In closely reading many of the Clinical Trials of the psychoactive drugs in the last thirty years, I found that the majority put varying levels of spin on the data. I didn’t expect that. I had spent my medical life believing that the Journal editing process and peer review process was a system that wouldn’t allow that. I was wrong as rain – wronger than I could have ever imagined.
Subsequently, I learned about things like ghost-writing, guest authoring, data manipulation techniques – something like an epidemic of corruption in our medical literature. When I first started to see these examples, I thought they were isolated incidents, but began to realize that deceit seems to have been the rule rather than the exception. So when people began to lobby for reform: funding declarations, conflict of interest statements, acknowledgement of authors, data transparency; it hardly seemed like there was any question that such measures were necessary, yet they have been heavily resisted.
One argument has been "what’s so wrong with editorial assistance?" Doctors are lousy writers. Ghost-writers produce much more readable articles. But ghost-writing is so much more than grammar and style, as this article makes clear. From my point of view, ghost-writing’s wrongness is self evident, but I think this article fleshes out the "why" of it in a compelling way:
Medical Ghostwriting and Informed Consent
by Almassi B.
Bioethics. 2013 . doi: 10.1111/bioe.12017. [Epub ahead of print]
Ghostwriting in its various forms has received critical scrutiny from medical ethicists, journal editors, and science studies scholars trying to explain where ghostwriting goes wrong and ascertain how to counter it. Recent analyses have characterized ghostwriting as plagiarism or fraud, and have urged that it be deterred through stricter compliance with journal submission requirements, conflict of interest disclosures, author-institutional censure, legal remedies, and journals’ refusal to publish commercially sponsored articles. As a supplement to such efforts, this paper offers a critical assessment of medical ghostwriting as contrary to good patient care, on the grounds that it contradicts established general principles guiding clinical ethics. Specifically, I argue that ghostwriting undermines trust relationships between authors and their readers, and between these readers and their trusting patients, and in so doing contradicts the duty of respect for patient autonomy by obstructing informed consent. For this reason, complicity in ghostwriting practices should be understood as a violation of the professional ethical duties of physicians and other healthcare workers.
Here are a few quotes along the way and the author’s conclusion:
Recent analyses characterize ghostwriting as plagiarism or fraud, and have urged that it be deterred through stricter compliance with journal submission requirements, thorough disclosure of conflicts of interest, author-institutional censure, legal remedies, and medical journals’ voluntary refusal to publish commercially sponsored articles. As a supplement to such efforts, I offer a critical assessment of medical ghostwriting as fundamentally contrary to quality patient care. While ghostwriting is a problem for research ethics, I argue here that it also contradicts established moral principles guiding clinical ethics. Specifically, medical ghostwriting contradicts respect for patient autonomy by impeding facilitation of patients’ informed consent, and as such should be understood as a violation of physicians’ professional ethical responsibilities.We may be especially but not exclusively concerned about authorship misattributions in journal publication. A former long-time drug company sales representative, Kimberly Elliott testifies that key opinion leaders can be handsomely financially compensated for giving lectures ‘largely based on slides supplied by the company’ – we might call this ghost lecturing. What Sismondo characterizes as ghost management includes corporate sponsors’ involvement throughout all phases of development and marketing, including but not confined to medical writers’ penned research and review articles made available for doctors’ ostensible authorship.… as described in The Observer in 2003:
Dr. David Healy, of the University of Wales, was doing research on the possible dangers of antidepressants, when a drug manufacturer’s representative emailed him with an offer of help. The email, seen by The Observer, said: ‘In order to reduce your workload to a minimum, we have had our ghostwriter produce a first draft based on your published work. I attach it here.’ The article was a 12-page review paper ready to be presented at a forthcoming conference. Healy’s name appeared as the sole author, even though he had never seen a single word of it before. But he was unhappy with the glowing review of the drug in question, so he suggested some changes. The company replied, saying he had missed some ‘commercially important’ points. In the end, the ghostwritten paper appeared at the conference and in a psychiatric journal in its original form – under another doctor’s name.I have suggested that critics of medical ghostwriting as an ethically and evidentially troubling aspect of contemporary commercialized research would do well to draw on the recognized professional bioethical duty of respect for patient autonomy, and specifically of the facilitation of patients’ informed consent. I have argued that ghostwriting obstructs informed consent by misleading (i) physicians and other medical professionals reading the research in published ghostwritten form, and (ii) these readers’ patients, themselves epistemically and medically dependent on their caregivers’ reliance on the testimony of ghostwritten research. I have argued that ghostwriting undermines critical assessment of the credibility of published medical research as expert testimony because of its authorial misattribution, and so encumbers physicians and other healthcare professionals assisting patients becoming to be sufficiently and accurately informed of their treatment options, benefits, risks, and other such considerations. Thus ghostwriting doubly undermines trust and the informed consent built upon it. Physicians have a compelling professional ethical duty, then, not to participate in ghostwriting, which should be clearly framed in medical education as contrary to trustworthy medical research and quality clinical care.
This is not to imply that professional medical writers have no place in medicine. Far from it: developing, acquiring, and publishing research can be a collaborative enterprise to which specialists bring their varied complementary strengths to the collective process. Writing and skill in scientific communication more broadly need not be disregarded as valuable specialized communicative contributions. A driving force behind commercial ghostwriting in medicine is to obscure the evidential weight of these varied intellectual contributions: making use of the value of authorship as an evidential indicator of research credibility while treating it as interchangeable and disconnected from research veracity. Authorship becomes a peculiar free-floating thing, able to be gifted and traded as long as these exchanges remain hidden. By recognizing transparency in one’s specific scholarly contributions to medical research as a requirement of medical ethics, as a matter of one’s duty of respect for patient autonomy, medical professionals can undercut this corrosion of authorship and so maintain trustworthy mechanisms of research publication.
My own take on this story has to do with the covenant between the sick and those who are entrusted with their care at any level. A medical researcher is no different from the primary care physician, obligated by the same ethic and responsibilities. Neither the marketing department at a pharmaceutical company nor the medical ghost-writer shares that obligation. In fact, often the task is the opposite – to make the drug look better than it is, safer than it really is.
If Martin Keller himself had written up Paxil Study 329, would he have concluded that Paxil was a safe and effective treatment for adolescent depression? I can’t know the answer, but my guess is that it would’ve been a lot harder for him to do that than it was for him to sign on to Sally Laden’s ghost-written version. Sally’s covenant was with the sales force of GlaxoSmithKline, not the patients who would be taking the drug – and that shows throughout the paper. In the David Healy example above, the real author was writing for the pharmaceutical company – not Dr. Healy.
In the Healy example, this statement is simply a lie, ‘In order to reduce your workload to a minimum, we have had our ghostwriter produce a first draft based on your published work. I attach it here.’ It’s an invitation to join in a different kind of covenant – and way too many accepted this kind of offer. Over time, it became something of a norm selecting for an upper echelon heavily populated by compromised pundits. The covenant between organized and academic psychiatry and mentally ill patients has become largely broken.
That ghost-management, ghost-lecturing, and ghost-writing have produced a ghost-specialty is self evident. The only real issue is what happens now? It is hardly likely that the current denizens of organized and academic psychiatry will be able to re-establish a rational covenant with the mentally ill among us…
Of course corrupted research is contrary to good patient care!
This is the problem with academic discussions, it takes hundreds of papers and years of conferences to come to a common-sense realization.
Finally I figured out that if put my url in the box, then my post will disappear. Too lazy to rewrite the posts that were lost, but I’d like to give you a heads up, Mickey. I posted a link to this post and an excerpt on my website at wileywitch dot com.
As always, your writing and the responses of people who comment here are helping me rethink psychiatry and psychosis in what I believe to be a fair and healthy way. Your website is invaluable.
Rock on.
Echoing wiley,
Your contributions through this website are of great value.
Thanks.
thnx, anonymous
Hi wiley,
Not to in any way disparage your website since I have not seen it, just wanted to clarify that I was echoing your comment that 1BOM’s website is of great value. Again, no offense intended in my clarification.
Though I do appreciate your posts Wiley so I guess I can also stick with your original thnx.
None taken. I understood your comment the first time.
I just notified Mickey because I don’t know how to do ping-backs, because I haven’t bothered to learn how to do them.
FYI
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
DENNIS S. CHARNEY, M.D. Dean
**Keynote Address**
“A Roadmap for Innovation in Psychiatry”
Innovations in Psychiatry Symposium
Advances in Understanding and Treating Depression
February 1, 2013
http://icahn.mssm.edu/static_files/MSSM/Files/About%20Us/Deans%20Office/Innovations%20in%20Psychiary%20Symposium%202-1-13_FINAL.pdf
1BOM, you would do a great service to devote some posts to what Jamzo just posted.
Jamzo, you would do a great service to post this to neuroskeptic. Particularly the claims Charney makes about imaging studies.
Jamzo,
I’m down in Florida for a few days and just took a look at the Charney Power Point you sent. I’m rarely speechless, but all I can think of to say is “OMG!”
Dr. Charney’s slides are a piece of work. The content descends into cargo cult hand waving, not to mention the loss of focus. You could call it throwing the kitchen sink at the model cargo plane. Lots of promissory notes that might keep the research dollars flowing, however.
Multiple layers of subghost-specialities are springing from its base in the unscientific “science” of Kraepelinian biopsychiatry, fed by ambition/money, the Big Business SuperGhost.
Years ago, starting on my journey to understand what was happening to/done to my young son, and to our family, I read (I do not remeber where or by whom) that the practice of psychiatry, at its best, is to try and see through lies in order to see more truth.
By this measure Standard Global Biopsychiatry is seen, by ever more of its recipients and honest practicioners, to have failed miserably.
Searches for truth are personal, unending, serendipitously giving us treasures not known beforehand, leading into what I hold to be the superior realms of philosophy, ethics and art.
I was fortunate. By the time of my son’s sudden heartstop and death at 28, I’d understood enough to have asked him to forgive me for thinking that psychiatry could/would help him, and other mistakes. “Mom, you could not have known,” he answered. He then said: “When you are old, I’ll help you, as you have helped me.”
The genetics of Bio-Psychiatry are damaged goods, its dominant genes ulterior to the best interests of vulnerable patients, ulterior to our variable, shared humanity.
Gravy train alert!
“Gravy train alert!”
And, therein lies part of the problem.
http://blogs.plos.org/retort/2013/03/02/discussing-obamas-brain-mapping-project/
Dr. Charney’s strategy will dovetail well with the $3 billion dollars that will be available if this gets greenlighted.
Charney, Nemeroff, Schatzberg and their ilk (and Charney is certainly right there with them, he’s just smarter about it), and the institutions and other researchers they represent, stand to get tens of millions out of this. And, they believe they are in the right since they have drunk the kool aid.
For 1bom, Dr. Bernard Carroll, …etc you have to fight this on your own time with the reward of? A feeling of righteousness?
Dr. Carroll’s message that the Charneys and Nemeroffs of the world are depriving more useful neuroscientific endeavors of prominence and money is right on. Cargo Science is always going to be more malleable and sexier.
But again, if you cannot convince major players that the Charney’s and Nemeroff’s of the world are costing them something they care about just as much as Charney et al want that money. Well then. Or at least sufficient impact their credibility with them. Well then.
Look at what is happening with the handling of electronic medical records.
Perhaps Charney can get referenced in the next State of the Union Address.
Who is going to finance a sufficient campaign for the kind of neuroscience we truly need?
I fear this fight is being lost.
Via comments on Neuroskeptic:
http://neuroself.com/2011/05/29/jonah-lehrer-is-not-a-neuroscientist/
“You see, the general public has wanted Lehrer to be a neuroscientist. And by this they haven’t meant they wanted him to have a PhD. I honestly don’t think they care about his degree. They want him – and anyone else they give the honorific – to understand the brain and then explain it. Pleasantly.
They want neuroscience to make as much sense as Jonah Lehrer’s writing does, and the brain to be as unthreatening as Jonah Lehrer makes it. He gives them hope that someday they’ll understand why they are bathing their neurons in all this alcohol and nicotine and caffeine and chocolate and Xanax and Prozac, and how they could better fiddle with whatever knobs are in that thing to bring on more and better happiness. And they want it to be like buying an iPhone. They want it to be intuitive and fun.”
Those who believe that neuroscience research really does have a very important contribution to make over time (gradually and by inches over the decades & within the context of human relationships and all the complexity that entails) to alleviating suffering need to figure out how to come up with effective counter messages to cargo cult applied neuroscience (CCAN?)
The charlatans aren’t doing the most harm. It’s the PT Barnums.
This is just beginning.
Ed Yong put it beautifully in a comment over at Neuroskeptic:
“Selling attractive narratives at the expense of interesting truths.”
At the expense of possibly important truths.
The problem is that the Charneys of the world bring in money. And, often that money would not be there for the good, as well as the rest, if not for them.
That’s a crying shame. That, combined with the level of entrenched power they hold, is going to be a very hard but to crack.
The brain is crucial. The study of the brain is crucial and deserves resources.
We just shouldn’t have to pay the price extracted by Charney, Nemeroff, et al to get it.
Just in case you think that Drs. Charney and Fava, and their message, will be fading from psychiatry any time soon:
Look under “Clinical Neuroscience, Psychiatry, Addictions” at the “One Mind for Research” Site
http://www.1mind4research.org/scientific-planning-committee
There are some enormously intelligent and gifted researchers under the “Additional Contributors” section. This is not a minor endeavor. Especially in the context of President Obama’s recent statement in his State of the Union Speech.
Looking at 1BOM’s and Dr. Carroll’s comments above: I’m not sure where you see things going for these coming 10 years but, to paraphrase an earlier post on this site, I don’t see a “new car” on the horizon anytime soon.
Nemeroff and Keller may have suffered some for their possible excesses.
But, Charney and Ryan are in greater positions of power than ever before.
See the video:
Keynote: Neuroscience for Mental Health: Lost in Translation?
Speaker: Tom Insel, National Institute of Mental Health
http://1mind4research.org/highlights-2012-one-mind-research-first-annual-meeting-may-23-25-2012
The ingenuity of some of these approaches is impressive. As an example, and one of the approaches referenced in Dr. Insel’s talk:
http://www.nature.com/nmeth/journal/v8/n1/full/nmeth.f.321.html
This is not a simple fight.
A bit more background:
http://neuromancy.southernfriedscience.com/?p=59
“Optogenetics” sounds as esoteric as “Das Ding an Sich”, until one gets familiar with these vocabularies and thinks one understands and can talk about ever more particles within the universes of the brains of mice and men – or the great Universe in which we are particles in an infinite.
I thank Annonymous – one or several – for links to interesting articles. When I let myself loose and lost in these realms, time flies while everyday chores are neglected. As in politics. Shiny projects deceptively outshine practical politics, for instance Single Payer Health Care for every American citizen and humane Care instead of business commodification…
as I think is dr Carroll’s point also.
From http://www.homelesstaksforce.org
The wealthiest nation on Earth has the widest gap between rich and poor than any other nation.
The fastest growing group of homeless people is children under the age of 9 years old.
More future patients in line for something new, something neuropsychiatric?
Shame.
Would recommend listening to the “476: What Doesn’t Kill You” episode of This American Life. Specifically the story of the woman who swallowed objects. It is a reminder that there is something noble that the most interventionist of psychiatry can accomplish. This is NOT to excuse the behavior of those who would use such stories as a shield for the behaviors you are criticizing. Nor those who extrapolate from such cases to justify whatever they wish to promote.
Just that the story is a striking reminder of the complexity of some of those who might down the line genuinely benefit.
Funnily enough, since she received the treatment through MGH, the physicians who helped her are probably heavily connected to one industry or another.
http://www.homelesstaskforce.org the importance of spelling…
Yes, Annonymous. It’s likely that down the line some might benefit from neuroscientific research, future remedies, future therapies. But I don’t accept that these endeavours are of greater value to society than everyday needs for affordable homes, equal access to health care, education. Politics. Priorities…
Conversely, I would not accept that the everyday needs for affordable homes, equal access to health care, education would entirely trump society’s/humankind’s need for long-term basic research into these kind of questions. I believe that a greater belief in the need for such work, even without clear short-term tangible benefits, would reduce the push for premature translation and monetization. It has been in part too strong a call for prioritization that has marginalized basic research and has advantaged the hucksterism that currently plagues the system. These basic science endeavors are a drop in the bucket in terms of budgets.