Prequel: the 20th century
20th century epidemics
September 1943, the US Army created “Operation Capricious,” a secret biowarfare program. It was described to higher-ups as purely defensive against insect pests enemy nations might use against America by bombing America with germ-infected insects, and placed under the direction of George W. Merck, president of the pharmaceutical giant, Merck & Co. The program produced and stockpiled bacillus anthracis (anthrax), clostridium botulinum (botulism), and other deadly bacteria until President Truman, who approved atomic weapons against Japanese civilians, approved and operationalized by the U.S. military in 1952 against North Korea and China. It was crude and unsuccessful, like all prior biowarfare efforts had been. As Jeffrey A. Lockwood, Six-Legged Soldiers: Using Insects as Weapons of War.
June, 1972. US signs the 1972 Biological and Toxin Weapons Convention (BTWC),
January 1976. Several soldiers at Fort Dix complained of a respiratory illness diagnosed as influenza. The following month, Private David Lewis, who had the symptoms, participated in a five-mile forced march, collapsed and died. The New Jersey Department of Health tested samples from the Fort Dix soldiers and found the common A Victoria flu strain, but two were not. They were Swine influenza A, related to the 1918 flu pandemic that killed 50-100 million people worldwide. The CDC verified the findings and informed both the WHO and the state of New Jersey. On February 13, CDC Director David Sencer called for mass immunization for the swine flu. The CDC Assistant Director for Programs of the Center for Disease Control, Bruce Dull, held a press conference on February 19 to discuss the flu outbreak at Fort Dix and, in response to reporters’ questions, mentioned the relationship of the flu strain to the 1918 outbreak. President Gerald Ford was officially informed of the outbreak memo on March 15 and the suggested immunization program. He met with a “blue ribbon” panel, which included Jonas Salk and Albert Sabin.[6] Ford then made a televised announcement in support of the mass immunization program. A hearing was held before the United States Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, and C. Joseph Stetler, drug company spokesman, requested government indemnity for the vaccine manufacturers. [7] Pharmaceutical companies Sharp & Dohme (Merck), Merrell, Wyeth, and Parke-Davis also refused to sell doses to the government unless they were guaranteed a profit, a concession the government also eventually made. [8]The House Appropriations Committee reported a special appropriations bill including $135 million for the swine flu immunization program. It was approved on April 5. Two days later, the World Health Organization held a conference to discuss the implications of a swine flu outbreak for poorer nations.
On April 8, an official from the Federal Insurance Company informed Merck & Co., a manufacturer of the swine flu vaccine, that it would exclude indemnity on Merck’s product liability for the swine flu vaccine starting from July 1, 1976. T. Lawrence Jones, president of the American Insurance Association, informed the Office of Management and Budget that the insurance industry would not cover liability for the vaccine unless the government extends liability protection. Merck’s chairman wrote a memo a day later, April 13, to various government agencies, including the White House, emphasizing the “duty to warn.” In May, other vaccine manufacturers, including Marion Merrell Dow, Parke-Davis, and Wyeth, were notified of their respective insurers’ indemnity problems. Assistant Secretary Theodore Cooper (HEW) informed the White House on June 2 that indemnity legislation will be needed to secure Merrell’s cooperation. In June, other vaccine manufacturers requested the same legislation. A little more than two weeks later, the Ford Administration submitted a proposal to Congress offering indemnity to vaccine manufacturers. J. Anthony Morris, a researcher in the FDA, was dismissed for insubordination and went public with findings that cast doubt on the vaccine’s safety. Three days later, several manufacturers announced they had ceased production of the vaccine. On July 23, the President urged Congress to take action on indemnification.
Six weeks later, Congress passed the legislation and Merrill submitted vaccine samples to the FDA for safety testing, which approved it on September 2. Merck made the first shipment of vaccines to state health departments by September 22. The first swine flu vaccinations were given at the Indiana State Fair but, a month later, three people died of heart attacks after receiving the vaccine at a Pittsburgh clinic. Investigation showed that the deaths were not related to the immunization. The President and his family received their immunizations before the television cameras. [10] On November 2, Gerald Ford lost the presidential election to Jimmy Carter.
In early November, cases of Guillain-Barré syndrome affecting vaccinated patients were reported in several states, including Minnesota, Maryland, and Alabama. [12] Three more cases of Guillain-Barré were reported in early December, and the investigation into cases of it spread to eleven states.
December 16, 1976, a one-month suspension of the vaccination program was announced and William Foege of the CDC estimated that the incidence of Guillain-Barré was four times higher in vaccinated people than unvaccinated. Joseph A. Califano, Jr. was sworn in as HEW Secretary January 20, 1977. On February 4, and informed Sencer that he would be replaced as the head of the CDC. The immunization program was not reinstated.
To this day there is no complete agreement about the causal relationship between the swine flu vaccine and Guillain-Barré syndrome, as noted in Gina Kolata’s Flu: The Story of the Great Influenza Pandemic 1918, the Search for the Virus That Caused It. She writes that the CDC did not have a “specific set of tests and symptoms to define Guillain-Barré” and that doctors who reported cases already knew that a link was suspected, so a bias in reporting was introduced. She quotes Keiji Fukuda, “…if a new virus gets identified or reappears, you don’t want to jump the gun and assume a pandemic is happening.”
