So first there was the New England Journal of Medicine series by Jeffrey Drazen and Lisa Rosenbaum suggesting a relaxation of the restrictions on industry affiliated experts writing editorial or review articles in the NEJM. Then came strong rebuttals in the British Medical Journal from both sides of the pond [UK: Elizabeth Loder, Catherine Brizzell, and Fiona Godlee][US: Robert Steinbrook, Jerome Kassirer, and Marcia Angell]. Now, Lancet Editor, Richard Horton, weighs in. :
by Richard HortonLancet. 2015 385:2238.
It’s hard to recall now, but there was a time in medicine’s recent past when interactions between physicians and the pharmaceutical industry were seen as positively virtuous. During medical school [a long time ago, 1980–86, at the University of Birmingham], most of our general medicine teaching was organised by the Department of Pharmacology and Therapeutics, led by the inspirational Martin Kendall. In weekly “roadshows”, 180 students would discuss clinical scenarios from a pharmacological perspective. Martin Kendall would lead the class through vignettes of patient management. He would do so by testing the students on stage, a ritual we all endured and enjoyed in equal part. An appreciation of, and respect for, the contribution of the pharmaceutical industry to clinical medicine was embedded in our training, and I think most of us felt better prepared for the practical aspects of subsequent ward work as a result. This mutuality extended to research. In 1985, I spent 3 months working at the Astra Laboratories in Mölndal, near Gothenburg, Sweden. At that time, the great Swedish cardiovascular physiologist, Björn Folkow, was at the University of Gothenburg. It was accepted [and encouraged] that senior faculty in Folkow’s department, together with post-docs and PhD students, would move seamlessly between university and industry. This symbiosis is hard to comprehend today. The conflict between those who see industry as an enemy to the values of medicine and those who see great possibilities from collaboration is exemplified by the recent argument between two great general medical journals, The New England Journal of Medicine and The BMJ.
I was in medical school even earlier [1963-1967], and I saw no split between Medicine and the Pharmaceutical Industry, having had something of the same experience as Horton. When I first started writing about the corruption in what I now think of as the «academic·industrial complex», I repeatedly said that I had only become aware of it after my retirement, around the time of Senator Grassley’s investigation [2008]. But then I read so many critics saying that we [psychiatrists] knew, or should have known, but were in denial, or that we were making lame excuses for some kind of passive collusion. So I stopped saying it. It had begun to sound like excuse making or an attempt to disavow responsibility even to me.
The changes in 1980 had a dramatic effect on my life. But after the dust settled, I think I had a Solomon-like view of things. It just wasn’t "a time for" my likes or the likes of me. Things were good in my world and my drifting away from mainstream psychiatry was more because it was irrelevant than anything else. My cluelessness was genuine. More than that, I hadn’t even considered the possibility of a corrupt «academic·industrial complex». That’s all the more remarkable considering I was on the faculty at Emory University, teaching in a Psychoanalytic Institute that was part of the Department of Psychiatry, whose chairman was Charlie Nemeroff, now seen as the poster-child for the «academic·industrial complex». The office where I practiced was minutes from the office I had when I was on the full time faculty – literally around a couple of corners.
Writing in The BMJ this week, two former Editors-in-Chief of the NEJM, Jerry Kassirer and Marcia Angell, call three recent NEJM articles [by the journal’s national correspondent, Lisa Rosenbaum] and an editorial [by the journal’s current Editor-in-Chief, Jeff Drazen], “A seriously flawed and inflammatory attack” on financial, largely pharmaceutical and device manufacturer, conflicts of interest. “We find it sad”, they write, “that the medical journal that first called attention to the problem of financial conflicts of interest among physicians would now backtrack so dramatically, and indulge in ad hominem attacks on those who disagree”. They accuse the NEJM of downplaying the importance of conflicts of interest in medicine. They allege the journal has “little understanding of the meaning of the term”. They call Lisa Rosenbaum’s three essays “rambling”, “fanciful”, and “data-free”. They also attack Drazen, their successor, for weakening the NEJM‘s conflict of interest policy. In an accompanying editorial, the BMJ‘s Editor-in-Chief, Fiona Godlee, together with the journal’s heads of research and education, notes that they are “deeply troubled” by Drazen’s “possible retreat from policies that prevent experts with relevant commercial ties from authoring commentary or review articles”. “We don’t find much to agree with in NEJM‘s anecdotal analysis…It is a mistake by NEJM to suggest that rigorous standards should be revisited.” There have been few such sharp rebukes by one journal editor against another. What led to this surprising assault?
Here’s where Horton loses me. I may have been naive about the «academic·industrial complex» before 2008, but it was sure easy to catch up. There was no surprising assault, just a reaction to a preposterous series in the New England Journal of Medicine. Has Horton been in suspended animation? One is tempted to think he’s being ingenuous here.
Lisa Rosenbaum posed a series of questions that have upset those who believe in the inimical influence of industry in medicine. For example, Rosenbaum asked whether it was reasonable to conclude that a physician with industry ties is motivated by a desire for financial gain? To what extent are reactions to industry influenced by reason or emotion? Why do we not take non-financial conflicts as seriously as financial entanglements? What unanticipated negative consequences might accrue from a hunt for wrongdoing? Why are the benefits of industry–academic collaborations persistently ignored? It would seem within the spirit of scientific inquiry to pose questions that challenge received orthodoxies. Rosenbaum accepts that gifts to doctors can have unacceptable influence. She agrees that past wrongdoings should not be excused. She believes that oversight of industry should not be eliminated. And she discusses evidence that industry-sponsored studies are more likely to be positive. Therefore, I don’t agree with the NEJM‘s critics that the Rosenbaum papers represent a reversal of policy by the NEJM. But while I don’t agree with these critics, I do think that the BMJ‘s analysis should be welcomed. A clear division of opinion in this argument helpfully clarifies both positions. The truth is likely to lie somewhere between these extremes. It’s time we found it.
I’ll be honest. I don’t even follow what Horton is saying. Of course it’s a reversal of policy. They even say it in their series [see Understanding Bias — The Case for Careful Study]. And I don’t know where his middle ground "somewhere between these extremes" would be. This post has been sitting on this screen all day while I went about doing this-and-that, and every time I glance over it, it makes me a little madder. Are he and Drazen pals? Or was he looking to not cross either set of colleagues? I wondered what policy the Lancet had but couldn’t find anything that made things clear. Anybody else got any thoughts?
Well, yes, I have some thoughts. As you know, I posted my own analysis of the Drazen/Rosenbaum articles and reach a somewhat in-between conclusion. Every movement has its extremists, such that now there’s a backlash against the most extreme “Pharma is bad” critics. I grant Rosenbaum that reflexive repudiation of all physician-industry ties is tarring with too broad a brush. I agree that great benefit has come from academic-industry collaboration, and that we shouldn’t throw out the baby with the bathwater. All in all, she makes several good points.
Unfortunately, there’s a political motive behind the very existence of the series, as you rightly describe in your posts (and that I omitted in mine). Rosenbaum and especially Drazen are being reactionary. The latter keeps referring to Pharma scandals as a few over-publicized anomalies. Of course, the nefarious entanglements of clinical practice and industry promotion, and also academic medicine and industry, are pervasive and well-documented. Extremist critics may unfairly overreach, but that’s a mere footnote on the main story: that industry bias and influence are alive and well. Rosenbaum’s papers may not represent a reversal of policy at NEJM, but Drazen’s comments, and his publication of this series, certainly seem to be.
I also don’t fully follow what Horton is saying, but I agree that scrutiny of the “academic industrial complex” and similar conflicts of interest ideally lie somewhere between the two extremes of unthinking complacency and knee-jerk indignation. My own view is that a re-embracing of traditional medical ethics, as opposed to business ethics, would help steer us back to where we belong.
“My own view is that a re-embracing of traditional medical ethics, as opposed to business ethics, would help steer us back to where we belong.”
Well said and surely the right path. I’ve internalized that there shouldn’t be the possibility of a conflict of interest. Seems mighty close to knee-jerk if not quite knee-jerk indignation. But it just doesn’t seem fair to the reader of a review article for them to have to “wonder.”
“there shouldn’t be the possibility of a conflict of interest”
Perhaps my view is colored by chairing my medical center’s CME Committee for nearly 10 years now. I originally got involved to keep Pharma out of our professional education. In the meantime, Pharma largely left of its own accord (I’m not complaining). The commercial influences on proposed CME events at my institution became subtler and more rare. My committee’s charge is not to preclude the possibility of COI, but to investigate and “resolve” possible COI, rejecting any proposal where irresolvable COI exists. E.g., a talk may be given about basic pathophysiology by a speaker with COI about treatment options, as long as treatment isn’t discussed. Occasionally we reject a proposal outright when the topic directly relates to the speaker’s business interest; sometimes we reject a proposal after reviewing their PowerPoint. But often, even “possible COI” turns out to be nothing — and I take my role quite seriously. I realize some “de minimis” bias may slip through the cracks, but by that point it’s in the noise of all the other minor pushes and pulls that affect any speaker. Of course, we always ask the audience afterward to evaluate the quality of the CME, including any perceived bias, and adjust our protocols accordingly.
I think the role of a journal editor should be similar. Yes, it isn’t fair for the reader of a review article to have to “wonder.” That’s what editors are for. If those editors upheld journalistic standards — and scrutinized possible COI — the way we physicians at large should uphold ours, neither our publications nor our practices would be vulnerable to the ever-present commercial interests that surround us. Anyway, that’s enough from me, I wonder if anyone else has any thoughts… Thanks for your stellar work on this blog.
I had dinner with a recently retired sales manager for a drug company. We agreed on several points. The drug business has changed. He spoke of a time where the drug reps and doctors had a personal relationship and sales as a number were not so important.
He tied the change to the increase in attractive people with little or no drug knowledge moving into the sales force. I related how I had to explain ritualistic feeding and the power of this on another blog several years ago.
We also agreed on how unsophisticated doctors are concerning business and conflicts. I related hearing verbatim TV and print ads relating drug information not relevant to my condition. He related paying doctors a fee for “market” research while sending in sales reps who pounded their message home. He considered it a success when I related my experience.
He related how drug companies now want all of the sales reps on some type of disciplinary program. They can never sell enough. He was reprimanded for writing good job on a reps monthly report. One set of reps were on their way out the door when a change in sales calculations from raw numbers to market share moved them from the bottom to the top of the sales list.
Pharma has changed and while there may be a residual glow from years past going forward doctors and patients must realize they are at their core a sales organization. The worse day in pharma is better than the best day in any other business.
Remember this, and the billion dollar fines are just the cost of doing business in the promotion of a multi-billion dollar selling drug.
Steve Lucas
i’m not surprised by the tone of the article and i’m in agreement with you dr mickey.
i respect dr horton very much and i think he has done a great job as lancet’s editor. i know some detractors do not like his politics but i think they’re usually fair and from the heart.
that being said, to mistake dr horton’s piece as his own opinion would be frightening. it’s pretty clear if you look at some of the accepted articles in the lancet, that some things are above his control. the lancet is an extremely prestigious journal, and there will be occasions where Elsevier tells him to ‘put a sock in it and do his job’.
being that it is elsevier’s most cherished publication, and noting that dr horton was forced to accept an editorial arguing that effects of antidepressants (which was funded by deutsche bank etc) are UNDERESTIMATED:
http://www.behaviorismandmentalhealth.com/wp-content/uploads/2014/05/Do-we-underestimate-the-benefits-of-antidepressants.pdf
do not take this piece as gospel. this is literally elsevier saying ‘do this, or we’ll fire you. if you don’t make it sound authentic, we’ll fire you’.
Gagan,
That explanation helps. I go hot and cold on Horton, and this is a very plausible explanation for why. Thanks
The way this NEJM and BMJ have framed and polarized this debate makes me very uncomfortable as well. This is beginning to feel like another pissing contest– not real popular with either the players or the spectators.
I would agree is that ethics is the central issue, but perhaps ethics in a broader sense that goes beyond vigilance about the influence of the profit motive in academic publications.
Conflict of interest is about more than money, as many have pointed out in earlier posts here. It’s more than prestige, or the pleasure of conversation with an intelligent and engaging company representative– though it’s vitally important to bring all that into the light of day, and this blog has done that better than any other resource I’ve explored. The most insidious secondary gains may be the ones that are not measured in currency.
I think of ethics as also including a commitment to not pretending that we understand things that are not yet understood, even if that makes us desperately uncomfortable, or even utterly miserable. Not looking for simple answers when, if we were really honest with ourselves, we know there could not possibly be any.
On a practical level, this means not using hard science methodologies for inappropriate applications in the softer ones– not relying on double-blind RCTs with huge sample sizes and byzantine designs when a smaller study would be likely to give a more useful result. Not using clinical assessment instruments to measure the efficacy of neuroleptic agents just because they are handy, or have demonstrated validity and utility in some very different context.
We can’t push past the limits of our understanding until we admit what those limits are.
Catalyzt,
Eloquently put…
Thanks
Global health folks sort of have to play nice with pharma because the issue is not overtreatment, it’s undertreatment. Whenever Paul Farmer talks about pharma in his lectures, he makes a point of acknowledging that PIH have been criticized for cozying up to pharma and his reply is “we WANT them engaged, we want them to give us free drugs”. Lancet is not only a global health journal but many would argue it is the flagship global health journal. So Horton does need to take care not to make them too mad.