more Gibbons…

Posted on Friday 10 August 2012

The current Psychiatric Times has an odd article on a familiar topic, Robert Gibbons latest assault on the FDA Black Box Warning about suicidality in children and adolescents on antidepressants [an anatomy of deceit…]. These Gibbons papers [Suicidal Thoughts and Behavior With Antidepressant Treatment, Benefits From Antidepressants] have been reviewed here ad nauseum. They purport to be a meta-analysis of previous clinical trials of Prozac and Effexor and claim to show the drugs to be more effective than the original analyses, and to debunk the notion of suicidality, particularly in youths. What’s not odd about the Psychiatric Times article is that it exists. It’s just the latest part of a systematic media campaign to spread the conclusions in these papers far and wide, beginning on the first day they appeared online in the Archives of General Psychiatry:

What is odd about this Psychiatric Times article? It is essentially an uncritical republication of Gibbons’ two articles in a public format. The original articles were light on data, obscure about methodology, and heavy on conclusions. This version takes that a step further – presenting only the conclusions in a matter of fact manner with no mention of the glaring conflict with previous meta-analyses that included these same studies. Here’s an abbreviated version:

CHILD & ADOLESCENT PSYCHIATRY
Antidepressants: Risk vs Benefit in Depression
Psychiatric Times
by Karen Dineen Wagner, MD, PhD
August 1, 2012

Dr. Wagner is the Marie B. Gale Centennial Professor and Vice Chair in the department of psychiatry and behavioral sciences and Director of Child and Adolescent Psychiatry at the University of Texas Medical Branch at Galveston. Dr. Wagner has been a consultant to and has received research support from manufacturers of antidepressants.

Two recent publications provide clinically relevant information about the risk to benefit ratio of antidepressants for the treatment of MDD in youths, adults, and the elderly. Gibbons and colleagues examined the benefits of antidepressants to determine whether there were differences in response rates based on severity of depression…

… Baseline severity of depression did not affect the efficacy of treatment for any of the medications. The antidepressants demonstrated benefit for patients with low and high levels of severity of depression.

Compared with adults, youths had a greater difference between anti-depressant-treated and placebo-treated patients in terms of response rates and remission rates… Baseline severity of illness did not affect outcome. These findings support the efficacy of fluoxetine treatment for depressed youths with low- to high-level depression severity. Since the analysis for youths only included fluoxetine, it is not certain whether these findings can be generalized to other antidepressants.

In a related article, Gibbons and colleagues examined the safety of the antidepressants with regard to suicidal thoughts and behavior in youths, adults, and the elderly who had participated in the fluoxetine and venlafaxine trials described above… Although there is an FDA warning about antidepressant use and the risk of suicidality in children, adolescents, and young adults [younger than 25], no significant difference in suicide risk was seen between youths treated with fluoxetine and youths treated with placebo… Youths who received fluoxetine had a more rapid reduction in depressive symptoms than those who received placebo. Depression severity was associated with suicide risk for both fluoxetine-treated youths and youths who received placebo.

Adult and geriatric patients treated with antidepressants had a significantly greater reduction in suicide risk over time compared with patients who received placebo. Approximately 2 weeks after treatment initiation, the beneficial effect of medication on reduction of suicide risk was noted. There was a significantly faster reduction in depressive symptoms for patients treated with antidepressants than for patients in the placebo group. Depression severity was significantly associated with suicide risk in adult and geriatric patients. It was found that both fluoxetine and venlafaxine decreased suicidal thoughts and behavior, which were mediated by a decrease in depressive symptoms during treatment.

These 2 articles by Gibbons and colleagues provide reassurance about efficacy and safety of fluoxetine for treating depression in children and adolescents. Although there was no significant effect of treatment on suicidal thoughts and behavior in youths, fluoxetine did not increase suicide risk in this population. However, since this analysis only included fluoxetine studies in youths, it is not possible to draw conclusions about other antidepressants for treating MDD in youths. Analyses of other antidepressant studies with children and adolescents are warranted.

The author, Dr. Karen Dineen Wagner, is certainly no stranger to controversy or to advocacy for the use of psychotropics in children:

[drug vs placebo curves for these studies]
  • 2008: In 2008, she was investigated by Senator Grassley for unreported pharmaceutical income along with  Dr. Charles Nemeroff, Dr. Joseph Biederman, Dr. Melissa DelBello, Dr. Timothy Wilens, Dr. Thomas Spencer, Dr. Alan Schatzberg, Dr. Martin Keller, Dr. A. John Rush, Dr. Karen Wagner, Dr. Jeffrey Bostic, and Dr. Frederick Goodwin. from the WSJ: "… stating in a letter that a researcher for the University of Texas who worked on a National Institutes of Health study involving the GlaxoSmithKline antidepressant Paxil did not disclose more than $150,000 in consulting and speaking fees paid to her by the company. Mr. Grassley made statements about Karen Wagner based on a comparison of records from the University of Texas and from Glaxo. Between 2000 and 2008, Dr. Wagner was engaged in an NIH study on the use of Paxil to treat teenage depression and another study on teen anxiety."
In addition, she has been an active player in the largely discredited Bipolar Child craze of Dr. Joseph Biederman. Here’s her COI declaration from a 2009 publicly viewable article:
Dr. Wagner has served as a consultant to and/or served on the advisory boards of Abbott Laboratories, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, GlaxoSmithKline, Janssen, Johnson & Johnson, Novartis, Organon, Ortho-McNeil, Otsuka, Pfizer, Solvay, UCB Pharma, and Wyeth-Ayers; and receives research support from the National Institute of Mental Health.
I was not surprised to see this article about the Gibbons papers in the Psychiatric Times as they are on the way to becoming some of the most media hyped studies in recent experience. Nor was I surprised that it was penned by a longstanding Pharma-friendly KOL like Dr. Wagner. I was dismayed that they didn’t mention her obvious conflicts of interest except to say "Dr. Wagner has been a consultant to and has received research support from manufacturers of antidepressants" which hardly touches her involvement in these issues. And I was horrified that this article essentially republished Gibbons’ conclusions uncritically making no mention of the extensive previous meta-analyses of this topic. Her final line ["Analyses of other antidepressant studies with children and adolescents are warranted"] implies that this is some open question when there are, in fact, multiple extensive analyses with opposite conclusions – something Dr. Wagner knows quite well, but ignores in this piece. She’s authored numerous articles in the Psychiatric Times on this issue already:
I consider this article more of the same – part of a campaign to once again challenge the black box warning in the service of something other than medically warranted ends. Haven’t we had enough of this kind of game playing?…
  1.  
    August 10, 2012 | 11:40 PM
     

    by Karen Dineen Wagner, MD, PhD is pushing this BS at the CABF-Child adolescent bipolar foundation now known as Mind Foundation or something–she is on their scientific advisory board alongside Joseph Biederman and other KOLs w COI like her. I love how the co author of PAXIL 329 Wagner has found roost pushing this information and her cronies too–to one of the largest and popular parents of ‘mental health labeled’ kids support sites around. These ppl never are held accountable for PAXIL 329 yet nothing stops them does it? push push push the pills on the kids!!!!!!!!!!

  2.  
    August 10, 2012 | 11:41 PM
     

    btw my tip to readers on how to read the psych times w/out signing up–right click the title and read the cache. I read all of the articles surrounded by psych adverts, and this place seems to be where all of the (ok some) of the corrupt cronies really say what they think… which is a lot of times pretty alarming from my perspective.

  3.  
    August 10, 2012 | 11:47 PM
     

    Sorry I just have to say she has a hell of a lot of nerve!!

    “These 2 articles by Gibbons and colleagues1,2 provide reassurance about efficacy and safety of fluoxetine for treating depression in children and adolescents.”

    these people are evil. they don’t care about kids! SSRI’s nearly killed mine w suicidal thoughts!!!!

  4.  
    stan
    August 11, 2012 | 12:15 AM
     

    If this wasn’t so tragic….it would be in tears laughing of how absolutely absurd these clowns are….these are the most criminal, shamed, tainted, & conflicted doctors imaginable holding cheer-leading practices for one another…I can almost hear them screaming out-loud “Go Big Pharma, Go!!!”…

    The hard reality & facts are this; nothing will change until these horrible shills are held academically/criminally responsible, & are once and for all banned from medicine by the profession itself…

    At some juncture…distant as it may appear…they will be judged…and if there is any sense of justice or right remaining on this planet….they will be judged harshly….

  5.  
    August 11, 2012 | 12:21 AM
     

    Here’s one of her financial disclosures for psych times http://www.psychiatrictimes.com/all/editorial/psychiatrictimes/pdfs/wagnerdisclosure.pdf odd disclosures

  6.  
    August 11, 2012 | 2:00 AM
     

    I would be willing to bet that Gibbons’ ‘work’ is the recent review referred to but not cited in the AACAP’s guide they wrote for social workers and professionals who serve kids and their families. It’s part of the ‘plan’ for dealing with the criminal mis’treatment’ that passes for mental health treatment and services for kids in foster care that resulted from the Carper investigation—the whole thing stinks. http://yakimavalleysystemsofcare.blogspot.com/2012/08/when-anecdotal-evidence-is-sufficient.html

  7.  
    August 11, 2012 | 3:22 PM
     

    If I were a doctor, I’d write the editor of Psych Times complaining about the poor quality of the content and bias of the authors.

  8.  
    August 11, 2012 | 3:32 PM
     

    Alto,

    Done done it…

  9.  
    August 11, 2012 | 3:51 PM
     

    Mickey–Thank you for writing Psych Times!!

  10.  
    August 11, 2012 | 3:54 PM
     

    btw who did you choose to write to ? Dr Schwartz, who owns more than 10K of Forest (pharma) stock? or Ronald Pies? lol (deaf ears! i bet!) http://www.psychiatrictimes.com/all/editorial/psychiatrictimes/pdfs/schwartzdisclosure.pdf and Pies must have thought they only wanted his signature http://www.psychiatrictimes.com/all/editorial/psychiatrictimes/pdfs/piesdisclosure.pdf w/out the boxes checked.

  11.  
    August 11, 2012 | 8:08 PM
     

    Thank you, Dr. Mickey!

  12.  
    Joel Hassman, MD
    August 12, 2012 | 9:37 AM
     

    Just got the issue yesterday and it reeks, er, reads like an APA sponsor of the ad nauseum crap of basically “this is what we do, so deal with it!”

    I was more interested in the 2 article slam on Whitaker’s book by HSteven Moffic and William Glazer. Here are 2 comments to get the flavor of their annoyance of the book, not that Whitaker gets it all right:

    First by Moffic: “what clearly seems more like an epidemic, other than the epidemic number of administrators now in our field, is the often vitriolic criticism toward psychiatry and psychiatrists.”

    And by Glazer, who was quite clearly annoyed throughout the piece, “we and our patients do not need to have that trust hijacked by misguided, ‘astonishing and startling’ conclusions presented in publications such as Anatomy Of An Epidemic. It is our obligation to protect that trust.”

    Isn’t anyone else besides me tired of this extremist rhetoric by both ends of this debate in our field that psychiatry is all right or all wrong? I’ll give Dr Moffic some credit, his piece was more accepting of the book’s opinions, but, find Ronald Pies’ piece “moving beyond hatred of psychiatry” that was the bottom of page 1 of the publication. I find his comment near the beginning to show his true cluelessness and efforts to try to intimidate writers in our field critical of his entrenched hierarchy with “I generally oppose the use of pseudonyms among bloggers, particularly health care professionals who hide behind fake names to launch cowardly attacks on their colleagues”. Really, we in the field are going to be heard and considered in the debate about pharmaceutical excesses with the usual crowd running the APA?

    Note how the loudest proponents of the status quo are least likely to be impacted by changes for the better, either retired or insulated in academic blankets of protection and breadwinners for their university administrators. People like Ronald Pies never address that observation, do they!?

  13.  
    August 12, 2012 | 10:57 AM
     

    Doc Hassman– I agree Moffic and Glazer ‘s “book reviews” of Whitaker’s book, Anatomy of an Epidemic’ are off base. Both sound like they are sending out warning signals to the cronies, watch out Whitaker’s book could expose what we are!”–clearly these are editorials, not book reviews because they are not reviews imo. Glazer’s was awful.

    How do you enjoy reading a magazine loaded w psych ads? is it in print? the online version (easy to read by reading caches ) is loaded w scrolling ads for seroquel, latuda, etc all surrounding the articles to the point it makes for a site I would never read on purpose.

    Also, what bothered me abt the Moffic ‘review’ of Whitaker’s book, is how it was a take down, and that guy writes at Mad in America site–hypocrite!

  14.  
    August 12, 2012 | 11:06 AM
     

    PS–I view the psych times mag as a psychiatry propaganda magazine mostly–because same as a ‘cult’ group they have a mission, a message and when the message gets stomped on ie whitaker’s book they come out defending their position and slamming any one who speaks against or differently from it. That sounds like a cult and it is a ‘medical’ profession? with dx that are not based on anything medical? and use pills that are a guessing game for patients that send them on sometimes life long journey quests of finding the right ‘med cocktail’?

    what is that all about?

    it’s creepy imo!

  15.  
    August 12, 2012 | 5:29 PM
     

    Moffic got pretty badly beaten up by commenters when he contributed a few articles to Mad in America, Bob Whitaker’s site. Most of what he posted was clueless, but some was not, but commenters were relentless.

    These psychiatrists are puzzled by negative opinions expressed by the public — they haven’t caught up to the Internet age, where any cat can hiss at a king.

  16.  
    August 12, 2012 | 6:18 PM
     

    From Moffic’s article How to End a Psychiatric Epidemic: The Redemption of Psychiatry http://www.psychiatrictimes.com/blog/moffic/content/article/10168/2081905 (posted June 11, 2012 online):

    “….Following are some of Whitaker’s key themes:

    • Psychiatric disability has increased concomitantly with the increase in psychotropic prescriptions
    • Long-term medications may be unnecessary for many patients, including subgroups of patients who have schizophrenia; in some cases, drugs may make the illness worse
    • Withdrawal symptoms may be worse than previously thought, especially when medications are suddenly stopped
    • Medications may cause—rather than correct—a chemical imbalance in the brain
    • Psychiatric thought leaders have been unduly influenced by large incentives from pharmaceutical companies, and these relationships have not been adequately disclosed
    • Premature or inaccurate diagnosis can lead to medication treatments that can precipitate a more severe disorder (eg, mistaking ADHD or unipolar depression for bipolar disorder)
    ….”

    Whether that’s a fair summation of Whitaker’s book or not, who can argue that those aren’t valid problems?

    I see Ron Pies has yet another article, Moving Beyond Hatred of Psychiatry: A Brave Voice Speaks Out, posing psychiatry yet again as beleaguered by wrong-headed, impolite people (maybe Scientologists), rather than taking into account that injured patients, with no other outlet, sometimes vent their rage online.

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