I started browsing the American Academy of Child and Adolescent Psychiatry web site several weeks ago when I was looking at Study 329. I was originally looking for their statements about the 2004 Black Box warning on antidepressants. While I found no policy statements, there were plenty of Press Releases of the AACAP’s opposition and later displeasure with the warning. I was surprised with the intensity of their reaction. This October 31, 2004 document entitled SUPPLEMENTARY TALKING POINTS FOR CHILD AND ADOLESCENT PSYCHIATRISTS REGARDING THE FDA BLACK BOX WARNING ON THE USE OF ANTIDEPRESSANTS FOR PEDIATRIC PATIENTS came out shortly after the warning was issued:
What do the research data suggest about the efficacy of antidepressants for treating depression in children and adolescents?
New research, such as the Treatment for Adolescents with Depression Study (TADS), confirms that using cognitive behavioral therapy (CBT) – a type of psychotherapy that focuses on managing negative emotions and thoughts – and fluoxetine (Prozac) results in successful treatment of moderate-to-severe adolescent depression. Seventy-one percent of the patients responded positively to the combination treatment of fluoxetine and therapy, which is a rate double the 35 percent response rate for patients on placebo. Over 60 percent of those assigned to fluoxetine alone were found to be responders by the end of the 12-week trial. This means that on average each practitioner would need to treat just three patients to see a strong response to fluoxetine. This is in contrast to the need to treat over 50 patients in order to see evidence of the medication causing suicidal ideation or suicidal behavior. The Work Group on Research finds this risk-benefit ratio for the treatment of pediatric depression acceptable for child and adolescent patients… [underlined in the original]
What is the downside of not using antidepressant medications to treat my child and adolescent patients with depression?
The NIMH TADS did not find an advantage of cognitive behavioral therapy (CBT) alone over placebo in the short term. However, CBT has been shown to be effective in other treatment studies of depression in children and adolescents. For that reason, effective treatment may include CBT or other evidence-based psychotherapies alone or with the antidepressant fluoxetine as a first-line treatment for depression. In particular, psychosocial treatment has been shown to have a protective effect against suicidal behavior or ideation when combined with antidepressant medication…
Why should childhood depression be treated with medications that carry any risk at all?
The AACAP Work Group on Research strongly supports the treatment of children and adolescents with depression despite risks. Pediatric depression is a real illness, with neurobiological underpinnings. Effective treatments for this disorder are available. Although antidepressant treatment carries risks, untreated depression has potentially greater risks, and treatment is effective, especially when started early. Depression is a serious illness, sometimes episodic and often chronic, when it occurs in childhood. In addition to the human suffering that occurs because of the depression, the symptoms can and do interfere with academic learning, peer relationships, and family interactions, often derailing normal development…
I didn’t expect that. The Black Box warning didn’t say they were contraindicated in kids, but the imperative tone here comes across as an injunction to treat. At the least, it certainly seems to overstate efficacy by my reading of the studies. And the TADS suicidality data is wide open for interpretation [The Real Suicide Data from the TADS Study Comes to Light][significant I…].
So it got me to browsing around and I continued to be surprised at the pro-medication bent to the site. Here are their practice guidelines [they call them parameters]. Take a look at Depression, Atypical Antipsychotic Medications, Bipolar Disorder. In a time when the front burner concern is the overmedication of children and teens, these recommendations seem both anachronistic and even suspicious [of pharma influence]…
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AACAP Practice Parameters are clinical practice guidelines developed by the AACAP Committee on Quality Issues to encourage best practices in child mental health… Parameters are categorized as patient-oriented and clinician-oriented.
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Patient-Oriented Parameters
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Clinician-Oriented Parameters
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They AACAP did not develop any of the parameters with the primary focus being doing what is in the best interest of any patient; of that I am absolutely certain.
I’m glad you have been looking at their site.
There appears to be a degree of zealotry and hubris.Along with that formula (seen in the 2001 JAACAP paper affair, has parallels in the DSM, …etc) of everything emerging from a large group of highly expert child psychiatrists, and then endorsed by an even larger group of highly expert child psychiatrists. So many how could one even begin to argue with them? But as Dr. Rachel Klein had said “Science is not run as a democracy.” I neither, I suspect, are parameter panels.
” I was surprised with the intensity of their reaction.”
“I didn’t expect that.”
“and I continued to be surprised at the pro-medication bent to the site.”
I’m very glad you have been looking at their site.
But, after the comments to your blog over the past few weeks (about Dr. Ryan, Dr. Wagner, Dr. Dulcan, Dr. DelBello, Dr. Bostic, Ms. Anthony, …etc and their stature within AACAP), frankly, I’m surprised by your surprise.
The AACAP summary of the TADS data is mostly hand waving. AACAP equivocates shamelessly between fluoxetine plus CBT and fluoxetine. That is how they come up with the statement that “… each practitioner would need to treat just three patients to see a strong response to fluoxetine.” The NNT of 3 (rounded up from 2.78) applies to fluoxetine plus CBT, not to fluoxetine alone.
The first primary, a priori, measure of efficacy in TADS was the CDRS-R [Children’s Depression Rating Scale – Revised]. Quoting from the TADS report [PubMed ID 15315995], “Planned contrasts on the CDRS-R slope coefficients across 12 weeks of treatment produced a statistically significant orderings of outcomes. Specifically, fluoxetine with CBT (P=.001) was statistically significant compared with placebo, whereas treatment with fluoxetine alone (P=.10) and CBT alone (P=.40) were not.” Thus, this pre-declared primary outcome measure was not significant for fluoxetine alone. The TADS report goes on to say that “Supportive contrasts performed on the week 12 adjusted means” did find fluoxetine alone superior to placebo (P=.002). That is a secondary measure of efficacy.
On a second pre-declared primary outcome measure, an end-of-treatment CGI improvement score, fluoxetine alone was superior to placebo (P=.001). Finally, on another secondary measure of efficacy, The Reynolds Adolescent Depression Scale (RADS), the planned contrast on slope coefficients was not significant for fluoxetine alone (P=.34), while a “supportive contrast” on the week 12 RADS data was significant for fluoxetine alone (P=.003).
Thus the data in TADS for efficacy of fluoxetine alone are quite mixed. This perspective has become lost in the hand waving from AACAP and other organizations about the imperative for use of SSRIs in depressed youth. One cannot generalize confidently from fluoxetine plus CBT to fluoxetine alone – and remember that most depressed adolescents will be treated in primary care sites that are not equipped to provide formal psychotherapy of the quality that the TADS patients enjoyed. One also cannot generalize confidently from fluoxetine to other antidepressant drugs in youth. Indeed, in the 2007 meta-analysis by Bridge and associates [PubMed ID 17440145], 61% of drug treated patients and 50% of placebo treated patients responded. Thus, the drug-attributable response rate was 11% and the Number Needed to Treat for response was 9 (Bridge et al said 10). That is very different from the portrayal by AACAP.
As always, the devil is in the details, and the details tend to get lost in propaganda.
“71. From 1999 to 2006, one pediatric specialist, Dr. Jeffrey Bostic, Medical Director of the Massachusetts Child Psychiatry Access Program at Massachusetts General Hospital, gave more than 350 Forest-sponsored talks and presentations, many of which addressed pediatric use of Celexa and Lexapro. Dr. Bostic’s programs, which took place in at least 28 states, had topics such as “Uses of Celexa in Children” and “Celexa Use in Children and Adolescents.” Forest also paid Dr. Bostic to meet other physicians in their offices in order to ease their concerns about prescribing Celexa or Lexapro off-label for pediatric use.
72. Dr. Bostic became Forest’s star spokesman in the promotion of Celexa and Lexapro for pediatric use. As one sales representative wrote, “DR. BOSTIC is the man when it comes to child Psych!” Between 2000 and 2006, Forest paid over $750,000 in honoraria for his presentations on Celexa and Lexapro.”
See pages 21 and 22 of
http://freepdfhosting.com/d920e52a76.pdf
(Lavish Entertainment and Gifts on pages 29 and 30 are probably also worth a read just as a reminder of the behavior of individual child psychiatrists that the academy has also seen fit to never express regret over. Were none of these individuals members of the academy. If this is just what lots of people were doing back then so it didn’t seem unusual, then where was the leadership from the academy and its regional academies?)
Dr. Bostic today:
“Optimizing Pharmacotherapy: Building Better Brains in Depressed Children”
http://www.masterpsych.com/child_adolescent_master_psychopharmacology_course_3.html
Between 1999-2006 $750,000 in honoraria for just presentations and that’s just from one pharmaceutical company.
“Building Better Brains in Depressed Children.”
Dr. Bostic is the chairman of the CME committee for AACAP.
CHAIR of their CME committee.
That’s how AACAP was leading then and that’s how it’s leading today.
And you were surprised by what you saw on their site? I mean come on 1BOM. I really hope your expression of surprise was a rhetorical device.
“Thus, the drug-attributable response rate was 11% and the Number Needed to Treat for response was 9 (Bridge et al said 10). That is very different from the portrayal by AACAP.” … and they know it. They quote Bridge’s TADS figures in their parameter for Depressive Disorders in contrast to their Talking Points…
“And you were surprised by what you saw on their site? I mean come on 1BOM. I really hope your expression of surprise was a rhetorical device.”
No feigned surprise here – genuine naivity. Recall, I left academia in the 1980s and practiced in a cocoon, teaching the Object Relations Theories of the British Middle School until retiring in 2003 [and after]. I was awakened by Senator Grassley’s investigations in 2008. The American Academy of Child and Adolescent Psychiatry is a very different entity from the salad days of yore…