This introduces a gigantic topic, polarizing at first breath, the source of a divisiveness that reaches into antiquity – what to do about Schizophrenia. But first, are these drugs efficacious? Are these drugs safe?
When it comes to the question of the psychotic Schizophrenic person, one has to always question whether you are doing something for the patient, with the patient, or to the patient. And often times, the patient himself isn’t much help, particularly under the sway of active hallucinations or compelling delusions. This is not, to me, something to be considered in a general way sitting in an armchair in your study. It’s something that has to be dealt with in proximity to the patient in question. Most people go through life neither experiencing nor being around active psychosis, and so thinking about the topic is uninformed by the disease in question – and in its more florid form, it’s a show-stopper. I remember my early days in psychiatry training in Grady Hospital in Atlanta. I thought of it as "Fort Apache, the Bronx" the name of a contemporary television show. On call at night, first he elevator bell would sound, and here would come a family or the police with some out of control, delusional person fighting and screaming. The staff who had been there for decades would settle things down, then I was supposed to do something definitive – like make a diagnosis, decide on a course of action, maybe sign commitment papers to force hospitalization. No matter what I did, somebody didn’t like it – the patient, the family, the police, the ward staff, sometimes even me.
After a time, it became easier, or at least clearer. The criteria were simple. Was the person mentally ill? yes/no. Was the person immediately dangerous to himself or other people? yes/no. That decision was going to be reviewed on the next day by someone higher up, and in a few days by a judge. I could answer those questions and didn’t have to deal with the fact that I was depriving a person of their civil liberties without due process of law for a day. I didn’t like doing it. Was I doing something for the patient, with the patient, or to the patient? In those days, there was Dr. Thomas Szasz and a host of antipsychiatrists who said I was being an agent of the State, not a doctor. And on those long nights, it seemed like I was always riding against the waves. If I thought the patient needed hospitalization, they didn’t agree. If I thought the patient didn’t need to be hospitalized, they wanted in. The on-call room was next to the nursing station with a window overlooking I-75/85. On several of those nights, I dreamed that it was falling off of the building and smashing onto the highway – a testimony to both what it’s like to be around that many psychotic people and my own wish to escape.
In the scope of things, those decisions that felt so cataclysmic in those early days were really not a problem for me. I could see that I was doing something for the patients after all. For one thing, they continued to be my patients and when they got better, we got on just fine. And I knew that had I seen them thirty years earlier, they would’ve ended up in Central State Hospital where way too many might have spent the majority of their lives suffering the kind of deterioration I read about in the older psychiatry texts and occasionally saw. I could see with my own eyes that the acute treatment of florid psychosis with neuroleptic medication was doing something for the patient. And even though I never particularly liked being in the situation of signing those papers, I came to agree that better someone like me than someone who didn’t know this strange illness called Schizophrenia inside and out [though I’ll admit to heavy reliance on the staff who had been there forever and just "knew" what to do].
But I never got there with the treatment of Chronic Schizophrenia. Schizophrenic patients are notoriously "non-compliant" in taking medication long term. There are plenty of reasons. The side effects or just how the stuff makes you feel is a rational reason. The medicine may ablate psychotic symptoms, but it doesn’t do much for the anhedonia [lack of pleasurable feelings] or other "negative" symptoms. But there are plenty of other reasons, like being controlled, poisoned, etc. And you don’t have to be around too long to realize that the florid symptoms have a positive "feel." A delusion explains the confusing world. Or as a patient once said, "You want to hear my voices? They keep me from feeling lonely out there on the road." So the treatment of acute psychosis had turned a chronic progressive illness for many into an illness where the psychotic symptoms remit, then return with another psychotic episode. And there’s little question that staying on medication lowers the frequency of relapses. And as the literature review here [RISPERDAL® CONSTA®] says, being on depot medication lowers the recurrence rate even more than counting on the patients to take it themselves. I expect that’s true. But I’m not sure we have the right to push constant medication. The courts don’t think so either.
So enter stage left, Janssen Pharmaceuticals who is offering to teach doctors how the be compliant with the injunction to keep people on medication by getting the patients to be on Long Acting Injectable Therapy [VITAL™], and thereby get the Schizophrenic Patients to be more compliant. They’ve even put together a program to make it easier for patients [Janssen® Connect™ Launches In California].
Of course INVEGA® SUSTENNA® is a patent extender. Of course Janssen® Connect™ and VITAL™ are attempts to sell more drugs. That goes without saying. That’s their right. It’s what Janssen does. But there are other considerations. Even if neuroleptics were completely benign, I’m not sure I’d agree with "forcing the issue" of medication. Maybe people with Schizophrenia need a fling with psychosis every once and a while as relief from the blandness of their experience otherwise, who knows? I sure don’t, but I don’t have to think about such questions because neuroleptics [no matter what generation] are not benign. That part is clear as a bell. So if you are a Chronic Schizophrenic, is the injunction to always be on medication something that is being done for you, with you, or to you? I can think of only a few situations where it’s that clear that it’s for you. And, by the way, these two drugs are targeted towards the Public Mental Health systems where most Schizophrenic patients receive treatment. There, it’s only clear that it’s good for the bean counters who do cost accounting in public medicine. Keep them on meds, lower hospital costs.
I just sat through a trial in Texas about a company named Janssen Pharmaceuticals who took a drug called Risperdal that by all rights was only indicated in Adult Schizophrenia and turned it into a blockbuster yielding $30+ billion in profit by invading Public Health Systems and Child Psychiatry [even though there were essentially no FDA approvals for children] using methods that were criminal – jury-rigged guidelines, hired KOLs, off label promotion by Sales Reps. Now, I’m reading about a company called Janssen with a drug called something very like Risperdal [9-hydroxy-risperidone] that is only for a few people in Public Health Systems who have an uncommon illness [Schizophrenia] – a company who is off and running with a new, peculiar marketing campaign. I find that disturbing. I can see them pitching this stuff to Formulary Administrators and Public System upper eschelon. Steven Shon has already given it a shot with RISPERDAL® CONSTA® in the TMAP guidelines. I can see this being touted to people treating Foster kids and other kids. I called my last post déjà vu because it reminded me of the 1970s, but I’m also having TMAP déjà vu because it reminded me of the very recent weeks as well.
Risperal reproached.
Same saga here as Eli Lilly Zyprexa.
Johnson and Johnson is a trusted brand we associate with babies.
Risperdal,Zyprexa,as well as the other atypical antipsychotics, are being prescribed for children, even though this is an unapproved, off-label use. An estimated 2.5 million children are now taking atypical antipsychotics. Over half are being given them for Attention Deficit Hyperactivity Disorder,many of these foster children.
Weight gain, increases in triglyceride levels and associated risks for (life-long) diabetes and cardiovascular disease.
Lilly made $65 billion on Zyprexa!
–Daniel Haszard
*Tell the truth don’t be afraid*
I’m confused. Back in your days at Grady, when you were acting as an agent of the State, helping to deprive innocent citizens of their Liberty without due process of law, did you conclude you were doing something FOR these people, or TO them?
Often FOR, Sometimes TO, Sometimes WITH
So the ends justify the means. Did anybody at J&J make such an argument?
Sorry. I’m only willing to debate this point with people who have been in this situation and seen the old State hospitals. I’m still a person who would commit and medicate a person in the throes of an acute psychotic episode who is dangerous. It’s why I’m not an anti-psychiatrist or a Szaszian. I’m not on the side of involuntary medication or involuntary hospitalization otherwise. I’m 70 years old and have heard the other side of that argument for at least 40 years, even tried it on for size. Of course I don’t think the ends justify the means. So, if you must, have your way with me. I’ll publish all the comments.
“There was less weight gain than I would’ve thought, and not as many cases of Diabetes or Tardive Dyskinesia.”
Less encountered – or less REPORTED? I suspect the latter.
Easy, Mickey, I realize it’s an unpleasant point, but it’s an indispensable principle (Liberty, that is).
I take issue with the argument that no one can go toe-to-toe with you unless they’ve seen what you’ve seen. What’s that called? The fallacy of “Argument from Experience”?
Allen
I agree with that. I’m usually a little softer on the FDA than most because I think they’re strait-jacketed, but in this area, I think the onus is on them to investigate situations like this where the reported data is non-intuitive. Even if they approve it with a bunch of adverse effects, it would be better to have accurate figures and warnings. We know that the weight gain, the metabolic syndrome, EPS, and TD are higher than reported with Risperdal. Why would it be less with the injectables? And what’s the hurry? Why not require a one or two year study? Efficacy is a late comer as an FDA directive. Safety is the original reason for there even being an FDA…
I don’t think your suspicions are over the top or misplaced. Marketing plans don’t emerge and roll out overnight. They include plans for years down the road. A company that took a drug for adult schizophrenia and turned it into a blockbuster by.among other things, illegally promoting its use in kids, is certainly capable of trying to promote the injectable for groups where compliance and follow up may be difficult–whether or not the drug is appropriate. Foster kids is a primary group.
Talbot,
After looking into all the twists and turns with TMAP and the Janssen Sales Reps, I’m in the guilty until proven innocent camp when it comes to Janssen. What’s that saying?
Dr Nardo:
Somewhat tangential to your post, but pertinent to your “softer” stance relative to the FDA: have you seen the recent news reports of that agency going full barrel after whistleblower scientists/staffers?
And to remind folks that only governmental employees have any so-called WB protections at all? The rest of the private sector employees are employees at whim. And when the whim of an organization turns its sights on YOU, the results are invariably grim.
This background always makes me wonder about the employees – Janssen, in this case – who desire to act ethically, but who like Dr. Balt so eloquently writes, believe that they cannot due to perceptions of career/financial/personal threat.
AEK,
Yeah, I saw it. I didn’t like it much either. It’s on my ‘look into’ list…
I’ve been on risperidone since 1997. I’ve recently cut my dosage from 6mg daily to 1mg daily and I feel like Robert De Niro from the film called, ‘Awakenings’. Best wishes. 🙂
Bear with me here —
I am wondering if, knowing that antipsychotics shorten lifespan, doctors are consciously or subconsciously trying to reduce the population of people with disruptive behavior problems by prescribing them.
In nursing homes, this has emerged as a conscious calculation in controlling those with dementia, trading off x number of years of life for docility in the present.
This would be a throwback to the eugenics movement of not so long ago, justifying the prescription of unproven life-shortening drugs to those the doctor deems socially undesirable.
You wrote: “So the treatment of acute psychosis had turned a chronic progressive illness for many into an illness where the psychotic symptoms remit, then return with another psychotic episode. And there’s little question that staying on medication lowers the frequency of relapses.”
I thought there was increasing controversy over these beliefs. Robert Whitaker’s book “Anatomy of an Epidemic” (among other sources) suggests that the long-term use of medication may be worsening the chronicity and progressiveness of schizophrenia. Have you read this book? What do you think of its conclusions and their relevance to the above statements?
Yes, I’ve read it [and liked it]. I’m not actually referring to long term maintenance on neuroleptics. I’m talking about treating acute psychosis and backing off if at all possible thereafter. I think Whitaker might disagree with even that. But if your question is about routine, long term use of medication to prevent relapse – I’m against that for many reasons. In life, patients make that decision themselves. They regularly stop the medications. I see that as not only their perogative but often good thinking. In patients who choose long term medication [and there are many of those], I would try to minimize that usage because of long term side effects. On the other hand, if a person is floridly psychotic and dangerous, I would treat with neuroleptic medications most of the time – as short a term as possible]. One thing often left out of these discussions is that even chronically schizophrenic people often improve in later life. The point would be to get them there unafflicted by other things like TD or DM. And the patients are not all the same. What’s good for one isn’t necessarily good for all. Human variation trumps schizophrenia every time.
That specific comment “the treatment of acute psychosis had turned a chronic progressive illness for many into an illness where the psychotic symptoms remit, then return with another psychotic episode” refers to something specific. When this illness was first described, it was called “dementia praecox.” People came into the hospital, deteriorated globally, and died early deaths. The chronic forms of the illness – hebephrenia, catatonia, etc. are rarely seen now. The progressive extreme deterioration isn’t so much seen, even in chronic patients. What we see is periodic psychotic episodes with variable chronic symptoms in between – presumably a result of treating the acute episodes. Very different from previous centuries.
Great posts from the frontlines of the J&J TMAP trial! Thanks for the citizen reporting!