Sunday, July 31, 2011

Book review: The Goose that Laid the Golden Egg, Accutane-the truth that had to be told: by Dr. Doug Bremner

The Goose that laid the Golden Egg is at times, gripping and emotionally driven.

The author, Dr.Doug Bremner takes the reader along on his deeply emotional and poignant journey in a driven quest to find the answers he longed for since age 4 of the untimely death of his beloved Mother.

Along that journey, Dr.Bremner takes us behind the scenes in the psychiatric and pharmaceutical worlds. Bremner, a psychiatrist at Emory University in Atlanta, Georgia, describes in detail just what one major drug company did, to attempt to paint him as a fraudulent expert witness and researcher, and seriously try and take him down personally and professionally as a result of his research findings regarding Accutane.

The story of Accutane, the acne drug that was gaining momentum in sales was also gaining momentum in negative statistics--of people acting on suicidal and homicidal thinking, while taking the drug. Bremner's research showing how the brain changed while on the drug is riveting, and it is apparent that Roche didn't like his findings.

Being tried for hours upon hours in over a dozen depositions regarding the Accutane cases, Bremner also takes an emotional journey,to find where his Mother was buried and find her birth family, at the same time.

The connection is a brilliant description of childhood trauma, which left unacknowledged, and eventually brought to the surface during a trying time in court with Roche.

It leaves the reader with the understanding that Bremner, a psychiatrist-- is in fact, a fragile human being, as we all are, and it depicts just how hard it can be to relive or face for the first time, deep emotional burial grounds.

At a certain point in the book, you will be alongside Doug and his siblings on that journey, resulting in standing in a poignant ceremony to finally give his Mother a final resting place.

It is clear that Bremner drew strength from his Mother, and from her memory to continue the Roche inquiries and stand tall in the face of being accused of being a fraud, his published papers were questioned,and so were the motives of finding his mother's relatives by his Father.

Bremner makes sure to add in the Nemeroff and GSK conflict of interest, and the stepping down of Nemeroff from Emory and leaving Emory as a result of his conflicts, and he addresses the pharmaceutical company payments to doctors. Ultimately Bremner shows how he brought down Roche's Accutane, which was eventually taken off of the market.

The poignant story of a grown man finding his Mother's ashes, and making sure she was never forgotten, and one man's stand against a pharmaceutical company is the depiction of never giving up on the people we love, or yourself, and standing up for something that is right, is the core of the Goose that laid the Golden Egg.


I recommend reading this book, I'm glad I did.



Find more reviews and blog posts about his book at Doug Bremner's blog, Before You Take That Pill.

words and pasta

what a great week of enjoying sentences, not just 1 or 2 words from my daughter. she is having an upswing in functionality, and plates of mostaccioli with homemade sauce for dinners at my home. we listen to music, and she often stands and looks out the patio window where she listens to the wind chimes in the breeze. as with the calm smile that moved across her face as we entered a grocery store one day last week, she continues to move toward a happier place in her being. i think the true success of people surviving situations such as hers is embedded deep into our soul and spirit, and as i talked with her doctor the other day, i used the phrase, human determination as a key factor to her being able to become more functional on a daily basis and hopefully one day experiencing a higher quality of life. i've been the grateful recipient of sentences such as "where is the potato chip bag?", "can i see the envelope?" "bathroom", "i don't want to go shoe shopping", "donut". she purchased her own ice cream by doing the money transaction herself, and eating as a result a grand chocolate ice cream bowl with snicker bar and kit kat added. i'm enjoying hearing her speak, but most of all i am enjoying and rejoicing for her, that she is able to say what she needs, and having the freedom to use her voice, less restrained by psych meds, which is what the connection of this recent speaking seems to be related to.....

Carl Elliott: Useless Studies, real harm

VIA New York Times:

"Op-Ed Contributor
Useless Studies, Real Harm

By CARL ELLIOTT

Published: July 28, 2011

Minneapolis

LAST month, the Archives of Internal Medicine published a scathing reassessment of a 12-year-old research study of Neurontin, a seizure drug made by Pfizer. The study, which had included more than 2,700 subjects and was carried out by Parke-Davis (now part of Pfizer), was notable for how poorly it was conducted. The investigators were inexperienced and untrained, and the design of the study was so flawed it generated few if any useful conclusions. Even more alarming, 11 patients in the study died and 73 more experienced “serious adverse events.” Yet there have been few headlines, no demands for sanctions or apologies, no national bioethics commissions pledging to investigate. Why not?"

continue reading here


hat tip to the great 1 Boring Old man blog.

Coming soon: A review of Dr.Doug Bremner's book, "The Goose that laid the Golden Egg"

Dr. Doug Bremner, author of the blog Before You take that Pill has written a suspense thriller, based on fact about the pharmaceutical industry and the acne drug Accutane.

Doug writes about his past connections with GSK, the selling of the antidepressant PAXIL, and the infamous Charles Nemeroff. The story begins to unfold as Doug tells of the suicide connections that began to show up in people who took the acne drug Accutane.


I'll be writing a full review once I finish the book. In the spirit of full disclosure that I love to write about, I was graciously given the book to read from Dr. Bremner. That will not influence the outcome of my review. I appreciate the opportunity to read the book and thank Dr.Bremner for that.

Thursday, July 28, 2011

AstraZeneca settles most Seroquel lawsuits

VIA NYTimes Antipsychotic Seroquel NEWS


"AstraZeneca Settles Most Seroquel Suits

By DUFF WILSON

The British drug maker AstraZeneca has settled in principle nearly all of the American product liability lawsuits over Seroquel, its blockbuster antipsychotic drug, the company said in a quarterly earnings report on Thursday.

All but 250 of the 28,700 cases have been settled, most with written agreements, AstraZeneca said in the securities filing. It had previously reported settling most of those cases, but the new filing showed how far the company has whittled away at the remaining product liability litigation. Last quarter, it had reported 2,600 outstanding cases.

Most of the plaintiffs argued that they had been misled about the risks of diabetes and weight gain caused by Seroquel, the company’s second-best-selling product with $5.3 billion in worldwide sales last year, behind the cholesterol drug Crestor.

In the filing on Thursday, AstraZeneca said it added $55 million last quarter to the previously reported $592 million set-aside, for a total of $647 million to settle the litigation."

Continue reading the NYT article HERE

Hat tip Pharmagossip.

Wednesday, July 27, 2011

computer problems

my old computer that had the fall from the moving truck last winter had hard drive crash and is challenging karma because who can afford to replace it? not me! i'm borrowing a friend's to type this, and let you all know i'll be back online as soon as i can be.


be sure to go to boring old man's blog (link on my side bar) and read the story of the day about the tmap ppl being busted in texas and the cyberonics connection! i can't type on a laptop worth beans, so this is my sign off ! see ya!

Tuesday, July 26, 2011

Former scientist at NIH Immunology lab fatally shoots psychiatrist then self

VIA Washington Post

"MCLEAN, Va. — A northern Virginia psychiatrist who was fatally shot by a patient in an apparent murder-suicide had been a mentor to hundreds of area therapists, his colleagues said Saturday.

Fairfax County police say Dr. Mark A. Lawrence was found dead inside his McLean home-office on Friday afternoon along with 62-year-old Barbara Newman, one of his patients. Police believe Newman, of Vienna, killed Lawrence and then turned the gun on herself. Police say the investigation is continuing and have not released any more details."


Continue reading the article.

New Zealand MP on teen suicides: "perhaps bury them at the entrance of the cemetery so their deaths will be condemned by the people"

VIA The Daily Post


"Controversial comments made by a local MP about the treatment of suicide victims have received both condemnation and support.

In his The Daily Post column, Waiariki MP Te Ururoa Flavell said he was concerned about the high number of youth suicides in his electorate.

Mr Flavell said more than 10 teenagers had taken their own lives in Kawerau in the past 12 months, while in the past three weeks two Rotorua teenagers had done the same.

"I say we are at a point now where we say, 'that is it, no more. No more suicides'.

"Perhaps we should make a very hard stand with this. If a child commits suicide, let us consider not celebrating their lives on our marae, perhaps bury them at the entrance of the cemetery so their deaths will be condemned by the people. In doing these things it demonstrates the depth of disgust the people have with this.

"Yes, it is a hard stance, but what else can we do?"
"

Read entire article here.

--

What else can they do?

Try taking a look at why the increase of teen suicide has happened, for example are they having increase in rx's of antidepressants or other drugs associated with suicidal thinking? there IS a black box warning for that on SSRI's. Shaming the teens after death by designating their burial place as one of condemnation is not the answer.


hat tip Bob Fiddaman.

Conflict of interest rules may be loosened up in 2012 by the FDA: PHARMA MONEY AT THE FDA!

VIA Bloomberg

THIS is why we have corporations running our health system folks! Good luck finding non-tainted approval processes of drugs now! Wonder why drugs get fast tracked for approval? It's a pharmaceutical companies dream come true!

from the article at Bloomberg

"Conflict-of-interest rules restricting scientists with financial ties to drug and device- makers from advising U.S. regulators may loosen next year, said Food and Drug Administration Commissioner Margaret Hamburg.

A 2008 policy limiting researchers who were paid by manufacturers from serving on advisory panels may be curtailing feedback the FDA receives, Hamburg told the advocacy group Public Citizen in Washington today. Changes may come through a renewal of the law letting the agency receive fees from companies such as Pfizer Inc. (PFE) for product reviews."



AND

"The rules shouldn’t be changed because financial interests influence the way products are evaluated, said Robert Weissman, president of Public Citizen. “We need stronger protection rather than less,” he said after Hamburg’s remarks."

Trainee Lawyer in U.K. hopes to sue AstraZeneca due to diabetes from antipsychotic Seroquel

VIA London Evening Standard

"A woman who was prescribed a drug to overcome depression today claimed it caused her to develop diabetes.

Sarah Audu, 37, took 450mg of Seroquel a day from 2005 until April last year. While on the drug her weight rose from 8st to 17st and she was diagnosed with Type 2 diabetes in 2007.

Seroquel contains the antipsychotic Quetiapine and is used to treat schizophrenia and severe depression.

Ms Audu, a trainee lawyer from New Southgate, hopes to sue the drug's maker, AstraZeneca. The company settled a major US lawsuit out of court last year, paying £128.5 million to thousands of American patients who suffered severe weight gain and developed diabetes while on the drug.

Ms Audu is looking for other patients who may have suffered side effects after taking Seroquel to join her in a legal action in the UK.

She believes that she developed diabetes as a result of her weight gain while on the medication. "When I came off the drug I started losing a pound of weight a day," she said. "Every two weeks I was losing a stone. The desire to eat sweet things just left. I'm now down to 10-11 stone.

"I could be on diabetes medication for the rest of my life. It's a horrible, unnecessary condition to have for someone who is already not feeling very well. I had no history of diabetes in my family. I was not warned of the possible side effects properly."

In September last year the European Commission approved Seroquel for major depressive episodes where antidepressants have not worked. It has been licensed in the UK since 1997."


Continue reading the article here.

--

There are 26,000 cases in litigation in the U.S. for diabetes claims from Seroquel use, in April 2010 AstraZeneca was fined $520 million by the U.S.Dept of Justice for the illegal marketing of the antipsychotic Seroquel. Seroquel has a black box warning for diabetes and recent warning added for QT Prolongation risk of sudden death.

Monday, July 25, 2011

Bring on the generics, so long blockbusters! Zyprexa,Seroquel,Lexapro,Geodon & more about to drop off the patent cliff

VIA PharmaGossip

These are blockbuster drugs, with more than $1 billion in annual global sales,
set to go off patent and get generic competition in the U.S. in the next two
years:

Oct. 2011 Zyprexa olanzapine schizophrenia/bipolar Eli
Lilly

Nov. 2011 Lipitor atorvastatin high cholesterol Pfizer

March 2012 Lexapro escitalopram depression Forest
Labs

March 2012 Seroquel quetiapine schizophrenia/bipolar
AstraZeneca

March 2012 Avapro/Avalide irbesartan high blood pressure

Bristol-Myers/Sanofi

April 2012 Provigil modafinil narcolepsy Cephalon

May 2012 Plavix clopidogrel clot prevention

Bristol-Myers/Sanofi

July 2012 Tricor fenofibrate high triglycerides Abbott

Aug. 2012 Singulair montelukast asthma/allergies Merck

Aug. 2012 Actos pioglitazone diabetes Takeda

Sept. 2012 Diovan valsartan high blood pressure Novartis

Sept. 2012 Geodon ziprasidone bipolar disorder Pfizer

Nov. 2012 Lidoderm lidocaine pain patch Endo

Dec. 2012 Atacand candesartan heart failure

AstraZenecaMarch 2013 Lovaza omega-3-acid high triglycerides
GlaxoSmithKlineAug. 2013 Temodar temozolomide brain tumors Merck
------
Note: Patent expiration/generic arrival dates can change due to litigation orregulatory issues.

Sources: Medco Health Solutions Inc., company Web sites.

via finance.yahoo.com

Dr. X's Free Associations blog: Addiction and Leadership

Addiction and Leadership via Dr.X's great blog:

Snippet

.."Clinically-speaking, reductionist explanations encourage flatfooted diagnoses and cookbook remedies. If it were all so simple, psychoactive substances would probably be far more effective "normalizers" of troubling internal states. But neurochemistry is not narrative, belief or meaning." -- Dr.X

Read the entire article here.

Fear and Loathing in Bioethics blog: Do psychoactive drugs increase rates of mental illness?

via Monday, July 25, 2011 Fear and Loathing Bioethics blog

Do psychoactive drugs increase rates of mental illness?

Robert Whitaker's
recent book about pharma and mental illness, Anatomy of an Epidemic, has been getting renewed attention since Marcia Angell wrote about it in the New York Review of Books. You can listen to an interview with Whitaker on "The Takeaway."

Big Pharma's Role in Mental Illness: PRI Public Radio International

"Claims that pharmaceutical companies play an enormous role in deciding what causes mental illness and how those illnesses should be treated.

For almost 40 years, conventional wisdom has been that mental illness is caused by a chemical imbalance in the brain. "Serotonin" is a household word, along with Prozac, Zyprexa and Zoloft. But recently, there's been a vigorous debate within the medical community over whether that line of thinking is accurate.


This summer Marcia Angell, a physician, senior lecturer at Harvard, and former editor-in-chief of The New England Journal of Medicine, wrote in the New York Review of Books that the chemical imbalance model of mental illness may be ineffective at best, and harmful at worst. In her article, Angell talked about medical journalist Robert Whitaker's book "Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America."

Whitaker researched years of drug trials and determined that pharmaceutical companies play an enormous role in deciding what causes mental illness, who qualifies as mentally ill, and how those illnesses should be treated. "In 1987, which is when Prozac comes to market, there were 1.25 million people on disability in the United State due to mental illness," he told The Takeaway. "Today, there's 4 million."

Read Marcia Angell's article in the in the New York Review of Books." PRI-Public Radio International

3 years of detailing one psychiatrist for the sale of AstraZeneca's Seroquel

Robert Franklin , Sacramento, CA

2-7-2002 Sit Down Call

"Dr. thinks R is better for positive symptoms but it is a rough drug he positions it between haldol & Zyprexa. He sd he really like S since it does not cause TD & can actually reverse TD. He sd of ail the drugs he wd like to know more abt S
board mtgs. Reminded r increase prolaciin/no eps and wt fav. nc reinforce wt fav w/ brecher since he is using too much Zyprexa!"


A few interesting snippets below including the infamous Dr.Michael Reinstein. Note the word quoted from the drug rep that Reinstein used for patients using Haldol and Seroquel: "Haloquel".



"Sero want 200 mg using lots do push dose up 1 did no penalty yto push dose up
he cannot go to kings game wants to go to Giants qame tho
Reinstein) no weight gain with Sero"

"Good long call did Reinstein said he would like to here more from Nazrallah"

"Sero I told him saw the diabetes group sign on door this is what we are selling is no weight gain he asked about how high can dose I said some docs go to 1000 and 1200 we sell 800 he said some patients he adds dose haldol I said thats what Reinstein calls "Haloquel"."


Read the pages of the drug reps for AstraZeneca detailing Dr. Robert Franklin Here in this internal document.

Saturday, July 23, 2011

titration down has been increase in words

this is exciting and great! i've been down the path w my daughter for years to know to embrace the moment and take things as they come and a couple of weeks ago i cooked my daughter her favorite pasta for dinner. getting ready has been an increasing struggle, the time of the day passes and she is slow to organize thoughts and get it all together to dress and go out. one of the days it was out by afternoon and i knew i could cook for her. as i was in the kitchen she came rushing around the corner and exclaimed, "the cat is on the table!"

The cat was on the table! eating the parmesean cheese! (I cleared that) this was the longest sentence i've heard in months.

So today, she was ready again. this last week she's been over 3 times for dinner and a drive, and walking with the dog. we write notes to communicate. she has a slow process time w words so i will sometimes write what i said in a short sentence for instruction and she will read it and she also writes me a note sometimes--like for socks and shoes.(to go shopping)

today she wanted the notepad from my purse. she separated all of the sheets left (a few were left) in the notepad. she removed the cardboard backing and i threw that away. i sat and relaxed and thought how great it was she was having a good day. she finished sorting the papers and she looked like she was going to ask something. she said "the cardboard". she wanted that back, so i got it. she sorted the papers again and this time, handed me the cardboard and said, "put it back with the lined papers".

that whole sentence! the words have been increasing as the dose of the last med Clozaril is being shaved down milligram by milligram. this takes months if not years. no room for a setback more than she has been having, and the doctor is great and doing this wholeheartedly. time will tell about this but for now i had to tell the word increase story. the struggle to get ready for the day is at times painfully slow, and patience is the word of the day on that. once outside, we move along pretty good. i told her one day "you are stuck but i am not, so follow me" and we navigate stores that way and the pace has increased a bit so she can do more things. some days it's going to the grocery store for items and then cooking. let me tell you the smiles are worth gold to me.

this is what i mean by savoring the day and the moments. i've learned to do this more and more. i don't expect anything to be the same the next time. i take it as it comes. some days she is doing great like today and the next she could be shut down again. i picture myself holding up 2 candles or torches as a flame of hope for her. i do feel sometimes i stopped living my life waiting for her to come back. it's been 6 years. along the way i've had really stop and see how i stopped moving forward as if i was holding down the fort until she came home or something. seeing that in myself has made a difference in my own life. life is going, and i am determined to enjoy it ALL!

Brophy Solicitors representing psychiatrist Patricia Casey go after Irish blogger AGAIN

It's apparent that Dr.Patricia Casey cannot handle bad press in the media and considers a mother's blog to be a stomping grounds for sending lawyers to dig up any words that do not please her, calling words and particular sentences on a blog defamatory and sending in her sharks (lawyers) that go by the name of Brophy Solicitors to do her house cleaning.

Leonie Fennell is an Irish blogger who writes about mental health issues based on her experience of losing her son to suicide when taking the antidepressant CELEXA.

Patricia Casey's law firm has sent Fennell another letter of intimidation declaring a discussion on the definition of bullying and as a matter of fact the lawfirm Brophy Solicitors want a discussion based on these 3 questions they have:


1.What part of this constitutes bullying?

2.What part of this constitutes an attempt to silence you?

3. Are you saying that the simple fact that you received a solicitor’s letter asking you to remove certain defamatory comments which you subsequently removed, constitutes intimidation?


Leave comments at Leonie's blog with your answers in solidarity supporting Leonie if you choose to do so, and let the lawyers know what the answers are, and I'm sure Dr. Patricia Casey will be reading also.

Another blog supporting Leonie is U.K. blogger and book author Bob Fiddaman's blog. Leave comments there too, and send the message clearly to the lawyers who want to pick apart Leonie's blog that freedom of expression and a personal blog are like a diary and Leonie has every right to express herself in any way possible.


Here's the sentence (yes now a sentence) the lawyers want removed from the Leonie Fennell blog:


"I will never be bullied, intimidated or silenced by Lundbeck or Professor Casey"

Stand tall, Leonie!

----
My comment I have left at Bob Fiddaman's blog and Leonie's blog

"IF Patricia Casey wasn't attempting to silence Leonie Fennell via monitoring her blog and picking apart each word she writes looking for defamatory commentary on purpose, then having lawyers keep tabs on the blog and find other words and sentences they feel (they feel) are offending to Patricia Casey, then I ask why did she hire a lawfirm in the first place? it sure wasn't to send sympathy cards!

What is bullying? using power to intimidate someone the person or group feels is an easy or weak target, often preying on the most vulnerable people.

What is intimidation? appearing larger than one actually is, tossing weight around or legal stature about in attempt to silence another person or get them to stop something the intimidator does not like.

You see, Brophy Solicitors and Patricia Casey Leonie is a mother, as am I and we have suffered the loss in 2 different ways of our children. Our children, who we carried for 9 months and nurtured and loved and sent off to school became victims of pharmaceutical company greed and profit in the name of "care" by psychiatrists. Leonie's son is dead, and my daughter is trapped in a disabled limbo unable to be the person she once was and is not even close to being a shadow of the person I once knew. Her brain is keeping a diligent candle of hope for all of us that it can repair itself from the damage of the psychiatric medications that damaged it, one day I hope to stand next to her and listen to her tell the world what that feels like, to have life stop as a teen and be stuck in a drugged state and crippled to the point of lack of communication and function in daily life. I hold the candle of hope every day she will be able to have a life one day and the years keep passing as I hang onto that small thread of hope.

Leonie has no chance of her son returning to her at all. She lost her son to death which is something a mother never gets over.

Leonie has the right to express herself on her blog, which is a personal diary, an outlet for her grief.

If Brophy Solicitors continue to cause undue grief and stress over reading her blog and picking apart the wording on behalf of a psychiatrist who claims to have 'sympathy' then Leonie in my opinion should take on a suit of her own. Harrassment of an individual on a continual basis with letters that are threatening to her, is unnecessary grief she must endure after having one of the most horrific experiences a mother can ever have, the loss of a child and outliving her son.


Patricia Casey also must not be thinking about how there are other victims of psychiatry around the world who will be outraged on Leonie's behalf. We will not tolerate this treatment of Leonie.

Also, each time Brophy writes a letter it draws more attention to the discussion and the result is causing Patricia Casey to appear as a bully and if they cannot see that, they need to sit back and understand this world of blogging reaches thousands of people on a 24 hour a day basis and the loss of respect will be served in a heaping dose to Dr. Casey as a result of not leaving Fennell alone in her grief.

Casey has much bigger fish to fry, I would hope. There are countless articles and radio podcasts and interviews that can lend a bad name and opinion of Casey long before Fennell came along and blogged about her. The Internet is a mirror and once words are cast there they are permanent, even if Leonie deleted her blog, the words are cached onto the Internet, Google is a wonderful thing that way! "

---

Who are Brophy Solicitors?

Defenders of Human Rights, and Public Body "Abuse of Power":

"We are fundamentally a human rights firm. The bulk of our work arises from actions taken by public bodies which have a negative effect on members of the public. We will protect our clients and fight for their rights no matter who the wrongdoer is.

The defendants in very many cases are local authorities and branches of government and we have developed considerable expertise over the years following substantial successes in most of the cases we bring. We have acted in cases where members of our immigrant community are being denied their rights and we also act in cases where members of the Traveller community are being denied their rights. This can cover everything from deportation to obtaining facilities for the disabled children of minority groups.

We have acted for all groups from residents’ associations who have been affected by road closures to individuals who have been wrongly convicted of criminal offenses. We have acted for language schools who have been adversely affected by new rules governing the admission of students into Ireland to study. We have acted for a Marina whose development has been substantially hampered as a result of difficulties with a government department.

Fundamentally, this part of our practice is aimed at any person who feels aggrieved by the actions of a public body whether a State body or a semi-State body."


Meet the Brophy Team

About us,Kevin Brophy, Karen Berkeley, Laura Gillen, Katie Mannion, Sarah McCoy.

Find Brophy Solicitors on FaceBook and Twitter social media outlets.

Address:
Brophy Solicitors,
38-40 Parliament St.,
Dublin 2,
Ireland.

Friday, July 22, 2011

Top 15 highest grossing prescription drugs in U.S.- Antipsychotics Seroquel # 6, Abilify # 5

VIA Business Insider

#6 ANTIPSYCHOTIC SEROQUEL BY ASTRAZENECA


#6 Seroquel


Made by AstraZeneca (AZN). Used to treat schizophrenia and bipolar disorder .

Gross: $4.4 billion

One-year growth: 4.8%

Five-year growth: 46.7%
------

# 5 Antipsychotic Abilify, BMS


#5 Abilify


Made by Otsuka and Bristol-Myers Squibb (BMY). Used to treat schizophrenia and bipolar disorder.

Gross: $4.6 billion

One-year growth: 15%

Five-year growth: 142.1%
--------

#13 antidepressant Cymbalta, Eli Lilly


#13 Cymbalta


Made by Eli Lilly & Co. (LLY). Used to treat depression and anxiety disorders.

Gross: $3.2

One-year growth: 14.2%

Five-year growth: 166.7%

Thursday, July 21, 2011

Where are they now? 15 years after the plans to sell the antipsychotic Seroquel

IN the NYTimes, in February 2009 the article discusses the internal emails and documents from AstraZeneca's Seroquel team members becoming public. The article discusses an AstraZeneca official named Richard Lawrence praising Lisa Aventis for her great "smoke and mirrors job" for minimizing the antipsychotic's adverse study findings.

It's well known that Study 15 discussed the weight gain issue and the internal documents prove that the key players 10-15 years ago knew the side effects and attempted and succeeded to bury negative evidence and succeed at selling the billion dollar blockbuster drug.

It's now 2011 and the negative outcome for patients is alarming, and very real. U.S. war vets are coming home with PTSD and being rx'd the drug for insomnia and dying in their sleep. Children are being given Seroquel. Seroquel has been approved as a depression treatment add-on. The drug has label revisions to include beyond the diabetes side effect, sudden death risk from QT Prolongation.

The email that boasts "no reliable evidence suggesting a causal relationship between SEROQUEL and diabetes" is evidence enough to show consumers the real reason the drug is sold: profit.

Profit before patient safety. There are 26,000 people who filed lawsuits for diabetes after taking Seroquel. In 2010 AstraZeneca was fined $520 million by the Dept of Justice for illegal marketing of Seroquel.

15 years later, where are those key players now? have they moved on with their careers? do they ever regret what they were part of with regard to the massive sales of this drug that have harmed so many as a result of their behind the scene tactics and smoke and mirrors? do they feel as if they lit a fuse and walked out of the room?

We read the statements in the media by PR from AstraZeneca always denying wrong doing and never admitting guilt with regard to lawsuits or the DoJ fines. Do the key players believe the same thing? are they in denial? what about CEO David Brennan? is this just business as usual? what about the innocent victims of the fallout of a massive marketing campaign? what about them?

EXHIBIT L
DATE: /ri/3/A7,
LINDA ROSSfRiOS


Seroquel Risk-Benefit team

Mission

Establish, review and
maintain AZ position on
risk-benefit in absolute
and relative terms

First review of emerging
safety and efficacy data

Members:

• Martin Brecher
• Joan Shaw
• Ron Leong
• Julia Manning
• Gil Block
• Rohini Chitra
• Susanne Fors
• Jonas Rastad
• Martin Jones

lead
AZ/SER 3992491

Wayne MacFadden, Richard Lawrence, 1996 Seroquel team, Seroquel Strike Force 1996, the ones who were behind the KEY MESSAGE:

"KEY MESSAGE: There remains no reliable evidence suggesting a causal relationship between SEROQUEL and diabetes."


The box warnings on the antipsychotic Seroquel now clearly reflect that causal relationship.

Gruesome crime to young boy included being drugged with antipsychotic SEROQUEL

The antipsychotic Seroquel,(quetiapine) often used off-label for insomnia, and being touted as an antidepressant add-on for bipolar disorder but created for the treatment of psychosis was part of a toxic drug cocktail the killer used to drug the young victim before killing him.

"Accused child killer Levi Aron force-fed his 8-year-old victim a toxic cocktail of prescription drugs before smothering him with a bath towel, authorities said yesterday.

Leiby Kletzky had several narcotics in his system, including hydrocodone, the schizophrenia drug quetiapine, Tylenol and the muscle relaxant cyclobenzaprine, according to the city medical examiner’s autopsy report."
New York Post article.

Tuesday, July 19, 2011

Arkansas takes on AstraZeneca September 2012: $5000k wanted for each Seroquel RX

VIA Bloomberg-July 2010 SEROQUEL NEWS

AstraZeneca to Face 2012 Trial in Arkansas Over Sales of Anti-Psychotic

"AstraZeneca Plc (AZN) must face a trial over claims by Arkansas that the drugmaker hid health risks of its anti-psychotic drug Seroquel when selling it to residents covered by the state’s Medicaid program, a judge ruled.

London-based AstraZeneca, which agreed in March to pay $68.5 million to resolve claims that it deceptively marketed Seroquel in a number of states, will face a September 2012 trial of a lawsuit filed by Arkansas Attorney General Dustin McDaniel over sales of the drug, Circuit Judge Chris Piazza in Little Rock ruled today.

Arkansas officials, who opted out of the March Seroquel settlement, contend AstraZeneca defrauded the state’s Medicaid program by failing to properly outline the anti-psychotic medicine’s risks in its warning label. The state seeks a $5,000 penalty for each Seroquel prescription written in Arkansas over an 11-year period starting in 1997, according to Fletcher Trammell, one of the state’s lawyers."

Continue reading Bloomberg article here

Seroquel and the sudden death warning on the label, why was the warning lost in the news headlines? what about people with mental illness?

Did the warning of sudden death and QT prolongation side effect warning make it to your newspaper headline? do you know someone or are you someone diagnosed with mental illness?

Has anyone ever wondered why drugs such as Avandia make the headlines but serious label revisions for antipsychotics don't?

Could it be discrimination? could it be that people with mental illness are discriminated against daily and treated as second class citizens? that this drug, the antipsychotic Seroquel is just considered one of those crazy people pills?

I'm not going to make people feel better by reading words candy coated such as "schizophrenics" or "crazy pills". What people with mental illness are up against in their lives are medications that don't work, meds that are forced on them due to court orders as discharge plans when leaving psychiatric hospitals, and drugs that have massive and serious, deadly warnings on the labels.

But, people say, "I care about my loved one, as long as they are here that is what matters."

No. At what cost do you want them here? have they been prescribed an antipsychotic for insomnia or as an add-on to their antidepressant? take the long list of side effects on both of those drugs and ask yourself just how much human determination do you expect your loved one to have?

You cannot overcome a crisis when loaded up on potent chemicals and even begin to think about long term and quality of life, hell they can't even speak or form words after a B-52 forced injection in the locked psych wards.

This is all America has to offer it's war veterans? drugs that can cause them to die in their sleep when treated for PTSD?

Why is the U.S.Dept of Veterans Affairs willing to risk the use of Seroquel and Paxil in a study for PTSD, and why was that study sponsored by AstraZeneca the makers of Seroquel?

Who are the mentally ill in America? are they people who matter? are they anyone with a mental illness diagnosis? the soldiers, the trauma survivors, the kids with bipolar disorder diagnosis, the mothers who suffer with post partum depression? the people with schizophrenia? your neighbors? your friends? your family members?

It's time for America to consider the billions of dollars spent on antipsychotics every year, and reconsider the treatment model for mental illness that has become a CASH COW FOR PHARMACEUTICAL COMPANIES.

It's time for label revisions such as QT Prolongation for Seroquel to be front page headlines in newspapers, and it's time for the FDA to consider the true health and safety of the people they are serving: the citizens of the United States of America and the most vulnerable ones at that.

Step up to the plate and stop the madness, call the FDA, call the White House, talk about second class citizens, and remind them people with mental illness matter!

AstraZeneca's antipsychotic SEROQUEL: new label revision includes risk of sudden death-QT prolongation

Still interested in taking the antipsychotic Seroquel for insomnia off-label? think again, know your medications, this is not a sleep aid. (and it's not an antidepressant)


Seroquel label fine print pdf click here:

QT Prolongation: Post-marketing cases show increases in QT interval in
patients who overdosed on quetiapine, in patients with concomitant illness, and in
patients taking medicines know to cause electrolyte imbalance or increase QT
interval. Avoid use with drugs that increase the QT interval and in patients with
risk factors for prolonged QT interval.


What is QT Prolongation?


QT Interval:


"In cardiology, the QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. In general, the QT interval represents electrical depolarization and repolarization of the left and right ventricles. A prolonged QT interval is a biomarker for ventricular tachyarrhythmias like torsades de pointes and a risk factor for sudden death."-wikipedia



The label changes listed on the info prescribing sheet


RECENT MAJOR CHANGES

Warnings and Precautions, Hyperglycemia (5.4), 1/2011

Warnings and Precautions, Hyperlipidemia (5.5), 1/2011

Warnings and Precautions, Weight Gain (5.6), 1/2011

Warnings and Precautions, QT prolongation (5.12), 6/2011

Warnings and Precautions, Hypothyroidism (5.14), 1/2011

Warnings and Precautions, Withdrawal (5.23), 05/2010


This is an antipsychotic, not an antidepressant, not a sleep aid, it was created for psychosis treatment and is now off-label used and being approved for just about everything imaginable. At what cost does AstraZeneca milk this patent? this is a potent neuroleptic and note that there are withdrawals warnings in the fine print also...

Monday, July 18, 2011

Placebo wins vs antidepressant for Alzheimers: study says reconsider antidepressants as first-line treatment

via The Lancet Sertraline or mirtazapine for depression in dementia (HTA-SADD): a randomised, multicentre, double-blind, placebo-controlled trial

The Lancet, Early Online Publication, 18 July 2011doi:10.1016/S0140-6736(11)60830-1

Summary

Background

Depression is common in dementia but the evidence base for appropriate drug treatment is sparse and equivocal. We aimed to assess efficacy and safety of two of the most commonly prescribed drugs, sertraline and mirtazapine, compared with placebo.

Methods

We undertook the parallel-group, double-blind, placebo-controlled, Health Technology Assessment Study of the Use of Antidepressants for Depression in Dementia (HTA-SADD) trial in participants from old-age psychiatry services in nine centres in England. Participants were eligible if they had probable or possible Alzheimer's disease, depression (lasting ≥4 weeks), and a Cornell scale for depression in dementia (CSDD) score of 8 or more. Participants were ineligible if they were clinically critical (eg, suicide risk), contraindicated to study drugs, on antidepressants, in another trial, or had no carer. The clinical trials unit at King's College London (UK) randomly allocated participants with a computer-generated block randomisation sequence, stratified by centre, with varying block sizes, in a 1:1:1 ratio to receive sertraline (target dose 150 mg per day), mirtazapine (45 mg), or placebo (control group), all with standard care. The primary outcome was reduction in depression (CSDD score) at 13 weeks (outcomes to 39 weeks were also assessed), assessed with a mixed linear-regression model adjusted for baseline CSDD, time, and treatment centre. This study is registered, number ISRCTN88882979 and EudraCT 2006-000105-38.

Findings

Decreases in depression scores at 13 weeks did not differ between 111 controls and 107 participants allocated to receive sertraline (mean difference 1·17, 95% CI −0·23 to 2·58; p=0·10) or mirtazapine (0·01, −1·37 to 1·38; p=0·99), or between participants in the mirtazapine and sertraline groups (1·16, −0·25 to 2·57; p=0·11); these findings persisted to 39 weeks. Fewer controls had adverse reactions (29 of 111 [26%]) than did participants in the sertraline group (46 of 107, 43%; p=0·010) or mirtazapine group (44 of 108, 41%; p=0·031), and fewer serious adverse events rated as severe (p=0·003). Five patients in every group died by week 39.

Interpretation

Because of the absence of benefit compared with placebo and increased risk of adverse events, the present practice of use of these antidepressants, with usual care, for first-line treatment of depression in Alzheimer's disease should be reconsidered.

Funding

UK National Institute of Health Research HTA Programme.




*Sertraline is Zoloft, mirtazapine is Remeron


hat tip to Dr.Steve Balt at Thought Broadcast.

Sunday, July 17, 2011

Psychiatrist says NO to drug reps



Via SMNews online

"A red circle with a line through it adorns the entrance to a psychiatric practice in Leonardtown, but it doesn’t refer to smoking or parking. Instead, the text inside reads “DRUG REPS” and warns medical salesmen not to darken the door.

Dr. Carol A. Paris, who has practiced there since 1999, didn’t always have this attitude, she said. For about four months in 2003, she was paid by a major pharmaceutical company — she won’t say which one — occasionally to talk to general practitioners about depression, which they might, because of a dearth of psychiatrists in Southern Maryland, be called upon to treat in their patients.

She was paid $650 per lunch meeting, which took about two hours each, she said."





Continue reading article HERE.



Irish Times: A cure worse than the illness? -- Robert Whitaker interview

VIA The Irish Times

BY Carl O'Brien

"Could psychiatric drugs be fuelling an epidemic of mental illness? Robert Whitaker, the award-winning author of a new book on the subject, raises disturbing questions for psychiatry.

WHEN ROBERT Whitaker, an award-winning medical reporter, came upon a study by the World Health Organisation on outcomes for patients with schizophrenia a few years ago, he was puzzled.

It said the best outcomes were for people from some of the poorest countries in the world – India, Colombia, Nigeria – rather than the richest countries. It didn’t make sense. How could the outcomes be so poor for well-off nations with access to specialist drugs?

“I was startled to find that just a small percentage of patients in those poor countries were on medication for their condition,” says Whitaker.

“At the same time, I discovered that the number of disabled mentally ill in the US had tripled over the past 20 years.”

It prompted a flurry of queries, but they all boiled down to a single, central question: why has the number of people plagued with mental illness problems been skyrocketing at a time when we have access to medicine that is supposed to be more effective than ever before?

The result of Whitaker’s investigation is Anatomy of an Epidemic, the first major book to investigate the long-term outcomes of patients treated with psychiatric drugs. Through thorough research and personal testimonies, he draws a chilling overall conclusion: that the drugs we so widely use may be doing more harm than good.

The book, published last year, is causing a stir in the US and prompting fiery responses from some members of the psychiatric profession. But it is also causing significant numbers of professionals to rethink their approach to prescribing drugs.

“It’s been a slowly, gathering impact. In the US, this is a very sensitive subject and immediately brings up all sorts of tensions,” he says.

Ironically, for an issue which is fast becoming a burning question in psychiatry, the question of how effective psychiatric drugs are over the longer term isn’t a new one.

Whitaker points to a paper by Jonathan Cole – regarded as the father of American psycho-pharmacology – in the 1970s entitled Is the Cure Worse Than the Disease? This indicated that anti-psychotic medication wasn’t the magic bullet that many hoped it was.

Cole reviewed all of the long-term effects the drugs could cause and observed that studies had shown that at least 50 per cent of all schizophrenia patients could fare well without the medication.

“Every schizophrenic outpatient maintained on anti-psychotic medication should have the benefit of an adequate trial without drugs,” Cole wrote at the time.

Whitaker maintains that psychiatry, in effect, shut off further public discussion of this sort. In the 1970s, he says, psychiatry was fighting for survival. The two main classes of drugs – anti-psychotics and benzodiazepines such as Valium – were increasingly regarded as harmful and sales declined.

At the same time, there was a dramatic increase in the number of counsellors and psychologists offering talk therapy and other non-drug based approaches.

“Psychiatry saw itself in competition for patients with these other therapists, and in the late 1970s, the field realised that its advantage in the marketplace was its prescribing powers . . . it consciously sought to tell a public story that would support the use of its medications, and embraced the ‘medical model’ of psychiatric disorders.”

But many studies show that psychiatric drugs – such as anti-depressants – are highly effective. There are tens of thousands of people who will attest to benefits of these drugs. Many say they simply couldn’t survive without them.

Whitaker counters he is not advocating the total avoidance of drugs. The short-term effects of many drugs are clearly beneficial. But, he says, when you look at the long-term impact of them, the literature consistently shows incredibly poor outcomes, with many becoming chronically ill as a result.

Most of these studies, he says, have received little or no coverage or have been “spun” to veil the real findings. It’s not in the interests of psychiatry or the pharmaceutical industry to highlight them.

He says the literature shows that many people can recover without recourse to drugs. As a result, more caution is needed and drugs should be administered more sparingly.

“You have to raise the question of what happens to medicated patients in the long term, compared with what happened in previous times,” he says.

There are obvious lines of attack against Whitaker’s findings: one is that the rise in the number of disabled mentally ill people is not due to medication, but may be due to other factors such as better diagnosis.

Whitaker says: “I agree that the correlation between the two – increased use of psychiatric medications and increased disability numbers – does not mean that the increased use of psychotropics caused the rise. But I never claimed that it did. As I say in the opening chapter of the book, the disability numbers simply raise a question.”

He agrees that the broadening of diagnostic categories has led to an ever-greater number of adults and children under the “psychiatric tent”. But, he maintains, if psychiatric medications were effective long-term treatments which helped people function well, then that increase in diagnosis and treatment shouldn’t lead to a rise in disability. “If you have drugs that exacerbate the long-term course of an ‘illness’ or can transform a milder illness into a more serious one, then the more that illness is diagnosed and treated, the greater the toll that illness will take on society.”

What makes Whitaker’s findings so powerful are that he did not come to this area with the baggage of an anti-drugs zealot or as part of an anti-psychiatry crusade. The opposite was the case.

As a reporter, he remembers investigating a trial involving the withdrawal of drugs from psychiatric patients – in which researchers carefully tallied the number of patients who became sick again and had to be re-hospitalised – and considering the practice to be outrageous and unethical.

“I began this long intellectual journey as a believer in the conventional wisdom,” he says. “I believed psychiatric researchers were discovering the biological causes of mental illnesses and that this knowledge led to the development of a new generation of drugs that helped ‘balance’ brain chemistry.”

There is a way forward, according to Whitaker, and it lies in parts of the world which have the best outcomes.

Western Lapland in Finland has adopted a form of care for its psychotic patients that has produced astonishingly good long-term outcomes, he says.

In follow-up checks after both two and five years, 80 per cent of first- episode psychotic patients in the region were either employed or back at school. Yet only about one-third of the patients were ever exposed to anti-psychotic medication, and only 20 per cent end up taking the drugs on a continual basis.

The questions for psychiatry, then, are urgent. Is our medical model of care really working? Does it help people struggling with psychiatric illness to get well and stay well? Is there a reason to believe the medicating of children will help them grow into healthier adults? As for now, we have lots of questions, but precious few definitive answers."--Irish Times,February 22, 2011

Saturday, July 16, 2011

A model of adverse antidepressant effects in human adolescents? paroxetine,Paxil

Via Pub Med

Int J Neuropsychopharmacol. 2011 May;14(4):491-504. Epub 2011 Feb 18.

Differential behavioural and neurochemical outcomes from chronic paroxetine treatment in adolescent and adult rats: a model of adverse antidepressant effects in human adolescents?


Karanges E, Li KM, Motbey C, Callaghan PD, Katsifis A, McGregor IS.
SourceSchool of Psychology, University of Sydney, Australia.

Abstract

Selective serotonin reuptake inhibitor use is associated with increased risk of suicidal ideation in adolescent humans, yet the neuropharmacological basis of this phenomenon is unknown.

Consequently, we examined the behavioural and neurochemical effects of chronic paroxetine (PRX) treatment in adult and adolescent rats. Rats received PRX in their drinking water (target dose 10 mg/kg) for 22 d, during which time they were assessed for depression- and anxiety-like behaviours. Subsequent ex-vivo analyses examined serum PRX concentrations, striatal neurotransmitter content, and regional serotonin and dopamine transporter (SERT, DAT) binding density. After 11-12 d treatment, PRX-treated adolescent rats showed a significant inhibition of social interaction while adults were unaffected. After 19-20 d treatment, adolescents failed to show an antidepressant-like effect of PRX treatment on the forced swim test (FST), while PRX-treated adults showed a typical decrease in immobility and increase in swimming. Two PRX-treated adolescents died unexpectedly after the FST suggesting a compromised response to physical stress. Despite their greater apparent adverse reaction to the drug, adolescents had significantly lower plasma PRX than adults at day 22 of treatment. Chronic PRX treatment had similar effects in adults and adolescents on striatal 5-HT (unchanged relative to controls) and 5-HIAA levels (decreased), while markers of dopaminergic function (DOPAC, HVA, DA turnover) were increased in adults only. SERT density was up-regulated in the amygdala in PRX-treated adolescents only while DAT density in the nucleus accumbens was down-regulated only in PRX-treated adults. These data suggest that the immature rat brain responds differently to PRX and that this might be of use in modelling the atypical response of human adolescents to antidepressants. The age-specific PRX-induced changes in dopaminergic markers and SERT and DAT binding provide clues as to the neural mechanisms underlying adverse PRX effects in adolescent humans.

FDA warns of children born with low IQ to mothers who take Depakote while pregnant (Valproate)

FDA warning for pregnant mothers who take anti-convulsant Depakote, Depakote ER, et al and their generics.The drug is commonly used as a mood stabilizer for bipolar disorder and commonly rx'd to children. It was rx'd to my daughter at age 11-17 and caused permanent body damage, Polycystic Ovary Syndrome, diagnosed by a doctor.

Valproate Products: Drug Safety Communication - Risk of Impaired Cognitive Development in Children Exposed In Utero (During Pregnancy

Valproate Products: Drug Safety Communication - Risk of Impaired Cognitive Development in Children Exposed In Utero (During Pregnancy)

Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics


[Posted 06/30/2011]

AUDIENCE: OBGYN, Neurology, Psychiatry

ISSUE: FDA notified healthcare professionals that children born to mothers who take the anti-seizure medication valproate sodium or related products (valproic acid and divalproex sodium) during pregnancy have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy. This conclusion is based on the results of epidemiologic studies that show that children born to mothers who took valproate sodium or related products throughout their pregnancy tend to score lower on cognitive tests (IQ and other tests) than children born to mothers who took other anti-seizure medications during pregnancy. See the Drug Safety Communication for a data summary and additional information.

BACKGROUND: In 2009, the agency warned against use of valproate during pregnancy because of the risk for neural tube defects. Valproate products are FDA-approved drugs to treat seizures, and manic or mixed episodes associated with bipolar disorder (manic-depressive disorder), and to prevent migraine headaches. They are also used off-label (for unapproved uses) for other conditions, particularly for other psychiatric conditions.

RECOMMENDATION: Healthcare professionals should inform women of childbearing age of the increased risk for adverse effects on cognitive development with prenatal valproate exposure, and should continue to counsel women of childbearing potential taking valproate about the increased risk of major malformations, including neural tube defects, when valproate is used during pregnancy. In addition, healthcare professionals should weigh the benefits and risks of valproate when prescribing this drug to women of childbearing age, particularly when treating a condition not usually associated with permanent injury or death. Alternative medications that have a lower risk of adverse birth outcomes should be considered. Patients should not stop taking valproate without talking to a healthcare professional.

The marketing of a product name: Claritin trademark on pillows





The makers of the allergy medication Claritin have licensed their product name and gone into home furnishings as a way of marketing their product with ever-so-subtle Direct-to-Consumer advertising.








The pillow depicts the image from the allergy product, how handy. Photograph courtesy of Scott Hensley who posted the pic on Twitter. Hensley is a writer and editor of NPR's Shots health blog.

Claritin trademark notice of allowance issued


On Tuesday, August 24, 2010, a U.S. federal trademark registration was filed for CLARITIN.

This trademark is owned by Schering ..., ********, Kenilworth, NJ 07033. Trademarkia.com is a free search engine of publicly available government records. Trademarkia.com is not a law firm and does not represent owners & correspondents listed on this page.
The correspondent listed for CLARITIN is SOPHIE B. ANGER of SCHER..., 2000 ..., KENILWORTH, NJ 07033-1310 .

The CLARITIN trademark is filed in the category of Furniture Products .

The description provided to the USPTO for CLARITIN is Bed pillows, memory foam pillows, hypo-allergenic pillows; and fiber beds.

The USPTO has given the CLARITIN trademark serial number of 85114214.

The current federal status of this trademark filing is NOTICE OF ALLOWANCE - ISSUED.

Trademarkia is the largest search engine for U.S. trademarks. Each month hundreds of trademarks around the world are filed by licensed attorneys in the Trademarkia network! You can register your trademark in 55 countries in the world through Trademarkia.


Word Mark:
CLARITIN

Status/Status Date:
NOTICE OF ALLOWANCE - ISSUED
3/8/2011

Serial Number:
85114214

Filing Date:
8/24/2010
Registration Number:
NOT AVAILABLE
Registration Date:
NOT AVAILABLE

Goods and Services:
Bed pillows, memory foam pillows, hypo-allergenic pillows; and fiber beds

Mark Description:
The mark consists of the word "CLARITIN" in a white stylized lettering outlined in dark blue on a colored background representing a blue sky, with white clouds to its upper right.

Type Of Mark:
TradeMark
Published For Opposition Date:
1/11/2011


Latest Owner:
Schering ...********Kenilworth, NJ 07033
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What about Schizophrenics?

Does anyone ever read the articles about antipsychotics being used for insomnia, anxiety, depression ever wonder about the people who suffer from severe psychosis or hallucinations, or hearing voices? do the drugs work for them?

I read a lot, and that is obvious when reading my posts. I've read and researched a lot about antipsychotics over the years because I have witnessed a loved one in a few extreme bouts of psychosis. The kind of psychosis that is dehibilating, scary for the person and scary for the people watching. I spoken with many patients over the years and they candidly told me the antipsychotics dull them down, and barely reduce the voices. I've met homeless people who told me they tried Seroquel and would rather do meth to squash their symptoms. I've witnessed all point restraints and forced injections in locked psych wards, and would see the results, which were ramped up and verbal adults become feet-dragging, drooling zombies. All loss of life and sparkles removed from their eyes.

I would think to myself, this isn't working. The patients would often be so verbal about certain meds (antipsychotics) that made them feel like crap that they would get a forced injection to silence them.

If the antipsychotics are not working for whom they are intended, then why are antipsychotics a top seller in America? who uses them? we read about soldiers being rx'ed Seroquel for insomnia and dying in their sleep. We read about children under age 10 being prescribed the powerful neuroleptics.

Who ever reads about a schizophrenic saying how great the drugs are? are they out there? from the people I've met and seen over the last decade I can tell you that I have seen the hand tremors, the lost soul eyes, the shaking and quivering lips. The weight gain, and the basic loss of quality of life on those drugs.

When drugs are mass marketed for other indications it tells me the drug isn't working for those original target market patients. It seems all of the new antipsychotics such as Saphris and Latuda are all eager for increased indications the same as Seroquel, which has turned into the most profitable cash cow for AstraZeneca anyone could imagine.

There's something wrong with this picture, because it seems that the people suffering with real psychosis and possible need of medication intervention are still suffering, and nothing is being done to find other ways to help. Other ways being different approaches to the treatment of psychosis, a reevaluation of how a person lives, the surrounding environment, and most of all, the most provocative throught of all, is how about allowing the person to exist as they are, accept them for who they are, psychosis included?

I accept my daughter for where she is at, and yes she has been trialed on most all antipsychotics and the ones that increased to the point of appearing to induce psychosis were Seroquel and Zyprexa in high doses prescribed inpatient by psychiatrists. It was horrible to watch and that was medicated psychosis.

Unmedicated, there is a glimpse that shows of the daughter I once knew. She laughs or giggles, and it seems she has interaction with something (stimuli people like to call the internal stimuli...)in her mind, and frankly it's endearing and she isn't hurting anyone by being this way.

Society wants to quell and squash psychosis, and the drug companies want to have more indications for their antipsychotics.

What about the people? the ones who are really at the root of this discussion?

Don't forget about them, there is still an unmet need in America, and that is proven by the full-house of inpatients in psych hospitals and units.

It's time for America to give some serious thought about how to offer people with psychosis a better way of living, and that is to question the medication based paradigm of care, and consider alternative living environments, which take the whole person in....





America has gone psychotic

VIA Stan's mental health blog

Zyprexa, Seroquel, Abilify, Geodon, Risperdal are neuroleptics designed for use in treating schizophrenia and treating psychosis. The drugs have increased in use for off-label such as insomnia. Be informed, these are not antidepressants or sleep aids, come on America you're a Pharma market target for antipsychotics, do you really want those side effects from a pill designed for treatment of psychosis? antipsychotics long term effects on your body should be considered before taking these drugs.


Article

Mass psychosis in the US by James Ridgeway


How Big Pharma got Americans hooked on anti-psychotic drugs



..."Has America become a nation of psychotics? You would certainly think so, based on the explosion in the use of antipsychotic medications. In 2008, with over $14 billion in sales, antipsychotics became the single top-selling therapeutic class of prescription drugs in the United States, surpassing drugs used to treat high cholesterol and acid reflux.

Once upon a time, antipsychotics were reserved for a relatively small number of patients with hard-core psychiatric diagnoses - primarily schizophrenia and bipolar disorder - to treat such symptoms as delusions, hallucinations, or formal thought disorder. Today, it seems, everyone is taking antipsychotics. Parents are told that their unruly kids are in fact bipolar, and in need of anti-psychotics, while old people with dementia are dosed, in large numbers, with drugs once reserved largely for schizophrenics. Americans with symptoms ranging from chronic depression to anxiety to insomnia are now being prescribed anti-psychotics at rates that seem to indicate a national mass psychosis.

It is anything but a coincidence that the explosion in antipsychotic use coincides with the pharmaceutical industry's development of a new class of medications known as "atypical antipsychotics." Beginning with Zyprexa, Risperdal, and Seroquel in the 1990s, followed by Abilify in the early 2000s, these drugs were touted as being more effective than older antipsychotics like Haldol and Thorazine. More importantly, they lacked the most noxious side effects of the older drugs - in particular, the tremors and other motor control problems."




Continue reading the article here via english.aljazeera.net

Friday, July 15, 2011

Forest Labs CEO, Howard Solomon faces exile from health-care industry--Lexapro & Celexa

VIA Bloomberg Business Week


Howard Solomon’s Career May Meet a Sad End

The Forest Laboratories CEO, who built his company’s fortune on the antidepressants Celexa and Lexapro, faces exile from the health-care industry

By Dune Lawrence

In part

..."Forest’s aggressive marketing of Celexa and flouting of regulations has put Solomon on a far less comfortable kind of stage, one at the center of a debate over the accountability of the pharmaceutical industry and its leadership, and the limits of government power. On Apr. 12, Solomon learned that the Office of Inspector General, or OIG, which handles the U.S. Health and Human Services Dept.’s efforts to fight waste and fraud in government health programs, is considering “excluding” him. Technically, this means exclusion from doing business with federal health programs such as Medicare, Medicaid, and the Veterans Affairs Dept. Functionally, it means a ban from the entire health-care industry. Personally, it is a censure, the equivalent of an official shaming. And for American business it seems to presage an increased government effort to hold executives accountable, making corporate misbehavior personal for leaders who may have seen monetary punishment as a mere line item for shareholders to bear.

The OIG has not announced a decision, at least publicly, but the potential move is already disrupting the company. Forest is facing a proxy battle and lawsuit from Carl Icahn, the corporate raider and activist shareholder. Companies he controls have built a stake of about 7 percent in Forest, nominated four new members for its nine-member board, and are suing the drugmaker in the Delaware Court of Chancery for details on why the government is seeking to bar Solomon."



Read the entire article here at Bloomberg.

---

Background


Health Care Fraud :OIG and Dept of Health and Human Services report for 2010: Big Pharma & Device makers Behaving Badly

From the U.S.Dept of HHS and the OIG the pdf report"The HCFAC program is designed to coordinate Federal, State and local law enforcement activities with respect to health care fraud and abuse. The Act requires HHS and Department of Justice (DOJ) detail in an Annual Report the amounts deposited and appropriated to the Medicare Trust Fund, and the source of such deposits."

Fraud by Pharmaceutical and Device Manufacturers and Related Individuals

In September 2010, Forest Laboratories, Inc. and Forest Pharmaceuticals, Inc. agreed to pay more than $313 million to resolve allegations of civil and criminal liability relating to obstruction of justice, the distribution of an unapproved new drug, Levothroid, and the illegal promotion of Celexa for use in treating children and adolescents. With respect to its civil liability, Forest paid $89 million to federal programs and $60 million to state Medicaid programs to resolve allegations that it caused the submission of false claims to federal health insurance programs by (1) illegally promoting the drugs Celexa and Lexapro for unapproved pediatric uses in treating depression, (2) paying kickbacks to physicians through a variety of programs designed to induce providers to prescribe Celexa and Lexapro in violation of the Anti-Kickback Statute, and (3) distributing Levothroid in violation of the Food, Drug, and Cosmetic Act (FDCA). To resolve its criminal liability, Forest agreed to plead guilty to felony and misdemeanor counts and pay a $164 million combined criminal fine and forfeiture.


---

It's hard to see the human side of the Solomon situation when focused on the criminal side and the illegal marketing of pharmaceuticals, I find it hard to believe people in charge of these companies don't see the people in the marketing target audience that may have been victims (kids for example) of the drugs rx'd to them because doctors were sold on the idea--from Forest Labs direct to physician influence.

Some have a soft spot for the people who work for Solomon (PharmaGiles) and wrote a post asking readers to consider the employees that have been with Forest a long time and PharmaGiles says in that post, "So I really hope Mr. Solomon and his board succeed in fighting off the predators. Forest employees (along with everyone else) know that the old boy is a huckster, but at least he's THEIR huckster."



What are your thoughts on Solomon, CEO of Forest Labs resigning, or being forced to resign at age 80 something? does the age matter? what about business integrity? do you think the fine will help curb these illegal marketing practices? should the CEO's do jail time?

Relday, the first once a month, subcutaneous antipsychotic being developed: (Risperdal revisited)

Via ZOGENIX Press release-Zogenix: RELDAY

Potential to Address $16 Billion World-Wide Antipsychotics Market

SAN DIEGO and CUPERTINO, Calif., July 12, 2011 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX - News), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, and DURECT Corporation (Nasdaq:DRRX - News), a specialty pharmaceutical company focused on the development of pharmaceutical systems based upon its proprietary drug delivery platform technologies, announced today a development and license agreement. Under the agreement, Zogenix will be responsible for the clinical development and commercialization of a proprietary, long-acting injectable formulation of risperidone using DURECT's SABER(TM) controlled-release formulation technology in combination with Zogenix's DosePro(R) needle-free, subcutaneous drug delivery system. The Companies will also share non-clinical development responsibilities. Zogenix expects to initiate clinical studies for the new product candidate, Relday(TM), in patients with schizophrenia in early 2012 following filing of an Investigational New Drug (IND) application.


Risperidone is one of the most widely prescribed medications used to treat the symptoms of schizophrenia and bipolar I disorder in adults and teenagers 13 years of age and older. Relday will be developed to address unmet clinical needs in this large patient population.

The Companies expect that, if approved, Relday will be the first once-monthly, subcutaneous antipsychotic product available in a needle-free delivery system to enter the long-acting injectable antipsychotic market. The existing long-acting injectable risperidone product, which achieved global net sales of $1.5 billion in 2010, requires twice monthly, 2 mL intramuscular injections with a 21 gauge or larger needle. The Companies also expect that, if approved, Relday will provide a new long-acting treatment option for patients that currently use daily oral antipsychotic products. The combined market for oral and injectable antipsychotic products is estimated at more than $16 billion in 2010. The Companies believe the SABER controlled-release technology will allow Relday to be delivered subcutaneously without a needle on a once-monthly basis with a simplified dosing regimen, improved pharmacokinetic profile and significant reduction in injection volume. This will be enabled by DosePro's unique ability to deliver highly viscous formulations.

Roger L. Hawley, chief executive officer of Zogenix, said, "Relday is the result of a focused preclinical formulation development effort with DURECT. We believe Relday has best-in-class potential because it consists of a proven drug with improved attributes that our market research indicates are preferred by psychiatrists. The target audience of U.S. psychiatrists can be covered efficiently with a relatively small sales force. Outside the United States, we expect Relday will be of great interest to prospective commercial partners. We look forward to working with DURECT to file an IND for Relday which will enable initiation of clinical development in early 2012."

James E. Brown, D.V.M., president and chief executive officer of DURECT Corporation, said, "Consummation of this collaboration further demonstrates the flexibility and broad potential associated with our SABER depot technology platform, which we are also employing in our POSIDUR(TM) program which is in Phase III as well as with proteins and peptides in multiple feasibility projects. In conjunction with the DosePro delivery system, our goal is to develop a product that meets psychiatrists' and patients' preference for a long-acting, subcutaneous, needle-free antipsychotic medication. Zogenix has successfully developed and commercialized a CNS product, and we are pleased to work with them on this exciting opportunity with Relday."


Mr. Hawley added, "We view this licensing deal as further validation of the value that our proprietary DosePro delivery system can provide to potential product candidates. We have demonstrated that physicians and patients are attracted to the technology with the launch of our first product, SUMAVEL DosePro, and we continue to focus on identifying new opportunities to more broadly leverage the technology."


Under the terms of the agreement, Zogenix will make an upfront payment of $2.25 million to DURECT, with the potential to pay DURECT up to an additional $103 million in future clinical, regulatory and commercial milestone payments based upon successful achievement of certain events. Zogenix will have exclusive global rights to commercialize Relday and will pay DURECT a royalty on Relday product sales."


DURECT press release, About DURECT:

"DURECT Corporation is a specialty pharmaceutical company focused on the development of pharmaceutical systems based on its proprietary drug delivery platform technologies to treat chronic debilitating diseases and enable biotechnology products. These platform technologies include the SABER™ Delivery System (a patented and versatile depot injectable useful for proteins, peptides and small molecule delivery), the ORADUR® sustained release oral gel-cap technology (an oral sustained release technology with several potential abuse deterrent properties), the TRANSDUR® transdermal patch technology, the DURIN™ Biodegradable Implant (drug-loaded implant system) and the MICRODUR™ Biodegradable Microparticulates (microspheres injectable system). DURECT also partners with pharmaceutical and biotechnology companies to develop and commercialize proprietary and enhanced pharmaceutical products based on its technologies. DURECT has seven disclosed on-going development programs of which six are in collaboration with pharmaceutical partners."

Thursday, July 14, 2011

Vegetable Garden in front yard victory! charges dropped

UPDATE:via Detroit News

Charges dropped against Oak Park woman over veggie garden

The city of Oak Park, Michigan has dropped charges against front yard vegetable garden owner, Julie Bass. But, the city went after her for her unlicensed dogs, she claims she got the licenses handled and the city says they didn't get the paperwork.

Hey, Oak Park, Michigan! you're in the spotlight now, the Bass family deserves to be left alone, stop harrassing them, because that's what it looks like!

9 year old autistic child forced hospitalization, forced drugging with 2 antipsychotics after wandering incident!-Canada

This is a MindFreedom Alert:


Here's the MindFreedom alert

9 Year Old Taken From Home, Forced Hospitalized and Forced Drugged in BC, Canada


ABBOTSFORD, British Columbia, Canada. -- Ayn Van Dyk, an autistic 9 year old girl was removed from her family, forced hospitalized and forced drugged after a wandering episode.

The BC Ministry of Children and Family Development took the child on the grounds that the father is overwhelmed, as he is a single father of three children, two of them diagnosed with severe autism. No suspicion of abuse has been alleged. Ayn was placed in a hospital and was medicated with two neuroleptic (antipsychotic) psychiatric drugs: She is receiving 75mg of Chlorpromazine (also known as Thorazine or Largactil) up to twice daily In addition, she is being administered Risperdal (Risperidone).

Ayn had never been given a psychiatric drug before.

Ayn's Story: Bubbly Little Girl


Her family describes Ayn Van Dyk as a bubbly little girl. She likes photography and baking. She loves pink and crafts. Ayn goes to school and her favorite subject is art, though she loves to write stories as well.

In 2003 she was diagnosed with autism, her family chose not to medicate her. On June 16, Ayn had been playing in the backyard of her family's home. Despite a a six-foot fence, she went missing. After frantically looking for her, without success, her father called 911 and a police search commenced. Ayn was found two hours later playing in a neighbor's backyard. Four days later, on June 20, Ayn Van Dyk was taken from her school and into custody by the BC Ministry of Children and Family Development, against the wishes of her family. Ayn was placed in a "specialized hospital" for evaluation, as she was deemed unsuitable for foster care at the time.

On June 28, 2011, despite objections by the Ministry of Children and Family Development, Ayn was released from the hospital and placed in a foster home, due to the hospital considering that 'hospitalization was no longer appropriate'.

Discharge documents report that Ayn was medicated receiving 75mg of chlorpromazine up to twice daily. The hospital documents also state that "We saw no bruises or evidence of physical abuse, and her body status (weight, height, vital signs) showed no evidence of neglect". The Ministry doesn't agree with the discharge and is now seeking a longer term hospital stay of a minimum of 6 weeks and is working toward getting Ayn accepted into the Children's Hospital resident patient program."
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Go to the MindFreedom link and see information on signing a petition and writing letters, wandering is a common occurance in many autistic children and removing her from the home, and locking her up was bad enough, let alone adding 2 chemical restraints --ANTIPSYCHOTICS ARE NOT APPROVED FOR USE IN CHILDREN UNDER AGE 10!!!! she's autistic! she isn't psychotic!

Oak Park, Michigan city planner Kevin Rulkowski says NO to mother's front yard vegetable garden, she faces jail time



UPDATE:charges DROPPED!


The city of Oak Park, Michigan is in hot water with citizens of America who believe in the freedom to choose which plants are suitable for their front yard garden.

A mother of 6 has planted a vegetable garden in her front yard, and the city of Oak Park, Michigan says move it to the backyard or you go to jail. The city is willing to spend the money on a trial with a jury to accomplish this ridiculous task.

In the day and age we live in regarding healthy eating for kids, Michelle Obama encouraging people to eat right and exercise, the City of Oak Park code needs to be revised.

In fact, I believe the mother of six should receive a commendation from the city of Oak Park, Michigan for setting a good example for others on how to be resourceful with their property, for showing children how to be frugal and not waste, and for growing organic vegetables that all flower at some point which, when planted in raised planter beds can be an example of 'being green' in America, planting and using what is planted. She conserves gasoline by not driving to the grocery store for vegetable purchase. She will no doubt recycle the plant waste into useable compost, and the children are learning horticulture skills that can be carried on into their adult lives in a positive way.


"That's not what we want to see in a front yard," said Oak Park City Planner Kevin Rulkowski."


City of Oak Park, Michigan contact information

click here

TECHNICAL PLANNING / SERVICES: 248.691.7450

Kevin Rulkowski-Director/City Planner
248.691.7450

Robert Barrett - Engineering Supervisor/Deputy Director of T & P
248.691.7580
Vicky Brooks - Office Coordinator
248.691.7463
Priscilla Laney - Administrative Clerk
248.691.7461
Isha Gillyard - Administrative Clerk
248.691.7462

City Council

Address:

City of Oak Park
13600 Oak Park Boulevard
Oak Park, MI 48237

--

I believe the city should hear from gardeners from around the world!
















*photo courtesy of the article linked above












Michelle Obama replants the White House Garden Spring 2011

Let's Move! America's Move to Raise a Healthier Generation of Kids