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Gibbons RD, Hur K, Bhaumik DK, Mann JJ.Arch Gen Psychiatry. 2005 Feb;62(2):165-72.
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Gibbons RD, Hur K, Bhaumik DK, Mann JJ.Am J Psychiatry. 2006 Nov;163(11):1898-904.
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Charles B. Nemeroff, Amir Kalali, Martin B. Keller, Dennis S. Charney, Susan E. Lenderts, Elisa F. Cascade, Hugo Stephenson, and Alan F. SchatzbergArch Gen Psychiatry. 2007 Apr;64(4):466-472.
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Nakagawa A, Grunebaum MF, Ellis SP, Oquendo MA, Kashima H, Gibbons RD, Mann JJ.J Clin Psychiatry. 2007 Jun;68(6):908-16.
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Gibbons RD, Brown CH, Hur K, Marcus SM, Bhaumik DK, Mann JJ.Am J Psychiatry. 2007 Jul;164(7):1044-9.
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Early evidence on the effects of regulators’ suicidality warnings on SSRI prescriptions and suicide in children and adolescents. [see peaks and valleys…]Gibbons RD, Brown CH, Hur K, Marcus SM, Bhaumik DK, Erkens JA, Herings RM, Mann JJ.Am J Psychiatry. 2007 Sep;164(9):1356-63.
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Brown CH, Wyman PA, Brinales JM, Gibbons RD.Int Rev Psychiatry. 2007 Dec;19(6):617-31.
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Gibbons RD, Segawa E, Karabatsos G, Amatya AK, Bhaumik DK, Brown CH, Kapur K, Marcus SM, Hur K, Mann JJ.Stat Med. 2008 May 20;27(11):1814-33.
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Barry CL and Busch SH.Pediatrics. 2010 125[1]:88-95.
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Gibbons RD, Mann JJ.Drug Saf. 2011 May 1;34(5):375-95.
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Robert D. Gibbons, Hendricks Brown, Kwan Hur, John M. Davis, and J. John MannArch Gen Psychiatry. 2012 Jun;69(6):580-587.
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Christine Y Lu, Fang Zhang , Matthew D Lakoma analyst, Jeanne M Madden, Donna Rusinak, Robert B Penfold, Gregory Simon, Brian K Ahmedani, Gregory Clarke, Enid M Hunkeler, Beth Waitzfelder, Ashli Owen-Smith, Marsha A Raebel, Rebecca Rossom, Karen J Coleman, Laurel A Copeland, Stephen B SoumeraiBMJ. 2014 348:g3596.
PSYCHIATRICNEWSby Mark Moran12/30/2014Abstract: This is the first of a two-part series on the 2004 FDA hearings on antidepressants and suicidality in adolescents. Part two will focus on the effect of the antidepressant label warning on prescribing and adolescent health.
From the beginning, and in the decade since, APA has protested the warning, predicting that it would prevent parents from seeking care for their children—and clinicians from prescribing antidepressants—and insisting that by far the greater danger was untreated depression.
‘We are concerned that the publicity surrounding this issue may frighten some parents and discourage them from seeking help for their children,’ child psychiatrist David Fassler, M.D., told the 2004 panel. ‘The most important point that I can make is that the biggest risk for a child with depression is to be left untreated…’
Darrel Regier, M.D., M.P.H., who is the former director of the APA Division of Research and testified at the hearings against the warning, noted that there were in fact no actual suicides among the thousands of teens treated in clinical trials reviewed by the FDA panel. Moreover, the FDA data on suicidal ideation associated with SSRI use was based on spontaneous reports, not on studies prospectively designed to systematically define and identify the incidence of suicidal thoughts or behaviors in teenagers taking the medications.
Regier believes the extraordinary media attention the hearings attracted is a case study in how data pertinent to public health can be obscured or distorted by overinterpretation of spontaneous reporting. “I think it calls into question the FDA’s entire system of spontaneous reporting,” he said. Regier said a promising step is the agency’s adoption, for use in future phase 3 clinical trials, of the Columbia Suicide Severity Rating Scale for any drug that is thought to have some potential for suicidal ideation [including dermatologic drugs such as Accutane].
‘I think the solution is more systematic reporting, which the FDA will start to move toward as the agency begins to have access to electronic health records used by large health systems and HMOs,’ Regier said. ‘This will give the FDA access to phase 4–type data on the long-term effects of medication side effects and associations with suicidal attempts and mortality from all causes.’
by Fava GA, Guidi J, Rafanelli C, and Sonino NPsychotherapy and Psychosomatics. 2015 84:1-3.
My own opinions are embedded in my narrative. I came into the world equipped for science – aptitude, interest, a father who taught chemistry and geometry. After a degree in mathematics, I headed to medical school intending a medical research career and, in fact, wound up my training in a lab bench based NIH fellowship. I lived and breathed evidence-based medicine [I would like to think I still do]. My first post-training posting was as an general internist in an Air Force hospital overseas [by special invitation from the US government – AKA drafted]. I had been well trained as a clinician, but what I quickly realized was that in training, I had always been located somewhere in the hierarchy of a team of some sort, and when it was just me and a patient, medicine was a different game altogether. What Giovanni Fava is calling clinical judgement is as good a way as any to describe the difference.
I think of that three years as the most important and intense period of my own medical training. I became so interested in the individual illnesses and unique experience of my patients that I returned to a psychiatry residency and added a psychoanalytic training program that ran in parallel. My post academic career was as an individual psychotherapist in a world where clinical judgement was on the front burner of every day.
There was another important and intense period of my own medical training after my psychiatry residency. I directed a psychiatry training program for a decade before leaving for practice during the storm in psychiatry that followed the coming of the DSM-III. And I noticed something in my dealing with my residents during those days. I often found myself preaching the gospel of evidence-based medicine – quoting studies, handing out articles, sending a resident to the library. But at other times, my sermon was equally passionate, but was much more in the range of Fava’s clinical judgement. When I noticed that contrast, I quickly realized that the theme of my message depended on which resident I was talking to, and what I thought that particular resident needed to learn. The point being that I don’t slightly see evidence-based medicine and clinical judgement as a dichotomy – in opposition. Medicine as I know it is practiced at the interface of group data and unique human experience [including my own].
When I look at that dozen articles I listed above, or read what Dr. Regier has to say, I’m aware that I’m a total snob. There’s not anyone that I would consider to be a clinician on the bylines of the articles on the list, or speaking in the PSYCHIATRICNEWS article. They’re Statisticians, Academicians, Researchers, or Administrative types. Even putting aside all the Conflict of Interest and Methodological issues in those papers [which are prodigious], I’m sure that I still wouldn’t change my mind about this no matter how long that list of population studies gets. And, by the way, I sense that the PSYCHIATRICNEWS article is a harbinger of yet another assault on the Black Box Warning [as if what it says on a package insert defines the truth].
I personally take this issue as a microcosm of a much more general point. I most respect the opinions of people who are deeply steeped in the findings of evidence-based medicine, but who remain immersed in clinical medicine throughout their careers [and show the tell-tale signs of having developed clinical judgement]. I don’t think that’s a tall order – more a baseline requirement. Back in 1980, the people who brought the DSM-III revolution in psychiatry to my own neck of the woods saw themselves as the prophets of evidence-based medicine. I sure didn’t object to that, but they were specifically disdainful of anything that slightly smacked of clinical judgement [as in "How do you know that?" or "But that’s just what you think" ad nauseum]. They were followed by a second wave who were even worse, in the range of contemptuous – the generation that became what we now call the KOLs [some of whom inhabit those author bylines above in the flesh]. They came at a time when psychiatry may have needed an encounter over its reliance on matters subjective, but in the process they turned clinical judgement into an object of ridicule rather than one for examination and inquiry.
There’s a strong pressure pushing this same trend in medicine in general – simplifying medical practice into the rote application of large group findings to the care of individual patients based on averages and statistics. That pressure comes from third party carriers, pharmaceutical companies, hospital conglomerates, governments, even professional organizations, etc. – anyone who tries to quantitatively deal with the healthcare of populations. So the amount of allowed contact, the access to diagnostic tests, the available treatments, just about everything is regulated based on algorithms and guidelines derived from large group studies. Meanwhile, patients increasingly clamor for individual attention, and are driven to distraction along with their doctors by the hoops they have to jump through when they get sick. Dr. Regier’s comment is typical of this particular mindset, "I think the solution is more systematic reporting, which the FDA will start to move toward as the agency begins to have access to electronic health records used by large health systems and HMOs."
WOW!
This reminds me of another doctor’s blog that focuses on diagnosis, medication, and care. Teaching at a VA facility this doctor is often faced with those who have fallen through the cracks or who have found themselves diagnosed with conditions they do not have due to the point and click nature of today’s medicine.
An example from a few years ago was a female veteran who was brought in and for brevity lets say she was a mess. The first order of business was care, food and fluids along with rest. This allowed a new baseline to be established, which dictated the diagnosis, which dictated her medication levels.
Sitting at the bed side and speaking with the patient the doctor found out she was on a limited income and the click and prescribe nature of her medical care had forced her to choose between food, shelter, and medications, leaving her in the emaciated disorientated state she was found, she did not have the mental health issues previously diagnosed.
The normal way to handle this case would have been to stabilize here and push her out the door with more medication. Stabilizing her, and learning of her condition, allowed for a proper diagnosis, a massive reduction in her medications, the pointed decision to make sure all medications were available at Wal-Mart or some other low cost outlet. Then putting her in touch with social services to improve her life situation after leaving the hospital, and hopefully preventing her return
What helped this woman were not statistics and population studies, but clinical judgment to recognize a person who had been harmed by those very protocols that were designed to help. The young students were all for point and click, the older doctor was for wait and listen.
Steve Lucas
It is affirmed above that DSM111 was in the service of establishing evidence based medicine. It is argued that the DSM111 approach insisted that therapeutic guidance should be exclusively derived from large sample,controlled clinical trials.
As a surviving member of the DSM111 Task Force I affirm that none of the above has the slightest relation to reality. We were faced with the tested fact that the use of psychiatric category labels led to complete unreliability. Clinicians who used the same label had random referents ,so clinical communication was largely noise. However ,this was not true for symptom and disability labels where inter-rater reliability was high. It became apparent that unrecognized criterion
variance was the basis for communication failure.
Therefore ,our task was to help clinical communication. Our response was to suggest that syndromal categories required specified inclusion and exclusion criteria . Further,minimum sets of symptomatic and sign manifestations that supported polythetic categories were suggested. The text emphasized that these definitions were not cast in stone and that clinical modifications may be justified.
We were careful to avoid any implied impact on therapeutic practice or any implication that these syndromes were homogeneous or due to a uniform cause as was hoped for with regard to disease. This disease definition was affirmed by certain disorders found due to objective studies of bacterial infection,endocrinological disorders,avitaminoses ,etc . However psychiatry was not that advanced,then or now.
Unfortunately,the text which specified our syndromal approach was largely ignored and the symptomatic criteria were treated as revelations from on high. However please read the text.
Our partially successful goal ,tested by arguable field trials, was that when one clinician said patient X has syndrome Y ,another clinician had a pretty good idea of what Y meant ,rather than making it up. We did eschew theoretical explanations since there were all too many and they couldn’t be all correct. At this point we would have preferred evidence (almost non-existent ) but could at least clarify clinical consensus.
Note that DSM111 had a phenomenal,unexpected success despite its reality limited goals .
Many will note that the above historical discussion is hardly new and has been stated before. Unfortunately ,the preceding discussions about DSM111 malevolent influences re therapeutics,etc., are excellent evidence that my boring affirmations have not penetrated. So I feel obliged to repeat. Maybe ,the correct inference is such an effort is doomed .
I am in agreement with Donald Klein that DSM-III was not motivated by any hidden agenda to hijack therapeutics in the direction of Pharma. Those were more innocent days. In the wake of DSM-III, Pharma just did what they were programmed to do – creative marketing. An unintended consequence of DSM-III was that its provisional syndromal definitions became set as orthodoxy, closely followed by structured interviews that exerted a tickbox type of methodologic imperialism in research studies. Robert Spitzer liked to say that the DSM-III syndromal definitions were just hypotheses to be tested but that perspective was quickly lost, as Don Klein affirms. For that to happen there was a de facto alliance of the American Psychiatric Association with the National Institute of Mental Health and academic institutions across the board. It came down to a tension between reliability on the one hand and validity on the other. Essentially, that is the same tension Dr. Mickey has just discussed here between EBM and clinical judgment. We need both.
Oddly enough I am neutral on this subject but for a different reason. I think a black box warning has an odd side effect…to cause clinicians to ignore other side effects because they presumably aren’t as important. If you’re going to give the drug, you should know all the effects and not just the highlighted ones. We could black box serotonin syndrome too but we don’t.
I was careful to say, “Back in 1980, the people who brought the DSM-III revolution in psychiatry to my own neck of the woods saw themselves as the prophets of evidence-based medicine“, but apparently not careful enough. I said it that way to recognize that my own experience during that time did not reflect the intent of the DSM-III framers, nor even the experience at other places.. But it sure is what happened at Emory University, even before the arrival of Dr. Nemeroff.
And I’ve accepted that the DSM-III was not PHARMA-driven, though again, in my neck of the woods, they arrived together. Back then, my only strong complaint about the DSM-III was the same as it is today – the creation of Major Depressive Disorder.
A year or so ago, I spoke to a high-up psychiatrist-administrator at UCSF Psychiatry. I mentioned black box warnings on drugs. She dismissed them out of hand, saying, in effect, that the FDA put them on drugs to demonstrate its authority, and they had no bearing at all on clinical practice.
Such is taught at one of the premier medical schools in the US.
Giovanni Fava (brother of Maurizio Fava) has published many papers on flaws in psychiatric practice that bear reading. He is one of the few concerned with long-term effects of psychiatric drugs and withdrawal difficulties.
In other news, you may have seen this on PBS Newhour a few nights ago http://www.pbs.org/newshour/bb/one-doctor-prescribing-data-improve-healthcare/ — a physician initiative to publish numbers-needed-to-treat of various drugs and treatments: http://www.thennt.com/
The FDA is a perfect example of decision making without the benefit of clinical judgment. All you need to know about the FDA is their stupidity in shutting down 23andme because they feared women would just run out and get unnecessary mastectomies.
Just to set the record straight, I know quite a few colleagues at UCSF department of psychiatry, and none of them teach what Alto just claimed. For that matter, we don’t know how accurate is Alto’s processing of her conversation with “a high-up psychiatrist-administrator at UCSF Psychiatry.”
NNT/ NNH is a simple calculation that all physicians should know how to calculate (1/control rate-experimental rate) and should calculate for any study they encounter that presents 2 group out come data such as placebo controlled trials. All one needs to calculate is the calculator on their smart phone, no fancy statistics or math. We insist that our trainees calculate and present this number for positive outcomes and major side effects for any such paper presented in our evidence based medicine classes.