our decision…

Posted on Wednesday 5 August 2015

While it’s tempting to just mount a counter·argument to this article as I and others have done so many times in the past, I’m going to forgo doing only that. If you’re reading this, you probably have your own views and arguments on this topic, and hearing mine wouldn’t add much. Dr. Friedman concludes that the Black Box Warning on antidepressants should be rescinded altogether. I’d prefer to also comment on certain other aspects of his argument, or more accurately, the logic of his argument [also, I’ll mention as an aside that I thought the article linked as toxic social pressure below [Suicide on Campus and the Pressure of Perfection] was interesting and worth a look]:
New York Times
by Richard A. Friedman
AUGUST 3, 2015

Is our culture of relentless achievement and success driving our young people to suicide? You would certainly think so, given the prevailing narrative in the media about the recent spate of suicides on college campuses: one high-achieving student after another succumbing to the toxic social pressure for perfection. It’s a plausible but incomplete explanation. No doubt the intense social pressure on young people, especially girls and young women, is daunting, but stress is only part of the story: We should also focus on adolescent mental illness and its treatment.

At least 90 percent of people who commit suicide have a diagnosable and potentially treatable mental illness like depression, or alcohol or other drug abuse problems, often in combination. Suicide is the third leading cause of death among young people and has been rising since 2007. The unidentified killer in this story is untreated psychiatric illness. In 2013, for example, 8.7 percent of people between the ages of 18 and 25 experienced a major depression episode in the previous year, but only half of them received any psychiatric treatment, according to the National Survey on Drug Use and Health. And in 57 percent of these episodes, patients were seen by a general practitioner or family doctor — neither of whom is typically an expert in the treatment of mental illness.

Worse, antidepressants, which can be lifesaving, are probably being underused in young people. Their use fell significantly after the Food and Drug Administration issued its so-called black-box warning in 2004, stating that all antidepressants were associated with a risk of increased suicidal feeling, thinking and behavior in adolescents. That warning was later extended to young adults. One very large study, including 1.1 million adolescents and 1.4 million young adults, examined data for automated health care claims for 2000 to 2010 from 11 health plans in the United States Mental Health Research Network. Disturbingly, the study found that antidepressant use plunged 31 percent among adolescents and 24 percent among young adults within two years after the F.D.A. advisory was issued…

Since there is no evidence that the F.D.A. black-box warning has been helpful, and there is a very reasonable possibility that it has discouraged patients from taking antidepressants and physicians from prescribing these medications, the government should rescind the black-box warning on antidepressants altogether. Parents and teenagers, and their doctors, too, should not be afraid of antidepressants and should know that they can be very helpful. Indeed, with careful use and monitoring, they can be lifesaving. The only thing we should all fear is depression, a natural killer that we can effectively treat.
He begins with a sociocultural phenomenon and its impact on the psychology of many college students – "the intense social pressure on young people, especially girls and young women" – as a potential cause of teen suicides – stress. But then says that there’s more – something called adolescent mental illness. That transition, from a sociocultural problem of modern life to a disease [biological?] is frequent and unexplained. He implies that it’s not stress, but something else. Is it in the genes? the water? the air? It’s never explained. Is it increasing in frequency? Apparently, otherwise he wouldn’t be talking about it in an article about "the prevailing narrative in the media about the recent spate of suicides on college campuses." So the problem isn’t toxic social pressure, or any of the other issues that we traditionally discuss about the difficulties of adolescence development, at least in Friedman’s mind. It’s adolescent mental illness.
The unidentified killer in this story is untreated psychiatric illness. In 2013, for example, 8.7 percent of people between the ages of 18 and 25 experienced a major depression episode in the previous year, but only half of them received any psychiatric treatment, according to the National Survey on Drug Use and Health.
There’a an illogic in this line of thinking that just slides right on by, often ignored. In logical terms, it’s a tautology. Increased suicide rate, ergo increased adolescent mental illness, ergo medicine required, ergo … And so he quotes Lu et al, one of the all time bad population studies in that it used an invalid proxy for suicidality [see all databases are not created equal…] on his way to his next piece of illogic. Parenthetically, that study didn’t show much of a "fall off." It rather showed that things leveled out instead of accelerating like a runaway train [see end of story…boxes black are back I…, boxes black are back I…, and unsupportable and totally irrational…].
But this NYT piece is just a rewrite of Dr. Friedman’s NEJM article from last year [Antidepressants’ Black-Box Warning: 10 Years Later] – I guess for public consumption. Before moving on to the final piece of logic, we should mention the Cochrane Collaboration meta-analysis of Antidepressants in Adolescence:
Cochrane Systematic Reviews
by Sarah E Hetrick, Joanne E McKenzie, Georgina R Cox, Magenta B Simmons, and Sally N Merry
14 NOV 2012

… Based on 14 of the trials [2490 participants in total], there was evidence that those treated with an antidepressant had lower depression severity scores than those on placebo, however, the size of this difference was small. Based on 17 trials [3229 participants in total], there was evidence of an increased risk [64%] of suicide-related outcomes for those on antidepressants compared with those given placebo…

The conclusion to these articles is always the same. Repeal the Black Box Warning.
The logic? We want people to save lives by prescribing more antidepressants to kids. The ones lost to this idiosyncratic and rare suicidality thing will be made up for in lives saved by giving the drug. The argument that is being offered is fine to say. But the mandate of the FDA is to tell me about the possible adverse effects of the drug so I can weigh the risk benefit ratio with every drug in every case. To suggest that the FDA should con me into a false sense of security by not telling me a potential danger is illogical to a fault. He can preach his gospel wherever he wants to, but don’t withhold the truth in the process. I’ve seen this suicidal reaction with my own eyes, by my own prescription. I’ve seen completed suicides, thankfully not in cases where I prescribed. And I’ve prescribed SSRIs to a few adolescents but watched them like a hawk. The drugs actually weren’t much help after all. Dr. Friedman says:
Since there is no evidence that the F.D.A. black-box warning has been helpful, and there is a very reasonable possibility that it has discouraged patients from taking antidepressants and physicians from prescribing these medications, the government should rescind the black-box warning on antidepressants altogether.
It is not the FDA’s job to be helpful in that way. They’re supposed to provide me with accurate information to pass on to my patients, and in this case, their parents. It’s our decision what to do with that information. Not the FDA’s and certainly not Dr. Friedman’s.
  1.  
    Bernard Carroll
    August 5, 2015 | 6:37 AM
     

    After the big Prozac study of treating depression in adolescents appeared in 2004, I ran a back-of-the envelope estimate of risks and harms. For the hard outcome of completed suicide, the data suggested equipoise: any suicides prevented by treating depressed adolescents with fluoxetine would be offset by about the same number of suicides provoked by the drug. So, as you point out, the NYT author Friedman goes beyond the data in asserting that untreated mental illness is the real culprit. Besides, where are the data on efficacy of current antidepressants in preventing suicide in dysphoric adolescents with alcohol or drug abuse problems or in those with first-episode psychotic breaks or in those with many forms of co-morbidity?

    So, Friedman’s hortative message turns out to be just hand waving – well intentioned, no doubt, but hand waving nonetheless.

  2.  
    August 5, 2015 | 2:11 PM
     

    The irony will be WHEN a family member sues a psychiatrist for NOT prescribing meds after a teen/young adult commits suicide, and the provider tries to use the black box warning as a defense.

    Damned if you do, damned if you don’t. Oh, and don’t wait for the antipsychiatry crowd to chime in basically saying patients should be abandoned in the first place, as just breathing oxygen and ingesting a reasonable amount of glucose and protein will save society, if they even admit there are some who have depression as a quantifiable disorder.

    Sheesh…..

  3.  
    WDM
    August 6, 2015 | 4:09 AM
     

    1. I wrote to NEJM last month about two mistakes in Friedman’s 2014 piece, in a paragraph he copied and pasted into an NYT Q&A after Germanwings.

    This is wrong:
    “the rate of suicidal thinking or suicidal behavior was 4% among patients assigned to receive an antidepressant, as compared with 2% among those assigned to receive placebo,1 although none of the suicide attempts documented in the trials were fatal.”

    There were 8 completed suicides, 5 on drug and 3 on placebo.

    He was reporting the findings of Stone, et al., 2009. In NEJM the reference was wrong, and in NYT he didn’t give one. (It’s http://www.bmj.com/content/339/bmj.b2880)

    2. I wrote to NYT at the same time, and they have since fixed it, and added a link to Stone at BMJ:

    “the rate of suicidal thinking or suicidal behavior was 4 percent among patients assigned to receive an antidepressant compared with 2 percent among those assigned to receive placebo. There were eight fatalities from suicide overall in the adult trials and there was no increased risk of suicidal behavior when analyses were pooled among adults”
    http://well.blogs.nytimes.com/2015/03/30/ask-well-depression-and-its-risks/

    NYT added:
    Correction: August 4, 2015
    An earlier version of one of the answers in this post referred incorrectly to the number of documented completed suicides there were in an analysis of clinical trials of antidepressants. There were eight completed suicides among adult patients; it is not the case there were none. (In a smaller study of pediatric patients none of the suicide attempts were fatal.) A reader pointed out the error last week.

    Should add: “She also pointed it out to Well in April.”

    3. I saw two of Yu’s BMJ charts in a WaPo article last year, and wrote (and deleted) a post about them.

    “There were 89 comments on [the WaPo] article. No one mentioned that the graphs, which were meant to show antidepressant prescribing declining after 2004 and suicidal behavior rising show something else.”

  4.  
    August 7, 2015 | 11:20 PM
     

    I cannot fathom why the NYTimes keeps publishing Friedman.

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