1 Boring Old Man

That ad in the last post for VITAL™ doesn’t say what it’s for, but this does:

It reminds me of those early days for me when I started a psychiatry residency in 1974. It was late in the Golden Age of Deinstitutionaliation when all the old State Hospitals were nearly emptied and the Community Mental Health Movement money was drying up like the pavement after a summer shower. The lectures still presented this as a triumph of the human spirit, but from my vantage point in a big city psychiatric emergency room, it felt more like the Siege of the Alamo. The police brought a stream of out of control psychotic people in from the streets where they’d arrived after a brief stay in what was left of a regional mental hospital. It was called "the revolving door," but it felt more like a water slide. The police were frustrated. The patients were frustrated and frustrating. We were too. So young residents would get hardened, and began to talk like Schizophrenia was a neuroleptic deficiency syndrome. In morning rounds, you’d hear "Schiz CUT [chronic undifferentiated type] stopped his meds two weeks ago" as if that was an explanatory narrative. At that time, Prolixin Decanoate was the injectable drug and teams with names like "community care" would visit boarding homes [the new hospitals] entreating patients to come in for their lixin shots. Sometimes, nurses were dispatched to give them in the boarding homes. Like I said, déjà vu.

I was older than the other residents, more used to chronic disease, and I didn’t get caught up in that cynicism so much. I’d seen the old State Hospital and been in the boarding houses. Neither was particularly inviting, but I had to agree that the latter version was relatively better. Periods of cynicism, disillusionment, and frustration are part of any medical training, but this particular version got to me. Later, as a chief resident and then training director, I wouldn’t let people get away with that Schizophrenia as a neuroleptic deficiency syndrome talk. I’d make them take a real history, and suggest that if they thought these medications were fun to take, "… go home tonight and take 1mg of Haldol and tell us how that felt tomorrow [if you can make it to work]." And I actually presumed the enthusiasm for Prolixin Decanoate had waned and didn’t give it much thought until earlier this year when I reviewed the European Schizophrenia Study:

Incidence of extrapyramidal symptoms and tardive dyskinesia in schizophrenia: thirty-six-month results from the European schizophrenia outpatient health outcomes study.
^{Lilly Research Centre, Eli Lilly and Company, Windlesham, Surrey, United Kingdom.}

by Novick D, Haro JM, Bertsch J, and Haddad PM.

Journal of Clinical Psychopharmacology. 2010 30(5):531-40.

^{The incidence of treatment-emergent extrapyramidal symptoms (EPSs) and tardive dyskinesia (TD) in schizophrenic patients, and the clinical characteristics associated with an increased risk of developing EPSs and TD were examined. Patients (N = 7728) in the 3-year, prospective, observational Schizophrenia Outpatient Health Outcomes study were examined according to baseline antipsychotic drug exposure. At baseline, 4893 patients (63.3%) had no EPS, and 6921 (89.6%) had no TD. Extrapyramidal symptoms and TD were assessed separately during follow-up: frequency and time to appearance from Kaplan-Meier survival curves and factors associated with time to appearance using Cox proportional hazard regression models. The cumulative incidence of EPS ranged from 7.7% (olanzapine) to 32.8% (depot typical drugs). Compared with olanzapine, patients taking depot typical drugs, oral typical drugs, risperidone, and amisulpride had a significantly higher risk of developing EPS. Differences from clozapine were marginally significant. High baseline clinical severity was associated with a significantly higher risk of developing EPS. The incidence of TD ranged from 2.8% (olanzapine) to 11.1% (depot typical agent). Compared with olanzapine, patients taking depot typical agents, oral typical agents, and risperidone had a significantly higher risk of developing TD. Baseline factors associated with a significantly higher risk of developing TD were age, EPS, a higher negative Clinical Global Impression score, and presence of gynecomastia. In summary, patients treated with typical antipsychotic agents (oral and depot) and risperidone had a higher risk of developing EPS and TD than patients treated with olanzapine. Higher baseline clinical severity was associated with EPS development, whereas age, presence of EPS, a higher negative Clinical Global Impression score, and presence of gynecomastia were associated with TD development.}

^{From Eli Lilly and Company, Windlesham, Surrey, United Kingdom; †Departament de Psiquiatrı´a, Universitat Auto`noma de Barcelona, Spain; ‡Sant Joan de De´u-SSM, CIBERSAM; §Sant Joan de De´u-SSM, Fundacio Sant Joan de De´u, Sant Boi, Barcelona, Spain; and ||Greater Manchester West Mental Health NHS Foundation Trust and University of Manchester, Manchester, United Kingdom.
Received September 14, 2009; accepted after revision July 9, 2010.
Reprints: Diego Novick, MD, Lilly Research Centre, Eli Lilly and Company,
Erl Wood Manor, Sunninghill Rd, Windlesham, Surrey, GU20 6PH, United Kingdom
The Schizophrenia Outpatient Health Outcomes study was funded by Eli Lilly and Company.
Copyright * 2010 by Lippincott Williams & Wilkins}

^{AUTHOR DISCLOSURE INFORMATION
Diego Novick is a Lilly employee. Josep Maria Haro has acted as a consultant, received grants, or acted as a speaker in activities sponsored by the following companies: AstraZeneca, Eli Lilly, GlaxoSmithKline, and Lundbeck. Jordan Bertsch was a statistical consultant for the SOHO study. Peter M. Haddad received honoraria for lecturing and consultancy from the manufacturers of several antipsychotic agents including AstraZeneca, Bristol-Myers Squibb, Eli Lilly, and Janssen-Cilag.}

I want to linger for a moment on that ad [“no is the beginning of yes”…]. It’s not an ad for their products [INVEGA® SUSTENNA® and RISPERDAL® CONSTA®]. It’s not even an ad for the services in that announcement up there [Janssen® Connect™]. It’s an ad for ways a doctor can get patients to use their products. In the third video [Importance of the Therapeutic Alliance], we’re told how to get to know our patients, gain their trust, then use it to "guide the patient" into using these injectables – "use the therapeutic alliance" they say. They even quote an APA blurb about the Therapeutic Alliance [see top graphic]. If I may allow my inner analyst to speak, that really pisses me off. The concept of the Therapeutic Alliance was Freud’s, though it was named later by Edward Bibbering. It is an alliance between the patient’s healthy ego and the analyst against the destructive forces in the patient’s mind. It is not make friends with the patients so they’ll trust you and do what you want them to do. And speaking of trust, why does the psychiatrist want the patient to use Long Acting Therapy? It’s because the psychiatrist doesn’t trust the patient to take the medication. Freud’s and Bibbering’s Therapeutic Alliance is built on mutual trust, hard earned. Janssen’s Therapeutic Alliance is a con job. So Janssen’s marketing target is psychiatrists, not patients – in fact, it’s doctors who see their task as keeping Schizophrenic patients medicated by making friendly [and apparently need to be taught how to do that].