SMALLPOX MYSTERIES

When the Centers for Disease Control last November changed the deadline for states to have smallpox vaccination plans in place by 2004 to Dec. 9 of last year, giving states two weeks to assemble their strategies, it was fair to assume that a threat was imminent and the rush justified. But like much of the plan to protect Americans against biological attack, the new deadline came without enough specifics to know whether it was needed and how it should be met. Congress can help make this much easier.

The immediate problem faced by policy-makers is that they know neither the level of risk from smallpox attack nor the risk of administering the vaccine. They know there is some chance that people who receive the vaccine will get sick, some seriously sick and some tiny number could die. But the last study on the subject was reported in 1968 and the changing medical demographics – more people, for instance, with suppressed immune systems – demands that a new study be done. One will be, but it is not expected to arrive until a new vaccine is approved, sometime in mid-2004.

Meanwhile, states are expected to inoculate public health officials next month and hospital health care response teams in the spring. Maine expects between 50 and 100 of the former and perhaps 3,000 of the latter, but no one knows for sure yet because the programs are voluntary. The Maine caregivers and their colleagues nationwide will be inoculated with a live virus that has been frozen for 30 years; it should be safe. It is noteworthy that Grady Memorial Hospital in Atlanta, the CDC’s home town, has declined to participate. A major reason for this is that the liability issues for the hospital staffs are not yet settled. Workers’ comp won’t cover voluntary acts and the Homeland Security bill didn’t protect the hospitals from lawsuits if an employee is sick or injured (negative side effects can range from blisters to blindness to skin sloughing off and disease entering to death) and nor should it have without some other compensation fund.

One possibility suggested by several people, including Bureau of Health Director Dora Mills, would be to create a federal fund like the National Childhood Vaccine Injury Fund, a no-fault way to compensate those injured as a result of being given the vaccine. This is a useful suggestion, considering the number of risks involved and what these volunteers are being asked to do should the nation be attacked with biological weapons. It is also similar to an idea contained in a question Sen. Susan Collins recently asked the General Accounting Office in a letter requesting the GAO evaluate the smallpox program. Sen. Collins, chairman of the Government Affairs Committee with oversight over Homeland Security, properly has asked for an evaluation of risks from inoculation, how information about participants will be gathered, how liability will be managed and how public concerns will be addressed.

Funding is also at the center of a less dramatic issue – the process of educating and inoculating the hospital workers requires about eight hours for each person; in Maine, that may be 24,000 lost work hours. Hospitals can make that up, but they will do so through one of the few adequate sources they have – your health care coverage.

And there is a question that dollars cannot solve. Smallpox is one of five major biological weapons the CDC warns could be used against Americans. The other four are anthrax, pneumonic plague, botulism and tularemia, for which there aren’t available vaccines. The unanswered risk question that comes from this is, what are the chances that, should the United States successfully execute broad protections against smallpox, that terrorists would have the incentive to use another type of biological weapon and how does this affect the levels of risk in the smallpox program?

So many unknowns greatly increase the chance of bad policy coming from bad information. The GAO study should help, but Congress must find more answers to these many questions so states and hospitals can make better decisions.