February 07, 2008

FDA Panel Gives Nod To Zyprexa Adhera

The FDA psychopharmacological committee yesterday voted to recommend that the full FDA approve Lilly's new Zyprexa Adhera, a two to four-week long-acting injectable formulation of the company's Zyprexa. The drug now awaits approval by the agency for treating schizophrenia, likely sometime later this year. Committee members noted that the drug should carry special labeling around its tendency to cause extreme sedation, and the FDA will likely slap a black box label on the drug around risks of diabetes and hyperglycemia, among other things. A few committee members recommended that the drug not be approved as a first-line treatment, but only be given when other injectables such as Haldol and Consta have failed.

I know a lot of readers will be disappointed by the recommendation, given all of the many well-known problems with the drug. But I'm not surprised by the move. If there's any decent news here, it's that the injectable market isn't a large one and this drug will not be used on many people. People who get this drug will have to have long-term, chronic psychosis and will have had to blow off their daily oral meds repeatedly before, I assume, any legitimate doctor would use an injectable on them.

That said, I hope that the FDA very closely monitors the safety of this drug once it's approved. I hope as well that doctors, patients and their families will be aggressive about filing adverse events reports if there are any untoward experiences using the drug. Also, I think given the dicey reputation of Adhera's pill form sister that doctors will be extremely vigilant in monitoring patients on this drug. Even Lilly stresses that patients should be closely monitored for signs of extreme sedation for at least an hour after receiving the injection.

I hope the company understands that there are many patient advocates out there who will closely monitor how the company markets and promotes this new product. In addition, if I hear of any off-label use of this drug in bipolar disorder or dementia, I'll make an issue of it.

So far, none of the advocacy groups such as TAC have cheered the drug's impending approval. I hope they keep their mouths shut. But if they want to stir the PR pot for Lilly, let them do so after they've had a nice fat injection of Adhera.

I've recently had to rethink my stance on the use of injectables because of a murder that was committed five blocks from my apartment, allegedly by an ex-convict with a long track record of extreme violence who was blowing off his meds and whom, for some reason, did not get admitted to a psych unit. The short story is that there is a very small portion of people diagnosed with schizophrenia who should be forcibly medicated with injectables. It's just about the only available option. I say that with much regret. I'll get into my thoughts on this another day.

Posted by Philip Dawdy at February 7, 2008 12:03 AM
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"The short story is that there is a very small portion of people diagnosed with schizophrenia who should be forcibly medicated with injectables. It's just about the only available option. I say that with much regret."

I've seen so much I agree, though people might hate my opinion. Though in my opinion, the injectable MUST be one that has proven to work for the patient proven over time, as in a year or more, then a patient [in my opinion again] must show a remarkable loss of ability to function, become violent, etc, before having that option.

Also, there is a population of patients I am concerned about regarding Zyprexa intra muscular. Inpatient psych units use Haldol and anything else that comes in anti psychotic sedation injectable form. Regular basis use.[even Benadryl].

The only anti psychotic that I actually wish was injectable is Clozaril. Some people may not agree with me at all; but it's the only drug that brings my daughter back to her own mind.

With that in mind, due to Clozaril not being in intramuscular form, others were used on her and all they did was sedate her for the ward, and one person told me it was a way to attempt to bring her back to taking her meds. But the Haldol and Abilify wasn't her medication that worked, so the forced injections inpatient did nothing in that regard but lengthen her stay and knock her out ALL day, to the point sometimes I had the nurse check her pulse. I'm serious.

If they would have given her injections of Zyprexa, I know the results, per her days of using it in pill form. Knocked her out for sleep, her eyes rolled up and she gained excessive amount of weight, and became aggressive.

So, with this said, and I say it knowing others will probably have words for me later here--I wanted to express my experience with anti psychotics and my daughter, and how the bottom line is injection form of these meds should only be given to a patient where success was shown on the drug, or it's not going to help, it could make it worse.

Clozaril for the record has shown to be one of the only anti psychotics to reduce aggression.

So in the case of someone who is extreme, such as the man who murdered someone-- it depends on what they for instance injected him with as to whether or not it would have made a difference.

Posted by: Stephany at February 7, 2008 04:18 AM

I guess my worry is that I've seen too many "legitimate" doctors in in-patient units using sedation to keep the unit quiet. Can't have the inmates, I mean patients, running amok and making noise. My experience is that since most meds don't work for most people, prescribers are quite motivated to try the latest release - off-label or not.

Better keep a sharp eye on this one...

Posted by: Paul at February 7, 2008 05:50 AM

What you're really saying in this last paragraph is that you are not against forced injectables for someone who can't manage a withdrawal properly and goes on and off meds and becomes violent during his withdrawals. One has to wonder if the system understood withdrawal better and educated both patients and professionals on the immense importance of gradual tapering whether we would be in this fix. Maybe they wouldn't ramp up the meds so fast and so much if everyone was aware of the dire consequences of "non-compliance", i.e. ill advised withdrawal. I think these situations arise from ignorance about just how meds work when you STOP them too quickly rather than "acute schizophrenia" frankly. Which really is not to say there aren't some violent psychotics running around who might need some temporary heavy duty sedation but check out their med and drug history before laying the blame entirely on their disorder. This is all a darn thorny problem because alternatives to this are labor intensive there is no doubt about it. Although in the long term there would be a lot more healing going on than there is now.

Posted by: Sara at February 7, 2008 08:04 AM

Yeah, I'm sure we can trust Lilly to do the right thing when it comes to protecting the health of the people who are forced to take its drugs, just like I have the utmost confidence that the FDA will be vigilant in monitoring adverse events and take action before a whole lot of lives are ruined.

It seems like a safe bet that long-acting injectables would rarely be used by any legitimate doctors, but psychiatrists will be shooting this crap left and right because they think that the biggest problem in 'treating' 'psychosis' is 'medication non-compliance.' At the very least, having more options of long-lasting injectables makes it easier to coerce people into taking daily oral drugs and doing anything else to avoid getting needle-raped and doped-up for a month.

Philip, I'm very interested to hear about the line of reasoning that leads you to believe that some people should be forcibly drugged with long-acting injectables. Until you get a chance to post the rest of the story, I will limit myself to saying that in order to convince me, there would have to be either:

A. Real evidence that 'schizophrenia' / 'psychosis' are actual diseases AND that the neuroleptics in question are treatments for them (rather that being just general sedatives/inhibitors that, if they do reduce violence, it's only because they reduce everything about a person, as has been my experience taking them).

B. A very compelling argument for prior restraint (i.e. restraining someone to prevent the possibility that they might commit a crime in the future). Recently some states have been keeping sex offenders locked up after completing their sentences solely to prevent them from having the opportunity to offend again, but generally prior restraint has been judged unconstitutional.

Posted by: UnderTheThresher at February 7, 2008 09:05 AM

Under, i agree with your concerns about lilly and the fda as well as with your concerns about how we treat psychosis in this culture. that said, there's probably no way for me to address the 'is schizophrenia/psychosis a real dx' in any way that will satisfy. i cannot even address the question of anti-psychotics since it's patently obvious that they are tranquilizers as opposed to 'treatments' in the classic sense.

as i've written before, i cannot make the ethical case for the use of anti-psychotics long-term in treating schizophrenia/psychosis because the meds are clearly damaging to a large proportion of patients when used long term and it's not clear to me that they prevent future episodes much of the time. in other words, you've placed an impossible set of conditions on me.

but the legal case for using these meds in some patients--and i stress the 'some'--is easier to make.

in the case of the accused murderer in seattle, the prior restraint argument is simple: the man was on parole following his release from an 11-year prison term for shooting an innocent civilian in 1995. as you know, ex cons of every stripe have all sorts of conditions placed upon their release from prison (have to get a job, must check in with parole officers, etc.) and i don't see a ton of difference in this case, except that his conditions revolved around a dx of schizophrenia, a long history of psychosis and violent behavior. i can assure you that this man had a very profound case of schizophrenia, certainly among the worst i've ever heard of. he acted violently and regularly threatened to kill parole officers and caregivers.

anyway, let me ask you something: why shouldn't society act to place conditions upon a man who refuses to take appropriate steps to control his delusions and violent behavior?

Posted by: Philip Dawdy at February 7, 2008 09:51 AM

Phillip, I understand that a very good and decent woman lost her life to this man. I am sorry.

The most common predictor of future violent acts is past violent acts. Having a label of mental illness, including schizophrenia, does not make a person more prone to violence.

That said, if there is some drug that makes a person less physically capable of committing violence, and someone have been convicted of a certain type and/or number of violent crimes, I have no problem with making that convicted criminal agree to forced medication as a condition of their parole, or even probation, even people who would have been convicted of crimes but for NGRI (not guilty by reason of insanity) pleas, but under no circumstance should someone who has never been convicted of a crime be forcibly drugging in my opinion.

Posted by: Sally at February 7, 2008 12:07 PM

Sally, where you said "The most common predictor of future violent acts is past violent acts." That is exactly what I was up against in on elite hospital psych ward with my daughter. They judged her ability to re-enter society based on her history. [and she was sent to the state institution without a SZ dx].

The dx of SZ in the extreme category is what is of concern here, the extreme cases, [and my daughter is one] where medications [and as any regular reader knows, I am all for no meds needed, etc]have proven to help and actually keep for example, my daughter alive and OUT of lock up.

If I had judged her based on past behavior/aggression as a predictor of future aggression, I never would have ever brought her back home to live with me.

I haven't and won't write more details than that re: my daughter, but wanted to chime in here, that once violent not always.

I feel we are talking too broadly here, and not to forget there is such a small percentage of ppl. with this severity of SZ; I certainly am not intending to minimize everyone's personal stories here, who have recovered from bad dx and medication nightmares, and hospital nightmares.We know those are horrific and recovery is real.

So is the hardcore SZ dx, that is difficult for some ppl to believe exists.

As always, I appreciate everyone's comments here, and enjoy the dialogue. If I had not witnessed my daughter "comeback to life" on Clozaril recently, I might be more skeptical, but I can't ignore her recovery and life, and she is on medication, in recovery. It really is mind blowing.

Posted by: Stephany at February 7, 2008 03:49 PM

i have been injected with this lovely thing, even though i repeatedly BEGGED them not to. even though i had an advance directive on file saying no to any antipsychotics, yes to only sedatives, so i can get my sleep and chill out on my own.

but NO. i once stayed an extra 10 days (after a 72-hours hold) thanks to the miraculous powers of sedation of injectable zyprexa.

i have gotten hyperglicemic due to regular zyprexa too, at which point i quit it cold (up until that time my psydoc was vowing that diabetes risk is strictly a google misinformation).

you think i'm disappointed by this news?

i have transcended having goals in this lifetime, but i still might make it a hobby to destroy eli lilly for what they did to me.

i am happier with my new wife after the xwife couldn't take my "bipolar symptomps" anymore, but she did not deserve going through what she went through at the hands of this fucking system.

Posted by: z0tl at February 7, 2008 06:35 PM

i will chime in one more thing, because i just read that post about someone's daughter, once violent, not always violent and say this:

on lithium, i never realized i was getting angry out of control, bordering on violent (verbally, i never get physical, but still).

everything seemed FUNNY to me. it seemed like i was having a good argument when my xwife was shitting in her pants at the way i was yelling at her.

& all of it because of bloody lithium. once i was off lithium (but that after 3.5 years), i never again had the problem of recognizing when i was getting angry.

on lithium (for me), angry looked simply funny; it was lala happy happy joy joy land for me. always.

while zyprexa was doing its devilish work (as my 2nd cocktail drug) and killing me softly, but surely.

as i look back upon my 5 years of medicated history, i am thankful i escaped alive from the grips of the goddam system.

& once more, lamictal is the MOTHER OF ANXIETY. i had such terrible anxiety while 2 years on lamictal and thought all along that it's me and my goddam "disease" but it was the insidious effects of this stupid anticonvulsant wanna be mood stabilizer that did that to me.

6 months after i quit lamictal and all of it was out of my system, i had, as before, pretty much ZERO anxiety yet again.

stupid dbsa-like line: meds are different for everyone... i beg to differ. all psych meds are evil IN THE LONG RUN and only necessary to stop AN EPISODE gone awry.

if you're full blown manic or suicidally depressed, by god get an injection of zyprexa and knock yourself out to live, but fucking as soon as you're out of the episode, GET THE HELL AWAY at least from antipsychotics, if not all.

good luck!

Posted by: z0tl at February 7, 2008 06:44 PM

ZOtl,

My daughter has come from 19 pills a day last year to one med. [I'm a pushy person who knows no boundaries when advocating for a reason.]

Once she fell apart and was in a major crisis, I made sure to note to the pdoc in the hospital that she had no reason to be on Li, the hand tremors stopped, etc.

I hear what you say, and have to say for the first time in a decade my 20 yr old is only on ONE med. Finally. Long term, and with age she may end up being off all meds. For now, Clozaril brought her back to this world we all live in. I'm going along with it as the rest. Still on meds myself.

Time, will tell, but rest assured, I get the big picture.

Posted by: Stephany at February 7, 2008 08:55 PM

Stephany, Thanks for your patience and understanding. You are right about past violence not predicting future violence, but I think the problem is that being labeled schizophrenic is even less likely than past history of violence to predict violence so forcibly medicated people based on the schizophrenic label is not only morally wrong, but serves no valid purpose. There is no medication that prevents aggressive behavior. Medication can reduce inhibitions and impair judgment leaving the potential for more violence, as you mention, making the problem worse, thus you release a violent criminal (who unlike your daughter has been convicted of a violent crime) and force them to take a drug that makes them physically uncomfortable at the very least and physically vulnerable at the most and you can expect more, not less, violence. Still if hypothetically there existed a drug that would make a violent person less violent and that person, already in prison, were given the choice of either taking that drug and being released or staying in prison, not because of what they might do but as punishment for what they are already deemed to have done, that would be, if not okay, then a less morally reprehensible and socially detrimental situation than the forced drugging of people labeled as having schizophrenia.

Posted by: Sally at February 8, 2008 03:35 AM

the ONLY thing that made me get violent was the issue of having to take meds "for the rest of my life" combined with "forced medication."

that was ALWAYS ALWAYS ALWAYS at the root of all my explosive _verbal_ violence and 8 people to hold me down for the zyprexa injection while locked up type of thing.

any cornered animal would fight for life like that.

i know nothing about schizophrenia, but i'll say here, it's my impression from hearing some stories that schizophrenics only get violent AFTER BEING MEDICATED.

often schizophrenia starts with extreme benevolence, i am God, messianic complex, want to save the world type of thing, then the white coats come in and KNOCK THAT DOWN COLD.

then the evil voices come, then it all turns satanistic, then it all feeds the media, which in turns feeds forced medication.

etc.

it's abominable what is happening to diagnosed people in this country.

i have fought all my life to escape a communist country (born and raised in r0mania, hah, the irony) and found out my freedoms were curtailed here more than i ever dreamed possible in the country i escaped from and i grew up 18 years under a dictator, you may remember him from cnn news: ceausescu was his name.

i was in the army while they had the revolution going that made it possible for me later to leave the country and escape to what i thought was ultimate freedom, only to find out 17 years later that it's just another cage, only disguised a bit better, because people have enough to eat, drive nice cars, & live in cozy homes.

the goddam irony.

anyhoo, it's not all bad, at least in this country, technically, we should be able to do something about it with that freedom of speech thing, neh?

aaaaaaaaaaaaaaaahahahahahaha, anyway, sorry, i must be having a manic episode and not know what the hell it is i be blabbering here....

Posted by: z0tl at February 8, 2008 09:45 AM

Stephany,

"Clozaril brought her back to this world we all live in".

Given the fact that so many psychotropic medications cause so many different side effects, I'm not sure one can distingish a medication bringing someone back. I believe it's possible clozaril just isn't causing the extreme side effects the other drugs had on her and she has been given time to adjust to coming off the other medications. It may be that it just appears clozaril is making your daughter better when in fact it just isn't causing the same side effects as the others. It would be interesting to know if your daughter would be in the same place today had all medications been stopped for the same period of time.

It just seems to me Pharma can make drug after drug that basically does the same thing as the older ones but because someone has gotten better we think the drug is worthwhile when in all likelyhood what has made the someone better is just not having the other medications in their system.

I honestly don't think long acting injectables are the way we want to be going especially when the tablets forms have proven so dangerous.


Posted by: jane at February 8, 2008 10:24 PM

She was off of meds for quite some time and this is why doctors had a clean slate, and dropped all old meds. To see someone truly gone, and come back, well i guess you'd have to witness this miracle. not quite sure anyone understands gravely disabled, and near death, unable to speak, and believing she was another person, losing massive amount of weight [all off of medication]and to have her standing in my house on clozaril sounds awful to some ppl. i am accutely aware of the deadly medication this is, and she is voluntarily taking it. she knows the dose and double checks the meds each time in her hand to make sure they are right ones. i guess when a 20 yr old can come back to home and see her dog, she knows the true meaning of coming back more than anyone else. i'm not here to defend her use of medication. she could go off of it anytime. since she isnt, that says something. for 9 months, i never thought i would see her again, hear her laugh or see her well.
i embrace her miraculous recovery, and so be it.

Posted by: Stephany at February 9, 2008 04:42 AM

Philip, you can make a good case for force-sedating violent criminals on the basis that their other rights are forfeit when they commit their crimes, but to me the assurance that this murderer had 'a very profound case of schizophrenia' that caused him to kill sounds about the same as if someone were to claim that a rapist raped because he had a really bad case of 'spring fever.' There is no such thing as an entity 'schizophrenia' that causes some people to be violent; 'schizophrenia' is a construct that, at best, encompasses some bits of the vast spectrum of human irrationality.

I live in one of the most violent inner-cities around, where gang-bangers regularly shoot and stab each other, and occasionally uninvolved bystanders, for totally insane reasons. As I see it, murder is murder, and since there is no real scientific evidence that 'schizophrenia' is an actual disease that causes people to be violent in the way that, say, rabies could, I don't see any basis for subjecting people who's irrationality gets labeled 'schizophrenia' to harsher sanctions than people who's irrational violence doesn't get so labeled, or even people who's violence we condemn but understand. (Heck, ours is the country that killed thousands of our own troops because we took and ran with the delusional belief that there were WMDs in Iraq because George Bush talks to God and God tells him to rid the world of evil.)

If forced sedative drugs really do prevent people from being violent (which is still an open question, especially in long-term use), then their use is not for medicating some patients, it's sedating some criminals: instead of keeping them locked behind bars, keep them locked up within their own minds. I can think of a lot of reasons why this is a scary Orwellian - type scenario that we as a society would be better off avoiding, but a compelling case could be made.


As for the specifics of this (alleged) murderer, I read a bunch of articles in the Seattle Times Newspaper online, and
I don't really have the words for how sad it makes me that this young lady's life was taken...

Several things about the coverage that stood out for me:

The articles are full of quotes from the suspect that seem clearly intended to illustrate that he's totally off his rocker, but when taken less than completely literally, several of them sound lucid to me. "Meds are popping my brain cells like popcorn" and 'claimed he was turned into a monkey [losing his higher humanity] after receiving Haldol' sound like very good descriptions of what being on heavy neuroleptics feels like.

Also, the threats he made against parole officers and 'caregivers', (of corse I don't support/condone/excuse threatening anyone) were consistently presented as further evidence of how 'mentally ill' he is. But nearly everyone despises their parole officers, and for someone who has been repeatedly involuntarily locked up and coercively treated to hate their 'caregivers' hardly requires a 'mental illness.' Some people who get mental illness labels are violent anyway, just like the population at large, but there are few experiences in American society that can create in a person the kind of rage against the world as repeated involuntary psychiatric commitment.

And, he would have been locked up for actually breaking a real law at the time of the murder except that unaccountable "Western State Hospital officials found him incompetent to stand trial."

Most significantly, I am reminded of the case of the man who pushed Kendra Webdale in front of a train in NY. He had repeatedly sought voluntary 'mental illness' treatment and been turned away, yet the case was turned into political fodder for passing 'Kendra's Law' which greatly expanded the scope and power of coercive 'treatment' in the state.

The Seattle Times says: "The day James Anthony Williams allegedly stabbed to death a stranger on Capitol Hill, the homeless, mentally ill ex-convict showed up at his probation officer's office agitated, defensive and, the officer wrote, "barely able to hold himself together."
Despite intense concerns about Williams' paranoid schizophrenia and violent behavior, the probation officer gave Williams a pair of Metro bus tickets and told him to come back in three days."

It just doesn't make sense to me to use an example of someone who, when he did cooperate with the requirements imposed upon him, was offered no real help, as a justification for why we need greatly expanded coercion. Surely we should first at least try something in the middle ground between giving people bus tickets and forcing injections of long-lasting toxic sedatives.

Posted by: UnderTheThresher at February 9, 2008 07:22 AM

I have never been interested in the psych field or meds until the Virginia Tech shooting, giving me a reason to look into the subject. It was a small non scietific look at the issue through the eyes of an engineer with no medical background. I guess i took it at face value agreeing that there were things that could have been done but in the end nobody should be blamed for it besides the actual killer.

All of that changed on 1/01/08, I live in Cleveland, OH. On that horrible morning I was awaking by a phone call from my uncle that my cousin had been stabbed to death the night before in Seattle and they had no clue who had done it. We all know now the alleged a$$hole who did this. I understand that there are alot of mentally ill individuals who benefit from treatment and that they far outweigh the number who don't and go on to kill. This being said when this jerk shot someone and got 11 years and goverment provided housing and spending money along with bus tickets, now he is only looking at 25 to 33 years for walking down a sidewalk and stabbing my cousin 17 times with an 8 inch butcher knife .
It seems to me Dr. Amnon Shoenfeld and others from King County involved in the treament of said jerk are using there ultra liberal view of the earth to let loose people on society that have no right to be part of it. They are using the people of Seattle as guinea pigs. They are so high on themselves about civil liberties and patient rights that his case worker was more concerned about getting him a monthly increase in his goverment stipend than his eronious behavior.
I ask of anyone who reads this, What ever happened to people that are just crazy and can't be helped? Did they just disappear because of legislation in the 50's about psych homes some people just need to be completely seperated from society.

Posted by: relative at February 13, 2008 03:49 PM
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