Free to Choose the Smallpox Vaccine

by J. Donald Millar

J. Donald Millar is vice chair and a distinguished fellow of the Public Health Policy Advisory Board, and is a former head of the Smallpox Eradication Program at the Centers for Disease Control and Prevention. This column is excerpted from a larger article appearing in the winter issue of Regulation, the Cato Institute Review of Business and Government.

As biohazard crews continue to test and decontaminate Capitol Hill offices plagued by anthrax spores, federal lawmakers are trying to wrap up legislation that would address U.S. preparedness for other future threats of bioterrorism. A pair of bills recently approved in the House and Senate would channel roughly $3 billion toward anti-bioterrorism efforts, including as much as half a billion dollars for the purchase of vaccine against one of the most frightening weapons: smallpox.

Despite that spending, the legislation proposed would not prevent a smallpox outbreak. Even after the federal government has stockpiled a huge inventory of smallpox vaccine, current guidelines still call for keeping it away from the public until there is a confirmed smallpox outbreak. This plan is a shortsighted recipe for unnecessary panic and no prevention. It's inconsistent with both public health principles and traditional American values.

The government should take a third way: make the smallpox vaccine available to the public on a voluntary basis. People will be free to choose to take it or not. That's what the government is now doing with an anthrax vaccine (although choice is limited at present to the people possibly exposed to the anthrax-laced letters).

The danger posed by smallpox is great (though, perhaps, not as great as indicated by the federal government's recent "Dark Winter" scenario). If terrorists were to unleash the variola major strain of the disease, which once racked the Indian subcontinent, 40 percent of the people who are infected would die. The numbers of the sick and dead from a smallpox attack would dwarf those from the recent tragic anthrax attack.

Fortunately, it does not appear as though the terrorists possess weaponized smallpox. But Congress clearly is worrying about that possibility. It is acting as though the smallpox threat is real and appears committed to spend large sums of money to counter it.

Two antiterrorism bills now under consideration on the Hill would allocate funding to purchase smallpox vaccine in 2002 and allow for more purchases in subsequent years. The purchases would add to the government's current stockpile of 15 million doses of the vaccine, and the 40 million doses currently in the pipeline from a federal Centers for Disease Control and Prevention (CDC)-recommended order in 2000. Health and Human Services Secretary Tommy Thompson has vowed that there will be a vaccine dose set aside for "every man, woman, and child."

Put special emphasis on the "set aside" part of that vow, because neither the legislation nor Bush administration guidelines would not make the vaccine available to the public until there is a confirmed smallpox outbreak. Why would the federal government - as the sole owner of a highly effective smallpox preventative measure - sit on its stockpile until a number of Americans actually become victims?

The stated reason for withholding the vaccine is that it has potential side effects if widely administered, especially for persons with HIV/AIDS. According to Surgeon General Dr. David Satcher, "You're always hesitant to immunize people against the disease unless there is going to be a risk."

That philosophy stands in remarkable contrast to the traditional "ounce of prevention" public health credo. Consider the statement made several years ago by former CDC director David J. Sencer, who headed the agency when it spearheaded the World Health Organization's global smallpox eradication program: "Stockpiling antibodies in the body is preferable to stockpiling vaccines on warehouse shelves."

To be sure, the danger posed from side effects is to be taken seriously. But, for those people not infected with HIV/AIDS, the vaccine's risks are both known and negligible. Instead of prohibiting the distribution of the disease until smallpox is unleashed on America, would it not be better for the federal government to inform the public of the risks and benefits offered by the vaccine, and then allow each individual to decide whether or not to avail himself of its protection?

This is a classic case for informed consent, decentralized decision-making, and individual weighing of the tradeoff between the small risk of an attack and the small risk of terrible side-effects from vaccination. Moreover, if enough people voluntarily choose to get vaccinated, terrorists might well judge that such an attack isn't worth their while. Even the alternative "wait-and-see" approach would be easier to implement if significant numbers of people were already vaccinated voluntarily.

The idea that the government would withhold the only effective means of protecting the population from a terrible disease until an epidemic is confirmed is new to public heath. Prevention, in this new concept, obviously has no meaning for the "sentinel" Americans who will become ill and die of smallpox as trigger for the government's response. That is not good public health, and is certainly not good protection from bioterrorism.

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