October 18, 2006

Prevention Of Psychosis Study, Ethical or Not?

Earlier this year, some researchers published an article in AJP in which they reported on an attempt to prevent teens identified by the docs as being at risk of experiencing psychosis by giving them Zyprexa. Another group of patients at similar risk were given a placebo. (Set aside for a moment how the docs think they know who is "at-risk.") I wrote about the study earlier here.

The basic story is that Zyprexa didn't do jack to prevent psychosis and also that many of the patients the docs identified as being at-risk never experienced psychosis after the study ended and they came off Zyprexa or the placebo.

Now, a psychiatrist in Portland, Oregon is challenging the ethics of the study in a letter to AJP:

"To the Editor: I am concerned that the article entitled "Randomized, Double-Blind Trial of Olanzapine Versus Placebo in Patients Prodromally Symptomatic for Psychosis" (1) lacked discussion regarding the ethics of treating young (average age=18.2 years) and nonpsychotic patients with the neuroleptic olanzapine for 1 year.

The authors anticipated this problem, and, as they point out, in prior studies 46%–80% of those labeled "prodromal" never develop schizophrenia after up to 2 years of observation and were probably false positives (p. 797). In their study, 16 of 29 participants (55%) in the placebo group never became psychotic after 2 years. We should, therefore, expect that approximately 17 of the 31 (55%) subjects who were given olanzapine were also false positives. More than one-half of the patients who were prescribed olanzapine were exposed to it unnecessarily—at doses ranging from 5 to 15 mg/day.

In addition to the patients’ average weight gain of 19 lbs, I am concerned with what other biopsychosocial repercussions there were for these young men and women after they were placed on the neuroleptic, without a clear indication, for a year. Isn’t our first and foremost obligation to "do no harm"?"

Here, one of the original study's authors defends their work (full letter here):

"Prevention is a new concept to psychiatry. We are used to functioning as post hoc diagnosticians and interventionists. Prevention interventions are common in other medical specialties and, by definition, they involve prescribing active treatments to a mixture of true positive and false positive persons. The clearest example is cholesterol lowering pharmacotherapy. As prevention, the strategy treats risk (high cholesterol) not disorder (coronary heart disease), and the vast majority of those treated are false positives.

We do agree with Dr. Block’s air of caution insofar as we feel that prevention treatment in schizophrenia, especially pharmacotherapy, belongs in the experimental domain for now. At this stage, our field possesses insufficient data to articulate specific treatment guidelines for those prodromally at risk beyond careful longitudinal monitoring and support (3). More research is needed to address this novel situation."

Are these docs behind the original study on drugs themselves? Or are they just arrogant? How many times do they plan to test their hypothesis? I cannot even begin to get into how much it angers me to hear these clowns compare slamming teens with 15 mgs. of Zyprexa with given cholesterol-lowing drugs to prevent heart disease. Perhaps these docs ought to take Zyprexa themselves and see how they feel about this ethical swamp before lining up people to take it who aren't even symptomatic.

More research isn't needed. These types of studies are unethical and must stop.

Posted by Philip Dawdy at October 18, 2006 12:01 AM
StumbleUpon Toolbar del.icio.us Digg it reddit
Comments

Of course I cannot be silent when I read anything w regards to Zyprexa.

"First Do No Harm". I have said that to doctor's faces, I skipped the letter writing at various points. I used that phrase a lot.


My daughter may not have been enrolled in a study but she may as well be called one now.

It just makes me cry when I read this.
I have been on the Zyprexa bandwagon since 1999. She was on doses as high as 15mg. She was only 11 years old. She often could not see, and her eyes rolled upwards and got stuck. The psych said it was a muscle problem, I read the fine print to him (ocular side effects) and went to the reg doc who said it was the Zyprexa and simple answer: benedryl. Not even Cogentin was rx back then to her. Being an honor student with her mind still in tact...she could not read. Those days were horrible. I fought the docs to lower the dose. Once at 10mg her agitation and eye issues lessened, at 7.5 even more and at 5mg nothing bothered her except the 40 lbs she gained.
Got the dose as low as 2.5mg for 6 months and she wanted to go off of it. Basically every time she tried to go off of Zyprexa she became psychotic and once catatonic in combo. I charted for years the adverse events on all doses of Zyprexa.
The worst was when she was on 30mg prescribed by a hospital in tandem with Haldol. She was very paradoxical on that. I could not believe they shot her up on 30mg of that shit. With a history of reaction on nothing higher than 15mg.

This just makes me sick. This med as well as Depakote has ruined my daughter's life. She has lost 40 lbs since being away from home and off of ZYprexa. She has been given the dx Polycystic ovarian syndrome from 6 yr depakote use, and no monitoring by pdoc re: her growing body and lack of menses. Until I read the box warning to the doc, re: monitoring this med in women under age 20. She is still only 18.

No meds she ever took were approved for use in children.

NONE.

I know, let's make it simple. Let's ban all psych meds from being dispensed to anyone under 18. That way they can just be symtomatic and suffer off meds, then make an informed decision as a legal adult to use em.

Now the pdocs just tell me "something else was going to emerge anyway".

That, is a cop-out. My daughter's life can never be given back to her. She is now what they warned me could happen. A person I won't recognize compared to who I lost.

I hope I can make a change using what I have learned. I sure intend on attempting to create a better way.

Posted by: Stephany at October 18, 2006 08:44 AM

One more comment re: Mothers/Parents/Caregivers and the dispensing of psych meds to children.

Once you become pro-active, you are labeled as a person who interferes with the docs.

A small tip for any parent in this boat now and wanting to jump ship, but the docs won't back down...fire the doc, get several opinions, use the word "observed" a lot, and then, after all of that, watch out, because once you fire a doc, and get several opinions, you could end up being labeled after 7 years "a parent who stops treatment.". Yeah. What a parent has to realize is once you enter the docs world, you are a threat to their ego. Especially if you are a woman.
Good luck, it takes balls to stay in it as long as I have and guess what, I'm a girl.
Talk about a glass ceiling.

I feel this is why so many parents end up worn out and beaten down, and give up.

Do not give up.

Another lure the docs did to me as a parent in 1999:

"You are so lucky your daughter got sick when she did, the medications are superior to those in the old days."

She trialed every single "new" atypical.

She is now on Clozaril. The "old gold standard".

If the psychiatric community was a watch-dog for all antipsychotics based on the side effects alone, then we could get somewhere.
If they took diabetes and lipids and agitation all as seriously as low white blood count, then it could save a lot of heartache and trashed bodies.

The Clozaril is so strictly monitored, due to death as a side effect, that it cannot be dispensed without bloodwork results of CBC to the pharmacy that fills the order. If the lab results come back questionable, the doc cannot give the CLozaril.

Shouldnt it be this way with ALL psychiatric meds? that careful monitoring of the patient and their body on these meds?

I would like to say that after 7 years doing this, I have gotten somewhere.

I was told, that "just wait, in 10 years there will be a cure." "Just wait, in your daughter's lifetime there will be a cure, a simple bloodtest that can tell us exactly what's wrong with her (psych wise)."

Well docs, we are closing in on the 10 year mark a look what's happened.

I heard a lot of bullshit from pdocs and false promises, and their rates increased.

I am sorry to report after a 7 year quest, this Mother has nothing positive to report.
A Mother that is known for being one of the most outspoken advocates in town. What about the ones that are afraid to speak to the docs.

I am trying to blaze a trail, and I hope I live to see an outcome that is a positive one. A Decade is a long time to see no changes in docs attitudes toward medicating children.

Sorry for the long post, but this is the top of the list topic here.

Children and psychiatric medications.
Damned if you do and damned if you dont.

Posted by: Stephany at October 18, 2006 10:36 AM

ZyPrexa and I have a long history.

http://alwaysonemorethingagain.blogspot.com/2006/09/zyprexa-agitation.html

Posted by: Stephany at October 19, 2006 07:52 PM

I was wondering if any of you could help me with this: I can't hear. Anyone have that problem? Like when people talk to me all of a sudden I'm in my own little bubble, and I could see the person, and even absorb some of the words, but I can't make any sense of what they are saying. Nothing makes sense. That sometimes happens when I read too. I remember once when I was at the Weekly, Philip asked me to read a one page press release on the city counsel, to give him my opinion -- but I couldn't read it. It didn't make sense. And I wanted SO hard to read it! I wanted so badley to be able to give him my opinion! But the more I read it the more it didn't make sense. It was like I was watching myself read it, totally as an observer -- and therefore I coudln't understand. It was horrible! When he then asked me about it, I had to give a total generic statment... I COULDN'T let him know I even wasn't able to read the damn thing. Here I was supposed to be the brilliant and motivated intern -- and yet the simplest task I coudlnt do. So embarrsing! Does anyone have a clue as to what I'm exprieincing??? It's really like a disability. I even dropped my Honors debate class... cuase, mainly, I was SO afraid people would be debating and I wouldn't be able to hear them. For years I thought my IQ was too low to hear and read -- but that dones't sound right either. Do any of you have any idea what's wrong with me? And how I could fix it? I really need help with this.

Posted by: Gwen at October 21, 2006 10:30 AM

Gwen,
This happens to my daughter a lot, most recently since June. She also is very smart, and an avid reader. She feels the same panic you express here in your post. She says I am talking and she cant hear the words, as if she has gone deaf, etc. It is frustrating, and the only advice I can give is to express this event to your doctor. In my daughter's situation, it appears when she is stressed out, receiving too much input in a conversation, alongside hearing voices from psychosis. Sorry I cant be much help here, but it is something happening to so one else, if that is any comfort.
Hang in there.
--Stephany

Posted by: Stephany at October 23, 2006 08:28 AM

Thanks, Stephany. It's good to know that I'm not the only one this is happening to. It has just gotten so bad. Like, this past summer I had to take a high school correspondence history class, which invloved a lot of reading... and my mom ended up taking taking the whole class for me, becuase I just coudln't comprehend the simple, eight-grade level reading. Really bad. Anyway, thanks for your support.

By the way, how is your daughter doing?

Gwen

Posted by: Gwen at October 23, 2006 10:31 AM

Gwen,
I understand what frustration you must feel not being able to read. Thanks for asking about my daughter. She is doing fairly well, though, like you are experiencing, she cannot read like she used to be able to do. She has been a college-level comprehension reader since she was 8 yrs old and now she does 8th grade level reading that comes with worksheets. Very basic. You aren't alone in this. I know it's hard, hang in there, okay?
~Stephany

Posted by: Stephany at October 23, 2006 05:20 PM

pic1.jpg

Patient Blogs. Sites.
Doctor Blogs. Sites.
Activists. News.
Social Networking. Forums.
Science. Big Pharma. Ethics.
Current Affairs
Seattle Stuff
Smoking. Stuff.

Info
About Furious Seasons
Email
Other Articles
ZYPREXA Documents
Alt ZYPREXA Documents Source
Blakemore-Brown Transcript

 Subscribe in a reader

Search


Recent Entries
$99 Left
$114 To Go
Winter Fundraiser, $134 To Go, Final Day
Ruth Lilly, Eli Lilly Heiress, Prozac Beneficiary Dies At 94
Winter Fundraiser, Final Day, Less Than $200 To Go
UCLA Psychiatrist Criticizes DSM-5
Winter Fundraiser, Barely $200 To Go
Most Popular Posts Of 2009
Winter Fundraiser, Less Than $300 Left, Let's Wrap It Up
Senate Health Care Bill Contains $1.25 Billion Gift To Sen. Stabenow
Travel Day, Comment Approval May Be Intermittent
Winter Fundraiser, Close But Stalled
Senate Health Care Reform Bill Contains Controversial MOTHERS Act, Abortion Study
Adult ADHD And Sleep Problems
Vic Chesnutt Dead At 45, Possible Suicide
Recent Comments

Stephany on Prevention Of Psychosis Study, Ethical or Not?

Gwen on Prevention Of Psychosis Study, Ethical or Not?

Stephany on Prevention Of Psychosis Study, Ethical or Not?

Gwen on Prevention Of Psychosis Study, Ethical or Not?

Stephany on Prevention Of Psychosis Study, Ethical or Not?

Stephany on Prevention Of Psychosis Study, Ethical or Not?

Stephany on Prevention Of Psychosis Study, Ethical or Not?

Archives
December 2009
November 2009
October 2009
September 2009
August 2009
July 2009
June 2009
May 2009
April 2009
March 2009
February 2009
January 2009
December 2008
November 2008
October 2008
September 2008
August 2008
July 2008
June 2008
May 2008
April 2008
March 2008
February 2008
January 2008
December 2007
November 2007
October 2007
September 2007
August 2007
July 2007
June 2007
May 2007
April 2007
March 2007
February 2007
January 2007
December 2006
November 2006
October 2006
September 2006
August 2006
July 2006
June 2006
May 2006
April 2006
March 2006
February 2006
January 2006
December 2005
November 2005
October 2005
September 2005
Resources
Mental Health America
National Alliance on Mental Illness
Depression and Bipolar Support Alliance
National Institute of Mental Health
McMan Web
Powered by
Movable Type 3.2