The Coming Plague (30 page)

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Authors: Laurie Garrett

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After laying out four different plans of suggested action, the Sencer memo suggested mass vaccination, sponsored by the federal government, conducted by local authorities and supported publicly at the highest possible level.
Within two weeks the snowball was roaring down an Alpine slope, gathering size as most sectors of the federal government, from congressional aides to the White House Office of Management and Budget, signed on.
March 24 found an extraordinary group of scientists gathered in the White House at President Ford's request. Edwin Kilbourne, polio vaccine inventors Jonas Salk and Albert Sabin, and a host of CDC and other federal researchers were asked point-blank by Ford, “Do you agree that the nation is facing a Swine Flu epidemic, and mass vaccination is necessary?”
There were no voices of dissent in that room.
That night, President Ford went on national television in a press conference that found him flanked by the icons of immunization, Sabin and Salk.
“I have just concluded a meeting on a subject of vast importance to all Americans,” the President said. “I have been advised that there is a very real possibility that unless we take counteractions, there could be an epidemic of this dangerous disease next fall and winter here in the United States … . Accordingly, I am asking the Congress to appropriate $135 million, prior to the April recess, for the production of sufficient vaccine to inoculate every man, woman, and child in the United States.”
Congress had no choice but to support the President. The politicians were nearly unanimous in their shared apprehension about being responsible for massive numbers of influenza deaths should they balk. Former Senator Edward Kennedy staffer Arthur Silverstein said there “was an almost unseemly race” on Capitol Hill to approve the President's $135 million vaccination appropriations request. Senator Kennedy said, “There is nothing more frightening to a society than an epidemic,” throwing his liberal weight behind the Republican President's request.
Only two members of Congress were sharply vocal in their criticism of the program. California Democrat Representative Henry Waxman and his New Jersey colleague Andrew Maguire denounced the program as a “rip-off”
that was guaranteed to generate profits for vaccine manufacturers. Consumer advocate Ralph Nader accused the government's health establishment of crying wolf, wasting taxpayer dollars.
Recognizing Ford's position, some members of Congress decided to exploit the President's absolute support of the flu campaign by attaching a long list of liberal riders to the immunization bill, adding $1.8 billion worth of social service spending and environmental protection funds to a bill they knew Ford could not possibly veto.
Meanwhile, when Osborn saw President Ford's press conference on television, she was outraged. Forced to work by telephone from Madison, Wisconsin, rather than in direct conference in Washington because her twin daughters were just seven years old, Osborn couldn't believe that the sober, cautious approach that all her colleagues had tried to follow was suddenly shoved aside.
“Everybody knows Salk and Sabin detest one another, and that they're the two most famous vaccinologists in the world,” Osborn told fellow FDA advisers she reached that night by phone. “Neither of them has been involved in this in any way. Putting them together with the President like that spells disaster.”
Years later, Osborn and Sencer would both argue that Ford's March 24 press conference marked the turning point, bringing healthy skepticism to an end and putting politicians in the Swine Flu driver's seat.
As support built in Washington, the pharmaceutical manufacturers played their trump card, telling Ford directly that their insurance carriers would not indemnify such hastily produced vaccines. Unless the government absorbed liability for all possible ill effects from the vaccines, drug companies could not possibly cooperate in the $135 million effort. Well before Congress approved, and the President signed Public Law 94–266 allocating funds for the flu campaign, word was out that the real price tag might exceed by millions of dollars the requested sum. Some liberal members of the House of Representatives accused the pharmaceutical industry of trying to pull off a major scam, milking taxpayers for hundreds of millions of dollars and refusing to accept any responsibility for vaccine product quality.
But on April 15, 1976, PL 94–266 was signed by President Ford in a televised ceremony. As he placed his signature on the bill, Ford dropped all pretense of doubt or conjecture, saying the Fort Dix virus
“was
the cause of a pandemic in 1918 and 1919 that resulted in over half a million deaths in the United States.”
Though dissent and controversy would increase in political and scientific circles over subsequent months, a seemingly intransigent White House and public health establishment would speak with ever-greater certainty about the likelihood of a catastrophe, and all semblance of theorizing and guesswork would disappear from official pronouncements. Anger built during the late spring in response to pharmaceutical manufacturers' insistence that no vaccine could or would be produced before the federal government agreed
to absorb full liability. Some politicians accused the industry of casting off all vestiges of public responsibility, while corporate representatives reminded members of Congress that they were working in a tough, highly competitive free market in which profit making (or, at the very least, breaking even) was essential to survival.
With a good deal more dissent than was engendered by the PL 94–266 enactment, Congress would eventually pass a law that officially waived corporate liability for Swine Flu vaccines, placing all legal culpability squarely on the shoulders of the U.S. taxpayers. It would be signed on August 12 and designated the National Swine Flu Immunization Program of 1976 (Public Law 94–380), scheduled to go into effect October 1, the same day the CDC planned to kick off the national flu vaccination program.
The nation would then be irrevocably committed.
It might not have made that leap from April's bill to the August open-ended liability price tag had it not been for a unique and entirely unexpected set of events in July. Throughout the spring and early summer of 1976, opposition to the very concept of a mass epidemic was building in both scientific and political circles.
Several leading physicians, notably consumer advocate Sidney Wolfe, vocally protested the government's dire forecasts of a million dead Americans, noting that the CDC had projected those numbers from a base of 500,000 dead in 1918–19, multiplied by the increase in the U.S. population size since that time, and factoring for other changes, such as air travel and urbanization, which were thought to speed the spread of airborne microbes. The dissident doctors attacked the projection, noting that medical science had advanced considerably in its ability to diagnose and treat influenza, and it was highly unlikely that even a super-virulent strain could kill 21 million people worldwide in 1976. After all, they said, most influenza deaths were usually produced not by the virus but secondarily by bacterial infections that took advantage of the weakened immune defenses of influenza-infected lungs. Bacterial pneumonia was easily treated in 1976 with a number of readily available antibiotics. Though the CDC insisted (and still would nearly twenty years later) that the 1918–19 virus killed massive numbers of people directly, without secondary bacterial infections, many vocal physicians maintained that some, perhaps most, of the lung hemorrhages and fatal heart attacks reported in 1918 might be treatable in intensive-care units in 1976.
There was also increasing skepticism about the basic assumption that the Fort Dix strain was equivalent to the deadly 1918–19 Swine Flu. There was no evidence of mass spread, and Fort Dix medical officer Bartley told
Science
magazine's Philip Boffey that Private Lewis might well have lived if he hadn't gone on the long winter march. Some Army physicians quietly told their civilian colleagues that it was possible even the dreaded virulence of the 1918–19 strain was more an environmental than genetic issue. Rather than ascribing the rampant spread and quick die-offs to some unique
characteristics of the virus, these researchers discreetly insisted it was World War I trench warfare conditions, horrendous overcrowding in military encampments, and the movement of hundreds of thousands of troops in jam-packed ships, submarines, and train cars all over the world that spread the disease.
Dr. E. Russell Alexander, chair of the University of Washington's School of Public Health, was a dissident member of the CDC's flu advisory committee. From the beginning he had advised that the government hold off on a mass immunization campaign and instead stockpile vaccines for possible use should an epidemic appear. As months rolled by without additional cases, Alexander's position drew support from many circles.
If the CDC was facing obstacles due to controversies in the United States, its ability to win over public health counterparts in other countries was firmly blocked by strong scientific skepticism. Though the World Health Organization lent official support to a global Swine Flu campaign in a special meeting convened in Geneva April 7–8, the backing was lukewarm, and fell short of recommending widespread vaccination. Instead, WHO suggested that national health ministries worldwide be on the alert for unusual flu outbreaks, consider adding Swine Flu vaccines to the list of immunizations offered to elderly citizens of richer nations, and stockpile supplies of vaccine once it was available. It seemed Russell Alexander's position was garnering support outside the United States, with the exception of Canada, where the CDC's arguments held sway.
On July 3 the prestigious British medical journal
The Lancet
published three articles critical of the American campaign. In the first, physicians from England's Harvard Hospital in Salisbury compared the A/New Jersey flu strain with two other varieties found in American pigs and a strain then common in England. Six human volunteers were injected with viral samples. The researchers concluded that the Fort Dix virus was “evidently intermediate in its virulence for man between a human virus and a swine virus … . The conclusion, therefore, was that in its present form, A/NJ/8/76 was less virulent in man than an established human influenza-A virus, but a good deal more infectious and virulent than two swine pathogens … tested previously.”
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In an accompanying essay, University of Sheffield Medical School professor Charles Stuart-Harris argued it was “a time for a continual reappraisal of all possibilities rather than for a change of tactics.” It simply wasn't time for a mass immunization campaign, he said, though it might be wise to stockpile vaccine just in case.
As had been stated previously by dissident American colleagues, Stuart-Harris insisted it was unwise to compare the 1918 pandemic to any 1976 possibility. The current virus simply wasn't as virulent, he said, and nowhere were human conditions as severe as those seen in the battlefields of World War I.
28
Finally, the publishers of England's leading medical journal dismissed
the dangers of the Fort Dix strain specifically, but not generally of influenza, and ominously concluded that “the whole exercise will be valuable practice for doing it when a really new influenza A does finally appear.”
29
Throughout May, June, and early July, the arguments in U.S. government circles centered not on whether or not to vaccinate but on how best to accomplish the task of making 200 million doses—for Americans alone—and mobilize local health authorities and the public before the fall. On June 22, despite serious difficulties, both the CDC and FDA vaccine advisory committees voted to proceed with the Swine Flu campaign.
“We have no choice,” Osborn told her colleagues.
But the vaccine trials hadn't gone at all well, and Albert Sabin did a 180-degree turnaround, becoming a vocal opponent of the campaign. None of the products seemed to work at all in children; the vaccines performed so poorly in young adults that even some campaign proponents openly worried that an acceptable formulation might not be found before the fall; nobody was sure how much flu antigen, or human antibody, was necessary to protect against a super-virulent virus, and one company, Parke-Davis, made 2 million doses of vaccine against the wrong flu strain.
30
Meanwhile, the Pharmaceutical Manufacturers Association continued its pressure on Congress and the White House, saying that no vaccine would be made unless something could be done about the liability issue. Two bills were stalled in Congress (HR105050 and S3785) that aimed in different ways to clear vaccine manufacturers of liability by shifting the burden to the federal government.
Debate on the matter was feverish both on the editorial pages of America's leading newspapers and in the halls of Congress, and pharmaceutical industry lobbyists were clearly concerned that their liability protection would be defeated.
Until August 2, 1976.
On that day, newspapers across America carried the headline news that several men had succumbed as a result of sudden severe respiratory ailments contracted, apparently, following attendance at an American Legion convention in Philadelphia during the week of July 21–24.
Few groups in the United States took patriotism as seriously as the American Legion, and in the country's bicentennial year it was more than appropriate that an organization dominated by World War II veterans should convene in Philadelphia, the cradle of the country's Declaration of Independence and Constitution. For four days in July several hundred members of the Pennsylvania Legionnaires division held meetings, sat at banquets, danced, and sipped cocktails in four Philadelphia hotels.
Liquor flowed most freely in the hospitality suites of thirteen candidates
for Legionnaire offices. Scattered throughout the luxurious old Bellevue-Stratford Hotel, these suites were sites of energetic handshaking and free cocktails.
On the second night of the meeting, two of the Legionnaires fell ill with symptoms that included fevers, muscle aches, and pneumonia. Because they were older men, the first cases raised no alarms.
31
Within a week, however, the Pennsylvania Department of Health was flooded with reports of acute pneumonia illnesses and deaths among people who had been inside Philadelphia hotels during the latter half of July. The count would eventually reach 182 cases (78 percent males); 29 deaths. Some 82 percent of the cases, when final numbers were tallied, would turn out to be American Legionnaires.
On August 2, with about 150 cases and 20 deaths then reported, the Pennsylvania health authorities issued a statement that was instantly frontpage news worldwide. Given the media moniker “Legionnaires' Disease,” the mysterious Philadelphia epidemic caused an intense escalation in Swine Flu fears.
Word hit Congress and the White House like a jolt of electricity, shocking the argumentative politicians into action. Various bills that sought to break the long deadlock on vaccine liability were hastily approved by House and Senate subcommittees and rapidly made their ways toward the floor for full legislative debate and possible approval. Fearing that the dreaded Swine Flu epidemic had arrived, the country's political leaders acted with atypical speed.
By August 5, when Sencer testified before the Senate's Health Subcommittee, the stage was set for almost immediate approval of liability-waiving legislation.
Proud of the rapid and thorough investigation responses of his CDC staff, Sencer could barely contain himself. His office had first learned of the Legionnaires' outbreak on Monday, and by Tuesday, CDC staff were able to positively rule out influenza as the cause of the mysterious deaths. Of course, they didn't know what
was
the cause of the Philadelphia ailments. Sencer was delighted to sit before Congress on Thursday, just four days after the outbreak was reported, able to allay the public's fears that the dreaded Swine Flu had finally arrived.
But Congress, far from applauding the news, grit its teeth and immediately reverted to its prior argumentative stance. Within minutes, all hope of rapid passage of a vaccine liability law was lost.
The following night, President Ford lashed out, saying he was “very dumbfounded” by Congress's actions. He came right out and told the Capitol Hill politicians that they would personally bear responsibility for millions of American deaths should a Swine Flu epidemic materialize.
Congress caved in.
Six days later, President Ford signed the National Swine Flu Immunization Program of 1976 (Public Law 94–380). The die was cast.
Within the bill's tediously argued language lay the seeds of the Swine Flu vaccine program's destruction. Though the politicians, the pharmaceutical industry, and insurance companies generally felt that the bill masterfully eliminated all remaining stumbling blocks to mass immunization, it actually created dangerous new obstacles. As would be seen in years to come, the public health problems created by Public Law 94–380 resonated perilously not only throughout the 1976–77 flu season but in all future new American vaccine campaigns. In a very real sense, the Swine Flu vaccine campaign of 1976 would eventually work to the advantage of the planet's microbes. The bill stated:
 
The United States shall be liable with respect to claims submitted after September 30, 1976, for personal injury or death arising out of the administration of swine flu vaccine under the swine flu program and based upon the act or omission of a program participant in the same manner and to the same extent as the United States would be liable in any other action brought against it.
32
 
The bill guaranteed that the U.S. government would respond financially to claims of damages associated with Swine Flu vaccination; put the legal defense job in the hands of the Attorney General; prohibited pharmaceutical companies from making “any reasonable profit” off Swine Flu vaccines; and ordered all individual immunizations to be accompanied by a signed informed consent form that “fully explained” the risks and benefits of the product. To mollify vaccine producers who did not take kindly to being ordered to forgo Swine Flu profits, the bill allowed “reasonable profit” for A/Victoria flu vaccines—“reasonable” was never defined. In the end, worried that Congress might later attach some arbitrary level of profit as unreasonable, the pharmaceutical companies donated A/Victoria and bivalent (A/Victoria plus A/New Jersey) vaccines to the federal government.
All of this was precedent-setting in the United States. Though vaccination campaigns, from point of purchase to distribution, were entirely government-operated in most of the world, they were a rarity in the United States. Typically, Americans were vaccinated by a personal physician, school nurse, or public health clinic nurse. The federal government's role was usually limited to identifying what types of vaccines were needed (through the CDC) and regulating their purity and safe manufacturing (through the Food and Drug Administration).
But now the U.S. government was up to its neck in the vaccine business, and the Pharmaceutical Manufacturers Association sat back comfortably, awaiting its instructions, its fifty-some members freed of liability concerns.
Though the CDC laboratory had before August 5 successfully ruled out Swine Flu as a cause of the Legionnaires' deaths, by the time the influenza vaccine liability law had been signed by President Ford it was obvious to the lab boys that solving the Legionnaires' puzzle was going to be terribly difficult. Though they worked around the clock, using every obvious scientific
trick they knew to tease out the culprit, it remained utterly elusive.
Joe McDade and Charles “Shep” Shepherd were stumped.
By August 31, their labs had scanned hundreds of tissue samples at the subcellular level of magnification with electron microscopes. They had used fluorescent antibodies against over a dozen different microbes to see if any of the patients were infected with the agents, including chlamydia, rickettsia, typhoid, pertussis, tularemia, plague, coccidioidomycosis, histoplasmosis, Marburg, Lassa, influenza, and choriomeningitis. They searched for fifteen different types of yeast and two types of mycoplasma. The team had also tried isolating viruses by infecting chicken eggs, monkey cells, human cells, guinea pigs, and mice with blood samples from the patients.
Microbiologist McDade and physician-scientist Shepherd conducted standard tests on blood tissue samples aimed at finding out what sort of microbe was responsible. They dumped various antibiotics in cultures, but got no consistent effects. They had used standard stains for visualizing bacteria under microscopes and saw nothing.
So they switched tactics. They put blood samples in test tubes with antibodies against all sorts of different microbes, and looked for the clumping reactions that meant a positive reaction had occurred. With this method, they had already tested for over twenty-six different microbes by the end of August, including various influenzas, Q fever, mumps, measles, adenoviruses, and a host of extremely rare diseases.
They tried another tactic.
Lung, liver, and kidney samples from the deceased Legionnaires were subjected to radioactive assays for heavy-metal poisoning (by such things as mercury, arsenic, thallium, nickel, cobalt—a total of twenty-three potentially toxic metals). And in hopes of finding a pesticide or other toxic chemical product, the team had already done 300 gas chromatography and mass spectral analyses by August 31. If any of these tests had found a contaminant, huge spikes would have appeared on the graph paper that spewed from the analytical machines. There were no unusual spikes.
33
This really annoyed McDade, who had been with the CDC just one year but had ten years' experience in microbiology detective work under his belt. Meticulous in both his work and his personal style, McDade routinely took every imaginable precaution against contamination or error in the lab. The bespectacled, blue-eyed scientist liked everything around him to be neat, trim, and predictable.
In his detective work, McDade spoke of the “algorithm of the investigation,” assigning each clue to its “dot position in the matrix.” Depending on which clues first fell into place, the algorithm would move across the matrix in a certain direction. Normally, the careful scientist had a set of clear epidemiological dots to assign to the matrix before he even received blood or tissue samples to study in his laboratory. And it usually wasn't long before McDade discovered several more matrix dots in the lab and the algorithm quickly flowed to completion.
But this Legionnaires' Disease paradox wasn't yielding any useful clues for the matrix. The epidemiologists couldn't figure out how, whatever the culprit was, people got sick. They couldn't even narrow the clues enough to tell whether the killer was a chemical or a microbe.
And absolutely nothing was working in the laboratory.
The CDC lab boys then began to realize the enormity of their task.
“Something is lurking in those hundreds of tissue and blood samples amassing in the CDC refrigerators,” Shep told Sencer, “but it isn't possible to narrow the search down by broad categories. We can't tell at this point whether we should be looking for a virus, bacterium, fungus, parasite, toxic chemical, or whatever. We need more information from the field.”
Sencer deployed two large teams of CDC investigations to Philadelphia. One concentrated on the Philadelphia hotels, the other studied the surviving patients and their families.
Fresh out of his residency training in clinical medicine and just four months away from his extraordinary journey to Yambuku to assist in the Ebola investigation, Dr. David Heymann was part of the Legionnaires' investigation. Lean, dark-eyed, and shy, he would look back on 1976 years later, expressing astonishment at his “unbelievable” experiences. The twelve months from August 1976 to the summer of 1977 would find the twenty-something Heymann in the eye of microbial storms in Philadelphia, Yambuku, and Cameroon.
When he left Atlanta for Philadelphia in August 1977, however, the junior EIS officer had no inkling of what was to come. Nor was he prepared for the public panic in Philadelphia, the extraordinary complexity of the Legionnaires' mystery, or the personal safety concerns that would ebb and flow discreetly through the CDC team.
Panic does not always go hand in hand with epidemics, nor does its scale correlate with the genuine gravity of the situation. Indeed, history demonstrates that population responses to disease are rarely predictable, often peculiar, and always key features of frustration for disease detectives who must sift through public accounts to find clues to the origin and cause of the epidemic. Where a hefty dose of public concern was warranted, as in the case of the 1918–19 pandemic, an oddly common feature was nonchalance. The usually vigorous New York press, for example, reported virtually no flu news that year until the week of November, by which time some 20,000 residents of the city had already died, victims of influenza.
34
Similarly, the specter of a latter-day global epidemic provoked little more than a shrug from most Europeans and North Americans. A Gallup poll in September 1976 revealed that while 93 percent of the adult population of the United States knew what Swine Flu was and were aware that an apparent strain of the disease had stricken Fort Dix, fewer than 53 percent said they were willing to be vaccinated. The abstract possibility of a million American flu deaths seems to have caused no collective or individual panic in the United States, except, perhaps, in some corners of government.
In contrast, public reaction to the twenty-nine deaths in Philadelphia was extraordinary. Heymann, completely uninitiated in matters of public relations and the media, found himself working in a massive fishbowl, every move made by CDC team members under the constant, often hostile, scrutiny of the nation's citizenry. The perlustration was compounded by widespread fear of contagion in Philadelphia.
Phrases like “explosive outbreak,” “mysterious and terrifying disease,” “Legionnaire killer,” and “killer pneumonia” filled press accounts, as well as the on-camera statements of Philadelphians and politicians.
35
Because American Legion members were stricken, and the nation had been polarized during its war with Vietnam, some members of the highly conservative organization insisted the deaths and ailments were tied to an unidentified left-wing sabotage. From the perspective of the left, events in Philadelphia fit neatly with the then vogue view that an unregulated chemical industry was raining toxic compounds upon the American people.

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