done nothing wrong…

Posted on Tuesday 10 March 2015

In the case of Dan Markingson at the University of Minnesots, you might recall that in spite of the university senate voting to have that case investigated, the President ordered only an investigation of the research program "looking forward", not the case itself [too deep to ignore…]. I guess we thought that the University President had done a bit of sleight of hand yet again [almost inevitable…]. But, sometimes things are bad enough to over-ride any attempts at diversion. The report came in last week, and it was a scathing indictment:
SCIENCEINSIDER
by Jennifer Couzin-Frankel
March 2015

A damning report on how the University of Minnesota [UM] protects volunteers in its clinical trials concludes that researchers inadequately reviewed research studies across the university and need more training to better protect the most vulnerable subjects. It also found that a “climate of fear” existed in the Department of Psychiatry, where concerns about clinical trials first surfaced.

The 97-page report, released 27 February, was prepared by a group of six experts appointed by the Association for the Accreditation of Human Research Protection Programs. It comes after years of complaints by some UM faculty members, led by bioethicist Carl Elliott. They charged that the school and its doctors failed to protect 27-year-old Dan Markingson, who died by suicide while enrolled in a psychiatric drug trial in 2004. They also expressed grave concerns about how Markingson’s death was investigated. [More on that case is here and here.[

Recently, Elliott’s crusade began having an impact. In December 2013, the UM Faculty Senate called for an independent review of current practices in clinical trials. The administration agreed to open its records to outsiders. Although the review did not look back at history, it nonetheless had plenty to say about how the university handles trials, which bring in millions of dollars from drug companies along with much prestige.

“[T]he external review team believes the University has not taken an appropriately aggressive and informed approach to protecting subjects and regaining lost trust,” the authors write. They examined protocols from 20 active trials as well as minutes from meetings of the institutional review board [IRB]. Many IRB members, the panel noted, did not regularly attend meetings from January to July 2014. “[T]here were no individuals on the IRB during this time period with expertise in adult hematology, oncology and transplant, cardiology, surgery, or neurology, although those fields taken together represented over 300 protocols. There was only one psychiatrist on the IRB, despite the fact that the Psychiatry Department submitted 85 protocols for review during the time period examined.” That doctor attended only four of the 26 medical IRB meetings at which new protocols were reviewed. “This departure not only contravenes the University’s own policy of having at least one member with ‘primary professional expertise in a scientific field relevant to the type of research reviewed by that panel,’ but also prompts concern about the quality of review.”

Fueling those concerns, the authors noted that the IRB spent an average of 3 to 5 minutes discussing each protocol, and there was “little discussion of the risks and benefits to subjects.” Most of the protocol changes the IRB asked researchers to make addressed administrative issues such as misspellings or adding standard language to a consent form. Requests by researchers running trials to modify who was eligible for a study—“changes that may increase or decrease risks to subjects—were almost always approved without any documentation of related discussion,” the authors write. “The review process, as documented in the minutes, does not reflect a meaningful discussion of the risks and benefits of research protocols and the necessary steps taken to protect human subjects in the face of scientific or ethical concerns”…
Surely ethics refers to more than a code of conduct, or the rules of right and wrong, or even the letter of the law. It comes from the word ethos, the culture of a place, and should offer a compass for navigating situations where there are no standing rules or precedents – something more felt than transcribed, something conveyed by example rather than memoranda or training manual. And when I’ve read about this case, their response has always been, "We did nothing wrong," but my mind always inserts, "And you didn’t do anything right either." I thought the external reviewers were most at the center when they said this about the ethos they encountered in their investigation:
In interviews, some University personnel described considerable “fatigue” related to what they considered unrelenting and unjustified criticism of the University’s human subjects protection program. In contrast, others expressed bewilderment and frustration that, in their view, the University has failed to understand and remedy problems stemming from and related to “Markingson.” Most striking was the commonly conveyed sense of doubt in leadership’s commitment to human subjects protection. The widespread characterization of a few researchers in the Department of Psychiatry as “untrustworthy” and as creating a “culture of fear” in relation to efforts to enhance the protection of research subjects was of major concern to the external review team.
Dan’s hospitalization was from 2003 to 2004. Around the same time, Allen Jones happened onto TMAP and blew a whistle. Jon Juriedini in Australia first wrote the JAACAP about Paxil Study 329 in 2003. Charlie Nemeroff got busted for the first instance of his unacknowledged COI around that time. These instances turned out to be the tip of an iceberg. It was as if the traditional medical ethics had been invaded by the ethos of commerce, that patients had become subjects to be recruited for clinical trials designed to sell drugs, and marketing had become the strong undertow that was pulling everything out to sea.

While Bioethicist Carl Elliot has lead the struggle to get action on the Markingson case, he hasn’t been alone. His colleague, Leigh Turner, has also been involved, and spoke up in the faculty meeting Friday where this report was released [see Research methods under fire]:
We’re acting as though this report is news, but in fact there’s been several years where concerns have been brought forward in very detailed, concrete ways,” he said at the meeting. Turner said University leadership hasn’t adequately responded to problems he says have been happening within the program for years, and he questioned University President Eric Kaler’s commitment to repair the program’s current state.
Even that sounds like an understatement. University President Eric Kaler, Psychiatry Chairman Charles Schulz, and researcher Stephen Olson have obstructed previous efforts for over a decade, sticking with the "done nothing wrong" refrain.

"We did nothing wrong" is a legal standard – the standard by which we define criminal behavior in a free society based on the rule of law. An ethical standard is different. For one thing, in medicine, it is impossible to do "nothing wrong." But beyond that, an ethical standard has to do with maintaining an ethos, a culture. In a Clinical Trial of a new medication, it’s incumbent on the trialist to be vigilant that the subject’s health and medical care is not compromised by participation.

In the case of Dan Markingson and the University of Minnesota, that ethos was betrayed down the line by …
  • the design and purpose of the C.A.F.E. study
  • the oversight function of the Institutional Review Board
  • the recruitment and inclusion of Dan Markingson
  • his ongoing psychiatric care
  • the subsequent responses of Institution
While we can never know how Dan might have fared had he been treated outside the Clinical Trial environment, we can easily see that the ethical imperatives that even allow these Clinical Trials were globally deficient in the case. And it’s equally apparent that the officials of the Institution in charge show little understanding of their ethical obligations, even when repeatedly reminded by the faculty of their own Department of Bioethics.

Carl Elliot, Leigh Turner, Mike Howard, and Dan’s mother, Mary Weis, have done something remarkable. They’ve moved rhetorical deliberations about medical ethics out if the ivory towers of academia; breathed a new life into them with this paradigmatic real world case; and taken their campaign to the streets. Likewise, the external reviewers appointed by the the Association for the Accreditation of Human Research Protection Programs who were given only a restricted scope of inquiry [too deep to ignore…, almost inevitable…, a paradigm…] were still able to identify fundamental deficiencies in the Clinical Trial Program at the University of Minnesota, even after a decade of opportunity to make needed changes since Markingson’s death. Elliot’s team and these reviewers have obviously "done something right."

But there’s much that remains. This is a local victory, but it addresses problems we all know have a much broader scope. So will this instance lead to a general investigation of the Institutional Review Board system to insure it provides functional oversight rather than simply signing off? Is there a mechanism to shut down Clinical Research programs that don’t create an appropriate ethos with the ethical imperatives that protect the subjects under study? And there’s one topic that isn’t even touched here: Should we even allow Clinical Trials that are undertaken for commercial purposes [like C.A.F.E.] that have no real medical/scientific value [experimercials]? While we can stand in awe of the energy it has taken for Carl Elliot’s group to get this far, there are going to have to be a lot more people devoted to "doing something right" to generalize their campaign…

Mickey @ 1:14 PM

a crying shame…

Posted on Sunday 8 March 2015

I was pleased to get responses to that old feeling… and impossibility…. In the end, Medicine and Psychiatry are clinical sciences and these are the kinds of topics we need to hear about and pass on – a withdrawal syndrome and a not so benign treatment. This morning, this was in my email in-box, and the bold, underlined title of this Free CME [Continuing Medical Education] credited activity, Adherence, Recovery, and the Role of LAIs in Schizophrenia caught my eye. I’ve learned that the most important thing on the page is usually the smallest, but it didn’t bring anything to mind:
It wasn’t that hard to figure it out. A year ago, the FDA approved Abilify Maintena®, a Long Acting Injectable [LAI] version of Aripiprazole [see here] [speaking of small print, "Otsuka" is at the very bottom of the page]. The study leading up to FDA approval is pretty much as expected for an industry-funded Clinical Trial [Otsuka]:
by Fleischhacker WW, Sanchez R, Perry PP, Jin N, Peters-Strickland T, Johnson BR, Baker RA, Eramo A, McQuade RD, Carson WH, Walling D, and Kane JM.
British Journal of Psychiatry. 2014 205[2]:135-44.
[clinicaltrials.gov: NCT00706654][with results]
They took patients stabilized on oral Abilify® and then divided them into three group: Oral Abilify®, Abilify Maintena® therapeutic dose, and Abilify Maintena® homeopathic dose. Abilify Maintena® was non-inferior to [the same as] Oral Abilify®:

The authors in red are either heavily industry-funded by or employees of Otsuka, The Study Director was Otsuka employee, Raymond Sanchez. There were 98 clinical trial sites, and an army of editorial assistants and consultants suggesting that it was ghost-written and ghost-analyzed. The senior listed author, John Kane, is in charge of the influential ACA funded NIMH RAISE study of the treatment of First Episode Schizophrenia. This study analysis seemed legit to me.

Except for the fact that the industry credits scrolled by like at the end of a Hollywood Blockbuster, and I kind of wonder why the industries were mostly for-hire or why they even bother to list academic authors as anything other than ticket holders for admission to an academic journal, my point really isn’t about Abilify Maintena® or even Long Acting Injectable antipsychotics. It’s about advertisement and conflicts of interest. Continuing Medical Education was made a requirement for licensure in my medical lifetime. The intent was to insure that as doctors age, they are kept abreast of the rapidly changing medical/scientific landscape. And our peer reviewed medical journals perform the same function. Traditionally, individual physicians paid for both – CME presentations and our Journals. But sometimes they are free

So last time, we had an LAI paper from an author at the Rand Corporation on the Janssen payroll [impossibility…]. Now comes a Free CME that was "supported by an independent educational grant from Otsuka America Pharmaceuticals, Inc", who happen to have a new LAI on the market [Abilify Maintena®], approved by the FDA based on an industry study with senior author John Kane, who happens to be funded himself by Otsuka, who happens to direct an NIMH Project treating Schizophrenia being picked up already by SAMHSA’s Block Grant program, who happens to write about the drugs used to treat Schizophrenia, and who was skeptical about Tardive Dyskinesia as far back as 1982.

So we wonder who is on the faculty of this Free CME?  So I clicked on the link to Adherence, Recovery, and the Role of LAIs in Schizophrenia:
Faculty
  • Christoph U. Correll, MD
    Professor of Psychiatry and Molecular Medicine
    Hofstra North Shore – LIJ School of Medicine
    Medical Director of Recognition and Prevention (RAP) Program
    The Zucker Hillside Hospital
    Glen Oaks, NY
  • John M. Kane, MD
    Professor of Psychiatry
    Hofstra North Shore – LIJ Health System School of Medicine
    Vice President
    Behavioral Health Services of the North Shore – LIJ Health System
    Chairman of Department of Psychiatry and Chief of Staff
    The Zucker Hillside Hospital
    Glen Oaks, New York
  • John Lauriello, MD
    Chancellor’s Chair of Excellence in Psychiatry
    Executive Medical Director of the Missouri Psychiatric Center
    School of Medicine, University of Missouri Health System
    Columbia, MO

Take a look at the Learning Objective and guess what you’re going to learn – for free. Oh by the way, John Lauriello, MD is the senior author of a glowing handout review of Abilify Maintena®.

Every "i" is dotted. Every "t" is crossed. All the way down the line. But when there’s a COI trail like this, we really can’t believe a word of it. Simply acknowledging COI doesn’t change the conflict one iota. It just makes people more bullet-proof and feel less guilty. It’s a crying shame. And shame is exactly what people who don’t keep things clean ought to feel…
Mickey @ 2:02 PM

impossibility…

Posted on Saturday 7 March 2015

As the comments rolled in on the post about the British Psychological Society‘s Report [back to the drawing board…], my mind was wandering. I was thinking about how similar the topics of contention sounded to the ones I heard 40 years ago when I arrived.  Then I clicked on PsychiatricNews, and this article [from the RAND Corporation] jumped up at me:
PsychiatricNews
by Vabren Watts,
March 3, 2015
&
Psychiatric Services in Advance:
Economic Grand Rounds
by Zachary S. Predmore, Soeren Mattke,, Marcela Horvitz-Lennon
January 2, 2015

Absract: This column presents findings of an analysis conducted to quantify the potential net savings to state budgets from interventions to improve adherence to antipsychotic drugs among patients with schizophrenia. Using a financial model based on published data, the authors estimated costs of direct medical care and criminal justice system involvement at state and national levels and validated it against findings from other cost studies. The model estimated an annual cost of $21.4 billion [in 2013 dollars] to Medicaid programs and other state agencies for people with schizophrenia. On the basis of data on the effect on outcomes of increased medication adherence, better adherence could yield annual net savings of $3.28 billion to states or $1,580 per patient per year. Innovations to improve adherence to antipsychotic drugs among schizophrenia patients can yield substantial savings in state budgets. States should consider interventions shown to increase medication adherence in this patient group.
[A Deinstitutionalization Timeline]. In the 1970s, as psychiatry residents, we still heard lofty lectures from administrative types about deinstitutionalization as a great triumph, and in some ways it was. But the part we saw didn’t look that way.   It was called the revolving door – chronic patients in the cycle of psychotic episode ···» hospitalization ···» stopping medication ···» another psychotic episode ···» another hospitalization ···»

… and around and around it went. They were closing a huge hotel. In Georgia, it was Central State Hospital AKA Milledgeville with 12,000 patients, with no place in the community that could absorb its occupants, particularly when psychotic. And so we heard a lot about medication compliance and depot medications. These mostly non-medical planners talked like psychotic illness is a medication deficiency syndrome. So, here we go again – as in "interventions shown to increase medication adherence":
Research has shown that several interventions improve antipsychotic adherence among persons with schizophrenia. Some of these studies have also provided direct evidence of the cost-effectiveness of these interventions. A recent study of patients with schizophrenia in the United Kingdom demonstrated that even small financial incentives [less than $25 per patient per month] increased adherence to antipsychotic medications from a baseline of 69% to 85%…

Replacing traditional oral therapy with long-acting injectable [LAI] antipsychotics has been shown to increase adherence… Thus using generic LAI antipsychotics could save more than $1,000 per patient per year…

Medication management programs, such as counseling by pharmacists or advanced practice nurses, are another potential method for increasing adherence. Two specific medication management programs — cognitive adaptive training, which attempts to change patients ’ behavior by modifying their home environment through use of signs, alarms, and checklists, and electronic medication monitoring, a computerized system that reminds patients to take their medications and tracks adherence — have also been shown to increase adherence to antipsychotics among patients with schizophrenia to 92%, compared with 73% adherence in the group that received treatment as usual…
Were I a patient reading that, I would likely be offended, maybe even wounded. "You think we stop medications in droves because we’re dumb, or forgetful? Why don’t you try taking it all the time!" And if you read the APA guidelines [1], medication adherence is in the background of many of the recommendations. And the IRT training Manual [3] for the NIMH/SAMHSA RAISE program spends no small amount of time trying to encourage medication adherence as in cooperation with treatment as in relapse prevention:
  1. Guideline Watch [APA  2009]
  2. and from the NIMH RAISE Project [now adopted by SAMHSA]
And what about Tardive Dyskinesia? This from the European Schizophrenia Study of over 7000 patients on medications for three years:
And so it has gone throughout history – the problem of Schizophrenia, of the psychotic states. Everyone has a solution for the part of the problem they are involved with themselves, and wants to overlook the other side of the coin. In this case, the RAND group is looking at the cost of recidivism to the State budgets [a very real problem], suggesting a policy that the mental health advocates will surely oppose [with very real examples of negative consequences]. And if you think about it, paying sick people to take medicine does have a bizarre ring to it. In this Rand example, the proposed solution is for society, not necessarily a given patient.

In my view, these are problems that have no general solution at present. If I hadn’t been a Straw Man in these discussions so frequently [I should say Straw Psychiatrist], I could work up a real dander about this report/recommendation. Instead, I’ve developed a hobby to occupy myself during debates of this kind – some way to silence my mind [and mouth] to keep me out of a dead-end discussion. I think about the impossibility of the problem as framed [I think that’s called being a contrarian if you say it out loud], or about why trying to answer it is a double bind. And I particularly try to think about the cases being brought up as exceptions as people wax eloquently pro and con. I tell myself that such reflections remind me of the essential impossibility of psychotic experience and illness; they remind me that the only real solutions come on a case by case basis and they are tentative; and thinking privately keeps me out of run-on arguments that I don’t want to be in. But sometimes, I find an opinion in there that seems right to me. This may be one of those times. This scheme has been tried, and it just didn’t work…

And I worry about this – a lot…
Dr. Mattke has received speaker fees and travel support from Janssen Diagnostics. The other authors report no financial relationships with commercial interests.
Janssen makes RISPERDAL® CONSTA and now INVEGA® SUSTENNA® – leading LAIs…
Mickey @ 2:31 PM

that old feeling…

Posted on Tuesday 3 March 2015

by Giovanni A. Fava, Alessia Gatti, Carlotta Belaise, Jenny Guidi, and Emanuela Offidani
Psychotherapy and Psychosomatics. 2015 84:72-81.

Background: Selective serotonin reuptake inhibitors [SSRI] are widely used in medical practice. They have been associated with a broad range of symptoms, whose clinical meaning has not been fully appreciated.
Methods: The PRISMA guidelines were followed to conduct a systematic review of the literature. Titles, abstracts, and topics were searched using the following terms: ‘withdrawal symptoms’ OR ‘withdrawal syndrome’ OR ‘discontinuation syndrome’ OR ‘discontinuation symptoms’, AND ‘SSRI’ OR ‘serotonin’ OR ‘anti- depressant’ OR ‘paroxetine’ OR ‘fluoxetine’ OR ‘sertraline’ OR ‘fluvoxamine’ OR ‘citalopram’ OR ‘escitalopram’. The electronic research literature databases included CINAHL, the Cochrane Library, PubMed and Web-of-Science from inception of each database to July 2014.
Results: There were 15 randomized controlled studies, 4 open trials, 4 retrospective investigations, and 38 case reports. The prevalence of the syndrome was variable, and its estimation was hindered by a lack of case identification in many studies. Symptoms typically occur within a few days from drug discontinuation and last a few weeks, also with gradual tapering. However, many variations are possible, including late onset and/or longer persistence of disturbances. Symptoms may be easily misidentified as signs of impending relapse.
Conclusions: Clinicians need to add SSRI to the list of drugs potentially inducing withdrawal symptoms upon discontinuation, together with benzodiazepines, barbiturates, and other psychotropic drugs. The term ‘discontinuation syndrome’ that is currently used minimizes the potential vulnerabilities induced by SSRI and should be replaced by ‘withdrawal syndrome’.
While Fava et al sure seem to have scoured the literature, considering the incidence, there wasn’t nearly as much data as I would’ve thought. They say themselves:
In the past decade, few studies assessed the presence of discontinuation symptoms, and the topic has attracted limited attention also as to literature reviews. To the best of our knowledge, in the English language there has been no systematic review on the clinical aspects of SSRI discontinuation according to established criteria. Yet, such knowledge is important because of the wide-spread use of SSRI in medical practice.
The supplementary material is all available on-line in tables in a Microsoft Word file.

As a psychiatry resident [1974-1978], my references for psychiatric drugs were textbooks, under an inch thick. They’re still around with the kind of underlining that you look back on and wonder what you thought you were doing. Almost everything ended up underlined or high lighted – like you could vacuum up the information with a yellow felt pen. But my point is that I don’t recall the drugs changing at some rate that required constant updating. There were the MAOIs and the TCAs [Monamine Oxidase Inhibitors and the Tricyclic Antidepressants]. They were laid out in neat tables with various columns of characteristics, describing how they differed. They were primarily inpatient drugs, used primarily on patients with the various melancholic depressions, but not so much for outpatients. We all knew the side effects because the patients told us about them all the time. While I never saw a fatality, we all worried about overdoses because a month’s supply prescription could be a fatal dose. I remember a rule of sorts – if a patient responded to an antidepressant, they should continue for at least six months because patients who stopped sooner had an increased incidence of relapse. But my point is that these weren’t long term drugs because depression wasn’t considered a long term problem and the everyday side effects – things like dry mouth and constipation were gladly left behind.

When the DSM-III and the SSRIs came along, things were different. Depression became a Disorder, Major Depressive Disorder, and the treatment became the antidepressant drugs that flowed from the pipeline. They were better tolerated and the old short-term rules just sort of evaporated. People stayed on them for long periods and thought of them as treating some kind of disease they had. Many seemed to think of them as keeping the disease at bay, and were afraid that if they stopped, it would come back. If they got depressed again, they said "my antidepressant has stopped working." I missed most of that, and a lot of what I learned about those drugs was from patients talking about their experiences. And there was a pattern. First there would be a "occasionally" symptom like decreased libido with Prozac®. Then it was "sometimes", then "often." I learned about withdrawal from a friend’s wife who had a hell of a time getting off of Paxil®. At first, I thought it was a Paxil® thing, but then I heard about it with other drugs. And so it went, learning from patients before it came from the traditional sources like journals. I actually learned most of what I know about SSRI withdrawal here from the comments of Altostrata and her Surviving ADs site – things like the withdrawal symptoms being interpreted as the "depression is coming back" or always tapering with discontinuation rather than stopping abruptly. That information is available now, but not "back in the day."

In this study by Fava et al, I kind of wish they had added OR ‘venlafaxine’ OR ‘duloxetine’ OR ‘desvenlafaxine’ OR ‘vilazodone’ to their search string of ‘withdrawal symptoms’ OR ‘withdrawal syndrome’ OR ‘discontinuation syndrome’ OR ‘discontinuation symptoms’, AND ‘SSRI’ OR ‘serotonin’ OR ‘anti- depressant’ OR ‘paroxetine’ OR ‘fluoxetine’ OR ‘sertraline’ OR ‘fluvoxamine’ OR ‘citalopram’ OR ‘escitalopram’. The drug I’ve seen the most withdrawal problems with is Effexor® [venlafaxine]. I have recently seen a particular patient who is on 350 mg of EffexorXR® daily [big dose], and is unwilling to even try to come down again, or try any maneuver like changing over to something else to then come down. Both she and her husband agree – she’s on it for life because she gets "so damn sick" with any attempt to lower the dose. That’s apparently not uncommon. I’ve sent her to Alto’s site, given her articles, but she’s not going to budge, at least not yet. The look on her face says volumes about the discomfort of withdrawal. I haven’t any idea what that dose of EffexorXR® for life will do, and worry about that. But for the moment, she’s very clear about what she’s going to do – stay on it.
An Editorial
by Guy Chouinard and Virginie-Anne Chouinard
Psychotherapy and Psychosomatics. 2015 84:63–71.

Conclusion: SSRIs have provided major therapy advancement in the treatment of depression and other mental disorders. Withdrawal symptoms may occur with SSRIs, similarly to other CNS drugs, and they must be identified and differentiated from relapse and recurrence of the original illness. The proposed diagnostic criteria will permit the identification of three types of withdrawal associated with SSRIs. Differentiating withdrawal from relapse and recurrence of the original illness will allow clinicians to more effectively reduce and withdraw SSRIs, and find a minimal therapeutic dose. It is most important to recognize persistent post·withdrawal disorders to prevent unnecessarily high doses and prolonged treatment.
In this same issue, there’s this editorial that proposes a classification of withdrawal syndromes based on Fava et al’s data. Since it’s available, I’ll just mention it. It’s pretty straightforward.

This paper set me to thinking about something. It’s a report of something I need to know about, but it’s 25+ years after I needed to know about it. The first article on withdrawal listed in Fava et al’s supplementary material is in 1988, around the time Prozac® was introduced, and there are number in the 1990s. But I didn’t learn about it through medical channels. As an old man, I have the time to root around about things, but I sure didn’t in 1988. And yet, in my first career [Medicine] and early in the second [Psychiatry] I just knew about things. I didn’t think about "keeping up." I just read my journals, went to meetings and conferences, and lived in a world populated by colleagues and patients. There was always a library around for looking up things I had questions about. I never much liked CME [Continuing Medical Education], so I picked things "of interest" rather than review courses. My point is that I didn’t think about "keeping up." Medical life just "kept me up." That seems to have changed in the 1980s. I wish I’d been perceptive enough to notice it happening. I’d always read review articles, but I no longer found them very interesting. Too upbeat. Too pie in the sky. Too future oriented. I don’t recall ever thinking about why, but I just gradually stopped that kind of general journal reading and read books of interest.

I would now say it was a reaction to the fact that the medical literature had been invaded by industry – there was a new, unseen player at the table. But I didn’t pick that up until much later – after I retired. When I read this article, I had "that old feeling" from before – some doctors passing along something they knew about to those who might not know it yet. I guess I think of it as a pipeline of information that had always been there, something I never really thought about until it changed. I’ve missed it…
Mickey @ 5:17 PM

back to the drawing board…

Posted on Monday 2 March 2015

Note: This post isn’t like most of my others. I’m not in the habit of simply saying what I think without documentation, or in areas this far outside of my area of expertise. But I’ve got a really strong feeling here. Take it for what it’s worth – just a strongly felt, definitively stated, but nonetheless speculative feeling… Maybe it’s a polemic too – my polemic… I titled and ended the last post <to be continued>… not just because I was going to have more to say on the topic, but because it’s the only thing I’m absolutely sure of – that this debate will keep on and on just like it has since the dawn of 1boringoldman time [in psychiatry] and for that matter, before…

    po·lem·ic
    noun
    1. A controversial argument, especially one refuting or attacking a specific opinion or doctrine.
    2. A person engaged in or inclined to controversy, argument, or refutation.
    A polemic is a contentious argument that is intended to affirm a specific understanding via attacks on a contrary position. Polemics are mostly seen in arguments about very controversial topics. The art or practice of such argumentation is called polemics… The word is derived from Greek polemikos, meaning "warlike, hostile", from polemos, meaning "war".
The BPS report is a polemic ["a contentious argument that is intended to affirm a specific understanding via attacks on a contrary position"]. It’s built on the failures and weaknesses of the current system, a system assumed to be created by psychiatry and psychiatrists, and proposing to reverse that approach as a way to solve its problems. I’m not going to go line by line through the British Psychological Society’s [BPS], Understanding Psychosis and Schizophrenia. It has already been well discussed by others who have done an excellent job of parsing it. I’d recommend reading:

on medications

I obviously agree with them about the paternalism of many psychiatrists [which side of the street?…]. And in reading through the official psychiatric positions [which I recommend doing]..
  1. Guideline Watch [APA  2009]
  2. and from the NIMH RAISE Project [now adopted by SAMHSA]
… it’s obvious that the main thrust of the recommendations is an attempt to keep patients on maintenance medications to prevent relapse as a primary goal. But we should note that Dr. Jeffrey Lieberman who was vice chair of the committee that produced the APA guidelines was at the same time the Principle Investigator of a major NIMH study [CATIE], that definitively showed that the patients didn’t agree, and didn’t stay on the medications:
Every compliance study I know of shows the same thing – differing only in the rate of discontinuation [and leave it at that…]. So while the contention of the British Psychological Society and Robert Whitaker’s Mad in America group that the official channels of psychiatry recommend ongoing maintenance medication as a first-line treatment is correct, it just doesn’t happen. Here’s a long term VA study of 2138 patients:
Medication compliance is already in the hands of the patients in the vast majority of cases. So the medication approach recommended by the BPS report is likely to make little to no change as it’s already in place. I would add to that my own anecdotal report on a small sample. I had more cases than most in psychotherapy and was pleased with the outcome. They were like the cases quoted here, "good prognosis" cases. I started with the belief that medication was only needed for acute episodes, but with experience, I changed my tune because relapses were so disruptive, discouraging, and expensive. I went from constant worry about relapse to less worry about relapse but constant worry about harms. As with any toxic medication, there’s only worry. The decision to use maintenance medication with holidays was, by definition, collaborative. The decision to stop medication down the road was always in the patient’s hands and they usually knew when to give it a shot. Again, I’m talking about a small number of patients with everything excepting this affliction in their favor – on the right end of the spectrum.

on the medical model and diagnosis

In storm duties… I talked about the bio·psycho·social model suggested by George Engel that, in my opinion, was never really implemented. It’s my "medical model" of choice. I would agree with the BPS that diagnosis can be stigmatizing and either used or experienced as an indictment. It can and has been used to imply an etiology when, in fact, none is known. And people can be misdiagnosed. Even worse, the categorical criteria can be intrinsically flawed [as they definitely are in the DSM-III+ with depression]. Those are all bad things to avoid or even preach against on any available pulpit. But the BPS report suggests that for those reasons, we should abandon categorization altogether, any model that underlies that categorization with it, and goes on to argue that the category doesn’t really exist, but simply represents phenomena along a spectrum with normal mental life.

I have no great love for the DSM-III+, but in this case, I think they did a decent job. First, the diagnosis was initially the gloomy Dementia Praecox popularized by Emil Kraepelin in 1893. In 1911, Eugen Bleuler re-evaluated the syndrome and coined the term Schizophrenia. He described a broad spectrum of people, presentations, and outcomes including complete recovery following a psychotic episode. With Bleuler, diagnosis was not destiny. In the 1980 DSM-III, they separated out Brief Reactive Psychosis and added duration and functional impairment to make sure that the diagnosis didn’t rest on symptoms alone, though they didn’t name a pathognomonic symptom [a symptom that is unique to a syndrome that nails the diagnosis]. I happen to think there is one – the complex described as negative symptoms [though they are inadequately described in the DSMs]. I’ve not seen a case where I was able to explore the history in depth and the negative symptoms weren’t present in some form or another long before the outbreak of frank psychosis [I’m including kids I grew up with and kids of my friends who later developed the classic disorder].

While that may seem an idiosyncratic idea, I’m mentioning it because it has implications. Antipsychotic medications do nothing for negative symptoms, and may make them even more pronounced, particularly in high doses. That could explain the reason so many discontinue medication – it doesn’t help them where they hurt. And it’s in the area of negative symptoms where those who recover are able to improve, either on their own or with help. But here’s what the APA guidelines say:
Treatment of negative symptoms begins with assessing the patient for syndromes that can cause the appearance of secondary negative symptoms. The treatment of such secondary negative symptoms consists of treating their cause, e.g., antipsychotics for primary positive symptoms, antidepressants for depression, anxiolytics for anxiety disorders, or antiparkinsonian agents or antipsychotic dose reduction for extrapyramidal side effects. If negative symptoms persist, they are presumed to be primary negative symptoms of the deficit state. There are no treatments with proven efficacy for primary negative symptoms.
And then this from the BPS Report:
At times, some people may appear inexpressive, withdrawn, listless, apathetic or unmotivated. They may find it difficult even to find the energy to prepare food or generally to look after themselves. Traditionally these difficulties have been thought of as ‘negative symptoms’: part of an illness. However, they can often be a result of feeling overwhelmed by experiences and trying to cope, or arise from feelings of helplessness and depression. They can also be unwanted effects of the drugs that people are often prescribed
So negative symptoms are either an untreatable indictment ["primary negative symptoms of the deficit state"] or not even there at all – just an illusion or artifact of other processes. Among the many "normalizing" assertions in the report, this one stands out to me as frivolous and potentially counter-productive or even harmful – as harmful as the gloomy APA interpretation. Whether one thinks as I do that the negative symptoms are the primary problem, or have some other way of understanding them, simply whisking them away is an abandoning intervention.

Speaking of the dawn of 1boringoldman time, on the first day I was a psychiatry resident, I was assigned several patients who were already on the acute ward where we worked. The first one I met was a twenty something year old mother of three who had been brought to the hospital after drowning one of her sons to death in the lake in Atlanta’s central park. She had been stopped by bystanders during her attempt to drown the second one, directed to do so by the voice of God. By the time I met her, she had been declared NGRI [not guilty by reason of insanity] and was awaiting definitive placement. She’d been there for a while, and was an obvious favorite of the nurses – a long-stay patient on a short-stay unit. One of the nurses took me aside and asked that I have my sessions with her at times other than between 3PM and 5PM when she watched the after-school children’s programs. The nurse called it "being with her kids" – something she had done with her children daily when they got home from school. The other patients intuitively complied and left the day room to her or sometimes even watched with her.

By the time I met Gloria, she was not psychotic. She would answer questions about what happened with her kids, but didn’t really engage the topic. Her family visited often, and they didn’t talk about her son’s death either. Like the nurses, there was always a tear nearly visible as their looks conveyed both the tragedy and their love. The thing that most struck me about her was her flattened affect and her literalness. She was on a low dose of a first generation neuroleptic which might’ve explained some of the emotional flattening, but I doubted that. It seemed like part of being her. We were taught in those days to assess abstracting ability by asking the meaning of proverbs. She had no idea what they meant. I’m not even sure she got the point of my asking. And her general literalness was pervasive in all conversaton – striking even to my then untrained ear. I awkwardly asked her mother about those things. I think I was wondering if the medication was responsible. But her mother knew exactly what I was asking and said something like, "Oh no, she’s always been like that! I only wish I’d known where it was headed!" And cried painful tears.

I didn’t know it then, but Gloria was the nidus for what I now think about this affliction. As dramatic and disruptive as the psychosis of Schizophrenia can be, I no longer think of it as primary, though it can certainly be an overwhelming and sometimes insurmountable problem. I see the baseline state as the primary affliction – what people call "negative symptoms" or Eugen Bleuler called "Anhedonia." It’s what I was trying to get at in birdman…. To Gloria’s literalness [living in a world without abstract meanings] and her difficulty experiencing or accessing an emotional compass, I would now add a confusion in reading and understanding the subtle but ubiquitous metacommunications in interpersonal experience. Those things contribute to the oft-expressed sense of non-being, of identity diffusion, of confusion, of deadness, or the many other ways people try to explain something that others rarely ever even think about because for them, it is intuitively present and operating automatically. I tried to talk about this in 1. from n equals one…, 2. from n equals one…, 3. from n equals one…, etc. with another example. I know that if a person showed up seeking psychotherapy with just those complaints without psychosis in the story, I’d still be likely to give it my best shot. Those things alone are heavy burdens to carry into a life, particularly a life among people.

I’m not trying to mount an antecdote war here, just trying to give an example. Effective psychotherapy requires a shared view of what the problem is, and is informed by the nature of the problem. Patients can learn how to identify, live with, compensate for, or even change what happens in these states of confusion if that’s the focus of the work. I’ve never seen a patient who came for a therapy who was hurt or demeaned by talking about negative symptoms [again the never word]. They already know about them – every day. And I worry that any approach that doesn’t take them on as a central focus will flounder much in the same way as relying only on medications does. In fact, some of the examples in their own report address these very problems and I was glad to see that. End of sermon.

on rights and laws

It’s not my area of expertise, but it sounds like Thomas Szasz redux to me. Their suggestions are likely to lead to the same thing that we already have in the US – Jails and Prisons filled with mental patients. Psychiatrists are no longer central the commitment process here and there’s no place to commit to, even if they were. It’s a judicial process and the only facilities available to Judges are Jails and Prisons. Maybe it’s different in the UK, but be careful what you ask for.

on etiology

Their traumatic theory is as speculative as some of the biological theories. I personally doubt its primacy, but how about some proof before NICE buys into the radical change in mental health policy suggested. Chasing trauma has had a powerful pull throughout history [and brought down some of the best of us], but only really worked in patients with clear PTSD as specifically defined. Having spent a career treating a lot of traumatic illness, I don’t personally think that Schizophrenia is primarily a post-traumatic syndrome – certainly not without some solid consistent evidence.

Note: All of that said, I’m the biggest supporter of an informed and focused psychotherapeutic approach to this illness affliction with the careful use of medications as you’ll ever find [in patients who will come]. But I’m afraid my read on this BPS Report is "back to the drawing board." It’s a polemic. Define what you have in mind in terms other than just not-what-those-psychiatrists-have-thought and set up a pilot project to prove it works. Be sure to take all comers…
Mickey @ 7:00 PM

<to be continued>…

Posted on Saturday 28 February 2015

It’s not easy to respond to the British Psychological Society’s [BPS], Understanding Psychosis and Schizophrenia, primarily because of the extensive use of negation throughout the report. In their discussion, the phenomena formerly called a symptom [like hearing voices] is not abnormal, but rather something seen in normal mental life. A negative symptom like anhedonia is not some primary aspect of a disease state but rather the result of being overwhelmed. There is not any underlying condition causing symptoms [the Szaszian formulation of the Myth of Mental Illness]. Medication is not treating some underlying pathology, but rather an optional adjunct some find helpful. Much of what is seen in these conditions is the result of being not understood or not listened to. In the etiologic dimension, the report suggests that these are people who have been traumatized by life experiences – not a flight into fantasy but a reaction to fact.

The points made in the report are certainly well known to all of us. Besides echoing the words of Thomas Szasz [who is nowhere mentioned in the report], it’s a position similar to the one expressed by Robert Whitaker in his books and by the bloggers on his web-site, Mad in America [Whitaker is referenced extensively in the report]. It also mirrors the ideas of the Recovery Movement and the Psychiatric Survivors Movement. The phrase coined in the report that seems to define the approach being generally advocated is "We need to replace paternalism with collaboration." In the section about recovery colleges, there’s a table contrasting these models as discussed in this report:

So the report recommends a list of fundamental changes in the systems of mental health care:
    Section 13: What mental health services need to do differently
       13.1 We need to move beyond the ‘medical model’
       13.2 We need to replace paternalism with collaboration
       13.3 We need to stop ‘prescribing’ and start supporting people to choose
       13.4 We need to make rights and expectations explicit
       13.5 We need to reduce the use of compulsion and mental health legislation
       13.6 We need to change the way we do research
       13.7 We need to change how mental health professionals are trained and supported

While I’m focusing on the overall thrust of the report, James Coyne of the PLoS blog, Mind the Brain, has addressed the content and I’d recommend looking at his take on the specifics of the report [“Understanding Psychosis and Schizophrenia” and mental health service users].

The report is so focused on negation of the medical approach of mainstream psychiatry that I’ve included some references for those who want to explore the official versions of that medical position further:
  1. Guideline Watch [APA  2009]
  2. and from the NIMH RAISE Project [now adopted by SAMHSA]
It’s highly unlikely that anyone reading this doesn’t already have strong feelings on one side or the other of the points raised in this report. And what’s striking to me is how little this particular debate has changed in the forty plus years since I first encountered it. Back then [the 1970s], the gulf was largely sorted by disciplines, much as it today. Somewhere, shortly after I arrived and started hearing this debate, I actually found myself in a library looking up the medical model of disease. In a way, that still strikes me as kind of humorous, in that I was at the time a fully trained internist with practice experience who knew nothing [yet] about mental illness. But I could tell that in those heated arguments of the day, the medical model of disease was a being seen as a bad thing. I was looking it up because I didn’t know what they were referring to. As you can see in the Section 13 table of contents above, those heated arguments are, if anything, even more heated today.

Just for clarification, there are two central medical models of disease. The one being referred to here holds that signs [things you see] and symptoms [things reported] are external manifestations of an internal cause [a disease]. Diagnosis is focused on locating the underlying cause [which is also the object of treatment, if possible]. Treatment of the symptoms themselves is a secondary focus. There are several corollaries. Aesculapian Authority refers to the traditional physician role – the assumption that the physician may recommend doing something painful or counterintuitive, but that recommendation has Therapeutic Intent and operates under the principle of Primum non nocere – "first, do no harm." Obviously, this BPS report questions the appropriateness of this model when applied to psychotic mental illness as well as the applicability of the corollaries.

The second central medical model of disease is the preventive model. How one implements the preventive model depends on what you see as the cause. In psychiatry, the preventive efforts have been on detecting a pre-psychosis marker. The BPS report has a different focus:
    Section 14: What we all need to do differently
    14.1 We need take on board that we’re all in this together – there is no ‘us’ and ‘them’
    14.2 We need to focus on prevention
       14.2.1 Prevention: towards a safer society
       14.2.2 Prevention: towards a more equal society
       14.2.3 Prevention: reducing discrimination and oppression
       14.2.4 Prevention: reducing harmful drug use and addressing its causes
       14.2.5 Prevention: what we can each do to protect our mental health
    14.3 We need to campaign against prejudice and discrimination
<to be continued>
Mickey @ 1:39 PM

storm duties…

Posted on Thursday 26 February 2015


Georgia Morning

A few years back, I made an attribution error [Adolf Meyer [1866-1950]…]. I credited Adolf Meyer, the influential early American Psychiatrist with the bio·psycho·social model. It was an easy error to make. Meyer’s model was psycho·biology and Meyer’s wife was a major founding figure in American Social Work. But looking back, it highlights how sometimes big things are happening all around you, but you’re too caught up in your own scene to see them:

George Engel [1913-1999] & Adolf Meyer [1866-1950]

The bio·psycho·social model was actually proposed by George Engel in 1977 in an article in Science – Mea Culpa:
by George L. Engel
Science. 1977 196[4286]:129-136.
The article opened with:
At a recent conference on psychiatric education, many psychiatrists seemed lo be saying to medicine, "Please take us back and we will never again deviate from the ‘medical model.’" For, as one critical psychiatrist put it, "Psychiatry has become a hodgepodge of unscientific opinions, assorted philosophies and ‘schools of thought,’ mixed metaphors, role diffusion, propaganda, and politicking for ‘mental health’ and other esoteric goals". In contrast, the rest of medicine appears neat and tidy. It has a firm base in the biological sciences, enormous technologic resources at its command, and a record of astonishing achievement in elucidating mechanisms of disease and devising new treatments. It would seem that psychiatry would do well to emulate its sister medical disciplines by finally embracing once and for all the medical model of disease.

But I do not accept such a premise. Rather, I contend that all medicine is in crisis and, further, that medicine’s crisis derives from the same basic fault as psychiatry’s, namely, adherence to a model of disease no longer adequate for the scientific tasks and social responsibilities of either medicine or psychiatry. The importance of how physicians conceptualize disease derives from how such concepts determine what are considered the proper boundaries of professional responsibility and how they influence attitudes toward and behavior with patients. Psychiatry’s crisis revolves around the question of whether the categories of human distress with which it is concerned are properly considered "disease" as currently conceptualized and whether exercise of the traditional authority of the physician is appropriate for their helping functions. Medicine’s crisis stems from the logical inference that since "disease" is defined in terms of somatic parameters, physicians need not be concerned with psychosocial issues which lie outside medicine’s responsibility and authority…
and ended with:
THE BIOPSYCHOSOCIAL MODEL AS A SCIENTIFIC MODEL
I hope the example of Mr. Glover, with all of its oversimplification, indicates how the working conceptual model used by the physician can influence the approach to patient care. The biopsychosociaJ model is a scientific model. So, too, was the biomedical model. But as Fabrega pointed out, by now it has become transformed into a folk model, actually the dominant folk model of the Western world. As such it has come to constitute a dogma. The hallmark of a scientific model is that it provides a framework within which the scientific method may be applied. The value of a scientific model is measured not by whether it is right or wrong but by how useful it is. It is modified or dis- carded when it no longer helps to generate and test new knowledge. Dogmas, in contrast, maintain their influence through authority and tradition. They resist change and hence tend to promote opposition and the promulgation of rival dogmas by dissident figures. The counter dogmas being put forth these days in opposi- tion to biomedical dogma are called "holistic" and "humanistic" medicine. They qualify as dogmas to the extent that they eschew the scientific method and lean instead on faith and belief systems handed down from remote and obscure or charismatic authority figures. They tend to place science and humanism in opposition. But as the history of the biomedical model itself has shown, progress is made only where the scientific method is applied. The triumphs of the biomedical model all have been in the areas for which the model has provided a suitable framework for scientific study. The biopsychosocial model extends that framework to heretofore neglected areas.
It was followed by this next article which was presented at the 1979 APA Convention and published in the American Journal of Psychiatry in the same month in 1980 that the DSM-III was presented and adopted at the APA Convention:
BY GEORGE L. ENGEL,, M.D.
American Journal of Psychiatry. 1980 137[5]:535-544.

Engel was actually a figure in my own life back in the day. I was an internist who had discovered that practicing medicine wasn’t quite like it had been in training. Following the patients from beginning to end, I quickly realized that there was more to doctoring than the science of disease I had learned, because the persona and the life of the patient had so much more to do with the treatment of patients than was apparent in the environment where I trained. I had learned about disease from the knowledge gained from groups united by diagnosis, but practicing medicine was with one patient at a time, and the one part was a lot bigger factor than I might have ever imagined. Engel was an internist who had become a major figure in psychiatry and psychosomatics. I had read his work and considered applying to psychiatry in Rochester where he was because he was there when I decided to add psychiatry to my skillset. But after spending three years in Europe as a soldier, I think I was ready to come home, and ended up in Atlanta where, unlike Rochester, today’s snow is considered a blizzard [‘southern born and southern bred‘ as they say]. I finished my psychiatry residency in 1977 and by 1979 & 1980, I was directing a residency, in Analytic training, and way too busy to know about the coming storm. I went to neither APA Convention [1979, 1980]. The young faculty like me stayed at home and kept the home fires burning.

So when Dr. Carroll said in his comment yesterday, "… we can agree about the historical failure consistently to implement the biopsychosocial model in the care of patients with schizophrenia", he wasn’t kidding. I really didn’t know that Engel had introduced that model during and as part of the controversies that swirled around in those days when the DSM-III was in the works. Thinking about it now, from my perspective I’m not sure it was consistently or fully implemented anywhere – period.

Southern storm duties call me right now. Wood for the fire, etc. But I think it’s a good place for me to take a breather and gather my thoughts. In the meantime, I refer you to the debate that went on in the comment section of my post which side of the street?…. It’s well worth the read both for content and how such exchanges should be conducted – respectfully…


I call it "winter park benches with chiminea"

Mickey @ 2:15 PM

birdman…

Posted on Tuesday 24 February 2015

I saw Birdman or (The Unexpected Virtue of Ignorance) Saturday night, one day before the Oscars, and by Sunday night, I was rooting for it to win, even though it was in the running with some other amazing films. In Atlanta, we had [still have] a film series at Emory called Movie Mania, attended by members of the Mental Health Community and trainees at large in the many different programs in the area. It’s only a matter of time before Birdman will be on the screen in one of those discussions – guaranteed. It’s a classic, in the genre and league with One Flew Over the Cuckoo’s Nest, but unlike that film [or A Beautiful Mind, or Shutter Island, or the King of Hearts] – in Birdman, neither Psychosis nor any kind of Mental Health anything is ever mentioned.

As much as I would love to talk on and on about this film, a Blog is no place to ruin a movie for those who haven’t seen it. So I’ll just make a few comments. In the movies, we all cheer for these characters played by Michael Keaton, Jack Nicholson, Russel Crowe, Leonard DiCaprio, and Alan Bates [Martin Scorsese’s Shutter Island may be an exception, but you’ll have to see it to know why]. We all cheer for the protagonists, even with their often tragic endings – everyone in the audience, including the psychiatry residents who then leave the film series to go back to the Emergency room and have to deal with the out of control psychotic people brought by the police, or by distraught family and friends [see this comment on the last post for their dilemma].

The brilliance of Birdman is that it’s not about mental illness, it’s about an aging actor who is searching for an authentic connection with life by adapting a serious drama [by Raymond Carver] about the power of love and connectedness on Broadway. His real success in life had been in his role in a series of popular heroic fantasy films in which he played the caped Birdman - a superhero with superpowers – but he lead something of a meaningless life otherwise with angst and failed relationships. We learn in the opening scene that, in private, he actually has Birdman’s superpowers, hears the voice of the character Birdman, and at times he actually becomes Birdman [again in private] under stress. So Michael Keaton [who was the first film Batman], is a character who contains the psychotic dilemma without anyone medicating him or anyone enthusiasticly aiming him towards recovery. He doesn’t even have a mental illness. He’s just a guy that can’t experience his sense of being in life, and also secretly is a superhero, but doesn’t feel his life in that role either.

I’m about to tell the end of the movie. I don’t think it will interfere with seeing it, but if you hate spoilers, bookmark this post and come back after you’ve seen it. By the way, see it for sure. When you see it, first read the blurb about Raymond Carver’s life. And pay particular attention to the Edward Norton and Emma Stone characters, who, like a Greek Chorus, narrate the dilemma throughout the film in their own lives. ‘I only feel real on the stage, not in my life.’

Keaton’s character achieves authenticity by using a real gun in the ending suicide scene on the opening night of the play. He doesn’t die, but shoots off his nose. While he achieves critical acclaim, it’s a hard act to follow obviously. Looking in the mirror in the hospital, he sees his reconstructed nose which is radically different [looks like a beak]. As a matter of fact, we notice that his bandages look like the Birdman mask. Seeing some birds, he goes to the window and opens it. Later, when his daughter [Emma Stone] comes in the room and sees the open window with him gone, she races to first look at the ground far below with alarm. Then she looks up, and smiles. The end. We smile too. We’re smiling for the Keaton character who seems to have escaped as the Birdman – flying free of the mess on the ground. But what we’ve seen in truth, is a man jumping from the window of a multistory building. That is a dilemma…

When I wrote which side of the street?…, I suppose I hoped I’d be able to focus on Jeffrey Lieberman’s inappropriate and pompous rant on Medscape and avoid the British Psychological Society‘s report. But I can see I’m not going to get away with that. That is, in fact, one of the things that I find so hard about discussing this topic. No matter what I say about psychosis as I see it, I’m seen as taking a side and get hit from some other side as a <something not good>. Mention using neuroleptic medication and I’m a power hungry self-righteous ‘MDeity‘ who loves committing people. Say something about the recovery metaphor, or the down-side of diagnoses, or over-medication, and I’m suddenly a naive 60s type who thinks ‘all you need is love‘ who doesn’t understand trauma. Talk about psychotherapy, and I’m an unrepentant psychoanalyst who way overvalues "talk therapy" and "fanciful theories." At 73, I may have visited each of those pastures along the way, but it was a long time ago and I no longer remember even what they felt like. They didn’t fit for me because each of them relies on a notion of causality, and I don’t know what causes psychosis, or even if it’s a single thing. I tend to use the term Schizophrenia and its traditional subtypes in conversation, but even that has changed for me. Catatonia has been split off in a very helpful way. And there’s no question that in early days, I included cases I would now see as having obvious Manic-Depressive Illness. The ground shifts when you’re without the more solid signatures of my Internist days. But it is what it is.

So I’ll talk about that British Psychological Society‘s report in a bit. And I’ll get back to Birdman [and hope others have thoughts about it too]. First, I guess I’ll have to at least touch on the endless interdisciplinary wars in mental health. But for the moment, there’s something else. This picture is the view from my front porch right now [that has shut down our whole county, closing the clinic I was supposed to work in today], and there are things to be dealt with like logs to bring in from that smaller open shed [I know there’s laughter in Boston, but this ain’t Boston. It’s wimpy Georgia…]:
Mickey @ 12:12 PM

which side of the street?…

Posted on Monday 23 February 2015

the background…
  • The British Psychological Society
    Division of Clinical Psychology

    This report of the British Psychological Society mirrors a widespread reaction against a purely biomedical explanation for psychosis, for Schizophrenia. They propose the alternative possibility that it can be an adaptation to childhood trauma and abuse. They advocate access to psychotherapy for these patients and suggest using neuroleptic medications only when helpful or requested, not as a steady diet. "Many people find that ‘antipsychotic’ medication helps to make the experiences less frequent, intense or distressing. However, there is no evidence that it corrects an underlying biological abnormality. Recent evidence also suggests that it carries significant risks, particularly if taken long term." This report comes from the UK where offering talk therapy to psychotic patients is apparently mandated, but not really available. Something like that.

  • New York Times
    January 18, 2015

    Tanya Luhrman is an Anthropologist at Stanford. Among her books, Of Two Minds is a study of the transformation within psychiatry in the 1980s. In this New York Times piece, she reports favorably on the British Psychological Society’s report above, saying: "The implications are that social experience plays a significant role in who becomes mentally ill, when they fall ill and how their illness unfolds. We should view illness as caused not only by brain deficits but also by abuse, deprivation and inequality, which alter the way brains behave. Illness thus requires social interventions, not just pharmacological ones. One outcome of this rethinking could be that talk therapy will regain some of the importance it lost when the new diagnostic system was young. And we know how to do talk therapy. That doesn’t rule out medication: while there may be problems with the long-term use of antipsychotics, many people find them useful when their symptoms are severe…"

  • New York Times
    January 27, 2015

    Luhrman had mentioned that the NIMH had abandoned the DSM-5 and instituted their RDoC Project. Paul Summergrad, current APA President, offered a short clarifying reply to her NYT piece: "Ms. Luhrmann notes approvingly that the National Institute of Mental Health, in beginning a program called Research Domain Criteria, determined that existing psychiatric diagnoses ‘were neither particularly useful nor accurate for understanding the brain, and would no longer be used to guide research.’ However, she does not mention a joint statement by the institute’s director, Dr. Tom Insel, and the former president of the American Psychiatric Association, Dr. Jeffrey Lieberman, which explained: ‘All medical disciplines advance through research progress in characterizing diseases and disorders. DSM-5 and RDoC [Research Domain Criteria] represent complementary, not competing, frameworks for this goal.’ Precisely."

  • Medscape
    February 18, 2015
the foreground…

In the Medscape article, Jeffrey Lieberman, immediate past President of the American Psychiatric Association, comes out of the gate with:
The article about mental illness was an incredibly unscholarly, misinformed, confused — at worst, unhelpful, and at best, destructive — commentary that will add to the confusion about the diagnosis of mental illness, enhance the stigma, and may lead some patients to doubt the veracity of the diagnoses that they have been given and the treatments that they are receiving. Specifically, Dr Luhrmann was prompted to write this by a report that came from the British Psychological Society, which is a professional organization in the United Kingdom. This report, titled Understanding Psychosis and Schizophrenia, suggested that hearing voices and having feelings of paranoia were common experiences; that they commonly occur in the course of everyday life, particularly in the context of trauma, abuse, or deprivation, and that they shouldn’t be considered symptoms of mental illness and attached to diagnoses because that is only one way of viewing them. Viewing diagnoses as normative mental phenomena has relative advantages and disadvantages. This strikes me as preposterous. It is, at best, phenomenologic relativism, and at worst, simply conflating symptoms with a disorder or a disease… Viewing it this way is, in a way, challenging the veracity of diagnoses and giving people who have symptoms of a mental disorder, license to doubt that they may have an illness and need treatment…
It is not my intent in this blog to defend or oppose the position of the British Psychological Society or Luhrman’s piece. Standards of proof transcend the opinions of any of us. It is, however, my intent to ask, "Who does Jeffrey Lieberman think he is?" "What gives him the right to lambast people who disagree with him with a string of contemptuous invectives like this?" "Does he not realize that if these critics overstate their case, it is at least partly in response to his kind of rigid self-righteousness?" And Tanya Luhrman didn’t write this because of the British report. It’s part of her long held opinion, one that runs as a thread throughout her academic career. But my central point is that Lieberman’s disdainful language and dismissive tone is way out of line no matter what she thinks – conduct unbecoming…
Next, the article addresses the fact that there is no evidence that antipsychotic drugs correct any biologic abnormality, which also is inaccurate. Antipsychotic drugs work through the antagonism or the blocking of dopamine. They may have other downstream and upstream effects with a neural pathway, but the link between dopamine activity and psychotic symptoms is indisputable. After making this point, which essentially equates symptoms with illness, the author says that this is consistent with the view taken by the National Institute of Mental Health [NIMH] Director Tom Insel…
We all know that antipsychotic drugs block dopamine. Neither how that affects psychosis nor whether dopamine is directly involved in the cause of psychosis is any more known now than it was when I first learned about it in the 1970s. Is he missing the point on purpose? To use one of his medical analogies, narcotics are a vital ingredient in treating kidney stones. If you’ve had one, you know what I mean. But kidney stones have nothing to do with opioid receptors. And as for Tom Insel’s blog about the NIMH abandoning the DSM in the run up to the release of the DSM-5, Luhrman’s article is clear that the position of the British Psychological Society is not the same as that of the NIMH. And I expect the joint statement later issued by Lieberman and Insel  came after a few rather steamy phone calls with a rant that rivals this one.
Why would such a report be printed in a widely respected publication such as the New York Times? What other medical specialty would be asked to endure an anthropologist opining on the scientific validity of its diagnoses? None, except psychiatry. Psychiatry has the dubious distinction of being the only medical specialty with an anti-movement. There is an anti-psychiatry movement. You have never heard of an anti-cardiology movement, an anti-dermatology movement, or an anti-orthopedics movement. What would give an anthropologist license to comment on something that is so disciplined, bound in evidence, and scientifically anchored? I can’t imagine how the New York Times editors would think that providing a platform for this would be useful. Maybe they want to be edgy. They want to be provocative and they think this is going to be somewhat controversial and attract readers. It may be interesting reading, but frankly, I think it’s irresponsible.
Besides his apparent misunderstanding of the functions of media, this is a low point. There is, indeed, an antipsychiatry movement, but this isn’t it. That movement is suffused with the same kind of contempt and disdain as his own comments here. If he doesn’t know the difference, I’ll be glad to send him the links that will make the differences immediately apparent. And as for his having to "endure" criticism by an Anthropologist, what does he think Anthropology actually is? Is my discipline is longer than your discipline really an argument he wants to make in an enlightened world? And are his amateur commentary on the motives of the New York Times evidence-based or simply a defensive screed? My vote is clear.
Among her publications are "Understanding the American Evangelical Relationship With God," "Case Studies in Culture and Schizophrenia," "Other Minds: Essays on the Way Mind Understanding Affects Mental Experience," "Of Two Minds: The Growing Disorder in American Psychiatry," and "Persuasions of the Witch’s Craft: Ritual Magic in Modem Culture." This hearkens back to the days when psychiatry had only fanciful theories about the mind and what caused mental illness in people, and also, unfortunately, when it tried to implement ineffective or, at times, harmful and even barbaric treatments. Thankfully, we are well past that. We now have scientifically developed and proven efficacious treatments that are safe and are changing and, in many cases, saving lives.
After thirty-five years of hearing dismissive phrases like "fanciful theories about the mind" about things that have been important to my own and many others understanding of mental illness and mental life, I am probably not the person to rationally even comment on this part, so I’ll pass. But I am a psychiatrist who actually uses the treatments he mentions in that last sentence and keeps up with the science involved. Both the British Psychological Society and Tanya Luhrman recognize the place of medications in treating psychosis, but imply that the medications have been over-used, which they have. They lobby for a place for "talk therapy" in the treatment of psychotic people, which I agree with no matter what one thinks about causality. And while I might generally differ with their contentions about etiology, theirs is a hypothesis to be proven just like any other, not something to mock.
Finally, when I read the article, disappointed and annoyed as I was, I tried to write a serious, responsible, and constructive letter to the editor, which I submitted within 24 hours. Seventy-two hours have elapsed since the article’s publication. I haven’t heard from the Times about their interest in publishing my response, so I assume they won’t publish it. The name that I publish under is my own. My credential is the Chairman of Psychiatry, Columbia University College of Physicians and Surgeons, one of the leading departments of psychiatry in the country, past president of the American Psychiatric Association, and author of the forthcoming book for the lay public called Shrinks: The Untold Story of Psychiatry. Assuming that my letter was not completely uninformed or incoherent, I would think that there would have been reason to accept it, given my credentials and the fact that I made a reasonable point. Let’s see if they print it. If they don’t, that adds further to my dismay over what I consider to be journalistically irresponsible behavior by this once-respected newspaper.
One of the rules about making a diagnosis, particularly in psychiatry, is therapeutic intent – a diagnosis is something you do for a patient, not to them. But Dr. Lieberman should be aware that the temptation in the minds of many readers of this piece with his level of self importance and entitlement is to see him as the object of diagnosis rather than an expert in diagnosis. And equally, one might legitimately ask why Medscape would publish his embarrassing rant.

My own dog in this hunt has to do with an acquired pet peeve. I wrankle when people personify psychiatry as in "psychiatry thinks …" as if psychiatry is a unity all of one mind. I have the same reaction to "psychoanalysis thinks …" for that matter. Because what comes next is usually something I don’t think. But I try to keep my mouth shut because I can see why people do that. He purports to speak for all of us. But I sure don’t think all that Dr. Lieberman says in this piece. And I don’t think what the British Psychological Society or Tanya Luhrman think either, though their general recommendation of more judicious use of medication and access to "talk therapy" have always been part of my own thinking about these patients. Since I don’t know what causes psychosis, I would justify both recommendations on other grounds. There is little question in my mind that the neuroleptic medication can prevent relapse, and in a significant number of cases, that’s an important dilemma added into the mix.

When I arrived on the scene in psychiatry forty years ago, the psychoanalysts were entrenched in the seats of power much as the bio-psychiatrists are now. Some spoke from an arrogant position similar to that taken by Dr. Lieberman here. Even as an immigrating rookie from another specialty, I could sort of smell where that was headed. So it was back then that I learned about what happens when a paradigm flows way beyond its defensible boundaries. And like now, there was money involved – billing medical insurance for long but often optional psychotherapies. A sense of rightness clouded their vision and they missed many opportunities to become right-sized, attacking or becoming defensive when they should’ve been listening and adapting. Sounds familiar. Things were lost in the process.

That epoch is too much a part of my own history for me to feel great comfort in extrapolating it into the present with any certainty, but for what it’s worth, it feels like it’s a pertinent analogy – a time to clean up our side of the street rather than point across the road. I have doubts that Dr. Lieberman is going to be any help at all in that enterprise…

Addendum: An earlier version:
  • by Jeffrey A. Lieberman
    Scientific American
    May 20, 2013
  • by Judy Stone
    Scientific American
    May 24, 2013

    "Conclusion: So many symptoms are now being medicalized, even absurdly, grief. It makes me wonder if there a DSM 5 diagnosis for someone who is self-serving, can’t accept criticism, and believes critics are prejudiced bigots? I was very disappointed to see Dr. Lieberman’s shallow, self-serving and evidence-free diatribe appear in Scientific American as a guest opinion. He failed to reveal important conflicts of interest. He made serious claims for which he presented no evidence. He has made thinly veiled personal attacks on his critics, without offering anything substantive to counter rationally…"

Mickey @ 6:00 PM

legitimately trying…

Posted on Sunday 22 February 2015

This morning’s thermometer says that we’re finally starting to thaw out down here a bit. Time for a real blog with graphs and numbers. Within the few years after the introduction of the Selective Serotonin Reuptake Inhibitor [SSRI] class of antidepressants, their association with suicidal ideation, suicide attempts, or suicides became the question of the hour based on case reports. There was an FDA Hearing in 1991 that didn’t find a signal sufficient for action. But by the next FDA Inquiry in 2004, meta-analysis of Clinical Trials was added to the case reports, and the FDA concluded that a signal justified adding a Black Box Warning to all antidepressants for adolescents, later extended to young adults. Throughout this period, investigators have also attempted to examine large practice databases to clarify this relationship.

No single source tells us all we want to know. Individual Case Reports have no Denominator so we can’t calculate and compare rates. Clinical Trials often have Placebo Controls, but are short duration and are subject to publication and other biases. And the large practice databases have no Placebo Controls for comparison. The study reported here is from  a large UK database that included roughly a quarter of a million patients with analyzable data. There was a disparity in the frequency of the prescribed antidepressants:
by Carol Coupland, Trevor Hill, Richard Morriss, Antony Arthur, Michael Moore, and Julia Hippisley-Cox
British Medical Journal. 2015;350:h51.

Objective: To assess the associations between different antidepressant treatments and the rates of suicide and attempted suicide or self harm in people with depression.
Design: Cohort study. Setting Patients registered with UK general practices contributing data to the QResearch database. Participants 238 963 patients aged 20 to 64 years with a first diagnosis of depression between 1 January 2000 and 31 July 2011, followed up until 1 August 2012.
Exposures: Antidepressant class [tricyclic and related antidepressants, selective serotonin reuptake inhibitors, other antidepressants], dose, and duration of use, and commonly prescribed individual antidepressant drugs. Cox proportional hazards models were used to calculate hazard ratios adjusting for potential confounding variables.
Main outcome measures: Suicide and attempted suicide or self harm during follow-up.
Results: During follow-up, 87.7% [n=209 476] of the cohort received one or more prescriptions for antidepressants. The median duration of treatment was 221 days [interquartile range 79–590 days]. During the first five years of follow-up 198 cases of suicide and 5243 cases of attempted suicide or self harm occurred. The difference in suicide rates during periods of treatment with tricyclic and related antidepressants compared with selective serotonin reuptake inhibitors was not significant [adjusted hazard ratio 0.84, 95% confidence interval 0.47 to 1.50], but the suicide rate was significantly increased during periods of treatment with other antidepressants [2.64, 1.74 to 3.99]. The hazard ratio for suicide was significantly increased for mirtazapine compared with citalopram [3.70, 2.00 to 6.84]. Absolute risks of suicide over one year ranged from 0.02% for amitriptyline to 0.19% for mirtazapine. There was no significant difference in the rate of attempted suicide or self harm with tricyclic antidepressants [0.96, 0.87 to 1.08] compared with selective serotonin reuptake inhibitors, but the rate of attempted suicide or self harm was significantly higher for other antidepressants [1.80, 1.61 to 2.00]. The adjusted hazard ratios for attempted suicide or self harm were significantly increased for three of the most commonly prescribed drugs compared with citalopram: venlafaxine [1.85, 1.61 to 2.13], trazodone [1.73, 1.26 to 2.37], and mirtazapine [1.70, 1.44 to 2.02], and significantly reduced for amitriptyline [0.71, 0.59 to 0.85]. The absolute risks of attempted suicide or self harm over one year ranged from 1.02% for amitriptyline to 2.96% for venlafaxine. Rates were highest in the first 28 days after starting treatment and remained increased in the first 28 days after stopping treatment.
Conclusion: Rates of suicide and attempted suicide or self harm were similar during periods of treatment with selective serotonin reuptake inhibitors and tricyclic and related antidepressants. Mirtazapine, venlafaxine, and trazodone were associated with the highest rates of suicide and attempted suicide or self harm, but the number of suicide events was small leading to imprecise estimates. As this is an observational study the findings may reflect indication biases and residual confounding from severity of depression and differing characteristics of patients prescribed these drugs. The increased rates in the first 28 days of starting and stopping antidepressants emphasize the need for careful monitoring of patients during these periods.

Supplementary Data: «link»

The overall percentages of completed and attempted suicides are shown in this table with significant values shown in red [among classes relative to SSRIs – among drugs relative to Citalopram]:
The main contribution from this study is "when" suicides and suicide attempts occur. The strongest signal is in the first 28 days after starting the antidepressant with a smaller signal in the 28 days after discontinuing the drug:
Here are some of the author’s comments from the full text of the article:
The suicide rates in our study cohort [43 per 100 000 in men and 9 per 100 000 in women] are higher than those in the general population in England [three year average rates of 12.4 per 100 000 in men and 3.7 per 100 000 in women for 2010-12]. Larger differences than this might be expected since our rates are in patients with a diagnosis of depression rather than in the general population. Studies showing greater differences, however, have tended to be in secondary care settings, where patients have more severe depression. These results are consistent with those of our previous cohort study in older people with depression, which found that trazodone, mirtazapine, and venlafaxine were associated with the highest rates of attempted suicide or self harm in people aged 65 or more.

Conclusions:
This study has found that rates of suicide and self harm were similar during periods of treatment with selective serotonin reuptake inhibitors and tricyclic antidepressants, but were higher for the group of other antidepressant drugs, with mirtazapine, venlafaxine, and trazodone being associated with the highest risks. The number of suicide events was small so the results for suicide should be interpreted with caution. Rates tended to be highest in the first 28 days after starting treatment and remained increased in the first 28 days after stopping treatment. These findings are of associations rather than causal effects and are particularly susceptible to confounding by indication, channelling bias, and residual confounding; further research is needed to confirm them. The results of this study indicate that patients taking antidepressant drugs should be carefully monitored, especially during early treatment with antidepressants and when stopping treatment.
In this cohort of almost a quarter of a million patients from general practices in the UK with a diagnosis of depression, 87.7% of them were put on an antidepressant drug [lest we have any question about the ubiquity of the use of antidepressants]. In a population study like this, it’s impossible to directly address whether suicidality can be attributed to the drugs or is related to the depression itself, but in either case, the study supports early treatment and the weeks after coming off the medications as the high risk periods. In the cases of trazodone [Desyrel®], mirtazapine [Remeron®], and venlafaxine [Effexor®], the increased incidence of suicidality does appear drug related [in this and other studies]. 

Why is this article being blogged here? It’s because it’s the first one of these big database studies on this topic that’s legitimately trying to convey something useful to the medical community, and I believe what they say. The others, so far, have just been tricks to undermine the Black Box Warnings.
Mickey @ 8:00 AM