Bipolar Image

A reader kindly sent me a link to a research graphic on bipolar disorder that she helped to create, from a site called, "TopCounselingSchools.Org", which provides information about degrees available in counseling. I know nothing about the site, but I liked the image, so I'm sharing it with you.

The Highs and Lows of Bipolar Disorders

It's a really nice graphic. Visually appealing, not glaring, not too much information in one place, nothing blinking at you, information organized into clearly defined sections, just enough information to get you started, provides its sources. I can't vouch for the stats, but they seem about right.

The whole image is too large for this post, so here's a piece of it:

The one thing I found confusing is that in the first section, there's this:

It's one of several general statistics in that section.

Then, in the next section, there's this:

The American statistic above is one of the first you come across. By the time I got to the second section, I'd forgotten that I'd already read the stat for America, and I started looking for it, and was confused when I couldn't find it. I eventually (like 10 seconds) figured it out.  The only thing I'd change would be to repeat the American figure with the others in this section, since the type of display is different from the original one. This is really just me being fussy and weird. It's a great graphic.

So check it out.

And thanks to the reader who sent it. I don't know if she wanted her name listed or not, so if she does, I'll update this post.

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.

No Worries, Lurasidone

This just in: In July, Lurasidone, originally approved for Schizophrenia, was approved by the FDA for treatment of Bipolar 1 depression.

You can now prescribe Latuda for your depressed, bipolar patients. I can't think of "Latuda" without hearing, "Latuda Matata".

Here's a link to the AJP in Advance abstract for Lurasidone Monotherapy in the Treatment of Bipolar I Depression: A Randomized, Double-Blind, Placebo-Controlled Study. The primary outcome measure was the MADRS, and the study was sponsored by Sunovion.

"Lurasidone treatment significantly reduced mean MADRS total scores at week 6 for both the 20–60 mg/day group (−15.4; effect size=0.51) and the 80–120 mg/day group (−15.4; effect size=0.51) compared with placebo (−10.7)"

According to a Wikipedia article that may be wrong,

"An effect size calculated from data is a descriptive statistic that conveys the estimated magnitude of a relationship without making any statement about whether the apparent relationship in the data reflects a true relationship in the population. In that way, effect sizes complement inferential statistics such as p-values."

I'm not sure what it means for an effect size to be 0.51, or for the placebo score not to be recorded with an effect size.

Once again, I went to ClinicalTrials.Gov, and lo and behold, I found:

Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression (PREVAIL3)

Now, I don't know for sure if this is the same trial they're talking about, but since it was last verified in August 2013, it seems likely (and it was first received in January 2011).

And miracle of miracles, the results are listed.

This may be a little hard to read, but the primary outcome result for Lorasidone 20-120mg is -11.8, and for placebo, -10.4. And the p value is 0.176, which, last I checked, is larger than 0.05.

The abstract had the difference for lorasidone as -15.4, but grouped into two separate dosage groups, 20-60mg, and 80-120mg. This appears to be a subgroup analysis, where you chop up your results into smaller groups after the study is over, and which is a no-no because it can yield spuriously positive results for individual subgroups (I'll get to how this works in a later post).

So the results on clinicaltrials.gov seem to indicate that there was no significant difference.

It turns out, there was another trial listed on clinicaltrials.gov, entitled, Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression. this study was first received in March 2009, and last verified in February 2013. There were no results reported for this study on the site.

So we have a 24 week study, conducted earlier than the 6 week study, with no results reported. And we have a 6 week study with conflicting results, depending on where you look.

I could be wrong about how to interpret this data. What do you think?