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Dr. Allen Frances: September 2010 Archives

September 2010 Archives

A Possible Compromise on Grief vs. Depression

By Dr. Allen Frances on September 8, 2010 4:48 PM   |   Comments   |   Bookmark and Share
Inconsolable grief

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We can take one further step toward finding common ground in my ongoing debate with Drs. Pies and Zisook. Dr. Pies has helpfully pointed the way in his latest piece, which can be found in the comments section here.

We agree that the problem is the fuzzy boundary between normal grief and Major Depressive Episode (MDE). It is at this mild end that our dispute lies. There is no dispute at the severe end -- severe depressive symptoms during bereavement are already meant to be diagnosed as MDE using the current guidelines in DSM-IV-TR. So the test case is someone who has lost a spouse or child and has just two weeks of sadness and loss of interest, appetite, sleep, and energy. Such a person would have to be diagnosed with MDE if we were to follow the DSM-5 suggestion to simply remove the Bereavement exclusion. 

Dr. Pies and I both disagree with the DSM-5 suggestion that two weeks is a long enough duration. There is no research suggesting that the distinction between normal grief and mild MDE can be reliably and validly made so early after the loss of a loved one in a griever with such mild and ubiquitous symptoms. This level of mild symptoms for this short a duration occurring in the immediate aftermath of a loss are just too common and too compatible with normal grief to be considered MDE.

Dr. Pies and I also agree that there is no need to medicate this griever having mild and completely expectable symptoms for so short a period. We would both instead recommend a combination of commiseration, empathy, support, and watchful waiting to see if the person goes on to have a normal evolution of grief (most will) or goes on to have enduring or more severe symptoms compatible with MDE. 

Dr. Pies worries more than I do that the current DSM-IV-TR criteria are too stringent and create a false negative problem- i.e. missing MDE during bereavement and withholding appropriate treatment from those who need it. He would make it easier to get an MDE diagnosis during bereavement than is currently possible using DSM-IV-TR, but would require much more stringent standards for its diagnosis than are being suggested for DSM-5. Dr. Pies suggests a one-month duration (not two weeks) and perhaps a higher threshold of symptom severity. 

Dr. Pies' suggestions are a reasonable way to balance the risks of false negatives vs. false positives. I worry much more than he does about false positive overdiagnosis and overtreatment. So I would prefer to stay where we are, but I could not strongly disagree with the Pies/Zisook suggestion. I would add to it just two exclusions. The diagnosis of MDE may be inappropriate if the individual's culture calls for a more profound expression of grief or if the individual has a personal history of a deep, but self-limited, grief in the past. 

So, where do we continue to disagree? I believe that to remove the Bereavement exclusion for MDE would disastrously open the floodgates to the misdiagnosis and overtreatment of normal grief (especially by hurried primary care physicians who do much of the prescribing). To me, the DSM-5 suggestion, as it stands now simply doesn't fly at all and is a public health threat. In contrast, Dr. Pies is willing to hold his nose and swallow a DSM-5 suggestion that he acknowledges will confuse grief with MDE. He invokes the image of saved suicides to defend his persevering effort to not miss any MDE patient, regardless of the negative consequences. 

I analyze the benefits and risks of the DSM-5 proposal quite differently. I don't see much benefit because I don't think the current rules result in many missed cases. DSM-IV-TR already allows extremely wide play for clinical judgment in deciding between grief and MDE. A clinician is welcomed to make an MDE diagnosis whenever he believes the specific circumstances warrant it, even with relatively mild symptoms in a grieving person (say, someone who has had previous depressions or previous prolonged grief). If the grief symptoms are severe, DSM-IV-TR insists that MDE be diagnosed. Clinicians do not find impediments to the appropriate diagnosis under the current system. It is an unproven and unlikely red herring that the DSM-5 change will save lives (or for that matter have any beneficial effect at all). 

But, as detailed in several previous posts, I believe the risks of the suggested change are great. I won't go through all the specific arguments yet again, but DSM-5 is promoting a needless expansion of psychiatric diagnosis that would reduce the dignity of grief, create insurance and job stigma, and result in unnecessary, expensive, and potentially harmful treatment. 

There is no proven efficacy for medication treatment given after just two weeks of mild symptoms in grievers. My guess is that the placebo response rates would be so high in this population that no active medication efficacy could ever be demonstrated. But medications do have side effects (including increasing suicidal symptoms in some people). 

My suggestion to Pies/Zisook is to not give up the fight with DSM-5 for an appropriate one-month duration requirement for milder MDE -- if not in all situations (my choice and theirs) then at least for MDE during bereavement. Swallowing a spoiled half loaf can be bad for the nation's health. We can assume that drug advertising to patients and marketing to doctors will result in a flood of treatment that they would also question. This should worry Pies/Zisook more than it does and stiffen their resolve to fight the good fight (with an admittedly unreasonable DSM-5) to require a one-month duration of symptoms. 

So let's be clear about a reasonable compromise. Reasonable people can disagree about the precise duration requirement before grief can be considered mild depression. Pies/Zisook suggest one month. I am OK with the DSM-IV-TR two months. Some people think it should be longer. No one but DSM-5 is suggesting two weeks, which seems like a really bad idea. 

This ongoing Talmudic debate with Pies/Zisook has been fruitful. A similarly careful risk/benefit analysis should be, but is not, occurring for all of the many questionable DSM-5 proposals.

DSM-5 Should Not Expand Bipolar II Disorder

By Dr. Allen Frances on September 7, 2010 4:31 PM   |   Comments   |   Bookmark and Share
One of the most important distinctions in all of psychiatry is often also the most difficult to make: Is the patient's depression part of a bipolar or a unipolar course of mood disorder? This is so consequential a decision because treating the depression of bipolar disorder with antidepressants can trigger problematic irritability, mood swings, and rapid cycling. To reduce this risk, patients receiving antidepressants for bipolar depression usually also receive either a mood stabilizer or an antipsychotic (or too often both). But the reduced risk of mood swings conferred by the covering medication comes at a potentially heavy cost in side effects and complications (especially dangerous weight gain and diabetes). The tough question is where to draw the diagnostic line between bipolar and unipolar mood disorder in a way that best balances the risks of taking vs. not taking the covering medication. 

The trend in diagnostic habits over the past 25 years has been clear. The boundaries of bipolar disorder have expanded widely at the expense of unipolar; the prevalence ratio between them is now about 1:3 as opposed to the previous 1:6. This has caused a markedly increased use of mood stabilizing and antipsychotic drugs; they have protective effects in those who need them, but harmful side effects in those who may not. 

Two factors account for this move toward bipolar (and away from unipolar) disorder. The first was the introduction by DSM-IV of a new official category (Bipolar II) that expanded the bipolar category into unipolar territory. Bipolar II describes patients who have depressions that alternate with hypomanic episodes (rather than with the manic episodes of classic Bipolar Disorder). Hypomanic episodes are milder and often briefer versions of classic mania and are therefore very much more difficult to diagnose. This is complicated further by the fact that brief periods of elevated mood can be provoked by drugs or medications. And it is often hard to distinguish the elevated mood of hypomania from a temporary return to normal mood in someone who has become accustomed to always feeling depressed. 

Patients with depression and hypomania are at the boundary separating bipolar and unipolar disorder. They could have been classified in either camp. We made the decision to describe them as Bipolar II in DSM-IV because the weight of the course, family history, and treatment evidence suggested that they sorted better with Bipolar Disorder. This was not an easy decision. We had to balance: 1) concerns that patients with bipolar tendencies would be harmed iatrogenically if they received antidepressants without coverage, against 2) concerns that some patients identified as Bipolar II were really unipolar and would receive the added burden of unnecessary and potentially harmful medication. This was a close call, but on balance it seemed safer to include Bipolar II as a new category. I still think this made sense, although the extent of the bipolar fad that followed was certainly surprising and remains a serious concern. 

We perhaps should have, but did not, anticipate how intense and effective the marketing and "education" campaign mounted by the pharmaceutical industry would be, alerting psychiatrists, primary care doctors, other mental health workers, and patients about the perils of previously "missed" bipolar disorder. This led to more accurate diagnosis and safer treatment for many patients, but like all fads, it overshot and has led to unnecessary medication for others who are now misdiagnosed as bipolar on very flimsy grounds. 

This brings us to two problematic changes being considered by the DSM-5 mood disorders work group: 1) allowing hypomania to be diagnosed just on the basis of increased energy/activity (no longer requiring the presence of elevated mood or irritability), and 2) reducing the duration requirement for a hypomanic episode (now set at four days by DSM-IV). As is usual with all the changes being considered for DSM-5, the lowered thresholds are meant to avoid missed diagnoses, but this seems far outweighed by the risks of overdiagnosis of Bipolar II Disorder and the consequent overtreatment with harmful medications.

We must accept that there is no currently available method that infallibly distinguishes bipolar from unipolar disorder at their boundary. Until we have a much deeper understanding of the different pathogeneses of unipolar vs. bipolar disorder, this crucial distinction must be based exclusively on clinical judgment using the admittedly arbitrary DSM rules of thumb defining the symptoms and duration of a hypomanic episode. Any decisions lowering the symptom and duration requirements for a hypomanic episode will feed what is already a bipolar fad.
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DSM-5 Temper Dysregulation: Good Intentions, Bad Solution

By Dr. Allen Frances on September 7, 2010 3:44 PM   |   Comments   |   Bookmark and Share
Sometimes you spot a serious problem and figure out a very well-intended solution, only to discover eventually that your solution created as much trouble as the original problem. The workers on DSM-5 have spotted an enormously worrisome problem: the wild overdiagnosis of childhood Bipolar Disorder, which has led to a massive increase in the use of antipsychotic and mood stabilizing medications in children and teenagers. 

Something clearly needs to be done to correct this. The proposed DSM fix -- a new diagnosis called "Temper Dysregulation with Dysphoria" -- is meant to provide a less risky diagnostic home for the kids currently misdiagnosed as bipolar. Unfortunately, temper dysregulation is just the kind of unhappy solution that you later come to greatly regret. It is a makeshift proposal, with considerable risks, and a disqualifying conceptual problem. 

How is it makeshift? As the DSM-5 work group candidly admits, the research evidence on this new diagnosis is remarkably thin, based on the very recent work of just one research group. Virtually nothing is known about its likely prevalence in the general population, whether it can be distinguished reliably from normal developmental or situational irritability, its relation to other disorders that present with temper outbursts, its course, its preferred treatments, or the tradeoff between treatment response and adverse complications. 

The criteria set for temper dysregulation require: 1) severe recurrent temper outbursts in response to common stressors; 2) occurring at least three times a week; 3) for at least a year; 4) in someone who is persistently irritable. 

The definition was created largely ad hoc with no systematic testing (outside of that one research program) of the performance characteristics of the items to determine how they would play if in wide general use. It is loosely written and in fact contains no exclusion for use in adults (which I assume is an oversight).

Why is such a makeshift solution being given any serious consideration? The work group freely admits that the scientific rationale is completely inadequate. Their proposal rests exclusively on two real and pressing clinical needs: 1) to reduce the overdiagnosis and overtreatment of bipolar disorder; and, 2) to do something to help the considerable suffering that these temper outbursts cause the children themselves, their parents and teachers, and society at large. 

But this attempted fix is itself highly risky and likely to set off its own cascade of unfortunate unintended consequences. The biggest problem with the proposal is that it is not nearly restrictive enough. While trying to rescue kids who are now misdiagnosed as bipolar, it will undoubtedly open the door to the misdiagnosis of normal kids who happen to be temperamental or in difficult family circumstances. Every effort must be made to distinguish mental disorder-level temper problems (that cause clinically significant distress and impairment) from those that are within the limits of a normal, but difficult temperament experiencing the aches and pains of growing up. 

This is hard to do. First off, there is enormous variability in what are considered appropriate expressions of temper across kids, across developmental periods, across families, and across subcultures. The definition of "severe" will likely vary greatly depending on the tolerance of the clinician, family, school, and peer group. The "stressors" that trigger the episodes may be minimal in some cases, remarkably provoking of readily understandable temper reactions in others. Family fights that are based in interpersonal problems will be translated into individual psychopathology. Finally, in the heat of battle, it will be forgotten that kids often do outgrow a developmentally or situationally triggered temperamental period in their lives. 

In expert hands, it is conceivable that the diagnosis might be contained to achieve just its intended goal of reducing the diagnosis of bipolar disorder, but in the real world many diagnoses are made by primary care clinicians who have limited expertise in psychiatry, little time with each patient, are dealing with harried family members who want a quick solution to a pressing problem, and are influenced by drug company salespeople. My experience tells me that this makeshift diagnosis may well become very popular and will spread to normal kids who would do a lot better without treatment.

Temper dysregulation also shares very difficult-to-define boundaries with about a dozen other mental disorders. It would be excluded in the differential diagnosis with Major Depressive, Dysthymic, Bipolar, Schizophrenic, Autistic, Separation Anxiety, and Post-traumatic Stress Disorders. It would be allowed to coexist with Oppositional, Conduct, Attention Deficit, and Substance Use, creating an artificial comorbidity with them and raising the risk of unnecessary and inappropriate treatment. For example, many drug-abusing teenagers will meet the criteria for temper dysregulation. Most often, the preferred intervention should be dealing with the substance problem, not adding a medication. 

Which brings us to the risks of treatment for this prematurely concocted diagnosis. Unfortunately, it is inevitable that this will often consist of atypical antipsychotic drugs because these are heavily marketed and may be helpful in reducing some forms of explosive temper outbursts. But their beneficial effects in some must be balanced against their very great dangers when widely used for the many. These medications often cause enormous and rapid weight gains, increasing the risk of diabetes, medical complications, and reduced life span. Their use in severely disturbed kids raises its own set of serious clinical and ethical questions, but it can be justified in extremely exigent circumstances. Their use in kids who are having disturbing (but essentially "normal") developmental or situational storms or are irritable for other reasons (e.g. substance use, ADD) would be disastrous, but it will happen and probably often. 

What is the conceptual problem? Temper dysregulation describes a single symptom, not a complete syndrome. It is at the same level of abstraction as fever or suicide -- it can occur as part of the presentation of any number of disorders, but is not a separate disorder in and of itself. In the distant past, psychiatry used to classify by symptoms, but found this to be cumbersome and much less satisfying than our current serviceable, if limited, syndromal approach. 

What is the solution? Severe, recurring, and persistent temper outbursts are a crucially important clinical and societal problem and deserve special attention. But given the limited state of current knowledge, it is premature to regard Temper Dyregulation as an independent coherent syndrome that would solve more problems than it would cure. There are two far better ways for DSM-5 to attempt to address this problem. 

DSM-5 could add a specifier, "With Explosive Outbursts," whenever this is a prominent part of the presentation of all of the dozen or so conditions in the differential diagnoses. Or it could add the specifier just to Oppositional Defiant Disorder and attempt to use this as a default away from Bipolar Disorder. Or "temper problems" could be one of the cross cutting dimensions, if these make it into DSM-5. Each of these possible conventions would make the point that temper outbursts are (again, like fever or suicidal thoughts) nonspecific symptoms of many disorders, not a specific and separate disease.
 
The criteria and text of DSM-5 should be as commendably clear as the drafts are that there are serious problems caused by the current practice of over diagnosis of childhood bipolar disorder. Specific guidelines should be recommended that would attempt to preempt the loose non-criteria-based diagnostic habits that have recently gained such unwarranted purchase.

These steps alone will, of course, not solve the dangerous "epidemic" of childhood bipolar disorder. There are limits to what DSM-5 can do in this regard. The NIMH and FDA may have to step up their involvement. There is a pressing need for an educational campaign to professionals and to the public to highlight the risks of overuse of atypical antipsychotics and to recommend caution in diagnosis and treatment of kids with temper outbursts. Much more research funding should be directed to this area. Funding for the study of explosive behavior has been inadequate in the past because it is an inherently difficult research topic, but the huge public health significance of widespread antipsychotic use should now give it a priority.

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