I first heard the term ghost-writing used in the scientific literature at the end of 2010 [see roaches…]. I must’ve known what was coming because I added added the roach to the ad image [from something our exterminator said, "For every roach you see, there are a hundred behind the walls"]. S
ure enough, six months later I got hold of The Rothman Report [see detestable…] that described a medical writing firm ghost-writing Risperidone® articles faster than they could find guest authors to front them. I guess one can only take in so much at a time. I exhumed that old STI ad to show the top line, the significance of which eluded me at the time – publication planning, advocacy development.
If you read the content of that STI ad, it talks about a lot more than just medical writing, but I was slow to catch on – apparently a lot of us were. By the time I saw the ad in 2010, Scientific Therapeutics Information Inc had been at it for a very long time [for example, managing the Paxil Launch in 1993]. Since then, it has gradually dawned on us that most all of the industry funded clinical trial articles in psychiatry are ghost-written. And these days, it’s right there in the Acknowledgments under editorial-assistance-provided-by. So exposing professional ghost-writing hasn’t made much of a difference [see rebranding…]. Industry and journal editors just adapted.
by Lisa Cosgrove, Steven Vannoy, Barbara Mintzes, and Allen ShaughnessyAccountability in Research. 2016 23[5]:257-279.
The relationships among academe, publishing, and industry can facilitate commercial bias in how drug efficacy and safety data are obtained, interpreted, and presented to regulatory bodies and prescribers. Through a critique of published and unpublished trials submitted to the Food and Drug Administration [FDA] and the European Medicines Agency [EMA] for approval of a new antidepressant, vortioxetine, we present a case study of the "ghost management" of the information delivery process. We argue that currently accepted practices undermine regulatory safeguards aimed at protecting the public from unsafe or ineffective medicines. The economies of influence that may intentionally and unintentionally produce evidence-biased-rather than evidence-based-medicine are identified. This is not a simple story of author financial conflicts of interest, but rather a complex tale of ghost management of the entire process of bringing a drug to market. This case study shows how weak regulatory policies allow for design choices and reporting strategies that can make marginal products look novel, more effective, and safer than they are, and how the selective and imbalanced reporting of clinical trial data in medical journals results in the marketing of expensive "me-too" drugs with questionable risk/benefit profiles…
… and then reading one of Karen Dineen Wagner‘s depositions [see author·ity…] –
| DEPOSITION OF KAREN DINEEN WAGNER, M.D., Ph.D. by Michael Baum, Esq., of Baum, Hedlund, Aristei & Goldman on Tuesday, July 16, 2013, page 28 [pdf page 8] |
|
| QUESTION Okay. So do you recall whether you had access to patient level data when you were working on this publication? | |
| ANSWER No. We have access — well, as an individual investigator, you have access to your patients. But the individual patient data from other sites, usually when the data is presented, it’s put together. So I don’t — I just don’t recall if I saw individual — individual data. | |
| QUESTION When you say "put together," does that refer to the pharmaceutical company compiling information and providing it to you? | |
| ANSWER The data is the property of the pharmaceutical company. | |
| QUESTION And so they collect it and provide some form of summary of it to you? | |
| ANSWER Correct. | |
| QUESTION And except for the patient level data that you had from your own particular site, you relied upon the information conveyed to you by the pharmaceutical company regarding the other sites. Is that correct? | |
| ANSWER In multicenter studies, each individual investigator has their own data and then it depends who sponsors the study. This was a Forest-initiated and Forest-sponsored study, so all of the data from the sites go to Forest. | |
| QUESTION Then they compiled it and then did statistical evaluations of it? | |
| ANSWER Yes. | |
| QUESTION Did you do any of the statistical evaluations yourself? | |
| ANSWER No. | |
| QUESTION It was essentially provided to you by Forest statisticians? | |
| ANSWER Correct. I’m not a statistician. | |
– that she hadn’t actually seen the data or participated in the analysis, even as a Principle Investigator for the study. And it wasn’t just that fact itself. It’s that she said it in such a matter-of-fact way, like what she was saying was some kind of explanation that we should understand. It reminded me of a piece from several years back that addressed what happened when a recruited author insisted on actually seeing the study data. See selling seroquel VII: indication sprawl… for a telling example in which Nassir Ghaemi did exactly that, and was summarily unrecruited.
I synopsized my own dawning awareness here because without having gone through that process, I doubt I could’ve read Alastair Matheson’s papers and really understood them. I might have seen his waving us off of focusing so much on ghostwriting [Ghostwriting: the importance of definition and its place in contemporary drug marketing] as a bias from his years working in industry. But that’s not how I see his writings now. He brings a fresh point of view to the discussion of this pharmaceutical invasion of the medical literature, having spent close to twenty years doing many of the things we write about [see rebranding… and directly as he proposes…]. He’s an "insider":
"I worked on over one hundred drugs, most of which were, in my estimation, mediocre products that could be better pitched if a more persuasive scientific angle could be found for them. I visited corporate headquarters and congresses; analyzed markets, products, and competitors; groomed key opinion leaders; ghostwrote manuscripts; developed publications plans; and devised marketing strategies."
- Published articles on science, commerce and publication ethics
- Unpublished empirical investigations
- Themes and reflections
Such devices are widespread in medicines peer-reviewed journal literature. But who is behind them, and whose interests are served? Here we come to the crux. Everyone is behind them, and each party benefits in its own way. Companies get the elixir of endorsement on which advocacy marketing depends; academics reap the rewards of authorial status and generally fed that they deserve top billing; journals sell reprints; and culturally I believe, academic medicine and its journals crave the sense that the research scene remains in their hands. It is customary for academic “investigators" to be placed at the front of the byline, and indeed, it is understandable that readers who will prescribe the drug want to read the opinions of qualified peers who have used it in their patients…
"Let me then define contemporary advocacy-based marketing punctiliously, as a practice in which content with potential commercial or promotional utility is planned, convened, funded, influenced or owned by a company, but communicated by, or disproportionately attributed to, the peers or opinion leaders of the intended customers. Advocacy marketing thus defined is routine in medicine and its scholarly literature, and the chief policy conclusion of this essay is that it should be banned outright."
Is that a cockroach in the STI header!!! How interesting.
Or did you photoshop that in Mickey?
yeah,
see roaches…
My first free association upon reading the above:
https://images.duckduckgo.com/iu/?u=http%3A%2F%2F1.bp.blogspot.com%2F-UHgyuKXbdX0%2FTfyWAjjs8lI%2FAAAAAAAAGZw%2F4fXVGmyAQNA%2Fs1600%2FSgt%252BSchulz.jpg&f=1
Thank you for this excellent summary of the integration problem. But recognizing the pervasive distorting/corrupting effect of integration does not let PhARMA, all professionals in the “mental health industry” (not just psychiatry), and the media off the hook on the subject of subterfuge.
It isn’t either/or. Even if finances and research were clearly separated, PhARMA would still lie for profit, and many professionals with a stake in seeing “mental health” as primarily biological would still make use of PhARMA’s distortions.
Strict standards of transparency in all research and publication need to be enforced across the board. Professionals who cross the line need to know they risk sanctions for malpractice and loss of licensure. PhARMA should live in fear of private civil suits and criminal prosecution for fraud (with individual liability as well as corporate fines on the table).
The AMA and APA should monitor PhARMA’s publications (“scholarly” and otherwise) and clearly disavow the hyperbole and lies. Had that occurred, we might have been spared decades of the “chemical imbalance” trope.
Thank you for this outstanding web site – professionals grappling honestly, in-depth and intelligently with crucial issues. It is invaluable. But I want to put in a word for other sources that can seem “unscientific” or “disrespectful” to doctors. For instance, while ghost writing first came to Dr. Nardo’s attention in 2010, I witnessed David Healy’s full exposition of ghost writing, integration and subterfuge at a 2004 conference organized by Peter and Ginger Breggin. I have a DVD of that presentation. David Healy’s book “Mania” (Johns Hopkins Press) laid it all out again in 2008.
If you haven’t already, check out the work of Britain’s Critical Psychiatry Network, or the British Psychological Society’s Division of Clinical Psychology (“Time for a Paradigm Shift”), ISEPP; Foundation for Excellence in Mental Health Care, Mad In America, MindFreedom International, the Hearing Voices Network. Also developments based on Finland’s Open Dialogue method. Have you read Recovery From Schizophrenia – an International Perspective (the final report on the WHO’s longitudinal studies)? Or the writings of David Healy, Jay Joseph, Grace M Jackson, Richard Bentall, Joanna Moncreiff, Barry Duncan, Mary Boyle, Alison Bass – and yes, Peter Breggin?
Some “alternative” writers and organizations can seem undecorous. But many are sound scholars and keen observers. They often prove right – like those who clamored for years about the very things Dr. Nardo has so well summarized here. And the tone of many advocates is understandable: those with “lived experience” have been dismissed for decades because they were “crazy.” They need to be heard – out of human decency, and because what they have to say is important.
All voices are important. Dr. Nardo’s and others are crucial as well – we need people to take a deep dive into the peer reviewed literature to see if it all adds up. But we also need the other voices. It is not always easy to look at the full spectrum, but it is important.
The issue I have raised in the past about some of the sources referenced above is not about them being unscientific or undecorous. One of the things I appreciate about 1bom’s writings is that he, for the most part, takes a what’s good for the goose is good for the gander approach to his own sacred cows (to mix metaphors). I am NOT arguing that clinical trials should be the end all be all and should be considered gold while clinical experience is considered lead. I am saying that to the extent one considers clinical trial information relevant that at least somewhat similarly rigorous standards of criticism should be applied to studies that comport with your clinical worldview as those that don’t. I don’t always agree with them, and it could be debated whether they are always decorous, but 1bom and Carroll come closer to doing that than most. 1bom to me embodies “Critical” psychiatry more so than some who take on that mantle. Having said that, if there is one doc in the forum who seems to take pains to give the references you mention their due it would seem to me to be 1bom himself. I have learned a lot from some of those resources (I first learned of the handling of Study 329 through Ms. Bass’ book for instance) but there is often enough a worldview that is too incongruent with my clinical experience, and a rigidity (va rigorousness) of thought that has made it difficult for me to often recommend them to my colleagues.
1bym,
I agree that 1bom is notably careful to be fair and rigorous, and almost all comments on this site are also thoughtful, showing a real desire to be fair. Everyone here is to be congratulated on that.
Re your, “… worldview that is too incongruent with my clinical experience …”: much of the problem we all have in addressing mental/emotional suffering is precisely one of “worldview.” That goes for social work, counseling, psychotherapy, psychology and psychiatry – we often can’t see things that are too out of step with our assumptions.
In particular, institutional psychiatry does little in-depth examination of its ultimate null hypothesis – that severe human emotional suffering is fundamentally a problem of some disease process, best addressed by physically invasive interventions. As institutions, the other “mental health” professions, having little money or courage of their own convictions, are feeble in offering and researching serious alternative null hypotheses.
Hence, one social worker I know gets results others simply don’t get, leaving them asking, “What did you do?” It can’t be explained in terms of their world views, they are unwilling/unable to extend those world views, and so they continue not to understand and go on about their business.
I think the same may be true of outsiders looking at Open Dialogue’s results with first episode psychosis, obtained without diagnosis and with few drugs – it is hard to conceive of within the standard U. S. clinical setting. Luckily, some here are attempting to put Open Dialogue to the test, so we may get a better idea of its usefulness. Ditto the World Health Organization’s long term findings about recovery from “schizophrenia” in developing countries. Both examples may be flawed, but the point is the mental health industry has so little curiosity about them that they are never seriously investigated.
I think it’s worthwhile for all of us to occasionally expose ourselves to approaches outside our own world views. The approaches may or may not work or convince us, but I think something is gained in the attempt.
Correction – as everyone undoubtedly saw, I gave hypothesis instead of null hypothesis.
I would like to think that strive to grapple with my assumptions, but would agree that doing so is challenging and I remain uncertain as to how effectively I do it myself.
I think that the hypothesis you suggest is sadly all too true of too much of institutional psychiatry. I should perhaps not use that phrasing, out of deference to George Dawson’s thoughtful criticisms of the overuse of the IP term, but it’s late in the week and it’ll do for this discussion I think.
However, I would like to suggest adding this corollary: institutional critical psychiatry perhaps does little in-depth examination of its ultimate hypothesis – that severe human emotional suffering is almost never significantly a problem of some disease process, and almost never necessitates at least adjunctive use of physically invasive interventions.
I am not sure that my corollary is any less or more true that your original version. Of what I understand of Open Dialogue and the work of the Hearing Voices network (as two examples), I don’t find them incongruent with my clinical experience. However, I have to admit that I do find incongruent the worldview that it is clear that the net benefit of physically invasive interventions to mental well being is so rare as to be almost mathematically insignficant. That they are almost always net destructive. That is for me much more than “outside.”
People need to speak their truth. Including those who hold that worldview. At the same time, sometimes the polarity of the discussions around mental health takes up so much oxygen that there isn’t much room for the kind of conversations that I think would also be beneficial. E.g., while the conflict of the two “ultimate” hypotheses above is important, so are conversations like this one:
http://www.nytimes.com/2013/04/28/magazine/our-feel-good-war-on-breast-cancer.html?pagewanted=all
It’s often hard to engage in a discussion about Melancholia vs MDD, or Bipolar Disorder Type 1 vs some huge mood spectrum, that parallels the one in that Orenstein piece. Because the discussion so quickly morphs to the “none of it is ‘real'” vs “real.” Again, people should have the right to express their views, but if almost every discussion is like Komen vs Cancer in America, then something feels lost.
<>
Wait are you saying life is a veil of tears and humans endure slings and arrows? I should write that down and publish it.
Life’s tragedy is that we get old too soon and wise too late. I should publish that one too.
1bym – Thanks for your thoughtful comments. The push-pull of bio vs psychosocial is a huge subject, but a (I hope, short) comment: Neither side at the extreme poles can prove their side wins by a shutout. But psychiatric drugs are like the old commercial – was it for Doritos? – “I bet you can’t eat just one.”
Everyone in institutional psychiatry seems to agree that the pills are “overprescribed.” But when it comes down to specific situations, we know how many pills are prescribed annually. Even Steve Scharfstein, as president of Sheppard Pratt and head of the APA, referred to the biopsychosocial model as too often amounting to the “biobiobio model.”
So, many critics of psychopharmacology understandably
don’t want to hear, “Sometimes it helps,” because of the justifiable fear that it is just the camel’s nose under the tent. I think many would be more flexible if institutional psychiatry were really open to Open Dialogue’s use of psychiatric drugs: no use unless the treatment team (including patient, family, other supporters) discusses the issue three times; use is to get patient through a crisis; try a short course of benzo’s first, before resorting to a short course “antipsychotics”; plan not to use the drugs long term. At 5 year follow up, most Open Dialogue patients are not on any psychiatric drugs; those who have used drugs have done so for a short time.
Open Dialogue adheres to its guidelines because the program is specifically organized that way and staff undergoes intensive training in the program. I would not hesitate to refer someone to them, because “Try this just for a short time” would mean exactly that. It would be madness to believe the same about Sheppard Pratt, Johns Hopkins, the Kennedy Krieger Institute, or University of Maryland Hospital. In 17 years as a social worker, I knew of only three psychiatrists in the Baltimore-Washington area who would have been different.
It’s a wide problem among intellectual elites in a log-rolling bubble and is not limited to psychiatry. Here’s a related article about this problem in economics and he mentions the replication crisis:
https://medium.com/@nntaleb/the-intellectual-yet-idiot-13211e2d0577#.z46v6ck2o
Googling Taleb I came across this review, and this puzzling statement:
“And some of his observations are just willfully perverse. He suggests, for instance, that administering mammograms to “women over 40 on an annual basis does not lead to an increase in life expectancy,” because a doctor, seeing a tumor, “cannot avoid doing something harmful, like surgery followed by radiation, chemotherapy, or both — that is more harmful than the tumor.””
http://mobile.nytimes.com/2012/12/17/books/antifragile-by-nassim-nicholas-taleb.html
How is that willfully perverse?
Taleb is an interesting cat and someone I’d like to get caught sitting next to on a plane:
https://en.wikipedia.org/wiki/Nassim_Nicholas_Taleb