More Bipolar Disease Mongering in a Respected Journal.

“The drug companies learned a while back that the best way to sell drugs was to sell diagnoses… selling the diagnosis is a way of opening up the new market. New diagnoses are as dangerous as new drugs, at least in psychiatry.”~ Dr Allen Frances, chair of DSM IV task force - Selling Sickness conference, 2011.

One of the main themes of both my book How Dysfunctional Families Spur Mental Disorders and this blog has been the incredible expansion of the bipolar diagnosis to anyone who is moody, chronically depressed and irritable, or chronically agitated. 

This has been done predominantly by some egocentric blowhard psychiatrists trying to make a name for themselves in conjunction with a well-documented and highly successful plan by several pharmaceutical companies to enlarge the market for their brand named, so-called atypical antipsychotics.  This marketing plan was documented with the release of Eli Lilly's own company marketing memos as part of a US Justice Department investigation - the so called Zyprexa Documents. These medicines are potentially toxic and do nothing to solve the interpersonal and psychological problems of many of the mental health patients to whom they are prescribed.

My colleague in Australia, Peter Parry, told me,  "Our director of training for psychiatry in our state quipped sarcastically that we may as well subsitute “mental disorder” with “bipolar disorder” and have the “DSM of Bipolar Disorders” and then recategorise subtypes like ‘adjustment bipolar disorder,’‘personality-based bipolar’ etc."  With some of the psychiatrists I know personally, this would actually be considered a good idea!

Many of the adults misdiagnosed with bipolar actually carry the diagnosis of borderline personality disorder and not bipolar. While medication can help these folks with some symptoms, most of these patients are in dire need of good psychotherapy.  Unfortunately, a lot of therapists do not like to work with them, so many end up seeing psychiatrists who use antipsychotics basically to shut them up.

"Disease mongering" is a term used for marketing techniques designed to accomplish what Dr. Frances alluded to at the top of this post.  The ongoing mongering of bipolar disorder by the pharmaceutical companies uses many tricks.  Often so-called researchers and practitioners alike do totally inadequate diagnostic evaluations using highly inaccurate and misleading symptom checklists; others employ the completely unvalidated concept of bipolar spectrum, or b.s. as I like to call it.

Bipolar ver. 4.1

A highly transparent example of disease-mongering was just published in a respected psychiatric journal, the Archives of General Psychiatry.  521 hospital-based or community psychiatrists in 18 countries in Asia, Europe, and Africa between April 1, 2008, and April 30, 2009 were involved in a “research” project which was designed to shape their thinking and diagnosing, and altering diagnostic paradigms in those countries.



The article is titled “Prevalence and Characteristics of Undiagnosed Bipolar Disorders in Patients With a Major Depressive Episode” and was “designed, conducted and prepared” by Sanofi-Aventis. Sanofi-Aventis markets an atypical antipsychotic named Solian, which is the brand name of the drug amisulpride.  It is not FDA-approved in the United States, which is probably one reason why this study was done overseas.

The supposed "results" of the study:

“These results are from a large, 3-continent, culturally generalizable study conducted by practicing psychiatrists. The data indicate that, whereas with application of the DSM-IV-TR criteria, 16.1% of patients with Major Depressive Episodes met criteria for either bipolar I or bipolar II disorder, this rate rose to 47% with application of the bipolarity-specifier criteria.

These results suggest that bipolar features are more frequent in patients with MDE than indicated by DSM-IV-TR criteria. Almost half of the entire 5098 cohort presented the core symptoms of bipolarity (elevated mood, irritable mood, or increased activity), and these symptoms led to unequivocal changes in behavior that were observable by others in a similar proportion of patients.”

What this means is that, if this were true, half of patients who exhibit Major Depressive Episodes are actually bipolar and should  be taking “mood stabilizers.” Not lithium, I suppose, but antipsychotics. 

The article  goes on to state: “Major depressive disorder, the most common psychiatric illness, is often chronic and a major cause of disability. Many patients with major depressive episodes who have an underlying but unrecognized bipolar disorder receive pharmacologic treatment with ineffective regimens that do not include mood stabilizers.”

All of the "researchers" recruited received fees, on a per patient basis, from Sanofi-Aventis in recognition of their participation in the study. The key lead authors, all with significant Pharma connections, did not disclose their personal ties. Quite a transparent example of how cultural beliefs are manufactured, and how direct involvement with Pharma is normalised.

So what's wrong with the study?  Well that hinges on the meaning of the term "bipolarity specifier" that was added to the usual, DSM criteria for bipolar disorder.  This assumes that this additional test has been validated as being predictive of actual bipolar disorder, which is a "fact" not in evidence.  It sounds in the study as if this were an established and valid measure.

Here's the defintion:

“This bipolarity specifier attributes a diagnosis of bipolar disorder in patients who experienced an episode of elevated mood, an episode of irritable mood, or an episode of increased activity with at least 3 of the symptoms listed under Criterion B of the DSM-IV-TR associated with at least 1 of the 3 following consequences: (1) unequivocal and observable change in functioning uncharacteristic of the person’s usual behavior, (2) marked impairment in social or occupational functioning observable by others, or (3) requiring hospitalization or outpatient treatment. No minimum duration of symptoms was required and no exclusion criteria were applied.”

People sleeping less, talking more, and doing more. This is how mental illness is now being defined in psychiatry’s leading journal.

One of the dead giveaways that this article is bipolar diseases mongering is the sentence:
“No minimum duration of symptoms was required and no exclusion criteria were applied.”
This means that any person who has a suddenly angry, agitated, or elated response to an environmental trigger (like a big fight with a family member or winning the lottery) could be labeled bipolar.

This would also mean that if they had an episode of emotional dysregulation for the same reason, the reaction would be labeled a bipolar episode. This makes almost anyone who has borderline personality disorder suddenly bipolar.

23.2% of their subjects had experienced episodes of elevated or irritable mood triggered by antidepressants and were also defined as bipolar.  This is almost comical. Irritibility is a common side effect of drugs like prozac and has absolutely nothing to do with bipolar disorder (unless tranquilizers cure mania, because they sure do cure that side effect). This incredible nonsense is straight out of Hagop Akiskal’s dishonest playbook. I heard him say once that if someone who is depressed gets agitated on an SSRI, he just “knows” that person is bipolar.

The word bipolar, in the sense advocated by this piece-of-you-know-what study, is showing up in common discourse everywhere, particularly among young people describing their unpredictable and volatile classmates.  You can even hear the word in pop songs used as a synonym for moody (e.g. “Hot and Cold” by Katy Perry).

Someone... call the doctor
Got a case of love bi-polar

The drug companies have really done a masterful job in bastardizing the diagnosis of real bipolar disorder, which is a serious mental illness.  The harm to both the field and to patients alike has been staggeringly immense.

Counting Symptoms that Don't Count

A horrible trend has been taking off for the last decade in psychiatric offices across the country. As fees for psychiatrists were ratcheted down by managed care insurance companies, especially for psychotherapy, psychiatrists have tried to keep up their income by becoming primarily prescription writers and seeing as many patients per hour as they possibly can. This has let to the infamous ten or fifteen minute "med check." In this short period of time, the context of the patient's life experiences as it affects a patient's psychological condition is seldom even evaluated, let alone taken into account, in making a determination of which medications and dosages are appropriate for a particular patient.

The time squeeze has also adversely affected the patient's initial diagnostic evaluation. A comprehensive evaluation takes at least forty five minutes, even if the doctor only superficially touches on all the relevant information that needs to be elicited from the patient. Initial evaluations now are often squeezed into a half hour, which often includes the time the doctor has to write his note, return phone calls, and/or go to the bathroom. If any reader plans to see a psychiatrist who does not schedule an hour for a new patient, I would advise that reader to run as fast as you can in the opposite direction!

So what does a doctor who spends so little time with a patient do to save time? I mean besides completely ignoring the patient's relationships, history of truama, humanity, etc. (One of my patients reported being screamed at by his last psychiatrist, "I don't want to hear about your mother!! I just do meds!"). Well, one thing they can do is ask only about symptoms, and blindly accept the patient's yes or no answer without even checking to see if the patient understands the difference between a transient mood state and a psychiatric symptom. Better yet, before the doctor even sees the patient, he or she can have the patient fill out a symptom checklist, and base his diagnosis entirely on that. (Of course, his secretary could make a diagnosis doing that, so the patient really wouldn't even have to talk to the doctor at all).

So, is it not true that the DSM, the diagnostic Bible in psychiatry, just lists symptoms as diagnostic criteria, and says how many of them you need to make a given diagnosis? No! It requires a doctor to also make a clinical judgment about the diagnostic significance of any symptom a patient reports. This involves asking follow up questions like a good newspaper reporter. Just because a patient reports staying up all night without feeling tired for seven days in a row does not mean that the patient also remembered to report that he was sleeping during the day, or was on a cocaine binge.

To illustrate better what I mean, I would like discuss the contents of an article called Avoiding Diagnostic Deficit Disorder in Bp Magazine. Bp Magazine is a periodical about patients' experiences with bipolar disorder. The disorder, which used to be called manic depression, is characterized primarily by distinct periods of severe mood elation and other periods of severe depression, separated by normal periods (euthymia) in between.

I was not able to find much online about the publishers of this magazine, and what I found may be faulty, but apparently the publisher, Green Apple Courage Inc., was founded by one Bill MacPhee, a patient with schizophrenia who was finally stabilized on medication and became productive again.

The primary advertisers for BP Magazine were listed on one web site as "Platinum sponsor Pfizer Inc. and Gold sponsors Bristol-Myers Squibb Company, Otsuka America Pharmaceutical, Inc. National mental health association advertisers include the Child and Adolescent Bipolar Foundation, Depression and Bipolar Support Alliance, Mental Health America and the National Alliance on Mental Illness." I started getting the magazine in the mail for free unsolicited, which usually means a pharmaceutical company is paying for mailing the publication to psychiatrists like me. Draw your own conclusion about whose interest the magazine might be best serving.

Anyway, the article expresses concern that bipolar patients might be misdiagnosed with something else, when the real danger nowadays is that a patient with something else will be misdiagnosed as "Bipolar II," which in my humble opinion is part of the Bipolar, My Ass Spectrum Disorder.  So it advises potential patients to tell their doctor about symptoms such as agitation, impulsivity, racing/obsessive/cluttered/busy thoughts, hypersexuality, hyperbuying, euphoria, decreased need for sleep, and use of alcohol or other agents to relax.  It advises that they report these other symptoms last: depression, anxiety, panic, and trouble concentrating.

The article neglects to point out the fact that in mania, these symptoms all have to occur at the same time, and be totally atypical for the way the person normally functions. I mean, true bipolars are like Jeckyl or Hyde (not both at the same time) for an extended period of time.  They do things while manic that are totally out of character for them. These characteristics of the symptoms are absolutely essential for determining their diagnostic significance.

We speak of the three p's: pervasiveness, persistence, and pathological.  The symptoms of mania in particular have to affect every aspect of the person's life regardless of the person's changing external circumstances, they have to continue for a full week at the very minimum, and they have to cause significant distress or impairment.  (Hypomania, hallmark of bipolar II, only has to last four days.  Not four minutes, four days.  It is the only condition in the entire DSM that does not require distress or impairment).  One also has to take into consideration the state of a patient's current relationships in order to rule out normal reactive mood changes.

But wait, there's more!  Every symptom that the article recommended reporting first is non-specific.  That means that each and every one of them can be symptoms of several different psychiatric disorders, depending on their other characteristics, or they may just be normal personal variants or the result of having a bad day.  I mean, anyone here ever go on a spending spree and buy more than they should have?  The nation's huge credit card debt screams out that this is hardly a phenomenon only seen in manic or hypomanic patients.

Let's take irritabilty, for another example. It can be a symptom of mania, but it can also be a symptom of major depression, dysthymia, generalized anxiety disorder, panic disorder, a personality disorder, the abuse of a variety of different drugs and alcohol, side effects of medications, having just had a big fight with your mother, or just feeling irritable for that day for no particular reason at all.

Now, the doctors who think everyone who comes to them is bipolar and is in serious need of drugs object to the DSM bipolar criteria for duration of symptoms.  That may be a legitimate criticism, but so far there is not a single shread of evidence linking brief mood swings like going into a rage to true bipolar I disorder.  The doctors pushing this idea basically pulled the idea that they are related out of their asses. 

To prove this, however, they do studies in which they diagnose people who do not meet the duration criteria for mood episodes as "bipolar not otherwise specified (NOS)," which is a diagnosis that is listed in the DSM.  What the NOS designation is supposed to be used for is people who just barely miss DSM criteria, like someone having manic symptoms for six rather than the required seven days. It is not supposed to be used for people who miss the criteria by a country mile, like a person having a ten minute mood episode.  I would call the tactic of using the NOS category for patients like that as Nothing Other than Stupid.

They then do studies which include patients that they have diagnosed with their version of the NOS disorder, thereby gathering a sample of subjects that contains a certain number of people who have ten minute mood swings.  They then look at their overall sample to see how many of their "bipolars" have this symptom, and voila!  A significant percentage do, therefore "proving" that bipolars can have ten minute mood swings.  If you don't understand the term circular argument, you can look up the term circular logic.  It might say that circular logic means the same as circular reasoning.  If you don't know what circular reasoning means, you can look that up and find out that it means the same as circular argument.

One blog reader asked me why I do not believe in brief mood swings.  Of course I believe in them.  They are just not symptoms of bipolar disorder.

More B.S. About Bipolar Spectrum

A psychiatrist who works at the University of Texas Medical Branch in Galveston occasionally writes for a newspaper for psychiatrists called the Psychiatric Times, which is usually relatively unbiased in its coverage of the field despite heavy advertising from pharmaceutical companies. Dr. Wagner is, however, one of those “experts” who advocate labeling children who exhibit behavior problems with what I believe to be phony brain diseases like ADHD and then drugging them.

We know that true bipolar disorder is a real brain disease that has a significant genetic component. Earlier studies indicated that if you have a bipolar parent, your odds of developing the disorder are 5 to 10 times higher than the general population. Since the prevalence in the general population is about 1 percent, that means you have a five to ten percent chance of developing the disorder yourself. True bipolar disorder usually manifests itself in the late teens or early 20’s, most frequently with a depressive rather than a manic episode. Although rare, I saw one patient who had his very first manic episode in his 80’s!

Doctor Wagner wrote a column about a study by Birmaher and others (Archives of General Psychiatry 2009, vol. 66, pp 287-296) that allegedly studied the children of bipolar patients. Birmaher’s data is already suspect in my mind because a third of his sample of parents was diagnosed with something called “bipolar II” disorder rather than actual manic-depressive illness. In over thirty years of practice and teaching residents in both the public and private sector in two states, I have seen only two or three patients that actually meet the DSM criteria for this supposedly common disorder, and I suspect that these patients were all just mild cases of Bipolar “I,” because they all responded to lithium.

Bipolar II as described in the literature is said to rarely respond to lithium, most likely because it is not bipolar disorder at all. In my experience, many patients seem to endorse some of the criteria for bipolar II when asked about them by a psychiatrist because they really do not understand what the doctor is getting at. This becomes readily apparent if the doctor follows them closely for an extended period of time. As I discussed in a previous post, many patients with borderline personality disorder are misdiagnosed as bipolar II by doctors who use symptom checklists.

The children in Birmaher’s study, according to Wagner, were studied when they were on average about 12 years old. In truth, we rarely have any idea whether a 12 year old is going to eventually have a manic episode. Yet supposedly 10% of the children in the sample were diagnosed as bipolar! This means that they had to have some version of a manic episode, because you cannot tell if a depressed adolescent will turn out to have bipolar disorder or unipolar depression.

Of this group, the rate of Bipolar I in the children was stated to be about 20% of the supposedly bipolar sample. Some 12 year olds actually do have mania and are psychotic, but they are extremely rare. I doubt that the diagnoses of these young children were accurate. Another hint that the diagnoses might be bull was that about three quarters of the allegedly bipolar children were diagnosed with “bipolar NOS.” NOS means “not otherwise specified,” and is now used by those who believe that any moody, difficult or temperamental child has bipolar disorder. Bipolar NOS can be and often is applied to kids with “mood swings” or even temper tantrums that last for only a few minutes! The authors in the study toss out the “Bipolar NOS” term in the paper as if it were a well-validated and well-accepted psychiatric diagnosis.

The authors of the study claim at the beginning of the article that they evaluated the “family environment” of their subjects, but in the study methodology section of the paper, the only environmental factor mentioned as having been evaluated was the family’s socio-economic status. Nothing was said, of course, about the disciplinary practices of the parents.

Interestingly, the rate of post traumatic stress disorder (PTSD) from physical abuse, sexual abuse, witnessing death, or family violence was significantly higher in the “bipolar” children in the study than in the “normal” controls - 16% versus 3%. Now why would children with a supposedly biogenetic disorder like bipolar disorder have a higher risk of being abused? Could it be that a high percentage of the children in this study who were diagnosed bipolar came from dysfunctional families, and the source of their apparent mood swings was family dysfunction? Many of the parents were diagnosed with bipolar II after all, and could instead have severe personality disorders. Furthermore, family dysfunction has to be pretty severe to lead to clear-cut PTSD in a child, so perhaps the 16% feature was just the tip of the iceberg.

Some who want to explain this all away have argued that bipolar kids, being difficult, often create the very chaos that leads to both child abuse and marital conflict. Parents who are frustrated and cannot agree upon what to do with their child frequently do have angry interchanges, and punishment can get out of control. Talk about blaming the victim! Still, I must admit that it is probably true that a difficult child is somewhat more likely to be “punished” with physical abuse than an easy one. But how do the folks advancing this sort of explanation account for the childhood sexual abuse? How do we blame that on a rambunctious child? “She was driving me crazy, so I raped her.” I don’t think so.

The Zyprexa Documents

In January 2009, drug company involvement in promoting the explosion of new and phony bipolar disorder diagnoses was clearly demonstrated by company memos that leaked out as part of a Justice Department settlement against the maker of the atypical antipsychotic Zyprexa (Ely Lilly) for off-label marketing of the drug. These memos were supposed to be kept secret, but were obtained by reporter Alex Berenson of the New York Times, as mentioned in an article in the paper on December 18, 2006. They were later put on the internet by another reporter, Philip Dawdy of the Seattle Weekly, on his Furious Seasons website (http://www.furiousseasons.com/zyprexadocs.html).

One of their strategies was marketing for “NCE’s” (New Clinical Entities) which were off-label indications. They specifically targeted doctors who would be seeing patients with substance-related disorders, anxiety, aggression, or borderline personality disorder. Family practitioners and other primary care doctors were singled out, but psychiatrists were also affected.

While admitting that Zyprexa was not indicated for "bipolar II," they nonetheless tried to convince doctors that relatively high functioning patients who were susceptible to "bouts of depression, low self esteem and pessimism about the future, then rebounding with bursts of high energy and social engagement" really had bipolar disorder. They knew doctors did not like using lithium and that they might feel that there was too much to manage with depakote, so that they could be easily convinced to use Zyprexa.

Their vision for primary care docs was to expand Lilly's market by "redefining how primary care physicians diagnose and treat complicated mood disorders." Marketing messages were to be aimed at "patient's symptoms and behaviors (rather than diagnosis)." The doctor was to be made to understand that the company reps were not talking about the seriously ill patient but the "complicated patient who has mood symptoms of irritability, anxiety, poor sleep and mood swings."

Fellow training director Aftab Khan describes a certain type of patient that he labels as having "Crappy Childhood Syndrome (CCS)." He says that whenever a particular patient has several of these diagnoses at the same time: Major depressive disorder, panic disorder, PTSD, generalized anxiety disorder, bipolar disorder not otherwise specified, bipolar II, intermittent explosive disorder, or somatoform pain disorder - or their diagnoses changes from one provider to the next or from one admission to next - then CCS is most likely what they really have.

I could not have said it better myself, although I would add that these patients continue to have highly negative interactions with their dysfunctional social systems even as adults.

Astra Zeneca free book

The drug rep from Astra Zeneca was in the University of Tennessee Department of Psychiatry office area today. In my mailbox, and in the mailboxes of all of the psychiatry residents (MD's in specialty training) was a free book. It was entitled, "Bipolar Disorder: Disease Management Guide."

Funny thing, there is no mention anywhere in this book of good old cheap, generic lithium, which is far and away the drug of choice for treating bipolar disorder. There was also no mention of the third choice, Tegretol, nor the fourth, Trileptal, nor "typical" (old and generic) anti-psychotic drugs - only information about brand-named atypical antipsychotic meds, Depakote ER, and Lamictal.

What is not discussed in this rather selective "guide" is of course entirely unsurprising. At least our residents have me to point out what this means.

The book also mentions the importance of screening patients for "subthreshold" presentations of the disorder, as well as for the diagnosis of "Bipolar NOS" (not otherwise specified). The book specifies that patients who have the latter diagnosis have hypomanic episodes that may last for only a few hours. Naturally, there is no mention of agitated depression, anxiety, interpersonal discord, or of the affective (emotional)instability characteristic of borderline personality disorder.

The existence of manic or depressive episodes that do not have to last for any significant amount of time is the party line for those drug company shills pushing for the diagnoses of pediatric (child) bipolar disorder, and "bipolar spectrum" in adults, which I like to refer to as B.S.

Let's medicate everyone with expensive, potentially toxic atypical antipsychotic drugs! After all, who among us has never had a mood swing?