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Showing posts with label disease mongering. Show all posts
Showing posts with label disease mongering. Show all posts

Tuesday, August 16, 2016

Bipolar versus Borderline: Disease Mongering Pill Pushers Stack the Deck




In my Psychology Today blogpost of 12/11/11, Bipolar or Borderline, I described how disease mongering, pill-pushing psychiatrists have done their utmost best to blur the distinction between the mood (affective) instability seen in borderline personality disorder (BPD) with the mood episodes characteristic of true bipolar disorder. 

This distinction is important because BPD is clearly a disorder of interpersonal relationships and behavior mixed in with a history of trauma and family dysfunction, while true bipolar disorder is a serious biogenic brain disease. BPD, while some of its symptoms do respond quite well to the right medications, should be treated primarily with psychotherapy, while bipolar disorder should be treated primarily with medication.

In the prior post I discussed the use of invalid symptom checklists in studies to exaggerate the incidence of bipolar disorder. They are also used by some incompetent psychiatrists to make diagnoses that justify snowing every patient who walks in the door with potentially toxic antipsychotic medication. In the June 2016 issue of the Journal of Personality Disorders, researcher Mark Zimmerman goes into some detail about exactly how corrupt researchers use slight of hand to distort their data (Improving the Recognition of Borderline Personality Disorder in a Bipolar World, pp. 320-335).

They are very good at it. And it matters. Zimmerman states: "Although BPD is as frequent as (if not more frequent than) bipolar disorder, as impairing as (if not more impairing than), and as lethal as (if not more lethal than) bipolar disorder, it has received less than one tenth [emphasis mine] the level of funding from the NIH [the National Institutes of Health] and has been the focus of many fewer publications in the most prestigious psychiatric journals."

And, Zimmerman points out, the difference is not due to just the fact that there were more drug studies for bipolar disorder. In fact, the amount of funding for the drug treatment of bipolar disorder was just a little more than 10% of the total.

As I have mentioned several times in this blog, self-report symptom checklists are meant to be screening devises. This means that if you are positive for bipolar disorder on the screen, it does not mean you have bipolar disorder. It means you should be evaluated further! Screening tests are designed to have a lot of false positives - people who come out as positive on the test but who do not actually have the disorder. In fact, the majority of people who screen positively do not have bipolar disorder.

Zimmerman specifically brings up the Mood Disorders Questionnaire (MDQ) that I discussed in the previous post. Get this: in one study by Frye and others in the journal Psychiatric Services in 2005, the authors found that one half of the patients who were positive for bipolar disorder on the MDQ were not diagnosed with bipolar disorder by the treating clinician.  

Their conclusion? They said the clinicians "failed to detect" or "misdiagnosed" bipolar disorder in these patients! Actually, the exact opposite is far more likely: it sounds like the clinicians' judgments tended to be correct.

Frye and others then went on to state that these patients were "inappropriately treated because they were given antidepressants instead of mood stabilizers." Again, exactly the wrong conclusion to draw from the authors' own data. Yet they went on to say that this completely false conclusion was "worrisome." Some of us would call this real chutzpah.

Bipolar, my ass researchers love to talk about the bipolar "spectrum," based on the crazy logic that if a given symptom appears slightly similarly in two people, they must both have a version of the same syndromic psychiatric disorder. Zimmerman asks why no one talks of a borderline spectrum, when clinically, many patients are diagnosed as having borderline traits. This means that out of the nine criteria, of which you are required to meet any 5,6,7, 8, or all nine to qualify for the diagnosis, the patients may only have three or four. 

In fact, as reported in the July issue of the American Journal of Psychiatry (Vol. 173, pp. 688-694), Zanarini and others followed 290 patients with BPD closely over 2 years. They found that "...the symptoms of borderline personality disorder are quite fluid..." This means that they come and go over time. This was particularly true for acute symptoms like self-mutilation. Therefore, people with the disorder may frequently go from 5 symptoms to 4, and suddenly they don't "have" it anymore - unless and until the 5th symptom recurs!

In actual reality, he said redundantly, those people who exhibit three or four of the nine symptoms look a lot more like those folks who have five or more than they do like those folks who have none of them. Now that sounds like a "spectrum" to me.

Thursday, July 4, 2013

Drug Company Financed Biederman on a Tear

In their continuing effort to label every acting-out child with bipolar disorder, Harvard doctor Joseph Biederman and his band of colleagues are now trying to add a THIRD disorder into the mix along with "comorbid" ADHD. 

According to a new journal article in the Journal of Clinical Psychiatry, "30% of the bipolar probands with bipolar I disorder met criteria for autism spectrum disorder." 

All the more reason to give autistic kids dangerous brand-named meds that don't do anything except drug them into oblivion, I guess. 

Tuesday, December 11, 2012

Is Marketing Drugs for Non-FDA Approved Uses Free Speech?




A recent ruling by a three-judge panel of the Court of Appeals for the Second Circuit in Manhattan threatens to legalize the marketing of snake oil without any restrictions. It maintains that the marketing  of pharmaceuticals by drug companies for conditions for which the FDA has not approved them is free speech!

Considering the ruling of the Supreme Court in the Citizens United case, many of us are highly concerned that if the lower court ruling is appealed and ends up there, that the current court will concur, and this will become the law of the land.

U.S. Supreme Court

As my colleague Ken Harvey says, only in America.

I have posted here several times about the huge fines levied against big Pharma drug companies for marketing psychiatric and other medical drugs for uses in conditions for which the FDA has not approved them as safe and effective. For a summary, see my last post on the subject.

Once a medication is FDA-approved for any indication, doctors are absolutely free to prescribed it for any other condition they see fit, but pharmaceutical companies are not allowed to market the drugs for these other conditions. This is important because pharmaceutical companies can run poorly-constructed studies that show that a drug might help this or that condition, and if there were no law against it, use their various marketing techniques and financial inducements to get doctors to prescribe the drug to larger and larger populations of patients.

Many of these powerful marketing techniques have been described by me in a series of previous posts (the last one being my post of August 7, 2012). The profits to be gained by so-called off-label marketing are enormous, and completely dwarf even the billion dollar plus fines levied by the U.S. Department of Justice. The fines are considered to be just a cost of doing business by Big Pharma.

This situation has also led to an explosion of disease mongering, in which the definitions of disorders like bipolar disorder for which certain drugs are FDA-approved are expanded beyond all reason (see my posts of 10/20/12 and 8/13/11).

The damage to patients, especially in the field of psychiatry, has been particularly horrendous. People with family and behavioral problems who are in desperate need of psychotherapy are instead given only drugs, many with potentially toxic side effects.  Patients unfortunately are all to eager to buy in to the proposition that their emotional problems or those of their children are merely the result of some brain dysfunction rather than their own behavioral difficulties.

(Disclaimer for the anti-medication lot: of course some psychiatric conditions do indeed result from brain dysfunction, and for those medication is the primary and most effective treatment, and psychotherapy is next to worthless. Which ones are those?  Read this blog! Also, medications can control anxiety and emotional reactivity so that psychotherapy becomes even more effective).

Just as an aside, readers may wonder if I think it should be illegal for doctors to prescribe medications for non-FDA approved indications. This is a complicated question, because of the crazy way the FDA in the U.S. works. For example, we know that if one SSRI antidepressant (Prozac, Paxil, Zoloft, Lexapro, Luvox, Viibrid) works for, say obsessive compulsive disorder, then they all do.

However, once one drug company does the studies that result in their getting an approval from the FDA for their product for this indication, the other drug companies have no financial incentives for doing studies with their own product. Doing the studies is expensive, and they know doctors know about the if one-then all idea, so they will use the other me-too drugs off label. I don't see anything wrong with doctors doing so in properly diagnosed patients (which, BTW, is unfortunately a big "if" nowadays).

Also, sometimes there is widespread clinical experience that shows that a given drug is effective for a certain indication for which studies have not led to FDA approval for that indication. For instance, many of us have successfully used SSRI antidepressants in patients with borderline personality disorder to decrease their emotional reactivity (neuroticism). The drugs do not stop the hyper-responsiveness that these patients show to problematic interactions, but they do raise the bar. It takes a higher level of stress to get them into a state of dysregulation than it would in an unmedicated state.  Hardly a cure, but still very useful.

There have been many studies to show that SSRI's do this, some performed by Emil Cocarro, a highly respected researcher. But so far, no drug company has, for a variety of reasons, made a petition to the FDA for this indication.

Dr. Emil F. Cocarro

I would be very much opposed to any action that would limit my ability to help my patients in this way. Unfortunately, many of my colleagues listen to drug company propaganda and use drugs in ways that are very inappropriate. I'm not sure what the solution to this quandary is, but of one thing I am certain: allowing Big Pharma to market drugs for unapproved indications ain't it.

Tuesday, October 30, 2012

New and Better Ways to Falsely Expand the Definition of Bipolar Disorder


Angst redefines angst!

Blowing Hot Air


The Journal of Affective Disorders, which really should be called the Disordered Journal of Bipolar My A--, is helmed by one Hagop Akiskal, about whom I have previously blogged (A Stupid Study and an Even Stupider Headline, 2/1/2011). On its website, the journal describes itself thus: “The Journal of Affective Disorders publishes papers concerned with affective disorders in the widest sense.” I think they must mean the wildest sense.

In several previous posts, I have described how the authors who regularly contribute to this journal are constantly on the lookout for new and improved ways to re-label patients with depression, anxiety, chronic ongoing interpersonal strife, and, in particular, borderline personality disorder (BPD) as really suffering from some form of mania.  Any form of mania.  Their creativity in spreading this outrageous nonsense is truly impressive.

In a journal article described by my post of 3/6/12, Relabeling Depressive Symptoms as Manic Symptoms, authors suggested that the presence of something that they label as subsyndromal manic symptoms (that is, symptoms that they believe are the same as those that are usually seen in mania episodes, but which are “below the threshold for mania" - whatever that means) are seen in the major depressive episodes (MDE’s) that are also characteristic of bipolar disorder.  

As I stated in that post:

“They discuss how some other authors reported that “the most common manic symptom during bipolar MDEs was irritability (present in 73.1% of the sample), followed by distractibility (37.2%), psychomotor agitation (31.2%), flight of ideas or racing thoughts, (20.6%), and increased speech (11.0%). 

“Now, of course, they do not mention that these very same symptoms are also seen in the major depressive episodes of people who never have had or will have a manic episode. And who respond to antidepressant medication and have no response at all to lithium (which is highly effective in bipolar disorder). Back in ancient history (the 70’s and 80’s) we labeled depressed patients who show such symptoms as having an agitated depression.

In another article described in my blog post of 8/13/2011, More Bipolar Disease Mongering in a Respected Journal, the authors found another way to create the fiction known as “subthreshold” mania – this time in another, major psychiatry journal, the Archives of General Psychiatry.

In this article, they introduced the term bipolarity specifier as if this were an established and valid measure.

As I described in the previous post, here's the definition:

“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.”

That last one, No minimum duration of symptoms was required and no exclusion criteria, is key. It 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 also makes almost anyone who has borderline personality disorder suddenly bipolar. The “research team” also included in their subthreshold category those patients who had experienced episodes of elevated or irritable mood triggered by antidepressants. Irritibility is a common side effect of drugs like prozac and may have absolutely nothing to do with bipolar disorder.

Some of my colleagues and I tore this study apart in a letter published in the Archives, and were answered with purposely misleading, phony “arguments,” as I described in my post of 6/19/2012,  Disease Mongering in a Respected Journal and Plausible Deniability.

Now comes another doosie of nonsensical research study, recently published online in the Journal of Affective Disorders, called Subthreshold bipolar disorder in a U.S. national representative sample: Prevalence, correlates, and perspectives for Psychiatric nosography by Hoertel, Le Strat, Angst, and Dubertret.  Jules Angst was also one of the authors of the Archives article as well.  I guess one could say that Angst is trying to redefine angst.

Jules Angst, M.D.


In this article they employ yet another brand new way to define “subthreshold” mania.  The criteria they used, in addition to the presence in a patient of an episode of major depression but who have not met the full criteria for an episode of mania or hypomania, is to include for purposes of the study anyone who answers in the affirmative to any one of three screening questions for bipolar disorder.

As I have mentioned many times in this blog, screening questions and questionnaires are purposely designed to cast a wide net, so that a lot of people who do not have the disorder are questioned further to make certain one way or  the other (false positives).  Their purpose is so researchers do not waste a lot of time questioning potential subjects who clearly do not have the disorder (false negatives). In other word, using screening questions to define a clinical entity is completely bogus by definition!

The reader can easily see why this is so by looking at the screening questions used in the paper:  1. In your entire life, have you ever had a time lasting at least one week when you felt so extremely excited, elated or hyper that other people thought you weren't your normal self? or (ii), In your entire life, have you ever had a time lasting at least one week when you felt so extremely excited, elated or hyper that other people were concerned about you? or (iii), In your entire life, have you ever had a time lasting at least one week when you were so irritable or easily annoyed that you would shout at people, throw or break things, or start fights or arguments?

Almost every patient with borderline personality disorder would answer at least one of these three questions in the affirmative.  Especially that third one.

The results of the study showed that people who met this screen for “subthreshold” hypomania (and who therefore had a "disorder" that had been merely defined into existence) were found, compared to depressed patients who did not, to be more likely to have been American born, and never to have been married. They were also less likely to earn more than $70,000 year.  They were more likely to have additional (comorbid) psychiatric disorders, especially personality disorders (other than borderline, interestingly, for which they mention later in the article they did not even bother to assess the subjects!) These included anxiety disorders, substance use disorders and dysthymia.

All of these findings are also true of patients with borderline personality disorder, which may have been what a significant percentage of these “subthreshold” manic patients had all along.

“But this sample of patients all were found to have had episodes of major depressive disorder (MDD),” you might protest. “So are you saying there is a sizable contingent of patients with borderline personality disorder who have co-morbid major depressive disorder?” Well, yes, that is true. But it is even more complicated than that.

The episodes of major depressive disorder seen in patients with borderline personality disorder are often qualitatively different from those in depressed patients who do not have this disorder.  These differences were described beautifully by my friend and colleague Kenneth Silk of the University of Michigan medical school in an article called, The quality of depression in borderline personality disorder and the diagnostic process, in the February 10th 2010 issue of the Journal of Personality Disorders (24:1, pp. 25-37).

Ken Silk, M.D


He describes how MDD in BPD is less likely to be characterized by a full contingent of physical or vegetative symptoms (poor appetite, energy, slowing of thought and behavior, and so on), and less likely to respond to the earliest antidepressant medications (tricyclics).  Their depression was far more likely to be characterized by emptiness, loneliness, and desperation over their interpersonal relationships. Their depressive symptoms tend to be far more changeable (labile) and liable to come on suddenly in response to environmental events than patients with MDD without BPD. 

Patients with BPD are also most likely to be dysthymic, or chronically depressed, when they do not seem to be in the midst of a major depressive episode. In other words, as Dr. Silk says, “…these patients may suffer from chronic dysphoric mood that is being misinterpreted [by psychiatrists] as a [medication] non-responsive major depressive episode.”

The depression of patients with BPD is also much more likely to be characterized by high levels of anxiety. In fact, again according to Dr. Silk, their depression may stem from their exhaustion and demoralization from their unsuccessful battles with their overwhelming anxiety. Patients with an anxious depression are the very ones that will be labeled with subthreshold manic symptoms in articles such as the one under discussion.

By the way, these qualitative differences in the experience of certain patients with depression are not sorted out by the research diagnostic interviews and symptom checklists frequently used in psychiatric studies.  Imagine that.

Saturday, August 13, 2011

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.

Monday, December 20, 2010

Epidemic of Mania, Pharmaceutical Company Type (Bipolar Disorder P.C.) Claims Seventh Victim

Just as I thought I had heard the last about drug company mania mania, yet another example pops up.  Posts on this subject are starting to become a regular feature on this blog.  For the seventh time, the Justice Department has fined a pharmaceutical company for off-labeling marketing one of their drugs for a psychiatric indication for which there is no data, and once again the psychiatric indication is mania.  I hope these posts have not become monotonous.

This time the company is Elan pharmaceuticals and the drug - seemingly always an anticonvulsant or atypical antipsychotic - is the anti-seizure medication Zonegran.


According to the justice department press release at http://www.justice.gov/opa/pr/2010/December/10-civ-1444.html,  "Elan promoted the sale of Zonegran for a wide variety of improper off-label uses including mood stabilization for mania and bipolar disorder, migraine headaches, chronic daily headaches, eating disorders, obesity/weight loss and seizures in children under the age of 16.

Elan’s off-label marketing efforts targeted non-epilepsy prescribers and the company paid illegal kickbacks to physicians in an effort to persuade them to prescribe Zonegran for these off-label uses. Under the terms of the plea agreement, Elan has agreed to pay a criminal fine of $97,050,266 and plead to a misdemeanor violation of the Food Drug and Cosmetic Act. EPI will also forfeit $3.6 million in assets.

In addition, Elan has agreed to pay $102,890,517 to resolve civil allegations under the False Claims Act and related state statutes that the company illegally promoted Zonegran and caused false claims to be submitted to government health care programs for a variety of uses that were not medically accepted indications and therefore not covered by those programs."




The company was not accused of trying to expand their market by expanding the definition of bipolar disorder the way Eli Lilly did with their marketing for Zyprexa (see my March 22 post, The Zyprexa Documents).   However, would anyone be surprised if they had done this as well?  Any moody patient becomes fair game for a bipolar diagnosis.

Typically, the company "targeted non-epilepsy prescribers."  Translation: primary care doctors and perhaps psychiatrists. Apparently they are fairly easy targets to manipulate.

Friday, May 14, 2010

Psychiatric Drugs

Some people who read my blog may get the wrong idea about where I stand on the issue of the use of psychiatric medications, so I want to make something perfectly clear: I am an advocate of the proper use of psychiatric medications, and I think that when used correctly, they are highly effective. I prescribe them to almost all of the patients I treat, including my psychotherapy patients. If fact, my patients who exhibit signs and symptoms of borderline personality disorder would not be able to engage in the type of therapy I do if their high emotional reactivity were not partially controlled on meds.

I even prescribe atypical antipsychotics, even though they can have toxic side effects. I monitor my psychotic patients' for the emergence of metabolic syndrome by checking their blood sugar, cholesterol, and triglycerides (fat). I watch them closely for the emergence of tardive dyskinesia, a neurological side effect that may emerge after long-term treatment with antipsychotic medications. (If you saw the movie "The Dark Knight," Heath Ledger's Joker character's mouth movements look a lot like this syndrome).

Without antipsychotics, many more patients would be living out on the street in cardboard boxes. Additionally, sometimes the atypicals are the only medications that stop certain patients with borderline personality disorder from severely mutilating themselves. They are not my first choice for that, but they are sometimes necessary.

On the basis of my obvious disgust with pharmaceutical companies' disease mongering and the sloppy use of diagnostic terms by many psychiatrists, I hope no one lumps me together in the same camp as Peter Breggin or Robert Whitaker, who grossly exaggerate the dangers of psychiatric medication and distort the studies in a fashion precisely opposite to the way the drug companies do. Nor I am a fan of Tom Ssazz or R.D. Liang, who think that there is no such thing as a psychiatric disease.

BTW, Dan Carlat posted on his blog an excellent description of PhARMA disease mongering by Adriane Fugh-Berman, available at http://bostonreview.net/BR35.3/fugh-berman.php.

One of the drug company strategies that is not described in this article is to label their critics as members of Scientology. Just so you know for certain, I think the idea that mental illness is caused by a volcano god (Xenu) and space aliens (body thetans) is just a wee bit ludicrous, and that Scientology is a dangerous cult. I remember when I was a resident receiving a mailing from them asking me to come and confess my sins. Clever.

I find that doctors who buy into disease mongering are usually well-meaning but incompetent. Some, however, are predators. On an earlier post, I mentioned something called sensory integration dysfunction. I said it was a "mysterious illness" which might have caused confusion to some readers. This "dysfunction" is not recognized as a disorder by the DSM or the International Classification of Diseases, and its descriptions in the literature are highly dubious. There are no adults who are diagnosed with it. Even if it does exist as a syndrome, it is could easily be something that is due to other factors like anxiety. Yet there are doctors who prescribe expensive "treatments" for it to the children of unsuspecting and naive parents. This is shameful.

Saturday, May 8, 2010

We Need more Order in Our Disorders

In keeping with current trends, I compiled a list of ten suggested new child mental disorder diagnoses for the Committees preparing the new diagnostic compendium in psychiatry, the DSM-V.

I had orginally included temper tantrum disorder, but someone else actually on a DSM-V committee beat me to it. (I thought that the peak incidence of that disorder was during the "terrible two's," but apparently I was incorrect).

Here's the rest of my list:

1. Chronic Incessant Questioning Disorder. This disorder is characterized by a verbal tic in which the sufferer keeps repeating the question, "Why?"

2. Seasonal Boredom Disorder. The peak incidence of this mental problem is during summer months.

3. Destination Impatience Disorder. A variant of ADHD only manifested on long car trips, this disorder is known informally as "Are We There Yet?" Disorder.

4. Adolescent Omniscience Disorder. This disorder is chartacterized by the automatic irrational cognition that parents do not know what they are talking about.

5. Legume Oppositional Defiant Disorder. A variant of ODD, this disorder is characterized by an adament refusal to eat vegetables.

6. Adolescent Teen Idol Copycat Disorder. A disorder characterized by an irresistable impulse to dress just like Lady Ga Ga.

7. Eye Rolling Disorder. This is an pathological, automatic response to parental lectures.

8. Compulsive Communication Disorder. This disorder is divided into four subtypes: predominantly cell-phone talking subtype, predominantly passing-messages-in-class subtype, predominantly computer-chatting subtype, and of course, predominantly text-messaging subtype.

9. Rambunctious Disorder. This disorder usually causes distress or impairment in total strangers, and is typically manifested on airplanes and in fancy restaurants.

Saturday, March 27, 2010

A Perfect Trifecta

In two prior posts, I discussed some of the deceptive marketing tactics used by Pfizer and Eli Lilly to market their drugs for off-label (non-FDA-approved) purposes, and to balloon the definition of certain psychiatric disorders. These techniques were well documented and became public as a result of settlements with the U.S. Department of Justice.

Eli Lilly, in particular, was in the business of promoting drugs for "bipolar disorder" defined in the loosest possible way to include patients with ordinary agitation, unhappiness, chronic anxiety, self esteem problems, moodiness,and the like. To briefly review the cases:

January, 2009: Eli Lilly pays a settlement to the DOJ of $1.4 billion for concealing side effects and off-label marketing of Zyprexa just as their biggest seller, Prozac was about to go off patent in 2001.

September, 2009: Pfizer agrees to a settlement for $2.3 billion for off label marketing of several drugs including the atypical anti-psychotic Geodon.

To complete a perfect trifecta, I now briefly turn to a third example. In May, 2004, Warner-Lambert agreed to plead guilty and pay more than $430 million to resolve criminal charges and civil liabilities in connection with its Parke-Davis division’s illegal and fraudulent promotion of its anti-convulsant drug Neurontin. One of the many uses that was touted for this alleged wonder drug was for bipolar disorder.

The reasoning went sort of like this: If some anti-convulsants like Depakote and Tegretol are effective in bipolar disorder, then they all must be. (We are hearing something similar about another one, Topamax, although that one may conceivably pan out).

Of course, that is an illogical and invalid conclusion. It is also noteworthy than benzodiazepines like Valium and Klonopin are very effective anti-convulsants - in fact epilepsy was the initial FDA-approved indication for Klonopin - but no one seems to pushing the idea that benzo's are effective in bipolar disorder. They are generic!

Actually, studies later indicated Neruontin was in fact completely ineffective for bipolar disorder. Nonetheless, the existence of those studies has not stopped psychiatrists from continuing to use it, because clinically they see "results." The results they are seeing, however, have nothing to do with bipolar disorder.

Neurontin is sedating. In fact, one of its main actions in the brain is to affect the neurotransmitter GABA, the very same neurotransmitter affected by benzodiazepines. Therefore, if you give it to a chronically agitated, moody patient whom you misdiagnose as bipolar, it seems to calm them down. Presto change-o, the drug "works."

Of course, after a while, the sedative effect is reduced and Neurontin does not work so well any more, but hey, who said anything about actually following these patients closely and asking a bunch of probing questions?

Monday, March 22, 2010

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.

Monday, March 15, 2010

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?

Friday, March 12, 2010

Psychiatry's Latest Manual Goes Too Far

Allen Francis was chairman of the task force that created the current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), which came out in 1994. Although this essay does not talk about the disease mongering of the pharmaceutical companies as a factor in the expansion of psychiatric diagnoses to "encompass every eccentricity," it does discuss the absurdity of some of the newly proposed diagnoses. Written by someone who should know. Click on the title of this post to link to the essay.