The Cipro Patent and Bioterrorism

David Resnik and Kenneth De Ville (2002) propose five conditions that should be met before the government overrides a patent on a pharmaceutical agent:

1. the medication plays a key role in the government's response to a bona fide national medical emergency;
2. there are no alternative remedies;
3. negotiations made in good faith to obtain the medication or a license to produce the medication have failed;
4. the government compensates the company nonetheless; and
5. the action is limited in time or has a sunset clause.

Resnik and De Ville specifically refer to bioterrorism and the decision to not override the patent on ciprofloxacin when individuals became infected with anthrax after contact with contaminated letters.

As physicians specializing in infectious diseases, our comments will be restricted to the first two conditions, which require medical judgments. We agree with the other three conditions but will not discuss them, because they are business issues.

The first condition is that ciprofloxacin would play a key role in the government's response to a bona fide national medical emergency. This is a compound statement and must be broken down to:

A. Was there a bona fide national emergency?
B. Would ciprofloxacin play a key role?

If the answer to both A and B is yes, then the following implied but unstated question must be added:

C. Was an adequate supply of ciprofloxacin available?

As clearly articulated by Resnik and De Ville, at no time did the number of actual cases of anthrax or potentially exposed cases or the method of spread rise to the level of a national medical emergency. There have been previous instances of terrorism involving injection of lethal amounts of poison into capsules, and other similar episodes, that resulted in deaths. For example, in 1982 there were seven deaths from cyanide injected into capsules of Tylenol (New York Times 1982). While frightening, neither these episodes nor the anthrax cases rose to the level of a national emergency. The potential for a massive release of anthrax spores into a large population exists and has existed for many years, but in the recent episode there was never evidence suggesting massive exposure. Furthermore, as also pointed out by Resnik and De Ville, person-to-person spread of anthrax is not a problem. Since different infectious organisms possess variable levels of contagiousness and lethality, it is critical that infectious disease specialists and epidemiologists be closely involved in governmental decisions. As pointed out by Resnik and De Ville, a single case of smallpox imparts significantly greater risk (and under certain conditions might represent a national emergency) than many more cases of anthrax.

If the anthrax cases had risen to the level of a national emergency, ciprofloxacin would have played a key role only in the initial phase of prophylaxis. Once isolates were available to indicate that the strain was susceptible to tetracyclines or penicillin, ciprofloxacin would no longer be the only effective prophylactic and therapeutic agent. This information should have been available to the Centers for Disease Control very early in the outbreak.

There is no reason to believe that there were inadequate supplies of ciprofloxacin available to manage even a large exposure. In addition to supplies available in the United States, there are additional stocks that the pharmaceutical company could have rapidly made available in an emergency. At no time was there a shortage, even though many people bought ciprofloxacin following the attack on the World Trade Center of 11 September 2001, just to have on hand in case of a bioterrorism attack (Reuter's Medical News 2001). At that time (which was prior to the first recognized case of anthrax from bioterrorism), Bayer reported that there was no need to fear a supply shortage. This statement was repeated multiple times by Bayer over the ensuing month. Furthermore, public-health officials already had enough ciprofloxacin stockpiled to treat 2,000,000 people...