watchful waiting…

Posted on Saturday 25 February 2012

The last post, I said I was obsessed, but maybe I should have said perplexed. I just don’t understand the seven year hegira Dr. Gibbons has been on to disprove the need for the black box warning on the antidepressants about the possibility of treatment emergent suicidality in children and adolescents. His persistence transcends reason. It’s Gibbons that seems obsessed. Before detailing his journey, here’s another version of his public statements, this time in the Los Angeles Times:
Study questions antidepressant link to suicide in kids
Los Angeles Times
By Shari Roan
February 06, 2012

In 2004, the Food and Drug Administration announced that antidepressant packages should carry a "black box" warning describing an increased risk of suicide and suicidal thoughts in children and youths up to age 25. The FDA action triggered a significant decline in antidepressant use among children and teens. Now, however, an analysis suggests there is no reason to believe that antidepressants influence suicidal thinking in kids.

The paper, published online Monday in the Archives of General Psychiatry, analyzed data from 41 clinical trials involving more than 9,000 adults and children. The adults were taking either the antidepressant fluoxetine or venlafaxine. The children were taking fluoxetine (Prozac). The study showed that adults had a decreased risk of suicidal thoughts and behaviors while taking an antidepressant. Among children, medications neither increased nor decreased suicidal thoughts or behavior.

The new study draws from a larger database than the research performed in 2004 that led to the "black box" warning. However, the data on children are limited to the one medication – fluoxetine. Several important points can be drawn from the new study, said the lead author of the paper, Robert Gibbons, a professor of medicine, health studies and psychiatry at the University of Chicago. It suggests that antidepressants reduce suicide rates by treating the underlying depression. If the treatment does not work, suicide risk remains the same or rises.

Moreover, antidepressants appear to affect children differently than adults with regard to suicide. "Maybe children think about suicide in part because of depression, but also maybe due to other reasons not related to depression that are not affected by antidepressants," Gibbons said in a news release. The impact of the "black box" warning, he said, was to reduce antidepressant prescriptions to kids – which was correlated with an increase in suicide rates in subsequent years.

"I hope that the warnings will not prevent depressed children and adults from getting treatment for depression," he said. "The greatest cause of suicide is untreated or undiagnosed depression. It’s very important that this condition be recognized and appropriately treated and not discarded because doctors are afraid to be sued."

After the Black Box Warning was added in 2004, there was a determined effort to debunk it using a variety of data. Here are Gibbons’ offerings:
At this point [2007], Gibbons was running with a herd of critics who filled the literature with data showing that antidepressant prescriptions for youth had plummeted after the warning [and they did] and that there was an uptick in adolescent suicides in 2004. I reviewed this flurry of articles and the people behind the campaign back in the Fall [worth a gander if you don’t know the history]:
Here’s Gibbons’ version of the graph from his last 2007 article:
[In the links there are many others]. One fine uptick! Notice the ordinate scale sleight of hand [it doesn’t start with zero to enhance the small difference]. Here’s the punchline. When the CDC updated their statistics, voila`:
So the controversy passed and the warning survived. Well, the controversy didn’t pass, it just became less noisy. But notice what Gibbons still says:
    The impact of the "black box" warning, he said, was to reduce antidepressant prescriptions to kids – which was correlated with an increase in suicide rates in subsequent years.
It’s not true, but I guess old positions die hard. Time continued to pass, and Gibbons’ publications continued off the grid:
Now he returns with a vengeance:

There’s an article in a big journal, press coverage, celebrity endorsements, and another article coming soon. It was cold and rainy here in the mountains yesterday and I occupied myself trying to vet this article [coming soon?…]. Alas, it can’t be done – at least not by me, not from here. In some ways, it’s a unique article in that it has no data, only methods and conclusions. I tried requesting the data, then intuiting the data, but failed in both areas. I can make no sense of the tables in the paper. I’m not a rocket scientist, but I can usually get there by plodding – and my plodder failed me. So I know of no other thing to do except apply the time honored medical principle of watchful waiting. I would prefer benign neglect, but the topic matters way too much for such luxury, and ignoring this kind of thing is what helped get us where we are today [no further comment…].

Dr. David Healy who has been in the eye of this storm from the start has a lot to say about this paper [Coincidence a fine thing], and I expect will have even more to say as things progress [it’s one of the central topics of his new book, Pharmageddon]. He points to Gibbons’ use of rating scale numbers to indicate suicidal ideation, a heavily debunked method discarded long ago. He has a story about Gibbons’ coauthor on another paper disavowing it. And, of course, there are the observations of Göran Högberg [covered in significant I…, significant II…, and significant III…]. But as usual, Healy should be read as a primary source, not in camera.

There is one thing that is included in Gibbons’ article that we can comment on – his conclusions. He says that his data shows that the SSRIs decrease suicidal ideation in adults and the elderly. But that wasn’t true for youth:
    In summary, we found that treatment with fluoxetine and venlafaxine decreased suicide risk in adult and geriatric patients and that the effect of treatment on depression severity appears to be the mechanism whereby antidepressants lower suicide risk in adult and geriatric patients. We found no evidence that fluoxetine increased risk of suicidal thoughts or behavior in youths.
While I question his conclusion, even if it’s correct it doesn’t support his recommendations. If antidepressants don’t have a positive effect in kids, why give them in the first place? His own conclusions in the article certainly don’t support this comment:
    "I hope that the warnings will not prevent depressed children and adults from getting treatment for depression," he said. "The greatest cause of suicide is untreated or undiagnosed depression. It’s very important that this condition be recognized and appropriately treated and not discarded because doctors are afraid to be sued."
At this point, I’ll suppress responding to his dim, reductionistic view of physicians or his lack of credentials to even have an opinion about treatment recommendations. And I’ve run out of titles for blogs that say much ado about nothing or full of sound and fury, signifying nothing, so I’ll fall back to the medical principle of watchful waiting and do just that…
  1.  
    February 25, 2012 | 12:49 PM
     
  2.  
    shun
    February 26, 2012 | 11:17 AM
     

    What are your qualifications to writer on medical matters?

  3.  
    February 26, 2012 | 3:17 PM
     

    old doctor…

  4.  
    Talbot
    February 27, 2012 | 10:47 AM
     

    Those sets of pubs using the same authors over and over, covering the same subject from different angles, in different journals over a relatively short period of time–that all screams pub plan to me, from every angle, as in pharma funding and ghost writers.

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