Who Are the Guardians Guarding?

In the face of all the proclamations that the world has been forever changed by the catastrophic events of 11 September 2001, one would think that people would eventually moderate these gloomy assertions and that the dialogue would return to normal. So far that does not appear to be the case, and the discussion of bioethical issues has not been tempered by the passage of time. In view of all this, I will take the liberty of commenting on the article by David Resnik and Kenneth De Ville (2002) in the overheated fashion of the day. The Cassandra approach does not appear to threaten professional careers. One need recall only Francis Fukuyama and Paul Kennedy, who survived their dire predictions about the end of history and the decline of the United States.

What is striking in Resnik and De Ville's analysis of the governmental right to override the patent on ciprofloxacin is the sense that nothing fundamentally has changed in the world. The anthrax scare represented something quite novel. As far as I am aware, it was the first time that there was widespread fear in the United States of contracting an illness for which there was an identifiable, proven, and available treatment. Moreover, administration of this treatment did not merely ameliorate a disease but turned a grim prognosis into one in which nearly all patients survived unscathed. Thus, this situation was vastly different from all prior exposures to health hazards including

1. vague, nonspecific risk factors such as electromagnetic radiation from power lines;
2. less ominous disease-producing agents such as E. coli O157;
3. fatal agents such as HIV but that impacted only on discrete segments of the population;
4. exotic lethal organisms such as the Ebola virus, which have not penetrated the United States; or
5. serious health risks such as nuclear radiation, for which there are no remedies.

Besides the unique medical aspects of the anthrax scare, one cannot overlook the role of bioterrorism as an unprecedented and incomprehensible agent for the dissemination of disease. The method of creating the health problem was something for which past history was not a useful guide.

These aspects of the anthrax scare clearly impacted on the reaction of the people living in or employed in high-risk areas, the response of health profession, and the approach of the federal government to the crisis. In the absence of an identifiable source or culprit that could be isolated, quarantined, or treated, it was inevitable that people would do whatever they could to reduce their risk and seize whatever means at their disposal to protect themselves. A run on ciprofloxacin seems not only predictable but also justified in light of people's natural inclination for self-preservation. Certainly, a reasoned analysis would indicate that for the average person the risk of contracting anthrax was nil. But computer models have consistently demonstrated that in any bioterrorism attack the panic that ensues has its own independent adverse effect on the operation of the healthcare system and the dynamics of the response to the crisis (Demidov 2002). No number of public-service announcements will defuse this response to the perceived threat. Thus, the irrational response to situations like the anthrax scare is an unavoidable feature, a reaction that cannot be ignored or inactivated by legislative fiat. The best that can be done under the circumstance is to adopt policies and strategies that limit the damage caused by the at-risk population trying to achieve self-protection by unreasonable means.

In this light, what is one to make of a company's right to preserve a patent on a potential treatment for an illness spread by bioterrorism? Resnik and De Ville analyze the problem almost exclusively from the vantage point of the harmful effects of governmental override on future activities by the pharmaceutical company and the deleterious impact on the profits and the corporate financial return on investment in drug...