Archive for August, 2009

Enough Already!

A psychiatric aide trainee has admitted to getting an 18 year old patient to swallow nails while in the  Allentown State Hospital. Four nails were removed from the patient’s stomach. Athena Marie Sidlar has pleaded guilty to reckless endangerment in the case and it appears as though she and her lawyer  are going to blame it on bipolar disorder. That’s right — bipolar disorder made her feed nails to a patient in a mental health facility. Her lawyer claims she is “trying to battle her affliction”.

I think it’s past time that we start questioning where it is that we draw the line between sick and sane and who gets to draw it. Also, I don’t think I’m alone in saying that people really need to stop using the mental illness defense. With people citing their supposed illness as the cause for everything from simple assault to this and killing their mother with a hatchet, is it any wonder people errantly associate mental illness with violent behavior? I am certain that there are many people to whom the bipolar label and stigma has been attached that would rightfully take exception to this association and the terribly irresponsible behavior that perpetuates it.

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August 29, 2009 at 7:01 pm

Ortho-McNeil-Janssen Drops Development of Monthly Injectable Risperdal

According to PharmLive, manufacturer Alkermes, Inc. was recently informed that Ortho-Mcneil-Janssen (commonly known as Janssen), a branch of Johnson & Johnson, has dropped development of a 4 week long-acting Risperdal injectable while still producing the bi-monthly Risperdal Consta. Risperdal is an atypical antipsychotic.

Janssen continues to commercialize RISPERDAL® CONSTA® (risperidone) Long-Acting Injection in over 60 countries worldwide. RISPERDAL CONSTA is based on Alkermes’ Medisorb ®  technology and is manufactured by Alkermes. It is the first and only long-acting atypical antipsychotic therapy available for both the treatment of schizophrenia and bipolar I disorder.

Of course with antipsychotics being the number one drug class by sales in the US, this isn’t going unnoticed by Wall Street. According to Reuters:

Alkermes Inc (ALKS.O) shares slipped as much as 13 percent a day after it said units of Johnson & Johnson (JNJ.N) have decided not to pursue further development of a four-week long-acting version of antipsychotic drug risperidone.

I’m no trader but a thirteen percent drop seems pretty substantial for a drug manufacturer, especially based on the halted development of just one drug. It would appear as though a lot of eggs were in this particular basket. In another view of antipsychotic use from the financial arena, Morningstar mentions the drug’s risks in passing while discussing the potential for competition and conflict of interest in one company marketing two monthly-injectable antipsychotics. (Emphasis mine.)

Without a once-monthly version, the bimonthly Risperdal Consta will probably have to compete with a once-monthly version of Johnson & Johnson’s drug Invega Sustenna, which has received approval from the Food and Drug Administration. While Invega Sustenna has demonstrated some issues with safety, we think it will pose strong competition in the United States on the basis of its convenience factor, if approved. Schizophrenia patients are often noncompliant with taking their medication, so physicians prefer to prescribe long-acting medications. We were surprised by the sudden move of Janssen to forgo the project, but we did wonder about the potential conflict of interest involved with marketing both Invega Sustenna and Risperdal Consta.

Clearly what are presented as numbers and sales among stock analysts translate to real people at street level. In frank financial terms, however, they are just conditions to factor into the gamble like mud on the horse track. To be fair, it’s not like America doesn’t have a consuming culture built largely around the idea of trading safety for convenience but antipsychotics are a far cry from Big Macs.

It was interesting to stumble across the issue from a purely financial standpoint and it does make one take notice. A manufacturer’s financial standing is on a fairly remarkable downturn based on one drug which would seem to indicate how important that drug or class of drugs is to the market. If there is any arena in which safety, efficacy and compliance are simply marketing conditions, one should at least question to what extent the market has an effect on the actual human beings that are buying or being forced to take those drugs.

August 28, 2009 at 12:13 pm

ABC Primetime: The Outsiders

Last night, ABC aired Primetime: The Outsiders which was supposed to highlight the Mad Pride movement. Oddly, it opened with a story on mustangs running wild on “government land” and being captured and broken at the hands of maximum security prisoners. While they briefly mentioned that the prisoners could relate to the captivity of the horses, they didn’t say what the horses might have done to be separated from their freedom. I’m pretty sure it wasn’t cocaine and robbing safes though. It seemed like such an obvious parallel to the many people confined in the psychiatric system that I honestly thought at one point that was going to be their angle, but no. Apparently the similarities were lost on them.

The show was predictably topical and seemed to reduce the movement to a group of weirdos who don’t know what’s good for them, however inadvertently. With few exceptions, when they mentioned someone going off meds, they were quick to follow with people’s fears about what that might lead to. When they showed people insisting on choice and rights in mental health they followed it up with an advocate of forced psychiatry who used the phrase, “rotting with their rights on” to describe those that don’t know what’s best for them. Of course, they couldn’t be bothered to show any real information to support these fears — but fear sells when facts fail.

In their role as mainstream media, ABC perpetuated the stigma that the Mad Pride and related movements fight so hard to bring to an end. They did what the media usually does, which is to lump all mental illness together with the violent schizophrenic as its flagship. Rather than allow this movement an uninterrupted voice by way of at least a full segment, they used a story of a sensational murder at the hands of a young man diagnosed as paranoid schizophrenic to punctuate virtually every sentiment from the Mad Pride crowd. (As a side note to anyone who saw the story, I can’t imagine that the kind of forceful institutional “care” offered by a public mental hospital would do much to ease a person’s fear of the CIA’s action through authority figures.) It wasn’t all bad. There was sincere talk of reducing the stigma associated with mental illness. Joe Pantoliano even said he wants the discussion of mental illness to be as “cool, sexy and trendy” as that of erectile dysfunction — whatever that means. Still, it lacked any of the impact that showing true balance would have had and even had an air of possibly using the movement as just another angle for the age old violent-mentally-ill story. I would love to have seen time given to statistics that are counter to popular notions, alternatives, people who have fully recovered, why people are leery of the system but I think that day is still pretty far off.

Imagine the impact that a story on recovery from “serious mental illness” could generate. So many people don’t even know it’s possible. With David Oaks (director of MindFreedom International) as a guest, I’d imagine that they could have had the opportunity to speak with a wealth of people who have left the psychiatric system to take care of their own emotional well being — with or without drugs. It seems like a vague half attempt to address Mad Pride and the idea of freedom of thought without showing in any depth any unquestionable success stories such as Stuart Baker-Brown or any number of others that comprise this movement. That said, David came across loud and clear and, as always, spoke well to the issue, unswayed by the many distractions thrown into the ring. If there is any good that came out of this, people watching may find that alternatives are out there. Many people don’t know their options and many more don’t know there is a movement behind them, a large and increasingly vocal group in their corner.

People that need to get violent impulses under control need to address them but no more or less whether accompanied by odd thought and behavior or not. There is a vast movement of people simply wishing to embrace their uniqueness and the highs and lows that life offers without having someone else determine to what extent they may experience them. There are people who wish to choose their own path to wellness and are willing to make some noise until that basic right is afforded them. Industries and governments shouldn’t be in a position to make these critical choices for us. Refusing drugs and confinement or demanding to take an active role in their own health regardless of their chosen path does not equal reckless abandon and opposition. Most who bear these diagnoses and resultant stigma have a lot more in common with the captured and broken mustangs in the first segment than the killer in the rest and it’s a shame that couldn’t come across.

August 26, 2009 at 5:12 pm 2 comments

Cecilia Casals

   On August 13, Cecilia Casals set herself on fire at the Mall of Americas in Miami, Florida and walked quietly and calmly among shocked onlookers for two and a half minutes. She suffered third degree burns over 75% of her body, from which she ultimately died three days later. This is a sensational enough story and it is not my intention to add to that. 

   Many of the people nearby were understandably frozen in shock. For that I can’t blame them. None, I’m sure, had ever seen anything like it before. The troubling thing (aside from the obvious) is that while three people made some attempt to help her ,even at risk of injury to themselves, many people’s first response was to reach into their pockets and pull out their cell phones and cameras to take pictures.  I must give credit to John Torres and the two others who attempted to come to her aid — for being human beings. While their actions were commendable, it’s a shame that they are the exception and not the rule.

   As it turns out, she had  a history of “mental health” issues and a criminal record for drug charges and attacking a boyfriend with a knife who, still in love with her, dropped the charges. People, as they often do, used her past to put her on trial in the press and over the internet but her past is irrelevant to the inaction of the people around her. We shouldn’t question the value of the life that was lost even at her own hand and when it happened, it wasn’t a “mentally ill” woman or a criminal that people saw. Nobody knew anything about her in that instant. She could have been anybody — you, me,  your mother or daughter — and when it mattered the most and precious seconds could have saved her, people took pictures. I can’t wrap my head around that. People are seeing the worst individual human tragedy they’re likely to see in their lives and instead of reaching for a way to help her, they reach for their phones so they can share it with friends and strangers alike.

 In a move that was both tactless and tasteless,  NBC Washington’s headline for the story read,  “Human Torch Had Issues Burning Inside.” Their website also offers a survey in the sidebar as to people’s response to the story. Unfortunately but not surprisingly, it’s 53% sad, 20% laughing, 13% bored and so on. That says a lot about us as a whole. Of the people that cared to offer a response, 33% were either laughing or bored by the story.

   This may be another instance in which the news media is not so much a window through which to see the world but a mirror. God help us if in that reflection is a mob of onlookers who have lost their last shred of regard for the life their neighbors and find humor in something so devoid of it .  I find it disgusting beyond measure that many among us would rather watch someone die than help them and miss the show.

August 22, 2009 at 9:45 pm 1 comment

Doctors, do your homework!

   It’s common practice in prescribing medicine to offer drugs for reasons other than their FDA approved purposes. This off label prescribing of drugs is nothing new and while we’d probably like to think doctors are prescribing drugs off label in a judicious and well thought out manner, that doesn’t seem to be the case. As it turns out, according to a University of Chicago study, more than 40% of prescribing doctors do not even know the approval status of drugs in relation to their indications.

   When the study was limited to drugs they’ve prescribed in the past year, the increase in knowledge was marginal at best. Psychiatrists demonstrated a greater knowledge of approval status than primary care physicians. This doesn’t mean they are more reserved in off label prescribing, just that they know better.

    You’d think that for a doctor’s salary you could expect them to do their homework, really know about the drugs they are so quick to dispense, and while it’s not limited to psych drugs its impact is substantial in that market. Drugs are approved based on efficacy and safety, basically a risk vs benefits scale. With such lax FDA standards, if a drug doesn’t gain approval, it is either highly ineffective, alarmingly dangerous or both. Most antipsychotics just squeak by but despite this the numbers for antipsychotics being prescribed in recent history have skyrocketed  — and it’s not because more and more people are becoming psychotic. Antipsychotics have seen such an increase in numbers that they’ve beaten out the old champion, lipid regulators, as of last year thanks to a more than 50% growth in sales over the course of four years. It just might have something to do with companies like Eli Lilly, who illegally marketed their antipsychotic Zyprexa off label for bipolar and dementia, for which it is not only not approved but proven ineffective. For a drug approved only for “diseases” that a relatively small part of the population are diagnosed with to beat cholesterol drugs in our Big Mac nation says more about marketing than it does about mental health.

   The level of disregard that such dangerous marketing implies is deplorable and the fact that doctors aren’t even putting the work in to know which drugs have which approvals is astounding. Even a small number of doctors not demonstrating a working knowledge of the drugs they dispense is shameful but to know that the numbers are nearing and in some accounts exceeding half — that’s frightening. We’re not talking about cold medicines here with side effects like drowsiness and upset stomach but drugs that often shorten lives by way of metabolic syndrome, stroke, heart failure and decrease quality of life in any number of ways for a lot of people. If you are a potential patient/consumer, do your homework. It’s entirely possible your doctor hasn’t done his.

August 21, 2009 at 9:41 pm

Sketch for a forthcoming painting…maybe

Girl With Dog Skull

   Here is the first of (hopefully) many periodic installments from my sketchbook. I’m using Moleskine notebooks right now. I like the tinted paper and the different styles and sizes available, plus the paper doesn’t get too roughed up when you erase, and I do…often. I’m not going to worry whether they appear complete or perfect. They are steps on the way. It’s just a glimpse of what may come to be paintings or at least some of the elements involved in my process — which is as random and disorganized as anybody who knows me even slightly might assume.

August 19, 2009 at 9:00 pm

The Chemical Imbalance Theory

   We’ve all heard of the chemical imbalance. What fewer are familiar with is the chemical imbalance theory. The concept has been so well embraced and often repeated that somewhere along the line people have dropped a critical part — that it’s only a theory — and a half theory at that.

   The problem with the chemical imbalance theory is that, like so many others in biological psychiatry, it was reverse engineered. From a 2005 study published by Jeffery LaCasse and Jonathan Leo regarding SSRIs being marketed based on the unfounded theory:

In 1965, Joseph Schildkraut put forth the hypothesis that depression was associated with low levels of norepinephrine, and later researchers theorized that serotonin was the neurotransmitter of interest. In subsequent years, there were numerous attempts to identify reproducible neurochemical alterations in the nervous systems of patients diagnosed with depression. For instance, researchers compared levels of serotonin metabolites in the cerebrospinal fluid of clinically depressed suicidal patients to controls, but the primary literature is mixed and plagued with methodological difficulties such as very small sample sizes and uncontrolled confounding variables… Attempts were also made to induce depression by depleting serotonin levels, but these experiments reaped no consistent results. Likewise, researchers found that huge increases in brain serotonin, arrived at by administering high-dose L-tryptophan, were ineffective at relieving depression.

   Researchers didn’t find an imbalance and devise a means of correcting it, they found a drug that, to some extent, had the desired effect and built a theory around how it might work. Never able to have consistent, measurable or reproducible results, the only constants in the chemical imbalance theory since its inception have been greater acceptance and increasing development and sales of selective serotonin reuptake inhibitors (SSRI). With direct-to-consumer advertising from pharmaceutical companies made easier in 1997 with the FDA conveniently loosening its ad guidelines at precisely the time when SSRIs had generated a more than substantial buzz, Pharma’s tv marketing machine went into overdrive, touting themselves as purveyors of chemical cures for known biological illness. With careful wording and lax guidelines, you can fairly easily tip-toe around the fact that the biological component to depression is just a shaky theory. 

   It is important to question how these drugs come into prominence and what role media and marketing play in that process. Even if we are skeptical of an ad blitz from pharmaceutical companies, many tend to see the news media as having some air of legitimacy, even more then than now. Having mentioned the almighty  chemical imbalance in various ways for any number of stories, the news media supports it as legitimate scientific knowledge having very little push from anyone to verify it as such.

   Building on the 2005 study, FSU doctoral candidate Jeffrey LaCasse and Jonathan Leo, a neuroanatomy professor at Lincoln Memorial University, shifted their focus to the news media’s portrayal of the chemical imbalance theory. They spent a year between 2006 and 2007 scouring the news. When a reporter mentioned chemical imbalance, typically as fact not theory, they contacted the news outlet and requested supporting information. None could be found. From an article in Medical News Today:

“Several reporters, psychiatrists and a drug company responded to the researchers’ requests, but Lacasse and Leo said they did not provide documentation that supported the chemical imbalance theory…

 …there are few scientists who will rise to its defense, and some prominent psychiatrists publicly acknowledge that the serotonin hypothesis is more metaphor than fact…when asked for evidence, reporters were unable to cite peer-reviewed primary articles in support of the theory.

Moreover, the researchers said, several of the responses received from reporters seem to suggest a fundamental misunderstanding of the theory’s scientific status. The “Diagnostic and Statistical Manual of Mental Disorders,” which almost all psychiatrists use to diagnose and treat their patients, clearly states that the cause of depression and anxiety is unknown, according to Lacasse and Leo. “

  So we have direct-to-consumer advertising selling the unsubstantiated claim of a chemical imbalance and its chemical correction all wrapped up in a package of sympathy and healing while the FDA allows them to play down the side effects and the news media offers free advertising by way of promoting the chemical imbalance myth unquestioningly — and no one seems too concerned that none of this is the result of objective scientific research. In addition, based on the reputation of the chemical imbalance, many other biological roots have been purported without proof and accepted without reservation by the public such as ADHD and bipolar disorder.

   If an industry is prepared to make such claims, especially when targeting people who are arguably at their worst and weakest points in life, the burden of proof should fall upon that industry and then upon anyone who administers drugs bearing the names of the companies that comprise that industry. Failure to demand something as fundamental as proof of the existence of the problem they claim to correct is endorsement of shady business of the highest order.  I know of no other establishment under the guise of medicine of which so little evidence is expected. If you claim to be able to cure a child’s cancer, that cancer must first be shown to exist. How is it that that level of certainty is not expected, much less demanded when tackling something as complex as the human brain?

August 18, 2009 at 2:34 pm 3 comments

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