WOULD A CORONAVIRUS VACCINE SIMPLY REPEAT THE 1976 SWINE FLU DISASTER?

Everyone believes we need a vaccine for the Coronavirus, right? That would solve everything. It’s just a question of how soon we can get it.

Well, maybe not. We’ve been here before, but few remember it, and those who do appear to have forgotten some obvious lessons.

Does anybody recall the infamous “swine flu” debacle of 1976, America’s bicentennial year?

The swine flu saga began when the federal government’s Center for Disease Control discovered the most recent incarnation of swine flu virus at Fort Dix, New Jersey, in early 1976. Prevailing theories suggested that the circumstances were ripe for a new pandemic.

In the previous  decade, it was estimated that as many as 240,000 Americans had died because they did not get a flu shot. Had 50 percent of the high risk population, particularly the elderly, been vaccinated properly with a serum that was 70 percent effective, 55,000 deaths might have been averted, officials said. Sound familiar to what’s going on today?

Regarding swine flu, one question remains to be asked — a century ago, in 1918, something extraordinary happened. Why? What accounts for the most devastating influenza epidemic history records? Epidemiologists have debated this for more than a hundred years.  Theories abound, but still nobody knows. Yes, this is “SCIENCE,” and these are the scientists, but they can’t agree.

In 1976, the federal government was accused of poor performance in getting vaccines to Americans in time for the flu outbreaks of 1957 and 1968, so this time the public health people wanted to be out front (Dr. Fauci, surely you agree!). Officials in the administration of Michigan’s Gerald R. Ford, an unelected president who was running for a full term that very year,  called a press conference and announced the possibility of a major recurrence. His chief of staff Donald Rumsfeld was sitting in the front row.

Ford & Co. referred to the swine flu epidemic of 1918-19, in which 20 million people had died worldwide. Privately, most of the administration’s health authorities thought the likelihood of an 1976 outbreak ranged from only 2-20 percent. Still, the head of the Center for Disease Control (CDC), David Sencer, wrote a memo to his superiors urging swift action. The drug manufacturers wouldn’t make the necessary efforts without a strong prod from the government. Sencer’s memo convinced everyone up the chain of command to Ford himself that drastic action was needed. After that, if Sencer’s recommendation was disregarded and then leaked, the political consequences would be grim.

So the program went forward. Insurance companies initially wouldn’t cover the drug manufacturers’ liability, but a special indemnification bill was extracted from Congress.  Mass immunizations didn’t start until October, but as the fall wore on the feared swine flu failed to spread as projected. In late November, the last blow came — physicians began reporting Guillain-Barre syndrome, a type of paralysis among the vaccinated. At least 535 contracted Guillain-Barre, and 23 of them died. Many others suffered different side effects.

The widow of a Grand Rapids, Michigan, shop foreman was awarded $285,000 in 1979 by the federal government in an out-of-court settlement. She sued after her 46-year-old husband, Robert Herbst, died in February, 1977, of Guillain-Barre, which attacks the nerve sheaths and causes paralysis. Robert got the shot on Pearl Harbor Day, 1976, when he was healthy and vigorous. He died exactly two months later. In 1980, a Virginia woman was awarded $325,789 in the first swine flu case involving a delayed reaction to the vaccine. As a result of the 1976 calamity, the federal government faced nearly 4,000 administrative claims and 1,391 lawsuits — seeking a total of $4.6 billion — arising from side effects of the vaccine. The feds wound up paying out hundreds of millions of taxpayers’ dollars.

The program was abruptly ended just after Ford lost the election, having inoculated an estimated 46 million people. It dragged $135 million out of Congress, sickened some of those vaccinated, and did not save anyone from the swine flu.

The verdict on the fiasco later written by two eminent Harvard professors stands out: For the swine flu doctors (think Fauci and Birx), health was an absolute value. Overestimating what had to be done to provide protection was merely inconvenient (think lock downs), while underestimating was morally noxious. The politicians who chose to contest the experts’ judgment could be vilified.

But what actually happened revealed that the experts’ attitude may not be that good a guide to public health decisions. The subsequent four decades haven’t necessarily permitted us to weigh the costs as well as the benefits of such attempts. True, public officials should not be blackmailed out of making these hard decisions, but fiascos like the swine flu inoculation program can’t be allowed to happen, either.

In 1977, Joseph Califano, newly-elected President Jimmy Carter’s first Secretary of Health, Education & Welfare (HEW), commissioned a report that reached some profound conclusions. Authored by Harvard Professor Richard Neustadt, who penned the seminal opus Presidential Power and had been a member of President John F. Kennedy’s brain trust, joined with his colleague, Harvey Fineberg, a medical doctor at Harvard’s School of Public Health, to write “The Swine Flu Affair — Decision-Making on a Slippery Disease.” Here’s what they found:

1. The influenza virus (like Coronavirus) has a “changing character, with spread and timing mortgaged to the processes of antigenic change about which there are painfully few documented observations. As for severity, the specialists are almost totally in the dark. Nothing is sure, not even why 1918 was the worst flu of all (by the way, “antigens” are surface proteins that camouflage the virus from the host’s antibodies).
2. “The effectiveness of influenza vaccine is relatively short-lived. Its effectiveness may be compromised by minor antigenic drifts in the virus, which are frequent. Moreover, most experts believe that, even in the absence of drift, effective protection lasts only for about a year.
3. “Influenza symptoms are widely misunderstood. Millions of Americans, and perhaps the doctors in the country, use the term for a variety of gastrointestinal troubles, such as “stomach flu,” which no flu virus causes, and no flu vaccine cures. Influenza is found in the respiratory tract, and there alone.
4. “Although it resides in the respiratory tract, it is by no means the only virus likely to be lurking there and may not be the major  source of flu-likes aches and fever. If not, then immunization against influenza (or Coronavirus), even assuming that the flu vaccine fits the strain and it actually immunizes, safeguards nobody from identical symptoms caused by other viruses.
5. “The multitude of causes of flu-like illness makes it difficult to estimate the year-to-year impact of the influenza virus on the public health. Especially in non-epidemic years, the proportion of flu-like illness actually caused by the flu virus is UNKNOWN. Without more evidence of swine flu’s spread than Sencer had in March, 1976, consider how these features mock his objectives … What a basis on which to build public consciousness and to seek support for preventative medicine! What a basis on which to risk the high repute of an establishment like CDC! What a basis, for that matter, on which to expose 46 million people to an unknown risk of side effects. And all this on the word of experts (today’s SCIENCE), overconfident in theories validated through but two or three pandemics, without any proper review of their logic by disinterested (objective) scientists. It is not that conclusions were inconsistent with evidence, but that the paucity of evidence belied the force with which conclusions were advanced.”

Neustadt and Fineberg asked that influenza’s features be contrasted with those of well-established Federal immunization targets like measles and polio, and smallpox in its day. For the established targets, causes, symptoms, treatments and risks are understood alike by doctors and laymen. Immunization “immunizes” (think Salk and Sabin in the 1950s); it prevents the symptoms for all time, or for several years at least. From decade to decade, there are no antigenic shifts. Compared to the “slippery” flu, these are stable targets indeed. Medical and public health professionals, Congressmen, administrators, parents, children, journalists and citizens at large all know what they are shooting at. (To be clear, “slippery” to Neustadt and Finberg means the virus is capricious, the disease elusive, and our remedies imperfect).

The two professors argued that the comparative aspect is critical. All diseases are slippery to some degree. All interventions risk, to some degree, the credibility of institutions. But to treat swine flu as though it were the polio of 20 years before was to beg for trouble. The two diseases had some tempting likenesses but in these key respects they were at opposite ends of the spectrum. When this country started on its campaign against polio after World War II it confronted a well-understood disease with methods that worked as advertised. Contrast the swine flu program of 1976. It oversold a method of ostensible protection from the paradigm of slippery diseases (Coronavirus, anyone?). The risk to credibility was rendered as extreme, as was the combination of its five slippery features.

Neustadt and Fineberg pointed out that, up to 1976, the Federal government had drawn a line, perhaps consciously, between stable and such slippery diseases. Swine flu represented the first Federally-sponsored and financed mass immunization at the slippery end of the spectrum. Diseases at the stable end had been elusive company. Its members shared an inferential basis of medical knowledge, public understanding and support, far beyond that now afforded flu (or Coronavirus). On the evidence of swine flu, it is tempting to propose a restoration of the former line, and consciously bar slippery diseases, flu included, from Federal immunization initiatives. The stress would be on research until they are rendered less slippery.

Can we be sure such research will be successful? Or is history about to repeat itself?

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