TWO MONTHS after a 19-year-old recruit died at Ft. Dix, N.J., with the swine flu, President Ford sat in the Cabinet Room of the White House with some of the world's leading virologists.
On Ford's right was Jonas Salk, the man who developed the first vaccine against polio. At Ford's left sat Albert Sabin, who devised the first polio vaccine people could swallow. The Secretary of Health, Education and Welfare was there, the head of the American Medical Association was there, the head of the American Academy of Pediatrics was there and they heard expert after expert recommend that the nation vaccinate 140 million Americans against the swine flu.
"Is there anyone here who disagrees?" Ford asked, peering up and down the table where 26 people sat in erect and attentive silence.
Nobody disagreed. Sabin said the country might think about stockpiling a vaccine but made no recommendation to do so. Salk said the best place to stockpile vaccine was in peoples' arms. The University of Michigan's Dr. Morton Hilbert warned that an epidemic could strike 20 million people before a stockpiled vaccine was in anybody's arm.
With that, Ford turned to HEW Secretary David Mathews and Assistant Secretary Theodore Cooper and said: "Go ahead and make the vaccine." In less than three weeks Ford signed a bill appropriating $135 million to vaccine 140 million people against the risk of a swine flu epidemic last fall.
The epidemic didn't come, still hasn't come and may never come. In its place came Guillain-Barre syndrome, a paralysis of the head, face and limbs named for the two French doctors who identified it 60 years ago. By the time HEW's Ted Cooper called a halt to swine flu vaccinations last months, 12 Americans vaccinated against swine flu were dead of Guillain-Barre and more than 250 paralyzed. The incidence of the disease among the vaccinated was seven times what it was in the unvaccinated.
The Guillain-Barre outbreak left the United States with 63 million doese of unused swine flu vaccine and 90 million people unvaccinated against any kind of flu, which marked the third straight time the nation had set out to vaccinate itself against a flu epidemic without doing so. 110,000 Dead
THE FIRST vaccination failure came in 1957, when an attempt was made to immunize the country against a new virus called Asian flu. Twenty million out of 200 million were vaccinated. The same experience repeated itself in 1968 with the Hong Kong flu, except that the country acted even less concerned and fewer than 20 million were vaccinated.
Both the Asian and Hong Kong flus triggered epidemics in the United States, making 130 million ill, costing the economy as much as $10 billion and killing 110,000 Americans. The Public Health Service still blames one-third of those deaths on its own decision to leave vaccination to clinics and private doctors without any federal money and coordination to help it along.
Pledging never again to leave mass flu vaccination to private whim, the Public Health Service undertook swine flu immunization as a national goal.
This is why so much public fuss and money was raised to make and test a vaccine. This is why White House meetings and congressional hearings were held to debate the best way to make the best vaccine. This is why President Ford was publicly pictured in the Oval Office being vaccinated.
In hindsight, the swine flu program was more than just the third straight failure of a flu immunization in the United States. Why dictate mass protection against an epidemic that still hasn't broken out? Why such a rush to get the vaccine into production and into peoples' arms? Why didn't doctors recognize that vaccination held a risk of paralysis and death from a syndrome that itself bad been recognized for 60 years?
The answers may be long in coming but in groping for them it might be useful to step back one year when swine flu broke out at Ft. Dix training camp.
The swine flu virus is one of two dozen peculiar to animals. There is a chicken flu virus, a turkey flu virus, a quail flu virus and a horse flu virus. There is even a flu virus borne by bears.
None but the swine flu virus has ever been carried by one human to another and, until Ft. Dix, the only time the swine flu virus was passed on by humans was in 1918 and 1919. The virus is believed to have been locked up in pigs ever since, with only a rare passage from pigs to farmhands and veterinarians. Never had the farmhands and vets passed it to other humans.
But in 1918 a pandemic started that almost surely involved human-to-human passage of swine flu. Not since the Plague had there been such terror identified with disease. No country was spared. As many as 500,000 died in the United States alone. Worldwide, the death toll was 20 million.
Birth rates declined all over the world as flu-stricken women died of heart failure and pneumonia in their last three months of pregnancy. Fully 40 per cent of the pregnant women admited to hospitals in Chicago and Philadelphia in the three peaks of the pandemic died of pneumonia brought on by the flu.
Against this background, swine flu broke out a year ago at Ft. Dix for the first time in more than 50 years. Then and now, the best available evidence is not that a handful of men were sick at Ft. Dix but that at least 300 and as many as 500 were stricken with swine flu. The evidence lies with the recruits who developed swine flu antibody long after the mini-epidemic had swept the camp.
One of the first recruits sick with swine flu died; but he died at the end of a forced night march. Virologists were unmoved by the one death. What moved them was that at least 300 men had come down in one place at one time with swine flu, unmistakably through man-to-man transmission. Swapping Genes
FOR MORE THAN 40 years, virologists have watched the swine flu virus in hogs. They've noticed that the virus itself has changed little the last 40 years but that starting in 1968 swine started to pick up human flu viruses.
At least three of the 16 recoginzed human flu viruses have shown up in hogs the last eight years. They are among the most potent: Hong Kong, Port Chalmers and Victoria - named for the locales where they were first identified. Hong Kong and Victoria caused human epidemics.
Almost all viruses change over time through mutation, but virologists believe they can also change through a hybrid process where animal and human viruses swap genes. Theoretically, enough of these swaps can occur to produce an animal virus that begins to look like a human virus. And vice versa.
This could mean that an animal virus changes to where it so resembles a human virus that it would be invited in by a human host. The trouble is the human host would possess no antibodies to ward off infection by the animal virus.
It is for this reason that virologists keep close track of viral change in birds, horses and pigs. They never know when their flu viruses might alter form to infect man.
"It wasn't because one recruit at Ford Dix died with swine flu that people got psyched up," said Dr. Harry Meyer, director of the National Institutes of Health's Bureau of Biologics. "It was because you never in the last 50 years saw an animal virus jump into man and infect as many as 500 people, which you know historically must have been the way it happened in 1918."
Meyer's remark raises an interesting scientific question, one that has been raised before by a handful of virologists. Nobody is 100 per cent certain that the virus that contaminated the world in 1918 was the swine flu because nobody had the ability to isolate and identify a virus in 1918.
It wasn't until 1931 that virology was able to isolate and identify the swine virus by taking it from that year's pig population. The connection with the outbreak of 1918 was made by comparing the swine virus of 1931 with the antibodies still in the blood of the pandemic's survivors.
Not all virologists came to trust the connection, even though the microscopic evidence heavily suported it. In 1964, three NIH virologists (Paul Brown, D. Carleton Gadjusek and J. Anthony Morris) went so far as to analyze blood drawn from the 200 residents of the remote Pacific island of Fais.
Faisians had missed the 1918 pandemic, but suffered a devastating blow of influenza in 1924. Brown, Gadjusek and Morris believed the 1924 cases in Fais were "trailers" of the same disease that shook the world six years before. The islanders had not suffered another attack of influenza since 1924, meaning their blood contained antibodies only to whatever virus hit Fais in 1924.
On analyzing the islander's blood, the three virologists concluded that the 1924 attack on Fais was not swine flu and that therefore the 1918 pandemic was not caused by swine flu. They published their findings in a 1969 paper still felt to be controversial.
"I can't ignore or discredit it but I never understood or accepted that paper," said Dr. Edward Kilbourne of New York's Mt. Sinal School of Medicine, who devised the first vaccine for use against swine flu. "All the other evidence we have is that swine flu caused the 1918 pandemic."
When the swine flu virus was isolated from the blood of a dozen sick recruits last year, it was taken to laboratories and injected into embryonic chicken eggs to see how it would grow. It did not grow well, which suggested different things to different virologists.
A few virologists (Tony Morris included) said this meant the virus had little potency, that if it was related to the flu virus that terrorized the world in 1918 it was a weak and distant relative. Hardly the kind of virus to scare up an epidemic.
"That's not true," said Dr. Walter Dowdle of Atlanta's Communicable Disease Center. "It's been difficult these last 20 years to get any viruses to grow in eggs and since some of these viruses have casued epidemics it indicates that viruses are changing their biologics, nothing else."
There have been other signs that the swine flu virus was a weak one, though admittedly the signs, too, were weak.
Only one of the sick recruits at Ft. Dix died and he died after suffering a fever through a forced march. None of the other sick recruits was even seriously ill.
A sergeant who marched with the dead recruit tried reviving him with mouth-to-mouth resuscitation.He didn't catch the virus. Samples of the virus were sent to Great Britain, where laws let doctors inject the virus into six volunteers. Two suffered an illness so mild it might have been a reaction to the injection. The other four were not sick at all.
The fact that the Ft. Dix virus did not grow well in eggs did not deter virologists from making a vaccine from it. Virologists have long learned how to recombine parts of a virus with parts of other viruses to produce a vaccine against the first virus, which is what they did with swine.
But when he used the recombinant method to make a swine flu vaccine, Mt. Sinai's Ed Kilbourne produced a vaccine that was missing the antibody to the enzyme neuraminidase. The absent antibody is the second line of defense against flu, the thing that keeps the flu virus from running wild once it strikes the host.
Testing began last April of 33 experimental swine flu vaccines the Public Health Service claims are the best ever made, with or without neuraminidase. Vaccine purity reached an all-time high in the swine vaccine. Doctors tested the vaccine for endotoxins, the bacteria contaminants that cause fevers in people being vaccinated. The Public Health Service said there were fewer endotoxins in the swine vaccine than in any other vaccine that had been made.
The first shots were given to the Bureau of Biologics' Harry Meyer, his wife and his assistant. Next came 200 doctors and researchers scattered throughout the National Institutes of Health. They got one of the strongest dosages in the tests and came down with enough fevers to have Meyer order the dosage be eliminated.
By the time testing ended last June, vaccine candidates were narrowed to six: those that produced the most antibodies in the blood and the fewest fevers.Fully 5,400 people in 17 states were given test vaccines, two-thirds of them adults and the rest children over 6.
Fewer than 5 per cent of those tested suffered fevers. No fevers ran more than 102 degrees and those for no more than one day. No convulsions in children were observed. No signs of any paralysis, palsy or neurological damage were seen anywhere in the test program. The First Crisis
TODAY, the Public Health Service insists it was never more careful in conducting tests of a new vaccine. When the National Multiple Sclerosis Society said it was concerned that the vaccine might damage the already damaged nerves of multiple sclerosis victims, NIH laid out the money for UCLA Medical School to run test vaccinations on 60 volunteers with the disease. Not one volunteer suffered so much as a twinge.
The first crisis came in the second week of October, three weeks after mass vaccinations had begun. People in some cities were lined up outside clinics and doctors' offices waiting to be vaccinated, fearful that an epidemic might break out. It was like that outside a Pittsburgh clinic, where three people in their 70s died hours after being vaccinated on the same morning.
Autopsies done that afternoon showed the victims died of heart attacks. All had hardened arteries and high blood pressure. All had waited anxiously on line for two hours. Allegheny County Coroner Cyril Wecht said they were victims of "poor public health." The Public Health Service called the deaths "unusual but not abnormal."
Vaccination went on until one day in December when the nation's top scientists visited the While House to discuss President Ford's last budget. At the lunch break, HEW's Ted Cooper told a White House aide that the Communicable Disease Center was receiving odd reports about paralysis outbreaks tied to vaccinations in Alabama. Cooper said the CDC suspected a bad batch of vaccine.
Just then the aide's phone rang. It was CDC Director David Sencer calling Cooper from Atlanta. People in at least three states outside Alabama were paralyzed after vaccination. There were at least two deaths. "What should we do? Should we recommend suspension?" Cooper asked. "I'm beginning to think there's no alternative," Sencer replied.
Cooper made one more phone call, with the help of the White House switchboard. He called Jonas Salk, who was at Orly Airport near Paris waiting for a plane to take him to India. Cooper told Salk what was happening. Salk suggested the vaccinations be stopped.
In days, the diagnosis was in. The paralysis victims had Guillain-Barre and the public learned of a new disease that was at least 60 years old. The cases multiplied in the weeks after that and twice the Public Health Service extended the ban on swine flu vaccinations. Caught Unaware
LOOKING BACK, the Public Health Service said it was caught unaware by the connection between vaccination and Guillain-Barre disease. A 20-year check of the medical literature showed just 11 cases out of more than 200 million vaccinations for diseases ranging from influenza to polio where the connection could be made. The Army had a record of 50 deaths from Guillian-Barre over the eight years ending in 1949, six of them in the weeks after vaccination. That was all.
A meeting was held last Tuesday at the Bureau of Biologics to discuss the present and future states of influenza vaccines, including swine flu. To hear at least two of the participants tell it, there was much heat and little light. The question of what kind of vaccine to make next year was left unanswered.
The immunity conferred on the 60 per cent (an estimate of any vaccine's effectiveness) of the 50 million Americans who were vaccinated last year is now wearing off. Immunity lasts anywhere from two to five months, no longer. If by some strange quirk of fate there is a swine flu outbreak before March, fewer than 10 million people who were vaccinated will have the antibody to ward it off.
Meanwhile, the country and the world seem to have escaped any epidemic of flu this year, which would be the first time in almost 10 years that has happened. The failure of the swine flu program bodes ill for next year, when influenzas of several kinds could easily rear their ugly heads.