence.” He gave them his reason later: “My general view is that you should be conservative about putting foreign material into the human body. That’s always true … especially when you are talking about 200 million bodies. The need should be estimated conservatively. If you don’t need to give it, don’t.” He also had a thought about how the public would behave if the virus came: “If you have spread combined with high surveillance then the surrounding communities will really go to work and the public will really cooperate each time flu is reported in a new place. If it hit Denver you could immunize Seattle, because everybody would move fast.”
He did not make a speech. “An unimpassioned man, he was so mild that other members we have seen recall but vaguely something about ‘stockpiling.’” Harold Schmeck of the New York Times, there as an observer, remembered it differently and more exactly: Alexander wanted to know “at what point do we stop going on with our preparations to immunize everybody and turn to stockpiling instead–what point in terms both of progress of our preparations and progress of the disease.” He asked this seriously. “It was not answered.”
Sencer had discussed the idea with his staff the day before and they had dismissed it. The reasoning, as the historians reconstruct it: inoculation takes two weeks to give immunity; infection brings illness in days; in two weeks flu could run through a city; with air travel, how could it be stopped short of the country unless everyone were immunized first; and the states, the private doctors and the public could not be counted on to respond fast. “‘Jet-spread’ and slow response combined to make a stockpile option moot. So staff had said.” Martin Goldfield and a colleague from New Jersey spoke for separating manufacture from inoculation and “were evidently bursting to elaborate, if asked.” They were not asked. The minutes record only that “the production of vaccine must proceed and that a plan for vaccine administration be developed.” Everyone the historians spoke to said that was as far as the meeting got. Alexander was not invited to the White House on 24 March; the man who drew up the list did not know him, and the others, “juggling numbers, did not propose him.”
Something of the same thought reached the White House by another route. James Cavanaugh of the Domestic Council recalled raising “the idea of going for vaccine production right away while holding off a bit on choosing among options for its distribution. He spoke with ‘somebody at HEW’ and was told no: ‘jet spread.’ He did not argue.” Vice President Rockefeller, after some meeting, suggested going to the Pentagon for a logistics officer who could work out how to inoculate the country in two to four weeks and beat the virus. “The thought wasn’t followed up. In Ford’s Administration, few of Rockefeller’s were.” Paul O’Neill at the Budget Office gave the historians the reason the White House never separated the two decisions: “So why decide twice? Commit now and be done with it. There isn’t time at the White House to create extra decisions for the man to make. He’s got plenty as it is. Besides, Sencer was ready to press his case. If we held off on part of it how would the President look: Pennypincher? Trading lives for bucks? Indecisive? Can’t make up his mind?”
2 April: Atlanta and the evening news
On 2 April Sencer put the programme to the state health officers at a large meeting in Atlanta. Goldfield opposed it in the room, repeated his opposition to the press outside, and was on all three network news programmes that night. The CBS transcript has him saying: “There are as many dangers to going ahead with immunizing the population as there are withholding. We can soberly estimate that approximately fifteen percent of the entire population will suffer disability reaction.” He shared Alexander’s view that immunization should wait for a second outbreak; he had a particular worry of his own about pregnant women, which the specialists discounted, and him with it. One of the country’s senior epidemiologists told him, in words he repeated to the historians: “Marty, you have some good points. I agree with much of what you say. But the decision’s made. Now is the time to close ranks. You are wrong to go public.” “By all accounts, including his own, Goldfield has not been forgiven.”
Alexander, hearing of the meeting, wrote Sencer a letter instead, which the historians quote at length and which is the fullest statement of the case. He had received the minutes of 10 March and found them accurate. “However, my reason for writing is to say once more that I strongly recommend some hesitation before beginning vaccine administration programs.” He conceded the risk: “like A/Victoria, we may be one of the first countries to be hit–but we may not. And most of our recent experiences with new variants–and the experience in 1918–was with a longer period of warning before the first severe wave (called the second wave in December 1918). Furthermore, although there might be some morbidity and mortality in an initial wave, there would still be some opportunity to have a major effect in dampening or preventing the second, third and other waves. And in so doing, we would have experience to guide us concerning the age distribution of severe and fatal disease.” Then the sentence that separates the two decisions: “As stated in the…minutes, ‘it was agreed that the production of vaccine must proceed and that a plan for vaccine administration must be developed.’ I, for one, do not agree that it need necessarily be carried out, unless there was another swine outbreak.” And the analogy the committee would hear again in June: “We spend large sums of money … stockpiling for military defense of the continental United States … with well worked-out contingency plans for use.” He closed: “There still seems to be time to be cautious if there is no further evidence of significant swine outbreaks by September. Of course, if they do occur, here or in the Southern hemisphere–the subject is dead.” He signed himself Sencer’s “half-a-hog colleague.” The historians remark that “the tone tells volumes about the relations of advisers to directors in Sencer’s world.”
The committee met again on 6 and 7 May, and the chronology records that Alexander “suggests that the final decision to vaccinate might be postponed pending further swine flu outbreak; consensus still opposes stockpiling, however.” On 17 May Albert Sabin, who had stood beside the President on 24 March, told an audience at the University of Toledo that the vaccine ought to be stockpiled pending a new outbreak.
21 and 22 June: Bethesda
The joint meeting of the committee and the Bureau of Biologics’ vaccine panel at Bethesda on 21 and 22 June had been called to hear the field-trial results, which showed that one dose did not work in children. Sabin asked for the second day to be given to stockpiling, and it was. His argument had two parts. First, Alexander’s: no swine flu had appeared anywhere, not even in the southern hemisphere where the season was approaching its peak, and the case for waiting was only strengthened if the children, the chief spreaders in past pandemics, were not to be immunized. Second, that with the right preparation the country could keep ahead of the virus. The stockpile was to be active: planning, training, “brigades of volunteers–high school age and up–recruited and trained locally, ready to immunize their neighborhoods the moment CDC should pass the word.” The minutes have him: “We must be able to do [immunize] everybody in an area in 1 to 2 days. We need a total voluntary effort, training…students and others in an assembly-line technique. We cannot rely on health professionals and existing doctors’ offices.”
Sencer answered with a staff study prepared in May, the only written piece of staff work on stockpiling the historians could find, and with William Foege, his assistant director for operations, seconding him. The study’s objections turned on timing. The committee’s minutes for 22 June summarise them: “the infeasibility of achieving any measure of adequate immunization of the country once cases or clusters of cases were occurring … once operational, most immunization programs would take two to three months to complete even if all elements functioned smoothly and personnel, vaccine supplies and other program ingredients were ample … once identified as causing cases, pandemic strains can be expected to become widespread in less than two months, … no rational basis for a general ‘stockpiling concept’ … more risk in this concept when one adds a two-week period of antibody development onto the vaccination timetable.” Sencer added that high-school volunteers “were bait for litigation,” which in the last week of June was a sensitive point. The historians found three of the study’s assumptions questionable: that emergency staff would have to be recruited and trained from scratch rather than kept like reservists; that emergency clinics would work a six-day week; and that commitment to a standby programme “would decline over time necessarily.” They note that “the adrenal charge of a perceived emergency was nowhere recognized.”
What turned the room, by Stallones’s account, was not the study but the states. “I had talked to Alexander, and I was impressed by his point of view, although in March I had been an enthusiast for going all the way. But what Foege said was impressive too, and to have it reinforced by the state people themselves struck me personally as compelling.” The state officials said their plans had gone too far to be remade on Sabin’s model. A clear majority reaffirmed mass immunization. “Storing doses in people, not warehouses, as Salk said, won the day.”
Alexander, for once, went on television. “I think the issue is, as time goes on, there–it’s becoming more evident that up till now there’s no sign of swine influenza outbreaks like the one that occurred in Fort Dix, New Jersey occurring in the United States. Most people think that the probability is there will not be an epidemic in the 1976-77 season due to swine influenza.” Senator Kennedy told the historians he recalled stockpiling “as an opportunity lost.” Within days of the meeting the insurers withdrew, and the vaccine sat in vats for the rest of the summer, stockpiled after all, by nobody’s decision.
What the record does not hold
Neustadt and Fineberg’s conclusion was that Alexander’s suggestion “embraced not alone the issue of a waiting game, but also the criteria for playing it. And failure to pursue them both, especially criteria, appears by hindsight sad, an opportunity lost.” Their lesson for next time was a version of his question: “What evidence on which things, when and why, would make us change the course we now propose, and to what?” In their reflections they went further than he had, and proposed that a programme like Sencer’s “could have done it had he made the starting date for his mass immunization contingent on a trigger everyone could understand … say a second outbreak of a given size.”
Whether a stockpile could have been emptied into arms in time if the virus had come is not something the record can settle. The one test the year offered ran the other way: when the law took effect on 1 October and the states that had vaccine began, it took them six weeks to reach six million people a week. Sabin had said one or two days for a whole area. The state commissioner who told the historians “we could have mass vaccinated this state in six weeks, and would have, if the situation with swine flu had become critical” was speaking of a state that had taken the money and done almost nothing. Both sides of the argument had the same instrument, the absence of the virus, and read it as they were disposed to.
Sources
- Richard E. Neustadt and Harvey V. Fineberg, The Swine Flu Affair: Decision-Making on a Slippery Disease, U.S. Department of Health, Education, and Welfare, 1978. Chapter 2 for Alexander, Schmeck, Sencer’s staff and the minutes of 10 March; chapter 3 for Cavanaugh, Rockefeller and O’Neill; chapter 6 for the meeting of 2 April, the CBS transcript of Goldfield, Alexander’s letter, the Bethesda meetings of 21 and 22 June, Sabin’s minutes, the CDC staff study and the minutes of 22 June, Stallones, and Alexander on television; chapter 12 for “an opportunity lost” and the trigger; Appendix C for 6 and 7 May and 17 May; Appendix D for the staff study itself, which is reproduced there as page images I have not transcribed. All quotations from Alexander, Goldfield, Sabin, Stallones, Cavanaugh, O’Neill, Schmeck, the minutes and the staff study are at second hand through this report. archive.org
- Theodore Cooper, “The National Influenza Immunization Program: Status Report, July 20, 1976–ACTION,” for the state of the vaccine in July. Gerald R. Ford Presidential Library. fordlibrarymuseum.gov
- David J. Sencer and J. Donald Millar, “Reflections on the 1976 Swine Flu Vaccination Program,” Emerging Infectious Diseases 12, no. 1 (January 2006), for the authors’ later statement of the case against waiting: “Public health officials were concerned that if immunization was delayed until H1N1 was documented to have spread to other groups, the disease would spread faster than any ability to mobilize preventive vaccination efforts.” wwwnc.cdc.gov