TCS Daily

Trial Lawyers vs. the Armed Forces

By Sydney Smith - January 2, 2004 12:00 AM

One of the greatest public health advances in the past century -- the conquest of infectious disease by immunizations -- is slowly but surely being undermined in this century thanks to the efforts of a few determined trial lawyers.

Litigation, and the fear it spawns, has touched just about every facet of vaccination programs. It has reduced the number of vaccine manufacturers over the past three decades - from twenty-five to four. It has touched childhood vaccines. It kept an FDA panel from approving an appropriate viral strain for this year's influenza vaccine. It helped stall the smallpox vaccination program. And now, it has moved the Department of Defense to halt their anthrax vaccination program. You know things are bad when even the armed forces are afraid of the trial lawyers.

The impetus behind the DoD's decision was a lawsuit brought by several service members who objected to the anthrax vaccination program for those who are deployed to high risk areas, such as the Middle East. Their attorney, Mark S. Zaid, says the anthrax vaccination program "ruins the lives of dedicated service members and their families." His stated goal is to terminate the program. Unable to prove that the vaccine has ruined any lives, he has instead argued that it's an investigational drug and thus can not be given to any serviceman without his consent. Mandated vaccinations against anthrax are therefore illegal. The judge agreed, accusing the Department of Defense of using our armed forces as "guinea pigs."

"Guinea pig," of course, implies that the vaccine is being given as part of an experiment, but nothing could be farther from the truth. The original guinea pigs in the anthrax vaccine story were goat hair mill workers from half a century ago. At that time, anthrax struck these workers at a rate of one to two percent per year. Most often it was cutaneous anthrax, but sometimes it was the more fatal inhalation anthrax. During the study, there were five cases of inhalation anthrax among mill workers -- four of whom died. All of the cases of inhalation anthrax were in unvaccinated workers. In a subsequent study, the vaccine was administered to 7,000 subjects to better assess side effects before it was finally approved in 1970. (For more on the vaccine's safety and efficacy, see this and this.)

The FDA approved the vaccine for "individuals who may come in contact with animal products that may be contaminated with Bacillus anthracis spores, and for individuals engaged in diagnostic or investigational activities which may bring them in contact with Bacillus anthracis spores. It is also recommended for persons at high risk, such as veterinarians and others handling potentially infected animals." The world being a much simpler place in 1970, the FDA failed to mention that it could also be useful for those who might face anthrax in a bioweapon. And thus, a loophole was born.

Mr. Zaid's argument is that the vaccine has not been specifically approved to prevent inhalation anthrax, and thus it's an investigational drug. However, the intent in developing the vaccine was to prevent inhalation anthrax, and it's ability to do so was specifically examined in the original studies. After the vaccine's approval, the incidence of anthrax dropped dramatically. After 1978, there was not one case of inhalation anthrax in the United States. Not, that is, until the autumn of 2001.

With such a dearth of naturally occurring disease, it's impossible to specifically test the vaccine's efficacy on people. At least, it's not possible to do that sort of testing ethically. It is, however, possible to test it in real guinea pigs, rabbits, and monkeys. And in those tests it's been effective.

We know that inhaled anthrax is deadly. We know that it's been developed as a bioweapon. We
have even had first hand experience with its use. And yet, just a little over two years after the anthrax attacks in the United States, one determined lawyer and a scientifically challenged judge, have managed to bully the Department of Defense into giving up an effective and safe defense against it. Our judicial system, arguably one of the greatest strengths of our nation, has effectively been turned into a fifth column in the war on terror. Who said irony is dead?

Sydney Smith is a family physician who has been in private practice since 1991. She is board certified by the American Board of Family Practice, and is a Fellow of the American Academy of Family Practice. She is the publisher of MedPundit.


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