(Updated on July 7 with a lengthy quote from AJC editor William Roberts.)
The authors call it “an in-office linguistic study” and write that it “was conducted to assess physician–patient discussions of mixed dyslipidemia.” But it’s really an Abbott marketing study for Niaspan, the company’s long-acting niacin product, and the question is: why is it published in the American Journal of Cardiology?
The study involves the recorded conversations of 12 cardiologists and 12 PCPs with 45 patients with low levels of HDL. The authors report that the physicians did a poor job in talking to their patients about dyslipidemia and patients did an even worse job in listening. After the conversations patients didn’t understand their lipid numbers and had only a fuzzy understanding of terms like HDL and triglycerides.
Overall, the visits did not contain discussions of specific health-related benefits associated with NER [niacin extended-release], such as a reduced risk of CVD or the regression of plaque in the arteries. Only 1 cardiologist stated in 1 visit that NER “. . . will improve your HDL and therefore protect you from having any heart blockages or development of plaque in the arteries.”
For the record, there is absolutely no evidence that NER can “protect you from having any heart blockages or development of plaque in the arteries,” and it is astonishing that a statement like that could be published in a respectable, peer-reviewed journal.
Despite the existence of clinical treatment guidelines, visits revealed minimal urgency to address low HDL cholesterol levels. Specifically, in 9 visits, the patients with low HDL cholesterol discussed, but did not initiate, treatment with NER.
Here’s their discussion of the physician-patient conversations about NER:
…conversations about treatment with NER appeared to lack several components to ensure successful, long-term adherence to therapy. Discussions focused on side effects (e.g., flushing) but did not describe the benefits of therapy in a way that was perceived as meaningful to patients…. This could negatively influence patient compliance, because, without appropriate information, patients might not be able to understand, recognize, and manage side effects such as flushing and might not understand the potential benefits of the therapy.
“Missing from the dialogue.” they write, “was a balanced discussion of risks and benefits.” But it should be clear by now that the authors’ idea of a balanced discussion does not include any skeptical views about the value of NER. What they really mean is that the physician should act as salesman, extolling the trumped-up benefits of a drug that has no risks (except the inconvenient flushing).
And in case it’s not completely clear, the entire point of the study is to increase usage of NER:
[NER] might be underused in community practice because of a perception of side effects that are more severe and less manageable than clinical data would suggest.
So what else is missing here? Discussion of any other drugs, for one thing. In the world of this study, NER is the only drug that needs discussing. And the only purpose in talking to patients is to get them to take the drug. It’s really very simple.
But there’s something even bigger that’s gone missing in the authors’ heads. In their haste to please the sponsor they’ve lost all track of any larger purpose or benefit. Diet and exercise are the only steps that nearly every expert in the field agrees can be useful in these sort of patients, yet there’s absolutely no discussion from the authors about this most important missing ingredient in the physician-patient interaction.
Please don’t misunderstand: although there is insufficient evidence to state with assurance that niacin therapy produces benefits in clinical outcomes, most experts feel that niacin has a valid place in the pharmacologic armamentarium used to treat lipid disorders. But the very first line of the indications and usage section of the NER label makes clear that this is only one element in a much larger picture:
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia.
There’s little doubt that many if not most physicians are poor communicators about lipids– and much else. And undoubtedly there may be great value to be gained from a serious, independent study designed to detect flaws in physician-patient communication in order to identify better communication strategies to improve patient outcomes. But of course this is not a real academic study, it’s an Abbott marketing study designed to provide a talking point for sales reps and CME lecturers, all tailored to increase usage of NER.
And that is why this study is so dangerous. It perverts something that could be quite useful and beneficial into something that becomes a marketing arm for a commercial interest. A perfect example of the subtle, and not so subtle, ways that commercial influences twist and distort research.
A recent editorial in the Lancet sharply observed that although the recent ADA meeting presented a plethora of studies on new and existing drugs, “there is a glaring absence: no research on lifestyle interventions to prevent or reverse diabetes. In this respect, medicine might be winning the battle of glucose control, but is losing the war against diabetes.”
So how does a study like this get done? It’s certainly not surprising that the study was approved by a commercial IRB firm, Independent IRB, Inc., whose services include delivering the “ability to assist clients in developing alternative processes for achieving research goals.”
And then there are the authors. The first author is Alan S. Brown, a cardiologist at Midwest Heart Specialists who is the “architect” of the group’s Cholesterol Management Program, which “a 1998 study showed… was 700 percent more effective at helping patients achieve their LDL goals, compared to 250,000 patients with heart disease in a nationwide study done a year earlier.” It will probably come as little surprise that Brown often contributes to journal supplements and is a frequent participant in commercially sponsored CME programs.
The corresponding author is Corey Eagan, a candidate for an MPH who works for MBS/Vox, in Parsippany, NJ. According to Corey Eagan’s page on LinkedIn, she is a Manager of Analytics at the company. Here’s how she describes her job:
Corey leverages her knowledge of linguistics and the healthcare industry to help draft study designs and analytic metrics for market research studies in healthcare communication.
She is responsible for managing a team of analysts, which she guides in mining transcripts of physician-patient dialogue for insights based on best practices and gaps in communication.
Corey also assists in the writing and editing of primary publications and posters based on these research insights.
It appears that for Corey there’s no difference between “market research studies” and “publications and posters based on these research insights.” That’s understandable.
What’s not understandable is why the editors of the American Journal of Cardiology couldn’t see the difference.
Update, July 7: Pharmalot’s Ed Silverman asked AJC editor William Roberts about the decision to publish the paper. Here is his answer:
So we asked William Roberts, the AJC editor and the executive director of the Baylor Cardiovascular Institute of Baylor University Medical Center in Dallas, about the decision to publish this paper. “I thought this was a plus or minus article to be honest. By that I mean borderline. It was gutsy to be published, to be frank with you. But this sort of thing (cholesterol lowering discussions with patients) comes up in physician all the time,” he tells us.
“The idea that it’s really an Abbott marketing study for niaspan, I think that’s a little strong…I’m not really interested in knowing the marketing literature of every pharmaceutical company, but my own view is the American people are not treated adequately with the lipid-lowering drugs that we have,” he continues. “…I’m in favor of articles that stimulate discussion of more lipid-lowering drugs or patients to take them…I thought this was an article in a way that had a purpose, a function…”
However, Roberts does acknowledge flaws. “It’s not the ideal authorship, by any means…If you look at the 650 articles published in the AJC each year, this is an exception….Is the quality diluted or contaminated if there is a pharmaceutical person as an author on the manuscript? You can debate that a good while…If I had to do it over again, I certainly woudn’t have allowed a single drug to be mentioned…In retrospect, discussion or mention of one drug and not a whole bunch of them is a little slick.”