Thursday, August 25, 2011

Controlling the Channels: Pushing the Pharma-Friendly Model of Diabetes

In keeping with my lazy habit of letting others write this blog for me, I will talk about a couple of commentaries included in the July, 2011 edition of Primary Care Medical Abstracts by my friends Rick Bukata and Jerry Hoffman. The first, I will argue, illustrates the concept previously blogged about by the anthropologist, Kalman Applbaum, on the idea of drug "channels" and how drug company marketing works to control these channels effectively. The take-home message in each case is how medical journals have been harnessed to the cause of selling drugs, despite lack of sound evidence, in ways that are usually opaque to the average reader.

Exhibit A for this commentary is a so-called expert consensus panel (McInnes et al., subscription required) on diabetic foot care, published in the British journal Diabetic Medicine. The panel appears to be what evidence-based gurus call BOGSAT, or "bunch of old guys sitting around talking," rather than a systematic evidence-based review with proper methods. The funding for the "old guys" came from a firm called SSL International, which has since been bought out by another firm, which makes a variety of health-related products, mostly for nonprescription home use. I don't see offhand that they make any diabetes drugs. Nothing is said in the article about conflicts of interest, or lack of same, among the authors.

The authors set out to answer the question of what kind of foot care should be provided for diabetics considered to be at relatively low risk. I was puzzled because the article does not say whether they are talking about Type 1 or Type 2 diabetes, so I have to imagine they mean both. It is therefore important to keep in mind that about 90 percent of patients seen by adult practitioners have Type 2 (adult onset) diabetes. As we have discussed in several previous posts, there is at present no compelling evidence that tight control of blood sugar levels (trying to get the hemoglobin A1c blood test within normal limits) effectively prevents the major complications of Type 2 diabetes, in particular diabetic neuropathy which is the cause of most foot problems.

So the "old guys" list four things that they think physicians should advise patients as part of good diabetic foot care. The second is: "maintaining adequate glycaemic control." They proceed to explain: "Numerous clinical studies have demonstrated the positive relationship between reductions in HbA1c and reduced risk of microvascular complications of diabetes, including neuropathy and foot ulcers." Now, this is sort of half right. Numerous studies have shown that if you have two groups of diabetics, one with high levels of A1c (poor control) and others with low A1c (good control), the first group will have many fewer complications. What has never been shown is that giving medicines in Type 2 diabetes to lower A1c reduces the incidence of complications.

So what evidence do these "old guys" cite to prove their point about better control leading to fewer complications, especially in the feet? They mention two references. The first, as Jerry pointed out in his commentary on the paper, was to the DCCT trial published in 1993, which showed that tight control reduced complications in Type 1 diabetics--that is, irrelevant to the vast majority of adult diabetics. The second reference is a paper by Boyko et al. in 2006. This paper has nothing to do with diabetes treatment or the prevention of complications. Rather it is the development of a prediction tool to show which diabetic patients are most likely to develop foot ulcers. Not surprisingly, one of the risk predictors is elevated HbA1c--though interestingly enough, this single factor increases one's risk of foot ulcers by only 10% above baseline, while other predictive facts double or triple the risk. But the Boyko et al. paper says nothing whatever about whether better glycemic control will prevent neuropathy or ulcers.

So what we have here in this journal is a supposed "expert consensus" on preventing foot complications in diabetics, claiming that better blood sugar control is a critical component of this prevention, but unable to cite a single clinical trial showing this to be true for the most common type of diabetes. So long as physicians think that the best way to prevent the complications of Type 2 diabetes is to lower HbA1c, they will write a lot of prescriptions for expensive medications, making the drug companies richer--but doing very little actually to prevent diabetes complications. In this way even an article that seems to be not at all about drug therapy manages to convey a drug-industry-friendly message--and the evidence be damned.

McInnes A, Jeffcote W, Vileikyte L, et al. Foot care education in patients with diabetes at low risk of complications: a consensus statement. Diabetic Medicine 28:162-167, 2011.

Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. New England Journal of Medicine 329:977-986, 1993.

Boyko EJ, Ahroni JH, Cohen V, et al. Prediction of diabetic foot ulcer occurrence using commonly available clinical information: the Seattle Diabetic Foot Study. Diabetes Care 29:1202-1207, 2006.


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Bernard Carroll said...

Howard, your general point is correct, but I have a slightly different take on this example. The article by the BOGs in Diabetic Medicine is a good example of soft messaging. In this case, however, the Scholl company that makes foot care products was the supporting corporation which paid for the BOGs to get together and to SAT. Scholl also paid through SSL International for professionals to turn the breeze shooting of the BOGSAT into a manuscript for publication. My take is that the stuff about control of HbA1c was just meant to look like hard clinical science propping up the otherwise anodyne material about good foot care (soft messaging for Scholl products).

Speaking of BOGSATs (thanks for that term, by the way) sponsored BOGSATS are pretty common in psychiatry. The Journal of Clinical Psychiatry has perfected the form, often in special sponsored supplements. The acknowledgments in these ghostwritten articles say something like This article is derived from a planning round table held in (name your watering hole) on (name the date). Another variant is planning consensus conference. Huh? The ones doing the planning are the professional ghostwriters. I have even seen one BOGSAT described as International Consensus Group for Anxiety and Depression - this to describe an ad hoc bunch of usual suspect KOLs rounded up for a promotional journal supplement. Lipstick on the pig.

Maybe the biggest BOGSAT of all is the army of DSM-5 consultants who would like to give us Pharma friendly innovations like psychosis risk syndrome.

Barney Carroll.

Michael S. Altus, PhD, ELS said...

Dr. Carroll,

What is the evidence that sponsored BOGSATs that you refer to are ghostwritten, and would you please provide some examples?

I am a freelance medical writer-editor who has a deep concern about ethics in preparing articles for publication. For example, I refer to AMWA Ethics FAQs (, which I wrote for the American Medical Writers Association. Although we agree about the problem of medical ghostwriting, I want to see substantiation before asserting publicly that ghostwriting has occurred.

Bernard Carroll said...

Dr. Altus, haven’t I given you examples of ghostwriting in the past? If you need instances of BOGSAT ghostwriting, here is a sampling.

The classic ghost written BOGSAT publication is Sally Laden’s production on behalf of Charles Nemeroff and his pals at Cyberonics: This is the infamous, incestuous paper in Neuropsychopharmacology promoting vagus nerve stimulation.

Another classic BOGSAT example is: It appeared in a Supplement to Journal of Clinical Psychiatry. The authors include the ubiquitous Charles Nemeroff, and the publication is self described as “Derived from the meeting “Update on Posttraumatic Stress Disorder,” July 11–12, 2002, in Adare, County Limerick, Ireland, held by the International Consensus Group on Depression and Anxiety. The Consensus Meeting was supported by an unrestricted educational grant from GlaxoSmithKline.” Notice the careful parsing “Derived from…” That is code for ghostwriting.

A final thought – maybe we should rename these gatherings BOGGSATs to recognize that our sisters in science also participate.

Michael S. Altus, PhD, ELS said...

Dr. Carroll, in the Aug. 19, 2009 entry, “Ghostwriting Stays in the Spotlight,” on the Carlat Psychiatry Blog (, you asserted that the article, “VNS Therapy in Treatment-Resistant Depression: Clinical Evidence and Putative Neurobiological Mechanisms” (Nemeroff CB and eight others. Neuropsychopharmacology. 2006; 31:1345-1355), was ghostwritten. I asked for evidence that this article was ghostwritten. You did not reply with evidence. Once again, you provide this article, which you describe here as the “classic ghost written BOGSAT production...” as an example of ghostwriting. Once again, I ask for evidence that this article was ghostwritten. I hope that you will provide evidence this time.

I find it helpful to start with definitions. I use the following, which I suggest that you could use. If you prefer to use other definitions, when I ask that you specify them.

AMWA Ethics FAQs (, which I wrote for the American Medical Writers Association, has the following definitions:
Q: What do "ghost authoring, “guest authoring,” and “ghostwriting” mean?
A: "Ghost authoring" refers to making substantial contributions without being identified as an author. "Guest authoring" refers to being named as an author without having made substantial contributions. “Ghostwriting” refers to assisting in presenting the author's work without being acknowledged. The term “ghostwriting” is often used to encompass all three of these practices.
Q: What does the phrase, substantial contribution, mean?
A: The phrase substantial contribution is often used with respect to determining authorship credit. A helpful explanation of what substantial contribution means is in the authoritative AMA Manual of Style: “A substantial contribution is an important intellectual contribution, without which the work, or an important part of the work, could not have been completed or the manuscript could not have been written and submitted for publication.”

The Neuropsychopharmacology article included the following acknowledgment: “We thank Sally Laden for editorial support in developing early drafts of this manuscript. We maintained complete control over the direction and content of the paper. Preparation of this report was supported by an unrestricted educational grant from Cyberonics Inc.”

Because Sally Laden was identified in the acknowledgments for her editorial support, she was NOT, by definition, a ghostwriter. The acknowledgment should have noted that Ms. Laden was supported by Cyberonics. Regardless, I am unaware of any evidence that ghostwriting or ghostauthoring occurred in the development of this article. Again, if there is any evidence, then I want to learn about it.

As Dr. Brody wrote in Hooked (page 130), “It is therefore pertinent to look at an especially egregious ethical violation—the ghostwriting [actually, ghostauthoring] of research publications.” An assertion of an occurrence of ghostwriting or ghostauthoring should be substantiated by evidence.

Bernard Carroll said...

Dr. Altus,

Happy to oblige further. An investigation into the Sally Laden – Charles Nemeroff – Cyberonics review article was conducted in the summer of 2006 by American College of Neuropsychopharmacology (ACNP), which publishes the journal in question, Neuropsychopharmacology. ACNP president Kenneth Davis, MD communicated to the membership in October 2006 that Sally Laden acknowledged that she was paid by Cyberonics to write the first draft of the article as well as later drafts. The ACNP memorandum indicated that Sally Laden did a great deal more than just provide editorial assistance. She did a review of the literature and developed an outline of the paper. The early drafts were reviewed only by Nemeroff and Cyberonics employee Steven Brannan, MD, who apparently ensured that the draft was on message for the corporation. In subsequent drafts, the other named authors strengthened the hard science surrounding the stealth infomercial. The ACNP memorandum also stated that Sally Laden undertook additional responsibilities that typically are the duties of authors, such as responding to the matters raised in review. There is no doubt that her role meets your own definition of ghost authorship and that it goes well beyond editorial support. I care nothing for your professional writers’ guild hair splitting about ghost authorship versus ghost writing. The key point is that the named authors were not transparent about Sally Laden’s real role, with the active collusion of Sally Laden herself.

I do not understand why your doubts continue on this point, Dr. Altus. After all, Sally Laden herself acknowledged in David Armstrong’s Wall Street Journal report on July 19, 2006 that she wrote the first draft of the article.