Flu Flop

IT IS TOO SOON to forget the swine flu program, or to pass it off as just one more Jerry Ford WIN campaign. It is too soon because the program is not quite dead; government officials now talk about a revival. It is too soon because in the program's failure lie disturbing consequences and important lessons. And it is too soon because so few members of the medical establishment seem to have learned those lessons.

Last week Robert H. Ebert, dean of the Medical School, and five other distinguished doctors wrote to The New York Times to explain how splendid the swine flu immunization program had been. Not ones to indulge in the luxury of hind-sight, the doctors defended the ill-fated campaign, writing that "faced with the situation at that time, we would have been forced to the same conclusion." Probably true, but nothing to boast about.

Doctors never like to admit that doctors may be wrong. But in the case of the swine flu program reluctance, especially on the part of government officials, to admit to mistakes has approached a level reminiscent of the methods of the Vietnam War policy makers. As in the Vietnam days, there has been an unwillingness to listen to outside opinions; a pattern of decisionmaking by a small group; an intolerance of dissenting views, both within and outside the government; and an inability to reevaluate policy as circumstances changed. Although the swine flu fiasco at times seemed laughable, amateurish, the reasons for its failure are serious, and bode ill for future endeavors.

Scientists in the Public Health Service persuaded Congress--and tried to persuade the public--that an influenza epidemic as devastating as that of 1918 was likely to occur this winter. The scientists also claimed that in six months they could produce a safe and effective vaccine to protect against this new strain of influenza.

The facts, available ten months ago as now, were otherwise:

The chances of a swine flu epidemic in 1976-1977 were always extremely small. One recruit in New Jersey died of swine flu, and the disease never reappeared. As the months passed, the chance of an epidemic went from unlikely to nearly impossible. When no one south of the Equator succumbed during the summer--the Southern Hemisphere's flu season--and when after eight months the New Jersey recruit remained the only victim, government officials should have admitted that their epidemic was not likely to occur and should have revised their policy accordingly.

New strains of flu reach America about once every ten years; since no one can predict what a new virus will look like, flu immunization is a chancy business. (Since the virus changes so frequently, flu immunization is also a profitable business for a few drug companies.) Officials at the Center for Disease Control in Atlanta were correct in assuming that this year, or next, or the one after a new strain of influenza would appear, but they were wrong in believing they could finally prevent a flu epidemic. The odds of predicting correctly what new strain will appear are small; when it arrives, in other words, the new strain probably will not be swine flu, but something entirely different.

A new influenza strain would pose no grave danger to healthy children or adults. Strains of flu cause more illness in their first year--and the illness they cause is more debilitating--than afterwards. To the elderly and to those with chronic illnesses, the prospect is frightening. To everyone else, the prospect is merely unpleasant. Moreover, the analogies to 1918 were misleading, since in that year's epidemic most deaths were caused by bacterial infections secondary to flu that now can be combatted with antibiotics.

There was [and remains] a substantial chance that the vaccine would not work. The flu vaccine is one of the least successful viral vaccines; even its champions usually estimate no more than 70 per cent effectiveness rate, and that figure is based largely on tests in the Army, where subjects may not be certified ill until they collapse on the parade ground. In general, the level of vaccine knowledge is low; when one vaccine works better than another, no one is quite sure why. This ignorance was exacerbated in last summer's rush program since researchers could not be sure that the virus they were working with was identical to the one that would strike.

It is not surprising, then, that researchers never found a vaccine that worked well in children; that in the 18 to 25-year-old range, two shots were needed for protection; and that every single vaccine was manufactured without neuraminidase, a protective enzyme that most scientists consider an important element of a vaccine's protection mechanism. Even today drug manufacturers do not understand where they went wrong; they don't know, for example, how the neuraminidase got left out of the recipe. And even now, no one knows whether the vaccine would do any good at all in protecting against a real epidemic.

There was no way to be sure the vaccine would be safe. Vaccines are dangerous. Just as no one can predict how they will work, so no one can be sure they will cause no harm. To meet the fall deadline, manufacturers rushed through the required process of testing first in animals, then in small groups of humans, and finally in larger groups. There was no time to study long-term effects; the government recommended the vaccine to pregnant women, for instance, after less than nine months of testing. Parke-Davis manufactured and had to discard over 1.5 million defective doses of vaccine; Americans were lucky that the program led to nothing more serious than several hundred cases of Guillain-Barre syndrome.

The government was justified in offering swine flu vaccine to the elderly and the chronically ill, and the manufacture of enough vaccine for all Americans may also have made sense. But the vaccine should not have been administered to healthy citizens unless it proved necessary--unless swine flu reappeared. Since even the most violent epidemic takes some weeks to spread, and since the government's surveillance system would have provided an almost instant warning, a stockpile policy would have offered adequate protection without subjecting anyone to unnecessary risk.

MANY CYNICAL Americans viewed the swine flu program as a Presidential election-year ploy. It may have been that, but the politics of the program ran far deeper. The Federal health establishment, even those advisers with no stake in a Republican victory, supported the program enthusiastically.

There are only about 20 well-known flu vaccine experts in the United States. They know each other well, serve on committees together and tend to view vaccine policy from the same perspective. They believe in the flu vaccine and they do not emphasize the harm vaccines can cause, either to subjects of clinical trials or to patients later on.

The two agencies that set vaccine policy in the United States, the Bureau of Biologics at the Food and Drug Administration and the Center for Disease Control, tend to rely repeatedly on the same few experts for advice. For example, the Bureau's semi-independent advisory board is chaired by Saul Krugman, who gained notoriety (unfairly, some researchers believe) for infecting retarded children with hepatitis in order to study their condition, and many other members of the board have also experimented in state schools for the retarded. The board is not likely, then, to rigidly enforce ethical standards against other researchers who do likewise.

This small group of men supported the swine flu decision, and, having committed themselves to it, did not waver. A few state officials dissented, but the vaccine establishment controls substantial amounts of public health funds; the establishment's decision will never be proved wrong--there might have been an epidemic--and it would have been politically foolish to argue. So few public health officials insisted that consumer representatives have a major voice in the decisionmaking. No one objected when the four drug companies that would profit from the program played such a major role in its planning.

WHEN ONE lonely bureaucrat threatened to disrupt the vaccine establishment's unanimity, the bureaucracy acted quickly to discredit him.

In the early 1970s, J. Anthony Morris, a respected vaccine researcher working at the National Institute of Health (NIH), began questioning the safety of some vaccines and the effectiveness of others, especially of flu vaccines. His superiors at NIH responded by taking away his support staff and laboratory space, killing his animals and cutting off his supplies. Eventually, Morris was left with nothing but a small office and a telephone.

Morris found an attorney (James Turner, a consumer lawyer and former Nader employee), initiated a grievance proceeding and publicized his case. His accusations led to a General Accounting Office investigation and to Senate hearings, which in turn led to a major shakeup in the vaccine regulatory agency. The Bureau of Biologics was revamped and transferred from NIH to the FDA, and in 1972 a grievance panel reinstated Morris and censured the agency for harassing him.

Soon, however, Morris again began to make his superiors uncomfortable. He asked whether slow-acting viruses in seemingly safe vaccines might cause serious illness decades after inoculation. He suggested that one now influenza vaccine might cause tumors, and charged that a major cell strain in which polio vaccine is grown was contaminated.

But Morris did not get into serious trouble until he attacked the swine flu program, charging that it would probably not work and might be very dangerous. Morris's boss asked a panel of vaccine experts--many of whom Morris had frequently criticized--to evaluate Morris's performance as a scientist. The panel concluded that most of Morris's experiments were "either not relevant...or...poorly designed and implemented."

While Morris's boss wanted him fired for "insubordination" and "inefficiency," an independent hearing examiner ruled that Morris's infractions were minor, and that the scientist should be suspended for at most five days. But Alexander M. Schmidt, then Commissioner of the FDA, overruled the examiner, and on July 16, 1976, J. Anthony Morris was fired.

The vaccine establishment treated other critics with similar, if more reserved arrogance. One state official, who asked not to be named, said he was given the impression that any open criticism of federal policy might result in less vaccine being shipped to his state. And when English and French authorities questioned America's panicky reaction, the U.S. vaccine establishment called their caution a case of sour grapes, claiming that if England has a vaccine-producing technology as advanced as America's it would have followed our lead--an ironic boast, given the production errors and delays that plagued the American program.

THE SWINE FLU fiasco has seriously affected immunization programs for other diseases. This year reported measles cases have been 64 per cent higher than in 1975, and next year the statistic undoubtedly will increase. The diversion of resources to the flu program, and the bad publicity justifiably associated with it, are at least partly to blame.

Immunization levels for measles, diphtheria, rubella and--most frightening--polio, have been falling for several years. In 1964 78.6 per cent of all children aged one to four had been vaccinated against polio, but by 1975 that figure had fallen to 63 per cent; many experts cite 80 per cent as the minimum level needed to prevent outbreaks. In Boston, a 1975 study showed that levels were lowest in the poor, black areas of Roxbury and North Dorchester, where in two schools surveyed the immunization level had fallen to 15 per cent. In inner cities and rural slums throughout the country, a 1940s-style outbreak of polio is not inconceivable.

If such an outbreak occurred, the swine flu program--and its government and industry apologists--would have to shoulder much of the blame. A planned initiative to boost immunization levels was set aside this year, as funds, personnel and attention were diverted to the swine flu program. In addition, many people have justifiably grown more skeptical of the wisdom of the vaccine establishment. If this skepticism leads them to shun all vaccines, the swine flu disaster will have been far more tragic than laughable.CrimsonLaura J. LevineSwine flu Shots: Bogus or Legitimate?