WINDY CITY BLUES

WINDY CITY BLUES

There is an academic ethics mess brewing in the windy city… at The University of Chicago. It involves a start-up Chicago corporation, a star statistician in the medical school, seed money in the form of NIH research grants, the American Psychiatric Association, and the chairman of the APA’s DSM-5 Task Force. It involves the appearance of self-interested bias in the DSM-5 process. It involves a recidivist pattern of failure to disclose material conflict of interest. And it involves academic journal editors (JAMA and JAMA Psychiatry) who did not do the right thing when the perps were outed.

I broke the story on this site back in November, right after a confession appeared on-line in JAMA Psychiatry by the gang of five perps (Robert Gibbons, Ellen Frank, David Kupfer, Paul Pilkonis, and David Weiss) . Indeed, it was I who had alerted the journal. Others have since weighed in here and here and here, for instance. The definitive summary and Timeline were the work of Dr. John M. (Mickey) Nardo here. Of course, readers of JAMA Psychiatry would never know that the authors were outed. The editors (Howard Bauchner for JAMA and Joseph Coyle for JAMA Psychiatry) allowed the authors to make it seem like they were making a spontaneous admission of nondisclosure, and they acquiesced in the withholding of key information that I had given to the journal.

It gets worse. We now know that the chair of the DSM-5 Task Force (Dr. David Kupfer) failed to disclose his financial conflict of interest on at least 4 occasions (#s 13, 15, 16, 19 in the Nardo Timeline). On two of those occasions he was representing the DSM-5 team and the APA! These lapses undermine his repeated assurances that COI issues were under control in DSM-5. If the chairman of the DSM-5 Task Force does not have his own act together concerning COI disclosures, then what are his assurances worth? Nevertheless, the APA released a statement that tried to whitewash Dr. Kupfer’s nondisclosures. They need to recalibrate their ethical compass.

The methods adopted in this affair are classic: Peddle unproven psychiatric screening scales backed up by black box statistics (a distressing specialty of Dr. Gibbons); publish a glowing report in JAMA Psychiatry, which you have infiltrated (Ellen Frank and Robert Gibbons are on the editorial board); get your corporate people inside the DSM-5 process (David Kupfer, Robert Gibbons, Paul Pilkonis); slant the DSM-5 process to endorse, however weakly, the kind of products you intend to market; start a corporation without telling anybody and establish a website  with advance marketing that touts your new academic publication in JAMA Psychiatry while highlightingDr. Kupfer’s key role in DSM-5; loudly proclaim (see page 4) the advent of population-wide screening but before doing any serious field trials or acknowledging that most positive screens will be false positives. This is the usual dodgy hand waving of wannabe entrepreneurs, whose vision is obscured by dollar signs. Oh, and did I mention regulatory capture of NIMH for over $11 million in funding while not producing a product worth a tinker’s damn?

In response to all this adverse commentary, the authors and the journal editors have gone to radio silence. They must be hoping it will blow over.  If anything, their silence has provoked even more searchlight questions that focus on what is happening at The University of Chicago.

For instance, who is bankrolling this start-up corporation? Last summer they brought on board an executive named Yehuda Cohen who is a mover and shaker in Chicago business circles. I am sure he doesn’t work for peanuts. He set up a website that must be staffed to respond to queries from consumers and professionals. Plus, the corporate office appears to be located in prime commercial space at 217 N Jefferson #600, Chicago IL 60661; phone 312-878-6490. E-mail: info@adaptivetestingtechnologies.com(from the website: you can find a picture of the neighborhood on Google). So, they are racking up significant operating expenses already. Heaven forfend that these expenses might be covered directly or indirectly by their NIMH funding! Are the responsible administrators at NIMH and at The University of Chicago looking and auditing?

It is also unclear whether they have a sound or even a legal business plan. Where will the high powered computing needed for their expansive applications be conducted? Do they have a computing facility at the corporate office? Or do they intend to perform the commercial computing through the NIH-supported Center for Health Statistics at The University of Chicago, which Dr. Gibbons personally directs? If so, did the University sign off on that plan? Is NIH aware of the plan?

In late November I asked NIH about the ownership of the data bases and algorithms on which the corporation relies for the business plan. I received a reply from NIH outlining the applicable federal policy and stating “We understand that the data are deposited and made available to the community per request through the Center for Health Statistics.” That had to be what Dr. Gibbons told them. Notice that no mention was made of the algorithms. I have replied to NIH, asking them to clarify the status of the algorithms, without which the data bases alone are of little use. I also pointed out to NIH that there is no mention of this public access option in any of the publications from these authors or on the corporate website. This situation is typical of the dissembling style we have seen before from Dr. Gibbons and Dr. Kupfer – lacking in candor and transparency.

The more one looks, the more questions arise. Is The University of Chicago being taken for a ride? Is NIMH being taken for a ride? Are we all being taken for a ride? Can we please have some transparency here? Can we please have some psychometric standards here? Will the APA step up to the plate? Will NIH step up to the plate? Will The University of Chicago step up to the plate?

WHEN IS DISCLOSURE NOT DISCLOSURE?

WHEN IS DISCLOSURE NOT DISCLOSURE?

Hint: When it is made by the Chairman of the DSM-5 Task Force.

Here is a case study in conflict of interest (COI). A remarkable confession has just appeared by a group of 5 prominent academics, writing in the journal JAMA Psychiatry. Having been outed to the Editors, they now admit to concealing pertinent financial information. One of the five is David J. Kupfer, MD, chairman of the DSM-5 Task Force and past chairman of the department of psychiatry at The University of Pittsburgh. The others are from Pittsburgh, Minnesota, and Chicago.

With millions in funding from NIMH, these folks have been developing new approaches to testing for anxiety and depression. The technical details are not important for this story. What matters is that they have clearly set their sights on a large market for diagnostic screening, epidemiological research, and clinical practice. They have recently published promotional reports talking up three products and projecting major applications – but before taking care of the nuts and bolts of scale development.

Their major report in JAMA Psychiatry contained a disclosure to the effect that they might at some time in the future consider commercial development of their depression scale. This disclosure was phony. We now know that, in lieu of frankly disclosing a major COI, they opted for a disingenuous, dissembling statement that was economical with the truth.

I thought the content of their report was sub-par, and the journal published a letter from me to that effect. They responded to my criticism with hand waving, and they tried to impugn me for bias related to my own (disclosed) COI. This foolish, ad hominem tactic aimed to divert attention from the substance of my critique – for which they had no adequate response.

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.

This deplorable episode casts a pall on the repeated assurances by Dr. Kupfer that COI issues were under control in the DSM-5 process. If the chairman of the DSM-5 Task Force doesn’t have his own act together, then what are his assurances worth? The new instruments proposed by this corporation bear an eerie resemblance to cross-cutting dimensional measures that were promoted for DSM-5 but that didn’t make the final cut. As far as I know, Dr. Kupfer didn’t declare his interest in this corporation for scrutiny vis à vis DSM-5.

Another lesson is that even Failure to Report notices can be weasel documents. I fault the Editors of JAMA Psychiatry, Joseph Coyle, MD, and of JAMA, Howard Bauchner, MD, for the non-rigorous standard they applied to the notice of Failure to Disclose. They acquiesced in another dissembling response.

Yet another lesson is that all authors are accountable for the accuracy of disclosure statements. Some of these authors might claim they relied on the lead author and president of the corporation, Robert Gibbons, PhD, a statistician at The University of Chicago, to make sure everything was kosher. Big mistake – just like the infamous case of the Nemeroff-led Cyberonics – vagus nerve stimulation review that failed to disclose that the academic authors (ahem) were paid consultants of the corporation. When your name is on the byline, be sure you cover the bases for your own protection, and don’t squawk when you are called out.

Finally, where is NIMH in all of this? Since when are public NIMH funds to be treated as commercial seed money? Who actually owns the algorithms and data bases on which the Gibbons corporation relies for its commercial aspirations? Why are they not publicly accessible? Is Thomas Insel on top of this?

PROFESSOR NEMEROFF GOES TO LONDON

THREE STRIKES AND …

Professor Charles Nemeroff is being honored today in London. He will deliver a high profile lecture at the Institute of Psychiatry, King’s College London, a component of The University of London. IoP and its associated Maudsley Hospital have long been at the forefront of psychiatric research in Britain. The occasion today is the establishment of a new program on mood disorders, and Professor Nemeroff’s topic will be “The Neurobiology of Child Abuse: Treatment Implications.” He will be introduced by Professor Allan Young and the vote of thanks will be proposed by Professor Sir Robin Murray, a former dean of IoP-Maudsley. In the chair will be Professor Carmine Pariante, a onetime colleague of Professor Nemeroff. The current dean, Professor Shitij Kapur, seems to be staying in the background.

On this side of the pond we are depressingly familiar with Professor Nemeroff. He is the poster boy for conflict of interest in academic psychiatry. I will not rehearse here all the ethics issues in which he has been compromised over the past 15 years. Suffice it to say that as a result of those issues he was dismissed from his departmental chairmanship at Emory University; he was required to resign as editor of the journal Neuropsychopharmacology; he was banned from involvement in NIH grants at Emory University for 2 years; he received an unprecedented sanction from the Ethics Committee and Council of The American College of Neuropsychopharmacology (ACNP), which included a 2-year ban on participating in ACNP meetings and committees; the Accreditation Council on Continuing Medical Education (ACCME) issued a punitive sanction on a program that he directed, finding commercial bias and requiring the program to be withdrawn; and he was referred by Senator Charles Grassley of the US Senate Finance Committee to the Inspector General of the US Department of Health and Human Services for investigation of grounds for criminal charges.

The administrators of IoP-Maudsley apparently ignored these warning signals when they announced over a month ago that they had tapped Professor Nemeroff for today’s honorific lectureship. Many other professionals were shocked, however, and they voiced their disapproval widely – directly to the IoP, in the mainline press, in the British Medical Journal, in on-line comments, and even in a video critique. University Diaries ran a critical commentary, as did the respected weblogs Pharmalot and 1Boringoldman. Significantly, the letter to British Medical Journal came from a psychiatrist affiliated with IoP itself.

The IoP responded with typical academic stonewalling. Professor Carmine Pariante and Professor Allan Young wrote to the Critical Psychiatry Network, defending the decision to engage Professor Nemeroff. Unfortunately for them, their letter contained 2 fatal mistakes. First, they highlighted the perceived academic distinction of Professor Nemeroff as justification for his selection, thereby confusing an ethics issue with a competency issue. Who cares about Professor Nemeroff’s supposed expertise? When such a compromised individual is given honorific status it sends the wrong message to junior faculty members and to trainees. It also sends the wrong message about the institution's values, as I have discussed before. The IoP will be tainted by this episode for years to come, and the responsible administrators deserve all the frowns and brickbats that will come their way.

The second fatal error in the IoP response was to cast the issue in terms of academic freedom. That claim is rank hypocrisy. The protests are ethics complaints, not disagreements about content or professional turf. Professor Nemeroff was impeached by his peers for ethical lapses, as the record of sanctions clearly shows. That is what sparked the protests. The IoP administrators are displaying glass eyes and tin ears.

We should also question the scientific judgment of the IoP administrators. Treatment implications of child abuse is a featured focus of Professor Nemeroff’s lecture. How much do the IoP administrators really know about Professor Nemeroff’s work in this area? Do they know how little he has published in this area? Do they know that he is on the public record with at least 2 instances of misrepresenting his work in this area?

Professor Nemeroff’s sole publication of original data in this area appeared in 2003 (PubMed ID 14615578). It was a secondary analysis of a large clinical trial, first reported in 2000, that originally did not consider child abuse as a moderating variable in the response of chronically depressed patients to an antidepressant (nefazodone) or to cognitive behavior therapy (CBASP). The 2003 report claimed that, in patients with a history of childhood trauma, response to CBASP was superior to response to nefazodone. At the same time there was no significant difference in response rates to drug or to CBASP between patients with or without childhood trauma histories. A portion of this report was later retracted (see PNAS 2005 November 8;102(45):16530) because the data concerning reduction of Hamilton depression scores had been misrepresented.

Notwithstanding the retraction, Professor Nemeroff discussed the retracted data without the necessary qualification in a 2008 Continuing Medical Education program – the same one that was sanctioned by ACCME. Use of retracted material in this way is inconsistent with ethically grounded teaching. It also is inconsistent with FDA standards for scientific reference publications. Among other requirements, the FDA standards state that scientific reference publications may not “be false or misleading, such as a journal article or reference text… that has been withdrawn by the journal or disclaimed by the author, or…” Professor Nemeroff then went further, stating in the video record that a history of childhood abuse or neglect “predicts poor outcome… particularly to pharmacotherapy.” That claim is outright false. The data simply do not support that claim.

Professor Nemeroff repeated these same misrepresentations on the video record a second time in January 2012 when he presented Psychiatry Grand Rounds at New York University. Once again Professor Nemeroff displayed sleight of hand in palming off a nonsignificant difference as both statistically and clinically significant. To reiterate, Professor Nemeroff’s own data do not show a statistically or clinically significant difference between chronically depressed patients with and without a history of child abuse in their responses to drug or to CBASP.

The question for today is, will Professor Nemeroff repeat these misrepresentations in his lecture at the IoP-Maudsley? Should he do that, then the 3-strike rule needs to be invoked. I nominate the administrators at IoP-Maudsley for the job of lowering the boom finally on Professor Nemeroff. That would be one way they might redeem themselves in this fiasco.

Oh, and by the way, Professor Nemeroff has apparently done nothing more in this area since the 2003 partially retracted secondary analysis of an earlier study. But others have been looking at his claims and have not confirmed them – see, for instance the Canadian study that found no difference in response rates to pharmacotherapy or cognitive behavior therapy in patients with and without histories of severe childhood maltreatment (PubMed ID 22428942). Will Professor Nemeroff acknowledge this non-confirmation of his narrative when he speaks today at the IoP-Maudsley? We are agog.

If the administrators of IoP-Maudsley wish to continue defending their selection of Professor Nemeroff as a world expert on the treatment implications of child abuse, then who am I to argue? I don’t need to argue… the record speaks for itself.

One final point: the IoP response to the Critical Psychiatry Network stated that Professor Nemeroff “will not be presenting any research that was funded by commercial companies or affected by commercial implications. Obviously, he will be declaring any relevant conflicts of interest prior to his lecture.” The administrators at IoP should be aware that Professor Nemeroff’s data on treatment implications of child abuse (such as they are) do, in fact, come from a commercially sponsored clinical trial. I would also bet dollars to donuts that Professor Nemeroff declares no relationship to Bristol Myers Squibb, the sponsor of that trial.

What are the larger lessons of this new affaire Nemeroff? Academic institutions like IoP-Maudsley need spine and due diligence to maintain decent standards and to put the hand wavers where they belong – not on center stage. Raise the bar, chaps!

BERNARD CARROLL

UPDATE 06-18-2013

We are waiting for a response from the Institute of Psychiatry… it could be a long wait. We have learned that Professor Nemeroff was unwilling to make publicly available the slides he used in his lecture yesterday. Hmmm.

Meanwhile, I should clear up some potential confusion about the data in Professor Nemeroff’s 2003 publication that I discussed yesterday. When I said the data showed no significant difference in response to cognitive behavior therapy (CBASP) between patients with and without early life trauma, I said that because Professor Nemeroff had made no claim that there was a difference. He made a variety of other claims, but not this one. I took this to mean that he had looked for a significant difference but didn’t find one. It is not possible for anyone to make an independent determination of what he found because he did not report the data transparently – there was no positive statement of sample sizes for different treatments, for example, and the remission rates were not consistently reported: some were stated numerically while others were only displayed graphically. For what it is worth, there might actually be a significant difference in response to CBASP between patients with and without early life trauma. We just cannot be sure. Let the record stand corrected. Maybe Professor Nemeroff can clear that up?

None of this alters the fact that Professor Nemeroff’s data show no significant difference in response to nefazodone between patients with and without early life trauma. And, none of this alters the misrepresentations by Professor Nemeroff that I discussed yesterday. In the sanctioned CME presentation in 2008 he positively stated on the video record that a history of childhood abuse or neglect “predicts poor outcome… particularly to pharmacotherapy.” That claim is outright false. The data simply do not support that claim, and, once again, he made no such claim in the 2003 publication.

Likewise, in the 2012 Grand Rounds presentation at NYU, Professor Nemeroff positively stated that patients with chronic depression but without a history of childhood trauma “did better with drug than with CBASP.” That also is a false statement (see Figure 1B of the 2003 publication). There is no significant difference and none was claimed in the paper.

Meanwhile, in both these misleading presentations that are on the video record Professor Nemeroff used the retracted material that I mentioned yesterday. He used it in classic hand waving fashion to embellish his narrative, but he used it without the required qualification that was given in his retraction notice!

Aren’t we all justified in asking the Institute of Psychiatry to release Professor Nemeroff’s slides from yesterday’s much publicized lecture?

BERNARD CARROLL

WALK THE WALK

WALK THE WALK

For some time a jeremiad theme has been dominant in the psychiatric sector of the academic-industrial complex. Blockbuster psychiatric medications are going off patent, the pipeline is viewed as alarmingly empty, and several corporations are scaling back or even abandoning their research programs in this area. Analyses of the reasons range from the enlightened to the pragmatic to the pedantic to the foolish. Everyone predicts that things will turn bleak in academic clinical research if the corporate spigot is turned off.

Lost in the wailing is a clear understanding that the defecting corporations are acting out of their own enlightened self interest. For 50 years, no fundamentally incisive innovations have occurred, so the defectors are telling the academics to get their act together in respect of better understanding disease mechanisms. Trouble is, too many academic clinical investigators have devolved into key opinion leaders promoting corporate marketing messages at the expense of generating original clinical science. Now they are squawking about being caught with their pants down.

The latest academic psychiatrist to opine about this issue is Steven Hyman at Harvard Medical School. In a new commentary that has just appeared, Dr. Hyman talks up his favorite theme of translational medicine, which sounds lovely until you perceive that he has no contemporary examples of same in psychopharmacology. It’s all airy rhetoric. Dr. Hyman is not just a Harvard professor – he is a former Director of the National Institute of Mental Health (NIMH). Then he was Provost at Harvard under President Larry Summers. Now he is Director of a psychiatric research center at Harvard.

Someone else who noticed Dr. Hyman’s new commentary is our fellow blogger Dr. John M. (Mickey) Nardo across at 1Boringoldman.com. His take on the Hyman piece is right on target. Basically, the Hyman commentary is a hortatory fantasy that we can all do better by buying in to his vision of interdisciplinary research, pooling the efforts of academia, industry, and government. Problem is, his vision hasn't worked so far. Here is an example.

   

Towards the end of his term as NIMH Director, Dr. Hyman set the ball rolling for new centers cast in his mold of translational research. Dr. Nardo mentioned “… a bunch of centers that haven’t produced very much.” The model of such failed centers is the one that existed at Emory University under the direction of Charles Nemeroff. It was called the Emory-GlaxoSmithKline-NIMH Collaborative Mood Disorders Initiative 5U19MH069056 (Principal Investigator Charles Nemeroff). It was conceived with all the right buzzwords about innovative models of drug discovery and translational benefit for patients through partnerships of academic centers with commercial drug makers (the Request for Applications (RFA) actually used this language). From the start, the Initiative was poorly managed and it never lived up to its billing. 

Annual Progress Reports from the Initiative to NIMH, obtained through a FOIA request, reveal unacceptably low scientific productivity, and lack of leadership to promote the intended scientific synergies among laboratories. When I assessed the overall productivity of this project four years after the end of the first 5-year funding period, it was apparent that the U.S. taxpayer received little value for the $5.3 million investment by NIMH. Only 7 original scientific publications could be attributed to the federal support (that count excludes a host of potboiler review articles and other academic padding). Five of these 7 originated from a single participating laboratory at Emory. The NIMH component, under Dennis Charney, also was a serious underperformer.

The collaborating drug company GlaxoSmithKline obtained valuable preclinical information from the Emory laboratories, much of which has never been published even though federal funding supported the work. If the data are being treated as confidential proprietary information by GSK, then that posture would be contrary to the spirit of the original RFA. Maybe GSK just decided it was worthless data. In addition, GSK benefited from the conduct of a Phase II clinical trial of one of their candidate drugs in posttraumatic stress disorder (PTSD), even though this study returned a negative result. Even worse, the trial did not meet the stated criteria of the RFA. It was not based on any well founded theory of PTSD. Instead, it was a routine, exploratory study of a new compound. Because the study design did not permit strong inference, nothing substantive was learned from the negative result. This Phase II trial could have been performed better and less expensively by GSK itself as a normal business activity. GSK certainly did not need scarce NIMH dollars for this routine, early Phase II trial. The Emory-GSK-NIMH Initiative added no scientific value.

Notwithstanding the clear evidence of under-productivity, NIMH under Director Thomas Insel, MD, continued the Initiative for all 5 years of the original funding period, and then renewed the Initiative for a second 5 year period at an increased funding level under a new P.I., Helen Mayberg, M.D. Dr. Mayberg is a respected clinical scientist, but she is not a psychiatrist, she is not a psychopharmacologist, and she has no track record of research in the priorities announced by the RFA. What actually is going on? Did NIMH just hand a favor to Dr. Insel’s former employer, Emory University, to the tune of another $6 million?

One lesson of this episode is that the chatter by federal scientific administrators (Hyman, Insel) about translational research strategies and innovative models of drug discovery is mostly vacuous rhetoric. The RFA was an imprudent conceit to begin with, having no base in solid clinical science, and this expensive Initiative failed catastrophically to meet its grandiose objectives. It is ironic that Dr. Hyman presumes to scold and sermonize to the field yet again about translational research, as it was he who set the ball rolling in the first place for the disastrous Emory-GlaxoSmithKline-NIMH Collaborative Mood Disorders Initiative. Last time I looked, nobody has been held accountable for the failure of the Initiative. Where is NIMH Director Thomas Insel when we need him to set standards of accountability and ethics?

So, the next time you hear academic psychiatrists lamenting how bad it is, remind them about this scandalous example of waste and mismanagement of federal research funding. Cleaning up cesspools like this would be a step to unblocking the drug development pipeline. And we need leaders who walk the walk, not just talk the talk.

DOES AMERICAN PSYCHIATRY MATTER?

DOES AMERICAN PSYCHIATRY MATTER?

The blogmeister of 1boringoldman.com has done it again. A semi-retired psychiatrist in rural Georgia, he has done more than anyone to document the follies and the ethical challenges of contemporary American psychiatry. His site is required reading for all who care about behavioral health issues.

In his latest posting he compared the domain of American psychiatry to Yugoslavia. Cast Melvin Sabshin as Marshal Tito. Sabshin was the medical director of the American Psychiatric Association in the late 1970s, the period leading up to DSM-III. Tito and Sabshin each strong-armed a confederation of sorts but failed to deal with the conflicts beneath the surface. Both leaders were faced with the prospect of their domains disintegrating – Tito’s at the hands of Moscow and Sabshin’s at the hands of insurance companies. Both persuaded wary stakeholders to sign on to a compromise, for want of anything better and fearing a worse outcome.

The domain of psychiatry hasn’t yet reached the stage of ethnic cleansing and genocide that we saw in Yugoslavia after Tito’s death, but it is well on the way. One only has to look at the vicious response of the American Psychiatric Association leaders to Allen Frances and other critics of DSM-5. The APA president in 2009, Alan Schatzberg from Stanford, went out of his way to smear Dr. Frances and Robert Spitzer, the architects of DSM-IV and DSM-III because he had no credible scientific response to their criticisms of the directions DSM-5 is taking. He was joined in this low act by David Kupfer and Darrel Regier, who are directing the DSM-5 effort. Where is the comity, Comrades? Where are the shared values? Why is the APA holed up in a bunker?

Then we have the unsavory sight of the APA lawyers threatening a blogfrauchen in the U.K. with a SLAPP lawsuit for alleged infringement on the APA’s intellectual property – as though the APA owns psychiatric classification! Talk about chutzpah. So now the confederation Sabshin cobbled together is breaking up and the stakeholders are starting to go their separate ways – psychologists, counselors, social workers, patient advocacy groups, even many psychiatrists. Christopher Lane in Psychology Today has said American psychiatry is facing “Civil War” over its diagnostic manual. Even an international psychiatric journal like British Journal of Psychiatry is distancing itself from DSM-5 and there is talk of abandoning DSM-5 for the next ICD classification.

Why is American psychiatry self destructing? Because the grand bargain forged in 1980 with DSM-III was a sham from the get-go and the promised benefits of diagnostic reliability have not materialized. They knew all along that reliability was a poor substitute for validity, but they settled for half a loaf. That compromise led us into the epistemologic quagmire of today, where there is no solid ground for clinical decisions or clinical research progress or drug development. A stunning absence from the DSMs to date is any statement about treatment. That compromise also led us to diagnostic inflation, which Pharma embraced. Pharma quickly filled the vacuum with experimercials that pretended to be real clinical science, and in the process diverted precious clinical research infrastructure away from genuinely important questions. Just look at the clinical trials er, experimercials, mill operating out of Massachusetts General Hospital at Harvard University.

What lies ahead? Stakeholders are going to vote with their feet. DSM-5 is likely to be a footnote in the history of psychiatric classification. The APA will become even less relevant than it is today, much like the American Medical Association, which now commands the loyalty of maybe 30% of U.S. physicians. Mel Sabshin will turn in his grave, the APA will lose revenue, ICD-11 will become the dominant classification of psychiatric disorders, and the quagmire will continue until a new synthesis arises from the ashes. If Yugoslavia is any kind of model, don’t hold your breath.