Sam Uretsky

Ignorance of the Law is Current Policy

Ignorantia juris non excusat. Ignorance of the law is no excuse. The premise of that famous legal theory is that people who engage in an activity have a responsibility to learn what the laws are, and don't have a right to use ignorance of the law as a defense.

If you drive, you're supposed to know what a STOP sign means, and if you hunt, you're supposed to know where to point your shotgun. But there's also the implicit assumption that the law is available to be learned, that the government won't make things up on the fly and then hold people accountable. That would be ex post facto, a law that criminalizes conduct that was legal at the time the act was performed, and it's a violation of the Constitution.

But the Constitution, according to George W. Bush, is "just a [expurgative deleted] piece of paper." (Some of the sources for that quote have since said that they only heard it second-hand, but it does seem to conform to the spirit of the Bush administration. In time, the quote will rank alongside Cornelius Vanderbilt's "What do I care about law? Ain't I got the power?")

The administration has learned the power of enforcing regulations without offering guidelines or rules. This has reportedly been a problem for documentary filmmaker Ken Burns, who has been working on a film about soldiers in World War II. Since it's well known that there are no atheists in foxholes, the soldiers notoriously invoked the Creator, but their heartfelt prayers for divine intervention may have to be obscured as offensive under the Federal Communications Commission.

More recently, broadcast news organizations have been dealing with the question of whether it's appropriate to show clips of the Commander-in-Chief using language that he apparently learned in the Texas Air National Guard.

According to the FCC Consumer Facts, "Enforcement actions in this area are based on documented complaints received from the public about obscene, indecent or profane material."

Instead of having a clear set of rules, broadcast stations are subject to the whim of the public and the delicate feelings of FCC staffers. The penalty for a bad guess is a fine of $325,000 for each occurrence. The result has been a policy of self-censorship that denies reality -- even, or perhaps especially, in news and documentary broadcasts.

The FCC isn't the only agency enforcing rules without guidelines. In 2004, the Drug Enforcement Administration, working with a group of pain management physicians, posted a series of guidelines for treatment of pain. This was important, since physicians who treat chronic pain are necessarily wary of being accused of over-prescribing narcotics. Clear treatment guidelines, coupled with good clinical documentation that the guidelines were followed, would have been a legal protection for physicians. This would have allowed more aggressive treatment of pain, and the alleviation of needless suffering.

But the guidelines were posted on the DEA Web site in August 2004 and removed in October. Physicians who practice pain management are faced with their own form of self-censorship -- under-treating pain for fear of the DEA inspectors.

The most recent report of enforcement without warning comes from the Food & Drug Administration. On July 22, the New York Times reported that Dr. Peter Gleason, a Maryland psychiatrist, had been arrested for promoting a drug for purposes other than those approved by the federal government. He had been appearing at conventions and seminars, advocating the use of sodium oxybate (Xyrem from Jazz Pharmaceuticals) for treatment of depression and pain. Sodium oxybate is a gamma hydroxybutyrate (GHB), a known drug of abuse, and is approved only for treatment of narcolepsy.

While pharmaceutical manufacturers are only allowed to promote drugs for approved uses, they have been allowed to have independent professionals speak about their own experiences with the drugs, and prescribers are allowed to use the drugs for outside of approved uses. Insurance companies may not pay for drugs used for unapproved indications, but the prescriptions are legal all the same.

Dr. Gleason admitted that he had received $100,000 for speaking about his experiences with sodium oxybate, but the practice of discussing non-FDA-approved uses is common and has been accepted by the FDA. Under the Reagan administration, when the rules were changed to permit prescribing for unlabeled uses, the FDA issued a statement saying that the regulatory offices often can't keep up with changes in practice. Granted, $100,000 is a lot, but there were never any rules or guidelines setting a dollar figure. Dr. Gleason and Jazz Pharmaceuticals may have abused the system, but there's a difference between a loophole and a violation.

It's simple, really. By not telling how the rules are going to be enforced, the administration can count on television stations, physicians and anybody else to err on the side of caution. With a climate of fear, self-censorship becomes a powerful tool, whether it's used to limit the distribution of pain-reliving drugs or the distribution of ideas.

Anyway, the prohibition on ex-post-facto laws applies to the Congress, not the Executive branch. And maybe George Washington issued a signing statement.

Sam Uretsky is a writer and pharmacist living on Long Island, N.Y.

From The Progressive Populist, September 15, 2006

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