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Tuesday, March 30, 2010

Glorified Dope Dealers

According to Psychiatric News of 2/5/2010, a study from Arkansas Medicaid showed an explosion of prescriptions from 2001 to 2005 for potentially highly-toxic "atypical," brand-named antipsychotic medications given to non-psychotic children .

Almost half of these prescriptions were given to children diagnosed with conditions for which there is not a single published clinical trial that supports the drugs' effectiveness: ADHD, depression, conduct disorder, oppositional defiant disorder, and adjustment reactions. I suspect that many of the rest were misdiagnosed as bipolar disorder, for which the drugs are in fact indicated, based on specious diagnostic criteria.

This situation is not unique to Arkansas by any means. I have been seeing it here in Memphis and hearing about it from people and psychiatrists all over the country. Agitation, temper tantrums, and acting out have been fraudulently re-labeled as “mood swings.” In my opinion, these drugs are given to children to quiet them down and shut them up so they do not cause distress to their clueless parents and their overwhelmed teachers.

The explosion of the use of these medications in children is an extension of a trend that began in the psychiatric treatment of adults about 15 years ago. I treat patients with personality disorders and also supervise residents as they do initial evaluations in our outpatient clinic. Patient after patient who arrives with an obvious personality disorder, and who comes from highly chaotic dysfunctional family systems,has carried a previous diagnosis of bipolar disorder.

For the vast majority, there is not a shred of evidence that they ever even came close to meeting the well-accepted criteria for bipolar disorder. Many others were actively using cocaine or methamphetamines at the time of their earlier diagnosis, the use of which can mimic mania.

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?

Wednesday, March 24, 2010

Dysfunctional Families and Mental Disorders: A Large New Study

In February's Archives of General Psychiatry (Vol 67[2], 2010, pp. 113-123) there are two articles from the same study (Green et. al.; Mclaughlin et. al.) adding new "proof" to what we already know about how maladaptive family functioning (parental mental illness, parental substance abuse, criminal behavior, domestic violence, physical and abuse sexual abuse, and neglect) are major risk factors for a host of mental disorders.

They do not even include personality disorders in the studies.

Really, the papers should have been published in one of my two favorite journals that specialize in papers that prove what any halfway-observant person already knows: Duh! and No ----, Sherlock.

There have been many earlier articles showing that certain types of family problems such as child sexual abuse are risk factors for certain disorders. Most of them show positive correlations.

These new studies upped the ante by looking at multiple forms of childhood adversity and many different disorders. (We already knew that these adversity types are pretty non-specific and are risk factors for many different disorders- this was confirmed in the new articles).

In the first article, in a survey of over 9200 subjects, the authors found that the different types of childhood adversities were highly correlated. This means that if you have been exposed to, say, domestic violence, the chances are excellent that you also have other adversities as well. Multiple adversities was the norm.

The higher the count, the more likely an individual was to have the various mental disorders that they looked at, although the increase in the strength of the association was smaller with each additional exposure.

By the way, the authors did not look at the severity of the traumas or how long they went on, which would be expected to be additional factors.

In the second article, maladaptive family functioning was also associated with the persistence of the individual mental disorders with which they correlated. This effect was NOT seen with other childhood adversities such as childhood financial adversity or parental divorce.

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.

Saturday, March 20, 2010

The Heritability Fraud

As I also discuss in detail in my upcoming book, another way that some "biological" psychiatrists twist the truth in order to justify their belief that certain behavioral problems are due to brain disorders is to try and make a case that they have their origins in genetics. Never mind that there is barely a legitimate neuroscientist alive that believes that any gene or any group of genes specifically codes for any complex behavior pattern in humans that varies widely from person to person.

Most of the "experts" who mislead the field by exaggerating genetic influences do concede that both genetic and enviromental factors play a part in creating behavioral syndromes. They have to, since the rate at which genetically identical twins both show the syndromes is almost never anywhere close to 100%. (Everyone seems to ignore a very important third factor: people's ability to anticipate upcoming events and their consequences and plan accordingly).

What they have done is to come up with a way to apportion these supposed causative factors into genetic and enviromental factors using a statistic called heritability.

Using studies of identical twins that were raised together versus those who were raised apart, they purport to estimate the "variance," or how much each of the various causative factors contributes to a certain disorder. The variance is expressed as a percentage of the total package. Variances are thusly assigned to genetic factors, "shared" environmental factors such as growing up in the same household, and "unshared" environmental factors.

In actuality, a determination of which parts of an environment are shared by siblings and which are unshared has a lot in common with finding water with a divining rod. Anyone foolish enough to think that both parents treat all of their children in anything remotely close to an identical manner must have no siblings and no more than one child.

The even more misleading tactic is to use the twin study statistic called heritability as a synonym for genetic. It is not. The statistic derived from twin studies is not a measure of genotype but of phenotype. Genotype refers to the actual sequence of molecule pairs in the DNA of which an individual’s genes are made. Phenotype, on the other hand, is the final result of the interaction between genes and the environment.

Most of the genes in a cell, even the ones that are at times active in a given type of cell such as a neuron, are in the “off position” most of the time. What turns them on or off are environmental influences. In regards to behavior issues, the social environment is especially important. One of the main purposes of the brain is in fact to interact with other brains.

Heritability is actually a mix of purely genetic influences and gene-environment interactional influences. There is no way to tell how much of each is present in the statistic. The determination of heritability can also be manipulated in a number of ways, such as by setting the bar for saying that a syndrome is present or absent. How much and how often does one have to drink to be an alcoholic, after all?

All human behavior, normal or abnormal, has a genetic component. That's because genes determine what the brain is capable of or incapable of, what it has a tendency to do and a tendency not to do, etc. They provide a range of options. They do not specify what behavior within that range will occur in a given environmental context. To say that genes play a role in creating a behavioral syndrome is a tautology.

In this post I will not go into more detail about what this all means. However, the absurdity of using heritability as a synonym for genetic is illustrated by a recent study published in the Journal of Adolescent Health (V.45 [6]:579-86, Dec. 2009) by van der Aa et. al. They looked at the heritability of high school truancy. The study pegged the "genetic" influence on this behavior at 45%!! Does anyone seriously believe that ditching school is determined by heredity?

Wednesday, March 17, 2010

Pfizer Fraudulent Marketing Techniques from the Bextra/Geodon Settlement

Many doctors scoff when they are told that they have been unduly influenced by pharmacuetical companies into prescribing certain drugs. They feel insulted that anyone might suggest that they could be bought off by just "a pen and a pizza" - a free meal and a trinket with a drug company logo plastered all over it.

They think the drug companies influence them only through the detail persons or drug reps that come by their office, or because, as a Dilbert cartoon showed a doctor saying to a patient, "I need you to take these pills because the pharmaceutical rep is smoking hot."

Well, the pen and the pizza have recently been banned, and the drug companies did not put up much of a fuss about it. Why? Because promotional trinkets and meals were the least important of their marketing techniques with physicians.

In September of 2009, Pfizer agreed to a settlement with the US Department of Justice of $2.3 billion for off-label marketing of several drugs, most prominently Bextra, but also including the atypical anti-psychotic Geodon.

The judgment was posted on the internet (http://www.justice.gov/usao/ma/Press%20Office%20-%20Press%20Release%20Files/Pfizer/Plea%20Agreement.pdf), with a list of their shady marketing practices, many of which appear to be common practice within the pharmaceutical industry. Among the most egrecious:

1. Doing market research to identify influential specialists to provide an “Advocate Concierge” for other physicians in terms of their ability to influence key medical societies, guideline committees, and specialty journals.

2. Convening so-called advisory boards, consultant meetings, and other forums for purposes of a “cascade of influence" in order to target high prescribing physicians.

3. Paying targeted physician airfare and hotel costs at lavish resorts and also paying them honoraria of $1,000 to $2,000.

4. They distributed treatment protocols to hospitals and physicians that advocated non FDA-approved uses for the drugs.

5. False and misleading claims of superior safety and efficacy were made by sales reps, with contests and other rewards to those that did this most successfully.

6. They also created sham physician requests for information about non-FDA approved usages. (They are not allowed by FDA rules to volunteer such information, but they are allowed to answer questions about unapproved uses if specifically asked about them by a physician). Promotional material was then sent to these physicians, who were usually high prescribers of the drug already.

7. Free samples were sent to physicians who had no need for any FDA-approved use of the drug.

8. They hired advertising agencies to prepare standard promotional slides at continuing Medical Education (CME) meetings. They had the slides certified by other vendors as CME.

9. They promoted the drugs for unapproved uses through a “publication strategy” whereby they initiated, funded, sponsored, and sometimes drafted or hired medical writer vendors to draft articles promoting unapproved usages, often without disclosing their role in this process.

10. They implemented a manuscript development process whereby a core marketing team at the company would plan potential publications and recruit “authors” for them. On some of these papers, the author was listed as “to be determined.”

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?

Sunday, March 14, 2010

Neural Plasticity

As I discuss in detail in my upcoming book, one way that some "biological" psychiatrists twist the truth in order to justify their belief that certain behavioral problems are due to brain disorders has to do with the neuroscientists' new toy, the Functional MRI (fMRI). fMRI machines, because they measure magnetic fields, can map both brain structure and brain function because the iron in blood that passes through the brain creates a magnetic field.

What researchers do is to use fMRI to compare certain brain structures and brain activity, particularly in the primitive part of the brain called the limbic system, in some diagnostic group with matched controls or "normals." For instance, an important brain structure called the left amygdala is smaller, on average, in patients who exhibit the signs of borderline personality disorder (BPD) than in "normals."

Of course, they are comparing averages, so the left amydala in some BPD patients is larger than those of the average "normal." Notice also that the scientists only occasionally compare different diagnostic with each other. Differences in amygdalar size and activity are found in any number of different diagnostic groups in psychiatry.

The more annoying source of misleading conclusions is that when a difference is found between a diagnostic group and "normals," that difference is automatically labeled an abnormality. If a patient has an abnormality, then of course they must have a brain disease. Actually, these scientists do not know if what they have found is an abnormality or not. What makes the use of the term abnormality totally misleading is that the brain, particularly in terms of limbic system structures, is plastic. This means that, in the normal brain, these structures can change in size to reflect activities that become important to a given individual. The changes can be very quick and substantial.

For example, in the February 2010 issue of the Archives of General Psychiatry (Volume 67 [2] pp. 133-143), Pajonk, Wobrock, Gruber et. al. found that after just three months of a vigorous exercize program, the size of a brain structure called the hippocampus increased an average of 16% in normals! It is also true that the part of the brain that controls finger movements is, on average, much larger in concert violinists than in non-musicians. The conclusions that the so-called biological psychiatrists would be, I guess, that both being a concert violinist and engaging in vigorous exercize are diseases!

Well-known personality disorder researcher and schema therapist Arnoud Arntz has told me that he has some unpublished preliminary evidence that the amygdala changes seen in BPD are reversible with three years of Schema Psychotherapy (a therapy method developed by Jeffrey Young). Thus, these so called "abnormalities" may in fact be conditioned responses from living in a chaotic and invalidating family environment. Not only may they be quite normal, they may be adaptations to the enviroment.

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.

Thursday, March 11, 2010

If you try to fail and succeed in doing so, which have you done?

Marsha Linehan is the current high guru in the community of therapists who treat Borderline Personality Disorder (BPD). Her "Dialectical Behavior Therapy" or DBT is touted as the most "empirically-validated" of all psychotherapy treatments for BPD. This claim is wildly overblown, as DBT is only empirically validated for the treatment of one symptom of BPD called parasuicidality. Parasuicidality includes suicide attempts as well as non-suicidal self-injurious behavior (SIB) such as cutting or burning oneself. Even improvement in that symptom seems to dissipate after two years in her studies. Patients in DBT are also hospitalized less that other BPD patients, but that is probably because DBT therapists will not hospitalize a BPD patient under most circumstances when other types of therapist might.

Another bone I have to pick with Dr. Linehan is the idea of hers that BPD patients show "apparent competence." What this means is that BPD patients often appear to have very good social skills, but they often do not seem to be able to use in emotionally-charged situations. Apparently, Dr. Linehan thinks that BPD patients do not really have these social skills, so the skills must be taught to them in her skills groups. Patients in DBT have to attend these groups in addition to individual psychotherapy.

My question is this: How can you demonstrate a competency that you do not have through repeated performance? Oh, you might fool someone once or twice, but BPD patients can demonstrate social skills over and over again. In fact, they are excellent judges of character, and can determine another person's vulnerabilities quicker than almost anyone else, in order to provoke from another person any reaction they want. They are well known to be master manipulators. How can they do that if they lack social skills? This question also brings into question their often-seen tendency to "split," or act as if they think people are either all good or all bad. Supposedly they can not "integrate" good and bad images of others, but more on that in a future post.

I think it more likely that they have the compentencies in question, but are choosing not to use them in certain situations. It is far simpler to fake incompetency than competency.

Some readers may have seen the movie "The Killing Fields" about the genocide in Cambodia. The Khmer Rouge killed anyone with an education. In the true story portrayed in the movie, a physician survives by pretending to be an illiterate peasant. In this case, acting as if he were incompetent was the most competent thing he could have done.

Tuesday, March 9, 2010

Recipe for producing frequent tantrums in children

Joseph Biederman is the Harvard Psychiatrist who has been pushing the diagnosis of "pediatric bipolar disorder." He also advocates the use of potentially toxic brand-named antipsychotic and mood stabilizing drugs for children who display symptoms of this alleged condition, because Lithium tends to not work in this population. That could be because these children are not bipolar to begin with. According to the New York Times, drug companies paid Dr. Biederman at least $1.6 million in consulting fees from 2000 to 2007, but for years he did not report much of this income to university officials, according to information given Congressional investigators.

Biederman argues against the use of any duration criteria for manic or depressive episodes in these so-called bipolar children. In the current DSM, hypomania - a mild form of mania - must be present constantly for at least four days, and a full-blown manic episode has to last seven. Although these time lengths are obviously arbitrary, they were put in the DSM so psychiatrists would not label normal mood reactivity as being due to bipolar disorder.

Biederman argues that mood swings in bipolar children can last just a few minutes and rapidly alternate. He further argues that pediatric bipolar disorder is unlike adult mania and is manifested by the key symptoms of temper tantrums and “explosive irritability.” There is no credible scientific evidence that such behavior is related to bipolar disorder. He just MADE THIS UP.

The folks writing the DSM-V are somewhat concerned about the widespread adoption of this ridiculous idea by doctors who only dispense drugs and do no psychotherapy, so they decided they might come up with a whole new mental disorder, discussed in an earlier post, called "temper dysregulation disorder."

Actually, children do not have to have any biogenetic disorder in order to display frequent temper tantrums. We used to call such behavior acting out.

There is a well-known recipe that parents can use to produce this behavior in nearly any child. Just follow the following steps:

1. Start with one parent who constantly tells a child to do or not to do something, but always caves in so the child always disobeys and always does whatever he or she wants to do.

2. Add in the other parent yelling and screaming at the child about this, but still allowing the child to do whatever he or she wants to do.

3. Stir up the mix by having the parents criticize one another’s parenting in front of the child and blame one another for the child’s behavior.

To make a child with borderline personality disorder, follow these additional steps:

1. Add parents who start blaming the child in addition to each other for all of the family problems, but still let the child always get his or her way.

2. Have the whole family invalidate what the child says and does as much as possible.

3. Have parents vascillate between hostile overinvolvement and hostile underinvolvement.

Optional: If a severe case is desired: add in neglect and/or physical and/or sexual abuse of the child.

One has to keep in mind that if parents who usually act this way somehow listen to advice and stop it, the child’s behavior will get worse before it gets better. Furthermore, if the parents occasionally lapse back in to old habits, the child’s misbehavior will continue on even longer before it stops.

This is due to something behaviorists call a variable intermittent reinforcement schedule. The child will keep testing the parents to see if they will revert to prior practices.

Monday, March 8, 2010

Temper dysregulation disorder with dysphoria

The DSM-V Committee has decided to float a trial balloon about this new "diagnosis." Supposedly their hope is that doctors will quit labeling kids as bipolar, since there is no evidence that the behavior of a typical temperamental kid is in any way caused by or linked to true bipolar disorder. I think the new term will just provide another, even more outrageous label that will provide justification for drug dealing docs to use sedating, brand named, potentially toxic atypical antipsychotic medication on kids

My comments to the DSM-V Committee about this new proposed diagnosis:

Temper Dysregulation Disorder with Dysphoria

This diagnostic category is crazy, and would only help those parents who want to avoid looking at their own behavior and its effect on their children and to avoid taking responsibility for it. There is not one shred of respectable scientific evidence that having frequent temper tantrums is a psychiatric disorder (let alone having three per week), and a world of evidence that shows that in a neurologically intact child with a normal IQ it is triggered by parental inconsistency in discipline. If any psychiatrist is so sheltered he has never personally witnessed a family behave this way, he can watch a very accurate portrayal of it on the TV show "Supernanny." You can also read about it in John Rosemond's nationally syndicated parenting advice newspaper column.

The idea that this "diagnosis" will help doctors avoid labeling acting-out children as bipolar is not a good reason for such deception. The people pushing the idea of manic children do not believe that a manic episode requires ANY duration. A few minutes for them is enough. The children and the families in their studies are never observed in their homes during troublesome interactions. The "experts" make diagnoses using symptom checklists that do not take in to account the context, pervasiveness, and exact time course of the symptoms. They recruit subjects from a website called bpkids.org that has a message boards in which parents advise each other on what to say and what not to say to doctors to get their kids diagnosed as bipolar. Some have been paid large sums by pharmaceutical companies which were not disclosed to their university.