Signed, Sealed, Delivered

My ABPN recertification certificate was delivered today. It was maximally inconvenient, because it had to be signed for. It says:

The American Board of Psychiatry and Neurology

Incorporated 1934

Member of the American Board of Medical Specialties

hereby declares

Me, MD

maintained certification in Psychiatry

on February 9, 2015

as a Diplomate of the American Board of Psychiatry and Neurology

Ongoing certification is contingent upon meeting the requirements of

Maintenance of Certification

Then it has the signatures, certificate number, and a blurb about certification being contingent on maintaining licensure.

First of all, shouldn't it be, "declares that?"

In the lower left hand corner is the seal of the ABPN:

And in the lower right hand corner is the seal of the ABMS:

I'm not sure how well you can see the ABMS seal, but the cap stone of "Excellence" rests on the three pillars of "Ethics", "Honor", and "Skill".

And the Latin ribbon reads, "Animus Opibusque Parati" or, "Prepared in Mind and Resources," which is, apparently, one of the mottoes of South Carolina. The other is, "Dum Spiro Spero" or, "While I Breathe, I Hope."

What about those images on the ABMS seal? I get the staff of Asclepius on the left, but the oil lamp on the right? Master Google didn't come up with a quick answer for me, but I'm thinking, genie? Maybe the three pillars of excellence are really just the three things the ABMS wishes it had. Or maybe it's that Neti Pot thing you use for nasal irrigation.

I don't know what the link is between the ABMS and South Carolina, but this is probably not the state you want to be linked with right now.

Silliness aside, what do you think of that, "Ongoing certification is contingent upon meeting the requirements of Maintenance of Certification?" Would you hang that on your office wall? I won't. It's like the ABMS wants your patients to think, "Hm, is my doctor still board certified? Maybe I should check." Just another way of intimidating doctors into keeping up with MOC.

The certificate came with yet another advertisement from Jim Henry, Inc., for ordering a frame. I'm so glad I didn't get one. My plan is to put this new piece of card stock away someplace, and remove the little rectangle that states that my certification expires at the end of 2015 from the frame on my present certificate.

Happiness is...

Have you seen Happify? It's an app that has you play games to increase your happiness. It claims to be science-based. For example, I just played, "Negative Knockout". You get 5 negative feelings, and then you destroy them with a slingshot. And you get extra points for destroying them with only two tries, although you get up to 5 tries.

Here's a screenshot:

Look familiar? Of course it does. It's Angry Birds.

Happify claims the benefits of this game are:

Reduce the impact of your negative thoughts
Stop ruminating on your worries
Feel empowered to control your thoughts

I guess it's a fair question. Can Angry Birds improve your life if you rename it, Negative Knockout?

And they even site research, a study done at Ohio State University that took place in Madrid. Students were asked to write down thoughts about their body image. Then half were told to throw out the piece of paper they wrote their thoughts on. The ones who kept their "thoughts" later demonstrated lower body image than the ones who threw them out.

There were two other tasks in the study: one in which the students were asked to write down beliefs about the Mediterranean Diet, and either throw away, leave, or keep their thoughts; another in which the students wrote their thoughts in a word-processing program and then either put them in the recycle bin, or didn't. Both tasks had results similar to the first.

There's another game called, "Uplift", in which you are supposed to tap hot air balloons with positive words, like cozy and jolly, and avoid tapping negative words like judgement and sad.

What can I say? I'm skeptical, at best. That may be because I haven't played enough Happify games-skeptical is one of those negative words.

There are also activities like, "Thx Thx Thx" that asks you to record today's happy moments.

The way it works is that you fill out a little questionnaire that asks things like how often you felt joy in the last week. And then it recommends a track based on your specific needs. And the tracks have the various games and activities. Some of the tracks are Conquer your negative thoughts, Hardwiring happiness, Cope better with stress, Get to know yourself better, Before happiness: Kick-start positive change. Several of these are premium tracks. Also, some of the games and activities within free tracks are premium. And you have a limited time to complete each track.

The tracks are created by experts. For example, the Conquer your negative thoughts track was:

Happify claims to have "combed through the body of positive psychology to build exercises in STAGE, that's savor, thank, aspire, give, empathize, the 5 essential happiness skills you'll develop by using Happify. And of course, you can track your progress.

I don't know anything about positive psychology, but I have noticed an interesting jargon phenomenon among 20 and 30-somethings these days. "Negativity" is to be assiduously avoided. So is being "Judgemental". And one must always aspire to "Productivity".

I don't think productivity is invariably a healthy thing. I also think sometimes one has to exercise judgement about people, and why is it the end of the world if one does? And negativity? I'm not really sure what that means. Is it feeling sad? That's life. Is it letting others know you're sad? That's intimacy. Is it pessimism? That has its role to play.

I'm not comfortable with the idea that negativity has to be conquered, or that happiness is necessarily something to pursue. The implication may be that you're a failure if you're not happy. I guess I've been influenced by Freud's famous therapeutic aim for his hysterical patients, "...Transforming... hysterical misery into common unhappiness."*

*Ihr hysterisches Elend in gemeines Unglück zu verwandeln, SE Vol II, Studies in Hysteria, p. 311. 

Shrinks Links, Etc.

I haven't posted anything in a few days. I've been busier than usual, lately, but mostly, having forced myself to read all of Jeffrey Lieberman's, Shrinks, and then to write an extensive review of it, I find I'm all blogged out, and I have nothing to say right now. I'm waiting for another topic to bubble up and inspire me.

In the meantime, I've noticed that the reviews of Shrinks keep piling up. So I thought I'd post some links, along with brief comments.

First, there's this piece, by Natalie Angier, in the NY Times, published on March 26, 2015. She seems to agree wholeheartedly with Lieberman's perspective, with about the same level of scrutiny of the facts.

There's a review by Leon Hoffman, MD, to be published in the Journal of the American Psychoanalytic Association. Hoffman points out Lieberman's descriptions of what are, in fact, his own clinical failures and blaming of the families of patients. He makes reference to Lieberman's antisemitic tendencies, comments on Lieberman's limited understanding of the complexities of the human condition, and questions one of Lieberman's most prominent excuses for the book, that it will help reduce the stigma of mental illness.

There are my reviews: Shrinks Review-Introduction; and Shrinks: The Untold Story of Jeffrey Lieberman's Oedipal Victory Over Papa Freud. Feel free to read them, if you haven't already.

There's another review by Robert Freedman, MD, in the May 2015 American Journal of Psychiatry. Freedman is all gung ho about the book, and sees Lieberman's brush with PTSD symptoms as evidence that he's tough and up for the fight to champion psychiatry.

As it happens, a colleague and I wrote a letter to the editor about this review, but it was rejected. Since it's not going to be published by the AJP, I guess I can include it here:

In his review of Shrinks: The Untold Story of Psychiatry (1), by Jeffrey Lieberman, Robert Freedman seems unaware of the irony of his statement about, "...the place Psychiatry has earned in society by helping patients and families, one at a time." Freedman writes about a young woman with schizophrenia, described in Shrinks, whose treatment failed because her family refused Lieberman's recommendations.

Freedman neglects to note, or notice, that it was Lieberman who failed to establish a sufficiently powerful therapeutic bond with both the patient and the family, to consider the individual psychologies of all of them, and to take into account the forces emanating from the family’s social milieu. Any mental health professional who treats patients every day would recognize that without this bond and effort at understanding the patient and family, treatment is doomed to fail, no matter how great the power of the medication or the authority of the physician. 

Indeed, Glen Gabbard (2) has recently commented: 

“The core of psychodynamic psychiatry is to look at each individual as a person with highly individual, even idiosyncratic features. This core principle of good psychiatric practice, and even good medical practice, may be obscured by our progress in so many areas of ‘hard science’ in our field.”

Lieberman’s patient was one of two mentioned in Shrinks whose treatment failed because of his inability to establish a rapport with family members who disagreed with him. Of the second patient, Lieberman states, "I told them quite bluntly that their decision to withhold treatment was both cruel and immoral though tragically, not illegal..." Freedman lauds Lieberman as, "...unshaken by any criticism that he confronts from the same 'rogues' who derailed the treatment...” by preventing the young, psychotic woman from continuing her psychotropic medications. In fact, it was Lieberman, himself, who derailed her treatment by alienating her family. It is puzzling why Freedman does not address Lieberman’s obvious failure as a physician and a clinician.

Unfortunately, Freedman’s review reinforces the valorization of the deleterious trend in contemporary psychiatry which prioritizes the biomedical model and devalues the biopsychosocial model, as first explicated by George Engel.

The rejection email we got from Robert Freedman referred to the letter as, "sprightly," but it stated that, unfortunately, there was only room for one review of Shrinks. That seems to miss the point that the letter was a review of the review. Whatever. So it goes.

Another review is from The Guardian, written by Lisa Appignanesi. She notes Lieberman's ties to the pharmaceutical industry, and therefore questions his enthusiasm about meds. She writes:

Yet it’s difficult to share Lieberman’s triumphalist certainties. No medical specialisation outside American psychiatry counts it a success to have vastly grown the number of those who suffer from its burgeoning classifications; to have promulgated the taking of regular medication by everyone, including toddlers suffering from a new DSM category of illness that in the past might have been termed “rambunctious childhood”; or to have boosted mood-altering pill-popping to an extent street pushers would consider a bonanza.


The final review is by Richard C. Friedman, MD, in Psychodynamic Psychiatry. This is an extensive review, fairly evenhanded, in fact, a bit too generous to Lieberman, in my opinion. But I'll quote the Conclusion:

On the front and back cover of Shrinks is a vacant, red couch—Lieberman’s symbol of…what? Incompetence? Sexual seductiveness? The cover seems to express his view that American psychiatry was falsely led by an empty couch, the equivalent of an empty suit. Possibly the vibrant red color suggests that Lieberman is criticizing psychoanalysis for a sybaritic quality. Or, perhaps, red was chosen simply as a marketing device, a tempting lure enticing potential customers to buy the book. And what of the word “shrinks”? Lieberman might have simply been deconstructing the use of the term in mass culture, but I don’t think so. Rather, I believe that he joins with those who use “shrink” as a term of devaluation. In doing so, he seems to take the role of Gulliver amidst the psychoanalytic Lilliputians. Shrinks is written in a popular style for a lay audience. It has academic ambitions, but dispenses with academic conventions. There are no references documenting the assertions and conclusions and no footnotes; there is simply a list—surprisingly brief—of “sources and additional reading” at the end. In expressing opinion without evidence Lieberman responds precisely like the “psychoanalysts” about whom he speaks with contempt. Finally, I must confess that I was taken aback by Lieberman’s reference to Freud as a “rogue,” “Psychiatry’s greatest hero and its most calamitous rogue” (p. 39). The dead are forever silent but I cannot help but wonder what Freud would have thought of Lieberman. I imagine he had to deal with many Liebermans in his time.


Finally, I'd like to go on record as acknowledging how much energy I've devoted to Jeffrey Lieberman, a man I've never met. There is something about him that invites this kind of response. Something infuriating. Something to think about.

Logos

You may have noticed my logo on the blog or twitter:

I drew this on a doodling app about 6 years ago. It's basically a caricature of my analyst's couch. I also think it looks like a cartoon nose. I submitted it, with wording, as part of a logo competition for my analytic institute's centennial celebration. It looked like this:

It didn't win, but people thought it was funny. I thought it would make a good t-shirt.

The couch drawing is kind of a joke, but I'm proud of it, so I use it. Also, it's a way of keeping my analysis, and my analyst, with me, although she's since gotten a new couch that looks nothing like this one.

And it's sort of a brand. I'm not sure what it "says" about me. Maybe that psychoanalysis is important to me, but I try not to take it, or myself, too seriously.

I think branding matters. Images, tag lines, they do make an impression. And perhaps more significantly, for large companies or institutions, a lot of thought goes into deciding on a look. A lot of thinking about what values they want to convey. And they pay consultants large sums of money to help develop that look.

Nike. Apple. Coke. Disney. You immediately picture the swoosh, the apple, the red and white, the castle. And they conjure feelings, and ideas, and memories.

That's what they're supposed to do.

The APA has a new logo. I read about it in the June 5, 2015 edition of Psychiatric News. And here it is:

From the article:

"[The] new APA logo signifi(es) the leadership of the modern psychiatrist as a physician of mind, brain, and body...The new logo graphically updates the image of psychiatry to express its expertise in biopsychosocial and integrated care..."

Well, I see a snake around a stick. That's the staff of Asclepius, signifying medicine. Or a way to remove the dracunculus parasite.

I see a brain, signifying, a brain.

The word, "mind", is there, but no accompanying image. Not really an image of a body, either, except that the brain is part of the body. Or it's the body of the snake.

If you consider only the image, it could be a logo for the American Neurological Association. Or the new movie, "Snakes on a Brain."

It's kind of perfect, really. There's a mention of mind, but the focus is on brain and medicine.

The APA's Office of Corporate Communications and Public Affairs also produced a document, "APA Brand Guidelines." I couldn't find it online. According to the article, its purpose is, "To help the APA administration, district branches, and state associations adopt the new logo and the related material that support it (such as a color palette and type fonts)..."

The article goes on, "This guide contains everything you need to understand and use our brand system. By consistently adhering to our brand architecture, you will strengthen our collective presence and thus the cause." This reminds me, eerily, of another successful branding system.

And there's a video, "...that reflects the values of modern psychiatry and their translation into the new logo..." Notice the number of doctors in white coats. And scrubs. Outside of residency, when do you see a psychiatrist in scrubs? Wait. I wear scrubs when I'm doing a lot of cooking.

I don't really understand what it's saying. There are images of happy people, a teenager in a car with his father, learning to drive. Some kind of team being coached, a kid riding on his father's back. There are shots of brain imaging, a guy trying on a jacket, another guy from the military with a little kid. It could easily be a commercial for an insurance company. It's that slick:

Remember, "logos" means word. Or reason.

Addyi

Addyi.

That's the proposed trade name of Flibanserin, the new "female viagra" drug that's making headlines because the FDA has not approved it, but agreed to call a panel to review their decision.

No idea how to pronounce, "Addyi."

There are all kinds of controversies here. The group, Even the Score, is complaining that the FDA is guilty of gender bias. They're funded, in part, by Sprout Pharmaceuticals, the company that makes flibanserin. The FDA claims they just don't think the benefits outweigh the risks, and they seem to have agreed to the review panel because of political pressure. Other women's advocacy groups, like Our Bodies Ourselves, are opposed to the drug, for the same reasons as the FDA. There are questions about the diagnosis of Hypoactive Sexual Desire Disorder, for which the drug is being developed.

All sorts of difficulties. And who knows the answers? I certainly don't. So let's look at the drug (FDA report of June 4, 2015).

Flibanserin was originally developed by Boeringer Ingelheim, as an antidepressant. Then Boeringer Ingelheim switched to evaluating it as a treatment for low sexual desire in women. I don't know how that switch came about. In 2012, Sprout Pharmaceuticals acquired flibanserin.

The FDA is now on its third review cycle for flibanserin. In the first review cycle there was a unanimous, 11 to 0 vote not to approve the drug:

The FDA agreed that the NDA could not be approved and issued a Complete Response letter in
2010, citing the following deficiencies:

*Lack of substantial evidence of efficacy because the phase 3 trials did not show a
  statistically significant change from baseline for one of the pre-specified co-primary
  efficacy endpoints.

*Overly restrictive entry criteria for the phase 3 trials, precluding a full assessment of
  efficacy and safety in the target population.

*The need for a DDI study to characterize the effects of a moderate CYP3A4 inducer and
  a moderate CYP3A4 inhibitor on flibanserin pharmacokinetics. The letter also asked the
  Applicant to submit results from a meta-analysis of phase 1 pharmacokinetic and safety
  data in women who concomitantly received flibanserin with an oral contraceptive (a
  weak CYP3A4 inhibitor).

*The need to complete the ongoing 12-week trial assessing the concomitant use of
  flibanserin with selective serotonin or norepinephrine reuptake inhibitors, with particular
  attention to possible exacerbation of depression.

*The need for a study assessing the effects of co-administered flibanserin and alcohol on
  tolerability, blood pressure and orthostatic vital signs.

*The need for a study assessing the effects of supra-therapeutic doses of flibanserin on
  orthostatic vital signs and risk of syncope in healthy premenopausal women.

*The need for an assessment of the risk of accidental injury with root cause analyses.

*The need for an assessment of the potential for human abuse because of central nervous
  system effects. 

The first study in premenopausal women ended in 2008. The primary outcome measures were changes from baseline in frequency of satisfying sexual events (SSE) and changes in desire, both measured by electronic diary entries kept by study subjects. The secondary outcome measure was change in distress associated with reduced sexual desire, assessed by diary entries and by using response to Question 13 in the Female Sexual Distress Scale-Revised (FSDS-R), which is, "How often do you feel bothered by low sexual desire," rated on a scale of 0-4.

There was no statistically significant difference in the measure of desire. The company blamed this result on "diary fatigue", and proposed using two questions from the desire domain of the
Female Sexual Function Index (FSFI-desire, which uses a 28-day recall period) to
assess changes in desire. I'm pretty sure the two questions are, "How often did you feel sexual desire," and, "How would you rate your level of sexual desire," in the past 4 weeks, on a 1-5 scale.

In other words, they wanted to change the primary outcome measure after the study was complete.

I quote the FDA report (p.11):

The Division advised that failure to meet one of the two co-primary efficacy
endpoints did not constitute an acceptable reason to alter a pre-specified and
agreed-upon endpoint. Furthermore, the Division and the Study Endpoints and
Label Development (SEALD) team had already shared with the Applicant
concerns regarding limitations of FSFI-desire instrument, regarding 1) recall bias
due to the use of a 28-day recall period, and 2) content validity of the two
questions. 


In the second review cycle, in 2013, the FDA cited:

*Numerically small treatment differences compared to placebo, which do not clearly
  outweigh the safety concerns.

*Concerns with content validity of the FSFI sexual desire domain, used as the co-primary
  efficacy endpoint in the new phase 3 trial, and used as a secondary endpoint in the two
  prior phase 3 trials.

*Concerns about how healthcare providers would identify appropriate candidates for
  flibanserin, taking into account the change in DSM diagnostic criteria.

*A clinically significant interaction with alcohol causing syncope and hypotension.

*Increased exposures to flibanserin with moderate and strong CYP3A4 inhibitors, causing
  clinically significant hypotension in some cases.

*Events of central nervous system depression (e.g., somnolence), some of which appear
  temporally associated with accidental injury. 


The FDA made several requests for additional data and analysis, if the drug was to be reconsidered.

In December, 2013, Sprout submitted a dispute resolution request, and asked that flibanserin be approved without additional data or analyses. This was denied in February, 2014.

And thus began Sprout's campaign to pressure the FDA into reassessing by invoking gender bias.

I apologize for my cynicism, but I suspect a political and social media campaign is cheaper and faster than additional research, especially when there is little expectation that additional research will improve the drug's prospects for approval.

What is flibanserin? It's a 5HT1A agonist and 5HT2A antagonist. It also binds moderately to 5HT2B & C, and dopamine D4. Its mechanism of action in HSDD is unknown.

There are significant interactions with fluconazole (7-fold increase) and ketoconazole (4.6-fold increase), and serious risks of hypotension and syncope, especially with concomitant alcohol use. Flibanserin is not a PRN drug, so interactions with alcohol are unavoidable, unless one completely avoids alcohol, which is unlikely in a general population.

Some alcohol-related data:

The exclusion criteria in the flibanserin studies are important to consider. One was a recent history (6 months) of major depression or history of a suicide attempt, or current suicidal ideation. Another was decreased sexual desire due to medication. So the studies could not assess decreased sexual desire due to depression, medication, or other psychiatric illnesses (another exclusion criterion). The generalizability of the results is therefore questionable.


But the bottom line is, does it work? If it does, then maybe women who are willing to risk the adverse events should be offered the drug. There are women who participated in the trials who feel they were helped by the drug, and are disappointed not to have access to it.

This is the FDA's efficacy conclusion (p.33):


The three pivotal trials conducted in North America of flibanserin 100 mg qhs showed a
statistically significant difference between flibanserin and placebo on the endpoints of SSEs,
FSFI-desire score (but not daily desire measured by an eDiary) and FSDS-R Q13 distress score.
These findings and the magnitude of the treatment effects are consistent across the three trials.
However, the treatment differences are numerically small. The FDA is seeking expert advice
from a multidisciplinary advisory committee panel as to whether these observed effects outweigh
...safety concerns... 

To clarify, the first two trials used the eDiary as the primary outcome measure for desire, the condition flibanserin is intended to treat, with no statistically significant results. The third trial switched to FSFI-desire score as the primary outcome measure for desire.

And the overall results(p. 5):

*From a median baseline of about 2-3 SSEs per month, flibanserin resulted in a median
  placebo-corrected increase of about 0.5-1.0 SSEs per month.

*From a mean baseline of about 1.8-1.9 on the FSFI desire score, flibanserin resulted in a
  placebo-corrected mean increase of 0.3-0.4 (the FSFI desire score range is 1.2-6.0).

*From a mean baseline of 3.2-3.4 on the distress score, flibanserin resulted in a placebocorrected
  mean improvement of 0.3-0.4 (on a scale of 0-4). 


We'll just have to wait and see.