Tag Archives: chemical imbalance theory

My Response to Dr. Pies’ Response

On November 18, 2015, Dr. Pies sent his response to my November 17 article to MIA.  MIA posted it, and forwarded a copy to me.  It reads:

“I have read Dr. Philip Hickey’s 8400+ word treatise, and I have only the following to say with regard to the two key points at issue:

  1. Notwithstanding my omission of quotation marks in my original Medscape article [1]—for which I take responsibility—the fact remains: I have never believed or argued that the so-called chemical imbalance theory (which was never really a theory) is merely a “little white lie.” It is that point of view—not merely typed words on the page—that has been falsely and carelessly attributed to me.
  2. I have never received a dime from any pharmaceutical company or private agency with any verbal or written understanding that I would “promote” (elevate, popularize, hype, etc.) a particular drug. If any of the papers I wrote or co-authored over a decade ago had the effect of putting a drug in a favorable light, it was because the best scientific evidence available at that time supported the drug’s benefit. Nothing in Philip Hickey’s belaboring of half-truths, innuendos and guilt by association demonstrates otherwise.

 

Sincerely,

Ronald Pies MD

  1. http://www.medscape.com/viewarticle/823368

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

I had ended my November 17 article on a questioning note:

“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.”

So the first thing that needs to be noted is that Dr. Pies hasn’t given me much to work with.

THE CHEMICAL IMBALANCE AND THE LITTLE WHITE LIE

He tells us now that despite what the “words on the page” might have conveyed, he has never “believed or argued” that the chemical imbalance theory is merely a “little white lie.”

And here, it has to be acknowledged, that Dr. Pies is making a very good point:  that the words and the idea conveyed aren’t always the same thing.  One could believe and argue that the chemical imbalance theory was a little white lie without every using those precise words.

So let’s try to phrase the question without using the words “little white lie”.  A “little white lie” is an inconsequential falsehood, told to avoid causing embarrassment or hurt.  So the question becomes:  did Dr. Pies believe, or argue, that the chemical imbalance hoax was an inconsequential falsehood, designed to shield individuals from embarrassment or hurt?

Of course, I have no way of knowing what Dr. Pies believes.  Nor, to the best of my recollection, have I even speculated on such matters.  But I do know that he has argued that the chemical imbalance theory is an inconsequential falsehood designed to shield individuals from guilt and self-blame.  Indeed, I provided an example of this in the November 17 article.

Here’s the quote from Dr. Pies’ August 4, 2001 post titled Doctor, Is My Mood Disorder Due to a Chemical Imbalance?:

“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.'”

My reading of this passage is that Dr. Pies is saying that the chemical imbalance theory is an inconsequential falsehood designed to shield individuals from guilt and self-blame.  Here’s another quote from the same paper:

“My impression is that most psychiatrists who use this expression feel uncomfortable and a little embarrassed when they do so. It’s a kind of bumper-sticker phrase that saves time, and allows the physician to write out that prescription while feeling that the patient has been ‘educated.’  If you are thinking that this is a little lazy on the doctor’s part, you are right. But to be fair, remember that the doctor is often scrambling to see those other twenty depressed patients in her waiting room. I’m not offering this as an excuse–just an observation.”

But, in fact, excusing the doctor’s actions is precisely what Dr. Pies is doing.  The doctor tells the falsehood, which is just a “bumper-sticker phrase” anyway, because she’s “a little lazy”, and has twenty other depressed patients in her waiting room.  In other words, the assertion is an inconsequential, and eminently excusable, falsehood.  And, in passing, I might add that over the years I have heard a great many psychiatrists assert unequivocally that depression is caused by a neurochemical imbalance, and I have never detected in any one of these individuals the slightest hint of embarrassment or discomfort.

And here’s yet another quote from Dr. Pies’ same paper:

“Ironically, the attempt to reduce the patient’s self-blame by blaming his brain chemistry can sometimes backfire. Some patients hear ‘chemical imbalance’ and think, ‘That means I have no control over this disease!’ Other patients may panic and think, ‘Oh, no—that means I have passed my illness on to my kids!’ Both of these reactions are based on misunderstanding, but it’s often hard to undo these fears.”

Now to me, it seems self-evident that if a psychiatrist tells a client:

Your depression is caused by a chemical imbalance in your brain

and if the client interprets this as indicating that he or she has no control over the depression (other than by ingesting drugs), and worries that he/she might pass this imbalance on to his/her children, this is not a misunderstanding.  This is an absolutely valid and reasonable inference from the psychiatrist’s statement.  To describe this inference as a misunderstanding on the client’s part is simply another attempt to exculpate psychiatry in this hoax, and to downplay the magnitude of the deception, and the damage and destruction it has wrought.  It also, incidentally, betrays a truly extraordinary degree of condescension towards the client.

So Dr. Pies has argued that the chemical imbalance theory is an inconsequential falsehood for which psychiatry carries minimal, if any, blame.  But, apparently, he now wishes to distance himself from this position.

Which raises the question:  what is Dr. Pies’ present position on the chemical imbalance theory?

And here we have solid, reliable, up-to-date information.  On April 11, 2014, Dr. Pies amended the “little white lie” phrase in the “Nuances…” article at Psychiatric Times to read “simplistic notion”, and some time between October 15 and November 5, 2015, he amended the Medscape version to read:  “simplistic formulation”.  Both phrases mean much the same thing:  an oversimplification.

And this is important, because Dr. Pies is not acknowledging that the chemical imbalance theory is false; just that it is an oversimplification.

However, the statement “Depression is caused by a chemical imbalance in the brain” is not an oversimplification.  It is simply false.  To describe the chemical imbalance hoax as a simplistic notion is yet another psychiatry-exculpating attempt on Dr. Pies’ part.  By promoting the chemical imbalance theory, psychiatry wasn’t just guilty of oversimplifying.  Psychiatry was perpetrating a monumental hoax:  a deliberate, self-serving deception, with widespread destructive and disempowering effects, which continue to this day.

. . . . . . . . . . . . . . . . 

With regards to the Medscape article, Dr. Pies tells us that he accepts “responsibility” for the omission of quotation marks.  But in fact, he doesn’t take this responsibility at all.  Instead, he continues to berate his critics for “falsely and carelessly attributing” to him material that he actually wrote.

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

CONFLICTS OF INTEREST

Dr. Pies tells us that he has never received payments from “any pharmaceutical company or private agency with any verbal or written understanding” that he would promote a particular drug.  This is an interesting statement, of course, but its relevance in this context is not clear, because neither Drs. Lacasse and Leo, nor I, have ever alleged anything to the contrary.  In fact, we’ve all taken particular pains to make this clear.

Drs Lacasse and Leo stated:

“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.”

And I, in the November 17 article, wrote:

“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.”

So I’m not sure why Dr. Pies felt the need to deny activities of which he has not been accused.

Dr. Pies continues:

“If any of the papers I wrote or co-authored over a decade ago had the effect of putting a drug in a favorable light, it was because the best scientific evidence available at that time supported the drug’s benefit.  Nothing in Philip Hickey’s belaboring of half-truths, innuendos and guilt by association demonstrates otherwise.”

With regards to this assertion, let me state at the outset that Dr. Pies is absolutely correct, in that there is nothing in my November 17 article that asserts, or even suggests, that Dr. Pies had entered into a specific agreement to promote a drug in return for payment.  Nor is there anything in my article that demonstrates that Dr. Pies was guided by anything other than “the best scientific evidence available.”

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

For these reasons, Dr. Pies’ insistence that his favorable comments concerning drugs were always supported by the “best scientific evidence available at that time”, struck me as an interesting challenge.  So I pulled up one of the articles that I had mentioned in the November 17 post.

The article is “Affective instability as rapid cycling: theoretical and clinical implications for borderline personality and bipolar spectrum disorders“, by Drs. Pies and MacKinnon.  The article is a literature review/opinion piece, published in Bipolar Disorders 2006: 8: 1-14. Here’s a quote:

“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 [Lamictal] 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.”

Reference 59 was a GSK funded study by Dr. Calabrese et al (2000).  This is the same Dr. Calabrese who was mentioned in the United States vs. GSK 2012 lawsuit.  (See my November 17 article for details.)

It is clear in this quote that Dr. Pies is indeed putting lamotrigine “in a favorable light”, but the evidence presented in the study does not support the conclusion.  In fairness to Dr. Pies, the claim to efficacy is asserted in the study’s abstract:

“Forty-one percent of lamotrigine patients versus 26% of placebo patients (p = .03) were stable without relapse for 6 months of monotherapy.”

In fact, as can be seen, Dr. Pies has quoted the above statement almost verbatim.  But the assertion is not justified by the evidence presented in the study.  It’s a complicated piece of research, but here’s the gist.

Three hundred and twenty-four individuals were enrolled in the preliminary phase of the study.  During this phase, participants were prescribed lamotrigine [Lamictal].  Initially they could take other psychotropic drugs also, but after 4-8 weeks of exposure to lamotrigine, “…all other psychotropic medications, including lithium, were tapered provided that patients met the criteria for wellness.”

Participants were eligible to enter the second phase of the study

“if they successfully completed the taper [from other drugs] while maintaining the minimum criteria for wellness, had no change in lamotrigine dosage during the final week of the preliminary phase, and had no mood episodes requiring additional pharmacotherapy or electroconvulsive therapy (ECT) after the first 4 weeks of the preliminary phase.”

From the initial pool of 324 participants, 182 met the above criteria and moved to the second (randomized) phase.

The second phase was scheduled to last for 26 weeks.  The researchers focused on three possible outcomes:

  1. completion of the 26-week period without additional pharmacotherapy
  2. completion, but with additional pharmacotherapy
  3. withdrawal from study (e.g., because of adverse events, consent withdrawn, lost to follow-up, etc.)

So to summarize:  during the first phase, the researchers identified 182 participants who were taking only lamotrigine, and met the study’s “criteria for wellness”.  Then, at the beginning of the second phase, they switched approximately half of these individuals, randomly selected, to placebo.

“At the start of this phase, patients immediately discontinued open-label lamotrigine and began double-blind treatment with lamotrigine or placebo.  Lamotrigine and matching placebo were supplied in 100-mg dispersible tablets and administered orally once daily.” [Emphasis added]

The primary outcome variable in this study was the need for

“additional pharmacotherapy for a mood episode or one that was thought to be emerging.” [Emphasis added].

Figure 1 shows the main results.

Calalbrese graph

These are survival graphs.  Survival in this context does not refer to life vs. death, but rather to survival in the study.  In the upper graph, the criterion for non-survival is the perceived need, and prescription of, “additional pharmacotherapy”.  In the lower graph, the non-survival criterion is drop-out for any reason, including the need for “additional pharmacotherapy”.  Other reasons given for drop-out were:  adverse events, withdrawal of consent, lost to follow-up, protocol violation, and other.

Survival in each graph is plotted against time (in weeks) on the horizontal axis.  At the beginning of the study, all participants in both graphs show a survival rate of 1.0 (or 100%).  With each passing week, some individuals are dropped, either because they needed additional pharmacotherapy (upper graph, A), or for any reason, including additional pharmacotherapy (lower graph, B).

As can be seen, the lamotrigine group has a consistently higher survival rate than the placebo group.  In graph A, this difference does not reach statistical significance.  There is a 17.7% probability that the difference might have arisen by chance alone.  But in graph B, the difference is more marked, and there is only a 3.6% probability that the difference could have arisen by chance.  The 41%-26% disparity mentioned in Dr. Pies’ article is the difference in final survival rates in Graph B.  If one refers across from the tail points of the two graphs to the vertical axis, one can read that the lamotrigine group has a final survival rate of 41%, and the placebo group 26%.

So, one might conclude from all this that lamotrigine is indeed more efficacious than placebo in this context, and that 41%-26% disparity reflects the magnitude of this difference.  But there are three problems with the study.  Firstly, there is a marked withdrawal effect evident in the survival graphs.  Secondly, the study’s primary criterion was not relapse as such, but rather a concern that relapse might be emerging.  And thirdly, the participants who dropped out for any reason were counted as having relapsed.

THE WITHDRAWAL EFFECT

If you look carefully at the graphs, you will notice that the attrition rate for the placebo group, in both graphs, is steepest during the first three weeks of the study, i.e. for the three weeks after these individuals have been precipitously taken off lamotrigine.

It is clear from inspecting the graphs that if this very high attrition rate had not occurred, or had been discounted from the research, the survival graphs for the remainder of the 26 weeks would be virtually identical.  To demonstrate this, I have redrawn both graphs omitting the data from the first three weeks.  So, starting with week four, I moved both graphs up the page to the 100% starting point, without altering their relative shapes/contours.  The results are shown below.  As can be seen, the survival rates for the lamotrigine group and the placebo group are virtually identical for both criteria.  I don’t have the raw data from which statistical significance could be assessed, but the graphs speak for themselves.

Modified graph Calabrese Suppes Bowden et al with border

Modified Graphs

What we are actually seeing in this study is a fairly marked withdrawal effect.  And in fact, the authors mentioned this possibility, in the Discussion section, though with considerable downplay.

“At the time of randomization, patients assigned to placebo had open-label lamotrigine abruptly discontinued.  Although rebound relapse into a mood episode after the abrupt discontinuation of lamotrigine has been reported in neither the neurologic nor psychiatric literature, this methodological feature remains a possible confound.” [Emphasis added]

But, in the “Affective Instability…” paper, Dr. Pies makes no mention of this possible confound, which actually nullifies the authors’ conclusions.

The conclusion that should have been drawn from the Calabrese et al study was that, apart from those individuals who “crashed” within the first three weeks following abrupt discontinuation of lamotrigine, there was no difference in efficacy between lamotrigine and placebo.  The presence of the marked and obvious withdrawal effect in this study is the more notable in that it would have been a very simple matter to safeguard against this.  All that was needed was to build in a three or four week taper at the start of each placebo trial.  This could have been done without breaking the blind, as both lamotrigine and placebo were given in identical tablets.

Incidentally, there’s an interesting discussion of withdrawal-related relapse in Joanna Moncrieff’s book, The Myth of the Chemical Cure, palgrave macmillan, 2009 (p 191-194).

DEFINITION OF RELAPSE

Here’s how the study’s authors defined the word relapse:

“…for the purpose of this study, relapse was operationally defined as the need for additional pharmacotherapy for a mood episode or one that was thought to be emerging.” [Emphasis added]

Ordinarily, in medical circles, the term relapse means a recurrence of the illness in question, and in psychiatric circles this would mean – in the case of “bipolar disorder” – a recurrence of what psychiatrists call “a mood episode”, either depressive, hypomanic, or manic.  But this is not how Drs. Calabrese et al used the term.  For them, an indication that a mood episode might be “emerging” was the threshold criterion.  And lest there be any doubt on this matter:

“The design of this study did not permit an analysis of time to relapse into a full episode of depression, hypomania, or mania since patients were withdrawn at the first signs of relapse.” [Emphasis added]

So when Drs. Pies and MacKinnon wrote that

“41% of lamotrigine-treated versus 26% of placebo-treated patients were stable without relapse during 6 months of monotherapy”

they were exceeding the evidence, in that stability without relapse, in the ordinary and customary sense of the term, was not the criterion against which the 41%-26% disparity was established.  The study provides no information at all on the matter of stability without relapse.

The study write-up does not tell us precisely what kinds of presentations would be considered grounds for believing that a “mood episode” might be “emerging”.  But it does seem likely that lamotrigine withdrawal effects would qualify.  Drugsdb.com gives the following “commonly reported” withdrawal symptoms for lamotrigine.

  • Anger, Rage or Hostility
  • Headaches
  • “Brain flashes” or “Brain zaps”
  • Tingling in areas around the body
  • Thoughts of Suicide and Other Irrational Thoughts
  • Dizziness
  • Severe Depression
  • Vivid Dreams and Nightmares

DROP-OUT VS. RELAPSE

The 41%-26% efficacy claim is based on the further assumption that all the individuals who dropped out because of adverse events, withdrawal of consent, lost to follow-up, protocol violation, and other, relapsed.  Here’s how the study authors justify this assumption:

“Bipolar disorder is a disorder of impulse control and impaired judgment, and poor compliance is a frequent consequence of both.  We therefore hypothesized that premature treatment discontinuations are related to early signs of relapse.  Thus, one clinically relevant measure of efficacy is survival in the study to the point of withdrawal for any reason.” [Emphasis added]

Which strikes me as tenuous at best.  One could just as validly hypothesize that the individuals concerned didn’t relapse, and were doing fine.  And besides, even if withdrawal for any reason is “one clinically relevant measure of efficacy”, it is not the same thing as relapse.  And a higher rate of stability without relapse is what Dr. Calabrese et al and Dr. Pies and MacKinnon claimed for lamotrigine.

This is a critical issue, because the individuals who dropped out are over-represented in the placebo group (19% vs. 12%), so including these participants in the relapse group was a clear bias in favor of lamotrigine.

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

CONCLUSION 

Dr. Pies’ statement in the “Affective Instability…” article:

“The study [Calabrese et al, 2000] found that 41% of lamotrigine-treated versus 26% of placebo-treated patients were stable without relapse during 6 months of monotherapy”

has the effect of putting lamotrigine in a favorable light.  The statement is also an accurate echo of what Dr. Calabrese et al stated in their abstract, but it is not supported by the evidence set out in the study.  Specifically, the above conclusion is nullified by strong indications of marked withdrawal symptoms in the placebo group, and by a non-standard definition of relapse.  Both of these factors had the effect of suppressing the calculated survival rates among placebo participants, and consequently inflating the perceived efficacy of lamotrigine.

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

I realize that this debate may have the appearance of a personal feud between Dr. Pies and myself.  So I want to make it clear that, for my part at least, this is not the case.  I don’t know Dr. Pies individually, nor have I the slightest interest in attacking him personally or wounding his reputation.  My interest is, and always has been, psychiatry’s spurious concepts, its destructive and disempowering “treatments”, and its long history of fraudulent research. Sadly, Dr. Pies has adopted as his mission the defense of psychiatry, and it is perhaps inevitable that we should occasionally clash.  But the target of my critique is psychiatry, not the individuals who promote and defend it.

 

 

 

 

Dr. Pies Is Back

This morning, I received, by way of a forward from MIA, the following from Dr. Pies.

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

 

I have read Dr. Philip Hickey’s 8400+ word treatise, and I have only the following to say with regard to the two key points at issue:

  1. 1. Notwithstanding my omission of quotation marks in my original Medscape article [1]—for which I take responsibility—the fact remains: I have never believed or argued that the so-called chemical imbalance theory (which was never really a theory) is merely a “little white lie.” It is that point of view—not merely typed words on the page—that has been falsely and carelessly attributed to me.
  2. 2. I have never received a dime from any pharmaceutical company or private agency with any verbal or written understanding that I would “promote” (elevate, popularize, hype, etc.) a particular drug. If any of the papers I wrote or co-authored over a decade ago had the effect of putting a drug in a favorable light, it was because the best scientific evidence available at that time supported the drug’s benefit. Nothing in Philip Hickey’s belaboring of half-truths, innuendos and guilt by association demonstrates otherwise.

 

Sincerely,

Ronald Pies MD

1. http://www.medscape.com/viewarticle/823368

 

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.”

 

Dr. Pies Responds

On November 5, Kermit Cole, Front Page Editor at Mad in America, forwarded to me the following email which he had received from Ronald Pies, MD.

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

 

From: Ronald Pies MD <contact-page@madinamerica.com>
Date: November 4, 2015 at 2:17:53 PM EST
To: kcole@madinamerica.com
Subject: Misstatements in Philip Hickey\’s blog Echo Misstatements by Lacasse & Leo

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

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

 

I will post a reply to Dr. Pies’ letter as soon as possible.

More on the Chemical Imbalance Theory

On October 23, 2015, Jeffrey Lacasse, PhD, and Jonathan Leo, PhD, published an interesting article on Florida State University’s DigiNole Commons.  The title is Antidepressants and the Chemical Imbalance Theory of Depression: A Reflection and Update on the Discourse.  Dr. Lacasse is assistant professor in the College of Social Work at Florida State University; Dr. Leo is Chair of Anatomy and Professor of Neuroanatomy at Lincoln Memorial University.  The article was originally published in the Behavior Therapist in the October 2015 issue, pages 206-213.

The article provides a concise overview of the chemical imbalance theory from its inception, through its vigorous promotion by pharma-psychiatry, to its present reduced, but not quite dead, state.

Here are some quotes from the article, interspersed with my comments:

“In the early 2000s, the serotonin metaphor of depression was widely advertised by the makers of antidepressants, including advertisements for citalopram, escitalopram, fluoxetine, paroxetine, and sertraline…In particular, Zoloft(sertraline) advertisements featuring the miserable ovoid creature were unavoidable in U.S. television and magazines.  An on-line repository of direct-to-consumer advertisements for psychiatric drugs lists many from 1997–2007 referring to a chemical imbalance, across many drugs and diagnostic categories (Hansen, 2015a, 2015b).”

The Hansen references mentioned in the above quote are worth examining.  Ben Hansen is the well-known psychopharmacological savant Dr. Bonkers.  The Bonkers Institute is always worth a visit.  The links for the above quote are 2015a, and 2015b.

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

“Since chemical imbalance is often presented as a rationale for taking SSRIs, some such patients now understandably feel lied to by their clinicians. Levine (2014) calls this ‘Psychiatry’s Manufacture of Consent.'”

“… in a rare controlled experiment on this topic, one group of depressed students were told they had a confirmed serotonin imbalance underlying their depression, while a control group was not (Kemp, Lickel, & Deacon, 2014). The group who was told they had abnormal serotonin levels found medication more credible than psychotherapy and expected it to be more effective. They also had more pessimism about their prognosis and a lower perceived ability to regulate negative mood states, yet experienced no reduction in self-blame. These results suggest that the chemical imbalance explanation may indeed be helpful in persuading patients to take medication but that this is likely accompanied by undesirable effects.” [Emphasis added]

The Kemp, Lickel & Deacon (2014) article is, in my view, one of the most important pieces of research in this field.  It provides clear evidence that falsely informing people that they have a brain abnormality is disempowering and damaging.  The article can be accessed here.  The truly compelling aspect of this matter is that such a piece of research needed to be done at all. Isn’t it obvious that lying to people in this way would be disempowering and destructive?  Would any legitimate medical specialty routinely operate in this way?

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

“Perhaps the most interesting part about both of these NPR pieces [that were referred to earlier in the article] is that neither reporter questioned the experts about the ethics of telling a falsehood to patients because you think it is good for them.”

“It is easy to imagine that a single prominent academic psychiatrist, authoring an Op-Ed in The New York Times, could have set the record straight on serotonin imbalance decades ago. Yet, to our knowledge, no one did so.”

If psychiatry were anything other than a branch of medicine (and I realize that’s debatable), it would have been mauled to destruction by the mainstream media long ago.  But the media and the general public have a great respect for medicine, and psychiatry has been afforded an undeserved share of this respect.  But, as I’ve mentioned in earlier posts, the mainstream media are beginning to see through the façade, and are finally reporting on the “diagnostic” proliferation, the false claims, and the destructive treatments.

. . . . . . . . . . . . . . . . 

“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’?”

The “little white lie” is, of course, a reference to the 2014 article by the very eminent and influential psychiatrist Ronald Pies, MD.  In that article, Dr. Pies characterizes the chemical imbalance theory as “…this little white lie…”

Dr. Pies has also insisted – arguably delusionally – that psychiatry never promoted the chemical imbalance theory of mental illness.  In a 2011 article he  wrote:

“In truth, the ‘chemical imbalance’ notion was always a kind of urban legend – never a theory seriously propounded by well-informed psychiatrists.”

In the article in hand, Drs. Lacasse and Leo provide clear and abundant evidence to the contrary.  They also, incidentally, provide a summary of Dr. Pies’ past financial relationships with pharmaceutical companies.  Apparently the eminent doctor has received funding from Glaxo Smith Kline, Abbot Laboratories, and Janssen Pharmaceutica.  He has also consulted for Apothe Com, a medical communications agency that assists pharma in the commercialization and promotion of new drugs.

“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.”

“We previously argued that the propagation of misleading advertising ‘is only possible in the absence of vigorous government regulation . . . or outcry from professional associations’…That outcry never came, and these issues weren’t addressed publicly until the patents for most blockbuster SSRIs had expired, and Big Pharma moved onto mood stabilizers and atypical antipsychotics. While we are hesitant to overemphasize conflicts-of-interest as an explanation for what has occurred, we can’t help but notice that the silence of psychiatry regarding chemical imbalance only ended when the profits had been extracted from the SSRI marketplace.”

Now that’s an interesting coincidence!

“Many mental health clients find it unacceptable, and perhaps a violation of ethical informed consent, for clinicians to give patients metaphorical explanations for their mental health problems and promote them as scientific truth.”

The chemical imbalance hoax, which was diligently and self-servingly promoted by pharma-psychiatry for decades, is perhaps the most destructive and far-reaching scandal of the modern era.  As a theory it was refuted almost from its inception, but was nevertheless promoted by psychiatrists and by massive advertizing campaigns, and served to increase sales of psychiatric drugs in every corner of the globe.  There is no way to calculate the number of lives that have been lost, or severely compromised, as a result of this activity.

Now, anti-psychiatry groups are exposing the truth, and pharma-psychiatry are quietly altering their message.  But there have been no apologies; no congressional hearings; no indictments; no CEO’s fired; no psychiatrists censured.  Just business as usual, as the pharma-psychiatry leaders prepare their next “great breakthrough” message.

This is an insightful article, on a very important topic, by two highly respected scholars.  It is well worth reading, and passing along.

Dr. Pies and Psychiatry’s ‘Solid Center’

Ronald Pies, MD, is one of American’s most eminent and prestigious psychiatrists.  He is the Editor-in-Chief Emeritus of Psychiatric Times, and he is a Professor of Psychiatry at both Syracuse and Tufts.

I disagree with many of Dr. Pies’ contentions, and I have expressed these disagreements in detail in various posts (for instance, here, here, and here).  But there is one area where I have to acknowledge Dr. Pies’ efforts:  he never gives up in his defense of his beloved psychiatry, even in the face of the most damaging counter-evidence.

For instance, on more than one occasion, he has asserted, with apparent sincerity and conviction, that psychiatry never promoted the chemical imbalance theory of depression!

Here’s a quote from Nuances, Narratives, and the ‘Chemical Imbalance’ Debate in Psychiatry, April 15, 2014:

“…the ‘chemical imbalance theory’ was never a real theory, nor was it widely propounded by responsible practitioners in the field of psychiatry.”

And from Serotonin:  How Psychiatry Got Over its “High School Crush”, on September 15, 2015:

“Alas, antipsychiatry bloggers continue to bang away at the notion that ‘Psychiatry’ (that sinister, monolithic corporate entity) deliberately duped the public by promoting a bogus ‘chemical imbalance theory,’ in cahoots with ‘Big Pharma.’ Suffice it to say that this line of argumentation is itself bogus, for reasons I have reiterated at length in several venues.”

His latest contentions in this area were demolished by Robert Whitaker on September 21, 2015, but Dr. Pies has demonstrated a remarkable resilience against factual material that runs contrary to his cherished notions.  So it remains to be seen whether or not he will be back with this particular message.

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

Meanwhile, he’s working on another buttress to shore up the crumbling psychiatric sandcastle.  On October 7, 2015, he published Psychiatry’s Solid Center in the Psychiatric times.  Here’s the opening paragraph:

“Most psychiatrists do not fit neatly into the biological or psychodynamic camps. Instead, like surgeons, they will implement tools that reduce the suffering and enhance the well-being of the patient.”

I’m not familiar with the state of psychiatry at Syracuse or Tufts, but in the rest of the US, the vast majority of psychiatrists very emphatically do fit neatly into the biological camp, and do conduct their practices in accordance with a simplistic biological model.

Of course, my experiences are limited by my horizons.  It may be that, outside of my ken, psychiatrists are busy providing hour-long therapy sessions to their clients – helping them identify and unravel their unconscious emotional conflicts, or engaging in family therapy, conflict resolution, skill training, etc.  Or maybe not.

Douglas Mossman, MD, Professor of Psychiatry, and Director of the Institute of Law and Psychiatry  at the University of Cincinnati, has written on this topic.  Dr. Mossman writes a regular column called Malpractice Rx in the publication Current Psychiatry.  The following quote is from an article dated June 2010, and is in response to a reader psychiatrist who had asked how he could “…attend to patients’ needs, be empathic, listen actively, and still produce proper documentation?”

“In medical malpractice cases, the jury decides ‘whether the physician’s actions were consistent with what other physicians customarily do under similar circumstances.’  Even psychiatrists who deplore 15-minute med checks recognize that they have become standard care in psychiatry.”

In other words, if all, or even most, psychiatrists are doing 15-minute med checks, then there is little chance of a successful malpractice suit.  He is also saying quite clearly that 15-minute med checks have become “standard care” in psychiatry.  And lest there be any residual uncertainty, at the end of the article under the heading BOTTOM LINE, Dr. Mossman wrote:

“Brief medication visits—also known as 15-minute ‘med checks’—have become standard care in psychiatry.”

Not much ambiguity there.

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

And Glen Gabbard, MD, a widely published professor of psychiatry at Baylor and, interestingly, Syracuse, has written in Psychiatric Times, on September 3, 2009:

“There can be little doubt in our current era that the brief ‘med check’ is becoming standard practice in psychiatry.”

This was in 2009, and there have been no indications in the interim that psychiatry is backing away from this approach.

So if the majority of psychiatrists are spending the majority of their practice time doing 15-minute med checks, isn’t it reasonable to infer that they might “fit neatly”, to use Dr. Pies’ own phrase, into the biological camp?  And in fact, Dr. Pies himself, in an earlier paper (Psychiatrists, Physicians, and the Prescriptive Bond) has written:

“Unfortunately, many prescriptions for psychotropics are written in haste—often after the infamous ’15-minute med check’ – and without any real understanding of the patient’s inner life or psychopathology.” 

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

Dr. Pies continues by telling us that he was fortunate in that his psychiatric training was fostered by those in what he calls the “great solid center” of psychiatry.  This is interesting, of course, and one can readily entertain feelings of joy and gratitude, that Dr. Pies apparently escaped the bio-reductionist nonsense, that has now become a dominant feature of psychiatric training and practice.

Dr. Pies continues:

“And critics of psychiatry who insist that the field has become exclusively ‘biological’ are also missing the larger and more enduring picture.”

Well I think I could count myself as a critic of psychiatry, and I have to say that one of us is certainly missing the bigger picture.  Since the 70’s, I have interacted with a great many psychiatrists in a wide range of contexts and locations, but I cannot recall one who conceptualized his/her role as anything other than the prescribing of drugs or high-voltage electric shocks to the brain.  And in fact, I can recall only one psychiatrist, an elderly man who had trained in Vienna in the ’30’s, who expressed even the slightest regrets or misgivings in this regard.  I can still remember his exact words:  “I was trained as a psychotherapist, but all they want me to do now is prescribe drugs.”

Every other psychiatrist I’ve ever met has expressed nothing but satisfaction with what is sometimes referred to as the “drug revolution” that, according to the rhetoric, has enabled psychiatry to take its “rightful place” as a legitimate science-based medical specialty.

. . . . . . . . . . . . . . . . 

Dr. Pies continues at some length on the wide-ranging aspects of his psychiatric training. He tells us that at one point in his training, he ran a poetry therapy group on an inpatient unit, and that he “…became a believer in pragmatic pluralism and psychiatry’s crucial role as a bridge between the medical sciences and the humanities.”

This last statement is ambiguous, in that it could mean that Dr. Pies believes that psychiatry should be such a bridge, or that psychiatry is such a bridge.  If Dr. Pies intended the former, then that’s interesting, though not pertinent to his main thesis, but if he meant the latter, then I suggest his contention is not only false, but entirely lacking in credibility.  Indeed, in my experience, it is one of psychiatry’s great priorities to dispel any such perceptions, and to establish itself as a “real” medical specialty with expertise in biochemistry, drugs, electric shocks, etc…  In this regard, it is noteworthy that Jeffrey Lieberman, MD, arguably the greatest and most eminent psychiatrist in the world today, has appeared in promotional videos wearing a white lab coat!  One wouldn’t want to make too much of this.  Perhaps he just couldn’t find anything else to wear.  But it certainly militates against the notion that psychiatry is involved in any bridge-building to the humanities.

Dr. Pies tells us that in his 35 years of practice, psychiatry has been such a bridge for him, and I certainly have no reason to doubt this.  But this is not, I suggest, an accurate description of psychiatry generally.  Indeed, with a measure of wistfulness, Dr. Pies himself concedes this point:

“Maybe that’s why I find it so troubling that many in the general public—and indeed, many within the profession—see psychiatry as having pitched its tent squarely and solely in the ‘biological’ camp.” [Emphasis added]

Note the phrase:  “…many within the profession…”  I would say the vast, vast majority within the profession, but let’s not quibble over details.

. . . . . . . . . . . . . . . . 

Back to Dr. Pies’ article: 

“This perception [that psychiatry has pitched its tent squarely and solely in the biological camp] is not without some foundation, and there is no question that, in the 1990s, American psychiatry took a ‘biological turn’ that has never fully swung back to the psychosocial end of the continuum.  But to view today’s psychiatry as merely biology-based is to see it ‘through a glass, darkly.’  When we look to the solid center of this profession, we see thousands of skilled clinicians, researchers, and teachers who are as comfortable with motives as with molecules. The solid center rejects the notion that we must choose between biology or psychology, between medication and psychotherapy.”

Well, perhaps we, on this side of the debate, are seeing psychiatry “through a glass darkly”, but I suggest it is more plausible that Dr. Pies is seeing his beloved profession through a rose-colored glass.  He tells us that there are  “thousands of skilled clinicians, researchers, and teachers who are as comfortable with motives as with molecules”.  This may be true.  But in their actual work, the vast majority of clinicians and researchers appear far more concerned with the latter.  Indeed, indifference to motivation has been enshrined in the DSM since Robert Spitzer’s DSM-III.  Within the context of “psychiatric diagnosis”, it doesn’t matter why a person might, for instance, be very suspicious of his neighbors.  If the suspiciousness crosses a vaguely-defined threshold of severity/implausibility, then it becomes a symptom of “schizophrenia”. Similarly, if a child is routinely disobedient to his/her parents, no attempt is made within psychiatry to explore why this might be so.  The disobedience is simply chalked up as a “symptom” of oppositional defiant disorder.  Similarly, no attention is given within the DSM as to why an individual is feeling depressed, anxious, angry, etc..  The presence of the particular thought, feeling, or behavior is all that’s needed to establish the “diagnosis”, and the “diagnosis” is all that’s needed to justify the prescription.  The why questions are never even asked.

Daniel Carlat, MD, Associate Clinical Professor of Psychiatry at Tufts, and author of the book Unhinged:  The Trouble with Psychiatry – A Doctor’s Revelations about a Profession in Crisis, is very open about this.  Here’s a quote from an interview he gave on NPR on July 13, 2010:

“…there’s kind of an unofficial policy among psychiatrists, at least among some, which is the don’t-ask-don’t-tell policy, which is that we have our patients coming in, we know we have 15 or 20 minutes to see them. We want to learn a certain amount about how they’re doing, obviously, because we want to make sure that our medications are working and that we know if we need to increase the dose or add something else.

But on the other hand, we don’t want to ask too many questions because if we start to hear too much information, then we’re going to run into a time issue where we’re going to have to kind of push them out of the office perhaps just at the point where they’re about to reveal something that could really be crucial to understanding their treatment.”

Sounds a bit like biological psychiatry to me.

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

Back to Dr. Pies:

“As a broad generalization, those in the center conceive psychiatric ‘disease’ as something that afflicts persons, not ‘minds’ or ‘brains’—a point stressed by the late Dr Robert Kendell.  Thus, the ‘mental versus physical’ debates are seen as sterile and fruitless. Those following the ‘Middle Path’ (to borrow a term from Buddhism) are preoccupied not with elaborate theories, but with relieving the suffering and incapacity of those who seek our help. Those in psychiatry’s solid center use the best established treatments to alleviate the patient’s illness—whether with ‘talk therapy,’ medication, or both.”

There are several noteworthy features in this paragraph.  Firstly, note that Dr. Pies has placed the word “disease” inside quotation marks.  In normal usage, this would indicate that he’s using the word to mean:  not a real disease. A  Freudian slip perhaps, as Dr. Pies has asserted the disease status of psychiatric “diagnoses” on many previous occasions.

Secondly, the first sentence in the above quote is a truly delightful piece of psychiatric spin.  Let’s open it up.  Dr. Pies is asserting that he and his right-minded colleagues in the “solid center” conceive of psychiatric disease as something that afflicts persons, not minds or brains.  But this is entirely incidental to the main issue.  Take, for example, depression.  Psychiatry conceives of this as an illness (provided a certain ill-defined level of severity is present) – specifically an illness of the brain.  Those of us on this side of the debate argue otherwise – that it is not an illness, but rather the normal, adaptive response to loss, or to an unfulfilling lifestyle.  But both groups agree, indeed it’s hard to imagine how we could disagree, that depression afflicts persons.  Even the most die-hard bio-reductionist would subscribe to that:  depression is a brain disease that afflicts the person who owns the brain!  While those of us on this side would say:  depression is a normal reaction to depressing events/circumstances that afflicts the person experiencing these events/circumstances.

What Dr. Pies has done here is make a statement that looks and sounds like an important distinction, but which in reality is banal to the point of meaninglessness.  And he’s used this non-distinction in his ongoing, futile attempt to defend his beloved profession.  But he’s avoiding the reality:  that psychiatry’s blatant promotion of its various illness theories is a hoax.

Thirdly, the statement “Thus, the ‘mental versus physical’ debates are seen as sterile and fruitless” has similar problems.  The issue is not “mental vs. physical”, posed by Dr. Pies as a kind of theoretical dichotomy.  The issue is whether or not depression, say, should be conceptualized as a normal response to depressing events/circumstances or as a neurological pathology.  This is not a sterile or fruitless debate, and by mischaracterizing it as such, Dr. Pies is either being deliberately deceptive, or has missed the point of the entire conflict.  In fact, whether depression should be conceptualized as a normal response or as a neurological pathology isn’t really a matter for debate at all.   It’s a question of fact:  do all the individuals whom psychiatry identifies as having depressive illness have a characteristic neural pathology?  After forty years of highly motivated and well-funded research, no such pathology has been identified, and the time honored notion, that depression is the normal response to depressing circumstances is as credible today as it has always been.

Fourthly, “Those following the ‘Middle Path’ (to borrow a term from Buddhism) are preoccupied not with elaborate theories, but with relieving the suffering and incapacity of those who seek our help.”  In other words, Dr. Pies and his stalwart colleagues from the solid center are not preoccupied with elaborate theories, (which is good to know, because as a general rule, most of his incursions in this area are riddled with error and fallacy), but with relieving the suffering and incapacity of those who seek their help.  And here again, dear readers, marvel at the spin – the implication, so beautifully and expertly wrapped up, that those of us who do feel strongly about psychiatric fallacy, deception, and destructiveness, are somehow neglecting our responsibilities to relieve the suffering and incapacity of those who seek our help.  Such cads we are.  But never worry, Dr. Pies and his cadre in the “solid center” will step into the breach of our remissness, pick up the slack, and minister dutifully to those who seek their help.  This is such a comfort!

As I’ve said on other occasions about Dr. Pies’ writings:  this is doctoral level spin.

. . . . . . . . . . . . . . . . 

Dr. Pies next provides brief sketches of Karl Jaspers, MD, Eric Kandel, MD, and Glen Gabbard, MD, all of whom Dr. Pies describes as exemplary of the “holistic tradition”.  These are interesting diversions, of course, but they shed no light on Dr. Pies’ primary thesis that “Most psychiatrists do not fit neatly into the biological or psychodynamic camp.”

CONCLUSION

The great irony of all this is that to the best of my knowledge, Dr. Pies has never aligned himself with the bio-reductionist majority, that has dominated psychiatry for the past 40 or 50 years.  But no amount of humanism or eclecticism can rescue him from  psychiatry’s fundamental and pervasive fallacy:  that all significant problems of thinking , feeling, and/or behaving regardless of their genesis – are illnesses.  The fact is that the vast majority of problems of thinking, feeling, and/or behaving are not illnesses, and that treating these problems as if they were illnesses is counter-productive, disempowering, stigmatizing, and deceptive.  This is the critical issue that no amount of psychiatric sophistry or verbal chicanery can neutralize.

Dr. Pies indicated in the article that he has a liking for poetry.  I also have a fondness for poetry, and in the current debate, I often find comfort in the poem Say not the Struggle nought Availeth, by the great Victorian poet Arthur Hugh Clough.  Here’s the third stanza:

“For while the tired waves, vainly breaking,
Seem here no painful inch to gain,
Far back, through creeks and inlets making,
Comes silent, flooding in, the main.”

The main, Dr. Pies, a symbol of that great, cleansing surge of truth and logic, whose flowing tide is already eating at psychiatry’s foundations, and which will one day, when the lifeline of pharma money dries up, wash psychiatry, and all its spurious trappings, into the depths of historical obscurity.

Psychiatry and the Pressure to Prescribe

Hugh Middleton, MD, posted  an interesting article on Mad in America, October 1, 2015.  It’s called Hey; Don’t Just Shoot the Messenger!    Dr. Middleton is a British psychiatrist who  is a founding member of the Critical Psychiatry Network, and was a co-author of the cardinal paper, Psychiatry beyond the current paradigm. (2012).

Dr. Middleton had attended a conference in London on September 18.  The conference had been organized by the Council for Evidence-based Psychiatry in order to address the topic:  “the iatrogenic harm caused by the over-prescription of psychiatric medications.”

Dr. Middleton’s paper is essentially his thoughts and reflections on this conference, and he raises some very fundamental points and questions which, in my view, warrant further discussion.  It is not particularly my intention to criticize Dr. Middleton’s paper, but rather to expand on some of the points he has made, and to supply some answers to the questions he has asked.  Here are some quotes from the article, interspersed with my comments and observations.

“Working as a psychiatrist exposes me to people who want medication as much as it does to those who don’t. We can question why and how those who want medication have come to that position, but it is commonly difficult to shift and the result is frequently a prescription with the advice ‘OK. If you want to find out whether meds can help, try this and see how you get on.’  Hardly expert knowledge or advice, but when it happens, most usually it is a response to a situation that would otherwise result in a request for another opinion and another doctor providing the prescription instead.”

I think it is indeed true that many people go to psychiatrists specifically to get drugs.  This is because it is widely known that psychiatrists will prescribe psychiatric drugs readily.  In fact, since about 1980 or so, they really don’t do much of anything else.

Dr. Middleton’s contention that this drug-seeking position is difficult to shift is probably true, but is not the primary issue, because in reality, most psychiatrists don’t try to challenge or shift that position.  For most psychiatrists, a “patient” returning at regular intervals for “med-checks” and refills is the ideal scenario. Within the psychiatric community, there is, I think, a great deal more concern expressed about non-compliant “patients” than there is about those who adhere faithfully to the prescription, and keep coming back for more.

In addition, defending the practice of over-prescribing on the grounds that refusal will simply drive the client to seek his drugs elsewhere strikes me as indefensible.  Essentially it amounts to:  “I must do something that’s ethically and professionally questionable, because if I don’t, somebody else will.”

. . . . . . . . . . . . . . . . . 

“Many of the distressing stories we heard at Roehampton were of people who had tried one antidepressant after another in the hope of relief … where was the belief that somehow, somewhere there is a pill that can safely and reliably relieve their distress coming from?”

Actually, it is psychiatry’s standard message, and has been for about the past 30 years:  we’ll try different medications, or combinations of medications, until we find the one that’s right for you:  the one that corrects the chemical imbalance in your brain.

In this regard, here are two quotes:  the first from the APA, and the second from the Mayo Clinic:

“Medication: Antidepressants may be prescribed to correct imbalances in the levels of chemicals in the brain. These medications are not sedatives, ‘uppers’ or tranquilizers. They are not habit-forming. Generally antidepressant medications have no stimulating effect on people not experiencing depression.

Antidepressants may produce some improvement within the first week or two of use. Full benefits may not be seen for two to three months. If a patient feels little or no improvement after several weeks, his or her psychiatrist can alter the dose of the medication or add or substitute another antidepressant.”  APA What is Depression 2015

“Medication strategies

If you’ve already tried an antidepressant and it didn’t work, don’t lose hope. You and your doctor simply may not have found the right dose, medication or combination of medications that works for you. Here are some medication options that your doctor may discuss with you:

Give your current medications more time. Antidepressants and other medications for depression typically take four to eight weeks to become fully effective and for side effects to ease up. For some people, it takes even longer.

Increase your dose. Because people respond to medications differently, you may benefit from a higher dose of medication than is usually prescribed. Ask your doctor whether this is an option for you — don’t change your dose on your own.

Switch antidepressants. For a number of people, the first antidepressant tried isn’t effective. You may need to try several before you find one that works for you.

Add another type of antidepressant. Your doctor may prescribe two different classes of antidepressants at the same time. That way they’ll affect a wider range of brain chemicals linked to mood. These chemicals are neurotransmitters that include dopamine, serotonin and norepinephrine.

Add a medication generally used for another condition. Your doctor may prescribe a medication that’s generally used for another mental or physical health disorder, along with an antidepressant. This approach, known as augmentation, may include antipsychotics, mood stabilizers (lithium or anti-seizure medications), anti-anxiety medications, thyroid hormone, beta blockers, stimulants or other drugs.” Mayo Clinic: Depression (major depressive disorder): Treatment-resistant depression 2015

. . . . . . . . . . . . . . . . 

Back to Dr. Middleton’s paper: 

“What was the person who went to the doctor because they were distressed by difficult circumstances actually looking for? They were having difficulty sleeping. The doctor might have prescribed a benzodiazepine sleeping pill, but we are all quite rightly very wary of benzodiazepines, and an SSRI is the more commonly used alternative. This is not because there is confidence it will work, but because that is all the doctor can do under such circumstances, and a prescription is frequently received as a symbolic token of concern and acknowledgment of the recipient’s difficulties.”

Actually, that is very emphatically not all that a physician can do under these circumstances.  A physician in these circumstances can (and, I suggest, should) conduct an examination to determine if the sleeplessness might be the result of an actual illness.  If, in the unlikely event that a genuine pathology is identified, the physician should either treat that pathology, or refer the patient to someone who can. But if no pathology is found, which would almost always be the case, the physician should inform the client that his sleeplessness is not a medical matter, and is therefore outside the scope of a physician’s practice.  The physician might also provide the person with a list of potentially helpful community resources.  Such a list might contain psychiatric survivor groups, life coaches, gymnasiums, nutritionists, counselors, etc…

Dr. Middleton’s contention that “…a prescription is frequently received as a symbolic token of concern and acknowledgment of the recipient’s difficulties” is probably true in some cases, but it is also somewhat condescending and patronizing, and does not constitute a justification for the prescribing of drugs that Dr. Middleton himself concedes are  “…of such dubious value…”, and that entail  “…so obvious a set of adverse effects…”

. . . . . . . . . . . . . . . . 

“I am sure practitioners reading this will recognise the cycle and the deeper and deeper holes they and their clientele can get into as it goes round and round, but what starts it? Why did that person go to the doctor when they were distressed by difficult circumstances?”

Here again, I think the answer to Dr. Middleton’s questions are clear.  Why do people consult psychiatrists when they are distressed by difficult circumstances?  Because for the past forty years, psychiatry, ably abetted by the pharmaceutical industry, has used every opportunity and every means at their disposal, to promote the hoax that distress (regardless of its source) constitutes an illness!  Since DSM-III (1980), any “…clinically significant behavioral or psychological syndrome or pattern that occurs in an individual and that is typically associated with…a painful symptom (distress)…” (DSM-III, p 6) is an illness, and psychiatry has incorporated this medical travesty into its daily business without any indication of compunction or misgiving.

Dr. Middleton goes on to ask:

“How can our institutions mark and respond to the fact that someone might have become overwhelmed and incapacitated by life’s challenges without having to identify them as ‘ill’?”

And here again, the answer is clear.  Our social, political, and community institutions cannot respond effectively and appropriately to individuals experiencing distress until the medical hoax has been exposed and ousted.  And the greatest obstacle to this exposure and ousting is psychiatry itself, whose response to the recent waves of criticism has been ever deeper entrenchment and ever more vehement insistence that their concepts are valid, and that their “treatments” are safe and efficacious.

No substantive progress is possible in the direction advocated by Dr. Middleton until psychiatry’s hoax is universally discredited and abandoned.

. . . . . . . . . . . . . . . . 

At this point Dr. Middleton moves, with enormous professional courage, to an even more fundamental issue:

“Put very bluntly, a lot of psychiatric prescriptions are issued (not only to detained patients) because a negotiation has been conducted between the prescriber, the patient and the patient’s associates resulting in ‘agreement’ that the patient should take something to quieten them down.”

Note that Dr. Middleton has not written that the individuals should take something to “treat their illnesses” or to “medicate their psychoses”.  The phrase he used is:  “to quieten them down”.  And in this regard, I think he is being entirely accurate and candid.

But his accuracy and candor inevitably compel us to ask, and indeed Dr. Middleton himself asks, a very important question:  why do we need to maintain the pretense that the individual has an illness, and that psychiatrists are the medical specialists who treat this illness, just to quieten someone down?  And we also need to address the entailed question:  why is it that the people whom psychiatry “quietens down”, are denied the rights and due process that have become an integral aspect of “quietening people down” in non-psychiatric contexts?

And here again, the answers are clear:  because psychiatry self-servingly and strenuously resists changes to the status quo in this area, and, at least here in the US, is avidly promoting legislation to expand its power, influence, and scope.

And, of course, the truly important question:  is this person, whom psychiatry deems to be in need of quietening down, actually expressing a genuine and important grievance in the only way that he or she knows how? never even gets asked.  Psychiatry, with its routine dismissal of people’s concerns as symptoms of illnesses, is the very epitome of disrespect.

The status quo is not the result of some blind or random historical processes.  Rather, it is the direct product of psychiatry’s insatiable lust for prestige and recognition, harnessed to pharma’s equally insatiable lust for profits.

. . . . . . . . . . . . . . . . 

“It isn’t nice, but very often psychiatrists find themselves powerless conduits of such forces [expectations of social order], and understanding what they do and why has to include a recognition of this. We have been drugging and incarcerating inconvenient people for centuries and although this must change, wider expectations remain and they are deeply embedded in our understanding of how an ordered society should conduct itself. Of course we have to shout as loudly as we can in criticism of those who cynically exploit the opportunities this provides, but we also have to address the core issues themselves.”

If Dr. Middleton is correct, and psychiatrists very often find themselves powerless conduits of the forces of social expectation, it has to be said that they have kept any misgivings that they entertain regarding such powerlessness deeply hidden.  I don’t ever recall hearing, or even hearing about, a psychiatrist who conceptualized the committal process as anything other than a necessary and benign step in the “treatment” of an “illness”, one of whose “symptoms” is anosognosia.  At the present time, here in the US, the Tim Murphy Bill is working its way through the legislature with the full and enthusiastic support of the American Psychiatric Association.

Dr. Middleton laments the fact that psychiatry has been  “…drugging and incarcerating inconvenient people for centuries…”, and although he calls for changes in this matter, he mitigates this call with the contention that  “…wider expectations remain…”

Dr. Middleton’s statements in this regard are not entirely clear, but he seems to be saying something along the lines:  there’s a dirty job here, and somebody has to do it.  This may indeed be true, but it skirts the fact that what makes psychiatric commitment and enforced drugging and electric shocks such a dirty job, is the deception, that it is being done to treat an illness.  This is the innermost core issue that we do indeed have to address.  And if the psychiatric hoax is eliminated, the other core issues actually become amazingly simple.  How can we, as a society, help people in distress, particularly those who have become agitated, aggressive, and/or suicidal?  Take the psychiatric elephant out of the living room, and an endless array of commonsense strategies present themselves.

People, both individually and collectively, have been successfully and compassionately ameliorating one another’s distress throughout human history.  It is not quantum physics, or high tech.  It involves no great biochemical or neurological insights.  There is no need for electrical equipment, and there are no treatment guidelines or treatment plans.

But when every potential strategy or development has to be subordinated to the fell hand of psychiatric hegemony, and when every proposal has to be integrated into the psychiatric hoax, genuine progress becomes impossible.

. . . . . . . . . . . . . . . . 

“Obviously there are those who think that what they do is appropriate and justified, but I would venture that many psychiatrists actually do what they do more often because they feel themselves to be powerless servants of wider social pressures, and would dearly like to be able to do it differently.”

Here again, I can only say that if indeed many psychiatrists feel themselves to be powerless servants of wider social pressures, they are keeping very quiet about it.  And as for the contention that they would dearly like to be able to do it differently, I can only ask:  what’s stopping them?

In my experience, psychiatrists generally are deeply attached to the medical model of human distress, and to the various broken brain theories, because, spurious and disempowering as these concepts are, they provide psychiatry with the appearance of legitimacy, and enable them to make a good living pushing pills.

I can accept that some psychiatrists “in their hearts” recognize that their profession is a sham, and that their “treatments” are a mockery of genuine medical practice, but it is also a stark reality that such misgivings seldom find expression in protests or other tangible action.  Dr. Middleton and the other members of the Critical Psychiatry Network are obvious exceptions to this observation, but it is also the case that they constitute a miniscule minority within the psychiatric community.

It is commendable and courageous of Dr. Middleton to address these issues in so outspoken a manner, but, in my view, his portrayal of psychiatrists as innocent victims of forces beyond their control is neither helpful nor convincing.  Psychiatrists embraced the expansion of their “diagnostic” net to include all manifestations of human distress, willingly and enthusiastically.  And they embraced the various chemical imbalance and other broken brain theories with the same self-serving ardor.  Neither these concepts, nor the actions on which these concepts confer the appearance of legitimacy, were forced on psychiatry.  Nor, in my view, is there any way that the embracing of these concepts and practices can be construed as honest error.  This was blatant and shameless turf-grabbing and drug-pushing.

Indeed, at the present time, when confronted with the kinds of criticisms embodied in Dr. Middleton’s own paper, it is the general response of psychiatry to re-affirm its commitment to these spurious concepts, to promote its principles and practices through PR and lobbying, and to denounce and marginalize its critics.  Only five months ago, the very eminent psychiatrist Jeffrey Lieberman, MD, Chair of Columbia Psychiatry Department and former President of the APA, denounced Robert Whitaker as “a menace to society”, on the grounds that Robert had expressed some criticisms of psychiatry, even though Robert’s criticisms have always been factual, measured, and respectfully worded.  That in itself was bad enough, but even more telling and disgraceful was the fact that, as far as I can ascertain, although there were some isolated expressions of disapproval from a few psychiatrists, there was no reaction of censure or disapproval from psychiatrists generally, or from any psychiatric association, to this extraordinarily uncivil, ungracious, and unprofessional remark.

Psychiatry is not something good that needs to engage in some soul-searching and minor corrections.  Rather, psychiatry is something fundamentally flawed and rotten.  It is, and consistently demonstrates itself to be, utterly beyond the remotest possibility of reform.

Book Review:  Depression Delusion, by Terry Lynch, MD, MA

In this truly remarkable, and meticulously researched, volume, Dr. Lynch annihilates psychiatry’s cherished chemical imbalance theory of depression.  Every facet of this theory, which the author correctly calls a delusion, is critically analyzed and found wanting.  Example after example is provided of psychiatrists promoting this fiction, the factual and logical errors of which are clearly exposed in Dr. Lynch’s lucid, seamless, and highly readable prose.

The book runs to 343 pages, and is laden with factual details, case studies, alternative perspectives, and hard-hitting commentary.  Dr. Lynch does not sit on the sidelines, nor does he seek any kind of collegial compromise with the chemical imbalance theory, which he unambiguously denounces as a groundless and destructive falsehood.  Here are some quotes that I think will convey something of the content, style, and cogency of this vitally important work.

“The world is engulfed in a mass delusion regarding depression.  The widespread belief that brain chemical imbalances are present in depression has no scientific basis.  In fact, this is a fixed belief that meets all the criteria of a mass delusion.  If you are one of the millions of people who believe that biochemical brain imbalances are known to occur in depression, then you too have become seriously misinformed.” (p 1)

“Despite the obvious complexity of the brain, some psychiatrists and GPs profess an understanding of this organ that is highly inconsistent with current scientific knowledge.  Their comments smack of a level of arrogance that in my opinion is downright dangerous.” (p 65)

“The brain chemical imbalance delusion has dominated medical, psychological and public thinking about depression for the past fifty years.  Parties with a vested interest see nothing wrong with this.  Nor do the vast majority of the general public, for whom the depression brain chemical imbalance idea feels as familiar and logical as raised blood sugar in diabetes.  There are two main reasons why psychiatrists and GPs have embraced the biochemical imbalance delusion with such enthusiasm.  This notion portrays doctors and their drug treatment in a positive light, as real doctors treating biological abnormalities consistent with the treatment of diseases generally in medicine.  Secondly, having observed for thirty years how my medical colleagues in psychiatry and general practice work, I do not believe they know any other way of understanding or responding to depression other than as an assumed biological abnormality.  I remain unconvinced that there is sufficient breadth of vision within mainstream psychiatry or medicine to see or to move beyond the rigidly held belief that depression is primarily a biological disorder.  Yet, the majority of the experiences categorized as depression are primarily emotional and psychological or have a significant emotional input.” (p 77)

“It is misleading to state that the brain chemistry of depression is not fully understood, when in truth it is really not understood at all.  It is also misleading to state that ‘research suggests’ that ‘depression is caused by an imbalance’ of brain chemicals.  It is drug companies, doctors and researchers who suggest this, not the research itself. As outlined in detail earlier the research itself does not suggest this at all and indeed contradicts this notion.” (p 149)

“In twenty years as a medical doctor, I have never, ever heard of a patient anywhere having their serotonin levels checked.”(p 153)

“Low serotonin cannot ever be identified since brain serotonin cannot be measured and we do not know what serotonin levels should or should not be.” (p 165)

“Providing societies with an apparently trustworthy rationale for avoiding the reality of human distress has resulted in increasingly costly mental health services within which recovery is a far rarer outcome than it should be.  Since the core issues are repeatedly side-stepped, they are not addressed or recognized within these mental health systems.  It is not surprising that the costs of such systems keep increasing with little hard evidence that these systems are providing value for money in terms of recovery.” (p 237)

“The most beneficial position for psychiatry is therefore the one that currently pertains.  By nailing its colours to the biological mast, psychiatry has successfully set itself apart from talk therapies.  As long as no biological abnormalities are reliably identified, there is no threat that their bread and butter will be removed from them to other medical specialties.  Maintaining the myth that biological solutions are just around the corner satisfies the public and maintains psychiatry’s position quite satisfactorily from psychiatry’s perspective, albeit between a rock and a hard place.  This position has no solid scientific foundation, but as long as the public do not realize this and psychiatry does not attempt to encroach on the territory of other medical specialties such as neurology, psychiatry’s position is secure.”  (p 277)

“When basic principles of correct reasoning and science are applied to the brain chemical imbalance idea, the flaws and inconsistencies of this belief become obvious.  When the depression brain chemical imbalance idea is rigorously examined, we find that like the emperor, it has no clothes.  These flaws and inconsistencies were known prior to Prozac coming on stream in 1988.  They were dismissed because they risked ruining a great story, from which many groups could profit enormously.” (p 342)

For those who wish to pursue topics further, there is a reference list at the end of each chapter.  There is also a comprehensive index and table of contents which make it easy to find specific sub-topics.

Pharma-psychiatry’s chemical imbalance theory of depression is one of the biggest and most destructive hoaxes in human history.  Dr. Lynch’s Depression Delusion might well be the work that finally lays this hoax to rest, and exposes the self-serving deceptiveness that has become a routine part of psychiatry’s endeavors.

Please read this book, keep it close to hand for reference, and encourage others to read it also.  Ask your library to buy a copy.  The spurious chemical imbalance theory is now so widely accepted that it will take enormous efforts to dislodge it.  In any debate on this matter, Dr. Lynch’s book will, quite literally, put the facts at your fingertips.

The Spurious Chemical Imbalance Theory is Still Alive and Well

On April 5, 2015, Scott Alexander, MD, a trainee psychiatrist, posted an article titled Chemical Imbalance on his website Slate Star Codex.  (The writer tells us that Scott Alexander is a blog handle and not his real name, but for convenience, I will refer to him as Dr. Alexander.)

Dr. Alexander begins by noting that there have been a number of articles recently that have criticized psychiatry for “botching the ‘chemical imbalance’ theory.”

“According to all these sources psychiatry sold the public on antidepressants by claiming depression was just a chemical imbalance (usually fleshed out as ‘a simple deficiency of serotonin’) and so it was perfectly natural to take extra chemicals to correct it.”

“This narrative is getting pushed especially hard by the antipsychiatry movement, who frame it as ‘proof’ that psychiatrists are drug company shills who were deceiving the public.”

[Actually, it’s proof that psychiatrists are either very misinformed or very deceptive.  Proving that many of them are drug company shills is a separate matter.]

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

As an example of this trend, he cites an article of mine that was published on Mad in America on June 6, 2014.  The article was titled Psychiatry DID Promote the Chemical Imbalance Theory, and was written specifically as a response to three statements made by the eminent psychiatrist Ronald Pies, MD.  Here are the three statements:

“…the ‘chemical imbalance theory’ was never a real theory, nor was it widely propounded by responsible practitioners in the field of psychiatry.” (April 15, 2012)

“In truth, the ‘chemical imbalance’ notion was always a kind of urban legend – never a theory seriously propounded by well-informed psychiatrists.’ (July 11, 2011)

“But I stand by my claim that no respected representatives of the profession seriously asserted a simple, ‘chemical imbalance’ theory of mental illness in general.” (September 2, 2011; response to comment on July 11, 2011 article)

My article was lengthy (6079 words), and I quoted seven prestigious psychiatrists in which a simplistic chemical imbalance theory was promoted unambiguously.

“In the last decade, neuroscience and psychiatric research has begun to unlock the brain’s secrets.  We now know that mental illnesses – such as depression or schizophrenia – are not “moral weaknesses” or “imagined” but real diseases caused by abnormalities of brain structure and imbalances of chemicals in the brain.”  Unlocking the Brain’s Secrets, by Richard Harding, MD, then President of the APA, in Family Circle magazine, November 20, 2001, p 62.

“ADHD often runs in families.  Parents of ADHD youth often have ADHD themselves.  The disorder is related to an inadequate supply of chemical messengers of the nerve cells in specific regions of the brain related to attention, activity, inhibitions, and mental operations.”  Paying Attention to ADHD, by Timothy Wilens, MD, Associate Professor of Psychiatry at Harvard Medical School, and Psychiatrist at Massachusetts General Hospital.  Op. Cit., p 65

“…the way nerves talk to each other, and communicate, is through the secretion of a chemical called a neurotransmitter, which stimulates the circuit to be activated.  And when this regulation of chemical neurotransmission is disturbed, you have the alterations in the functions that those brain areas are supposed to, to mediate.  So in a condition like depression, or mania, which occurs in bipolar disorder, you have a disturbance in the neurochemistry in the part of the brain that regulates emotion.”  Causes of Depression, a video by Jeffrey Lieberman, MD, Psychiatrist-in-Chief at NewYork Presbyterian/Columbia University Medical Center, and then President-elect of the APA.  Video made by The University Hospital of Columbia and Cornell. (June 19, 2012)

“The various forms of mental illness are due to many different types of brain abnormalities, including the loss of nerve cells and excesses and deficits in chemical transmission between neurons; sometimes the fault may be in the pattern of the wiring or circuitry, sometimes in the command centers, and sometimes in the way messages move along the wires.” (p 221) [Emphasis added] Nancy Andreasen’s book The Broken Brain: The Biological Revolution in Psychiatry (1984).  Nancy Andreasen, MD, PhD, is Chair of Psychiatry at the University of Iowa.  She served on the DSM-III and DSM-IV Task Forces, and is past president of the American Psychopathological Association and the Psychiatric Research Society.

“Since the pharmacological agents that ameliorate depression and mania appear to act upon and alter the concentration and metabolism of the biogenic amines in what are presumably corrective directions, it may be inferred that in the affective disorders there exists a chemical pathology related to these compounds…positive evidence is slowly accumulating and negative evidence is thus far lacking.” [Emphasis added] opinion piece for the American Journal of Psychiatry (September, 1970, p 133), titled Affective Disorders:  Progress, But Some Unresolved Questions Remain, by Morris Lipton, PhD, MD.  The late Dr. Lipton was Chair of Psychiatry at Chapel Hill at the time of writing.

“Depression is known to be caused by a deficit of certain neurochemicals or neurotransmitters, especially norepinephrine and serotonin.” (p 47) Daniel Amen, MD, from his bestselling book Change Your Brain, Change Your Life (1998)

 I also provided the following quote from the psychiatry textbook Psychiatry (2003),  Tasman, Kay, and Lieberman (eds.)

“A final reason for studying the mechanisms of psychopathology is to inform our patients, their families, and society of the causes of mental illness.  At some time in the course of their illness, most patients and families need some explanation of what has happened and why.  Sometimes the explanation is as simplistic as ‘a chemical imbalance,’ while other patients and families may request brain imaging so that they can see the possible psychopathology or genetic analyses to calculate genetic risk.” (p 290, Vol 1)

I made the point that although this passage is not entirely clear, it does suggest that it is OK to tell clients and their families the chemical imbalance lie if they ask for an explanation.

Dr. Alexander reproduces two of my quotes – those from Drs. Harding and Lieberman – and continues:

“I have no personal skin in this game. I’ve only been a psychiatrist for two years, which means I started well after the term ‘chemical imbalance’ fell out of fashion. I get to use the excuse favored by young children everywhere: ‘It was like this when I got here’. But I still feel like the accusations in this case are unfair, and I would like to defend my profession.”

And here’s his defense: [incidentally, he confuses Mad In America with me personally, but his meaning is clear.]

“I propose that the term ‘chemical imbalance’ hides a sort of bait-and-switch going on between the following two statements:

(A): Depression is complicated, but it seems to involve disruptions to the levels of brain chemicals in some important way

(B): We understand depression perfectly now, it’s just a deficiency of serotonin.

If you equivocate between them, you can prove that psychiatrists were saying (A), and you can prove that (B) is false and stupid, and then it’s sort of like psychiatrists were saying something false and stupid!

But it isn’t too hard to prove that psychiatrists, when they talked about ‘chemical imbalance’, meant something more like (A). I mean, look at the quotes above by which Mad In America tries to prove psychiatrists guilty of pushing chemical imbalance. Both sound more like (A) than (B). Neither mentions serotonin by name. Both talk about the chemical aspect as part of a larger picture: Harding in the context of abnormalities in brain structure, Lieberman in the context of some external force disrupting neurotransmission. Neither uses the word ‘serotonin’ or ‘deficiency’. If the antipsychiatry community had quotes of APA officials saying it’s all serotonin deficiency, don’t you think they would have used them?”

In other words, he’s saying that the quotes from Drs. Harding and Lieberman were not simplistic chemical imbalance assertions, but were in fact more nuanced, and that they recognized the complicated, contextual aspects of depression.

So let’s take a look at the quotes in detail.  First, Dr. Harding:

  1. Neuroscience and psychiatric research has begun to unlock the brain’s secrets.
  2. We now know [note the unambiguous expression of certainty]
  3. that mental illnesses such as depression or schizophrenia
  4. are not ‘moral weaknesses’ or ‘imagined’,
  5. but real diseases
  6. caused by abnormalities of brain structure and imbalances of chemicals in the brain.

And Dr. Lieberman:

  1. Brain circuits are activated by neurotransmitters.
  2. Disturbances in this chemical neurotransmission lead to disturbances in function.
  3. So [implying causality],
  4. in depression or mania, there is a disturbance in brain neurochemistry.

Dr. Alexander contends that these quotes do not promote a simplistic chemical imbalance theory because:

1.  Neither mentions serotonin by name! I had never said that they mentioned serotonin by name.  Nor had there been any mention of serotonin in Dr. Pies’ original statements.  The issue was (and still is) that they promoted the chemical imbalance theory.  Dr. Alexander’s introduction of serotonin is irrelevant, and is, I suggest, an example of precisely the kind of intellectual dishonesty which he attributes to me.

2.  Both talk about the chemical aspect as part of a larger picture. This is simply false.  Dr. Harding clearly cites “imbalances of chemicals’ as a cause of mental “diseases”.  The fact that he also promotes abnormalities of brain structure does not modify or contextualize the primary contention.  And the fact that his article was embedded in a five-page “Special Advertizing Feature” for Paxil leaves little room for doubt as to his meaning. 

3.  Dr. Alexander contends that Dr. Lieberman’s statements about chemical imbalance was made in the context of  “…some external force disrupting neurotransmission.”  This, I suggest, is a very creative reading of Dr. Lieberman’s statement:

“And when this regulation of chemical neurotransmission is disturbed, you have the alterations in the functions that those brain areas are supposed to, to mediate.  So in a condition like depression, or mania, which occurs in bipolar disorder, you have a disturbance in the neurochemistry in the part of the brain that regulates emotion.”

Dr. Lieberman makes no reference to an external force disrupting neurotransmission, but even if such an external force were implied, the fundamental message is clear:  conditions like depression and mania are caused by disturbances in chemical neurotransmission, i.e. chemical imbalances!

. . . . . . . . . . . . . . . . 

It’s noteworthy that Dr. Alexander made no mention of the other quotes in my article, e.g:

Nancy Andreasen, MD, an eminent psychiatrist:

“The messages passed along these circuits are transmitted and modulated primarily through chemical processes.  Mental illnesses are due to disruptions in the normal flow of messages through this circuitry” (p 219)

Daniel Amen, MD, successful CEO and Medical Director of six psychiatric clinics, and a Distinguished Fellow of the APA:

“Depression is known to be caused by a deficit of certain neurochemicals or neurotransmitters, especially norepinephrine and serotonin.”

There’s not much ambiguity there.

And, incidentally, Dr. Alexander’s statement:  “If the antipsychiatry movement had quotes of APA officials saying it’s all serotonin deficiency, don’t you think they would have used them?” is a red herring.  In Dr. Pies’ original statements, to which I was responding, there’s no mention of APA officials.  Rather, Dr. Pies’ contentions embraced “responsible practitioners in the field of psychiatry”; “well-informed psychiatrists”; and “respected representatives of the profession”.

. . . . . . . . . . . . . . . . 

In addition, I also provided numerous unambiguous quotes promoting the chemical imbalance theory from :

  • Child and Adolescent Bipolar Foundation;
  • Depression and Bipolar Support Alliance;
  • Mental Health America; and
  • National Alliance for the Mentally Ill

and I pointed out that all of these organizations had eminent psychiatrists on their advisory boards, and that it was reasonable to infer that these advisers approved, or at least had made no objection to, the chemical imbalance messages.

. . . . . . . . . . . . . . . . 

Nevertheless, Dr. Alexander concluded:

“So if you want to prove that psychiatrists were deluded or deceitful, you’re going to have to disprove not just statement (B) – which never represented a good scientific or clinical consensus – but statement (A). And that’s going to be hard, because as far as I can tell statement (A) still looks pretty plausible.”

Dr. Alexander himself concedes that statement (B) is false, but he refuses to accept the evidence I presented in the quotes – clear evidence that leading psychiatrists did promote the simplistic and false chemical imbalance theory.  And I should stress that I limited my search to psychiatrists who had achieved a measure of eminence and stature in their field (because that was the challenge presented by Dr. Pies).  If I had widened my search to include less prestigious psychiatrists, I’m sure I could have found a great many more.  The fact is that the promotion of the chemical imbalance theory is no secret.  I have personally heard dozens of psychiatrists proclaim it with total confidence, and I truly could not begin to estimate the number of clients I’ve talked to over the years who told me that their psychiatrists had told them they had a chemical imbalance in their brains, and that they needed to take the pills for life to correct this imbalance.  Even today, I regularly receive emails from readers contesting the assertions in my posts and telling me in no uncertain terms that they have chemical imbalances in their brains that cause their problems.

In addition, the simplistic chemical imbalance theory is still being promoted by some prestigious psychiatrists.  Cognitive Psychiatry at Chapel Hill (CPCH) has published 10 Common Myths About Psychiatry on their webpage.  Here are two quotes:

“Actually, the majority of patients we see have an actual illness or imbalance (much like diabetes), that with the proper treatment, the imbalance is corrected and they are no longer ill.”

“… many patients that see a Psychiatrist actually have an illness or imbalance that is causing a mental discrepancy. Once this imbalance is corrected, they are, in fact, cured of their mental illness.”

. . . . . . . . . . . . . . . . 

Dr. Alexander’s article was critiqued on Mad in America by Rob Wipond on April 15, 2015.  Rob’s article cites numerous other examples of psychiatrists promoting the chemical imbalance theory of depression.

The promotion of the chemical imbalance theory did occur, and continues to occur, and is a most shameful chapter in psychiatry’s history.  It is arguably one of the most destructive, far-reaching, and profitable hoaxes in history.

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

But, although the chemical imbalance theory has been soundly refuted, and the more astute psychiatrists, such as Dr. Pies, are actively distancing themselves from it, Dr. Alexander is clearly still a believer.  Here’s his final paragraph:

“So this is my answer to the accusation that psychiatry erred in promoting the idea of a ‘chemical imbalance’. The idea that depression is a drop-dead simple serotonin deficiency was never taken seriously by mainstream psychiatry. The idea that depression was a complicated pattern of derangement in several different brain chemicals that may well be interacting with or downstream from other causes has always been taken seriously, and continues to be pretty plausible. Whatever depression is, it’s very likely it will involve chemicals in some way, and it’s useful to emphasize that fact in order to convince people to take depression seriously as something that is beyond the intuitively-modeled ‘free will’ of the people suffering it. ‘Chemical imbalance’ is probably no longer the best phrase for that because of the baggage it’s taken on, but the best phrase will probably be one that captures a lot of the same idea.”

This paragraph is not entirely clear, but here’s my best shot at a paraphrase:

  1. Psychiatry never promoted a simple chemical imbalance theory.
  2. But psychiatry did promote a complicated chemical imbalance theory.
  3. The complicated chemical imbalance theory is plausible.
  4. There are chemicals involved in depression. [This is non-contentious.  Brain chemicals are involved in literally everything humans do, think, and feel, from the simplest eyeblink, to writing great works of art, and everything in between.]
  5. It’s useful to emphasize that brain chemicals are involved in depression, in order to convince people that depression is a serious problem that can’t be conceptualized in ordinary human terms.
  6. But we can’t use the term “chemical imbalance” any more because it’s been outed as a hoax.
  7. We need a new phrase that will mean essentially the same thing.

How about Chemical Imbalance, Version II?

And lest I be accused of putting words in Dr. Alexander’s mouth, here are some quotes from earlier in his paper:

“In other words, everything we do is caused by brain chemicals, but usually we think about them on the human terms, like ‘He went to the diner because he was hungry’ and not ‘He went to the diner because the level of dopamine in the appetite center of his hypothalamus reached a critical level which caused it to fire messages at the complex planning center which told his motor cortex to move his legs to…’ – even though both are correct. Very occasionally, some things happen that we can’t think about on the human terms, like a seizure – we can’t explain in terms of desires or emotions or goals an epileptic person is flailing their limbs, so we have to go down to the lower-level brain chemical explanation.

What ‘chemical imbalance’ does for depression is try to force it down to this lower level, tell people to stop trying to use rational and emotional explanations for why their friend or family member is acting this way. It’s not a claim that nothing caused the chemical imbalance – maybe a recent breakup did – but if you try to use your normal social intuitions to determine why your friend or family member is behaving the way they are after the breakup, you’re going to get screwy results.”

So if a person is despondent because of a marital break-up, one can’t conceptualize his despondency in ordinary human terms.  Doing so will produce “screwy results”.

“There’s still one more question, which is: are you sure that depression patients’ experience is so incommensurable with healthy people’s experiences that it’s better to model their behavior as based on mysterious brain chemicals rather than on rational choice?”  [Note the spurious implication that there are only two options.]

“And part of what I’m going on is the stated experience of depressed people themselves. As for the rest, I can only plead consistency. I think people’s political opinions are highly genetically loaded and appear to be related to the structure of the insula and amygdala. I think large-scale variations in crime rate are mostly attributable to environmental levels of lead and probably other chemicals. It would be really weird if depression were the one area where we could always count on the inside view not to lead us astray.”

And there it is – the very core of bio-psychiatry!  Political opinions (and, presumably political activity), criminal behavior, and, by implication pretty much anything else that we do think, or feel, are all best conceptualized in terms of brain structure and chemicals.

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

Twenty-five years ago an elderly friend of mine lost his wife in a car accident.  They had been married for sixty years.  I visited him, and found him understandably despondent.  His demeanor, normally active and curious, was downcast and withdrawn.  His face was haggard; his shoulders slumped; he was at times tearful; and his gait was slow and heavy.  We talked, and he told me that he felt utterly lost.  I asked him what was the worst thing about his situation.  He thought for a long while, then said:  “I have nobody to talk to.”

His words, which I’ve never forgotten, seemed to me to embody some of the essential elements of grief and despondency:  loneliness, helplessness, and isolation.  But according to Dr. Alexander, this kind of thinking is “screwy”.  Despondency is really a matter of chemicals, and we need to “convince” people to abandon their intuitive assessments of their feelings of despondency, and to recognize the psychiatric “truth” that, whatever its trigger, depression is essentially  “…a complicated pattern of derangement in several different brain chemicals…”.  And we should embrace this “truth”, despite the fact that several decades of highly motivated research has failed to identify any such “derangement” or “imbalance” or whatever similar term Dr. Alexander would choose.

So, just when we imagined that we had begun to lay this particular piece of inanity to rest, here it is surging back from a brand new psychiatrist, prescription pen poised, ready to put the world to rights, one aberrant molecule at a time.

This isn’t just faulty logic and poor science.  It is a fundamentally dehumanizing and intrinsically disrespectful way of conceptualizing human loss and suffering.

 

The Chemical Imbalance Theory:  Still Being Promoted

On November 28, Psychiatric Times published an article titled Psychiatric Diagnosis and Treatment of Somatizing Neuropsychiatric Disorders.  The authors are Daniel T. Williams, MD, and Alla Landa PhD, both from Columbia University Psychiatry Department.

The article’s lead-in states:

“Although the somatizing disorders cover a vast array of symptomatic domains across many medical specialties, this article addresses the broad topic conceptually.”

The so-called somatizing disorders have an interesting history in psychiatry.  DSM-III-R (1987) states:

“The essential features of this group of disorders are physical symptoms suggesting physical disorder (hence, Somatoform) for which there are no demonstrable organic findings or known physiologic mechanisms, and for which there is positive evidence, or a strong presumption, that the symptoms are linked to psychological factors or conflicts.” (p 255)

DSM-IV (1994) states:

“The common feature of the Somatoform Disorders is the presence of physical symptoms that suggest a general medical condition (hence, the term somatoform) and are not fully explained by a general medical condition, by the direct effects of a substance, or by another mental disorder (e.g., Panic Disorder).” (p 445)

DSM-5 (2013) states:

“All of the disorders in this chapter [Somatic Symptom and Related Disorders] share a common feature:  the prominence of somatic symptoms associated with significant distress and impairment.” (p 309)

Note that the requirement that the symptoms are not fully explained by a general medical condition has been dropped from DSM-5.  In this latest edition of the manual, the only requirements are that the symptoms are distressing, disruptive, and excessive, the assessment of which is inevitably subjective.

Note also that Drs. Williams and Landa refer to these “diagnoses” as neuropsychiatric disorders, essentially begging the question that they involve neurological pathology.  There is no evidence to support this position.  Nor is there any rational support for the notion that worries and concerns about medical matters should be conceptualized as illnesses, even if the individual’s level of distress and preoccupation is extreme.  But a detailed critique of this matter is beyond the scope of this post.

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

The Williams and Landa article is detailed and comprehensive.  It addresses the phenomenology, epidemiology, and developmental course of the so-called somatization disorders.  Under the heading “Postulated pathogenic influences,” the authors present working hypotheses from psychoanalytic theory, learning theory, behavior analysis, social-affective neuroscience, autoimmune sensitization, and theories of dissociation.

On the topic of social-affective neuroscience, the authors state:

“Recent advances in social-affective neuroscience suggest that early interpersonal environment may interact with genetic predisposition and epigenetic changes to affect the neural circuits involved in interpersonal emotions and physical pain. This type of predisposition makes a person particularly sensitive to emotional stressors and presents difficulties in regulating emotional and somatic distress 12.  This could explain the variable vulnerability to somatization under similar stressors among different individuals. It also points to the need to carefully evaluate these relevant vulnerabilities in psychotherapeutic exploration of each patient’s unique biographical narrative.”

The essential point being expressed here is that people develop “excessive” concern about their health or “excessive” sensitivity to pain, because of neural circuitry anomalies.  These anomalies, in turn, stem from the interaction of a hypothesized genetic predisposition and the individual’s early interpersonal environment.

Aberrant neural circuits are fast replacing the discredited chemical imbalances that constituted the cornerstone of biopsychiatry until effectively debunked by psychiatry’s critics.  At present, the aberrant circuits are being postulated with a measure of caution; note the terms “suggest” and “could explain” in the above quote. But in general, the circuitry hypothesis is being actively promoted, and is gathering a good deal of traction.

Incidentally, reference # 12, cited in the above quote, is to an article by Dr. Landa and two other Columbia researchers.  Here’s the final statement from the abstract:

“Specifically, the proposed theory and research review suggest that psychotherapeutic and/or pharmacological interventions that foster the development of affect regulation capacities in an interpersonal context will also serve to more effectively modulate aberrantly activated neural pain circuits and thus be of particular benefit for the treatment of somatoform pain.”

Note:  “…psychotherapeutic and/or pharmacological interventions…”, and particularly the suggestion, which is also becoming common in psychiatric circles, that psychotherapy and drug treatment have essentially the same effect:  the modulation of “aberrantly activated” neural circuits.

Certainly psychotherapy affects people’s brains.  All human activity affects the brain. But the notion that talking to a person empathically and sincerely (whether in a professional capacity or simply as a friend) is on a par with the ingestion of psychiatric drugs makes a mockery of human interaction.

The authors discuss the treatment implications of these various “postulated pathogenic influences,” including the need to restructure learned patterns and the establishing of therapeutic rapport.  Under the heading “Approach to treatment,” the authors stress the importance of psychosocial factors:

“…do the symptoms serve to avoid a constellation of stressors with ensuing functional impairment, by allowing the patient to retreat into ‘the sick role’? Moreover, might the symptoms be the body’s reaction to overwhelming stress?”

“Many patients may not be able to articulate the complex environmental stressors that produce feelings of shame or inadequacy. They may cling to the identity of the medically ill patient as a ‘safer’ refuge from life’s adversities. Therefore, the psychiatrist should present the diagnostic hypothesis of SSD tentatively and supportively, noting that it is not mutually exclusive of coexisting physical illness.”

Under the heading “Treatment options,” Drs. Williams and Landa list and discuss:

  • Reassurance, placebo, suggestion and psychoeducation
  • Individual or family psychotherapy
  • Psychodynamic strategies
  • Behavior modification
  • Cognitive-behavioral therapy
  • Group psychotherapy
  • Mindfulness, meditation, progressive relaxation, deep breathing

All of this, apart from the unwarranted implications of neurological illness, sounds fairly encouraging.  But then there’s this:

“Psychopharmacological agents may have specific therapeutic benefit for comorbid psychiatric disorders, including anxiety, depression, obsessive-compulsive disorder, and psychosis, all of which may coexist with and complicate SSDs. In addition, these agents may have nonspecific (placebo) benefits. For patients who have difficulty in grasping the concept of somatization, who have discomfort with psychotherapy, or who want a ‘medicine’ to legitimize the validity of their physical illness and recovery, a supportive discussion of the role of these medications in normalizing brain neurotransmitter function can be helpful. The medicine can be the needed aid that helps the psychotherapy go down.” [Emphasis added]

The fact is that there are no psychiatric drugs that normalize brain neurotransmitter function.  Indeed, the opposite is the case.  Every psychiatric drug on the market today produces abnormal brain function.  So either Drs. Williams and Landa aren’t aware of this, or they are advocating that therapists should deceive their clients on this very fundamental issue.

Unfortunately, but perhaps inevitably, this kind of patronizing disrespect is still widespread in psychiatry, and is fundamentally incompatible with the lofty rapport-building and therapeutic sentiments expressed earlier in the article.  Therapeutic rapport and systematic deception are mutually exclusive.

The very eminent psychiatrist Ronald Pies, MD, has written that the chemical imbalance theory is a kind of “urban legend” – never promoted by well-informed psychiatrists.  Well, Dr. Williams, according to his bio, has been on the faculty at Columbia University for forty years!  He has authored more then 60 publications in peer-reviewed journals and standard textbooks in the fields of psychiatry and neurology.  I think it is reasonable to suppose that he would meet Dr. Pies’ standards for being well-informed, and yet here he is advocating the promotion of the spurious chemical imbalance theory!