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COPYRIGHT 2003 A Thomson Healthcare Company
By implementing a national smallpox vaccination program on Dec. 13, 2002, (1) President George W. Bush launched the first vaccination campaign undertaken in the interest of national security rather than public health. (2) He also sparked public debate about a program that bears potential safety and risk implications for medical professionals, emergency personnel, and the public.
Under this program, the federal government initially will require immunization only of those individuals most likely to come under biological attack, such as military personnel and embassy personnel serving overseas. (3) Later, the government will administer vaccinations on a voluntary basis to medical professionals and emergency personnel. (4) The president also suggested in his address that smallpox vaccine soon will become available to all Americans who insist on immediate immunization. (5)
These developments carry tremendous legal implications. In the months to come, courts undoubtedly will struggle to define the circumstances under which the government may compel smallpox vaccination. At the same time, individuals excluded from the initial round of vaccinations likely will sue to demand protection. The chosen method of vaccine distribution already has generated controversy in both the medical and legal communities. (6) These issues will become even more compelling should a smallpox outbreak actually occur.
New Concerns About an Old Disease
Before it was eradicated, smallpox was a highly infectious and sometimes fatal viral infection. Characterized by fever and a rash that causes scarring and pitting, it has been mentioned frequently in recent years as a potential weapon of terrorism. (7)
Outbreaks of smallpox have occurred from time to time for more than 3000 years. (8) Prior to the 18th century, epidemics occurred so frequently that practically everyone in the world eventually contracted the disease. (9) Most of these outbreaks involved variola major, or "the speckled monster," as it was known in England. (10) By the end of the 19th century, however, a milder form of the disease, variola minor, had spread from South Africa to Florida, throughout the United States, into Latin America, and back across the Atlantic to Europe. (11)
The earliest attempt to combat smallpox consisted of a practice known as "variolation." By intentionally exposing healthy individuals to the pus or powdered scabs of minimally ill smallpox patients, Asian physicians in the 1600s discovered that they could create immunity without the serious effects of the naturally occurring illness. This practice later proved successful in slowing the spread of smallpox in Europe and the American colonies. (12)
The real breakthrough in smallpox prevention occurred nearly a century later, however, after rural farmers observed a link between exposure to a bovine illness and smallpox immunity. English physician Edward Jenner demonstrated in 1796 that the injection of a healthy individual with fluid extracted from the cowpox lesion on a milkmaid's hand created immunity against smallpox. From this experiment, the modern practice of vaccination arose. (13)
In 1967, the World Health Organization (WHO) launched a 10-year global smallpox vaccination campaign. The last infection from person-to-person contact occurred in Somalia in 1977, and WHO declared the disease eradicated three years later. (14) Vaccination of civilians promptly ceased everywhere, and by 1990, the United States had stopped vaccinating its military personnel, as well. (15)
Even as the process of vaccination was winding down, WHO warned that the continued storage of smallpox virus in research laboratories could lead to another epidemic. (16) An expert committee recommended in 1980 that laboratories destroy their variola stocks or transfer them to one of two "reference laboratories" located in Russia and the United States. (17) The WHO executive board later recommended the destruction of all smallpox samples, but concern that this would forever preclude additional smallpox research led to several extensions of the compliance deadline. The most recent deadline, which called for the elimination of all smallpox samples by the end of 2002, has been suspended indefinitely in response to the Sept. 11 terrorist attacks and recent anthrax incidents in the United States. Fearful that terrorists already have obtained the variola virus and smallpox soon might be employed as a bioweapon, WHO has decided that existing samples should be retained, at least temporarily, for use in developing more effective vaccines. (18)
Other reasons exist for the growing concern about the potential misuse of existing variola stocks. After defecting in 1992, a former deputy director of the Soviet Union's civilian bioweapons program, Ken Alibek, revealed that the Soviet government had produced smallpox virus in large quantities for use in bombs and intercontinental ballistic missiles, and that Russia has attempted to create more virulent and contagious strains of variola. (19) Even today, Russia maintains an industrial facility capable of producing tons of smallpox virus annually. (20) Dwindling financial support and security problems at Russian laboratories have raised concerns that some of this material might fall into the hands of terrorists. (21)
Equally troubling is a recent Central Intelligence Agency (CIA) assessment that four nations--Iraq, North Korea, Russia, and France--possess covert stocks of smallpox virus. (22) Only two facilities--the Centers for Disease Control and Prevention (CDC) in Atlanta, and the State Research Centre of Virology and Biotechnology in the Russian city of Koltsovo--have received authorization to maintain stocks of smallpox virus. (23) All other nations reported by 1983 that they no longer possessed such material. (24) Yet an official at the CIA's Weapons Intelligence, Nonproliferation, and Arms Control Center recently described the quality of information regarding these undisclosed variola stocks as ranging from "medium" to "very high." (25)
The same intelligence review also concluded that the man accused of masterminding the Sept. 11 attacks, Osama bin Laden, recently devoted money and personnel to the procurement of bioweapons, including smallpox. While a Bush administration intelligence official said that there was "no reason" to believe that bin Laden had succeeded in acquiring lethal pathogens, the attempt alone underscores the potential for bioterrorism in the future, as well as the urgent need to prepare defenses against it. (26)
The Disease and its Management
When it existed, smallpox had no specific treatment and was prevented effectively only through vaccination. (27)
The more severe and common form of the disease, variola major, produced a two- to three-day prodrome of fever, malaise, headache, and backache. (28) Severe abdominal pain and delirium sometimes accompanied these signs. (29) A milder form of the disease, variola minor, produced a lower fever, a less extensive rash, (30) and fewer constitutional symptoms. (31)
Smallpox derives from a Latin word for "spotted". Its name refers to the raised rash that served as the true hallmark of infection. This rash appeared first in maculopapular form, then progressed to papules, vesicles, pustules, and finally, by about the 14th day, to scab lesions. Smallpox rashes generally arose first on the oral mucosa, face, and forearms, before spreading to the trunk and legs. Lesions created by smallpox rashes have been described as feeling like "firm round objects embedded in the skin." As the scabs separated from the dermis, they left behind pitted scars. (32)
Beyond the skin, mucosa, and reticulum cell hyperplasia, other organs seldomly were affected. Secondary bacterial infection occurred...
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