made in america…

Posted on Monday 7 April 2014

by Peter Parry
Journal of Clinical Medicine. 2014 3:334-347.

Pediatric bipolar disorder is a diagnosis that arose in the mid 1990s in the USA and has mostly remained confined to that nation. In this article a young American man (under a pseudonym) describes his experience of having the diagnosis throughout his adolescent years. His story was conveyed via correspondence and a meeting with the author, an Australian child psychiatrist. The young American’s story reveals several issues that afflict contemporary psychiatry, particularly in the USA, where social and economic factors have contributed to the rise of a dominant biomedical paradigm—or “biologism”. This focus on the “bio” to the relative exclusion of the “psychosocial” in both diagnosis and treatment can have serious consequences as this young man’s story attests. The author explores aspects of his tale to analyze how the pediatric bipolar disorder “epidemic” arose and became emblematic of a dominant biologism. This narrative points to the need, depending on the service and country, to return to or retain/improve a balanced biopsychosocial perspective in child and adolescent mental health. Child psychiatry needs to advocate for health systems that support deeper listening to our patients. Then we can explore with them the full range of contextual factors that contribute to symptoms of individual and family distress.
While it’s refreshing to read a case study, the topic is anything but pleasant. Peter Parry, an Australian Child Psychiatrist, met an young American on-line who had spent his adolescence being treated for Childhood Bipolar Disorder. Later, on a visit to the US, Dr. Parry met and interviewed the young man in person. I’ll not even attempt to summarize what the former patient has to say. It’s on-line and he says it quite well for himself. Likewise for Dr. Parry whose commentary is a particularly clear outline of the damage that can be done when treatment is driven by ideology – in this case the biological mania that swept through psychiatry with the Bipolar Child diagnosis, part if a larger wave of what he calls "biologism." The child lost his adolescence in a medication fog. It’s an important developmental period for all of us, but particularly for a gay man coming into his identity. And Dr. Parry appropriately points out that this epidemic was Made in America.

This is one of those articles that keeps on giving. Back in my underlining days, I would’ve painted the whole thing yellow with my highlighter, but there’s one part that I thought was particularly important in the sea of importants:
3.5 Projective Identification and “Munchausen’s by Proxy”

It is traditional wisdom in child psychiatry that parents often project unresolved issues onto their offspring. The children may identify and act out accordingly. Some extreme versions of this can lead to “Munchausen’s syndrome by proxy”, where a parent , through having an ill child, vicariously gains desired attention from respected medical experts for unmet and disavowed dependency needs. It appears that once Adam left the home his mother produced spurious medical symptoms and diagnoses for herself, in other words her own likely case of Munchausen’s disorder.

An early critique of PBD noted that not only could parents have a psychological investment in the PBD diagnosis, but so too could a range of others including the pharmaceutical industry, academic child psychiatry, schools and cons umer advocacy groups. The authors speculated whether PBD may be a “variant on Munchausen’s syndrome”.

This is not to say that there need be any negligence or mal-intent at all. Factors operate at systemic and subconscious levels. Adam’s mother, his doctors and others no doubt acted with Adam’s best interests in mind. A dominant paradigm is hard to see when you’re living and working within it.
Again, it’s refreshing to hear someone talking about Projective Identification, something I consider one of the most powerful forces on the planet. Projection proper is easy. You walk into a room with a stranger and the first thing he says is, "I know that you and my mother have been plotting …" You immediately know that you are the placeholder for his fear. The case may be hard, but at least you’re not struggling wondering if he’s right, as you’ve met neither he nor his mother before. Projective Identification is much more difficult. The patient, whom you know [and knows you], comes for a session late in the day and says, "You’re tired. Listening to patients all day. You don’t want to hear my troubles." And she’s right, at least sort of. You are tired. It is the end of the day. Is the patient making an observation about you that’s true? or projectively identifying an internal sense of unimportance, or perhaps a rage at not being listened to, or something else? The point is that both is the probable answer – that’s the Identification part. The Projection lands on something that is at least partially true.

“Munchausen’s by Proxy” is one of the most difficult of things because all of the forces are unconscious, subjective, and as likely to effect the treaters as the treated. The case of Rebecca Riley should remain emblazened on all of our minds to remind us of the tragic possibilities. While it’s not Parry’s central point, it is an important point. Was the Bipolar Child epidemic largely an example of this phenomena? In the post about Rebecca, I quoted a piece from a deposition of Dr. Biederman:
"But the patients that come to me, and the families in tears and despair with these type of problems, I in good faith cannot tell them, ‘Come back in ten years until we have all the data in hand.’ I still need to use medicines that I am assuming that if they work in adults, with appropriate care and supervision, may also work in children."
Peter’s comments here are dead center:
This is not to say that there need be any negligence or mal-intent at all. Factors operate at systemic and subconscious levels. Adam’s mother, his doctors and others no doubt acted with Adam’s best interests in mind. A dominant paradigm is hard to see when you’re living and working within it.
[I would change hard to sometimes impossible]. And he’s also offering a hint at the correct solution, get an outside opinion [or two or three]. People who are otherwise rational and sane do crazy things when under the spell of Projective Identification. An outside person can often see it clearly. When it’s happening to you, it’s hard to see, but one of the hints is that you’re about to do something out of the ordinary [and rationalizing it]. Dr. Biederman’s comment is something that felt compassionate to him, I expect. But it’s still a crazy, unmedical assumption that, as we all know, mushroomed into an epidemic that became an affliction in its own right to people like Adam. And speaking of Projective Identification and spells, the recent reminders about SRA [satanic ritualized abuse] epidemic is another example, in my opinion [see un·retraction watch…]. The power of Projective Identification underlies my only rule for living:
Never accept an invitation to go crazy…
Mickey @ 11:37 AM
Filed under: politics
simply ‘fuel the fire’…

Posted on Sunday 6 April 2014

In the Fall of 2012, having had a chance to look at the raw numbers for the first time, I sent a series of posts to the Ethics Committee of the American Academy of Child and Adolescent Psychiatry along with a request that they consider retracting their article. I had written Dr. Andres Martin the year before [letter], but he hadn’t responded. Here’s my 2012 letter:

To: The American Academy of Child and Adolescent Psychiatry Ethics Committee
Date: September 22, 2012

In 2001, the JAACAP published an article on the use of Paroxetine [Paxil] in adolescent depression, now known as Study 329:

Journal of the American Academy of Child and Adolescent Psychiatry, 2001, 40[7]:762–772.

It has been widely seen as the paradigm for a period in psychiatry when we were at our worst – an industry financed, ghost-written article that made claims of both efficacy and safety that were unsupported by its data. The article has been the centerpiece for numerous successful legal suits, the most recent being a $3 Billion settlement by GSK with the DOJ in which they admit all allegations. Calls for retraction of this article began a decade ago, but have been repeatedly rejected – at first by defending this indefensible article, then later for unclear reasons, likely political, related to a fear of embarrassing the Editor, the AACAP, and the "Authors" [many of whom remain active in the organization].

Psychiatry is in decline, largely because the increasing awareness of the extensive alliance between the pharmaceutical industry and academic psychiatry has undermined confidence in the traditional ethic of medicine. Fledgling moves to reform the extensive conflict of interest problems in our specialty, however, will have no traction if organized and academic psychiatry refuse to acknowledge the problem in need of reform. Child and Adolescent psychiatry is at the center of the growing storm of complaints about over-medication, particularly of children.

Your predecessors have refused to retract this article, saying it is factually correct, or that the Journal is not responsible for its distortions, or worse, saying nothing. It is not factually correct. It was published over the objections of peer reviewers. And saying nothing is tantamount to treating cancer by watchful waiting. It has earned its right to be retracted in courtroom proceedings and media across the land. If you’re not familiar with its history, I’ve appended a series of blog posts about it to the end of this email. Alison Bass’s Pulitzer Nominated book Side Effects is another good resource.

I urge you to familiarize yourself with this story if you don’t already know it, and implore the Ethics Committee to retract Study 329 from the literature. It’s the right thing to do and a right time to do it.

John M. Nardo MD
retired psychiatrist and psychoanalyst

I thought this letter had a chance of being well received. The 329 data was now public and I’d done my homework, The $3 B suit had just been settled by GSK. I used my long name and spell checked it several times. Looking back, rereading it, the "familiarize yourself with this story" part was a little cheesy, but otherwise not bad for a non-English Major. The letter was received warmly by the President of the AACAP, the President Elect, and the Chair of the Ethics Committee who assigned a member of the Committee to work with me, presumabely to present it at the meeting coming up in several months. We had several amicable exchanges. I sent her Alison Bass’s book. All very civilized.

The meeting came and went and I heard nothing. Somewhere down the road, I got a terse email. It was going to be handled by the editor. No action taken. It was a surprise – reading more like a second notice on an overdue water bill than the collegial  and professional emails earlier. That’s the last I heard from them. Now, in retrospect, I read this:

Tuesday, January 22, 2013 • 12:00–1:00 pm EDT/11:00 a.m. – 12:00 p.m. CDT

Conference Call Minutes

Council members in attendance: Martin J. Drell, M.D., President; Paramjit T. Joshi, M.D., President-Elect; David R. DeMaso, M.D., Secretary; Steven P. Cuffe, M.D., Treasurer; Louis J. Kraus, M.D., Assembly Chair; Laurence L. Greenhill, M.D., Steven Adelsheim, M.D., Mark Borer, M.D., Stephen Cozza, M.D., Deborah Deas, M.D., Joan Luby, M.D., Neal D. Ryan, M.D., Jennifer S. Saul, M.D., Margaret L. Stuber, M.D., Sourav Sengupta, M.D., M.P.H., Marika Wrzosek, M.D.

Council members absent: Warren Y.K. Ng, M.D., Harsh K. Trivedi, M.D.

Others participating: Andrés Martin, M.D. Staff: Heidi B. Fordi, Mary Billingsley, Jill Brafford, Larry Burner, Yoshie Davison, Colleen Dougherty, Genifer Goldsmith, Rob Grant, Earl Magee, Kristin Kroeger Ptakowski

Study 329: Andrés Martin, M.D., M.P.H

As an author of the JAACAP article, Keller et al 2001, Neal Ryan recused himself from this conversation. Dr. Martin briefly summarized the situation regarding Study 329. He and the JAACAP Action Editors [AEs] reviewed this issue over the past 6 months, and shared a letter outlining the situation, steps taken, and their determinations, with Academy leadership. In short, Study 329 and the article published in JAACAP about it, Keller et al 2001, was mentioned in a federal lawsuit against GlaxoSmithKline [GSK], but none of the criminal charges related to the article itself. This is the 4th time the Journal has conducted an inquiry into the circumstances surrounding Study 329 and Keller et al 2001 since its publication, and it has again been determined that while the article is not perfect, the ethical concerns raised by the GSK lawsuit are not substantiated. The AEs consulted with many individuals in making their determination, including several lawyers and editors of other academic journals, and have decided not to take any action against the paper. Both the Academy and the Journal received inquiries from the press about the situation and what was to be done, and Dr. Martin and the AEs believe that there is little to gain in responding and that doing so would simply ‘fuel the fire.’

hat tip to 1boringyoungman…
I don’t do moral outrage very well, but this would be a good place to practice if I wanted to learn. That report to the AACAP Council reads like they’re making a policy decision about pesky door-to-door salesmen. The Ethics Committee was  waved off from above, clearly. It’s hard to imagine him saying "but none of the criminal charges related to the article itself" and "the ethical concerns raised by the GSK lawsuit are not substantiated" with a straight face, much less to the committee. Then I remembered a peculiar episode that happened around the same time though I hadn’t connected the dots. In the fall of that year, the Chronicle of Higher Education published an article [Academic Researchers Escape Scrutiny in Glaxo Fraud Settlement] pointing out that the academics who signed on to Paxil Study 329, a prominent part of the $3 B settlement, had gotten off without a even a hand-slap [see the only enduring contract…]. In response, GSK’s lawyer wrote this letter to the Chronicle:
Chronicle of Higher Education
October 1, 2012

To the Editor:

As counsel for GlaxoSmithKline LLC in its recently concluded settlement with the United States government, I write to correct some significant factual inaccuracies in "Academic Researchers Escape Scrutiny in Glaxo Fraud Settlement" [The Chronicle, August 6]. The piece focuses on a peer-reviewed journal article published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry reporting the results of a clinical trial sponsored by Glaxo­SmithKline [Study 329] of Paxil® [paroxetine hydrochloride] for the treatment of major depressive disorder in adolescents [the article was "Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial," by M.B. Keller et al., in the July 2001 issue]. Unfortunately, your piece incorrectly states that, as part of its government settlement, GlaxoSmithKline admitted that the journal article "was part of the fraud" and "constituted scientific fraud." In fact, GlaxoSmithKline made no such admission and vigorously disputes that the journal article was false, misleading, or fraudulent.

As part of its settlement with the government, GlaxoSmithKline pleaded guilty to a misdemeanor violation of federal law related to the marketing of Paxil for use by patients under 18, an unapproved, "off label" use for Paxil. While the law permits physicians to prescribe medications for such off-label uses, manufacturers are not permitted to market them for such purposes. The charging document filed by the United States, known as an information, contains many allegations that are either inaccurate or incomplete, that tell only part of the story, and that draw unwarranted conclusions from disputed facts. Throughout the investigation, the settlement process, and the guilty-plea proceeding, GlaxoSmithKline made clear to the government and to the court that it did not agree with all of the factual allegations made in the information. In particular, GlaxoSmithKline has consistently denied and disputed the allegations that the journal article was false or misleading. Nothing in the settlement or the guilty plea has changed Glaxo­SmithKline’s position on the journal article. Most important, Glaxo­SmithKline did not admit and has not admitted that the journal article was part of any fraud or that it was false or misleading.

Your piece also incorrectly states that the journal article "was actually written by Glaxo-hired authors to overstate the benefits and understate the risks of a highly profitable Glaxo drug." While GlaxoSmithKline did hire a medical writer to provide editorial assistance to the clinical investigators, a fact that the journal article itself acknowledged, control over the contents of the manuscript remained at all times with the clinical-investigator authors who provided substantial comments on and input into the manuscript. GlaxoSmithKline believed then and continues to believe that the journal article reflects the honestly held views of the clinical-investigator authors.

Thomas H. Lee II

Editor’s note: The federal "criminal information" document in the Paxil case repeatedly describes the journal article as "false and misleading." It also notes that GlaxoSmithKline distributed the article to its marketing department and its sales representatives, who used it to promote the use of the drug for children and adolescents. In addition, the criminal information says that a contractor hired by Glaxo­SmithKline wrote the first draft of the article and incorporated changes made in the article by researchers and another GlaxoSmithKline employee. The plea agreement between GlaxoSmithKline and the U.S. Department of Justice states that GlaxoSmithKline "expressly and unequivocally admits that it committed the crimes charged in the information, and is in fact guilty of those offenses."
If you read the settlement agreement and the government complaint, their letter doesn’t hold water. Jon Juriedini and Leeman McHenry quickly responded [‘Any Reasonable Person’ Would See Glaxo Study as Fraud][see also the only enduring contract…]. Ever since I read that letter from GSK’s lawyer, I’ve wondered why he wrote it. It just makes him look silly to anyone who reads the settlement and complaint. Unlikely any reader of the Chronicle of Higher Education would see it as anything other that humorous. But now, coming when it did, I wonder if Andrés Martin was feeling a strong pressure to finally retract Paxil Study 329, and GSK wrote that letter cover the authors and the Journal against some kind of legal action, or maybe to justify not retracting it, or to make the authors and journal not ‘thrown under the bus’ by GSK. I even wonder if one of those lawyers Martin mentions consulting wasn’t Thomas Lee, the author of the Chronicle letter.

I’m not so grandiose as to think that my letter was the impetus for all that wheeling and dealing, for the GSK Chronicle letter, for the AACAP to go silent and dig in its heels even further. Because the call for retraction was coming from everywhere at that time [and ever since]. And I have no notion of the potential legal ramifications of JAACAP retraction the article. But I do feel sorry for the members of the AACAP Ethics Committee. It must be mighty disillusioning to be preparing to debate a thorny ethical issue like this one and to essentially be taken off the case and have its domain simplified down to "the ethical concerns raised by the GSK lawsuit are not substantiated" by a decree from above. What’s an Ethics Committee for if it’s not to deal with such matters?

Whatever all of this means in the end, the American Academy of Child and Adolescent Psychiatry and it’s Journal have lost sight of the reason they exist – to take care of the needs of mentally ill kids, and to do no harm. Neither the accepting editor, Mina Dulcan, nor her successor, Andres Martin, seem to have grasped these fundamentals. They’ve had numerous opportunities to make things right, and they’ve declined those chances, even now blocking anyone else from taking a look [like their own Ethics Committee]…
Mickey @ 3:52 PM
Filed under: politics
a sunny day…

Posted on Thursday 3 April 2014

And so I’m at a coffee house in Black Mountain, NC on a beautiful sunny day and I pull out my iPhone for a bit of free WiFi, after a morning visiting with relatives, and I’m stunned. Yesterday’s article on Paxil Study 329 was pretty great [Controversial Paxil paper still under fire 13 years later], but today’s news is more substantial. Today, the EU voted [Europe votes for clinical trial transparency]:
It’s soon going to be the law in Europe that drug clinical trials are publicly registered and results reported. MEPs have today voted by a huge majority to adopt the Clinical Trials Regulation, 547 in favour and 17 against.
AbbVie, one of the two U.S. companies trying to stop Europe’s drugs regulator from releasing previously secret clinical trials data, said on Thursday it had withdrawn lawsuits against the watchdog. The decision follows a move by the London-based European Medicines Agency [EMA] to accept a new set of redacted documents submitted by AbbVie, along with the company’s rationale for removing certain commercially confidential information. "A significant portion of data will be disclosed while protecting the information that is commercially sensitive," AbbVie said in a statement. "As a result, AbbVie has withdrawn its lawsuits." The EMA said the "very limited redactions" would have no significant impact on the readability of the clinical study reports that were at the centre of the litigation.
It is, indeed, a sunny day…
Mickey @ 5:57 PM
Filed under: politics
parsing “some”…

Posted on Thursday 3 April 2014

Some say former U. professor Martin Keller’s paper was ghostwritten and should be retracted
The Brown Daily Herald
By Isobel Heck
April 2, 2014

Former University Professor Martin Keller published a 2001 paper on the drug Paxil that has allegedly been ghostwritten by GlaxoSmithKline.

Two weeks ago, Edmund Levin and George Stewart, members of the American Academy of Child and Adolescent Psychiatry, sent a letter to the editor of the Academy’s journal, requesting an explanation as to why a controversial study led by former Brown Professor Emeritus of Psychiatry and Human Behavior Martin Keller has not been retracted.

The paper — which details the findings of Study 329 and focuses on the effects of the drug Paxil on adolescent depression — has been continually criticized since its publication in 2001.

While Levin and Stewart have worked to get the paper retracted, Jon Jureidini, a professor at the University of Adelaide in Australia and a member of the nonprofit Healthy Skepticism, has been working with his team to reanalyze the original data and republish the results…
"some say" is a bold statement. In the case of Paxil Study 329, "some" means anyone who looks into the study [and is not a listed author]. It has become the symbol of an era when ghostwritten, industry funded studies were the rule for psychiatric drugs, and science and its methods were things to be played with rather than tools for knowledge.

There are a number of reasons study 329 percolated to the top of the pile as an example of the widespread scientific misbehavior in clinical trial reporting. It was about using medication in children. It is an obviously jury-rigged report on first reading. It was authored by an army of top level child psychiatrists and published in a first line journal. One wonders why the authors, the company [GSK], and the Journal [Journal of the American Academy of Child and Adolescent Psychiatry] hasn’t  simply retracted it and  moved on. Instead, they persist in their denial.

Were it not for the persistence of people like Dr. Levin, Dr. Stewart, Dr. Juriedini, and the Healthy Skepticism group, it might have just faded away, as I think the authors, the Journal, GSK, the American Academy of Child and Adolescent Psychiatry, and Brown University hoped. But that’s not going to happen. It’s too important to acknowledge, not just to "some," but to "all" the level of corruption that had filtered into academic psychiatry and its literature. It’s important for one simple reason – they are traditionally good things, and tolerating this kind of corruption will destroy them for the future.
Mickey @ 9:54 AM
Filed under: politics
at first glance…

Posted on Tuesday 1 April 2014

Milwaukee Journal Sentinel
By John Fauber
April 1, 2014

While university doctors who moonlight for drug companies have faced intense scrutiny in recent years, new research suggests much larger sums of money are being paid to their bosses — the leaders of medical schools and hospitals who serve on drug company boards. Looking at the world’s 50 largest drug companies, researchers found that 40% had at least one board member who held a leadership position at a U.S. academic medical center — including medical school deans, chief executive officers, department chairs and university presidents.

The average annual compensation from the drug companies was $313,000, according to the paper published today in the Journal of the American Medical Association. "These relationships present potentially far-reaching consequences beyond those created when individual physicians consult with industry or receive gifts," the researchers wrote.

Others who were not a part of the paper said such lucrative moonlighting for drug companies with vested interests simply should not be done by university leaders who oversee independent research and the instruction of medical practitioners…
hat tip to Pharmagossip
One doesn’t have to say very much about this one. What’s wrong with this picture is obvious at first glance…

from JAMA 2014 311[13]:1353-1355.
Mickey @ 10:35 PM
Filed under: politics
the summer of 09 – five years later…

Posted on Monday 31 March 2014

In October 2012, I first read the article below and blogged about it  [speaking of forests…]. That was before the Board of Trustees of the APA met in December and finalized what was going to be included in the DSM-5. While this article was published in print after the DSM-5 was already on its way to the printer, it appeared on-line several months before. In fact, it was originally submitted the previous summer after being partially presented at the May 2012 APA Annual Meeting. So I assume it was written under the assumption that the Cross-Cutting Dimensions would be included in the DSM-5. Back then, it helped me finally realize that the Task Force leaders didn’t believe in the neoKraepelinian model any more. They were over Robins and Guze. They’d said it repeatedly, but I hadn’t heard it to the extent they meant it. No wonder they didn’t do the Revision they were assigned to do. They had other fish to fry. But as I was preparing this, my first-ever 1boringoldman DSM-5 one year anniversary series [the summer of 09…, the endless summer [of 09]…], I read it in a different light:
by Darrel A. Regier, William E. Narrow, Diana E. Clarke, Helena C. Kraemer, S. Janet Kuramoto, Emily A. Kuhl, and David J. Kupfer
American Journal of Psychiatry. 2013 170:59-70.

… Emil Kraepelin, who pioneered the separation of schizophrenic and affective psychoses into separate diagnostic groups in 1898, noted later in a 1920 publication — prescient in its anticipation of a current polygenetic environmental interaction model of mental disorders — that the strict separation of these categorical diagnoses was not supported. We are now coming to the end of the neoKraepelinian era initiated in the U.S. by Robins and Guze with a renewed appreciation of both the benefits and limitations of a strict categorical approach to mental disorder diagnosis.

The ultimate goal is to build on the progress achieved with categorical diagnoses by continuing with longitudinal follow-up of patients with these diagnoses, incorporating cross-cutting dimensional measures judiciously into the diagnoses where they prove useful, and in some cases recommending simple external tests [such as a cognitive test for mild neurocognitive disorder] that might improve the reliability and move toward a more mature scientific understanding of mental disorders. A noted philosopher of science, Carl Hempel, observed that “although most sciences start with a categorical classification of their subject matter, they often replace this with dimensions as more accurate measurements become possible”.

Clinicians think dimensionally and adjust treatments to target different symptom expressions in patients who may have the same categorical diagnosis. The intent of DSM-5 is to provide a diagnostic structure that will more fully support such dimensional assessments with diagnostic criteria revisions, specifiers, and cross-cutting symptom domain assessments. The goal is to support better measurement-based care and treatment outcome assessment in an era when quality measurement and personalized medicine will require new diagnostic approaches."

At the time this was written, the Task Force had given up on the attempt to add in biological parameters to the DSM-5 [Neuroscience, Clinical Evidence, and the Future of Psychiatric Classification in DSM-5], but their hopes for the cross-cutting dimensions were still alive. I had taken  cross-cutting dimensions to mean symptoms that crossed diagnostic entities, but I think there was more to it. They were actually looking for anything that could be measured or quantified, like the kind of thing Madhukar Trivedi was so obsessed with – called measurement based care. Reading it now, it seems as if the practice they were planning for psychiatrists was modeled on the Clinical Trial motif [rather than the other way around], and the measurement would be like those in Clinical Trials -  a psychometric of some kind – as in the example above. In fact, we know that’s what they meant from Jane Costello’s DSM-5 resignation letter [summer of 09]:

03/27/2009 Dr. Jane Costello resigns from the DSM-5 Child and Adolescent Disorders workgroup. In her letter of resignation, she said:
"…The tipping point for me was the memo from David and Darrell on February 18, 2009, stating “Thus, we have decided that one if not the major difference between DSM-IV and DSM-V will be the more prominent use of dimensional measures in DSM-V”, and going on to introduce an Instrument Assessment Study Group that will advise workgroups on the choice of old scale measures or the creation of new ones."

When I look at my timeline of the Affair d’Kupfer, it seems impossible not to conclude that their company with its Computerized Adaptive Testing had been planned to take advantage of the addition of dimensional measures to the DSM-5 from the very start. Insider trading, profiteering, whatever you want to call it, it’s a huge conflict of interest. So one part of my reading of this article was that it strengthened my suspicions of unethical play by Dr. Kupfer and his colleagues.

And while I’ve never been in love with the DSM-anything, it seems to me as if something kind of sleazy went on here that needs to see the light of day. This agenda for the DSM-5 was set over a decade ago. It was at a time when Steven Hyman was Director of the NIMH. And, as a matter of fact, Darrell Regier, who later became Co-Chair of the DSM-5 Task Force was coming to the end of a 25 year career at the NIMH. So somewhere around 2002, Steven Hyman agreed for the NIMH to go in with the APA to fund a long series of symposia based of their agenda for the DSM-V/5; Darrell Regier went from the NIMH to APIRE [American Psychiatric Institute for Research and Education] part of the American Psychiatric Foundation where he has primarily worked on the DSM-5; they published the A Research Agenda for the DSM-5; and, oh yeah, Dr. Robert Gibbons began to work on his CAT psychometrics funded by the NIMH. It now appears to me that there was a grand plan here – a grand plan to use the DSM-5 Revision to effect a major paradigm shift in psychiatry just like the DSM-III had been used in 1980 – a grand plan hatched by the power players at the NIMH, the APA, and the APF. History was going to repeat itself.

So no wonder they tried to wave off Drs. Spitzer and Frances. Those guys were still thinking about categories and reliability. They didn’t want their input. They wanted them to get out of the way of the new version of the new psychiatry. No wonder they spent so little time looking at the categories that were in need of work. They weren’t interested in descriptive categories anymore. Little surprise that they appointed an Instrument Assessment Study Group to come up with ways to measure dimensions. That was the plan in the first place. And perhaps it also explains the most striking feature of this DSM-5 Task Force. They were impervious to infuence from anything – huge changes in the climate of psychiatry, scandals galore, a major rebellion in the public forum, the exit of  PHARMA from the scene, failed Field Trials. Nothing had any impact on their course. They were on a predefined mission.

And they’re still at it. Steven Hyman is back from a sabbatical as Harvard’s provost, now Directing the Stanley Center. Along with Tom Insel, he supports the NIMH RDoC, a clone of the DSM-5′s dimensions. And everything Hyman writes recently ends with some way of "luring" PHARMA back to CNS drug development [and supporting the academic-pharmaceutical complex]. They had a dream for the new century and they tried like hell to make it work – clinical neuroscience with measurement based care. Algorithms for treatment defined by clinical trials using dimensions. The idea was behind the great trials from Hyman’s era at the NIMH [STAR*D, CATIE, etc]; it drove the DSM-5 Revision effort for it’s lifespan; and it didn’t work…
Mickey @ 6:57 PM
Filed under: politics
the endless summer [of 09]…

Posted on Monday 31 March 2014

"I don’t want to be lying on my deathbed and asking, ‘What was all that about?’"
attributed to Marlon Brando

In the last post, referring to the Schatzberg, Scully, Kupfer, Regier letter in respsonse to Dr. Frances, I said, "That’s the low point of this story for me – a school playground bully response that has no place in any serious dialog." But in another way, it was a high point for the DSM-5 Revision enterprise, because after that, everything just seemed to continue to roll down hill.

For one thing, at around this same time, Senator Grassley’s investigation of prominent psychiatrists who had under-reported their outside income was moving ahead full steam. And with that came the more widespread exposure of the research and marketing misconduct involving academic psychiatrists and the Pharmaceutical industry – along with legal suits that flushed out a stream of incriminating documents from the discovery process. If there had ever been a time for organized psychiatry to eat some humble pie, this was it. But that was not to be. In fact, the President of the APA was, himself, on Senator Grassley’s bad-boy list and one of the authors of the nastygram in response to Dr. Frances – Dr. Alan Schatzberg of Stanford.

I don’t need to say anything about Dr. Frances’ campaign and the overwhelming support it received from outside psychiatry. You read about it in the popular media: Psychology Today, Psychiatric Times, Huffington Post. There is a point I would make about it. Frances’ original complaint was primarily about the process of the DSM-5 Task Force, but the general reaction was more to some of the suggested diagnostic changes, to the exclusively biological focus, and to the suggested motive of the promotion of medications. While I wouldn’t argue with any of those things, there wasn’t much discussion of the actual Revision of the Diagnostic and Statistical Manual of Mental Illnesses. There were many places where the system had glaring problems that were even bigger than the limitations inherent in a descriptive classification. Two that come to mind are Major Depressive Disorder and Generalized Anxiety Disorder that were being used loosely in practice as synonyms for unhappy person and nervous person. My point? The main purpose of the revision got lost is the process.

So back to things going downhill. The DSM-5 Task Force’s responses to the onslaught of criticism was either defensive, or pompous, or absent. I don’t know what was happening inside their bunker, but from out here, it looked like a stubborn silence. But, maybe they were just busy dealing with problems of their own. Recall that the paradigm shift that underpinned the DSM-5 Task force effort had two prongs: Adding in the biological findings to the DSM-5 Diagnostic Categories and the addition of of "Cross Cutting Dimensions." In July 2001, they had to come out publicly and admit that the findings they had banked on for the first part just hadn’t materialized. They made a big bet back at the turn of the century that the science they hypothesized would be there in time for the DSM-5, and it wasn’t. So:
by David J. Kupfer, M.D. and Darrel A. Regier, M.D., M.P.H.
American Journal of Psychiatry 168:672-674, 2011.
And by this time, the results of the DSM-5 Field Testing were expected, and the DSM-5 Task Force published this piece in the AJP preparing us for the not very encouraging results of the Field Trials [Alternative title: Don't get your hopes up]:
by Helena Chmura Kraemer, David J. Kupfer, Diana E. Clarke, William E. Narrow, and Darrel A. Regier
American Journal of Psychiatry 2012 169:13-15.
Then along came what seemed like a natural extension of the mood of the times, the allegation that the industrial/financial contamination that was being now discussed openly afflicted the very DSM-5 Task Force itself:
A Pernicious Problem Persists
PLoS Medicine
by Lisa Cosgrove and Sheldon Krimsky
March 13, 2012
While the Field Trial results were presented at the APA meeting in the summer of 2012, they weren’t published until later, right before the final meeting of the APA Board of Trustees where the decisions were made about what stayed and what went. The results were terrible, no better than the DSM-II that started this whole series based on reliability:
The DSM-5 Revision process had appeared on the radar screen for most of us when Dr. Spitzer and later Dr. Frances brought it to our attention. Before that, it had mainly been something the APA insiders were involved in, but certainly not part of the everyday parlance of the man on the street, or for that matter, the psychiatrist, psychologist, social worker, etc. on the street. And while both of the former Task Force leaders knew there was something wrong, their comments about the process were lost in the din of scandal and objections to the particularly objectionable changes they proposed – like the disappearing Bereavement Exclusion, or the Psychosis Risk Syndrome nee Attenuated Psychosis Syndrome, or the changes in ADHD or Autism. Those of us who criticized their DSM-5 proposals pointed to the fact that many changes were weighted towards more medication, more overdiagnosis, etc, and those were important things to focus on to be sure.

By the time the Board of Trustees was given the final draft,  many of the really shaky additions had fallen by the wayside [like the Attenuated Psychosis Syndrome] and they’d given up on the dream of adding the biomarkers and biological correlates to the mix [because there weren't any]. The fact that the parts of the DSM-IV that had needed an overhaul had been ignored was itself ignored. The only thing left of the grand plan from the 2002 book [A Research Agenda for the DSM-V] or the 2009 Commentary [The Conceptual Development of DSM-V] was the addition of "Dimensions" to the diagnostic scheme. The Board of Trustees wisely said no to the proposed version.

So it was a bust all around, a failed enterprise, a New Coke, an Edsel. Said journalist Benedict Carey:
"They plotted a revolution, fell to debating among themselves, and in the end overturned very little except their own expectations…" "… many experts inside and outside the process said the final document was not radically different from the previous version, and its lessons more mundane than the rhetoric implied."
Said Robert Burns:
But, Mousie, thou art no thy lane,
In proving foresight may be vain;
The best-laid schemes o’ mice an’ men
Gang aft agley,
And lea’e us nought but grief an’ pain
For promised joy!
To a Mouse On Turning her up in her Nest with the Plow by Robert Burns
Is there anything more to say as the first anniversary approaches? Maybe…
Mickey @ 8:00 AM
Filed under: politics
the summer of 09…

Posted on Sunday 30 March 2014

"I don’t want to be lying on my deathbed and asking, ‘What was all that about?’"
attributed to Marlon Brando

We’re approaching the one year anniversary of the release of the DSM-5, an event shrouded in confusion, contention, and disappointment. I don’t recall many of us paying very much attention to it before the summer of 09, though the revision process was by then a decade old. In June 2009, the leaders published something of a state of the revision Commentary in the AJP. By then, the chairs had been appointed [April 2006], the Task Force [July 2007] and Workgroups [July 2008] populated, and work was underway. Although there had been an extensive series of symposia in the interim, this Commentary was little changed from their earlier book, A Research Agenda for the DSM-V, published in 2002:
by Darrel A. Regier, William E. Narrow, Emily A. Kuhl, and David J. Kupfer
American Journal of Psychiatry. 2009 166:645-650.
While a lot of this Commentary is about their processes of the previous decade, there are several things of note. They reviewed the creation of the DSM-III from the Feighner criteria and the RDC, attributing it all to the influence of Robins and Guze, the neoKraepelinians. They talked about a 1980 expectation that subsequent basic research would validate those categories – something that hadn’t happened. They pointed to the high rates of comorbidity, the heavy use of the NOS designation, the fact that medications were not diagnosis specific, and the failure to find biological markers for the categories. They saw these things as evidence that it was time for a change in direction – a paradigm shift. Their solutions included [as always] finding the missing biomarkers, including biological correlates with the diagnoses, and adding "dimensional" elements to the diagnostic system – "cross-cutting dimensions."
The single most important precondition for moving forward to improve the clinical and scientific utility of DSM-V will be the incorporation of simple dimensional measures for assessing syndromes within broad diagnostic categories and supraordinate dimensions that cross current diagnostic boundaries. Thus, we have decided that one, if not the major, difference between DSM-IV and DSM-V will be the more prominent use of dimensional measures in DSM-V.
Neither Dr. Spitzer [DSM-III, DSM-IIIR] nor Dr. Frances [DSM-IV] were mentioned in this article even in passing. Perhaps Dr. Spitzer’s ommission had to do with his earlier calling the DSM-V Task Force out for its secrecy policies, but the reason for their omission of Dr. Frances and their general negativity towards the DSM-IV wasn’t clear [maybe they had a premonition]. Another thing, in spite of heavily referencing elsewhere in the article, this comment is reference-free:
… we have come to understand that we are unlikely to find single gene underpinnings for most mental disorders, which are more likely to have polygenetic vulnerabilities interacting with epigenetic factors [that switch genes on and off] and environmental exposures to produce disorders.
Then, later that month, Dr. Frances spoke up. If you don’t know the story of why, it’s worth your time to read Gary Greenberg’s later article in Wired that tells the story, Inside the Battle to Define Mental Illness:
Psychiatric Times
by Allen Frances
June 26, 2009
Frances summarizes his numerous concerns at the end of his article:
My concerns arise from the following:
  • Their ambition to achieve a paradigm shift when there is no scientific basis for one.
  • Their failure to provide clear methodological guidelines on the level of empirical support required for changes.
  • Their lack of openness to wide scrutiny and useful criticism.
  • Their inability to spot the obvious dangers in most of their current proposals.
  • Their failure to set and meet clear timelines.
  • The likelihood that time pressure will soon lead to an unconsidered rush of last-minute decisions.
This is the first time I have felt the need to make any comments on DSM-V. Even when the early steps in the DSM-V process seemed excessively ambitious, secretive, and disorganized, I hoped that I could avoid involvement and believed that my successors deserved a clear field. My unduly optimistic assumption was that the initial problems of secrecy and lack of explicitness would self-correct and that excessive ambitions would be moderated by experience. I have decided to write this commentary now only because time is running out and I fear that DSM-V is continuing to veer badly off course and with no prospect of spontaneous internal correction. It is my responsibility to make my worries known before it is too late to act on them…
Notice that in the Commentary and in Dr. Frances’ article warning of the pitfalls in the trajectory of the DSM-5 Task Force, so far we have heard next to nothing about any of the diagnostic categories themselves. The Co-Chairs are focused on their disappointments or dis-satisfactions with previous efforts. Dr. Frances is worried about the push for a paradigm shift, and the way they’re approaching the revision itself. But the actual diagnoses themselves are still not on the front burner. The APA response came less than a week later from the President of the APA [Alan Schatzberg], the APA Medical Director [James Scully], and the DSM-V Co-Chairs [David Kupfer and Darrel Regier]. They hardly took Frances’ critique as constructive criticism [to say the least]:
Psychiatric Times
By Alan F. Schatzberg, James H. Scully Jr, David J. Kupfer, and Darrel A. Regier.
July 01, 2009
Let me get the rotten part out of the way at the beginning:
Finally, Dr. Frances opened his commentary with the statement, “We should begin with full disclosure.”  It is unfortunate that Dr. Frances failed to take this statement to heart when he did not disclose his continued financial interests in several publications based on DSM-IV.  Only with this information could the reader make a full assessment of his critiques of a new and different DSM-V.  Both Dr. Frances and Dr. Spitzer have more than a personal “pride of authorship” interest in preserving the DSM-IV and its related case book and study products. Both continue to receive royalties on DSM-IV associated products. The fact that Dr. Frances was informed at the APA Annual Meeting last month that subsequent editions of his DSM-IV associated products would cease when the new edition is finalized, should be considered when evaluating his critique and its timing.
That’s the low point of this story for me – a school playground bully response that has no place in any serious dialog. Dr. Frances shook it off, turned the other cheek, and moved on. I can’t seem to. I hear that nastiness in everything since. But I do want to mention something else from their article.
As documented in the recent American Journal of Psychiatry article [Regier, et al., 2009], the use of dimensional assessments to reconceptualize psychopathology represents the most practical and evidence-based way of moving our field forward. Recent studies underscore the readiness of clinicians in both primary care and specialty mental health settings to adopt dimensional instruments on a routine basis [Duffy et al., 2008, Trivedi et al., 2006].
The articles mentioned hardly represent any groundswell for "dimensional" diagnoses. Two are from Dr. Regier himself and the other is from the STAR*D team – Dr. Trivedi, long obsessed with measurement based care. Like the Commentary, this response is heavily focused on the Dimensional Diagnosis concept.
Psychiatric Times
By Robert L. Spitzer
July 02, 2009
Literally, on the next day, Dr. Spitzer weighed in, again commenting on the closed shop way things were proceeding. By this point, the field trials were eminent, yet no one outside the Task Force knew what was even being tested, or how. By July of 09, the DSM-V/5 Revision had moved from esoterica in the background to the front page; the APA and the DSM Task Force had become entrenched in a bunker mentality; and the rest of the world was about to enter the dialog…
Mickey @ 10:06 AM
Filed under: politics
under this rug…

Posted on Friday 28 March 2014

"My contacts tell me that a reliable source on the APA Board of Trustees informed members that the APA attorney has declared that there was no conflict of interest, effectively preempting any action by the Assembly."
Bernard Carroll – comment on not a peep…

I think it is likely true that the APA attorney declared that there was no conflict of interest in Dr. Kupfer’s actions detailed previously. While it’s hard to imagine what legal machinations the Attorney went through to come up with such an absurd conclusion, I’ve had my say about that multiple times. So for the moment, I want to talk about something else. Is a legal standard even appropriate to bring up in this case? We’re not talking about a person charged with a criminal offense going to trial or a civil suit alleging damages of one kind or another. And even in those situations, the opinion of a legal adviser isn’t the final word, it is only an opinion. Those verdicts comes from a Judge or a Jury.

In this case, the person under question is a high ranking official of the American Psychiatric Association tasked by the Board of Trustees to oversee a $25 M revision of the APA’s Diagnostic and Statistical Manual, a process over a decade in the making. The question is by what standard should such a person be judged. In the many debates about conflicts of interest over the life of the DSM-5 Revision process, the topic invariably revolved around the ties between DSM-5 Task Force members and the pharmaceutical industry – for example this point-counterpoint debate in the Psychiatric Times in 2009 involving Dr. Kupfer. The idea that a leader of the DSM-5 Task Force would be part of founding a company that produced screening instruments for things he was also supporting for inclusion in the manual never occurred to anyone. It was too outlandish to consider. But that’s what he did. And in an article about those tests in a peer reviewed journal, he omitted the required disclosure.

I presume that if we had the APA’s lawyer’s opinion, it would be something like: although the company was named, formed, incorporated in two states, professionally managed, and had a website, it had not yet officially launched its products, so technically that meant it wasn’t a conflict of interest. Something like that. That kind of technicality is well known to us from 20/20, or Mafia cases. This isn’t about such things. This is about medical ethics and integrity. And it’s not some Monica Lowensky dalliance – it’s in the direct line of duty. I can’t personally find a way to read this story as anything but profiteering. I gasped when I first heard it. Apparently the editor of JAMAPsychiatry did too, measured by the form of the published apology [Failure to Report Financial Disclosure Information]. I expect the members of the Board of Trustees at the APA gasped too [at least I hope so]. This wasn’t an ethical lapse. It was an active attempt to get away with something that went awry. No need to look at any rules to know that. Even if they had waited to incorporate their company until after the DSM-5 came out, or Kupfer had declared it along the way, it was still a misuse of his position for personal gain. There’s no piece of this caper that isn’t conduct unbecoming the chair of such an enterprise.

All of that is obvious. If it is indeed true that "the APA attorney has declared that there was no conflict of interest, effectively preempting any action by the Assembly," that does not mean that the APA Board of Trustees must remain silent, because that silence screams indifference or worse. They may be afraid of getting sued for slander by Dr. Kupfer, but they need to be even more frightened of their silence putting the finishing touches on the demise of an already heavily tarnished ethical reputation. They have to speak. There’s just no more room under this rug…
Mickey @ 7:37 PM
Filed under: politics
not a peep…

Posted on Friday 28 March 2014

I guess I can take down the crossed fingers about the Open Letter to the APA concerning the Affaire d’Kupfer [see credibility…]. The Board of Trustees met three weeks ago and there hasn’t been a peep that I know about. After all the questions about conflicts of interest among members of the DSM-5 Task Force and Dr. Kupfer’s defensive responses, for him to turn out to have a significant hidden conflict of interest himself is bad enough. But for the APA’s Board of Trustees to simply ignore that it even happened takes things over the top. I expect there will come a day when they will regret that decision. I sure do already.

In legal terms, the facts of the incident are uncontested. Dr. Gibbons, a statistician at the University of Chicago adapted a method of psychometric testing to measure anxiety and depression using NIMH Grant funding. The Clinical testing was done under contract with Dr. Kupfer’s department of psychiatry in Pittsburgh. The focus of the psychometric was an aspect of diagnosis being championed by Dr. Kupfer as DSM-5 Task Force chairman – "dimensions." They published an article about the test, hiding the fact that they had formed a company to market the test commercially. When this was discovered and they were confronted, they admitted their culpability publicly. Four of the five authors were directly affiliated with the DSM-5 Task Force, with Dr. Kupfer as the chair. It is simply not possible that this was anything but active deceit. Those are the facts.

When all of this was revealed, the Speaker of the Assembly of the APA was asked to report on the incident to the APA Board of Trustees. She concluded that they shouldn’t have done it, but that it did no damage and the fact that Dr. Kupfer was involved did not offer commercial advantage to their company [that is, of course, an absurd conclusion]. There was no comment in the report that addressed the why of it – why he/they did it. And to return to my letter above, she did not address the ethical issues raised by this whole episode.

The traditional medical ethic is that physicians should not even have the appearance, much less an actual conflict of interest. In recent times, that standard has been downgraded to an injunction to declare conflicts of interest publicly. I for one feel that is an unwise loosening of standards. But to have a clear conflict of interest and keep it hidden is to ignore even this depreciated standard. And for the APA itself to not even see this as something to act on in the case of an official in an important position of authority within the APA is to essentially say that they have no ethical policy at all.

I hope that’s not true, and that some commentary or action will be forthcoming. But so far, not a peep…
Mickey @ 12:00 AM
Filed under: politics