Some Interesting Responses On The BMJ Site About The Restoration Of Paroxetine Study 329


http://www.bmj.com/content/351/bmj.h4629/rapid-responses

Re: No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility

It is refreshing to see the BMJ publish an article highlighting the corruption, collusion and dangerously unethical behaviors among the pharmaceutical and psychiatric industries, university medical departments and government “regulators.” I’d like to tell my teen-aged daughter all about the “retraction.” Unfortunately, she died from SSRI-induced akathisia, Serotonin Toxicity and prescribed suicidality. When she was experiencing life-threatening SSRI-induced side effects, her doctor did what many misguided doctors incompetently do: increased the toxin. Sadly, her death-and the deaths of hundreds of thousands of other innocent children, is not retractable.

Perhaps lawmakers might some day pass universal Informed Consent laws so that parents can be accurately informed prior to prescribing. Doing so would help better protect children from the torture and deaths that occur when profits are valued more than people…

Competing interests: No competing interests

18 September 2015
Kristina K. Gehrki
Educator & Advocate
None
Fairfax, VA 22030

Re: No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility

Thanks to Peter Doshi for his thorough overview of how the bastions of psychiatry and a top university ignored shoddy science, rampant conflicts of interest, ghostwriting, and the interests of children’s health (in my opinion) from the notorious study 329. Note the study and those involved played prominent roles in Boston Globe reporter Alison Bass’ 2008 book, Side Effects, “A richly detailed account of the disgraceful self-serving ties between drug companies and the psychiatric profession,” as described by former New England Journal of Medicine editor Arnold Relman.

Competing interests: No competing interests

17 September 2015
Susan Molchan
psychiatrist
Bethesda, MD

Paroxetine trial reanalysis raises questions about institutional responsibility

I wanted to say thank you for publishing this article. I was once on Paxil myself, as a newly 20 year old, for panic disorder without agoraphobia. While taking just 1/4 of the normal starting dose (5mg was my dose), I displayed flat affect and a “zombie” like appearance. This was within several weeks, about two. I then became suicidal.

For something that is supposed to be an ANTI-depressant, I’m amazed at how PRO mental disorder it truly was.

I’m a very happy woman, and was always a happy teenager. This was not normal. The small, sane part of my brain told me I needed to tell someone I was feeling this way, but I didn’t want to – they would try to stop me if I did tell someone. I will never forget what that feeling was like, and I truly wonder if I am a PTSD patient now because of it.

In the end, I did try to hurt myself. I was very lucky to have my mother and a very close friend stop me and take me to the doctor. They pulled me off Paxil completely and switched me to another SSRI and a benzodiazepine to ease the withdrawal side effects from the Paxil. I’ve been on this SSRI ever since, and it has now been about 10 years.

Everytime I see an article like this, my heart breaks. I truly hope that this research saves other adolescents from experiencing what I went through. I wouldn’t wish it on my worst enemy.

Competing interests: No competing interests

17 September 2015
Tracy Eisen
Student Nurse
Phoenix, AZ

No correction, no retraction, no apology, no comment = No science

Peter Doshi’s incisive commentary on the reactions to the RIAT re-analysis of Study 329 by its authors and the institutions, organizations, and corporations that stand behind them should be required reading for all mental health trainees — and, indeed, for all health care trainees.

Study 329 nicely illustrates the dangers that Marcia Angell pointed out in her 2004 volume, The Truth About the Drug Companies: How They Deceive Us and What to Do About It.

We all should be skeptics regarding hyped-up claims of efficacy — whether the agent is Paxil or CBT or psychoanalysis. We are only just beginning to understand the ways in which “body” and “mind” interact. New neuro-imaging techniques yield wonderful “pictures” of the brain . . . but these pictures might be usefully compared to what we see when we train a telescope on the night sky. Our vision is enhanced by a hundred-fold . . . but we still do not see more than the tiniest slice of what is really “out there.” The fact that we now can see so much more should not make us think that we now see the whole picture.

We also shouldn’t fall victim to another common error. The fact that an intervention is aimed at a specific target does not mean that the intervention affects only the target. [This is as true for psychoanalysis as it is for Paxil.] Our interventions always affect people in many unintended ways as well as those we intend.

Pharmaceutical advertisements usually give the impression that drugs affect a specific part of the body; they close their eyes to the fact that the drugs are disseminated throughout the body, with many unintended effects. [If they are mentioned, these “side effects” are put in small print, thus magically reducing their importance.]

Interventions aimed at affecting the mind are prone to the same error — but helping a person to “change their mind” often (or USUALLY) affects their life (and their relationships with others) in many unintended ways, too.

“Evidence-based medicine” or “empirically supported treatments” are put forth as a kind of gold standard these days. But “Restoring Study 329” demonstrates that we shouldn’t mistake iron pyrite (“fool’s gold”) for the real item, especially when someone has a vested interest in keeping a good bit of the evidence hidden from view. If we’re going to endorse “evidence-based medicine” we’d better be sure that we’ve got all the evidence and not just a cherry-picked subset.

Competing interests: No competing interests

17 September 2015
Paul M Brinich
Psychoanalyst. Clinical Professor (Emeritus) of Psychology and Psychiatry
University of North Carolina at Chapel Hill
Chapel Hill, NC 27516 USA

GSK ambiguity

Dr Doshi’s article might give the impression that an independent FDA review of the Study 329 data came to a different conclusion to GSK’s claims the trial had shown paroxetine worked. But in fact an approvable letter from FDA to GSK states: ” we agree that the results from … Study 329… failed to demonstrate the efficacy of Paxil in pediatric populations with MDD”. [but] “we agree that it would not be useful to describe these negative trials in the labeling”.[1]

In the media flurry surrounding these articles yesterday and today, GSK seem to lay the blame for a positive write up of the data on Keller and colleagues, while Keller and colleagues hint that GSK involvement compromised them. None of us – journals, regulators, academics, or doctors – come out of this with much credit.

1 http://2spl8q29vbqd3lm23j2qv8ck.wpengine.netdna-cdn.com/wp-content/uploa…

Competing interests: An author on Restoring Study 329, a founder member of RxISK.org and an expert witness in psychotropic cases both pro and con drug induced harms.

17 September 2015
David Healy
Doctor
Hergest Unit, Bangor

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2 comments

  1. solo49

    “Pharmaceutical advertisements usually give the impression that drugs affect
    a specific part of the body; they close their eyes to the fact that the drugs
    are disseminated throughout the body, with many unintended effects. [If they
    are mentioned, these “side effects” are put in small print, thus magically
    reducing their importance”.] BMJ article.

    Concerning the above statement: In the case of psychoactive drugs,
    pharmaceutical advertisements clearly do Not usually give the impression that
    a particular part of the body (i.e. brain and central nervous system) is
    primarily being targeted. That tell tale strategy appears to have been
    abandoned in the late 1950’s during which time e.g. ADHD was known as
    ‘Minimal Brain Dysfunction’.

    More over, what stretch of imagination or enhanced vision may have
    given rise to the foregone conclusion that, ‘side effects’ of psychoactive
    drugs in particular (those including ‘spellbinding’, suicidal ideation and
    self harm), should be deemed ‘unintended’ despite the ‘magical’ if not
    culpable reducing of their importance?

    Clearly, and as a fateful consequence of such crafted reductions and omissions;
    when patients complain about ‘side effects’ whether under regular psychoactive
    drug maintenance or upon withdrawal; is it not unusual for them to be diagnosed
    with some weightier mental or emotional disorder than the one they were originally
    being ‘treated’ for and for which more drugs will then be prescribed??

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