Friday, October 07, 2005

Lessons learned from the 1976 Swine Flu Program

Read Annex 11 to the .Pandemic Influenza Response and Preparedness Plan in full.

"On January 27, 1976, an outbreak of respiratory disease was identified at Ft. Dix, New Jersey. On February 12 the CDC influenza laboratory notified the CDC Director that a swine influenza virus strain had been isolated from patients that possessed hemagglutinin and neuraminidase subtypes that had not circulated for more than 50 years.......An emergency interagency meeting was held on February 14, and state health officials were notified on February 18. On March 10, the Advisory Committee on Immunization Practices (ACIP) reviewed available data and concluded that person-to-person transmission of swine influenza had occurred but there was no way to determine whether or not a pandemic would occur. CDC notified the Department of Health and Human Services and recommended mass immunization. On March 24 President Ford met with CDC, FDA, and NIH representatives and other experts. There was a unanimous recommendation to initiate mass immunization.......

"The first vaccine was shipped to State Health Departments on September 22 and the first injections were given on October 1. Vaccination programs proceeded based on state plans and capacities, with some aggressively implementing mass vaccination and others implementing more limited programs. Overall, between October 1 and December 16, more than 40 million civilians were vaccinated; 85% by public sector providers (this compares with ~10 million persons vaccinated during the previous influenza season). Several million more were vaccinated in Veterans Administration and Department of Defense programs..........

"By the time the vaccination program ended, 532 GBS (Guillain-Barré syndrome) cases and 32 deaths had been reported. CDC surveyed neurologists in several states and calculated the GBS risk among vaccinated and unvaccinated persons. The results suggested an increased risk among those who were vaccinated. On December 16, based on CDC�s recommendation and after consultation with the President, the Assistant Secretary for Health announced the suspension of the swine influenza vaccination program. Although some persons at high-risk for severe influenza complications received the swine influenza vaccine subsequently, the large-scale vaccination program was not resumed. Neither a swine influenza pandemic nor focal outbreaks following the one initially identified at Fort Dix occurred.....

"Program decisions made early in the process were not modified based on new information Â? e.g., the absence of any Swine influenza cases detected by surveillance following the Ft. Dix outbreak Â? because of concerns over logistical obstacles and impact on program support by the medical community, policy-makers, and the public....

"Drs. Feinberg and Neustadt were asked by the Carter administration to review the swine influenza program, focusing specifically on the decision-making process. They concluded in The Epidemic That Never Was, 'Decision-making for the swine flu program had seven leading features. To simplify somewhat, they are:
Â? Overconfidence by specialists in theories extrapolated from meager evidence.
Â? Conviction fueled by a conjunction of some preexisting personal agendas.
Â? Zeal by health professionals to make their lay superiors do right.
Â? Premature commitment to deciding more than had to be decided.
Â? Failure to address uncertainties in such a way as to prepare for reconsideration.
Â? Insufficient questioning of scientific logic and of implementation prospects.
Â? Insensitivity to media relations and the long-term credibility of institutions.'"

I worked on an international health plan in the White House in 1977, early in the Carter Administration. I recall the mass immunization campaign against the swine flu organized by the previous administration as a debacle, costing a fortune, and probably causing some real harm in the hope of preventing a threat of a pandemic flu -- a threat that was not on that occassion real. A Washington Post reporter totalled the cost:
About 45 million people had been immunized. The federal government eventually paid out $90 million in damages to people who developed Guillain-Barre. The total bill for the program was more than $400 million.

Other observers are even less sympathetic to the Ford Administration. Donald Rumsfeld, who was then and is again the nation's Secretary of Defense, it has been charged by the Whale website, "made the imminent 'swine flu' a political issue to add some spark to the campaign of President Ford." Lawrence Gostin of Georgetown Law School gives Big Pharma a share of the blame: "The pharmaceutical industry convinced political leaders to hold it harmless against lawsuits while, at the same time, profiting from a massive vaccination program actively promoted by government."

This time there seems to be a lot more evidence that an Avian Flu pandemic is a serious and imminant threat. Public health officials recall both the history of the 1918 flu pandemic and that of the mythical 1976 swine flu pandemic. Still, we walk a fine line between inadequate reaction and over reaction to the threat. Certainly we need to postpone decisions that can be postponed, and reexamine dicisions with new evidence as time goes by and experience with the epidemic accumulates. Certainly too, it is wise to invest in means to prevent a possible pandemic, even if that pandemic never actually occurs. Still, one hopes for people with the proper training, long experience, and mature professional judgment to lead in the decision making. My recent blog entries include evidence suggesting that President Bush's top flu pandemic advisors, William R. Steiger and Stewart Simonson, may not have that needed background.

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