By Kimberly Kindy
Washington Post Staff Writer
Saturday, May 9, 2009
As U.S. health officials consider rolling out a plan to inoculate the nation against swine flu in the next several months, they are haunted by the events that unfolded the last time the government stepped in to head off a surprise flu outbreak.
In the fall of 1976, dozens of Americans died within 48 hours of receiving a swine flu vaccine. To allay the public fears that threatened to unravel the mass inoculation program, President Gerald Ford rolled up his shirtsleeve and received his shot in front of television cameras.
More than 40 million others followed his lead. But two months later, the campaign was abruptly stopped: More deaths had followed, and hundreds were reporting serious side effects, including paralysis.
Already, medical experts and vaccine watchdog groups are urging the Obama administration to apply the lessons learned 33 years ago. In a public statement last week, former health and human services secretary Mike Leavitt recommended that officials study the federal investigation of the 1976 program. Administration officials said they are keenly aware of the history.
"We're all reviewing the process that took place in 1976 to understand the lessons learned," said Richard E. Besser, acting director of the federal Centers for Disease Control and Prevention. "We may, as a nation, be faced with a similar decision" about how to address a flu pandemic.
If there was a single factor behind the debacle three decades ago, it was the speed of the decision-making, fueled by a political climate in which dissenters were chastised and punished, government records show.
"They moved too quickly. Mistakes were made," said Harvey V. Fineberg, president of the National Academies' Institute of Medicine, who investigated the scandal for the federal government. "People had vivid memories of the 1918 flu epidemic, of young people dropping dead. It colored everything."
Production and field-testing of the vaccine was rushed. Among other problems, the single-shot doses that were produced did not work on children. Vaccine production was shut down by the time the error was caught, and it was too late to produce second doses.
"The first thing we learned is this must be done in a step-by-step fashion. There are points along the way that you need to build in where people can say yes or no" to allow for adjustments, said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases. "In 1976, it was like a choo-choo train."
The atmosphere was vastly different than it is today.
Congressional inquiries at the time and the report Fineberg co-authored, called "The Swine Flu Affair: Decision-Making on a Slippery Disease," found that the process was fast-tracked largely by David J. Sencer, then director of the CDC, who lost his job over the debacle. Fineberg's report described Sencer as a "wily autocrat" who managed, with little evidence that a pandemic would ensue, to steamroll the president into announcing a national campaign.
Sencer had many defenders, and in an interview last week he stood by his decision, saying: "If there had been swine flu, we would have had deaths in the thousands. Given the state of knowledge of influenza at the time, I think we made the right decision."
Records show that Sencer wrote a March 18, 1976, memo -- signed by Assistant Secretary of Health, Education and Welfare Theodore Cooper -- that outlined four possible government responses. The memo recommended one of those responses, a mass inoculation campaign, emphasizing the political fallout if a pandemic struck. "A decision must be made now," the memo said.
The memo, a government official said during the later investigation, was "a gun to our head."
Within two weeks, Sencer had recruited Jonas Salk, acclaimed for his development of the first polio vaccine, who encouraged Ford in a private meeting to endorse Sencer's plan to immunize every American as soon as possible. Hours later, Ford announced the decision to the nation with Salk at his side.
Sencer wrote his memo just weeks after health officials had detected the swine flu strain at Fort Dix, an Army training post in New Jersey. It was largely contained there, and within months -- before the first shot was given -- it was thought by most medical officials to no longer be a pandemic threat.
"It didn't matter," said Richard P. Wenzel, chairman of internal medicine at Virginia Commonwealth University, who identified the strain in some of the first victims in 1976. "The die was cast. This was a different era."
The production of the vaccine was also fast-tracked. And when hundreds of Americans began developing Guillain-Barré syndrome, a neurological disorder that can cause paralysis, experts blamed the speedy development.
Federal health officials say they have been more deliberate in their decision-making this time around.
Robin Robinson, a director at the Department of Health and Human Services who oversees pandemic responses, said that even as officials take steps to develop a swine flu vaccine with sufficient doses for every "man, woman and child," those plans would be dialed back if the pandemic "fizzles out."
But watchdog groups fear a repeat, particularly because laws passed after the terrorist and anthrax attacks of 2001 allow for accelerated production and field tests of a vaccine in an emergency. On April 26, the Obama administration declared the spread of swine flu a public health emergency.
"We don't want them unnecessarily speeding up field tests," said Barbara Loe Fisher, president of the nonprofit National Vaccine Information Center, which frequently criticizes vaccine policy. "There are many reasons to be concerned if they take this path."
Food and Drug Administration spokeswoman Mary Long said it is too early to say whether a vaccine would be developed on an accelerated timetable, "but there is flexibility" to do so, given the public emergency declaration.
Even if the production were not accelerated, Wenzel and others said that decisions about vaccine production, distribution and risks need to be clearly spelled out to the public.
"Talk to Americans like you are sitting with them at the kitchen table," he said. "Disclose the risks."
Warren Cikins, an Alexandria resident who says his life was dramatically altered by the swine flu scare, gives the same advice.
Three weeks after receiving his shot 33 years ago, Cikins suffered his first in a series of autoimmune disorders, temporary blindness in his right eye, which lasted a year. That was followed by chronic back problems, along with colitis, he said.
Cikins, a former county supervisor, said he thinks that his ailments are related to the flu vaccine, although he was never able to prove that.
This time around, 78-year-old Cikins said, the government should disclose the risks of getting vaccinated balanced against those of getting the flu.
"I am angry," he said. "They knew a certain percentage of us would suffer serious repercussions, and they withheld this from us. They need to let people make an informed decision."
The federal government ultimately reached court settlements and paid more than $90 million to hundreds of victims who said the 1976 vaccine caused neurological problems. In its final reckoning, the government counted 25 deaths associated with the shots.
In the medical community, however, there is disagreement about the rate of adverse reactions. Wenzel said neurological disorders showed up at seven times the rate seen with regular flu vaccines.
But Michael Hattwick, a former CDC official who tracked and analyzed the reactions in 1976, said that one in every 100,000 people developed a neurological disorder, a rate that he thinks is similar to what would be seen with other vaccines if they were tracked as carefully.
The potential risks were disclosed in the fine print of a two-page consent form at the time, he said.
"There are a lot of unknowns, but I believe you'd find the same rate with any flu shot," Hattwick said. Still, he said, "people should be told."
Staff writer Ceci Connolly and staff researcher Madonna Lebling contributed to this report.