Editorial:

Truth and Misleadingness

With the legal demise of the FDA’s significant scientific agreement standard for evaluating health claims, the concept of misleadingness has become legally important. The Court has decided that health claims are protected by the First Amendment if they are truthful and not misleading. We all understand truthfulness, or at least each of us thinks we do. But what about misleadingness? Can we agree about what is or is not misleading?

Most readers have probably seen articles and/or promotional materials stating that X antioxidant is ten, a hundred or a thousand times more potent than Y antioxidant. Are such claims truthful? Are they misleading?

In this issues’s Q&A column, a reader asks about Ward Dean’s and John Morgenthaler’s statement (in Smart Drugs & Nutrients) that pramiracetam is 15 times stronger than piracetam, when the pramiracetam manufacturer’s suggested dose is only half that of piracetam. Is this misleading? Is it truthful?

If the FDA ever decides to obey the courts and conform to the US Constitution, these questions are going to have to be answered. I, for one, don’t think it is going to be easy. In Smart Drugs & Nutrients, Dean and Morgenthaler present scientific data showing that pramiracetam is at least ten times more potent than piracetam in protecting rodents from electroshock-induced memory disruption. Are these data truthful (i.e., valid)?

There are two items of evidence offered. First, the graph on page 54 of Smart Drugs & Nutrients shows three dose-response curves, roughly parallel to each other, merely shifted by dose. It’s classically elegant data, and it shows that pramiracetam is at least ten times more potent than piracetam.

The second item is a study [Poschel, 1983] in which 150 mg doses of pramiracetam helped memory in Alzheimer’s patients. 150 mg of pramiracetam is approximately 1/15th of the recommended dose for piracetam!

So there is a factual basis for the 15-times-more-powerful claim. But is it misleading? I think that it is. In humans, in clinical practice, for clinical responses other than electroshock disruption of memory, pramiracetam is only a few times more potent than piracetam, as evidenced by the manufacturer’s recommended dosage.

Because Dean and Morgenthaler stated the basis of their 15-times figure, I was not misled. I realized it was a SWAG based on limited data with no specific (i.e., scientific) control and, therefore, was not to be taken in an absolute context. However, I am not an average reader. There are many people without my experence who might have been misled. If I had edited Smart Drugs & Nutrients, I would have said “up to” 15 times more potent instead of “about” 15 times more potent.

Ideally, the non-misleadingness criteria should be about setting a context for information that maximizes its clarity and utility and simultaneously minimizes any possible misleadingness. But how is misleadingness to be measured? What standard will be used?

Since misleadingness is based on the way people receive information, it is to a significant extent “in the eye of the beholder.” When a man sees a car advertisement in a magazine or on television in which a scantily clad, smiling woman accompanies the car, does he think that buying that car will increase his chances of attracting women? Although many men would vehemently say, “No!” I would bet money that a lot of psychologists and psychiatrists would testify in court that the sexy woman definitely creates a subconscious expectation of sex that becomes associated with the car. That’s why advertising firms get the big bucks. But do we really want to say that this is misleading?

If the blatant sex-pitch ad is to become illegal, where are we going to draw the line? What about the couples in the 4x4 SUV ad in which the woman in the featured car is smiling at her partner while the woman in the “other” car is frowning and making veiled comments about her partner’s masculinity?

I find such ads humorous. But I suspect that some people take them seriously.

Back to our earlier question; are antioxidants more or less powerful than each other? It all depends on the context. One antioxidant that is very effective for scavenging superoxide radicals may be singularly incompetent at quenching hydroxyl radicals. Which context is more important? The answer likely depends upon the person making the decision. Somebody suffering from hemochromatosis (iron toxicity) is going to have hydroxyl radicals big time. However, somebody suffering from a severe copper deficiency is likely to have more of a problem with superoxide radicals.

So is it misleading to talk about one antioxidant being more powerful than another? I would argue yes. Without any discussion of the context for the antioxidant’s “power,” it would be like saying that oranges are twice as nutritious as blueberries without mentioning any particular nutrient or health benefit. Without a context, can anybody really understand which antioxidant (or fruit) it would be best to buy?

When is the context sufficient? How slight a misleadingness will or will not be tolerated? Will the FDA try to stretch their “misleadingness standard” for dietary supplements far beyond that for foods, drugs and medical devices? Will we have a different labeling/claims standard for supplements than for cars, insurance, toothpaste and/or children’s toys?

We shouldn’t. But I’ll bet on the FDA.