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"Protecting the health and informed consent rights of children since 1982."

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www.washingtonpost.com

How to Prepare for Smallpox

By Ruth J. Katz

Saturday, June 1, 2002; Page A19

The popular television program "ER" ended its season with a cliffhanger: a quarantine imposed after two desperately ill children were brought to the emergency room with an infectious disease eerily reminiscent of smallpox.

Life sometimes parallels art, and federal public health experts are right now considering how best to prepare the nation for just such a scenario. This is strictly emergency planning: The risk of a deliberate release of smallpox is considered low, and top health officials in the Bush administration have explicitly said that this has not changed since Sept. 11.

Questions about who should receive the smallpox vaccination and when are complex. Immunizing the entire population with the vaccine we have now is likely to carry a high price -- thousands of serious complications and hundreds of deaths. But vaccinating only those who would be on the front lines of an epidemic, primarily health care workers, is hazardous too. Careful guidelines have to be followed to prevent people who have been vaccinated from infecting those who have not been. The "ring strategy," which calls for isolating those who have been infected in an attack and vaccinating anyone who has been in contact with them, has not been tested in decades.

Other factors must be weighed as well. There are no FDA-approved smallpox vaccines; existing products are all considered "investigational" and will likely remain so for the foreseeable future. The government has contracted for a newer vaccine that may be safer, but it will not be ready for use for some time. More research is needed to determine how much the current vaccine can be diluted and still remain effective.

There is strong public demand for the vaccine but no consensus on whether access should be given to anyone who wants it. Implementing a sound policy is further complicated by misperceptions, with many physicians and lay people believing that smallpox is almost always fatal (it actually kills about 30 percent of its victims) and that the vaccine is as safe as most childhood vaccines (it may be the most dangerous one available).

The multiple dimensions of the issue, and the stakes involved, argue for thoughtful decision-making. The advisory committees studying the smallpox vaccine had expected to complete their expert review in the fall of this year. Between now and then, an ambitious schedule of regional meetings had been established so we could hear from professional medical organizations and groups representing patient populations, health care workers, public health officials, emergency response workers and the public. Now the Bush administration is asking for an abbreviated process leading to recommendations by the middle of this month.

As we expedite our work, we must be vigilant about doing it right. Whether or not it is true, the public is likely to interpret efforts to broaden access to the smallpox vaccine as sign of an increased threat. The federal government will achieve the greatest compliance with its recommendations, and evoke the least anxiety, if most people are confident that action rests on a solid foundation of knowledge.

We need to understand the science better and to know whether state and local governments are prepared to respond. Equally important, we need to educate the stakeholders about all the potential risks and benefits. Unless the American people believe that we have used an inclusive process to gather the facts and weigh them judiciously, the credibility of the entire public health system may be undermined.

The swine flu fiasco of the late 1970s illustrates what can go wrong. No one doubts that President Gerald Ford acted with the greatest concern for the citizenry. Nonetheless, his decision to try to inoculate all Americans against a potentially lethal strain of flu in just nine months backfired in a way that damaged public confidence. Concern about side effects forced the mass vaccination program to be suspended soon after it began. The much-feared virus never materialized, and the government response looked, at best, uninformed.

The official response to the recent anthrax scare was equally unimpressive. No one seemed in charge, and no one spoke to the public authoritatively about what was and was not known concerning the danger. The result was widespread fear and an erosion of faith that can only weaken future capacity to address the genuine threat of bioterrorism appropriately.

The Bush administration is now pushing hard on the smallpox vaccine, and it may well have valid reasons for doing so. But public health, not politics or public relations, needs to be the driver here. If the administration is only seeking to show that it is "tough on smallpox" and prepared for anything in the struggle against terrorism, health experts, elected officials and the American public should protest the hijacking of a carefully formulated policymaking process. Planning for a smallpox epidemic is not an event being staged for television.

The eradication of smallpox worldwide ranks as one of the great triumphs of public health. If there is a chance of its return, we need to combat it with the same wisdom and determination used to vanquish it in the first place. But in the absence of a clear and present danger, we can surely take the time to exercise care and to be thoughtful.

The writer, associate dean at Yale University School of Medicine, is a member of the National Vaccine Advisory Committee. These views are her own.

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