persistence…

Posted on Thursday 3 January 2013

If there was a recurrent theme on this blog in 2012 besides the DSM-5, it would be articles that scream out for retraction: something old; Keller et al’s Paxil Study 329 [2001] and something new; Gibbons et al’s two articles on antidepressants in adolescents [2012]. The latter is summarized here:
This two part meta-analysis was a tangle of high class statistical reanalysis of historical data that concluded that antidepressants were safe and effective for depression in adolescents. It was also the latest in a series of articles by Dr. Gibbons and his colleagues dating from the black box warning about suicidality added to the SSRIs in 2004 trying to discredit the FDAs advisory. It was also a bit of methodological sleight of hand worthy of a Darwin Award. A number of us wrote letters to the Archives of General Psychiatry protesting a medley of scientific distortions and omissions that lead them to their unsupportable conclusions. Rather than accepting the various letters for publication in the Journal, they were accepted to an online forum that I called the Cantina at the end of the Galaxy because it was hard to locate and would leave no lasting imprint on the permanent record. I elected to decline the Cantina outright and publish my letter here on the blog. Others protested to the Journal Editor and later to the parent Journal Editor [JAMA]. After quite a lag, their protest was successful and their letters were published in this January issue of the Archives of General Psychiatry, newly renamed JAMA Psychiatry. You can read them here in the Microsoft Word [.doc] format [sans references]:
  1. spielmans.doc: The letter from Glen I. Spielmans PhD; Jon Jureidini PhD, MBBS, FRANZCP; David Healy, MD; and Robert Purssey, MBBS, FRANZCP – followed by a response from Robert D. Gibbons, PhD; C. Hendricks Brown, PhD; Kwan Hur, PhD; John M. Davis, MD; and J. John Mann, MD.
  2. carroll.doc: The letter from Bernard J. Carroll, MB, BS, PhD, FRCPsych – followed by a response from Robert D. Gibbons, PhD; C. Hendricks Brown, PhD; Kwan Hur, PhD; John M. Davis, MD; and J. John Mann, MD. – followed by Dr. Carroll’s letter to the Editor [unpublished] following publication.
  3. an anatomy of a deceit 4… the letter: My letter published here on the blog.
I actually see the publication of these letters as something of a triumph, but let me back up a bit. One of the things I learned along the way was that traumatized people spend a lot of their mental energy trying to prevent the past, often automatically, outside their awareness. It makes sense that if something cataclysmic happens and you are overwhelmed, that thing becomes the most dangerous thing on the planet. So the two common responses – not remembering and vigilance to prevent a recurrence – can flow together to produce a fearful, avoidant life. Getting better doesn’t mean getting over something. The past is an indelible part of experience. Getting better means keeping the trauma clearly in mind and knowing when it’s stirred up so as to see the present more realistically.

My last several posts have been kind of cerebral, and I’m aware that I’m trying to work something out in my mind. The changes in psychiatry in the 80s had a major impact on my life, and I think I became avoidant in response. I drifted away from matters academic, attended fewer and fewer meetings, read less in the journals, let subscriptions lapse. I found a fine life, but it was cloistered compared to the years before. That must have happened to a lot of us. I now feel lousy about becoming so avoidant, like I avoided a responsibility to look at what was happening in the profession. I know that I often quipped that I only felt like a psychiatrist or a doctor in my office. Other places I felt like a stranger in a strange land. Instead of becoming bored with the endless discussions of new versions of old drugs or dreams of an unrealized future and avoiding those meetings, I wish I’d gone and said something. I now believe I was "preventing the past" by not putting myself in the vulnerable situation I was in at the height of all the changes.

And I think I find myself now finally in the position of joining in with a new kind of "preventing the past" that feels a lot better. An untold number of articles slid into our literature in the last twenty-five years that were like these Gibbons et al articles – deceptive science with hidden agendas. My response was to not read them, so I didn’t know how off track they really were. I have an enormous respect for the people who did read them all along the way and responded to the distortions. Several of the main watchdogs are represented in the responses to these Gibbons’ articles: Healthy Skepticism [Glen Spielmans, Jon Juriedini, Rob Purssey], David Healy, and Bernard Carroll. These are people who have stuck to the task for years, at times when the only feedback was criticism and ad hominem attacks. Their contributions have been invaluable.

So those letters are triumphs because they persisted in not only vetting the literature, but fighting for the right to have their opinions heard against an editorial gradient. Their letters and Dr. Gibbons’ reponses are all worth taking the time to read. Here’s a sample from Dr. Carroll’s last comment to the editor:

… I hope this communication will serve as a wakeup call to JAMA Psychiatry.

In their response, Dr. Gibbons and associates tried to defend themselves against criticism on several issues. Here I will limit myself to the most important of those issues, namely, invalidation of the aggregate analyses by inclusion of Lilly Study LYAQ. To be brief, what they say about Lilly Study LYAQ is dissembling prevarication that does not pass the straight face test.

In their original report the authors repeatedly stated that the focus is major depressive episodes. They also repeatedly stated that the time period of treatment for their analyses is 6 weeks. You can easily verify these statements by searching the report on the relevant terms, as I have just done. Neither of these requirements was met in Lilly Study LYAQ. Please refer to the report of that study. All subjects (well, 172 of 173) had primary diagnoses of attention deficit-hyperactivity disorder (ADHD) but the authors did not frankly acknowledge in their original report that all subjects had primary diagnoses of ADHD. This omission is deplorable. As for mood diagnoses, fewer than half had diagnoses of major depressive episode. Gibbons and co-authors seriously misrepresented the facts here in their reply, chiefly by equivocating non-major depressive diagnoses with major depressive episode. In the original report they stated “all (youth) subjects had depression (similar to MDD)” but inspection of Table 1  reveals that this statement is false.

In a second act of reprehensible dissimulation, Gibbons and associates prevaricated about the duration of treatment with fluoxetine before atomoxetine was commenced in Lilly Study LYAQ. In the original report they emphasized that “we restricted analysis to the first 6 weeks of treatment so that all studies included all time points (ie, study and time are unconfounded).” In their current reply they say that the duration of treatment with fluoxetine before atomoxetine was commenced in Lilly Study LYAQ was up to 42 days. However, it is quite clear from the original report of LYAQ that this period was only 3 weeks for the great majority of cases (see text and Figure 2). Only a few outliers went as long as 6 weeks on fluoxetine before atomoxetine was started. Thus the great majority of cases in LYAQ did not qualify for the requirement of 6 weeks treatment – which is a requirement highlighted even in the subtitle and throughout the text. The reply by Gibbons and associates on this issue is lacking in candor – it is patently misleading.

I stand by my statement that inclusion of Lilly Study LYAQ invalidated the aggregate analyses by lack of conforming diagnoses and design. As for the remaining issues, the authors’ replies are a similar mix of evasiveness and distinctions without a difference.

Finally, let me say to you, Dr. Coyle, that I am appalled that you as editor-in-chief would publish such a self serving reply from the authors without basic peer review for its veracity. I happen to believe that the deficiencies of the reports by Dr. Gibbons and associates are such that a retraction would be appropriate and I am surprised that you as editor-in-chief are not requesting same, now that you have seen an array of critical letters. I urge you once again to reconsider your decision.
  1.  
    Fid
    January 3, 2013 | 5:34 PM
     

    Tenacity and just plain doggedness is the key that will eventually unlock the Pharma box of secrets. Keep at em.

  2.  
    Catalyzt
    January 3, 2013 | 11:13 PM
     

    Thanks so much for posting… there are some very rowdy, bad-ass MFT and PsyD interns who, I think, are getting pretty sick of being pressured by clinics into making psych referrals for garden-variety situational depression. I happen to be one of them, and I am definitely going to be directing some traffic to this URL so my brothers and sisters know what’s going down at JAMA Psych. Very grateful.

  3.  
    Nancy Wilson
    January 3, 2013 | 11:17 PM
     

    I am not surprised by Dr. Coyle’s behavior. He has fiduciary responsibilities. See

    http://tinyurl.com/b4wzr3k

  4.  
    January 4, 2013 | 5:04 PM
     

    Strong language from Dr. Carroll! Is the entire exchange conducted at this level?

    I commend Dr. Carroll and all the other protesters for their terrier-like persistence.

    As for avoidant behavior, some would call it having a life. But now you’ve found the crimes being committed in the name of psychiatry, Dr. Mickey, you’ve done yeoman’s work on the front lines.

  5.  
    January 14, 2013 | 7:23 PM
     

    January 14, 2013

Sorry, the comment form is closed at this time.