Some Lessons, and Concerns

Fear of a Swine Flu Epidemic in 1976 Offers Some Lessons, and Concerns, Today

By ANDREW POLLACK
Published: May 8, 2009

With fears of swine flu engulfing the nation in 1976, Janet Kinney got vaccinated to make sure she would be able to take care of her children. Instead, her children ended up taking care of her.

About a week after getting the swine flu shot, she recalled, “I was so weak I couldn’t push down the toaster button.” She spent a month in the hospital, paralyzed from the neck down, before gradually recovering.

With health authorities now gearing up for what could be a huge vaccination campaign against a new strain of swine flu, the experience of 1976 is raising a note of caution.

The feared swine flu epidemic of 1976 never materialized. And several hundred people, including Ms. Kinney, who is now 68 and lives in Gig Harbor, Wash., developed Guillain-Barré syndrome, a rare neurological condition that causes temporary muscle weakness or paralysis. More than 30 of those people died.

Many experts say they do not think a vaccine for the new flu strain, called H1N1, would raise a similar risk for Guillain-Barré. But answering that question is difficult because to this day, no one has figured out why the 1976 vaccine caused the disease, in which the body’s immune system mistakenly attacks the nerves.

Indeed, some researchers still question whether the vaccine did cause Guillain-Barré, particularly since flu vaccines in other years have been linked to little or no risk of the disease.

“It doesn’t make sense that one flu strain would cause Guillain-Barré syndrome where none of the others have,” said Dr. Paul A. Offit, a vaccine expert at Children’s Hospital of Philadelphia.

Still, many experts consider the matter settled. The Institute of Medicine of the National Academy of Sciences concluded after an extensive review in 2003 that the “evidence favored acceptance of a causal relationship” between the 1976 vaccine and the syndrome. It stopped short, however, of saying the evidence “established” a causal relationship.

“It’s really not all that controversial anymore,” said Dr. Lawrence B. Schonberger, who as a young epidemiologist at the Centers for Disease Control and Prevention in 1976 gathered the initial evidence that led to the vaccination program being halted that December. Dr. Schonberger, who is still with the agency, found that for people who got vaccinated, the rate of getting a diagnosis of Guillain-Barré in the next six weeks was more than seven times as high as for those who did not get the vaccine.

In all, the vaccination resulted in nearly one extra case of Guillain-Barré for every 100,000 people immunized, which would translate into roughly 450 cases for the 45 million people who got the shot.

Some critics challenged the findings, arguing that some diagnoses were mistaken and that vaccinated people were more likely to self-report having Guillain-Barré than others because it was in the news.

But some studies canvassed health records for all diagnosed cases and had the diagnoses confirmed by experts. One of the leading critics worked on his own study, which confirmed the magnitude of the increased risk.

The more intriguing question is how the vaccine triggered the syndrome. One hypothesis was that the vaccine, rushed into production, was contaminated with Campylobacter, a type of bacterium that does cause Guillain-Barré. The Institute of Medicine said this was unlikely but could not be totally excluded.

A more likely explanation is that something in the vaccine resembled something in the nerve cells. When the body’s immune system mounted an attack on that component of the vaccine, it also then attacked the lookalike in the nerves.

Irving Nachamkin, a professor of pathology and laboratory medicine at the University of Pennsylvania, examined some 1976 vaccine that had been saved by a scientist in Texas. In a paper published last year in The Journal of Infectious Diseases, he and colleagues reported that mice given the vaccine made antibodies that reacted with gangliosides, which are components of nerve cells. An antibody attack on gangliosides is part of the disease mechanism of Guillain-Barré.

But when Dr. Nachamkin tested two flu vaccines from other years which were not linked to the syndrome, the mice also made those antibodies. So the mystery remains about what was unique, if anything, about the 1976 vaccine.

In particular, the most important question now would be whether the unique factor was that it was a vaccine against a swine flu rather than a human flu. If so, that could raise concern about a vaccine for the new flu strain, which is made mostly of swine virus.

Dr. Nachamkin plays down such worries. “There’s no evidence to suggest it’s a swine-derived-virus problem,” he said.

Others say there are lessons to be learned even without solving the mystery. One is that any medicine or vaccine given to tens of millions of people is likely to have side effects, so surveillance systems need to be in place.

Another is that risks have to be weighed against benefits. Had there been a swine flu epidemic in 1976, the number of lives saved by a vaccine would have dwarfed the small number of cases of Guillain-Barré. But in 1976, the vaccine was given even though the epidemic did not materialize.

“The math is overwhelmingly in favor of vaccine if there’s an epidemic,” said Dr. Harvey V. Fineberg, the president of the Institute of Medicine and co-author of “The Epidemic That Never Was,” a book about the 1976 episode. “It’s in the absence of disease that this rare effect looms large.”

This time, officials say the decision to make the vaccine will be divorced from the decision to use it. The manufacturing decision is likely in the next couple of weeks and will probably be yes. But the decision on using the vaccine will probably not be made until the fall.

For her part, Ms. Kinney, who says the syndrome left her unable to run down stairs, said she would not take the vaccine if offered. “I’m just not willing to take that chance,” she said.

Would she even need to? One intriguing idea is that if the new flu strain is similar to the 1976 strain, people who got vaccinated then might, possibly, have some protection now.

The C.D.C. says it will eventually study that question. Peter Palese, a flu expert at Mount Sinai School of Medicine, said he doubted that would be the case because the two viruses appear quite different.

Still, if it were the case, the oft-maligned 1976 vaccination campaign might end up having done some good after all.

http://www.nytimes.com/2009/05/09/health/09vaccine.html?hp

Officials Are Urged to Heed Lessons of 1976 Flu Outbreak

By Kimberly Kindy
Washington Post Staff Writer
Saturday, May 9, 2009

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.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

I remember this only too well. I got a swine flu shot at the Newman Center on the Edinboro University Campus back in 1976 and got pretty sick for about 24 hours. I was 18 at the time. I went on a date that night and got sick after dinner and had to go home. No matter the guy was a jerk anyway. -Beth

COULD IT BE FACTORY FARM FLU?

COULD IT BE FACTORY FARM FLU?

F. William Engdahl, Global Research

- What are the symptoms of this purported Swine Flu? That's not at all clear according to virologists and public health experts. They say Swine Flu symptoms are relatively general and nonspecific. 'So many different things can cause these symptoms. it is a dilemma,' says one doctor interviewed by CNN. 'There is not a perfect test right now to let a doctor know that a person has the Swine Flu.' It has been noted that most individuals with Swine Flu had an early on set of fever. Also it was common to see dizziness, body aches and vomiting in addition to the common sneezing, headache and other cold symptoms. These are symptoms so general as to say nothing.

The US Government's Center for Disease Control in Atlanta states on its official website, 'Swine Influenza (swine flu) is a respiratory disease of pigs caused by type A influenza viruses that causes regular outbreaks in pigs. People do not normally get swine flu, but human infections can and do happen. Swine flu viruses have been reported to spread from person-to-person, but in the past, this transmission was limited and not sustained beyond three people.' Nonetheless they add, 'CDC has determined that this swine influenza A (H1N1) virus is contagious and is spreading from human to human. However, at this time, it is not known how easily the virus spreads between people.

How many media that have grabbed on the headline 'suspected case of Swine Flu' in recent days bother to double check with the local health authorities to ask some basic questions? For example, the number of confirmed cases of H1N1 and their location? The number of deaths confirmed to have resulted from H1N1? Dates of both? Number of suspected cases and of suspected deaths related to the Swine Flu disease?

According to Biosurveillance, itself part of Veratect, a US Pentagon and Government-linked epidemic reporting center, on April 6, 2009 local health officials declared a health alert due to a respiratory disease outbreak in La Gloria, Perote Municipality, Veracruz State, Mexico.

They reported, 'Sources characterized the event as a 'strange' outbreak of acute respiratory infection, which led to bronchial pneumonia in some pediatric cases. According to a local resident, symptoms included fever, severe cough, and large amounts of phlegm. Health officials recorded 400 cases that sought medical treatment in the last week in La Gloria, which has a population of 3,000; officials indicated that 60% of the town's population (approximately 1,800 cases) has been affected. No precise timeframe was provided, but sources reported that a local official had been seeking health assistance for the town since February.' What they later say is 'strange' is not the form of the illness but the time of year as most flu cases occur in Mexico in the period October to February. . .

Then, most revealingly, the aspect of the story which has been largely ignored by major media, they reported, 'Residents believed the outbreak had been caused by contamination from pig breeding farms located in the area. They believed that the farms, operated by Granjas Carroll, polluted the atmosphere and local water bodies, which in turn led to the disease outbreak. According to residents, the company denied responsibility for the outbreak and attributed the cases to "flu." However, a municipal health official stated that preliminary investigations indicated that the disease vector was a type of fly that reproduces in pig waste and that the outbreak was linked to the pig farms.'

Since the dawn of American 'agribusiness,' a project initiated with funding by the Rockefeller Foundation in the 1950's to turn farming into a pure profit maximization business, US pig or hog production has been transformed into a highly efficient, mass production industrialized enterprise from birth to slaughter. Pigs are caged in what are called factory farms, industrial concentrations which are run with the efficiency of a Dachau or Bergen-Belsen concentration camp. They are all conceived by artificial insemination and once born, are regularly injected with antibiotics, not because of illnesses which abound in the hyper-crowded growing pens, but in order to make them grow and add weight faster. Turn around time to slaughter is a profit factor of highest priority. The entire operation is vertically integrated from conception to slaughter to transport distribution to supermarket.

Granjas Carroll de Mexico (happens to be such a factory farm concentration facility for hogs. In 2008 they produced almost one million factory hogs, 950,000 according to their own statistics. GCM is a joint venture operation owned 50% by the world's largest pig producing industrial company, Smithfield Foods of Virginia. The pigs are grown in a tiny rural area of Mexico, a member of the North American Free Trade Agreement, and primarily trucked across the border to supermarkets in the USA, under the Smithfields' family of labels. Most American consumers have no idea where the meat was raised.

Now the story becomes interesting.

The Times of London interviewed the mother of 4-year-old Edgar Hernandez of La Gloria in Veracruz, the location of the giant Smithfield Foods hog production facility. Their local reporter notes, 'Edgar Hernández plays among the dogs and goats that roam through the streets, seemingly unaware that the swine flu he contracted a few weeks ago - the first known case - has almost brought his country to a standstill and put the rest of the world on alert. 'I feel great,' the five-year-old boy said. 'But I had a headache and a sore throat and a fever for a while. I had to lay down in bed.''

The reporters add, 'It was confirmed on Monday (April 27 2009-w.e.) that Edgar was the first known sufferer of swine flu, a revelation that has put La Gloria and its surrounding factory pig farms and 'manure lagoons' at the centre of a global race to find how this new and deadly strain of swine flu emerged.'

That's quite interesting. They speak of 'La Gloria and its surrounding factory pig farms and 'manure lagoons.'' Presumably the manure lagoons around the LaGloria factory pig farm of Smithfield Foods are the waste dumping place for the feces and urine waste from at least 950,000 pigs a year that pass through the facility. The Smithfield's Mexico joint venture, Norson, states that alone they slaughter 2,300 pigs daily. That's a lot. It gives an idea of the volumes of pig waste involved in the concentration facility at La Gloria.

Significantly, according to the Times reporters, 'residents of La Gloria have been complaining since March that the odor from Granjas Carroll's pig waste was causing severe respiratory infections. They held a demonstration this month at which they carried signs of pigs crossed with an X and marked with the word peligro (danger).' There have been calls to exhume the bodies of the children who died of pneumonia so that they could be tested. The state legislature of Veracruz has demanded that Smithfield's Granjas Carroll release documents about its waste-handling practices. Smithfield Foods reportedly declined to comment on the request, saying that it would 'not respond to rumours.'
http://www.globalresearch.ca/index.php?context=va&aid=13408