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Swine Flu

A Look At Responses to Pandemic Influenza:
The Swine Flu Experience of 1976

Korey D. Harvey

May 2, 2008
Foreward

This paper provides a relatively brief description of the influenza virus, including the three occasions in the 20th century in which an influenza pandemic inflicted high mortality, though the Spanish Flu Pandemic of 1918 is chief among them.  It continues with a rendition of the events of the Swine Flu Affair, viewed as a public health failure in response to a pandemic that never arrived.  Following the account of the Swine Flu Affair are study questions, conclusions, and commentary—mostly with an eye toward preparation for the next pandemic.

The Swine Flu Affair offers keen insights into the perils of large government action predicated upon exigency; it also offers profound lessons on the nature of the human condition—mostly in the form of conflict: between the need for passion in one’s beliefs hedged against dispassion in calculation; between the theoretical need for policy makers with broad technical knowledge and the practical reality of decision makers who are men of politics; between the innate urge to act immediately against perceived threats and the contempt for prudence; and finally, perhaps, between the desire for technological and medical progress and the denial of the permanent and existential truth that sometimes no amount of preparation and advancement can prevent disaster.  
Statement of the Public Health Problem:

Background Information on Influenza & Previous Influenza Pandemics

I.          Influenza and The Seasonal Flu

Every year, between 5 and 20 percent of Americans contract influenza (flu); as a result, more than 200,000 Americans are hospitalized and about 36,000 Americans die from the flu annually.[1]  The flu is an illness of the respiratory system caused by influenza viruses, of which there are two main types: A and B.  These two viruses cause the flu that most Americans are familiar with, often called “the seasonal flu.”[2]  These two types are subdivided into different subtypes and different strains.  The annual flu vaccinations generally provide levels of protection against types A & B (there is also a Type C, which is not thought to cause epidemics.)[3]  Certain population groups are usually more susceptible to complications from the flu and should receive the flu vaccine every year.  The elderly, the young, and persons with pre-existing respiratory problems, diabetes, and heart disease are the primary population groups at higher risk.  Common symptoms of the flu include fever, headache, sore throat, dry cough, muscle aches, vomiting and other stomach illnesses.  However, the flu can cause severe complications, especially in higher-risk subpopulations, that can range from deadly bacterial pneumonia and dehydration to congestive heart failure.[4]  The flu is contagious and susceptible of person-to-person spread through the inhalation of the virus from an infected person’s coughs or sneezes or from touching respiratory droplets containing the virus.[5] 

II.         Pandemic Flu

The availability of vaccines coupled with natural immunities resulting from life-long exposure to the most common influenza viruses generally ameliorate the possible catastrophic effects of influenza on the human population.  But, from time to time, and on three major occasions in the 20th century, influenza viruses caused world-wide epidemics (pandemic.)  The complete absence of, or low levels of natural immunity within the human population, can give rise to a catastrophic pandemic.  There is no single strain or type of influenza that is the pandemic flu; rather, any number of possible types or strains of influenza can cause a pandemic because the sine qua non of pandemic flu is an absence of immunity, whether natural or conceivably by ineffective vaccine.[6]  This absence of immunity occurs when there is a reassortment of the proteins within one of the Influenza A subtypes—what virologists call an antigenic shift.  In two of the three major influenza pandemics of the 20th century, these antigenic shifts have occurred as a result of human influenza Type A viruses mixing with animal influenza Type A viruses.[7]  The severity of a pandemic influenza virus can be exacerbated depending upon the ease with which it is transmitted from person to person.[8]   

20th Century Influenza Pandemics

            In the previous century, three influenza pandemics wreaked havoc upon the world’s human population: the Spanish Flu of 1918, the Asian Flu of 1957, and the Hong Kong Flu of 1968.  Flu pandemics have been named in association with geographic locations, often where they were first identified or where they are believed to have originated.  It is important to note that the influenza strains responsible for these three pandemics have official designations within the nomenclature of virology, e.g., the so-called Spanish Flu is truly designated as the H1N1 subtype of the Influenza A virus.[9] 

            The Spanish Flu Pandemic of 1918

            The one of the worst pandemics in modern history, the Spanish Flu, hit the world simultaneously and in three separate waves.  The first wave began in the spring and early summer of 1918.  This first wave of influenza had high morbidity, but a low rate of mortality in comparison with the two succeeding waves.  In the late summer and fall of 1918, the second wave of Spanish Flu spread across the globe, followed by the third and final wave in the winter of 1918-1919.  Waves two and three were characterized by both high morbidity and exceptionally high rates of mortality.  Virologists are still baffled and without explanation as to why there were three waves in the pandemic.  After the final wave dissipated, 50-100 million people died from influenza and its complications.  There were two unique characteristics of the 1918 pandemic that have perplexed epidemiologists for years: 1) excessive mortality among the young, ages 20-40, but fewer than expected deaths among the elderly, and 2) an exceptionally high rate of mortality among all age groups.[10]

 

             

            The Asian Flu Pandemic of 1957 & the Hong Kong Flu Pandemic of 1968

            Both of the influenza viruses that caused the 1957 and 1968 pandemics were descendants of the 1918 Spanish Flu virus, but lacked its virulence.  These two successor viruses arose from genetic shift and reassortment with existing avian influenza viruses.[11]  Advances in technology and quicker identification of viruses moderated the death toll in both the 1957 and 1968 pandemics.  In the 1957 pandemic, there was also evidence of residual immunity from the Spanish Flu, but people younger than age 65 had no immunity, which lead to a pandemic among school children.  In all, about 69,800 Americans died from the 1957 pandemic, as opposed to the 675,000 who died from the 1918 Spanish Flu pandemic.  Likewise, in the 1968 pandemic, which occurred during winter school holidays, the death toll was even lower—an estimated 33,800 Americans.  The 1968 virus’s similarity to the 1957 virus provided a background level of immunity.  In both the 1957 and 1968 pandemics, fatalities were ameliorated by vaccine production and, especially in 1968, by advances in antibiotics for secondary bacterial infections.[12] 

            Key Points -- Summary

            The project to reconstruct the 1918 Spanish Flu virus led to as many questions as it did answers.  The discovery that influenza can genetically adapt in the absence of genetic reassortment with animal influenza viruses, and that influenza epidemics are not predictable or cyclical, demand increased world-wide surveillance and detection of influenza.  Furthermore, the discovery that the 1918 virus was, in fact, exceptionally virulent, and not just exacerbated by pre-modern medical practices, makes the threat of a new, virulent strain of influenza a real possibility.  Though some scientists have predicted that the next pandemic may result from the “avian flu,” the H5N1 strain that caused a scare in 1997 and 1998, there is little evidence to support such hypothesis because none of the strains which caused the three previous pandemics have much in common with this “avian flu” strain.  Furthermore, the H5N1 “avian flu” strain was highly resistant to human-to-human transmission.[13]  But, the new knowledge obtained from the reconstruction of the 1918 virus, especially with regard to independent genome adaptation of viruses, prohibits conclusively ruling out the H5N1 strain as a possible source of the next pandemic. 

 

Case Study in Pandemics:

            The Swine Flu Affair of 1976 – The Non-Emergence of a Pandemic

I.          Background Information: The Swine Flu Outbreak at Fort Dix, New Jersey

            In January 1976, at Fort Dix, New Jersey, several hundred military personnel began experiencing respiratory complications, some of them very severe.  At Fort Dix recruits lived in crowded barracks during what was a cold winter.  A number of the recruits were hospitalized and treated for infections; however, one recruit refused to be hospitalized, and succumbed.  On February 12, epidemiologists at the Centers for Disease Control and Prevention (CDC) in Atlanta, Ga., identified the cause of the one death as the H1N1 Influenza A virus.  A state-run lab in New Jersey also confirmed that the H3N2 influenza virus (the Victoria strain) was also circulating at Fort Dix; the H3N2 virus had been the dominant circulating influenza virus since 1968.[14] 

            The identification of the H1N1 virus, which was referred to as “swine flu” because it was believed to have been transmitted from swine to humans prior to the 1918 Spanish Flu pandemic, caused alarm at the CDC.  Though the H1N1 virus did cause the Spanish Flu pandemic, it had not been observed or seen in humans since 1957.  There had been vaccines for the H1N1 virus, but because it had practically disappeared, most of the recruits, many in their teens and early 20s, had not received vaccines giving protection against the H1N1 virus, nor did they have any natural immunity.  As many as 230 recruits contracted the H1N1 virus, causing one fatality and severe infections.[15]  That was the extent of the knowledge that the scientists and policy makers at CDC and within the federal government had in the opening months of 1976.  In addition, most epidemiologists and virologists at the time held the incorrect assumption that influenza pandemics were cyclical, perhaps occurring as often as every 10 years.[16]  In that context, the identification of the H1N1 virus set the stage for a massive governmental undertaking to prevent a repeat of the 1918 pandemic.      

II.         Scientists & Policy Makers  

            On February 14, 1976, a group of scientists called together by Dr. David Sencer, Director of the CDC, met for the first time to discuss and react to the identification of the H1N1 virus at Fort Dix.  The men present decided that they knew little about the extent of the H1N1 outbreak.  Was it an isolated event or would more cases emerge in a matter of days?  They agreed that the first step was to implement an increased, nation-wide surveillance for early hints of the outbreak of pandemic; they also decided that since they had too little information, no press advisories should be made just yet.  Why provoke alarm before all the facts were in?[17]

            However, five days later, firm in the belief that press leaks of the Fort Dix outbreak were unavoidable, Sencer called a press conference.  In the press advisory issued by Sencer, the 1918 pandemic was mentioned, as was the fact that the H1N1 virus was the cause of that pandemic.  The next day, The New York Times ran a story referencing the 1918 pandemic with the CDC press advisory.  Going one step further, the NBC Nightly News broadcast reported the story with background photographs of individuals wearing gas masks.[18]  The government’s inability to understand the press’s appetite for sensational news, controversy, and dissent would plague the government’s response throughout this entire ordeal.

            On March 10, the group that met on February 14 reassembled in a meeting of the Advisory Committee on Immunization Practices (ACIP).  Technically an arm of the Surgeon General’s office, ACIP was in reality comprised of scientists appointed by CDC Director Sencer.  It was the duty of ACIP to make official recommendations for the vaccines in advance of the upcoming flu season; for ACIP, time was quickly running out.  If the flu vaccines to be produced were to include protection against H1N1, a decision would have to be made immediately.  By the time ACIP met on March 10, vaccine manufacturers had already produced 20 million vaccines for the upcoming flu season, all of them giving protection against the H3N2 A/Victoria strain, which had been in circulation for several years, and had infected hundreds of the recruits at Fort Dix.[19] 

            In addition to CDC Director Sencer, several prominent epidemiologists participated in decision making from the beginning of the government’s response.  Chief among the non-governmental experts at the time was Dr. Edward Kilbourne, arguably the most renowned epidemiologist in America.  Just before the H1N1 outbreak occurred at Fort Dix, Kilbourne had published his opinion in The New York Times that influenza pandemics were cyclical, occurring about every 10-11 years, and that the next pandemic would be imminent.[20]  Kilbourne’s weight as the top epidemiologist in the country, and his absolute belief in pandemic cycles, would be a primary factor in the government’s response.  With Kilbourne backing him, Sencer prepared to convince his superiors that a pandemic was possible, and that bold measures had to be taken to head off 1918-like mortality rates.

            At the March 10 meeting of ACIP, several things were agreed to: 1) despite no empirical evidentiary basis, the possibility of a pandemic existed; 2) with no knowledge of why the 1918 pandemic was so deadly, the fact that one of 12 soldiers who were known to have contracted H1N1 at Fort Dix had died, and was cause for alarm; and 3) no one under the age of 50 would have natural immunity to H1N1.[21]  The lack of real, verified information would plague the government’s response from start to finish, while staffers within the CDC were not entirely unaware of political reality:

There was nothing in this for CDC except trouble.  Here we were at the end of one flu season with time to try to do something before the next flu season.  The obvious thing was to immunize everybody….Yet, on the other hand, if there weren’t a pandemic we’d be charged with wasting public money…crying wolf….It was a no-win situation.[22] 

 

With almost no dissent, the scientists present at the March 10 meeting had decided on a course that would lead to disaster—rapid production of vaccines for H1N1, and universal vaccination, the logistics and practicality of which were even larger than imagined.  There was dissent; Dr. Russell Alexander, of the Public Health School of the University of Washington, urged vaccine production, but not immediate, mass vaccination.  Alexander instead urged stockpiling—“My general view is that you should be conservative about putting foreign material into the human body….especially when you are talking about 200 million bodies….If you don’t need to give it, don’t.”[23]  A man who practiced a science of prudence, Alexander was ignored.  Worried about what was called “jet spread,” the rapid spread of the influenza virus before mass vaccination is possible, prevented any real discussion of stockpiling the vaccine, despite opinions from in-the-field personnel who insisted mass vaccination is possible even after the outbreak of pandemic (assuming a good surveillance and identification system.)[24] 

As early as the first meeting of ACIP under Sencer, a pervasive bias permeated all levels of thought and action; it was a bias that was both internal and external to CDC, and its sister agencies—the National Institutes of Health, the National Institute of Allergies and Infectious Diseases, and the Bureau of Biologics in the FDA.  It was an odd kind of bias, one rooted in the unique politics of the academy.[25]  The varying fields of medicine and research do not co-exist in a state of harmony; they vie for attention and prestige, but often more importantly, for money.  Epidemiology and virology—the study of epidemics and viruses, respectively—are indissolubly linked, as is their practical application: preventive medicine.  As disciplines within the academy, epidemiology and virology, do not occupy the upper stratum in terms of prestige, power, or money.  Likewise, within the medical field, preventive medicine is not championed.  At least, such were the lamentations of many of the scientists involved in the government’s response:

Kilbourne, for one, not only championed his theories, but was keen to make the country see the virtues of preventive medicine.  Swine flu seemed a splendid opportunity.  Others also saw the chance to demonstrate the value of public health practice…Dr. Reuel Stallones, Dean of the Public Health School at the University of Texas, recalled for us: ‘The rewards have gone overwhelmingly to molecular biology which doesn’t do much for humanity.  Epidemiology ranks low in the hierarchy….Yet it holds the key to reducing lots of human suffering.’[26]

 

            With near unanimity within ACIP, Sencer began his effort to convince the upper echelon of policy makers to commit to mass production of a vaccine followed by mass vaccinations.  Sencer authored a nine page memorandum directed to David Matthews, then Secretary of the Department of Health, Education, and Welfare; but Sencer had to know this memorandum would reach the highest levels of the executive branch of the federal government.  It was, in fact, immediately sent to President Ford’s principal deputies in the White House, including the heads of the Office of Management and Budget and the Domestic Council, two of the agencies within the Executive Office of the President.  Sencer’s memorandum expressly stated that the H1N1 virus at Fort Dix was related to the virus that caused the 1918 pandemic, and most curiously, Sencer stated as an “assumption,” that there existed “a strong possibility that this country will experience widespread [swine] influenza in 1976-1977.”[27]  Sencer also asserted with certainty that influenza pandemics occur in regular intervals of 10 years.  He concluded his assumptions stating if the government acted, no demographic group could be left out—a “goal of immunizing 213 million people in three months.”[28]  There was absolutely no empirical basis whatsoever for Sencer’s statement about cycles of pandemics, nor was there any evidentiary basis for his statement that there was “a strong possibility” of a pandemic.  But, Sencer was the Director of CDC, and widely respected.  None of the men who would make the final decision on Sencer’s proposals had any knowledge with which to challenge his statements or assumptions; they were politicians, not scientists. 

            In his memorandum, Sencer crafted four possible avenues of governmental action.  A brilliant bureaucrat who knew his audience lacked any ability to second-guess his assumptions, Sencer likely deliberately worded his memorandum so that the first three options—no action, minimum action (producing vaccines but no mass inoculation plan), and government only action (without the use of private medical providers, which was inherently cost prohibitive in terms of money and administrative capability)—were to be intuitively rejected by the reader.  Then, Sencer presented his fourth option—the federal government paying for the vaccine, and administration of the vaccine through a combined effort of the federal government, state governments, and private health providers.  Sencer projected the cost of the program to be $134 million.[29] 

            There was a fourth dimension to the government’s response—not just politics, which is always present to some degree, but election year politics.  President Ford was seeking election (he succeeded President Nixon following his resignation, so for Ford, he was seeking to be retained, though not reelected, as President.)  Following the Watergate scandal, Nixon’s resignation, and Ford’s subsequent and very unpopular pardon of Nixon, and in the midst of widespread opposition to the nation’s intervention in Vietnam, public confidence in government had waned.  Ford faced a tough challenge not only from the eventual Democratic nominee, but also from within the Republican Party; the day after Ford would announce the government’s response to the Fort Dix outbreak, Ford would be stunned with a loss to California Governor Ronald Reagan in the South Carolina primary.  The confluence of election year politics, exacerbated by unparalleled scandal and a President mired in both internal and external political warfare, with the special politics of the CDC, proved a recipe for unmitigated failure.[30]

            Sencer’s memorandum made its way up through the chain of command within the Department of Health, Education and Welfare (HEW).  Sencer’s superiors bought his pitch.  Accordingly, HEW Secretary Matthews sent a communication to the Director of the Office of Management & Budget (OMB) stating that there was evidence of an oncoming pandemic that could kill as many as one million people in the United States.[31]   Matthews was acting on Sencer’s memorandum; hyperbole begat hyperbole.  The communication was turned over to the chief deputy at OMB, a young budget hawk named Paul O’Neill, who would later be President George W. Bush’s Treasury Secretary from 2001-2003.  O’Neill was immediately skeptical of the alarm raised, especially for the $134 million price tag.[32]  In the Nixon and Ford administrations, budget policies generally centered upon cutting, not enlarging budgets of existing agencies.  Furthermore, with respect to HEW and the CDC, the administration policy was one of preference for discretionary funds for state government and private intervention, not federal action.  In that context, a plea from Sencer, whose agency was on the budgetary chopping block, for $134 million in emergency funds for an unprecedented federal intervention, was met with skepticism.[33]

            O’Neill, though not a scientists had budget staffers with specialized training in public health.  They immediately voiced their concern with Sencer’s plans, and furthermore, with his assumptions and projections.  O’Neill’s chief health budget hawk, Victor Zafra, read The New York Times article of February 20, “and had been waiting since for CDC to come in crying doom.  He and his assistants deeply suspected a cooked-up job.”[34]  But Zafra’s relationship with the technicians within HEW and the CDC were too strained due to constant budget fights to obtain any more analysis to confirm their suspicions.  Despite reservations grounded in both evidentiary and fiscal considerations, White House policy makers who raised the possibility of stockpiling the vaccine were constantly met with Sencer’s response: “jet spread,” too late, catastrophe.  Even Vice President Nelson Rockefeller suggested stockpiling, asserting that HEW had no idea how to carry out such a massive operation.  He, too, was either ignored, which was not uncommon in the Ford administration, or was simply out-shouted by Sencer’s forecast.[35]

            Within days of the arrival of Sencer’s memo at the White House, Ford met with his top budget and domestic policy advisers on March 22, with HEW Secretary Matthews and his chief deputy in attendance.  Having reviewed Sencer’s memorandum, the President and his advisers arrived at the topic of election politics, which is neither unexpected nor inappropriate.  As one adviser present later recounted: “[T]his was a no-win position politically.  There was no good to come of it as the election was concerned…if there were no pandemic, a lot of people would have sore arms in October.  If there were a pandemic, no matter how much we’d done it wouldn’t be enough.”[36]  Furthermore, the President’s advisers arrived at a logical political conclusion; regardless of Sencer’s facts, which they were ill-equipped to challenge even if they wanted to, one conclusion loomed large on their horizon.  As one adviser said, “[t]here is no way to go back on Sencer’s memo.  If we tried to do that, it would leak.  That memo’s a gun to our head.”[37] 

            Before he decided, Ford called together a group of scientists, which he wanted to include persons outside of Sencer’s cabal within CDC and ACIP.  Of the attendees at this March 24 meeting, none expressed any dissent from Sencer’s assumptions or recommendations, despite absolutely no spread of the H1N1 virus since the early January outbreak at Fort Dix.  In retrospect, several of the scientists there lamented keeping their silence as to their lingering doubts they had.  Many stated they thought such a meeting was staged to give the appearance of Ford wanting outside input.  Ford and his deputies later insisted the meeting was not staged, and that real and diverse opinion was sought.  Nevertheless, the attendees had the feeling that Sencer’s course of action had already been agreed to, and that the meeting was merely pro forma.[38]  Departing from the meeting, Ford immediately went to the Press Room in the West Wing and made the announcement: mass production of vaccines paid for by the federal government followed by nation-wide administration to all Americans.  Ford said he was sending a request to Congress for $135 million to fund what would officially be designated as the National Influenza Immunization Program.[39]  There would be no turning back.

            It took no time for the press to cry politics.  Though it should have been expected both by the White House and by Sencer’s group, little thought seems to have been given to countering negative press.  On the day the program was announced, press scrutiny immediately began to destabilize confidence in the government’s response.  NBC and CBS both relied upon sources within the CDC itself that characterized the program as “a crazy program,” that was “rotten to the core” and “unwarranted” and “unnecessary.”  CBS news, through its venerable and trusted newsman Walter Cronkite and reporter Robert Pierpoint, reported to its national audience:

Some experts seriously question whether it is logistically possible to inoculate two hundred million Americans….But beyond that, doctors and public health officials have told CBS News that they believe such a massive program is premature and unwise, that there is not enough proof of the need for it.[40]

 

Bad press relations and the onslaught of open dissent were followed by the first field trials of the vaccines.  The results were not encouraging.  Single doses of the vaccine were practically ineffective on children.  A single, whole dose resulted in reactions ranging from soreness to high fever.  Split doses of the vaccine did not immunize.  Even if a split vaccine could be tweaked to work, the possibility of producing significantly more doses of vaccine was near impossible.    Arguments for stockpiling in the press became rampant as the program’s reputation steadily spiraled.[41] 

            As worries that field trials would delay the goal of implementing vaccination by July escalated within the program, a development for which CDC and HEW had recent experience and should have reasonably foreseen, shattered any hopes of adhering to the original timeline.  That development was the absolute refusal by the vaccine manufacturers to proceed unless they were indemnified, either by their insurance companies or by the government.  Liability insurance providers, being incapable of projecting possible adverse effects upon a population of 200 million, simply would not insure the vaccine manufacturers.  The manufacturers refused to self-insure themselves.  All vaccine production came to a halt.[42]  Though the government, now nearly six months removed from the outbreak at Fort Dix, and with no evidence pointing toward an oncoming pandemic, could have suspended the program—essentially, cutting its losses before a mediocre disaster became a credibility-debilitating disaster—it pressed forward.  Ford inquired of HEW Secretary Matthews whether the Sencer’s projections in March were still accurate.  He was told they were, despite an ascendancy of evidence and opinion to the contrary.  Therefore, at Ford’s urging, Congress quickly passed what was termed the Swine Flu Tort Claims bill, Public Law 94-380, which directed that all claims arising from the vaccination program be filed against the federal government.  Manufacturers were therefore given near blanket, absolute immunity.  Manufacturers would only be liable for negligence, but not unforeseen, adverse side effects.  As a result, insurance companies for the manufacturers profited around $8.5 million; they insured manufacturers, but the federal government was hit with the tort claims.[43]

            After the impasse over indemnity was resolved, production resumed.  Vaccinations, originally planned to begin no later than July, began on October 1.  Ten days later, three elderly patients with pre-existing cardiac complications died after receiving the vaccine.  Though it is probable that the vaccine was not the root cause of their deaths, once again, an inability to head off and influence press inquiries plagued the government’s response.  The county health examiner who conducted autopsies on the elderly patients speculated that the vaccine may have caused their deaths.  The press wires picked up the story.  Immediately, nine states suspended vaccinations.  As vaccinations continued in some states, the press kept toll of deaths possibly related to the vaccinations, reaching perhaps as high as 40.  The program was seriously wounded, but limping forward.  The CDC, as the agency identified by the press and the public responsible for the program, had utterly failed to foresee and prepare for the possibility that deaths could follow vaccination, but not be a result of it.  Rather than priming the press ahead of time with warnings, the CDC was stuck in a slow, impossible-to-win game of reaction.  Vaccinations in some states continued, and by December 16, some 40 million Americans had received the vaccine, despite a lackluster participation by private physicians, who conducted an estimated 15% of the vaccinations.[44]

            The death blow for the program came in November 1976.  A physician in Minnesotta reported to CDC that one of his patients had developed Guillain-Barré Syndrome (GBS), which is similar to polio that causes debilitating paralysis and even death.  Initially, the CDC ignored the report, though it had been long-established that vaccinations, especially flu vaccinations, have been speculated to cause GBS.  A week later, three additional cases, one causing death, arose.  When CDC, upon a cursory investigation, realized it could not discount the possibility that the vaccine may induce GBS, informed the White House.  On December 16, President Ford ordered the program suspended indefinitely.  Though nearly a year of planning had occurred, the actual life of the program lasted for just under three months.  It would never be revived.[45]    

            After the program had been terminated, it was viewed by its creators as a failure, a disaster.[46]  After Ford’s defeat in the November 1976 election, President Carter’s new HEW Secretary commissioned two Harvard professors, Richard E. Neustadt and Harvey Fineberg, to study and give a full recounting of what they termed “The Swine Flu Affair.”  Their study, a formal report issued under the auspices of HEW, has been quoted extensively herein.  The authors of the report came to several conclusions, chiefly, that the program was heavily affected by the biases and personal-academic agendas of its key participants.  Furthermore, they identified what they termed seven “leading features” of the program:

1.                Overconfidence by specialists in theories spun from meager evidence.

2.                Conviction fueled by a conjunction of some preexisting personal agendas.

3.                Zeal by health professionals to make their lay superiors do right.

4.                Premature commitment to deciding more than had to be decided.

5.                Failure to address uncertainties in such a way as to prepare for reconsideration.

6.                Insufficient questioning of scientific logic and of implementation prospects.

7.                Insensitivity to media relations and long-term credibility of institutions.[47]

 

            Though the program was viewed as a catastrophe, both by its participants and by newsmen and public citizen alike, it was not without its high points.  As the HEW report’s authors recounted, CDC developed an efficacious surveillance system that would aid the agency in identifying future epidemics.  Furthermore, though the H1N1 swine flu pandemic never materialized, the publicity of the vaccinations introduced many Americans to the concept of regular, annual flu shots.  And finally, in the short actual life of the program—about two and a half months—40 million Americans were vaccinated, which is itself an astonishing achievement and is, indeed, encouraging, should bioterrorism or a future pandemic require fast, mass vaccinations.  Moving from the theoretical to the practical, it can be done.[48]  However, despite the good emanating from the experience, as the report authors noted, the credibility of the CDC had been severely damaged, just in time for the onslaught of the HIV/AIDS epidemic.  Just two years after the program’s end, one newsman said, “CDC was almost the last federal agency widely regarded…as a good thing….Now, CDC’s lost its innocence.”[49]  Unfortunately, as the AIDS epidemic spread, perhaps the risk of crying wolf twice in a decade was one the CDC was likely unwilling to take.

III.       Advances in Epidemiology and Virology after 1976

Seeking to shed light on the origin of the 1918 Spanish Flu, and seeking answers as to why mortality was so high generally, and especially within young, healthy adults, scientists undertook to reconstruct the deadly 1918 Spanish Flu virus.  The results of the project sponsored by the National Institutes of Allergy and Infectious Diseases provided answers that both shocked and alarmed researchers.  For years, it has been hypothesized that a lack of modern medical equipment and practices (respirators, antibiotics, rigid surveillance, etc.) exacerbated the mortality of the 1918 pandemic.  After reconstructing the 1918 virus, researchers discovered that one of the virus’s surface proteins, its HA gene, was exceptionally virulent, increasing the virus’ pathogenicity (ability to produce disease), and conceivably its communicability as well.[50] 

            After the discovery that the HA gene of the 1918 virus was far more virulent, researchers began to postulate theories as to the high mortality of the 1918 pandemic.  Some scientists postulate that the excessive or larger than expected death toll among healthy, young adults may have been a result of the HA gene’s virulence; essentially, the extreme pathogenicity caused perfectly healthy immune systems to over-activate, leading to severe disease and fatal tissue damage to otherwise healthy adults.  But why did fewer elderly adults die than expected?  Again, answers are somewhat elusive, but scientists believe that an earlier flu pandemic in 1847 may have given at least partial immunity for the elderly.[51]   

            The central question that researchers sought to answer about the 1918 virus was its origin.  After reconstructing the virus, researchers reached conclusions that only gave rise to more questions and more alarm.  Contrary to decades of speculation, the 1918 flu virus was not transmitted from swine to humans.[52]  In fact, the 1918 virus was not the result of gene reassortment between a human and animal virus, as was previously thought necessary for pandemics.  Though the reconstruction strongly suggests that the ultimate origin of the 1918 virus was avian, the 1918 virus underwent gene adaptation instead of gene reassortment.  In other words, the virus adapted by itself, from its original avian host directly to a human host, and achieved a measure of virulence that has since been unparalleled.      Researchers also discovered that during the 1918 pandemic, at least two different strains of the H1N1 virus were circulating, one of them being more virulent due to its ability to latch on to its host’s cells.  On the whole, the researchers believe that its precursor or immediate source was “hidden in an obscure ecological niche before emerging in humans.”[53] 

 

Study Questions

            The HEW report mentioned and cited herein poses a number of questions for policy makers, scholars, and numerous other interested parties to consider given the swine flu program experience.  In addition to broad-based questions that address the core of bureaucratic practices, the report’s appendix has a number of technical questions in regard to a future pandemic.  Among the broad-based questions that arise:

1.               How shall top policy makers, without being scientific experts, address fundamental policy questions involving future pandemics?  How much deference should they give their subordinates—the experts?

2.               How should top policy makers inform the public of future pandemics, especially given that such informing may require highly technical information?

Quite frankly, many of the technical and broad-based questions posed in the report are very typical of academics and bureaucrats.  Many of them fall into that category of inquiry that exists because they are expected to exist.  In other words, they are questions which beg either a laconic reply or a stating of the obvious; they serve little practical purpose.

            Now, more than 30 years removed from the “Swine Flu Affair,” questions do persist; but they are questions that actually should be asked.  That is, they can be asked as long as certain assumptions regarding the very nature of the human condition are understood.  Among them:

1.               How have predictions for influenza changed, if at all, and what new knowledge do we have regarding the virulence of the Spanish Flu and the alleged cycles of pandemics?

2.               How are both the mistakes and the successes of the “Swine Flu Affair” directly applicable to the next pandemic?  More specifically:

(a)             How can the government’s public health agencies avoid unforeseen consequences of inadequate press relations?

(b)            Has there been any resolution to the issue of indemnity for vaccine manufacturers?  With regard to the next pandemic, or perhaps, even a response to bioterrorism, how can the federal government avoid delays caused by concerns regarding liability for manufacturers? 

(c)             Even if concerns over liability are quickly put aside, if a new, never-before-used vaccine is released for mass inoculation, how will public health agencies convince the public that it is safe?  In the event of an actual catastrophe, will it even be necessary to overcome concerns over side-effects?   

3.               How can governmental agencies responsible for making scientific, empirically-based recommendations to non-expert policy holders avoid the rush to unprecedented action, as occurred with the swine flu program?  How can these high level policy makers be assured they have been given all possible options?

4.               Though it was a minor problem in context, how can emergency, mass vaccination programs elicit more support from private physicians—at least, more than the percentage (15% of total vaccinations) in the short-lived swine flu program?

 

 

Answers & Commentary in the Context of Future Pandemics & Threats

Emerging Answers to Questions Raised by the Swine Flu Affair

            Before proposing any answers to the questions, it would probably be useful to state the key problems the swine flu program faced in 1976.  The seven major factors listed in the HEW report aside, the key problems were:

1.               Failure of the scientists & advisers to policy makers to moderate their biases (can they ever be eliminated?)

2.               Failure of the same scientists to re-evaluate empirical evidence as time passes.

3.               Failure of the same scientists to seek out the opinions of experts in the private sector and within the academy to exclude dissent.

4.               Failure of government agencies to effectively communicate with the press and, similarly, to foresee the unintended consequences of not warning the press and the public of the likelihood of deaths temporally close, but not arising from administration of the vaccine.

5.               Finally, that which was perhaps most responsible for a continuing escalation of the program, especially at its earliest stages, was the careless use of unqualified projections and hyperbole within memoranda and communications by the scientists to their non-expert, policy-making superiors.  (Recall CDC Director Sencer’s memorandum read by the President stating a “strong possibility” of a flu pandemic, without any shred of supporting evidence.)

Answers to the questions posed should be qualified with the statement that as our technologies continue to advance, predictions and projections of future pandemics may be increasingly possible, and their effects ameliorated.  Predictions for the nature of the next pandemic are not really any more possible than they were 30 years ago, especially since we now know that pandemics are not cyclical; but, better and world-wide surveillance systems exist.  Yet, surveillance systems are not without difficulties—for example, it is likely that China deliberately concealed the severity and nature of the SARS outbreak that caused enormous fright in 2003.  As long as governments conceal the outbreak of pandemics, it will continue to hinder preparation by other countries, perhaps with catastrophic consequences.

            In regard to the functioning of government, the press missteps in the Swine Flu Affair are generally less likely to occur today.  As the size of the federal bureaucracy has steadily increased, it has not been without positive developments.  Federal agencies tend to have more political appointees—perhaps both good and bad in terms of policy making.  But, with respect to press relations, federal agencies have acquired more skill, often with seasoned communicators occupying top press posts.  The likelihood of misstatements and major blunders with careless wording emanating from federal agencies is not as great as it was 30 years ago.  Perhaps more important, the ability to foresee, detect, and head off debilitating criticism of successful and properly functioning programs is more likely with these seasoned operators.    Similarly, a smooth and seasoned press operation has a better probability of successfully educating the public through mass media, regardless of the technical nature of the information.  Bureaucrats don’t often have the instinct required to talk in terms that a layman will understand.

The question of indemnity for vaccine makers will likely never permanently subside.  In the event of an unforeseen pandemic requiring fast manufacture of a new vaccine, Congress will probably have to provide some level of special immunity for vaccine makers.  Manufacturers and insurance companies tend to take their bottom lines seriously, so this problem is unlikely to disappear (indeed, perhaps it is not proper to label it a “problem;” it’s merely a byproduct of our modern economic system, which is reacting to an increasingly litigious society, is it not?) So, how can future programs, similar to the swine flu program, encourage more participation from private health care providers, especially physicians, under those circumstances?  Perhaps this is not as big a problem in retrospect; it’s possible, and maybe more than possible, that low participation by private physicians was a result of both a lack of confidence in the swine flu program and a lack of perceived need for the mass vaccinations.  It is hard to believe that private physicians, in the midst of a true pandemic, would participate at such low levels as in the swine flu program.  But, a recent experience does give pause.  In 2003, the federal government created a program to vaccinate approximately 1,000,000 military personnel and essential civilian first responders for smallpox, fearing its use as an agent of bioterrorism.[54]  Though more than 500,000 military personnel were vaccinated, of the targeted 500,000 civilian personnel, fewer than 40,000 elected to receive the vaccine.[55]  In a blast from the past, the likely cause of low civilian participation: lack of knowledge about both the efficacy and safety of the quickly-rolled out vaccine and concerns over liability for health care institutions and providers who were to administer the vaccines.[56]  The failure of a vaccination program with a target goal 1/200th the size of the swine flu program of 1976 gives cause for alarm.  But is it possible that the government has at least learned from the 1976 mistakes with respect to stockpiling, coupled with vigilance and heavy surveillance?  Possibly.  Though some scientists have predicted that the next pandemic may result from the “avian flu,” the H5N1 strain that caused a scare in 1997 and 1998, there is little evidence to support such hypothesis because none of the strains which caused the three previous pandemics have much in common with this “avian flu” strain.  Furthermore, the H5N1 “avian flu” strain was highly resistant to human-to-human transmission.[57]  But, the new knowledge obtained from the reconstruction of the 1918 virus, especially with regard to independent genome adaptation of viruses, prohibits conclusively ruling out the H5N1 strain as a possible source of the next pandemic.  In preparing for a possible pandemic of the H5N1 “avian flu,” the government has stockpiled 6 million vaccines, with a target goal of 20 million; additionally, more than 35 million doses of antiviral drugs to mitigate a possible H5N1 pandemic have also been stockpiled.[58]  With rigid international surveillance, it’s possible the stockpiling of tested vaccines could reduce mortality.  Yet, administration of the vaccines in the wake of the 2003 smallpox program disaster still leaves lingering doubts as to the successful implementation of the plan.

Finally, turning toward the biases of scientists charged with providing expert opinion to non-expert policy makers, there seems to be no universal panacea.  Biases are innate within all men, especially those who have spent a lifetime specializing in an academic or other technological field.  The fatalist view is to hope that such men act with prudence, self-moderating their biases and intentionally seeking out the opinions of colleagues who may disagree or offer alternative options.  A practical though partial solution is to require a system of peer-review, wherein an independent referee or moderator is charged with gathering outside and diverse expert opinion to review, and if necessary, challenge scientific assumptions and prescribed courses of action.  If this moderator-referee is not independent of the agencies he is charged with subjecting to quality control, he would be just another supernumerary bureaucrat.


Afterward

For more information on the specific tort claims that arose in response to the administration of the Swine Flu vaccinations, consult Unthank v. United States, 732 F.2d 1517 (10th Cir. 1984).  Another case of interest is a similar tort claim based on the polio vaccine, Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974.)  Without diving deeply into an another realm of public policy discussion,  it seems, at least on the surface, that Unthank and Reyes, taken together, highlight that government lawyers tend not to think as plaintiff lawyers do.  In drafting the statute giving immunity to manufacturers of the vaccine and establishing a tort claims process that takes years to conclude, when defending claims, the defendant has a continuingly diminished ability to draw upon a jury’s gratitude for vaccines and good-intentioned public health interventions as time drags on.

Congress, in the face of emerging threats of bioterrorism, is attempting to address this and other issues with liability for vaccines.  Experience will likely dictate a continual evolution of public policy toward liability in the face of exigency.  Of late, Congress’ evolution on the issue may concern lay man and tort lawyer alike.  Between 2003 and 2005, in creating what has been named and referred to as Bioshield, or preparation for biological warfare and biological terrorism, Congress addressed the issue of liability for vaccines yet again.  The Congressional acts do not look kindly toward tort claims: there is no judicial review of claims put through the administrative process, there is a one year statute of limitations that runs from the date of the vaccination, there is a higher than normal standard of proof required at trial, and, any victim could see his financial recovery reduced by the introduction of comparative fault with respect to the manufacturer, the victim, and the health care provider.  For a more in-depth analysis, see “Immunity for Immunizations: Tort Liability, Biodefense, and Bioshield II,” by Lincoln Mayer in the Stanford Law Review at 59 Stan. L. Rev. 1753.   

The federal government is in a continual process of preparing and anticipating the next influenza pandemic.  As the government’s preparedness plans evolve, official recommendations and planning documents are usually available online.  The current documents are available online, through the White House, at

http://www.whitehouse.gov/homeland/pandemic-influenza.html.

               



[1] “Influenza: The Disease.”  http://www.cdc.gov/flu/about/disease/index.htm.  Retrieved on April 24, 2007.   

[2] “The Influenza Virus.”  http://www.cdc.gov/flu/about/viruses/index.htm.  Retrieved on April 24, 2007.

[3] More information on the subdivision of Types A and B influenza viruses is available online at http://www.cdc.gov/flu/about/viruses/types.htm.  More in-depth information is not necessary for this case study.

[4] “Flu Symptoms.”  http://www.cdc.gov/flu/about/disease/symptoms.htm.  Retrieved on April 24, 2007. 

[5] “How Flu Spreads.”  http://www.cdc.gov/flu/about/disease/spread.htm.  Retrieved on April 24, 2007.

[6] http://www.pandemicflu.gov/index.html#.  Retrieved on April 24, 2007.

[7] The three subtypes of Influenza A viruses which caused the three flu pandemics are H1N1, H2N2, and H3N2.  Two of these pandemics were a result of the reassortment of influenza viruses thereby leading to antigenic shifts.  The H1N1 virus that caused the 1918 Spanish Flu still remains a mystery as to its beginnings.  There are three methods of antigenic shift; each method involves the transmission of an influenza virus from one species to another.  See Edwin D. Kilbourne, “Influenza Pandemics of the 20th Century.”  http://www.cdc.gov/ncidod/EID/vol12no01/05-1254.htm.  Retrieved on April 25, 2007.  

[8] http://www.pandemicflu.gov/index.html#.  Retrieved on April 24, 2007.

[9] “Pandemics and Pandemic Threats Since 1900.”  http://www.pandemicflu.gov/general/historicaloverview.html.  Retrieved on April 24, 2008.

[10]Morens, David M., and Fauci, Anthony.  “The 1918 Influenza Pandemic: Insights for the 21st Century.”  Journal of Infectious Diseases.  April 2007.  Available online: http://www3.niaid.nih.gov/about/directors/pdf/morens_fauci.pdf

 

[11] Taubenberger, Jeffrey, and Morens, David.  “Influenza Revisited.”  Emerging Infectious Diseases.  Online at http://www.cdc.gov/ncidod/EID/vol12no01/05-1442.htm.  Retrieved on April 25, 2008.

[12] “Pandemics and Pandemic Threats Since 1900.”  http://www.pandemicflu.gov/general/historicaloverview.html.  Retrieved on April 24, 2008.

[13] Taubenberger, Jeffrey, and Morens, David.  “Influenza Revisited.”  Emerging Infectious Diseases.  Online at http://www.cdc.gov/ncidod/EID/vol12no01/05-1442.htm.  Retrieved on April 25, 2008.

[14] Neustadt, Richard, and Fineberg, Harvey.  “The Swine Flu Affair: Decision Making on a Slippery Disease.”  Page 5.  This report by Neustadt and Fineberg was commissioned by the U.S. Department of Health, Education, and Welfare and is available online at https://biotech.law.lsu.edu/cphl/history/books/sw/index.htm.  Hereinafter, the report will be cited as “Neustadt.”

 

[15]Gaydos, J., Top, F., Hodder, R.A, Russell, P.K.. “Swine Influenza A Outbreak, Fort Dix, New Jersey, 1976.”  Emerging Infectious Diseaseshttp://www.cdc.gov/ncidod/EID/vol12no01/05-0965.htm

[16] Neustadt, 6.

[17] Id., 7.

[18] Id., 8.

[19] Id., 9.

[20] Id., 6.

[21] Id., 11-12.

[22] Id., 11.

[23] Id., 13.

[24] Id.

[25] Perhaps it is apropos to repeat an aphorism often attributed to former Secretary of State Henry A. Kissinger: “University politics are vicious precisely because the stakes are so small.”

[26] Id., 12.

[27] Id., 15.

[28] Id.

[29] Id., 15-16.

[30] Id., 24.

[31] Id., 19.

[32] Id., 20.

[33] Id., 17.

[34] Id., 20.

[35] Id., 20-21.

[36] Id., 25.

[37] Id.

[38] Id., 27-28.

[39] Id., 29.

[40] Id., 29-30.

[41] Id., 44-46.

[42]Id., at 49.  The primary concern of manufacturers and their insurance providers was not necessarily the costs that could arise from judgments against manufacturers for adverse side effects.  Rather, the primary concern, especially of insurers, was their contractual duty to defend claims.  Viewed in the context of a population of 200 million, the cost of simply defending claims, let alone settling them, was cost-prohibitive.  (Neustadt, 53).

[43] Id., 60.

[44] Id., 65-68.

[45] Id., 68-70.

[46] Id., 3.

[47] Id., 1-2.

[48] Id., 1-3.

[49] Id., 97-98.

[50] Devitt, Terry.  “Gene from 1918 Virus Proves Key to Virulent Influenza.”  University of Wisconsin—Madison News.    http://www.news.wisc.edu/10241.  Retrieved on April 24, 2008.  An influenza virus has two surface proteins, as evidenced in its nomenclature (e.g., H1N1).  These two surface proteins, hemagglutinin (H or HA protein) and neuraminidase (N protein), both play two key roles in the life of the influenza virus.  The H protein enables a virus to stick to the cells of its host, giving rise to infection.  The N protein serves as the liberator of the virus—it allows newly formed viruses to escape from its host.  For more information, go to http://www3.niaid.nih.gov/healthscience/healthtopics/Flu/Research/ongoingResearch/Pandemic/fluSurvivors.htm.

 

[51] Morens, David M., and Fauci, Anthony.  “The 1918 Influenza Pandemic: Insights for the 21st Century.”  Journal of Infectious Diseases.  April 2007.  Available online: http://www3.niaid.nih.gov/about/directors/pdf/morens_fauci.pdf

[52] Though it had been speculated generally for decades that the 1918 flu virus was transmitted from swine to humans, as early as 1936, Professor Richard Shope noted that a previously unknown influenza virus appeared in swine in the Mid-West in the summer or autumn of 1918, but that virus moved from humans to swine, not from swine to humans.  (http://www.cdc.gov/ncidod/EID/vol12no01/05-1254.htm). 

[53] Id.

[54] Richards, Edward P.  “Public Health Law as Administrative Law: Example Lessons.”  Journal of Health Care Law and Policy.  10 J. Health Care L. & Pol'y 61, at 851.

[55] Id., 852.

[56] Id., 853.

[57] Taubenberger, Jeffrey, and Morens, David.  “Influenza Revisited.”  Emerging Infectious Diseases.  Online at http://www.cdc.gov/ncidod/EID/vol12no01/05-1442.htm.  Retrieved on April 25, 2008.

[58] National Strategy for Pandemic Influenza Implementation Plan One Year Summary.  July 17, 2007.  http://www.whitehouse.gov/homeland/pandemic-influenza-oneyear.html#exec.  Retrieved on April 25, 2008.

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