JURIST Guest Columnist Ed Richards, Director of the Program in Law, Science, and Public Health at the Louisiana State University Law Center, says that President Bush's bird flu plan raises a number of legal issues even apart from the question of whether it's the right policy response to the threat of a flu pandemic…

Over the past two months, bird flu has gone from an obscure concern of epidemiologists to an international scare. The President has unveiled a multi-billion dollar plan to cope with bird flu. This plan has been criticized by some as too little, too late, and by others as a giveaway to the drug industry and a strategy to divert attention from his failures in the aftermath of Hurricane Katrina. There is some truth in all of these criticisms. Most of what follows focuses on the narrow legal issues raised by bird flu control measures, not the larger policy question of whether bird flu merits its current attention from politicians.

The President's Plan

The President's plan has five components: surveillance; vaccine development; stockpiling Tamiflu; immunization programs; and quarantine and other restrictions.

Surveillance

There is already a global flu surveillance system, including cooperating hospitals and health care institutions in the United States. Public health surveillance – reporting infected persons to the state, and investigating the source of the infection – raises personal privacy issues. The United States Supreme Court upheld public health reporting in Whalen v. Roe, 429 US 589 (1977), which dealt with mandatory reporting of narcotics prescriptions. Some physicians opposed disease reporting in the late 1800s and the early 1900s, but it was generally accepted until the 1980s, when civil libertarians mounted a public relations campaign to prevent reporting of HIV. While this opposition to HIV reporting affected some other reporting systems, flu surveillance has not been controversial in the United States. Surveillance has been controversial in China, where most flu strains originate, because it affects trade and travel. The Chinese experience with SARS – which showed that fear of disease can be more disruptive than the disease – has made them more receptive to participating in the global flu surveillance system.

Flu surveillance could become controversial if being reported would result in individual sanctions or inconvenience. This could range from being under house arrest (home quarantine) to being put in a quarantine facility. While this would be an acceptable use of the state's police power, it would be politically unpopular. Since physicians tend to not bother with disease reporting in general, reporting rates could be expected to fall if there was patient resistance.

Vaccine Development

The current system of producing vaccines is slow, but known to be safe. Slow is mostly a problem because of Congressional incompetence, not because of the flu cycle. Congress does not want to buy flu vaccine for the entire population on the long term contracts necessary to justify a major commitment by the drug industry. Worse, Congress only wants to buy a minimum amount of vaccine. In a good year, this means that supplies are tight and inevitable distribution bottlenecks result in shortages – there is a shortage of vaccine right now (Nov 2005), despite all the problems with vaccine shortages last year. In a bad year, like 2004, one of the producers will have problems that make its vaccine unavailable, leading to huge shortfalls because there is no backup vaccine available. Congress also forces vaccine makers to make one vaccine, guessing about the most likely strain to spread. If you guess wrong, as happened in 2004, the vaccine is less effective. It would be better to hedge our bets with multiple vaccines.

Rather than systematically reform the general flu vaccine system, which would have benefits every flu season, the current plan stresses the development and stockpiling of experimental vaccines based on the existing bird flu strain. Approving and use of this vaccine will require waiving the regulations on experimental drugs, as well as assuring manufacturers that they would be protected against any legal liability. This can be done through the BioShield Program authorized by Congress.

Tamiflu

Stockpiling Tamiflu is expensive and subject to real problems with distribution. It is also not a magic bullet. It can make an important difference in the course of flu for strains that are susceptible, and that would be essential if there were a large number of cases. There is no assurance, however, the eventual strain of bird flu will be susceptible, and the more Tamiflu in circulation, the greater the chance that it will be ineffective. The more the government focuses on Tamiflu, the more individuals stockpile the drug themselves and use it for every cold. It may also be the wrong choice – secondary infections with bacteria cause many of the deaths from flu, and stockpiling only anti-viral drugs does nothing to deal with potential shortages of antibiotics.

Immunization Programs

Many people will resist vaccination with an experimental vaccine, which raises the issue of mandatory vaccinations. Current federal policy does not include mandatory vaccinations, and, outside of some laboratory workers, there are no mandatory vaccination laws for adults. While it is expected that the United States Supreme Court would still uphold mandatory vaccination laws, most politicians are unwilling to support mandatory vaccinations. The United States Supreme Court complicated the traditional vaccination laws by limiting the use of religious exceptions – if states allow religious objections (which are not required by the Court), they must also allow exemptions based on other beliefs. Add in the experimental nature of the vaccine, and it is unlikely that Congress or the state and federal governments will pass mandatory vaccination laws, and that agencies will be reticent to order these through administrative orders or regulations.

Many other persons would demand vaccine, which is expected to be rationed based on the individual's risk of contracting bird flu, the risk of spreading it to others, and chance that the flu will kill them. There will be legal challenges to the rationing system, but these are unlikely to be successful because the courts will defer to agency. More likely will be work actions based on access to vaccine. For example, rationing plans often exclude risks to the worker's family, such as allow health care workers to be vaccinated, but not their families. Since this puts the families at risk, many health care workers may refuse to come to work unless their families are also protected.

Quarantine

Quarantine and other restrictions are the most troubling part of the plan. Quarantine and travel restrictions are useful to keep isolated outbreaks from spreading. SARS was such an outbreak. It appeared in a limited number of locations and there were clear links between the outbreaks. If a dangerous flu epidemic could be detected at its origin, probably in south China, it might be possible to contain it with quarantine while other control measures such as vaccines were ramped up. This is not the usual pattern with flu. In a pandemic the virus appears in many places at about the same time.

Quarantining large numbers of persons in U.S. cities would require extensive social support, such as providing food and medical care to the quarantined in
dividuals, and assuring that they are paid for lost time at work. There are no provisions for these social services in the federal plan, and no states or localities have the resources to provide them. This would reduce voluntary compliance with quarantine, raising the issue of enforcement. The federal government has no state rules of engagement for quarantine, and is unlikely to do so: what politician wants a guideline on when to shoot the soccer mom and her kids escaping in the minivan?

Conclusion

Focusing on one strain of flu out of the large universe of possible candidates for a killer pandemic is the wrong strategy. The focus should be on improving the response to the yearly epidemics. This will make us better prepared if a deadly strain emerges, and will save thousands of lives and billions in economic losses every year. There should be stable, long term funding for vaccine purchase, and it should include enough redundant vaccine to allow for manufacturing failures, bad guesses on the pandemic strain, and to avoid distribution bottlenecks.

The Congress and the President have ignored the problem of people who refuse to take the vaccine. Stopping an epidemic of flu requires a higher percentage of the population to be vaccinated for flu than we have ever achieved. This is because you have to start over each year because each flu outbreak is a slightly different strain. Even in health care, where unvaccinated workers are a threat to patients, there are no mandatory vaccination requirements and many health care workers refuse to be vaccinated. Before worrying about the logistics of massive quarantine, Congress and the President need to face the difficult political problem of individual vaccinations.

If concerns about bird flu are transformed into a rational approach to mitigating our yearly flu pandemics, they will serve a useful purpose. If they are used to justify massive spending on drugs and hypothetical vaccines, without addressing the fundamental issues of flu control, they will merely repeat the mistakes of the swine flu campaign and leave the public worse off in the long run.

Edward P. Richards is a professor of law at Louisiana State University Law Center and Director of the Program in Law, Science, and Public Health
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