The return of Carter’s Little Liver Pills?

 

In 1868, a fellow named Carter formulated a patent medicine and named it after himself, the famous “Carter’s Little Liver Pills.”  It turned out, amazingly, that there were few human ailments these wonderful pills could not cure: sick headaches, biliousness, torpid liver, constipation and indigestion, sluggishness . . . the list went on and on. Truly Mr. Carter was a boon to humanity.

Except that, of course, the pills did little of what was claimed. They turned out to be pretty good laxatives; everything else was advertising hype. In 1959 the Federal Trade Commission (FTC) made the company drop the word “liver” from its name, considering it false and misleading advertising.

Today the Food and Drug Administration (FDA) does most of what the FTC did for Mr. Carter’s pills. It is apparently fairly easy to design a scientific-appearing study that will prove just about anything you want it to; as my father used to say, “Figures don’t lie, but liars figure.” Poorly-designed but impressive-sounding pseudo-scientific studies have been used to foist countless frauds on a public (and medical profession) that in general does not have the sophistication to tell a well-designed study from a sham (for an example, see the now thoroughly-discredited Wakefield study that purported to show a connection between the MMR vaccine and autism — and all the people, including medical professionals, that were taken in by it). Among other functions, the FDA strives to ensure that prescription drugs are supported by reliable studies showing that a medication’s benefits outweigh its risks for its intended purposes. Drug companies are not allowed to promote their wares for “off-label” indications, that is, maladies for which there is not good evidence that the drug in question does any more than a good sugar pill would.

But this consumer-protection function of the FDA is under attack. The February 6th JAMA relates the story of a drug company and its salesman who promoted their medication for numerous off-label uses, even claiming it was safe in elderly and pediatric patients, despite the label warning specifically stating that safety was not shown in those populations. They were investigated by the Department of Justice; the drug company pleaded guilty, the salesman didn’t and was convicted. He appealed his conviction on the basis of his FIrst Amendment right to free speech. The appeals court sided with the salesman.

This case will be appealed further, so there’s no telling how it will ultimately turn out. But it is conceivable, based on this verdict, that drug companies could start making marketing claims based on pseudo-scientific sleight-of-hand that physicians and their patients might have a hard time seeing through, all in the holy name of Free Speech.

But free speech used to make false claims about potentially dangerous substances should not be protected.  Nobody likes government regulation; but when dealing with medications with a great potential for harm as well as good, I would rather trust government-employed scientists charged with protecting the common weal than a bunch of slick salesmen charged with maximizing their companies’ profits.