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Long-acting injections of antipsychotics: pharma can’t shake the stigma, or the data! 05/17/2012

Posted by ALT in Pharmaceuticals, Treatments, Uncategorized.
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13 comments

In honor of Robert Whitaker’s recent kick-ass article beautifully re-affirming the central premise of Anatomy of an Epidemic (namely that anti-psychotic medications worsen long-term outcomes for patients, making schizophrenia into a chronic, lifelong disease when in its natural state it is episodic; and therefore that patients who refuse treatment with antipsychotics are scientifically justified in doing so), I thought we might launch our own little expedition into the stormy seas of antipsychotic/neuroleptic discourse.

I’m steering us straight towards the tempest, towards the ever-blurrier line between “compliance,” “adherence,” and outright “forced treatment,” towards a history of Orwellian language shift that simply can’t seem to shake the truth.

Long-acting injections of antipsychotic medication

Long-acting injections are monthly, time-released, intramuscular injections of antipsychotic medications.  They figure prominently in current “assisted outpatient” therapeutic practice (ie, forced drugging outside the walls of the psychiatric institutions), and are being heavily promoted by drug companies who see expiration dates on patents for oral antipsychotic medications looming in the near future or already arrived.  Can the pharma marketing machine succeed in making LAIs the next wave of antipsychotic blockbuster drugs?

It’s going to take a serious makeover.  You see, long-acting injections have got something of a “bad image” in the press, and in the hearts and minds of the people.  Perceived as brain-altering drugs violently administered to unwilling subjects, clinicans’ last resort to enforce adherence to an un-agreed-upon reality [treatment plan], a hideously efficient way for pharma to make a buck or two [hundred].

But is this really a case of “bad image”, of misperception… or is it an accurate appraisal of long-acting injections’ intended and fully acknowledged clinical applications?

As clinicians we struggle on a daily basis with patients who do not want treatment because they do not perceive that medication helps or because they do not conceptualise their experiences within a medical illness framework.  Long-acting injections have often been used to enforce adherence in patients who do not or will not take medication; they can be a mechanism allowing clinicians to take control.

-Richard Gray, RN, PhD*in “Antipsychotic long-acting injections in clinical practice: medication management and patient choice” [emphasis added]

And furthermore…

According to systematic reviews approximately 40–60% of patients with schizophrenia are known to be partially or totally non-adherent to oral antipsychotic medication. Long-acting injections are indicated where medication adherence is a cause for concern. Thus it is argued by some that it might seem reasonable to consider such injections for approximately half of patients with schizophrenia.

- authors Maxine Patel, Mark Taylor and Anthony S. David** in “Antipsychotic Long-Acting Injections: Mind the Gap” [emphasis added]

Yep.  We had you guys all wrong.  This isn’t about forcing patient adherence to clinicians’ treatment plans, and it certainly isn’t about expanding the market for LAIs.

Funny thing.  “Long-acting injections,” when first introduced in the 1960s, were referred to as “depot injections” … but the name acquired a strong stigma and had to be changed:

Many proponents of LAIs [long-acting injections] have attempted to dodge this [image problem] by rejecting the term ‘depot,’ which was perceived to be stigmatizing, in favour of ‘long-acting injection’ … this was partly an attempt to move away from stigmatizing stereotypes, and also to promote therapeutic optimism for a population for whom hope can be all too scarce.

- Patel et al in “Antipsychotic Long-Acting Injections: Mind the Gap

As late as 2008, long-acting injections of Risperidone were still being called “depot” injections, but by 2009 articles like the one cited above made clear that this terminology had been abandoned.

But they couldn’t shake the stigma

Not only that, but serious, data-based challenges to the forced administration of long-acting injections –- and, more fundamentally, the existence of any clinical value for antipsychotics whatsoever —  are rapidly multiplying.  As one example:

We are embracing the increased use of outpatient commitment laws that force people to take antipsychotic medications, and we do so under the belief that these drugs are a necessary good for those people. This is an extraordinary thing for a society to do, to force people to take medications that alter their minds and experience of the world.

Yet, here is the story told in Anatomy of an Epidemic: If we look closely at Harrow’s study [citation here] and a long list of other research, there is good reason to believe that these medications increase psychotic symptoms over the long-term, increase feelings of anxiety, impair cognitive function, cause tardive dyskinesia with some frequency, and dramatically reduce the likelihood that people will fully recover and be able to work. If this is so, how can we, as a society, defend our increasing embrace of forced treatment laws?

-Robert Whitaker, author of Anatomy of an Epidemic, in the aforementioned kick-ass essay

From pharma’s perspective, another Orwellian language shift is needed.  Time to reset the dial of public opinion on long-acting injections… and so I give you the newest name for an old terror:

Intramuscular Medication

That does sound better!  It doesn’t make me think of needles.  Doesn’t even sound like an injection… sounds more like a “muscle relaxer,” only more intra.

I first saw the term a few weeks ago in Dr. H. Steven Moffic’s delightful little Psychiatric Times blog entitled “Is it time for Re-institutionalization?

Recently, I was asked to write a request to possibly extend the outpatient commitment of a patient of mine. What for, I said to myself? This would be a waste of time because he had not exhibited any more dangerous behavior, was taking care of himself, and was compliant with his intramuscular medication. However, when as part of the ongoing monitoring of my patient’s improvement, I asked him to rate on a 0-10 (best) scale how well the medication was working, he said “0”. When I asked why, he said it was because he didn’t need the medication. Uh, oh, I thought. Could this be Anosognosia?…

There’s no way he’ll be committed longer, but will he stay on the medication voluntarily? Without it he’d surely relapse into psychosis and possible dangerousness. If he then went inpatient again, would he only stay a few days, not enough to address his ideas about the medication? It didn’t help enough the first time around.

-Dr. Steven Moffic

But it’s cropping up elsewhere, too – in the academic literature, and in drug company advertising materials, of course.  You can even see the shift in brand names as new antipsychotic injections are approved over time; the earliest approved LAI, Janssen’s Risperdal, is frequently referred to as LARI [Long-acting Risperidone Injection], while the more recently approved Zyprexa injection’s official brand name is “Zyprexa Intramuscular.”

I forecast the increasing encroachment of the term “intramuscular medication” into the official, APA/pharma-approved, “therapeutic” language, until our fears of “long-acting injections” are a half-forgotten nightmare that no longer sees the light of day.

OR

Or we could insist on calling a spade a spade.

So-called “antipsychotics” are nothing of the kind (they’ve actually been shown to cause psychosis), and are much more appropriately referred to by their first given name, neuroleptic, which literally means “brain damage inducing.”  Why?  Because that is what the research proves, over and over again, they do.

From now on let’s choose names that accurately describe the items to which they’re attached.  For example, “rose” = a pretty flower that smells good.  A few other examples:

Intramuscular Medication = Neuroleptic (brain damage inducing) Injection

Non-compliant Patient = Conscientious Objector to the Chemical Takeover of His Mind

That sums it up pretty clearly, doesn’t it?


* (Oh, and by the way, Richard Gray has received funding and/or fees from AstraZeneca Pharmaceuticals, Bristol-Myers Squibb, Janssen Pharmaceuticals, Eli Lilly, Otsuka Pharmaceuticals and Pfizer.)

** (And it should come as no surprise that the authors have been reimbursed for attendance at scientific conferences and have received consultation fees from Janssen-Cilag and Eli Lilly, received investigator-initiated grants from Janssen-Cilag and Eli Lilly, have worked on two clinical drug trials for Janssen-Cilag, and have received hospitality and advisory or speaker fees from AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Janssen-Cilag within the past 5 years.)

Flowers in the Bloodstream: one man’s quest to make the prescribing of long-acting antipsychotic injections an ethical obligation 01/19/2012

Posted by ALT in Mental Health News, Mental Health Policy and Inititatives, Pharmaceuticals.
Tags: , , , , , , , , ,
7 comments

This is an ad I saw in my sidebar the other day.  Look at what they did.  It’s so devilishly clever, isn’t it?

(click image to enlarge)

If you’re a real “psychiatrist who cares,” you’ll talk to your patients about [or, rather, talk them into] a long-lasting injection of anti-psychotic medication – essentially, Risperdal — directly into their bloodstream.

Now some patients are not going to be compliant when it comes to having these akathisia-, diabetes-, tardive dyskinesia-causing, brain-shrinking drugs with [at best] dubious efficacy forcibly slow-released in their bodies for a month.  So Janssen has kindly provided several little educational videos (accessible by clicking on the ad, or here) to help doctors figure out how to do that.

They’re set up to look like academic lectures, and they have nice-sounding titles like “Positive Engagement: Therapeutic Alliance & Long-acting Therapy Given by Injection in the Treatment of Schizophrenia.”  I felt really good after I read words like “positive,” “engagement,” and “therapeutic.”

But then I watched one of them.

It features a man by the name of Xavier Amador, Ph.D. giving a powerpoint lecture designed by Janssen.

Xavier Amador, for Janssen Pharmaceuticals

In it, he explains what is really meant by those lovely words I mentioned above.

Most fascinating is the manner in which he approaches “therapeutic.”  According to Xavier, part of the problem with schizophrenics is that they don’t always agree that they’re suffering from a lifelong illness, that recovery is impossible, and that they need drugs for the rest of their lives.*  They don’t know they’re sick!

There’s a special name for this in psycho-babble – it’s called anosognosia.

Here’s the key: folks who do know they’re sick (again, by the above definition), are the ones most likely to take their medications.  To be compliant.  And so the real role of the “psychiatrist who cares” is to therapeutically convince the patient that he is indeed sick in this manner, and that he should take his meds, preferably via injection.

Dr. Xavier Amador, funded by Janssen, has spent a good deal of his professional career hawking an evidence-based practice (he calls it “LEAP”) guaranteed to do just that.

He goes into greater detail in another presentation, also funded by Janssen, which he gave at a government-sponsored conference in New Jersey last year.

Entitled, “I am not sick, I don’t need help,” the presentation is all about anosognosia, how it “impairs common sense judgment about the need for treatment,” and how overcoming it is “one of the top predictors of long-term medication adherence.” [which he appears to equate with recovery]

What causes anosognosia?  Our beloved Amador posits that it may be

Psychological defense? “Culture” and/or Education?  Or Neuropsychological Defects??

- Xavier Amador, in his presentation “I am not sick, I don’t need help” [emphasis added]

Yes, it is somewhat funny that a self-proclaimed “academic” would stand – in all seriousness – in front of a slide bearing that message.

But as it turns out Amador has been standing in front of silly slides and saying equally ridiculous things for years.

Amador and anosognosia go way back

All the way back to 1997, in fact, when Amador was involved in the trial of Ted Kaczynski, also known as the “Unabomber.”  Kaczynski did not want to mount a defense based on a plea of mental illness or insanity and actually went to great lengths to block his attorneys from doing so.  He maintained that his actions were deliberate, a logical result of his personal philosophy as outlined in his Manifesto and extensive journals (which he stated he kept, in part, to prove that he was not “mentally ill”).  Kaczynski wanted people to understand the motivations for his actions and not have them be discredited as the “ravings” of a schizophrenic – and he was willing to risk the death penalty in order to so.

Nevertheless, a court-ordered psychiatric evaluation conducted found him to be schizophrenic (full text available here – also by court order, so that the public might gain a “better understanding of the Unabomber’s [schizophrenic] motivations”).

That he was found to be schizophrenic really comes as no surprise.  As one of my favorite studies shows, even people displaying no psychiatric symptoms whatsoever have little trouble obtaining that label.

And what were Kaczynski’s symptoms? His “lack of personal relationships,” his “delusional thinking involving being controlled by modern technology,” and (drumroll, please) anosognosia.

Amador, who served as an independent expert for the court, reviewed Kaczyinski’s extensive psychiatric records, neuropsychological test results, and the infamous unabomber diaries. Amador then supplied the court with mounting evidence that Kaczynski’s refusal to be evaluated related to anosognosia, a manifestation of Kaczynski’s schizophrenia.

- from this article on Amador’s anosognosia activism

That one of Kaczynski’s three main symptoms of schizophrenia was his detailed and carefully documented denial of having it and resistance to being labelled doesn’t appear to strike Amador as funny.  I might add that Kaczynski’s other main symptom — “delusional” worries about the all-important role technology seems to play in our society and the isolating effects that understandably follow — has troubled me, and hundreds of thousands of others, from time to time.  Does that make us all sick?

I guess it does if they say it does!

The article goes on to share some of Amador’s initial inspiration to coin and then promote the term “anosognosia:”

It was his experience as a clinician and as a brother of someone with schizophrenia, Amador said, that led him to do research on anosognosia, “which is not to be confused with denial,” he emphasized, although in the beginning, he did not make that distinction. “That’s what I called it when my brother refused to take his medications, and that is what I called it when after his third hospitalization, I found his Haldol in the trashcan,” said Amador.

I suppose there’s no other possible explanation for a thinking, feeling, decision-making, adult human being throwing his Haldol in the trash can.

From a made-up word to the DSM-V: Amador takes anosognosia to the next level

About a year ago, when the DSM-V Task Force was really going at it hot and heavy, Xavier Amador issued this appeal on the Internet:

Dear Friends,

 …Right now, there is no proposal to measure insight in persons with schizophrenia or bipolar disorder much less require that clinicians diagnose a subtype (with or without insight or with or without anosognosia). Such a requirement will drastically change treatment plans and hospital discharge plans. If a doctor has to diagnosis a lack of awareness of illness, then s/he is ethically obligated to address this problem, this symptom, and the non-adherence to treatment it causes. Rather than simply send the person on their way with a prescription they will never fill. I hope you will comment on the website Dr. Torrey recommends below.

We don’t have much time as the deadline for public comments is less that one month away…

Best wishes,

Xavier Amador

[emphasis added]

Doctors will be obligated to ensure adherence to treatment plan…  “psychiatrists who care” must make sure their patients take their meds (perhaps in the form of injection)…

Isn’t that the exact sales pitch Janssen is using for their long-acting injection of Risperdal?

If anosognosia is officially added as a “symptom” of schizophrenia in the DSM-V, it essentially would make prescribing long-acting anti-psychotic injections to folks who “don’t know they’re sick” an ethical obligation!

Sounds like Janssen, and any other pharmaceutical company that manufactures a “flowers-in-the-bloodstream” shot, is going to score.  Big time.

Thanks in part to the presumably very well paid** Amador.

And that’s just one more reason why we need to protest the DSM-V.

Join me in Philadelphia — or do it from anywhere else in the world! — on May 5thin saying “enough is enough.”


*This definition of schizophrenia, though it is endorsed by the APA [American Psychiatric Association] and NIMH [National Institute of Mental Health], is of course completely false.  See Robert Whitaker’s research, and also the work of Loren Mosher, as proof. Also, a few recovery stories as living proof.

**Just how well paid?  We’ll know his exact price in just a couple of months, but for this kind of a score, I’m expecting to see a lot of zeros.

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