Wednesday, August 31, 2011

Charges dropped against Detroit mom in the 'Risperdal' stand-off

News from the Detroit Free Press

Charges have been dropped against Maryanne Godboldo , who was accused of firing a gun at Detroit police officers when they accompanied CPS to remove her daughter from the home, due to the mother not giving the child the antispsychotic Risperdal.

from the article:

"The charges against Godboldo were dismissed at her preliminary examination in 36th District Court in Detroit. Judge Ronald Giles agreed with her lawyers that the court order to remove Godboldo's 13-year-old daughter was not valid."

AND

"She was accused of firing a gun at police who had accompanied a state Child Protective Services employee to Godboldo's home on Blaine on March 24.

The employee had a Juvenile Court order to take Godboldo's 13-year-old daughter after Godboldo had been accused of neglecting her by discontinuing a psychotropic drug. Godboldo has maintained she has the right to decide her daughter's medical treatment.

Police said Godboldo barricaded herself in her home with her daughter and shot at them.

After hearing testimony at Godboldo's preliminary examination in 36th District Court on Monday in Detroit, Judge Ronald Giles ruled that the court order was not valid and that there was insufficient evidence that Godboldo fired at police officers."

AND

"Godboldo, whose daughter is now in the custody of her sister Penny Godboldo, is working to get her child back."

Read further here.


Back story articles at the Detroit Press.

Saturday, August 27, 2011

Alternatives to Psychiatry Conference 2011: ISEPP featuring Robert Whitaker, Thomas Szasz, M.D. and more



ISEPP Conference October 28-29, 2011 Los Angeles, CA

from the site:

International Society for Ethical Psychology and Psychiatry (ISEPP)

October 28-29, 2011 in Los Angeles, CA @ Double Tree by Hilton
13+ CEUs available for psychologists, MFTs, counselors, social workers & nurses!

FOR MORE INFO, DOWNLOAD OUR BROCHURE / CLICK HERE TO REGISTER FOR CONFERENCE!

Topics Include:

    • Safe, humane, life-enhancing methods of treating adults, children, families and couples in psychological distress without reliance on psychotropic drugs.
    • Consumer-centered interventions that help people move towards full recovery.
    • Restoring psychotherapy as a first-line intervention in behavioral health.
    • What parents and families can do to help children without reliance on psychotropic drugs.
    • Withdrawing from psychotropic drugs: Clinical indications, safety and supervision concerns.
    • The impact of the pharmaceutical industry on evidence-based clinical mental health practice.
    • Treating children and adults with integrative care.

    Panel Presentations, Roundtable Discussions, Meet the Authors & More!

    • Psychotherapist Panel: Experts Discuss How They Work, Followed By Breakout Sessions on Each Clinical Approach!
    • Early Psychosis Intervention Panel: How Can We Best Help Those in Crisis?
    • Psychiatric Survivors Panel: Consumers Relay Their Experiences in the Mental Health System. Panel members include Nancy Rubenstein Del Giudice.
    • Evidence-Based Literature Panel: What Clinicians Should Know About the Scientific Literature.
    • The Bipolar Child Panel: Analyzing an Epidemic.
    • 50 years after “The Myth of Mental Illness”: Reflections on modern psychiatry.

    Confirmed Speakers (This list is being updated daily; our schedule is available here).

    • Paula J. Caplan, Ph.D.
      "When Johnny and Jane Came Marching Home: How All of Us Can Help Veterans"
    • Nicholas Cummings, Ph.D
      "Restoring Psychotherapy as a First-Line Intervention"
    • Thomas Szasz, M.D.
      "Varieties of Psychiatric Criticism"
    • Robert Whitaker
      "Psychiatry's Response to Anatomy of an Epidemic: What the Emperor Says When He Has No Clothes"





    Go here to see the entire speaker line up and other information about this alternative psychiatry conference, held in October in Los Angeles, CA.

    Friday, August 26, 2011

    summer happens

    wild blackberry pie


    6 cups of wild blackberries just picked, baked to perfection, served hot with vanilla ice cream, ahh summer happens.

    Thursday, August 25, 2011

    AstraZeneca's elite sales force: doctors, institutions, research organizations and politicians

    VIA Seroquel Lawsuit Blog

    AstraZeneca has posted the Q1 (first quarter) financial report for 2011. The report includes payments to physicians, institutions (Harvard (Mass General), Yale, etc) research organizations and political campaign contributions.

    It's quite apparent that funding of doctors and politicians has a lucrative pay off for the pharmaceutical company, once you take a look at the reports, you can see how intertwined the business world, political world and pharmaceutical world are...the force behind the machine is massive. The sales of the billion dollar blockbuster antipsychotic is prime example of an elite and influential sales force in action. The sales force isn't what you expect, when considering the report is not a database of pharmaceutical sales representatives, instead it's a sales force of KOLs (Key Opinion Leaders), doctors and political campaigns where AstraZeneca pays the best of the best in their eyes, because they promote their agenda and products in various ways.

    The AstraZeneca Q1 payments are example of the strong foothold pharmaceutical companies have in America's fabric, intricately woven and delicate, America appears to be a corporate funded country, which is highly influenced by corporations such as AstraZeneca. Americans on average probably have no idea just how influential the company is, but when you take a look at the payment reports, it becomes crystal clear. The word stakeholdercomes to mind.

    AstraZeneca's political contributions Q1 2011.........




    Continue reading AstraZeneca's elite sales force: doctors, institutions, research organizations and politicians at the Seroquel Lawsuit Blog.


    Medication price comparison tool

    VIA Pharmagossip

    Great medication price comparison shopping tool for 2 cities: Chicago & Fortworth/Dallas.

    Article

    "Chicago Internist Leslie Ramirez Has Built A Poweful Tool For Health Care Price-Shopping

    You hand over the prescription to the pharmacist after waiting in line at the drop-off window. It’ll be ready in twenty minutes, he says. So you go and read a magazine, do a couple laps around the store, and then wander back. Finally your pills are ready. Here’s a question. Do you have any idea what the bill will be?

    If you’re like me you don’t know if it’s going to be $5 or $175. If the former, there’s a sigh of relief. If the latter, hopefully insurance will step up. If insurance denies payment, you can always wait a few more days to see if the problem goes away on its own.

    There are few transactions more byzantine than those at the pharmacy counter. And what makes it more frustrating is that pharmacists and doctors rarely help. When prescribing an eye drop or filling a statin prescription, they offer little information on what it will cost. If you ask they’ll say that it depends on your insurance. That’s true, but not helpful.

    Leslie Ramirez, an internist working in Chicago, decided to build an simple and elegant Web solution. Ramirez has a practice with lots of uninsured and under-insured patients who would incur out-of-pocket prescription expenses. “It’s sad and it’s frustrating to hear patients say, ‘I didn’t get my blood pressure medicine because it was $100, even though you told me I was about to get a stroke’,” she says.

    Two years ago Ramirez spent $20,000 of her own money to build the first version of a Web site that lists actual pharmacy prices. She got the data by calling around to pharmacies in Chicago and getting price quotes for common pills. The list grew to include 550 different drugs and she had to hire helpers to make the calls, though as the site grew in popularity, pharmacies began sending in their own updated price lists.

    What she found surprised her. There was no rhyme or reason to any of the pricing. Take Glucophage, a common treatment for diabetes. In Chicago Walgreens charges 4 cents a pill if you buy 270 while CVS charges 38 cents a pill in groups of 60. What other industry has 9x variance?"

    via FORBES.

    I checked Chicago prices for antipsychotics quetiapine (Seroquel) and Abilify prices, and WOW!

    30- 100mg Seroquel from $180-248

    Quetiapine Fumarate (also known as Seroquel)

    Non-Generic 100 mg
    PHARMACY PRICE QUANTITY UNIT PRICE LAST CHECKED
    Walgreens
    w Savings Card
    $180 30 tablets $6.00 2/1/2011
    Costco
    no club membership required to use pharmacy
    $184 30 tablets $6.13 3/13/2011
    Walmart

    $187 30 tablets $6.23 3/6/2011
    Osco
    you can ask this pharmacy to price match
    $192 30 tablets $6.40 4/28/2011
    CVS

    $197 30 tablets $6.57 6/23/2011
    Target

    $206 30 tablets $6.87 7/17/2011
    Walgreens

    $248 30 tablets $8.27 7/18/2011


    ABILIFY (Aripiprazole) $545-$696 for 30 5 mg tablets

    Use the handy and easy to use tool HERE at Leslie's List. Great tool, I hope it expands to other cities.

    Point of Law news: Seroquel mass tort settlement?

    VIA Point of Law:

    Seroquel mass tort settlement?

    Alison Frankel is reporting claims that the last major chunk of the Seroquel litigation is settling confidentially at the nuisance rate of about $92 million for 2300 claims (after the first 25000 or so cases settled for an even smaller $647 million). These are figures that reflect avoiding the costs of defense rather than any risk of loss. Some plaintiffs who envisioned big pots of gold after being recruited by firms that advertised for Seroquel plaintiffs and then had their claims sold en masse to the chicken pluckers are disgruntled, but mass-tort litigation is designed to benefit the attorneys, rather than any plaintiffs, victims or otherwise. (Separately, I find it fascinating that attorneys are not allowed to hire runners to recruit clients—with the result that some attorneys effectively act as "chicken-catchers" indistinguishable from runners.)-Ted Frank

    Further reading:

    U.K. alert: antipsychotic Seroquel XL 50 mg tablets and pain relief med Nurofen Plus mix up in U.K.

    VIA Pharmagossip:

    THURSDAY, AUGUST 25, 2011

    Class 4 Drug Alert (Caution in use): Reckitt Benckiser (UK) Ltd - Nurofen Plus Tablets containing rogue Seroquel XL 50mg tablets - EL (11)A/21 : MHRA
    Reckitt Benckiser (UK) Ltd has received three reports of rogue Seroquel XL 50mg tablets in cartons of three different batches of Nurofen Plus tablets. We understand cartons of Nurofen Plus tablets contained only rogue cut-down blisters of Seroquel XL tablets and no Nurofen Plus tablets were present. The rogue Seroquel XL tablet cut-down blisters included parallel imported tablets (from two different PLPI companies) and originator product.

    The three batch numbers in the table above are the numbers on the Nurofen Plus tablet cartons which can be used to identify the at-risk stock.

    Seroquel XL tablets are made by a different company (AstraZeneca) at a different site. Manufacturing errors by Reckitt Benckiser and AstraZeneca are not considered to be part of the cause at this stage.

    We have some information to suggest possible links between these cases. It is possible that these problems are linked to product consolidation and/or erroneous examination of returns. Work is ongoing to obtain more information but the full facts may never be fully established.

    Recipients are requested to remain vigilant about this issue and requested to report any further cases or additional concerns promptly to DMRC on 020 3080 6574.

    There are marked visual differences between the two products but we have been informed that two patients took Seroquel XL instead of Nurofen Plus tablets.

    For medical information enquiries related to Seroquel XL Tablets please contact AstraZeneca Ltd medical information department on 0800 783 0033. For medical information enquiries related to Nurofen Plus Tablets please contact Reckitt Benckiser (UK) Ltd medical information department on 0500 455 456.

    Recipients of this Drug Alert are requested to bring it to the attention of relevant professionals by copy of this letter. Primary Care Trusts are asked to forward this information to General Practitioners, Community Pharmacists and relevant clinics by copy of this letter.

    Yours faithfully
    Ian Holloway
    MHRA DMRC Manager

    from MHRA gov in U.K.


    Dear Healthcare Professional,
    Reckitt Benckiser (UK) Ltd
    Nurofen Plus tablets
    PL 00327/0082 and PL 00063/0376

    Nurofen Plus Tablets containing rogue Seroquel XL 50mg tablets PL 00327/0082 and PL 00063/0376
    Pack size Batch number Expiry date PL First distributed
    32 Tablets 13JJ 03/2014 00327/0082 30 April 2011
    32 Tablets 57JJ 05/2014 00063/0376 21 June 2011
    32 Tablets 49JJ 05/2014 00063/0376 1 July 2011
    Reckitt Benckiser (UK) Ltd has received three reports of rogue Seroquel XL 50mg tablets in cartons of three different batches of Nurofen Plus tablets. We understand cartons of Nurofen Plus tablets contained only rogue cut-down blisters of Seroquel XL tablets and no Nurofen Plus tablets were present. The rogue Seroquel XL tablet cut-down blisters included parallel imported tablets (from two different PLPI companies) and originator product."

    Nurofen:(wikipedia)

    Nurofen is the brand name of a range of pain-relief medication made by Reckitt Benckiser. Introduced in 1983, the Nurofen brand was acquired following Reckitt Benckiser's acquisition of Boots Healthcare in 2005. The brand is primarily marketed and sold in the United Kingdom, other parts of Europe, Australia and New Zealand.[1]
    There are 11 variants of Nurofen, all of which contain the analgesic ibuprofen as the active ingredient. Ibuprofen was developed by the research arm of Boots. Some variants of Nurofen contain other active ingredients; for example, Nurofen Cold & Flu contains the non-sedating decongestant pseudoephedrine. Nurofen can help reduce back pain, menstrual pain, fevers or headache.

    Nurofen Plus
    Nurofen Plus is a pain relief medication based on codeine and ibuprofen."


    VA spent $846 million for more than 6.6 million prescriptions of Seroquel for soldiers


    VIA National Journal:

    VA Spent $717 Million on a Drug Deemed as Effective as a Placebo

    ..."Although the paper focused on risperidone, its authors also questioned the effectiveness of other second-generation antipsychotic drugs, including Seroquel, also known by its generic name, quetiapine. The VA told Nextgov that it spent $846 million on Seroquel over the past decade for more than 6.6 million prescriptions.

    Besides prescribing Seroquel for use as an antipsychotic drug, both VA and Defense Department physicians prescribe it as a sleep aid, even though the drug has been implicated in the deaths of two Marines who took large doses."


    Unbelievably reckless prescribing practices, placing soldiers at risk for sudden death via box warning for QT Prolongation, diabetes, weight gain, for a sleep aid! Seroquel is an antipsychotic, so is Risperdal. They are hardly simple sleep aids. I wonder if the veterans were given true informed consent when they were prescribed Seroquel for sleep?


    Hat tip to SEROQUEL LAWSUIT BLOG.

    VA spends $717 million proving antipsychotic Risperdal is no better than placebo for PTSD

    VIA National Journal


    "Over the past decade, the Veterans Affairs Department spent $717 million for an antipsychotic drug to treat post-traumatic stress disorder that a recent study shows is no more effective than a placebo.

    Data provided by the department in response to a Nextgov query showed that VA doctors wrote more than 5 million prescriptions for risperidone from October 2000, the beginning of fiscal year 2001, through June 2010. Risperidone is the generic name for Risperdal, a second-generation antipsychotic drug originally developed by the Janssen Pharmaceuticals division of Johnson & Johnson to treat severe mental conditions such as schizophrenia and bipolar disorder.

    But a paper by VA researchers published on August 2 in the Journal of the American Medical Association concluded, "Treatment with risperidone compared with placebo did not reduce PTSD symptoms."






    Adjunctive Risperidone Treatment
    for Antidepressant-Resistant Symptoms
    of Chronic Military Service–Related PTSD


    Context

    Serotonin reuptake-inhibiting (SRI) antidepressants are the only FDAapproved pharmacotherapies for the treatment of posttraumatic stress disorder (PTSD).

    Objective

    To determine efficacy of the second-generation antipsychotic risperidone as an adjunct to ongoing pharmacologic and psychosocial treatments for veterans with chronic military-related PTSD.


    Design, Setting, and Participants

    A 6-month, randomized, double-blind, placebocontrolled multicenter trial conducted between February 2007 and February 2010 at 23 Veterans Administration outpatient medical centers. Of the 367 patients screened, 296 were diagnosed with military-related PTSD and had ongoing symptoms despite at least 2 adequate SRI treatments, and 247 contributed to analysis of the primary outcome measure.

    Intervention Risperidone (up to 4 mg once daily) or placebo.

    Conclusion

    Among patients with military-related PTSD with SRI-resistant symptoms, 6-month treatment with risperidone compared with placebo did not reduce PTSD
    symptoms.


    Trial Registration clinicaltrials.gov Identifier: NCT00099983


    hat tip Seroquel Lawsuit blog.

    Wednesday, August 24, 2011

    FDA warns: Antidepressant Celexa : Abnormal Heart Rhythms Associated With High Doses

    From FDA:


    Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses

    [Posted 08/24/2011]

    AUDIENCE: Psychiatry, Cardiology

    ISSUE: FDA notified healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Changes in the electrical activity of the heart (prolongation of the QT interval of the electrocardiogram [ECG]) can lead to an abnormal heart rhythm (including Torsade de Pointes), which can be fatal. Patients at particular risk for developing prolongation of the QT interval include those with underlying heart conditions and those who are predisposed to low levels of potassium and magnesium in the blood.

    Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day. Previously, the citalopram drug label stated that certain patients may require a dose of 60 mg per day. The citalopram drug label has been revised to include the new drug dosage and usage recommendations, as well as information about the potential for QT interval prolongation and Torsade de Pointes. See the FDA Drug Safety Communication Data Summary for additional information.

    BACKGROUND: Celexa (citalopram hydrobromide) is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs).

    RECOMMENDATION: Citalopram causes dose-dependent QT interval prolongation. Citalopram should no longer be prescribed at doses greater than 40 mg per day. Citalopram should not be used in patients with congenital long QT syndrome. Patients with congestive heart failure, bradyarrhythmias, or predisposition to hypokalemia or hypomagnesemia because of concomitant illness or drugs, are at higher risk of developing Torsade de Pointes. See the FDA Drug Safety Communication for additional recommendations for healthcare professionals and patients.


    Hat tip to FIDDAMAN:"Double Whammy for Lundbeck".

    Tuesday, August 23, 2011

    Lilly payments to doctors database: Q1 2011, look who's there: Melissa DelBello

    Lilly, maker of antipsychotic Zyprexa (among others)has it's Q1 2011 report of payments to doctors and entities posted:

    * note Melissa DelBello one of the infamous conflicted researchers out there, CONTINUES to take pharma income. DelBello sits on C.A.B.F. Child Adolescent Bipolar Foundation advisory council along with Joseph Biederman et al.


    A few top payments:

    HARVARD CLINICAL RESEARCH INSTITUTE BOSTON MA NA $767,564 $767,564

    MILLENNIUM PSYCHIATRIC ASSOCIATES LLC CREVE COEUR MO SICURO, FRANCO $508,666 $508,666

    COMPREHENSIVE NEUROSCIENCE INC PHILADELPHIA PA GUTIERREZ, MARIA $465,163 $465,163

    COMMUNITY CLINICAL RESEARCH INC AUSTIN TX BROWN, DAVID $413,998 $413,998

    BRIGHAM & WOMEN'S HOSPITAL BOSTON MA NA $372,235 $372,235

    LAKE CHARLES CLINICAL TRIALS LLC LAKE CHARLES LA YADALAM, KASHINATH $313,157 $313,157

    CONSORTIUM OF RHEUMATOLOGY OF RESEARCHERS NORTH AMERICA INC FONDA NY KREMER, JOEL $304,830 $304,830

    CLEVELAND CLINIC FOUNDATION CLEVELAND OH HSI, ERIC $284,554 $284,554

    ATLANTA CENTER FOR MEDICAL RESEARCH ATLANTA GA RIESENBERG, ROBERT $246,842 $246,842

    INDIANA UNIVERSITY INDIANAPOLIS IN CHIOREAN, ELENA $225,097 $225,097

    PSYCHIATRIC PROFESSIONAL SERVICES INC CINCINNATI OH DEL BELLO, MELISSA $215,174 $215,174

    NORTHWEST CLINICAL RESEARCH CENTER BELLEVUE WA KHAN, ARIF $208,986
    $208,986
    BEHAVIORAL CLINICAL RESEARCH INC NORTH MIAMI FL LAPEYRA, OLGA $201,715 $201,715

    COMPASS RESEARCH LLC ORLANDO FL CURTIS, CRAIG $196,157 $196,157

    ---

    Meissa DelBello is tucked away under PSYCHIATRIC PROFESSIONAL SERVICES INC .


    Lilly's disclosures are part of the company's CIA (Corporate Integrity Agreement)with HHS for the illegal promotion of the antipsychotic ZYPREXA which included a $1.4 billion dollar fine.

    When one considers the outpouring (that continues) from pharmaceutical companies such as Lilly and AstraZeneca to entities and physicians even after massive fines, CIA's and lawsuits for drug injuries (such as diabetes)it is clear that fines and CIAs do nothing to change the business practices, in fact it seems it's business as usual.

    For researchers such as Melissa DelBello who specialize in child and adolescent psychiatry, it makes you wonder how any study they are connected to would be without speculation regarding the direct influence pharma has in their personal bank accounts.


    That is not chump change DelBello pocketed in Q1 2011 from Lilly...$215,000.

    AstraZeneca expands payments to doctors database: includes money given to institutional research


    AstraZeneca was required to disclose payments to physicians in their 2010 CIA (Corporate Integrity Agreement)(click this for the AZ page) and AstraZeneca has now updated that searchable database to include institutions (such as Mass General, Yale)


    "AstraZeneca’s reporting meets the requirements of our April 2010 corporate integrity agreement with the Office of Inspector General of the US Department of Health and Human Services, and incorporates key elements of the Physician Payments Sunshine provisions in the Patient Protection and Affordable Care Act, which provisions have not yet taken effect."

    According to Tony Jewell, as he told me on Twitter the disclosures are part of HCR law.



    Go check it out and see how much money your doctor (or you) earned from AstraZeneca, the pharmaceutical company that makes the antipsychotic Seroquel, which has a box warning for QT Prolongation (increased risk of sudden death) and diabetes.


    The diabetes lawsuits are in current settlement final stages with the 26,000 claimants.See the Seroquel Lawsuit blog documents pertaining to the settlement terms.


    APRIL 2010

    HHS press release:

    Tuesday, April 27, 2010
    Department of Justice


    Pharmaceutical Giant Astrazeneca To Pay $520 Million

    WASHINGTON – AstraZeneca LP and AstraZeneca Pharmaceuticals LP will pay $520 million to resolve allegations that AstraZeneca illegally marketed the anti-psychotic drug Seroquel for uses not approved as safe and effective by the Food and Drug Administration (FDA), the Departments of Justice and Health and Human Services’ Health Care Fraud Enforcement Action Team (HEAT) announced today. Such unapproved uses are also known as “off-label” uses because they are not included in the drug’s FDA approved product label.

    The Wilmington, Del.-based company signed a civil settlement to resolve allegations that by marketing Seroquel for unapproved uses, the company caused false claims for payment to be submitted to federal insurance programs including Medicaid, Medicare and TRICARE programs, and to the Department of Veterans Affairs, the Federal Employee Health Benefits Program and the Bureau of Prisons.

    Under the terms of the settlement, the federal government will receive $301,907,007 from the civil settlement, and the state Medicaid programs and the District of Columbia will share up to $218,092,993 of the civil settlement, depending on the number of states that participate in the settlement. The allegations were originally brought in a lawsuit under the qui tam or whistleblower provisions of the False Claims Act and various state False Claims Act statutes.

    Under the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the FDA. Before approving a drug, the FDA must determine that the drug is safe and effective for the use proposed by the company. Once approved, the drug may not be marketed or promoted for off-label uses.

    The FDA originally approved Seroquel in September 1997 for the treatment of manifestations of psychotic disorders. In September 2000, FDA proposed narrowing the approval for Seroquel to the short term treatment of schizophrenia only. In January 2004, the FDA approved Seroquel for short term treatment of acute manic episodes associated with bipolar disorder (bipolar mania). In October 2006, the FDA approved Seroquel for bipolar depression.

    The United States alleges that AstraZeneca illegally marketed Seroquel for uses never approved by the FDA. Specifically, between January 2001 through December 2006, AstraZeneca promoted Seroquel to psychiatrists and other physicians for certain uses that were not approved by the FDA as safe and effective (including aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness). These unapproved uses were not medically accepted indications for which the United States and the state Medicaid programs provided coverage for Seroquel.

    According to the settlement agreement, AstraZeneca targeted its illegal marketing of the anti-psychotic Seroquel towards doctors who do not typically treat schizophrenia or bipolar disorder, such as physicians who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons.

    In March 2006, AstraZeneca brought certain conduct to the attention of the government and then cooperated in the investigation of the allegations being settled today.

    The United States contends that AstraZeneca promoted the unapproved uses by improperly and unduly influencing the content of, and speakers, in company-sponsored continuing medical education programs. The company also engaged doctors to give promotional speaker programs on unapproved uses for Seroquel and to conduct studies on unapproved uses of Seroquel. In addition, the company recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct. AstraZeneca then used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel.

    “Illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers’ pockets,” said Attorney General Eric Holder. “This Administration is committed to recovering taxpayer money lost to health care fraud, whether it’s by bringing cases against common criminals operating out of vacant storefronts or executives at some of the nation’s biggest companies.”

    The United States also contends that AstraZeneca violated the federal Anti-Kickback Statute by offering and paying illegal remuneration to doctors it recruited to serve as authors of articles written by AstraZeneca and its agents about the unapproved uses of Seroquel. AstraZeneca also offered and paid illegal remuneration to doctors to travel to resort locations to “advise” AstraZeneca about marketing messages for unapproved uses of Seroquel, and paid doctors to give promotional lectures to other health care professionals about unapproved and unaccepted uses of Seroquel. The United States contends that these payments were intended to induce the doctors to prescribe Seroquel for unapproved uses in violation of the federal Anti-Kickback Statute.

    “Rooting out health care fraud is a top priority for the Obama Administration, said Kathleen Sebelius, Secretary of the Department of Health and Human Services. “Today’s settlement sends a clear warning to any individual or company seeking to defraud our health care system and returns hundreds of millions of dollars of taxpayer money to the Medicare trust fund where they belong. It reflects the unprecedented energy, resources, and new ideas that this administration has devoted to identifying, prosecuting, and ultimately preventing health care fraud. With the new anti-healthcare fraud resources in the Affordable Care Act, there has never been a worse time to try to steal from our health care system.”

    “Consumers are entitled to rely on the claims pharmaceutical companies make about the drugs they sell,” said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. “Working with our federal and state partners, we will protect the integrity of our public health programs by ensuring that kickbacks from drug companies do not taint the medical decisions of health care professionals."

    “When pharmaceutical companies interfere with the FDA’s mission to insure that drugs are safe and effective, they undermine the doctor-patient relationship and put the health and safety of patients at risk,” said Michael L. Levy, U.S. Attorney for the Eastern District of Pennsylvania. “People have a legal right to know that pharmaceutical companies are marketing their drugs only for uses approved by the FDA and that their doctors’ judgment has not been affected by misinformation from a pharmaceutical company trying to boost revenues.”

    In addition to the civil settlement agreement, resolution of the matter includes a Corporate Integrity Agreement (CIA) between AstraZeneca and the Office of Inspector General of the Department of Health and Human Services. The five-year CIA requires, among other things, that a board of directors committee annually review the company’s compliance program and certify its effectiveness; that certain managers annually certify that their departments or functional areas are compliant; that AstraZeneca send doctors a letter notifying them about the settlement; and that the company post on its website information about payments to doctors, such as honoraria, travel or lodging. AstraZeneca is subject to exclusion from Federal health care programs, including Medicare and Medicaid, for a material breach of the CIA and subject to monetary penalties for less significant breaches.

    “As a result of this Corporate Integrity Agreement, the actions of AstraZeneca will be more transparent, its Board of Directors held more accountable, and the names of physicians receiving payments will be disclosed -- all leading to better protection for patients,” said Department of Health and Human Services Inspector General Daniel R. Levinson.

    The government’s investigation was triggered by a whistleblower lawsuit filed under the FCA’s qui tam provisions in the Eastern District of Pennsylvania. As part of today’s resolution, James Wetta, the whistleblower in that action, will receive more than $45 million from the federal share of the civil recovery.

    This settlement is part of the government’s emphasis on combating health care fraud and another step for the HEAT initiative, which was announced by Attorney General Holder and Secretary Sebelius in May 2009. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid fraud through enhanced cooperation. One of the most powerful tools in that effort is the FCA, which the Justice Department has used to recover almost $2.8 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Department’s total recoveries in FCA cases since January 2009 are over $3.75 billion.


    The civil settlement was reached by the U.S. Attorney’s Office for the Eastern District of Pennsylvania and the Commercial Litigation Branch of the Justice Department’s Civil Division. This investigation was conducted by the Department of Health and Human Services Office of Inspector General, U.S. Postal Service’s Office of Inspector General and the FDA’s Office of Criminal Investigations. Assistance was provided by representatives of FDA’s Office of Chief Counsel and the National Association of Medicaid Fraud Control Units."

    --HHS -U.S. Department of Health & Human Services, April 2010

    Sunday, August 21, 2011

    don't forget me

    she stood looking down at the fan as the breeze added relief from the warm summer afternoon, and i felt crippled inside. how do you encourage, support and tell someone about life that is happening now after months if not years have passed since the person truly comprehended all of life's happenings? it is a great burden within my heart and it often weighs heavy on my mind. my chest seizes up and i feel actual pain there along with the lump in my throat from stifling what could be gut sobs if i allowed myself to open the flood gates of emotion.

    still feeling the sting of the loss of my home, lately wanting to just walk into my backyard--causes me to stop the emotions, feel nothing, don't tap into it because i can't function that way anymore. no more pain. no more grief and crying. it's the now and time to embrace it. it is my own ability to remain above that personal grief (and guilt) of losing my home that enables me to encourage my daughter, that life does go on, and it can hurt but one thing i tell her i want her to feel and know is that i haven't gone anywhere.

    i watched her silently think to herself as she looked down at the fan blowing. she wiped a few tears from her eyes. i assured her it was OK to have emotions, to feel mad, to want to know what happened.

    this is quite a gift, quite an enormous task i take seriously, is being a mom of someone who in essence left us--her mind trapped her in a world of silence. no words for so long. yesterday she asked me "for the paper in your pocket", which was the grocery list we used to shop for dinner items. honestly, it's painful seeing someone lose years of their life, especially your child. i feel great responsibility for her life and future.

    i admit to feeling uncomfortable when she is emotional, isn't it easier for all of us to not deal with other's grief and pain. it's so much larger than life. the little things during the day, getting chores done, walking the dog all fade into the background when faced with "how to tell someone it is 2011 life has in fact changed and people have in fact moved on without you". i have this person who needs to know joy, have friends, feel she matters in this world, hanging on and re-entering life, i want desperately to tell her things are still the same, but they are not.


    i made the salad and as i opened the oven to check on the pasta dish baking, she watched me. "life is a constant flow, it changes and we cannot stop that, but i am still here, we all are, the sun still rises and sets", i heard myself say. offering my commentary that i've learned to embrace myself the last few years. i am acutely aware of her and her feelings.

    after dinner i gave her a bowl of ice cream. she pointed to the mint chip flavor as we shopped earlier in the grocery store. she still likes notes so she can read what is happening. i wrote her a note that said 'bowl of ice cream-yours'. she handed me the note and said, "how much?" i answered with a question, "1 bowl?" she nodded and i edited the note. she read it and pointed to the word bowl. she said, "bowl full". edited note said, "1 bowl full of ice cream" when we were done. i told her she was in charge of my note writing grammar from now on.

    what i carry in my heart the most is how i want her to know she is not a forgotten person. i carry all of her memories, her favorite foods, all of it in my memory and heart. sometimes, she looks at me with a blank face when i ask her what she wants for dinner. one time in the grocery store last week i realized she may not remember. i had to go through the archives in my memory for that. thus the caesar salad i made for her last night, with fresh lemon juice and shredded parmesan cheese. she ate it with gusto.

    i smiled.

    "focus on the positives", i said later as i placed my arm around her shoulders.



    how much she will remember or how long this lucidity will last is an unknown. i embrace that and enjoy the moments now, because i have learned they are truly golden.



    Seroxat Sufferers Stand Up and be Counted blog news: The McGorry Seroquel Drug Trial complaint documents

    "McGorry, with the financial assistance of Seroquel manufacturer Astra Zeneca, wanted to carry out a clinical trial [of sorts] with children, amongst others, who had not yet been diagnosed with a psychotic illness.

    Psychiatrists, psychologists and researchers from all over the world lodged a complaint when they heard of the planned trial.

    McGorry pulled the trial and now denies that the complaint had anything to do with his decision. If the 9 page complaint didn't change McGorry's mind...then what did?" --
    Bob Fiddaman

    Click the title of this post, or click here to see the documents and a news clip of McGorry at the Seroxat Sufferers Stand up and be counted blog. The blog is a great source of information, authored by a GSK PAXIL (Seroxat in U.K.)victim, and book author, Bob Fiddaman.


    Quote: AstraZeneca "Made patients into guinea pigs in an unsupervised drug test"-Michael Levy

    AstraZeneca, makers of the antipsychotic Seroquel in the news in April 2010 for illegal marketing of the drug. The fine of $520 million by the Dept of Justice was just business as usual.

    The 26,000 cases in litigation for diabetes are in process of being settled with final details of payout to the claimants, and the award amount for this permanent body damage is insulting. The drug was marketed illegally, and it is my opinion if the drug wasn't on the market in such a reckless way (thanks to the FDA for approval?)these patients who may have taken the antipsychotic for off-label use might not be diabetic today!



    A statement in the ABC news clip:


    AstraZeneca..."made patients into guinea pigs in an unsupervised drug test."--Michael Levy

    I agree and the drug test continues! the drug is being dosed out to Veterans for PTSD, to people for insomnia, and used in behavior control settings such as the incarcerated youth in Louisiana and New Orleans restrained with antipsychotics, where Seroquel is one of the drugs.



    Page 9 of the Seroquel Lawsuit blog host of settlement document packet pages shows that claimants in the lawsuit who were Medicaid, Medicare patients will have part of their award money removed from final payout to pay back the Government. The Government fined AstraZeneca $520 million already and now the plaintiffs--the injured person---pays back as well.

    In my opinion all of the payout to the claimants, which pay attorney fees and possible liens should have been covered as part of what AstraZeneca paid. The injured claimant is receiving such a lowball award, anything removed from that is a smack in the face, an insult to injury and furthers the atrocity that has happened to them, as victims of corporate crime, lies, skewed studies, buried studies and a massive marketing plan that in the end place patent over patient, and profit before patient.





    Would you "sign here"?


    *images courtesy of, and found in Google Images

    Saturday, August 20, 2011

    Drug trial for Seroquel on kids in Australia scrapped! Professor Patrick McGorry

    VIA The Age:


    "FORMER Australian of the Year Patrick McGorry has aborted a controversial trial of antipsychotic drugs on children as young as 15 who are "at risk" of psychosis, amid complaints the study was unethical.

    The Sunday Age can reveal 13 local and international experts lodged a formal complaint calling for the trial not to go ahead due to concerns children who had not yet been diagnosed with a psychotic illness would be unnecessarily given drugs with potentially dangerous side effects.

    Quetiapine, sold as Seroquel, has been linked to weight gain and its manufacturer AstraZeneca, which was to fund the trial, last month paid $US647 million ($A623 million) to settle a lawsuit in the US, alleging there was insufficient warning the drug may cause diabetes."


    Read the article HERE.

    Hat tip FIDDAMAN.


    Read more about Patrick McGorry at Fiddman's blog, where he has an extensive list of articles in the AstraZeneca trial scrapped post, here.


    Standing tall in the face of Big Pharma

    Leonie Fennell and Tony Donnelly, parents of Shane Clancy faced the pharmaceutical manufacturer Lundbeck square in the eye in a in-house meeting on the premises of Lundbeck in Copenhagen. They were in essence facing the company that sells the antidepressant Celexa, the one their son Shane was prescribed just days before--and he became suicidal and homicidal and his life ended in violence.

    Seeking the truth about the SSRI induced connection to their son's death, they met with officials at Lundbeck in Copenhagen for the 2 year anniversary of Shane's death.Click on this link to the Seroxat Sufferers blog and see the photo of the parents standing so bravely at the Lundbeck entrance, hand in hand.

    The loss of Shane has fueled Leonie's fire to seek answers in what she saw happen to her son: he started taking an SSRI and became a different, a violent person, who had as a result a horrific death.

    I saw my own daughter at age 13 change that way on the SSRI Zoloft. She had never voiced suicidal thoughts or actions until that drug nearly killed her with what I saw as a direct connection and SO DID HER DOCTOR when I found one for a second opinion--her reaction was one they had seen before---thankfully, she did not hurt herself when hanging out the car door on a freeway! I thank God for that. It's in her medical chart now that NO SSRI's can be tolerated.

    Please go to Leonie Fennell's blog and read her post about the Lundbeck meeting. Besides meeting with officials, they handed out 1500 leaflets about the dangers Cipramil (Celexa)which includes a photo of her beloved Shane.

    I thank Leonie and Tony for taking their grief and using it as fuel to advocate and raise awareness for mental health patients all around the world, in a global effort to warn based on experience no one wants to ever have, I salute them, Bob Fiddaman and many others... for we are actually all standing tall in the face of pharma together...as a result of pain and suffering nearly too great to face, but courage happens to be a base advocates use to take risks to find truth.



    Leonie Fennell's blog.


    *Note: SSRI's were recklessly prescribed by inpatient psychiatrists, and the list includes Luvox,Zoloft added to what I did not know was an SSRI Immpramine already in place by a PCP for 'bedwetting'. Psychiatrists did not heed my warnings of behaviors associated with psych meds for YEARS. Once inpatient, they do what they want, they all have their own drug cocktail they trial and that is the atrocity that happened to my child, who now has a doctor working diligently to address the medication damage and who has recently told me, " I see potential", when we were discussing the grand return of her clarity with thinking and speaking ability returning. The last decade is a tale of forewarning to people with children on psych meds, they can do damage in many ways. This is my experience with my now adult child. There are doctors who believe they can do anything based on arrogance, I've met them too. Unfortunately, they trialed drugs known to cause her problems, only to admit later they shouldn't have. You know what I'd like to say to them today?


    Friday, August 19, 2011

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    Diabetes from taking antispsychotic Seroquel: CDC stats on life with diabetes


    The Seroquel Lawsuit blog is reporting in with a claimant's settlement packet from the ongoing litigation cases--26,000 cases of people becoming diabetic after ingesting a prescription medication, an antipsychotic called Seroquel sold by AstraZeneca.


    The figures show the claimant will be receiving under $6000.00 once the attorney fees are removed from the $11,000 offer, and that claimant does not have medicaid or medicare amounts removed or it could be less, as some people will be receiving less--medicaid and medicare get their money back, the lawyers get their cut and the claimant, the injured person gets an insulting settlement amount.

    Let's look at the fact sheet on diabetes from the CDC:


    Deaths among people with diabetes, United States, 2007

    Diabetes was the seventh leading cause of death based on U.S. death certificates in 2007. This ranking is based on the 71,382 death certificates in 2007 in which diabetes was the underlying cause of death. Diabetes was a contributing cause of death in an additional 160,022 death certificates for a total of 231,404 certificates in 2007 in which diabetes appeared as any-listed cause of death.
    Diabetes is likely to be under reported as a cause of death. Studies have found that about 35% to 40% of decedents with diabetes had it listed anywhere on the death certificate and about 10% to 15% had it listed as the underlying cause of death.
    Overall, the risk for death among people with diabetes is about twice that of people of similar age but without diabetes.

    Estimated diabetes costs in the United States, 2007
    Total (direct and indirect): $174 billion

    Direct medical costs: $116 billion

    After adjusting for population age and sex differences, average medical expenditures among people with diagnosed diabetes were 2.3 times higher than what expenditures would be in the absence of diabetes.
    Indirect costs: $58 billion (disability, work loss, premature mortality)

    Complications of diabetes in the United States

    Heart disease and stroke

    In 2004, heart disease was noted on 68% of diabetes-related death certificates among people aged 65 years or older.

    In 2004, stroke was noted on 16% of diabetes-related death certificates among people aged 65 years or older.

    Adults with diabetes have heart disease death rates about 2 to 4 times higher than adults without diabetes.

    The risk for stroke is 2 to 4 times higher among people with diabetes.

    Hypertension

    In 2005–2008, of adults aged 20 years or older with self-reported diabetes, 67% had blood pressure greater than or equal to 140/90 millimeters of mercury (mmHg) or used prescription medications for hypertension.

    Blindness and eye problems

    Diabetes is the leading cause of new cases of blindness among adults aged 20–74 years.

    In 2005–2008, 4.2 million (28.5%) people with diabetes aged 40 years or older had diabetic retinopathy, and of these, 655,000 (4.4% of those with diabetes) had advanced diabetic retinopathy that could lead to severe vision loss.

    Kidney disease

    Diabetes is the leading cause of kidney failure, accounting for 44% of all new cases of kidney failure in 2008.
    In 2008, 48,374 people with diabetes began treatment for end-stage kidney disease.
    In 2008, a total of 202,290 people with end-stage kidney disease due to diabetes were living on chronic dialysis or with a kidney transplant.

    Nervous system disease

    About 60% to 70% of people with diabetes have mild to severe forms of nervous system damage. The results of such damage include impaired sensation or pain in the feet or hands, slowed digestion of food in the stomach, carpal tunnel syndrome, erectile dysfunction, or other nerve problems.

    Almost 30% of people with diabetes aged 40 years or older have impaired sensation in the feet (i.e., at least one area that lacks feeling).
    Severe forms of diabetic nerve disease are a major contributing cause of lower-extremity amputations.

    Amputations

    More than 60% of nontraumatic lower-limb amputations occur in people with diabetes
    In 2006, about 65,700 nontraumatic lower-limb amputations were performed in people with diabetes.

    Dental disease

    Periodontal (gum) disease is more common in people with diabetes. Among young adults, those with diabetes have about twice the risk of those without diabetes.
    Adults aged 45 years or older with poorly controlled diabetes (A1c > 9%) were 2.9 times more likely to have severe periodontitis than those without diabetes. The likelihood was even greater (4.6 times) among smokers with poorly controlled diabetes.

    About one-third of people with diabetes have severe periodontal disease consisting of loss of attachment (5 millimeters or more) of the gums to the teeth.
    Complications of pregnancy

    Poorly controlled diabetes before conception and during the first trimester of pregnancy among women with type 1 diabetes can cause major birth defects in 5% to 10% of pregnancies and spontaneous abortions in 15% to 20% of pregnancies. On the other hand, for a woman with pre-existing diabetes, optimizing blood glucose levels before and during early pregnancy can reduce the risk of birth defects in their infants.
    Poorly controlled diabetes during the second and third trimesters of pregnancy can result in excessively large babies, posing a risk to both mother and child.
    Other complications

    Uncontrolled diabetes often leads to biochemical imbalances that can cause acute life-threatening events, such as diabetic ketoacidosis and hyperosmolar (nonketotic) coma.

    People with diabetes are more susceptible to many other illnesses. Once they acquire these illnesses, they often have worse prognoses. For example, they are more likely to die with pneumonia or influenza than people who do not have diabetes.

    People with diabetes aged 60 years or older are 2–3 times more likely to report an inability to walk one-quarter of a mile, climb stairs, or do housework compared with people without diabetes in the same age group.

    People with diabetes are twice as likely to have depression, which can complicate diabetes management, than people without diabetes. In addition, depression is associated with a 60% increased risk of developing type 2 diabetes."

    -----

    Those are sobering statistics for people who may not have ever become diabetic if it wasn't for taking Seroquel.There are, no doubt many claimants who do not have a family history of diabetes, and for the 26,000 claimants as example, many became diabetic after taking the antipsychotic.

    Seroquel is associated with U.S. veterans and soldiers dying in their sleep and is used often for insomnia off-label.

    Noting the Seroquel Lawsuit blog documents: page 37 shows the number of death cases this law firm represented at 14. The payout for a death is $12,755, before any fees are removed.

    Death from Seroquel got $12,000? less fees? 11 cases of diabetes are in kids under age 18. Kids under age 18 get $23,000 less the fees.

    What price does one place on the value of a life? the claimants who became diabetic from Seroquel use now face a host of possible health related problems, that in short could end their lives sooner than if they had not ever taken the medication and become diabetic.

    This is an outrage, it is unacceptable. The pharmaceutical company AstraZeneca has been fined $520 million by the Dept of Justice in April 2010 for illegal marketing of Seroquel. It is becoming evident that the victims here are being stomped on--victims of a marketing plan that was in the works before the drug was on the market, and the victims of diabetes as a result and now--victims of corporate crime--get under $6,000 to pay their medical bills and hell, maybe pay for their funeral cost.

    The tax payer (YOU) will be paying for their care, with Medicaid and Medicare, maybe disability payments too. Diabetes is a serious disease, the pancreas doesn't work the way it should, and all from Seroquel.

    Considering that Seroquel is being touted for anxiety, insomnia, MDD, depression in bipolar and is being advertised in magazines featuring this statement: "Still trying to get ahead of your cloud of depression?" (see link for photo of that advert)I firmly believe the general public should be aware of the facts of Seroquel; that it is a neuroleoptic with a box warning for QT Prolongation which means:

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

    The antispychotic is not an antidepressant nor is it a simple sleep aid. The risks of taking this drug outweigh the benefit in my opinion, and the box warnings should be taken seriously, far more seriously than the advertisement depicting a depression cloud looming... never forget people were injured via death, diabetes, pancreatitus from Seroquel, and never forget they are permanent outcomes.

    There should be a great outpouring of empathy for these claimants, because not only have they been injured by a pharmaceutical, they have been rolled by the lawyers who settled with AstraZeneca for chump change, instead of taking them down in court. If the claimants refuse this offer, they might finally be heard.