off the science grid…

Posted on Sunday 2 February 2014


Fiddamans blog
by Bob Fiddaman
January 31, 2014

You’d have to be from the planet Zog if you didn’t know who Karen Wagner was.

Her name is synonymous with antidepressant pediatric studies. She added her name to the Paxil 329 ghostwritten paper without actually looking at the raw data [which showed an increased rate of suicidal thoughts in kids taking Paxil] – The result of that piece of Pharmafia fraud told millions of prescribing physicians that Paxil was safe to use in children and adolescents…when in actual fact it wasn’t. Wagner has been relentless to disprove those who believe antidepressant use in kids is wrong. She sees no problem with it…despite overwhelming evidence that shows just how dangerous antidepressant use in kids can be.

An article published in Clinical Psychiatry News [Treating youngsters’ depression means going off the FDA grid] a couple of days ago shows Wagner, once again, promoting the use of SSRi medication in children and adolescents. Wagner was present at a psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry where she claimed that "…60% of youngsters will respond favorably to their first antidepressant medication – generally a selective serotonin reuptake inhibitor (SSRI)" Wagner also went on to claim that Switching to a different antidepressant will help about 50% of those who don’t respond. But adding psychotherapy will grab about 10% more – bringing the total response rate up to around 70%". She was referring to a 2008 study, TORDIA [Treatment of Resistant Depression in Adolescents].

So, Wagner hits the stage at these types of events, she’s a key opinion leader, in other words, those employed in the same field as her look up to her, respect her, hang on to her every word. She is the Geldof of the pop world, pushing her message at every given opportunity. Quite why she sticks her middle finger up at evidence that shows kids kill themselves whilst on these drugs kind of alarms me.

So, is Wagner on a mission to help depressed children and teens, does she genuinely care about this population or are there more sinister undertones? It would help if she and the article published in Clinical Psychiatry News was actually more transparent about her relationship and financial ties to the pharmaceutical industry [Pharmafia]. Upon reading the article I had to do a double take at the end… "Dr. Wagner has no financial relationships with pharmaceutical companies"…
As you can see, Fid’s not very taken with Karen Wagner [nor am I]. She has only one message, one that she’s preached forever. And this is it. Her industry connections are legend and well covered in the rest of Fid’s blog post. In the piece in Clinical Psychiatry News, they report further down that she says:
Venlafaxine is one of many antidepressants that are not approved for use in children and teens. Treating depression in youngsters almost always means off-label prescribing. Only two antidepressants – fluoxetine and escitalopram – are Food and Drug Administration–approved for children and teens, and only fluoxetine is approved for children younger than 12 years. And data are actually mixed about fluoxetine; a recent published study showed it was no different from placebo over 6 months. Of the older, more well-known antidepressants, only two have positive data for youngsters. One randomized study of citalopram posted positive findings for its primary endpoint [American Journal of Psychiatry 2004;161:1079-83]. The other is sertraline, which had positive overall findings in a pooled analysis, although the individual studies were negative [JAMA 2003;290:1033-41].
It is lost on no one that the two studies of "the older, more well-known antidepressants" that she reports as positive are studies she, Karen Wagner, did. I wasn’t impressed with either [clinically insignificant study…, tuning the quartet…].
Studies on all of the other drugs were negative, including mirtazapine [two studies], nefazodone [two], paroxetine [three], and venlafaxine [two].
Notice that she now includes all three Paroxetine studies in the negative column, including the one we know as Paxil Study 329, the one she’s an author on, the one that concludes, "Paroxetine is generally well tolerated and effective for major depression in adolescents." There’s more:
This doesn’t mean the medications won’t work – they do benefit some children, Dr. Wagner said. But parents need to know that the studies in children were not positive. However, she added, the safety profiles were all reasonably good…
As we all know, including Karen Wagner, the meta-analysis of these studies and an FDA panel didn’t share her enthusiasm for their safety profile. She continues:
The newest evidence for duloxetine in youngsters with depression looks lousy. In two highly anticipated, yet-unpublished, phase III trials, duloxetine and fluoxetine – which is already approved for kids – completely fell apart relative to placebo, Dr. Wagner said…
If you’re confused, you’re in good company. Where does her statement "…60% of youngsters will respond favorably to their first antidepressant medication – generally a selective serotonin reuptake inhibitor (SSRI)" come from? I have no idea where that comes from. She then proceeds to go through the antidepressants one by one, shooting down the efficacy of all save two, the ones that she personally studied and reported herself as positive. She tells us that she "has no financial relationships with pharmaceutical companies" yet at the time she reported these positive studies, she was heavily involved with the respective pharmaceutical companies and was assisted by their funding, their resources, and their employees as coauthors. 

That leaves the Treatment of Resistant Depression in Adolescents [TORDIA] study, one of those NIMH funded clinical trials contemporary with many of the other industry funded trials she mentions. She was an author on that one too. I’ve never commented on that study – for a reason. It’s super-convoluted and reported in pieces in a bunch of different journals. But since it’s the center of her talk, I expect I’ll dig up those papers and go through it soon [but don’t hold your breath for great clarity].

The title of this article about Dr. Wagner’s presentation is Treating youngsters’ depression means going off the FDA grid. But from the content, one wonders if it shouldn’t have been titled Treating youngster’s depression means going off the science grid
  1.  
    February 2, 2014 | 3:26 AM
     

    I emailed the author of the article, asked her if she was going to rectify the claim that Wagner wasn’t on the pharmafia payroll.

    She never replied.

  2.  
    Tom
    February 2, 2014 | 9:02 AM
     

    Pharma HO.

  3.  
    Steve Lucas
    February 3, 2014 | 7:21 AM
     

    Then we have this just released gem:

    http://brodyhooked.blogspot.com/2014/02/reps-on-safety-issues-or-sounds-of.html

    Drug reps lie! Who would have thought such a thing?

    Steve Lucas

  4.  
    wiley
    February 3, 2014 | 8:27 PM
     

    Children are the most powerless people the “it” of psychiatry can feed on. That the biological supposition is so thoughtlessly dominant that psychiatrists aren’t questioning parents and their relationships with children before giving children drugs evidence that their religion is dehumanizing. It’s also cut from the same fabric that requires universities to be surrogate parents for people who should be treated like adults and expected to behave as adults— students and their parents, are now seen as “consumers”.

    Ka-ching.

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