That’s right, The Snake Pit. It’s not the freaky mental hospital in the movie “One Flew Over the Cuckoo’s Nest.” It is the modern American jail, which now holds more mentally ill people than psychiatric hospitals.

I listened to a lecture by Judge Steve Leifman of the Miami-Dade County Court system, who realized five years ago that he was seeing many mentally ill people who were arrested for minor crimes like pushing a shopping court down the street (many of them were homeless), or whose family called the police, hoping to get help, only to have their loved one thrown into the slammer. People that are mentally ill stay in jail eight times longer for minor misdemeanors than other people. Often they get lost in places like “The Forgotten Floor” of Miami-Dade County jail (it’s actually four floors), because the State of Florida does not have enough psychiatric facilities to take them as a transfer. And so they stagnate in the County jail system.

Check out this video of an investigative report called “The Forgotten Floor”. It’s frightening.

Judge Leifman has taken an active role in reform, helping to create programs to divert mentally ill people who get arrested away from the criminal system and directly into treatment, and pushing the state to take responsibility for the mentally ill. Our State of Georgia has had its share of problems, with a rash of documented deaths occuring in inpatient psychiatric facilities due to neglect and over crowding. Maybe we could learn something.

Since the establishment of the DSM V Shadow Team to track the proceedings of the DSM committee in response to their paranoid decision to keep all of their meetings a secret and not allow anyone to keep notes or talk to the press, we have been quietly reviewing psychiatric nosology and contemplating the architecture of psychiatry. The ongoings of the “mainstream” DSM committee were chronicled in an article in this month’s Time magazine (remember when you used to read that? So do I) called “Redefining Crazy: Researcher Revise the DSM-V” where it made the point that psychiatrists were spending more time arguing than coming to consensus (Hey Dr Hyman, I thought you weren’t supposed to talk to the press? I am gonna have to tattle on you to David).

However several recent articles by journalists who seem to have granted themselves honorary degrees in psychiatry and who quote whatever ridiculous opinion from psychiatrists that happens to cross their desk as if it is, well, worth quoting, have prompted us to speak out.

First off, the New York Times wrote an exceedingly lame editorial regarding the decision of the Department of Defense to not award the Purple Heart (the medal received by soldiers who are wounded in combat) for combat-related posttraumatic stress disorder (PTSD). Here is their lame comment:

PTSD can be difficult to diagnose, with symptoms that can arise later in life, far from the battlefield and are not necessarily linked to any specific actions of an enemy. So the Pentagon contends that it has no choice but to exclude its sufferers from the Purple Heart, given to those whose injuries result from direct and intentional action by the enemy…

The military is, in fact, moving forward merely by mentioning PTSD and the Purple Heart in the same breath. Imagine Gen. George Patton, who so notoriously slapped a quivering enlisted man, learning that his beloved Army was even considering giving medals to those whose combat tours left them mentally shattered.

Frankly I found this letter to be patently offensive, ill informed and incorrect. First off, General Patton was an idiot, and should not be celebrated for physically abusing soldiers. Secondly, PTSD is very much related to combat exposure, is not difficult to diagnose, and is not delayed in onset. The NYT morons go on to opine that “Purple Heart may not be the answer — not until, perhaps, advances in brain science bring full objectivity to the diagnosis of mental injury.” And exactly what “brain science” is that? The same morons who publicized dubious science such as the search for the neural correlates of morality or trumpeted a drug that would preserve marital fidelity are now turning those brain scanners against the recognization that war is hell and can be associated with life long mental wounds?

Next on the journalist role call is an article in Scientific American (”Soldier’s Stress: What Doctors Get Wrong About PTSD“) by David Dobbs. An example of one of his (highlighted) retarded statements is “misdiagnosed soldiers receive the wrong treatments and risk becoming mired in a Veterans Administration system that encourages chronic disability.” Since when does the VA want chronic disability? If anything they are invested in reducing their costs. And who is he to say who is “misdiagnosed”? Not everyone develops PTSD, but for those who do, it is real, believe me, and it doesn’t matter what some pointy headed professors (or journalists) who are seeking attention with provocative statements say.

Dobbs taps into an underbelly of academic psychiatry that looks for approval from others by trying to look like they buck the trend about trauma and PTSD, with the basic message that PTSD is an overblown diagnosis created by a bunch of cry babies. Most of these “detractors” he quotes were authors of articles in a moronic special issue of the Journal of Anxiety Disorders in 2007 on PTSD. These authors purport to be offering important and controversial papers that will undermine the diagnosis of PTSD but instead they just send up a bunch of hot air balloons. Simon Wessely, a psychiatrist from the Institute of Psychiatry in London, writes a convoluted “historical” piece that seems to imply that we should pay attention to the role of secondary gain (e.g. getting disability benefits) in the development of PTSD. Big deal, some people want disability payments, does that mean PTSD is a bullshit diagnosis? I don’t think so. It would have been more interesting if Simon had written a piece telling us about who was the mystery woman at his institute involved in the Sex and Seroquel scandal who said that she needed to be punished by the head of the Seroquel Study Team for reading a paper about Risperdal.

Next in the Journal we have Richard McNally, who gets a lot of mileage out of pointing to his study showing that people who think they were abducted by aliens have psychophysiological responses that look like PTSD as evidence that PTSD is a bs diagnosis (if those aliens did that to my rectum I think I would have PTSD too, wouldn’t you)? He makes the point that if you tightened the criteria for PTSD that there would be fewer veterans classified as having PTSD (based on an article that revised the estimate downward from 14% to 9%). So what? As we pointed out in a letter to Science in 2007 that still would mean 236,000 Vietnam veterans with PTSD 30 years later.

Last time I saw Richard he broke his glasses down the middle during a lecture he was giving and had to hold up one half to read his slides, which he called his “monacle”, which together with his spirited presentation made him look like a mad professor, indeed.

Next we have Paul McHugh, MD, the evil troll who used to second as chairman of psychiatry at Johns Hopkins School of Medicine in Baltimore. Last time I saw him lecture was whining about one of his “case reports” of a woman claiming childhood sexual abuse ”how could that woman have been sexually abused by her father? That family was one of the most prominent families in Baltimore!” as if that made any frigging difference. They write:

PTSD, as presently diagnosed, described, and treated, has failed to improve on what had been standard teaching. It has redefined and overextended the reach of a long-recognized natural human reaction of fear, anxiety, and conditioned emotional reactions to shocks and traumas.

In other words, nothing like the old days, when guys killed Japs and enjoyed it, and gals got raped and if they didn’t stop sniveling you could just give them a good wack to help them get over it.

 

 

 

 

 

 

 

 

 

Robert Spitzer wrote an editorial in this special issue which promised a radical revision, but instead merely recommended requiring that the person be personally exposed to the traumatic event, and dropped a few of the symptom criteria like irritability that were not specific to PTSD. Another editorial was written by the sociologist Allan Young and the epidemiologist Naomi Breslau. Last time I saw Allan he was reading a paper about the Yale Neurosciences PTSD program as an object for study by sociologists with the basic thesis that PTSD is a “social construct”. Frankly when I see a sociologist who studies mental health my instinct is to run in the opposite direction as quickly as I can. For what it’s worth here is the abstract of their paper. Let me know if you can understood it; I sure as hell couldn’t:

As represented in the DSMs, the PTSD syndrome coheres through cause and effect relations among diagnostic features. Research practices routinely ignore this essential characteristic, by atomizing the diagnostic features, especially the role of memory. The failure to confront this contradiction explains the failure of research to fully engage the pathological process that justifies the PTSD diagnostic classification. Several papers in this collection direct readers’ attention to this fundamental problem. We are pessimistic that their insight will lead to positive results.

 

They don’t sound very optimistic. Does that mean they are not resilient and are vulnerable to PTSD? Don’t worry guys if you get sick I’ll make sure that you do not go on disability and become chronic charges of the government.

 

 

 

 

 

 

 

What these guys are saying is that PTSD is “not reliable, not accepted” often made up to get victims’ compensation and compare that to “accepted” diagnoses like major depression and bipolar. What’s more their cronies on the mainstream DSM wants to drop Dissociative Disorders as diagnoses all together, for no better reason than because they, well, want to. Well I’ve got news for you guys just because drug companies made billions off of the pedalling of depression (and not PTSD) doesn’t make that disorder somehow more “real”. And the suffering of patients with PTSD and Dissociative Disorders for that matter is very real, thank you very much.

Bye now.

I was concerned to learn that Philip Dawdy who writes on the Furious Seasons blog was about to get kicked out of his appartment in Seattle. I grew up in Olympia WA and interviewed for a position in the Department of Psychiatry at the University of Washington in 2000 where I noticed that outside the University Hospital there was a sign that not only could you not smoke in the hospital, you couldn’t smoke outside of the hospital, and in fact you had to move 200 yards AWAY from the hospital to smoke. I mean my wife is Italian born Italian and I am used to going to bars, restaurants, parties, etc, where everyone smokes. I think that this recent Seattle phenomenon is a sign of Eco-Fascism and as a psychiatrist I have to try and interpret what the root pathology might be. Hmmm… could it be an arrest at the oral stage of development ala Freud?

Anyhoo, rumours state that my sister Anne Bremner, local Seattle lawyer and noted legal analysis commentator on CNN and FOX as well as lawyer for Amanda Knox in the Perugia Italy case, also a smoker, is getting similar harassments from Seattle Eco-Fascists, even though she owns her own property! We are going to have to get the half-cousins from Eastern Washington to come over there with their guns!

Rumours are that Anne might take on Philip’s case pro bonno! Do the Eco-fascists have a good legal basis for their actions? Only time will tell!

I felt so UPSET about this situation that I had to write a letter as a psychiatrist and physician scientist outlining my concerns, and here it is.

To whom it may concern,

I am writing in regard to Philip Dawdy, a resident of your apartment complex. Mr. Dawdy has been diagnosed with bipolar disorder, a mental condition. Mr. Dawdy is currently addicted to nicotine in the form of smoking cigarettes. In my medical opinion, stopping the smoking of cigarettes may disrupt his mental condition in an unacceptable way, and it is therefore medically contraindicated for him to stop smoking cigarettes. Forcing him to either stop smoking cigarettes or to move out of his apartment is not in his best medical interest.

Sincerely

 

 

 

 

 

J. Douglas Bremner, M.D.

Professor of Psychiatry and Radiology

Atlanta, Georgia

 

 

 

 

 

 

Take this letter and use as you will, Philip.

Good Luck.

Dr. B.
[Note: the name of my university and the letter with my university's letterhead have been redacted at the request of the Dean of my university following a complaint from an outside source. It was pointed out to me by the Dean that use of my university's name and letterhead for personal use (which this was judged to be) was a violation of university policies. Also people have taken this post to indicate that I am an advocate for smoking. I do not advocate smoking as it can cause heart disease and lung cancer. This blog is for entertainment purposes and is to be taken as medical advice. ]

After posting about the increase in psychotropic drug use in children and commenting that doctors should stop giving antipsychotics to children without schizophrenia I got some words of praise from Philip Dawdy at Furious Seasons and some interesting information from Lisa Van Syckel who gave me a list of ages and drugs given to kids in NJ which I found shocking, as well as data on antipsychotic drug sales to kids in NJ. Here are some examples of kids given antipsychotics in NJ:

• A months old infant on chloral hydrate (sleeping pill).
• A two year old on Strattera (ADHD psychotropic drug).
• A three year old on methylin (methylphenidate, or Ritalin, a stimulant ADHD drug)
• A four year old on Concerta (extended release methylphenidate for ADHD)
• A two year old and a three year old on Risperdal (risperadone)
• A three year old on Adderall (amphetamine salts)
• A two year old on Ativan (lorazepam) (sedative, sleeping pill)
• A three year old on Ritalin
• A three year old on Focalin (dexmethylphenidate, ADHD stimulant drug)
• A four year old on Zyprexa (olanzapine)
• A three year old on Paxil (paroxetine)
• A three year old on Seroquel (quetiapine)
• An infant on Valium (diazepam)
• A four year old on Ambien (sleeping pill)
• A four year old on Prozac (fluoxetine)

Meanwhile sales of antipsychotic drugs to children continues to climb (data from NJ)

Shocking!

Come on guys! Here is some more free continuous medical education (CME) that is not funded by pharma! Babies don’t sleep through the night but they don’t need a pill! Toddlers have tantrums but don’t have bipolar disorder in need of antipsychotic drugs! It doesn’t matter if three year olds don’t concentrate because they aren’t in school anyway and they don’t need ADHD drugs! Three year olds don’t develop “major depression!”

Stay tuned for more CME.

[originally posted November 20, 2008]

Dan Abshear wrote on November 20 2008

“Bad Baby, Take Your Risperdal!” That title is intriguing.

Parents may give their kids drugs to displace their own fallacies and shortcomings as a parent? Get their kids on meds as an excuse?

It’s possible, and while I’m not a shrink, I’ve thought of this possibility in the past.

Regardless, I’m opposed to medicating kids in such a way, so thanks for the post,

Dan

Lisa Van Syckel wrote on November 20 2008

Dr. Bremner has been quite gracious to the Physicians who prescribe. Dr. Ilena Bernal,NJ, who was a psychiatrist at UMDNJ Behavioral Health prescribed my daughter risperdal without my consent. Dr. Robert Hendren a clinical Trial Investigator for risperdal at UMDNJ Behavioural health. Was he aware that children were given the investigational drug risperdal w/out parental consent? It was my belief that he did, and his peer reviewed paper on psychotic children in a hosptal setting is flawed!! and he has refused my calls to discuss this issue…

It should be noted that there are apprx. 39,000 children in NJs Foster Care Program. In Oct of 2006, 39,517 psychotropic drugs were prescribed for NJs most vulnerable children. Senator Joseph Vitale NJ has blocked a Parental informed consent bill from his [legislative docket. The parental informed consent bill would require such for prescription of psychotropics to kids (that don't work for them anyway, editorial note)]

Barbara wrote on November 20 2008

Doug, you wrote Three year olds dont develop major depression! I would add that three year olds that have been abused look depressed but are suffering from Acute Stress Disorder or PTSD. Charlie Whitfield has a new book coming out where he writes about the topic…

Doug Bremner wrote on November 20 2008

Hi Barbara, thanks for writing in. I totally agree that abused three year olds can have behavioral disturbances that are related to brain disturbances. However I think the problem is that psychiatrists are seeing these kids and saying they have a ‘chemical imbalance’ related to ‘major depression’ and the treatment of choice is an SSRI. Although these kids certainly have problems with their brains I think that giving psychotropics to them is highly problematic as they are not the same as classic adult major depression (where there have been positive clinical trials, albeit the results are not as great as some might think) and on top of that there have been no clinical trials in three year olds of SSRIs, and the studies in teens with ‘depression’ are negative. So not discounting the disorders, just the approach to treatment.

Lisa Van Syckel provided the following post on November 20 2008

Thursday, May 4, 2006

By EILEEN STILWELL

Courier-Post Staff

Had Laurie Yorke known about the potential for harm to her son four years ago when a child psychiatrist prescribed Paxil, a popular antidepressant, to treat a single panic attack, she would have said, “No thanks.” “Instead, taking the drug as prescribed launched her adolescent son on a two-year emotional roller coaster that triggered two suicide attempts and outbursts of aggressive and psychotic behavior that forced the former “A” student out of school, she said. ” “The good news said Yorke, a registered nurse, is her son, Ryan, now 18, has survived, unlike many other adolescent Paxil users.” “Yorke spoke passionately Wednesday at a press conference called to release a study on a deceptive marketing practice commonly used by drug companies.” Read more about Laurie Yorke’s experiences here.

A post about Laurie’s son on antidepressants is posted here.

Bristol Myers Squibb (BMS) recently started a TV ad for their drug Abilify (aripiprazole) which has gotten a lot of people in a tizzy prompting me to look closer at this new claim for a psychiatric drug. First of all, I previously gave honorable mention to Abilify as one of the medications with the goofiest names “Where Do They Come Up with those Goofy Names for Prescription Medications Anyway?”)

Back then I mused that perhaps the manufacturers thought that their anti-psychotic pill would make non-functional mental patients jump out of their chairs and start climbing the corporate ladder. Well I don’t know if it will make you climb the corporate ladder, but the akathisia you could get might make you feel like you wanted to jump out of a chair. Not to mention wanting to jump up and go pee if you develop second generation antipsychotic induced diabetes. This medication is an antipsychotic (apparently not mentioned in the TV ads) and these drugs can can have some nasty side effects.

So is this drug really useful for depression? The ads hype the fact that over half of people may not respond to antidepressant medications, but that seems like a self serving turnaround on the part of the drug companies (including BMS maker of Serzone (nefazodone)) who have been telling us for years that their antidepressant drugs are magic bullets for depression.

So what do the studies actually show?

In the first study of Abilify, 362 patients were randomly assigned to Abilify or placebo for six weeks after a failed trial of antidepressants. There was a -8.8 v -5.8 change on the Montgomery Asberg Depression Rating Scale (MADRS), a difference of 11.5%. 23% of patients on Abilify versus 5% on placebo had akathisia, a potentially very disturbing side effect where you feel like you are jumping out of your skin or cannot sit still. Restlessness was seen in 14% v 3%. Fatigue was also more common. Berman RM et al J Clin Psychiatry 2007; 68: 843-53.

In the second study of Abilify, 381 patients who had failed at least one antidepressant medication trial were treated for eight weeks with an antidepressant followed by the addition of Abilify or a placebo for six weeks. Abilify showed an -8.5 change on the 26 item Montgomery Asberg Depression Rating Scale (MADRS) versus -5.7 for placebo, a difference of 2.8 points, a difference of 11%. 26% of patients on Abilify versus 4% on placebo had akathisia, and 10% versus 1% had restlessness. Marcus RN et al, J Clin Psychopharm 2008; 28(2):156-165

.

Conclusions? Abilify is more likely to make you want to jump out of your skin than it is to cure your depression. An 11% improvement over placebo is not that great and is set off by the fact that Abilify has a lot of nasty side effects and doesn’t work better than other treatments of refractory depression like lithium (which also can have nasty side effects). I don’t watch TV ads because I have TiVo but I can only imagine how it was presented by BMS

That settled, now we can move on to my favorite study that I found in the literature: Egashira N et al, Aripiprazole inhibits marble-burying behavior via 5-hydroxytryptamine (5-HT)1A receptor-independent mechanisms. European Journal of Pharmacology. 592(1-3):103-8, 2008 Sep 11.

I wonder if the September 11 publication date is a coincidence? OK, conspiracy theory time now. Maybe BMS is trying to tell us that if our government officials had been on Abilify they wouldn’t have lost their marbles and allowed 9/11 to become a reality?

Any other theories?

 

[originally posted on November 6, 2008]

Anonymous Reader wrote on November 7 2008

Doug

I think you’ve gone too far this time. For years, I’ve been trying to find a way to stop my mice from burying their marbles without affecting their locomotor activity, and now we finally have an effective agent, thanks to the creative genuises at Kyushu University and Otsuka Pharmceuticals. At least our taxpower money didn’t go into this one!

Doug Bremner wrote on November 7 2008

Anonymous, just writing in jest. I have nothing against research on marbles, just thought the study title sounded funny. Cheers.

This post was discussed by Philip Dawdy at Furious Seasons with an active discussion there.

Therapy Patient wrote on November 12 2008

I couldn’t link to the marble-burying article because it required a password, but if marble-burying represents anxiety (in a lab animal?) then I’d agree (though I enjoyed your humorous interpretation more). My interpretation of what I feel when I take Abilify (1 pill of 5mg dose after not having been on the medication for many months) is a dramatic reduction in anxiety in 20-30 minutes, so I imagine if I buried marbles when anxious that I’d stop.

Not counting the many things I experienced which were possible side-effects, the effect I disliked the most about Abilify was the way it took away my feelings. Gone. I did not feel happy or sad. I lost my sense of humor and effectively became a robot. I typically am not depressed though, so am not in the same situation as the study subjects. A positive effect was that oddly, I lost all tendencies to procrastinate, focused on the most important thing first and got large quantities of work done. It’s not a fair trade off for me, though.

Doug Bremner wrote on November 12 2008

Welcome, therapy patient. I have no idea what marble burying is supposed to represent. I just thought it sounded funny. Personally I lost my marbles years ago and haven’t been able to find them since.

A quote from a physician describing the results of study published this week in the New England Journal of Medicine on the effects of Zoloft (sertraline) or cognitive behavioral therapy (CBT) or a combination of the two on childhood anxiety disorders, describing the results of the study as “incredible”, lead me to take a look at the study myself to see if this claim was in fact, er, credible, or more of the same fare we have been dished out regarding the use of SSRIs in children, such as the infamous Study 329 of paroxetine (Paxil) in the treatment of depression in teenagers.

The current study looked at 488 children between the ages of 7 and 17 years who had the diagnosis of separation disorder, social phobia, and/or generalized anxiety disorder (GAD). They received 14 sessions of cognitive behavioral therapy, sertraline (up to 200 mg per day), a combination, or placebo for 12 weeks. The authors reported a score of “much improved” or greater on the Clinical Global Impression-Improvement Scale in 81% of kids treated with combination drug/therapy, 60% for CBT alone, 55% for sertraline, and 24% for placebo.

However, using a categorical outcome like “improvement” can be misleading. Take the example of the infamous Study 329 which pointed to the outcome of a 50% or greater improvement on the Hamilton Depression Scale as evidence for benefit of paroxetine in the treatment of childhood depression. The original primary outcome of the 329 Study was improvement in depression as measured by the Hamilton Depression Scale. The authors later “changed their minds” about what they should focus on, a fact that came out later. It is important to define a primary outcome in advance, otherwise there is a tendancy to fish around for a positive result, which may lead to something that is just a fluke being interpreted as due to something real.

In the sertraline/CBT study, the authors (as far as we know) had “improvement” as their primary outcome. However improvement can be misleading. Let’s focus on the sertraline treated group alone, since CBT has no side effects and I am fine with people using CBT, and since the authors did not report a statistically better outcome of the combination therapy compared to CBT alone (although the press releases trumpet, incorrectly, that the combination is better) Say the primary goal is to run a mile in 10 minutes (or whatever, I say as I sit on the couch). If out of 100 people running, people wearing green shirts do it, on average, in 9 minutes 45 seconds, and people wearing red shirts do it in 10 minutes 15 seconds, you could have a result where 60% of the green shirts make the goal versus 25% of the red shirts, which sounds like a big deal, even though there is only a 5% difference in their times.

So lets look at these studies. In the case of Study 329, 66% of kids treated with Paxil (paroxetine) were “much improved” or better as measured by the Clinical Global Impression Scale (CGI) [criteria used in the Zoloft study] versus 48% of those treated with placebo, which they reported as statistically significant. Not bad, you say, however they did not find a significant change in their primary outcome, and to report the study as positive is a violation of the rules of clinical trials, as pointed out in a subsequent letter to the editor. In fact, if you look at the actual data, the Ham D score went from a baseline of 19.0 in both groups, to 8.2 in the paroxetine group and 9.9 in the placebo group, a paltry 3% difference in a 56 point scale which was not reported as significantly different because it was not, well, different.

So now let’s turn to the “incredible” results of this week’s study of sertraline (Zoloft) in kids. Although there was a difference in “responders” based on much improved on the CGI of 60% versus 24% for placebo, when you look at the actual data, the Pediatric Anxiety Scale, a 30 point scale, went from 18.8 at baseline to 9.8 in the zoloft group, and from 19.6 to 12.6 in the placebo group, a difference of 9%, again, not reported as statistically significant because it was not, in fact, very different. In fact only CBT (not combination) was better than placebo on the anxiety scale. My clinical methodology experts tell me that a study is pretty weak if it only shows a positive outcome on a single categorical (yes/no) outcome and not on the continuous (multi item) scale. And the combination group had no comparison group. Just, here is your psychotherapy (66% get better), and now open up your mouth and let me give you a yummy blue pill that Mommy says is going to make you better (80% get better).

OK, dictionary time.

incredible Pronunciation [in-kred-uh-buhl] adjective

1. so extraordinary as to seem impossible; incredible speed.

2. not credible; hard to believe; unbelievable: The plot of the book is incredible.

[Origin: 1375-1425; late ME incredibilis]

Related forms incredibility, incredibleness, noun

incredibly, adverb

Incredible, indeed.

[originally posted on Oct 31 2008]

COMMENTS
Philip wrote on Furious Seasons on November 3, 2008

Philip wrote about this study on his post which triggered a string of comments including ‘Bremner sucks cuz he does research on Paxil’. Seriously though folks I have already gone over this in detail on my site here before (see also here and other sites, as well.

John Grohol wrote on Psych Central on November 3, 2008

Bremner’s off-the-cuff analysis wrongly suggests the current researchers had no specific outcome objectives

.
He also states that I did not focus on the combination CBT and zoloft group, which had an 80% response rate, which was statistically significant and in his opinion clinically significant. You can read the rest of his post here.

As I will write on his site:

I did not mean to imply that there was no specific outcome. By saying they used ‘much improved’ I understand that you could take it that way, but I very much know that much improved corresponds to a 2 on the CGI [very much improved is a 1, so subjects had either a 1 or 2 post treatment] which is a validated scale used throughout clinical trials, by myself and others. And I have no reason to doubt that it was chosen a priori as the primary outcome measure, although I guess we can wait for the lawyers and their experts to go digging through the emails and files as they always inevitably seem to do, to attempt to prove a change in primary outcome [these days with clinicaltrials.gov primary outcomes are registered in advance]. However, my criticism was of using the CGI as the primary outcome in isolation, and that what I consider the more relevant Pediatric Anxiety Scale did not show a significant change (time by treatment interaction) for zoloft OR combination compared to placebo. Also, that the combination group had no comparison (i.e. CBT plus placebo) and the combination group knew they were getting zoloft. Having categorical (yes/no, ie. CGI) and not continous (anxiety scale) outcomes makes it, not necessarily a negative trial, but not strong either, and certainly not “incredible” as described in the press.

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