Saturday, January 03, 2004

More on the Anthrax Vaccine

Sometimes bureaucracies act swiftly. In the wake of a December 23 order preliminarily enjoining the Army's administration of the anthrax vaccine to nonconsenting soldiers, the FDA required only one short week (and over the holidays, at that) to complete its approval of the vaccine for protection against inhalation anthrax. This has probably rescued President Bush from any necessity to issue a potentially embarrassing presidential waiver authorizing the vaccine's mandatory administration to unwilling armed services personnel, and has also cleared the way for the Department of Defense to place a $30 million order for more vaccine.

It is a little startling to observe the level of disgruntlement that the district court's preliminary injunction has meanwhile sparked. Even if one disagreed with the ruling on the legal merits (as would not seem effortless to do, as of the date of its issuance, when the FDA had yet to give explicit approval of the vaccine for protection against inhalation anthrax), one might conclude, in a philosophical spirit, that reasonable jurists could differ over how much solicitude to display for American soldiers forced to submit, over their objections, to a vaccine involving nontrivial risks and debatable efficacy. But in some quarters, medium to high dudgeon has instead broken out, with accuracy an occasional casualty. Even Ted Frank, a justly respected commentator who usually takes pains to get it right, has wandered into uncharacteristic misstatement, mistakenly alleging, in a post somewhat tendentiously captioned "Anthrax Vaccination Pseudoscience," that "trial lawyers" prevailed upon a federal judge to "ban" the vaccine's "use." (The judge merely enjoined the military's administration of the vaccine to unwilling recipients, expressly permitting its administration to soldiers giving their informed consent.)

The "trial lawyers" behind all of this, by the way, scarcely qualify as rabid members of the plaintiffs' posse, if their vitae on the web are any guide. Mark Zaid appears to be an occasional thorn in the government's side, but his practice seems to focus largely on public policy matters, like the military anthrax case, not suited to the generation of stratospheric fees. (We'll see if he writes and chastises us for saying that.) Meanwhile, John J. Michels, Jr., is an alumnus of the U.S. Air Force Academy, served a 14-year stint as an officer before entering the reserves, and is a partner at McGuire Woods -- scarcely a plaintiffs' bastion.

Putting aside all the politics and the rhetoric, what about the scientific merits? Critics of the injunction ruling seem uneasy shouldering the burden of proving the vaccine's safety and efficacy -- admitting the absence of controlled clinical studies measuring the vaccine's effectiveness against inhalation anthrax in humans, as they must, and relying in large part on anecdotal data and animal studies of the sort that toxic tort claimants are perennially slammed for invoking. The injunction's critics seem more comfortable attacking the vaccine's doubters for failing to prove its inefficacy -- a posture that more readily permits the critics their usual rhetorical devices, including the brandishing of epithets like "pseudoscience."

Well, it's not an easy matter, is it, bearing the burden of proof? But to whom should we really assign it, when medical interventions are administered against the subjects' will? Would it really be so outrageous, to be as finicky in this context as we are in others?

Ted Frank responds: "I've corrected the error in describing the injunction as a ban on the vaccine. [Ted Frank's revised post is available here. --ed.] The opinion is still wrong. It failed to grant Skidmore deference to the informal FDA opinion (even as it acknowledged that the evidence in favor of the injunction was complex and contradictory), and then performed a balancing of interests that gave no weight to the fact that we're at war. I think Smith makes a persuasive case that the judge's balancing of interests was poor."
Fed. R. Evid. 702: If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.