This is a prequel to an upcoming article on the different outcomes between the West’s approach to Covid and China’s. They were to the largest natural human trials in history, so the lack of professional interest is remarkable. In the meantime, here’s a freebie, a stroll down nightmare lane..
In January 1976, soldiers at Fort Dix complained of a respiratory illness, which was diagnosed as influenza. The next 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, while the majority of samples were of the more common A Victoria flu strain, two were not.
The atypical samples were sent to the Centers for Disease Control in Atlanta, Georgia, which found evidence of Swine influenza A, related to the 1918 flu pandemic which killed 50-100 million people worldwide.
The CDC verified the findings and informed both the World Health Organization and the state of New Jersey. On February 13, CDC Director David Sencer completed a memo calling 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 questions from reporters, 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, then made a televised announcement in support of a mass immunization program.
At a Senate hearing, C. Joseph Stetler, drug company spokesman, requested government indemnify the vaccine manufacturers. Sharp & Dohme (Merck), Merrill, Wyeth, and Parke-Davis refused to sell doses to the government unless they were guaranteed immunity and a profit, concessions the government eventually made.
Congress authorized $135 million ($72 million today) for swine flu immunization on April 5. Two days later, the WHO held a conference to discuss the implications of a swine flu outbreak for poorer nations.
Then, 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 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 extended liability protection.
The chairman of Merck wrote government agencies and the White House emphasizing his “duty to warn”. In May, other vaccine manufacturers including Marion Merrell Dow, Parke-Davis, Wyethwere notified of indemnity problems by their respective insurers.
Assistant Secretary Theodore Cooper (HEW) informed the White House on June 2 that indemnity legislation will be needed to secure Merrell’s cooperation. During 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.
Bruce Dull stated at a flu conference on July 1 that there were no parallels between the 1918 flu pandemic and the current situation and, later that month, FDA researcher, J. Anthony Morris, was dismissed for insubordination and went public with findings that cast doubt on the safety of the vaccine.
Three days later, several manufacturers announced they had ceased production of the vaccine. In the latter part of the month, investigations into alleged swine flu outbreaks in other parts of the world found no cases of the strain. On July 23, the President sent a letter urging Congress to take action on indemnification.
In early August an outbreak of illness in Philadelphia was thought to be related to swine flu. Though it was later found to be an atypical pneumonia (thereafter called Legionnaires’ disease) President Ford urged Congress to take action on the indemnification legislation. Four days later, both Houses passed the legislation.
Merrill became the first company to submit samples to the FDA’s Bureau of Biologics 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 inoculations were given at the Indiana State Fair.
One month later, in October, three people died of heart attacks after receiving the vaccine at the same Pittsburgh clinic, sparking an investigation and recall of that batch of vaccine. Investigation showed that the deaths were not related to the immunization. The President and his family received their immunizations before the television cameras. On November 2, Gerald Ford lost the presidential election to Jimmy Carter.
Also in early November, Albert Sabin published a New York Times editorial, Washington and the Flu. He agreed with the decision to create the vaccine and be prepared for an outbreak, but criticized the “scare tactics” used by Washington to achieve the goal. He suggested stockpiling the vaccine and having a wait-and-see strategy. Cases of Guillain-Barré syndrome affecting vaccinated patients were already reported in several states, including Minnesota, Maryland, and Alabama.
Three more cases of Guillain-Barré were reported in early December and the investigation into cases of it spread to eleven states. On December 16, 1976, a one-month suspension of the vaccination program was announced by CDC head Sencer. William Foege of the CDC estimated that the incidence of Guillain-Barré was four times higher in vaccinated people than in those not receiving the swine flu vaccine.
The President told reporters that he agreed with the suspension, but defended the decision to create the immunization program. Joseph A. Califano, Jr. was sworn in as Secretary of Health, Education, and Welfare on January 20, 1977. On February 4, Sencer was informed that he would be replaced as the head of the CDC. The immunization program was not reinstated.
Aftermath
In At Law: Swine Flu Vaccine: What Is Fair?, Laurence Gostin wrote “the swine flu affair fails to tell us whether, in the face of scientific uncertainty, it is better to err on the side of caution or aggressive intervention.” There is not even complete agreement about the causal relationship between the swine flu vaccine and Guillain-Barré syndrome, as noted in Gina Kolata’s book Flu: The Story of the Great Influenza Pandemic of 1918 and 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”.
Glaxo Smith Kline Pandemrix vaccine was given to 6 million people in Britain and millions more across Europe, but was withdrawn when doctors noticed a rise in narcolepsy cases among those who received the jab. In June, a 12-year-old boy was awarded £120,000 by a court that ruled he had been left severely disabled by narcolepsy caused by Pandemrix.
The win ended a three-year battle with the government that argued his illness was not serious enough to warrant compensation. Narcolepsy is a permanent condition that can cause people to fall asleep dozens of times a day, even when they are in mid-conversation. Some suffer from night terrors and a problem with muscular control called cataplexy that can lead them to collapse on the spot. (Guardian, Sept. 25, 2015)
By August 2009, it was clear that Glaxo Smith Kline’s Pandemrix vaccine had caused lifelong narcolepsy and cataplexy–an incurable, lifelong condition requiring extensive medication–in ten thousand people. A 2014 report said the government expected to receive a bill of approximately $330 million, with 60 victims expected to receive $5.5 million each. The crippled children were quickly forgotten and the entire affair swept under the rug. Until now..
Reading
Swine Flu Chronology January 1976—March 1977. NIH.
Past Pandemics: Gerald Ford and the 1976 Swine Flu Outbreak.
