Tuesday, January 31, 2012

A Gun To Our Head: The 1976 Swine Flu “Debacle”

For a nationwide effort deemed--in the perfect vision of historical hindsight--a “debacle,” the coordinated efforts of multiple federal agencies, state health departments, and local volunteer organizations and individuals to prevent a “strongly possible” (Neustadt, et al., 1978) swine influenza epidemic in the winter of 1976-77 were uniquely successful from several perspectives. Prior to 1976, there existed no organized, efficient way to rapidly manufacture and deploy hundreds of millions of doses of vaccine, no way to perform nationwide disease and adverse-effect surveillance in real time, and no appreciation for the legal and logistical challenges that would result from such an effort. The lessons our public health infrastructure learned from the 1976 “debacle” are important tools we still use today.

The story starts with the sudden appearance of a respiratory disease outbreak among Army recruits returning from Christmas break to Fort Dix, New Jersey, in January 1976 (Gaydos, 2006). Martin Goldfield, a civilian epidemiologist (who would later strongly and publicly criticize the vaccination campaign), sent samples from the Fort Dix patients to the Centers for Disease Control (CDC), where on February 12th, lab director Walter Dowdle reported that a previously unidentified viral vector was swine influenza antigenically similar to the virus responsible for the 1918 pandemic. On Feburary 14th, CDC director David Sencer met with representatives from the Food and Drug Administration’s Bureau of Biologics (BoB) and National Institute for Allergy and Infectious Disease (NIAID) (both of which were responsible for licensing and testing vaccines), the Army and Dr. Goldfield to discuss the potential early outbreak.

By March, all reported cases (500 total, all in young, previously healthy recruits) were still confined to Fort Dix, but Sencer and his colleagues knew three worrisome facts so far: (1) human-to-human transmission was occurring, (2) no “herd immunity” existed in patients younger than 62 years old, and (3) traditional “high risk” groups did not apply--this virus was attacking the young and healthy, just as in 1918. On March 13th, Sencer sent an “action-memorandum” to the Secretary of Health, Education and Welfare (HEW) that became the motivating declaration for the nascent national immunization campaign. In the memorandum, Sencer wrote of a “strong possibility” that a swine influenza epidemic would occur during the 1976-77 season, and that the government must act swiftly and decisively to prepare. Although the memorandum was moderate in its tone, it argued that “less than 100% coverage” by vaccination would be “socially and politically unacceptable.” In subsequent meetings with Secretary Mathews (HEW), Sencer boldly argued with even more certainty that an epidemic would occur. Mathews took Sencer’s memo to the White House, where it was felt to be “a gun to our head” -- the social and political fallout of failing to prepare would indeed be a nightmare. President Ford chose to act and announced his decision to the public, flanked by vaccination luminaries Salk and Sabin, on March 24th.

The CDC, with limited time and resources, focused on encouraging planning by state health authorities, setting standards, allotting administrative funds to the states, purchasing vaccine on their behalf, conducting surveillance of disease and adverse effect activity, and encouraging involvement of private physicians and volunteer organizations. In comparison, the state and local public health organizations were responsible for planning the logistics of vaccine distribution and administration, injection gun acquisition and other details, using CDC-written educational materials to prepare the public. The CDC was simply unequipped to work on a state or local level, except to help in defraying costs and advising.

On the vaccine side of the effort, the NIAID and BoB acted as liaisons between the federal government and private vaccine manufacturers. These organizations conducted field trials and testing, and were instrumental in the decision to stop manufacture of the Victoria flu strain vaccine (which had been responsible for the 1975-76 flu season, including the majority of Fort Dix cases). Instead, it was decided to use all available resources to manufacture swine flu vaccine and combine it with the existing 30 million doses of Victoria vaccine to create bivalent vaccine doses for those at highest risk.

The coordination of these organizations across the federal, state and local levels was unprecedented and, in many ways, worked well. The first doses of swine flu vaccine were given in October 1976 and before the campaign was stopped, 40 million doses were given (over twice as many as had ever been given in any previous flu season) (Zimmer, 2009). However, the epidemic never materialized. Furthermore, 532 cases of Guillain-Barre syndrome occurred (and were reported “upstream” from local to federal authorities, in almost real-time, to the CDC’s first-ever computerized epidemiologic surveillance system), prompting cessation of the campaign in December (Turnock, 2009). In a sense, the rapid cessation of the program was as much a success of multi-level public health coordination as was the initiation of the 1976 swine flu immunization campaign. There is reason for optimism that the skills the public health system learned from 1976 will be useful the next time a metaphorical gun is held to its head.

References:

Gaydos J.C., Top F.H., Hodder R.A., Russell P.K. (2006). Swine influenza A outbreak, Fort Dix, New Jersey, 1976. Emerging Infectious Diseases. Atlanta, GA: Centers for Disease Control.

Neustadt RE, Fineberg HV. (1978). The swine flu affair: Decision-making on a slippery disease. Washington, D.C.: Government Printing Office.

Turnock B.J. (2009). Public health: What it is and how it works (4th ed). Sudbury, MA: Jones and Bartlett Publishers.

Zimmer S.M., Burke D.S. (2009). Historical perspective--emergence of influenza A (H1N1) viruses. New England Journal of Medicine. Boston, MA: Massachusetts Medical Society.