Clinician Attitudes About Commercial Support of Continuing Medical Education: not willing to pay increased fees to eliminate pharmaceutical sponsors

According to a survey given at CME events, only 15% of the respondents were willing to do something about the pharmaceutical and medical device company funding, such as increased fees to attend the CME (Continuing Medical Education) courses.

from the Archives of Internal Medicine:



HEALTH CARE REFORM-May 9, 2011

Clinician Attitudes About Commercial Support of Continuing Medical Education
Results of a Detailed Survey

Jeffrey A. Tabas, MD; Christy Boscardin, PhD; Donna M. Jacobsen, BS; Michael A. Steinman, MD; Paul A. Volberding, MD; Robert B. Baron, MD, MS


Arch Intern Med. 2011;171(9):840-846. doi:10.1001/archinternmed.2011.179

Background Pharmaceutical and medical device company funding supports up to 60% of accredited continuing medical education (CME) costs in the United States. Some have proposed measures to limit the size, scope, and potential influence of commercial support for CME activities. We sought to determine whether participants at CME activities perceive that commercial support introduces bias, whether this is affected by the amount or type of support, and whether they would be willing to accept higher fees or fewer amenities to decrease the need for such funding.

Methods We delivered a structured questionnaire to 1347 participants at a series of 5 live CME activities about the impact of commercial support on bias and their willingness to pay additional amounts to eliminate the need for commercial support.

Results Of the 770 respondents (a 57% response rate), most (88%) believed that commercial support introduces bias, with greater amounts of support introducing greater risk of bias. Only 15%, however, supported elimination of commercial support from CME activities, and less than half (42%) were willing to pay increased registration fees to decrease or eliminate commercial support. Participants who perceived bias from commercial support more frequently agreed to increase registration fees to decrease such support (2- to 3-fold odds ratio). Participants greatly underestimated the costs of ancillary activities, such as food, as well as the degree of support actually provided by commercial funding.

Conclusion Although the medical professionals responding to this survey were concerned about bias introduced from commercial funding of CME, many were not willing to pay higher fees to offset or eliminate such funding sources.


Author Affiliations: Office of Continuing Medical Education (Drs Tabas, Boscardin, and Baron), Departments of Emergency Medicine (Dr Tabas) and Medicine (Drs Boscardin, Steinman, Volberding, and Baron), University of California San Francisco School of Medicine, and International AIDS Society–USA (Ms Jacobsen and Dr Volberding), San Francisco.
---


The ones unwilling to change, face the facts that the bias is there by taking action and not supporting CME that has pharma-med device funding by attending (meaning don't attend) are THE PROBLEM.

Until medical professionals (doctors) stop taking drug samples from reps, stop taking income on a speaking circuit from pharma, and stop supporting CME funded by pharma, then they fuel the problem of industry conflicts of interest.

In essence those doctors ARE the reason America is loaded with COI. The 15% are to be commended, and I hope they only participate in future non-pharma funded CME or they too become hypocrites.

Healing Homes: An Alternative, Swedish Model for Healing Psychosis, directed by Daniel Mackler

Healing Homes: An Alternative, Swedish Model for Healing Psychosis

"Healing Homes: An Alternative, Swedish Model for Healing Psychosis

By Daniel Mackler


"Healing Homes, a feature-length documentary film directed by Daniel Mackler, chronicles the work of the Family Care Foundation in Gothenburg, Sweden -- a program which, in this era of multi-drug cocktails and psychiatric diagnoses-for-life, helps people recover from psychosis without medication.

The organization, backed by over twenty years of experience, places people who have been failed by traditional psychiatry in host families -- predominately farm families in the Swedish countryside -- as a start for a whole new life journey.

Host families are chosen not for any psychiatric expertise, rather, for their compassion, stability, and desire to give back. People live with these families for upwards of a year or two and become an integral part of a functioning family system. Staff members offer clients intensive psychotherapy and provide host families with intensive supervision.

The Family Care Foundation eschews the use of diagnosis, works within a framework of striving to help people come safely off psychiatric medication, and provides their services, which operate within the context of Swedish socialized medicine, for free.

Healing Homes weaves together interviews with clients, farm families, and staff members to create both a powerful vision of medication-free recovery and an eye-opening critique of the medical model of psychiatry."
--

"If you want to think of alternatives to biological psychiatry and its treatments for mental disorders, watch Healing Homes and ask yourself: Which way is better? The words of a young mother, finding refuge on a farm in Sweden, will stay with you: "If you do not have love, you cannot help." Healing Homes is a moving, thoughtful, and inspiring film."

- Robert Whitaker author, Anatomy of an Epidemic and Mad in America


Robert Whitaker, clip from film "Take These Broken Wings"

Antipsychotics worsened cognitive function in Alzheimer's patients: American Journal of Psychiatry, outcomes from CATIE-AD

Cognitive Effects of Atypical Antipsychotic Medications in Patients With Alzheimer's Disease: Outcomes From CATIE-AD

Lon S. Schneider Dollars for Docs Lilly, maker of ZYPREXA

SCHNEIDER, LON S Calif. Los Angeles Eli Lilly $5,149 2010
Q1-Q3 Advising/Consulting and International Education Programs: $4750, Travel Expenses: $399 LON S. SCHNEIDER, MD, INC.

SCHNEIDER, LON S. Calif. Los Angeles Eli Lilly $7,500 2009
Q1-Q4 Advising/Consulting and International Education Programs: $7500.0 LON S. SCHNEIDER, MD, INC.

Pierre N. Tariot Dollars for Docs Pfizer, Lilly

TARIOT, PIERRE N Ariz. Phoenix Pfizer $6,180 2009
Q3-Q4 Professional Advising: $147.00, Expert-Led Forums: $4000.00, Meals: $721.00, Business Related Travel: $1312.00 TARIOT, PIERRE N

TARIOT, PIERRE N. Ariz. Phoenix Eli Lilly $6,250 2009
Q1-Q4 Advising/Consulting and International Education Programs: $6250.0 TARIOT, PIERRE N.

Cognitive Effects of Atypical Antipsychotic Medications in Patients With Alzheimer's Disease: Outcomes From CATIE-AD Am J Psychiatry Published May 15, 2011


Cheryl L.P. Vigen, Ph.D., Wendy J. Mack, Ph.D., Richard S.E. Keefe, Ph.D., Mary Sano, Ph.D., David L. Sultzer, M.D., T. Scott Stroup, M.D., Karen S. Dagerman, M.S., John K. Hsiao, M.D., Barry D. Lebowitz, Ph.D., Constantine G. Lyketsos, M.D., M.H.S., Pierre N. Tariot, M.D., Ling Zheng, Ph.D., and Lon S. Schneider, M.D.

Objective: The impact of the atypical antipsychotics olanzapine, quetiapine, and risperidone on cognition in patients with Alzheimer's disease is unclear. The authors assessed the effects of time and treatment on neuropsychological functioning during the Clinical Antipsychotic Trials of Intervention Effectiveness–Alzheimer's Disease study (CATIE-AD). Method: CATIE-AD included 421 outpatients with Alzheimer's disease and psychosis or agitated/aggressive behavior who were randomly assigned to receive masked, flexible-dose olanzapine, quetiapine, risperidone, or placebo. Based on their clinicians' judgment, patients could discontinue the originally assigned medication and receive another randomly assigned medication. Patients were followed for 36 weeks, and cognitive assessments were obtained at baseline and at 12, 24, and 36 weeks. Outcomes were compared for 357 patients for whom data were available for at least one cognitive measure at baseline and one follow-up assessment that took place after they had been on their prescribed medication or placebo for at least 2 weeks.

Results:

Overall, patients showed steady, significant declines over time in most cognitive areas, including in scores on the Mini-Mental State Examination (MMSE; –2.4 points over 36 weeks) and the cognitive subscale of the Alzheimer's Disease Assessment Scale (–4.4 points). Cognitive function declined more in patients receiving antipsychotics than in those given placebo on multiple cognitive measures, including the MMSE, the cognitive subscale of the Brief Psychiatric Rating Scale, and a cognitive summary score summarizing change on 18 cognitive tests.

Conclusions:

In CATIE-AD, atypical antipsychotics were associated with worsening cognitive function at a magnitude consistent with 1 year's deterioration compared with placebo. Further cognitive impairment is an additional risk of treatment with atypical antipsychotics that should be considered when treating patients with Alzheimer's disease.
---

Clinical trial information: drugs used antipsychotics Zyprexa, Seroquel, Risperdal and antidepressant Celexa

CATIE-Alzheimer's Disease Trial

Sponsor: National Institute of Mental Health (NIMH)

Information provided by: National Institute of Mental Health (NIMH

ClinicalTrials.gov Identifier: NCT00015548

Purpose

The CATIE Alzheimer's Disease Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The study is for people with Alzheimer's disease who are having trouble with their thinking or behavior. In particular, this study is trying to find out the best treatment for people who have hallucinations (seeing or hearing things that aren't there), delusions (false beliefs), or agitation. The design of the trial helps to increase the chance that participants in the study receive a medication that helps them. The study uses three medications known as atypical antipsychotics (olanzapine, quetiapine, risperidone), which are the newest medications that are currently available for treating these problems. Participants may also receive an antidepressant (citalopram). The trial lasts for 36 weeks. Participants are given a thorough evaluation at no cost to ensure that this study is appropriate. In addition, the caregiver, family member, or friend who comes with the participant will be offered an educational program about Alzheimer's disease.


The 2 principal investigators, listed above in Dollars for Docs database

Investigators

Principal Investigator: Lon Schneider, MD University of Southern California

Principal Investigator: Pierre Tariot, MD University of Rochester

Health Authority: United States: Federal Government

--

The Federal Government should not allow doctors who take income from pharmaceutical companies to be Principal Investigators in drug trials. That's my opinion.

In fact, why does the Government allow doctors to take any personal income from pharmaceutical companies, and why does the United States government allow pharmaceutical companies to pay them?

Until that connection stops we have a corporate ran health system in America, the DoJ fines for illegal marketing are stacking up, kids are being placed on antipsychotics like candy, the health system in America is tainted by manufacturer influence and until that stops, we have no pure scientific studies to consider as truth and unbiased.


There is already a FDA black box warning for antipsychotics and use in patients with Dementia.

Love story: Sanofi’s Lovenox and a pharma paid doctor, Victor Tapson

FROM POGO (Project on Government Oversight)

Paul Thacker writes about Lovenox , a block buster blood thinner made by Sanofi-Aventis, and Dr. Victor Tapson who plead with the FDA that a generic version of Enoxaparin might not be as safe as the name brand version.

Could their be a reason for this?

Is there a conflict of interest?

Find out by reading Paul Thacker's article at POGO blog.

daisies in the grass and some music

Atrocious,unacceptable psychiatric treatment for teens:Carney Hospital fires 29 after alleged sexual assault of patient

Caritas Health Care and Steward Health Care are in the news for an alleged sexual assault of a teen in the Carney teen psych unit.

Steward, "which bought Carney and five other Catholic hospitals in the Caritas Christi network last year, has given the hospital $1.5 million to renovate the unit as a result of the investigation, which Walczak said will make it safer and improve care." --from the Boston Globe

---

Thank God it appears (from the article info) that a patient was able to get out somehow to report this atrocious crime to authorities who took action. Far too many times, inpatient wards/units cover up incidents, and fail to report or write up incident reports to proper authorities. In my opinion, this place will probably find more happened than they want to believe if more come forward and tell their stories. The fact that they fired so many people means there was most likely a failure to log, record and report for quite some time.

Many psychiatric hospitals (and I've been inside as a visitor to 3 separate inpatient units during audits & joint commission reviews several times in the last decade) are known for cleaning up files, records and literally the grounds and premises, as well as furniture purchasing, to prepare for audits, and reviews for accreditation.

One red flag if you are a visitor of a loved one at one of these places, is to watch for simple planters at the front doors filled with flowers, signage upgrades for no smoking boundaries boldly placed where they should be according to local state law, new furniture in entry lobby areas, notes/posters posted on entry walls stating patient rights that were not there before.

It became such common predictor of state or hospital reviews that I always know when these internal reviews are happening, and many times it's only "spruced up" for the duration of the internal audit. I've seen staff added to make it appear (and was given an inside tip by one that this was what was happening) that patient level acuity was appropriate.

I've seen the planters, the new board room furniture. The fresh paint.

It is a sad reality that many times, hospitals get away with cover-ups this way at the expense of innocent victims called patients, the most vulnerable of them all. Kids, teens loaded up on psych meds and locked inside with no exit for help.



Hat tip to thinkshrink, Dr.David Bransford.

poem of the day

I am the captain of my soul

Invictus

Out of the night that covers me,
Black as the Pit from pole to pole,
I thank whatever gods may be
For my unconquerable soul.

In the fell clutch of circumstance
I have not winced nor cried aloud.
Under the bludgeonings of chance
My head is bloody, but unbowed.

Beyond this place of wrath and tears
Looms but the Horror of the shade,
And yet the menace of the years
Finds, and shall find, me unafraid.

It matters not how strait the gate,
How charged with punishments the scroll.
I am the master of my fate:
I am the captain of my soul.

~William Ernest Henley

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Receive $450 for trialing Seroquel vs Lithium

Jim Edwards: How Seroquel, a Risky Antipsychotic, Became a “General Purpose” Mental Health Drug

VIA B NET:

How Seroquel, a Risky Antipsychotic, Became a “General Purpose” Mental Health Drug

..."The ISMP said:

the adverse event data show quetiapine [Seroquel] has become a general purpose psychiatric drug with most reported injuries occurring outside its core indication for treatment of the most severe mental disorders, schizophrenia and psychosis.

In the off label category more than half the cases were for sleep disorders and insomnia. The next largest group was anxiety, and the remainder was divided among many other medical uses including autism, panic attack, headache, restlessness, nervousness, dementia and agitation.

The report is yet another in a series of publications from a variety of sources that suggest some psychiatric doctors are abusing their patients with Seroquel."

Read it all here at Jim Edwards, BNET

Check out my 'seroquel the wonder drug trials' label, for more articles on this patent extender wonder drug that makes bank for AstraZeneca.

HAT TIP PharmaGossip and WriteWithStan.

AstraZeneca's David Brennan: "we will no longer pay for doctors to attend international scientific and medical congresses"

VIA Reuters: (AstraZeneca, makers of antipsychotic Seroquel)

AstraZeneca pulls plug on free trips for doctors

In an industry first, drugmaker AstraZeneca (AZN.L) is scrapping payments for doctors to attend international medical congresses.

The move follows increased scrutiny of the $850 billion-a-year industry's potentially undue influence on prescribers and could put pressure on rivals to follow suit.

AstraZeneca chief executive David Brennan announced the change of policy in low-key fashion at an industry conference in Istanbul earlier this month.

"We have decided that we will no longer pay for doctors to attend international scientific and medical congresses but will instead focus our educational efforts on local educational opportunities for healthcare professionals," he said.

AND

"Bribery legislation is an issue for pharmaceutical companies because doctors can be seen as government officials in those countries where they work for state-funded health systems. So, payments to them could trigger questions over corruption.

Johnson & Johnson (JNJ.N) last month agreed to pay $78 million to settle British and U.S. charges it paid bribes and kickbacks to win business overseas, in the first settlement by a big drug company since the United States began scrutinising the industry under the FCPA more than a year ago. [ID:nN08230585]

AstraZeneca itself is being investigated by the U.S. Department of Justice and the Securities and Exchange Commission in connection with the FCPA. The company said last month it was looking into inappropriate conduct in countries including China."


HAT TIP to the great PharmaGossip.

Some Medical Deans Fail to Disclose Outside Income on University Web Sites, Report Says

VIA The Chronicle of Higher Education-read the entire article here:

Some Medical Deans Fail to Disclose Outside Income on University Web Sites, Report Says

By Katherine Mangan

"At a time when medical schools are facing unprecedented scrutiny for potential conflicts of interest, a number of their deans have either failed to disclose or underreported the income they received for serving on health-industry corporate boards, according to a report to be presented next month at a national faculty meeting.

A shortened version of the report, "Failure by Deans of Academic Medical Centers to Disclose Outside Income," appeared in the March 28 issue of the Archives of Internal Medicine. Its findings will be presented at the annual meeting of the American Association of University Professors, in June, in Washington.

"Deans are supposed to be exemplars," said the report's lead author, M. Felix Freshwater, a Miami physician and voluntary professor of surgery at the University of Miami's School of Medicine.

The authors compiled a list of all medical-school deans in the United States as of June 2009 and compared the income the deans reported on their universities' Web sites with what the companies reported to the U.S. Securities and Exchange Commission.

They found that seven of the 161 deans served as directors of a total of 10 health-industry companies. The compensation those seven deans earned for their board service ranged from $11,250 to $640,038, with a median of $217,454."


and

"The University of Miami's Web site underreported the income received by its medical dean, Pascal J. Goldschmidt, for two outside directorships by 39 percent and 82 percent, according to the report. The dean said his reported income did not include stock options that he held but had not exercised."



Isn't U of Miami where Charles Nemeroff went to after leaving Emory University for COI?

Huh.

Time Healthland: Drugging the Vulnerable: Atypical Antipsychotics in Children and the Elderly

VIA Time Healthland:

Drugging the Vulnerable: Atypical Antipsychotics in Children and the Elderly


Pharmaceutical companies have recently paid out the largest legal settlements in U.S. history — including the largest criminal fines ever imposed on corporations — for illegally marketing antipsychotic drugs. The payouts totaled more than $5 billion. But the worst costs of the drugs are being borne by the most vulnerable patients: children and teens in psychiatric hospitals, foster care and juvenile prisons, as well as elderly people in nursing homes. They are medicated for conditions for which the drugs haven't been proven safe or effective — in some cases, with death as a known possible outcome.

The benefit for drug companies is cold profit. Antipsychotics bring in some $14 billion a year. So-called "atypical" or "second-generation" antipsychotics like Geodon, Zyprexa, Seroquel, Abilify and Risperdal rake in more money than any other class of medication on the market and, dollar for dollar, they are the biggest selling drugs in America. Although these medications are primarily approved to treat schizophrenia and bipolar disorder, which combined affect 3% of the population, in 2010 there were 56 million prescriptions filled for atypical antipsychotics."

Continue reading this article HERE.


Hat tip to PharmaGossip.

"Essentially Lied" : the two words that got a retraction: Stan Kutcher and PAXIL 329

Stan Kutcher is a co-author of the antidepressant study, PAXIL 329. The study is infamous for being ghostwritten, and the data showed that teens could become suicidal on the drug, yet that data was buried.

Stan Kutcher, from Halifax, Nova Scotia, Canada recently ran for the Liberal party in an election (that he lost). This saga unfolds with Kutcher demanding a retraction and apology via a lawsuit threat to the local Coast newspaper for printing an article about the PAXIL 329 (exposing Kutcher for being part of the corrupt study as a co-author) where book author Alison Bass was quoted with now infamous words.

Justin Ling from the Halifax Media Co-op has a follow up story to the Coast retraction.

Retraction Reaction

Under threat of lawsuit, The Coast apologizes for two words.

by Justin Ling

"Faced with allegations of defamation, political bias and being a Scientologist, news editor Tim Bousquet was forced to retract his story about Halifax's Liberal candidate, a popular antidepressant and a study that's been blackballed in the medical community.

And all because of two words."


Read the entire article here.



Further reading

legal document-deposition of Sally Laden (ghostwriter of PAXIL 329) pages 359/360

How about replacing your benzo with Seroquel? Weill Medical College of Cornell University's Dr. James Kocsis :past pharma income from AstraZeneca

Seroquel, Seroquel, Seroquel, Seroquel the antipsychotic wonder-drug, James Kocsis and AstraZeneca income

Major Depression
Generalized Anxiety Disorder


Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines

This study is currently recruiting participants.

Verified on November 2010 by Weill Medical College of Cornell University


First Received on November 18, 2010. No Changes Posted
Sponsor: Weill Medical College of Cornell University
Collaborator: AstraZeneca

Information provided by: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01244711

Contacts
Contact: James H Kocsis, MD 212 7465913 jhk2002@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065

Contact: James H Kocsis, MD 212-746-5913 jhk2002@med.cornell.edu

Principal Investigator: James H Kocsis, MD

Sponsors and Collaborators

Weill Medical College of Cornell University
AstraZeneca
More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University ( James H Kocsis, MD )


Dr. James Kocsis

"James H. Kocsis, MD is a Professor of Psychiatry at Weill Medical College of Cornell University, Attending Psychiatrist at the New York-Presbyterian Hospital and Director of the Affective Disorders Research Program at the Payne Whitney Psychiatric Clinic, all located in New York, New York. In addition, Dr. Kocsis is a member of the Adjunct Faculty at Rockefeller University."

Background

Dr. James Kocsis, MD

Cognitive Behavioral Analysis System of Psychotherapy and Brief Supportive
Psychotherapy for Augmentation of Antidepressant Nonresponse in Chronic Depression

The REVAMP Trial

James H. Kocsis, MD; Alan J. Gelenberg, MD; Barbara O. Rothbaum, PhD; Daniel N. Klein, PhD;
Madhukar H. Trivedi, MD; Rachel Manber, PhD; Martin B. Keller, MD; Andrew C. Leon, PhD;
Steven R. Wisniewski, PhD; Bruce A. Arnow PhD; John C. Markowitz, MD; Michael E. Thase, MD;for the REVAMP Investigators

Financial Disclosure:

Dr Kocsis reports receiving researchsupport from AstraZeneca, Burroughs Wellcome Trust, CNS Response, Inc, Forest Pharmaceuticals, the National Institute on Drug Abuse, the NIMH, Pritzker Consortium, and Sanofi Aventis;participating on the speakers bureau for AstraZeneca, Pfizer Inc, and Wyeth; and acting as a consultant to Wyeth.


Funding/Support: The REVAMP study was sponsored
by the NIMH.

All medications for this study were donated by Forest Laboratories, GlaxoSmithKline, Organon
Pharmaceuticals Inc, Pfizer Inc, and Wyeth Pharmaceuticals.

Role of the Sponsor: The NIMH had no further role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the paper for publication.

Previous Presentations: This study was presented in part at the 47th New Clinical Drug Evaluation Unit meeting; June 12, 2007; Boca Raton, Florida.
---


Looking at the list of his co-authors it appears these doctors run in packs regarding conflict of interest and "research". NIMH doled out the cash and took no further responsibility or accountability in the outcome of data interpretation, etc.

Currently James Kocsis is part of the Seroquel vs Lithium study at Weill Cornell Medical College, NewYork-Presbyterian Hospital.

Receive $450 for trialing Seroquel vs Lithium at Weill Cornell Medical College, New York Presbyterian Hospital

Study Investigating the Use of Quetiapine (Seroquel) and Lithium in Patients with Bipolar Disorder

Age: 18-68

Criteria: Patients who are experiencing symptoms of bipolar disorder and are willing to take Lithium or Seroquel

Duration/Length: 9 study visits over 6 months

Contact: Courtney Shelly at 212-746-5705

Location: Weill Cornell Medical College, New York Presbyterian Hospital

Reference #: 1007011132

Compensation: $50 per study visit.

Dr. James H.Kocsis:

James H. Kocsis, MD is a Professor of Psychiatry at Weill Medical College of Cornell University, Attending Psychiatrist at the New York-Presbyterian Hospital and Director of the Affective Disorders Research Program at the Payne Whitney Psychiatric Clinic, all located in New York, New York. In addition, Dr. Kocsis is a member of the Adjunct Faculty at Rockefeller University.

AstraZeneca spends $743 million in defense of Seroquel lawsuits, continues to trial Seroquel for the bipolar spectrum

AstraZeneca's blockbuster antipsychotic Seroquel will soon have a patent expiration and it appears that no DoJ fine or diabetes lawsuit can stop the company from going after the multiple use category for an antipsychotic.


Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression
Condition:
Acute Bipolar Depression
Interventions:
Drug: Quetiapine fumarate XR; Drug: Lithium carbonate
2
Completed
Quetiapine Fumarate (Seroquel) as Mono-Therapy or Adjunct to Lithium in the Treatment of Patients With Acute Mania in Bipolar Disorder
Condition:
Acute Mania in Bipolar Disorder
Interventions:
Drug: Quetiapine Fumarate; Drug: Lithium
3
Recruiting
A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative,Study
Condition:
Acute Bipolar Mania
Interventions:
Drug: Quetiapine fumarate; Drug: lithium
4
Recruiting
Multimodal Neuroimaging of Treatment Effects in Adolescent Mania
Conditions:
Mania; Adolescent; Bipolar
Interventions:
Drug: Quetiapine & Placebo; Drug: Lithium and Placebo; Other: Healthy Controls
5
Completed
Efficacy and Safety of Seroquel and Lithium as Monotherapy in Acute Mania Treatment in Bipolar Disorder Patients
Conditions:
Mania; Bipolar Disorder
Interventions:
Drug: Quetiapine Fumarate; Drug: Lithium
6
Completed
Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients
Conditions:
Major Depressive Disorder; Treatment Resistant Depression
Interventions:
Drug: Quetiapine XR; Drug: Lithium carbonate
7
Recruiting
Functional and Neurochemical Brain Changes in First-episode Bipolar Mania
Condition:
Bipolar
Interventions:
Drug: lithium; Drug: quetiapine
8
Unknown †
Treatment of Mania Symptoms With Drug Therapy

Conditions:
Bipolar Disorder; Schizophrenia
Interventions:
Drug: Divalproex-extended release (DVP-ER); Drug: Lithium; Drug: Quetiapine
9
Completed
Adult Bipolar Mania
Condition:
Acute Mania
Interventions:
Drug: Quetiapine fumarate XR; Drug: Lithium; Drug: Placebo
10
Recruiting
Comparative Effectiveness Study for Bipolar Disorder
Condition:
Bipolar Disorder
Interventions:
Drug: Lithium; Drug: Quetiapine
11
Completed
Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder
Conditions:
Bipolar I Disorder; Alcohol Dependence
Interventions:
Drug: Quetiapine fumarate; Drug: lithium; Drug: divalproex
12
Completed
Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
Condition:
Bipolar I Disorder
Interventions:
Drug: quetiapine fumarate; Drug: lithium; Drug: divalproex
13
Completed
Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
Condition:
Bipolar Disorder
Interventions:
Drug: Seroquel®, quetiapine fumarate (atypical antipsychotic); Drug: lithium (mood stabilizer); Drug: divalproex (mood stabilizer)
14
Completed
Seroquel in Bipolar Depression Versus Lithium
Conditions:
Bipolar Disorder; Bipolar Depression; Depression
Intervention:
Drug: Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)
15
Completed
Quetiapine Fumarate Bipolar Maintenance Monotherapy
Condition:
Bipolar Disorder
Intervention:
Drug: quetiapine fumarate
16
Recruiting
Efficacy of Quetiapine XR Versus Placebo as Concomitant Treatment to Mood Stabilizers in the Control of Subsyndromal Symptoms of Bipolar Disorder

Completed
Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy
Conditions:
Bipolar Disorder; Bipolar Depression
Interventions:
Drug: Quetiapine XR; Drug: sertraline
18
Completed
Treatment and Outcome of Early Onset Bipolar Disorder
Condition:
Bipolar Disorder
Interventions:
Drug: Lithium; Drug: Olanzapine; Drug: Divalproex; Drug: Risperidone; Drug: Quetiapine; Drug: Ziprasidone; Drug: Aripriprazole
19
Recruiting
Continuation Electroconvulsive Therapy (C-ECT) for Relapse Prevention in Major Depression
Condition:
Depression
Interventions:
Device: Thrymatron System IV device (CONSOLIDATION ELECTROCONVUsLIVE THERAPY) plus PHARMACOTHERAPY; Drug: PHARMACOTHERAPY
20
Recruiting
Quetiapine Sr As Adjunctive Treatment In Mixed States of Bipolar Disorder
Condition:
Mixed States in Bipolar Disorder
Intervention:
Drug: quetiapine SR

Recruiting
Brain Derived Neurotrophic Factor as a Predictor of Response to Treatment in Bipolar Depression and Mania: 16-weeks Follow-up With Quetiapine XR
Condition:
BIPOLAR DISORDER
Intervention:
Drug: quetiapine
22
Recruiting
Functional and Neurochemical Brain Changes Bipolar Depression
Condition:
Bipolar
Intervention:
23
Completed
Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder
Condition:
Bipolar Disorder
Interventions:
Drug: Lithium Carbonate; Drug: Optimized Treatment (OPT)
24
Terminated
Pilot Study of the Effects of Circadian Rhythms on the Treatment of Bipolar I Depression.
Condition:
Bipolar Disorder
Interventions:
Behavioral: IPSRT; Behavioral: Collaborative Care
25
Completed
Antidepressant Incomplete Response Depression
Condition:
Major Depressive Disorder
Intervention:
26
Recruiting
Brain Derived Neurotrophic Factor as a Predictor of Response to Treatment in Bipolar Depression and Mania
Condition:
BIPOLAR DISORDER
Intervention:
27
Recruiting
Treatment Resistant Depression in Bipolar Disorder - A Randomized Controlled Trial of Electroconvulsive Therapy
Condition:
Treatment Resistant Bipolar Depression
Interventions:
Procedure: Electroconvulsive therapy; Other: Treatment as usual
28
Unknown †
Effectiveness of Family-Focused Treatment Plus Pharmacotherapy for Bipolar Disorder in Adolescents
Condition:
Bipolar Disorder
Interventions:
Behavioral: Family-Focused Treatment Plus Pharmacotherapy; Behavioral: Enhanced Care Plus Pharmacotherapy
29
Completed
Treatment-Resistant Depression, Hippocampus Atrophy and Serotonin Genetic Polymorphism
Condition:
Major Depression
Intervention:
Other: Open label pharmacotherapy
30
Recruiting
Juvenile Bipolar Disorder Outpatient Program
Conditions:
Bipolar Disorder; Attention Deficit Disorder With Hyperactivity
Intervention:
Drug: Psychopharmacotherapy
31
Terminated
Treatment Resistant Bipolar Depression
Condition:
Bipolar Depression
Interventions:
Drug: Escitalopram; Drug: placebo

Completed
Quetiapine Extended Release (XR) in Bipolar Patients With Comorbid Generalized Anxiety Disorder (GAD)
Conditions:
Bipolar Disorder; Anxiety; Anxiety Disorders; Substance Use Disorders
Interventions:
Drug: Quetiapine XR; Drug: Placebo for quetiapine XR
12
Completed
Seroquel in Bipolar Depression Versus Lithium
Conditions:
Bipolar Disorder; Bipolar Depression; Depression
Intervention:
Drug: Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)
13
Recruiting
Efficacy of Quetiapine XR Versus Placebo as Concomitant Treatment to Mood Stabilizers in the Control of Subsyndromal Symptoms of Bipolar Disorder
Condition:
Bipolar Disorder
Interventions:
Drug: Quetiapine; Drug: Placebo

Seroquel in Bipolar Depression Versus SSRI
Conditions:
Bipolar Disorder; Bipolar Depression; Depression
Interventions:
Drug: quetiapine fumarate (Seroquel); Drug: paroxetine; Behavioral: mood stabilizing activity
17
Completed
A Randomized Control Trial Comparing Quetiapine to Risperidone in Bipolar Disorder With Stimulant Dependence
Conditions:
Bipolar Disorder; Cocaine Dependence; Methamphetamine Dependence
Intervention:
Drug: quetiapine, risperidone
18
Completed
Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
Condition:
Bipolar Disorder
Interventions:
Drug: Seroquel®, quetiapine fumarate (atypical antipsychotic); Drug: lithium (mood stabilizer); Drug: divalproex (mood stabilizer)
19
Unknown †
Quetiapine SR and Divalproex Sodium ER in the Treatment of Anxiety in Bipolar Disorder With Panic Disorder and/or GAD
Conditions:
Bipolar Disorder; Panic Disorder; Generalized Anxiety Disorder
Interventions:
Drug: quetiapine SR; Drug: divalproex sodium ER; Drug: placebo
20
Recruiting
Efficacy and Tolerability of Topiramate for the Treatment of Bipolar Mania and Alcohol Use in Adolescents and Young Adults
Conditions:
Bipolar Disorder; Alcohol Abuse
Interventions:
Drug: quetiapine + placebo; Drug: Quetiapine + Topiramate

Quetiapine for Bipolar Disorder and Alcohol Dependence
Conditions:
Bipolar Disorder; Alcohol Dependence
Intervention:
Drug: Quetiapine
26
Completed
Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder
Conditions:
Bipolar I Disorder; Alcohol Dependence
Interventions:
Drug: Quetiapine fumarate; Drug: lithium; Drug: divalproex
27
Completed
Pediatric Bipolar Depression
Condition:
Bipolar Depression
Interventions:
Drug: quetiapine XR; Drug: Placebo
28
Completed
Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy
Conditions:
Bipolar Disorder; Bipolar Depression
Interventions:
Drug: Quetiapine XR; Drug: sertraline

Completed Has Results
Study Comparing the Tolerability of Seroquel IR With Seroquel XR in Patients With Bipolar Depression
Condition:
Bipolar Depression
Interventions:
Drug: Quetiapine Immediate Release; Drug: Quetiapine Extended Release
32
Recruiting
Acute Psychotherapy for Bipolar II Depression
Conditions:
Bipolar Disorder; Depression
Interventions:
Drug: IPSRT plus placebo (IPSRT-PLA); Drug: IPSRT plus quetiapine
33
Completed
Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
Condition:
Bipolar I Disorder
Interventions:
Drug: quetiapine fumarate; Drug: lithium; Drug: divalproex
34
Completed
European Study to Describe Hospital Stay in Patients Admitted for Acute Bipolar Manic Episodes
Condition:
Acute Bipolar Manic Episode

Completed
A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder
Condition:
Bipolar I Disorder
Intervention:
Drug: Quetiapine
38
Unknown †
An Add-On Trial of Quetiapine in Patients With Bipolar Disorder and Cocaine Dependence
Conditions:
Bipolar Disorder; Cocaine Dependence
Intervention:
Drug: Quetiapine
39
Recruiting
Brain Derived Neurotrophic Factor as a Predictor of Response to Treatment in Bipolar Depression and Mania: 16-weeks Follow-up With Quetiapine XR
Condition:
BIPOLAR DISORDER
Intervention:
Drug: quetiapine

Recruiting
Functional and Neurochemical Brain Changes in First-episode Bipolar Mania
Condition:
Bipolar
Interventions:
Drug: lithium; Drug: quetiapine
45
Completed
Phase 3 /Seroquel SR Acute Mania Monotherapy - US
Conditions:
Affective Psychosis, Bipolar; Manic Disorder; Manic-Depressive Psychosis; Mania; Manic State; Psychoses, Manic-Depressive
Intervention:
Drug: Quetiapine fumarate (Seroquel) SR
46
Completed
Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling
Condition:
Bipolar Disorder
Intervention:
Drug: quetiapine fumarate or valproate
47
Completed
Effect of Quetiapine on Sleep Architecture in Bipolar Depression and Major Depressive Disorder
Condition:
Bipolar Disorder
Intervention:
Drug: Seroquel

---

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

Seroquel XR monotherapy vs. Seroquel XR plus Lithium: AstraZeneca sponsored study for acute bipolar mania in KOREA (STAR)

Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative, (STAR)

This study is currently recruiting participants.

Verified on April 2011 by AstraZeneca


Sponsor:
AstraZeneca

Information provided by:
AstraZeneca

ClinicalTrials.gov Identifier:
NCT01254721

Purpose

The primary objective of this study is to compare the efficacy of Seroquel XR monotherapy compared with Seroquel XR plus lithium in the treatment of acute bipolar mania by evaluation of the changes from baseline in Young Mania Ratings Scale (YMRS) total score to Day 29 using the last observation carried forward method.


Research Site

Recruiting

Changnyeong-gun, Gyeongsangnam-do, Korea, Republic of

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair:
Joon Woo Bahn

12th Floor, Hae Sung Building, No.2, 942-10, Daechi 3-dong, Gangnam-gu, Seoul, Korea (135-725)

Principal Investigator:

Yeon Ho Joo
Asan Medical Center, St. Asan medical center 86, Songpa-gu, Seoul Korea


Responsible Party:

AstraZeneca ( Marketing Company Medical Director )

ClinicalTrials.gov Identifier:
NCT01254721 History of Changes
Other Study ID Numbers:
D1443L00086

Study First Received:
December 3, 2010
Last Updated:
April 11, 2011

Health Authority:
Korea: Institutional Review Board
---

Note that the non XR version of Seroquel has already been trialed as monotherapy against Lithium add-on for bipolar mania in CHINA. Sponsored by AstraZeneca,and Health Authority: China: State Food and Drug Administration

Quetiapine Fumarate (Seroquel) as Mono-Therapy or Adjunct to Lithium in the Treatment of Patients With Acute Mania in Bipolar Disorder (MANIA)-This study has been completed. -CHINA

Audit report: 1 in 7 nursing home patients given antipsychotics

VIA PBS News Hour:

Audit Finds Widespread Use Of Anti-Psychotic Drugs In Nursing Homes‎
By: Betty Ann Bowser

As the Inspector General for the Department of Health and Human Services, Dr. Daniel Levinson is the person at the federal government who's in charge of protecting the integrity of programs like Medicare and Medicaid. That means he's also supposed to keep an eye on how those big budget health programs are working for you and me.

Recently, after his office reviewed thousands of medical records of seniors on Medicare, Dr. Levinson issued a disturbing report that found one in seven nursing home patients were given anti-psychotic drugs that may have increased their risk of sudden death.

The OIG report said 88 percent of the seniors who received the drugs had dementia. The Food and Drug Administration has stated very clearly that these drugs -- called atypical anti-psychotics -- should only be used to treat schizophrenia and bi-polar disorder, not dementia.

Continue reading the the article here.

Article excerpt from: Mind Drugs, Inc.: How Big Pharma and Modern Psychiatry Have Corrupted Washington and Destroyed Mental Health in America

Excerpt from forthcoming book Mind Drugs, Inc.: How Big Pharma and Modern Psychiatry Have Corrupted Washington and Destroyed Mental Health in America, By Christopher Byron

from The Fix:

America's Most Poisonous Pill

"It's not Adderall, or even Oxy. It's Klonopin, a highly-addictive prescription drug that doctors are doling out for an exploding list of unapproved uses, leading to unintentional overdoses, hellish withdrawals and thousands of deaths.

AND

"Seventies-era rock star Stevie Nicks is the poster girl for the perils of Klonopin addiction. In almost every interview, the former lead singer of Fleetwood Mac makes a point of mentioning the toll her abuse of the drug has taken on her life. This month, while promoting her new solo album, In Your Dreams, she told Fox that she blamed Klonopin for the fact that she never had children. “The only thing I’d change [in my life] is walking into the office of that psychiatrist who prescribed me Klonopin. That ruined my life for eight years,” she said. “God knows, maybe I would have met someone, maybe I would have had a baby."


Read the entire outstanding article, and excerpt HERE where the author covers the Harvard KOL Joseph Biederman, Big Pharma and more. It's spot on.

HAT TIP to PHARMAGOSSIP.

Lilly cuts jobs in Ireland: antipsychotic Zyprexa sales in 2010 topped $5 billion

VIA InPharm

Lilly is downsizing its plant in County Cork, Ireland due to patent losses, while the antipsychotic with diabetes black box warning and prior lawsuits by injured patients remained a top seller bringing in $5 billion in revenue in 2010.


hat tip to Pharmalot.


Zyprexa caused my daughter undue pain and suffering, a 100lb.+ weight gain, ocular crisis, and metabolic syndrome according to one doctor. The Zyprexa was illegally marketed by Lilly (documented in internal documents) and Lilly plead guilty to the crime. I find it astounding that doctors still prescribe this drug.

Read this:

Eli Lilly Pleads Guilty to Illegal Marketing of Zyprexa
By Marilyn Mann, 1 U.S. Securities and Exchange Commission, Washington, DC

I. Off-Label Marketing of Zyprexa

On January 15, 2009, the Department of Justice announced 2 that Eli Lilly and Company (Lilly) had agreed to plead guilty and pay $1.415 billion for promoting its drug Zyprexa (olanzapine) for uses not approved by the Food and Drug Administration (FDA). This included a criminal fine of $515 million, the largest ever in a health care case, and the largest criminal fine for an individual corporation ever imposed in a U.S. criminal prosecution. The criminal information 3 charged the company with promoting Zyprexa for such unapproved uses as treatment for dementia in elderly persons. In the plea agreement Lilly admitted its guilt to a misdemeanor criminal charge. It also entered into a civil settlement agreement under which it will pay up to an additional $800 million to the federal government and certain state governments to resolve civil allegations originally brought in four separate lawsuits under the qui tam provisions of the federal False Claims Act."

AND

"Lilly’s promotion of Zyprexa for dementia was far from a victimless crime. Zyprexa and other antipsychotics have been linked to an increased risk of death in elderly patients 10 and have also been shown to be of little or no value in reducing dementia-related symptoms. 11 Zyprexa can also cause significant weight gain, elevated cholesterol levels and diabetes. 12 Thus, the available medical evidence suggests that Lilly’s off-label marketing of Zyprexa led to widespread adverse effects and a significant number of deaths."

III. Conclusion

While it is easy to find fault with pharmaceutical companies that promote drugs for off-label uses, it also should be recognized that pharmaceutical companies do not directly administer drugs – physicians do.

Owing to recent revelations about the influence of the pharmaceutical industry over the practice of medicine, 19 public perception of the relationship of the drug industry, doctors and scientists is at an historic low. 20 A number of proposals for increased transparency in relationships between the pharmaceutical industry and medical profession are being circulated. 21 Several states have enacted laws that require disclosure of payments made by pharmaceutical companies to physicians, 22 and similar legislation that would impose such requirements on a national level has been introduced in Congress. 23 To this observer, it seems likely that the trend will be toward increased disclosure of financial relationships between the medical profession and the pharmaceutical industry as health reform proposals are enacted over the next couple of years."

-Marilyn Mann is a branch chief in the Division of Investment Management, U.S. Securities and Exchange Commission
---

Yes, I agree this was far from a victimless crime and I am the mother of one of the victims who was prescribed this drug under age 18 when the drug was not approved for use for children under age 18 (try age 11!) No one can give a child or teen those years back.

Lilly earning sales revenue of $5 billion dollars in 2010 while my daughter learns to talk, read and write again and will never be the same, ever.

*my photographs of Zyprexa bottles that were my daughter's.

Florida's doctors hired to evaluate kids in state custody are paid by pharma: Seroquel in the Florida Juvenile Justice system

VIA Palm Beach news:

"Florida has plied children in state juvenile jails with heavy doses of powerful antipsychotic medications.

The pills, widely viewed as the "big guns" of psychiatry, can cause suicidal thoughts and other dangerous side effects.

Yet, in state-run jails and residential programs, antipsychotics were among the top drugs bought for kids - and they routinely were doled out for reasons that never were approved by federal regulators, a Palm Beach Post investigation has found.

Reacting to the newspaper's findings, the head of Florida's Department of Juvenile Justice ordered a sweeping review of the department's use of antipsychotic medications. As it stands now, DJJ doesn't track prescriptions and has no way of telling whether doctors are putting kids on pills simply to make them easier to control.

"This is a very important issue," said Broward County Public Defender Howard Fink­elstein, whose office represents children in juvenile court. "If kids are being given these drugs without proper diagnosis, and it is being used as a 'chemical restraint,' I would characterize it as a crime. A battery - a battery of the brain each and every time it is given."

In some cases, the drugs are prescribed by contract doctors who have taken huge speaker fees and other gifts from makers of antipsychotic pills, companies that reap staggering profits selling medications, The Post found.

The medications have poured out at such a rate, said one former inmate, that even a confused teenager could tell that this wasn't how things were supposed to be.

"The questions recently brought to our attention are serious, and deserve answers based on a careful, thorough and independent review of the facts," said Wansley Walters, who was appointed DJJ secretary in January by Gov. Rick Scott. Citing the ongoing probe, Walters declined to answer questions about how the department has handled the potent medications.

A look at the sheer numbers of drugs purchased, though, suggests a startling story is unfolding in state homes for wayward kids.

In 2007, for example, DJJ bought more than twice as much Seroquel as ibuprofen. Overall, in 24 months, the department bought 326,081 tablets of Seroquel, Abilify, Risperdal and other antipsychotic drugs for use in state-operated jails and homes for children.

That's enough to hand out 446 pills a day, seven days a week, for two years in a row, to kids in jails and programs that can hold no more than 2,300 boys and girls on a given day."

Continue reading the article HERE.

Where you'll find this:

"For kids in DJJ custody, the state buys enough Seroquel to make such doses possible: More than 217,500 tablets in 24 months . The department bought more of the heaviest Seroquel tablets, at 400 milligrams, than it did of any of five lighter tablets.

DJJ has continued dispensing the drug even though Florida has claimed it was harmful. In March, the state alleged in a lawsuit against AstraZeneca, the maker of Seroquel, that the drug "produced dangerous side effects."

The Seroquel regimens described by Paula amounted to alarmingly high doses, said Dr. Glenn Currier, an associate professor of psychiatry at the University of Rochester in New York."

and this: No informed consent

"In at least 40 cases since 2008, DJJ files have lacked proof that parents or guardians gave consent before children were put on medications, were apprised of possible side effects or told that doctors were adding drugs or adjusting dosages.

At Impact House, a residential program in Jacksonville, one child was put on drugs, taken off them, or had dosages and combinations adjusted six times in a six-month period. He began on Risperdal and ultimately was put on Seroquel. His files contained no evidence that anybody ever had notified his parents to gain consent."

---
22% increase of antipsychotics prescribed to pediatric age group

This is becoming standard practice, whether people want to believe it or not. It should not take news investigative stories such as this to expose the fact that children are being given antipsychotics as chemical behavior control treatment.

Antipsychotics are being dosed out as if they are not potent neuroleptics with serious side effects and black box warnings. Casual abuse by doctors and systems such as this one in Florida is a crime being committed against the children of America and it needs to be stopped. NOW.


Increase in pediatric through teen antipsychotic rx's increase 22% according to this FDA report-pdf:

5 CONCLUSIONS

"All of the antipsychotic agents studied except for olanzapine had an increase in the number of dispensed prescriptions over the past 5 years.

Dispensed prescription for Abilify® (aripiprazole) increased the greatest amount (135%). Antipsychotic use among pediatric patients aged 0-17 years have increased 22% over the past 5 years. Use among pediatrics aged 0-2 years and 3-6 years accounted for less than 1% of the total for each of the antipsychotic agents studied.

Risperidone *(Risperdal) was the most commonly dispensed atypical antipsychotic agent among pediatrics, especially those aged 7-12 years. Aripiprazole pediatric prescriptions are most commonly dispensed to adolescents aged 13-17 years.

Trends for patient data were similar to that of prescription data. Psychiatrists prescribe the majority of antipsychotic prescriptions dispensed. In younger children (7-12 years old), concomitant use with stimulant medications were most common for aripiprazole, risperidone and olanzapine. *(Zyprexa)

Mood stabilizing agents, other antipsychotics and antidepressants were the most common concomitant class of products used with quetiapine *(Seroquel) and ziprasidone in this age group as well as for older age groups."

---

Has America had a sudden surge in psychosis and reason for medicating psychotic children under age 17, or is there another reason? could it be the heavy hand in pharmaceutical DTC and influence via payments to doctors, drug reps to offices, and parents seeking help for children via medication? what are the answers?

What happens to this generation of children? will they learn to cope and be resilient adults in crisis?

Will these children become life time recipients of disability via SSI and Medicaid/Medicare and end up being part of the broken mental health system in America that has a revolving door to psych wards and little to offer for out patient care other than a case manager and a medication rx?


Do you care about the future of 1 million children on antipsychotics


Are you a taxpayer? If you care about the government housing these children and drugging them on your dollar you should.

Then consider the human aspect of the situation. These kids have not been given a choice to take these life altering medications. Many have lacked informed consent. Many parents have lacked informed consent. This is a crisis, and the children of America are suffering at the hands of big industry calling the shots.

*I am a parent, with a child who was thrust into the mental health system the last decade, and I have witnessed horrors in the system no one should ever have to... the injustice happening to kids is heartbreaking and many are foster kids and wards of the state. I am not a Scientologist or affiliated with that group or anyone else.

AGIS one of the largest healthcare insurers in the Netherlands is causing undue pain and suffering for MS patient

Agis is one of the largest health care insurers in the Netherlands. AGIS has a disabled woman with MS and mostly bedridden waiting for support cushions for approximately 3 months.

This is the latest of the bed support cushion saga from Herrad:

"Still no news about the support cushions that I was supposed to get on Tuesday, an hour before the appointment my occupational therapist rang to cancel the appointment.


Johanneke was angry to have to be the one to tell me the bad news; luckily she had the faxes with agreement from my health insurance that we could order the cushions.


She hopes that she can persuade Agis to pay for the cushions, as per the agreement with them.


That was in March, Johanneke then asked Quattron, on 2nd April to make the support cushions.


I was led to believe this would take two weeks, finally some weeks ago I heard they would be here on 17th may.


Feeling let down by them all, February we had an appointment with a representative from Quattron.


Dennis told us once Agis gave the go ahead they could be made in two weeks; Johanneke said getting the ok from Ages was a formality.

Now Agis and Quattron have a disagreement and until that is resolved no support cushions for me or anyone else."-Herrad 5-20-11

--

Her husband and full-time caregiver, Richie:

"Friday, May 20, 2011
Agis screw up again.

When some one puts up a real fight to make something good out of a bad situation I would have thought the organisations that are there to support them would be able to do their part.

Herrad has been let down again.

Her muscles do not support her torso so she can not sit up- she slowly moves to one side or the other and has to be sat up to stop unbearable strain being placed on her neck- she has a neck injury which is easy to aggravate and causes great pain. I prop her up best I can with cushions and on a good day this enough- on a bad day I have to correct her position every few minutes.

Her medical team advised a special cushion be made to give her the support that will make her able to sit comfortably. The insurance company (Agis) agreed and she was measured up. The cushion was to be delivered this week but Agis is now in dispute with the supplier so they have stopped the whole deal.

We find out on the day the cushion should arrive."-Richie, 5-20-11

Agis: website

"We also execute the Exceptional Medical Expenses Act for 3 million Dutch citizens. This makes us one of the largest healthcare insurers in the Netherlands. Apart from the basic insurance package we provide supplementary insurance packages for both the individual and the collective market.Agis operates nationwide in the Netherlands with Amsterdam, Utrecht/Amersfoort and Apeldoorn as our core regions.
In all our activities the customer is the focal point and we are always working on improvements in healthcare from that perspective. Quality is a key issue and we use validated experiences of patients to help care providers to improve their services."

--

My Open letter to AGIS

Richie and Herrad have waited long enough and the treatment and service provided by the insurance company and cushion maker are unacceptable.

Herrad is bed-bound with fast progressing multiple sclerosis and cannot wait one more day to recline safely in bed, nor should her husband and caregiver have to constantly adjust her body for comfort due to not having the cushions for support that were orderd and promised by a set date.

The incompetence has reached a level of unacceptable and this patient is suffering as a result of that incompetence. It is quite apparent this company does not take patient suffering seriously, nor places patients as the "focal point".

Please remedy this situation within the next week.

Thank you.

inspiration

Climb every mountain,

Search high and low,

Follow every highway,

Every path you know.

Climb every mountain,

Ford every stream,

Follow every rainbow,

'Till you find your dream.

A dream that will need

All the love you can give,

Every day of your life

For as long as you live.

Climb every mountain,

Ford every stream,

Follow every rainbow,

Till you find your dream

A dream that will need

All the love you can give,

Every day of your life,

For as long as you live.

Climb every mountain,

Ford every stream,

Follow every rainbow,

Till you find your dream.

-Sound of Music

'climb every mountain'

Medical Schools plug holes in Conflict-of-Interest policies: ProPublica Dollars for Docs, Stanford and Kiki Chang

VIA ProPublica Medical Schools Plug Holes in Conflict-of-Interest Policies:

"Stanford University has taken disciplinary action against five faculty members at its medical school after determining they violated school policy by giving paid promotional speeches for drug companies, a spokesman said."

AND

"Paul Costello, a Stanford spokesman, declined to identify the disciplined faculty members or discuss their penalties. But in a written statement, he said the "actions are significant" and have or could impact the doctors' compensation or positions.

Stanford is one of several medical schools that took action against faculty members, overhauled conflict-of-interest policies, or provided additional education to staff members following ProPublica's report."

*The ProPublica article does not list Chang as one of the 5 faculty members who received disciplinary action.

But I suspect he could be. That's my opinion.

This is my connecting of the "dots" I've been watching and writing about for a long time. I had found Chang in Dollars for Docs in December 2010, and knew of Stanford's COI policy.

One would hope Kiki Chang, a KOL in the child bipolar arena is not conflicted with current pharma income, but one must always question this type of authority that directly influences parents of children.
---

Dollars for Docs database

Kiki Chang , Stanford; Advisory board at CABF (Child Adolescent Bipolar Foundation)

Dollars for Docs:

CHANG, KIKI Calif. Stanford Eli Lilly $5,963 2009

Q1-Q4 Healthcare Professional Education Programs: $1463.0, Advising/Consulting and International Education Programs: $4500.0 CHANG, KIKI

Just say no to drugging of kids for profit: APA annual meeting had protestors

Their signs say:

Psychiatry: drugging kids for profit

Stop Psych Drugging of Children


*photograph courtesy of an anonymous APA 2011 attendee

NIMH sponsored study results presented at APA annual meeting: Add-On Lithium No Help in Bipolar Disorder

The APA (American Psychiatric Association)is reporting news at their annual meeting based on studies and this is one of those studies.

From Clinical trials gov

Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder (LiTMUS)

This study has been completed.


First Received on April 24, 2008. Last Updated on July 22, 2010 History of Changes
Sponsor: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00667745

Purpose
This study evaluated whether lithium included as part of optimized medication treatment improved overall level of illness, symptoms of mania and depression, and quality of life in people with bipolar disorder.


Condition Intervention Phase
Bipolar Disorder
Drug: Lithium Carbonate
Drug: Optimized Treatment (OPT)
Phase IV



Detailed Description:
Bipolar illness, a brain disorder that causes dramatic changes in a person's mood and energy, affects about 2.6% of adults in the United States. Bipolar disorder is characterized by cyclical periods of extreme highs and lows, known as episodes of mania and depression. A person undergoing an episode of mania often experiences euphoric moods, increased energy, and aggressive behaviors, while a person in a depressed state often experiences low moods, lack of energy, and feelings of sadness. Lithium is a widely used mood stabilizing medication that has been shown to reduce the occurrence and intensity of manic episodes and may lessen depressive episodes as well. Including lithium as a part of a personalized medication treatment approach may be the most effective means of improving symptoms of bipolar disorder. This study will evaluate whether lithium included as part of optimized medication treatment improves overall level of illness, symptoms of mania and depression, and quality of life in people with bipolar disorder.

Participation in this study lasted for 6 months. All participants had an initial assessment that included an interview and questionnaires to confirm a diagnosis of bipolar disorder, vital sign measurements, a blood draw, and if female, pregnancy. Eligible participants were then assigned randomly to receive either optimized medication plus lithium or optimized medication without lithium. Participants in both groups received 6 months of monitored treatment with their medication regimens, as prescribed by their study doctor. Participants attended study visits every 2 weeks for the first 8 weeks and then once a month for 4 more months. These visits lasted between 45 and 60 minutes and included medication adjustments and questions about symptoms, side effects, and quality of life.

We would like to acknowledge that medication was kindly donated by Ortho-McNeil Janssen Scientific Affairs, LLC. "

From MedPageToday: Add-on Lithium no help for bipolar

"HONOLULU -- Lithium carbonate added to guideline-directed mood stabilizer therapy for bipolar disorder provided little benefit but increased the adverse effects in a major trial, researchers said here.

Results from the closely watched LiTMUS (Lithium Treatment Moderate Dose Use Study) trial showed no difference in the two primary endpoints among patients receiving lithium plus optimized mood stabilizer therapy compared with mood stabilizers alone, said Joseph R. Calabrese, MD, of Case Western Reserve University in Cleveland.

But adverse effects were more frequent early in the 24-week trial, he told attendees here at the American Psychiatric Association's annual meeting.

Still, he said the 283-patient trial didn't rule out a possible benefit for lithium in patients more able to tolerate the drug.

One-third of patients in the study required dosage adjustments because of adverse effects related to lithium treatment. Calabrese said results of a so-called responder analysis were still pending, but it may be that lithium was significantly beneficial in the other two-thirds of patients.

Lithium was once the standard of care for maintenance therapy in patients with bipolar disorder, but it has lost favor with clinicians in recent decades because of its adverse effects and need for blood-level monitoring for dose titration.

Anticonvulsants such as carbamazepine and second-generation antipsychotic drugs including olanzapine (Zyprexa) and risperidone (Risperdal) have taken lithium's place because of their mood-stabilizing effects in bipolar disorder.

But clinicians have been unsure whether combining these agents with lithium would improve outcomes. Consequently, the National Institute of Mental Health stepped in to sponsor the LiTMUS trial, which the mental health community hoped would settle the question.

The trial was patterned loosely after the successful STAR*D study of antidepressant therapy, using broad inclusion criteria in an effort to mirror real-world treatment patterns."

"The trial was sponsored by the National Institute of Mental Health. Ortho-McNeil-Janssen supplied study medications.

Calabrese reported consulting or speaking fees from Abbott, AstraZeneca, Bristol-Myers Squibb, Cephalon, Dainippon Sumitomo, EPI-Q, Forest, France Foundation, GlaxoSmithKline, Janssen, Johnson & Johnson, Lundbeck, Ortho McNeil, Otsuka, Pfizer, Repligen, Servier, Solvay, Supernus, Synosia, Takeda, Wyeth-Ayerst, Merck, sanofi aventis, and Schering-Plough."
--

Dr. Joseph Calabrese

Professor of Psychiatry
Director, Division of Ambulatory Care
Director, Mood Disorders Program
Co-Director, Bipolar Disorder Research Center, Case Western Reserve University

Dollars for Docs database

CALABRESE, JOSEPH RICHARD

Ohio Cleveland Pfizer $806 2009

Q3-Q4 Professional Advising: $350.00, Business Related Travel: $456.00 CALABRESE, JOSEPH RICHARD

Calabrese, Joseph Ohio Cleveland GSK $11,500 2009

Q2-Q4 Consulting: $11500.00 Speaking: $0 Joseph Calabrese

Calabrese, Joseph Ohio Cleveland GSK $7,000 2010

Q1-Q3 Consulting: $0.00 Speaking: $7000.00 Joseph R Calabrese


*photograph courtesy of an anonymous APA 2011 Annual meeting attendee from France