Friday, April 30, 2010

The Second PhARMA Company Fined by DOJ in Just One Week

In my post of March 27, 2010, A Perfect Trifecta, I mentioned that a lot of psychiatrists seemed to be using an anti-epileptic drug called Topamax in patients whom they had diagnosed - often incorrectly - as having bipolar disorder.

It turns out that my observation was no accident. For the second time in just one week, the U.S. Department of Justice fined a pharmaceutical company for off-label marketing of drugs for psychiatric indications. Two Johnson & Johnson subsidiaries, pharmaceutical manufacturers Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc., have agreed to pay $81 million to wrap up a probe of their Topamax promotions.

Just like with AstraZeneca, the companies did not admit guilt, and just like with AstraZeneca, the fine was a paltry sum compared to the money they made from the drug being misused. The drug has NO psychiatric indication at all.

According to settlement document posted on the Justice Department website, during the period from January 1, 2001 through December 31, 2003, the companies promoted the use of the drug for a variety of psychiatric conditions, including but not limited to bipolar disorder and drug and alcohol dependency.

According to the Justice Department press release, Ortho-McNeil paid doctors to come with sales reps on detailing calls and suggest unapproved uses for the drug. Doctors also were allegedly hired to speak at meetings and dinners about off-label Topamax use.

Five drug companies so far have been proven to have a vested interest in expanding the diagnosis of bipolar disorder for their own profit.

Wednesday, April 28, 2010

Yet Another Case of Glorified Dope Dealing

My perfect trifecta
Is perfect no more
Trifecta means three
But now there are four

The U.S. Department of Justice just announced that they have fined AstraZeneca $520 million for off-label marketing of its atypical antipsychotic drug, Seroquel. Seroquel is a highly sedating and powerful "atypical" antipsychotic medication that is the second worst offender of all antipsychotic medications for causing a dangerous side effect called metabolic syndrome. Metabolic syndrome leads to an increase in sugar, cholesterol, and/or triglycerides (fat)in the patient's blood. It can lead to actual diabetes.

AstraZeneca is the fourth drug company recently made subject to huge fines for phony marketing schemes for their psychiatric drugs (the other three were the subjects of previous posts).

Among the "conditions" that Seroquel was touted for, beside schizophrenia and mania for which it is indicated, were aggression, Alzheimer’s disease, anger management, anxiety, ADHD, depression, post-traumatic stress disorder, and - get this - insomnia. I have personally seen several patients given the drug by other docs who were prescribing it for sleep. It works, but there are much safer alternatives in most cases.

According to the Justice Department official website, "The United States contends that AstraZeneca promoted the unapproved uses by improperly and unduly influencing the content of, and speakers, in company-sponsored continuing medical education programs. The company also engaged doctors to give promotional speaker programs on unapproved uses for Seroquel and to conduct studies on unapproved uses of Seroquel. In addition, the company recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct. AstraZeneca then used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel.

The United States also contends that AstraZeneca violated the federal Anti-Kickback Statute by offering and paying illegal remuneration to doctors it recruited to serve as authors of articles written by AstraZeneca and its agents about the unapproved uses of Seroquel. AstraZeneca also offered and paid illegal remuneration to doctors to travel to resort locations to "advise" AstraZeneca about marketing messages for unapproved uses of Seroquel, and paid doctors to give promotional lectures to other health care professionals about unapproved and unaccepted uses of Seroquel. The United States contends that these payments were intended to induce the doctors to prescribe Seroquel for unapproved uses in violation of the federal Anti-Kickback Statute."

Of course, a half billion dollar fine is chicken feed for the company, which made billions off of this drug. It is just a cost of doing business for them.

Saturday, April 24, 2010

A Splitting Headache

In my blog post of March 11, 2010, I described what I believe to be an absurdity that has been promulgated by the mental health profession about patients with borderline personality disorder (BPD). These individuals were said by theorist Marsha Linehan to have “apparent competency,” by which she meant that they appear to have certain abilities in some contexts which they in fact do not possess. I wondered how they were able to demonstrate competencies through performance that they actually lacked, and I opined that it is much easier to fake incompetence than competence. Perhaps it is the incompetence that is more apparent than real, and is in fact a highly-motivated but well-hidden choice.

Another popular idea in the field about patients with BPD is that they engage in something called splitting. Anyone who has treated a patient with the disorder in psychotherapy has ample eyewitness evidence that they often talk about other people as if they were, in their essence, either Gods or complete piles of horse manure, with nothing in between. This is splitting behavior. The fact that they sometimes act this way is an extremely valid observation, but what does it mean?

First of all, “splitting” others into “all good” and “all bad” categories was originally presumed by psychoanalysts to be a defense mechanism. A defense mechanism is a mental coping maneuver meant to both partly express and to ward off any feelings that a person might experience, as well as any accompanying impulses, that they find unacceptable in themselves. For example, a person who does not like to think of himself as angry at his father might “take it out” on someone else. This is an example of a defense mechanism called displacement.

Whenever we are faced with someone who does something heinous or who inspires us, we all have a tendency to “split,” or think of the person as all or mostly good, or all or mostly bad. This is completely normal. Many of us feel that child molesters, to take a common example, are monsters with no redeeming qualities whatsoever. Mother Teresa, on the other hand, is viewed by some as a true and flawless saint.

What happens in a situation in which someone else does something wonderful one day and something absolutely heinous the next, or vice versa? For example, what if your own father raped you one day when you were thirteen, and bought you a pony the very next day? (This actually happened to a patient I know of). Even therapists have trouble putting something like that together. Some therapists even accuse patients of making things like that up. Is it surprising that our patients might have to think about these characteristics separately in order to avoid severe cognitive confusion?

Along came a psychoanalyst named Otto Kernberg. He began to talk about “splitting” not as a defense mechanism but as a deficit. He believed that patients with BPD literally lacked the ability to see both good and bad in others or themselves simultaneously. According to his theory, future patients with BPD failed to negotiate a childhood developmental stage called rapprochement, which, according to the theory, takes place around the age of two. “Normal” two year olds supposedly then develop the ability to integrate good and bad images.

The problem with this formulation is that social psychologists have actually studied children to find out when normal children develop this ability, instead of just sitting around theorizing about it. In fact, three different studies using three completely different methods [Donaldson, S., & Westerman, M. (1986). Development of children’s understanding of ambivalence and causal theories of emotions. Developmental Psychology, 22(5), 655-662; Harter, S. (1986). Cognitive-developmental processes in the integration of concepts about emotions and the self. Social Cognition, 4(2),119-151; Selman, Robert. (1980). The Growth of Interpersonal Understanding. San Diego: Academic Press] all came to the same conclusion. Normal children do not begin to develop this ability until they reach the age of about eleven and a half. They do not get especially good at it until they are about fifteen years old.

Of course, analysts never read social psychology, so they are unaware that their theory is utter nonsense. They also ignore evidence from their own observations which should cause them to doubt the veracity of their “ego deficit” theory. They will readily acknowledge that patients with BPD are master manipulators. The patients with BPD know how to size anyone up in a very short time in order to best figure out how to make him or her personally feel either helpless, guilty, or angry in dealing with them. How could they do this so well if they were not able to gauge other people’s strengths and weaknesses simultaneously? This is an easy question to answer. They could not.

I once mentioned to an analyst that when any of my patients with BPD are in the right mood, they are easily able to list other people’s good and bad points at the same time. He responded that this observation does not prove that they are really able to see good and bad qualities simultaneously! I wondered: how on earth could a patient ever prove to this therapist that he or she is capable of anything?

Another point about splitting that applies to everyone, not just patients with BPD, is that when you are absolutely furious with someone else, you never feel like bringing up all their best qualities. Likewise, if you wish to butter someone else up, bringing up all of their faults is not in your best interests! Heaven forbid we should think of any of our patients as smart enough to know this.

In my opinion, splitting is only sometimes a defense mechanism, and it is never an ego deficit. It is rather an interpersonal strategy designed to elicit specific reactions from other people in the patient’s important relationships.

Wednesday, April 21, 2010

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.

Saturday, April 17, 2010

The Language of Love

At the beginning of J. R. R. Tolkien's The Hobbit, a normally unadventurous fellow named Bilbo is standing in front of his home when a rather mysterious looking old man happens by. Bilbo wishes a good morning to the stranger. To Bilbo's surprise, the outsider does not return the greeting in the expected fashion. Instead, the newcomer questions the meaning of Bilbo's statement.

He inquires whether Bilbo intends to wish him a good morning or to state that it is a good morning whether or not either of them wants it to be. Or does" good morning" mean that it is he, Bilbo, who feels good that morning or that it is a morning on which to be good? Bilbo, a bit perplexed, answers that he means all of those things at once.

Perhaps the old man had reason to suspect that the hobbit was not feeling so friendly as the cheery" good morning" might indicate. The old man was Gandalf the wizard. Unbeknownst to Bilbo, he was familiar with Bilbo and was also well acquainted with the tribe of hobbits to which Bilbo belonged. He knew about their mistrust of strangers and their dislike of the new and the unknown. He also knew that hobbits tended to be polite at times when they did not really wish to be.

Knowing all of this, it would be difficult indeed for anyone to take Bilbo's friendly salutation at face value. As a matter of fact, the wizard was right on target when he questioned the meaning behind the statement. Bilbo was uncomfortable with the presence of a stranger and did not trust him at all. He was probably concerned that the old man's presence might indicate that the morning was not going to be good at all.

In my second book, Deciphering Motivation in Psychotherapy, I look at hidden aspects of language, and in particular its inherent ambiguity. Any sentence in any language can have at least two different meanings. Even a simple "I love you" can be interpreted on multiple levels, as I will soon illustrate. But first, some background information about how any sentence always has a dual reference.

The first of the two meanings is the literal meaning of the words used, while the second is the what the sentence means in the context of the relationship of the two people having the conversation. In order to understand this second level, one also has to understand that words can also be actions that do things that go well beyond talk. Linguists refer to this phenomenon as "speech acts."

For instance, if I go up to someone and say, "I hear you are having a party Saturday night," I am not only relaying information about what I heard someone say, I may also be actively fishing for an invitation. If I fish for an invitation in this manner, I am also indirectly acknowledging the fact that within this particular relationship, I do not have the right to simply ask the person directly to invite me to the party. I am most likely also not entitled to ask why I had not been invited in the first place. The way I fish for an invitation says a lot about the relationship I have with the person I am speaking with. Linguists refer to this level of communication as the pragmatics of language.

When it comes to language among members of a family system, sometimes family members must keep their intentions ambiguous. Language seems especially well constructed to allow individuals to keep their private thoughts and plans ambiguous. Ambiguity is especially handy if a person's intentions may or may not be at odds with the rules by which the family operates. In dysfunctional families, family members are often conflicted or confused about certain family rules. They may feel, for example, that they are in a "damned if you do - damned if you don't" situation. If so, they can make use of the inherent ambiguity of language to keep their intentions unclear.

Now back to "I love you." A man in couple's therapy loudly complained about his wife's jealously and insecurity whenever he so much as spoke to another woman. "Why do you raise such a big fuss?" he asked his wife, with obvious frustration. She replied, "I do it because I love you."

As much of language does, "I love you" can have two completely opposite or antithetical meanings. It can mean something selfish or something altruistic. Of course, it can also mean both simultaneously.

Most people who hear the wife's "explanation" in the example above will assume, because of her apparent insecurity, that the selfish version applies. In other words, they roughly translate the statement into, "Because I am insecure and dependent and need you so badly, I cannot stand the thought of anyone else having you even innocently, so I make a fuss even if it drives you nuts."

The meaning people often do not pick up on is the altruistic meaning. Roughly translated, the sentence might mean, "You're the one who is insecure. It really gives your ego a boost when I act so hopelessly dependent on you. If I did not act that way, you would be crushed! I'm willing to make myself look like the insecure one because I love you so much; I am willing to do that for you."

Do wives ever do this? My opinion: they do it all the time. And so do husbands, parents, siblings, and children.

Why would the wife need to be ambiguous about what she means by "I love you"? If the husband really knew that she was only acting insecurely for his benefit and did not really feel that way, her behavior would no longer boost his ego when she threw a fit. It might even deflate it even more. Therefore, she has to be deceptive in order to have her intended effect on him.

Unfortunately, this issue may make the pragmatics of the simple "I love you" even more complex. Suppose the couple is psychologically sophisticated and the husband starts to wonder if maybe the wife is laying the insecurity on too thick and that it might be put on only for his benefit. If his wife is correct about his being the insecure one, his ego would start to deflate.

If this were to happen, the wife might then start to act in ways that lead the husband to yet a different, third interpretation of the wife's original explanation: "She is rationalizing her behavior as being for my benefit to cover up the fact that she is really selfish."

If the wife succesfully made him think that, she would then be able to continue to provide the altruistic service. Linguistically, she would be acting out yet a fourth interpretation: "My behavior really is for your benefit. However, since you suspect it and I am trying to keep it a secret, I will let you think that interpretation #3 is correct. That way, you will not know that I am in fact acting this way for your benefit."

Are people really clever enough to come up with crazy and complicated schemes like this? As they used to say on the old TV show, Laugh In, you bet your sweet bippy they are. I see it all the time from patients in therapy. These motives are not, however, something people readily admit to. As therapists, however, we have ways of getting it out of them!

Wednesday, April 14, 2010

Attachment: the Latest Dirty Word in Biological Psychiatry

The crowd that wants to substitute the “bio-bio-bio” model for the bio-psycho-social model in psychiatry apparently freaks out if anyone brings up the wealth of studies that look at the effects of attachment behavior and attachment trauma on human behavior.

Attachment phenomena are those interactional variables that are present in the relationship between babies or children with their primary caretakers. These patterns affect the child’s psychological development as well as his or her adult intimate relationships.

Attachment patterns are loosely classified as “secure” or “insecure.” Insecure attachments are further subcategorized as “avoidant/dismissive,” “ambivalent/preoccupied,” or “disorganized.”

Clear evidence ties parental behavior problems and parenting styles with subsequent behavioral and interpersonal relationship problems in their children. Those children with disorganized attachments, for example, become overcome with anxiety, confusion, and paralysis whenever they are involved in intimate relationships. The literature shows that the best predictor of how a mother will bond with her child is the nature of the attachment bond the mother had with her own mother.

At the recent meeting of the American Academy for Child and Adolescent Psychiatry in Hawaii, some of the so-called researchers who have been diagnosing bipolar disorder in young children were presenting their material. Peter Parry, an Australian academic psychiatrist who is, to say the least, highly skeptical about pediatric bipolar, relates the following:

“They had no answer to attachment and trauma. Melissa DelBello, when I asked her about her presentation on neuroimaging in Pediatric Bipolar Disorder (PBD) - which was incredibly detailed and actually quite well put together and I complimented her on that – I said that the findings presented seem to have considerable overlap (a phrase she'd kept using about findings with PBD and ADHD) to the neuroimaging findings presented by Alan Schore etc re attachment trauma.

She initially said she didn't understand my question; after repeating it she twice said that there are some differences with ADHD. I eventually had to again repeat that I wasn’t talking about ADHD - I was talking about the amygdala and right frontal changes she was showing with PBD which they also find in the attachment/developmental trauma literature - at which point she conceded they hadn't looked at that population.”

This interchange is typical of the way some researchers who are overly tied to a pet theory attempt to avoid looking at or talking about any data that would call their theories into question. Usually they just avoid answering any questions that would do this, and subtly change the subject. I admire Dr. Parry’s persistence in not letting her get away with that.

Monday, April 12, 2010

Your Spouse's Secret Mission

On October 4, 2009, newspaper advice columnist Carolyn Hax printed a letter that said:

“Three years ago, during my senior year of high school, my parents divorced. My dad has quite a bit of money and I was worried that he might get involved with gold diggers. I go to college out of state, so I haven't had many opportunities to get to know Joan. But the other day, my brother told me Joan had, unasked, told my dad: "I just want to go on record that I don't think you should pay for your daughter's law school. I don't approve.

Unfortunately, this isn't her first comment like that. … More important, I think it's horrible that she would position herself to cause a rift between my father and me over issues that are none of her business. I don't care how my dad chooses to spend his money, but I'm furious that she is nice to my face while making these comments behind my back.

...I'm going home for a visit soon, and I think I should give my dad a heads-up. What should I say? He doesn't know I know about the law school comment, and I don't want to drop my little brother in the grease.”

Carolyn Hax wisely advised the writer not to pre-judge the matter before confirming what she heard.

I of course do not know what is true in this particular family, but I would like to share a pattern I have frequently come across as a therapist who works with individuals on family systems issues, and which possibly might apply here.

Sometimes a spouse "volunteers" to appear to be the villain in a family drama so parents will not be angry at grown children or vice versa in cases in which the parent and adult child cannot be honest with one another about their real feelings.

Using this family as a hypothetical case, perhaps it is Dad who is feeling overburdened financially - maybe he also plans to put the writer's brother through school - but feels too guilty to say no to her, or feels obligated to put her through law school.

Hearing her husband's complaints about this in private, and to shield the father, the step mother makes it sound as though she is the one who objects. She says this in front of the writer's brother, knowing it will get back to her. This way, the writer gets angry with her and not with the father, and if he does decide not to pay, it appears as if he is not to blame but that he is totally under her gold digging thumb.

It may be hard to believe anyone would sacrifice themselves like this for a spouse, but I find it happens with surprising frequency. I e-mailed Ms. Hax about this, and she replied that she did not find it surprising at all, as she has done it herself.

Friday, April 9, 2010

Able Was I Ere I Saw Abilify

You've all seen them. Screaming, direct-to-consumer advertisements for Abilify for use as an adjunct to antidepressant drugs in treating depression. "Only a third of depression responds to an antidepressant alone! Ask your doctor about Abilify!"

Just before these ads started, I predicted that as most antidepressants were going off patent, so that they would be available as cheaper generics instead of just as expensive brand-name medications, we would start to hear about how ineffective or problematic they were. I was right. Newspaper stories and even journal articles on this subject have become more and more frequent. We hear that antidepressants can increase suicidal ideation (misleading, but I won't cover this in this post), how they are completely ineffective for mild to moderate depression, and even how they don't work at all in true Bipolar patients who are in the depressive phase of their illness (Complete B.S. Also not covered here; I describe the hanky panky employed by the authors of a major journal article that came to this conclusion in my upcoming book).

Meanwhile, use of potentially highly toxic "atypical" antipsychotics like Abilify has skyrocketed. Many patients think Abilify is an antidepressant.

Now another atypical, Seroquel (quetiapine) has received an FDA approval for use as an adjunct to antidepressants. Of note is that its manufacturer, AstraZeneca, also tried to get it approved as a treatment for depression all by itself. Even the FDA, which is often in bed with the pharmaceutical companies, rejected this effort.

So what about that one-third business touted in the Abilify ads? It is a totally misleading figure. Notice ads use the word "depression" and not "major depressive episodes." This is important distinction because there are several types of depression. The two most prominent are dysthymia and major depression.

Dysthymia is a chronic mild form of depression that is usually caused by CCS (crappy childhood syndrome) and/or is reactive to ongoing interpersonal difficulties. It has never responded particularly well to antidepressants, but responds better to psychotherapy.

Major Depression, however, is a true inherited brain disorder. While it is often triggered by external stress, it can also occur spontaneously and can occur in otherwise well-adjusted, relatively happy individuals. It is usually self-limited, meaning it often goes away by itself after 6 to 18 months - only to return some time later.

It is characterized by what we used to refer to as "vegetative symptoms," or "diencephallic" symptoms: difficulty staying asleep, loss of appetite with weight loss, poor energy, loss of pleasure from activities that were previously enjoyed by the individual, poor concentration, and loss of sex drive. It is often also characterized by a complete and all-encompassing sense of utter doom, futility, and loss of joy. The more severe form is called "melancholia" and may also be characterized by feeling the worst when one first wakes up in the morning.

While dysthymia may have some of these symptoms, in major depression the symptoms are pervasive and persistent. This means that they are present almost all day almost every day for two weeks straight at the very minimum. People do not "come out of it" when they are forced to go out and do things, while dysthymic depression tends to lessen considerably when the patient is otherwise occupied or distracted.

Clearly there is overlap in the symptoms of the two types of depression, but the distinction is important. If your sample of patients includes both types - as in the more generic use of the word "depression" in the Abilify adds - then the percentage of people in your sample responding to the drugs will be lower. Many so called "empirical" randomized clinical trials of drugs do a terrible job of distinguishing the two types of depression due to their use of symptom checklists, as discussed in a previous post.

Another issue is that patients who do have major depression and do not respond to one antidepressant often do respond to a second or even a third agent. The one third figure in the ad also applies to patients who have only been tried on one agent.

Last, one can have both dysthymia and major depression. This is called double depression. If the antidepressant is given to this type of patient, the vegetative symptoms often go away, but the patient is still left with his chronic mild depression due to his crummy life. It is totally misleading to say that these patients only had a partial response to antidepressants, but these folk are also included in Abilify's one third figure.

The last point I would like to make is that we have always known than antipsychotics can augment antidepressants in some patients who don't respond to the antidepressants alone - the old ones do this too. However, an antipsychotic augmentation strategy is the last one a good psychiatrist will employ. (I am not referring here to depressed patients who actually become psychotic - hear voices, have delusions, etc.- when they go into a major depressive episode. In these patients, an antipsychotic combined with an antidepressant is the first choice). Lithium and thyroid hormone can also augment anti-depressants, and are far safer. Even one of the managed care panels I am on sent out a newsletter trying to make that point with psychiatrists!

Wednesday, April 7, 2010

Borderline or Bipolar?

As psychiatrists have gone from doing both psychotherapy and prescribing psychiatric drugs to doing basically nothing but writing prescriptions, many of them have fallen into some very bad habits. When all you have is a hammer, everything starts to look like a nail. In this case, when all you have are drugs, everything starts to look like a brain disease.

Personality problems, anxiety, agitation, and reactions to problematic family and other interpersonal interactions have been widely mis-labeled as biological/genetic brain diseases. Quite a change from when real brain diseases like autism and schizophrenia were thought to be behavioral disorders!

One of the worst trends in this regard is the use by psychiatrists of “symptom checklists” to save time in making a psychiatric diagnosis on their patients. Frankly, the doctor’s secretary could make a diagnosis just as easily as the doctor could using this shortcut. Patients are quizzed about specific symptoms without even seeing if they understand what the symptom must be like in order to be clinically significant.

The evaluation of psychiatric symptoms must take into account their psychosocial context, their pervasiveness, and their time course in order to distinguish them from everyday mood reactivity due to life experiences. Additionally, some symptoms are seen in a wide variety of different psychiatric conditions, and an understanding of these three factors, as well as the taking into account of the presence of other symptoms necessary in order to qualify for a given diagnosis, is essential in differentiating the different disorders.

For example, symptoms seen in a variety of psychiatric disorders as well as in normal people under stress include:

• Impulsivity
• Irritability
• Aggression
• Hostility and Rage
• Moodiness and sudden mood changes
• Agitation
• Poor Concentration
• Disorganization

Irritability can be seen in anxiety, major depressive disorder, dysthymia, mania, personality disorders, and in someone who’s just having a bad day.

Nowhere is this problem more problematic than in the differentiation between a major mood disorder called bipolar disorder (which used to be more accurately called manic-depression), and a personality disorder spawned by dysfunctional families called borderline personality disorder (BPD). Psychiatric drugs only help with anxiety and reactivity in the latter disorder – psychotherapy is by far its most important treatment. True bipolar disorder, on the other hand, does not really respond to psychotherapy at all, but is treatable and preventable with certain medications.

In my 35 years experience of taking complete psychiatric histories, and in my 18 years of experience watching psychiatric residents (trainees) taking psychiatric histories, I know that asking patients about prior episodes of mania is one of the more difficult things to do in psychiatry. Almost everybody has been euphoric, partied all night, and felt on top of the world at one time or another. Patients almost invariably answer yes if asked about theses symptoms. The patient has to be made to understand that in mania, these symptoms are really extreme, have to last several days, be relatively unresponsive to anything that is going on in the environment, and be completely different from the patient’s normal functioning. It literally has to be a Jeckyl and Hyde situation.

You also have to rule out other potential factors that may account for a patient’s “yes” answer. For example, it may seem absurd when you think about it, but many psychiatrists stop after asking a patient about whether they have ever had a period in which they stayed up all night for several days while remaining energetic. They don’t ask obvious follow-up questions like, “Did you nap in the daytime?” “Were you using methamphetamines or cocaine at that time?” or even, “How much coffee were you drinking then?”

Furthermore, despite objections from the people who wrote the diagnostic manual in psychiatry, some psychiatrists believe that a “manic” period can last just an hour or two, or even a few minutes. They say that folks who have brief mood swings or go into a rage are “rapid cyclers” or have “sub-threshold bipolar disorder.” There is absolutely not one bit of credible scientific evidence that short-duration “mood swings” are in any way related to bipolar disorder. The docs pushing this idea literally made this up in order to justify selling and prescribing more drugs. They pulled it out of their you-know-whats.

Ironically, a patient who is actively manic and one who is acting out from borderline personality disorder look nothing alike if seen when symptoms are present. The difference is not subtle at all! Furthermore, if psychiatrists know the tricks of the trade (and most do not), they can get a patient with BPD to turn off and on most of their symptoms like a faucet. Manic patients stay manic no matter what the doctor does in the short term short of knocking them out with sedatives.

Nonetheless, the purveyors of bipolar disorder (my ass), tout a screening symptom checklist called the Mood Disorder Questionnaire (MDQ). They claim it is almost as accurate as a full psychiatric interview in diagnosing bipolar disorder. Sure it is – a really, really BAD psychiatric interview. Actually, patients who score positively are just as likely to have borderline personality disorder as bipolar disorder, according to a study published online March 23 in the Journal of Clinical Psychiatry by Mark Zimmerman and colleagues. They found that of the 98 patients who screened positive on the MDQ, 23.5% were ultimately diagnosed as having bipolar disorder and 27.6% as having borderline personality disorder.

My colleague in the Association for Research in Personality Disorders, Joel Paris, MD, of McGill University in Montreal agreed with Dr. Zimmerman, saying that the MDQ scale is "completely invalid." As he told Medscape Psychiatry, "The scale lists all the symptoms of bipolar disorder, but it does not attach any time scale."

Another study in the Journal of Clinical Psychiatry by the same group (Reggero, Zimmerman et. Al. V,71:1, January 2010, pp.26-31) showed that 40% of patients in their sample who met clear DSM criteria for borderline personality and not for bipolar had been misdiagnosed as bipolar by a prior mental health professional, as well as 10% of all of the other patients.

These patients are getting potentially toxic medications while not receiving the psychotherapy they need. IMHO, this situation borders on criminality.

Friday, April 2, 2010

Debating the Downside of Psychiatric Diagnosis

There was an excellent debate on PBS about psychiatric diagnosis and the DSM-V between DSM-IV editor Allen Francis and APA president Alan Schatzberg. You can see it at: I have respect for Alan Schatzberg, but his comments about ADHD indicate that he REALLY needs to read my upcoming book.

Thursday, April 1, 2010

Is “Data” the Plural of “Anecdote?”

The title of this post is an old joke in scientific circles. Most scientists would argue that there is a big difference between scientific data and a collection of anecdotes (stories about a personal experience). For most hard science, this is often somewhat true. However, I am here to argue that, in the behavioral sciences, data is indeed the plural of anecdote.

One charge that biological psychiatrists level at psychotherapists is that there are not enough “empirical” data that “prove” its effectiveness. This is particularly true of the more humanistic and relationship-oriented therapies. Hence, they say, therapy is “unscientific” and should be thrown out because it is not “evidenced-based medicine.”

Of course, many of the randomized, placebo-controlled, double-blind drug studies (randomized = the use of chance alone to assign the participants in an experiment or trial to different groups; placebo = inert sugar pill; double-blind = the person evaluating the research subject does not know if the subject received the placebo or the active medication)can be every bit as biased as the worst anecdotal evidence. We are now living in an age of “marketing-based medicine,” as opposed to evidence –based medicine.

As an aside, it is actually impossible to do a double blind, placebo-controlled study in psychotherapy. That would mean that the therapists in the study would have to not know what treatment they were administering – that is, they would have to be incompetent. Not really a fair test of the treatment! Furthermore, one cannot have a relationship between two people that is completely inert like a sugar pill, so finding a good control treatment is difficult.

And then there is the matter of choice. Unless one completely dismisses the concept of free will, one has to know that no matter what intervention a therapist uses, a patient can choose not to respond to it. Maybe the patient is just feeling contrary that day. Contrast this with some drugs. Can one choose not to go to sleep if highly-potent anesthesia is administered? I think not.

We cannot read minds, and there are precious few laboratory tests by which we can monitor changes in feelings, cognitions, or even behavior. Mental health professionals who do “empirical” experiments regarding the effect on the psyche of drugs or psychotherapy therefore rely on their own observations and on psychological tests.

However, how a given individual chooses to respond to a psychological test on a given day is in all instances an anecdote, as is any observation that the experimenter makes. The result always involves a highly subjective assessment of the feelings, cognitions, or behaviors in question, either by the experimenter or by the subject. It is in no way empirical.

The designers of some psychological tests seem to know this, because they design their tests to include measures of what is termed “test validity.” By this they mean they incorporate into the test ways to screen out the subjects who have exaggerated some aspect of their mental state and others who have minimized it. Subjects can do so either consciously or subconsciously. If done consciously, we speak of those who are “faking good” or “faking bad.”

Validity is obtained by having a high number of test items. Some of the test items are so extreme that even a psychotic patient would not endorse them unless they were trying to look bad. Other items are repeated several times using different wording and sentence structure to see if the subject answers consistently. If subjects are lying, they often will not. The prime example of a test which incorporates this strategy is the MMPI (Minnesota Multiphasic Personality Inventory). It has 567 test items.

The vast majority of “empirical” psychological measures used in clinical trials consist of a much smaller number of items and have no validity scales. If the experimenter instead assesses the mental state of someone else through their own subjective judgment, he or she has all the possible bias inherent in any other clinical anecdote.

Now of course, when psychological tests are employed in clinical trials, if the study is properly randomized and the number of subjects is sufficiently large, one hopes that the number of subjects faking good or bad will be equal in the group of patients receiving active treatment and the group of people receiving a sham treatment. These folks would then cancel one another out, so to speak, leading to a valid result. Unfortunately, there is no way to know for sure whether any two groups are really comparable in this regard, and the number of subjects in clinical trials is often somewhat smaller than necessary for the testers to be even somewhat confident that they are.

Because free choice exists and because judgments about mental states are by necessity subjective, a psych test is just not comparable to a blood calcium level or a bacterial count. Hence, a psych test is an anecdote. As I said in the beginning, in psychiatry and psychology, data is indeed the plural of anecdote.

Subjects who take psychological tests may be faking, but they can also be somewhat uninterested. They may answer test items without really thinking about them very much, or even answer completely randomly. If they are being paid to be a research subject, they know that they will receive remuneration regardless of whether or not they are diligent. Test subjects may also have completely different ideas about what individual test items even mean.

Other motives can come into play. A prime example is performance on IQ tests. Egalitarians are always dismayed when anyone points out that African American students score, on average, more poorly on IQ tests than white students (of course, some black students do far better than the average white student).

The IQ test difference can be easily explained, not by racial differences, but by the fact that African American folks have a very good reason to be unmotivated to do well on IQ tests, and therefore do not take them as seriously as do whites. No means currently exist to accurately assess the strength of motivation test takers have to do well, but such motivation certainly influences scores on tests. Some researchers have found that people will generally do better on tests if they are paid to do so than if they are not.

As many African American commentators have pointed out, not all that long ago blacks who looked smart or who strived for upward social mobility were called “uppity” and were in significant danger of being lynched. The comic Chris Rock tells a joke about a black motorist in the old South who stopped at a stop sign, and was therefore shot by a police officer because he had the ability to read the sign. (This fear has been turned on its head as it has been transmitted from one generation to the next. Doing poorly on intellectual tests is actually lauded in some black communities, where doing well is equated with “acting white”).