Back in February 2012 [a book review…], I read an article by statistician Robert Gibbons et al that purported to be a meta-analysis showing that antidepressants are effective in adolescent depression and are not associated with suicidality as a side effect. It turned into a cause célèbre when I found that he made a habit of opposing any Black Box Warning. He’d done it with Neurontin® before. Since then, he’s done it with Chantix®. His pattern has been repetitive. He reports on data from the drug company given to him exclusively – not publicly available – attacking the FDA’s Black Box Warning. Then there’s a simultaneous media campaign that follows [very monotonous…]. The papers don’t show the data and are filled with so much statistic-ese that I can’t really vet them. My presumptive conclusion has been that he’s a PHARMA shill, specifically working for Pfizer/Wyeth [since their drugs are involved]. When confronted about his articles, he generally spits back.
In another thread, Dr. Gibbons has been developing some computerized psychometric screening tools for anxiety and depression, funded by the NIMH:
by Robert D. Gibbons, David J. Weiss, Paul A. Pilkonis, Ellen Frank, Tara Moore, Jong Bae Kim, and David J. Kupfer.American Journal of Psychiatry. published on-line Aug 9, 2013
Conclusions: Traditional measurement fixes the number of items but allows measurement uncertainty to vary. Computerized adaptive testing fixes measurement uncertainty and allows the number and content of items to vary, leading to a dramatic decrease in the number of items required for a fixed level of measurement uncertainty. Potential applications for inexpensive, efficient, and accurate screening of anxiety in primary care settings, clinical trials, psychiatric epidemiology, molecular genetics, children, and other cultures are discussed.
The Computerized Adaptive Diagnostic Test for Major Depressive Disorder [CAD-MDD]:
A Screening Tool for Depressionby Robert D. Gibbons, Giles Hooker, Matthew D. Finkelman, David J. Weiss, Paul A. Pilkonis, Ellen Frank, Tara Moore, and David J. Kupfer.Journal of Clinical Psychiatry. 2013 74[7]:669–674.
Conclusions: High sensitivity and reasonable specificity for a clinician-based DSM-IV diagnosis of depression can be obtained using an average of 4 adaptively administered self-report items in less than 1 minute. Relative to the currently used PHQ-9, the CAD-MDD dramatically increased sensitivity while maintaining similar specificity. As such, the CAD-MDD will identify more true positives [lower false-negative rate] than the PHQ-9 using half the number of items. Inexpensive [relative to clinical assessment], efficient, and accurate screening of depression in the settings of primary care, psychiatric epidemiology, molecular genetics, and global health are all direct applications of the current system.
by Gibbons RD, Weiss DJ, Pilkonis PA, Frank E, Moore T, Kim JB, and Kupfer DJ.Archives of General Psychiatry. 2012 69[11]:1104-12.
CONCLUSIONS Traditional measurement fixes the number of items administered and allows measurement uncertainty to vary. In contrast, a CAT fixes measurement uncertainty and allows the number of items to vary. The result is a significant reduction in the number of items needed to measure depression and increased precision of measurement.
by Bernard J. Carroll, MBBS, PhD, FRCPsychJAMA Psychiatry. 2013 70[7]:763.
In summary, it is very clear that Carroll is not a fan of multidimensional item response theory and computerized adaptive testing as applied to the process of psychiatric measurement. It is, however, completely unclear that his lack of enthusiasm is based on any scientifically rigorous foundation. Indeed, his knowledge of these methods seems lacking. Finally, Carroll is quick to point out the acknowledged potential conflicts of others as if they have led to bias in reporting of scientific information. In this case, it is Carroll who has the overwhelming conflict of interest. As developer,owner,and marketer of the Carroll Depression Scale–Revised, a traditional fixed-length test, it is not surprising that the paradigm shift described in our article would be of serious concern to him.
by Robert D. Gibbons, PhD, David J.Weiss, PhD, Paul A. Pilkonis, PhD, Ellen Frank, PhD, and David J. Kupfer,MD.JAMA Psychiatry. Published Online: November 20, 2013. doi:10.1001/jamapsychiatry.2013.3888
To the Editor: We apologize to the editors and readers of JAMA Psychiatry for our failure to fully disclose our financial interests in an article1 that reported a diagnostic tool, the Computerized Adaptive Test for Depression [CAT-DI]. Following acceptance of the paper, we disclosed that “The CAT-DI will ultimately be made available for routine administration, and its development as a commercial product is under consideration.” The company that owns the rights to CAT-DI and several related tests is Psychiatric Assessments, Inc [PAI], which uses the trade name of Adaptive Testing Technologies [ATT] on a website describing these tests. Lead author Robert D. Gibbons, PhD, is the president and founder of PAI,which was incorporated in Delaware in late 2011, then registered to do business in Illinois in January 2012. Dr Gibbons awarded “founder’s shares in PAI” to us, yet all 5 of us failed to report our financial interests in connection with our article and again in a Reply to Letters to the Editor regarding the article. Neither PAI nor ATT has released the CAT-DI test [or any other test] for commercial or professional use, but our ownership interests were relevant to the research article and Reply we submitted and should have been disclosed to the editors. Our submitted disclosure lacked transparency, and we regret our omission.
Hint: When it is made by the Chairman of the DSM-5 Task Force.Healthcare Renewalby Bernard CarrollNovember 21, 2013
As I am not a person who suffers fools or insults gladly, their evasive response caused me to do some checking. I quickly learned that the gang of five are shareholders in a private corporation. Before their paper was accepted by JAMA Psychiatry, the corporation was incorporated in Delaware and soon after registered to do business in Illinois. Those facts were not disclosed in the original report or in the published letter of Reply to me. These omissions were acknowledged in the notice of Failure to Report that appeared on-line today.
It gets worse. Other things that I learned – and that I communicated to the journal – make it clear that the corporate train had left the station in advance of the letter of Reply. For instance, a professional operations and management executive [Mr. Yehuda Cohen] had joined the corporation. He had established the corporate website, where he was featured as a principal, along with the gang of five. The website also displayed a professionally crafted Privacy Policy, dated ahead of the letter of Reply. This document identified what appears to be a commercial business address for the corporation. The notice of Failure to Disclose is silent on these facts.
So, the published notice of Failure to Disclose still withholds pertinent information, which makes a mockery of the weasel words that they have not released any tests for commercial or professional use. Not yet, they haven’t. But they are under way, make no mistake. This prevarication creates the impression of a habitual lack of transparency. Considering that I gave the journal all this information, one has to be surprised that JAMA Psychiatry went along with this prevarication. Plus, would it have killed them to apologize for their foolish attempt to smear me, as I requested? In correspondence with me, the Editor in Chief of JAMA didn’t want to go there, and he refused to publish my letter that detailed the facts, citing the most specious of grounds. The Editor of JAMA Psychiatry has ducked for cover when I faulted him for publishing the ad hominem material in the first place.
It hasn’t been lost on any of us following the story that there’s something very suspicious about Dr. David Kupfer being part of this project. Why is he part of an effort to develop a product to screen for anxiety and depression in waiting rooms of doctor’s offices? That’s hardly his usual line of work. But lest one question his being a member of the PHARMA-friendly KOL set, one doesn’t have to look very far – like to the recent further assault on the antidepressant Black Box Warning [stories like the one told here…], published by the Journal of Psychiatric Research [with article authors and an editorial board that reads like a Who’s Who from this KOL Klan]. But what about Dr. Kupfer’s involvement with this psychometric CAT-DI/CAT-ANX business? That’s where the story is headed.
… But I have an even further complaint.Throughout the whole DSM-5 process, they kept talking about adding a "cross-cutting" "dimensional" diagnostic system into the DSM-5. For a long time, I couldn’t even figure out what they were talking about. Towards the end, I finally got it that they were referring to symptoms that "cut" "across" the diagnostic entities – things like anxiety or depression. I was horrified, because I projected that the next step might be asking the FDA to approve medications for these "cross-cutting" diagnoses. Doing a clinical trial on symptomatic anxiety or depression seemed a sure road to rampant over-medication to me. But by the time I figured out what they were talking about, it was clear that the APA trustees weren’t going to approve adding this dimensional system, and I kept my fears to myself.
But when I saw these articles about quick screening tests for anxiety and depression, paid for with NIMH money, a part of a commercial development company, my conspiracy theory radar began to beep out of control. I’m no fan of diagnosis by a symptom list anyway. So the notion of waiting room screening for psychiatric symptoms leading directly to some symptomatic treatment with medications was bad enough. But for the leader of the DSM-5 Task Force who was pushing to make this dimensional system part of the DSM-5 to be involved in a commercial enterprise that would opportunize on the addition takes this story to the level of certifiable scandal.
Behaviorism and Mental Healthby Phil HickeyDecember 23, 2013
INTERPRETATION
It is difficult to put a benign interpretation on Dr. Kupfer’s role in this matter. It is clear that he believed in the merits of the dimensional system, and that, in his role as DSM-5 Task Force Chair, he promoted this system with as much vigor as he could muster. Even when the APA Board of Trustees voted in December 2012 to retain the categorical approach, he laid the structural groundwork for the introduction of dimensional assessment at a later time, and crafted a numbering system [5.1; 5.2; etc.] whereby the manual can be updated easily and at frequent intervals.
During the DSM-5 deliberations, it was obvious to anyone that if the APA replaced the categorical model with a dimensional model, then there would be a vastly increased market for dimensional rating scales, and that the profit potential was enormous. Given all of this, and given the lack of transparency in the Gibbons et al article, it is difficult to avoid the conclusion that Dr. Kupfer’s motivation was at least partly financial, and that he used his position as DSM-5 Task Force Chair to further his own financial agenda.
If a more benign interpretation can be put on these events, I would be interested in hearing it. But it’s clear that psychiatric credibility has taken yet another hit. Dr. Kupfer is a graduate of Yale’s medical school. He joined the University of Pittsburgh in 1973, and became chairman of the psychiatry department in 1983. He continued as department chair until 2009, and is now a professor of psychiatry at that establishment. He has published more than 800 articles, books, and book chapters, and has served on the editorial boards of various journals. And, of course, as mentioned earlier, he served in the prestigious position as chair of the DSM-5 Task Force. He is, in every sense of the term, an eminent psychiatrist.
So I am left with two questions: Firstly, why hasn’t Dr. Kupfer issued some kind of explanation for the lack of transparency? The JAMA Psychiatry letter of apology was just a stark statement of fact, which leaves a huge cloud of doubt not only over Dr. Kupfer, but also over DSM-5 and psychiatry generally. Secondly, why are we not hearing widespread expressions of concern from psychiatry about this matter? To the best of my knowledge, the only psychiatrists who have spoken out on this are Bernard Carroll, who exposed the matter in the first place, and Mickey Nardo, who has been retired for ten years.
This kind of silence in these kinds of situations has become characteristic of psychiatry, through scandal after scandal, in recent years. It is very difficult to avoid the impression that neither psychiatry’s leadership nor its general body has any interest in ethical matters. There is only one agenda item in modern American psychiatry: the relentless expansion of psychiatric turf and drug sales. They’ve promoted categorical diagnoses and chemical imbalances strenuously for the past five decades.Now that these spurious notions are on the point of expiration, psychiatry is developing dimensional diagnoses and neurocircuitry malfunctions as the rallying points of the “new and improved” psychiatry.
But the bottom line is always the same: turf and money. Something is truly rotten in the state of psychiatry.
Things like that last two paragraphs always make me wince. I feel defensive and always wish "organized psychiatry" had been substituted for "psychiatry." But I have to admit that I agree with everything Phil says including that "Something is truly rotten in the state of psychiatry." This is more than a scandal. It’s about a concerted effort to build the entire specialty of psychiatry around psychopharmacology; to make the change to diagnosis by symptom [anxiety and depression]; and to create a screening instrument for waiting rooms that skips even taking a history, wasting the doctor’s valuable time. Look at the printout, prescribe a psychotropic.
That’s a very fair summary. Your request for Dr. Kupfer to explain his undeclared COI is reasonable. And, as I said on Health Care Renewal, the editors of JAMA and of JAMA Psychiatry did not demand a high standard of candor and full disclosure, either. Subsequently, it appears Dr. Kupfer also failed to disclose his COI in a second publication, this time in JAMA. That second instance directly concerned DSM-5.
You are right to flag the risk of these mini-scales being used for quick and dirty evaluations. Indeed, the authors have declared the goal of making it possible to complete the scales using a cloud version on mobile devices, with the result being downloaded directly into the patient’s electronic health record! In my book, that is not responsible clinical management, especially when compounded by the authors’ failure to perform basic steps in scale development, such as test-retest reliability and discriminant validity. Their anxiety scale is especially weak.
Meanwhile, the game of non-transparency is still going on. In late November I brought this matter to the attention of the Director of NIH (Frances Collins) and the Director of NIMH (Thomas Insel). My specific query concerned whether the Gibbons corporation claimed proprietary ownership of data bases and algorithms derived from federal funding for the private benefit of their commercial activity. I received a reply from NIH, spelling out the applicable federal policy and stating that the data bases would be made available upon request by the Center for Health Statistics at The University of Chicago, which Dr. Gibbons directs. No mention was made of the algorithms.
In reply, I pointed out that Dr. Gibbons may have told NIH that the data bases are available upon request but that nobody else knows that, because there is no mention of this provision in any of the publications about these scales. Even worse, there is no public disclosure of this option on the corporate website. I suggested that NIH should give guidance to Gibbons, Kupfer, et al about the need for transparency in this matter.
A related issue concerns the unknown status of the corporation’s computing facility. I raised with NIH the question of whether Dr. Gibbons plans to provide the commercial service through the federally funded computing facility with which he is associated at The University of Chicago. If that is his intention, it may not be allowed under current federal policy. I also suggested that effective liaison between NIH and The University of Chicago about these issues would be appropriate, unlike what happened in the Nemeroff affair at Emory back in 2008. We’ll see what comes back next time from NIH.
Dr. Carroll,
Thanks for the additional information. And thanks for sticking with this story and the fine sleuthing! There’s nothing in this that’s good for psychiatry at any level. Such an instrument in the hands of busy primary care physicians could undermine all the concerted efforts many are making to curb this cult of overmedication. And from my side, I think Dr. Kupfer really is “participating in and encouraging a scheme to trivialize human experience.” There is nothing in the history or tradition of psychiatry or, for that matter, any other mental health field that supports that.
Specifically, the whole DSM-V/DSM-5 Enterprise was on a shaky trajectory from the start. Rather than attempting to refine the diagnostic system, they were using the revision to shape psychiatry to fit the agenda of a small but powerful group within psychiatry. That was the complaint about the psychoanalytic influences on the DSM-II in 1968 and the influence of the midwestern neo-Kraepelinians with the DSM-III in 1980. This time, they really blew it – and though I’m surprised that Dr. Kupfer seems to have had his finger in the dark side of this mess, it may be an example of the saying absolute power corrupts absolutely. Because as this story plays out, corrupt is increasingly the word that comes to mind…
WOW!!
Steve Lucas
Listening used to be such a valuable part of psychiatric care. Now the oligarchs of psychiatry are trying to patent and make an obscene amount of money from an instrument that has no scientific validity, and that controls the conversation to a degree that is overtly loaded in favor of a quick diagnosis and knee-jerk prescription for one of more drugs without having to have a conversation with the sufferer.
It isn’t “dehumanizing” so much as it’s dehumanized already, to the degree that humanity is an imposition that must be immediately thwarted in favor of an hypothesis supported by an industry that has to lie, cheat, and steal to give the slightest appearance of being scientifically grounded for the sake of making billions in profits. The mere fact that such huge amounts of money are being diverted from funding more productive and necessary investments in the human prospect is mortifying. Besides being able to provide money for appropriate extended care for disturbed people who cannot care for themselves and need sanctuary and personal care, and solving problems of homelessness and poverty, there are infinitely more better ways to spend the fruits of the labor of the world’s workers for the benefit of all. As it is, most of the people who need help with mental crises and suffering, are not getting the best care and too many are victims of polypharmacy that causes more problems than it solves. The dehumanized “it” of psychiatry is of one piece with the dehumanized structure of oligarchy and globalization.
In literature and film, we have apocalyptic scenarios of the human population being decimated or worse so that an individual person has value just for being human, instead of dreaming of taking down the institutions that diminish us. The “it” of psychiatry diminishes us with these glib little charts and questionnaires and it’s drive to medicate us— it can’t be bothered to listen to the little people any more because the little people can’t afford them. Those that want to talk about what is tormenting them are “lacking insight” or need to spend a lot more money than most people have for the privilege of being heard and not being given a label that could cripple them.
Glad to see you fine professionals slaying some of these dragons. Right now, really listening to what the KOLs are saying and criticizing it is the most valuable thing anyone could do for this field and it’s clients/victims. Personally, I find it deeply therapeutic to read the work of psychiatrists taking “it” to task, not least because I have benefited so much from psychiatrists/psychologists in the past. I haven’t benefited this much from psychiatrists/psychologists, since the eighties and whoo-hoo! it’s helping. I can hear them better, now, because I’ve heard them through you.
In the past, mental health professionals have helped me stop playing the “tapes” of the horrible things my parenting units said about me in the past. You guys helped me to stop playing the “tapes” of a decade of biological psychiatry. Life is so much rosier without them.
A few points from this excellent post:
First, it is an excellent post, I bow in awe to your research and thorough ties to all the commentaries above.
Second, although just reinforcing my earlier rude comment about how Kupfer reminded me of Mr Magoo, my apologies now to Mr Magoo, he was just an sensory deprived guy who would never do intentional harm to those around him.
Third, this just reinforces my disgust and dismay for any and all who continue to be members of the APA if Kupfer is a primary example of what this “organization” consists of per leadership. You are judged by not only who you associate with, but by silence and lack of dissent, you are guilty of being dishonest, disingenuous, and I think there is an element of criminality to some of this, again, just my opinion.
Lastly, I think there is an element of plain projection going on above in the assaults on Dr Carroll’s character here. And projection is usually practiced by characterologically impaired individuals who have either no clue how to be responsible and appropriate, or, if my criminality position has merit, truly behaviors of the antisocial.
Which I truly think is what pervades much of the leadership that trolls the halls of not only the APA, but a sizeable portion of psychiatric academia these past 15 plus years. Again, how do you with any conscience want to associate and support this type of thinking and action as a psychiatrist? That is a question posed to readers, not you Mickey!
Happy New Year, may the ball drop on some losers’ heads this year!
1bom,
Wow
Although I agree with much of what has been said, I do want to put in a word in support of the notion of dimensional assessments of symptoms. When we do not know what are fundamental “disorders’ and we do not even know if these exist in a categorical way, the use of a dimensional assessment that could then be followed over time – for whatever intervention one wants to employ – seems to be of use.
This system really does not do that. It seems to take a dimensional approach but then associates it to a disorder. I agree with all that has been said about the limits of this approach as well as the blatant conflicts revealed here.
I am reminded that prior to 1980 here was generally a vetting process practiced in our society. Those above, on the same level, and those a person supervised all had to have a positive impression of a person for them to advance.
In the last 30 ears we have moved away from this model.The young, baby boomers, have advance through often questionable means, withholding information, undermining others, and then claiming great superiority when announcing some hidden piece of information.
Today the very first comment to questioning a person’s theory is; you don’t understand. The conversation stops there or deteriorates into a personal attack like the one highlighted against Dr. Carroll.
This response is not limited to psychiatry but is found in all of society including the clergy and business. Ignoring the facts, or withholding the facts, for personal gain and then shouting down those asking questions has created a very course society where little discourse is accomplished.
Interestingly that 1980 date represents when the WW II veterans started to retire and their privileged, spoiled children started to assume positions of authority. Greed is good is still the battle cry of many who find themselves manipulating any situation, at any cost, for personal gain.
Steve Lucas
Sandy,
In general medicine, there’s an initial period where signs and symptoms function as diagnostic pointers. Some are pathognomonic and some are dimensional [pain, edema, dyspnea, etc]. After a diagnosis, in some cases, following symptoms is a way to follow treatment. In other cases, treating symptoms is something one does for the patient, but not very indicative of success with the disease itself, and sometimes both [diuresis]. In psychiatry, there’s always the temptation to see the symptom as the pathological process itself. The patients certainly think that way.
So I agree with you that having something to follow is part of initiating any treatment. I’m happy to think about that on a case by case basis, because when I extrapolate a dimensional system in the current environment, I see nothing but trouble for us and our patients. We are already in trouble with defining the symptom as the disease. And there’s a mammoth industry waiting to find a way to opportunize on symptomatic treatment. I should say, “opportunize some more” on symptomatic treatment. Were Dr. Kupfer’s dimensional system adopted, the next thing would be FDA approvals keyed to dimensions.
Since a lot of our medications are symptomatic anyway, that might seem like a good idea, but again, in the current climate, it would open the commercial floodgate even further. If the DSM-5 Task Force chief is poised to take advantage of the “dimensions” – Pfizer is not far behind.
I hate thinking this way, but our recent reality has to always be in the mix. The most cynical marketing campaign of the bunch was Zyprexa [Zyprexa: the other early years…] in which Lilly trained their reps to encourage PCPs to see mental illness as symptoms as a way of undermining referral – since PCPs are oriented towards symptomatic treatment and represent access to a much larger market.
It’s my long winded way of saying that I don’t disagree with your point, but that the unintended consequences of a dimensional system feel like a further disaster waiting to happen.
Steve, I know it’s all the rage to hang everything on the Baby Boomers these days and to hold the Great Generation up as the bastion of humanity that their children have ruined, but bear in mind that when you say that “Baby Boomers” are to blame, you are also saying that women and people of color, after entering the main stream professions in large numbers and integration have ruined everything. You’re saying that all the Boomers who stood up to domestic abuse, sexual harassment, sexual abuse, rape, the sexual abuse of children, and the physical abuse and neglect of children ruined everything.
Many good things happened while Baby Boomers were in their prime. If there is an effect that is particular to Boomers, it is that they were—- like all other baby boom populations— a very large group who came of age at a time when they had a lot of competition among their own large population. They weren’t competitive out of a personal flaw that was mystically manifest among their generation, they were competitive because that’s what the Generation before them told them they had to be in order to be taken seriously and to advance in colleges and businesses.
One day, people of later generations will find themselves in the same position, and because the Boomers were the generation before them, the people in generations after theirs aren’t likely to think the Boomers are to blame for the world “their generation left” in their wake.
Mickey,
I agree with you. I am thinking of developing a dimensional scale to use in my own practice. I have developed the basic outlines. I am trying to get to the essence of what it is I am actually tracking when I work with people over time. I can send it to you. I wonder if you or others think this is foolish and/or reflecting of my own hubris given that others have spent careers developing this sort of thing.
Questionnaires preceding diagnosis are an entirely unnecessary formality. The goal is to prescribe drugs; a diagnosis is only the means to that end. Any diagnosis will do.
It seems to me that the Gibbons efforts are fig leaves to disguise this. A few taps on your iPhone and poof, you have a diagnosis for a patient. There can be an app that permits printing of the prescription from the iPhone. Zip, zap you’re done. The patient is conveniently pigeonholed and with any luck, will stop complaining. If not, escalate to the next prescription.