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2001: Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial. "Paroxetine is generally well tolerated and effective for major depression in adolescents."by Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, Birmaher B, Hagino OR, Koplewicz H, Carlson GA, Clarke GN, Emslie GJ, Feinberg D, Geller B, Kusumakar V, Papatheodorou G, Sack WH, Sweeney M, Wagner KD, Weller EB, Winters NC, Oakes R, and McCafferty JP
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2002: Fluoxetine for Acute Treatment of Depression in Children and Adolescents: A Placebo-Controlled, Randomized Clinical Trial. "Fluoxetine was superior to placebo in the acute phase treatment of major depressive disorder in child and adolescent outpatients with severe, persistent depression."by Emslie GJ, Heiligenstein JH, Wagner KD, Hoog SL, Ernest DE, Brown E, Nilsson M, and Jacobson JG
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2003: Efficacy of sertraline in the treatment of children and adolescents with major depressive disorder: two randomized controlled trials. "…sertraline is an effective and well-tolerated short-term treatment for children and adolescents with MDD."by Wagner KD, Ambrosini P, Rynn M, Wohlberg C, Yang R, Greenbaum MS, Childress A, Donnelly C, Deas D; and the Sertraline Pediatric Depression Study Group
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2004: A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents. "…treatment with citalopram reduced depressive symptoms to a significantly greater extent than placebo treatment and was well tolerated."by Wagner KD, Robb AS, Findling RL, Jin J, Gutierrez MM, and Heydorn WE
[Paradoxically, Karen Wagner and some of her co-authors in these studies were later on the ACNP [American College of Neuropsychopharmacology] Task Force convened to report on these questions after the Black Box Warning was added by the FDA in 2004:]
Family Practice NewsBy WHITNEY MCKNIGHTFebruary 26, 2015Taking a thorough family history and understanding how to prescribe off-label medications can help physicians achieve more favorable outcomes when treating children and adolescents for depression, according to Dr. Karen Dineen Wagner. In addition, a willingness to prescribe newer, virtual therapies increases the chance for remission of depression in these patients, Dr. Wagner said at the annual psychopharmacology update held by the Nevada Psychiatric Association. Left untreated, the severe depression that occurs in just under 10% of U.S. teens and the more mild depression that occurs in about 12% can lead to severe impairment later in life, she said.“If you think about it, that’s really a high prevalence in an adolescent disorder,” said Dr. Wagner, the Marie B. Gale Centennial Professor of Psychiatry and Behavioral Sciences at the University of Texas in Galveston. One out of six of these teens will go on to have depression and other psychosocial impairment in adulthood, as well as suicidal ideation [J. Am. Acad. Child Adolesc. Psychiatry 2010;49:980-989].
Even with treatment, the odds for recurrent depression later in life are 2:1 in favor of the mood disorder, according to Dr. Wagner, who cited a study showing that of 140 teens treated for depression, more than 90% experienced full remission, but more than half were depressed again an average of 6 years hence. More than three-quarters of those treated for depression went on to have nonmood disorders such as anxiety, substance abuse, and eating disorders [J. Affect. Disord. 2013;298-305]…
Repeated treatment failure, whether psychotherapeutic or pharmacogenic, therefore, might be related more to parental depression than the child’s own. “Check carefully for that. And keep in mind that the depressed parent may not be the one bringing in the child or teenager for treatment,” Dr. Wagner said [JAMA Psychiatry 2013;70:1161-1170]…
Currently, the only approved pharmacologic options for children and teens are fluoxetine, which is indicated for use in 8- to 17-year-olds, and escitalopram, indicated for use in 12- to 17-year-olds. Dr. Wagner noted that escitalopram has only one study to back its efficacy in teens and that a second study including children as young as 6 years old was negative. Fluoxetine has three studies to back its efficacy in children and adolescents. If the age-appropriate medication elicits no response, the only pharmacologic treatments are off label. “Be sure you document that in the chart,” Dr. Wagner said.
Having surveyed available data from controlled pediatric depression trials, Dr. Wagner said the only two off-label medications she recommended physicians consider for their pediatric or adolescent patients were sertraline, which has been shown negative in individual trials but in a priori pooled analyses was found positive twice, and citalopram…
Even though some parents might worry about the demonstrated link between suicide and some antidepressants in teens, Dr. Wagner said clinicians should counsel families that the risk for suicide in untreated depression was higher at 12% [most antidepressants are around 1%] [JAMA Psychiatry 2013;70:300-310].
Making it somewhat easier to predict treatment courses is that about 60% of adolescents who respond early to antidepressant treatment will go on to remission, Dr. Wagner said. Resisting pressure from parents and patients to end the course of treatment too soon if they see early signs of recovery as synonymous with cure is important for avoiding relapse. Dr. Wagner recommended “starting the clock from the time when the child shows signs of having gotten well, and then adding 1 year.” She also said that tapering dosage over “a couple of months” was a valid approach, depending on the original dose…
Given that there is a notable placebo response rate in this population, and CBT is not thought to have harmful side effects, physicians might be tempted to start there, but Dr. Wagner said the combined effectiveness of CBT with medical management of depression was more efficacious than CBT alone. She cited a study showing that after 12 weeks, adolescents treated with fluoxetine in combination with CBT achieved a 73% response rate, whereas CBT only had a 48% rate. It wasn’t until week 36 in the study that the two methods reached parity. Fluoxetine alone in this cohort reached a 62% response rate by week 12, and an 81% response rate at week 36. “So, that’s what I say to parents, ‘Do we really have the time for psychotherapy alone to work?’ ” [Arch. Gen. Psychiatry 2007;64:1132-43]…hat tip to 1boringyoungman…
it is important to distinguish individual, quid-pro-quo, corruption from institutional corruption. The former is a story of “bad apples.” For instance, a politician takes a bribe in return for a political favor. That is quid-pro-quo corruption. Institutional corruption is of a different—and more societally damaging—type. Institutional corruption is a not a “bad apple” problem, but a “bad barrel” problem. The basic concept of institutional corruption is this: There are “economies of influence” that create “incentives” for behaviors by members of the institution that are antithetical to the institution’s public mission. When this happens, the “corrupt” behavior may become “normative,” and even go unrecognized as problematic by those within the institution…
That is a lot of sick kids and by extension a lot of sick parents.
I cannot help but to keep going back to the psychopath as defined by the book Snakes in Suits. Here we see the business person who is willing to say or do anything to get ahead. Manipulation is their stock in trade and of course they are never held responsible for any actions. This has been dialed back and now we use the word narcissist.
An important part of this behavior was the loss of the vetting process that occurred around 1980 as the Greatest Generation retired and those young hot shots were promoted and taught to change jobs before they got caught with a problem. We also see the institutional corruption issue coming forward as those in large corporations found it easy to blame the “system.” Those who have worked for small companies find this hard to comprehend since personal responsibility is related to company size.
A practicing doctor knows all too well he/she is responsible for their patients and off label recommendations will come back on them, not the drug company.
Part of my attachment to this blog is my struggle with the clergy. Church is not what it use to be. A minister is hired who exhibits the same psychopathic behaviors as one relieved of his duties. Another minister repeatedly speaks from the pulpit of his battles with depression, ADHD, dyslexia, and insomnia. The area supervisor does not see themselves as manipulative in protecting these people, but as an aggressive visionary.
The denomination has set a legal action as its standard for intervention. They also see all issues as only a difference of opinion and the resolution for this is a years long process designed to make people go away.
HCR has for years highlighted how no person is held responsible, but large fines are paid for drug company wrong doing. Single fines in the billions are now not uncommon, but the company admits no wrong doing.
Psychiatry leads medicine due to its small size and soft end points. Medicine leads business due to its size, fast approaching 20% of GDP, and we see the sales and business attitude of pharma infecting almost all business of any size.
This has set up a conflict where mega corp can do what it wants while the small enterprise plays by the rules. This has all been led by our university’s who feel entitled to set the standards that benefit them the most, while leaving those in the real world scratching to survive.
This is a good example of an academic who has done very well prescribing what is essentially illegal activities and never having to deal with the real world fall out of the children who will be over medicated, all the while the doctors involved will take the fall.
I think I still prefer the word psychopath.
Steve Lucas
Sociopath?
Ferrell,
If it quacks like a duck…
I believe that Dr. Wagner has received what many in her field perceive as well-deserved acclaim. Only in a different ethical context could her positions be called those of a psychopath or in any way out of bounds.
(Off-label prescribing is extremely common in the US and held to be a right by many physicians.)
From what I can tell from Robert Whitaker’s essay, he provides an ethically oriented framework in which questionable reasoning like Wagner’s does compute. I haven’t read his book yet, but it sounds like it’s going to make waves.
I’m glad he dispatched the “bad apples” argument right off.
Over the millennia physicians who were clearly socially respected and who were teaching others have dispensed advice that was widely believed to be effective that we now know to be drivel. Everything from bloodletting to trephination.
The problem is that we don’t know what causes depression in kids, any more than people in the middle ages knew what was causing plague. Every hypothesis can be shot full of holes with counterexamples with little effort. When humans don’t have science that can give clear answers they turn to magic and religion. Treating kids with antidepressants has about the same amount of success as faith-healing or homeopathy. (Homeopathic remedies work as well as placebos, as do antidepressants in kids. The difference is homeopathic remedies are probably safer.)
“Biological” psychiatry has a lot of money behind it, and that means it will gain a lot more attention and credibility than other magical or religious paradigms which lack such funding. The priests of that religion believe their dogma, especially when they get so much money and status for doing so.
But this is not a “bad apple” or “bad barrel” problem alone. It comes from the fact that only a small percentage of people have enough of a scientific worldview to see through the pseudo-scientific jargon, and there are plenty of other people willing to capitalize on that. Look at how many people believe in “creation science”.
If we were an intelligent species boys would ride girls bicycles.
Establishment psychiatry continues to promote, to stand by, to explicitly encourage & reward this type of behavior. Indeed Wagner is Establishment psych. It is amazing that she was part of so many industry-sponsored ghost-written studies as Mickey mentions, including one of the most notorious, if not THE most notorious (Study 329 on Paxil) that reported results exactly opposite of what was found and suppressed evidence of dangerous side effects in kids, & her career hums along. It’s sick– psychopathic and on a super-institutional level.
12% risk of suicide in depression, says Dr. Wagner? Well, with 25% of us Living With A Mental Illness, surely at least 12% of us must be Living With Depression, right? 12% of 12% is 1.4%. That’s what, about 4 million suicides? RIGHT. Even if you take that as “lifetime risk” and hence stretch it out over fifty years, that would be 80,000 suicides a year from depression alone! And since we gotta leave SOME room for impulsive acts by the non-depressed facing a jail term or a bad case of cancer or something … maybe 100,000 a year? Sorry. That does not compute.
Guess that’s why she’s so blase about placing the risk of suicide from an antidepressant at 1%. Holy crap, that’s a lot of people! So if 1 million new patients are put on them this year (quite possibly conservative) that will be 10,000 suicides? Since down here in Reality Land we only have 38,000 suicides a year, that would mean more than 25% were due to antidepressants. I’d be a little nervous if I were Dr. Wagner.