Tag Archives: conflict of interest

Sluggish Cognitive Tempo – A New Diagnosis?

On April 11, 2014, journalist Alan Schwarz (brief bio here) published an article in the New York Times on this topic, titled Idea of New attention Disorder Spurs Research, and Debate.  Alan has written extensively on the rising rates of the condition known as ADHD, and on the abuse of the drugs that are used to “treat” this condition. He has drawn a good deal of criticism from psychiatry’s believers.

In the NY Times article Alan draws attention to the fact that sluggish cognitive tempo (SCT) is being promoted as a new disorder  “… characterized by lethargy, daydreaming and slow mental processing.”  He makes the obviously valid point, that the formalization of such an entity  “… could vastly expand the ranks of young people treated for attention problems.”

The NY Times article was prompted by the fact that the Journal of Abnormal Psychology featured this emerging “diagnosis” in its January 2014 issue.  The issue contained eleven articles on the topic.  These articles addressed questions like:

  • Is SCT a sub-domain of ADHD?
  • Is SCT a disorder in its own right?
  • What are the symptoms of SCT?
  • What are SCT’s co-morbidities?
  • In what ways does SCT differ from ADHD, inattention type?
  • How does SCT differ from depression and anxiety, etc.?

It is a central theme of this website that mental illnesses/disorders, including ADHD and SCT, have no ontological or explanatory significance, are not a helpful way to conceptualize human existence, and in fact are intrinsically disempowering and stigmatizing.  The fact that these so-called illnesses are adduced by their psychiatric inventors to legitimize toxic treatments adds to their destructiveness.  The details of these critiques need not be repeated here.

HISTORY OF SCT

Sluggish cognitive tempo is not a new concept.  ADHD has long been criticized, even by psychiatrists, as embracing two very different kinds of presentations:  inattentiveness, on the one hand, and hyperactivity/impulsivity on the other.  DSM-III-R (1987) acknowledged this problem and created the new “diagnosis” 314.00 Undifferentiated Attention-Deficit Disorder (p 95).  The manual describes this condition as follows:

“This is a residual category for disturbances in which the predominant feature is the persistence of developmentally inappropriate and marked inattention that is not a symptom of another disorder, such as Mental Retardation or Attention-deficit Hyperactivity Disorder, or of a disorganized and chaotic environment.” [Emphasis added]

DSM-IV (1994) also acknowledged this issue, and split ADHD into three distinct “diagnoses.”

  • ADHD Combined type
  • ADHD Predominantly inattentive type
  • ADHD Predominantly hyperactive-impulsive type

DSM-IV-TR (2000) created the “diagnosis” 314.9  Attention –Deficit/Hyperactivity Disorder Not Otherwise Specified

“This category is for disorders with prominent symptoms of inattention or hyperactivity-impulsivity that do not meet criteria for Attention-Deficit/Hyperactivity Disorder.  Examples include:

1.  Individuals whose symptoms and impairment meet the criteria for Attention-Deficit/Hyperactivity Disorder, Predominantly Inattentive Type but whose age at onset is 7 years or after.

2. Individuals with clinically significant impairment who present with inattention and whose symptom pattern does not meet the full criteria of the disorder but have a behavioral pattern marked by sluggishness, daydreaming, and hypoactivity.” [Emphasis added]

DSM-5 has two residual categories in this area:

  • Other Specified ADHD (314.01)
  • Unspecified ADHD (314.01)

These “diagnoses” do not mention sluggishness, daydreaming and hypoactivity specifically, but these attributes are clearly embraced by the definitions.  This is particularly the case in that practitioners working with DSM-IV-TR would have become accustomed to conceptualizing this particular presentation as a “sub-diagnosis” of ADHD and, in addition, DSM-5 did not repudiate the SCT example given in DSM-IV-TR.  DSM-5 offers no examples of the residual diagnoses, the most reasonable interpretation of which is that the older examples are still to be considered valid as well as any others that individual practitioners encounter/invent as they go about their work.

It is noteworthy also that the DSM-5 main entry on ADHD contains the phrases: “mind seems elsewhere” and “may include unrelated thoughts.”  These phrases did not occur in the DSM-IV-TR main entry, and are clearly intended to embrace the notion of daydreaming.

So it is clear that the APA’s notion of ADHD (predominantly inattentive type) has long embraced daydreaming and lethargy, and it was probably inevitable that psychiatry, with its ever-expanding agenda, would eventually begin to conceptualize this as a distinct “illness.”  So today we have sluggish cognitive tempo emerging as a “diagnosis” in its own right, and attracting comment and attention.

CURRENT STATUS OF SCT

Earlier this year, Catherine Saxbe MD, a psychiatrist, and Russell Barkley PhD, a psychologist, wrote a paper reviewing the history of research on sluggish cognitive tempo.  The paper, The second attention disorder? Sluggish cognitive tempo vs. attention-deficit/hyperactivity disorder: update for clinicians, was published in the Journal of Psychiatric Practice.  Here’s a quote:

“Sluggish cognitive tempo (SCT) refers to an impairment of attention in hypoactive-appearing individuals that first presents in childhood. At this time, it exists only as a research entity that has yet to debut in official diagnostic taxonomies. However, it seems likely that a constellation of characteristic features of SCT may form the criteria for a newly defined childhood disorder in the foreseeable future, provided limitations in the extant findings can be addressed by future research.”

The authors expressed the belief that sluggish cognitive tempo is an unfortunate name for the disorder  “…since the term sluggish is associated with connotations of being retarded, slow-witted or just plain lazy.”  They remind us that

“More than semantics is at stake here.  The nosology reflects the way we conceptualize a disorder, view our patients, and how they understand themselves.”

They suggest that “concentration deficit disorder” or “developmental concentration disorder” or “focused attention disorder” would be better names for the problem, and appear to be entirely blind to the fact that the negative effects of referring to a child as “sluggish” pale to nothing compared with the stigma and disempowerment inherent in the notion that he is a “patient” with a “mental illness” (regardless of the name given to this illness).  In addition to which, of course, must be reckoned the destructive effects of the “treatments.”

Here are some more quotes from the Saxbe and Barkley article:

“No large-scale medication trials have examined response to stimulants specifically in SCT, but one recent investigation shows promise for the potential use of atomoxetine.”

and

“This is an exciting finding and warrants further investigation as it is the first published report to show improvement in SCT with any medication.”

and

“Given the overlap of SCT with anxiety and depression, perhaps selective serotonin reuptake inhibitors (SSRIs) might be [another] possible treatment.”

The study in question is Wietecha L. et al., titled Atomoxetine improved attention in children and adolescents with attention-deficit/hyperactivity disorder and dyslexia in a 16 week, acute, randomized, double-blind trial.  This appeared in the November 2013 issue of Journal of Child and Adolescent Psychopharmacology.  The paper is a study of the efficacy of atomoxetine in the “treatment” of various attention problems including SCT.  Atomoxetine is a selective norepinephrine reuptake inhibitor (NRI) marketed as Strattera by Eli Lilly.  The study (Wietecha et al.) found that:

“The atomoxetine-treated ADHD-only subjects significantly improved from baseline to Week 32 on…all K-SCT [Kiddie-Sluggish Cognitive Tempo Interview] subscales…”

and

“This is the first study to report significant effects of any medication on SCT.”

All of this is particularly interesting because:

  1. Ritalin, which is now off patent, and other stimulants, are reportedly ineffective in the “treatment” of SCT “symptoms.” (Saxbe and Barkley, 2014, p. 47)
  2. Atomoxetine, which is still on-patent, is now “proven” effective in this area.
  3. Linda Wietecha works as a Clinical Research Scientist for Lilly USA, LLC
  4. According to Dollars for Docs, the following co-authors on the study have also received money from Eli Lilly in the period 2009-2012: Bennett Shaywitz, MD, $963,003; Stephen Hooper, PhD, $16,540; David Dunn, MD, $56,886; and Keith McBurnett, PhD, $5,000.
  5. Russell Barkley, PhD, co-author of the article cited earlier, received $120,283 from Eli Lilly for consulting, speaking, and travel between 2009 and 2012 (Dollars for Docs), and as recently as February of this year gave a lecture tour in Japan sponsored by Eli Lilly.

All of which raises the interesting question:  is SCT disorder being promoted at the present time by Eli Lilly’s paid hacks as a way of increasing sales of atomoxetine (Strattera) while it is still on patent?

PSYCHIATRIC CREDIBILITY

Interestingly, and sadly, most of the research and promotion of SCT has been done by psychologists rather than psychiatrists.  This fact prompted Jeffrey Lieberman, MD, President of the APA, and very eminent psychiatrist to  tweet on April 11 “no credible psychiatrist takes this [SCT] seriously” in response to Alan Schwartz’s article in the New York Times.  Dr. Lieberman seems to be unaware that in DSM-IV-TR (2000), the APA created a specific “diagnosis” for the sluggishness/daydreaming/hypoactivity presentation (using those exact words), and that this “diagnosis” has been clearly retained in DSM-5 (though without those specific words).  I’ve never been aware of any great outcry from organized psychiatry, or from individual practitioners, on this matter.  So, if we are to take Dr. Lieberman at his word (and why would we not do that?), there must be an enormous dearth of “credible psychiatrists” within the APA’s ranks.

In this context, it is also noteworthy that the Wietecha et al. article was published in the Journal of Child and Adolescent Psychopharmacology, which suggests – at least to me – that the journal takes SCT seriously.  The editor-in-chief is Harold Koplewicz, MD, psychiatrist, founding member and President of the Child Mind Institute.  Dr. Koplewicz has held many prestigious positions, and has received numerous awards, including the 2009 American Psychiatric Association McGavin Award for lifetime contributions to child psychiatry.  But alas, he must now be considered a psychiatrist with no credibility.

And

The Saxbe and Barkley article was published by the Journal of Psychiatric Practice, the editor of which is John Oldham, MD, Senior VP and Chief of Staff at the Menninger Clinic, and a psychiatry professor at Baylor College of Medicine.  Dr. Oldham is a past President of the APA (2010-2011), and of the American College of Psychiatrists (2010-2011).  He has also been President of the International Society for the Study of Personality Disorders, and was a member of the DSM-5 Personality Disorders workgroup.  But, here again, no credibility!

The general point here is that psychiatry has embraced the concept of medicalizing daydreaming. Dr. Lieberman either doesn’t realize this, or is trying to conceal the fact.

DISCUSSION

It would be easy to get distracted by this recent attempt to promote childhood daydreaming as a mental illness.  As mentioned earlier, daydreaming, or to use psychiatric terminology, “the persistence of developmentally inappropriate and marked inattention,” has been a specific “mental illness” since DSM-III-R, 1987, (p 95).

The fact is that any human presentation can be considered a mental illness.  All that is needed is the APA’s say so.  And the APA made their position absolutely clear in the foreword to DSM-II (1968).  In the paragraph where they discuss what “diagnoses” should be included in the manual, they state:

“The Committee has attempted to put down what it judges to be generally agreed upon by well-informed psychiatrists today.” (p viii)

In other words:  if we say it’s a mental illness, then it’s a mental illness!

In subsequent editions of the manual, they offer a definition of a mental disorder, which when stripped of verbiage boils down to:  any significant problem of thinking, feeling, and/or behaving.  And who decides something is a problem?  A psychiatrist, of course.

Sluggish Cognitive Tempo (or concentration deficit disorder, as Drs. Barkley and Saxbe would prefer to call it) is more psychiatric nonsense.  But that’s all it is – more of the same; another inevitable result of psychiatry’s fundamentally flawed, spurious, and destructive medicalization of human existence.  Psychiatry continues to expand its net of entrapment into all aspects of life and into every corner of the globe.

By all means let’s speak out against this latest encroachment, but let us not lose sight of the corrupt and spurious engine that has been driving this endeavor since the 1950’s, or of the trail of human suffering and destruction that it has left, and continues to leave, in its wake.

Nor let use lose sight of the fact that many of the greatest writers, scientists, and artists were chronic daydreamers.  We can only imagine how much better the world would be today if these individuals had received the benefits of modern psychiatric treatment. We can also look forward to a better future – a future where daydreaming will be routinely recognized as the illness that it is, it’s victims will be “treated” appropriately with psychiatric drugs, and this plague, that has beset humanity since pre-historic times, will finally be eradicated.

* * * * * * * * *

There is absolutely no facet of human existence that psychiatry will not pathologize in the pursuit of its own self-serving agenda.

‘ADHD’ and Dangerous Driving

In 2006, Laurence Jerome, a Canadian psychiatrist, and two colleagues wrote a paper titled What We Know About ADHD and Driving Risk: A Literature Review, Meta-Analysis and Critique.  It was published in the Journal of the Canadian Academy of Child and Adolescent Psychiatry in August, 2006. The primary result of the meta-analysis was:

“Current data support the utility of stimulant medication in improving driving performance in younger ADHD drivers.”

The study is lengthy and well-referenced, but in keeping with standard psychiatric practice, it conceptualizes and presents ADHD as a “…common psychiatric disorder…” with symptoms of “…inattention, impulsiveness and hyperactivity…”  In other words, they present ADHD as something that a person has rather than as something that a person does. The problem with this approach is that it creates the impression that meaningful or significant correlations/effects have been found, where in fact all that has happened is an elucidation of the terms used.

For instance, the authors refer to a study by Fried et al. (2006) and state:

“Fried et al. (2006) evaluated driving behavior using the DBQ [Driving Behavior Questionnaire] and found that the ADHD group had significantly more lapses, errors and violations than controls.”

On the face of it, this looks like an interesting finding.  It purports to be an important fact that has been discovered about people who have this condition.  But in reality, lapses, errors, and violations are an integral part of the definition of ADHD.  The DSM criteria includes:  careless mistakes; difficulty remaining focused; mind seems elsewhere; easily distracted; forgetful; etc…  One doesn’t get into this group in the first place without a history of habitual lapses, errors, and violations.  The fact that these habitual lapses and errors carry over into a person’s driving behavior isn’t particularly surprising.

There are several other examples of this in Jerome et al., e.g.:

“A number of studies examined cognitive abilities associated with safe driving performance. Measures of both inattention and impulsivity were found to be higher in the ADHD groups as compared to controls.”

Here again, inattention and impulsivity are defining features of the condition labeled ADHD.  All that has actually been found here is that people who are inattentive and impulsive are inattentive and impulsive! The study reports that people who carry a “diagnosis” of ADHD are involved in more collisions, and receive more traffic citations than controls.  This is interesting, but again, hardly surprising for the reasons discussed above.  One could look at all this simply as benign, meaningless verbiage, but in reality, the constant repetition of these factoids reinforces the notion that the label ADHD refers to a real illness, and that this “illness” has real sequelae, in the same way that kidney failure, for instance, usually entails edema and anemia.

EFFECTS OF PSYCHOTROPIC DRUGS

The authors discuss several studies on the effects that stimulant and non-stimulant drugs that are used to “treat” ADHD have on driving behavior.  The results were mixed.  The authors draw attention to some methodological problems in this area and also concede that “…all currently available studies are industry sponsored.”

NEUROLOGY

Dr. Jerome et al. posit a neurological deficit as the source of the impulsivity and inattention.

“Core functional impairments in executive function related to response inhibition, working memory and flexible strategic response help explain both general ADHD pathology and its specific manifestations in problem driving in this group.”

This paper, as noted earlier, was written in 2006.  Note the cautious language in the quote above:  “…help explain…”  Today, eight years later, there’s still no definitive neural pathology known to be causally associated with these problem behaviors, and the “illness” is still being “diagnosed” by subjectively assessing, and counting, the individual’s actions.  In fact, and this is particularly compelling, the American Academy of Child and Adolescent Psychiatry in its current practice parameters for ADHD state unambiguously that unless there is a clear history of severe head injury, or other neural pathology

“…neurological studies…are not indicated for the evaluation of ADHD.” [Emphasis added]

At this point Dr. Jerome et al. make the great leap of faith:

“…it was not the knowledge base of driving skills that differentiated the driving problems in ADHD youth so much as their inability to apply these rules at the appropriate time and under the appropriate circumstances. In other words the problem is an output problem; they can ‘talk the talk but they can’t walk the walk’.” [Emphases added]

Note the words “inability” and “can’t.”  This is one of the fundamental problems in the “diagnosis” of ADHD and other psychiatric “illnesses” – the logically flawed leap from “doesn’t” to “can’t.”  And this unwarranted leap is the basis for the conclusion that the individuals in question have an illness, and, in extreme cases qualify for disability.  A person with kidney failure doesn’t and can’t produce urine.  But a person “with” ADHD can, with proper training, learn to behave in a more attentive and less impulsive manner.

In former times, children who were routinely inattentive and impulsive were considered to be in need of training and discipline.  By and large, school teachers and parents provided this.  In fact, the training was usually provided before the matter even became an issue.  Today these children are spuriously and arbitrarily labeled as ill, and are given pills.  The pills suppress the problem behavior, but in many, perhaps most, cases the underlying problem of self-discipline is never addressed.  So these children grow up and, not surprisingly, they become inattentive and impulsive drivers, with a reportedly 50% increased risk of negative driving outcomes.  The “diagnosis” of “illness” contains within itself the disempowering, and incidentally false, message that the individual was incapable of acquiring the level of discipline, attention, and self-control needed for successful classroom participation.  Psychiatry has given these parents, and the children themselves, the false message that their brains are malfunctioning, that the pills will correct the problem, and that attempts to teach discipline and self-control in the normal manner are futile.  With pharma-psychiatry’s successful expansion of this “diagnosis” to the adult population, the disempowerment has become a more-or-less permanent “disability.”

The role that the initial “diagnosis” and subsequent drugging played in transforming what used to be an eminently remediable problem into a permanent disability is seldom addressed or even acknowledged.  The psychiatric fiction has to be maintained:  these individuals were “sick” as children and are still “sick” as adults.  Their inattention and impulsivity are still “symptoms” of the same debilitating “illness.”  Psychiatrists for the past sixty years have insisted that they are discovering real illnesses.  They remain self-servingly blind to the fact that, firstly, they invented these illnesses, and secondly, that their active promotion of these “illnesses” has created a culture in which personal effort and self-discipline are routinely marginalized in favor of the spurious and inherently disempowering notion of pharmaceutically correctable impairments.

Jerome et al. do pay passing acknowledgement to the need for “psychological strategies,” but it is clear that they conceptualize the matter as a medical problem with a pharmaceutical remedy:

“Experimental studies indicate that stimulants and to a lesser extent non-stimulant drugs used to treat ADHD improve areas of driving performance.”

These, incidentally, are the same industry-sponsored studies mentioned earlier.

and

“In particular the question of adherence to medication regimens over time to improve driving skills is likely to be a critical question based on our knowledge of poor long-term medication adherence for young adults with ADHD.”

and

“The individual attending physician has an opportunity to reduce morbidity and mortality for the individual ADHD patient as well as contribute to improved public health for the driving population at large by making the roads safer one driver at a time.”

and

“A number of jurisdictions including Canada and UK now require physicians to report ADHD drivers thought to be at risk of problem driving to the Ministry of Transportation.”

and

“The question of medico-legal liability is in its infancy with no established case law for physicians found negligent of failing to adequately treat ADHD patients with the appropriate medications to reduce driving risk. Whilst the available literature does not yet provide clear evidence that stimulant medication should be the standard of care for problem drivers long term, it is probably only a matter of time before this question will be debated in a legal arena.”

DISCUSSION

At the present time the pharma-psychiatric system is being widely exposed as the spurious, destructive, disempowering fraud that it is.  Organized psychiatry is responding to these criticisms not by cleaning up its act, but instead by increasing its lobbying activity in the political arena.

In particular, they are actively promoting the notion of involuntary community “treatment” with coerced “medication.”  Under this system, which is established by law in more than 40 US states, a judge can order an individual to attend the local mental health center and to abide by the center’s “treatment” plan.  The plan usually entails a requirement to take psychiatric drugs, sometimes the long-lasting injectable variety.  Here’s how Jeffrey Lieberman, MD, President of the APA, describes the program:

“There’s also other forms of psycho-social treatment that are very, very helpful. Sometimes people who have schizophrenia don’t want treatment, or don’t feel they need treatment, or just plain forget about treatment. In those cases, with what’s called assertive community treatment, a case manager or somebody that’s assigned to work with that person will go out to find them, will go to their home, you know, ‘You haven’t come to the clinic, you haven’t come to the office, you haven’t shown up, what’s going on here, you need to get your medication, you need to go through your rehabilitation,’ so they’ll get after them.”

This all sounds very cozy and friendly, and you know – come on down to the mental health center, you know, we care about you, etc., etc… But within the silk glove, there’s the mailed fist of confinement and coerced drugging.  Readers can check out the other side of the story at National Coalition for Mental Health Recovery, PsychRights page on OutPatient Commitment, and by searching for assertive outpatient commitment on Mad in America.  Dr. Lieberman is talking about people labeled with schizophrenia, but it doesn’t take too much imagination to see how the concept could be adapted to a wide range of other “diagnoses,” including ADHD.

As of yet, the ominous prediction in the final Jerome et al. quote above has not come to pass.  But is the day approaching when individuals “diagnosed” with ADHD during childhood will be subjected to special screening when they apply for a driving license?  Might their licenses be made contingent on their ingestion of psychoactive drugs?  After all, impulsive, inattentive drivers constitute a danger to themselves and others.  If, as psychiatry claims, their impulsivity and inattention are the result of a “mental illness,” then doesn’t it make sense that they be committed?  Isn’t it in their own interests and the interests of the public at large that they be coerced to take their “medications”? Such a move would be consistent with psychiatry’s long-standing expansionist agenda and with pharma’s objective to sell more drugs.

And lest my concerns be considered groundless speculation, here are some interesting quotes.

From Oren Mason, MD, a blogger physician, co-owner of Attention MD, and associate professor at Michigan State University.  He specializes in the “…diagnosis and management of attention deficit disorders and related conditions” (Ritalin Saves Truckers’ Lives. Soccer Moms’, Too, February 2014):

“There is a public health issue when inattentive or impulsive behaviors occur on busy, public streets and highways.”

and

“…we could potentially prevent 100,000 injuries and deaths every year with consistent use of ADHD medications.”

Incidentally, according to Dollars for Docs, Dr. Mason received $208,459 from Eli Lilly for speaking, consulting, travel, and meals between 2009 and 2012.

And from Brian Krans, an assistant editor at HealthLine News (Could Ritalin Be the Way to Keep Truckers Safe on the Road? January 2014):

“Another new study says that undiagnosed attention-deficit hyperactivity disorder (ADHD) may be the cause of many safety issues for drivers on the road.”

Note how ADHD has become the cause of the problem behaviors, rather than just another name for them.

and

“… research shows that medications like Ritalin and Adderall may be beneficial to help them increase reaction time [presumably should read decrease], reduce accidents, and ultimately save lives.

Interestingly, Healthline.com runs a good many ads for ADHD “medications.”  They are clearly marked Advertisement, but the font is very small.

and

“So, should truckers be screened for ADHD instead of self-medicating with harder drugs?”

There is an implication here that ADHD “meds” will reduce the incidence of truckers driving under the influence of speed.  In fact, Ritalin and most other ADHD “meds” are stimulants and are widely abused.  RitalinAbuseHelp.com states that

“Ritalin is taken by recreational drug users for its cocaine-like high.”

and

“Ritalin is taken by workers such as truck drivers to stay awake for long shifts.” [Emphasis added]

Here are some more interesting quotes:

From the American Academy of Pediatrics 2011 practice guidelines on ADHD:

“Given the inherent risks of driving by adolescents with ADHD, special concern should be taken to provide medication coverage for symptom control while driving.  Longer-acting or late-afternoon, short-acting medications might be helpful in this regard.”

And from the American Academy of Child and Adolescent Psychiatry: ADHD Practice Parameters:

“Single daily dosing is associated with greater compliance for all types of medication, and long-acting MPH [methylphenidate] may improve driving performance in adolescents relative to short-acting MPH…”

And from psychologist Russell A. Barkley, PhD, Clinical Professor of Psychiatry and Pediatrics at the Medical University of South Carolina in Charleston, and author of numerous books and studies on ADHD, quoted in this New York Times article from 2012:

“Medication [for drivers who have ADHD] should not really be optional…”

And Dr. Barkley is an eminent man.  I know this because on his website it says that he is “…an internationally recognized authority on attention deficit hyperactivity disorder (ADHD or ADD) in children and adults…”  I also know that he is conscientious and caring.  His website states that he “…has dedicated his career to widely disseminating science-based information about ADHD.”  If proof is needed of his dedication to disseminating information, one need only open the “books” tab on his website.  He has 16 different titles for sale at prices ranging from $14.41 for some paperback book versions to $131.75 for his rating scale books.  One can also subscribe to his newsletter ADHD Report for $105 per year.

Dr. Barkley is well regarded by the pharmaceutical industry.  Dollars for Docs reports that between 2009 and 2012, he received $120,283 from Eli Lilly alone, for consulting, speaking and traveling.  In February of this year he conducted a five-day, multi-city lecture tour of Japan sponsored by Eli Lilly.  And according to  his CV, in 2004-2005, he was awarded a grant of $99,750 from Eli Lilly to study the “Effects of atomoxetine on driving performance in adults with ADHD.”

Dr. Barkley has also reportedly served as a consultant/speaker to Shire, Medice, Novartis, Janssen-Ortho, and Janssen-Cilag.

Dr. Barkley played a significant role in the relaxing of the age-of-onset criterion from 7 to 12 in DSM-5.  As early as 1997, he and the equally eminent Joseph Biederman, MD co-authored Toward a Broader Definition of the Age-of-Onset Criterion for Attention-Deficit Hyperactivity Disorder (Journal of the American Academy of Child and Adolescent Psychiatry, September 1997).  In this article they state, apparently without the slightest hint of irony:

“We can see no positive benefits of the recommended AOC [age of onset criterion] except that it would certainly limit the number of children (and probably adults) with diagnosed ADHD.  Some special education districts or managed health care companies who might wish to restrict the access of those with ADHD to their services could conceivably see such a restriction as advantageous, but this is purely financial self-interest.”

So, all things considered, when Dr. Barkley tells a New York Times reporter that medication for drivers with ADHD “should not really be optional,” perhaps we should be concerned.

Over the past 60 years, pharma-psychiatry has demonstrated, time and again, that there is no human problem that they can’t exploit for their own benefit and, in the process, make ten times worse.  I will be watching this latest foray into road safety with trepidation.

Investigation of Dan Markingson’s Death

I have written on Dan Markingson’s death in an earlier post, and I encourage readers who are not familiar with the case to have a look.

It is generally accepted by those of us on this side of the debate that psychiatry does more harm than good, and is organizationally and individually responsible for a great many deaths worldwide every day.

These deaths, however, are seldom laid at psychiatry’s feet.  Coroners return verdicts of suicide, homicide, heart attacks, choking, etc…  Occasionally psychiatric practice is mentioned as a contributory factor, but not often.

Dan’s death was attributed to suicide, but behind that suicide there was a good deal of ethically questionable psychiatric treatment and research.  The University of Minnesota conducted an investigation into Dan’s death, but the investigation was marred by conflicts of interest, and its findings, which exonerated the research team from responsibility, were not credible.

After a great deal of pressure from various sources, the University’s Senate recently approved a resolution calling for an independent investigation into Dan’s death.  I also wrote a post on this.  The University undertook to conduct such an investigation, but present indications are that this will also be a whitewash.  For instance, the University’s President, Eric Kaler, has stated that the proposed review will not look into the matter of Dan’s death, but instead will focus only on the general policies and procedures currently in place.  Here’s a quote from an interview with President Kaler that was published in the Minnesota Daily on December 11, 2013: 

“It [the Senate’s call for an independent investigation] certainly resulted as a consequence of a lot of repetitive publicity about the Markingson case, but it’s not a review of the Markingson case; it’s a review of what we are doing now and what we’re going to do moving forward.”

Carl Elliott, PhD, Bioethics Professor at the university, has been pushing tirelessly in this matter, literally for years.  On April 8 he published Markingson Case Supporters: We Need Your Help on his website.  In this update he points out that

“…evidence is accumulating that Dan Markingson was not the only patient who died or was seriously injured in psychiatric research studies at the university.”

He also asks for help and support in urging the State Governor Mark Dayton and the University Board of Regents Chair Richard Beeson to take appropriate steps to ensure that Dan’s death and the deaths of the other research participants are investigated thoroughly by independent authorities

Carl’s post contains phone numbers for the Governor and the Regents Chair, along with a suggested message.  Please take a look at Carl’s article, and if you agree, please add your voice to this call for transparency and integrity.

**********

CORRECTION:

In this post I stated that the University of Minnesota had conducted an investigation into Dan’s death and had exonerated the research team.

In fact, the university did not conduct any investigation of Dan’s death.  See a link here.

I apologize for the error.

 

 

Justina Pelletier and Boston Children’s Hospital

Justina Pelletier is the 15-year-old girl who is at the center of a dispute between her parents and the Psychiatry Department at Boston Children’s Hospital.

Justina, who lived with her parents in Connecticut, had been diagnosed with mitochondrial disease, a rare and debilitating illness, and had been receiving treatment for this from Mark Korson, MD, Chief of Metabolism Services at Tufts Medical Center in Boston.

In February of last year, Justina’s parents took her to Boston Children’s Hospital with flu-like symptoms.  Dr. Korson had recommended an admission to Boston Children’s so that Justina could be seen by Alex Flores, MD, a gastrointestinal specialist who had recently transferred from Tufts to BCH.

But instead, Justina’s care was taken over by the psychiatry department.  She was “diagnosed” with somatoform disorder (“it’s-all-in-your-head”), and BCH reported the parents to the state of Massachusetts for medical child abuse.  The complaint was taken by the Department of Children and Families (DCF), and within 24 hours Judge Joseph Johnston awarded custody of Justina to the Massachusetts DCF, and ruled that she had to stay at BCH.

The parents continued to press for Justina’s release from BCH, but were hampered in these efforts by a gag order that Judge Johnston had imposed.

In January of 2014, having spent almost a year in psychiatric care at BCH (nine months of which were in a locked ward), Justina was transferred to the Wayside Youth and Family Support Network in Framingham, Massachusetts.  She was still in the custody of the DCF, and still under the care of psychiatrists at Boston’s Children’s hospital.  In February of 2014, Justina’s father, Lou Pelletier, alarmed at the deterioration in his daughter’s medical condition, decided to break the gag order, and go public, despite the risk of imprisonment.  There was a huge outcry, and Massachusetts child protective services stated on February 28, 2014, that they are actively working to return Justina to Connecticut and the care of Tufts.

“The timetable for the shift of the teenager to her home state has not been set, and it is unclear just how much the Massachusetts Department of Children and Families is retreating from the girl’s case. But Loftus [DCF spokesperson] said child-protection officials from both states, the juvenile judge handling the case, and lawyers for the parents are actively working on identifying a new placement in Connecticut. He would not say what places are under consideration, but in cases like this, the child could be returned back to her home, or placed in a foster home or a residential treatment facility.

If she were to live at her family’s home in West Hartford, Conn., child-protection officials in that state, who would likely oversee the case, would likely demand that the girl receive services at home or that she attend a day program.”

Because of the gag order, which was in place since November 17, 2013, and the official secrecy that normally attends these matters, it’s difficult to establish all the facts.  But the gist of the conflict seems to be that the psychiatrists at BCH disputed the diagnosis of mitochondrial disease.  (In fact, there are indications that they may even have disputed whether such a disease even exists – an extraordinary accusation coming from psychiatry!)  They also, apparently, formed the belief that the parents were dysfunctionally invested in the notion that Justina was gravely ill, and were subjecting her to needless medicines and treatments.  During the eleven months she was at BCH, the psychiatrists placed very strict and stringent limits on how much contact the teenager could have with her family.  There’s a copy of a January 8, 2014, letter here from Kathleen Higgins, RN, a former BCH employee, to the DCF Commission.  The letter provides a great deal of insightful background.

The parents protested vigorously that Justina had been taken off the medicines for mitochondrial disease, and they stated that her physical condition had deteriorated markedly during her stay at BCH.

DISCUSSION

Somatoform disorder is a DSM-IV term.  It refers to a group of psychiatric “diagnoses,” the common feature of which is “…the presence of physical symptoms that suggest a general medical condition…and are not fully explained by a general medical condition…”  (DSM-IV, p 445).  In addition, “…there is no diagnosable general medical condition to fully account for the physical symptoms.” (ibid)  Like all psychiatric “diagnoses,” it has no explanatory value and is nothing more than a destructive and unreliably applied label.

So essentially what’s happened here is that Dr. Korson, a pediatrician who is board-certified in Clinical Biochemical Genetics, an associate professor at Tufts University School of Medicine, and a specialist in mitochondrial diseases, has been treating Justina for about three years for mitochondrial disease.  (According to the site MitoAction, “Dr. Korson is universally recognized as an expert in clinical practice for mitochondrial patients.”)  He sends her to BCH for a gastrointestinal consult with Dr. Flores.  And within 24 hours, the psychiatry department hijacks her, rejects the mitochondrial disease diagnosis, substitutes a “diagnosis” of its own, files a medical abuse report with DCF, and supports a DCF petition to have Justina made a ward of the state.  Prior to all this, Justina had no mental health history of any kind.

As soon as they realized what was happening, the parents sought to remove Justina from BCH – but when the teenager became a ward of the state, that door was closed, and the judge ordered that Justina be kept at BCH.

Justina’s case has focused a great deal of attention on these matters generally.  One of the points that has emerged fairly clearly is that BCH’s procedure for pursuing a commitment of this kind is a well-oiled machine.  The BCH physicians and staff on the one hand, and the DCF staff on the other, work closely to prepare their cases, and the courts are usually cooperative.  Psychiatric evidence is afforded a high measure of credibility and deference, and, as in this case, the child is routinely ordered to remain at BCH.

The problem with all of this is that BCH stands to make a great deal of money on every child that is court-ordered to remain in their care.  The conflict of interest is glaring.  It’s like a judge routinely sending convicted criminals to a private prison that he himself happens to own.  The difference is that any judge who engaged in activity of this sort would be looking at criminal charges and disbarment.  But in psychiatry, this sort of thing is common.

The matter is particularly compelling in that reports are emerging that BCH tends to pursue these kinds of court orders in cases where the family has “good insurance.”  Justina was kept at BCH for eleven months.  I have seen no reports as to the size of the bill, but I’m sure it wasn’t trivial.

BCH AND HARVARD

David R. DeMaso, MD, is the head of psychiatry at BCH.  He is also a professor at Harvard, and is a member of Harvard’s Psychiatry Department Executive Committee. He is evidently highly regarded at the University, and has his own Harvard Catalyst page.  There’s a tab on this page labeled “Similar People,” and one of the people listed as “similar” to Dr. DeMaso is our old friend Joseph Biederman, MD, the eminent inventor of pediatric bipolar disorder.  This is the bogus diagnosis that legitimized the prescribing of neuroleptic drugs to children as young as two years old for temper tantrums.  Even some psychiatrists spoke out against this spurious and destructive activity, but the practice continues.  The fact that Dr. DeMaso would allow Dr. Biederman’s name to remain on his Similar People tab seems noteworthy.  There is also a “connections”  page on Harvard Catalyst, listing three publications co-authored by Dr. DeMaso and Dr. Biederman.

Dr. Biederman is on record as promising Johnson & Johnson a positive result for their drug Risperdal if they would fund his study.  Why would any reputable physician allow someone like that to remain on his “Similar People” tab?

I did a PubMed search to see if there were other links between BCH psychiatrists and Joseph Biederman.  In addition to the DeMaso publications, I discovered papers co-authored by Joseph Biederman and at least two other members of the BCH Department of Psychiatry “Leadership Team:”  Joseph Gonzalez-Heydrich, MD (7 articles, as recent at 2012); and Deborah Waber, MD (3 articles, as recent at 2012).

PUBLIC OUTCRY

None of Justina’s story would have come to light had there not been an extensive and vigorous public outcry.  This in turn would not have happened if Justina’s father, Lou, had not breached the court’s gag order.  The fact that our courts can effectively prohibit a parent, on pain of imprisonment, from speaking out against his child’s enforced psychiatric treatment ought to be a huge concern.  Our legislative and legal systems have been hoodwinked by psychiatry for too long.  The right to free speech is our most fundamental political freedom.  The fact that a state court would so cavalierly suspend such a right to promote the agenda of BCH’s psychiatry department suggests a measure of partiality on the part of the court in an area where the child’s welfare ought to be the paramount consideration.  There had never been the slightest indication that Justina’s parents had been abusing or neglecting her.  In fact, they brought her to BCH on the advice of the child’s physician to get help for the flu-like symptoms.  By any conventional standards, they were being dutiful and attendant.  The gag order was clearly an attempt to prevent them from drawing adverse publicity to BCH’s psychiatry department.  Courts are supposed to be impartial.  Why would the court in this case have assumed that the psychiatry department’s motives were benign, that its “diagnoses” were valid and accurate, and that its practices were judicious and efficacious?  Why did the court not recognize the financial conflict of interest when it ordered that Justina be kept involuntarily in the locked psychiatric ward at BCH?

BCH’s psychiatrists kept Justina in a locked psychiatric ward for nine months.  Apparently it never occurred to them that they might have made an error, or that they had acted too hastily. Psychiatry seldom engages in anything even remotely akin to critical self-scrutiny.  They have resisted the parents’ protests at every step of the way, and have been backed throughout by the court.  It is only because of the public outrage that the facts are emerging.  Massachusetts’ Department of Public Health has called for a full investigation of the matter.  One can readily imagine the kinds of pressures that will be brought to bear to whitewash the entire affair.  Let us all, individually and collectively, do what we can to ensure that this does not happen.

A Blood Test for Schizophrenia with 83% Accuracy?

INTRODUCTION

An NBC online News article dated October 15, 2010, carried the noteworthy title New blood test may help detect schizophreniaThanks to Francesca for the link.

The article was written by Natasha Allen, a freelance medical journalist.  The gist of the article is that there is a new blood test called VeriPsych which “researchers say” is 83% accurate in discriminating people who are “schizophrenic” from people who are not.

One of the researchers – Michael Spain, MD, Chief Medical Officer of Rules-Based Medicine, is quoted as saying:

“There is a certain amount of denial when a child is diagnosed with schizophrenia. You wish that your child did not have that…It is a good test to convince parents or even the patient to stay on medication, as opposed to just subjective opinion.” [Emphasis added]

The article also points out that Rules-Based Medicine is the company that makes the test and funded the study.

The study itself is published in Biomarker Insights, a peer-reviewed journal that began publishing in 2006 and is owned by Libertas Academia.  The study appeared in the May 2010 issue and is called Validation of a Blood-Based Laboratory Test to Aid in the Confirmation of a Diagnosis of Schizophrenia. There are 24 authors.  The lead author is Emanuel Schwarz of the Institute of Biotechnology, University of Cambridge, UK.  The Institute of Biotechnology had reportedly served as consultants to Rules-Based Medicine.  Five other authors, including Sabine Bahn, MD, PhD, MRCPsych, have links to the Institute.

An additional four authors, including Dr. Spain, report links to Rules-Based Medicine Inc.

Another author reports links to Psynova Neurotech Ltd., Cambridge, UK (a subsidiary of Rules-Based Medicine).  And another reports links to the Stanley Medical Research Institute, Chevy Chase, Maryland.

Here’s the study’s abstract:

“We describe the validation of a serum-based test developed by Rules-Based Medicine which can be used to help confirm the diagnosis of schizophrenia. In preliminary studies using multiplex immunoassay profiling technology, we identified a disease signature comprised of 51 analytes which could distinguish schizophrenia (n = 250) from control (n = 230) subjects. In the next stage, these analytes were developed as a refined 51-plex immunoassay panel for validation using a large independent cohort of schizophrenia (n = 577) and control (n = 229) subjects. The resulting test yielded an overall sensitivity of 83% and specificity of 83% with a receiver operating characteristic area under the curve (ROC-AUC) of 89%. These 51 immunoassays and the associated decision rule delivered a sensitive and specific prediction for the presence of schizophrenia in patients compared to matched healthy controls.”

Which means that if you perform these 51 tests on a person’s blood and collate the results using VeriPsych’s algorithm, the result will predict schizophrenia with 83% accuracy.

In the conclusions section of the article it states:

“In this multicenter study, we discovered and validated a biomarker panel for schizophrenia based on biological and technical reproducibility of the molecular signature.”

“High classification performance demonstrated that the decision rule could identify schizophrenia patients with high accuracy irrespective of the disease duration or treatment state.”

“In summary, the present findings demonstrate the applicability of a rapid and non-invasive test to confirm the presence of schizophrenia.”

And their work is not finished!

“We anticipate that the 51-plex assay panel will result in the future development of a differential diagnostic test that can distinguish among various neuropsychiatric disorders such as schizophrenia, bipolar disorder and major depressive disorder.”

Under “Acknowledgement,” the authors tell us that the study was “instigated and supported” by:

  • Rules-Based Medicine
  • Psynova Neurotech Ltd
  • Stanley Medical Research Institute 

The authors express their thanks to various colleagues who assisted in the research.  And they singled out for special thanks “…Dr. Fuller Torrey for his support and suggestions.”

PROMOTION AND PUBLICITY

After the research article was published, the information about VeriPsych was picked up by the following media sources:

October 6 2010, a site called MPR put up a sort of ad that reads “VeriPsych schizophrenia diagnostic aid available,” and gives a number to call RBM for more info.

A site called Fast Company put up an article called Veripsych Says It Can Spot Depression, Schizophrenia In Blood on their site, no date given.

Singularity Hub put up an article Blood Tests to Diagnose Schizophrenia, Other Brain Disorders on the Horizon, by Jeremy Ford on Jan 18, 2011.

On October 13, 2010, livescience put up Natasha Allen’s article under the title It’s in the Blood: New Hope for Detecting Schizophrenia.  Here Ms. Allen is listed as a MyHealthNewsDaily Contributor.

Mental Healthy (UK) site ran an article Blood Test to diagnose schizophrenia and depression by Catherine Walker (probably in 2011), after Dr. Sabine made a presentation at the 2011 APA annual conference.

Psychiatric Times ran the headline Blood Tests for Diagnosis of Schizophrenia and Depression? on August 10, 2011

But three months later, on November 8, 2011, they also put up an article called Blood Tests for Diagnosis of Schizophrenia and Depression: Not Ready for Prime Time.

On October 28, 2012, Oxbridge Biotech Roundtable put out an article An afternoon with Prof. Sabine Bahn: Bridging prognosis, diagnosis and treatment.

Bipolar burble (a blog) did a post on this on April 18, 2011.  But the author of the blog put this at the end:

“This is a money-grab taking advantage of desperate mentally ill people.

I actually find this ‘diagnostic aid’ blood test for schizophrenia to be bordering on unethical. VeriPsych can cover their ass with math and statistics and probabilities and legal-eze and I’m sure that makes it ‘OK,’ but if you ask me, they are a hair’s breath away from lying. It feels irresponsible to me to hand out these kinds of results about a very serious illness based on one study. One. And there is so much math needed to make this model work that I would fall down dead if there wasn’t a mistake in there somewhere. Nobody gets it right the first time.”

 So we have a blood test for schizophrenia!  The Holy Grail – at last.  Schizophrenia, the darling “diagnosis” of psychiatry, can now take its rightful place in the halls of medicine, soon to be followed by bipolar disorder and major depressive disorder.  And disgruntled, misanthropic naysayers, such as myself, can slink cringingly into our narrow beds of shame and ignominy.

BUT WAIT!  THERE’S A GLITCH!

On January 2, 2013, the following notice appeared on VeriPsych’s website.  (VeriPsych is the name of the blood test, but it is also the name of the company that marketed the test and is affiliated with Rules-Based Medicine, which apparently is now called Myriad Rules-Based Medicine.)

“Thank you for visiting the VeriPsych website and for your interest in VeriPsych, the first blood-based diagnostic aid for schizophrenia.

 We have temporarily suspended offering the VeriPsych test in an effort to improve its utility. In 2010, we conducted a beta launch confirming that the test worked as intended; however, in close collaboration with our medical and scientific partners, we collectively determined that the product needed further refinement to better fit the needs of patients and healthcare providers. Accordingly, we have shifted our focus onto the development of new transformative molecular diagnostic tools that address bi-polar disorder and major depression, in addition to schizophrenia. We are extremely excited by the progress made in bringing these diagnostic products to physicians and, most importantly, to the patients that can benefit from them. Unfortunately, there is currently no timeline for the availability of these new products in the United States or any other markets.

If you would like to receive information about our next generation of tests and their availability, please enter your email below. We will use this email distribution to release updates and news about the development of these new tests.

Thank You.”

Note the phrases:

  • in an effort to improve its utility
  • the product needed further refinement
  • there is currently no timeline for the availability of these new products 

HISTORY OF THE FINANCIAL ASPECTS

2005

Psynova Neurotech, established in 2005 by Sabine Bahn and Chris Lowe, PhD, Director of Cambridge University’s Institute of Biotechnology

2008

AUSTIN, Texas–(BUSINESS WIRE)–Rules-Based Medicine, Inc. (RBM), the leading multiplexed biomarker testing laboratory, announced today that it is partnering with Psynova Neurotech to co-develop and commercialize a blood test for the diagnosis of schizophrenia. RBM and Psynova will focus on the unmet clinical need for an objective and reliable diagnostic test to accelerate and optimize the treatment of schizophrenia. Under the terms of the agreement, the companies will collaborate on the validation, regulatory approval and manufacture of a diagnostic blood test for schizophrenia that will be sold worldwide exclusively by RBM.

2010

May, 2010 Schwarz et al article published in Biomarker Insights journal 

2011

Professor Sabine Bahn, MD, PhD, MRCPsych, Director of the Cambridge Centre for Neuropsychiatric Research (CCNR) and Director/Cofounder of Psynova Neurotech Ltd, presented her research at the APA annual conference in Hawaii (May 14-18)

April 27, 2011 Myriad Genetics announced that it was going to acquire RBM and set up a subsidiary known as Myriad RBM, running it from RBM’s existing premises in Austin

June 23, 2011 According to Business Weekly, Myriad Genetics completed the $80 million cash acquisition of the PsyNova + Rules-Based Medicine company.

August 10, 2011 Michael Spain, MD, Chief Medical Officer of Myriad RBP is quoted in Psychiatric Times as saying that “…psychiatrists in a variety of treatment settings have ordered the test for hundreds of psychiatric patients,” at a cost of $2,500 per test, and that “…numerous insurance carriers…” were paying for it.

January 2, 2013

VeriPsych suspends the test.

So what happened?  What went wrong?  Within psychiatric circles, a valid blood test for the condition known as schizophrenia would be the media equivalent of aliens landing in Times Square.

Unfortunately, everybody concerned, including Fuller Torrey and the Stanley Medical Research Institute are keeping their heads down.  The timing of the sale of PsyNova for $80 million seems significant.  That is an awful lot of money for something that “needs further refinement” and for which no marketing date is available.

CRUNCHING NUMBERS

I have no inside information as to what went wrong on this study, but here’s a little analogy that might go some way to explaining the matter.

Suppose my wife and I decide to rent out the upstairs of our house, but we particularly don’t want tenants who play loud music.  So we decide to develop a test that will enable us to distinguish these individuals from people who play their music quietly.  We live in a small village, and we decide to conduct our research here.

There are 100 houses in our village, and for simplicity’s sake let’s say that there’s one person living in each house and we have 10 items of information on each person.

So we walk around the entire village every day for, say, a month.  We carry a decibel meter and we take noise measurements at each house.  At the end of a month, we average the daily readings from each premises and then we begin bumping this data against the ten items that we know about each occupant.

Let’s say that one of these items is age, and we find a correlation between age and noise.  The older the occupant is, the lower the decibel number.  But the correlation isn’t all that good.  There are some noisy old folks, and some quiet young people.  So we arbitrarily decide that we’re going to use , say, 20% of a person’s age, as a negative factor on the noise predictor scale.

Another item of information that we have is whether each individual is right or left-handed, and we notice that the left-handed people are far noisier than those who are right-handed.  So we give being left-handed a 60% weighting.  People who are left-handed will get 0.6 (60% of 1) added to their noise-prediction score.  Right-handed people get 0.  And so on for the rest of the information.

Then we add up each person’s scores on the noise prediction scale, and if we’re lucky, all the high scorers will be noisemakers and all the low scorers will be quiet people, and voila, we have a simple way to predict if a prospective tenant will be noisy or quiet.  The string of fractions (60% left-handed – 20% age + … etc) is called an algorithm.

In actual research, however, results are seldom that clear cut.  It is more likely that we will have a scale that discriminates with less than perfect accuracy – say 60%.  So we start to “tweak” the weightings that we assigned to each item of information.  Instead of 60% for left-handedness, perhaps it would be better it if were 65%.  Or perhaps the age score should be weighted at 27%, and so on.  Doing this by hand would be tedious and time-consuming, but with computers one can bump any combination of weightings against the criterion measure with little difficulty.  And in this way, we find the combination of fractions that gives us the most predictive algorithm.

The authors of the study started with 181 blood tests, from which they identified 51 tests that had some correlation with the “schizophrenia” group.  They then ran these 51 tests on 806 participants (577 schizophrenia; 229 controls), and from this data they developed an algorithm that separated the schizophrenia participants from the controls with an 83% accuracy rate.  They report that “…all elements of the data set were used to train the algorithm.”

“Training” the algorithm is what I’ve called tweaking in the example above.  But there’s a problem.  By tweaking the data so thoroughly, what I’ve actually produced is a noise algorithm that may work reasonably well for our village at this point in time.  It might not work in the next village or even in our village next year.  (It may be, for instance, that the high correlation that we found between noisiness and left-handedness is a complete fluke that has no validity outside our village.)  This is particularly pertinent in that noisiness is not some kind of inherent trait like left-handedness or tallness.  Rather it’s a behavior, and behaviors are acquired (or not acquired) through a complex and highly individualized process of interaction between a person and his environment.  Two people who are inherently very different might both score high on a measure of noise, while identical twins might score at opposite ends of the scale.

The general point is that if one is working with a discrete set of data and a fairly large number of variables, it’s usually possible to construct an algorithm that will separate the individuals with a reasonable degree of accuracy along a given criterion.  In other words, if one can tweak the algorithm more or less indefinitely, and add, or drop, variables at will, a pattern will eventually emerge.  The pattern is not necessarily spurious.  It may be a real pattern, but it only applies to the individuals concerned.  I don’t know if this is what happened in the Schwarz et al study, but it might be something along those lines.  All concerned are staying fairly quiet about it.  So perhaps we’ll never know.

VALIDITY AND RELIABILITY OF THE SCHIZOPHRENIA LABEL

Another critical issue in this matter is the nature of the criterion variable and the accuracy with which it can be measured.  In my hypothetical noise study, I have a fairly objective measure (decibels).  But it’s not perfect, because, firstly, I’m taking only one measurement per day, and secondly, I’m taking measurements from the street, and, for this reason, houses that are built closer to the street will, other things being equal, score higher than houses that are set further back.  In the case of the condition known as schizophrenia, the situation is hopelessly confounded because all the DSM items that define the condition are vaguely-defined behaviors, the assessment of which is inevitably subjective.  In other words, if you choose, say, 1,000 people at random and ask 20 psychiatrists to examine all of them and identify and list those who “have schizophrenia,” you will get 20 different lists.  (There will be some overlap, of course, but you will not get perfect concordance.)  So an algorithm that’s been trained on the basis of one of these lists may not work very well on another.

In this regard, there are two interesting quotes from Emily Deans, MD, a Psychiatry Department instructor at Harvard, in the second Psychiatric Times article mentioned earlier.

“Since the diagnoses are based on a recipe list of symptoms from DSM-IV and not known brain pathology, new biologic markers and tests are re-searched and validated against the formal diagnostic criteria.  These criteria are designed to be assessed by mere observation and questioning of the patient.  Thus, biomarkers only end up as valid as the original criteria, or less so, depending on the validation of the scale used in research…” [Emphasis added]

and

“…biomarkers based on DSM-IV will never be as useful as ground up research to link known brain, gene, and MRS findings to the patient’s symptoms.”

What Dr. Deans is saying here, in effect, is that schizophrenia, as defined by DSM (which is the only way it can be defined) will never be linked reliably to specific neural pathology.  This is something that we “mental illness deniers” have been saying for decades.  Psychiatrists, on the other hand, have been saying, with a level of confidence bordering on recklessness, that schizophrenia (as defined by DSM) is a brain illness, and they even claimed to have identified the neural deficit involved (the now discredited dopamine theory of schizophrenia.).

But it should not be concluded that Dr. Deans or psychiatrists generally are retreating from the bio-psychiatric perspective.  Rather, psychiatry’s position is shifting from the “schizophrenia-is-a-brain-illness” stance of former years to “schizophrenia-is-many-brain-illnesses” which is becoming the rallying cry of the present.  And they’re going to identify each one through ground-up molecular research any decade now.  Meanwhile, by some extraordinary coincidence, neuroleptic drugs are the appropriate “medication” to correct all of these illnesses.  What a stroke of luck!

STOP PRESS

I was about to publish this post last week, when I ran one last Internet check on VeriPsych to see if there were any updates.  To my surprise, I found a promotional video which was published on YouTube on February 11, 2014.  The video is titled New Blood Test for Schizophrenia.  Here’s a quote from the narrator:

“Researchers…at the University of Cambridge have been working on a blood test for schizophrenia for many years.  A first test was launched in 2010, but later withdrawn from the market, as the price tag of around 2000 Euros was too expensive for wide usage.”

So VeriPsych was withdrawn because it was too expensive.  The earlier announcement on the VeriPsych website (that is still there at the time of this writing) said that it needed “further refinement” in order to “improve its utility.”  So does it need refinement or a price cut?

Another quote:

“They have now developed a new version, which they claim is cheaper, and provides more detailed information for the diagnosis.  The test looks at certain proteins in blood samples of patients to distinguish between different kinds of mental illnesses.  Researchers say that the new test is able to diagnose schizophrenia with a certainty of 83%, and depression with a certainty of about 90%.  Although the test could never stand on its own, it provides doctors and patients with valuable backup information.”

 But the test isn’t quite ready for market yet.

“Sabine Bahn and her colleagues want to launch the new test within this year.”

The video is professionally produced and will probably catch some attention, but there are too many unanswered questions.  Firstly, why was the test pulled if, as reported, it had been selling well and its cost was being reimbursed by insurance companies?  Secondly, if it just needed a price cut, couldn’t this have been done more or less instantly rather than being off the market for 13 months?  Thirdly, is this the same test with the 51 “disease signature” analytes that was described in the original study?  If so, then where did the additional information concerning depression screening with 90% accuracy come from?  If not, has the new test been written up in a peer-reviewed journal?  Fourthly, – and most importantly – what prompted the January 2013 statement that the test “needed further refinement,” if the 2010 beta test had confirmed that “the test worked as intended”?

To me, it just seems like we have too many questions.

 

DSM-5: Dimensionality: Conflicts of Interest

In DSM-5 – Dimensional Diagnoses – More Conflicts of Interest? which I posted on December 23, 2013, I drew attention to the fact that David Kupfer, MD, in his position as head of the DSM-5 Task Force, was vigorously promoting a dimensional model of assessment while at the same time was positioning himself to benefit financially if such a system were to be adopted by psychiatry generally.

Dr. Kupfer’s potential conflict of interest was exposed by Bernard Carroll, MD PhD, and has been investigated and publicized by Mickey Nardo, MD.

The APA investigated Dr. Kupfer’s activities, and in their report they acknowledged that he should have disclosed his interests, but they assured us all that no harm had been done.

Psychiatry has had its share of scandals in the past few years, and the response from the profession’s leadership has been remarkably consistent:  inconsequential censoring of the culprits, followed by a speedy return to business as usual.  The general attitude seems to be that the public memory is short; that the storm will blow over; and that all will be well.  And above all – there must be no admission of fundamental systemic problems within psychiatry itself.

And there was a time when those kinds of tactics worked.  But not any more.  Because now we have the Internet – and we have Mickey Nardo – who blogs as 1 boring old man.

Dr. Nardo is not letting this thing go.  On January 21, he posted open letter to the APA.  The opening paragraph is compelling:

“It has been a dark time for psychiatry. Since the investigations of Senator Grassley exposed significant corruption and unseated three chairs of Psychiatry in 2008, there has been a series of disturbing exposures involving widespread ghost writing, guest authoring, and questionable clinical trial reporting; escalating widely publicized settlements by pharmaceutical companies involving psychoactive drugs and implicating prominent psychiatrists; charges of overmedication and entrepreneurialism; the drying up of the pharmaceutical pipeline; recurrent charges of ubiquitous Conflicts of Interest in high places; and an ongoing and divisive process that spanned the DSM-5 Revision process. Besides the gravity and frequency of the problems, their handling by the administrative levels in our specialty have played poorly in the eyes of the public and our currency is at an all time low.”

Dr. Nardo challenges the thoroughness of the APA’s investigation, which, he notes, is being widely perceived as a “whitewash.”  He continues:

“Our specialty is in a steady decline, much of it our own making, and we don’t need to help it along by ignoring this obvious issue of integrity.”

The foundation of psychiatry is the notion that virtually all problems of thinking, feeling, and/or behaving are in fact illnesses that need to be treated by medically trained practitioners primarily through the use of psycho-pharmaceutical drugs.  The DSM is the document that lists and codifies these putative illnesses, and as such must be regarded as the main cornerstone of this foundation.

Even the possibility that the revision of this document has been corrupted by financial considerations should be sending Richter 9 shock waves through the entire profession.  But instead, there’s barely a murmur.

In the article mentioned above, Dr. Nardo has created a time line of the major events in this affair.  It makes interesting reading.

There is an urgent need for Dr. Kupfer to meet the press, and to provide complete and candid answers to the various questions that are being asked.  Riding out the storm, and waiting till it blows over, is no longer a viable strategy for public figures in any walk of life.

 

Training Of Psychiatrists: What The Future Holds

Joel Yager, MD, is a Professor of Psychiatry, University of Colorado at Denver School of Medicine.  He started his career as a US Army psychiatrist in 1969, and has held a wide range of clinical and teaching positions in the intervening years.  He has received numerous awards, including lifetime achievement awards from the National Eating Disorders Association (2008) and from the Association for Academic Psychiatry (2009).  He has published more than 200 peer-reviewed papers, many of which are concerned with the training of psychiatrists.

In January 2011, Dr. Yager published The Practice of Psychiatry in the 21st Century: Challenges for Psychiatric Education, in the journal Academic Psychiatry.  This paper received favorable comment from Jeffrey Lieberman, MD, President of the APA, in the article Training the Psychiatrists of the Future, in the November 26, 2013 issue of Psychiatric News.  As my regular readers will know, I am an avid fan of Dr. Lieberman’s, and it is my belief that anything he recommends warrants close scrutiny.

The stated purpose of Dr. Yager’s article is:

“To consider how shifting scientific, technological, social and financial pressures are likely to significantly alter psychiatric practice, careers, and education in the 21st century…”

and to review

“…trends and innovations likely to have an effect on tomorrow’s psychiatrists and their educators.”

It’s a wide-ranging and optimistic article.  Here are some quotes, interspersed with my thoughts and observations.

. . . . . . . . . . . . . . . .

“Measurement-based disease-management care will progress as even chronically ill psychiatric patients increasingly use computer-based tools in waiting rooms to rate their clinical status before office appointments.”

From his use of the terms “disease” and “ill,” it is clear that Dr. Yager is immersed in the medical model.  There is nothing in the article to suggest even an awareness of the fact that this model is under considerable criticism at the present time, nor that this reality may have some relevance for psychiatrist training.

Is there a hint of condescension in the phrase “even chronically ill psychiatric patients”?  And is having the client fill in boxes on a computer screen in the waiting room an improvement over talking to him in the office?  Will the 15-minute med check be reduced to 10 minutes?

. . . . . . . . . . . . . . . .

“Given that psychiatroids [which I think means nurse practitioners, general practitioners, physician assistants, etc., who are authorized to prescribe psychopharmaceutical products] anywhere can virtually manage many psychiatric patients located anywhere, ‘outsourcing’ assessment and even psychotherapy is constrained only by regulatory statutes governing licensing, any of which might be modified in ‘free-trade agreements’ if health systems think they can offer sufficient quality at the right price and manage the political processes and the outcry. With increasing globalization and falling trade barriers, if a strong business case can be made for the economic advantages, couldn’t we outsource elements of psychiatric diagnostic and management?  If Walmart and Dell do it, why can’t Humana or Kaiser-Permanente?”

So when a client calls the mental health center after hours, he might find himself talking to someone in India or Nigeria?  Provided the “outcry” can be managed, of course.

As to the final question:  “If Walmart and Dell do it, why can’t Humana or Kaiser-Permanente,” perhaps the answer is:  because helping people with deeply personal troubles and concerns is fundamentally different from selling them laundry detergent and computer monitors.  Or perhaps for psychiatrists it isn’t really so different?

. . . . . . . . . . . . . . . . 

“Certain types of ‘translational’ research favor extra-university settings. Non-academic, clinical-trials organizations, utilizing community practices, have increasingly replaced academic centers for industry sponsored clinical trials (accounting for more than half of such studies). Pharmaceutical and medical-device companies increasingly sidestep delays and hassles imposed by universities’ Institutional Review Boards by employing time-efficient private IRBs. Parenthetically, today’s increasingly restrictive academic zeitgeist regarding Pharma might discourage some excellent clinical researcher-teachers from academic careers and, instead, lead some of the brightest to private practices or industry positions with better financial rewards.”

This isn’t entirely clear, but I think Dr. Yager is lamenting the fact that the belated efforts of university research departments to extricate themselves from the grip of pharma corruption may drive some of “the brightest” clinical researcher-teachers away from academia and into industry positions, where they would be spared the “delays and hassles” of university IRB’s.

But surely the “delays and hassles” of the IRB’s are a reaction to the widespread corruption that existed in university-pharma relationships.  The fact is that pharma hijacked academic research and produced an entire generation of bogus research to support and promote pharma’s advertizing message.

Dr. Yager may be correct in saying that the additional scrutiny that is now in place may encourage researchers towards the private clinical-trials organizations.  But it reads like he’s also endorsing such trends by pointing out that there will be career opportunities here for psychiatric researchers.  Do we have any reason to believe that private research centers, unhindered by the “delays and hassles” of the IRB’s, will be any better able to resist pharma’s corrupting overtures than the universities were just a few years ago?  Is it possible to have ethical research without “delays and hassles”?  With the recent exposure of widespread corruption in academic psychiatric research, many of us on this side of the debate have wondered if and how pharma would try to get around the new rules.  Has Dr. Yager given us the answer?

. . . . . . . . . . . . . . . .

“Conceivably, psychotherapies might be prescribed according to individual nervous-system and information-processing characteristics, perhaps based on patient (and therapist) polymorphism variants.”

I tried to picture how this might work, and came up with the following scenario:

Woman; mid-thirties; nervous; enters mental health center; approaches reception desk; asks to see a therapist.  Receptionist takes saliva swab from client and puts it into port on computer.  Moments later, computer clicks and information appears on screen.

Receptionist:  “OK – your therapist will be Phil Hickey, Cubicle 6.”
Client:  “Oh, I was wanting to talk to a woman.”
Receptionist:  “Well, the computer has assigned you to Phil based on your individual nervous-system and information-processing characteristics.  These are derived from your polymorphism variants.  Phil is your best match.”
Client:  “But I need to talk about very sensitive stuff.  Couldn’t you assign me to a female therapist?”
Receptionist:  “Sorry, the computer will kick it out.  But Phil is very good.  You’ll like him.”
Client:  “But I’ve heard bad things about him.  All the psychiatrists say he’s a cad and a bounder.  And he causes mental illness stigma.”
Receptionist:  “Well maybe.  But he has the best polymorphism variants for your case.  You’ll get along great.”
Client:  “I’d really prefer to see a female therapist.”
Receptionist:  “Sorry, I can’t help you.  You could try Old-Fashioned Counseling.  They’re on Seventh Street, next to the old movie theater.”
Client:  “Thanks.  I’ll try there.”
Receptionist:  “OK.  We hear that a lot.”

Maybe I’m misinterpreting Dr. Yager.  And maybe the scenario I’m describing is ridiculous.  But when I started in this business in the 60’s, the idea that childhood misbehavior is an illness to be corrected by drugs would also have seemed ridiculous.

. . . . . . . . . . . . . . . .

“Combine genomics, proteinomics, epigenetics, and personalized medicine with pharmaceutical advances, and we have tomorrow’s psychopharmacologists. Focus on cognitive-enhancers, including ‘nootropic agents’ (intelligence-and memory-enhancing drugs); ’empathogens;’ and other ‘hedonics;’ work out the ethical practice boundaries; and you might produce cosmetic psychopharmcologists (not just drug-pushers).”

I don’t understand this paragraph, but the general gist seems to be that psychiatry is going to get a whole lot better sometime soon.  I did look up the word cosmetic in my Merriam-Webster:

“cosmetic adj: …1: of, relating to, or making for beauty esp. of the complexion : BEAUTIFYING < ~ salves> 2: done or made for the sake of appearance: as a: correcting defects esp. of the face <~surgery> b: DECORATIVE, ORNAMENTAL c: not substantive: SUPERFICIAL <~ changes> 3: visually appealing…”

Is Dr. Yager saying that psychiatrists in the future will be more focused on incidentals than on issues of substance?  And what about those last four words – “not just drug-pushers.” Is he admitting that psychiatrists today are just drug-pushers?

. . . . . . . . . . . . . . . .

 “Some entrepreneurs might consider the idea of ‘spot-market’ pricing underutilized psychiatric beds and services (think PriceLine during low-occupancy periods).  Some might ‘package’ traveling mental health teams to manage psychiatric aftermaths of man-made terror and natural disasters.”

This is truly an amazing notion.  I find myself visualizing a kind of mental health clearing house, where one can get a psychiatric bed or a med check at reduced price by calling the 800 number and keying in the dates/times that you will be available.  Presumably you’d also have to know your own polymorphism variants!

And the traveling mental health teams “packaged” to respond to disasters anywhere in the world.  Sounds like Ethan Watters’ worst nightmare.  (Ethan Watters is the author of Crazy Like Us: The Globalization of the American Psyche.) 

. . . . . . . . . . . . . . . .

“Key to lifelong-learning is ‘critical thinking.’ Educators must ignite and nurture trainees’ ‘crap-detectors’…specifically, their abilities to discern and deconstruct all sorts of propaganda: deceptive research and marketing studies from the ‘pharmaceutical-industrial complex,’ the ‘psychoanalytic-industrial complex,’ the ‘CBT-industrial complex,’ and other special-interest groups. Trainees require proficiency in separating facts from ‘factoids’ and ‘spin.'”

I suppose a good example of spin would be connecting the phrases “pharmaceutical-industrial complex,” “psychoanalytic-industrial complex,” and “CBT-industrial complex” in the same sentence with the implication that they pose equivalent challenges to the integrity and intellectual honesty of psychiatry’s new recruits.

. . . . . . . . . . . . . . . . .

“First, psychiatry is intrinsically hugely satisfying, offering sustained doctor–patient relationships and deep, comprehensive understandings of humanity, plus attractive lifestyles, regular hours, and a relatively low call-burden.

Second, psychiatry’s treatments are increasingly effective. We have more to offer regarding accountability.

Finally, one of psychiatry’s central contributions, more than many other medical specialties, is to offer meaning.  Psychiatry contributes substantially to generating and sustaining the culture’s significant narratives (and myths) regarding human nature. Thanks to phenomenal knowledge growth in neuroscience, developmental psychology, and other bio-psycho-social domains, as our sciences get better, so do our stories. The deep professional satisfactions of psychiatric educators have always included, and will continue to include, helping to synthesize and disseminate the cutting-edge, evidence-based cultural narratives for our trainees and for society.”

To which I can only respond that now I finally understand the term “ivory tower”!

SUMMARY

Perhaps I’m being unfair.  The article is essentially a cheer-leading piece.  Dr. Yager is clearly keen on his vocation, and perhaps didn’t intend his remarks to be taken so literally or to be scrutinized so closely.

However  … he did publish the paper in Academic Psychiatry, a prestigious journal that:

“…features original, scholarly work focused on academic leadership and innovative education in psychiatry, behavioral sciences, and the health professions at large.”

And … when Jeffrey Lieberman, MD, President of the APA, co-authored (with Richard Summers, MD), his ground-breaking piece on psychiatric education – Training the Psychiatrist of the Future  on November 26, 2103 – he used Dr. Yager’s article as his spring-board.

So it appears that organized psychiatry takes the article seriously and believes that it has relevance for training psychiatrists of the future.

As I’ve said many times, perhaps we, on this side of the debate, should just scale back our endeavors and let psychiatry destroy itself.  It’s doing an excellent job.

Psychiatry’s Over Reliance On Pharma

I recently read The NIMH-CATIE Schizophrenia Study: What Did We Learn? by Jeffrey Lieberman, MD, and T. Scott Stroup, MD, MPH.  The article was published in the American Journal of Psychiatry 168:8, August 2011.  

Here are two quotes:

“When the CATIE study was designed in 1999-2000, the prevailing opinion of researchers and clinicians alike was that the newer (second-generation) antipsychotic drugs were vastly superior to the older (first-generation) antipsychotic drugs in efficacy and safety. This largely reflected the results of studies sponsored by the manufacturers of the new drugs…, marketing messages of pharmaceutical companies and the hopes of many who wanted better treatments.”

“CATIE helped to demonstrate that, although the introduction of second-generation antipsychotic drugs brought new options for treatment of psychosis, the major advance many had hoped for remains elusive.”

Let’s take a look at the first passage.  Essentially what’s being said is that by about the year 2000, psychiatric researchers and practitioners believed that the second-generation neuroleptics were vastly superior to the older drugs in effectiveness and safety.

The CATIE study debunked these beliefs, as is acknowledged clearly in the second quote.

EFFECTIVENESS AND SAFETY

Here is a list of the second-generation neuroleptics introduced prior to the year 2000 with the main adverse effects associated with the use of each drug as listed in the 2001 PDR.

  • Clozapine, Clozaril (1989).  Adverse effects:  agranulocytosis (black box); seizures (black box); orthostatic hypotension (black box); neuroleptic malignant syndrome; tardive dyskinesia; akathisia, etc… 
  • Risperidone, Risperdol (1994).  Adverse effects:  extrapyramidal disorders; akathisia; aggressive reaction; joint pain; weight gain, etc… 
  • Olanzapine, Zyprexa (1996).  Adverse effects:  neuroleptic malignant syndrome; tardive dyskinesia; akathisia; weight gain; postural hypotension; joint pain; extremity pain, etc… 
  • Quetiapine, Seroquel (1997).  Adverse effects:  neuroleptic malignant syndrome; tardive dyskinesia; orthostatic hypotension; seizures; hypothyroidism; cholesterol and triglyceride elevations; etc… 

Each entry in the PDR is a verbatim copy of the manufacturer’s FDA-approved labeling information and is updated annually.  It is clear, from the adverse effects listed with each of these products, that the respective manufacturer acknowledged clearly that there was a real danger of serious and potentially irreversible adverse effects.

With the exception of clozapine, the manufacturers also acknowledged that their efficacy data was based on very short-term trials.

  • risperidone                  3 weeks
  • olanzapine                   6 weeks
  • quetiapine                    6 weeks 

The entry for olanzapine (Zyprexa) stated explicitly:

“The efficacy of ZYPREXA was established in short-term (6-week) controlled trials of schizophrenic inpatients…

The effectiveness of ZYPREXA in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials.  Therefore, the physician who elects to use ZYPREZA for extended periods should periodically re-evaluate the long-term usefulness of the drug for this individual patient… [emphasis added]

ZYPREXA is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder.

The efficacy of ZYPREXA was established in two placebo –controlled trials (one 3-week and one 4-week), with patients meeting DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode with or, without psychotic features…

The effectiveness of ZYPREXA for longer-term use, that is, for more than 4 weeks treatment of an acute episode, and for prophylactic use in mania, has not been systematically evaluated in controlled clinical trials. Therefore, physicians who elect to use ZYPREXA for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient…” [emphasis added]

Against this background, it’s difficult to afford much credence to the assertion of Drs. Lieberman and Stroup that the responsibility for psychiatrists’ false beliefs that these products were vastly superior to the old drugs in efficacy and safety can be laid at the feet of pharma.

It is noteworthy that Drs. Lieberman and Stroup mention not only industry sponsored studies, but also pharma’s “marketing messages.” [emphasis added]

This strikes me as an extraordinary admission.  America is the birthplace of aggressive marketing, and we all know how successful it can be in the selling of cars, vacuum cleaners, etc…  But for a group of people, who routinely claim that they are a bona fide medical profession, to admit that they were duped by tawdry marketing ploys raises serious concerns about their credibility and competence.

Drs. Lieberman and Stroup are defending psychiatry’s overly zealous adoption of the newer drugs by blaming the pharmaceutical companies’ misleading research and commercials.  But the much more fundamental issue is:  why did psychiatrists believe these messages despite the fact that the PDR entries for the drugs in question provided abundant justification for caution and restraint?

It’s difficult to avoid the suspicion that the various largesse showered on psychiatry by the pharma industry might have played some part.

It’s also clear that psychiatrists’ love affair with these drugs and their vulnerability to pharma marketing continue to this day.

In the third quarter of 2013, the second-generation neuroleptic Abilify (aripiprazole), with over $1.5 billion in sales, was not only the best selling neuroleptic drug in the US, it was the highest grossing of all prescription drugs.  It was also the most heavily promoted neuroleptic in 2011 (the last year for which I can find data), and accounted for 38% of neuroleptic promotional spending.

However, there is nothing in the current PDR entry, which is available online, to suggest that it is any safer than the other products.  All the usual second-generation neuroleptic adverse effects are listed, including tardive dyskinesia, akathisia, weight gain, metabolic problems, neuroleptic malignant syndrome, etc…  There are also two black box warnings:  increased mortality in dementia-related psychosis; and increased suicide risk in children and young adults.

In addition, efficacy studies were limited to 6 weeks.

SUMMARY

So in 2011, we had Drs. Lieberman and Stroup blaming pharma advertizing for psychiatry’s misplaced enthusiasm for the newer neuroleptics, while side-stepping the obvious corollary:  that psychiatrists were taken in by these promotions.  Now, two years later, the problem is still with us.  Psychiatrists apparently are still responding positively to the marketing messages; and neuroleptic drugs, which in former times were barely a blip on the sales charts, are now acquiring blockbuster status.

Dr. Lieberman Thanks Dr. Scully

As my regular readers know, I am a big fan of Jeffrey Lieberman, MD, eminent President of the American Psychiatric Association.  I study his bulletins on Psychiatric News avidly, not only for the insights they provide in the areas of human frailty and self-deception, but also for their literary qualities of obfuscation and semantic distortion.

It is, therefore, with some alarm that I confess that I missed the good doctor’s epistle of December 13.  This was pointed out to me by a reader, who was also kind enough to say that without my clarificatory commentary, he is simply unable to fathom Dr. Lieberman’s insights and erudition.

So with profound apologies for the oversight, let’s take a look at Jay Scully Deserves Our Thanks for a  Job Well Done. 

Jay Scully, MD, has been CEO and Medical Director of the APA for ten years, but has now retired.  In this context, Dr. Lieberman wrote some very nice and gracious things about Dr. Scully, e.g.:  his calm manner, his keen mind, consummate professionalism, etc. – all of which I’m sure are well earned.  But Dr. Lieberman – true to form – couldn’t resist the urge to extol also the merits of psychiatry, and to minimize its failings, both of which are daunting challenges.

“At a time when American medicine’s relationship with the pharmaceutical industry was being scrutinized, psychiatry became the poster child for medical conflict of interests. APA found itself squarely in the cross-hairs of a government inquiry led by Sens. Charles Grassley (R-Iowa) and Herbert Kohl (D-Wis.), and Jay steered APA and our profession through this crisis. With great integrity, he helped to restore public confidence. Under his leadership, APA eliminated industry-sponsored symposia at its annual meetings and restricted industry relationships of APA members serving on its clinical practice guideline committees and the DSM-5 Task Force and work groups.”

This is Dr. Jeffrey at his dissembling best.

“… psychiatry became the poster child for medical conflict of interests.”

What’s noteworthy here is the skillful way in which he conveys the impression that psychiatry’s becoming the “poster child” for medical conflicts of interest was something that just fell upon psychiatry – out of the blue, so to speak – rather like a lightning bolt or a freak storm or a flash flood.

In fact, psychiatry became the poster child, to stay with Dr. Jeffrey’s unusual phrase, for medical conflicts of interest because half of the top earners of pharma money from 2009 to 2013 were psychiatrists. (Dollars for Docs)  This wasn’t just something that happened.  This was a case of psychiatry wallowing whole-heartedly  and shamelessly in the pharma trough, and cooperating with enthusiastic avarice in pharma’s infomercials to the obvious detriment of clients.  Apparently Dr. Lieberman, with the arrogance characteristic of his profession, believes that we’ve all forgotten this, and that he can now safely rewrite this sordid chapter of psychiatry’s history in this sanitized fashion.

Dr. Lieberman also neglected to explain that the reason psychiatrists are in demand with pharma is that psychiatry has the unique distinction in medical circles of being able to invent new illnesses more or less at will.  New illnesses mean new markets for drugs, and the lure of such a cozy arrangement for pharma scarcely needs to be mentioned.

Then more on Dr. Scully’s virtues:

“… he helped to restore public confidence.”

Apparently one of Dr. Lieberman’s most fundamental beliefs is that if he says something often enough, it will become true.  He actually seems to believe that public confidence in psychiatry has been restored.

“… eliminated industry-sponsored symposia at its annual meetings and restricted industry relationships of APA members serving on its clinical practice guideline committees and the DSM-5 Task Force and work groups.”

One of the fundamental principles of spin is:  distract – draw attention away from the areas of weakness.  Note what Dr. Lieberman has done.  For the bulk of Dr. Scully’s leadership, industry-sponsored symposia (I would say infomercials) were standard fare at APA conferences.  In fact, they were only voted out in 2009, seven years after Dr. Scully took office, and the decision was not to stop them, but to phase them out.  It was also decided that the APA would continue taking pharma money/advertizing in its journals and for fees for their annual meeting exhibit hall.  I am not aware of a single psychiatrist who spoke out against this blatantly corrupt practice until it had been exposed repeatedly by others.  Senator Grassley’s investigations began in 2008!

And with regards to the DSM-5 Task Force members, it should be noted that the conflict of interest restrictions placed on them were generous in the extreme – DSM panel members were allowed to receive

“…US$10,000 per year from industry (e.g., for consultancies), and panel members are allowed to have up to US$50,000 in stock holdings in pharmaceutical companies.” (Cosgrove and Krimsky, PLLO Medicine, March 13, 2012)

And further – it was recently brought to light by Bernard Carroll, MD, that David Kupfer, MD, Chair of the DSM-5 Task Force, appears to have had an undisclosed conflict of interest in a computerized assessment instrument at the very time that he was singing the praises of the Task Force for its pure and unconflicted qualities.  See my post on this matter.

Back to Dr. Lieberman.  It gets worse:

“Jay stood firm in the face of critics of psychiatric treatment who are both a vestige and continued cause of the stigma surrounding mental illness.”

Here again I call on my special skills in the unraveling of Dr. Lieberman’s esoteric style of expression.  What Dr. Lieberman is trying to say is this:

  • Dr. Scully stood firm in the face of critics.

What did he do?  What does “stood firm” mean?  Did he tell the critics to “shoo”?  He did not, to the best of my knowledge, ever respond meaningfully to any of our concerns.

  • These critics, in which group, of course, I would have to number myself, are the cause of the stigma surrounding “mental illness.”

Not only is this false, it betrays such an extraordinary level of arrogance.  According to Dr. Lieberman, every ill that befalls psychiatry is somebody else’s fault.  Again, I find myself asking – where do they get the gall?

  • Vestige of the stigma.

And here, my patient readers, even I – with my detailed and sympathetic understanding of Dr. Lieberman’s dysfunctional communications style – am at something of a loss.  What I think he means is that psychiatrists (think knights in shining armor) have been battling against this stigma for decades.  And now, when they’ve finally got it just about knocked down, we critics are still hanging around challenging psychiatry (how dare we!) and looking generally like the slime trails left by snails on garden walls and other places.  (Maybe I haven’t got it entirely correct, but that’s the best I can do.)  Anyway, the essential point is that we’re all cads and bounders, and even if the good doctor got a little confused in his wording, his sentiment – as always – was beyond reproach.

DSM-5 – Dimensional Diagnoses – More Conflicts of Interest?

BACKGROUND

On November 20, JAMA Psychiatry (formerly Archives of General Psychiatry) published an interesting letter.  It was headed: Failure to Report Financial Disclosure Information,  and was signed by Robert D. Gibbons PhD, David J Weiss PhD, Paul A. Pilkonis PhD, Ellen Frank, PhD , and David J. Kupfer MD.

The letter is an apology for failing to disclose a financial interest in an article, Development of a Computerized Adaptive Test for Depression, that had appeared in Archives of General Psychiatry a year earlier (November 2012).  The article described a computerized questionnaire for depression (the CAT-DI) and was generally positive with regards to the potential usefulness of the test in clinical settings.  In the article, the authors had clearly stated that they had no conflicts of interest, but that:

“The CAT-DI will ultimately be made available for routine administration, and its development as a commercial product is under consideration.” (p 1)

But they did not disclose that they had already formed a company, Psychiatric Assessments, Inc. (PAI), the apparent purpose of which was to market the test.  According to the Delaware Division of Corporations, PAI was incorporated on November 29, 2011.  The Gibbons et al article was accepted for publication on Jan 4, 2012, and was published in November 2012.  So there was certainly plenty of time for the authors to disclose their financial interest.

The matter came to light earlier this year.  Bernard Carroll, MD, PhD, who incidentally blogs on Health Care Renewal, wrote a letter to JAMA Psychiatry critiquing the Gibbons et al article, and challenging the validity, usefulness, and need for the CAT-DI.  Dr. Carroll’s letter is dated July 2013, and contains a clear conflict of interest disclosure to the effect that he himself receives royalties from depression scales that he has developed.

Dr. Gibbons et al responded to Dr. Carroll’s letter in the same issue. Dr. Carroll was not convinced by this response, did some investigating, and uncovered the existence of PAI and the conflict of interest.  He has documented this matter in a post When Is Disclosure Not Disclosure? on Health Care Renewal.

We’ve seen so many conflicts of interest scandals in this field in recent years, that it might be tempting to shrug this off as just more of the same.  But, there’s a bigger issue.

DSM-5 AND DIMENSIONAL ASSESSMENT

First a little history.  In the Introduction to DSM-IV (1994) it states:

“It was suggested that the DSM-IV Classification be organized following a dimensional model rather than the categorical model used in DSM-III-R.  A dimensional system classifies clinical presentations based on quantification of attributes rather than the assignment of categories and works best in describing phenomena that are distributed continuously and that do not have clear boundaries.  Although dimensional systems increase reliability and communicate more clinical information (because they report clinical attributes that might be subthreshold in a categorical system), they also have serious limitations and thus far have been less useful than categorical systems in clinical practice and in stimulating research.  Numerical dimensional descriptions are much less familiar and vivid than are the categorical names for mental disorders.  Moreover, there is as yet no agreement on the choice of the optimal dimensions to be used for classification purposes.  Nonetheless, it is possible that the increasing research on, and familiarity with, dimensional systems may eventually result in their greater acceptance both as a method of conveying clinical information and as a research tool.” (p xxii)

Under a dimensional system a person might be described as having a certain score on an anxiety scale, rather than having generalized anxiety disorder, or a certain score on a depression scale rather than having major depressive disorder, and so on.  When this notion was floated in 1994, it seemed to me that it would be a big improvement over the traditional DSM “diagnoses,” but in the intervening years I’ve come to the conclusion that psychiatry could compromise and exploit a dimensional diagnosis just as readily as a categorical diagnosis.  But that’s a separate subject.

The central issue here is that one of the authors of the original Gibbons et al study is David J. Kupfer, MD, chairperson of the DSM-5 Task Force.  Given that DSM-IV had floated the notion of dimensional assessment, it was entirely reasonable that the DSM-5 Task Force should give the matter some consideration.  And they did.  Here are some quotes from their Introduction to DSM-5 under the heading Dimensional Approach to Diagnosis (p 12-13)

“Indeed, the once plausible goal of identifying homogeneous populations for treatment and research resulted in narrow diagnostic categories that did not capture clinical reality… (p 12)

This is a somewhat elaborate way of saying that the “diagnoses,” collected and set out in successive revisions of the manual, have no validity – they don’t “capture” reality!  This is a truly amazing admission, given that it is precisely the alleged ontological reality of these “diagnoses” that has constituted the conceptual underpinning of psychiatry and the legitimization of the drugging for the past 60 years.  The current edition of psychiatry’s diagnostic manual has the unique distinction of denying the validity of its subject matter in its own introduction.  But that’s also a separate subject.

“The historical aspiration of achieving diagnostic homogeneity by progressive subtyping within disorder categories no longer is sensible…” (p 12)

(Just in case there was any doubt as to the meaning of the previous quote.)

“The adjacent placement of ‘internalizing disorders’ characterized by depressed mood, anxiety, and related physiological and cognitive symptoms, should aid in developing new diagnostic approaches, including dimensional approaches, while facilitating the identification of biological markers.” [emphasis added] (p 13)

In other words, we’re introducing a dimensional approach through a back door.  “Internalizing” will become the dimension underlying the various diagnoses in that category.

“…the…dimensional DSM-5 approach and organization structure can facilitate research across current diagnostic categories by encouraging broad investigations within the proposed chapters and across adjacent chapters.  Such a reformulation of research goals should also keep DSM-5 central to the development of dimensional approaches to diagnosis that will likely supplement or supersede current categorical approaches in coming years.” [emphasis added] (p 13)

It doesn’t take too much reading between the lines here to see that there was clearly some momentum within the Task Force to adopt a dimensional approach.  The categorical approach of the past is subjected to considerable criticism (in fact, I would suggest, total repudiation), and although DSM-5 didn’t adopt the dimensional approach whole-heartedly, it’s clear that the alterations in the manual’s layout and structure were adopted with a view to encouraging a dimensional approach in the future.

“The organizational structure [of the manual] is meant to serve as a bridge to new diagnostic approaches without disrupting current clinical practice or research.” [emphasis added] (p 13)

All of which leads us to wonder where within the DSM-5 Task Force was the momentum towards a dimensional framework centered, and in this regard it is clear that Dr. Kupfer has been a big fan of the dimensional approach.

In an April 2013 article in Nature, Mental health: On the spectrum, writer David Adam stated:

“The problem is that biologists have been unable to find any genetic or neuroscientific evidence to support the breakdown of complex mental disorders into separate categories. Many psychiatrists, meanwhile, already think outside the category boxes, because they see so many patients whose symptoms do not fit neatly into them. Kupfer and others wanted the latest DSM to move away from the category approach and towards one called ‘dimensionality’, in which mental illnesses overlap. According to this view, the disorders are the product of shared risk factors that lead to abnormalities in intersecting drives such as motivation and reward anticipation, which can be measured (hence ‘dimension’) and used to place people on one of several spectra. But the attempt to introduce this approach foundered, as other psychiatrists and psychologists protested that it was premature.” (p 2)

and

” When Kupfer and his DSM-5 task force began work in 2007, they were bullish that they would be able to make the switch to dimensional psychiatry. ‘I thought that if we did not use younger, more-basic science to push as hard as we could, then we would find it very difficult to move beyond the present state,’ Kupfer recalls.” (p 5)

 and

” In the middle of 2011, the DSM-5 task force admitted defeat. In an article in the American Journal of Psychiatry, Kupfer and Darrel Regier, vice-chair of the DSM-5 task force and the APA’s research director, conceded that they had been too optimistic. “We anticipated that these emerging diagnostic and treatment advances would impact the diagnosis and classification of mental disorders faster than what has actually occurred.” The controversial personality-disorder dimensions were voted down by the APA’s board of trustees at the final planning meeting in December 2012.” (p 5)

and

“On the question of dimensionality, most outsiders see it as largely the same as DSM-IV. Kupfer and Regier say that much of the work on dimensionality that did not make the final cut is included in the section of the manual intended to provoke further discussion and research.” (p 6)

and

“Once the evidence base strengthens, he says, perhaps as a direct result of the NIMH project, dimensional approaches can be included in a DSM-5.1 or DSM-5.2” (p 6)

In December 2011, Emily Kuhl, PhD (the Senior Science Writer on the DSM-5 Task Force), Darrell Regier, MD (Task Force Vice-Chair), and Dr. Kupfer co-authored an article for the AMA’s Virtual Mentor.  The article is called Patient-Centered Revisions to the DSM-5.  The word “dimensional” occurs ten times in this article.  Here are some quotes:

“Supplementing binary diagnostic categories (in which the diagnosis is either present or absent) with dimensional quantitative rating scales (in which symptoms are measured along a continuum) will better capture the nuances of mental illnesses, including co-occurring conditions and disease severity, and could result in earlier, more accurate identification of psychiatric illness and provision of care.”

“Theoretically, this would allow psychiatrists to document limitless variations in personality by providing dimensional ratings of personality traits, domains, and facets; this level of specificity should make a designation of personality disorder trait specified more clinically meaningful than the DSM-IV’s personality disorder NOS in terms of better understanding patients’ symptom presentations and treatment needs.”

There is also a reference to the use of scales and questionnaires to implement dimensional assessment:

“A patient who indicates that she has been experiencing moderately depressed mood for the past 2 weeks, for instance, would be given a corresponding assessment for depression…”

“Many of the proposed dimensional assessments for the DSM-5 are drawn from existing tools…”

And, incidentally, Ellen Frank, PhD, one of the co-authors of Gibbons et al, served on the DSM-5 Task Force as Text Coordinator for mood disorders.

DISCUSSION

So we have three main themes:

1.  Dr. Kupfer, during his tenure as DSM-5 Task Force Chair, was heavily invested in the promotion of dimensional assessment, initially as a replacement for the traditional categorical system, and later, when it became clear that this was not achievable, as an ancillary component of the categorical system.  It is also clear that he conceptualizes DSM-5 as a bridge between the categorical “diagnoses” of the past and the dimensional ratings that he visualizes for the future.

2.  At the same time, Dr. Kupfer was a major shareholder in a private company that was designing a computerized assessment tool that would plausibly be much in demand if the dimensional system were implemented.

3.  Dr. Kupfer, along with his co-authors, failed to disclose their conflict of interest in the November 2012 JAMA article, and in fact only did so later when the conflict was exposed by Dr. Carroll.  This, incidentally, was about the same time that Dr. Kupfer was issuing assurances that the ties of 70% of Task Force members to Pharma did not sway their judgment.

NIMH FUNDING

The CAT-DI research that was written up in the original Gibbons et al article was funded by a grant from the National Institute of Mental Health (a department of the NIH).  The article cites the following grant number:  R01-MH 66302.  On the NIH’s RePORTER website there are 23 entries under Robert Gibbons’ name since 1990.  Nine (9) of these entries are linked to the 66302 number:

 

Project Year Total Cost
MH066302 2002 $380,713
MH066302 2003 $381,740
MH066302 2004 $375,025
MH066302 2006 $634,030
MH066302 2007 $581,084
MH066302 2008 $554,052
MH066302 2009 $555,007
MH066302 2009 $368,885
MH066302 2010 $1,127,810
Total $4,958,346

 

So since 2002, Dr. Gibbons and his colleagues have drawn down a total of almost $5 million in public money to develop a psychiatric assessment instrument that they now plan to promote for private profit.  This has prompted Dr. Carroll to write:

“…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 [Director of NIMH] on top of this?”

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.