The Flawed 1976 National “Swine Flu” Influenza Immunization Program

Influenza has been in the news a lot lately, enough so to stir memories of the flawed National “Swine Flu” Influenza Immunization Program of 1976.* What was the 1976 “Swine Flu Affair” all about? It started on January 27, 1976, when a small outbreak of mild respiratory illness occurred at the Fort Dix Army Base in New Jersey. Throat cultures taken from sick soldiers grew out what laboratorians at the Centers for Disease Control and Prevention (CDC) identified as a “swine-like flu virus which was believed to have been inactive in the human population since 1930 with the exception of a handful of cases of swine-to-person transmission.”** (pp. 1-2) CDC observers decided that human-to-human transmission (between soldiers) had occurred at Fort Dix, which in turn suggested that an “antigenic shift” had occurred or was occurring in the human influenza virus, an event which in the past had always been followed by a worldwide pandemic of influenza. Moreover, the swine flu was believed to have been the agent of the century’s worst flu pandemic in 1918-1919 in which approximately 500,000 Americans died.

David J. Sencer, M.D.
Source: http://images.google.com/imgres?imgurl=http://www.cdc.gov/od/images/sencer.jpg&imgrefurl=
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On February 14, 1976, David J. Sencer, M.D., CDC director (1966-1977), followed up on the Fort Dix data from the CDC laboratory by calling his peripatetic superior, Theodore Cooper, M.D., Health Education, and Welfare assistant secretary for health. Sencer noted that one of the sick soldiers, Pvt. David Lewis of Ashley Falls, Mass . , had died after leaving against medical advice to participate in a forced five-mile march at night, during which he collapsed. This death was forever cited as the “fatal index case,” suggesting a dangerous lethality of the newly-discovered flu germ. In fact, no further cases of swine flu ever were reported at Fort Dix, elsewhere in the U.S. or, according to the World Health Organization, in the world. However, CDC officials discovered unprocessed throat washings obtained from fully-recovered recruits who had been sick with the flu in January and early February 1976. CDC laboratorians who processed them identified nine (9) more cases positive for the swine-flu-like virus. Saddled with this new positive test information, what could CDC officials do but…do something! So they did. Intensive surveillance and testing was about to result in a false alarm at great personal cost to many Americans.

Theodore Cooper, M.D. (left) and President Ford (center)
Source: http://www.nih.gov/about/almanac/images/Ford07011975a_72dpi.jpg

Sencer prepared his now-famous March 11, 1976, memorandum bearing the heading “Swine Influenza: ACTION,” which contained seven facts, e.g., Fact #2: “The virus isolated at Fort Dix is antigenically related to the influenza virus which has been implicated as the cause of the 1918-1919 pandemic which killed 450,000—more than 400 out of every 100,000 Americans.” Furthermore, he argued forcefully and repeatedly that the only way a pandemic could be halted was through a program that would immunize most (95%) of the US population; a half-hearted or more conservative vaccination effort would be little better than none at all.” (**, p. 7)

In the memo, Sencer identified four possible courses of action and their respective pros and cons, and recommended that President Gerald Ford adopt the fourth option:

1. The federal government could take ‘no extraordinary action’ and depend upon the private health care market to serve those customers who wished to be immunized.

2. The federal government could mount a “Minimum Response,” which would include recommending that vaccine manufacturers produce enough doses to immunize the entire US population, and limiting its own activities to public awareness campaigns, research and monitoring, and purchase of vaccine for federal beneficiaries.

3. The federal government-public sector could carry out the entire immunization program, including purchasing enough vaccine for the entire population and administering the vaccine to the public by federal agencies and state health departments.

4. The federal government could purchase the vaccine but distribute it through a variety of channels, ranging from physician offices to community clinics.

Sencer rapidly involved and directed medical officials both inside and outside the CDC in the decision making, including American vaccine warrior-heroes Drs. Jonas Salk and Albert Sabin, prior to meeting with President Ford on March 24, 1976. At the meeting with the president ( 3:30 pm in the Cabinet Room), according to one observer, “Ford welcomed the group, briefly described the purpose of the meeting, and as planned, deferred to the HEW representatives. Sencer, Cooper [and others] made presentations on the swine flu data and a strategy for preventing an epidemic. Following the presentations, first Salk and then Sabin very strongly urged the president to mount a mass immunization campaign such as Sencer had outlined; reportedly neither failed to mention in passing the significance of his own work in laying the foundation for medical undertakings of this kind. Ford asked for opinions from the other doctors, but apparently only about five of the outside scientists (including Salk and Sabin) participated very actively. The discussion touched on the same topics as the meeting on Monday—the non-government scientists agreed with the Public Health Service that no figure could be placed on the probability of an epidemic; the 1918-19 disaster was another recurring topic. None of those who spoke up had a disparaging word for the immunization proposal.

“President Ford asked at least twice whether anyone present had any reservations about this course of action,” according to an observer. “He asked if it was the unanimous recommendation of this group that they proceed. The leading doctors said ‘Yes’ and he said ‘Now, if any doctor here has a sense that this is not necessary, if there is any doubt in his mind about it, I would like him to tell me so now.’ And I remember that there was a very long silence that went on for what seemed minutes, and nobody said a word. President Ford broke the silence and raised some other questions which got the group talking again. He said a second time, some minutes later…. ‘If anyone has any doubt about this [and] would like to speak to me privately about this, I would like him to do so. I will be in my office for the next ten minutes if anyone wants to come in.” He said to me, ‘Jim, you make sure that they come in.’” (**pp. 11-12) None arrived. President Ford felt that the absence of any criticism from the scientific group left no question as to the appropriate course of action.

Then President Ford, on the same March 24, 1976, only one day after his surprise loss to Ronald Reagan in the North Carolina Republican presidential primary, announced on national television his recommendation to the American public for a crash nation-wide influenza vaccination program to include “every man, woman and child.” Congress responded promptly to the president’s call for funds (appropriations were voted by the Senate April 9, by the House April 12, and signed into law April 15, 1976). Vaccine was produced, field tested, and evaluated in April, May and June. There were problems with producing the vaccine. Nevertheless, between October 1 and December 16, 1976, the U.S. Public Health Service, through state and local public health department “public sector providers,” rapidly spread out among the citizenry to successfully vaccinate 85% of 40 million voluntary vaccinees in 10 weeks (the other 15% of the 40 million voluntary vaccinees received their vaccinations from “private sector providers”). There was great variation among states in vaccinating their citizenry. For example, a skeptical New York City held off on vaccinations, preferring to wait for a shred of evidence that a pandemic was materializing, whereas always dutiful Minnesota immunized two-thirds of eligible adults.

Then, on November 21, 1976, a “Minnesota physician reported to his local health authorities a patient who had contracted an ascending paralysis, called Guillain-Barré syndrome, following swine flu immunization. The physician said he had just learned of this possible side-effect from a cassette-tape discussion of flu vaccination prepared for the continuing education of family practitioners by a California specialist. The Minnesota immunization program officer, Denton R. Peterson, dutifully called CDC and spoke to one of the surveillance physicians there. The latter expressed no interest in the single case, but Peterson was sufficiently bothered to conduct a literature search and did indeed discover previous case reports. “We felt we were sitting on a bomb,” he told investigators. Within a week three more cases, one fatal were reported to Peterson. Two came from a single neurologist who remarked that he had observed this complication of flu vaccine during his residency training. More anxious than ever, Peterson again called the CDC, where the surveillance center was just being told by phone of three more cases in Alabama. The next day they learned of an additional case in New Jersey. By then the CDC was taking the problem seriously.” (** pp. 24-25) Still, Sender was not impressed.

The federal government abruptly suspended the NIIP pending analysis of Guillain-Barré cases emerging in the vaccinated population. Eventually, 532 cases of vaccine-related Guillain-Barré syndrome and at least 25 deaths occurred. One CDC official recalled that he had expected side effects upon the nervous system of some vaccinees, but he had no notion on what scale. No one expected a high frequency and no one then explored the policy implications, particularly in the absence of pandemic, which indeed turned out to be exactly the case. CDC research showed that the actual risk for Guillain-Barré was only about 1 in 1,000 among people who had received the vaccine, which was about seven times higher than for people who did not receive the vaccine.***

The vaccine manufacturers had anticipated the potential for serious side effects from the vaccines they manufactured and had insisted on indemnification by the federal government before releasing pandemic vaccine. Harmed vaccinees and their families sued the federal government and eventually received millions of dollars in damages. Sencer was let go as CDC director. Many people faulted him for his dogged pursuit of universal influenza vaccination.

One observer of the swine flu affair, Dr. Russell Alexander of the Public Health School at the University of Washington, expressed his view that the clinical side of medicine had been shortchanged in the decision making processes. He told federal investigators after the fact: “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.” (P. 13) Indeed, Sencer ignored the case for “watchful waiting” before proceeding with the vaccination program, even though no swine flu had shown up anywhere, not even in the southern hemisphere where flu season was reaching its peak. Even Sabin, who had earlier advocated universal vaccination, later argued for stockpiling the vaccine and, if a pandemic began, to keep ahead of the spread by vaccinating quickly. He called this stockpiling “active, not passive, not mere warehousing of vaccine.” Proper measures, he said, included both planning and training of volunteers ready to immunize their neighborhoods the moment CDC should pass the word. (**, p. 11) Sencer (and Salk) said “No!” to this idea, saying that the flu would move too fast in a pandemic. Vaccine should be stored in people, not warehouses!

The 1976 federal mass influenza vaccination program would be but a historical note except that CDC officials, currently led by Director Julie Gerberding, M.D., and National Institute of Allergy and Infectious Diseases officials, currently led by Director Anthony Fauci, M.D., are ratcheting up their warnings about the potential for the H5N1 avian flu threat in Asia to reassort or otherwise mutate into a form easily communicated between humans, resulting in a human pandemic similar to the one in 1918. Does this sound familiar? The U.S. Department of Health and Human Services (DHHS) published in August 2004 its “Pandemic Influenza Preparedness Plan,” which has been used as a model by individual states. Does this new plan reflect learning from the 1976 debacle? Please see Biot #179 available at: http://www.semp.us/biots/biot_179.html for more on this question.

Sources:

*The Kennedy School of Government, Harvard University, has published seven case components on the swine flu affair, which are available for a small charge at www.ksg.harvard.edu/case

**”The Swine Flu Affair: Decision-Making on a Slippery Disease” by Richard E. Neustadt and Harvey Fineberg, M.D., published by the US Department of Health, Education, and Welfare, GPO Stock No. 017-000-00210-4, in Kennedy School of Government case, “Swine Flu (C ), 1980; available for a small charge at:

http://www.ksgcase.harvard.edu/.

*** “A Shot in the Dark: Swine Flu’s Vaccine Lessons” by David Brown in the Washington Post, Monday, May 27, 2002, p. A09; also available online at:

http://www.washingtonpost.com/ac2/wp-dyn/A14517-2002May26?language=printer.

Additional sources:

1. SEMP Biot #117: “What Does Roz Lasker Know about Public Reaction to a Smallpox or Dirty Bomb Terrorist Attack?” at http://www.semp.us/biots/biot_117.html.

2. SEMP Biot #136 : “ Minnesota's Smallpox Vaccination Experience” at

http://www.semp.us/biots/biot_136.html

3. SEMP Biot #162 “What Is Swine Flu?” at http://www.semp.us/biots/biot_162.html.

4. SEMP Biot #149 “What Is Avian Flu” at http://www.semp.us/biots/biot_149.html).