prelapse: but there’s more…

Posted on Tuesday 12 May 2015

Recently, when I was reviewing two RCTs for Brexpiprazole, a derivative of Abilify®, I found that each study had only one academic author for each. The rest were pharmaceutical company employees. Both articles had "editorial assistance" [AKA ghost-writers] from the same firm and both were funded and administrated by the drug’s sponsor – Otsuka. Looking further, the two academic authors were from the same Department of Psychiatry at Hofstra and both were associated with the Feinstein Institute. And the two studies were spread over 117 clinical sites all over the US and World [the spice must flow…]. So everything about the studies was industry generated. But there’s more. One of the Brexpiprazole academic authors was also the senior author on a recent Abilify Maintena® RCT and both of them were part of a free CME about Abilify Maintena® [machiavellian medicine lives…]. Otsuka is certainly getting its money’s worth from the Department of Psychiatry at Hofstra. But there’s more. One of the authors on everything I just mentioned, Dr. John Kane, is the Principle Investigator on the NIMH RAISE-ETP [Recovery After an Initial Schizophrenia Episode] Project as well as being Chairman of Psychiatry at Hofstra. That was last week.

But there’s more. This week, I read Johanna Ryan’s article [The Once and Future Abilify: Depot Injections for Everyone?] and found that Dr. John Kane is Principle Investigator on the PRELAPSE study I’ve been talking about here using Abilify Maintena® in first episode Schizophrenia. The study is going to be done by a new CRO, Vanguard Research, at the Feinstein Research Institute. Watch the video to hear Dr. John Kane, founder of Vanguard, discuss this PRELAPSE RCT and hear how the Vanguard network arose from the NIMH study [RAISE?]. Now look at this Newsday article describing the $28M deal to do this study.
Vanguard will manage a clinical trial evaluating Abilify Maintena®, a once-monthly injectable version of a blockbuster drug made by Otsuka America Pharmaceutical Inc. Vanguard is majority owned by North Shore-LIJ. Dr. John Kane, the health system’s senior vice president of behavioral health services, owns a minority stake.
So Abilify® is about to go off-patent, and we have all of this activity – and every bit of it has Dr. John Kane plastered right in the middle of things. The rule is supposed to be that there shouldn’t even be a possibility of Conflict of Interest. In this tangle, Conflict of Interest is all there is to see. This is going to be a short post, because I can’t think of anything to say. The PRELAPSE study is designed to carve out a new commercial indication for Abilify Maintena®, not for any valid clinical reason that’s apparent to me. This is the Academic·Industrial·Complex with Dr. John Kane and Otsuka at the helm at its worst. I rest my case on the evidence as presented…
Mickey @ 10:45 PM

prelapse: prequel2

Posted on Tuesday 12 May 2015

Back in the 1970s, the depot injectable antipsychotics were around and much discussed as a solution to non-compliance in patients who had frequent relapses because as soon as they left the hospital, they stopped taking medications. There were Prolixin Clinics, and visiting nurses who took the medication to the patients. It seemed to me that it sounded like a better idea than it was, at least in the inner-city environment where I worked. Besides the Big Brother [1984] feel to the scheme, many of the patients were as unlikely to show up for their monthly injection as they were to take their oral medication.  In recent history, the Long Acting Injectable [LAI] Atypical Antipsychotics tend to be released late as the drugs go off-patent, presumably as a patent extension ploy [above].

The  PRELAPSE study that I introduced in prelapse: prequel1  is unique in my experience. I was alerted to it by Johanna Ryan of RxISK and Mad-in-America in her well researched post [The Once and Future Abilify: Depot Injections for Everyone?]. They are proposing to start off with a depot antipsychotic in first episode of Schizophrenia. I suppose the logic is to get off "on the right foot" by using a depot medication from the get-go to pre-empt any noncompliance problems. Their proposal is to divvy up clinical sites, half of which will use treatment-as-usual with oral antipsychotics of the clinician’s choice, and the other will use the injectable Abilify Maintena®. They plan to compare the groups at two years.

Well, out of the gate, that study doesn’t make much sense. First, do I want to commit a patient to maintenance antipsychotics the day I meet him/her? What about the patients whose psychosis is short-lived and may never return?  Brief Reactive Psychosis it’s called? What about at least giving the patient the chance to recover and remain medication-free if possible. The depot medications have traditionally only been used for patients who have a recurrent relapsing pattern and are medication non-compliant. And there are plenty of people who would see this scheme as "forced drugging." But my complaint is something else, and why I started with the Dan Markingson story in prelapse: prequel1. When you treat a case of a first episode of Schizophrenia, you pick a drug and a dose, and monitor the response – adjusting the dose or changing drugs based on the patient’s clinical response. Some patients are very sensitive to the EPS symptoms or other side effects of one drug, and you don’t know that until you try. The goal is the minimum effective dose and that’s determined by usage. Some patients don’t respond to one medication, but another works just fine. With a depot medication, you’re committed from the start.

That’s what I think happened to Dan Markingson. He was started on a fixed dose of a drug in a blinded study. I don’t think he ever fully responded. He needed a clinician who was on top of things and tried upping the dose, or changing drugs – the kind of medication tweaking that’s necessary with many of the drugs we use in medicine. With depot medication, that’s always going to be impossible. I’d never do what’s suggested in this study in the real world of clinical psychiatry. Since these depot medications have been around for at least forty years, why didn’t we think of doing this a long time ago? There must be some other factor in deciding to try this scheme in first episode cases.

Well we know what that factor might be. Abilify® is a blockbuster drug extraordinaire, topping the revenue charts with $5.7B in profits last year. And it’s about to go off-patent meaning that the generic version is just around the corner. We’ve already discussed the fact that Otsuka is submitting Brexpiprazole to the FDA for approval. Brexpiprazole is a kissing cousin to Abilify® that they hope will help them hold on to some of the Abilify® market share [see the spice must flow…, machiavellian medicine lives…, and chunk of change…]. And this push seems to be in that same mold, extending the use of Abilify Maintena® into the first episode cases. But there’s another big piece of this story that gets us into a Conflict of Interests realm. Stay tuned…
Mickey @ 12:00 PM

prelapse: prequel1

Posted on Tuesday 12 May 2015

It’s not easy to talk about the condition we call Schizophrenia these days. Much of the controversy is about long the term management, giving antipsychotic medication not to treat an existing problem, but rather to prevent relapses – the chronic treatment of the chronic patient. Our existing antipsychotic medications aren’t much fun to take – having side effects, and in some cases, irreversible and debilitating side effects. On the other hand, maintenance antipsychotics do significantly decrease the incidence of relapse. And the tendency of patients with Schizophrenic illness to spontaneously stop taking medications is legendary. Anyone reading this likely has an opinion about how to deal with maintenance antipsychotics, and mercifully, that’s not what this post is about so we can table that particular rhetoric and its usual discord for the moment.

One solution is to use depot antipsychotics meaning the patient gets a shot monthly rather than pill[s] daily. And in some instances, these depot injections have been court ordered – known as a form of the "forced drugging" bitterly opposed by many activists. Again, not exactly the topic here, but it’s getting closer. I think almost all of us agree that the first episode of Schizophrenia is a special case. While the course up ahead is  unknown, most feel that our best chance of preventing a downhill course of illness is in how we handle that initial episode [we’d like to keep a psychotic break from ever happening at all, but efforts in that sphere have yet to bear fruit]. And that brings us to a case most of us know pretty well by now – Dan Markingson [his story is here].

Putting aside all the tragedy of that story for the moment, Dan was in a study for patients having their first episode of psychosis [CAFE]. It was a fairly straight-forward trial. The patients were blindly assigned to one of three Atypical Antipsychotics and followed for a year. You left the study one of three ways: Completion; Voluntary Withdrawal; Removed by a clinician [non-response]. This study was a clone of an earlier NIMH study, CATIE, except CAFE was acute rather than chronic cases. But that’s a big difference. The chronic patients in CATIE were known antipsychotic responders put on medication to see how long they would take it – a tolerability study. I can’t imagine treating a person with a first break with an unknown medication and dose. Treating an acute episode means adjusting the dose or changing drugs based on the response. I wouldn’t mind the patient or rater being blinded, but not the clinician. Had I been on the IRB, I’m sure I would’ve voted "no."

By my read of Dan’s case, he didn’t ever really respond to the medication, and after six months, he suicided – a tragedy that might have been prevented had his doctors been more vigilant and done the usual playing with medication and dose until they found something that worked. While that might not have worked, it was certainly a real possibility that was never tried – and if he hadn’t been in that study, it would’ve surely been attempted. And that brings us to another study in the works – PRELAPSE – the real topic of this post. Here’s the blurb from Clinicaltrials.gov:

The goal of this project is to show that the best possible option for preventing relapses in patients suffering from first episode [<1 year of anti-psychotic medication] or early phase [<5 years of lifetime exposure to anti-psychotic medication] schizophrenia is by enhancing medication adherence. The study is designed to answer the question of whether the use of long-acting injectable [LAI] antipsychotics early in the course of treatment can break the cycle of frequent relapse that affects so many patients with early phase schizophrenia. The participating research sites [not individual patients] will be randomly assigned to either medication prescribed by their treating physician [with no restrictions] or to a regimen that involves a monthly long acting injectable antipsychotic. The sites will be assigned on a one to one basis to either of the arms taking into account types of patient population and geographical area. Patients enrolled in the study will participate in regular assessments either over the phone or in person and be followed for a period of 2 years. The primary outcome measure is time to first hospitalization.
The drug here is Abilify Maintena®, the depot form of Abilify® [Aripiprazole]. So the study brings up two semi-separate issues: the use of depot medications to deal with medication compliance and the treatment of a first episode of Schizophrenia with a fixed dose of depot medication. This is a stopping place, but there’s more to come…
Mickey @ 10:00 AM

about time2

Posted on Sunday 10 May 2015

by Elizabeth Loder and Trish  Groves
British Medical Journal. 2015 350:h2373

Heeding calls from the Institute of Medicine, WHO, and the Nordic Trial Alliance, we are extending our policy. The movement to make data from clinical trials widely accessible has achieved enormous success, and it is now time for medical journals to play their part. From 1 July The BMJ will extend its requirements for data sharing to apply to all submitted clinical trials, not just those that test drugs or devices. The data transparency revolution is gathering pace.2 Last month, the World Health Organization [WHO] and the Nordic Trial Alliance released important declarations about clinical trial transparency.

These announcements come on the heels of the US Institute of Medicine’s [IOM] report on sharing clinical trial data, which called for a transformation of existing scientific culture to one where “data sharing is the expected norm.” The efforts of industry, too, must be acknowledged, some of which caught many people by surprise. In particular, Medtronic’s cooperation with the Yale University Open Data project and GlaxoSmithKline’s leadership on data disclosure efforts stand out.

WHO’s statement on public disclosure of clinical trial results and the accompanying rationale reiterate the organisation’s support for registration of clinical trials. WHO declares that the main results of clinical trials should be posted on a clinical trial registry or other acceptable website and submitted for journal publication within a year of study completion. The expectation is that results will be “made available publicly at most within 24 months of completion.” The statement does not call for mandatory sharing of primary data from trials but instead “encourages” sharing of research datasets “whenever appropriate.”

In a move that is particularly welcomed by Ben Goldacre, cofounder of the AllTrials campaign, WHO also recommends disclosure of previously conducted but unreported clinical trials in a searchable and free registry and says it is “desirable” that these trials should be published in a peer reviewed journal. Goldacre notes that this is important because “the overwhelming majority of prescriptions today are for treatments that came onto the market — and were therefore researched — over the preceding decades rather than the past five years”…
Mickey @ 10:34 PM

about time1

Posted on Sunday 10 May 2015

Mickey @ 9:55 PM

doesn’t compute…

Posted on Sunday 10 May 2015

The article synopsized below comes from the Family Practice News, taken from a psychopharmacology update held by the Nevada Psychiatric Association. The speaker is Karen Dineen Wagner who is the Vice Chair of the Department of Psychiatry and Behavioral Sciences and Director of the Division of Child and Adolescent Psychiatry at the University of Texas Medical Branch in Galveston. She is one of two candidates being currently voted on for President Elect of the American Academy of Child and Adolescent Psychiatry. But that’s hardly a full résumé. She was on Senator Grassley’s list of academic psychiatrists who had unreported pharmaceutical income. She was an author of on the byline of just about every industry created ghost-written Clinical Trial of antidepressants in adolescent depression – the 2004 Citalopam article drawing a public rebuke from the Journal Editor [and costing Forest $313M in fines] [see collusion with fiction…]:
In this update, she recommends routine treatment of adolescent depression with antidepressants, off-label, ignoring the Black Box Warning, and gives a script of what to say to over-ride parent’s worries about suicidality with the SSRIs in kids. Speaking of scripts, she has one for tossing off treatment with psychotherapy [CBT] altogether [too slow for her liking I guess]. She’s a frequent contributor to the Psychiatric Times where her articles often play up psychopharmacologic efficacy and downplay safety recommendations.
Family Practice News
By WHITNEY MCKNIGHT
February 26, 2015
Taking a thorough family history and understanding how to prescribe off-label medications can help physicians achieve more favorable outcomes when treating children and adolescents for depression, according to Dr. Karen Dineen Wagner. In addition, a willingness to prescribe newer, virtual therapies increases the chance for remission of depression in these patients, Dr. Wagner said at the annual psychopharmacology update held by the Nevada Psychiatric Association. Left untreated, the severe depression that occurs in just under 10% of U.S. teens and the more mild depression that occurs in about 12% can lead to severe impairment later in life, she said.

“If you think about it, that’s really a high prevalence in an adolescent disorder,” said Dr. Wagner, the Marie B. Gale Centennial Professor of Psychiatry and Behavioral Sciences at the University of Texas in Galveston. One out of six of these teens will go on to have depression and other psychosocial impairment in adulthood, as well as suicidal ideation [J. Am. Acad. Child Adolesc. Psychiatry 2010;49:980-989].

Even with treatment, the odds for recurrent depression later in life are 2:1 in favor of the mood disorder, according to Dr. Wagner, who cited a study showing that of 140 teens treated for depression, more than 90% experienced full remission, but more than half were depressed again an average of 6 years hence. More than three-quarters of those treated for depression went on to have nonmood disorders such as anxiety, substance abuse, and eating disorders [J. Affect. Disord. 2013;298-305]…

Repeated treatment failure, whether psychotherapeutic or pharmacogenic, therefore, might be related more to parental depression than the child’s own. “Check carefully for that. And keep in mind that the depressed parent may not be the one bringing in the child or teenager for treatment,” Dr. Wagner said [JAMA Psychiatry 2013;70:1161-1170]… 

Currently, the only approved pharmacologic options for children and teens are fluoxetine, which is indicated for use in 8- to 17-year-olds, and escitalopram, indicated for use in 12- to 17-year-olds. Dr. Wagner noted that escitalopram has only one study to back its efficacy in teens and that a second study including children as young as 6 years old was negative. Fluoxetine has three studies to back its efficacy in children and adolescents. If the age-appropriate medication elicits no response, the only pharmacologic treatments are off label. “Be sure you document that in the chart,” Dr. Wagner said.

Having surveyed available data from controlled pediatric depression trials, Dr. Wagner said the only two off-label medications she recommended physicians consider for their pediatric or adolescent patients were sertraline, which has been shown negative in individual trials but in a priori pooled analyses was found positive twice, and citalopram…

Even though some parents might worry about the demonstrated link between suicide and some antidepressants in teens, Dr. Wagner said clinicians should counsel families that the risk for suicide in untreated depression was higher at 12% [most antidepressants are around 1%] [JAMA Psychiatry 2013;70:300-310].

Making it somewhat easier to predict treatment courses is that about 60% of adolescents who respond early to antidepressant treatment will go on to remission, Dr. Wagner said. Resisting pressure from parents and patients to end the course of treatment too soon if they see early signs of recovery as synonymous with cure is important for avoiding relapse. Dr. Wagner recommended “starting the clock from the time when the child shows signs of having gotten well, and then adding 1 year.” She also said that tapering dosage over “a couple of months” was a valid approach, depending on the original dose…

Given that there is a notable placebo response rate in this population, and CBT is not thought to have harmful side effects, physicians might be tempted to start there, but Dr. Wagner said the combined effectiveness of CBT with medical management of depression was more efficacious than CBT alone. She cited a study showing that after 12 weeks, adolescents treated with fluoxetine in combination with CBT achieved a 73% response rate, whereas CBT only had a 48% rate. It wasn’t until week 36 in the study that the two methods reached parity. Fluoxetine alone in this cohort reached a 62% response rate by week 12, and an 81% response rate at week 36. “So, that’s what I say to parents, ‘Do we really have the time for psychotherapy alone to work?’ ” [Arch. Gen. Psychiatry 2007;64:1132-43]…
hat tip to 1boringyoungman… 
Robert Whitaker has a new article on Mad in America [Psychiatry Through the Lens of Institutional Corruption] in which he discusses his and Lisa Cosgrove’s new book. I’m holding off until I’ve actually read the book [Psychiatry Under the Influence], but in this article there’s an interesting distinction where he contrasts Institutional Corruption versus Individual Corruption
it is important to distinguish individual, quid-pro-quo, corruption from institutional corruption. The former is a story of “bad apples.” For instance, a politician takes a bribe in return for a political favor. That is quid-pro-quo corruption. Institutional corruption is of a different—and more societally damaging—type. Institutional corruption is a not a “bad apple” problem, but a “bad barrel” problem. The basic concept of institutional corruption is this: There are “economies of influence” that create “incentives” for behaviors by members of the institution that are antithetical to the institution’s public mission. When this happens, the “corrupt” behavior may become “normative,” and even go unrecognized as problematic by those within the institution… 
… and I had that in my mind when I read this article in Family Practice News about Wagner’s Update. To me, this one smacks of both a "bad apple" and a "bad barrel" candidate. It’s hard for me to get my mind around the fact that her biased recommendations on the treatment of adolescent depression based on publicly discredited studies, ghost-written with her name on the bylines, preaching a gospel of off-label prescribing and ignoring the FDA Black Box Warning, would have her in an endowed chair in a respected Department of Psychiatry, and in the running for President of the American Academy of Child and Adolescent Psychiatry. It just doesn’t compute…
Mickey @ 3:14 PM

for us all to hear…

Posted on Friday 8 May 2015

Former Governor Arne Caulson to the University of Minnesota Board of Regents [04/07/2015]
Mickey @ 3:56 PM

zero tolerance…

Posted on Thursday 7 May 2015

In the process of being involved in an in depth reanalysis of a Clinical Trial with full access to the raw data is that far and away, the most important deterrent to bias is strict adherence to the a priori Protocol as approved by the Institutional Review Board before commencing the study. A properly constructed Protocol covers all the bases before the batter even enters the box. It should be even possible to pre-program the analysis of the results prior to starting the study. Once you see the results, or even get a whiff of the results, Old Man Bias raises his ugly head whether you know it or not. I’m beginning to think the same thing about financial conflicts of interest. There’s a new article in the New England Journal that suggests that we’re too paranoid about industry misconduct these days, and jumping to conclusions [Reconnecting the Dots — Reinterpreting Industry–Physician Relations]. It feels like a biased report to me, designed to bring me around to a more tolerant position, but it had the opposite effect – pushing me in the direction of zero tolerance.

I recently reviewed two articles [both published ahead of print] on Brexpipradole, a new Atypical Antipsychotic apparently under review by the FDA for approval [the spice must flow…]:
by Correll CU, Skuban A, Ouyang J, Hobart M, Pfister S, McQuade RD, Nyilas M, Carson WH, Sanchez R, and Eriksson H.
American Journal of Psychiatry. 2015 Apr 16 [Epub ahead of print]
by Kane JM, Skuban, Ouyang, Hobart, Pfister, McQuade, Nyilas, Carson, Sanchez, and Eriksson.
Schizophrenia Research. 2015 Feb 12. [Epub ahead of print]
I hadn’t realized it, but I have something of a protocol when I look at a Clinical Trial these days:
  • Funding:
    These were both industry funded and industry managed studies [Otsuka and Lundbeck].
  • Trial:
    I look for who is in charge, an academic or company PI/Coordinator. These were both coordinated by the same industry employee. I also look at how many sites? US vs non US? academic vs CRC? These studies used 117 site! All over the place. And I look to see if the results have been posted – in this case neither had them…
  • Authors:
    Academic versus industry? In both articles, there was only one academic author for each, both from the same department of psychiatry, both with extensive industry affiliations. Everybody else was a company employee.
  • Acknowledgements:
    I look for "editorial support" AKA ghost-writers. Each of these had an individual ghost-writer but both from the same company.
  • Chemistry:
    In this case, Otsuka now has the number one selling drug, now going off-patent [Abilify®] so I looked to see if it is a knock-off of Abilify® [which it is]:
All of that came before reading the paper. But even with all of that, I missed something – that these same authors had been part of the Clinical Trial of Abilify®Maintena and its "free" CME [machiavellian medicine lives…].

So what’s my point? I think a better question is what’s their point? Of what use is an industry-funded, industry-orchestrated, industry-analyzed, ghost-written, blockbuster clone article ticketed into a scientific journal by professional KOL physicians who had little if anything to do with it? Maybe the drug is okay, and maybe not. For sure, it’s presented in its Sunday best in these papers. Is it any better than Abilify®? as good? worse? We’re unlikely to know from this made for television production. It just all seems like such a silly game being played – and played in the American Journal of Psychiatry and Schizophrenia Research at that.

The only positive thing I can say about all of this is that at least I could find out all of that stuff in a short period of time. It wasn’t so long ago that I could’ve found very little of that information. But when I was in practice, I could never have spent the time looking up stuff to know I was reading media productions rather than scientific articles. That’s why I’m becoming a zero tolerance person for Conflicts of Interest. It takes too long to wade through all of that to find out what I need to know about a medication. I’m not "too paranoid about industry misconduct these days, and jumping to conclusions [Reconnecting the Dots — Reinterpreting Industry–Physician Relations]." I’m just tired…
Mickey @ 6:11 PM

the rise and ??? of the guild…

Posted on Wednesday 6 May 2015

There’s something kind of unique about the last paradigm shift in American Psychiatry [see roots… and agendae…]. It didn’t happen just because of changes in the ways people thought or some scientific advances. It was orchestrated by the American Psychiatric Association and effected by a change in the Diagnostic System [which nail?…, a card laid…]. The changes were dramatic, and instituted by the professional organization itself instead of being put together after the fact. The 1980 DSM-III was a cause rather than a resultI don’t think it was imposed, because it caught on so quickly. But it wasn’t a grass roots change for sure. What it meant was that there was a concentration of power in the APA. The organization was put in charge in a different way. That’s a speculation on my part, but I think it’s pretty close. Since then, American psychiatrists have looked to the APA for direction. One could also say that in 1980, American psychiatry became homogenized. The internal discord that came before essentially faded away. Instead of being a forum where dissidents shook fists at each other, dissidents just faded away. Again, that’s my speculation based on my own observations – evidence-based but with a very small sample. In that sense, Levine and Whitaker are using the word «psychiatry» correctly to describe the homogeneous APA membership [in a guilded cage…].

The DSM-III was a raging success. Psychologists and Social workers gained more access to third party medical reimbursement by agreeing to accept the carriers’ terms. The insurance companies paid psychiatrists well for Med Checks. The analysts finally got around to settling for a role as psychotherapists and began training psychologists and social workers after losing a suit. PHARMA was generous to the academics with grants, and the drugs flowed out of the pipeline at a steady rate. Over the ensuing years, psychiatrists became medicators, the role Managed Care assigned to them. Tom Insel talked on about Clinical Neuroscience.

And then the Primary Care Physicians began to prescribe psychiatric medications, and a subset of the new academic psychiatrists got exposed as crooked; many of the industry-funded RCTs were questioned; the pipeline ran dry; the wondrous brain discoveries didn’t materialize; the medications didn’t turn out as planned; the cost-cutting kept happening; and the DSM-5 bombed; the anti-psychiatry forces were on the ascendancy… well, you know the rest. And I expect psychiatrists are looking to the APA for guidance. After all, that was now the seat of power, the self proclaimed compass for the medical specialty of psychiatry.

So at the 35 year mark since the last "shift," psychiatry seems to be back where it started. In 1980, the paradigm shift was orchestrated by the APA [and financed ultimately by PHARMA]. Now we’re looking for another "shift" it seems, but the direction isn’t apparent. There’s plenty of advice, and it’s surprisingly uniform. From Government Programs and Managed Care, the APA [and here], and Primary Care, the recommendation is Collaborative Care. Several stated reasons:
  1. Population Studies suggest that the incidence of untreated mental illness is high.
  2. Most psychiatric medication is prescribed by primary care physicians.
  3. Mentally ill people are high service users of medical facilities costing billions.
Here’s how Jurgen Unützer, M.D. describes Collaborative Care:
Although we have effective pharmacological and psychosocial treatments for most common mental disorders, they are not widely accessible, and only a minority of patients receive them. Many patients are not on medications at therapeutic doses or for long enough to see positive effects, while others continue to use medications even if they are not effective. As few as 20 percent of patients started on antidepressant medications in primary care show substantial clinical improvements. The situation is not much better for those referred for psychotherapy. Many who are referred don’t go. Others may receive an insufficient number of visits or ineffective forms of therapy, leaving big opportunities to close the gaps between what we know and what we do.

One way to help close these gaps is for psychiatrists to work more closely with our colleagues in primary care using a collaborative care approach. Originally developed and tested by Dr. Wayne Katon and colleagues at the University of Washington in the early 1990s, collaborative care has been examined in the treatment of depression and anxiety disorders in more than 80 randomized, controlled trials and has consistently been found to be more effective than care as usual. In such programs, psychiatrists work closely with primary care physicians and mental health care managers [usually a licensed clinical social worker, nurse, psychologist, or therapist]. Each team has a designated psychiatric consultant who provides systematic treatment recommendations on patients who are not improving as expected…
I said above, "There’s plenty of advice, and it’s surprisingly uniform." I was referring to Robert Whitaker:
… So I don’t believe it will be possible for psychiatry to change unless it identifies a new function that would be marketable, so to speak. Psychiatry needs to identify a change that would be consistent with its interests as a guild. The one faint possibility I see – and this may seem counterintuitive – is for psychiatry to become the profession that provides a critical view of psychiatric drugs. Family doctors do most of the prescribing of psychiatric drugs today, without any real sense of their risks and benefits, and so psychiatrists could stake out a role as being the experts who know how to use the drugs in a very selective, cautious manner, and the experts who know how to incorporate such drug treatment into a holistic, integrated form of care. If the public sees the drugs as quite problematic, as medications that can serve a purpose – but only if prescribed in a very nuanced way – then it will want to turn to physicians who understand well the problems with the drugs and their limitations. That is what I think must happen for psychiatry to change. Psychiatry must see a financial benefit from a proposed change, one consistent with guild interests.
Sounds like Collaborative Care to me. And Mad in America blogger Sandra Steingard takes that suggestion further, into the overall training of psychiatrists, in a comment on this blog:
But with the ACA, the ability of psychiatry to survive independently is quickly fading. Mickey has addressed this in some of his posts about the move to integrated care. And speaking as a psychiatrist who has spent her career in public sector work – where some of the most impaired and disenfranchised seek care [and have no other option] – we do not have the option to ignore the economic issues. This is one reason why I believe that for change to occur, many of the current functions of psychiatry need to be taken away from psychiatry and medicine. I think it is legitimate and important for there to be branch of medicine whose practitioners truly understand the judicious use of psychoactive drugs. They are complicated substances. I just do not think that function needs to be at the core of what we offer to people who experience the vast array of emotional/cognitive problems that currently fall under the umbrella of psychiatric attention [and to re-state, this is not intended to criticize the work of those who found their ways into doing psychotherapy as physicians. This was a viable career path for many at the time].
This is a lot to wrap one’s mind around. At a time in history when the main complaints about psychiatrists are that they don’t spend enough time with patients talking with them about their lives, and that psychiatrists are obsessed with biology and drug treatments, the solution is a model where the psychiatrist has no direct patient contact and is primarily an expert in using drugs?

I’m going to have to reread this stuff and let it settle…


Update: Sandra Steingard just wrote and clarified her comment above [which I really appreciate]:

I would like to elaborate a bit on what I have in mind because it seems I have not been as clear as I would like. My concept has nothing to do with collaborative models where a physician opines about a person he has never met. It also has nothing to do with assessment scales. It also is in no way tied to the widespread use of psychoactive substances for a myriad of quasi disorders for which drug efficacy is marginally if at all established. I continue to believe that the problems we are trying to address are complex and it often take time to establish a relationship and hear the full story. I see no way around that. And while I think there are ways to use the drugs to help people, I think there is still much we do not understand and this leads me to have a therapeutic conservatism in how the drugs are used. But the drugs are going to be used and some specialty in medicine would do well to make it their business to understand them, to be sophisticated about the inevitable polypharmacy, and to to delve into the consequences of long term use and withdrawal effects.

There is a model in Norway that centers around the primary care doctor. A team gets called in and meets with the person and the physician and others in the social network. A psychiatrist is part of the team. But the focus is on the talk and in coming to an understanding of the problem. Others can be brought in as needed – peers, employment specialist, therapists. When I think of collaborative care I have this in mind not checking a person’s latest PHQ-9 and suggesting an increase in the fluoxetine.
Mickey @ 8:00 PM

the guilded age…

Posted on Tuesday 5 May 2015

In guilding the lily… and in a guilded cage…  I discussed a sequence of articles that constitute a loose back and forth between Robert Whitaker and his followers with various psychiatrists. The debate is superficially about how the "Chemical Imbalance" metaphor came into being. I want to react further to the very first article in the bunch, the interview with Robert Whitaker by Bruce Levine, a Psychologist/Activist who blogs on Mad in America and is also an independent author.
Truthout
by Bruce Levine
March 5, 2014

Bruce Levine’s Question: Is it really possible for psychiatry to reform in any meaningful way given their complete embrace of the "medical model of mental illness," their idea that emotional and behavioral problems are caused by a bio-chemical defect of some type? Can they really reform when their profession as a financial enterprise rests on drug prescribing, electroshock and other bio-chemical-electrical treatments? Can psychiatry do anything but pay lip service to a more holistic/integrative view that includes psychological, spiritual, social, cultural and political realities?

Robert Whitaker’s Answer: I think we have to appreciate this fact: any medical specialty has guild interests, meaning that it needs to protect the market value of its treatments. If it is going to abandon one form of treatment, it needs to be able to replace it with another. It can’t change if there is no replacement in the offing. 

When the APA published DSM-III, it basically ceded talk therapy to psychologists, counselors, social workers and so forth.
Of course, that’s exactly what happened! But this is the first time I’ve ever seen it written down in this matter-of-fact way [or for that matter, written down at all]. But the Talk Therapy Cession Decree of 1980 must have been brokered in a back room and kept under lock and key, because it was never openly discussed – it just happened. Since I was  primarily a Psychiatrist Talk Therapist, I ended up leaving academic psychiatry, the APA, and the world of Managed Care and practicing for the next twenty-five years [which explains why I was so oblivious to so much of what happened in that quarter century]. I guess I’m glad the Talk Therapy Cession Decree of 1980 was such a well kept secret. If I’d known about it, I might have missed my whole career.
Psychiatry’s three domains, in the marketplace, were diagnostics, research, and the prescribing of drugs. Now, 34 years later, we see that its diagnostics are being dismissed as invalid; its research has failed to identify the biology of mental disorders; to validate its diagnostics; and its drug treatments are increasingly being seen as not very effective or even harmful. That is the story of a profession that has reason to feel insecure about its place in the marketplace.

Yet, as you suggest, this is why it is going to be so hard for psychiatry to reform. Diagnosis and the prescribing of drugs constitute the main function of psychiatrists today in our society. From a guild perspective, the profession needs to maintain the public’s belief in the value of that function. So I don’t believe it will be possible for psychiatry to change unless it identifies a new function that would be marketable, so to speak. Psychiatry needs to identify a change that would be consistent with its interests as a guild…
This particular view of psychiatrists is made even more explicit in Dr. Levine’s initial question:
Is it really possible for psychiatry to reform in any meaningful way given their complete embrace of the "medical model of mental illness," their idea that emotional and behavioral problems are caused by a bio-chemical defect of some type? Can they really reform when their profession as a financial enterprise rests on drug prescribing, electroshock and other bio-chemical-electrical treatments? Can psychiatry do anything but pay lip service to a more holistic/integrative view that includes psychological, spiritual, social, cultural and political realities?
There can only be one possible answer to those questions in their stated form – "No!" A decidedly loud "No!" at that. And following Whitaker’s logic, psychiatry has painted itself into such an impossible corner that it can only escape by coming up with some completely different thing to do with itself [like the Collaborative Care currently being suggested by SAMHSA and the APA]. So if you’re a psychiatrist who completely embraces the medical model of mental illness, or has the idea that emotional and behavioral problems are caused by a biochemical defect, or whose practice rests on drug prescribing, electroshock and other bio-chemical-electrical treatments, or who only pays lip service to a more holistic/integrative view, or who signed on to the Talk Therapy Cession Decree of 1980, or who accepts the APA as the representative guild that defines psychiatry – you’re in the group Whitaker is prognosticating about here.

Dr. Levine’s comment which contains a definition of psychiatry that I was talking about when I said "My own complaint about Whitaker and his followers is that they use the word «psychiatry» as if it represents a personified unitary entity, but I’ll clarify that point later" in my last post [in a guilded cage…]. In 1980, I was a trained psychiatrist running a psychiatry training program and was in training as a psychoanalyst. But what I really was was an Internist who had become fascinated with the psychology of my medical patients and decided that’s what I wanted to treat. I was doing psychiatry for obvious reasons, and psychoanalysis because those were the guys who I thought knew how and where to listen. It wasn’t the theories that mattered to me, it was listening to the background and I was well pleased with the training I was getting. And then the world went kind of crazy, and all that business in Dr. Levine’s definition came up. It’s not that I was opposed to biology. I had come from a background steeped in that. But, as they say, "Been there, Done that, Got my tee shirt."

I’m not giving my history as a template for others. It was my road, not a highway system. But I fled from the direction mainstream psychiatry was taking  because I didn’t want to go in that direction [and because I thought it was a bad idea]. I was absolutely fine with the ambiguity of psychology, philosophy, biology, and socio-something I had found. In the years that followed, "my kind of" psychiatry was vilified and I became pretty isolated. But I was plenty busy and found my work satisfying and effective enough for my patients. But here’s my only real point. I am and was a psychiatrist that whole time. Psychiatrists are physicians who specialize in the treatment of mental illnesses. The revolution of 1980 was because people thought that psychoanalysis had too much influence on psychiatry. They were right. I sort of knew that at the time, and I know it even more now. But changing over to a system where another dead european guy, Emil Kraepelin, got to have too much influence wasn’t okay with me either [all ears…, an open question…].

Dr. Levine’s questions have a lot of his guild in them too. Whitaker’s response, not so much – more balanced. But there’s something missing in what they’re both saying. They’re coming into a story in the phase of paradigm exhaustion and there’s an as yet undetermined paradigm shift in the offing. They’re using the term «psychiatry» as if their definition encompasses all psychiatrists [and it doesn’t, even now]. And they’re not taking into account that the winds are changing already [or even considering that they are part of the as yet undetermined paradigm shift in the offing]. They’re assuming that there really is a Talk Therapy Cession Decree of 1980 that’s binding [and there isn’t] and that psychiatrists as a group really are like the ones in this straw man version of «psychiatry». And speaking of paradigm exhaustion, Managed Care is wearing a bit thin these days too…
Mickey @ 4:00 PM