Pristiq's FDA Chances: Depression – Yea; Menopause – Nay

As more info on Pristiq continues to roll out, I'll do my best to track them quite closely.

While Wyeth scrambles to resolve issues in its Puerto Rico plant to meet FDA standards, Ms. Kathleen Kerr of Newsday recently reported on Pristiq's potential to be approved for use in depression and hot flashes resulting from menopause. I was so excited to see some decent reporting on a mental health issue in a paper other than the NYT. It was also nice to see that it didn't end with "Shares of Wyeth fell 38 cents Friday to close at $51.50 on the New York Stock Exchange."

"If Pristiq wins Food and Drug Administration approval, it will be the first antidepressant and only non-hormonal remedy marketed specifically for hot flashes. But Pristiq isn't without problems – it poses rare suicide risks in young people."

Continue reading “Pristiq's FDA Chances: Depression – Yea; Menopause – Nay”

Celebrity sensitivity: Britney’s mental illness

Britney SpearsI originally posed a theory that Britney Spears might be suffering from a mental illness such as postpartum depression (PPD) or bipolar disorder. Furious Seasons linked to an article on tmz.com (by way of Celebrity Baby Blog – wtf?) where “sources say doctors at her rehab facility think the underlying reason for her trouble may be post-partum depression.”

As for my theories:

“Sources tell TMZ that Britney’s doctors have two operating theories — either that she suffers from post-partum depression or bipolar disorder. The doctors strongly believe post-partum is the problem.”

At least I got the plausible diagnoses. Damn, I’m good.

(A nice pic of the former ‘sexy’ days of Ms. Spears.)

UPDATE: The Trouble With Spikol also wrote her own take on it too.

Mean behavior isn't always mental illness

OK – I continue my streak of NYTimesing (lookee! A verb!) and post a link to an essay by Dr. Richard Friedman about how chronically "mean" people may not have a mental illness. They are just… well, mean.

Friedman raises an interesting point about how psychiatry and psychology try to explain away so much of people’s behaviors via diagnosis that people aren’t left any room to be "normal." Mean people don’t need to be lumped into a category of "anger disorder" or some crazy nonsense like that. Perhaps there are people who have extreme issues with anger and need to learn behavioral techniques to get it under control. But other people at their very core like to hurt, manipulate, and demean others. This is not a mental illness. This is a human, sinful nature.

Panic disorders relieved by talk and behavioral therapies

The NYT published a story on Feb. 6 about how talk therapy aids panic disorders.

The study seems interesting. The psych world is excited because of its promising results. The results do seem hopeful but give the sample size, it's too early to tell.

"A team of New York analysts published [in The American Journal of Psychiatry] the first scientifically rigorous study of a short-term variation of the therapy for panic disorder, a very common form of anxiety. The study was small, but the therapy proved to be surprisingly effective in a group of severely disabled people… The brand of therapy tested relies on core tenets of analysis, like the search for the underlying psychological meaning of symptoms. But unlike traditional psychoanalysis, it focused on relieving symptoms quickly, and was time-limited. Previous studies of similar approaches have shown some promise for other disorders, like depression."

Perhaps Dr. David H. Barlow, a psychologist at Boston University, had the best insight:

"[He] said… that the study was too small to be conclusive but that 'the authors should be congratulated for actually  taking the first step in doing the hard work of beginning to evaluate treatments” that are widely used without good supportive evidence.

The researchers tested a pared-down version of analysis tailored specifically for panic attacks, the breathless, paralyzing dread that strikes some 1 percent to 2 percent of people, seemingly out of nowhere. Previous studies had found that other kinds of therapy — including exposure techniques, in which people learn to diffuse their anxieties by facing them one small step at a time — can relieve panic attacks in half to two-thirds of patients, depending on the severity and type of anxiety."

The article doesn't mention where the estimated "some 1 percent to 2 percent of people" comes from so I'll probably do some digging around to find out how many people are estimated to suffer from anxiety disorders and panic attacks. It's also interesting to note that studies used a form of psychological behavioral therapy to help patients manage their symptoms.

"Half of the group received a form of relaxation training, in which they learned how to moderate their arousal by tensing and relaxing specific muscle groups. The other half received psychodynamic therapy, working with their therapist in two weekly sessions to understand the underlying meaning of their symptoms — when the reactions first started and how they might be linked to loss, broken relationships or childhood experiences that unconsciously haunted their current lives."

Relaxation techniques — don't Ativan and Klonopin achieve the same result except much faster?

"After 12 weeks, 39 percent of those working with relaxation techniques improved significantly on standard measures of anxiety and reported fewer panic-related problems in their relationships and work. But almost three-quarters of those receiving psychodynamic therapy reported similar benefits. "

Thirty-nine percent of 49 patients equals about 19 patients who "improved significantly." It's not brain science, but you've left with another 30 who didn't. However, nearly 75 percent of the sample size "reported similar benefits" from psychodynamic therapy. Perhaps it wasn't revealed in the American Journal or it's a shoddy article thrown together at the last minute, but I'd like to know what "similar benefits" the study is speaking of.

Also, isn't 12 weeks longer than most clinical trials funded by drug companies? Perhaps I'm thinking that's just the first phase of a clinical trial…?

"One former patient treated with this therapy began to have panic attacks after witnessing a young woman die of an illness, said her doctor, Fredric N. Busch, a Cornell psychiatrist and a co-author of the new study.

The patient, who was not a part of the study, described the death as deeply unfair, and in sessions explored perceptions of unfairness in her work and her life, including her childhood. “Once she was able to understand this pattern, the panic became less frightening, she felt safer and was eventually able to get rid of the symptoms,” Dr. Busch said."

I'm no doctor, but this sounds more like Post-Traumatic Stress Disorder. This example makes PTSD sound less like a mental illness and more like a behavior to be unlearned. Perhaps it's true? How do events "trigger" a mental illness? Is it inherited or can it be acquired? What a debatable topic. Oy.

"The researchers said that even if this approach was not for everyone, it appeared to be especially beneficial for a particular group. In an analysis of individual patient’s responses, the researchers found that those who also had a personality disorder, like avoidant personality, showed significantly greater improvement than those whose symptoms were related solely to anxiety. Patients with multiple diagnoses are usually more difficult to treat. "

It's nice to think that these techniques could replace anti-anxiety meds. But alas, they won't; Big Pharma wouldn't allow it. But a girl can dream, can't she?

(The boss won't let me skip lunch and leave early so… here are your updates…)

Be more active

Taking a break from pharma for a bit, one of my suggestions for "Staving off the blues" is being "more active." I never fail to include my disclaimer that being more active does not make mental illness disappear. It helps to temporarily relieve symptoms associated with those who suffer from chronic mental illness.

I’ve been attempting to exercise for 25-45 minutes twice a week. (Doesn’t always happen.) But for the days when I do, I get a "high" that elevates my mood for about an hour or so. Nevermind that my mood may drop off two to three hours later or that I wake up depressed in the morning. Those precious few minutes of exercise helped me to feel good for a little while. And every little bit helps.

Blogs: Possibly induced by antipsychotics

I’ve been following soulful sepulcher and am captivated by her story of her daughter, Lindsay, struggling with multiple health issues: childhood bipolar disorder with psychosis possibly induced by antipsychotics, not to mention chiari malformation and syringomyelia. (I feel like I’m forgetting something.) She’s also struggled through the state mental health system. I’ve never been in a state hospital, but these stories don’t particularly encourage me to end up there anytime soon. My heart goes out to her and her daughter, Lindsay. Having been in private psychiatric hospitals, I can confidently say that they are no cakewalk. My mind can’t fathom the depths of the environment at a state hospital. Can’t. Fathom.

In a related matter, psychiatric patients owe their love and gratitude to Eli Lilly for creating Zyprexa, one of the biggest medical shams in the psych market. Go to soulful sepulcher’s blog to read more.

Babies and toddlers are mentally ill

The new fad? Diagnosing young children with mental illness.

Oh and I mean young.

Originally, I’d written about how psychiatrists are diagnosing mental illness in infants. Mental health blogs now are all over the Rebecca Riley case and rightly so.  She was a 2½-­year-old toddler diagnosed with ADHD and bipolar disorder. How a psychiatrist can diagnose a child that young is beyond me.

intueri has written a brilliant post about the case and diagnosing children that young:

“We need to stop labeling behavior as pathological just because it causes us inconvenience. We also need to stop using diagnoses as means of absolving us of our responsibilities (”it was the bipolar that made me say those mean things to you; it wasn’t me”). We, as providers, need to stop colluding in these goals: We need to stop the belief that a pill will always cure everything.”

(linkage attribution: Furious Seasons)

Catching up: Furious Seasons

I’ve been out of it. Really out of it.

In my backlog of reading, Furious Seasons has posted the results of what he’s entitled, "The Zyprexa Chronicles."

The judge ruled in favor of Lilly.

Holy crap. I knew this would happen, but hoped it wouldn’t.

This all occurred on Feb. 13, so I’m really behind the times here. (Did Punxsawtawney Phil see his shadow yet?) But it’s a reminder to, not just the blogosphere, but also to the media that, well, pharma companies are more powerful and have more sway in court.

After reading a bit more on the situation (ok – I’m getting all my info from ONE blog), it seems that the judge hasn’t really ruled against blogs using or disseminating these documents (MindFreedom.org being the exception apparently) but these leaked documents could cause Lilly "irreparable harm." What? Documents that need to be made public would harm Lilly? It’s David against Goliath. Mainstream media — CBS, ABC, NBC, AP — haven’t picked up on this story. The majority of Americans – I’d venture to say the majority of Zyprexa consumers – don’t know about the proven side effects of this drug. I highly doubt it would cause "irreparable harm."

Classic quote:

"The way reporters work is a good deal for the public. We get paid like school teachers, think like lawyers and detectives, fight like Marines when necessary and write like… oh, nevermind."

Man, ain’t it the truth. Especially the schoolteacher pay. Except in Brooklyn, NY where they’ll pay a starting teacher at $40K because they need teachers in the inner city. But I digress.

"So, Ms. [Marni] Lemons (Eli Lilly spokeswoman), what I reported on yesterday — that your company was talking about potentially downplaying glucose increases noted in studies used to approve Zyprexa for long-term use in bipolar disorder — was based on these documents and it sure looks to me like your employees were strategizing all over the Lilly email system. I contacted your press office on Monday and asked them to respond to several questions about that document. Your people never responded….

The same goes for you people at the FDA. Stop telling me to file FOIAs in order to get basic public information that affects millions of people that should already be freely available on your website."

For those who don’t know, FOIA stands for Freedom of Information Act, in which anyone can write to a governmental agency and appeal for documents that have been made public. The nice part about this? The agency can black out information that don’t want you to know. They can deny your request, block out some data, or block out so much that the document ends up being useless. Oh, and FOIAs take forever and freaking day to arrive because the gov’t sends them when it’s convenient for them.

Furious Seasons has also been following the NYT’s coverage about a child diagnosed with ADHD and bipolar, who was killed and supposedly overdosed on medication. Riiight. Unfortunately, from what I can see – perhaps I’ll find a bit more – the NYT is extensively covering mental health issues. Perhaps they’re getting a ton of hits on the Zyprexa series and have figured out that people actually care about mental health topics. Whatever the reasoning, I’m glad they’re doing it.

Astute observation from Furious Seasons:

"This whole diagnose-medicate-blame-the-"illness"-for-bad-outcomes nonsense has got to stop. It’s bad enough in adults and teens, but in kids it is a complete outrage. It is interesting to me, though, that when a child dies, the skeptical questions are asked. When an adult has awful results from taking Zyprexa, say, or Paxil, the media is largely silent."

More to come on other blogs…