Unintended consequences of antidepressant black box warning?

11 04 2007

An article by Charles Nemeroff and colleagues in the Archives of General Psychiatry this month reports reports on the “Impact of Publicity Concerning Pediatric Suicidality Data on Physician Practice Patterns in the United States.” (If you don’t have access to the journal, you can read a report on the article here.)   The authors show that antidepressant prescription rates for children and adolescents have declined and there has been a shift in proscriber patterns from “generalists” (PCPs) to “specialists” (generally psychiatrists) since the FDA placed a black box warning related to suicide risk.  The warning includes the following statement: “Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders.”  You can read the entire warning in a .pdf here).

The study does not study who is not getting medication that might have in the past–just that fewer kids are getting the medicine.  Whether that is ultimately good or bad remains to be seen.

Kelly Posner, who headed the FDA/Columbia Reclassification study, spoke at our Department Grand Rounds last month and lead a seminar with a smaller group of us about the reclassification scheme.  (The reclassification project looked in detail at reported adverse events that started this controversy.)   She clearly thought the consequences of the warning would be mostly negative.   She shared her concern (which has been stated by others as well) that the unintended consequence of the black box warning will be fewer youth treated for depression and more deaths by suicide, as a result.  From what I have read, that remains an empirical question and one that will require careful interpretation of data before inferring causality. What is clear is that the black box warning was probably based more on political and emotional concerns than on science (see also Marshall, Posner, and Greenhill, 2006), and that the risk of untreated depression is probably greater than the risk of adverse events from treatment.

[mounting soapbox]  That said…when this discussion comes up I think it is important to add psychotherapy and counseling to the landscape.  Untreated depression can be deadly, but that doesn’t mean the treatment has to be medication.  [coming down off soapbox]

What are the implications for risk assessment?   I’m still trying to understand that.  How I am guiding our clinicians at this point is this:   When conducting a risk assessment of an adolescent or young adult in the first weeks following initiation of antidepressants, we need to note that antidepressants have been recently started.  But rather than name this as a “risk factor” we would do better to note how the medication response will be monitored and indicate the risk-related symptoms that are being targeted by the medication.  That is, connect the medication to the risk factors it is designed to reduce, more than to the risk it might carry.

References

  1. Marshall, R. D., Posner, K., & Greenhill, L. (2006). Risk Perception Research and the Black Box Warning for SSRIs in Children. Journal of the American Academy of Child & Adolescent Psychiatry, 45(7), 765.
  2.  Nemeroff, C.B. et al. (2007. Impact of Publicity Concerning Pediatric Suicidality Data on Physician Practice Patterns in the United States.  Archives of General Psychiatry, 64:466-472.

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Categories : dissemination, evidence-based therapuetics, medication, professional culture, psychotherapy, risk assessment, suicide

Clinician response to violation of the “social contract”

7 02 2007

I had a stimulating conversation with a senior colleague in the CSPS yesterday. One part of the conversation centered around what happens for us, as clinicians, when the patient does not fulfill his/her end of the “social contract” that is implied when someone goes to a mental health professional. The assumed contract is that the professional gets to ask all kinds of personal questions, make recommendations about intimate details of a person’s life, and the patient is expected to accurately, honestly, and completely answer our questions, cooperate with recommendations, and be appreciative in the process.

In a previous post about risk and patient Choice, I offered ideas about how to approach a particular instance of patient patient choice (sometime known as “noncompliance”), including some initial documentation suggestions. But that post didn’t address how to handle the emotions that accompany working with a patient who exercises his/her freedom by not answering our questions or by refusing our help.

Clinicians experience a range of emotions in these situations under these circumstances. Helplessness, anger, and fear come to mind first. From a family therapy perspective, this calls for what Murray Bowen (1978) called “differentiation”–the ability to remain engaged, present, and available while not becoming reactive, defensive, or distant. Easier said than done! Especially hard when clinicians often feel a duty to protect patients from harm.

The first step is to name what is going on. “This person is violating the ’social contract’ and it is making me angry. I’m also afraid that this person could die while in treatment with me.” Next is some cognitive work: “This person did not give up the right to direct his life, keep his privacy, and make choices when he sought professional help.” Along with that, your best friend is good old fashion consultation. I plan to post more in the future about how to get consultation from colleagues about suicide risk, but for now, I think the main thing is for us, as clinicians, to explicitly frame the consultation in term of our emotions. “I am afraid and angry because a person I am working with, who has high risk of suicide, is not cooperating with my attempts to assess and intervene.” That frames the consultation discussion as being about “how am I going to work with this person given my emotions?,” rather than “how can I get this person to do what I want, given how difficult he is.”

As always, there is much more to say about this. This discussion of the therapeutic social contract and patient choice is not specific to patients with suicide risk. But it deserves special attention in the context of suicide risk because the stakes are high, the issue is loaded, and medical-legal preoccupations kick in and complicate everything. More to come…

References

Bowen, M. (1978). Family Therapy in Clinical Practice. New York: Aronson Publishers.


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Categories : family, patient choice, psychotherapy, therapeutic alliance, treatment planning

Clinician anxiety–what’s it about?

1 02 2007

When the “S” word comes up, many clinicians feel on edge. I’m sure that more than one factor (and different factors for different people) that contributes to the anxiety, but they are different enough that it affects how we would target training. Here are some possibilities:

  1. Uncomfortable with the pain and despair of another.
  2. Squemish about suicide and it’s morbid implications.
  3. Unsure of having the right skills to assess and treat.
  4. Worried about medical-legal implications of losing a patient to suicide.
  5. Concerned that suicidality will “hijack” the treatment.
  6. Incredulous that someone consider destroying him/herself.
  7. Fearful of losing a person the therapist cares about.
  8. Worried about not being able to help.

As I said, the source of anxiety probably varies, but I think it’s worth asking which is the most prominent so that we can (a) address it in ourselves and (b) target clinician education at the right set of issues.


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Categories : psychotherapy, suicide, teaching/training, therapeutic alliance

Post from AAS/SPRC Workshop-Thoughts about staying therapeutic

4 01 2007

I’m in Ohio this week at a “train the trainer” workshop developed by the American Association for Suicidology (AAS) and the Suicide Prevention Resource Center (SPRC). The workshop is called “Assessing and Managing Suicide Risk: Core competencies for mental health professionals.” The training has been excellent so far.

The material focuses a lot on the therapeutic stance and alliance, including some excellent video of a master clinician interviewing a suicidal patient. It reminded me of something I’ve been emphasizing in the trainings I do: that a good therapist is a good therapist….the skill set is not radically different for the suicidal person. The problem is that many of us have been trained (by formal training or by our anxiety) to go into a some other mode when we encounter a person with suicidal ideation: we throw our best therapeutic skills out the window and become the suicide police. We often deprive people of our best skills because we feel we have to focus on nothing but their immediate safety. It is an unfortunate tendency because in the midst of deperation is when people most need compassion, empathy, and humanity–and a therapist who is as interested as they are in relieving the psychache.

So the challenge in developing and delivering training is to give equal weight to two important messages that are in some tension with one another:

“You must have a knowledge, training, and competencies specific to suicide. You must ask about it, document about it, and pay special attention to it.”

and

“Don’t get stuck on the suicidality or go into some different interpersonal mode. Compassionately tend to the person, the pain, and the problem, just as you always you.”

I think the training today did a good job of striking that balance. I hope my presentations and clinical work do too.


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Categories : psychotherapy, teaching/training, therapeutic alliance