The US Food and Drug Administration has approved the first-ever injectable antipsychotic that lasts for three months, according to a press release from the pharmaceutical company Janssen. The approval occurred on the basis of one clinical trial in which the injectable drug prevented relapses more effectively than did placebo. The patients randomly switched to placebo, however, were put into sudden withdrawal from the antipsychotics they’d been taking.
The study, published in March in JAMA Psychiatry by a team of researchers from the pharmaceutical companies Janssen and Johnson & Johnson, was a randomized, multicenter trial that ran from April of 2012 to April of 2014 in 8 countries. Of 506 patients diagnosed with schizophrenia originally enrolled in the study, 305 were given the oral version of the antipsychotic drug paliperidone palmitate for about seven months, and after several months on a one-month injection they were then randomized to taking either the 3-month injectable version of paliperidone palmitate (Invega Trinza) or a placebo.
It was not detailed how long the patients were taking antipsychotics before the study began. But the patients who were suddenly switched (and apparently to a degree unknowingly switched at the time, due to the double-blinded nature of the study) from the antipsychotic to placebo were significantly more likely to experience “symptoms,” “relapses” or land in hospitals, stated the authors.
Though not mentioned in the abstract or press release, in the study itself the authors stated that putting some of the patients through this abrupt withdrawal without any tapering or special supports was purposeful. “The use of a randomized withdrawal design mimics sudden discontinuation of treatment, which commonly occurs under typical clinical conditions in patients with schizophrenia,” the authors wrote.
Some studies have suggested that abrupt withdrawal from antipsychotics can itself exacerbate symptoms and induce relapses.
“With this new treatment option, healthcare providers can give patients greater independence by enabling them to focus less on taking their medication and more on other aspects of their treatment plan,” stated the press release from Janssen.
Though they were not as likely to have been hospitalized, the study authors noted that the people who received the injection were two to six times as likely to have experienced symptoms like headaches, weight gain, inflammation of the nasal passages and upper pharynx, and akathisia.
Berwaerts J, Liu Y, Gopal S, and et al. “Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial.” JAMA Psychiatry, March 29, 2015. doi:10.1001/jamapsychiatry.2015.0241. (Abstract)
U.S. FDA Approves INVEGA TRINZA, First and Only Four-Times-A-Year Treatment for Schizophrenia (Janssen Pharmaceuticals press release, May 19, 2015)
Moncrieff, J. “Does Antipsychotic Withdrawal Provoke Psychosis? Review of the Literature on Rapid Onset Psychosis (supersensitivity Psychosis) and Withdrawal-Related Relapse.” Acta Psychiatrica Scandinavica 114, no. 1 (July 1, 2006): 3–13. doi:10.1111/j.1600-0447.2006.00787.x. (Abstract)
I can’t stand reading these news stories any more. Things are getting worse and worse. What are we doing about these things?
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me neither Ted. This makes me want to cry…and it is why I don’t seek this shit out anymore. I know it’s happening. I work to do what I can in front of me…what I’m called to do in every moment…supporting and educating those who seem to find their way to me…You too are also clearly doing that which you can. I avoid masochism when I can. I think we all do what we can and we all have different gifts and skills. And so we move forward. I think you’re right in some circles it’s getting worse…I also think that more and more people are becoming aware because of the work we do…so that in other circles new ways of thinking are taking root. The split down the middle remains, though, obviously.
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How can these people get away with this? Never mind. The tobacco industry continues to thrive. But a good question. What are we doing and who are “we”?
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We try to remember $62 BILLION dollar Settlement by US DOJ Attorney General Holder with Johnson & Johnson, the parent company of this subsidiary; Jannsen Pharmaceutical, developers of the injectable Invega Sustenna; of which was the subject of the suit, as well as this “new” drug.
(Keeping in mind, the settlement criteria in most States was to: further educate, legal defense, & …)
Action may begin at one’s own Local, County & State level, here in the States- I am not familiar with other countries and their “Rule of Law”.
Thanks MIA for posting-
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This study is fucking insane. Withdrawal from antipsychotics is strong even after just a month. A few months in, you’re going to have withdrawal symptoms and neurological injuries. All sorts. Like vomiting reflex, muscle tightness, trouble sleeping, scary dreams, uneasiness, ..
What a dumb way to say the new drug is better than the old, or that it’s anymore safe/effective.
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I cannot say at precisely how long it takes for certain damages to set in, it varies from person to person, but a few friends and myself had symptoms after just months. The first time .. after being put on Paxil and Zyprexa, with no real symptoms of mental illness before, I was forced to cry and had intense withdrawal when I stopped taking the drugs for just a few days.
My other friends had similar symptoms, but their first time trying to stop was after 1 year about. Zyprexa and risperidol jacked them up, causing vomiting and other violence muscle reactions in both, and neither was able to fully recover for some time. My pal on risperidol luckily didn’t get put back on the drug, instead his doctor opted for a stomach/vomit inhibitor drug of some sort..
http://www.obamasweapon.com
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“Medication adherence” has always been a huge goal of Pharma. They won’t stop until they’ve found mechanisms to ensure 24/7 365 dosing. And they will do so convinced that their cause is a noble one.
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Plus, now big Pharma has a big medication adherence campaign to remind all American to take their medications, not just the ‘mentally ill’ It involves billboards, TV ads, etc. David, if live outside the US, consider yourself lucky They are greasing the skids for the inevitable push back when depot injections become the ‘treatment of choice’ for anyone who shows the slightest sign of psychosis or disturbance.
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The frightening ways this will be used!
I can hardly wait until they begin to use if for depressed patients as they have the pill versions of anti-psychotics. Is anyone even trying to keep psychiatry in it’s place or is social control and profit so important that they are given free run?
Ignorant and cruel study and those running it should be charged with assault. But pharma got the results it was looking for as fabricated as they are.
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“Researchers” from drug companies are not true scientists. They are lackeys and lickspittles who are paid to fabricate these cruel and ridiculous pseudo studies like this one. And, once again, the FDA has shown its true colors. What an unholy alliance exists between psychiatry the drug companies and the FDA, the troika that will destroy all of us before it’s over with.
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FDA officials as well.
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Isn’t this the exact same type study Robert Whitaker pointed out was unethical years ago, only worse? And antipsychotic withdrawal induced super sensitivity manic psychosis, is a known withdrawal effect of the neuroleptics, not a “return of symptoms,” as the medical industry regularly fraudulently claims.
“With this new treatment option, healthcare providers can give patients greater independence by enabling them to focus less on taking their medication and more on other aspects of their treatment plan,” stated the press release from Janssen.” I’m quite certain force medicating people with known “torture” drugs is not giving “patients greater independence.” And it’s my understanding that “other aspects of their treatment plan” usually consists of nothing. In my case, I had to “best” of psychiatric care, thus had a psychologist telling me to quit all my activities and concentrate on the meds. And my psychiatrist was insisting I quit my regular moderate exercise regime, he claimed regular moderate exercise was a “sign of mania.”
Personally, I’m allergic to all the neuroleptics, and my grandmother was allergic to the one she was put on decades ago – no other family history of so called “mental illness” (the psychiatric industry apparently doesn’t understand the difference between the words “psychic” and “psychotic,” is what my family learned).
The last time I was forcibly injected I ended up punching myself in the chest until the short term injection wore off. The psychiatric practitioners who weren’t intelligent enough to comprehend the words “your drugs make me sick,” did confess they’d never seen such an adverse allergic reaction to a neuroleptic afterwards. What happens to those who are allergic to the neuroleptics, that are injected with a three month supply of the drug?
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Fred,
I agree that the field of psychiatry needs to be better regulated, not sure of eliminating psychiatry altogether as some suggest because my daughter sincerely needs an expert in pharmacology to help her safely wean off these deadly neuroleptics before they permanently damage her brain or kill her…Please be respectful of those among us who simply can’t pull themselves up ‘by the bootstraps’ because discontinuation syndrome is a very real issue and the fear of ending up in the hospital due to super sensitivity psychosis and ending up on even more drugs is very real. I for one, hold out that psychiatrists will feel comfortable enough to visit this site regularly and see that our alternative directory needs more names!
Fred, I have the highest regard for your work and I’m thankful for your leadership. Truly. But I don’t agree with suggesting that we should shoot psychiatrists with a needle and exile them on a ‘space shuttle’, even though you are obviously being humorous. This only serves to exacerbate the growing hostility between consumers/family members and their treatment providers and make it less likely that the few good psychiatrists who are left will be willing and able to have a dialogue with us and learn from the anecdotal evidence and convince their peers to support our movement.
That having been said, I once sampled my son’s seroquel (only 1/3 of his tablet out of fear) and I was shocked at what happened to my body and my psyche from less than a single dose. And the effects took several days to wear off. It was a negative experience and very frightening. Because of my experience, I think all prescribers and caregivers should be required to take a neuroleptic at least once and write in a journal about their experience. I think this would result in far fewer prescriptions written because psychiatrists would understand why so many people are non compliant with their medications. This may also make it more likely that we would finally get some research funding to understand the nature of super sensitivity psychosis when people discontinue a dopamine blocking agent, protocols for safely weaning off people, and the formation of badly needed social supports for people who are voluntarily withdrawing from meds for any reason.
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MadMom, I greatly appreciate your comments and your experience and advocacy! In the early eighties at a CMHC a psychiatrist offered the staff the op to take one haldol pill. Everyone refused.
I was stressed beyond stressed and had family relatives who were either emotionally abusive or just unaware and no one did any research on medication for me. I was desperately holding out not to take them and the one person who could have should have been aware bought into the entire big pharma mindset. So as my brain was literally fracturing in terms of rational versus nonrational thinking patterns I ended up taking the meds. I regret that still.
Your voice is so important for others especially family members. You get it! I hope someday your family can achieve true health and peace. It did come for me but after a decade long sturuggle. Unlike this research folks are not their disease not their medication they are in stuggle mode and only through trial and error and hard work and I really think luck , fate and self agency – help – all these factors most folks can come out of this hard life mode.
so many haven’t but so many could!
Can you go on the road? Or maybe we need a global traveling show with multiple voices and stories!
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I was just fantasizing how nice it would be to have a MAD PRIDE van and travel all over the country talking about the wealth of alternatives for treating emotional distress and extreme states. People just need confidence on how to deal with a crisis. If we could give one another confidence and rebuild the village, so to speak, where human beings and neighbors care for one another, we could get millions of Americans off these harmful medications and improve the quality of life
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Three-month Injectable Antipsychotic… OMG that is just plain EVIL .
What if a person starts having bad reactions besides the intended one, can a surgeon remove the injection residue ?
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omg i didn’t even think of that. Yes what about adverse reactions; You can’t quit the medications so you have to endure the adverse reactions; how horrible.
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LOL!
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I thought they needed at least two studies to get a drug approved? And of course, the study design is ridiculous, as if the only options are a long-acting injection and immediate withdrawal to nothing! They should have had a maintenance group with medication as usual and a slow tapering group for comparison. They could also have compared the impact of psychosocial supports between the groups, which I bet they did nothing about. Not to mention the ones on placebo still thought they were taking the drug! What if they came into their physician and said, “Doc, this stuff doesn’t seem to be working for me any more – I’m feeling really weird. Can we make an adjustment?” Would they completely ignore this person’s needs for the interests of the experimental design?
Cruel and stupid, and it’s amazing that the FDA swallows this crap. Copy cat’s point is also well taken – if it’s not working or making things worse, how do you stop?
—- Steve
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oh how awful and terrifying for those who had med’s dropped cold turkey. How can we allow such cruel unethical acts to be forced upon people in need of kindness?
Where is the integrity of the horrible researchers? Withdrawal is such a serious act, one in which people should be treated with compassion and allowed time for their bodies to recover from being addicted to such strong drugs. Shame shame on whichever center of ‘higher’ unethical instate allowed this to happen. This experimentation has got to stop and the drug companies must invent a way to successfully help those who want to get off their life damaging drugs.
Keep speaking up , write to these research monsters and let them know of their cruelty, their trauma inducing acts which cause whole communities to suffer.
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My daughter’s experience on a depot injection of Invega was horrible. She became much worse and to have no agency over what goes in ones’ body, is so psychologically harmful, a deep depression goes hand in hand with this type of coercive ‘treatment’. There are degrees of harm of course and it is equally harmful for people to know that if they refuse to take an oral medication, a triad of doctors will sign a medication ‘override’ making it legal for orderlies to jump a patient, pull down their pants and inject them with force. Brutal.
I’m convinced that people metabolize these drugs differently. I’m positive that there were times my daughter was getting a higher than normal dose in her bloodstream or a lower than normal dose due to her metabolism while on these awful depot injections. Whatever built in mechanism these injections rely on to provide a steady stream to the bloodstream, they are not infallible, believe me. They are risky and should be outlawed.
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The biggest problem with parents of the psychiatrically oppressed is their continuing persistent belief that within psychiatry there are psychiatrists (the really good ones that know how to use psychiatry for the benefit of their loved one ) They share this belief with other various educated true believers who have in common the shared no lived experience non experience and respect for the principle of respecting the pseudo scientific university titled and “educated” underneath it all. All this instead of primarily respecting the survivors of atrocities beyond their comprehension and truly seeking them out for the real answers they and their loved ones so badly need.
I’m not here to make psychiatrists comfortable. I will not hobble or dilute my lived experience for anyone . If psychiatrists and psychiatry are all sent to Mars and yes I would send them immediately if I had the power. The very next moment “regular oh so wonderful doctors “would pick up the slack without missing a beat and it would still be doctor delivered pseudo scientific psychiatric modalities as usual. Thats why we need Health Freedom for the people and Mars for the would be and wannabe controllers of others. I will fight against psychiatric and all other cartel and whatever oppression that interfere with human rights for as long as necessary Stockholm syndrome notwithstanding. Remember if the good psychiatrists are so good why are they not there with us on the street when we demonstrate for our human rights ?
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Fred:
You have every right to be angry, very very angry. And you ask a good question…
Why are the good psychiatrists not marching with us in the streets? I would posit the following reasons because they focus on the issues, not the people.
Deomoizing psychiatrists rarely gets our movement anywhere. Here are just a few of the reasons as I see them:
Because:
10 No one invited them
2) No one invited them again and again
3) Because no one is tracking a mailing list related to people who are invited to protests, keeping all addresses current, tracking the mailings, and the outcomes of each mailing
3) Because no one developed a national organizing committee to coordinate protests dates, times, priorities, purposes, and messages, etc.
4) Because no one is developing a strategic, consistent multi-year communications plan in regards to the media
4) Because no one raised enough money to rent a permanent office space
5) Because no one raised enough money to hire permanent staff whose jobs were to coordinate protest events, provide resources and training to other protesters, etc.
5) Because no one is solely focused on building a national coalition with other social justice movement leaderss
6) Because no one is solely focused on training and leadership development for protesters.
Do you want me to go on? I could list 100 or more reasons why psychiastrists didnt show up. The same reason applies to why other activists, consumers, psychiatric survivors, and family members didn’t show up
If we are going to blame anyone for our problems, lets start with ourselves.
This doesn’t take away from the incredible and marvelous that organizers of the International Day of Protest against Shock, Its a tremendous accomplishment and the leaders of the protest as well as every attendee deserves a lot of praise but if you want psychiatrists to attend, the protests will have to reach a new level of organization and attendance. The protests will have to have cachet, guarantee of media coverage, famous speakers, funding, timing for media tie-ins, and other resources.
This will all come in time. Have faith and it will happen
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Great post madmom,
Personally, as much as I hate what psychiatry stands for, I have a hard time demonizing them, particularly when 80% of all psych meds are prescribed by non psychiatrists. Why isn’t anybody for example getting on PCPs who are responsible for this and sending folks into the horrific grasp of psychiatry because we all know what happens with this history of psych meds.
The PCP prescribes a med that someone has a bad reaction to which is then blamed on some bogus mental illness which leads to a referral to a psychiatrist. And we know the rest of the story.
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The only reason I would want psychiatrists to come to demonstrations for human rights is so that the “good ones ” how many are we talking about 7 or 8 ? could publicly state to crowds of people what a bogus cult psychiatry is and how they apologize for having been brainwashed into accepting a position within it and explaining how and when they will pay reparations for their part in lending credibility to such a crime against humanity abomination. How could anyone that chooses to systematically harm children and other human beings not be considered a pariah ?
Here’s what must go on inside of the heads of anyone who accepts the title of psychiatrist as their own. Best stated by Abraham Isaac Kook , ” The fragmentation of thought produces a decline , a weakening of thought . For how can one engage in thought if he believes that whatever is outside his own skull is nothing but a profuse confusion and that the [meaning of the] world and life is only what is found in his own tiny mentality ?…
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This is sad times. Not only are more people in the US going to be put on depot neuroleptics one way or another (cough–court orders–cough), the practice will persist even when these drugs go off patent. Mental Health, Inc. just gets worse, the more control you give it.
I’m also wondering…why is it OK to torture “schizophrenics” like this, but not others? Are we that low on the totem pole? (Ohhhh, wait…yeah…yeah, we are). Any antipsychotic will cause changes in the brain. Rapid withdrawal of said drug will cause problems. The problems aren’t actually a disease, and the effects of withdrawing a psych med suddenly can be Hell on earth, especially w/ a heavy hitter like an Antipsychotic.
Sad times. Stating the obvious–that drugs cause problems, sometimes worse than the original problems–is dangerous. All research, all discussion about “mental illness” has to occur along pre-approved lines. Truth is irrelevant.
Ugh. I read this abstract of a study from the late 70s, maybe 80s…they compared Valium to Prolixin in prevention of relapse of psychosis. Valium actually did pretty well. See…that’s my other problem…not all drugs are terrible. People would line up for a Xanax depot, lol. But shrinks refuse to give potentially fun drugs to low status people, choosing instead chemical straight jackets. Sometimes, drugs do help severe distress…I just think its a question of which drugs, and who decides….
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