why data transparency? I…

Posted on Thursday 1 January 2015

PSYCHIATRICNEWS alert
[The Voice of the American Psychiatric Association and the Psychiatric Community]
December 30, 2014

A combination of the antipsychotic olanzapine and the antidepressant fluoxetine proved superior to placebo for acute treatment of bipolar I depression in patients aged 10-17 in a randomized control trial published online in the Journal of the American Academy of Child and Adolescent Psychiatry.

The double-blind study by researchers at Eli Lilly and Company randomized 170 young patients with bipolar I disorder experiencing an acute depressed episode to the olanzapine/fluoxetine combination [OFC] and 85 to placebo for up to eight weeks of treatment. The primary efficacy measure was mean change in the Children’s Depression Rating Scale-Revised [CDRS-R]…
The issue of the hour is DATA TRANSPARENCY in Randomized Clinical Trials [RTCs], mainly industry funded RTCs of medications, particularly those submitted for FDA Approval. This announcement in the PSYCHIATRICNEWS came out the same day the study was published [on-line] in the JAACAP. There are several reasons one might want to look into this announcement. First, the Pediatric Bipolar I diagnosis is controversial, to say the least. It was quite the rage for a time after being introduced by Dr. Joseph Biederman and colleagues at Harvard and swept through the Child Psychiatry world. In 2008, Dr. Biederman was on Senator Grassley’s list for undisclosed pharmaceutical income and later censured by Harvard, the fad began to pass. Many doubt that Bipolar Disorder in the pediatric age group even exists, or at least exists in any sizable number. Second, these are old drugs – Prozac® and Zyprexa®. Why is Lily promoting its combo version [Symbiax®] at this late date? Why are they publishing a trial in kids now when both Prozac® and Zyprexa® are off-patent? But the thing that struck me about this announcement is what it doesn’t say. It doesn’t say:
    The double-blind study by Dr Melissa DelBello with the Division of Bipolar Disorders Research, University of Cincinnati College of Medicine, randomized 170 young patients with Bipolar I disorder experiencing an acute depressed episode to the olanzapine/fluoxetine combination [OFC] and …
… even though she’s the only psychiatrist [and the only non-Lily employee] on the author byline. And, by the way, she was on Senator Grassley’s list too as an academic with undisclosed PHARMA income:
Olanzapine/Fluoxetine Combination in Children and Adolescents With Bipolar I Depression: A Randomized, Double-Blind, Placebo-Controlled Trial
by Holland C. Detke, Ph.D., Melissa P. DelBello, M.D., John Landry, M.Math, and Roland W. Usher, M.S.
Journal of the American Academy of Child and Adolescent Psychiatry. published online 12/24/2014

Objective: To assess the efficacy and safety of olanzapine/fluoxetine combination [OFC] for the acute treatment of bipolar depression in children and adolescents.
Method: Patients 10-17 years of age with bipolar I disorder [BP-I], depressed episode, baseline Children’s Depression Rating Scale-Revised [CDRS-R] total score ≥40, Young Mania Rating Scale [YMRS] total score ≤15, and YMRS-item 1 ≤2 were randomized to OFC [6/25-12/50 mg/day olanzapine/fluoxetine; n=170] or placebo [n=85] for up to 8 weeks of double-blind treatment. The primary efficacy measure was mean change in CDRS-R using mixed-model repeated measures methodology.
Results: Baseline-to-week-8 least-squares mean change in CDRS-R total score was greater for OFC-treated patients than for placebo-treated patients [-28.4 vs. -23.4, p=.003; effect size=.46], with between-group differences statistically significant at week 1 [p=.02] and all subsequent visits [all p<.01]. Rates of and times to response and remission were statistically significantly greater for OFC- than placebo-treated patients. The most frequent treatment-emergent adverse events in the OFC group were weight gain, increased appetite, and somnolence. Mean weight gain at patient’s endpoint was significantly greater for OFC- than placebo-treated patients [4.4 kg vs. 0.5 kg, p<.001]. Treatment-emergent hyperlipidemia was very common among OFC-treated patients. Abnormal increases in hepatic analytes, prolactin, and corrected QT interval [QTc] were also common or very common but generally not clinically significant.
Conclusion: OFC was superior to placebo and approved by the US Food and Drug Administration [FDA] for the acute treatment of bipolar I depression in patients 10-17 years of age. Benefits should be weighed versus the risk of adverse events, particularly weight gain and hyperlipidemia.
Unlike the industry RCTs in the past where the academic authors are mentioned up front, the announcement says "The double-blind study by researchers at Eli Lilly and Company randomized..." [at least they’re honest]. So this is an industry study inserted directly into the academic, peer reviewed literature. And who did the study? who wrote it? There’s probably an answer to that question in the acknowledgements in the paper:
    "The authors also thank Shannon Gardell, PhD, and Rodney Moore, PhD, of inVentiv Health Clinical [funded by Eli Lilly and Co.] for assistance in drafting/editing the manuscript."
inVentiv Health Clinical is a full service Clinical Research Organization [CRO] that likely both managed the study for Lily and wrote [ghost wrote] the paper. A glance at Dr. DeBello’s COI declaration tells us that she’s certainly still in the pharmaceutical orbit:
    Dr. DelBello has received grant or research support from … Amylin Pharmaceuticals, Eli Lilly and Co., Pfizer, Otsuka, Merck, Martek, Novartis, Lundbeck, Purdue, Sunovion, and Shire. She has served as a consultant to Bracket, Guilford, Pfizer, Dey Pharma, Lundbeck, Springer, Sunovion, and Supernus…
From its approval in 2003 to 07/26/2013, Symbiax® was not approved for Pediatric Use. At that time, the label was changed [Drugs@FDA] and the patent was extended [Pediatric Extension?FDA Orange Book]:
    Children and Adolescents — The efficacy of SYMBYAX for the acute treatment of depressive episodes associated with Bipolar I Disorder was established in a single 8-week, randomized, double-blind, placebo -controlled study of patients, 10 to 17 years of age [N=255], who met Diagnostic and Statistical Manual 4th edition-Text Revision (DSM-IV-TR) criteria for Bipolar I Disorder, Depressed.
The  FDA Approval in adolescents was apparently based on this study.

It’s not my intention to specifically challenge these results. But since the DSM-III, there has been a steady creep in diagnosing Bipolar Disorder from the classic Manic-Depressive Illness of Kraepelin’s days. And I see a remarkable number of people who announce that they’ve been "told they are Bipolar" and they simply don’t fit. Also, in reviewing the more papers on Pediatric Bipolar Disorder, my skepticism level hovers around DEFCON 1. Likewise, I see no reason for a COMBO medication. Taking two pills a day if they’re needed is no great burden. So my suspicions that the goals here are commercial rather than medical. But I don’t doubt that depressed adolescents feel better taking Zyprexa® or Symbiax®. I question whether it’s a good idea to prescribe it, particularly in the fixed dose COMBO pills. But the fact that it is a likely ghost-written, industry produced, COI-laden, commercially-driven RCT is not all that bothers me about this study.

Stay tuned…
Mickey @ 8:00 AM
Filed under: OPINION
did nothing medical…

Posted on Tuesday 30 December 2014

It would be hard not to know about the case of Dan Markingson, a young psychotic man who killed himself while in a clinical trial at the University of Minnesota in 2004 [see A referenced summary of the Dan Markingson case]. Bioethicist Carl Elliot at UM has kept us abreast of the ongoing attempts to block any thorough investigation of the case on his blog Fear and Loathing in Bioethics. In a recent post, Carl mentions a presentation at an ethics conference that defended the handling of the Markingson case by UM.
Fear and Loathing in Bioethics
by Carl Elliot
December 16, 2014

Well, no conflict of interest unless you count a $13,781 fee paid by the University of Minnesota to give expert testimony on this exact issue.  So yeah, if you want to get all technical and everything, then I guess that might count as a conflict. But can you really expect a research ethics expert to keep up with arcane issues like conflicts of interest? I mean, come on.
Well, Ernest Prentice had another problem besides his unacknowledged conflict of interest. He neglected to scope out his audience at the conference before he stepped into it, feet first…
Ernest Prentice, an associate vice-chancellor at the University of Nebraska, seems to have trouble with conflicts of interest, and not just his own.  According to Dr. Judy Stone, who attended Prentice’s talk on the Markingson case at this year’s PRIM&R meeting, Prentice also claimed to be unaware of the astonishing conflicts of interest on the IRB whose performance he defended…
He apparently didn’t notice that Dr. Judy Stone who has written extensively about the Markingson case in Scientific American was sitting in the audience…
Scientific American
Blog:  Molecules to Medicine
by Judy Stone
December 15, 2014
This Blog by Dr. Stone is a must-read, both because it adds to the facts about the Markingson case, but also because it is a classic take-down of Goliath proportions. An old mentor once told me, "Know your audience." And it is likely that Ernest Prentice has learned the wisdom of that advice first hand [in the Q&A that followed his talk]…

The higher-ups apparently think that they can get the Markingson case to go away. But that’s never going to happen. The ethical issues are too fundamental. As much as people love to debate about medical model[s] of disease and evidence-based medicine, medicine itself is much older that these scientific methods. It rests on two ancient intertwined principles:
  • Aesculapian authority: Authority is granted to the physician with the implicit contract that it will be used in the service of the patient, and for no other reason.
  • Primum Non Nocere: "First, do no harm." This injunction comes from antiquity and essentially says that there will be vigilance for anything that will hurt the patient, including therapeutic zeal.
In the case of Dan Markingson, it is obvious that there was betrayal of both of these principles. Dan was quite ill with a disorder that carried a guarded prognosis – Paranoid Schizophrenia with florid delusions of manifest lethal content. The physician recommendation [Aesculapian authority enforced by judicial authority] was not driven by his needs, but rather by the physician’s need to populate a clinical drug trial. And there is no question that the patient was harmed by being given only a maintenance dose of a blinded medication for six months with no apparent response to the treatment. So Dan was involuntarily committed to a treatment plan that would never have been suggested for him had it not been part of a clinical trial protocol to study maintenance medication. As he had never really responded, there was nothing to maintain. And one can hardly claim that his one doctor’s visit per month is anything like the necessary vigilance.

The usual topic of this blog is the betrayal of these principles by an academic journal, its authors, a pharmaceutical company, or a regulatory body that provides misinformation to patients and physicians about a drug or treatment. The cause is invariably related to conflicts of interest involving money. This case has those same roots, but is at the other end – the process of generating the information. So not only was Dan betrayed as a sick person, but the clinical trial was betrayed by including a subject that didn’t belong. The UM administration, the involved doctors, even the presenter at the conference above, all make the same argument, "We did nothing wrong." While that’s not true, it’s not even the point. They accepted the medical responsibility for Dan Markingson, but they did nothing medical. And that’s why this case won’t go away…
Mickey @ 10:43 AM
Filed under: OPINION
the recommendation?…

Posted on Monday 29 December 2014

Rarely do you get to see an industry production that has all of these elements rolled into one article, but look no further. This article has all the right moves. It’s a review article in an industry friendly CME journal, Journal of Clinical Psychiatry. Its got some well known KOLs for guest authors: Alan Schatzberg former Chairman at Stanford, former Corcept principle, former APA President, former Sally Laden client, formerly included on Senator Grassley’s PHARMA income non-reporter list; Rakesh Jain, a principle in the CME conglomerate US Psychiatric and Mental Health Congress; and Michael Thase, just-about-everybody’s KOL.
by Alan F. Schatzberg, MD; Pierre Blier, MD, PhD; Larry Culpepper, MD, MPH; Rakesh Jain, MD, MPH; George I. Papakostas, MD; and Michael E. Thase, MD
Journal of Clinical Psychiatry 2014 75[12]:1411–1418.

Six clinicians provide an overview of the serotonergic antidepressant vortioxetine, which was recently approved for the treatment of major depressive disorder in adults. They discuss the pharmacologic profile and receptor-mediated effects of vortioxetine in relation to potential outcomes. Additionally, they summarize the clinical trials, which demonstrate vortioxetine’s efficacy, and discuss findings related to safety and tolerability that have high relevance to patient compliance.
In former times, this kind of industry-driven review article came from "roundtables" – KOL meetings that may or may not have occurred. But it’s different now – teleconferences among the various KOLs.
    … highlights from a series of teleconferences held in the spring of 2014. The series was chaired by Alan F. Schatzberg, MD… The faculty were Pierre Blier, MD, PhD…; Michael E. Thase, MD…; George I. Papakostas, MD…; Larry Culpepper, MD, MPH…; and Rakesh Jain, MD, MPH…
The article is obviously ghost-written by a professional medical communications company – apparently paid by the journal.
    This evidence-based peer-reviewed Academic Highlights was prepared and independently developed by Healthcare Global Village, Inc., with support from Physicians Postgraduate Press, Inc…
All of the guest authors have extensive industry connections. I’ve just included two from each, the two companies involved with marketing Vortioxetine – 100% onboard.
    Financial disclosure: Dr Schatzberg received grant funding and/or honoraria for lectures and/or participation in advisory boards for … Lundbeck/TakedaDr Blier received grant funding and/or honoraria for lectures and/or participation in advisory boards for … Lundbeck Takeda Dr Culpepper received grant funding and/or honoraria for lectures and/or participation in advisory boards for … H. Lundbeck A/STakeda. Dr Jain received grant funding and/or honoraria for lectures and/or participation in advisory boards for … LundbeckTakeda. Dr Papakostas received grand funding and/or honoraria for lectures and/or participation in advisory boards for Lundbeck Takeda. Dr Thase received grant funding and/or honoraria for lectures and/or participation in advisory boards for … H. Lundbeck, A/S Takeda.
The actual article is odd. For example, it has a discussion of the meanings of NNT and NNH, but neglects to say what Vortioxetine’s NNT actually is. It discusses the changing drug/placebo differences in clinical trials of antidepressants with a borrowed graph, but doesn’t show a graph of any Vortioxetine values. It mentions six positive clinical trials but not the four negative ones.


[from the FDA Medical Review]

It even has a discussion of Irving Kirsch’s negative meta-analysis of antidepressant trials and a blurb about how the Affordable Care Act expands mental health benefits. There’s a pitch for Collaborative Care and encouragement for Primary Care Physicians to prescribe antidepressants. The review ends with:
    "Robinson et al in a 2005 study estimated that primary care providers are the sole contacts for more than half of patients with mental illness and that depressive symptoms are present in nearly 70% of patients visiting primary care providers. A patient in a primary care setting, particularly one who has recently acquired mental health coverage through the ACA or Mental Health Parity and Addiction Equity Act, may have one or more coexisting acute or chronic conditions, and to the extent possible, an antidepressant that will not aggravate and might be helpful for these conditions is preferable. A favorable tolerability profile also may improve patient adherence to treatment, leading in turn to not only a reduction in depressive symptoms but a reduced risk of behavioral or social actions that could adversely affect the patient’s overall health and well-being."
So now we have another SSRI on the market called Brintellix® [AKA Vortioxetine], with a review article in the style of so many professionally-written industry-driven articles that have been the flotsam and jetsam of the psychiatric literature for several decades.

At times, when I wear thin with all the anti-psychiatry criticism, the kind that assumes all psychiatrists think the same [stupid] [wrong] things, I’m tempted to get defensive or argue. Then I read an article like this, in a journal like this, by authors like these, and it helps me hold my tongue and turn the other cheek. There’s absolutely nothing here to defend. Fortunately, we don’t see articles like this so much any more, at least in any places that matter. But it’s bad enough that we ever had them in the first place [or that anybody is still writing them].


In the FDA Medical Report on Brintellix®, the reviewer conveniently included a list of all of the FDA approved treatments for Major Depressive Disorder:

It reminded me of my early days in psychiatry. The drugs available then were the ones in the top two boxes [pink]. In those days, the phrase Major Depressive Disorder would’ve referred to a group of severe conditions I think of as the Melancholic Depressions. I thought of them as diseases, nouns, entities [Depression with a capital "D"]. They aren’t common, but when you see a case, there’s nothing routine about it. The patients are quantitatively profoundly depressed. But there are qualitative features that are striking. It’s as if the affect-generator has been turned to a single frequency – self-hating gloom. Those were the patients we treated with the Tricyclic antidepressants. Sometimes they responded. Sometimes they didn’t. And sometimes they were treated with ECT. People like me who usually spend their days talking to depressed people [depression with a little "d"] are stopped in their tracks when Melancholic Depression is the problem. It’s something else.

When the DSM-III came along in 1980, the phrase Major Depressive Disorder took on a new meaning. If you saw a case of Depression with a capital "D", you could say Major Depressive Disorder with Melancholic features or some such as if there were a continuum between Depression [noun] and depression [symptom] [which isn’t true in my opinion]. Depression had lost its meaning. Any symptomatic depression became known as "MDD" and had graduated – had become a disease [and the most common DSM-III diagnosis at that]. But that’s not the end of the story. In the DSM, there are criteria required to make a diagnosis of "MDD." They’re soft compared to the Melancholic Depressions, but they are at least criteria. So I had a specific reason for posting about this review article, an article I would usually just let pass. But when I read that last paragraph, I started writing:
    "… primary care providers are the sole contacts for more than half of patients with mental illness and that depressive symptoms are present in nearly 70% of patients visiting primary care providers. A patient in a primary care setting, particularly one who has recently acquired mental health coverage through the ACA or Mental Health Parity and Addiction Equity Act, may have one or more coexisting acute or chronic conditions, and to the extent possible, an antidepressant that will not aggravate and might be helpful for these conditions is preferable."
According to this article, you don’t even have to meet the watered-down DSM-III criteria for "MDD" to get put on an antidepressant medication anymore. All you have to do is go to your GP for any reason and have some depressive symptoms ["particularly" if you have recently acquired mental health coverage]. Brintellix®, with…
    "A favorable tolerability profile also may improve patient adherence to treatment, leading in turn to not only a reduction in depressive symptoms but a reduced risk of behavioral or social actions that could adversely affect the patient’s overall health and well-being."
In an article from the former chairman of psychiatry at Stanford? From a former APA president? That’s the recommendation? Unbelievable!…
Mickey @ 8:00 AM
Filed under: OPINION
kudos…

Posted on Friday 26 December 2014

Inside Philanthropy
by Tate Williams
December 23, 2014

MacArthur just gave $400,000 to a popular blog about flawed and fraudulent science, so it can deepen its coverage and build a comprehensive database of journal retractions. We chatted with the program officer behind the grant about why got Mac into the science watchdog game, and the foundation’s adventurous side program for such grants. 

Since editor and physician Ivan Oransky and science writer Adam Marcus launched Retraction Watch in 2010, the blog cataloging retracted articles in science journals has drawn a lot of attention, and had more fodder than it can keep up with.

Now, thanks to a two-year grant from the MacArthur Foundation, Retraction Watch is going to expand from a scrappy watchdog to a full-fledged monitoring program that will catalog nearly all retractions issued by major journals in a database, and do deeper analysis of the root causes. 

As Ivan Oransky told the program BioCentury This Week, “It’s easy and fun — and useful — to write about the fraud in particular cases, but looking at the big picture is always much more interesting and important. And so we’re going to be able to do that and to look at the scale of these things and see what’s actually happening”…
[see also Retraction Watch is growing, thanks to a $400,000 grant from the MacArthur Foundation] Good for the MacAurthur Foundation! Adam and Ivan’s blog is top notch already, promoting a level of transparency in science reporting long needed. Adding in-depth reports on the details and reasons for the retraction will just put icing on the cake. In the psychiatric literature I follow, there are a number of articles, particularly articles on clinical drug trials funded by industry, that should have never been published, have not been retracted, and still show up as references. While it would be an extremely tricky undertaking, I can coneive of some group that might undertake investigation of articles so identified by multiple observers. I’m not aware of that being done, but there’s a need. The journal editors themselves seem reticent to undertake such a task, and that’s understandable. But it does science nor medicine no real service to let this kind of article stand in perpetuity. But that’s not for Retraction Watch to worry with right now – just a wish list item for the universe. Their proposed expansion into investigative work and cataloging sounds ambitious enough, and a real solid addition to the science watchdog world…
Mickey @ 9:00 AM
Filed under: OPINION
not hardly…

Posted on Thursday 25 December 2014

Ben Goldacre tweeted a document, a letter to UK doctors from Pfizer. I don’t know the specifics of the UK regulatory agencies and how they differ from the FDA. I don’t know what a CCG is. But I don’t think we need to  know those things to get what Pfizer is trying to get said in their letter – their unimaginable letter. He posted a jpeg that was too small to read, so I transcribed it for all to experience first hand.

ben goldacre @bengoldacre
This @pfizer threat at UK doctors is especially amusing given they were done for off-patent promotion of pregabalin. https://twitter.com/bengoldacre/status/547492475544559616?s=03
ben goldacre ‏@bengoldacre
This threatening letter to UK drs from @pfizer is farcical copyright fearmongering. Always use scientific drug names.


Pfizer             Worldwide Biopharmaceutical Businesses

[Date]

[CCG Address]

Dear [NAME]

Re: Lyrica® (pregabalin) pain patient

I am writing to ensure thay  you are informed about the relatively unususl issues surrounding the loss of exclusivity situation for the Pfizer product Lyrica® (pregabalin) so you can take necessary action to prevent patent infringement by your organization.

An appendix is attached describing the factual aspects of the situation in detail to ensure that you have the full information available. You will see that, whilst tyhe basic patent for pregabalin has expired and regulatory data for pregabalin has expired in July 2014, Pfizer has a second medical use patent protecting pregabalin’s use in pain which extends to July 2017. Pfizer conducted further research and development on pregabalin leading to its use in pain and hence was granted a second medical use patent for this indication. This patent does not extend to pregabalin’s other indications for generalized anxiety disorder (GAD) or epilepsy.

As a result of the pain patent, we expect that generic manufacturers will only seek authorization of their pregabalin products for use in epilepsy and generalized anxiety disorder and not for pain, whilst Pfizer’s pain patent is in place. Generic pregabalin products therefore are expected not to have the relevant information regarding the use of the product in the PIL (Patient Information Leaflet) and SmPC (Summary of Product Characteristics). In other words, the generic pregabalin products are expected tro carry so-called "skinny labels" and will not be licensed for use in pain.

In the circumstances dwscribed above, Pfizer believes the supply of generic pregabalin for use in the treatment of pain whilst the pain patent remains in force in the UK would infringe Pfizer’s patent rights.This would not be the case with supply or dispensing of generic pregabalin for the non-pain indications, but we believe it is inccumbant on those involved to ensure that slinny labeled generic products are not dispensed and used for pain.

In this regard, we believe the patent may be infringed, even potentially unwittingly, by pharmacists and others in the supply chain, if they supply generic pregabalin for the pain indications. Without information, guidance, and practical solutions from the authorities. Pfizer believes that multiple stakeholders, possibly without realizing, may contribute to patent infringement which would be an unlawful act. This runs contrary to the government’s established policy of rewarding additional research by granting a second medical use patent.

We also note that, by issuing guidance, your CCG is able to influence patterns of prescribing ans dispensing in your area. We believe these powers must be exercised responsibly and with a view to avoiding the infringement  of Pfizer’s pain patent.

In view of the above, Pfizer requests that you use appropriate guidance to prescribing clinicians withing your CCG to help ensure that our pain patent is respected and that all prescribing clinicians are aware of the pain patent situation. There are a number of ways in which this might be achieved, but the simplest solution, we believe, is for clinicians to be advised to prescribe Lyrica® by brand when prescribing pregabalin to treat neuropathic pain. Pharmacists will then be able to dispense Lyrica® against such prescriptions and this will ensure that they do not infringe the pain patent. In addition this will mean that patients with pain will be provided with a PIL that describes the use of pregabalin in pain.

Your CCG may also consider reviewing patient records retrospectively (in advance of the availability of generic drugs) and use prescribing decisions support mechanisms such as Scriptwatch to support appropriate ongoing prescribing. We are willing to discuss, or assist CCG’s with, the development of other solutions.

We should also note that, in our view,(i) CCG guidance instructing or encouraging the usage of generic pregabalin in pain would amount to procurement of patent infringement (an unlawful act); and (ii) your CCG is under an obligation to address the risk of wide scale infringement of Pfizer’s patent rights. Pfizer therefore formally reserves all of its legal rights in this regard.

If you have any questions in relation to the above please contact Pfizer LTD on 01304 616161.

Yours Sincerely,

Ruth Coles
Legal Director


UPDATE

ben goldacre @bengoldacre
So @Pfizer UK press office are being very coy about whether this threatening letter to GPs is genuine. Embarrassed? http://boingboing.net/2014/12/24/pfizer-threatens-pharmacists.html
    hu·bris ‘hyu br?s
    noun.
    Overbearing pride or presumption; arrogance:

After being fined $2.3B for off-brand promotion with their non-product Neurontin®, Pfizer brought out Lyrica®, a molecular clone, ran it for its patent life, and now want to extend the exclusivity for a secondary patent for the same use they got fined for in the first place. And the way they propose to do that is threaten GPs and Pharmacists.

I’ve never prescribed Lyrica®, and only refilled Neurontin®. The thing I’ve noticed is that patients are reticent to stop Neurontin®, and I suspect it is because it has a mild Benzo-like antianxiety effect. The problem with this system is contained in this letter. "This runs contrary to the government’s established policy of rewarding additional research by granting a second medical use patent". That’s built on the notion that pharmaceutical companies should be rewarded in return for developing new drugs for the betterment of our patient’s lives. They’ve turned that into a mechanism to make gajillions off of medications that have a minimal effect [if that] and then sell that effect to the public that clamors for the drug so they can be like the pretty lady on the television dancing her way through an exotic vacation.

Do we really want to reward companies for developing life-style drugs?  What is the point of trying to rein in escalating healthcare costs if what we’re doing is making it easier to go to the doctor and get the made for t.v. "ask your doctor if Lyrica® is right for you" drug with a prescription plan? And when they come up with something that may be a life-saver for some, like the new Hepatitis-C drugs, do we really want to let them use their patent exclusivity to sell the 90 day treatment at $1000/day? And with this silly ploy, do we really want to let Pfizer intimidate doctors and pharmacists by using patent laws to insist on their writing Brand prescriptions? or the NHS? or anybody? Not hardly…
Mickey @ 8:52 AM
Filed under: OPINION
happy holidays…

Posted on Thursday 25 December 2014

 
 
Mickey @ 1:00 AM
Filed under: OPINION
transinstitutionalization? IV…

Posted on Saturday 20 December 2014

I’m back from my tangent now. I wasn’t offering my objections to that legal study [An Institutionalization Effect…] as a proof in transinstitutionalization? III…, but more as an example of a place where having the numbers work out in some mathematical model is one thing, but it doesn’t necessarily prove the relationship in the conclusions. My own guess is that the shoddy implementation of deinstitutionalization, the rise in violent crimes from 1980 through 2000, and our becoming the biggest jailer on the planet are definitely related to each other, but that all three are parameters that relate to something else, something unmeasured that has something vital to say about our country’s as yet unwritten history of the second half of the 20th century. I expect that the way we’ve dealt with chronic mental illness in general belongs in that unwritten story too.

I don’t know anything much about incarceration except that it’s something societies do when they don’t know what else to do. The creation of a dual system [prisons and asylums] had an intent apparent in the very names we use to talk about them, and by the mid twentieth century, that distinction between institutions had lost its meaning. The coming of effective antipsychotic medications at the mid-century mark may have been the key that unlocked the door to the State Hospitals, but it was anything but a cure. Whether you think of psychotic illness as biological or psychological, a disease or a collection of conditions, or something else – the antipsychotics are symptomatic medications [nothing like penicillin that cures certain infections or insulin that replaces something that’s not working right]. They are often dramatically effective for the positive symptoms of acute psychosis but do nothing of note for the less dramatic negative symptoms [anhedonia, cognitive deficits, lack of motivation, etc.] nor for the often elaborate delusions seen in chronic paranoia.

One of he things I liked about the articles by Seth Prins was that he transcended all the rhetoric that often goes with this issue and seemed to be after the facts. What was not in his data that I wanted to see was the distinction between jails and prisons. I couldn’t find anything omnibus on jails for mental illness prevalence, but I did, at least, find some comparative total incarceration rates:

I’ll have to admit that I’m overwhelmed by these numbers. I had no idea that the incarceration rates were this high. I keep running across the phrase, "America’s experiment with mass incarceration," a label that seems apt [apparently it was an easier experiment to do than it has been to undo]. And it has hardly been cheap…

 

Speculations about the causes for our high rate of incarceration and the over-representation of the mentally ill in the prison and jail populations are met with divisive opinions about what to do about either situation. One pole, for example, supports the solutions proposed by the Treatment Advocacy Center advocatng community commitment including mandated medication. On the other pole, there is strong opposition to those methods from civil libertarians groups [see here-we-go-again?]. While the debates are often cached in terms of biomedicine and psychiatry versus other mental health disciplines and the civil liberties, or neuroscience versus humanism, my impression is that the mental health disciplines as a group [psychiatry, psychology, social work, etc.] have been otherwise preoccupied for the last quarter-century, and with the exception of those directly employed by public facilities or those involved in brain research, they have been monotonously saying the same things they said a long time ago. There is so much in this story to decry, and there’s certainly still a lot of decrying going on, but solutions or progress? not so much.

It may not be completely apparent in the segments I clipped from the Prins articles, but his reason for advocating that we focus our attention on accurate assessments of the distributions of mental illnesses in these incarcerated populations isn’t just to document the problem:
    Our ability to accurately measure the impact of such programs, in addition to changes in more fundamental causes of the prevalence of mental illnesses in prisons [such as drug policies], depends largely on the sorts of estimates summarized in this review. Also of interest to policy makers and practitioners is the fact that most of the roughly 2.3 million incarcerated individuals in the United States will be released, contributing to the approximately 4.8 million individuals — a majority of the U.S. corrections population — who reside in the community on probation and parole. About 43% of these individuals will be detained again within three years. As such, accurately measuring the prevalence of mental illnesses “inside the walls” is essential for community corrections planning. Given the existence of brief, well-validated instruments that screen for mental illnesses, such as the Brief Jail Mental Health Screen, K6, and Correctional Mental Health Screen, reporting standards for routine assessments upon intake are clearly feasible.
He’s proposing that we develop a knowledge base that allows us to evaluate the effectiveness of the various correctional programs in an ongoing way, something that might get us away from the endless speculating and ideological bickering. In the journal with his recent article, there was a companion commentary from several authors from the School of Social Work at Temple University that I thought was intriguing:
Commentary: Not Just Variation in Estimates: Deinstitutionalization of the Justice System
by Jeffrey Draine and Miguel Muñoz-Laboy
Psychiatric Services. 2014 65[7]:873-873.

… In 2002, the first author and his colleagues questioned the presumption that the large number of incarcerated people with mental illness was attributable to failures in the assessment and treatment of mental illness and concluded that there is no reliable evidence that directing resources toward psychiatric treatment would have a significant impact on incarceration rates. In this commentary, we argue that this conclusion remains true. In the article by Prins, the implied logic is that there is interpretive value in examining variations in the rates of mental illnesses in jails and prisons to discern the impact of psychiatric interventions. Holding to the principle that the most parsimonious explanation is best, the factor that explains the variation in the proportions of prisoners with mental illness is variation in correctional policy and practice among jurisdictions and over time, rather than variation in access to treatment for mental illness or in how mental illness is assessed or counted in prisons and jails. The more recent variation in rates of mental illness is also likely enhanced by the beginning of a shift in correctional policy: the decline of incarceration in prisons.

Abramson laid the groundwork for examining connections between deinstitutionalization of psychiatric treatment and the rising number of incarcerated people with mental illnesses. Historically, institutions such as orphanages, poorhouses, and asylums have, each in their own time, experienced a profound increase in their populations, which was followed by a period of deinstitutionalization. Initially, the reasons given for deinstitutionalization are humane treatment, but eventually the most persuasive arguments center on cost and efficiency in state systems and the availability of plausible alternatives. In the United States, practice shifted from poorhouses to outdoor relief, charity movements, and social work; from orphanages to child welfare systems, foster care, and juvenile justice systems; from asylums to community mental health; and now from prisons to community corrections.

With the emergence of community corrections and the eventual downsizing of prisons and jails, many people with mental illness once incarcerated in conventional facilities will more often be involved in various forms of community corrections… Correctional health care policy focused on large prisons and jails has not caught up with the impact of deinstitutionalization in the provision of psychiatric care to vulnerable populations. As a result, a growing number of individuals with serious psychiatric disorders are left without reliable access to effective psychiatric treatment. This commentary seeks to refocus attention away from efforts to establish a standard for rates of incarcerated persons with mental illness in conventional facilities with the aim of informing mental health interventions. The action is not there. The place for action in innovation, change, and planning is in community settings. Our goal should be to document variations across place and time in how the differences and changes in corrections practices interrupt effective care and to develop creative ways to recognize as a reality in the justice system the ongoing changes in corrections environments and the broad variation in incarcerated populations.
The title says it all. They’re proposing that the variablility in the data isn’t just some kind of measurement error, but represents a potential source of valuable information about various correctional programs, something that could be further developed to find answers in a data driven system – another kind of deinstitutionalization [this time jails and prisons] that is evidence-based and focused on a community correctional system that includes patients with mental illness. I expect neuroscientists and humanists alike can find things in this approach to worry about. But it would be hard to argue with trying something different informed by a different mind-set, particularly if it proceeded by iteration based on constantly changing and accurate contemporary data. It would be hard to make a bigger mess than the one we have right now…
Mickey @ 9:00 PM
Filed under: OPINION
transinstitutionalization? III…

Posted on Friday 19 December 2014

I started this by reading one paper by Seth Prins and then another, the reports from the Bureau of Prisons, and an international study from Oxford – but I looked at a lot of others along the way. The data available isn’t very good. It’s hard to get excited about self-reporting questionnaires from prisoners as an accurate index of the prevalence of mental illness among the incarcerated. And the more precise information [diagnosis by interview] isn’t comprehensive. Throw in the fact that psychiatric diagnosis has radically changed in the period under question, and things get pretty mushy. But there’s something else that makes all of this infinitely more confusing, at least to me – a ringer. This is the population of incarcerated people in American Public State and Federal prisons:
And here’s the rate of incarceration over a long period of time:
The US now has far and away the largest prison population in the world no matter how it’s measured – the trend starting in the 1970s and continuing to escalate until around 2000 when it finally began to slow [see Incarceration in the United States]. Independent of the reasons for this dramatic change, it makes it very difficult to isolate the forces acting on the Mentally Ill population.

Whereupon 1boringoldman goes off on a tangent

My problem is that transinstitutionalization as a concept both makes good sense and makes absolutely no sense at all. It was a huge happening, moving half a million people into the community, many of whom had chronic psychotic illnesses and a history of having been institutionalized. In my time [1970s], there was plenty of commerce among the jails, the police, the psychiatric emergency rooms, and the dwindling mental hospitals, but there was nothing that felt like it had to do with past history – even then. It felt like a today problem. The problem was with actively psychotic people with no place to stabilize them or chronic patients living on the streets with no place to go. And as brisk as the traffic between the hospitals and the jails, I don’t recall prison being in the mix. We had a model, but no way to adequately implement it. So I went back and started over. I began with this graph in transinstitutionalization? I…:

It’s all over the Internet [Google Images] – little wonder that I found it. It comes from a 2011 Law Journal article that’s not even about transinstitutionalization. It’s about violent crime eg homicide:
by Bernard E. Harcourt
The Journal of Legal Studies. 2011 40[1]:39-83.
[full text on-line]

Previous research suggests that mass incarceration in the United States may have contributed to lower rates of violent crime since the 1990s but, surprisingly, finds no evidence of an effect of imprisonment on violent crime prior to 1991. This raises what Steven Levitt has called “a real puzzle.” This study offers the solution to the puzzle: the error in all prior studies is that they focus exclusively on rates of imprisonment, rather than using a measure that combines institutionalization in both prisons and mental hospitals. Using state-level panel-data re- gressions over the 68-year period from 1934 to 2001 and controlling for economic conditions, youth population rates, criminal justice enforcement, and demographic factors, this study finds a large, robust, and statistically significant relationship between aggregated institutionalization [in mental hospitals and prisons] and homicide rates, providing strong evidence of what should now be called an institutionalization effect — rather than, more simply but inaccurately, an imprisonment or incapacitation effect.
The premise is that in the dip between deinstitutionalization and mass incarceration, there was a dramatic [and related] spike in violent crime – proxied by homicide. On the left below, I’ve lifted and added the homicide rates from Harcourt’s paper [note the scale differences] and on the right, I’ve taken the drama out of it by fitting the homicide spike to the same scale as the other parameters].
As much as I love graphs, regressions, and correlations, I don’t buy that premise for a single second, because that time-span happens to have been my adult life – and I’ve noticed that there were some other things going on: like the Civil Rights Movement, the War in Viet Nam, the Cuban Missile Crisis, the Assassinations [JFK, MLK, RFK], the Cold War, the Sixties Protests and Drug Cultures, Watts, the rise of the Drug problem in the 70s, Watergate, Reaganomics, tax cuts, spending cuts, growing national debt, personal computers, the rise of corporations, massive wealth inequity, the end of the Cold War, the medicalization of psychiatry, the businification of medicine, Monica Lewinsky? – just to mention a few among the gajillion other factors that might matter.

I have no real dog in that particular hunt, but it got me to thinking about what Seth Prins proposed about transinstitutionalization in that first article I looked at [see transinstitutionalization? I…], and my experienced life during the period in question:
    Discussion In the debate summarized above, proponents of the transinstitutionalization hypothesis may be mistakenly drawing a causal connection between two merely correlated trends: the decline in availability of state psychiatric hospital beds and the rise in prevalence of SMI in jails and prisons. More specifically, they may [a] misinterpret deinstitutionalization as a flood of individuals who were released from state psychiatric hospitals only to be arrested and incarcerated, [b] conflate evidence that people released from psychiatric hospitals often require re-hospitalization with evidence that jails and prisons are serving that function [c] erroneously assume that people who require inpatient services are clinically and demographically similar to people with SMI who wind up in jails and prisons and [d] underestimate the effectiveness of high quality community-based treatment. The evidence against the transinstitutionalization hypothesis is compelling because [a] most people released from state psychiatric hospitals do not appear to end up incarcerated, [b] the characteristics of people with SMI in jails and prisons differ from both the characteristics of people who were deinstitutionalized and the past decades’ increasingly forensic state psychiatric hospital population, and [c] many agree that community-based treatment works for the majority of people with SMI.
… and for the same reasons I mentioned above, I agree with him. I don’t questions that our jails in many big cities are functioning like the short-term mental facilities we no longer have, and that the criminal justice system has had to take over some of the functions better handled by an intact community-based, mental health system. And I sure don’t doubt that many mental patients in prisons shouldn’t be there, and wouldn’t be there were there some reasonable system of ongoing care that functioned properly. And if transinstitutionalization were just a slang for the obvious truth – that our society has failed in its basic function of taking decent care of the less fortunate among us – I suppose this wouldn’t matter. But it’s more than that. It implies an inevitability, an excuse for our indifference to the lot of the chronically mentally ill. It’s just way too simplistic and leaves out huge swathes of related history.

[to be continued]
Mickey @ 10:00 PM
Filed under: OPINION
transinstitutionalization? II…

Posted on Thursday 18 December 2014

This is where we left off:

by Seth J. Prins, M.P.H.
Psychiatric Services. 2014 65:862-872.
Objective: People with mental illnesses are understood to be over-represented in the U.S. criminal justice system, and accurate prevalence estimates in corrections settings are crucial for planning and implementing preventive and diversionary policies and programs. Despite consistent scholarly attention to mental illness in corrections facilities, only two federal self-report surveys are typically cited, and they may not represent the extent of relevant data. This systematic review was conducted to develop a broader picture of mental illness prevalence in U.S. state prisons and to identify methodological challenges to obtaining accurate and consistent estimates.
Methods: MEDLINE, PsycINFO, the National Criminal Justice Reference Service, Social Services Abstracts, Social Work Abstracts, and Sociological Abstracts were searched. Studies were included if they were published between 1989 and 2013, focused on U.S. state prisons, reported prevalence of diagnoses and symptoms of DSM axis I disorders, and identified screening and assessment strategies.
Conclusions: Definitions of mental illnesses, sampling strategies, and case ascertainment strategies likely contributed to inconsistency in findings. Other reasons for study heterogeneity are discussed, and implications for public health are explored.

[These are a colorized versions of his figures with lots of tailoring to make them fit, but I think they are at least a reasonable fascimile of his findings for just looking over, but if you’re really interested, get the original. Each diamond represents the results of one of the studies he looked at.]
We don’t have any choice here but to start with his methods in detail:
Methods: A systematic review of the scholarly literature was conducted to identify studies that presented prevalence estimates of mental illnesses in prisons. Articles were included if they were published in peer-reviewed, English-language journals between January 1989 and December 2013, focused on U.S. state prisons, reported prevalence estimates of diagnoses or symptoms of DSM axis I disorders, and clearly identified the denominator for prevalence proportions.
Articles were excluded if they did not present original data; focused solely on axis II disorders, youths, jails, or foreign prisons; selected samples only of people with mental illnesses or substance use disorders; presented only combined jail and prison prevalence estimates; did not present prevalence estimates [for example, presented only mean scale scores or odds ratios for disorders]; or the denominator for prevalence estimates was not apparent. Samples selected on the basis of substance use were excluded given the high rates at which substance use disorders co-occur with mental illnesses among incarcerated individuals, which would therefore not provide good estimates of mental illnesses per se. A review of the prevalence of substance use disorders in prisons was beyond the scope of this report.
MEDLINE, PsycINFO, the National Criminal Justice Reference Service, Social Services Abstracts, Social Work Abstracts, and Sociological Abstracts were searched. For MEDLINE and PsycINFO, combinations of the following medical subject headings [MeSH] were used: mental disorders, mental health, prevalence, incidence, epidemiology, psychotropic drugs, drug therapy, prisons, and prisoners. For the remaining databases, similar keyword combinations, including axis I disorder terms, were searched…
The initial search yielded 3,670 non-duplicated articles. Based on titles and abstracts, 3,388 articles did not meet inclusion criteria and were excluded… Full texts of the 282 remaining articles were reviewed, and an additional 254 studies were rejected based on exclusion criteria outlined above… Twenty-eight articles were thus included in the review…
First off, I think Seth Prins is a real scientist. He took a relatively large unmanageable literature, clipped it down to size using the usually solid techniques of analysis, and presented it without "dolling it up." But 3670-»3388-»282-»28 is quite a bit of paring down, and leaves us with questions about what this sample actually represents. The variability among the studies is equally striking. But that’s not his doing. It’s what he found to work with. Most of his in-depth discussion is about the many sources of variability in his findings and are too much for a blog post, but his message is clear, and I buy it. Debates, opinions, policies, and public dollars are riding on the numbers of mentally ill people in our prisons, why they are there, and how they got there. We need a whole lot better data than we have to make evidence-based decisions about how to proceed. He mentions some instruments that might help in doing that, though I’m unfamiliar with them [I expect most of us are]:
As such, accurately measuring the prevalence of mental illnesses “inside the walls” is essential for community corrections planning. Given the existence of brief, well-validated instruments that screen for mental illnesses, such as the Brief Jail Mental Health Screen, K6, and Correctional Mental Health Screen, reporting standards for routine assessments upon intake are clearly feasible. Even in the absence of such standards, prison administrators, working in collaboration with mental health policy makers and practitioners, can [at relatively low cost] calibrate such screening instruments to their populations and begin collecting valid and reliable prevalence estimates.
In my own dancing around through this literature over the last week or so, I’ve been finding the same thing Prins found in his formal analysis – heterogeneity². There are innumerable local studies, specific to certain areas, places, kind of detention facility, etc, but when I aim for the big picture, what I find is researchers struggling to do some kind of meta-analysis with widely divergent methodologies [big surveys with questionnaires or small focused studies with precise instruments]. This next one is a world-wide study, that’s actually an update from a previous meta-analysis and has broken out the US data longitudinally [and it’s available on-line]:
by Fazel S and Seewald K
British Journal of Psychiatry. 2012 200[5]:364-373.

BACKGROUND: High levels of psychiatric morbidity in prisoners have been documented in many countries, but it is not known whether rates of mental illness have been increasing over time or whether the prevalence differs between low-middle-income countries compared with high-income ones.
AIMS: To systematically review prevalence studies for psychotic illness and major depression in prisoners, provide summary estimates and investigate sources of heterogeneity between studies using meta-regression.
METHOD: Studies from 1966 to 2010 were identified using ten bibliographic indexes and reference lists. Inclusion criteria were unselected prison samples and that clinical examination or semi-structured instruments were used to make DSM or ICD diagnoses of the relevant disorders.
RESULTS: We identified 109 samples including 33 588 prisoners in 24 countries. Data were meta-analysed using random-effects models, and we found a pooled prevalence of psychosis of 3.6% [95% CI 3.1-4.2] in male prisoners and 3.9% [95% CI 2.7-5.0] in female prisoners. There were high levels of heterogeneity, some of which was explained by studies in low-middle-income countries reporting higher prevalences of psychosis [5.5%, 95% CI 4.2-6.8; P = 0.035 on meta-regression]. The pooled prevalence of major depression was 10.2% [95% CI 8.8-11.7] in male prisoners and 14.1% [95% CI 10.2-18.1] in female prisoners. The prevalence of these disorders did not appear to be increasing over time, apart from depression in the USA [P = 0.008].
CONCLUSIONS: High levels of psychiatric morbidity are consistently reported in prisoners from many countries over four decades. Further research is needed to confirm whether higher rates of mental illness are found in low- and middle-income nations, and examine trends over time within nations with large prison populations.
As with Prins, first to the methods:
Method: We identified publications estimating the prevalence of psychotic disorders [including psychosis, schizophrenia, schizophreniform disorders, manic episodes] and major depression among prisoners that were published between 1 January 1966 and 31 December 2010. For the period 1 January 1966 to 31 December 2000, methods are described in a previous systematic review conducted by one of the authors. For the update and expanded review, from 1 January 2001 to 31 December 2010, we used the following databases: PsycINFO, Global Health, MEDLINE, Web of Science, PubMed, National Criminal Justice Reference Service, EMBASE, OpenSIGLE, SCOPUS, Google Scholar, scanned references and corresponded with experts in the field. Key words used for the database search were the following: mental*, psych*, prevalence, disorder, prison*, inmate, jail, and also combinations of those. Non-English language articles were translated. We followed PRISMA criteria. Inclusion criteria were the: [a] study population was sampled from a general prison population; [b] diagnoses of the relevant disorders were made by clinical examination or by interviews using validated diagnostic instruments; [c] diagnoses met standardised diagnostic criteria for psychiatric disorders based on the ICD or the DSM; [d] prevalence rates were provided for the relevant disorders in the previous 6 months.
 
The full text version on-line has a comparison of the actual studies. Notice that the numbers fall here too – down to 25 different studies. Their method, like Prins, looked only at papers where diagnosis was made by interview. Their significant findings were higher rates of severe mental illness in prison in low income countries; an increasing prevalence of Major Depressive Disorder over time in the US; but no increase in the prevalence of psychosis in the US prison population. If anything, it fell.
 
So, what about transinstitutionalization?…
Mickey @ 1:54 PM
Filed under: OPINION
transinstitutionalization? I…

Posted on Wednesday 17 December 2014

There is so much divisiveness in discussions of matters that have to do with Mental Health and Mental Illness that it’s sometimes difficult to separate the wheat from the chaff. There’s a strong backlash to the medicalization of psychiatry, the heavy use of medications, the DSM-III etc. diagnostic system, and the claim/implication that all mental illness has some biological basis. On the other side there are claims that psychological counseling focusing on trauma and recovery will clear up most problems now called mental illness. It’s kind of hard to find much to read that doesn’t have some sort of rhetorical bias, visible in the first several paragraphs.

Back in my days on the wards as the de-Institutionalization of mental hospitals was winding down, it would’ve been pretty hard for anyone to maintain a belief that things were going very smoothly. Our admission units were full of people, many psychotic, and hospital beds were evaporating like a sno-cone dropped on hot pavement. At seminars and meetings, the topic was often punctuated by the Szasz meme of that day about the Myth of Mental Illness, and then back to work at the Grady Hospital Emergency room where things didn’t feel a bit mythical at all. Nobody I knew wanted to re-open any huge mental hospitals again. We just wanted short term beds to stabilize patients, and that didn’t mean just medicate, it meant trying to find a source of food and shelter that worked – a social placement, a life. The flow and the dwindling resources worked against that goal, resulting in the revolving door hospitalizations, very high rates of recidivism, and homeless people on the streets and sleeping under the bridges. The back-up promised by the Community Mental Health Movement seemed to be disappearing. The police that had to deal with these patients were fed up and vocal about it when they brought someone in for the second time in a week because the last hospitalization was so brief.

There was a concept, transinstitutionalization, frequently mentioned in these discussions:
    transinstitutionalization A process whereby individuals, supposedly deinstitutionalized as a result of community care policies, in practice end up in different institutions, rather than their own homes. For example, the mentally ill who are discharged from, or no longer admitted to, mental hospitals are frequently found in prisons, boarding-houses, nursing-homes, and homes for the elderly.
    A Dictionary of Sociology , 1998

I must’ve internalized the idea. I recently used this graph from this article to illustrate it in a few blog posts [functional improvement…, what they’re for…]:
Ever since I wrote those posts and read the interesting comments here, I’ve found myself looking for more actual data. Who are the people involved? What’s known about the jail populations? How many are psychotic or mentally ill people in jail for being afflicted with the age old severe mental illnesses? How many are people on the substance abuse train that’s swept through the world? But I haven’t found as much data as I’d hoped. Then recently, I ran across the article below. It opened with:
    The popular account of why people with serious mental illnesses [SMI] are overrepresented in jails and prisons is usually structured as follows: deinstitutionalization, combined with inadequate funding of community-based treatment for individuals in need of mental health services, has led to the criminalization of mental illness and attendant increases in incarceration rates. This represents a return to the conditions that psychiatric institutions were originally designed to alleviate. Indeed, the mainstream assumption that the state psychiatric hospital and criminal justice systems are functionally interdependent — a phenomenon described as transinstitutionalization — is commonly accepted.
Which is exactly what I thought from long ago. I looked further into the article:
by Prins SJ
Community Mental Health Journal. 2011 47[6]:716-722.

Abstract: Although there is broad consensus that people with serious mental illnesses [SMI] are overrepresented in correctional settings, there is less agreement about the policy trends that may have created this situation. Some researchers and policymakers posit a direct link between deinstitutionalization and increased rates of SMI in jails and prisons, a phenomenon described as transinstitutionalization. Others offer evidence that challenges this hypothesis and suggest that it may be a reductionist explanation. This paper reviews claims from both sides of the debate, and concludes that merely increasing access to state psychiatric hospital beds would likely not reduce the number of people with SMI in jails and prisons. A more nuanced approach is recommended for explaining why people with SMI become involved in the criminal justice system and why developing effective strategies to divert them out of jails and prisons and into community-based treatment is needed to improve both their mental health and criminal justice outcomes.
The abstract was more of a teaser than an abstract, so I commandeered his Discussion section where he fleshes out what he’s getting at:
Discussion In the debate summarized above, proponents of the transinstitutionalization hypothesis may be mistakenly drawing a causal connection between two merely correlated trends: the decline in availability of state psychiatric hospital beds and the rise in prevalence of SMI in jails and prisons. More specifically, they may [a] misinterpret deinstitutionalization as a flood of individuals who were released from state psychiatric hospitals only to be arrested and incarcerated, [b] conflate evidence that people released from psychiatric hospitals often require re-hospitalization with evidence that jails and prisons are serving that function [c] erroneously assume that people who require inpatient services are clinically and demographically similar to people with SMI who wind up in jails and prisons and [d] underestimate the effectiveness of high quality community-based treatment. The evidence against the transinstitutionalization hypothesis is compelling because [a] most people released from state psychiatric hospitals do not appear to end up incarcerated, [b] the characteristics of people with SMI in jails and prisons differ from both the characteristics of people who were deinstitutionalized and the past decades’ increasingly forensic state psychiatric hospital population, and [c] many agree that community-based treatment works for the majority of people with SMI.

This is not to say, however, that conclusive evidence currently exists on either side of the debate. More rigorous analysis to clearly define the causal relationship between deinstitutionalization and the overrepresentation of people with SMI in jails and prisons is certainly warranted [for example, retrospectively matching archival inpatient, arrest, and incarceration records]. The arguments presented above should also not imply that the cases for and against increased access to inpatient services are irreconcilable. Indeed, the most important takeaway from this debate may be a fact that is often overlooked by policymakers working to address this issue: people with mental illnesses are not a homogenous population. Increased access to acute and intermediate psychiatric beds may, in fact, be necessary for a small but high-risk, high-cost group of people with severe mental illnesses who cycle through emergency rooms and the criminal justice system without obtaining the treatment they need [Pasic et al. 2005 ]. For these individuals, shortages of 24-hour hospital care [and for this group and others with SMI, affordable housing more broadly] are indeed a problem.

Nevertheless, increased access to inpatient services may not be an optimal focus for a multi-systemic criminal justice/mental health policy strategy. The ramifications of casting too wide an inpatient net would not only be expensive, but would move away from the goal of full community integration of people with mental illnesses that is the hallmark of the rights and recovery movement [New Freedom Commission on Mental Health 2003 ]. Pragmatically, it might be argued, that reinstitutionalizing people with SMI who become involved in the criminal justice system is the lesser of evils, since treatment conditions in psychiatric hospitals are bound to be better than those in jails and prisons. This reasoning, however, addresses one problem by creating a new [but familiar] one, and avoids tackling the issues at the heart of the matter.

Broadly speaking, the popular account of current mental health policy is correct: people with SMI are being ‘‘locked up’’ in jails and prisons as was the case 200 years ago. Understanding why this is happening, however, is important for developing strategies to appropriately divert people with SMI out of jails and prisons and into the treatment they need to become productive members of their communities. The history of deinstitutionalization provides an intuitive but reductionist narrative about the reasons why people with SMI are overrepresented in correctional settings. At the very least, policymakers and researchers should treat the transinstitutionalization hypothesis with caution and not as a presupposition. Failure to approach this issue with the nuance it requires may unwittingly imply expen- sive interventions that will benefit only a fraction of the population at issue. For the large remainder of people with SMI in jails and prisons, other causes of their involvement with the criminal justice system should not be ignored. In this regard, shifts in philosophy and ideology behind the concept of deinstitutionalization are still relevant. For the majority of this group, the key to staying out of hospitals, jails, and prisons may be a place to live, a job or some income support, a meaningful relationship or social network, quality healthcare, or linkage to treatment instead of frequent arrest for substance use disorders — fundamental needs that can best be redressed in the community, not psychiatric or correctional institutions.
I was looking for numbers, and what I found was a think piece, but it was a good think piece. So I wrote the author at the listed email address asking for references. Of course, the email bounced back not found. But in looking around, I found this next article which is what I wanted to ask him about in the first place:
by Seth J. Prins, M.P.H.
Psychiatric Services. 2014 65:862-872.

Objective: People with mental illnesses are understood to be over-represented in the U.S. criminal justice system, and accurate prevalence estimates in corrections settings are crucial for planning and implementing preventive and diversionary policies and programs. Despite consistent scholarly attention to mental illness in corrections facilities, only two federal self-report surveys are typically cited, and they may not represent the extent of relevant data. This systematic review was conducted to develop a broader picture of mental illness prevalence in U.S. state prisons and to identify methodological challenges to obtaining accurate and consistent estimates.
Methods: MEDLINE, PsycINFO, the National Criminal Justice Reference Service, Social Services Abstracts, Social Work Abstracts, and Sociological Abstracts were searched. Studies were included if they were published between 1989 and 2013, focused on U.S. state prisons, reported prevalence of diagnoses and symptoms of DSM axis I disorders, and identified screening and assessment strategies.
Conclusions: Definitions of mental illnesses, sampling strategies, and case ascertainment strategies likely contributed to inconsistency in findings. Other reasons for study heterogeneity are discussed, and implications for public health are explored.

The reason I had kept on looking is what he says [highlighted in red]. Everything I found went back to only a few references. So Seth Prins went looking for data too. I think I’ll defer what he found [or didn’t find] to the next post before this one runs off the page. Here are the two often quoted reports he mentioned:
The problem with these reports? It’s in the methods – self report questionnaires:
    "Among this handful, two reports by the U.S. Bureau of Justice Statistics have been cited at least 1,100 times, according to a recent query of Google Scholar. These reports used self-report surveys and defined mental illnesses as a current mental or emotional condition, a prior overnight stay in a “mental hospital,” or endorsement of symptoms of mental disorders in the Diagnostic and Statistical Manual of Mental Disorders [DSM]. Prevalence estimates were three to 12 times higher than in community samples, reaching as high as 64%."

Take a look at the first page of each report and you’ll see what he means…
Mickey @ 4:22 PM
Filed under: OPINION