I suppose it was bound to happen, but it still rankles. Here is the back cover of last week’s issue of the decreasingly prestigious New England Journal of Medicine:


Here’s the front cover:

It’s the 200th Anniversary issue, no less. Some might protest that ‘probiotics’—live bacteria of ‘good’ varieties, as far as the gut is concerned—aren’t all that implausible, and that there is some trial evidence that they help for some conditions. That’s true, but as is typically the case even for the somewhat plausible end of the “CAM” spectrum, the hype greatly surpasses the evidence. The abstract of the most recent systematic review that I could find for probiotic treatment of irritable bowel syndrome (IBS: symptoms and signs that best match the claims in the advertisement above) concluded:

Probiotics appear to be efficacious in IBS, but the magnitude of benefit and the most effective species and strains are uncertain.

The accompanying editorial begins with this statement:

Probiotics are widely consumed and the widespread advertising is often not really justified by the evidence. Many products were never studied as such and some companies use studies performed with other (and different) products for advertising even during medical conventions. Evidence of benefit is still patchy and the clinician has to take into account the variability of the strains, the doses, the quality of the trials and clinical relevance of end points.

That’s pretty much the state of the field. In the case of the NEJM ad, we can tell that the evidence is lacking merely by looking at the small print in the little box on the left near the bottom:

*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Yup, it’s the trusty ol’ Quack Miranda Warning. How vulgar of the NEJM to display it, if you’ll excuse my snobbery. It’s funny: I’m old enough to remember when that journal had no commercial advertisements at all, and that its decision to institute them was controversial, to say the least. In 1979, Editor-in-Chief Arnold Relman wrote:

What responsibility should the Journal take for the ads that appear in our pages? Should we review our advertising copy just as we do the content of scientific articles?

Some readers evidently think so. A Toronto oncologist writing in this week’s correspondence section chides us for allowing what he claims are inappropriate and misleading statements to appear in a series of ads…

We get many letters of this kind. They usually include, as this one did, not only a complaint about an ad but also a reprimand to the Editor for dereliction of duty. Our Toronto reader accuses us of “contributing to an increase in iatrogenic illness” by our laxity. A more common rebuke is that we are “lending the Journal’s prestige” to an adman’s pitch.

Well, I think that I am as concerned about truth in advertising as the next person, but I can’t agree with our correspondent on this issue. I don’t believe that it makes sense for us to review our advertising except in the most general way, even though we are, of course, free to reject any ad that we do not wish to run. We occasionally exercise that option, but only when there has been an obvious violation of good taste or propriety. In my opinion, that is about as far as we ought to go.

We should not, and we cannot, critically review the therapeutic claims and prescribing information in each of our ads. That would ask more of our consultants than we have a right to expect, and it would involve us in protracted investigations and negotiations. We would be in the untenable position of seeming to endorse or disapprove certain products. Most troublesome of all, such a policy would have us competing with the FDA, which has statutory authority to regulate the advertising of prescription drugs and other medical products.

The Kefauver-Harris Act, signed into law in 1962, vested complete authority with the FDA for the regulation of prescription drug advertising. Pursuant to this authority, the FDA adopted regulations that, in essence, require that all promotional material be accurate, balanced, and consistent with the therapeutic claims approved by the FDA…

We accept ads only for drugs approved by the FDA…

Is DSHEA the Culprit?

I agree that if there are to be ads at all, it isn’t realistic to expect the Journal’s editors and reviewers to comb each of them for accuracy, although it would be relatively easy to spot outliers such as this one. It is also reasonable to follow FDA criteria for therapeutic claims, which are fairly stringent if not perfect. So what happened here? Has the policy changed since 1979? The current Advertising Policies page reveals only two, relevant entries:

14. All advertisements must be clearly germane to the practice of medicine.

15. Advertiser represents and warrants that all advertisements and pharmaceutical products they advertise are compliant with all applicable laws, rules, and regulations in the country where the advertisement will be seen. Advertisements for pharmaceutical products (including NDA products) that are subject to US Food and Drug Administration (FDA) oversight must comply with FDA regulations regarding advertising and promotion.

Maybe the problem lies in the “must comply with FDA regulations” clause. Prior to 1994, this probably supported Dr. Relman’s contention about accepting ads only for drugs approved by the FDA. In 1994 the DSHEA law—crony capitalism at its most rotten—was passed. DSHEA made it possible to comply with FDA regulations merely by limiting efficacy claims to “supports (‘structure and functions’)” and by including, of course, the Quack Miranda Warning.

If my suspicion is correct, it seems that a review of the NEJM’s advertising policies is long overdue. I’m not holding my breath, because it’s been clear for several years that someone in that editorial boardroom isn’t minding the store. Want evidence? Look here, here, here, herehere, here, and here.

Posted by Kimball Atwood