Paxil, Seroxat : Reputations for sale? a review of the PAXIL 329 scandal: Stan Kutcher

Stan Kutcher is the Liberal candidate for office in Halifax, Nova Scotia, Canada.

Politics aside it is alarming that Kutcher, a co-author of the infamous Paxil 329 study (see links below for background on study 329) does not want the public to know about his connection, to the point of an article being retracted from a local paper. *the article is viewable if click on 'cached'. *also viewable here in this 'scribed' link. The article quotes author Alison Bass: "They essentially distorted the outcome measures, and essentially lied." Alison Bass is author of the book Side Effects and authors a blog.

Hat tip to Bob Fiddaman for noting that this candidate who also works in the Canadian mental health system is one of the Paxil 329 authors.

They buried data showing teens became suicidal on Paxil.

The study is one of the most scandalous in research psychiatry and Kutcher doesn't appear to want the truth out just days before the Canadian elections.

The co-authoring of the Paxil 329 study is a fact, and one Kutcher cannot hide, though local papers retracted the story discussing the study, the study still exists. This is where politics and psychiatry and pharma all intersect, with scandal and corruption as key search terms.
~~~

Article below is from bcc news via news.bbc.co.uk

Reputations for sale?

Fiona Godlee is the editor in chief of the British Medical Journal and has written this article about Secrets of the Drugs Trials.

"Panorama's account of GlaxoSmithKline's successful attempts to market Seroxat for use in children, despite the fact that its own published trial found evidence of serious adverse effects and failed to show benefit, is fascinating but depressingly familiar.

What is even more depressing is that such behaviour is still so widely tolerated within medicine.

There has been no shortage of outcry or official condemnation - including clear statements from the World Association of Medical Editors, the International Committee of Medical Journal Editors, and industry itself through its Good Publication Practice guidelines - that undeclared conflicts of interest and ghost writing are unacceptable.

But, you might reasonably ask, what use are such huffings and puffings in the face of the individual rewards on offer from drug companies.

Let's be clear what is and is not acceptable. There is nothing wrong with getting help from medical writers, provided they and their source of funding are clearly acknowledged.

Nor is there anything wrong with academics or clinicians working with industry, provided they remain personally accountable for everything they say.

What is clearly wrong is writers, academics, or clinicians concealing under their coat tails an army of company spin doctors intent on distorting the scientific record.
Legislation is not going to happen soon - the powerful industry lobby will make sure of that. Regulation is still inadequate.

So what can we do to change the blind-eye culture of medicine? In the interests of patients and professional integrity I suggest intolerance and exposure.

We shouldn't have to rely on investigative journalists to ask the difficult questions.
So at meetings, why not slow hand clap any speaker who does not begin their talk with a sentence or slide declaring their conflicts of interest?

And if journals discover authors who are guests on their own papers, they should report them to their institution, admonish them in the journal and probably retract the paper.

Reputations for sale are reputations at risk. We need to make that risk so high it's not worth taking."

via news.bbc.co.uk

hat tip to PharmaGossip http://pharmagossip.blogspot.com/2011/04/bbc-news-panorama-reputations-for-sale.html

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From Furious Seasons

Paxil, Lies, and the Lying Researchers Who Tell Them

April 30, 2008

Paxil, Lies, and the Lying Researchers Who Tell Them -Philip Dawdy

"I'd thought it wasn't possible for the infamous Paxil Study 329 to be even more infamous, but I was clearly wrong. A new paper, based upon court documents, is out and, while you need to understand stats more than usual to understand what's going on, it's clear that GlaxoSmithKline and the study's authors were up to some deceptive crap. Not that that wasn't clear before.

For newbies, Study 329 was published in the Journal of the American Academy of Child and Adolescent Psychiatry in 2001. It claimed that Paxil was good for treating depression in kids and that patients didn't suffer many adverse effects from taking the drug. The study, however, was one of the most corrupt I have ever seen in all of psychiatry--and that's saying something--and contained all sorts of jury-rigged data, hidden data and, yes, it was ghost written as well. That means many of the big name psych docs such as Martin Keller whose names were on the study didn't have much of an idea of the supporting data. The paper has been thoroughly discredited at this point, but has never been retracted by the journal.

Healthy Skepticism has been questioning this study for years and has a resource page here. "

Continue reading Furious Seasons article here.

Why does Stan Kutcher want to hide this information from the Canadian voters?


Further current reading from a retired Psychiatrist

Article-"Sally's World":

"•Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial

by Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, Birmaher B, Hagino OR, Koplewicz H, Carlson GA, Clarke GN, Emslie GJ, Feinberg D, Geller B, Kusumakar V, Papatheodorou G, Sack WH, Sweeney M, Wagner KD, Weller EB, Winters NC, Oakes R, and McCafferty JP
Journal of the American Academy of Child and Adolescent Psychiatry.

2001 Jul;40(7):762-72.

This study was supported by a grant from GlaxoSmithKline… The authors acknowledge the contributions of the following individuals:… Editorial assistance was provided by Sally K. Laden, M.S.

Her work with Dr. Keller was poorly received, and Study 329 has become a paradigm for the misrepresentation of science in the psychiatric literature – a legend with its own literature. "
----

Update: Why 'The Coast' Pulled the Stan Kutcher Article by Bob Fiddaman links to retraction or lawsuit article.

View the article here at scribed "Kutcher demands retraction may sue the 'Coast' paper".

AstraZeneca spends $743 million in defense of Seroquel lawsuits while victims have received zero $ to date

VIA
PharmaGossip:

Source AstraZeneca AstraZeneca PLC First Quarter Results 2011

$743 million spent in legal defense of Seroquel diabetes lawsuits.

Projected settlement for victims $12,000 less tax & lawyer fee.

The victims have not received settlement funds as of this date.
----

Evidence

Transparency/Concealing Data; Efficacy; Study 41; Email from Seroquel Global Brand Manager, Simon Hagger, on behalf of the Seroquel SR Communications Team advising that they are under clear instruction from the highest level in AZ not to discuss details surrounding Trial 41 with any external partners, which would include study investigators.
http://dida.library.ucsf.edu/tid/tgv09b10

Reinstein; Email string suggesting Reinstein deviated from a Seroquel study protocol making his results suspect
http://dida.library.ucsf.edu/tid/mov09b10

Study 15; Email string about whether to publish “failed” Study 15 as an abstract
http://dida.library.ucsf.edu/tid/nhv09b10

Off-label; “all off-label slides are financed outside of commercial for obvious legal reasons”
http://dida.library.ucsf.edu/tid/piv09b10

Research Control; Commercial/Sales; Email string between Jeffrey Goldstein, Michael Czupryna (Global Team; development), and Andrew Goudie (UK researcher) regarding the funding for quetiapine research transitioned from the responsibility R&D to Sales and Marketing
http://dida.library.ucsf.edu/tid/pjv09b10

Commercial/ Sales; Diabetes; Contemplating Study 125 endpoints based on potential adverse effects on US sales
http://dida.library.ucsf.edu/tid/mpv09b10

2004 Geoff Birkett-
Subject: RE: Brief Highlights (Seroquel) - Third Quarter Results
Team

We are really on a roll.
Enjoy the Standalone - those of you attending.

I know you are all working flat out - but I can tell you that SET , and everyone in AZ ,
really appreciates the work you are doing and the impact that you are having.

Keep driving the brand I never thought that I could say Seroquel is
Astrazeneca's major megabrand.... Now I can.,..
THANKS for what you are doing, geoff

http://dida.library.ucsf.edu/pdf/lhv09b10

Read all 243 internal documents from AstraZeneca HERE at University of San Francisco Drug Industry Document Archive.

Further reading: Corporate Integrity Agreement $520 million dollar Dept of Justice fine

The 75 page AstraZeneca Corporate Integrity Agreement, 4-27-2010, pdf document

Psychiatrist Mounir Belcadi in Dollars for Docs : AstraZeneca & Lilly

Consumer alert:

California Psychiatrist Mounir Belcadi is a paid speaker for Lilly and AstraZeneca. (makers of Seroquel & Prozac, et al)

Dollars for Docs database

BELCADI, MOUNIR Calif. Santa Rosa Eli Lilly $18,200 2009
Q1-Q4 Healthcare Professional Education Programs: $18200.0 NORTH BAY PSYCHIATRIC ASSOCIATES, INC

Belcadi, Mounir Calif. Santa Rosa AstraZeneca $10,800 2010
Q1-Q2 Speaker compensation NORTH BAY PSYCHIATRIC ASSOCIATES

Legal Malpractice? Scamming Seroquel victims without intent to represent in court: Miller Firm

Source: anonymous Seroquel lawsuit victim/plaintiff Exclusive

This post will be updated as my source reveals more information from the conversation via telephone with the Miller Firm.

Backstory: The plaintiff hired the firm in the above letter, that firm turned around without notificication and gave the case to the Miller Firm.

4-26-11

Plaintiff received return phone call from Miller Firm after repeated attempts to contact re the packet delivering settlement information, per the lawsuit against AstraZeneca that according to Bloomberg was settled in August 2010. To this date there are no plaintiffs who have received settlements from the Miller Firm who claim to represent 630 clients.

The Miller Firm representative told my source they have no intent on going to trial with cases and in fact believe their cases are not worthy of a lawsuit. The only option will be for the clients to accept the offer of approximately $12,000 before taxes and lawyer fees removed. If the client refuses the offer of the settlement they are not going to continue to represent the client, the cases are and will be closed.

The hold up according to the rep at the Miller Firm is waiting for the Government to waive the Medicaid/Medicare cases.

QUESTIONS

1. Why is another firm (Garrison Firm)in charge of the packets and asking for Goverment waiver of Medicaid/Medicare?

2. Is AstraZeneca going to pay the victims or is the U.S taxpayer?

3. How many victims of Miller Firm 630 clients are Medicaid/Medicare clients?

4. Why did the Miller Firm tell my source they do not want any personal case information?

5. Is this legal malpractice? never having intent on representing clients in court? never reading any client information on how the drug injury happened?

THESE ARE NOT VICTIMLESS CRIMES there is a great injustice happening to people injured by Seroquel and now finding out that their lawyers are not going to help them settle with any trial or information of their case. How can they choose a settlement offer if they never had client information?
--
**Update: evening 4-26-11 email from anonymous plaintiff source


"Many more questions than answers!

This again is not passing the logic or ethics test.

These backroom deals made in secret are certainly not any form of justice; taken in even the most liberal context.

Why would medicare/medicaid give a reimbursement waiver….isn't that like saying government is going to cover the cost of treating victims of AstraZeneca's wrong doing? In fact, why isn't the government taking legal action to cover the insurmountable cost of treating those harmed by AstraZeneca's Seroquel?

If these cases were/are without merit, why did these firms agree & advertise to represent those individuals injured by Seroquel?

Why were plaintiffs not kept up to date or made aware of what these settlement negotiations entailed?


Why did plaintiff attorneys with supposedly an ethical & professional obligation to their clients’ best interest not want information & facts that were pertinent to individual cases? 630 cases settling for an estimated guess of $12,000 per case...law firm gets a tad over three million, and those injured by Seroquel 5 to 7 thousand dollars for a life time affliction caused by Seroquel.

(That’s if government decides to grant a reimbursement waiver!).

Do the math yourself...what is the cost of treating diabetes and like conditions for a single year? Then figure out the cost down the road when more serious health issues come into play?

This doesn't even take into consideration the pain, suffering, loss of income & quality of life many injured by Seroquel have and continue to endure daily. Who is going to pay for the continued health care over the many years to come? Not AstraZeneca, not these law firms pocketing millions; it's the tax payer & victimized individuals once again that will foot the bill.

How about those victims that weren't using medicare/medicaid?

We see endless headlines about huge pay outs to Government for these pharmaceutical corporate crimes...but the facts are that those injured & victims of these crimes are left to fend for themselves. Government goes after their piece of the pie.States get their slice.Lawyers get a nice huge heaping slice of pie w/ ice cream on top...doctors get pie served to them. AstraZeneca & alike continue getting all the pie they want including ownership of the bakery.

Victims of the crimes get to continue being victims...that's what are government, lawyers, and the courts call justice in America.

What ever happened to the treasured American concept of receiving your day in court before a jury of your peers; deciding upon the delicate & imperfect scales of justice the merits & outcome for these cases? I'm guessing a billion dollar legal team with an endless/bottomless well of political influence contributions buys something far more than mere justice now a days."

What can be gleaned from this latest news?

It appears all settlements claims have been centralized with Garrison Firm for settlement packet distribution.

No offers are going out until the medicare/medicaid issues are resolved, whether or not you as a plaintiff used either of those services.

No individual information or particulars besides the use of Seroquel and having diabetes or related condition was used in the settlement negotiations.

That’s means whether you were prescribed Seroquel off label, for sleep, anxiety, depression, were force treated in an institutional setting, or for any other reason off label or approved use it makes no difference.

From statements made from this law firm’s representative, the law firms that have signed on to this settlement offer do not believe anyone they represent has a case worthy of going to trial. This means this was a quick settlement money grab & not a true legal representation. One would wonder why they took these cases in the first place.

They are sounding little different than AstraZeneca Lawyers. The only ones that are going to get a fair shake & a substantial amount of compensation from this litigation are the lawyers.That is cold reality at this juncture.

Do plaintiffs have a case for refusing this settlement and pursuing possible legal malpractice claims?

Absolutely, it will take time & effort, but Yes! Remember, this is not a class action suit. It is a tort litigation where each case and individual should receive prudent and diligent representation which appears to not have happened in many (if not all) the cases in this settlement."

Phoebe Snow a heroic caregiver, mother and singer

RT @pharmagossip
RT @WriteWithStan: RIP Phoebe Snow http://ow.ly/4Hjiz substance over stardom - http://on.today.com/gi5KnM

"The loss of this unique and untouchable voice is incalculable," Cameron said. "Phoebe was one of the brightest, funniest and most talented singer-songwriters of all time and, more importantly, a magnificent mother to her late brain-damaged daughter, Valerie, for 31 years. Phoebe felt that was her greatest accomplishment."

Deceptive marketing tactics for Risperdal could cost Johnson & Johnson billions

VIA Pharma Gossip:

Tuesday, April 26, 2011

Possible billions sought in drug marketing suit The Post and Courier, Charleston SC - News, Sports, Entertainment

COLUMBIA -- It's now up to a Spartanburg County judge to decide how much a Johnson & Johnson subsidiary should pay South Carolina for deceptive marketing of an antipsychotic drug. If the judge agrees with attorneys for the state, that number could be in the billions of dollars.


Last month, a jury ruled that Janssen Pharmaceutica, Inc. -- a subsidiary of the New Brunswick, N.J.-based drug manufacturer -- had violated the South Carolina Unfair Trade Practices Act by sending misleading letters to about 7,200 doctors in South Carolina downplaying the links between diabetes and its schizophrenia drug Risperdal.

The blockbuster antipsychotic lost patent protection in 2008. Johnson & Johnson said last month that Risperdal Consta, the long-acting version of the drug, generated $1.5 billion in sales last year.


The company also made tens of thousands of drug marketing-related phone calls that minimized Risperdal's link to diabetes, improperly claimed the drug was safer than other competing medications, and enclosed misleading information inside drug packages, the jury found.

In the Nov. 10, 2003, letter, a Janssen official said research showed Risperdal was not associated with an increased risk of diabetes when compared to other drugs or patients receiving no treatment at all.


"Evidence also suggests that RISPERDAL is associated with a lower risk of diabetes than some other studied atypical antipsychotics," Janssen vice president Ramy Mahmoud wrote.


The company also argues that, if South Carolina had truly feared for patients' safety, the state would have requested an injunction stopping any prescriptions from being filled, noting that an expert for the state testified that there were no facts to support any risk of death in the elderly as a result of taking the drug.

"There is no evidence in the record that Risperdal has actually caused any South Carolina patients to experience adverse effects related to the alleged risks," Janssen attorneys wrote in a brief filed April 15. "This case is novel: there was no precedent -- not a single authority -- that so much as suggested that an FDA-approved package insert could be the subject of a state law deceptive trade practices claim."

AND---

"Violations of this South Carolina law carry potential penalties of up to $5,000 apiece. In a court exhibit, attorneys for the state argued that they see the number of violations as potentially including every single prescription, sample box or "Dear Doctor" letter written since the mid-1990s -- numbers that reach into the millions when totaled up.


Considering the 620,000 Risperdal prescriptions written for people on Medicaid and the state health plan alone, that could mean more than $3.1 billion -- without even taking into account any of the sample boxes or "Dear Doctor" letters the state also argued were in violation of the law."


Janssen spokesman Greg Panico said the company was disappointed in the South Carolina jury's verdict but did not know if it would appeal, the action Janssen has taken against a Louisiana verdict ordering the company to pay nearly $258 million for misrepresenting Risperdal's links to diabetes."

via postandcourier.com

the dog days are over

harness some of that energy!

$ 9 billion spent on antipsychotics : Abilify & Seroquel, the re-marketing of antipsychotics as 'antidepressants' pays off for Big Pharma

Antipsychotics have been pushed as 'add-on' for treatment of depression, as off-label use for insomnia and more. This is surely a pay off for the Big Pharma cos that saw $9 billion dollars in sales in 2010.

America is the Atypical Nation, does anyone ever learn to cope without medication?

Something's up with this, it's time to look in the mirror and ask yourself if you are part of that 9 billion dollar antipsychotic industry, just what are your plans for the future? the drugs are potent chemicals with a massive side effect profile.

Article here, via PharmaGossip, on how much Americans paid out for prescription drugs in 2010. This is a new day and age when antipsychotics run with the top ten and heartburn meds!! wake up America!

Seroquel diabetes lawsuit settlement: Plaintiffs have not received settlement or information packets from Miller Firm

The Miller Firm was given plaintiff cases from the firm Saiontz and Kirk. When the anonymous source-plaintiff telephones Saiontz and Kirk that firm turns around and phones Miller Firm for updates, because NO ONE has any answers on what the settlement offer is for the clients or where the packets are--the information packets were promised via letter to my anonymous plaintiff to arrive "in the next three weeks".

It has now been 6 weeks and no information packet regarding the AstraZeneca Seroquel diabetes settlement has arrived.

March 7, 2011

Saiontz and Kirk

..."it is our understanding that values on client's cases have not been fully determined at this time and that a settlement packet,which will include the amount of the offer, will be sent to you, hopefully, in the next three weeks."

The Miller Firm, which apparently settled with AstraZeneca on behalf of clients refuses to speak about the cases, and if one telephones them to inquire, all you are given is a voice recording telling clients not to call.

Ask for the Seroquel lawsuit 'recording' (703) 519-8080

Perhaps Bloomberg reporters which reported the news without names,and apparent insider "facts" on how the lawsuit was settled, should phone Miller Firm and ask them where the client packets are, or how much monetary settlement each client will receive. Ask HOW Miller Firm can deduct how much one client receives vs. the other, when in fact the Miller Firm has never interviewed my anonymous client/plaintiff, ever.

*Image courtesy of Seroquel Lawsuit Blog found courtesy of and at Google Images

New antipsychotic Latuda now being trialed for Bipolar 1 Depression: fast-tracked to the FDA?

Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression

Sponsor: Sunovion Information provided by: Sunovion ClinicalTrials.gov Identifier: NCT00868959

Take a look at that page link to the clinical trials dot gov site. This drug study looks 'iffy'.

Not very much information, no named principle investigators, and this drug was just FDA approved last Fall 2010 for Schizophrenia.

Now it's being fast-tracked for approval for broader use.

Responsible Party: Sunovion ( Executive Director, Clinical Research ) ClinicalTrials.gov Identifier: NCT00868959

History of Changes Other Study ID Numbers: D1050256, EUDRACT No. 2008-007483-42 Study First Received: March 23, 2009

Last Updated: April 11, 2011 Health Authority: United States: Food and Drug Administration Read more about this and saphris etc http://chekhovsgun.blogspot.com/2009/09/lurasidone-asenapine-iloperidone.html MacGuffin blog. The side effects are just peachy. *blogger has a spacing html problem. i've been writing my own html all week, excuse this post for spacing and links not up to snuff--tired of writing it in 'code'!

nothing but blue skies ahead

for my friends who read lips (like me)and know ASL i chose this version of i can see clearly now to 'listen' while reading. a while back, i blogged about surviving a few of life's big ticket items, and i'm here to say that I HAVE SURVIVED. a year ago the days were darkened as i stood on my front porch of my (now old home)home. i had just arrived back from the long hours drive of taking my daughter out and the sky opened up with a massive deluge of rain, that resulted in the waterfall falling on the porch and over the head of the young man who walked up at that very moment to tape the 'foreclosure' paperwork all over my house. they go for the front door and the garage door, using the blue tape that college students use to tape posters on walls in dorm rooms, i think its painters tape. i pause, as i write and think, thank God that's over.

thank God that's over.

the long and dragged out divorce proceedings, where i have been representing myself in court for months, talking to judges and finally succeeding in a settlement i could live with is finished, which leads me to sit back and take a deep breath and look back at how insurmountable all of the last year was in my mind, and this was not an easy accomplishment. i write this for anyone who may be facing these situations--it is possible, and it is grueling. there were doctor visits to monitor blood pressure and chest pains, bronchitus--and when the doctor told me to save money and keep her posted on my high blood pressure by going to the fire station to have them take the blood pressure...i said, forget it. i'll survive, this is life happening and nothing is going to lower that bp doc. once it's over it'll be low. it was a couple of months later at my new apartment, that i noticed i didn't have the chest pains accompanying my daily life. no more trips to the dump with items and junk. it was in fact complete. there are pains of knowing what i left behind, ppl in that situation inevitably walk away and leave things. i'm one of them.

i made a conscious decision not to dwell on it. repeat. i made a conscious decision not to dwell on it.it was imperative to my embracing the change and standing tall in my new circumstances to shut off the emotions. i would not recommend riding out foreclosure to anyone, is my advice. it's not for the weak at heart.i do recommend standing up for yourself in an oppressive and ill relationship and moving on, that was in fact the best thing i ever did for myself years ago. finalizing it in court closed the chapter, and that was a great day. better every day since. those 'big ticket' items followed in the last 3 years bankruptcy and my dad being killed in a plane crash, my daughter in and out of hospitals. so round it all up and tell yourself: i can do this. seriously, you will get through it.

quote of the day

In the depth of winter I finally learned that there was in me an invincible summer.-

Albert Camus

cages

It's a Beautiful Day was a band formed in San Francisco, California in 1967, the brainchild of violinist David LaFlamme

"The group's signature song "White Bird" was inspired by the experiences David and Linda LaFlamme had while living in Seattle. In an ironic twist on the band's name, the sad song was partly inspired by Seattle's rainy winter weather. In a later interview, David LaFlamme said:

"Where the 'white bird' thing came from ... We were like caged birds in that attic. We had no money, no transportation, the weather was miserable. We were just barely getting by on a very small food allowance provided to us. It was quite an experience, but it was very creative in a way."

click on the photo to the upper right & to listen to this bittersweet and poignant song.

my daughter used a lot of self-determination today to get outside.

Anatomy of the White House- PhRMA (not to mention those Pfizer $million dollar box seats at the DNC)

VIA Pharmagossip February 2010

Billy Tauzin

Former lawyer for GSK charged with 4 counts of making false statements and more :regarding the alleged antidepressant Wellbutrin

VIA Pharmagossip:

Reuters) - A former lawyer for GlaxoSmithKline (GSK.L) has been reindicted for obstructing a probe into the company's marketing practices for a drug after the first indictment was dismissed because of errors by prosecutors, the Justice Department said on Thursday.

Lauren Stevens was charged again with four counts of making false statements, one count of obstruction of justice and one count of falsifying and concealing documents related to Glaxo's promotion of the anti-depressant drug for weight loss, which had not been approved by the Food and Drug Administration.

The original indictment filed in November was dismissed last month by a federal judge in Maryland who found that prosecutors made mistakes when presenting the case to the grand jury.

A grand juror had asked prosecutors whether it was relevant that Stevens relied on advice of other lawyers when she responded to the FDA's investigation, according to court papers. The advice Stevens received from other lawyers is central to her defense in the case.

The judge found the prosecutors had given an incorrect answer that "either substantially influenced the decision to indict or, at the very least, creates grave doubt as to that decision."

Stevens, who worked as associate general counsel at Glaxo but has since retired, was accused of concealing documents and making false statements to the FDA about the extent of which the company promoted the drug Wellbutrin for unapproved uses."

Antipsychotic INVEGA approved for use in children age 12-17 yrs for Schizophrenia

VIA PR NEWS:

"FDA grants approval for use in 12-17 year age group TITUSVILLE, N.J., April 11, 2011 /PRNewswire/ --

The U.S. Food and Drug Administration (FDA) on April 6 approved INVEGA® (paliperidone) extended-release tablets for the treatment of schizophrenia in adolescents 12 to 17 years of age.

The efficacy of INVEGA® to treat schizophrenia in adolescents was established in one six-week clinical study. INVEGA® is an atypical antipsychotic medication and was first approved in the U.S. in December 2006 for the treatment of schizophrenia in adults.

Janssen Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., markets INVEGA® in the U.S. Schizophrenia is a complex, chronic brain disorder that causes a variety of symptoms which can include hearing voices, having fixed false beliefs or delusions, disorganized thinking, and unusual behaviors. It can begin in adolescence or early adulthood, and about one percent of adults in the general population has schizophrenia. The prevalence of schizophrenia in adolescents is not known, but it is estimated to be less than in the adult population.

"Although rare, schizophrenia in adolescents is a very serious and disabling brain condition that affects every aspect of an adolescent's life and has significant consequences," said Husseini Manji, M.D., F.R.C.P.C., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. "This new indication for INVEGA® provides an additional option for clinicians who treat adolescents with schizophrenia and further demonstrates our commitment to helping people with diseases of the brain."

*Invega is a cheap knock-off of Risperdal

The side effects not limited to:

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with the use of antipsychotic medications, including paliperidone. Clinical manifestations include muscle rigidity, fever, altered mental status, and evidence of autonomic instability (see full Prescribing Information). Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and close medical monitoring, and treatment of any concomitant serious medical problems.

QT Prolongation: Paliperidone causes a modest increase in the corrected QT (QTc) interval. Avoid the use of drugs that also increase QT interval and in patients with risk factors for prolonged QT interval. Paliperidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias. Certain circumstances may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval.

Tardive Dyskinesia (TD): TD is a syndrome of potentially irreversible, involuntary, dyskinetic movements that may develop in patients treated with antipsychotic medications. The risk of developing TD and the likelihood that dyskinetic movements will become irreversible are believed to increase with duration of treatment and total cumulative dose, but can develop after relatively brief treatment at low doses. Elderly women patients appeared to be at increased risk for TD, although it is impossible to predict which patients will develop the syndrome. Prescribing should be consistent with the need to minimize the risk of TD (see full Prescribing Information). Discontinue drug if clinically appropriate. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. The metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.

Hyperglycemia and Diabetes- Hyperglycemia, some cases extreme and associated with ketoacidosis, hyperosmolar coma or death has been reported in patients treated with atypical antipsychotics (APS), including INVEGA®. Patients starting treatment with APS who have or are at risk for diabetes mellitus should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. All patients treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia. Some patients require continuation of anti-diabetic treatment despite discontinuation of the suspect drug."

Generation RX : a documentary that deserves your time

This documentary Generation RX (here's a trailer clip to view) is available on Netflix for viewing and I highly recommend watching it.

It's a matter of public duty at a certain point to speak out when someone such as myself has witnessed over a decade of the drugging of a child with psychiatric medications.

That being said, I am going to write about it, and then put the lid back on my emotions, because this--is my 'sacred emotional burial ground'. (title of my blog name meaning)

Viewing the film was not just difficult it was haunting, because it is a chilling expose' on how the life of a child can be shortened, their soul and spirit crushed as a result of the brain being altered as the child grows while taking drugs such as Ritalin, Adderall, Zyprexa, Risperdal, and other psychiatric medications.

Dr. Peter Breggin uses a great analogy in the film where he discusses the drug effects on certain parts of the brain, and how the result is basically destroying the "human being" part of the brain--the person.

Their souls, and for kids their spirits are destroyed, crushed, snuffed out and dumbed down with these drugs. How do I know this? because I saw it happen to one of mine due to a wrong diagnosis. Over a decade ago there was little information, and hardly and Internet loaded with it as we have today.

As I watched this film, I was flooded with an emotion, a desire I hadn't felt and I've felt them all--I wanted, and I mean wanted my child back.

It cannot happen, obviously.

So the lid on the emotions has to go back down on my own spirit, you see mine was equally destroyed along with my child's as a result of the last decade.

This is a glimpse into my memory bank, I can close my eyes and my child is jumping on the trampoline with glee and joy, or swinging on the playset.

Recently, I took my daughter on a drive along the water. There was a park where people were playing and enjoying the day with their families. It caught my eye, and it caught my daughter's eye also. In her silent world, she looked out the car window at the kids on the swingset. I thought to myself, does she see that scene and feel what I do?

She's still here, a shell of the person she once was, and people may never see the person I knew before. The worst part for me, is wishing with all of my gut, heart and soul that she will be happy and cared for and have a future and all the while knowing she never got to finish her hopes and dreams.

It was excruciating to watch this brilliant child of mine struggle to say "2 more" when I took her to shop recently for items needed (such as socks). It's like we've had 2 lifetimes. All of the other life is in memories, scrapbooks and photos. It's all in my heart. I accept her the way she is now, and enjoy with great joy the time spent with her, I wish I could give the last decade back to her, rewind the tape and see how it turned out.

It turned out this way, that's where we are at. I hope parents of young children heed my caution and understand that psychiatric medications are potent chemicals that change the brain, have side effects that are medically crippling and emotionally stunting.

In the film, there is a clip of a video from this NIH conference in 1998. The next decade will prove to virtually explode with the psychiatric diagnosing and medicating of children. Drug companies such as Lilly, the maker of Zyprexa and Prozac had PR marketing schemes to target children, and have been fined by the Dept. of Justice for doing so. Those fines for the Big Pharma companies are meaningless, they go on with business as usual, and build that cost into their budget, and the buckets of money keep rolling in.

The kids are not alright in America.

This is a nation that depends on drugs to feel, to stop feeling and to cope. The casual use of antipsychotics such as Seroquel for insomnia and more are opening the door to futures that could end up like my adult child.

There will be no more baseline of a personality to compare to, on or off of drugs because once the child is medicated, the actual child has changed...childhood is lost, and when doctors ask the parents for a baseline the parent will only know how the child is on medications.

If these medications worked, why is the standard line "find the right cocktail" of drugs still used by doctors to patients? why are the psych wards still full? these drugs are not cures and they are rarely symptom relief.

They come with black box warnings for diabetes, polycystic ovary syndrome...death. Recent news from one study at Harvard says antidepressants are linked to breast, and ovarian cancer as well as heart attack risk.

There are no life time or long term studies on what happens to 'Generation RX' -- though I have been personal witness to a study of 'one'.

I can't give her back those years. All I can do now is continue to go forward and be at her side, and hope for the future to hold good days for her. Bittersweet are the scenes we see when we go on a drive, of children playing in parks. Which leads me to now write to my daughter: I am sorry, so very sorry for the loss of your childhood and teens, I hope with all of my heart that you know I love you and wish that never happened.

my new backyard

while focusing on the present and not the past i realize this is a present, a true gift of nature near my new apartment, and i count my blessings several times when i'm there.

it's important to embrace the past and accept challenges or events that occurred (such as my daughter's demise by the decade + of psych meds damaging her brain) and then take that and put it away, as in a box in your mind, a compartment. there is no way to focus on the present or future if one is always immersed in the past or painful experiences. this is another life lesson that wasn't just discovered by me, but was embraced by me to be able to keep pushing my life full of change forward.

most importantly it leaves space open for feelings to return such as happiness and joy. i've recently felt both. one of the days was while at this beach. the sun was glistening on the water while my dog romped and played, and i felt it. like a warm beam of sunlight entering my soul.

i let it in.

Johnson & Johnson fined $70 million :BRIBERY

WASHINGTON (MarketWatch) -- Johnson & Johnson on Friday agreed to pay $70 million to settle charges brought by the U.S. Securities and Exchange Commission and the Department of Justice it bribed public doctors in several European countries and paid kickbacks in Iraq. The SEC alleges that since at least 1998, subsidiaries of the company paid bribes to public doctors in Greece who selected J&J surgical implants, public doctors and hospital administrators in Poland who awarded contracts to J&J, and public doctors in Romania to prescribe J&J pharmaceutical products. J&J subsidiaries also paid kickbacks to Iraq to obtain 19 contracts under the United Nations Oil for Food Program, the SEC said. A resolution of a related investigation by the United Kingdom Serious Fraud Office is anticipated.

VIA http://www.marketwatch.com/story/jj-fined-70-million-over-bribery-allegations-2011-04-08

Where's the criminal charges? fines don't bring true justice! Review from one year ago: fined $81 million for illegal marketing of TOPAMAX

http://www.justice.gov/opa/pr/2010/April/10-civ-500.html

Two Johnson & Johnson Subsidiaries to Pay Over $81 Million to Resolve Allegations of Off-Label Promotion of Topamax Epilepsy Drug Approved by FDA Promoted for Psychiatric Uses

"The government alleged that Ortho-McNeil Pharmaceutical promoted the sale of Topamax for off-label psychiatric uses through a practice known as the "Doctor-for-a-Day" program. Using this program, Ortho-McNeil hired outside physicians to join sales representatives in their visits to the offices of health care providers and to speak at meetings and dinners about prescribing Topamax for unapproved uses and doses."

Tainted by pharma income: Mental health advice site Healthy Place medical director Dr.Harry Croft: AstraZeneca and more

The mental health website Healthy Place touts itself as being an online source for mental health news and support.

The site is loaded with pharmaceutical company advertising from AstraZeneca selling Seroquel, Lilly selling Straterra and Cymbalta, Forest selling Lexapro, Bristol Myers-Squibb selling Abilify and Pfizer selling Pristiq.

The fine print on the site discloses the drug company sponsored ads and the site also disclosed that the medical director Dr. Harry Croft works for AstraZeneca as a speaker and other pharma companies.Croft earned $42,000 from AstraZeneca*.

Croft's SPEAKING HONORARIA (2004-2011) :

Astrazeneca, Bristol-Myers-Squibb, Forest Laboratories, GlaxoSmithKline, Eli Lilly, Pfizer, Sanofi-Aventis, Wyeth

For a mental health advice site to be so heavily entrenched in pharmaceutical connections, with conflict of interest with the medical director(who receives income as a paid speaker for the same drug advertising companies plus others), patients & consumers should be aware of the potential for biased health advice.

*The information regarding Dr.Harry Croft's pharmaceutical income from AstraZeneca was found on ProPublica "Dollars for Docs" database.

your future is without boundaries

today i walked in new stomping grounds from the woods with unfurling fern and daffodils to a muddy trail that lead to a lake and onto this glorious expanse of heaven on earth.

Introducing a new blog: Dr.Mark Foster

Dr. Mark Foster explains on Robert Whitaker's Mad In America blog, about his termination from the hospital and his plans for a hopeful future that will be opening doors in a positive way for mental health wellness.

Foster was fired for sharing his open-minded views on psychiatry by the hospital where he was employeed, which is under the corporate entity Centura:

" got a call from a different administrator saying that the corporation had received an unspecified complaint regarding my alternative views. He said, “We have become aware of your blog and are concerned that your methods fall outside of the standard of care and that they may adversely affect patient safety. We need to make sure that our physicians are representing the hospital well."

Expressing his views on a blog was in fact the reason for this doctor's termination, which I find to be a loss of academic freedom and freedom of speech. Dr.Foster's patients were in fact upheld by Dr.Foster by the Oath that many doctors and psychiatrists don't heed in my opinion. Foster did not do harm. Isn't that what doctors are supposed to do? not harm patients such as patients who are given heavy amounts of psychotropic medications by some doctors? Mark Foster took the time to actually explore the life situations with his patients and ask and find out what was needed for appropriate care. This is rare, and I commend the doctor for taking this time, and for ultimately losing his job over doing so.

This is not the last you will hear from Dr.Mark Foster.He plans on opening a much needed resource for patients withdrawing from psychiatric medications, and is working alongside a mental health advocate who survived being drugged on psychotropics, as well as writing a book about her life.

Take a look at the new blog, Healthy Living in Colorado which is also a new beginning for Mark Foster.

Kudos to him for continuing to keep his voice out there, and thanks to Robert Whitaker for hosting Foster's letters on Mad in America blog. Both of these voices are needed and appreciated in the mental health community.

16 year Lithium user's kidney's failed: & she has had a successful kidney transplant

Ex-Bipolar patient, and blogger Ruth who writes The Belle of Cowbell, the Bipolar Therapist has had a successful kidney transplant.

Ruth has received the gift of a new kidney from her daughter. Best wishes to you and your daughter for speedy recoveries, and for Ruth, best wishes for a long life ahead with a working kidney!

"My diminishing kidney function is the result of taking lithium carbonate for 16.5 years for manic-depression, which I no longer have."