Interesting article in Clinical Psychiatry News, Psychoactive Drug Nomenclature System Devised, by Mitchel Zoler.
Joseph Zohar, David J. Nutt, David J. Kupfer, Hans-Jurgen Moller, Shigeto Yamawakie, Michael Spedding, and Stephen M. Stahl have all been busy coming up with a new way to describe psychoactive medications. It's a 5 Axis system (I guess they were homesick for DSM-IV), and the plan is for it to be web-based, so it can be in a constant state of revision.
The idea behind it is that, according to the example in the article, you have a patient with an anxiety disorder, for whom you prescribe, say, celexa, which is an antidepressant. So the patient wonders why you're telling him he has one condition, and giving him a drug for another.
Here's my list of the axes-but you can view them in the article, in a nice table, complete with two examples:
Axis 1- Class and Relevant Mechanism
What neurotransmitters it affects, and what it does at the molecular level.
Axis 2- Family
This seems to overlap with Axis 1.
Axis 3- Neurobiologic Activity
Includes neurotransmitter effects, and broader physiologic effects.
Axis 4- Efficacy and Major Side Effects
What conditions it's good for, and what else it does on the experiential level.
Axis 5- Indications
Formal FDA approvals, I think.
The Pros:
The physicist, Richard Feynman, had an interesting father. He would say to young Feynman, "You see that bird over there? I can tell you its name, but first, I'll tell you what it does."
Names, categories, titles, they're all important, but they often don't give you that much information about whatever they're naming. "Sparrow" doesn't tell you anything. You need to connect that word with a certain type of bird.
So it's a good idea to describe drugs by what they are and what they purportedly do. You end up with a lot more information than you get from "SSRI" or "Prozac".
And on the flip side, "antidepressant" only tells you one thing that a particular drug does. If it does other things, you won't know it from that one word.
I quite like the idea of putting all the relevant information out there right from the start.
The Cons:
Who is this for? I can see where it would be useful for medical students studying for pharmacology exams. Or for psychiatrists, to tweak our memories, or help us clarify things to our patients, although personally I'd like an Axis 6 with Cyp450 enzyme data.
But what about non-psychiatrist prescribers. Could this be a sneaky way to promote off-label prescribing? If you look at the chart in the article, Axis 4 for amytriptyline is "anxiety;chronic pain", not "depression", which is listed in Axis 5 as "Major Depressive Disorder".
And does listing the known molecular mechanism of action, e.g "Increases synaptic 5-HT and norepinephrine" right next to the conditions the drug is used to treat, e.g. "Depression", sneakily imply that too little synaptic 5-HT causes depression, and more synaptic 5-HT is what "cures" depression? Because we just don't know if that's true.
Is this system for patients? Will it really be helpful, or more helpful than just telling these details to patients as part of discussions surrounding medication?
The question of who this system is for, as well as the plan to make the classification system web-based are particularly relevant, in light of the fact that I couldn't access the original article. Well, I could, for $35.95.
My feeling is that this idea is being presented as an ongoing collaborative model, but really, it's proprietary. And forgive me if I have concerns about where they're heading with it. This quote is from the Zoler article:
"This is the first step in a long process. We’re trying to wake up a 50-year-old nomenclature into a living document that will be used over the next decades and may someday merge with DSM [Diagnostic and Statistical Manual of Mental Disorders]," said Dr. Stephen M. Stahl, a panel member and psychiatrist affiliated with the University of California, San Diego.
What will it mean to "merge with DSM"? Will new diagnoses be created based on how medications are being prescribed? Or with what frequency they're being prescribed? After all, David Kupfer, one of the authors, was the chair of the DSM-5 task force.
And how will this affect getting FDA approval for medications? If a drug is being used off label at a high frequency, will this be a way to extend a patent? In other words, is noting the usage of a drug a way of establishing that said drug is effective for a different indication than the one it was originally approved for.
My main concern stems from the memory of those little books I got from drug reps when I was a resident. Nice little pictures with colorful neurotransmitters happily making their way around a bunch of big receptors. All written by Stephen M. Stahl.
The final paragraph of the Zoler article:
Dr. Zohar said he has been an adviser or consultant to or received research support from eight drug companies. Dr. Nutt said he has been an adviser or consultant to eight drug companies. Dr. Stahl said he has been an adviser or consultant to more than 30 drug companies. Dr. Goodwin said he had been an adviser or consultant to 12 drug companies.
Bottom line: I think more information about medications is a good thing. But not if it's misleading. And not if there's an ulterior motive to presenting the information. Hopefully, this type of system can be used for the good of patients.
Welcome!
Welcome to my blog, a place to explore and learn about the experience of running a psychiatric practice. I post about things that I find useful to know or think about. So, enjoy, and let me know what you think.
Saturday, November 30, 2013
Tuesday, November 19, 2013
The Couch, First Session
I've been thinking about writing this post for a long time, and I'm still not sure what I want to express with it, but it feels important.
I read this post on 1BoringOldMan. It's about how psychoanalysis wasn't focused enough on signs and symptoms, and DSM, starting with III, is focused too much on them, resulting in the loss of ability to really understand ones patients.
This struck me because as much as this blog is about the practice of psychiatry, and as much as I post about coding and insurance and medications and policy, I mostly leave out what I mostly do, which is psychotherapy, and specifically, psychoanalysis.
I think I'm cagey about it because analysis has so fallen from grace that it's a little embarrassing to acknowledge that this is what I trained to do. If I were 85 years old, I could say I trained back in the days when all psychiatrists did analytic training. But I'm not 85. And I graduated from my training institute about a year and a half ago.
I feel like it's discrediting to "admit" I'm an analyst, that I won't be taken seriously as a psychiatrist, or as a physician. And I have this sneaking suspicion that many of the folks who speak derisively about analysis don't know much about it. And that many of the people who disparage Freud haven't read him.
So what I'm gonna do here is write about what's involved in analytic training and practice, and then describe some of my thoughts and feelings about what I do, and why I chose to do it, and why I think it's worthwhile, in several posts.
To become an analyst, you need to apply to and be accepted by a psychoanalytic training program or institute. I filled out an application which asked for my demographic information, my education and work history, publications, memberships in professional organizations-basic CV stuff. It also asked for 2 references, where else I was considering applying or had applied, and names and dates of any psychotherapy or psychoanalysis I've had. That last was the most personal piece of information on the form, which might seem surprising. They could've asked about my toilet training or primal scene exposure. Or at least about why I want to be an analyst. But there were no short essays or personal statements.
They don't need that kind of personal information on the application. Instead, they have interviews. These are very different from the kinds of interviews I had for college, where it was mostly informational, or medical school or residency, where interviews function as supplements to an application. These were the grueling crux of the application process.
I interviewed with 2 different analysts, 2 times each. I don't remember for sure, but I think each of the 4 interviews lasted at least an hour, maybe 90 minutes. Or it might have just felt that long. The first interview with each analyst was a get-to-know-me session. The second involved more getting to know me, following up on things I spoke about the first time around. And I also had to present a case, which seems like it would be the hardest part, but it wasn't. It was the easiest.
I bought two suits. I wore one to the first interview with Dr. G, and the other to the first interview with Dr. E. Then I had them dry-cleaned, and I switched off for the second interviews. I also prepared two different therapy cases, each of which reflected certain challenges, and the ways in which I work with patients, and my ability to think analytically.
I had a lot of internal debate about how I wanted to come across. Specifically, just how neurotic did I want to appear. Too much, and they'd think I was unstable. Too little, and they'd know I was lying. I had an intuitive sense that I was about the right amount of neurotic for this kind of training-you don't train to be an analyst if you're not at least a little screwed up-but I wanted to make sure to seem like it.
I discovered pretty quickly that how I wanted to seem was irrelevant. And that discovery made me want to do psychoanalytic training all the more. Because the people I interviewed with did not shy away from asking difficult questions about my family, my motivations, my conflicts. And they did not settle for pat answers. And they pursued important topics. And they did so with kindness and without judgement. And I realized that I wanted to be able to do what they were doing.
My residency did a pretty good job with psychodynamic psychotherapy training. It was emphasized strongly. And I'm grateful for that. But my feeling now is, "If that were all the training I'd ever had in insight-oriented therapy, I wouldn't be able to do therapy in a way that I consider meaningful."
It shocks me when I think about the things I missed with patients early on, often transference issues, that are now so obvious. Ten years from now I'll probably be thinking the same thing about my 2013 work. But that's good. Because it means I'm constantly trying to improve.
They talk about the "tripartite" model of training, at my institute, at any rate, and others like it.
Part 1-Classes
Part 2-Supervised Analytic Cases
Part 3-Personal Analysis
Part 1-Classes
Mondays and Wednesdays, 7-10pm, 4 years. The readings are extensive. There are papers and case descriptions to be written. There are nerve-racking case presentations, reading ones process notes to an analytic deity and waiting to hear what people think about the work you're doing. Examples of classes:
Freud, Early Theories
Freud, Infantile Sexuality
Psychoanalytic Listening
Technique
Child Development
Adult Development
Character and Neurosis
Case Development
Cognitive Neuroscience
Psychic Trauma
Theory of Narcissism
Ethics
Borderline Conditions and Paranoia
Empirical Approaches to Psychoanalytic Thinking
Relational Psychoanalysis and Intersubjectivity
Dreams
Affects and Affect Pathology
Gender and Sexuality
Universal Phantasies
Termination
...and more
Part 2-Supervised Analytic Cases
Around the end of the first year of classes, you're expected to pick up an analytic patient, usually from the low-fee treatment center. Analyses last quite a long time, so you can expect to accept a low fee for quite a long time. And most analytic candidates have finished their residencies, or PhD's, or Psy-D's, or Social Work Degrees, and are seeing private patients. In other words, this is a loss of income.
You see the patient, on the couch, 4-5 times per week, and you have supervision once a week. Over the course of training, you pick up at least 2, but often 3 or 4 additional analytic cases, often low-fee, 4-5 times per week, and supervision once a week for each. And you have to treat both genders.
Yes, I did write, "On the couch." And yes, it feels like you're in a Woody Allen movie. Patients lie on the couch, and you sit behind them. As archaic as it sounds, it's quite useful.
There are initial writeups of your "control cases", 6 month summaries, and a final summary, either before you graduate, or when the patient terminates treatment, whichever comes first.
Part 3-Personal Analysis
In some ways this is the easiest of the three parts. You show up, 4-5 times per week, you lie on the couch, you free associate, or try to, and you leave. And you pay your monthly bill. The fee is set between you and your TA, or training analyst, so if you can't afford it, the TA will cut you some slack on her regular fee.
The truth is, this is the hardest part of the process. One well-published senior analyst likes to say that an analysis is like getting a PhD in yourself. It forces you to look at all the things about yourself you've been trying to hide from since childhood-shame, guilt, anger, aggression, sadness, longing, sexuality, tenderness, competition, cruelty, to name a few. It forces you to question your assumptions about yourself, the people in your life, and the world around you. It asks you to give up your accustomed ways of interacting with the world, defenses that have protected you most of your life, and move on to other ways to be that don't cause as much pain. And it asks you to establish an intimate bond with someone you can never truly get to know.
You can say that all good therapies, of whatever stripe, try to achieve the same goal-a better adjusted self. But it's not the same. And I'm not knocking other therapies-I practice them.
Before I began my training, I was in face to face psychodynamic psychotherapy twice a week, for several years. And my therapist was an analyst. It doesn't even come close to what analysis is like. The frequency, the supine position, the wacky isolation from not seeing the analyst with the simultaneous vulnerability of being totally exposed to this stranger, these induce an intensity that I can't imagine being replicated in other types of therapy.
The personal analysis has evolved over the years. It used to be a "reporting analysis". This meant that your analyst, in whom you confide your deepest, darkest thoughts and feelings, and into whom you pour all your transferential feelings towards primary figures in your life, would report on your progress to the progression committee, which included people you regularly work with. Nice.
What often happened was that candidates would stay in their training analyses until they graduated, and then they would quit the training analysis, and change to a private analyst, with whom they could be honest.
At some point, someone figured out that this wasn't a good setup, and reporting analyses were done away with.
TA's are a bit of a controversial issue these days. After you graduate from a training program, you can go on to get certification, which involves being immersed in the treatment of several unsupervised analytic cases, over several years. and an extensive writeup of these cases, which will be presented to a national certifying body. Once you've done that, you can then go on to be even further certified as a training analyst. I don't even know what's involved. I think you may have to sacrifice sheep. Or emotional support ducks.
The idea is that training analysts have so much more, uh, training than everyone else, that they're the only ones who are qualified to treat analytic candidates, who represent a special subgroup of analysands, because they're also students, and eventually colleagues, and you WILL bump into your analyst outside of his office, at conferences, or the annual institute dinner, or in the tiny elevator that takes you to your classes. The only reason that never actually happened was that I walked away and took the stairs. For real. The nice thing about analysis is that it's okay to be rude to your analyst. It's all grist for the mill.
I'll continue in a later post. For now, we do have to interrupt.
(For the next post in this series, Use the Couch, Luke, Click HERE).
Saturday, November 16, 2013
The Comfort of Dogs
Source |
An article in the NYTimes, Emotional Support, With Fur, Draws Complaints on Planes, describes the practice of bringing Emotional Support Animals (ESA's, mostly dogs), onto airplanes, where they sit on their handlers' laps, rather than under the seat in a cage, where regular pets have to ride. They also fly free.
I hadn't heard of ESA's. When I worked in a hospital setting, there were therapy dogs that visited with patients. It was actually quite amazing to see their effect. There was a beautiful golden retriever who was universally loved. He would come onto the unit, and even non-verbal, nearly catatonic patients would smile and pet him.
So I got curious about what an emotional support dog is. According to the US Dog Registry,
"An emotional support dog is a dog that provides comfort and support in forms of affection and companionship for an individual suffering from various mental and emotional conditions. An emotional support dog is not required to perform any specific tasks for disability like service dogs are. There are meant solely for emotional stability and unconditional love."
The "mental and emotional conditions" include most psychiatric diagnoses and cognitive conditions. The National Service Animal Registry notes exclusions as follows:
Neither deviant behavior (e.g., political, religious, or sexual) nor conflicts that are primarily between the individual and society are mental disorders unless the deviance or conflict is a symptom of a dysfunction in the individual. According to Title II of the American with Disabilities Act of 1990, current or future interpretation of psychological disabilities excludes common personality traits such as poor judgment or a quick temper.
Unlike service dogs, who undergo rigorous training to assist people with limited mobility, hearing and visual impairment, some psychiatric conditions, and certain medical problems, emotional support dogs have no specific training. The only requirement for an emotional support dog is a letter from a doctor indicating that you have a condition for which an emotional support dog is warranted. Once you have that, you can take your dog anywhere, including restaurants and airplanes, and you can even live in places that don't allow dogs. There are services that provide such letters. One template for the letter looks like this:
[Date]
To Whom It May Concern:
[Full Name of Patient] is my patient and has been under my care since [date]. I am intimately familiar with his/her history and with the functional limitations imposed by his/her emotional/mental health-related issue.
Due to this emotional disability, [patient first name] has certain limitations coping with what would otherwise be considered normal, but significant day to day situations. To help alleviate these challenges and to enhance his/her day to day functionality, I have prescribed [patient first name] to obtain an emotional support animal. The presence of this animal is necessary for the emotional/mental health of [patient name] because its presence will mitigate the symptoms he/she is currently experiencing.
Sincerely,
(Physician’s name and title)
You can officially register your emotional support dog, for a fee, and get a kit that includes a certificate, ID card, dog tag, and for an additional fee, a service dog vest.
A reasonable question, I think, is how useful, psychologically speaking, are emotional support dogs? And for that matter, how useful are dogs, in general, for "emotional" problems?
There are three official roles that dogs play in emotional conditions. There's the emotional support dog, which is used by an individual for emotional support, which can obviously be defined very broadly. There are therapy dogs, who are trained to bring comfort to strangers, or groups of strangers, in a hospital or assisted living facility, for example. According to the American Kennel Club, "It is unethical to attempt to pass off a therapy dog as a service dog for purposes such as flying on a plane or being admitted to a restaurant."
And there are service dogs for psychiatric conditions. For example, Autism Assistance Dogs are trained to help their handlers fall asleep when they have insomnia, and provide deep pressure during panic attacks (source). And Psychiatric Assistance Dogs can assess the safety of a situation in the case of paranoia or hallucinations, can remind their handlers to take their meds, and can interrupt self-harming behaviors (same source). Think of the training involved in all that.
An article entitled, Do animal-assisted activities effectively treat depression: a meta-analysis, "found some empirical support for the therapeutic effectiveness of dog-assisted activities/therapy for treating depression." But it noted that the studies were limited in number and quality.
What was really interesting was where I found the reference to this article. It was here, in The United States Army Medical Department Journal: Canine-Assisted Therapy in Military Medicine, April to June 2012, edition. This is a huge document that I'm quite interested in reading, in my copious free time, of course. I did peruse the section entitled, Research on Benefits of Canine-Assisted Therapy for Adults in Nonmilitary Settings; Knisely, et al, Pp. 30 and following. This section cited the Virginia Commonwealth University Center for Human-Animal Interaction (CHAI), which has done some interesting research on the topic of animal assisted therapy.
I don't really have an opinion about taking emotional support dogs onto airplanes, or into restaurants. I can see both sides. Apparently there have been a lot of complaints, but dogs and humans go way back. We're clearly wired to respond to each other. One theory I read somewhere when I was researching getting a dog states that humans were able to evolve into non-olfactory focused beings who walk upright because we had dogs to do the sniffing for us, and this was supposedly advantageous for our survival.
I have a colleague (psychiatrist) who brings her dog to work. My dog is too skittish for that, but it's interesting to consider incorporating animals into psychiatric outpatient treatment. I'd like to see more studies on the topic.
Wednesday, November 13, 2013
Choose Wisely, Indeed
There are two health PR campaigns taking place in New York City right now. You see signs on bus stops, in the subway, etc.
One is the NYC Girls Project, with the tag line: I'm a girl and I'm beautiful the way I am. It's directed mainly at girls, ages 7-12, who risk developing negative body images that can lead to eating disorders, drinking, drugs, acting out sexually, suicide, and bullying. It's a well-meaning program, certainly.
Then there's Bloomberg's Combat Obesity project, with ads about too many sugary drinks, reducing portion size, exercising more.
Some would say that these two are at odds with each other. "I'm a girl and I'm beautiful the way I am, except that I need to lose some weight."
It doesn't quite work.
Choosing Wisely is an initiative of the ABIM (American Board of Internal Medicine) Foundation, which tries to encourage patients to make evidenced based choices with their physicians. To this end, Choosing Wisely asks "national organizations representing medical specialists... to “choose wisely” by identifying five tests or procedures commonly used in their field, whose necessity should be questioned and discussed."
On September 20, 2013, the APA released its Choosing Wisely list:
1. Don’t prescribe antipsychotic medications to patients for any indication without appropriate initial evaluation and appropriate ongoing monitoring.
2. Don’t routinely prescribe two or more antipsychotic medications concurrently.
3. Don’t use antipsychotics as first choice to treat behavioral and psychological symptoms of dementia.
4. Don’t routinely prescribe antipsychotic medications as a first-line intervention for insomnia in adults.
5. Don’t routinely prescribe antipsychotic medications as a first-line intervention for children and adolescents for any diagnosis other than psychotic disorders.
I could, of course, be completely scathing and give you my own, sarcastic version:
1. Take a good history and follow up with your patients.
2. Keep a list of what you've already prescribed.
3. There's a reason Janssen Pharmaceuticals is coughing up $2.2 billion.
4. Clozaril doesn't just make you drowsy.
5. We're trying to combat, not create obesity in children.
The truth is, #5 really upsets me. Well, they all do, but #5 most of all. There's an inherent conflict of interest.
According to npr.org, which does not lie, "Since the mid-1990s, the number of children diagnosed with bipolar disorder has increased a staggering 4,000 percent." Now why is that, DSM, published by APA?
And people suffering from bipolar disorder sometimes get psychotic, no? And many antipsychotics are FDA approved for the treatment of bipolar disorder, correct?
(Source)
(Don't' forget Lurasidone (Latuda), now approved for bipolar depression, as well.)
Leaving aside Bipolar disorder, and schizophrenia, there are so many children being prescribed atypical antipsychotics for everything from ADHD to depression to behavioral problems, that all this Choosing Wisely stuff is too little too late.
It doesn't quite work, does it.
One is the NYC Girls Project, with the tag line: I'm a girl and I'm beautiful the way I am. It's directed mainly at girls, ages 7-12, who risk developing negative body images that can lead to eating disorders, drinking, drugs, acting out sexually, suicide, and bullying. It's a well-meaning program, certainly.
Then there's Bloomberg's Combat Obesity project, with ads about too many sugary drinks, reducing portion size, exercising more.
Some would say that these two are at odds with each other. "I'm a girl and I'm beautiful the way I am, except that I need to lose some weight."
It doesn't quite work.
Choosing Wisely is an initiative of the ABIM (American Board of Internal Medicine) Foundation, which tries to encourage patients to make evidenced based choices with their physicians. To this end, Choosing Wisely asks "national organizations representing medical specialists... to “choose wisely” by identifying five tests or procedures commonly used in their field, whose necessity should be questioned and discussed."
On September 20, 2013, the APA released its Choosing Wisely list:
1. Don’t prescribe antipsychotic medications to patients for any indication without appropriate initial evaluation and appropriate ongoing monitoring.
2. Don’t routinely prescribe two or more antipsychotic medications concurrently.
3. Don’t use antipsychotics as first choice to treat behavioral and psychological symptoms of dementia.
4. Don’t routinely prescribe antipsychotic medications as a first-line intervention for insomnia in adults.
5. Don’t routinely prescribe antipsychotic medications as a first-line intervention for children and adolescents for any diagnosis other than psychotic disorders.
I could, of course, be completely scathing and give you my own, sarcastic version:
1. Take a good history and follow up with your patients.
2. Keep a list of what you've already prescribed.
3. There's a reason Janssen Pharmaceuticals is coughing up $2.2 billion.
4. Clozaril doesn't just make you drowsy.
5. We're trying to combat, not create obesity in children.
The truth is, #5 really upsets me. Well, they all do, but #5 most of all. There's an inherent conflict of interest.
According to npr.org, which does not lie, "Since the mid-1990s, the number of children diagnosed with bipolar disorder has increased a staggering 4,000 percent." Now why is that, DSM, published by APA?
And people suffering from bipolar disorder sometimes get psychotic, no? And many antipsychotics are FDA approved for the treatment of bipolar disorder, correct?
(Source)
(Don't' forget Lurasidone (Latuda), now approved for bipolar depression, as well.)
Leaving aside Bipolar disorder, and schizophrenia, there are so many children being prescribed atypical antipsychotics for everything from ADHD to depression to behavioral problems, that all this Choosing Wisely stuff is too little too late.
It doesn't quite work, does it.
Sunday, November 10, 2013
New POLL Article! and Obit
I just posted a new article and discussion on POLL. Please check it out, and comment freely.
The article, Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications , compares the studies submitted to the Swedish regulatory agency for approval of 5 SSRI's, with the articles that were eventually published based on those studies.
They note 3 problematic areas.
1. Multiple Publication-individual studies yielded multiple publications, without acknowledging that they came from the same study. Also, subsets of data from multiple studies were pooled to create new publications.
2. Selective Publication-studies that made the drug look good were published more often than studies that showed no difference from placebo.
3. Selective Reporting-studies ignored the results of intention to treat analyses in favor of per protocol analyses, which make the drug look better.
In case you've forgotten, in an intention to treat analysis, subjects who dropped out of a study, for whatever reason, are analyzed as thought they had completed the study, with the last available result carried forward.
In a per protocol analysis, subjects who drop out are ignored in the final analysis. Since many subjects drop out due to adverse effects, or lack of effect, if you don't include those subjects, your results will look better (the subjects who tolerate the drug well and do better on it are more likely to remain in the trial).
Please check out the study and comment (I already wrote that, but it bears repeating).
On another, related note, Ann Wolpert, MIT's director of libraries since 1996, died last month. The reason this is relevant is because she was a big believer in open access, and beginning in 2000, developed DSpace,
"an open-source digital archive for research that has been adopted by more than 1,000 institutions worldwide. DSpace ensure(s) that there (is) a common, permanent platform for library material. Then, in 2009, she conceived the MIT Faculty Open Access Policy, where professors give the Institute permission to disseminate journal articles for open access through DSpace@MIT. In turn, those articles can be republished on open Web sites like the Public Library of Science or PLOS. It was the first policy of its kind in the United States, and has been imitated by other universities around the globe." (Jason Pontin, MIT Technology Review Editor)
“(Wolpert) believed in open access, but it went deeper than that...Her central insight was that in the age of the Internet, a great research library could serve not only as a window into scholarly output for given members of university and research communities, but also as a window for the world at large into the scholarly enterprise. That was a great and thrilling idea...” (Hal Abelson, Class of 1922 Professor of Computer Science and Engineering at MIT and founding director of both Creative Commons and the Free Software Foundation (source))
POLL, our free online journal club that uses open access articles, was created in the spirit of Wolpert's work. Please make use of it.
The article, Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications , compares the studies submitted to the Swedish regulatory agency for approval of 5 SSRI's, with the articles that were eventually published based on those studies.
They note 3 problematic areas.
1. Multiple Publication-individual studies yielded multiple publications, without acknowledging that they came from the same study. Also, subsets of data from multiple studies were pooled to create new publications.
2. Selective Publication-studies that made the drug look good were published more often than studies that showed no difference from placebo.
3. Selective Reporting-studies ignored the results of intention to treat analyses in favor of per protocol analyses, which make the drug look better.
In case you've forgotten, in an intention to treat analysis, subjects who dropped out of a study, for whatever reason, are analyzed as thought they had completed the study, with the last available result carried forward.
In a per protocol analysis, subjects who drop out are ignored in the final analysis. Since many subjects drop out due to adverse effects, or lack of effect, if you don't include those subjects, your results will look better (the subjects who tolerate the drug well and do better on it are more likely to remain in the trial).
Please check out the study and comment (I already wrote that, but it bears repeating).
On another, related note, Ann Wolpert, MIT's director of libraries since 1996, died last month. The reason this is relevant is because she was a big believer in open access, and beginning in 2000, developed DSpace,
"an open-source digital archive for research that has been adopted by more than 1,000 institutions worldwide. DSpace ensure(s) that there (is) a common, permanent platform for library material. Then, in 2009, she conceived the MIT Faculty Open Access Policy, where professors give the Institute permission to disseminate journal articles for open access through DSpace@MIT. In turn, those articles can be republished on open Web sites like the Public Library of Science or PLOS. It was the first policy of its kind in the United States, and has been imitated by other universities around the globe." (Jason Pontin, MIT Technology Review Editor)
“(Wolpert) believed in open access, but it went deeper than that...Her central insight was that in the age of the Internet, a great research library could serve not only as a window into scholarly output for given members of university and research communities, but also as a window for the world at large into the scholarly enterprise. That was a great and thrilling idea...” (Hal Abelson, Class of 1922 Professor of Computer Science and Engineering at MIT and founding director of both Creative Commons and the Free Software Foundation (source))
POLL, our free online journal club that uses open access articles, was created in the spirit of Wolpert's work. Please make use of it.
Ann Wolpert |
Saturday, November 9, 2013
MHPAEA Addendum
Yesterday, in Parity or Parody, I posted about the new rules for the Mental Health Parity and Addiction Equity Act (MHPAEA).
A later article in the NY times, Equal Coverage for the Mentally Ill, states that, in fact, insurers ARE required to offer Mental Health and Substance (MH/Sub) coverage. This is not consistent with the government sites I referenced (DOL, CMS), but perhaps those sites hadn't been updated yet to reflect the new rules.
Regardless, I maintain that the excessively complicated details of the Act will make it possible for insurance companies to continue to restrict coverage for MH/Sub care.
I was struck by one paragraph, in particular, in the article:
The effect on costs is uncertain. Insurers fear that the expenses of high-cost inpatient treatment or long-term rehabilitation of patients suffering from mental health disorders or substance abuse will drive up insurance costs, but experts say the number of people receiving high levels of care will be too small to have a significant effect on overall costs. And in the long run, better care could cure enough people to save billions of dollars a year in medical costs, lost wages and reduced productivity associated with alcoholism and other addictions.
Who are we "saving billions" for? The article seems to make the assumption that the interests of insurance companies coincide with those of the government, and the people. Myself, I don't believe insurers care about lost wages and reduced productivity, especially if it means a dent in their bottom line.
And I don't even know where to start with the phrase, "Better care could cure enough people to save billions of dollars a year." Key words here include "could", "cure", and "better".
(Here's a link to the Final Rule. Good luck reading it.)
A later article in the NY times, Equal Coverage for the Mentally Ill, states that, in fact, insurers ARE required to offer Mental Health and Substance (MH/Sub) coverage. This is not consistent with the government sites I referenced (DOL, CMS), but perhaps those sites hadn't been updated yet to reflect the new rules.
Regardless, I maintain that the excessively complicated details of the Act will make it possible for insurance companies to continue to restrict coverage for MH/Sub care.
I was struck by one paragraph, in particular, in the article:
The effect on costs is uncertain. Insurers fear that the expenses of high-cost inpatient treatment or long-term rehabilitation of patients suffering from mental health disorders or substance abuse will drive up insurance costs, but experts say the number of people receiving high levels of care will be too small to have a significant effect on overall costs. And in the long run, better care could cure enough people to save billions of dollars a year in medical costs, lost wages and reduced productivity associated with alcoholism and other addictions.
Who are we "saving billions" for? The article seems to make the assumption that the interests of insurance companies coincide with those of the government, and the people. Myself, I don't believe insurers care about lost wages and reduced productivity, especially if it means a dent in their bottom line.
And I don't even know where to start with the phrase, "Better care could cure enough people to save billions of dollars a year." Key words here include "could", "cure", and "better".
(Here's a link to the Final Rule. Good luck reading it.)
Friday, November 8, 2013
Parity or Parody?
An article in the Times, Rules to Require Equal Coverage for Mental Ills.
Okay, so there's "parity". What does that boil down to, and what problems can we foresee?
This is the very brief description of the Mental Health Parity and Addiction Equity Act from the Department of Labor site:
The Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) requires group health plans and health insurance issuers to ensure that financial requirements (such as co-pays, deductibles) and treatment limitations (such as visit limits) applicable to mental health or substance use disorder (MH/SUD) benefits are no more restrictive than the predominant requirements or limitations applied to substantially all medical/surgical benefits. MHPAEA supplements prior provisions under the Mental Health Parity Act of 1996 (MHPA), which required parity with respect to aggregate lifetime and annual dollar limits for mental health benefits.
I tried to read a little about the details of the Act, but it wasn't easy. From what I could glean, from the DOL site, as well as CMS, there's good news and there's bad news.
The good news:
-The criteria and standards for medical necessity determinations must be made available upon request
-Ditto the reason for a denial
-There can't be a separate deductible for Med/Surg and Mental Health/Substance; they need to be combined.
-There were already parity requirements in place with respect to aggregate lifetime and annual dollar limits, but these now apply to Substance treatment
-If your plan covers Out-of-Network providers for med/surg, it needs to cover out-of-network for MH/Sub.
The bad and confusing news:
-The Act does not mandate that a plan provide MH/SUD benefits.
-The Act does not apply to issuers who sell health insurance policies to employers with 50 or fewer employees or who sell health insurance policies to individuals.
-The regulations provide that the “predominant/substantially all” test applies to six classifications of benefits on a classification-by-classification basis. The regulation also includes other rules and definitions that are necessary in order for plans, issuers and their advisers to apply this general parity test.
This is where it starts to careen off into the stratosphere. I truly don't get the test and classifications, but I'll share the little bits and pieces that I partially grasp.
The general rule is that a plan may not impose a financial requirement or quantitative treatment limitation applicable to mental health or substance use disorder benefits in any classification that is more restrictive than the predominant financial requirement or quantitative limitation of that type applied to substantially all medical/surgical benefits in the same classification.
The six classifications of benefits are:
Inpatient in-network;
Inpatient out-of-network;
Outpatient in-network;
Outpatient out-of-network;
Emergency care;
Prescription drugs.
Examples of financial requirements are copays, deductibles, and out of pocket maximums. Examples of quantitative treatment limitations are number of visits and days of coverage.
There are also Non-Quantitative treatment limitations, including medical management standards limiting or excluding benefits based on medical necessity or medical appropriateness, plan methods for determining usual, customary, and reasonable charges, refusal to pay for higher-cost therapies until it can be shown that a lower-cost therapy is not effective (also known as fail-first policies or step therapy protocols), and exclusions based on failure to complete a course of treatment.
The test for determining parity refers to levels of types of financial requirements or treatment limitations. The level of a type of financial requirement or treatment limitation refers to the magnitude of the type of financial requirement or treatment limitation. For example, different levels of coinsurance include 20% and 30%, different levels of copays include $15 and $20, or different levels of an episode limit include 21 inpatient days per episode and 30 inpatient days per episode.
To determine if a quantitative financial requirement (such as a copay) or quantitative treatment limitation (such as a visit limit) is permissible, the parity analysis must be applied for that type of financial requirement or treatment limitation within a coverage unit for each of the six classifications of benefits separately. A coverage unit refers to the way in which a plan groups individuals for purposes of determining benefits, or premiums or contributions (for example, self-only, family, employee plus spouse).
If a type of financial requirement or quantitative treatment limitation applies to substantially all medical/surgical benefits in a classification (for example, if a copay applies to substantially all medical/surgical benefits), then it may be permissible for that requirement or limitation (the copay) to apply to mental health or substance use disorder benefits. Generally, a financial requirement or treatment limitation is considered to apply to substantially all medical/surgical benefits if it applies to two-thirds or more of the medical/surgical benefits for the same classification and coverage unit.
The predominant level of a type of requirement or limitation applicable to medical/surgical benefits within a classification is the most restrictive level of the requirement or limitation that can be imposed on mental health or substance use disorder benefits within that classification...If, for example, for self-only coverage a $10 copay is the predominant level of copay that applies to substantially all inpatient in-network medical/surgical benefits, that is the most restrictive copay that can apply to inpatient in-network mental health or substance use disorder benefits.
A plan may not create sub-classifications for generalists and specialists to determine separate predominant financial requirements and treatment limitations that apply to substantially all medical/surgical benefits. However, if the predominant level of a type of financial requirement that applies to substantially all medical/surgical benefits in a classification is the one charged for a medical/surgical specialist, then that “specialist” financial requirement can be applied for all mental health or substance use disorder benefits within that classification. On the other hand, if the predominant level of a type of financial requirement that applies to substantially all medical/surgical benefits in a classification is the one charged for a medical/surgical generalist, then the financial requirement charged for all mental health or substance use disorder benefits within that classification cannot be higher than the “generalist” financial requirement for medical/surgical benefits.
Oy.
Let's try this. A patient comes to see me. I'm classified as Outpatient, Out-Of-Network. The patient is single, so that's a self-only coverage unit. He is also diabetic, and his endocrinologist is also out-of network. His insurance pays 80% (the financial requirement) of the usual and customary fee (the non-quantitative treatment limitation) for endocrinologists in his region, and he is responsible for the rest. That's the level of coverage. And the percentage payment is the type of financial requirement (as opposed to if he had to pay a copay).
But two thirds of self-only covered patients in the region who are treated by endocrinologists have out of network coverage (in that plan or a different one?) that pays only 70% of the usual and customary fee, making 70% the most restrictive level of requirement. So when he submits my bill to his insurance, he will only be reimbursed 70% of the usual and customary fee. (Is this the customary fee for psychiatrists, or endocrinologists?) And if 2/3 of coverage for endocrinologists is at the 70% rate, but 2/3 of coverage for all outpatient treatment is at an 80% rate, then my bill will be reimbursed at the 80% rate.
Well, I'm glad we cleared that up.
I'm wondering if the upshot will be that MH/Sub just stops being covered. Period. There's no requirement for an insurer to cover it. The MHPAEA only requires that if it's covered, it has to be covered with parity, as defined in the very complicated details that I don't understand.
Moreover, it's obvious that insurance companies will find ways to apply these byzantine rules to their advantage.
The real twister here is that we're comparing apples and kumquats. I'm not referring to the question of whether psychiatry is a "medical" endeavor. I'm only considering the type, and more importantly, frequency, of treatment used in psychiatry, vs. say, cardiology (that would be a level of treatment, and a quantitative treatment limitation).
Admittedly, I'm an anomaly, because I see some patients as frequently as 4 times per week in psychoanalysis (more on this in a future post). I don't think patients visit their cardiologists 4 times per week over the course of a number of years. So does "no more restrictive" mean that my patients will be covered for as many visits per year as they would make to a cardiologist, assuming they needed one?
"Because of the MHPAEA, we are only required to cover you for a maximum of 4 sessions per year, rather than our previous cap of 40 sessions per year, because you see your cardiologist 4x/year."
What a windfall for the insurance companies. Remind me to buy stock in United healthcare.
And don't forget to join POLL, our Psychiatry Online Lifelong Learning journal club over on LinkedIn.
Okay, so there's "parity". What does that boil down to, and what problems can we foresee?
This is the very brief description of the Mental Health Parity and Addiction Equity Act from the Department of Labor site:
The Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) requires group health plans and health insurance issuers to ensure that financial requirements (such as co-pays, deductibles) and treatment limitations (such as visit limits) applicable to mental health or substance use disorder (MH/SUD) benefits are no more restrictive than the predominant requirements or limitations applied to substantially all medical/surgical benefits. MHPAEA supplements prior provisions under the Mental Health Parity Act of 1996 (MHPA), which required parity with respect to aggregate lifetime and annual dollar limits for mental health benefits.
I tried to read a little about the details of the Act, but it wasn't easy. From what I could glean, from the DOL site, as well as CMS, there's good news and there's bad news.
The good news:
-The criteria and standards for medical necessity determinations must be made available upon request
-Ditto the reason for a denial
-There can't be a separate deductible for Med/Surg and Mental Health/Substance; they need to be combined.
-There were already parity requirements in place with respect to aggregate lifetime and annual dollar limits, but these now apply to Substance treatment
-If your plan covers Out-of-Network providers for med/surg, it needs to cover out-of-network for MH/Sub.
The bad and confusing news:
-The Act does not mandate that a plan provide MH/SUD benefits.
-The Act does not apply to issuers who sell health insurance policies to employers with 50 or fewer employees or who sell health insurance policies to individuals.
-The regulations provide that the “predominant/substantially all” test applies to six classifications of benefits on a classification-by-classification basis. The regulation also includes other rules and definitions that are necessary in order for plans, issuers and their advisers to apply this general parity test.
This is where it starts to careen off into the stratosphere. I truly don't get the test and classifications, but I'll share the little bits and pieces that I partially grasp.
The general rule is that a plan may not impose a financial requirement or quantitative treatment limitation applicable to mental health or substance use disorder benefits in any classification that is more restrictive than the predominant financial requirement or quantitative limitation of that type applied to substantially all medical/surgical benefits in the same classification.
The six classifications of benefits are:
Inpatient in-network;
Inpatient out-of-network;
Outpatient in-network;
Outpatient out-of-network;
Emergency care;
Prescription drugs.
There are also Non-Quantitative treatment limitations, including medical management standards limiting or excluding benefits based on medical necessity or medical appropriateness, plan methods for determining usual, customary, and reasonable charges, refusal to pay for higher-cost therapies until it can be shown that a lower-cost therapy is not effective (also known as fail-first policies or step therapy protocols), and exclusions based on failure to complete a course of treatment.
The test for determining parity refers to levels of types of financial requirements or treatment limitations. The level of a type of financial requirement or treatment limitation refers to the magnitude of the type of financial requirement or treatment limitation. For example, different levels of coinsurance include 20% and 30%, different levels of copays include $15 and $20, or different levels of an episode limit include 21 inpatient days per episode and 30 inpatient days per episode.
To determine if a quantitative financial requirement (such as a copay) or quantitative treatment limitation (such as a visit limit) is permissible, the parity analysis must be applied for that type of financial requirement or treatment limitation within a coverage unit for each of the six classifications of benefits separately. A coverage unit refers to the way in which a plan groups individuals for purposes of determining benefits, or premiums or contributions (for example, self-only, family, employee plus spouse).
If a type of financial requirement or quantitative treatment limitation applies to substantially all medical/surgical benefits in a classification (for example, if a copay applies to substantially all medical/surgical benefits), then it may be permissible for that requirement or limitation (the copay) to apply to mental health or substance use disorder benefits. Generally, a financial requirement or treatment limitation is considered to apply to substantially all medical/surgical benefits if it applies to two-thirds or more of the medical/surgical benefits for the same classification and coverage unit.
The predominant level of a type of requirement or limitation applicable to medical/surgical benefits within a classification is the most restrictive level of the requirement or limitation that can be imposed on mental health or substance use disorder benefits within that classification...If, for example, for self-only coverage a $10 copay is the predominant level of copay that applies to substantially all inpatient in-network medical/surgical benefits, that is the most restrictive copay that can apply to inpatient in-network mental health or substance use disorder benefits.
A plan may not create sub-classifications for generalists and specialists to determine separate predominant financial requirements and treatment limitations that apply to substantially all medical/surgical benefits. However, if the predominant level of a type of financial requirement that applies to substantially all medical/surgical benefits in a classification is the one charged for a medical/surgical specialist, then that “specialist” financial requirement can be applied for all mental health or substance use disorder benefits within that classification. On the other hand, if the predominant level of a type of financial requirement that applies to substantially all medical/surgical benefits in a classification is the one charged for a medical/surgical generalist, then the financial requirement charged for all mental health or substance use disorder benefits within that classification cannot be higher than the “generalist” financial requirement for medical/surgical benefits.
Let's try this. A patient comes to see me. I'm classified as Outpatient, Out-Of-Network. The patient is single, so that's a self-only coverage unit. He is also diabetic, and his endocrinologist is also out-of network. His insurance pays 80% (the financial requirement) of the usual and customary fee (the non-quantitative treatment limitation) for endocrinologists in his region, and he is responsible for the rest. That's the level of coverage. And the percentage payment is the type of financial requirement (as opposed to if he had to pay a copay).
But two thirds of self-only covered patients in the region who are treated by endocrinologists have out of network coverage (in that plan or a different one?) that pays only 70% of the usual and customary fee, making 70% the most restrictive level of requirement. So when he submits my bill to his insurance, he will only be reimbursed 70% of the usual and customary fee. (Is this the customary fee for psychiatrists, or endocrinologists?) And if 2/3 of coverage for endocrinologists is at the 70% rate, but 2/3 of coverage for all outpatient treatment is at an 80% rate, then my bill will be reimbursed at the 80% rate.
Well, I'm glad we cleared that up.
I'm wondering if the upshot will be that MH/Sub just stops being covered. Period. There's no requirement for an insurer to cover it. The MHPAEA only requires that if it's covered, it has to be covered with parity, as defined in the very complicated details that I don't understand.
Moreover, it's obvious that insurance companies will find ways to apply these byzantine rules to their advantage.
The real twister here is that we're comparing apples and kumquats. I'm not referring to the question of whether psychiatry is a "medical" endeavor. I'm only considering the type, and more importantly, frequency, of treatment used in psychiatry, vs. say, cardiology (that would be a level of treatment, and a quantitative treatment limitation).
Admittedly, I'm an anomaly, because I see some patients as frequently as 4 times per week in psychoanalysis (more on this in a future post). I don't think patients visit their cardiologists 4 times per week over the course of a number of years. So does "no more restrictive" mean that my patients will be covered for as many visits per year as they would make to a cardiologist, assuming they needed one?
"Because of the MHPAEA, we are only required to cover you for a maximum of 4 sessions per year, rather than our previous cap of 40 sessions per year, because you see your cardiologist 4x/year."
What a windfall for the insurance companies. Remind me to buy stock in United healthcare.
And don't forget to join POLL, our Psychiatry Online Lifelong Learning journal club over on LinkedIn.
Thursday, November 7, 2013
Try This! It's Fun!
A friend sent me a link to Google Books Ngram Viewer. You can look up words, in various languages, and see how frequently those words showed up in books, during a specific time frame.
For example, I looked up Psychiatry, Psychoanalysis, Freud, CBT, ambivalence, Ego, and Id, and it came out like this:
I looked these up in English, but there are language variations you can use, such as British English and American English, and other languages. There's even an English Fiction category.
I thought it was a bit strange that there were spikes in both "Ego" and "Id" in the early 1800's, while Freud was born in 1856.
I checked Oxford Dictionaries Online, and Ego's origin was listed as early 19th century, from Latin, literally, "I". Freud used the German word, "Ich", which also means "I".
Id's origin was listed as:
1920s: from Latin, literally 'that', translating German es. The term was first used in this sense by Freud, following use in a similar sense by his contemporary, Georg Groddeck.
So I don't know where the early 1800's spike came from. I'll have to check my trusty OED, if I can find the magnifying glass that came with it.
I threw "ambivalence" into the mix because I was pretty sure it was coined by, or at least used very early on, by Freud. Since it first appears around 1910, that may be correct. Looks like another job for the OED.
For example, I looked up Psychiatry, Psychoanalysis, Freud, CBT, ambivalence, Ego, and Id, and it came out like this:
I looked these up in English, but there are language variations you can use, such as British English and American English, and other languages. There's even an English Fiction category.
I thought it was a bit strange that there were spikes in both "Ego" and "Id" in the early 1800's, while Freud was born in 1856.
I checked Oxford Dictionaries Online, and Ego's origin was listed as early 19th century, from Latin, literally, "I". Freud used the German word, "Ich", which also means "I".
Id's origin was listed as:
1920s: from Latin, literally 'that', translating German es. The term was first used in this sense by Freud, following use in a similar sense by his contemporary, Georg Groddeck.
So I don't know where the early 1800's spike came from. I'll have to check my trusty OED, if I can find the magnifying glass that came with it.
I threw "ambivalence" into the mix because I was pretty sure it was coined by, or at least used very early on, by Freud. Since it first appears around 1910, that may be correct. Looks like another job for the OED.
Sunday, November 3, 2013
POLL!
We did it! Drs. James Amos and George Dawson (of the Real Psychiatry blog) and I created a LinkedIn group entitled, Psychiatry Online Lifelong Learning (POLL). Here's the description:
This is a free Psychiatry journal club. Links to free articles, along with managers' initial comments, will be posted at regular intervals. Enthusiastic discussion is highly encouraged.
The purpose of this group is to foster professional interaction and collaboration, and to promote the principle of lifelong learning so important to continued growth as a clinician.
The group is primarily intended for psychiatrists, but anyone with an interest in psychiatry, and a scientific bent, is welcome to apply for membership.
We ask simply that comments be respectful and relevant to the discussion at hand.
And guess what? The first discussion has already begun, kicked off by none other than Dr. James Amos of The Practical Psychosomaticist blog. There's a timely article entitled,
Collaborative Care for Patients with Depression and Chronic Illnesses, byWayne Katon, et al.
So don't delay! Head on over to LinkedIn, and apply for membership. If you don't already have a LinkedIn account, it's free and easy to set one up, and not a bad thing to have, in any case.
We're really excited about this, and we'd like it to be something good for everyone. So please help us, and yourself, out by joining and participating.
Thanks.
This is a free Psychiatry journal club. Links to free articles, along with managers' initial comments, will be posted at regular intervals. Enthusiastic discussion is highly encouraged.
The purpose of this group is to foster professional interaction and collaboration, and to promote the principle of lifelong learning so important to continued growth as a clinician.
The group is primarily intended for psychiatrists, but anyone with an interest in psychiatry, and a scientific bent, is welcome to apply for membership.
We ask simply that comments be respectful and relevant to the discussion at hand.
And guess what? The first discussion has already begun, kicked off by none other than Dr. James Amos of The Practical Psychosomaticist blog. There's a timely article entitled,
Collaborative Care for Patients with Depression and Chronic Illnesses, byWayne Katon, et al.
So don't delay! Head on over to LinkedIn, and apply for membership. If you don't already have a LinkedIn account, it's free and easy to set one up, and not a bad thing to have, in any case.
We're really excited about this, and we'd like it to be something good for everyone. So please help us, and yourself, out by joining and participating.
Thanks.
Friday, November 1, 2013
By The Wayside
I've started to read up on tricyclics, since I did my residency in the age of SSRI's, and I rarely used a tricyclic in training, although I knew all about them for boards (except how to comfortably prescribe them). And in fact, I've never prescribed an MAO-I, which is also something I knew about for boards.
So I started to look back at the early articles on imipramine, and I found:
THE TREATMENT OF DEPRESSIVE STATES WITH G 22355 (IMIPRAMINE HYDROCHLORIDE)
Now, as far as I'm concerned, the AJP people are being jerks about this, because the article was published in 1958, and they still only allow access to the abstract, without a subscription. A historian friend, who is also the head of library archives at the oldest psychoanalytic institute in the US, told me that if it's more than 50 years old, it's basically open source (that's not how she phrased it, so don't hold her to my misunderstandings).
But I gleaned some interesting things from the abstract. Here it is:
Over a three-year period, more than 500 psychiatric patients of various diagnostic categories were treated with imipramine hydrochloride. It was demonstrated that the compound has potent antidepressant action. Best responses were obtained in cases of endogenous depression showing the typical symptoms of mental and motor retardation, fatigue, feeling of heaviness, hopelessness, guilt, and despair. The condition is furthermore characterized by the aggravation of symptoms in the morning with a tendency to improvement during the day. Treatment with imipramine hydrochloride resulted in full or social recovery in a high percentage of the patients. As a rule, the initial response was evident within 2 to 3 days, while in some cases 1 to 4 weeks of therapy were required. In view of the symptomatic nature of the action of imipramine hydrochloride, therapy must be maintained as long as the illness lasts. The side effects noted were relatively slight, and with the exception of one case of severe allergic exanthema necessitating discontinuance of treatment, no serious complications were encountered. In some cases of depression, particularly those associated with organic brain damage or schizophrenic psychosis, transitory states of agitation or exacerbation of the psychotic features were noted. These observations suggest the importance of a proper selection of the patients as to type and etiology of depression. While in a number of instances, neurotic, schizophrenic or other depressions were also benefited by the drug, particularly when used in combination with chlorpromazine, electroshock or psychotherapy, it is concluded that imipramine hydrochloride is primarily indicated and effective in the treatment of endogenous depression.
First of all, consider how the presentation style has changed over the years. There are no, Intro, Method, Results, Conclusions sections. No demographics, No HAM-D (1960, if you recall from my post). No MADRS. No p-value. No percentage changes. Nada. Just:
"It was demonstrated that the compound has potent antidepressant action", and, "...a high percentage of patients."
Now look at the disease description:
"...endogenous depression showing the typical symptoms of mental and motor retardation, fatigue, feeling of heaviness, hopelessness, guilt, and despair. The condition is furthermore characterized by the aggravation of symptoms in the morning with a tendency to improvement during the day."
Typical symptoms of endogenous depression are:
~mental and motor retardation
~fatigue
~feeling of heaviness
~hopelessness
~guilt
~despair
~aggravation of symptoms in the morning
None of the, "Most days for two weeks" stuff, or "Not better explained by another condition".
To my thinking, it's a pretty good way of describing a serious depression.
And then there's how they understand the response:
"Best responses were obtained in cases of endogenous depression..."
"...full or social recovery in a high percentage of the patients. As a rule, the initial response was evident within 2 to 3 days, while in some cases 1 to 4 weeks of therapy were required."
I'm curious about the precise meaning of "social recovery", and how it differs from "full" recovery, and how they can tell.
There's the acknowledgment that it isn't for everyone, together with suggestions about who may benefit more, and less:
"...a proper selection of the patients as to type and etiology of depression. While in a number of instances, neurotic, schizophrenic or other depressions were also benefited by the drug, particularly when used in combination with chlorpromazine, electroshock or psychotherapy, it is concluded that imipramine hydrochloride is primarily indicated and effective in the treatment of endogenous depression."
Notice the diversity of the complementary treatments: Chlorpromazine, electroshock, psychotherapy.
There's a description of side effects that doesn't try to pretend that it's not a problem for anyone:
"The side effects noted were relatively slight, and with the exception of one case of severe allergic exanthema necessitating discontinuance of treatment, no serious complications were encountered. In some cases of depression, particularly those associated with organic brain damage or schizophrenic psychosis, transitory states of agitation or exacerbation of the psychotic features were noted."
No muss, no fuss, no defensiveness, just, "Yeah, some patients got agitated or psychotic".
In other words, the people we think it's good for tolerated it well. And the people who tolerated it poorly, well, that's partially why it's not good for them. But it's also not as good for them as for the people with endogenous depression, and we know this because they needed additional treatment modalities for beneficial effects.
And finally, it's not a cure. It treats the symptoms of endogenous depression, and should be used while the endogenous depression lasts. There's no claim that these patients will need to stay on the drug forever.
"In view of the symptomatic nature of the action of imipramine hydrochloride, therapy must be maintained as long as the illness lasts."
It just seems so straightforward. I don't find myself wondering what they're really trying to say, and what they're hiding. A lot has changed along the way.
So I started to look back at the early articles on imipramine, and I found:
THE TREATMENT OF DEPRESSIVE STATES WITH G 22355 (IMIPRAMINE HYDROCHLORIDE)
Now, as far as I'm concerned, the AJP people are being jerks about this, because the article was published in 1958, and they still only allow access to the abstract, without a subscription. A historian friend, who is also the head of library archives at the oldest psychoanalytic institute in the US, told me that if it's more than 50 years old, it's basically open source (that's not how she phrased it, so don't hold her to my misunderstandings).
But I gleaned some interesting things from the abstract. Here it is:
Over a three-year period, more than 500 psychiatric patients of various diagnostic categories were treated with imipramine hydrochloride. It was demonstrated that the compound has potent antidepressant action. Best responses were obtained in cases of endogenous depression showing the typical symptoms of mental and motor retardation, fatigue, feeling of heaviness, hopelessness, guilt, and despair. The condition is furthermore characterized by the aggravation of symptoms in the morning with a tendency to improvement during the day. Treatment with imipramine hydrochloride resulted in full or social recovery in a high percentage of the patients. As a rule, the initial response was evident within 2 to 3 days, while in some cases 1 to 4 weeks of therapy were required. In view of the symptomatic nature of the action of imipramine hydrochloride, therapy must be maintained as long as the illness lasts. The side effects noted were relatively slight, and with the exception of one case of severe allergic exanthema necessitating discontinuance of treatment, no serious complications were encountered. In some cases of depression, particularly those associated with organic brain damage or schizophrenic psychosis, transitory states of agitation or exacerbation of the psychotic features were noted. These observations suggest the importance of a proper selection of the patients as to type and etiology of depression. While in a number of instances, neurotic, schizophrenic or other depressions were also benefited by the drug, particularly when used in combination with chlorpromazine, electroshock or psychotherapy, it is concluded that imipramine hydrochloride is primarily indicated and effective in the treatment of endogenous depression.
First of all, consider how the presentation style has changed over the years. There are no, Intro, Method, Results, Conclusions sections. No demographics, No HAM-D (1960, if you recall from my post). No MADRS. No p-value. No percentage changes. Nada. Just:
"It was demonstrated that the compound has potent antidepressant action", and, "...a high percentage of patients."
Now look at the disease description:
"...endogenous depression showing the typical symptoms of mental and motor retardation, fatigue, feeling of heaviness, hopelessness, guilt, and despair. The condition is furthermore characterized by the aggravation of symptoms in the morning with a tendency to improvement during the day."
Typical symptoms of endogenous depression are:
~mental and motor retardation
~fatigue
~feeling of heaviness
~hopelessness
~guilt
~despair
~aggravation of symptoms in the morning
None of the, "Most days for two weeks" stuff, or "Not better explained by another condition".
To my thinking, it's a pretty good way of describing a serious depression.
And then there's how they understand the response:
"Best responses were obtained in cases of endogenous depression..."
"...full or social recovery in a high percentage of the patients. As a rule, the initial response was evident within 2 to 3 days, while in some cases 1 to 4 weeks of therapy were required."
I'm curious about the precise meaning of "social recovery", and how it differs from "full" recovery, and how they can tell.
There's the acknowledgment that it isn't for everyone, together with suggestions about who may benefit more, and less:
"...a proper selection of the patients as to type and etiology of depression. While in a number of instances, neurotic, schizophrenic or other depressions were also benefited by the drug, particularly when used in combination with chlorpromazine, electroshock or psychotherapy, it is concluded that imipramine hydrochloride is primarily indicated and effective in the treatment of endogenous depression."
Notice the diversity of the complementary treatments: Chlorpromazine, electroshock, psychotherapy.
There's a description of side effects that doesn't try to pretend that it's not a problem for anyone:
"The side effects noted were relatively slight, and with the exception of one case of severe allergic exanthema necessitating discontinuance of treatment, no serious complications were encountered. In some cases of depression, particularly those associated with organic brain damage or schizophrenic psychosis, transitory states of agitation or exacerbation of the psychotic features were noted."
No muss, no fuss, no defensiveness, just, "Yeah, some patients got agitated or psychotic".
In other words, the people we think it's good for tolerated it well. And the people who tolerated it poorly, well, that's partially why it's not good for them. But it's also not as good for them as for the people with endogenous depression, and we know this because they needed additional treatment modalities for beneficial effects.
And finally, it's not a cure. It treats the symptoms of endogenous depression, and should be used while the endogenous depression lasts. There's no claim that these patients will need to stay on the drug forever.
"In view of the symptomatic nature of the action of imipramine hydrochloride, therapy must be maintained as long as the illness lasts."
It just seems so straightforward. I don't find myself wondering what they're really trying to say, and what they're hiding. A lot has changed along the way.
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