Friday, September 30, 2011

Seroquel XR goes generic in 2016

Via First Word AstraZeneca settles US patent litigation over generic Seroquel XR

"AstraZeneca announced that it settled US patent litigation surrounding Seroquel XR (quetiapine), allowing Handa Pharmaceuticals to launch a generic version of the antipsychotic on November 1, 2016, or earlier upon certain circumstances. No financial terms of the deal were disclosed. "We believe this agreement reaffirms our intellectual property rights and is the right business decision for AstraZeneca at this time," commented CEO David Brennan.

Under the deal, the pending legal action between the two companies, which was filed by AstraZeneca after Handa sought approval for a generic version of Seroquel XR, will be dismissed. Handa has agreed that "both patents asserted by AstraZeneca…are valid and enforceable," and in return, the UK drugmaker granted the company a licence to enter the US market with generic Seroquel XR. AstraZeneca noted that the product "is protected by patents and other exclusivity rights that range from March 2012 to November 2017."

Handa's chief operating officer Stephen Cary said that the settlement resolves a case that was scheduled to go to trial on October 3. AstraZeneca indicated that the remaining patent infringement litigation regarding Seroquel XR is ongoing, with the trial in federal court in Trenton, New Jersey expected to go ahead as planned. Panmure analyst Savvas Neophytou remarked that although there are a number of other challenges remaining, "Handa's formulation was the most dangerous in our view, as it contained the least amount of overlap with AstraZeneca's patents."



Read more HERE

Seroquel XR, 750 $million a year in sales for AstraZeneca

AstraZeneca press release 9-30-11

"AstraZeneca enters into a settlement agreement with Handa Pharmaceuticals regarding US SEROQUEL XR® patent litigation

Thursday, 29 September 2011

AstraZeneca today announced it has entered into a settlement agreement in its US SEROQUEL XR® patent infringement litigation against Handa Pharmaceuticals, LLC ("Handa") regarding Handa’s proposed generic version of AstraZeneca’s SEROQUEL XR (quetiapine fumarate) extended-release tablets.

The agreement settles the patent infringement litigation filed by AstraZeneca following Handa’s submission to the US Food and Drug Administration of an Abbreviated New Drug Application (ANDA) for a generic version of SEROQUEL XR. Under the settlement agreement, Handa does not dispute that both patents asserted by AstraZeneca in the US patent litigation are valid and enforceable.

As part of the agreement, AstraZeneca has granted Handa a licence to enter the US market with generic SEROQUEL XR on 1 November 2016 or earlier upon certain circumstances. SEROQUEL XR is protected by patents and other exclusivity rights that range from March 2012 to November 2017.

AstraZeneca and Handa will file a proposed Consent Judgment with the US District Court for the District of New Jersey requesting the Court dismiss the pending legal action between AstraZeneca and Handa. The remaining SEROQUEL XR patent infringement litigations remain on-going.

“We believe this agreement reaffirms our intellectual property rights and is the right business decision for AstraZeneca at this time. SEROQUEL XR remains an important part of our company’s portfolio benefiting patients and physicians throughout the world,” said David Brennan, CEO of AstraZeneca.

This settlement will have no impact on the Company’s full year 2011 financial guidance. As is customary, the Company will review its financial guidance in conjunction with its Third quarter and Nine Months 2011 Financial Results announcement on 27 October.

NOTES TO EDITORS

On 13 December, 2010 Handa announced that its ANDA, seeking approval for generic copies of SEROQUEL XR, had received tentative approval from the US FDA. Handa further announced that they believed they are the first applicant to file for 50, 150, 200 and 300mg tablets and, that they will be entitled to 180 days of marketing exclusivity for these tablet strengths upon receipt of final regulatory approval.

About SEROQUEL XR

SEROQUEL XR, a once-daily, extended-release tablet formulation of quetiapine fumarate, is approved in the US in adults for (1) add-on treatment to an antidepressant for patients with major depressive disorder (MDD) who did not have an adequate response to antidepressant therapy; (2) acute depressive episodes in bipolar disorder; (3) acute manic or mixed episodes in bipolar disorder alone or with lithium or divalproex; (4) long-term treatment of bipolar disorder with lithium or divalproex; and (5) schizophrenia."

Thursday, September 29, 2011

for october


Now blue October, smoky in the sun,
Must end the long, sweet summer of the heart.
The last brief visit of the birds is done,
They sing the autumn songs before they part.

Listen, how lovely---there's the thrush we heard
When June was small with roses, and the bending
Blossom of branches covered nest and bird,
Singing the summer in, summer unending---

Give me your hand once more before the night;
See how the meadows darken with the frost,
How fades the green that was the summer's light.
Beauty is only altered, never lost,

And love, before the cold November rain,
Will make its summer in the heart again.


~robert nathan
'now blue october'

Interview: Dr. Jenny Yip, O.C.D.and Pediatric and Adult Behavioral Clinical Trials

This is an interesting interview of Dr. Jenny Yip by Dan Sfera who runs South Coast Clinical Trials in California.

This time, the interview focuses on a non-medication therapy for O.C.D. featuring Dr. Jenny Yip. The interview covers CBT (Cognitive Behavior Therapy), the use of medications vs. non medicated approach, kids in drug trials, and the risks and side effects of using standard medication treatment for O.C.D. which is the use of SSRI's.

She discusses how doing the "work" for CBT is beneficial for long term positive outcome vs. short term relief using medications.

She uses exposure therapy and includes the family when working with children. Dr. Yip's web site is here. She says in the interview they sponsor the clinical trials which as a result offers free treatment for use of the trial participant's data, and they take no pharma money for funding of which she comments, "we're probably taking patients away from them".(pharma)by not using medications in their treatment or study trials.

Dr. Yip says many patients "want just a pill to fix them" and are not familiar with SSRI side effects; "if you want that quick fix, you can take it, but it won't go away" you have to put in effort, and hard work for exposure therapy to be successful.

There are pediatric studies that use CBT, not drugs in the trial for O.C.D., which Dr. Yip emphasizes has very minimal risk vs. a medication based study and treatment.



I'm glad to see alternative therapies offered to kids and adults that are not medication based, which I believe is a good place to start before adding any medications.

Dr. Yip also states in the interview that CBT works for depression, bipolar, and mood disorders, though she said she believes CBT and medications would be necessary for Schizophrenia.

----



*Disclosure: Dan Sfera asked me to review this video interview, and after watching I thought it might be of interest to my readers. Sfera's business is in the clinical drug trial arena, but on his website(s) as you can see he offers all sides/views and is willing and eager to interview patients, doctors, anyone who has had poor results using the medications, etc. Contact him if you want an interview to tell your story about your psych med experience, good or bad.


Tuesday, September 27, 2011

How Do Research Clinics Get Paid in Clinical Trials? Dan Sfera explains


I asked Dan Sfera of South Coast Clinical Trials in California, how his clinical trial business gets paid by the pharmaceutical companies (the process)and also discussed his father Adonis Sfera when I discovered his name as a Principal Investigator (PI)for the antipychotic Latuda (one of many study locations) study for Bipolar 1 Depression--and then again in Dollars for Docs database.

Dan was nice enough to answer my questions and then go ahead and make a video response answering all of the topics. It's another facet to the pharmaceutical industry that people can learn about, as part of knowing how their medications were approved, from start to finish and the players involved along the way.



Here's Dollars for Docs database.Dan explains how the research money from Cephalon is used in the video.

Thanks for answering my exciting questions, Dan!

So long Seroquel, the all-purpose antipsychotic that made billions for AstraZeneca



Time to say farewell to the original Seroquel patent, of course there is still Seroquel XR for your over-priced antipsychotic wonder drug needs.

And drug trials too!

325 studies will surely continue to extend that original patent in the form of $$$$ for AstraZeneca quite nicely.


Update 9-30-11

*Seroquel XR goes generic in 2016

Ex-GSK employee Jane Nieman video deposition: PAXIL (Seroxat in U.K.) and birth defects


Exclusive video deposition of ex- GSK employee, Jane Nieman in the case of GKS vs. Kilker

From the Seroxat Sufferers Stand Up and Be Counted blog by Bob Fiddaman.

"Items of disclosure showed that another patient had discovered she was pregnant in December 2000 while being treated with Paxil. However, she reported that at six months gestation the pregnancy had to be terminated because the fetus was diagnosed as having Truncus arteriosis. Her physician told her that the child would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered, if he was able to make it to that time.

The video deposition sees lawyers probe Nieman for answers. What she revealed was damning for GlaxoSmithKline. It's also interesting to note that Nieman digs herself an even bigger hole when she suggests to lawyers that the initial report that concluded that the patient's termination was "almost certain" [related to Paxil] may have been a clerical error. Under oath she said;

"There's always the possibility someone made the mistake and checked the box wrong."



Go here to view the videotaped deposition of Jane Nieman and find the transcripts as well.


It seems that GSK had a hard time keeping track of pregnancy on Paxil statistics, and got worse at it as the years passed according to the testimony.....

Monday, September 26, 2011

Program to Evaluate the Antipsychotic Response to Lurasidone (PEARL), Chalk Talk videos featuring Dr.Stephen Stahl


Everything you want to know about the new antipsychotic Latuda brought to you by Dr.Stephen Stahl, who lists the manufacturer in his financial disclosures list among most all of the other pharma cos you can imagine.

Considering the source of the "Chalk Talk" series of videos, take note of who is teaching you about the antipsychotic. The Dr.Stahl learning video series is hosted on the drug manufacturer site.



LATUDA "Chalk-talk" Videos

Expert reviews of clinical data

Explore LATUDA with Stephen M. Stahl, MD, PhD as your guide.

Click on these links to view videos:
Chalk-talk - The LATUDA Clinical Trials Program
Chalk-talk - LATUDA PEARL 2 (Study 3) Data
Chalk-talk - LATUDA PEARL 1 (Study 4) Data
Chalk-talk - Efficacy Summary of the LATUDA Clinical Trials Program
Chalk-talk - Dosing and Administration of LATUDA
Chalk-talk - The LATUDA Safety Database and Adverse Reactions

Some of the side effects and cautions

LATUDA is contraindicated in any patient with a known hypersensitivity to lurasidone HCl or any components in the formulation. Angioedema has been observed with lurasidone. LATUDA is contraindicated with strong CYP3A4 inhibitors (e.g., ketoconazole) and strong CYP3A4 inducers (e.g., rifampin).

WARNINGS AND PRECAUTIONS

Cerebrovascular Adverse Reactions, Including Stroke: In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks) including fatalities compared to placebo-treated subjects. LATUDA is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with administration of antipsychotic drugs, including LATUDA. NMS can cause hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant serious medical problems for which specific treatments are available.

Tardive Dyskinesia (TD): TD is a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements that can develop in patients with antipsychotic drugs. There is no known treatment for established cases of TD, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Given these considerations, LATUDA should be prescribed in a manner that is most likely to minimize the occurrence of TD. If signs and symptoms appear in a patient on LATUDA, drug discontinuation should be considered.

Metabolic Changes

Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.

Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.

Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, LATUDA elevates prolactin levels. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds. In short-term, placebo-controlled studies, the increase in prolactin was greater in LATUDA-treated female patients; the median change from baseline to endpoint for females was 1.5 ng/mL and was 1.1 ng/mL in males. The increase in prolactin concentrations was dose-dependent. The proportion of female patients with prolactin elevations ≥5x ULN was 8.3% for LATUDA-treated patients versus 1% for placebo-treated female patients. The proportion of male patients with prolactin elevations > 5x ULN was 1.9% versus 0.6% for placebo-treated male patients.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia/neutropenia has been reported during treatment with antipsychotic agents. Agranulocytosis (including fatal cases) has been reported with other agents in the class. Patients with a preexisting low white blood cell count (WBC) or a history of drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy, and LATUDA should be discontinued at the first sign of a decline in WBC in the absence of other causative factors.

LATUDA and sun are registered trademarks of Dainippon Sumitomo Pharma Co. Ltd.
Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Dainippon Sumitomo Pharma Co. Ltd.




Current study for Bipolar 1 Depression

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

Sponsor: Sunovion

ponsors and Collaborators
Sunovion
Investigators
Study Director: Medical Director, MD Sunovion

---

Dr.Stephen Stahl

FRIDAY, SEPTEMBER 10, 2010

FDA Bad ad alert: Stephen Stahl's email and promotion of antipsychotic Lurasidone: not for sale yet!
:

Steven Stahl promo EMAIL

"To my fellow Boston area Psychopharmacologists:

Just a head's up about a local educational program I hope you can attend related to schizophrenia. The content is based both upon my textbook, Stahls Essential Psychopharmacology, and two cases from my private practice. Although supported by Pharma and not CME (a new company Sunovion with a drug in the pipeline is the sponsor), there is no mention of any product here, just information on disease state, what I think is a very a cool update (understandable) on genomics, neuroimaging and the prodrome related to schizophrenia, and illustrated after the first didactic lecture with two cases taken from my practice. I will be lecturing, along with my colleague Steve Potkin from the University of California Irvine. We will also be giving the program in New York the next day (Saturday September 25). "

$$$$$$$$$$

Disclosures: Dr. Stahl receives grant/research support from AstraZeneca, Biovail, Bristol-Myers Squibb, Cephalon, Cyberonics, Eli Lilly, Forest, GlaxoSmithKline, Janssen, Neurocrine Bioscience, Organon, Pfizer, Sepracor, Shire, Somaxon, and Wyeth; is a consultant to Acadia, Amylin, Asahi, AstraZeneca, Biolaunch, Biovail, Boehringer-Ingelheim, Bristol-Myers Squibb, Cephalon, CSC Pharma, Cyberonics, Cypress Bioscience, Eli Lilly, Epix, Fabre Kramer, Forest, GlaxoSmithKline, Jazz, Neurocrine Bioscience, Neuromolecular, Neuronetics, Nova Del Pharma, Novartis, Organon, Otsuka, PamLab, Pfizer, Pierre Fabre, Sanfoi Synthelabo, Schering Plough, Sepracor, Shire, Solvay, Somaxon, Takeda, Tetragenix, and Wyeth; and is on the speaker’s bureau of Pfizer.

*Sunovion (formerly Sepracor)

---

It seems obvious doctors who teach about the drug shouldn't have these conflicts of interest, but it appears this is the way the pharmaceutical companies have found a way to influence the doctors in a trickle down effect, by using the KOLs to host teaching videos and seminars.... like the one Dr.Steve Balt wrote about in his Dollars for Docs post, where he says:

"On the other hand, I would like to learn more about Latuda and whether/how it differs from other antipsychotics on the market (including generic first-generation agents). If possible, I would also like to question Steve Stahl directly about some of what he’s written about this drug (including his Sunovion-funded articles). What better forum to do this than in a public symposium??"



I'd be thinking, Stahl is a paid Sunovion speaker the entire time.....




Disclosure statement snapshot from this CME course led by Stahl.

Sunday, September 25, 2011

Dr.Steve Balt: Dollars for Docs, Pfizer and a $306 dollar questionable "meal"

Dr.Steve Balt

Has found himself in the ProPublica Dollars for Docs database. What is intriguing about this find, is that Dr.Balt says he did not receive income from Pfizer and what is shown in the database is a meal.

This brings up questions of the integrity and accuracy of the Dollars for Docs database, and whether or not all doctors are reported by drug companies as receiving income or meals just by attending an event sponsored by that company.

As Dr.Steve Balt thinks out loud on his blog about an upcoming antipsychotic Latuda event:

"I wouldn’t be surprised if Sunovion reports a $1000+ payout to me if I attend this half-day symposium. (Facility rental + A/V costs + Xeroxing/handouts + coffee service + refreshments, all divided by the # of docs in attendance.) I frankly don’t want my future patients searching my name on Dollars For Docs and finding I received a huge “payment” from Sunovion in Q3 2011. On the other hand, I would like to learn more about Latuda and whether/how it differs from other antipsychotics on the market (including generic first-generation agents). "



There is a disclaimer on the ProPublica site:

If you are a listed practitioner and believe you are listed in error, please contact us atornstein.weber@propublica.org.


I'll be interested to know if Sunovion does report his attendance at the event, in the form of Dollars for Docs...


" I fantasize an article in the American Journal of Psychiatry entitled "Ask them about their lives!"-1 Boring Old Man blog

" "I fantasize an article in the American Journal of Psychiatry entitled "Ask them about their lives!"

Go read 1 Boring Old Man blog ..ask them about their lives for a retired psychiatrist's candid commentary on throwing medications at "symptoms" instead of asking patients about their life and what is happening....

Saturday, September 24, 2011

Harry Magnet's review: A Psychiatrist Criticizes His Own Profession: A Review of “Unhinged” by Daniel Carlat

Click here or on the title of this post, and read Harry Magnet's Blog extensive review of psychiatrist Dr. Daniel Carlat's book, Unhinged.

Carlat, if you aren't familiar with him, was once an Effexor sales hired gun, until he gave it up, had a mea culpa and decided to counter-detail by returning to a few doctor's offices and explaining the drug in more real terms.

Carlat, is the Editor-in-Chief at The Carlat Psychiatry Report, as well as a doctor-blogger.

Read Carlat's SATURDAY, NOVEMBER 24, 2007 Dr. Drug Rep blog post where he tells of his $30K he earned in 2002 along with the link to the NYT article discussing that.



Carlat's book, "Unhinged" was published about the same time as Robert Whitaker's Anatomy of an Epidemic.

Harry's blog has reviews of BOTH books.

Take a look.



autumn 2



"A journey of a thousand miles must
begin with a single step."

- Chinese Proverb


Friday, September 23, 2011

Robert Whitaker speaking on the need for revolution in the mental health system

Introduced by David Oaks from MindFreedom

Just when the FDA advisory panel wants to address antipsychotics in kids: ABILIFY label revision for kids as young as 6 years old arrives

I'm not so sure that the FDA advisory panel understands metabolic syndrome or permanent movement disorders such as lip smacking (uncontrollable)or body twitching, tremors, shuffling gait, the weight gain that is caused by metabolic changes by an antipsychotic isn't your typical childhood obesity (if there is one)due to eating chips and drinking sodas in front of X Box all afternoon, this is serious stuff.

On the heels of this so-called concern for kids on antipsychotics, the FDA has already approved the antipsychotic Abilify for use in kids age 10-17 and as young as 6 years old for autistic behavior control, and now comes a new label revision highlighting the side effects that cause concern. Why have they approved Abilify for kids when these risks were already there?



From Reuters

"The FDA in the next month to six weeks will release a revised label for Abilify, a drug sold by Bristol-Myers Squibb Co and Otsuka Pharmaceutical and approved to treat schizophrenia in adolescents, bipolar disorder in children 10 to 17 years old and irritability associated with autism in those as young as six.

"We ask that with this upcoming revision that you carefully consider the language around pediatric use and adverse events," said Dr. Geoffrey Rosenthal, the committee's chair and director of Pediatric and Congenital Heart Center at the University of Maryland Medical Center.

Abilify's new label will detail the drug's latest clinical trials, warn of metabolic concerns and remind doctors to monitor weight and symptoms of diabetes in all patients, said Dr. Thomas Laughren, FDA's psychiatry products chief. The pediatric section of the label would contain a reference to those warnings, he said..

Such revisions, which are already incorporated into Johnson & Johnson's antipsychotic medication Invega Sustenna, are being considered for other similar drugs on a case by case basis, Laughren said.

The new generation of antipsychotic medications has raised a wave of concerns as they are increasingly being prescribed for a host of uses and for younger and younger patients, with little conclusive research addressing their impact on children and sometimes with little evidence they work."

Dr. E. Fuller Torrey flashback: Stanley Medical Research Institute in lawsuit for brain harvesting without consent

VIA WA PO

Md. research institute’s brain-collection practices on trial in Maine civil case

ALFRED, Maine — "The practices of a prestigious medical research institute that studies schizophrenia and bipolar disorder are on trial in Maine, where the organization collected at least 99 brains from organ donors.

Anne Mozingo, of York, contends that the Stanley Medical Research Institute and a man working on its behalf removed her late husband’s entire brain without her consent after he died of a brain aneurism in 2000. She said she agreed to donate only small brain tissue samples."


AND

"From the mid-1990s to 2003, Stanley Medical Research Institute used a network of “brain harvesters” in Maine and three other states to collect hundreds of brains for use in the study of schizophrenia and bipolar disorder. The brains were packed in dry ice and shipped by FedEx to the institute.

Cyr, who also worked for the Maine Medical Examiner’s Office, was paid more than $150,000 to collect brains and other organs from at least 99 bodies from 1999 to 2003, according to court documents.

Mozingo’s lawsuit is one of more than a dozen that were filed against the institute by Maine families alleging that their relatives’ full brains were removed without their consent.

Most of the complaints have been settled out of court, but three have gone to trial.

The first one to go resulted in a mistrial in January 2010 after the plaintiff testified that he chose to put the case before a jury because he didn’t want to settle. The judge ruled the statement implied to jurors that the defendant was offered a financial settlement to avoid a trial.

A second case went to trial last fall, with the jury siding with Stanley, Cyr and the institute’s former executive director, Dr. E. Fuller Torrey."


Reading for background:

SATURDAY, MARCH 21, 2009

Stanley Medical Research Institute, Joseph Biederman, Fuller Torrey and TAC


I attended a lecture and heard Torrey speak

When I heard Fuller Torrey speak in person, he said he wishes he had his schizophrenic sister's cat's brain for his collection.--NAMI funded lecture I attended in June 2006, featuring Fuller Torrey from TAC (Treatment Advocacy Center and affiliated with Stanley Foundation). In person, Fuller Torrey speaks of pro-forced out patient treatment to prevent violence in Schizophrenic populations and considers bipolar the same as schizophrenia.

Torrey believes, according to his public speech, that Schizophrenia is caused by an airborne virus found in cat feces, and he believes that Haldol (antipsychotic) is an anti-viral medication.

When I asked him in person why Haldol is an anti-viral medication he said he did not know. He believes in preventative treatment and the Stanley Foundation holds a patent to an under the skin disk for a slow release of Haldol into a body.
~
Drug implant offers hope, spurs worry,By Ellen Barry, Globe Staff, 9/26/2003-Boston Globe:

"Researchers said yesterday(2003 article) that they are prepared to seek FDA approval of a surgically implanted tablet that could deliver daily doses of psychiatric medication for as long as a year."




More

MONDAY, JULY 30, 2007

Brain Harvesting :Torrey,TAC and Stanley Medical Institute



Brain Harvesting :Torrey,TAC and Stanley Medical Institute

Brain Harvesting Lawsuits:Torrey-Stanley Foundation-Seattle

2005 article of interest:

"Virginia Hendricks can't help but feel betrayed. Just a few days after her son Jim died unexpectedly, the King County Medical Examiner's office called, asking to take a sample of her son's brain. Instead, without permission, the county sent Jim's entire brain, plus his mental health and medical history files to the Stanley Medical Institute in Bethesda Maryland."

"The sister of a homeless, mentally ill man named Bradley Gierlich is suing King County as well. In a lawsuit filed late Friday, the family claims nobody ever gave permission to harvest organs. Bradley Gierlich's brain was sent to Stanley medical by King County anyway."

"The suit accuses King County and Stanley Medical of outrage, negligence, violation of privacy, interference with a dead body, violations of the Washington Anatomical Gift Act, and civil conspiracy."

Thursday, September 22, 2011

Dr X blog has an update on the brutal beating of California man

"and the beating was so violent, continuing even after the young man's heart-wrenching cries for 'Dad' stopped as he fell unconscious."


Fullerton Police Beat Schizophrenic Man To Death: An Update.

Those men are atrocious human beings, and yes those are the type of police that give parents the worst nightmares, parents of vulnerable citizens of our society...they beat him to death with inner rage, and he was defenseless.

Wednesday, September 21, 2011

Was Rebecca Riley's death not warning enough? another 4 year old on psych meds

This is disturbing, that these drugs that are not approved for safe use in 4 year olds are being given to them anyway. Was the death of 4 year old Rebecca Riley not warning enough for parents? do they know what these drugs actually do to the child's growing body and brains?

Abilify

Ritalin

Clonidine

from CNN:

" 4-year-old Shelby wakes. She sleepily uses the potty, dutifully washes her hands, and then accepts a white capsule from her mother, Victoria*. (*Last name has been withheld.)
The blond-haired, blue-eyed little girl swallows the medicine easily. "And then she's off—to take care of the pets, play with play dough, and just be Shelby," says Victoria.

The capsule contains 20 milligrams (mg) of Ritalin (methylphenidate), the prescription stimulant used to calm and focus children with attention deficit hyperactivity disorder (ADHD). After dinner, Shelby takes more meds -- 2.5 mg of Abilify and .05 mg of clonidine. The preschooler has been on daily medication since she was 2, when she slept only about four hours a night and threw frequent, violent temper tantrums that sometimes left her mother with bruises and bite marks.

A psychiatrist at the local children's hospital diagnosed bipolar disorder. For a year, Shelby was on increasingly potent doses of Risperdal (risperidone), an antipsychotic, and Depakote (divalproex), an antiseizure drug that's also used to reduce mania."
---

This is disturbing, what are these people thinking? How about Depakote's black box for pancreatitus? antipsychotics increased chances of sudden death or blood clots or Depakote's Polycystic Ovary syndrome black box warning for women under age 20?

Bipolar 2 year old?

What's happening America?


From the article:

(remember this is a 4 year old)

"...her outbursts gave way to medication side effects including slurred speech, tremors, weight gain, and an inability to walk without stumbling, her mother sought another opinion. This psychologist disagreed with the initial diagnosis, suggesting that Shelby didn't have bipolar disorder but rather a combination of ADHD and oppositional defiant disorder (ODD). He prescribed Ritalin."

Maybe the mother should watch PBS Frontline the Medicated Child, read about Rebecca Riley dying at age 4 ....

Monday, September 19, 2011

autumn


"You can't cross a sea by merely
staring into the water."

- Rabindranath Tagore


*my pic of a favorite lake

1 Boring Old Man Blog: watch Healy and Whitaker video

The CASPER Conference
Community Action on Suicide Prevention, Education, and Research
Dr. David Healy and Robert Whitaker

"It’s almost three hours long, but worth the investment to hear these guys in person. Healy talks about suicidality with the antidepressants and Whitaker focuses on the long-term use of psychotropics."--from 1BOM blog

go here, and watch, listen to Whitaker and Healy.


the retired psychiatrist's follow-up to the Healy/Whitaker video:


"That was just a quick run through, but the point is that the whole history of the story is in that "grain of sand" – again, hidden in plain view. We owe a debt of gratitude to the people like David Healy, Robert Whitaker, Casper, Bernard Carroll, Paul Thacker, Allen Jones, and the countless others who smelled this rat and gave us the tools to begin to read between the lines [from the top down as well as the bottom up]. The only way to make a dent in this sorry edifice is to keep linking the elements until denial is no longer even possible." 1 BOM blog

Sunday, September 18, 2011

Need a grant? go to Eli Lilly!



Various entities such as Medscape, various NAMI groups, CHADD,Inc ; American Academy of Child and Adolescent Psychiatry, Duke University School of Medicine, Yale, Massachusetts General Hospital, various Mental Health America chapters,New York Association of Psychiatric Rehabilitation Services, and American Foundation for Suicide Prevention have tapped into Eli Lilly's grant funding , at the grant office. Here's the Q1 and Q2 disclosure registry.

Take a look and see if any of the grants were given to support something you were involved in, just for interest sake. NAMI groups in particular sure know where to find the cash, --who to go to--the pharmaceutical company, Eli Lilly, makers of Prozac, Strattera,Cymbalta and Zyprexa....

Thursday, September 15, 2011

J & J goes to trial March 2012 for marketing of antipsychotic Risperdal, Arkansas seeks $10K per prescription written

The state of Arkansas goes after $10,000 per prescription written in a 13 year period, Johnson and Johnson's antipsychotic Risperdal

VIA Bloomberg

"The state seeks a penalty of as much as $10,000 for each Risperdal prescription written in Arkansas over a 13-year period starting in 1994 in connection with the Medicaid fraud claim, Robert Cowan, one of the state’s lawyers, said in an interview in August.

J&J’s lawyers countered J&J and Janssen officials provided proper warnings about Risperdal’s diabetes risks on the drug’s label and that federal regulators had approved that label.

The state’s efforts to tie its labeling claims to Medicare fraud should fail because “compliance with federal drug labeling statutes and regulations is not a condition of payment or participating in a” state Medicaid program, the companies’ lawyers said in a July 29 court filing.

State Lawsuits

J&J and the Janssen unit have been sued by 11 states seeking reimbursement for Medicaid or other public funds paid on Risperdal prescriptions, the company said. The lawsuits allege that J&J promoted the drug for dementia, mood and anxiety disorders and other unapproved uses, or downplayed risks."


Wednesday, September 14, 2011

Dr.Mark Foster: Tried and True Methods For Achieving Mental and Emotional Well-being (w/out meds)

Dr.Mark Foster has a post up with a list of 'tried and true' ways to achieve wellness.

Tried and True
Methods For Achieving
Mental and Emotional Well-being

(And none of them involve medications)

by Mark Foster, DO

Here's a small part:

" Celebrate life

a. Grow flowers. Cultivate a vegetable garden. Have houseplants. Plant trees.

b. Get a pet. Dogs, cats, hamsters, fish, lizards, rabbits--there is some cute critter out there that will soften your heart and meet your lifestyle requirements.

c. Ride and take care of horses if you can. Being around horses has proven to be therapeutic for humans.

d. Be around infants and children. Nothing is quite as life-affirming as the sound of children laughing or playing in the park.

e. Surround yourself with things that are alive, that give and receive love.

5) Daily meditation

a. Prayer

b. Yoga

c. Deep breathing / relaxation techniques

d. “Spend less time as a human doing, and more time as a human being.”"

--


You might remember Dr.Foster from Robert Whitaker's Mad In America blog:


After 25 Posts on this Website, Dr. Mark Foster is Terminated by his Employer


On September 18, 2010, Mark Foster, a family physician in Littleton, Colorado, began his “Letters From the Front Lines” blog for this website. In it, he writes eloquently and thoughtfully about his changing views about psychiatric medications and psychiatric diagnoses. He writes of his efforts to prescribe the medications in a much more cautious manner than before, and to help some of his patients wean from the drugs.

He has posted 25 times. Many readers have written to me to tell of how much they enjoy his blog, and are moved by it. And now here is the news: On March 15, his employer, Littleton Adventist Hospital, fired him.

Mark’s employer told him his termination was “without cause,” meaning that there was no “reason,” in terms of his performance, for his being fired. At that meeting, Mark said, his employer denied that it had anything to do with his blog. Instead, this was what Mark was told: “It is clear that your interests and the hospital’s have diverged, and it is best that we part ways.”--Robert Whitaker


It's nice to see a doctor give a list of non-medicated ways to approach well-being in life.

PhRMA defends dollars to docs, disses ProPublica :"ultimate goal of these interactions: strengthening patient care"

PhRMA, Pharmaceutical Research and Manufacturers of America chimes in with a defense of the pharma cos and doctor's relationships via speaking, consulting (taking income)with an anti-ProPublica retort in the L.A. Times.

From the PhRMA site:

PhRMA Statement on Interactions with Healthcare Professionals

Washington, D.C. (September 6, 2011) — Pharmaceutical Research and Manufacturers of America (PhRMA) Executive Vice President and General Counsel Diane Bieri today issued the following statement on interactions with healthcare professionals:

“Interactions between biopharmaceutical research companies and healthcare professionals play a critical role in improving patient care and fostering appropriate use of medicines, and peer education programs – in which expert physicians meet with their fellow healthcare providers on behalf of biopharmaceutical research companies – represent one important element in these interactions."


From L.A.Times

Healthcare: Why drug company-doctor interactions are good for patients [Blowback]:

Diane Bieri, executive vice president general counsel for the Pharmaceutical Research and Manufacturers of America, responds to The Times' Sept. 8 Op-Ed article, "What the doctor ordered."

"We stand by the quality of these ethical relationships and, therefore, we support transparency. We understand that patients may want to know if their physicians collaborate with companies, and they should also understand how their care improves as a result. That is why we supported the physician payment sunshine provisions of the 2010 healthcare reform bill, which will require companies to report payments for services or other transfers of value to physicians, with the government posting this information on a public website. We eagerly await regulations on how to proceed with implementation. Companies also comply with internal policies, FDA regulations and the PhRMA Code on Interactions with Healthcare Professionals, which includes details specific to peer speakers' medical expertise, reputation and experience. These relationships are closely monitored to ensure they remain informative and ethical.


Unfortunately, ProPublica's Dollars for Docs series -- the name alone is enough to convey the sensational nature of the material -- threatens to potentially undermine the ultimate goal of these interactions: strengthening patient care. The fact is, ProPublica's series would not be possible if many companies were not already being transparent about relationships with physicians.

The lesson is clear. Rather than be alarmed, patients should take pride in their doctors serving as part of a vast team of scientists and physicians who closely monitor the medicines they prescribe, share findings with healthcare peers and offer feedback to biopharmaceutical companies. The collaborative relationship between doctors and the biopharmaceutical industry ensures that cutting-edge treatments will continue to enhance patient care."

-- Diane Bieri PhRMA



Interesting Gardasil, Merck, Perry discussion and articles at Pharmalot,OpenSecrets & Alison Bass


If you're interested in Merck, the Gardasil vaccine, and Perry's pharma money and want of a mandate for Texas girls to get the injection (which he now says was a mistake)read OpenSecrets and view video of the Bachmann comments that spurred Perry to say the executive order was not a good idea, then go over to Pharmalot,for article, video and comment section discussion. It's a lively debate, and one worth having, it opens the public arena discussion to pharma contributions to political candidates and Gardasil, and whether it's hype, disease-mongering or an aggressive ad campaign by Merck.

More on that by Alison Bass where she says, "But I wish the media would use this opportunity to explore the public health ramifications of allowing a drug manufacturer to aggressively target the wrong population for an expensive and possibly unnecessary vaccine."



Additional reading

Mother Jones-"Rick Perry's Price Revealed!" $30,000 from Merck not $5000.00


*Gardasil ad that was in magazine

Tuesday, September 13, 2011

Paul Thacker: How An Ethically Challenged Researcher Found A Home at the University of Miami: NEMEROFF

From Paul Thacker at Project On Government Oversight-POGO a great article at Forbes:

How an Ethically Challenged Researcher Found A Home at the University of Miami

"The ensuing scandal became central to an investigation by Senator Charles Grassley into undisclosed payments from companies to prominent physicians—a practice that puts patients at risk and drives up healthcare costs. As Grassley’s lead investigator on the matter, I had a ringside seat as arguably the most powerful psychiatrist in the country was forced from prominence, eventually leaving Emory."--Paul Thacker

Read the entire article HERE.

Monday, September 12, 2011

Seroquel Lawsuit Blog:Why does AstraZeneca want former medical advisor John Blenkinsopp's deposition sealed?

Listen to the audio tape of AstraZeneca's former medical advisor, John Blenkinsopp at the Seroquel Lawsuit blog:



"They came at me with a number of potential claims all of which were trying to intimate that Seroquel was not associated with weight gain none of which I would approve, the data pointed in the opposite direction."-Blenkinsopp


See what else AstraZeneca wants to keep from the public for viewing.....at the Seroquel Lawsuit blog

American Academy of Pediatrics: The Immediate Impact of Different Types of Television on Young Children's Executive Function

The Immediate Impact of Different Types of Television on Young Children's Executive Function

Angeline S. Lillard, PhD, Jennifer Peterson, BA

- Author Affiliations

Department of Psychology, University of Virginia, Charlottesville, Virginia

ABSTRACT

Objective: The goal of this research was to study whether a fast-paced television show immediately influences preschool-aged children's executive function (eg, self-regulation, working memory).

Methods: Sixty 4-year-olds were randomly assigned to watch a fast-paced television cartoon or an educational cartoon or draw for 9 minutes. They were then given 4 tasks tapping executive function, including the classic delay-of-gratification and Tower of Hanoi tasks. Parents completed surveys regarding television viewing and child's attention.

Results: Children who watched the fast-paced television cartoon performed significantly worse on the executive function tasks than children in the other 2 groups when controlling for child attention, age, and television exposure.

Conclusions: Just 9 minutes of viewing a fast-paced television cartoon had immediate negative effects on 4-year-olds' executive function. Parents should be aware that fast-paced television shows could at least temporarily impair young children's executive function."


In other words, watch fast-paced cartoons and become at risk for learning disabilities, or (shock!) ADHD, and you know there are meds for that.


What is executive function?:

"Executive function is a set of mental processes that helps connect past experience with present action. People use it to perform activities such as planning, organizing, strategizing, paying attention to and remembering details, and managing time and space.

If you have trouble with executive function, these things are more difficult to do. You may also show a weakness with working memory, which is like "seeing in your mind's eye." This is an important tool in guiding your actions.

As with other learning disabilities, problems with executive function can run in families. It can be seen at any age, but it tends to become more apparent as children move through the early elementary grades. This is when the demands of completing schoolwork independently can trigger signs of a problem with executive function.

The brain continues to mature and develop connections well into adulthood. A person's executive function abilities are shaped by both physical changes in the brain and by life experiences, in the classroom and in the world at large. Early attention to developing efficient skills in this area can be very helpful. As a rule, it helps to give direct instruction, frequent reassurance, and explicit feedback."


Executive Function Disorder: rarely tested, rarely addressed, yet with devastating consequences:

"One of the most common invisible neurological disabilities that can cause a lifetime of misery and failure is called Executive Function deficit. Executive function (EF) is the "little boss" inside your head that "tells" how to plan, what, how and when to speak and or take action. When executive function is impaired, a person can be disorganized, impulsive and "always behind" everyone else. EF is often co-morbid with learning disabilties, autism, Aspergers, and ADHD. EF is also rarely tested for by schools when conducting educational pyschological evaluations."


Disease Mongering

Media hype headline of the day:

"Watch cartoons such as Sponge Bob Square Pants, your child at risk for mental illness"

Or, "Cartoons increase risk for mental illness"


Or, "Preschoolers at risk for mental illness if allowed to watch cartoons"


C.A.B.F. Scientific Advisory Council member Robert Findling trialing antipsychotic Abilify on 5 yr olds, America's kids on psychiatric drugs




Children in America are at high risk for being diagnosed with a mental illess and medicated for acting like kids, especially if their parents are diagnosed bipolar.

'Experts' like to call the elevated moods 'symptoms', which brings 'cyclotaxia' into the discussion and more.


Child Adolscent Bipolar Foundation is the largest parent support group on the 'Net for parents of kids with mental illness diagnoses or psychiatric 'disorders' Many are parents of children diagnosed Bipolar, ADHD, OCD and Schizophrenia. The influence begins with their Scientific Advisors, and the influence of the pharmaceutical companies is proven by the advisor's personal lives, the advisors who take money from pharma cos that make the drugs to treat these 'illnesses'. It's safe to say the site is pro-med and pro-diagnosis.

There is a parent forum where parents can share their stories with each other, and that is where I was encouraged over a decade ago to drug my child to the eyeballs for her (now wrong and removed dx) Childhood Bipolar Disorder. I was given advice by people 'inside' CABF and in particular which psych meds were the popular med cocktail of choice by 'experts'.

Back then it was Depakote, Lithobid, Zyprexa, and many kids were given benzos in the afternoon for the 5 o clock 'meltdowns' that were happening. No one questioned the 3pm dose of meds these kids were taking or withdrawal symptoms from the drugs such as antidepressants Zoloft that many were taking, and switching to and from.....


CABF bpkids Scientific Advisory council is brimming with impressive KOL's, impressive with bank accounts lined from pharmaceutical companies. Robert Findling joins the ranks with Melissa DelBello($215,000 in Q1 2011 from Eli Lilly)and Christoff Correll, Kiki Chang and of course Senator Grassley busted Joseph Biederman.


Robert Findling Seroquel XR study

Findling was the Principal Investigator of the AstraZeneca sponsored trial of the antipsychotic Seroquel XR on 10 year olds for Pediatric Bipolar Depression.


Robert Findling PubMed

Early symptoms of mania and the role of parental risk

Abstract

OBJECTIVES:

The objectives of this study were to: (i) describe the phenomenology of youths diagnosed with subsyndromal bipolar disorders; (ii) describe the phenomenology of youngsters who are the children of bipolar parents, who are also experiencing subsyndromal symptoms of bipolar disorder (patients with 'cyclotaxia'); and (iii) explore which symptoms may be most useful in identifying youths with cyclotaxia.

METHODS:
Four hundred outpatients between the ages of 5 and 17 years received a diagnostic assessment and psychometric questionnaires pertaining to mood symptomatology and psychosocial functioning. Parental diagnostic information was also obtained. Children and adolescents were assigned to one of three diagnostic groups: a 'syndromal bipolar disorder (BP)' group (n = 118), a 'sub-syndromal bipolar (SUB-BP)' group (n = 75), or a 'non-bipolar (NON-BP)' group (n = 207). In addition, based on parental diagnoses, youths were assigned to either a high genetic risk group (n = 167) or a low genetic risk group (n = 233).

RESULTS:
Youths with subsyndromal bipolar disorders were found to have intermediate degrees of manic symptoms than youths with bipolar disorder and youths without a bipolar diagnosis. Offspring of parents having a bipolar disorder were more likely to show symptoms of hypomania and mania than youths without a bipolar parent. Youths at genetic risk for developing a bipolar disorder were not found to be at higher risk for having a diagnosis of attention-deficit hyperactivity disorder or a disruptive behavior disorder. Finally, results suggest that elevated mood with irritability and rapid mood fluctuations are the key distinguishing characteristics of 'cyclotaxia'.

CONCLUSIONS:
There exists a group of youngsters who are the offspring of a parent/parents with a bipolar disorder who do not suffer from BP 1 or BP 2, yet have elevated mood symptoms and psychosocial dysfunction. As a result of these observations, treatment studies are needed for youths with 'cyclotaxia'.

Robert Findling Pharma ties (Dollars for Docs)




Findling is on the Editorial board at MedScape with Christoff Correll, both on the CABF advisor council.

MedScape Board Member details (financial disclosures)

Robert Findling

Professor of Psychiatry and Pediatrics, Case Western Reserve University, Cleveland, Ohio

Robert L. Findling, MD, has disclosed the following relevant financial relationships:

Received grants for clinical research from: Abbott Laboratories; Addrenex; AstraZeneca Pharmaceuticals LP; Bristol-Myers Squibb Company; Forest Laboratories Inc; GlaxoSmithKline; Johnson & Johnson Pharmaceutical Research & Development, L.L.C; Eli Lilly and Company; Neuropharm; Otsuka Pharmaceuticals Co. Ltd; Pfizer Inc; Shire; Supernus Pharmaceuticals; Wyeth Pharmaceuticals Inc.
Served as an advisor or consultant for: Abbott Laboratories; Addrenex; AstraZeneca Pharmaceuticals LP; Biovail Corporation; Bristol-Myers Squibb Company; Forest Laboratories, Inc; GlaxoSmithKline; Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; KemPharm; Eli Lilly and Company; Lundbeck Research USA, Inc; Novartis Pharmaceuticals Corporation; Organon Pharmaceuticals USA Inc; Otsuka Pharmaceutical Co., Ltd.; Pfizer Inc.; sanofi-aventis; Sepracor Inc.; Shire; Solvay Pharmaceuticals, Inc.; Supernus Pharmaceuticals; Validus; Wyeth Pharmaceuticals Inc.
Served on the speakers bureau for: Bristol-Myers Squibb Company; Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; Shire

Christoff Correll

Associate Professor of Psychiatry and Behavioral Sciences, Department of Psychiatry, Albert Einstein College of Medicine, Bronx, NY; Medical Director, Recognition and Prevention Program, Department of Psychiatry Research, The Zucker Hillside Hospital, Glen Oaks, New York

Christopher U. Correll, MD, has disclosed the following relevant financial relationships:

Served as an advisor or consultant for: Actelion Pharmaceuticals, Ltd; AstraZeneca Pharmaceuticals LP; Bristol-Myers Squibb Company; Boehringer Ingelheim Pharmaceuticals, Inc.; Cephalon, Inc.; Eli Lilly and Company; Janssen Pharmaceutica Products, L.P.; Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; GlaxoSmithKline; F. Hoffmann-La Roche Ltd; Medicure; Otsuka Pharmaceutical Co., Ltd.; Pfizer Inc.; Schering-Plough Corporation; Supernus; Takeda Pharmaceuticals North America, Inc.; Vanda Pharmaceuticals Inc.
Served as a Data Safety Monitoring Board Member for: Bristol-Myers Squibb Company; Cephalon, Inc.; Otsuka Pharmaceutical Co., Ltd.; Supernus




Finding the kids to medicate, if they aren't meeting the criteria then something is wrong, find a reason to medicate them!


Kiki Chang, C.A.B.F Scientific Advisory council, Stanford University

Experts Close to Defining Bipolar Criteria in Children

"While rare, the occurrence of bipolar I and II disorders in children no longer seems a matter of dispute. Yet researchers and clinicians struggle to define a group of symptomatic children who don't meet full diagnostic criteria.

Based upon the number of sessions devoted to the topic at the recent annual meeting of the American Academy of Child and Adolescent Psychiatry (AACAP), the debate over the existence— and definition—of pediatric bipolar disorder is alive and well.

However, the focus of the debate appears to have shifted a bit. After many years of deliberation, the existence of “true mania” (and therefore the potential existence of bipolar disorder itself) in children, appears to be generally agreed upon. The majority of child and adolescent psychiatrists seem to concur that while rare, distinct episodes of mania that would meet DSM-IV diagnostic criteria for bipolar I disorder, can and do occur in children, said Kiki Chang, M.D., an assistant professor of psychiatry at Stanford University.

“Bipolar II,” Chang continued, “is harder [to diagnose in children], but still definable.” Chang chaired one of many sessions on pediatric bipolar disorder during the AACAP annual meeting in Toronto in October. “BP-NOS [not otherwise specified], is harder even still,” he said."

"Still Definable" says Kiki Chang

Kiki Chang pharma ties

Kiki Chang



Currently Recruiting!

Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder



Purpose

"The purpose of this study is to test the effectiveness and tolerability/safety of aripiprazole (abilify) in children with subsyndromal symptoms of bipolar disorder who also have a bipolar parent and other family member with a mood disorder."



The heavy cloak of pharmaceutical influence and tainted KOL's (Key Opinion Leaders)defining, defining which kids are vulnerable to 'mental illness' is part of the epidemic that has entrenched America. The mental illness epidemic that the pharmaceutical companies push, via lining these doctors of influence pockets with cold cash, and the prestige created within the psychiatric circle is a frightening portrayal of the new culture in America. The new way of defining illness and children.

Once the kids are medicated, there are no longer baselines of kids for anyone to see. Children are lively, high spirited, wiggle, and talk too much. If they don't teachers and parents question if they are now depressed. If they are too lively, they could be subsymdronal bipolar, on the cusp of being defined bipolar, which appears according to these studies and KOL opinions, is not too far off.



The ramifications of drugging young for mental illness and preventative measures, are enormous.


A life lived on psych meds and on the growing brain has negative outcomes, I know, because my daughter is re-learning how to speak in sentences and take showers daily at age 23 as a result of this medication based medical model America calls psychiatry.





Sunday, September 11, 2011

Interview with the Seroquel Lawsuit Blog Author at Seroxat Sufferers Stand Up and Be Counted blog by Bob Fiddaman

Exclusive interview with the Seroquel Lawsuit blog author via Seroxat Sufferers Stand Up and Be Counted blog



SNIPPET

"If there was one message you could give to claimants in the Seroquel litigation, what would it be?

I would hope Seroquel Claimants would become informed and active participants in this process, look at the evidence...."





*Seroxat is antidepressant PAXIL in the U.S.

*Seroquel is the antipsychotic made by AstraZeneca

Friday, September 09, 2011

Merck makers of GARDASIL vaccine bankrolled anti-parent bill


12 year olds in California no longer need parental consent to receive medical care related to sexually transmitted disease.

Gardasil, associated with 28 deaths in 2008: is a controversial vaccine for the prevention of sexually transmitted HPV. Controversial, due to the young age the vaccine is promoting for in girls, whether it's beneficial for boys, and a host of other reasons, such as deaths reported, convulsions after receiving the vaccine. It's also controversial due to the nature of the topic, and poses the question of whether or not schools can make this a mandatory injection required for attendance....for a sexally transmitted disease. It begs to question the ethics of the vaccine and whether or not kids as young as 12 should have it, because that means it is assumed they are sexually active.

Parents being left out of the loop without being part of informed consent for the 12 year olds is a dangerous gamble in my opinion. Let's say the worst case scenerio occurs and the child has convulsions or dies after the injection. What would the parent do, when they found out it was related to a vaccine they had no idea the child had received?

From Drug Injury Watch:

"...28 deaths in 2008 associated with Gardasil, the vaccination for human papillomavirus (HPV), up from 19 deaths in 2007. The total number of Gardasil-related deaths is 47 since the vaccine was approved in 2006. Overall, the FDA documented 6,723 "adverse events" related to Gardasil in 2008, of which 1,061 were considered "serious," and 142 considered "life threatening."


Merck bankrolls the politicians in California

From Cal Watchdog

"Key California legislators passing an anti-parent bill grabbed campaign financing from the gigantic Merck conglomerate, a CalWatchDog.com investigation revealed. The legislation is AB 499 by Assemblywoman Toni Atkins, D-San Diego. In the bill’s language, it “authorizes a minor, who is 12 years of age or older, to consent to medical care related to the prevention of a sexually transmitted disease.”

Current law allows such care only with a parent’s permission. AB 499 passed both houses of the Legislature and awaits a decision by Gov. Jerry Brown."

AND

"Total that Merck donated to legislators voting yea on AB 499: $39,500". See the article for the list of names.

Pharmaceutical companies are top federal campaign contributors according to Open Secrets.




Merck lobbying

in 2011:



Profit over patient safety?

The pharmaceutical industry is fueling a corporate America, where patients are part of marketing plans, and are political ladder climbing rungs.

Industry profits when Americans blindly follow the herd.

In this case, I'd read as much about the side effects of Gardasil as possible, and make an informed choice, which the California politicians have just placed the burden upon innocent 12 year olds to do.

CDC VAERS

Adverse Events

Reports to VAERS Following Gardasil®

"As of June 22, 2011, approximately 35 million doses of Gardasil® were distributed in the U.S. and VAERS received a total of 18,727 reports of adverse events following Gardasil® vaccination: 17,958 reports among females and 346 reports for males, of which 285 reports were received after the vaccine was licensed for males in October 2009. VAERS received 423 reports of unknown gender. Of the total number of VAERS reports following Gardasil®, 92% were considered to be non-serious, and 8% were considered serious."



VAERS LINE LIST REPORT pdf: