Tag Archives: bipolar

More on the Biological Evidence for “Mental Illness”

On January 10, 2017, I put up a post titled The Biological Evidence for “Mental Illness”.  It was published simultaneously on Mad in America.  The post was a response to an earlier comment from Carolina Partners in Mental Healthcare PLLC, which included the assertion “mental illnesses have a long history of biological evidence.”  In my January 10 article, I challenged this assertion and pointed out that no such evidence existed.  The article generated some comments, most of which were favorable.  There was one comment, however, from Michael, who asserted:

“Your rebuttal that there are no scientific studies to these cases can be dismissed with a quick google search.”

In my response to Michael, I asked him to cite me some references to support this assertion.  On  January 15, Michael wrote back citing three studies:  the first on the neurobiology of depression; the second on the neurobiology of “schizophrenia”; and the third on the neurobiology of “bipolar disorder”.

I examined these studies, and started to draft a response to Michael, but as I was writing, I realized that the subject matter warranted a wider audience and needed to be put up as a post.  This is not because the studies cited are particularly compelling.  As we shall see below, they are not. But rather, because what has happened here is something that occurs routinely in these debates.  Psychiatry proponents claim there is evidence to support their position that “mental illnesses” are caused by biological malfunctions – but when pressed for references, they either don’t respond at all, or they dish up the kind of references cited by Michael.

All three papers are literature reviews.

THE PAPER ON DEPRESSION

Maletic V, Robinson M, et al, Neurobiology of depression: an integrated view of key findings, Int J Clin Pract, 2007 Dec; 61(12): 2030–2040.

From the point of view of Carolina Partners and  Michael’s original assertion, this study is particularly easy to rebut.  In fact, the authors do it for us.  Here’s the conclusion:

“Major depressive disorder is an illness with significant neurobiological consequences involving structural, functional and molecular alterations in several areas of the brain. Antidepressant pharmacotherapy is associated with restoration of the underlying physiology. Clinicians are advised to intervene with MDD using an early, comprehensive treatment approach that has remission as the goal.” [Emphasis added]

Note that the authors are stating clearly that the structural, functional, and molecular neurobiological alterations are consequences of depression, not causes.

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

But the article has many additional points of interest.  Here are some quotes:

“Although much information still needs to be attained, imaging and other methods have begun to elucidate the neurobiological abnormalities associated with MDD. In particular, several prefrontal and limbic structures and their interconnected circuits have been implicated in affective regulation (Figure 2). These neuroanatomical areas include the ventromedial prefrontal cortex (VMPFC), lateral orbital prefrontal cortex (LOPFC), dorsolateral prefrontal cortex (DLPFC), anterior cingulated cortex (ACC), ventral striatum (including nucleus accumbens), amygdala and the hippocampus. Abnormalities in these areas have been shown in patients with MDD compared with healthy controls and thus suggest a foundation for the symptomatic expression of MDD (24, 25). However, these deviations may be obscured or not present at the individual patient level and thus, these findings cannot necessarily be considered pathognomonic.” [Emphasis added]

Note the admissions that:

“…much information still needs to be attained…”
“…imaging and other methods have begun to elucidate…” [Emphasis added]
“…implicated in affective regular…” [implicated in is not synonymous with causative of]
“…suggest a foundation…” [Emphasis added]
“…deviations may be obscured or not present at the individual patient level…” [Emphasis added]

This doesn’t sound very definitive or convincing.

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

“Combining the evidence from these genetic, cross-sectional, and clinical treatment studies suggests that morphological differences in the hippocampus may be a predisposing factor in MDD, but changes can also accumulate in the course of the disease and thereby create an obstacle to full recovery.”

Again, note the vagueness:

“Combining the evidence…suggests…” [Emphasis added]
“…differences in the hippocampus may…” [Emphasis added]
“…be a predisposing factor in MDD…”

The ever-present predisposing factor – not quite the same thing as a cause – but good enough to convey the impression of causality.

But look at the last phrase in the quote:

“…changes can also accumulate in the course of the disease and thereby create an obstacle to full recovery.”

What the authors are suggesting here is that depression  causes neurological pathology “in the course of the diseases” and that this pathology could create an obstacle to full recovery.  Of course the drugs and hi-voltage electric shocks to the brain that psychiatrists routinely use to “treat” depression also cause neurological pathology.

And lest it be feared that I’m cherry-picking quotes that are particularly vague and unconvincing, the word “may” occurs 21 times in the paper, e.g. “this abnormal activity pattern may be responsible for the manifestations of symptoms associated with MDD”; “Symptomatically, disruptions as a result of proinflammatory cytokines may be experienced as fatigue, loss of appetite and libido as well as hypersensitivity to pain.”  The word “could” occurs three times and the word “suggest(s)” ten times.

Here’s the final sentence of the study:

“Once remission is attained, maintenance of effect may become the more appropriate term, rather than relapse prevention, to emphasise the necessity for an ongoing collaboration between patient and physician in order to maintain neurobiological homeostasis.”

And what do you think is going to happen in this “…ongoing collaboration between patient and physician…”?

Here’s a clue:

“Disclosures
Vladimir Maletic has served on the Speaker’s Bureau or has been a consultant for Eli Lilly and Company and Cephalon.  He did not receive any financial compensation for his work on this manuscript. His co-authors are each employees and/or shareholders of Eli Lilly and Company”

And incidentally, according to Dollars for Docs, Dr. Maletic received $841,342 from pharmaceutical companies between August 2013 and December 2015.  In 2015 alone, he received 460 payments from pharma companies for a range of activities including promotional speaking, honoraria, consulting, education, food and lodging, etc.  According to his biography on Global Medical Education, he is a Professor of Neuropsychiatry and Behavioral Science at the University of South Carolina School of Medicine.

THE PAPER ON “SCHIZOPHRENIA”

Ross CA, Margolis RL, et al, Neurobiology of Schizophrenia,  Neuron, October 5, 2006, 52, 139–153

Here again, the authors themselves have provided the rebuttal of Michael’s assertion.  The final section of the paper is Conclusions and Possibilities for Future Research.  Here are the first two sentences.

“In conclusion, we now believe that the molecular genetics of schizophrenia are sufficiently advanced such that etiology-based studies of the neurobiology of schizophrenia are both justified and feasible. The field is still in its infancy, and we must struggle to integrate our rudimentary knowledge of schizophrenia genetics with our scarcely better developed understanding of normal human brain function.”

So, etiology-based studies of the neurobiology of “schizophrenia” are justified and feasible.  Which, of course, is a clear admission that the evidence is not to hand.

Later in the same section there’s this gem:

“The genes associated with schizophrenia may have a spectrum of different pathogenic effects, altering neuronal development, neuronal plasticity, and signal transduction. While undoubtedly a great oversimplification, it may be of heuristic value to postulate that variations in particular genes can affect particular neurobiological processes (Figure 6), in turn causing specific phenotypes.” [Emphasis added]

So the genes associated with “schizophrenia” may have a spectrum of different pathogenic effects.  This is very vague.  The use of the word “may” clearly implies that they also may not have such effects.  But in any event, the evidence for such effects is not adduced in the paper.

And the assertion “…it may be of heuristic value to postulate that variations in particular genes can affect particular neurobiological processes…in turn causing specific phenotypes”, simply means that the hypothesis that genetic variations affect neurobiological processes, which in turn cause psychiatric “symptoms” may have value in encouraging us to explore and learn, which isn’t particularly profound.  Any hypothesis can act as a stimulus to explore and learn.

Here are three more quotes from the section headed Neuropathology:

“Neuropathological investigations of schizophrenia…have not found any evidence of the usual features of neurodegenerative diseases, such as inclusion bodies, dystrophic neuritis, or reactive gliosis.  There is intriguing, though not always consistent, evidence of subtle cytoarchitectural anomalies in entorhinal gray matter…and in other corticolimbic regions, and an abnormally high frequency of aberrant neurons in the white matter underlying prefrontal cortex…temporal, and parahippocampal regions…While these findings remain open to various interpretations…together they provide suggestive evidence for subtle abnormalities in neurodevelopment in schizophrenia, such as disordered cortical neuronal migration, consistent with the observation of subtle behavioral, neurological, and morphologic abnormalities.” [Emphasis added]

“Gene expression array studies have compared the expression profiles, in a number of different brain regions, of schizophrenias and controls…These studies have yielded inconsistent results and still need to overcome the difficulties inherent in the usage of postmortem brain tissue.” [Emphasis added]

“These studies may allow us to reconceptualize our definitions of the psychiatric disorders, including schizophrenia, based on a better understanding of etiology and pathogenesis.”

They may indeed – but clearly the authors are not saying that the evidence is in.  In fact, in the Introduction to the article, they stated that:

“We argue in this review that a definitive study of the neurobiology of schizophrenia is now possible.”

The definitive study is “now possible”!  This paper is dated October 2006, more than ten years ago.  Why haven’t we seen the definitive study yet?  Could it be, could it possibly be, that psychiatry, driven by its own self-centered considerations, is barking up the wrong tree?

Under the ACKNOWLEDGEMENT heading, the paper states:

“NARSAD, Stanley Medical research institute, NIMH, NINDS, and Johns Hopkins Psychiatry provided support.”

AND INCIDENTALLY

The word suggests(s) occurs 26 times; may, 57 times; can, 28 times; might twice; and could seven times.

THE PAPER ON “BIPOLAR DISORDER”

Muneer A, The Neurobiology of Bipolar Disorder: An Integrated Approach, Chonnam Med J., 2016 Jan; 52(1):18-37

Once again, let’s start with the author’s own assessment of his paper.  The Conclusion section begins:

“A broad assessment of the current literature was done to bring to light the underpinnings of mood disorders in general and BD in particular. These are stress-related conditions with overt expression in individuals with an underlying genetic vulnerability. Modern neuroscience is utilizing animal models and conducting human research with increasingly sophisticated methods to unravel their pathophysiology. Significant strides have been made in understanding the neurobiology of affective illnesses, and in this regard new targets and biomarkers have been identified. Diverse biological systems act in concert in perpetuating the disorders. While obstacles in research remain in the basic scientific and clinical domains, there is no doubt that a representation is emerging that is providing a consolidated view regarding the development of these intractable conditions. It is hoped that new knowledge will translate into novel therapeutic measures that have both preventive and curative value for patients with bipolar spectrum disorders.”

Note:

“Modern neuroscience is [working]… to unravel their pathophysiology.”  The clear implication is that they haven’t unraveled it yet.

“Significant strides have been made in understanding the neurobiology of affective illnesses,”.  This is not what researchers say when they’ve made the great discovery.  They say Eureka!

“… new targets and biomarkers have been identified.”

Biomarkers sounds pretty good.  After all, it is widely claimed by psychiatry proponents that the identification of the elusive biomarkers is just around the corner.  It is widely promoted that the biomarkers, when discovered, will clinch the biological pathology issue once and for all.  So is that what the author is saying here?  Well, no.

It is clear from the text that what this author means by “biomarkers” is simply a biological factor that correlates to varying degrees with the bipolar label.  The author presents a few examples, but for illustrative purposes, let’s examine just one:  cortisol levels in the blood stream.

“Early in the trajectory of BD, episodes occur secondary to stress but there is blighted psychobiological resilience and defective coping that increase vulnerability to recurrent affective exacerbations with illness advancement.12  This impairment is principally provoked by the hypothalamic-pituitary-adrenal (HPA) axis, which does not function properly in patients with BD.13 Patients with BD have a hyperactive HPA axis, high levels of systemic cortisol, and nonsuppression of its circulating levels in the dexamethasone suppression test or the dexamethasone/corticotrophin-releasing hormone (DEX/CRF) test.14

This is a bit technical, but here’s the translation:

  1. In the early stages of those behaviors, thoughts, and feelings that psychiatrists label bipolar disorder, episodes of mania and depression occur in response to stress.
  1. But, as more episodes occur, there also occurs blighted psychobiological resilience, which presumably means reduced psychological resilience coupled with impairment in general health. These deteriorations are provoked by the HPA axis, “which does not function properly in patients with BD”.  Note the term provoked, which isn’t quite the same as caused.  Also note the cautious wording in the final clause:  “does not function properly in patients with BD”.  At first glance, this seems to be saying that the malfunctions cause the “BD”.  But when read more carefully, no such causal connection is stated or even implied.  All that’s being asserted is that HPA malfunction and being labeled BP are correlated.  The causation, if it exists at all, could go either way.
  1. People labeled BP have high cortisol levels as measured by the two tests mentioned.

From all of this, the author concludes:

“From this perspective, HPA axis irregularities seem to be a genetic attribute endowing vulnerability to mood disorders.”

Note the vagueness:  “seems to be” and “vulnerability”.  Not quite the same as cause.

But there’s more.  The evidence for the HPA “irregularities” is the elevated cortisol level, which, incidentally, is just an average figure.  In the study cited, several of the BD “patients” had cortisol levels in the same range as the controls.  But more importantly, it’s been common knowledge since the 50’s that high alcohol consumption is associated with high cortisol levels, and, according to DSM-IV:

“As the Manic Episode develops, there is often a substantial increase in the use of alcohol or stimulants which may exacerbate or prolong the episode.” (p 330)

This is echoed in DSM-5, which notes a

“…tendency for individuals with bipolar 1 disorder to overuse substances during an episode.” (p 131)

So the elevated cortisol may reflect nothing more than frequent heavy drinking.

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

 In general, Dr. Muneer makes no claim that a biological cause to “BD” has been established.  Indeed, the paper is characterized by caution and guardedness in this matter.  For instance:

“…it is probable that most of the cortisol-GR [glucocorticoid receptor]-related mechanisms alluded to above are a sign of the putative genetic underpinning.” [Emphasis added]

Putative means assumed or believed to be the case.

“Given that the mechanisms of HPA axis dysregulation are incompletely known at present, as is its role in dictating the risk of the disease in vulnerable subjects, current work is beginning to unravel the molecular targets of illness development and progression in BD.” [Emphasis added]

“In bipolar patients, major mood episodes of either polarity result in an inflammatory response that has been convincingly shown in several studies.” [Emphasis added]

So the “episodes” cause the biological malfunction rather than the other way round.

Under the heading LIMITATIONS, the author states:

“The following caveats should be kept in mind while deducing any inferences with respect to the neurobiology of BD:
1) Not all predisposed individuals are afflicted by BD, which underscore the issues of genetic epistasis and hitherto little known mechanisms that mediate resiliency.
2) There are large gaps in knowledge due to the absence of good animal models replicating BD.
3) Technological advances are needed to reproduce findings from animal research in human samples.”

Note the truly exquisite optimism in item 1 above.  Not all the people who have the biological correlate in question go on to develop the thoughts, feelings, and actions which psychiatry labels BD.  So these individuals must have some as yet unknown “mechanisms” that confer resilience.  But the alternative perspective, that this is simply not a fruitful line of inquiry, isn’t even addressed.

SUMMARY

None of the three studies put forward by Michael as evidence that “mental illness” is biologically caused come even close to establishing this premise.  Indeed, in each case, the authors are quite clear that the evidence for this premise is not to hand.  The articles are essentially discussion papers which discuss the implications of previous research, and express the hope that more definitive findings will be available some time in the future.

Meanwhile, psychiatrists and their supporters continue to claim that “mental illnesses” are real illnesses caused by brain pathology, that need to be corrected by drugs and/or high voltage electric shocks.  These assertions remain unsubstantiated despite decades of highly motivated and lavishly funded research.  For these assertions to acquire even a semblance of validity, psychiatry needs to demonstrate convincingly that all (or at last the great majority) of the individuals “diagnosed” with a particular “mental illness” have a clear and identifiable neural pathology, and that the causation runs from the pathology to the problems of thinking, feeling, and/or behaving in question.  Weak correlations to neurophysiological processes or genetic variations are irrelevant, as I showed in the original article.

And while psychiatrists, for self-serving reasons, continue their inane efforts to “unravel” the neurobiological causes of these so-called illnesses, more obvious natural causes are studiously ignored and neglected.  Tampering irresponsibly with a person’s brain because he is depressed, while ignoring  those features of his lifestyle and recent history that have been known from time immemorial to precipitate depression, is reckless folly.

My Response To Dr. Pies

In the October 2015 issue of the Behavior Therapist (pages 206-213), Jeffrey Lacasse, PhD, and Jonathan Leo, PhD, published an article titled Antidepressants and the Chemical Imbalance Theory of Depression: A Reflection and Update on the Discourse,

I thought the article had particular merit, and I drew attention to it in a post dated November 2.  The post, More on the Chemical Imbalance Theory, was also published on Mad in America.

In that post, I quoted a number of passages from the Behavior Therapist article, including:

“When our physicians are educating us, we prefer they not tell us any lies, white or otherwise.  Unfortunately, characterizing the chemical imbalance metaphor as a ‘little white lie’ communicates a paternalistic, hierarchical approach that sounds suspiciously like the days of medicine that we thought we had left behind.  It’s a ‘little white lie’ if you’re a psychiatrist; if you’re a confused, vulnerable depressed person who agrees to take an SSRI after hearing it, you might not consider it so little.  After all, if your trusted physician tells you that you have a chemical imbalance in your brain that can be corrected with medication, not doing so sounds foolish, if not scary (Lacasse, 2005).  How many patients with reservations about SSRIs have agreed to take medication after being told this ‘little white lie’?”

and

“Pies blames the drug companies for running misleading advertisements about chemical imbalance, belatedly admits he should have said something sooner, but fails to mention that he was paid to help them promote their products at the time the advertisements were running.”

On November 5, I received the following email, forwarded from Mad In America:

Message sent by: Ronald Pies MD

Message:Dear Mr. Cole:

Philip Hickey\’s blog, \”More on the Chemical Imbalance Theory\”—posted on your website—references a recent paper by Lacasse & Leo (\”Antidepressants and the Chemical Imbalance Theory of Depression\”) which contains incorrect and misleading information re: my views, as well as an unsupported claim re: supposed “conflicts of interest”  Lacasse & Leo impute to me. These misstatements by Lacasse & Leo are, unfortunately, repeated in Hickey\’s blog.  This is unacceptable and must be publicly corrected. In brief, Lacasse and Leo’s misrepresentations are as follows:

1.  They misattribute the phrase “little white lie” to me, with regard to the so-called “chemical imbalance theory.” In reality, this unfortunate phrase was originally used by Mr. Robert Whitaker in an interview with Bruce Levine. The link is: http://brucelevine.net/psychiatry-admits-its-been-wrong-in-big-ways-but-can-it-change-a-chat-with-robert-whi/

In the article I subsequently wrote, cited by Lacasse & Leo (http://www.medscape.com/viewarticle/823368), my use of that phrase was in direct reference to Whitaker’s interview and to his own choice of words. I made this clear as far back as April, 2014, in a comment I posted beneath my Medscape article (available online). Careful scholars would surely have observed this and not falsely attributed Whitaker\’s phrase to me. The Medscape article has since been corrected.

2.  Citing information properly disclosed by me over a decade ago, Lacasse & Leo allege that I was “paid to help [pharmaceutical companies] promote their products…” This is categorically false. The allegation by Lacasse & Leo was not based on any direct knowledge of my professional or contractual arrangements dating back to 2003. Never, at any time, have I accepted any monies from pharmaceutical companies (or anyone else) with the intent or purpose of promoting their products. Nor have I ever had any ongoing financial relationships with any pharmaceutical companies.

A detailed rejoinder to Lacasse & Leo will appear in the winter issue of \”The Behavior Therapist,\” where the Lacasse & Leo article originally appeared. However, I respectfully request that you run a correction on your website as soon as possible; e.g., by posting this communication. I consider this a matter that impinges on my professional reputation, and I reserve all rights in pursuit of a just resolution.

Sincerely,
Ronald Pies MD
Professor of Psychiatry

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

MY RESPONSE

In his email, Dr. Pies raises two objections.  Firstly, he contends that the phrase “little white lie” as applied to the chemical imbalance theory was misattributed to him, on the grounds that the phrase had been used earlier by Robert Whitaker.  Secondly, he states that he has never accepted payment from pharmaceutical companies with the intent or purpose of promoting their products.

THE LITTLE WHITE LIE

On April 15, 2014, Dr. Pies published an article – Nuances, Narratives, and the ‘Chemical Imbalance’ Debate in Psychiatry – on Medscape.

The third paragraph of this article reads:

“Now, if you were to give credence to a recent online polemic posing as investigative journalism1, you would probably choose the first or second statement. In the narrative of the antipsychiatry movement, a monolithic entity called ‘Psychiatry’ has deliberately misled the public as to the causes of mental illness, by failing to debunk the chemical imbalance hypothesis. Indeed, this narrative insists that, by promoting this little white lie, psychiatry betrayed the public trust and made it seem as if psychiatrists had magic bullets for psychiatric disorders. (Lurking in the back-story, of course, is Big Pharma, said to be in cahoots with Psychiatry so as to sell more drugs).”

The “polemic posing as investigative journalism” (Ref #1) is an ungracious, and, in my view, unwarrantedly cynical, reference to Bruce Levine’s March 5 2014, interview with Robert Whitaker.  In that interview, Robert is quoted as saying:

“By doing so [promoting the chemical imbalance theory], psychiatry allowed a ‘little white lie’ to take hold in the public mind, which helped sell drugs and of course made it seem that psychiatry had magic bullets for psychiatric disorders. That is an astonishing betrayal of the trust that the public puts in a medical discipline; we don’t expect to be misled in such a basic way.”

It is obvious in this quote, and from the surrounding text, that Robert is using the term “little white lie” as an understatement.  This is clear from the next sentence:  “…an astonishing betrayal of the trust that the public puts in a medical discipline…”.  It is also noteworthy that the phrase is inside quotation marks, which are often used to negate the substance of the enclosed material.

But in Dr. Pies’ statement in the Medscape article, there is nothing to suggest that understatement was intended, and nothing to suggest that the sentiment entailed was anything other than Dr. Pies’ own position.

Specifically, he did not place the phrase inside quotation marks.  And more generally, characterizing the chemical imbalance theory as a “little white lie” is consistent with the psychiatry-exculpating tone of Dr. Pies’ piece.  It is also consistent with the tone of other articles that Dr. Pies has written.  For instance, in Doctor, Is My Mood Disorder Due to a Chemical Imbalance? (2011), Dr. Pies wrote:

“Many patients who suffer from severe depression or anxiety or psychosis tend to blame themselves for the problem. They have often been told by family members that they are “weak-willed” or “just making excuses” when they get sick, and that they would be fine if they just picked themselves up by those proverbial bootstraps. They are often made to feel guilty for using a medication to help with their mood swings or depressive bouts.…So, some doctors believe that they will help the patient feel less blameworthy by telling them, ‘you have a chemical imbalance causing your problem.'”

A little white lie is an inconsequential falsehood, told to avoid causing embarrassment or hurt.  And this is precisely how Dr. Pies is presenting the chemical imbalance hoax in the passage quoted above:  a benign falsehood that will “help the patient feel less blameworthy”.

So, those of us reading Dr. Pies’ “Nuances…” article had every reason to read his description of the chemical imbalance theory as a little white lie, as his own position, and absolutely no reason to infer anything to the contrary.

In addition to this, Dr. Pies himself seems knowledgeable of these matters, and skilled in navigating these kinds of linguistic intricacies.  For instance, in the “Nuances…” article, Dr. Pies states:

“In the narrative of the anti-psychiatry movement, a monolithic entity called ‘Psychiatry’ has deliberately misled the public as to the causes of mental illness, by failing to debunk the chemical imbalance hypothesis.”

Here, Dr. Pies has made it perfectly clear that the characterization of psychiatry as a “monolithic entity” is not his position, but rather that of the antipsychiatry movement.

But no such construction is attached to his use of the phrase “little white lie”.

For Dr. Pies to contend that Drs. Lacasse and Leo misattributed the phrase to him is inaccurate and unreasonable.  The notion that “careful scholars” would have searched through the comments string and found Dr. Pies’ clarification is not convincing.  If Dr. Pies was aware that there was a misleading phrase in the article, he should have corrected it, not relied on his readers to search through a comments string looking for a correction, of whose existence they had no inkling.  The responsibility for the miscommunication sits squarely on his own shoulders.

And there are indications that Dr. Pies clearly understands this.  The “Nuances…” article which appeared in Medscape on April 15 2014, had been published earlier, on March 11, 2014, in Psychiatric Times.  But a month later, on April 11, it was updated on that siteIn the later version, the phrase “little white lie” has been changed to “simplistic notion”.  My interpretation of this at the time was that Dr. Pies had recognized that his earlier statement had been woefully inaccurate, and frankly insulting to people who had been harmed by the falsehood in question, so he made the change.  For some reason, a similar change was not made in the Medscape article until about two weeks ago, when its wording was amended to “simplistic formulation”.  If Dr. Pies didn’t believe that he had misexpressed himself, why did he feel the need to make these amendments?

So, to summarize the “little white lie” issue:

  1. In the original Psychiatric Times and Medscape articles, Dr. Pies characterized the spurious chemical imbalance theory as “this little while lie”. There was nothing in the wording of this statement to suggest that this was anything other than his own position.
  1. At some point in the next few weeks, Dr. Pies realized that his statement was inaccurate, or that he had misexpressed himself, and made an appropriate correction in the Psychiatric Times article, but not in the Medscape piece.
  1. In October 2015, Drs. Lacasse and Leo, accurately and appropriately, attributed the “little white lie” phrase in the Medscape article to Dr. Pies.
  1. Sometime in the last two weeks, the Medscape article was amended to read “simplistic formulation”.
  1. On November 4, 2015, Dr. Pies unjustly accused Drs. Lacasse and Leo of misattributing the phrase to him.

 . . . . . . . . . . . . . . .

CONFLICTS OF INTEREST

Here’s the entire passage from the Behavior Therapist article:

“Thus, while we don’t know why Ronald Pies himself didn’t speak out on the chemical imbalance issue decades ago, readers should be aware of his past financial relationship with pharmaceutical companies. He sounds vaguely critical of the drug industry in his recent articles and never discloses any history of financial conflicts-of-interest. However, Pies has received funding from GlaxoSmithKline, Abbot Laboratories, and Jannsen Pharmaceuticals—the makers of Paxil, Wellbutrin, Lamictal, Depakote, and Risperdal (Chaudron & Pies, 2003; Pies & Rogers, 2005).  For years, Paxil and Wellbutrin were advertised as correcting a chemical imbalance in the brain. These three companies have recently been fined a combined $6.7 billion for illegal marketing of their products.Pies has also consulted for ApotheCom, a ‘Medical Communications Agency’ that ‘provides services to support the commercialization of new products…[including]….publications planning, [and] promotional communications…’ (Pharma Voice Marketplace, 2015). While useful context, this isn’t uncommon among academic psychiatrists, and some would say it was par for the course in the 2000s.  However, in a public forum, more transparency is preferable.  Pies blames the drug companies for running misleading advertisements about chemical imbalance, belatedly admits he should have said something sooner, but fails to mention that he was paid to help them promote their products at the time the advertisements were running.

It’s important to realize that organized psychiatry doesn’t always remain silent, such as when the interests of psychiatric prescribers and pharmaceutical companies converge. In the mid-2000s, press releases endorsed by some of the most prominent psychiatrists in the United States were issued objecting to the FDA black box warning on SSRIs (e.g., American College of Neuropsychopharmacology, 2006; Healy, 2012). The APA also issued a press release defending antidepressants (APA, 2004; Healy, 2006). This was at a time when the chemical imbalance metaphor was omnipresent in direct-to-consumer advertising.  While that was seen as a pressing issue to present to the public, misleading messages on chemical imbalance were not.”  (p 209)

Footnote 1 reads:

“We want to be clear that we are not accusing Ronald Pies of anything.  Conflicts-of-interest are routine in academic psychiatry and many of the major pharmaceutical companies have been fined in the recent past.  We do believe that readers deserve to know of his past financial relationships with the drug companies that promoted their products as correcting a chemical imbalance.  The details of these financial relationships are not publicly available.”

I think the above text is clear, and speaks for itself.  It is noteworthy that Drs. Lacasse and Leo take specific pains to protect Dr. Pies from any kind of unjust criticism (“…we are not accusing Ronald Pies of anything.”)  It is also noteworthy that in his email Dr. Pies does not deny that he has consulted for ApotheCom.  Nor does he deny that he received payment for such consultations.  Nor does he deny that ApotheCom’s business is providing “services to support the commercialization of new products”.  Nor does he deny that he received payments from the other drug companies named.  Nor does he deny that these other companies promoted the spurious chemical imbalance theory in their ads.

Dr. Pies simply asserts that he has never accepted payments from pharmaceutical companies with the intent or purpose of promoting their products, and that he has never had ongoing financial relationships with any pharmaceutical company.  This is an unusual rebuttal, in that Drs. Lacasse and Leo never accused him of either of these activities.  I’ll discuss this in more detail later.

In the interests of clarity, I should point out at this stage in the discussion that the terms “promote” and “promotion” are value-neutral, and subject to degrees.  A person may promote a good thing (e.g. world peace), or a bad thing (e.g. racial hatred), and may promote something minimally or avidly.  In addition, a person might promote something  for payment, or gratuitously.

So, if a psychiatrist were to mention to a colleague, in the course of a private conversation, that he finds such and such a drug helpful in alleviating such and such a problem, he has, in effect, promoted the drug in question.  And, he, presumably, would consider this promotion to be a good thing.  Similarly, if a pharmaceutical company launches a massive advertizing campaign on a particular drug, this would also be considered a promotion of the product in question, and, if it resulted in an increase in sales, would be considered a good thing by the company in question.

Similarly, if a psychiatrist writes and publishes an opinion piece in which a certain drug is mentioned favorably, this is a promotion.  In fact, even a relatively neutral mention of a drug by an eminent psychiatrist could be construed as a promotion, along the lines of incidental placement of commercial products in movies.

Dr. Pies also asserts that the “allegation by Lacasse and Leo was not based on any direct knowledge” of his professional or contractual arrangements dating back to 2003.  And he indicated no intentions to make any such information public.

Here, however, are some facts that are in the public domain, interspersed with my comments and reflections.

1.  In July 2002, Dr. Pies published The ‘softer’ end of the bipolar spectrum in the Journal of Psychiatric Practice. He acknowledges that the article is “supported by an unrestricted grant from GlaxoSmithKline.”  The article is a literature review/opinion piece.  Here’s the abstract:

“The prevalence and diversity of bipolar disorder may be under-appreciated. Recent data suggest that when clinicians look beyond strict DSM-IV criteria for bipolar disorder, we find that as many as 5%-7% of the general public may suffer from some form of ‘bipolar spectrum disorder.’ At the same time, the comorbidity between bipolar disorder and other psychiatric conditions may create understandable confusion in diagnosis and treatment. Recognition of bipolar depression and the ‘soft end’ of the bipolar spectrum demands not only the identification of the hallmarks of bipolarity, but a heightened awareness of the problems of missed diagnosis and inappropriate treatment. By attending to some key historical and clinical clues, the psychiatrist is more likely to detect bipolar spectrum disorder and provide appropriate treatment for it.” [Emphasis added]

And here’s a quote from the “Treatment Recommendations and Conclusions” section:

“In the mean time, recent evidence suggests that lithium is at least moderately effective in many depressed bipolar patients,41 and that the anticonvulsant lamotrigine may be a feasible alternative to antidepressants in some depressed bipolar patients.42” [Emphasis added]

Lamotrigine (Lamictal) is an anticonvulsant made by GlaxoSmithKline.

Reference 42, on which Dr. Pies’ recommendation is reliant, is Calabrese JR, Bowden, CL, et al. A double-blind, placebo-controlled study of lamotrigine monotherapy in outpatients with bipolar I depression, J Clin Psychiatry 1999.  This study was funded by Glaxo Wellcome, which in January 2000 merged with SmithKline Beecham to become GlaxoSmithKline.  Three of the authors, John Ascher, MD, Eileen Monaghan, and David Rudd, PharmD, were GW employees.  In addition, the authors thank Gary Evoniuk, PhD, and Elizabeth Field, PhD for “editorial assistance with the manuscript.”  Dr. Evoniuk was, and incidentally still is, an employee of GSK.  According to her bio, Dr. Field worked for GSK from 1989 to 2001, and with astonishing candor, describes her work there as follows:

“I managed an international department of 24 medical publication professionals who wrote/edited manuscripts for peer-reviewed journals describing the results of GSK-sponsored clinical trials in conjunction with the author/investigators. This group supported almost all products in development and marketed by GSK” [Emphasis added]

So it is clear that GSK had a very considerable input into the wording and presentation of the Dr. Calabrese et al article.  The conclusion of the study was:  “Lamotrigine monotherapy is an effective and well-tolerated treatment for bipolar depression.”

So essentially what we’ve got here is:  Glaxo Wellcome funds, and is heavily involved in the production of, a 1999 study which finds in favor of its drug lamotrigine (Lamictal).  And in 2002, GSK contracts with Dr. Pies to write an article on the “bipolar spectrum”, in which Dr. Pies, largely on the basis of Drs. Calabrese’s and Bowden’s findings, recommends the drug, albeit with a measure of caution, for “some depressed bipolar patients”.

But the plot thickens, for this is the same Dr. Calabrese who was described in United States vs. GSK (2012) as “…GSK’s greatest proponent for the use of Lamictal in the treatment of bipolar disorder…”  Dr. Bowden is also mentioned frequently in the same lawsuit.

To provide context for this discussion, I have attached to this post  – as Appendix A – a copy of the Lamictal section of the GSK lawsuit.  It’s a sordid tale, which describes in close detail how GSK illegally and vigorously promoted Lamictal as a “treatment for bipolar disorder”.  The outcome of this lawsuit was that GSK was fined $3 billion, the largest fine for activity of its sort in American history.

I need to emphasize that my introduction of the GSK lawsuit material is to provide context.  Dr. Pies is not named in the complaint, and there is no suggestion from any source that he was complicit in GSK’s illegal activities.  Nor am I suggesting that Dr. Pies was complicit in the activities of Drs. Calabrese and Bowden.  But Dr. Pies did lend credence to their work, by quoting them, and by relying on their findings, even though the extensive GSK involvement in the creation of their report was, and still is, public information.

There are two paragraphs in the United States vs. GSK complaint that have particular relevance.

“471. Just as troublesome as the Lit Alerts and Faxbacks, were the numerous studies by Calabrese, distributed by GSK, which suggest the efficacy and use of Lamictal in patients with bipolar II.”  [Emphasis added]

In other words, the distribution of the Calabrese studies was an integral part of the illegal promotion of Lamictal for bipolar disorder.  And Dr. Pies, by publicizing, and lending credence to, these studies, became a significant, though unwitting, link in this distribution chain.

Paragraph 474 is also important.

“474. GSK’s extremely aggressive off-label campaign for Lamictal included spending large sums of money in the form of unrestricted grants, membership on advisory boards and speaker’s fees on physicians and researchers who served as ‘national thought leaders.’ As with campaigns for other drugs, the campaign for the use of the drug Lamictal in the treatment of bipolar disorders began with the widespread promotion of ‘disease awareness.'”  [Emphasis added]

In other words, GSK’s awarding of unrestricted grants was also an integral part of their promotional campaign, and as we shall see below, Dr. Pies was the recipient of several unrestricted grants from GSK.  Additionally, Dr. Pies’ opening statement in the “Softer End” article that “… 5%–7% of the general public may suffer from some form of ‘bipolar spectrum disorder.'” sounds very like the “widespread promotion of ‘disease awareness'” mentioned in paragraph 474 above.

Given the extent and vigor of GSK’s illegal promotional campaign, it was perhaps almost inevitable that a person of Dr. Pies’ academic stature and unimpeachable reputation for personal integrity, would become a “target” for GSK’s talent scouts.

In 2008, Nassir Ghaemi, MD, et al published an article Publication Bias and the Pharmaceutical Industry: The Case of Lamotrigine in Bipolar Disorder in Medscape.  The article takes to task the drug industry generally (and GSK in particular) for not publishing, and perhaps even concealing, research studies that show their products in a negative light.  Dr. Ghaemi et al focus specifically on “studies with lamotrigine in bipolar disorder”.  Here’s a quote from their abstract:

“In this paper, we review the case of studies with lamotrigine in bipolar disorder, describing evidence of lack of efficacy in multiple mood states outside of the primary area of efficacy (prophylaxis of mood episodes). In particular, the drug has very limited, if any, efficacy in acute bipolar depression and rapid-cycling bipolar disorder, areas in which practicing clinicians, as well as some academic leaders, have supported its use.” [Emphasis added]

Obviously I don’t know if Dr. Ghaemi et al  had Dr. Pies in mind when they were writing this, but as quoted earlier, Dr. Pies had written in 2002 that “recent evidence suggests that…lamotrigine may be a feasible alternative to antidepressants in some depressed bipolar patients.”

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

In passing, I should probably comment on the term “unrestricted grant”.  Strictly speaking, this means that the money is given with no strings attached.  The grantee is assured the freedom to express and publish his views with no pressure from the grantor.  In practice, there often are pressures, subtle and otherwise.  Here’s what the distinguished Professor Emeritus of Medicine at UCLA, Jerome Hoffman, MD, wrote on this matter on June 12, 2013, in a guest post on the blog site Common Sense Family Doctor:

“Excuse me, but Pharma doesn’t throw away its money. There is no such thing as an unrestricted grant; if it didn’t buy value in return, why would they pay for it? And if the author didn’t write something they like to read, do you think he’d ever get another unrestricted grant?”

And here’s what the highly-respected psychiatrist Daniel Carlat, MD, wrote on June 17, 2007:

“While the term ‘unrestricted’ implies that the company had no strings attached to its money, the reality is that any physician or MECC (medical education communication company) who receives drug company funding knows that their lecture or article will be closely perused by those with the cash, and that future ‘gigs’ will be dependent on whether the company feels their product is shown in a favorable light.”

As we will see later, Dr. Pies has received several unrestricted grants from GSK.

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

2.  In December 2002, Dr. Pies wrote an opinion piece: Combining lithium and anticonvulsants in bipolar disorder: a review, for the Annals of Clinical Psychiatry.  The article was funded  ” by an unrestricted grant from GlaxoSmithKline.”  Here’s a quote from the abstract:

“More recent reports suggest that lithium may be safely and effectively combined with lamotrigine, and perhaps with topiramate, although controlled studies are required.” [Emphasis added]

Here are some quotes from the body of the article:

” Since 1994, there have been at least 21 open-label, uncontrolled case reports or studies examining lamotrigine in bipolar disorder, with a cumulative control group of over 300 patients (26,27). While a review of this literature is beyond the scope of the present paper, a few points are worth noting. In their own review of 14 open clinical reports involving 207 patients with bipolar disorder (66 with rapid cycling), Calabrese et al. (26) concluded that lamotrigine demonstrated moderate-to-marked efficacy in depression, hypomania, and mixed states; however, efficacy in hospitalized manic patients was not clearly shown, and many of these studies used lamotrigine as add-on (adjunctive) therapy. In the Bowden et al. study (27), lamotrigine was evaluated in patients with refractory bipolar disorder, either as monotherapy (n = 15) or as add-on therapy (n = 60). A total of 23 subjects (31 %) were taking lithium at the initiation of the study; three additional patients received lithium later in the study. Overall, both rapid-cycling and nonrapid-cycling patients experienced symptom reduction and functional improvement over the course of 48 weeks.” [Emphasis added]

Reference 27 is a Glaxo Wellcome-funded study by Drs. Bowden, Calabrese, et al.  Four of the authors were GW employees.

Here are some more quotes from Dr. Pies’ article:

“The patient populations in open studies of lamotrigine have been quite heterogeneous, and lamotrigine has been used as both add-on and monotherapy.  These studies have suggested lamotrigine’s efficacy in depressed, hypomanic, and mixed bipolar patients.” [Emphasis added]

Lamotrigine monotherapy is generally well tolerated.” [Emphasis added]

“From the standpoint of pharmacokinetic interactions, the combination of lamotrigine and lithium appears to pose no significant problems. Specifically, administering lamotrigine with lithium does not significantly alter the pharmacokinetics of lithium (35). Preliminary indications indicate that the combination of lamotrigine and lithium is well tolerated in most patients.” [Emphasis added]

“The addition of lamotrigine to lithium seems most useful for patients refractory to lithium alone who show prominent depressive symptoms and/or rapid cycling.”

But a product can also be promoted by criticizing the competition, in this case, divalproex, (Depakote):

“A larger cohort study of lithium-divalproex [Depakote]combination has yielded mixed results. Specifically, in an open study, Calabrese et al(19) examined large cohorts of rapid-cycling bipolar patients ( N = 271), over a 6-month study period. Of the total group, 215 had comorbid alcohol or drug abuse, 56 did not. In the group as a whole, the combination of lithium and divalproex was associated with marked acute and continued antimanic efficacy in 85% of patients and marked antidepressant efficacy in 60%. However, only one half of patients experienced bimodal mood stabilization.  Premature discontinuation of treatment was disproportionately associated with refractory depression compared with refractory hypomania/mania/mixed states ( n = 41 vs 14). Comorbid alcohol/substance abuse did not directly affect response rates in compliant patients, but did worsen prognosis by increasing rates of poor compliance. The majority of patients receiving lithium/divalproex therapy who required additional treatment were depressed. Indeed, at the time of presentation, most patients with rapid-cycling bipolar disorder are in the depressed phase of illness, which appears to be the “hallmark” of rapid cycling (19).  Given this observation, and that antidepressant use has been discouraged in rapid cyclers, the authors note the pressing need for a pharmacotherapy that markedly reduces depressive symptoms without provoking ‘switching’ or cycle acceleration.” [Emphasis added]

Here again, note that reference 19 which Dr. Pies is citing is a study conducted by Dr. Calabrese, Bowden, et al in 2001, and was funded by Glaxo Wellcome and NIMH.

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

3.  In October 2002, Dr. Pies published Have we undersold lithium for bipolar disorder? as an editorial in the Journal of Clinical Psychopharmacology. The editorial was funded by an unrestricted grant from GSK.  Here’s a quote from the conclusion:

Lamotrigine looks very promising for bipolar depression and prophylaxis, but more studies are needed to define and solidify its role. The same goes for topiramate. Olanzapine, while useful in mania and perhaps as an adjunctive agent in bipolar depression, has yet to prove itself as monotherapy in bipolar prophylaxis. Furthermore, concerns about the neuroendocrine effects of valproate and olanzapine—both of which have FDA labeling in bipolar disorder—must also give us pause. As for gabapentin, there are still no randomized, controlled studies of monotherapy showing this agent to be effective in any type or phase of bipolar disorder.”  [Emphasis added]

Here’s another quote from the body of the editorial:

“Recently, Calbrese et al.13 presented data from two large, double-blind, placebo-controlled, studies comparing lamotrigine and lithium in the maintenance treatment of bipolar I disorder. While both active agents delayed time to ‘any’ bipolar event, a separate analysis (manic/hypomanic/mixed vs. depressive events) found that lamotrigine had more robust effects than lithium in delaying onset of depressive episodes.” [Emphasis added]

Reference 13 is to: Calabrese JR, Bowden CL, et al. Lamotrigine or lithium in the maintenance treatment of bipolar I disorder [abstract NR 236]. Presented at the American Psychiatric Association Annual Meeting, Philadelphia, PA, 2002.

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

4.  In February 2006, Dr. Pies and Patricia Marken, PharmD, co-authored an opinion piece Emerging Treatments for Bipolar Disorder: Safety and Adverse Effect Profiles in the Annals of Pharmacotherapy. The article was “supported by an unrestricted grant from GlaxoSmithKline.”  Here are the authors’ conclusions:

“Pending the results of ongoing controlled studies, several emerging agents may be useful additions to the therapeutic arsenal for BPD.” [bipolar disorder]

And here are some quotes from the body of the paper:

Lamotrigine [Lamictal] is the only newer AED [anti-epileptic drug] with randomized, placebo-controlled data supporting its use as maintenance treatment in BPD.” [Emphasis added]

Lamotrigine is the most studied of all emerging treatments for bipolar maintenance.72 It appears to be more useful in bipolar depression than in mania.72” [Emphasis added]

Lamotrigine was well tolerated, with an adverse event profile similar to that of placebo. Lamotrigine did not appear to induce mania and was not associated with sexual adverse effects,79 weight gain,80 or withdrawal symptoms.79” [Emphasis added]

Reference 72 is to a study by Drs. Bowden, Calabrese et al, 2003.  It was funded by GSK.  Four of the authors were GSK employees, and a further five GSK employees are acknowledged for assistance “in the preparation of this article.”

Reference 79 is to Bowden et al, 2004.  Three of the six authors were GSK employees.

And at the end of the Drs. Pies and Marken article (before the references) it states:  “We gratefully acknowledge Drs. Jacqui Brooks MBBCh MRC Psych and Laurie Barclay MD for their contributions during the preparation of this manuscript.”  No information is provided as to Dr. Brooks’ or Dr. Barclay’s affiliations, or who was paying for their contribution.  But Dr. Brooks’ bio is online, and according to this, she is currently Senior Vice President Medical Strategy at RMEI [Robert Michael Educational Institute].

Dr. Brooks’ bio also states:

“Seasoned healthcare executive with strong blend of clinical (trained psychiatrist) and strategic leadership accomplishments. Documented capacity to analyze evolving environments, provide strategic direction, and successfully lead teams in developing innovative, high-quality products and brand strategies. Proven success in business growth and development in the medical communications environment.” [Emphasis added]

There is no indication in Dr. Brooks’ bio that she ever worked as a psychiatrist.  Her employment history shows that from 2002 to 2005, she was working for ApotheCom Associates as VP Scientific Affairs, Senior Medical Director.  ApotheCom describes itself as “…a Global Medical Communications Powerhouse…”  PharmaVoice provides the following description:

“ApotheCom provides services to support the commercialization of new products at a global level as well as promotional programs for the US market. Services include thought-leader optimization, publications planning, promotional communications and education programming.”

Drs. Pies’ and Marken’s “Emerging Treatments…” article was published on January 10, 2006, so was probably developed during 2005, and it seems likely that Dr. Brooks’ contribution to the manuscript was in her capacity as an ApotheCom employee.  I have no way of knowing who was paying for ApotheCom’s services with regards to this paper, but it is in the public domain that in 2002, GSK made an educational grant to ApotheCom Associates for an article by Robert Hirschfield, MD.

Nor have I any information as to what kind of contribution Dr. Brooks might have made to the manuscript in question.  But her career and bio summary suggest that it might have been more in the area of “brand strategies” and “business growth” than psychiatric technicalities.  Why would an experienced and eminent psychiatrist-writer, like Dr. Pies, need help with a manuscript on the treatment of bipolar disorder from a “seasoned healthcare executive”, employed by a company that specializes in thought-leader optimization, publications planning, promotional communications and educational programming?  It is, I think, particularly noteworthy, that in the acknowledgement of Dr. Brooks’ contribution to “the preparation of the manuscript”, no information is provided concerning her affiliations, or who was paying for her services.  This, I suggest, constitutes, at a minimum, incomplete disclosure.

I was unable to find any information on Laurie Barclay, MD.

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

5.  In August 2006, Dr. Pies and D.F. MacKinnon, MD, published: Affective instability as rapid cycling: theoretical and clinical implications for borderline personality and bipolar spectrum disorders in the journal Bipolar Disorders.  The article, which is a literature review/opinion piece, was “Supported by an unrestricted grant from GlaxoSmithKline.”

Here are the article’s conclusions:

“The same mechanism may drive both the rapid mood switching in some forms of bipolar disorder and the affective instability of borderline personality disorder and may even be rooted in the same genetic etiology. While continued clinical investigation of the use of anticonvulsants in borderline personality disorder is needed, anticonvulsants may be useful in the treatment of this condition, combined with appropriate psychotherapy.” [Emphasis added]

Note that lamotrigine (Lamictal) is an anticonvulsant.

And here are some interesting quotes from the article:

“To our knowledge, there are only two randomized,  double-blind, placebo-controlled studies of anticonvulsants in well-defined rapid cycling populations, both by the same group, and only one currently in the literature (59). In the published study, 182 rapid cycling patients were randomized to lamotrigine monotherapy or placebo. The study found that 41% of lamotrigine-treated versus 26% of placebo-treated patients were stable without relapse during 6 months of monotherapy. Patients with rapid cycling bipolar II disorder consistently experienced more improvement than did bipolar I patients. Most patients who were assigned to double-blind treatment were in the midst of a depressive episode, suggesting antidepressant effects of lamotrigine in bipolar disorder, consistent with the results of a separate, open-label trial of lamotrigine versus lithium in rapid cycling patients (60).” [Emphasis added]

Reference 59 is to a 2000 Calabrese, JR, Bowden, CL et al study funded by Glaxo Wellcome.  Four of the authors were GW employees, and the authors acknowledge assistance from Gary Evoniuk, PhD and Tracey Fine, MSc “in the preparation” of the article.  Both Dr. Evoniuk and Ms. Fine were GW employees at the time this study was conducted.  Ms. Fine’s position was Medical Publications Specialist.

Here’s another quote from Drs. Pies’ and MacKinnon’s opinion piece:

“Preliminary data suggest that lamotrigine may also have benefits in borderline personality disorder, with or without comorbid bipolar disorder.  In an open case series of eight medication-refractory borderline personality disorder patients without concurrent major mood disorders, lamotrigine produced sustained remission in half of those who completed the trial, with notable benefit against impulsive sexual, drug-taking, and suicidal behaviors.(69)” [Emphasis added]

Reference 69 is to: Pinto OC and Akiskal HS, 1998 which was funded by Glaxo Wellcome.

Here are more quotes from the Drs. Pies and MacKinnon opinion piece:

“Randomized, double-blind, controlled studies using lamotrigine appear warranted in this population; however, until these are completed, the utility of lamotrigine in borderline patients remains uncertain.  Nevertheless, one can conclude from the juxta-position of these studies of anticonvulsants in rapid cycling bipolar disorder and borderline personality disorder that at least some anticonvulsants are effective in alleviating not only the affective instability common to both conditions, but also specific measures of what have heretofore been considered fixed traits among borderline patients.” [Emphasis added]

Note how the initial note of skepticism pending the completion of randomized controlled trials is effectively neutralized by the material after the words:  “Nevertheless one can conclude…”.  And note the strength of the assertion:  One can conclude that some anticonvulsants (e.g. Lamictal?) can remediate what have previously been considered fixed traits!

“Once the biological roots of mood instability are better understood, there may be much more to contribute to the understanding of the development of our conventional notions of character and personality.”

And, presumably, more perceived justification for the use of psychiatric drugs to “fix” problems of personality and character.

“We conclude that in at least a sub-group of cases, borderline personality disorder may be an atypical presentation of a primary mood disturbance, probably related to the broad spectrum of bipolar-like disorders. It is premature to recommend anticonvulsants in the routine treatment of patients with borderline personality disorder; however, it seems that anticonvulsants may belong in the psychiatrist’s armamentarium for treatment of this condition.”

Here again, note how the appropriate cautionary lead-in is neutralized by the statement after the word “however”.  The suggestion that anticonvulsants belong in a psychiatrist’s “armamentarium” clearly entails the notion that these products should be used in the “treatment” of “borderline personality disorder”.

And as mentioned before, a drug can be promoted by knocking the opposition, in this case divalproex (Depakote).

“The second randomized, double-blind, controlled study (61) involved a 20-month, parallel group comparison of 60 patients with a history of recent rapid cycling bipolar I or II disorder.  Patients were randomized to lithium or divalproex monotherapy in a balanced design after stratification for bipolar type I and II. For subjects on either lithium or divalproex, about half suffered a relapse: a third into depression, and one-fifth into mania or hypomania. Although clearly better than placebo, it appears there was no benefit of divalproex versus lithium.”

Reference 61 is to a study by Dr. Calabrese, et al.  The study was funded by the NIMH and the Stanley Medical Research Institute.

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

DISCUSSION

I don’t think there can be any doubt, that in the five papers discussed above, Dr. Pies and his various co-authors did make numerous favorable mentions of the drug lamotrigine, and that the articles were funded by grants from GSK.

Dr. Pies could, of course, respond to all this by stating that he helped promote Lamictal on its merits alone, and that this promotion had nothing to do with the funding and/or manuscript assistance that he coincidentally received from the manufacturer of this product (GlaxoSmithKline).  And he could contend that he cited the studies by Drs. Calabrese and Bowden purely on their merits.  And all of this could well be true.

But as Dr. Pies himself wrote in a Psychiatric Times article – The Age of Conflicts—of Interest – on August 1, 2008:

“…the physician or researcher may not even be aware of his real motivation. We are all quite capable of rationalizing our own self-interest in the name of the patient’s well-being,’  ‘the need for the latest technology,’ and so on.”

Dr. Pies could also argue that in the above examples, I have cherry-picked the quotes, and that his treatment of these topics is more balanced than I have portrayed.  And indeed, there would be an inevitable measure of truth to this contention.  Obviously I can’t quote the articles in their entirety, and  Dr. Pies does sometimes mention drawbacks in the sponsor’s drug, and positive aspects of a competitor’s product.  But I have tried to be fair, by selecting quotes that convey the general tone of each piece with regards to lamotrigine, and, I encourage readers to consult the articles in question, and decide this matter for themselves.

Dr. Pies could certainly quibble over any particular quote – or even over any particular paper – as to whether it constitutes promotion of a pharma product.  But of greater importance is the cumulative effect of the multiple passages quoted above in the context provided by the GSK lawsuit complaint and the multiple GSK-sponsored studies.  In this post I have discussed and quoted from five opinion pieces, authored or co-authored by Dr. Pies.  All of the articles were funded by GSK, and all refer to studies conducted by Dr. Calabrese et al.  And remember, Dr. Calabrese is described in the GSK lawsuit as “…GSK’s greatest proponent for the use of Lamictal in the treatment of bipolar disorder…”

In my view, Dr. Pies’ statements in the various articles would appear, to an impartial reader, as recommendations or promotions of lamotrigine.  And it is worth pointing out that I am neither particularly skilled, nor particularly systematic, in conducting literature searches.  It is entirely possible that a more competent searcher would uncover a great deal more material of a comparable nature.  And it also needs to be borne in mind that I have focused on only one drug – Lamictal.  A search of Dr. Pies’ writings concerning other pharma products could conceivably reveal similar complications.  I did, for instance, come across a 2005 article written by Dr. Pies and Winkelman which stressed the efficacy of the sleeping pill eszopiclone (Lunesta), manufactured by Sepracor, now Sunovion.

This reported efficacy was based on Ref # 146, a 2003 study by Andrew Krystal, MD et al.  The Krystal et al study concluded:

“Throughout 6 months, eszopiclone improved all of the components of insomnia as defined by DSM-IV, including patient ratings of daytime function. This placebo-controlled study of eszopiclone provides compelling evidence that long-term pharmacologic treatment of insomnia is efficacious.”

There were seven authors of this study.  Three of the authors are listed as “consultants, investigators and advisory board members to Sepracor.”  A fourth author is listed as a Sepracor consultant.  And the remaining three authors were Sepracor employees.

In their opinion piece, Drs. Pies and Winkelman did not point out that the Krystal et al study was largely a Sepracor in-house project.  Nor did they disclose the funding source (if any) for their opinion piece, but in their acknowledgement section, they wrote:

“The authors would like to acknowledge Sepracor Inc. for its assistance in the preparation of this manuscript.”

I have no way of knowing what this assistance entailed, but it does imply that Sepracor did – at the very least – have some collaborative input in the wording of the article.  It seems unlikely that any such input would work to the detriment of their product.  Why would an eminent psychiatrist of Dr. Pies’ stature need help from a pharmaceutical company to write an opinion piece on the treatment of insomnia?  What kind of help did Sepracor provide?

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

It also needs to be stressed that, as far as I know, Dr. Pies has done nothing wrong, in any formal sense of the term.  He has accepted grant money from pharmaceutical companies to write opinion pieces on various psychiatric topics, and if he came down in favor of the grantor’s product, there are no definite indications that his motivations were anything but pure.  It also needs to be stated that Dr. Pies is a prolific writer, and that the articles cited above represent only a tiny fraction of his published work.  It is possible that a more comprehensive review of his writing over the period in question would show that these kind of industry-sponsored opinion pieces constituted a small fraction of his overall output.

A further question in all of this is why Dr. Pies should be so upset at the suggestion that he had received payment to write articles that helped promote psychiatric drugs.  If Dr. Pies believes that the drugs are efficacious and generally benign, why shouldn’t he help promote them, and why shouldn’t he be afforded reasonable compensation for this activity, particularly when he discloses these arrangements in the papers.  Why should the acceptance of payments in these matters have any bearing on his professional reputation?

But over-riding all of this, is the obvious fact that Dr. Pies has mis-read the phrase  “…he was paid to help promote their products…”  Specifically, he has apparently formed the belief that the phrase purports to describe his motivation in these transactions.  In fact, the use of the passive voice (he was paid) makes it clear that it is the payer’s motivation that is the matter of focus, not the payee’s.

To clarify the distinction, compare the two statements:

He was paid to help promote the drugs.

And

He accepted payment to help promote the drugs.

The first statement clearly entails the notion that the payers were paying the individual with the intention – and presumably expectation – that he would help promote the drugs.  The statement tells us nothing about the payee’s intentions, or even his awareness, of the payer’s intentions.  The second statement, by contrast, clearly purports to describe the payee’s motivation, but Drs. Lacasse and Leo made no statement of that kind.

There is a perfect parallel to this in the drug industry’s widespread use of “thought leaders” to promote their products.  This particular hoax was thoroughly explained by Daniel Carlat, MD, in his 2010 book “Unhinged”.  Here’s how it worked:

A drug rep would approach a psychiatrist and tell him that he – the psychiatrist – was considered a “thought leader” or “key opinion leader” in the area, and that they would like to recruit him to give lectures and presentations to other psychiatrists on the value of a particular drug.  The drug company would train the psychiatrist, and would provide slides and other teaching aids, and would pay the psychiatrist for delivering the presentation.

And this is where it gets subtle.  The psychiatrist thought that the targets of these endeavors were the psychiatrists in the audience – that he was being paid to promote the drug in question to them.  In reality, and this was what Dr. Carlat exposed, the lecturer-psychiatrist himself was the actual target.  By getting him to extol the merits of a drug to his peers, the drug company was actually generating pressure within the lecturer to prescribe the drug more frequently himself.  And the tactic was extremely successful!

So, from the psychiatrist’s point of view, the following statement would be true:

I was paid to give lectures on this drug.

But from the drug company’s point of view, the following statement was true.

We paid him so that he would prescribe this drug more often.

Obviously the psychiatrist in question would object to the latter statement, because he had no knowledge of the drug company’s motivation or tactics.

Similarly, with regards to GSK’s “unrestricted grants, there can be no doubt, given the context outlined above, that GSK was awarding these grants to help promote Lamictal.  And this is the case, even though from Dr. Pies’ point of view, he was merely accepting payment from GSK to write scholarly articles.

In short, like the psychiatrists in Dr. Carlat’s account, he was systematically misled as to the real purpose of the articles.

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

It is worth remembering that this matter began with Dr. Pies’ efforts to distance psychiatry from the chemical imbalance theory of depression, and to lay the blame, or at least some of the blame, for this hoax, onto pharma commercials.

The central point of this entire issue is that at the time these deceptive commercials were running, and running very successfully, Dr. Pies was contracting with these same companies to write articles about their products, and his payments came, at least in part, from revenues generated by these very ads.  Dr. Pies’ current condemnations of pharma’s past excesses would be more convincing today if he had lodged clear statements of protest at the time, or better still, if he had refused to accept their grant contracts, on the basis that the money was tainted.

FINALLY

One of my main purposes in writing this website is to draw attention to psychiatry’s spurious foundations, and to its inherently destructive and disempowering “treatments”.  I also critique the work of writers who seek to promote or exculpate psychiatry, including Dr. Pies.

But my critiques are always directed towards the issues, and are always directed at errors of fact or logic.  In particular, I take special pains to avoid anything that could, even remotely, be construed as a personal attack, or an attack on an individual’s character.  In the case of Dr. Pies, I have always afforded him the respect due to a person of his stature, and have frequently expressed the belief that his primary error is one of loyalty:  that he loves his chosen profession, in the word’s of Shakespeare’s Othello, “not wisely but too well”.

I have read and re-read Dr. Pies email, and in the light of that communication, I have re-read my earlier post.  But I can find nothing in that post that could reasonably be considered false, malicious, or defamatory.

But I’m also a realist, and I recognize the obvious fact that we are all capable of being biased in respect of our own writings.  I am open to suggestions concerning this matter, and if Dr. Pies were to specify which statement or statements on my part have generated a sense of grievance on his, I would be happy to take another look at the document.  And if, in the light of such re-examination, Dr. Pies’ expressions of concern are credibly vindicated, then I will apologize publicly, and retract the statement(s) in question.

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

Appendix A:  Section IX of United States of America vs. GlaxoSmithKline, PLC

  1. GSK’S OFF-LABEL MARKETING OF LAMICTAL
  1. In December 1994, Lamictal (active ingredient lamotrigine) was FDA approved for use as adjunctive therapy in adults with partial seizures, and as adjunctive therapy in the generalized seizures of Lennox-Gastaut syndrome in adults and pediatric patients ages two and older.
  1. However, despite the narrow indications for which it was approved, GSK heavily marketed Lamictal for the treatment of bipolar disorders both before and during the period it was pending a supplemental new drug application for treatment of bipolar I disorder, which was finally granted by the FDA on June 20, 2003.
  1. Off-Label Promotion to Bipolar Patients
  1. GSK’s aggressive marketing of Lamictal prior to its approval for use in the treatment of bipolar I disorder proved extremely lucrative. Lamictal grew by 33% in the year 2000 (with total U.S. sales of $210 million) and continued to grow in the following years. In a press announcement for year 2003 GSK boasted that Lamictal was approaching ‘blockbuster status’ with sales that grew by 31% to approximately $1 billion.
  1. Curiously, there is no data that would support a commensurate rise in partial seizures in adults or Lennox-Gastaut Syndrome, the only approved indications for Lamictal prior to June of 2003.
  1. Ultimately, the aggressive and illegal pre-approval marketing served the dual purpose of reaping significant gains prior to approval for treatment of bipolar I disorder as well as assuring GSK of a nationwide network of health care providers ready to prescribe the drug for bipolar disorders the minute it received FDA approval.
  1. Over the course of nearly ten years of off-label marketing of Lamictal, billions of dollars in sales were generated prior to the 2003 indication for bipolar I, as alleged infra.
  1. Accordingly, GSK, in promoting Lamictal by willfully misrepresenting the FDA approved uses, engaged in egregious and knowing off-label marketing.
  1. Off Label Promotion for all Bipolar Disorders
  1. Despite the fact that Lamictal was only FDA approved for treatment of partial onset seizures in 1994, since its launch, sales representatives were trained to promote the drug as an effective treatment for all bipolar disorders.
  1. Although there are several types of bi-polar disorders, as alleged infra, bipolar I is the most severe and the most rare. Notably, the drug was never approved by the FDA for bipolar II disorder or any of the four (4) other variations on bipolar disorder listed below.
  • Bipolar I disorder involves episodes of severe mood swings, from mania to depression.
  • Bipolar II disorder is a milder form, involving milder episodes of hypomania that alternate with depression. Bipolar II is a more broadly defined mental illness and encompasses more patients.
  • Cyclothymic disorder describes even milder mood changes.
  • With mixed bipolar disorder, there is both mania and depression at the same time, resulting in a person having feelings of grandiosity and racing thoughts, often resulting in an irritable, angry and moody feeling.
  • Rapid-cycling bipolar disorder is characterized by four or more mood episodes that occur within a 12-month period. Some people experience multiple episodes within a single week, or even within a single day. Rapid cycling tends to develop later in the course of illness. Women are more likely than men to have rapid cycling. A rapid-cycling pattern increases risk for severe depression and suicide attempts.
  1. Despite the lack of any bipolar related indication until 2003, sales representatives were provided with materials designed to promote the drug for global bipolar disorders. Even after it received approval for bipolar I disorder in 2003, sales representatives were trained not to call attention to the distinctions among the various types of bipolar disorder unless a physician inquired.
  1. As evidence of the pre-indication marketing and training, one need look no further than the 2001 GSK Selling Resource Guide for Lamictal. The Resource Guide provides scripts for sales reps to address requests for information on Lamictal and bipolar depression suggesting that there were numerous inquiries into this usage. 7AC 0000413-0000430.
  1. In furtherance of their bipolar marketing efforts, GSK engaged in an aggressive campaign aimed at pushing sales representatives to use the FaxBack program discussed in the Resource Guide as a marketing tool.
  1. Specifically, in the aforementioned 2001 Resource Guide, sales representatives were instructed to direct the physicians to “Faxback Number 5” for information regarding the use of Lamictal and bipolar disorder. This faxback incorporated the findings of Dr. Joseph R. Calabrese, and others, which positively detailed the use of Lamictal in patients suffering from bipolar I and II, mania, unipolar depression, and as a monotherapy. 7AC 0000419
  1. Most troublesome is the fact that GSK was aware of its illegal strategic use of the FaxBack program, yet made a conscious and deliberate effort to cover up its actions.
  1. For example, at a management training program in July 2002, Relator Hamrick was instructed by a manager-in-training that, with respect to the detailing of Lamictal for bipolar to psychiatrists, the record of every contact report should automatically include the phrase ‘Dr. inquired about bipolar disorder” thereby effectively circumventing the requirements of the FDCA with regards to disseminating literature concerning non-approved uses.
  1. In addition to the FaxBacks, GSK frequently distributed “Lit Alerts” to its sales force allegedly for the purpose of educating the drug reps. The Alerts, essentially a cliff-note version of a drug specific study, were routinely carried by sales representatives to aid in answering any questions posed by physicians. The fact that the Lit Alerts were, by their very nature, off label marketing tools, makes their distribution by GSK even more egregious.
  1. Specifically, in August 2002, a Lit Alert was distributed to Lamictal sales representatives discussing the use of Lamotrigine as an augmentation agent in treatment resistant depression (‘TRD’), a use for which it has never received approval. 7AC 0000431-0000433.
  1. Subsequent to the TRD Lit Alert, in April 2003 GSK distributed another study titled ‘Lamictal as Maintenance Treatment in Recently Manic or Hypomanic Bipolar I Patients.’ This Lit Alert served only to fan the flames of an already rampant bipolar campaign and was referenced widely in sales calls. 7AC 0000434-0000438.
  1. Just as troublesome as the Lit Alerts and Faxbacks, were the numerous studies by Calabrese, distributed by GSK, which suggest the efficacy and use of Lamictal in patients with bipolar II.
  1. Although Lamictal never received an indication for bipolar II disorder, GSK maintained its effective off label campaign and continued to forge strong relationships with its prescribing physicians ultimately pushing the boundaries by suggesting Lamictal’s effectiveness as a treatment option for bipolar II disorder.
  1. In fact, since the dosage of Lamictal must be increased slowly from a subtherapeutic level to a therapeutic level, acute mania and Bipolar II never received an indication.

“2. GSK’s Improper Use of National Thought Leaders to Promote the Off-Label Marketing of Lamictal

  1. GSK’s extremely aggressive off-label campaign for Lamictal included spending large sums of money in the form of unrestricted grants, membership on advisory boards and speaker’s fees on physicians and researchers who served as ‘national thought leaders.’ As with campaigns for other drugs, the campaign for the use of the drug Lamictal in the treatment of bipolar disorders began with the widespread promotion of “disease awareness.”
  1. Key figures in GSK’s national promotion of Lamictal for treatment of bipolar disorders prior to its indication were Dr. Joseph R. Calabrese of Cleveland, Ohio and Dr. Charles L. Bowden of San Antonio, Texas.
  1. As previously discussed, Dr. Calabrese, in particular, was GSK’s greatest proponent for the use of Lamictal in the treatment of bipolar disorders and published articles advocating the use of Lamictal in bipolar disorder as early as 1998. Dr. Calabrese has widely published his opinion that there is need for a greater awareness of the prevalence of bipolar disorders in the United States, stating that the disease impacts as many as 4% of the total population (11,000,000 people) yet is ‘largely undiagnosed.’
  1. In his promotion of the use of Lamictal for bipolar disorder, Dr. Calabrese wrote about a new nomenclature (‘above the line/below the line’) advocating that Lamictal was clearly superior to other commonly prescribed medications such as Lithium. Dr. Calabrese also defended the drug from the accusation that the risk of serious side-effects, such as Stevens- Johnson Syndrome4, outweighed the benefits of prescribing the medication.

4 Stevens-Johnson syndrome is a rare, serious disorder in which the skin and mucous membranes react severely to a medication, in this case, Lamictal, or infection. Often, Stevens-Johnson syndrome begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, eventually causing the top layer of your skin to die and shed.  4612704 117

  1. In addition to journal articles, in 2002 Dr. Calabrese even published a greatly abbreviated, highly commercialized version, of his 1998 study (being careful to identify Lamotrigine by its GSK product title Lamictal) in an internet bulletin called “Fast Breaking Comments.” In this interview, Dr. Calabrese blatantly publicizes his determination that “lamotrigine (Lamictal) is effective in the treatment of patients with rapid cycling bipolar II disorder.” 7AC 0000439-0000441.
  1. To date, Lamictal has not received an indication for rapid cycling bipolar II disorder. However, GSK placed great emphasis on this study and sales representatives were expected to read and be familiar with Dr. Calabrese’s theories and statistics for use in off label marketing.
  1. Dr. Bowden began publishing his opinions concerning the efficacy of Lamictal in the treatment of bipolar disorder as early as 1998. Dr. Bowden became a widely sought after speaker for GSK, and GSK sales representatives nationwide were encouraged to try to persuade Dr. Bowden to make presentations on his findings in their geographical area.
  1. GSK’s Off-Label Marketing to Psychiatrists
  1. Seizure disorders – the only approved indication for Lamictal during the 1998 through 2003 period – were treated by neurologists, not psychiatrists. Notwithstanding that fact, GSK began requiring its sales representatives to detail Lamictal with psychiatrists and family practitioners many years before the approval for bipolar I disorder.
  1. It is clear that these ‘details,’ which were prevalent throughout the nation during this period, were directed at persuading physicians to prescribe Lamictal off-label for the treatment of bipolar disorder and through the use of free samples, ‘thought leader’ lunches, dinners and CME’s, and distribution of studies favorable to GSK, particularly the Calabrese 4612704 118 studies, GSK was extremely successful in persuading physicians to begin prescribing the drug off-label.
  1. As confirmation of the detailing of psychiatrists, a quick review of the contact sheets written up by the sales representatives shortly after the physician visits confirm the fact that the purpose of these visits was solely to market Lamictal for the treatment of bipolar disorders. The following is representative of the quantity of the off label physician visits by sales representatives including Ron Crews, Joan Schindler and Betty Hosler5
  • 9/13/00 Dr. Douglas Gregory (psychiatrist) ‘Had long discussion about Lamictal, is afraid of rash….Rash is severe side effect which has caused death in several patients….’Stevens Johnson Syndrome’….Gave him Calabrese article and encouraged him to talk to Marciniak [local GKS ‘thought leader’;
  • 10/18/00 Dr. McClure [Dr. Scott H. McClure, psychiatrist] Is getting more comf w/ lamic, thought it [conference put on by GSK]was informative More comfortable with Lamictal for bi-polar;
  • 10/26/00 Dr. Crandall (psychiatrist) “[D]iscussed Bowdens’ lecture, she is afraid of the rash;
  • 10/30/00 Dr. Gamblin (psychiatrist) ‘very pos. about lam. (Lamictal) has over 50 patients on it’…’Trained with Bowden sorry he missed it ‘ (referring to lecture in Colorado Springs that GSK arranged with Dr. Bowden as the speakers);
  • 10/30/00 Dr. McClure [Dr. Scott H. McClure, psychiatrist] ‘Said he is more comf.with Lamictal as monotherapy [in the treatment of bipolar disorder] after hearing Bowden likes the bottles of 25 only, not the kits (Lamictal) samples’;
  • 1/8/01 Dr. Harazin [Dr. Jeffrey Harazin, psychiatrist] ‘Lamictal is on it’s way’;
  • 03/21/01 Dr. Marciniak [psychiatrist] detailed by GSK District Manager for Lamictal in bipolar;
  • 05/23/01 Dr. Gregory [psychiatrist] attended noon lecture at Pikes Peak Mental Health with Dr. Paul Wender speaking, detailed on Lamictal;

5 These notes have been reproduced exactly as they were written in the contact reports by the individual sales representatives and entered into the Passport system following each sales call.

  • 06/12/01 Dr. Gamblin [psychiatrist] again detailed on Lamictal;
  • 06/19/01 Dr. Richard Marciniak [psychiatrist] detailed on Lamictal and offered a free fly fishing trip;
  • 06/21/01 Dr. Richard Marciniak again detailed on Lamictal and offered speaker/dinner engagement at local restaurant (Warehouse);
  • 07/05/01 Dr. Gamblin again detailed for Lamictal;
  • 07/19/01 Dr. Richard Marciniak again detailed on Lamictal and stated it is his choice for treatment of bipolar, as well as discussing dosage amounts and titration;
  • 07/30/01 Dr. Fred Michel detailed on the use of Lamictal for the treatment of children (‘Uses very little Lamictal in kids but would like to use it more.’);
  • 03/14/02 Dr. Julie Sanford [psychiatrist] detailed for using Lamictal in the treatment of bipolar;
  • 03/15/02 Dr. Gamblin had not yet seen the Calabrese study but did not want to drive to Denver for CME’s;
  • 03/15/02 Dr. James Spadoni [psychiatrist] detailed for the use of Lamictal in bipolar;
  • 03/19/02 Dr. Marciniak agreed to be paid by GSK to speak about Lamictal for bipolar as well as Wellbutrin at a lunch for local physicians in Colorado Springs;
  • 03/19/02 Dr. Stephen Mueller [psychiatrist] confirmed attendance at the bipolar/Lamictal physician’s meeting in Colorado Springs, Colorado;
  • 03/20/02 Dr. Gamblin again detailed for prescribing Lamictal for bipolar disorder;
  • 04/03/02 Dr. Marciniak detailed for Lamictal and confirmed that he would accept paid assignment to do GSK’s CME program on June 7, 2002;
  • 04/03/02 Dr. Spadoni [psychiatrist] detailed for use of Lamictal in bipolar disorder;
  • 04/10/02 Dr. Gamblin detailed for use of Lamictal in bipolar disorder with reference to the Calabreze study;
  • 04/24/02 Dr. David Caster [psychiatrist] detailed for Lamictal in bipolar disorder;
  • 04/25/02 Dr. Rosalyn Kneppel [psychiatrist] detailed for Lamictal in bipolar disorder;
  • 04/29/02 Dr. Nancy Sharpe, a Colorado Springs psychiatrist, was detailed for Lamictal in bipolar disorder; this doctor, who has a large Medicaid practice, asked the GSK sales representative about proper dosage amounts;
  • 05/01/02 Dr. Brian Grabert, a pediatric neurologist, was invited to be on GSK’s advisory board for an upcoming San Diego, California conference; 05/06/02 Dr. Gamblin detailed once again for Lamictal and now said he feels quite comfortable using it;
  • 05/08/02 Dr. Rosalyn Kneppel [psychiatrist] again detailed for Lamictal in bipolar disorder;
  • 05/08/02 Dr. Jeffrey Harazin again detailed for Lamictal in bipolar and now said he uses it ‘first line’ for bipolar disorder;
  • 05/13/02 Dr. Stephen Mueller, psychiatrist, again detailed for Lamictal in bipolar and requested pricing information;
  • 05/17/02 Dr. Marciniak agreed to do a talk and stated that he is using Lamictal more for bipolar now that he has more samples;
  • 05/20/02 Dr. Elliott Cohen, psychiatrist, detailed for Lamictal and he requested more samples;
  • 05/20/02 Dr. Rosalyn Kneppel [psychiatrist] again detailed for Lamictal in bipolar disorder and said she is using half the dosage [recommended for seizures] because of concerns about the rash;
  • 05/20/02 Dr. James Polo detailed for use of Lamictal in bipolar disorder in adolescents;
  • 05/22/02 Dr. Ralph Everett, child psychiatrist detailed for Lamictal in bipolar and after having stated he did not like it, was given a comparison to Zoloft by the GSK rep;
  • 05/22/02 Dr. Scott McClure, psychiatrist, again detailed for Lamictal in bipolar and Dr. McClure asked the GSK rep. how to dose if a patient was already on Depakote for bipolar and was given ‘the Calabrese study’ by the rep;
  • 05/23/02 Psychiatrists Dr. Anne League, Dr. James Spadoni and Dr. Julie Sanford were treated to lunch at a local Colorado Springs restaurant by the GSK sales representative and given American Psychiatric Association guidelines relating to Lamictal;
  • 05/23/02 Psychiatrist Pamela A. Brickers of Colorado Springs, CO was detailed by a GSK representative and was given a copy of ‘the calabrfese [sic] study’;
  • 05/29/02 Dr. Julie Sanford was detailed on Lamictal for bipolar and the GSK rep went over a study/comparison with Zoloft that was favorable to GSK’s product;
  • 05/29/02 Dr. James Spadoni and Dr. Richard Marciniak detailed for Lamictal;
  • 05/30/02 Dr. Brian Grabert detailed for Lamictal for his pediatric patients;
  • 06/05/02 Dr. Brian Grabert again detailed for Lamictal and discussed the rash;
  • 06/17/02 Dr. Honie Crandell again detailed for Lamictal in the treatment of bipolar disorder and confirms that it is her drug of choice for this disorder.
  1. In addition to targeting psychiatrists for detailing, prior to the FDA approved indication for bipolar I, GSK sales representatives were instructed to devote virtually all of their free sampling activities to psychiatrists, rather than neurologists. A routine practice that was documented in the contact reports of physician details as well as the first-hand experience of Relator Thorpe.
  1. GSK’S Off-Label Promotion of Lamictal Resulted in Patient Harm
  1. Although the FDA issued recommended dosing for Lamictal for its seizure indications, there were no such dosing guidelines for use in patients suffering from any form of bipolar disorder prior to the FDA approval in 2003. As such, there existed an acute risk of overdosing and resulting complications.
  1. Since the FDA did not establish a recommended dosage for Lamictal for use off label, and because the potential side effects were so severe if not dosed correctly, once the sales representatives had successfully gotten a physician to inquire about its use for bipolar, they were instructed to use the phrase ‘start low and go slow.’
  1. On information and belief, this “catchphrase” came directly from the GSK marketing department and was used by sales representatives throughout the country as a way to remind physicians to start with a small dose and raise the dosage very slowly in the treatment of bipolar I disorder in children and adolescents especially.
  1. Given the lack of dosing information, coupled with the intense campaign for use as a treatment for bipolar disorders, the contact reports referenced in the preceding paragraphs evidence physicians routinely inquiring about dosage and titration from the sales representatives themselves.
  1. On information and belief, as a direct and proximate result of the lack of proper dosing of Lamictal when used off-label, patients suffered both reported and unreported severe side effects including death.
  1. The Federal Drug and Cosmetic Act (“FDCA”) and its regulations require that adverse events due to prescription medications be promptly reported. However, ample evidence exists of widespread under-reporting of adverse drug reactions, even when drugs are being prescribed for their approved uses. (Mintzes, B., Bassett, K., Wright J.M.. Drug Safety without Borders: Concerns about Bupropion. Can. Med. Assoc. J., 2002;167(5); Moride Y, Haramburu F, Requejo AA, Begaud B. Under-reporting of Adverse Drug Reactions in General Practice. Br J Clin Pharmacol 1997;43(2):177-81; Bates DW. Drugs and Adverse Drug Reactions. How Worried Should We Be? JAMA 1998;279(15):1216-7; Okie, S., Safety in Numbers – Monitoring Risk in Approved Drugs, N.E.J.M., 352:1173-1176, March 2005.)
  1. On February 14, 2003, Relator Hamrick became aware of an incident involving the dangers of off-label prescription particularly when combined with the widespread laxity in adverse event reporting when he called on Dr. J. Vitanza, an allergist.
  1. Mr. Hamrick was informed that one of Dr. Vitanza’s patients had been prescribed Lamictal for bipolar I disorder (prior to its approval by the FDA) and noted in the patient’s chart an incidence of rash. Assuming that the patient’s psychiatrist would report the rash incident, Dr. Vitanza failed to report the occurrence to the FDA. After observing that the physician was not going to file an adverse event report, Mr. Hamrick filed his own, based upon his second-hand knowledge of the incident. 7AC 0000442-0000443.
  1. As a result of the underreporting of rash occurrences, physicians failed to be properly alerted to the potential danger of the rash which had, on a few occurrences, developed into Stevens-Johnson Syndrome.
  1. In addition to the unreported incidents of rash, often resulting from off-label prescriptions, at least one death resulted from the use Lamictal for bipolar I disorder.
  1. Dr. Julie Sanford, a psychiatrist who was consistently detailed by GSK sales representatives to prescribe Lamictal for bipolar disorders, prescribed the drug for a patient that subsequently died. Since Dr. Sanford was not a neurologist likely to be treating a patient for a seizure disorder, it should have been apparent to GSK officials receiving a copy of her adverse event report that the drug was, in all likelihood, prescribed for a non-indicated use.
  1. Nevertheless, in a May 22, 2001 letter to Dr. Sanford from GKS’s “Global Clinical Safety and Pharmacovigilance” division, there is a reiteration of adverse event reporting: the patient, who had been given Lamictal experienced headache and died, and other patients of whom she was aware also experienced rashes subsequent to receiving therapy with Lamictal. 7AC 0000444.
  1. Significantly, the “Global Clinical Safety and Pharmacovigilance” division, while allegedly interested ‘in obtaining as much information as possible concerning reports of suspected adverse reactions for the purpose of continuing to monitor and evaluate drug safety’ made no inquiry into the issue of the purpose of the supposed therapy.
  1. Of even more concern, in a conversation with Relator Thorpe, Dr. Sanford, a psychiatrist married to key opinion leader Dr. Marciniak, revealed that the patient who died was in fact being treated for bipolar I disorder.
  1. Clearly, when combined with the lack of recommended dosage, the off-label use of Lamictal made for a recklessly dangerous combination for patients resulting in severe rashes, including Stevens Johnson Syndrome, and even death.
  1. GSK Targeted Federal Health Care Programs for Off-Label Use
  1. GSK’s off-label marketing tactics also helped put their products on Tricare/Champus formularies for uses not approved by the FDA.
  1. For example, GSK focused on psychiatrist Dr. James Polo because of his position at Evans Army Hospital, Fort Carson, Colorado. As a result of the persistence of GSK, Lamictal was actually placed on formulary for treatment of bipolar disorders prior to receiving such an indication.
  1. GSK began seriously attempting to influence Dr. Polo in the late 1990’s by making arrangements for and paying for all of the food and liquor at the annual Colorado Spring Psychiatric Association Christmas party at Dr. Polo’s home, with 60-70 physicians in attendance.
  1. A simple review of just a few GSK contact reports in 2001 and 2002 clearly indicates that GSK sales representatives “detailed” Dr. Polo to enlist his aid in placing Lamictal on the Tricare/Champus formulary at Fort Carson for use in the treatment of bipolar disorders:
  • 4/23/02 Dr. James Polo detailed on Lamictal and Wellbutrin, invited to GSK speakers program, ‘he saw the green journal and asked if on lamictal on formulary, he said yes but for neurology only; he will champion it for p.t.’
  • 5/20/02 Dr. James Polo detailed on Lamictal with note ‘he was not attending the Tricare meeting this week, wsr for pts. w depression and concentration difficulties, lamictal is now a favorite of his and uses it in adol with bi-polar.’
  • 7/15/02 Dr. James Polo detailed on Lamictal and reported that ‘Lamictal is no longer restricted to neurology’ meaning it was now available on the Tricare formulary.
  • 07/24/02 Dr. James Polo detailed on Wellbutrin and Lamictal and reported “Lamictal free for all psyches.’
  1. As evidence of the success of the GSK engineered approval of Lamictal for use as a psychiatric treatment on the Fort Carson Tricare formulary, Dr. Kenneth Gamblin, a high volume Medicaid psychiatrist was told, (according to the July 17, 2002 GSK contact report) about availability of Lamictal on the Tricare formulary. Subsequently, according to the aforementioned contact report, he ‘…has started several new pts.’
  1. Upon information and belief, GSK targeted other high volume federal healthcare providers for off-label use of Lamictal and by the second quarter of 2007, Lamictal held a 14.1% share of the Medicaid market.”

 

Antidepressant-induced Mania

It is generally recognized in antipsychiatry circles that antidepressant drugs induce manic or hypomanic episodes in some of the individuals who take them.  Psychiatry’s usual response to this is to assert that the individual must have had an underlying latent bipolar disorder that has “emerged” in response to the improvement in mood.

The problem with such a notion is that it is fundamentally unverifiable.  Psychiatry defines “bipolar disorder” by the presence of certain behaviors and feelings.  If a person meets these criteria, he/she is said to have bipolar disorder.  What immediately needs to be noted is that bipolar disorder, in common with psychiatry’s other “disorders” has no explanatory value.  To illustrate this, consider the following hypothetical conversation.

Parent:  Why does my son behave in these extreme ways?
Psychiatrists:  Because he has bipolar disorder.
Parent:  How do you know he has bipolar disorder?
Psychiatrist:  Because he behaves in these extreme ways.

The only evidence for the illness is the very behavior that it claims to explain.

As spurious as this is from a logical point of view, the notion of a latent bipolar disorder is even worse.

Why did my son become manic after starting on antidepressant drugs?
Because he had a latent bipolar disorder.
How do you know he had a latent bipolar disorder?
Because he became manic.

What psychiatry is doing here is applying their spurious explanation retrospectively Before the individual showed any signs of mania, he must have had bipolar disorder because he became manic at a later date.  But nobody could ever have verified that hypothesis, because the occurrence of a manic or hypomanic episode is the primary criterion for such a “diagnosis”.

Although the “latent bipolar disorder” is psychiatry’s usual explanation for these episodes, one occasionally encounters acknowledgement that the antidepressant was the primary causative factor, and in practice, the two conflicting theories exist side by side.

  1. The manic/hypomanic episode was caused by the antidepressant drugs.
  2. The episode was caused by the underlying latent bipolar disorder.

Theory 2 is more popular in psychiatric practice, and is routinely told to those clients who experience this kind of mood switching.  Up till now it has been difficult to challenge theory 2, because it is essentially unassailable.  One can’t prove or disprove the existence of something that is inherently latent.

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

But recently some evidence has been published that favors theory 1:  that the manic/hypomanic episodes stem primarily from the antidepressant drugs.  In November 2013, Psychiatric Times published an article by Ross Baldessarini, MD, a Harvard psychiatrist, et al titled ‘Switching’ of Mood From Depression to Mania With Antidepressants.  

The article reports on, and discusses the implications of, a meta-analysis conducted by the same authors (Antidepressant-associated mood-switching and transition from unipolar major depression to bipolar disorder: A review, Baldessarini RJ, et al, Journal of Affective Disorders, May 2013).  Here’s the opening paragraph of the Psychiatric Times article.

“Bipolar disorder often presents initially with one or more episodes of major depression, and an episode of mania or hypomania may first occur during treatment with an antidepressant, stimulant, or other agent with mood-elevating effects. Such ‘switching’ of mood into mania, a mixed-state, or psychosis can be dangerous. This switching is particularly prevalent among juveniles and young adults exposed to treatment with an antidepressant or stimulant for a depressive, anxiety, or attention disorder. Such pathological shifts of mood and behavior may represent adverse drug actions or a manifestation of undiagnosed bipolar disorder.”

The authors go on to state that they had reviewed available research on two topics:  a) antidepressant-associated mood switching; b) changes of diagnosis from unipolar depression to bipolar disorder.

They identified 51 studies involving nearly 100,000 individuals who had been diagnosed with major depressive disorder (MDD) without a history of mania or hypomania, and who had been treated with an antidepressant.  They found that mood switching (i.e. to mania or hypomania) occurred in 8.2% of participants within an average of 2.4 years of antidepressant use, or 3.4% per year.  (The rate of mood switching was 4.3 times greater among juveniles than among adults.)

The authors also reviewed 12 other studies in which individuals who were initially considered to have unipolar depression (MDD),  were assigned a new diagnosis of bipolar disorder because of the occurrence of spontaneous (i.e. no antidepressant associated) mania or hypomania.  These switches occurred in 3.3% of the individuals studied within 5.4 years, i.e. 0.6% per year.

So, manic or hypomanic episodes were 5.6 (3.4 ÷ 0.6) times more likely per year for people diagnosed with MDD who were taking antidepressants than for people with the same diagnosis who were not taking these drugs.

The authors’ comments on this difference in the Psychiatric Times article are interesting:

“A particularly intriguing finding was the large apparent excess of antidepressant-associated switching over reported spontaneous diagnostic changes to bipolar disorder. This raises questions about the diagnostic, prognostic, and therapeutic implications of antidepressant-associated reactions.”

“If the relatively low rates of new bipolar diagnoses are not due to under-reporting, their marked difference from rates of antidepressant-associated mood switching leaves open the possibility that direct pharmacological, mood-elevating actions of antidepressants may be involved in mood switching, in addition to hypothesized “uncovering” or perhaps even “causing” of bipolar disorder. Of particular concern is that these ambiguous possibilities leave specifically uncertain the potential value of long-term treatment with antimanic or putative mood-stabilizing agents.”

In the Journal of Affective Disorders article, they also state:

“An important, unresolved question is of the significance of AD-associated mood-switching. Two plausible possibilities are:  [a] responses reflecting the presence of BPD, or [b] a direct pharmacological effect of mood-elevating treatments that may be transient, relatively rapidly reversible, and not followed by a change in diagnosis…The several-fold higher proportion of patients with mood-switches among unipolar MDD patients than the rate of later re-diagnoses of BPD is consistent with the possibility that some AD-associated mood-switches may represent pharmacologic reactions (AD-induced mania).  It is also likely that AD-associated risk will be greater than spontaneous mood-elevations regardless of cause. It is important to note that the reported rates of re-diagnosis to BPD may be somewhat overestimated if some cases involve drug-related mood-elevation and not only spontaneous mania–hypomania. That is the ratio of AD-associated mood-elevations to new diagnoses of BPD may actually be even higher than we found.” [Emphasis added]

What the authors are pointing out here is that antidepressants are clearly implicated in the “excess” incidents of mania/hypomania, and they have even raised the question of a direct causal link.

Their brief reference to “diagnostic…implications” isn’t entirely clear, but is, I think, a challenge to the DSM-5 decision to allow these kinds of antidepressant-induced manic episodes to count towards a “diagnosis of bipolar disorder.”

In DSM-IV, incidents of this kind were excluded:

Note:  Manic-like episodes that are clearly caused by somatic antidepressant treatment (e.g., medication, electroconvulsive therapy, light therapy) should not count toward a diagnosis of Bipolar I Disorder.”  (p 332) [Emphasis added]

But in DSM-5, this has been changed to:

Note:  A full manic episode that emerges during antidepressant treatment (e.g., medication, electroconvulsive therapy) but persists at a fully syndromal level beyond the physiological effect of that treatment is sufficient evidence for a manic episode and therefore, a bipolar I diagnosis. (p. 124) [Emphasis added]

So under DSM-5, the possibility that the mania was caused by the antidepressant has been eliminated in favor of the popular psychiatric notion that it “emerged” during the antidepressant use, and the manic episode can be adduced to support a “diagnosis of bipolar disorder.”  This is psychiatric spin of a very advanced order:  eliminating the DSM-IV admission that the drugs have the potential to inflict this kind of damage, while at the same time expanding the concept of bipolar disorder, which is good for business.

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

But, here come Dr. Baldessarini et al collating and publishing research, some of which, incidentally, has been around since the late 60’s/early 70’s, clearly establishing a large excess of manic episodes among people taking antidepressant drugs.  And, notably, they have taken the additional step of writing up their findings in Psychiatric Times, a medical trade publication written for “psychiatrists and allied mental health professionals who treat mental disorders”, with a circulation of 40,000.

And, perhaps most significant of all, is Dr. Baldessarini et al’s reference to “prognostic and therapeutic implications.”

“Indeed, it is not even proved that drugs considered to be mood-stabilizing are highly protective against antidepressant-associated mood switching, although such protection is widely assumed.  Moreover, there is very limited evidence that prolonged antidepressant treatment provides substantial protection against recurrences of bipolar depression and that it might contribute to emotional instability or rapid cycling.”

In other words, in cases where antidepressant-associated manic episodes have occurred, continued use of antidepressants “might contribute” to instability and rapid cycling, i.e., recurrent manic episodes.

. . . . . . . . . . . . . . . . 

There has been an increasing recognition on this side of the debate that the so-called antidepressant drugs precipitate manic, and even violent, reactions, in some of the individuals who take them.  There has even been speculation that use of these products is linked to the much-publicized incidents of murder-suicide in recent years.  Brian, at AntiDepAware, has amassed a great deal of anecdotal, but compelling, information on this issue.  Joseph Glenmullen, MD, a psychiatrist, has discussed antidepressant-linked mood switching in his book Prozac Backlash  (2000).  He describes several cases from his practice, including individuals who became floridly psychotic, sometimes with graphically violent themes , after taking SSRI’s.

Psychiatry has resisted suggestions to conduct a definitive study on this matter, relying instead on repeated dogmatic assertions that the “meds” are wholesome and necessary, and that the incidents are the result of “untreated mental illness.”

But the Baldessarini et al study and, incidentally, an earlier Offidani et al study of which Dr. Baldessarini was a co-author, represent a major assault on that notion.  Tragically neither article appears to have attracted much attention in the psychiatric field, where antidepressants are still being prescribed routinely as front line “treatment” for depression and various other “disorders”, and no major alert with regards to mood-switching has been issued..  I have no inside information on this matter, but it occurs to me that Dr. Baldessarini et al have written the Psychiatric Times piece in an attempt to disrupt this complacency, and to generate some recognition among their colleagues of the enormous implications of antidepressant-induced manic episodes.  But perhaps their efforts have been in vain.  It is now 14 months since the publication of the Psychiatric Times piece, and 19 months since the original journal article, but no major change in psychiatric prescribing is evident, and psychiatrists are still telling victims of this effect that they must have had an “underlying bipolar disorder”, that the drug has activated.  As I’ve said many times, psychiatry does not take kindly to criticism.  And this appears to be true even when the criticism is from one of their own.

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

Disclaimer:  In writing this post I have used terms like “bipolar disorder”, “major depressive disorder”, etc., in order to describe the journal articles being reviewed.  This was simply a reflection of the fact that the authors had used these terms, and should not be read as an indication of any endorsement on my part of the validity or usefulness of these terms.  Indeed, it is the central tenet of this site that the so-called psychiatric diagnoses have neither explanatory nor predictive validity, and are destructive, disempowering, and stigmatizing.

Life Is Bipolar

This post was submitted by a reader.

 

I am a 30 year man who finally realized a few months ago (after finding this website) that he is not mentally ill but just an adult who often acts like a child. I dabbled with some “official” drugs (meaning prescribed) in the last few years when I was first diagnosed  with depression (was put on anti deps + anti anxiety pills) and then bipolar a year later (this time it was mood stabilizers and sleeping pills).

Before that I went to the occasional therapy session when I hit some intense lowpoints but always told them that I refuse to take their drugs and usually never returned for a second visit. But throughout the years it seems my problems went from bad to worse and a few times I’ve even been on the edge of ending it all or at least wanting to not endure this suffering any longer. I also could never really afford the expensive doctors but after telling my parents what’s been going on, they agreed to pay for whatever is needed.

I also tried alternative paths like yoga, zen, veganism, raw veganism, and of course the other extreme of sex drugs and rock n roll but none of that seemed to help at all except shallowly and temporarily. It seemed that my underlying condition was something for which there was no cure. Existence itself was the disease. Or so it felt.

So in autumn 2012 I finally gave in and took the pills.

I also tried cognitive behavioral therapy after the depression diagnosis but I didn’t really like the therapist because he was spending too much time thinking and I didn’t want to pay for that.  It was just frustrating. I thought that I can do this on my own (as I had always in the past).

I felt terrible taking the pills. I was tired and had these strange anxiety symptoms when just walking on the street e.g. I felt like my jaw was suddenly locked or that my motor skills were somehow compromised. I even took anxiety medicine before going to a party to be calm. When one time I took the whole prescription with after drinking a bottle of gin, I blacked out on my floor for the next 24 hours. The doctor refused to give me more of them after I told her about that. I didn’t want them anyways as I knew I wanted to stop all of these pills.

Which I did. Against my doctors orders. I told her that I felt better and dont need them anymore so I slowly weaned myself off them and started the year of 2013 clean and quit seeing the shrinks. Although I now know I was right that I didn’t need them it turns out that my issues were far from gone. So fast forward 10 months and I’m back at the doctors office. This time the diagnosis is bipolar which for some reason didn’t fit my symptoms the previous time (a year earlier).

(I had also undergone a psychiatric evaluation earlier that year (spring 2012) where they thought I was bipolar but because apparently I didn’t fit the description, they just gave me nothing at all and told me to find a cognitive therapist. I moved to another country so I didn’t pursue this until the depression diagnosis mentioned above).

So autumn 2013. I was in a new relationship and it seemed that my issues were coming to the fore again, not that they ever really went away. The depressive episodes were bad and my girlfriend urged me to call the psychiatist I saw a year earlier. She wasn’t available but her colleague was who prescribed me the mood stabilizers “Lamictal” for bipolar (she even said I should’ve been diagnosed bipolar earlier). I started them but because they had zero affect, after about 3 months, I quit them. During this time I again saw a therapist (neuropsychologist) but I didn’t really like her style especially after learning about the behavioral approach here. I told her that this mentall illness stuff is totally spurious to which she seemed very confused. So I ended that also. I sent them both a kind email at the end of the year about my disbelief in their position (ie. the notion of mental “illness) so it was sayonara once again to the psych-pharma industry.

The big revelation for me was when I found an article on this site called “Bipolar is not an illness”, which I read sometime in november 2013. It seemed like a light switch flicked on in my mind. I realized this whole psychiatry mental illness stuff is complete nonsense. It’s also a business where it’s practitioners seem to be as blinded as the customers. And the drugs dont even work for me! I know they might make some people feel better… After reading the many comments on the various articles on this site I realized that I am in control of my behavior and I must take responsibility. The symptoms associated with the diagnosis are just human problems that I can tackle individually. At least so I hope. Besides if there is a cluster of symptoms which fit my predicament best, it is Borderline Personality Disorder. Again, these are also just human problems but
the doctors wrote that one off for some reason…

This was just before last christmas after which I haven’t been on any drugs or gone to therapy. I still have problems but I am dealing with them as I would deal with other problems. A few times I’ve made the mistake of over estimating a revelation only to find out that another depressive episode is happening once again and my not so developed coping skills are challenged. It’s not easy I admit to get out of these but somehow I do. I just can’t help but think there is an existential crisis lurking around the corner that I am distracting myself from. I am still a little apprehenisive about the question of who is in control of this thing called “me”.

I also quit smoking and drinking and coffee in the new year and plan to keep it that way. I intend to get on top of my bad habits this year. Every month I will tackle on a few new challenges to exercise my willpower and self-discipline to get back on track in life. But I am ultimately responsible for my actions.  I ordered a few books on Dialectical Behavioral Therapy (a workbook + journal) which I look forward to beginning.  Any experiences with those? Other suggestions and feedback is also welcome.

All this time I was right about one thing.  There is no cure for existence (besides death of course…) which includes highs and lows. Nor should there be as that is what makes life interesting. Yet I do want to be happy which is not easy for such a highly sensitive, extremely self-critical person such as myself.

The universe is bipolar.  There is no fixed personality. There are no absolute labels to describe because we are capable of so much change if we want.

I fully support the dessimation of the whole psychiatric industry.

Thanks for reading. Have a nice day.

In friendship,

Anon

Mental Health After Newtown

On March 5, 2013, a bipartisan panel of leading mental health experts and parents of children with “mental disorders” held a conversation (that’s newspeak for meeting) in Washington D.C. on the topic: Violence and Severe Mental Illness.

The invited panelists were:

Thomas Insel, MD, Director of NIMH
Harold Koplewicz, MD, President of Child Mind Institute
E. Fuller Torrey, MD, Founder of Treatment Advocacy Center
Michael Welner, MD, Founder and Chairman of The Forensic Panel
Michael Fitzpatrick, MSW, Director of NAMI
And three parents of “diagnosed” children

 The panelists were asked to consider the following questions:

1.  In what ways is mental illness more – or less – treatable than other serious medical conditions?
2. What are the greatest obstacles to seeking treatment for individuals suffering from mental illness and their families?
3.  Among individuals with untreated and severe mental illness, when, if at all, is violence – directed at the self or others – most likely?
4.  What is the record of federal, state, and local programs geared towards improving health outcomes among individuals with severe mental illness?
5.  What are the most effective federal, state, and local programs for prevention and early detection of severe mental illness in children and young adults?
6.  How can federal programs be improved to reduce barriers to access and improve outcomes for individuals with severe mental illness?

Often the questions one asks determine the kind of answers that one will receive.  In my opinion, it is pretty clear where these questions are going: – more drugs and more involuntary “treatment” for more troubled teens.

After the conversation, the panel issued a statement, which contains some interesting quotes:

 “…this subcommittee is working to identify precisely what federal resources — in support of both research and care — are being devoted to those among the mentally ill who are most prone to violence: the severely mentally ill who are not being treated,”

Note the assumption: that the “mental illness” individuals who are most prone to violence are the “seriously mentally ill who are not being treated.”  They formed this panel presumably to enquire open-mindedly into these matters – but after just a few hours’ meeting (sorry, conversation) on day one, they’ve already got it all figured out:  it’s the ones who are slipping the net who are the violent ones.  And by “seriously mentally ill,” they mean “schizophrenic, bipolar, and depressed.”

So the name of the game is:  identify those individuals who might someday become violent, and get them drugged up.  Then we can all relax.

Amazingly, no mention was made of the fact that SSRI antidepressants have been linked to episodes of serious violence, including homicides.

Another quote:

“…we must confront the realities of severe mental illness and the connection to violence. We must also learn about the barriers and challenges facing parents who are trying to take care of someone who has a severe mental illness.”

What they mean by “barriers and challenges” is the fact that since deinstitutionalization, it is difficult to get someone, particularly a child, into a state hospital.

Another quote:

“The subcommittee’s forum is part of an ongoing review…into whether federal dollars devoted to mental health are reaching those individuals with the most serious mental illnesses and to ensure the most effective treatments are available to them.”

The issue here is that the mental health centers still offer some psychosocial services, such as counseling, case management, social skills training, etc…  Many of these services have been supplanted by drug administration in recent decades.  The agenda here is to accelerate this process.

The MDs on the panel are an interesting group.  Three are ardent supporters of  the brain disease theory and the pharmaceutical psychiatry.

Dr. Insel is Director of NIMH, and made his reputation in psychiatry by promoting SSRI’s!  Read more here.

Dr. Harold Koplewicz is described by Wikipedia as a “…pediatric psychopharmacologist and biological psychiatrist known…for his often-controversial advocacy of the increased use of psychotropic drugs for children diagnosed with ADHD and other mental health issues.”

Dr. Torrey is a psychiatrist and schizophrenia researcher.  He is executive director and founder of the Treatment Advocacy Center whose stated goal (per Wikipedia) is the elimination of “legal and clinical obstacles to the treatment of severe mental illness.”  He has been outspokenly critical of deinstitutionalization and is in favor of involuntary drugging of people diagnosed with “mental illness.”

Dr. Welner is a forensic psychiatrist who has provided testimony in many high-profile cases involving criminal violence.  He does not appear to be a staunch brain disease supporter.  For instance, here’s a quote he gave to the Huffington Post:

“Mass killers can be men who “are painfully aware of themselves as social and sexual rejects in a society that values social desirability”.”

Wow! A psychiatrist who sees a person as a person and not just a broken brain.

The fifth professional on the panel is Michael Fitzpatrick, Director of NAMI.  NAMI’s website has a brief biography which states that he “…held senior management positions in state government, in nonprofit agencies in both the mental health and primary health sectors and in the private sector where he developed successful education, employment, housing, outreach and rehabilitation programs.”  This certainly sounds pretty good.  But I have never known NAMI to be anything other than a mouthpiece for Big Pharma, from whom they receive substantial funding.  Whether Mr. Fitzpatrick can impact the panel in anything other than a more-screening-more-drugs direction remains to be seen.

It looks to me that what we have here is a government-sponsored enquiry with a stacked deck.  I predict the following “findings:”

1.  We need more pediatric psychiatrists.
2.  We need regular mandatory screening of all school-children for “mental illness.”
3.  We  need to make it easier to commit people, especially children, to psychiatric hospitals.
4.  We need to have mandatory injections for individuals who won’t take drugs orally.
5.  We need to divert mental health funds that are being used in psycho-social areas to drug “treatment.”

Meanwhile, the petition to the White House to investigate the link between SSRI’s and violence has disappeared.  Vanished!  You might wonder why.

Here’s a clue.  The pharmaceutical industry spends more money lobbying Washington politicians than any other industry

There are no mental illnesses.  It’s a house of cards – a great ploy to medicalize every human problem and to sell drugs.  And it has been phenomenally successful.

So let’s keep busy.  Read about the SSRI-violence petition here and here.  Write to politicians.  It’s a relatively small research question.  What proportion of people who commit mass murder had been taking SSRI’s or other drugs that increase the availability of serotonin or dopamine in the brain?

Childhood Bipolar Disorder

Prior to about 1994, childhood bipolar disorder was virtually unheard of.  DSM-III-R (1987), in the section on manic episode, states, “…studies indicate that the mean age at onset is in the early 20s.  However…a sizable number of new cases appear after age 50.”(p 216)  Of course a mean age of onset in the early 20’s could include young children.  The section on major depressive episode, however, contains the following:  “The average age of onset is in the late 20s, but a major depressive episode may begin at any age, including infancy.” (p 220)

If, in fact, the APA envisaged the possibility of bipolar disorder occurring in infancy, wouldn’t they have included some similar phrase in the mania section?

DSM-IV (1994) confirms the mean age of onset in the early 20s, but extends the range downward to “adolescence.”  There is no indication of this condition in younger children.

In 1994, Joseph Biederman, a Harvard psychiatrist, began to promote the concept of childhood bipolar disorder.  In this he was ably abetted by the pharmaceutical industry, with which he was financially entangled to a degree that destroys any semblance of credibility.  Biederman’s financial conflicts were exposed by Sen. Charles Grassley, who has long pushed for complete disclosure in this area.  The NY Times did a very interesting article on the subject, the first paragraph of which reads as follows:

“A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given Congressional investigators.”

The complete article is well worth a look.

Some psychiatrists were alarmed by this development, and spoke out, but the majority (of course) played along.  After all, business is business.

Between 1994 and 2003, there was a 40-fold increase in the number of American children who received this “diagnosis.”  I haven’t been able to find more recent figures, but my impression is that it continues to rise.

Almost without exception, the presenting problem in these children is severe misbehavior and temper tantrums, secondary to ineffective parenting.

The “treatment” consists of drugs: anti-psychotics, anti-convulsants, and lithium carbonate.  The side-effects of these drugs in adults are listed below:

Major Tranquilizers

  • neuroleptic malignant syndrome (potentially fatal)
  • fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
  • tardive dyskinesia (an irreversible condition involving severely disfiguring and uncontrollable movements, especially constant chewing/grinding movements of the jaws accompanied by tongue protrusion)
  • drooling, tremor (uncontrolled shaking);
  • seizure (convulsions);
  • flu-like symptoms;
  • trouble swallowing;
  • penis erection that is painful or lasts 4 hours or longer.

Anti-convulsants

  • liver damage
  • birth defects in offspring (e.g., spina bifida)
  • pancreatitis

Lithium Carbonate

  • kidney damage
  • birth defects in offspring
  • tiredness
  • uncontrollable shaking
  • muscle weakness, stiffness, twitching
  • excessive thirst
  • frequent urination
  • seizures

The side effects in young children, whose organs are still developing, are unknown.  Tardive dyskinesia should cause particular concern, in that in the initial stages it is masked by the major tranquilizers, and so is usually quite advanced by the time it is detected.  The condition is irreversible.

The recent “epidemic” of childhood bipolar disorder is just the most recent example of disease-mongering by psychiatrists, but it is somewhat egregious, in that it involves exposing children as young as two years to extraordinarily dangerous drugs.  Even the APA, not noted for restraint in this general area, has expressed some concerns, and there have been indications that DSM-5 will caution against excessive use of this so-called diagnosis.  But don’t get too excited.  The word is that the revision, due out later this year, will simply offer suggestions for alternative “diagnoses.”  My guess is that the drug prescriptions, however, will continue unabated – or even increase.

The reason that psychiatrists can expand the scope of their diagnostic categories with such ease is that the diagnostic concepts have no validity in the first place.  Wood doesn’t become stone just because we say so. And ordinary problems of life don’t become illnesses just because financially-motivated psychiatrists say so.  Childhood temper tantrums are nothing more than childhood temper tantrums.  Re-defining these as symptoms of an illness is arbitrary, unwarranted and unproven.  For the past sixty years, the primary agenda of American psychiatry has been the medicalization of ordinary human problems in order to legitimize the administration of drugs.

The concept of mental illness is nonsense – but in the hands of psychiatrists, it is dangerous and destructive nonsense.

The psychiatrists, of course, say that they are trying to alleviate the previously unrecognized suffering of these children and their families, and that the dovetailing of their selfless devotion with their own financial interests is purely incidental.

But in fact, labeling children as bipolar and prescribing drugs as a substitute for learning to cope is simply one more step in psychiatry’s endless process of disempowerment.  The message they give to these families and to these children is – you can’t cope.  Come to us you huddled, helpless masses, and we will drug you – for money.

Diagnosis

I am writing this post as a response to a comment posted by medical blog in my previous post, More on So-called Bipolar Disorder.

In the summer of 2001 I became very ill.  The symptoms were exhaustion and mild nosebleeds. I went to three different practitioners, but they all were dismissive of my concerns, assured me that I was in good health, and sent me on my way.   On August 8th of that year I was admitted to the hospital in Greeley, Colorado with complete kidney failure.  The nephrologist at the hospital gave me the diagnosis that had eluded the earlier doctors:  Wegener’s Granulomatosis – a rare autoimmune disease that attacks lungs, kidneys, and airways. I have been on dialysis every since.

The reason I tell this story is to illustrate the meaning and significance of a medical diagnosis. In my case there were certain signs and symptoms.  For instance, I told the doctors that I was tired and that this was not characteristic of me.  I told them of the nosebleeds.  And they could see that I was dragging.  By the time I got to the second doctor, I was also vomiting and having difficulty sleeping.

Now the point is that until I got to the hospital in Greeley, there had been no diagnosis.  One doctor said:  “maybe you’ve got the flu?”  But it didn’t feel like flu, and this tentative diagnosis wasn’t very convincing.

When we ask for a diagnosis we are asking for an explanation.  So if you‘re very tired and you’re spitting up dreadful-looking phlegm, a doctor might diagnose pneumonia and would be able to substantiate this diagnosis through observation and lab tests.  And – and this is critical – he would be able to show a clear causal link between the pathology and the symptoms.

In my case, the diagnosis of Wegener’s Granulomatosis explained the exhaustion (increased toxicity due to kidney failure) and the nosebleeds (Wegener’s Granulomatosis is believed to be triggered by an airborne pathogen and so the immune system becomes particularly active in this area).

The key is explanation. A good diagnosis pinpoints the pathology, explains the symptoms, and directs treatment.  This is the model that has lifted Western medicine out of the charlatanistic quackery that predominated prior to about 1880.  Modern medicine is remarkably successful precisely because it is based on an understanding of the pathology involved.  Now obviously, as in my case, it sometimes isn’t easy to make a diagnosis, but in the vast majority of cases, people seeking medical help receive an accurate diagnosis early in the process, and this diagnosis guides and directs treatment, usually with a good deal of success.

Now let’s consider the so-called mental health diagnoses.  Take the condition known as Attention Deficit Hyperactivity Disorder.  The American Psychiatric Association says that this is a mental illness. In other words, ADHD is a diagnosis.  And they list the symptoms of this diagnosis.  I have reproduced these so-called symptoms in an earlier post, and it’s not necessary to reproduce them here, but here are three fairly typical items from the list:

  • often avoids, dislikes or is reluctant to engage in tasks that require sustained mental effort (such as schoolwork or homework)
  • often leaves seat in classroom or in other situations in which remaining seated is expected.
  • often runs about or climbs excessively in situations in which it is inappropriate…

Now what the APA have done is this:  they have asserted that these are the symptoms of the mental illness that they call ADHD.  Now if this means anything, it should mean that ADHD is the explanation of these misbehaviors.  And this is precisely how the so-called diagnosis is used in practice.  When a parent asks why his child is so unruly and undisciplined, the reply he is given is:  because he has ADHD.  The putative mental illness is routinely proffered as the explanation – as the underlying pathology which explains why the child is so misbehaved.

But in fact if one examines the matter further, one finds no substance to this so-called diagnosis.  ADHD is nothing more than a name for this kind of misbehavior.  The acid test here is the question:  how do you know he has ADHD?  And the only possible answer is:  because he is so unruly and undisciplined.  The only evidence for the so-called diagnosis is the very behavior it is supposed to explain.

Real diagnoses involve real pathology that one can identify, test for, and hopefully ameliorate.  Wegener’s Granulomatosis, for instance is a real disease.  And it is recognized as a diagnosis today because Dr. Wegener, a research pathologist working in Germany in the 1930’s, noticed certain microscopic anomalies in corpses he was dissecting.  He began to tie these anomalies with symptoms observed before the individuals had died.  His work was interrupted by the war, but after the war he refined his observations, and the diagnosis was firmly established.  At first there was no treatment for WG – it was effectively a death sentence – but gradually drugs became available, and today the disease is eminently treatable, though because of its rarity, the diagnosis is often missed (as in my case).

In contrast, consider the so-called diagnosis ADHD.  Prior to 1950 this diagnosis did not exist.  Today it is deeply embedded in psychiatric practice, and indeed in our collective consciousness.  This change occurred – not because of a discovery – but because an APA committee decided that ADHD is an illness.  As preposterous as this sounds, it is exactly what has happened.  In the six decades from 1950 to the present, the primary business of the APA has been redefining the ordinary everyday problems of living (that our ancestors tackled using ordinary time-worn tactics) as mental illnesses.  And this has been done in collaboration with the pharmaceutical companies for one reason:  profit – the selling of prescription slips and the selling of drugs.  Psychiatry has degenerated into nothing more than drug-pushing.  And the process of pathologizing normal problems of living continues.  The much-heralded DSM-5 promises even further inroads in this direction.

The fundamental problem with the APA’s approach emerges from their definition of a mental disorder:

… a clinically significant behavioral or psychological syndrome or pattern that occurs in an individual and that is associated with present distress…or disability…or with a significantly increased risk of suffering death, pain, disability or an important loss of freedom.  (DSM-IV-TR, p xxxi)

If you examine this definition carefully, it is clear that it means nothing more than:  any significant human problem.

It’s a castle built from sand.  The logic is as follows:

  • Any human problem is a mental disorder.
  • X is a human problem
  • Therefore X is a mental disorder!

As facile and ridiculous as this sounds, it is exactly what has happened.  The simple assertion that childhood misbehavior is a mental illness explains nothing.  It is simply a device used to legitimize drugging these children.

And the real causes underlying these problems are never even pursued.  Parents are off the hook; the school is off the hook; the community is off the hook. And the cash registers at the pharmacy go ker-chung.

And similar considerations apply to all the other DSM creations.  Depression is not an illness.  It is a feeling we get in response to a major loss or when things are not going well for us.  It has been pathologized by the APA and the pharmaceutical companies for gain.  The so-called bipolar disorder is not an illness – it is largely rudeness and irresponsible behavior – again pathologized for gain.

It is said that the drugs work, so why quibble?  Well the simple answer is that they don’t work nearly as well as the psychiatric hype would have us believe.  But this post is already too long; perhaps we can pursue this another time.

Once again, apologies to my regular readers for the repetition.  Medical blog, if you’re still reading, I can appreciate how a medic, schooled in the rigors of scientific research, might view all this with a measure of skepticism.  It’s a great deal easier to dismiss me as a crank than to face the alternative:  that modern psychiatry is an enormous hoax which is draining dollars from genuinely needed services and undermining notions of self-help and personal responsibility that are keystones of a thriving society.  Please feel free to come back on any of these issues.  It’s not just a question of trying “harder and smarter.”  Some of the problems that confront people are truly overwhelming and require outside help.  But they are not illnesses and the help needed is not drugs.

 

 

More on So-called Bipolar Disorder

A few days ago, I received the following email:

Hi Phil,

I would like to hear from you how we can survive the bipolar disorder, as I understand bipolar is a very serious disease.

Regards,

[Name]

The question seems important enough to warrant a more public response, though I have omitted the writer’s name to safeguard confidentiality.

So here’s my reply.

Firstly, the condition known as “bipolar disorder” is emphatically NOT a disease.  Rather, it is a loose cluster of behaviors which psychiatrists – in concert with the pharmaceutical companies – have called an illness with the purpose of selling drugs.

The DSM criteria for this so-called diagnosis are set out in my earlier post on this subject.

In practice, the behaviors likely to attract a “diagnosis” of bipolar are:

  • Hyperactivity of any kind for an extended period
  • Marked irritability; grouchiness; snapping at family, co-workers, etc.
  • Marked boastfulness; expressions of grandiosity
  • Pronounced sleeplessness
  • Excessive talk; rapid shifting from topic to topic
  • Temper tantrums
  • Behavior that would normally be called “irresponsible,” e.g. sexually reckless activity; buying sprees; gambling; risky ventures; etc.

Traditional psychiatry says that if you’re functioning in this fashion, you have an illness called “bipolar disorder.”  The formal criteria call for a certain number of behaviors within certain time frames.  Also, a measure of oscillation is required – i.e. the “symptoms” abate periodically, then resurge.  And so on.  In practice, any of the behaviors listed above will attract this “diagnosis.”  And the “treatment,” of course, is: drugs.  Usually lithium carbonate – but in the past decade or so other drugs are being used to impact these behaviors.  Especially worrying in this regard is the prescription of these drugs to very young children to treat tempter tantrums.  (I am aware that temper tantrums as such are not included in the DSM criteria list, but over the past decade or two, proneness to temper tantrums has been conceptualized as “mood swings,” and has become a kind of backdoor feature of this so-called mental illness.)

But, back to the question in the email.  What should one do?

Well the answer, of course, depends on what kind of problem behavior we are talking about.

Let’s say that the problem behavior is irritability and temper tantrums.

The first requirement is to describe the problem clearly and completely.  “Temper tantrum” can mean different things – everything from stomping one’s foot and saying “drat,” to throwing the furniture out the window.  So if a person feels that he/she has problems with anger control, the first thing is to write down exactly what kind of behaviors are occurring and with what frequency (Daily? Weekly? Monthly? etc..)

Duration is important.  Has it been going on for years or just in the past few days?

Context is also critical.  Where does the problem behavior occur?  At home?  Work?  When visiting in-laws? etc..  Or perhaps everywhere?

And triggers.  What kind of situations seem to “trigger” the anger response?  Other people’s driving?  People talking on cell phones?  Outbursts of anger usually occur when we feel frustrated or attacked.  Frustration arises when we are trying to do something but can’t manage to do it.  And attacks may be real or imaginary.

And substance abuse.  Is there a problem with alcohol or other drugs?

And so on.  The point being that a simple phrase like “temper tantrums’ or “bipolar disorder” tells us nothing.  What’s needed is a detailed written statement of the problem.

I do not know the enquirer personally, so it would not be proper for me to give him/her specific advice.  And I don’t know if temper tantrums is the issue or what – but the point is this:  specify the problem as honestly as possible and with as much detail as possible.

Often at this point the solutions start to suggest themselves.  For instance, if a person is routinely throwing temper tantrums when the car breaks down, then maybe it’s time to get some repairs done or get a new car – or even just decide to get stoical about it – try to let it wash over one.

The point here is that finding solutions to behavioral problems is not quantum physics – usually if one has done a thorough and honest job identifying the problem, then the solutions are forthcoming.

In this regard it is often helpful to break problems down into components and tackle them one at a time.  Or to set intermediate goals.  A person who identified over-talkativeness as a problem might initially aim to sit silent for one minute, then two, and so on.

I have mentioned elsewhere in this blog the importance – indeed I would say the necessity – of having at least one good friend – someone with whom one can be completely honest.  Often the kinds of problems we are talking about here benefit from a second perspective.  Other people often see us more accurately than we see ourselves.  A best friend can be a spouse, a brother, sister, or just the guy who lives next door.  The point is that if I have a significant behavioral problem and if I genuinely want to change this, then asking for help is clearly a positive step.

Some other pointers:

  • Try to find and pursue an activity that is incompatible with the target activity.  For instance if you feel a temper tantrum coming on, start singing or whistling.  It’s difficult to have a temper tantrum while singing a happy tune.
  • Acknowledge successes. If you had been having daily temper tantrums and you’ve got it down to one per week – that’s great – acknowledge the gain, but keep working.
  • Avoid triggers as much as possible.  If a person finds that he has temper tantrums whenever the dog starts barking, then maybe it’s time to get rid of the dog – or get one of those bark suppression collars.

I’ve picked the example of temper tantrums and used it in this reply.  But I’m conscious of the fact that this might not be the issue of the enquirer.  That’s one of the problems with the term “bipolar disorder.”  It simply is not specific enough.  But the essential point here is that whatever the behavior is that attracted the diagnosis of bipolar disorder, this behavior can be identified, specified clearly, and remediated.  And in this regard you have to do what we all have to do with life’s problems – exploit your strengths to counter your weaknesses.  In other words – use your ingenuity.  Find solutions to the problem.  Don’t give in.  Don’t go on doing things the same.  Break patterns, etc..

If your problem behavior, in fact, lies in some other direction and you would like further thoughts, don’t hesitate to come back and let me know the specific behaviors that are causing concern.

Now, of course, having said all this, I should add that you can take the conventional step:  go see a psychiatrist and take the “happy pills.”  I’m not recommending this course of action, but I’m sure you realize that it is an option.  Drugs can be effective in suppressing certain kinds of behavior.  However, they always have negative side effects, and although they may suppress the worst aspects of the problem behavior, the result is a far cry from normal human existence.

DSM and Disability

Every society in every generation makes errors.  Some of the errors are minor.  Some are major.  One of the great errors of the 20th century was this:  we accepted the spurious notion that a wide range of life’s problems were in fact illnesses.  This spurious notion was initiated with good intentions – to provide shelter and humanitarian care for a relatively small number of individuals whose plight was truly dreadful.  But then the concept of mental illness took off, fuelled largely by the efforts of psychiatrists to legitimize their status as “real” doctors.

And then came the drug companies, who formed an alliance with the psychiatrists.  These mutually enchanted partners have been dancing heel-to-toe ever since, accumulating wealth and power to the great detriment of individuals and society.

Once it was firmly established that a wide range of ordinary problems of living were “really” diseases, it was a relatively easy step to conclude that individuals manifesting these problems might qualify for disability benefits under programs established by various governments.  In the United States the government entity involved is the Social Security Administration, and at the present time the following “diagnostic” categories are grounds for a disability determination.

Organic mental disorders

Schizophrenic, paranoid, and other psychotic disorders

Affective disorders

Mental retardation and autism

Anxiety related disorders

Somatoform disorders

Personality disorders

Substance addiction disorders

Now it needs to be acknowledged that some of the problems embraced in the above list are genuine medical problems and are definitely disabling.  These include:  serious brain damage and mental retardation.  But the vast majority of the so-called diagnoses listed are not genuine illnesses in any meaningful sense of the word.  They are problems of living.  They are problems of living that have been artificially medicalized for the benefit of psychiatrists and their allies the pharmaceutical companies.  These spurious “diagnoses” include:  schizophrenia, depression, bipolar disorder, anxiety disorders (including post-traumatic stress disorder), substance addiction, etc.. All of these problems are remediable, but under the bio-psychiatric system of pseudo-care, the individuals concerned receive little or nothing in the way of genuine help – in fact, they receive little more than a steady supply of mood-altering drugs.

Paying disability benefits to these individuals is an insult to the genuinely disabled people who have real medical problems which restrict so severely their ability to function.

In addition, the payment of disability benefits to the so-called mentally ill is a great disincentive for these individuals to try to resolve their problems and learn functional ways of living.

All of the “symptoms” of the so-called mental illnesses can be fabricated.  A diagnosis of schizophrenia, for instance, is based entirely on what the individual says and does during an examination interview.  There is no lab or clinical test for schizophrenia.  Occasionally an examiner may question family members, but the “diagnosis” decision rests on the individual’s self-report.  That’s how the system works.  If you don’t mind the stigma of being considered “crazy,” you too can acquire a diagnosis, and with a little help from the mental health services, you can be awarded disability status and a modest monthly income.

And it doesn’t end there.  If you go to college, you may qualify for a variety of academic accommodations.  Michael Rose, PhD, writing in the July/August 2010 issue of the National Psychologist says:

“With the proper documentation, students may qualify for a wide range of learning aids, such as extra time to take tests, use of a private room for tests, word banks, use of a word processor with spell check and help from a proofreader.  A specific documented disability, typically made within the past three years, has been the basis for approved accommodations at most institutions of higher learning.

Besides qualifying for extra help that will likely improve grades, students may qualify for a range of vocational rehabilitation services (paid tuition, books, dormitory costs, computers) that are not dependent on family or individual income.” (pg 18)

I cannot think of a better way of trapping people in a dysfunctional state than providing them with multiple rewards and benefits contingent on their continued dysfunctionality.  As I have noted elsewhere:  Is this a great country or what?

Back in the 1990’s there was a great push to get people off the welfare rolls.  It is an open secret that Social Services departments in many areas were encouraging their welfare clients to enroll at the mental health center and establish a “diagnosis” so that they could then apply for a disability determination from Social Security.

I could never prove this, but I know of a number of parents who were actively coaching their children in attention-deficit and other kinds of dysfunctional behavior so that the child would qualify for a Social Security income.  It’s a simple fact in America today that if you teach your child to misbehave seriously from an early age, and take him regularly to the mental health center for “help,” you stand an excellent chance of having him qualify for a Social Security income.  I have known families with more than one child receiving Social Security “disability” payments for no other reason than chronic misbehavior and lack of discipline.

I discussed the spurious nature of Attention Deficit Hyperactivity disorder in an earlier post, but I’m repeating the diagnosis “symptoms” below for convenience.

The APA’s eighteen criteria for this fictitious illness are:

Inattention

a)      often fails to give close attention to details or makes careless mistakes in schoolwork, work, or other activities
b)      often has difficulty sustaining attention in tasks or play activities
c)      often does not seem to listen when spoken to directly
d)     often does not follow through on instructions, and fails to finish schoolwork, chores, or duties in the workplace (not due to oppositional behavior or failure to understand instructions)
e)      often has difficulty organizing tasks and activities
f)       often avoids, dislikes, or is reluctant to engage in tasks that require sustained mental effort (such as schoolwork or homework)
g)      often loses things necessary for tasks or activities (e.g., toys, school assignments, pencils, books, or tools)
h)      is often easily distracted by extraneous stimuli
i)        is often forgetful in daily activities

Hyperactivity/Impulsivity

a)      often fidgets with hands or feet, or squirms in seat
b)      often leaves seat in classroom or in other situations in which remaining seated is expected
c)      often runs about or climbs excessively in situations in which it is inappropriate (in adolescents or adults may be limited to subjective feelings of restlessness)
d)     often has difficulty playing or engaging in leisure activities quietly
e)      is often “on the go” or often acts as if “driven by a motor”
f)       often talks excessively
g)      often blurts out answers before questions have been completed
h)      often has difficulty awaiting turn
i)        often interrupts or intrudes on others (e.g., butts into conversations or games)

I have only one question for my readers.  How hard would it be to train a child to function in this way?

Next Post:  Another Interesting Book

Bipolar Disorder Is Not An Illness

This post was edited and updated on June 24, 2013,  to address comments received from readers.  I thank them for their input.

. . . . . . . . . . . . . . . .  

DSM-IV’s criteria for a manic episode are given below:

A. A distinct period of abnormally and persistently elevated, expansive, or irritable mood, lasting at least 1 week (or any duration if hospitalization is necessary).


B. During the period of mood disturbance, three (or more) of the following symptoms have persisted (four if the mood is only irritable) and have been present to a significant degree:

(1) inflated self-esteem or grandiosity
(2) decreased need for sleep (e.g., feels rested after only 3 hours of sleep)
(3) more talkative than usual or pressure to keep talking
(4) flight of ideas or subjective experience that thoughts are racing
(5) distractibility (i.e., attention too easily drawn to unimportant or irrelevant external stimuli)
(6) increase in goal-directed activity (either socially, at work or school, or sexually)
or psychomotor agitation
(7) excessive involvement in pleasurable activities that have a high potential for
painful consequences (e.g., engaging in unrestrained buying sprees, sexual
indiscretions, or foolish business investments)

C. The symptoms do not meet criteria for a Mixed Episode

D. The mood disturbance is sufficiently severe to cause marked impairment in
occupational functioning or in usual social activities or relationships with others, or
to necessitate hospitalization to prevent harm to self or others, or there are psychotic
features.

E. The symptoms are not due to the direct physiological effects of a substance (e.g., a
drug of abuse, a medication, or other treatment) or a general medical condition (e.g.,
hyperthyroidism).


Note
: Manic-like episodes that are clearly caused by somatic antidepressant
treatment (e.g., medication, electroconvulsive therapy, light therapy) should not count
toward a diagnosis of Bipolar I Disorder.

The manic episode is an important part of the DSM system because it acts as the basis for a diagnosis of Bipolar Disorder. DSM lists several variations of Bipolar Disorder, each with its own specific criteria, but in general, if a person has had a manic or hypomanic episode, he has bipolar disorder.

Let’s take a look at criterion A. This criterion calls for a distinct period of abnormally and persistently elevated expansive or irritable mood, lasting at least a week… The DSM defines elevated mood as: an exaggerated feeling of well-being or euphoria or elation. Expansive mood is defined as a lack of restraint in expressing one’s feelings, frequently with an over-evaluation of one’s significance or importance. Finally irritable mood is defined as being easily annoyed and provoked to anger.

So the very basis for a diagnosis of Bipolar Disorder is either feeling particularly good about everything or feeling particularly grumpy and angry. How can the same illness manifest itself in such completely different ways? And bear in mind that these are not relatively trivial, incidental aspects of the so-called illness. These are the defining features. The very essence of bipolar disorder – according to DSM – is an episode of profound happiness or an episode of profound grumpiness and irritability. This is indeed a strange illness.

But let’s move on to criterion B. This provides a list of seven specific “symptoms,” three of which must be present for a positive diagnosis. (Incidentally, if the mood problem in criterion A is “only irritable,” then four items are needed from the list.)

This practice of providing a list of symptoms and specifying how many must be present in order to provide a diagnosis is very common in DSM and raises obvious difficulties. First is the arbitrariness of the number chosen. Why three? Why not two or four? The answer, of course, is because the APA says so. The second objection is that different groupings of three will generate very different presentations. For instance, a person meeting criteria 1, 3 and 4 will be grandiose, overly talkative, and somewhat scattered in his choice of topics. Whereas a person who meets criteria 2, 5, and 7 will be sleeping very little, very distractible, and will be maxing out his credit cards in unrestrained buying sprees. The notion that these two presentations are in fact manifestations of the same illness is untenable. This is particularly so in that the only justification for this position is that the APA say so.

A more important difficulty stems from the question: Why should these problems be considered indications of illness? Let’s look at each of the so-called symptoms in turn.

1. inflated self-esteem or grandiosity.
In this context it is worth noting that one of the “symptoms” of a major depressive episode is “feelings of worthlessness…” So if you haven’t got enough self-esteem, you’re depressed, but if you have too much, you’re manic. This raises the question: how much self-esteem is OK, and how much (or how little) is pathological? Who decides? In practice, of course, intake workers at mental health centers and hospitals make the decision, and the decision-making is intrinsically subjective and unreliable. In an informal way, we have all encountered individuals who are “full of themselves” to an obnoxious degree. Intuitively we attribute this kind of behavior either to an attempt to mask a marked sense of inferiority or to poor socialization training during childhood. The notion that this character trait is really a symptom of an illness is an extreme position for which the APA offers no proof. Indeed there isn’t even an argument. The APA simply says so.

2. decreased need for sleep…
This is a complex subject. A great deal has been learned about sleep but much remains unknown. Sleeplessness might well be an indication of some neurological damage or illness, but might on the other hand be simply a reflection of individual differences. There are numerous reports in history of prominent individuals who managed perfectly well on four or five hours sleep each night. Others need eight or nine. It would require a neurological examination to determine if a particular sleep pattern were pathological or a variation of normal. But even if a pathological condition were established, this would indicate a neurological condition, not a so-called mental illness. It is also worth noting that a “decreased need for sleep” very often is nothing more than excessive intake of caffeine or other stimulant drugs.

3. more talkative than usual or pressure to keep talking
We’ve all encountered individuals who talk too much – who hog the conversation. This phenomenon is best conceptualized as rudeness, i.e. a disregard for the normal conventions that direct social intercourse. This particular form of rudeness is usually the result of poor training during childhood. Small children sometimes talk excessively and try to dominate social relationships in this way. If steps are not taken to train them towards a more give-and-take approach to conversation, they often carry this trait into adult life.

4. flight of ideas or subjective experience that thoughts are racing
DSM defines flight of ideas as: “A nearly continuous flow of accelerated speech with abrupt changes from topic to topic that are usually based on understandable associations, distracting stimuli, or plays on words. When severe, speech may be disorganized and incoherent.”

It’s clear from this definition that the real issue here is not so much flight of ideas as flight of speech. Most people in fact experience flight of ideas on a fairly regular basis. It’s called stream of consciousness, and it flows like a babbling brook, swishing and eddying around twists and turns, over rocks and sand banks, endlessly changing and shifting. Even as I write these words, for instance, my thoughts have flitted to actual streams and rivers I have known. The problem is not that the person experiences a bewildering array of successive ideas, but rather that he puts these ideas into words. Most of us learn to censor stream of consciousness material at an early age and to confine our speech to items that have meaning and relevance for our listeners. A small number of poets and song-writers have managed to make a good living by dispensing with this kind of censorship, but most of us confine our verbal utterances to those ideas that have cogency and relevance for others. We call it discipline or self-control. Once again, it is lacking in small children whose early speech does indeed reflect stream of consciousness material. Proud parents are usually delighted with this initially, because it represents a major developmental breakthrough. Most parents, however, fairly soon begin the process of training and coaching that results in what we would call normal speech. If this training does not occur or is thwarted or frustrated for whatever reason, then the individual grows up without acquiring this skill. As with many skills normally acquired in childhood, it can be extremely difficult to learn in later life.

This facet of the manic presentation then is best conceptualized as a deficit in training and socialization, rather than a symptom of a medical condition.

5. distractibility (i.e., attention too easily drawn to unimportant or irrelevant external stimuli)
This is essentially the same thing as the flight of ideas discussed above. The effect of splitting this phenomenon into two separate “symptoms” is to increase the likelihood of a positive “diagnosis.” Remember, it takes three (or more) symptoms for a diagnosis. If a person displays flight of ideas, he will almost certainly also meet the criteria for distractibility. So you get two hits for the price of one. The primary purpose of DSM is to generate business for psychiatrists.

6. increase in goal-directed activity (either socially, at work, or school, or sexually )or
psychomotor agitation

Most people would probably see an increase in goal-directed activity as a good thing. Painting the garage or mowing the yard is better than vegetating in front of the television. But this is not quite what the APA has in mind by “goal-directed activity.” Elsewhere in the text they describe goal-directed activity that is “excessive” and as examples they mention: “ taking on multiple new business ventures…without regard for the apparent risks…,” “…calling friends or even strangers at all hours of the day or night…;”
“…writing a torrent of letters on many different topics to friends, public figures, or the media.”

It is clear that the real issue here is not goal-directed activity as such but rather irresponsible and inconsiderate activity. Once again, responsibility and consideration for others are attributes that we acquire during childhood through the normal methods of parental discipline, coaching, role modeling, etc.. When we see a person displaying a marked deficit in these areas the most parsimonious assumption is that his/her training and discipline in these areas was for some reason neglected or deficient. The notion that the person is ill is certainly not obvious. The APA offers no proof or even arguments for this position.

7. excessive involvement in pleasurable activities that have a high potential for painful consequences (e.g. engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments) 
Once again, what’s involved here is what most people would call irresponsibility: the kind of behavior we try to discourage in our children through the normal time-honored methods of discipline and example. The notion that these kinds of irresponsible and self-indulgent behaviors are in fact caused by a diagnosable illness is quite a reach. Bipolar disorder, like most of the other DSM diagnoses, is not something a person has, but is rather something that a person does. It is constantly presented by the APA, and by practitioners in the field, however, as something a person has (like diabetes) and something that is best treated with drugs.

I realize that many people reading this post will say that I’ve got it all wrong – that I’ve misrepresented the reality of the condition called bipolar disorder.  They might say that people with this “diagnosis” are “crazy” – not just irresponsible or self-indulgent.  And there is a measure of truth in this.  Some of the individuals who are assigned this label do sometimes behave in a “crazy” fashion.  But it’s important to note that in the DSM, this aspect of the matter – “psychotic features” – is included almost as an afterthought.  It is not one of the defining features of a manic episode.  Rather, it is something that may be present.

What the APA is doing here is trying to have their cake and eat it too.  By including the possibility of psychotic features, they create the impression that this is a very serious matter; but by not making psychotic features a requirement, they manage to extend the diagnostic net to include people with relatively mild problems.

I will discuss psychotic features in later posts on the topic of “schizophrenia.”

The fact that lithium has a calming affect on individuals who behave in this manner is often cited as proof that the behavior in question really does stem from an illness. The logic is untenable. A couple of beers can be very effective in helping shy people overcome their inhibitions. Very few rational people would conclude from this that shyness is an illness and alcohol a “medication.” In addition, lithium has a calming effect on all people – not just those who carry a diagnosis of bipolar disorder.

Lithium carbonate is a salt – found widely in nature – and until 1949 was sold openly in the United States as a substitute for table salt. Besides having a salty taste, lithium salt has a calming effect on people’s behavior. With regards to the latter, the mechanism of action is unknown. There have been numerous proposed theories, but none has produced conclusive evidence or gathered much support.

In some respects the shyness/alcohol analogy mentioned earlier is even more apt. The chronically shy person can acknowledge his problem and take corrective action using the normal time-honored methods of effecting personal change. Or he can simply drink a couple of beers before every social situation. Either solution to the problem will work. Similarly the manically irresponsible person can acknowledge his problem behaviors and tackle them in the normal way – or he can take lithium carbonate. The latter is often quite effective in dampening the behavioral excesses, but like the alcohol, it also has some long-term side effects.

The central point of this and my earlier posts is that there are no mental illnesses. There are problems of living – problems that human beings encounter, sometimes resolve, sometimes live with. The so-called mental illnesses are an attempt to explain or understand these phenomena, but as explanations they are spurious, unhelpful, and indeed, counter-productive. They are merely labels.

A perfect analogy to the mental illness explanation of human problems is the phlogiston explanation of fire or the witchcraft theories of illness and crop destruction. The popularity of a concept is often independent of its validity. The phlogiston theory of fire is a good example. This theory, which held sway among scientists during the 1600’s and most of the 1700’s, maintained that combustible objects contain an element called phlogiston which was released when the object was burned. Non-flammable objects simply didn’t have this substance. Towards the end of the 1700’s evidence was gradually amassed to debunk the theory in favor of the oxygen-combination ideas of today. Many scientists, however, including Joseph Priestley (the discoverer of oxygen!), tried to cling to the older theory. Similarly, in former years, sickness and crop failures were often attributed to witchcraft. Here again, we have a spurious theory, i.e. that sickness and crop failures are caused by the actions of these so-called witches. Such thinking – back in the days – was very widespread, and witch-burnings were popular events. But the concept was nonsense, and today, thanks to science, we have a better understanding of the causes of illnesses and crop failures. Popularity is a very unreliable barometer for conceptual validity. Phlogiston doesn’t exist. There’s no such thing as witchcraft. And there are no mental illnesses. Fire, however, does exist. Crop failures and illness are realities. And human problems of living are real. People are complex and diverse and the problems we encounter on our journey through life are also complex and diverse. Some of the problems we meet are relatively minor and easy to deal with. Others can be truly overwhelming. Some are indeed medical problems and require medical help. Others do not.

The so-called mental illnesses are problems that do not require medical help. The medicalization of all human problems of living is as spurious as the phlogiston and witchcraft theories mentioned earlier. It is also counter-productive. Drugs are not an effective solution to life’s problems any more than the burning of so-called witches was a solution to crop failures or illness.

The medicalization of all human problems is about turf. The American Psychiatric Association is the psychiatrists’ trade union, and has as its primary agenda the promotion of its members’ interests. There’s nothing intrinsically wrong with this – all trade associations do the same. That’s why they exist. The problem with the APA, however, is that they have been so successful. At the present time one would be hard pressed to identify any problem of human living that is not covered by a DSM “diagnosis.” The purpose of these diagnoses is to legitimize psychiatric intervention and the prescription of drugs in any and every human problem.

At the risk of repetition, I am not saying that people should not use drugs. It is not for me to tell people what they should or should not ingest. These are decisions that people have to make for themselves. What I do object to, though, are the spurious notions that these pharmaceutical products are medicines, and that they are being prescribed to combat illnesses.

Next Post: Adjustment Disorder:  Everyone can have a mental illness