Articles

The New England Journal of Medicine Sinks a Bit Lower

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 in: Clinical Trials, Herbs & Supplements, History, Legal, Medical Ethics, Pharmaceuticals, Politics and Regulation, Science and Medicine, Science and the Media

Leave a Comment (35) ↓

35 thoughts on “The New England Journal of Medicine Sinks a Bit Lower

  1. ConspicuousCarl says:

    If they are so worried about stepping on the FDA’s toes by making their own editorial decisions, why don’t they just shut down the whole magazine?

  2. rork says:

    I’m not sure “most troublesome of all” FDA stuff was honest. Seemed like tacked-on rationalization, but maybe I’m wrong (are they really talking about getting sued?). For the other reasons given I was sympathetic. I also figure the impact of that ad in stuff average people read might be greater than NEJM – yeah, maybe now I am rationalizing. Gotta go read that broccoli article now.

  3. “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. ”

    “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…”

    Wow, what a load of rationalizing, evasive BS. In no sense is the FDA or the Kefauver-Harris Act intended to exclude editorial oversight by publishers of advertisements or any other content. We’re not talking about regulation; we’re talking about editorial oversight. A publisher is free to enact higher, stricter standards if they so choose.

    It’s also self contradictory or at least inconsistent. In one sentence, he states they are free to use their judgment to reject ANY ads they do not wish to run, and in another sentence, implies they either cannot or should not exercise any judgment on which ads to air as long as the ads meet FDA regulations and their own arbitrarily established criteria of good taste and propriety.

    Frankly, adding the part about not wanting to step on the FDA’s toes just torpedoes their whole position for me as rationalization for publishing any ads they choose.

    I would expect a prestigious medical journal to have higher standard for publishing ads beyond “it isn’t currently known to violate FDA regulations and isn’t in bad taste”. Will the NEJM accept ads for homeopathic products, energy drinks, Reiki clinics, etc?

  4. daijiyobu says:

    As a loose observation, I wonder if mislabeled-as-science textbooks then push journals to then follow into that crap direction — even quality journals like NEJM — as opposed what I’d often expect, that even junk studies published as scientific support — in poor-quality journals — then change the academic textbook side.

    Some may even say pollute instead of change or push.

    For instance, Elsevier’s naturopathic “Textbook of Natural Medicine” 3rd edition is under an imprint of “science”, and it’s full of the science-ejected and -unsupported:

    a science textbook without the rigorous science to support its label and claiming science anyway [so not pushed or an effect of journal-published quality findings].

    Dog-tail, tail-dog: I’m wondering which is wagging which.

    Seems NEJM is going towards the latter in this instance.

    And dare I say, getting into the racket of the naturopathillogic.

    -r.c.

  5. Janet Camp says:

    I know someone who died a couple of years ago from colon cancer. She self-diagnosed herself (she had “lost her faith in allopathic medicine”) and used a product like this to “treat” her “imbalance”. When she finally went to a real doctor she was Stage IV. Of course she then wanted every possible real treatment, which she got at taxpayer expense because she was by then, of course, impoverished.

    Does the NEJM care at all that they are lending legitimacy to this product? Do they realize that people like my friend would use such an ad to argue with me while I would be trying to persuade here to take her symptoms of distress and bleeding to a real doctor? Yes, she was stupid, but how can she get smarter with junk like this propping up her position?

    The Editor’s thought processes aren’t good enough to be a gopher, let alone an editor. I will never again use a reference from this journal for anything.

  6. Jeff says:

    It’s worth noting the NEJM probiotics ad is sponsored, not by a supplement company, but by Bayer Healthcare LLC, a pharmaceutical multinational.

    Probiotics research goes beyond the treatment of IBS, e.g., relieving symptoms of Antibiotic-Associated Diarrhea, even cancer prevention.

  7. daijiyobu says:

    And there has to be a ‘diarrhea of the brain’ joke in here somewhere, anyone?

    -r.c.

  8. Xplodyncow says:

    I don’t work for a journal, so maybe I’m wrong about how things work, but is it possible no one sees these ads until it’s too late? (She asked naively.) Perhaps the layout of the back cover was “Bayer Ad Here” until just before the journal went to press. I’m pretty sure ad space is negotiated well ahead of time, but I don’t think content is part of the discussion. And the actual ad frequently comes in at the very last second.

    It will be interesting to see whether there is any follow-up in NEJM about this.

  9. Chris says:

    Xplodyncow, this is totally off topic, but your username creates an interesting image of an exploding cow in my head. Oh poop (well, try one thing on topic), now it is an eye worm!

  10. Cowy1 says:

    ” is it possible no one sees these ads until it’s too late? (She asked naively.) Perhaps the layout of the back cover was “Bayer Ad Here” until just before the journal went to press”?

    Still a ridiculous embarrassment for the journal. Considering it is on the the most read scientific journals in existence it is pretty embarrassing that they can’t drop some quack advertisement because it is clearly a waste.

  11. umvue says:

    But… but… but…

    Having published in renowned journals such as European Radiology and the Journal of Lipids Research I finally make it into the NEJM (that and JAMS are the ONLY journals any of my non-academic friends have ever heard of)

    N Engl J Med. 2011 Dec 15;365(24):2255-67. Epub 2011 Nov 15.
    Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy.
    AIM-HIGH Investigators, Boden WE, Probstfield JL, Anderson T, Chaitman BR, Desvignes-Nickens P, Koprowicz K, McBride R, Teo K, Weintraub W.

    and you’re telling me this isn’t the bestest most rigorous toughest smartest journal in the whole universe?!

    I beg to differ. ;)

  12. umvue says:

    But… but… but…

    Having published in renowned journals such as European Radiology and the Journal of Lipids Research I finally make it into the NEJM (that and JAMA are the ONLY journals any of my non-academic friends have ever heard of)

    N Engl J Med. 2011 Dec 15;365(24):2255-67. Epub 2011 Nov 15.
    Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy.
    AIM-HIGH Investigators, Boden WE, Probstfield JL, Anderson T, Chaitman BR, Desvignes-Nickens P, Koprowicz K, McBride R, Teo K, Weintraub W.

    and you’re telling me this isn’t the bestest most rigorous toughest smartest journal in the whole universe?!

    I beg to differ. ;)

  13. JPZ says:

    LMAO

    Let me get this straight. BMJ article authors did a systematic review that concluded probiotics “appear to be efficacious in IBD.” And you prefer to highlight an editorial that dismisses their work without one bit of actual evidence why this editorialist disagrees. I take it that you will throw out a review if you don’t like it and if there is a guy/girl (editorial review) who supports your point of view? Call “Medical Hypothesis” quick!

    And for “Quack Miranda,” Cheesus are you that blind to current US FDA regulations? So, if an officer of the law fails to provide a Miranda Warning to a criminal, do you think the officer can get off clean by saying, “Regardless if the government requires it, I don’t actually have to say that stuff do I?”

    I honestly can’t figure out if you are just making a joke or can define a new clueless.

  14. nybgrus says:

    And you prefer to highlight an editorial that dismisses their work without one bit of actual evidence why this editorialist disagrees.

    And for “Quack Miranda,” Cheesus are you that blind to current US FDA regulations?

    Not to jump in an attack or defend (though I reckon one could speculate at my leanings rather easily and accurately) but I believe the point of Dr. Atwood’s post here has been to state his opinion that the NEJM should be of a higher standard – perhaps even the “highest” standard.

    As such, even though some evidence and biological plausibility exist for the use of probiotics in IBS and perhaps other GI indications, it is indeed very patchy and of low quality. That topic has been touched upon at the blog many times, and since the focus of this piece was not about the efficacy of probiotics but the standards of the NEJM I don’t see it as a huge flaw that Dr. Atwood did not devote an extra 1000 words to demonstrating why his editorial snippet was accurate. The point was, IMO, to state that the ad did not meet what he thinks the standards of the NEJM should be in terms of promoting something.

    Secondly, the quack miranda is required for all such products. The argument is not that they shouldn’t say it in certain cases, but that (once again per the higher standards Dr. Atwood is wanting) the NEJM shouldn’t run ads or print material on anything that requires a quack miranda warning. In other words, if the material is good enough to be in the NEJM it should be good enough to have the QM removed.

    That’s not to say that a lower teir journal couldn’t/shouldn’t print such material – just that the NEJM should stand as the highest bastion of print standard in medicine.

    At least, that is what I got from it anyways.

  15. Harriet Hall says:

    My objection to the ad is that it is not for a product clinically proven to work for anything. It only claims to contain 3 clinically tested strains of bacteria: they have been tested individually, but the product Colon Health has not. It doesn’t even mention IBS. It claims to help guard against occasional constipation, diarrhea, and gas, to support nutrient absorption and lactose digestion, and to support overall digestive health and immunity.

    A typical pharmaceutical ad in the NEJM contains an elaborate listing of medical information with references to clinical studies. This, instead, is a typical diet supplement ad with vague claims and no supporting evidence. The Colon Health website doesn’t contain any scientific studies but is full of testimonials.

    I’ve been reading the NEJM for four decades, and I’m not going to cancel my subscription over this because I have a lifetime subscription. The NEJM conveniently places most of its ads in a separate section before the main text, making them easy to ignore: I never even open those pages. I agree with Dr. Atwood that the Colon Health ad and its placement were unworthy of the NEJM.

  16. weing says:

    If this pans out, doctors will really start giving patients a lot of shit.

    http://www.sciencedaily.com/releases/2011/10/111031114945.htm

    Or maybe they’ll just stop washing their hands after going to the loo.

  17. @JPZ:

    My intent was exactly as explained by nybgrus and Harriet Hall. Perhaps I didn’t make that sufficiently clear. Neither the editorial nor I dismissed the systematic review; we both agreed with it. Its complete conclusion was, “Probiotics appear to be efficacious in IBS, but the magnitude of benefit and the most effective species and strains are uncertain” (my emphasis). The point I made, supported by both the systematic review and the editorial, is that probiotic hype (including this ad) “greatly surpasses the evidence.” I am not blind to current FDA regulations; I cited them as such, pointing out that those that are relevant to this case, including the Quack Miranda Warning, are due to DSHEA. Finally, I don’t think that the NEJM should be advertising products that require a Quack Miranda Warning, and neither, apparently, did the NEJM editorial staff prior to DSHEA.

    KA

  18. marilynmann says:

    @umvue Disappointing result to the AIM-HIGH trial, although not particularly surprising considering (1) the trial was stopped early and (2) in the Coronary Drug Project trial, the benefit from niacin monotherapy over 5 years was modest (3) we would expect that in patients already on a statin it would be hard to show benefit from an additional therapy. My guess is that if there is a benefit from adding niacin to a statin, that it is small and takes a long time to emerge.

    @Kimball Atwood I wonder if Dr. Relman has changed his views since 1979. I attended the National Physicians Alliance conference in Washington last year. One of the speakers was Marcia Angell, another former editor-in-chief of the New England Journal. Dr. Relman and Dr. Angell are now married to each other (Dr. Relman was also there). Dr. Angell said she had come to the conclusion that medical journals should not run advertising from the pharmaceutical industry at all. She didn’t mention dietary supplements but I doubt she would feel differently about them.

  19. marilynmann says:

    Also, this is an interesting letter by Dr. Relman that was published in The New Yorker.

    http://www.newyorker.com/magazine/letters/2012/01/09/120109mama_mail1

  20. JPZ says:

    Heh, seriously?

    So, the LEGALLY REQUIRED “Quack Miranda” is what upsets you? Do you get that way about those big notices on the visor of your car? You know, air bags and such. Walk much?

    I guess what you are saying is that it is about the evidence? If the systematic review says that some probiotics work for IBD, that must be wrong? Shouldn’t we focus on the evidence supporting Phillips Colon Health? Review that. Is it all hype?

    Can you focus on the issue at hand?

  21. Quill says:

    Like most ads, the language is vaguely cheerful and non-specific. But what is such an ad doing on the back of a magazine that is sent out to doctors and other medical professionals who should know better?

    The first strain “supports nutrient absorption.” How is this measured? Was it ever measured? How is this “support” done? The helpful superscript directs the reader to the notation that this Colon Health best is “among leading brands.” Leading what? Sales? Measured effectiveness?

    The second strain “helps guard against occasional constipation, diarrhea and gas” (again apparently best “among leading brands”). What exactly is the mechanism of this guarding? What is being guarded for or against? Apparently this “guard” is only part-time or perhaps sleeps a lot because this guarding only is done occasionally. On what occasions? And if it “helps” do all this, what is it helping?

    The third strain (again best “among leading brands!”) “supports overall digestive health and immunity.” Again, how is this measured? Supports “immunity”? From what, exactly? Salmonella? Rancid grease? And it’s only “overall” health, eh? Nothing specific? Sort of like a Pop Tart being “part of a complete and balanced breakfast”?

    This product is the best “among leading brands.” Well! Should be a wealth of data out there, no? Lots of RCTs among these brands, yes? Perhaps they got the Framingham Heart Study to add all these brands to their subjects? 8,000 nurses used different “leading brands” for five years? Perhaps even they just gave out boxes of the stuff at a frat party and asked the next day which house farted less?

    I really do like the tag-line, though. “3 Strains, Many Benefits.” (Sounds more like they found something useful about constipation than anything else.) One can imagine that the “many benefits” has a lot to do with Phillips-Bayer’s bottom line if they get this product launched than anyone’s actual bottom needs.

    Oh wait. Silly me! There is that disclaimer, the infamous Quack Miranda Warning. So this pill isn’t actually designed to do anything useful except be marketed as a profitable dietary supplement. As the song goes, “Nice work if you can get it.”

  22. -Sigh- really? You’re protesting ads? Have you all at SBM ever taken a gander at your ads?. Inspect each of those for clinical benefit, do you?

  23. I particularly like
    “Natural Anxiety Remedy
    http://www.NeverGiveUpFitness.com
    Fight Depression, Anxiety, OCD
    with our Exercise Solution!”

  24. Oh but that flex-protect-D looks like good stuff.

  25. nybgrus says:

    -Sigh- really? You’re protesting ads? Have you all at SBM ever taken a gander at your ads?. Inspect each of those for clinical benefit, do you?

    last I checked, this forum was not the NEJM. And the ads have been discussed here and lamented about, but the conclusion was that the content is not directly under the control of the editors and… this is not the NEJM.

    So, the LEGALLY REQUIRED “Quack Miranda” is what upsets you?

    No, the fact that a product which LEGALLY REQUIRES it is being advertised in what is supposed to be the medical journal.

    I can understand Michele’s lack of understanding as a lay person, but JPZ should know better and his posts lately seem rather full of venom for some reason.

    Note I stated above:

    That’s not to say that a lower teir journal couldn’t/shouldn’t print such material – just that the NEJM should stand as the highest bastion of print standard in medicine.

    It is the same way I am disgusted at The History Channel, The Learning Channel, and even The Discovery Channel because of the downright stupid shows which do not promote history, learning, or discovery. I turn on The History Channel and expect a great documentary on WWII or the Panama Canal, not a show called My Big Fat Gypsy Wedding or Ice Road Truckers. Do I say those shows should never exist? No. They should just be on different channels.

  26. @JPZ: Please focus on the issue at hand, and stop being a dick. The Quack Miranda Warning bothers me, not because it is legally required but because it demonstrates that the product has not met the standard of evidence that would permit it to be approved by the FDA—and thus not require the QMW. Get it? Perhaps you disagree with that standard for inclusion of an ad in the NEJM. Fine, you’re entitled to your opinion. The NEJM editors did not disagree with that standard, at least in 1979.

    @michele: It’s odd: I don’t see any ads on my computer, although I don’t doubt that you do. There is a huge difference between a hard-copy journal with hundreds of editors and reviewers and a generous subscription income, of course, and a blog with a few editors who work around their real jobs and no subscription income at all. Nevertheless, I’m sure that all of the editors/writers here would prefer to have no ads, if we could afford it.

  27. I should have added, as nybgrus suggests above, that as long as we have ads we probably have no control over what they may be (Drs. Gorski and Novella can verify this). This is not the case for the NEJM.

  28. @Kimball Atwood, your blog could control ad content if you made other back-end and editorial decisions, those decisions may cause more of a financial burden upon your blog. The same goes for NEJM.

    I don’t see a big difference.

  29. marilynmann says:

    Odd, I don’t see any ads on this site. In any case, I have a WordPress blog and it is possible to pay a small annual fee so that ads will not appear on your site.

  30. rork says:

    Crappy adds at places where they have no effect harms the folks who bought the add – it is a good thing.
    On skeptical blogs they are often very interesting, trying to sell the very thing that the article is warning us against, highly confirming the need for article. That happens here lots.

    I have wondered how much it helps a blog to click on some of the crazy ads (as if they are working on me).

  31. Rork, interesting perspective. Have you considered that google results are primarily listed by popularity of sites, so that visiting CAM sites may raise their Google status, making them more prominent to non-”skeptics”?

  32. nybgrus says:

    your blog could control ad content if you made other back-end and editorial decisions, those decisions may cause more of a financial burden upon your blog. The same goes for NEJM.
    I don’t see a big difference.

    You don’t see a big difference between this blog and the NEJM? Nor the completely tu cuocque nature of your argument?

  33. David Gorski says:

    Or the difference between how journals and magazines seek out advertising and how online advertising works.

  34. David Gorski says:

    Have you considered that google results are primarily listed by popularity of sites, so that visiting CAM sites may raise their Google status, making them more prominent to non-”skeptics”?

    Incoming links matter far more than traffic. That’s why we use the rel=”nofollow” tag when linking to quack websites in order not to increase their search engine rank.

Comments are closed.