guidelines…

Posted on Monday 20 May 2013


Anthony Rothschild, M.D.Antidepressants do “really work” and do not “cause suicide,” said Anthony Rothschild, M.D., at APA’s 2013 annual meeting today during a discussion of his second book in the Evidence-Based Guides series, the evidence-based guide to antidepressant medications [American Psychiatric Publishing, 2012]. Rothschild is the Irving S. and Betty Brudnick Endowed Chair and Professor of Psychiatry at the University of Massachusetts Medical School.

Rothschild said that although clinicians have successfully used antidepressants to treat millions of patients suffering from depression for 50 years, Kirsch et al. published in 2008 a paper claiming that although antidepressants are statistically superior to placebo, the magnitude of the drug-placebo difference is small and that these differences were clinically relevant only in patients with severe depression. Surprisingly, he said, the paper received considerable attention in the media, including radio, front-page newspaper coverage, and “60 Minutes.” Rothschild said that the focus on questions about whether antidepressants really worked needlessly upset patients and their families. He pointed out that many experts in the field have argued that the analysis by Kirsch and colleagues was seriously flawed because it relied upon unusual statistical techniques biased against antidepressants.

Rothschild also discussed the fact that some have questioned whether treatment with the SSRIs and other antidepressants can induce suicidal ideation and whether they worsen existing suicidal ideation. Although the totality of the reliable scientific evidence indicates that SSRIs and other antidepressants do not cause suicide, the FDA has required that all antidepressants contain a black-box warning that they are associated with “suicidality” in children, adolescents, and young adults up to age 24. Rothschild said that clinicians should be aware of two important points: [1] the FDA’s black-box warning does not indicate that antidepressants increase the risk of suicide in anyone or that they increase the risk of suicidal thinking or behavior in patients ages 25 and older; and [2] although the FDA used the concept of “suicidality” as a proxy for completed suicide, they are not the same thing. The term “suicidality” has been criticized as grossly overestimating the risk of suicide and as not being as clinically useful as more specific terminology such as ideation, behavior, attempts, and suicide.

The workshop included discussions regarding the fact that antidepressants are prescribed for many patients in addition to those who have major depressive disorder, including patients with bipolar disorder, posttraumatic stress disorder, schizophrenia, and personality disorders, as well as those with medical illnesses. The workshop reviewed the use of antidepressants for so-called off-label use—to treat illnesses for which the medications do not have U.S. Food and Drug Administration approval—and emphasized that practicing clinicians need to understand the use of antidepressants among several special populations, including children and adolescents, geriatric patients, and pregnant and lactating women.

Among all the hooplah about the APA Convention and the release of the DSM-5, this simple report in the Psychiatric News is the most upsetting thing I’ve read so far. It’s about a presentation at the meetings by Anthony Rothschild, editor of an American Psychiatric Publishing Company book, The Evidence-Based Guide to Antidepressant Medications. The APA has been publishing treatment guidelines since the DSM-III came into being. They’re always discussed reverently, an accomplishment. Treatment guidelines sound good on paper, but have been a major conduit for corruption [as in TMAP, as in Dr. Trivedi’s algorithm projects, etc]. The APA versions have the inevitable "Evidence-Based" title added  in for good measure.

I find this article infuriating. First, he takes on the efficacy of antidepressants. As we all know, the efficacy of the modern antidepressants is much lower and variable than we’ve been lead to believe. Most practitioners already know that from usage if they follow people closely. Dr. Rothschild takes the most extreme critic, Dr. Kirsch, and talks as if the fact that Kirsch’s methodology has been questioned as proof that the complaint has no validity. Rothschild’s bias is clear – similar to Robert Gibbons discussions. Anyone can easily find multiple other studies that confirm the complaint that the newer antidepressants operate in the range of "Lite."

But his discussion of suicidality and the Black Box warning is where Rothschild’s bias shines. It’s hard for me to imagine anyone that prescribes SSRIs hasn’t seen akathisia – agitation with aggression. It’s not common, but it’s not rare either. He does what most people do, get lost in semantics, but basically is lobbying against our knowing about something that is very real. They could easily say the truth. It is an unusual reaction that is quite frightening to patients and can lead to lethality. But Rothschild takes the it-doesn’t-happen road. That seems so un-medical to me, particularly in an official, "evidence-based" guideline book. This whole presentation reeks of drug promotion don’t-worry-about-it rhetoric instead of responsible information giving.

I’m a doctor. I need to be told the truth, not an opinion. I had to learn about the low efficacy, the akathisia, and the withdrawal syndromes on my own – by causing the problem in my own patients. I resent that, particularly from a professional organization. I still use these drugs with appropriate caution. That’s true of almost any drug in any field of medicine. But I ignore guidelines of this type in psychiatry because I can’t trust what they say, just like I don’t trust Rothschild’s presentation. I also now tend to ignore new drugs until they’ve been around for a while and stood the test of time…

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