Saturday, January 28, 2012

AstraZeneca Seroquel - a father's anguish - Government killed his son by way of prescription pad


 Via PharmaGossip


A father’s anguish: Military killed my son with prescription pad | The Daily Caller


A father who has lost two sons to war told The Daily Caller that the U.S. Central Command’s policy of allowing troops to deploy with a 180-day supply of the antipsychotic Seroquel has contributed to the deaths of troops and veterans. Seroquel, he said, has tragic side effects that military leaders have ignored in their quest to combat insomnia and post-traumatic stress disorder (PTSD) among fighting men and women.

The father, West Virginia school principal Stan White, said there are better ways to treat troops and veterans who suffer from PTSD. But because the maker of Seroquel, London-based AstraZeneca, has so much influence over Congress and the military, he insisted, that peer counseling and other treatment options are being shoved aside in favor of low doses of the drug.

White’s suspicions are slowly being validated by a series of studies, legal settlements, and military rulings — including a recommendation from the Department of Defense’s own advisory body on pharmaceuticals.

“I think AstraZeneca is so strong and has so much power that no one can speak out,” said White, who has remained stoic despite his losses. “Money talks. I truly believe AstraZeneca and other big pharma companies have control over Congress.”

His first son, Army Sgt. Robert White, died in combat in Iraq. When Robert’s younger brother Andrew returned from his own tour in the Middle Eastern country, a Veterans Administration doctor prescribed a combination of Seroquel and antidepressants for his PTSD.

Andrew died at home, and the state of West Virginia ruled that an accidental medication overdose was to blame.

But his father believes the “dangerous” pill cocktail killed him. And he told TheDC that he has identified 300 other soldiers and veterans who died from sudden cardiac arrest while taking Seroquel and antidepressants in combination.

Evidence supporting his theory has continued to accumulate, including a September 2011 study from the European Society of Cardiology which linked the “combined use of antipsychotic and antidepressant drugs” with an increased risk of sudden heart attacks.
Seroquel has been on the market since 1997, and in that time doctors have widely experimented with prescribing it for “off-label” purposes that the FDA has not approved. The drug, a mood stabilizer, is approved to treat schizophrenia and bipolar disorder, but it has also been used to treat insomnia in Parkinson’s disease patients, dementia in adults of all ages, and a variety of disorders in children.

Doctors have free rein to prescribe medications for off-label uses, and the FDA’s ever-growing avalanche of advisories sometimes makes it difficult for physicians to know what has been approved and what has not.

A 2009 University of Chicago national survey of physicians, for instance, found that one in eight doctors thought Seroquel was approved for treating dementia, even though the FDA had issued a specific warning against it.

Drug marketers, however, are forbidden to promote their products for any purpose not approved by the FDA.

In April 2010 AstraZeneca conceded that it had crossed that line, agreeing to pay the U.S. government $520 million to settle claims related to its illegal promotion of Seroquel for off-label uses.

Read the rest of this disturbing & important article by clicking on links below
NEXT: A massive increase in government spending on Seroquel 
NEXT: AstraZeneca's $32.6 million lobby shop

Cash Rich AstraZeneca pacifying stock holders with 5bn dollar buy back, while continuing criminal business as usual

Cash Rich AstraZeneca pacifying stock holders with 5 bn dollar buy back, while continuing their criminal business as usual model. If you haven't gotten the message by now, AstraZeneca has bought some powerful friends in very high places within our government. Especially when you look at the puny amounts they have paid in fines to walk away unscathed from a throng of unconscionable crimes without admitting any guilt or wrong doing; and then went on to pay even less to those persons health & lives they have destroyed or ended by their unsafe products and unscrupulous business practices. You only can just begin to fathom the depth of greed and conspired evil intent involved in this elitist masquerade that has been perpetrated against the citizens of America, and others from around the world.

From The Independent

AstraZeneca to return billions to shareholders

Cash-rich drugs giant to keep investors happy with another huge buyback worth up to $5bn 

Mark Leftly and Laura Chesters Sunday January 29, 2012  

AstraZeneca, the FTSE 100 pharmaceuticals giant, will announce an estimated $3bn (£2bn) extension to its share buyback programme this week.

A hugely cash generative business, AstraZeneca has been keeping investors happy over the past two years by purchasing $2.1bn of shares in 2010 and around $4bn in 2011. The group will confirm another round of share buybacks in its full-year results this week, with the consensus expectation $3bn and analysts at UBS expecting as much as $5bn.

Savvas Neophytou, analyst at Panmure Gordon, said he had a "conservative" forecast – this still came to $1.5bn – as he felt that AstraZeneca might hold back some cash for acquisitions. He added: "The

share buyback programme will be extended for sure. There are also a number of opportunities for the company to invest in."

However, AstraZeneca, whose chief executive is David Brennan, right, has faced some disappointments recently in its drug pipeline. For example, its latest blockbuster drug (those likely to have sales of more than $1bn) is expected to be the diabetes treatment Dapagliflozin, but the US Food and Drug Administration has demanded more clinical trials before giving approval. The UBS analysts expect fourth-quarter sales to be fractionally down on the previous year at $8.611bn.

Michael Mitchell, healthcare analyst at Seymour Pierce, said that there was a "question over whether a better use of money" would be investing in new drugs or buying companies with strong research and development records.

Friday, January 27, 2012

Ohio doctor wrote nine AstraZeneca Seroquel prescriptions per hour . Senator targeting big prescribers

From Propublica

Senate Watchdog Targets High-Prescribing Medicaid Docs

by Charles Ornstein and Tracy Weber
ProPublica, Jan. 24, 2012, 2:04 p.m.
An influential U.S. senator is grilling officials in nearly three-dozen states, demanding to know how they are cracking down on physicians who prescribe massive amounts of potentially dangerous prescription drugs.

Iowa Republican Charles Grassley sent letters to 34 states Monday asking what steps they had taken to investigate doctors whose prescribing of antipsychotics, anti-anxiety drugs and painkillers to Medicaid patients far exceeds that of their peers.
The request is a follow-up to a 2010 letter Grassley sent all states that requested statistics on top prescribers of these drugs.

“These types of drugs have addictive properties, and the potential for fraud and abuse by prescribers and patients is extremely high,” Grassley wrote in Monday’s letters. “When these drugs are prescribed to Medicaid patients, it is the American people who pay the price for over-prescription, abuse, and fraud.”

ProPublica reported in November that Florida allowed at least three physicians to keep treating and prescribing drugs to the poor amid clear signs of possible misconduct. One doctor kept prescribing narcotic pain pills to Medicaid patients for more than a year after he was arrested and charged in 2010 with trafficking in them.

A number of the top-prescribing Medicaid doctors around the country are listed in our Dollars for Docs database of payments made by 12 pharmaceutical companies to physicians for speaking and consulting Medicaid, jointly funded by the states and federal government, provides health care coverage to about 60 million low-income enrollees.

Grassley, the senior Republican on the Senate Judiciary Committee, has long argued for greater transparency in health care. The painkillers and mental health drugs Grassley is inquiring about are among the top drivers of Medicaid drug spending.

His letter to Ohio notes that the top prescriber of the anti-psychotic Abilify wrote 13,825 prescriptions in 2009 — about 54 prescriptions per weekday. Ohio paid $6.7 million for that those prescriptions, state officials reported to Grassley.

The biggest prescriber of another anti-psychotic, Seroquel, wrote 18,890 scripts at a cost of $5.7 million. Grassley wrote the tally would amount to nine prescriptions per hour. When Ohio submitted the data to Grassley last year, it did not identify the doctors by name or license number.

“After an extensive review of prescribing habits of the serial prescribers of pain and mental-health drugs in Ohio, I have concerns about the oversight and enforcement of Medicaid abuse in your state,” he wrote. “While I am sensitive to the concerns of misinterpretation of the data you provided, the numbers themselves are quite shocking.”

Grassley’s letter to Maine cites a physician who wrote 1,867 prescriptions for the powerful painkiller OxyContin in 2009, nearly double the second-highest prescriber. The doctor also wrote 1,723 prescriptions for another painkiller, Roxicodone, nearly three times as many as the next highest prescriber.

Calls to officials in Ohio and Maine have not been returned.

In his letters to the 34 states, Grassley asked that officials tell him by Feb. 13 what action, if any, they have taken against top prescribers, whether those doctors are still eligible to bill Medicaid, whether any of the doctors were referred to their state medical boards for investigation, and what systems have been set up to track possibly excessive prescribing, among others.

Grassley is sending letters to 12 other states that never provided him data, as requested, on their top Medicaid prescribers. Four other states will not receive follow-up letters because the senator felt their initial responses to his 2010 letter were adequate.

ProPublica reported in November that since Grassley’s initial letter requesting the data in 2010, Louisiana, Arizona, Oklahoma and New York have kicked some high-prescribing physicians out of Medicaid. California has temporarily suspended or placed restrictions on 15 to 20 doctors in the past two years for prescribing disproportionately high volumes of painkillers and antipsychotics to Medicaid patients.

But Grassley said more needs to be done.

“When a doctor writes more prescriptions than seems humanly possible, it makes sense to ask questions,” he said in a statement to ProPublica. The statement noted that some states never responded to his original letter in 2010.

“If state and federal taxpayers are being cheated because of inappropriate prescriptions,” Grassley said, “the state and federal governments have to get to the bottom of it and stop it.”

Thursday, January 19, 2012

UPDATE: J&J Risperdal - TEXAS "TMAP" TRIAL "GUILTY" - Settles for Chump Change - AstraZeneca Seroquel Next?

UPDATE: J&J Risperdal anti-psychotic drug - TEXAS TMAP TRIAL "GUILTY" then settles for chump change while admitting to no liability or fault - corporate crime pays very well - will AstraZeneca & Seroquel be next?


Incredible & Shocking news out of Texas this morning, as a settlement is reached in the J&J TMAP Risperdal trial. J&J has made a estimated 28+ billion dollars on this drug and the energizer profit bunny is still going & going....J&J hid harmful side effects, buried damning studies, lied, lied some more, marketed the drug off label illegally to children, paid off government officials, and so much more.....& what one goes to prison, just some meaningless cost of doing business fines or settlements...and the crimes and corporate raping of America and society continues unabated....what went on in this backroom deal?...this goes way beyond not smelling right...why didn't the jury have an opportunity to make a rational judgement based on the evidence & reach a verdict?

I sincerely hope people get angry, sick, & tired of these backroom deals, subversion of our justice system, and the elitist corporate power brokering when it comes to these crimes that have destroyed countless victims lives…where is their justice? The answer to that question; There is none

SO WHAT HAS REALLY CHANGED? I suspect, very little….so very little indeed…

I invite you to read the real story & tragedy behind TMAP -  this is what J&J, AstraZeneca, Lilly, & BMS actually did to countless thousands & thousands of children...the victims don't get to just walk away unscathed while profiteering beyond imagination...All of America should feel ashamed today...the Texas Attorney General Gregg Abbott should look in the mirror and see the people he is supposed to represent...he should go personally to witness the carnage...visit with the victims...instead of making amiable political backroom deals with criminal corporations...shameful doesn't begin to tell this story..

from - Medicating Aliah


Latest Update highlights from the Washingtonpost Thursday, January 19, 2:09 PM

Johnson & Johnson subsidiary settles Texas lawsuit over anti-psychotic drug for $158 million

AUSTIN, Texas — Texas and a subsidiary of health care giant Johnson & Johnson reached a $158 million settlement in a Medicaid fraud lawsuit Thursday, allowing the drugmaker to pay a fraction of the potential $1 billion in penalties and fines that state officials had initially sought.

The lawsuit was one of dozens of state and federal cases alleging that the company committed fraud by making false or misleading statements about the safety, cost and effectiveness of the expensive anti-psychotic medication Risperdal, and improperly influencing officials and doctors to push the drug.
Janssen Pharmaceuticals Inc., one of the J&J subsidiaries that had been sued, said in a statement it will pay the money to fully resolve all claims in Texas. The company said it is not admitting any liability or fault with the settlement.

 But analysts called the $158 million figure a victory for J&J, which made billions off Risperdal, because the deal allowed the company to avoid a much larger verdict in a state with a reputation as an easy place to win big jury awards.

The settlement also is far less than the $327 million Johnson & Johnson recently was ordered to pay in South Carolina and the $258 million it was ordered to pay in Louisiana in Risperdal lawsuits.
“For Johnson & Johnson, it’s a mighty easy result,” said Eric Gordon, a clinical professor at the University of Michigan’s Ross School of Business. “The legal team at Johnson & Johnson are doing high fives.”



from marketwatch

J&J to pay $158 million to settle Risperdal case

CHICAGO (MarketWatch) -- Johnson & Johnson's Janssen Pharmaceuticals unit said Thursday it has reached a settlement with the State of Texas under which it will pay $158 million "in full resolution of all claims" in litigation over its antipsychotic drug Risperdal. The deal will cover claims brought by the state in 2004 for Medicaid overpayment from 1994 to 2008 "and will circumvent potentially lengthy and costly appellate activities," the company said. Sharing in the money will be the original plaintiff, his attorneys, the state of Texas and the federal government. Shares of Johnson & Johnson JNJ -0.32% were down about 1% in morning action.



from 1 Boring Old Man blog

speaking of nails in the coffin… 


Posted on Thursday 19 January 2012

Update 10:20 AM: I just got this email from Austin: "I wanted to let you know that a settlement is being announced this morning in Austin. I have no additional details right now, but should learn more later today."

Update 10:40 AM: PHARMALOT TWITTER: Johnson & Johnson to settle charges brought by Texas AG of illegally promoting Risperdal: sources.. announcement due shortly…

Update :
J&J Said to Settle Texas Risperdal Anti-Psychotic Drug Case
By Jef Feeley and Margaret Cronin Fisk
January 19, 2012, 10:23 AM EST

Johnson & Johnson agreed to settle Texas officials’ claims that the drugmaker fraudulently marketed its Risperdal anti-psychotic drug and end a trial over the allegations, people familiar with the case said. The settlement will be announced in court today, the people said.
SIDE NOTE: The comment section should be buzzing with excellent feedback well worth reading...

**updates to this post will be done as information becomes available**

Thursday, January 12, 2012

Nenad Borojević, former head of the Institute of Radiology and Oncology in Belgrade & The Doctor at the center of AstraZeneca's Bribery & Violations of the Foreign Corrupt Practices Act was found hanging in a forest

Nenad Borojević (file)

Nenad Borojević, former head of the Institute of Radiology and Oncology in Belgrade & The Doctor at the center of AstraZeneca's Bribery & Violations of the Foreign Corrupt Practices Act was found hanging in a forest.

We haven't heard much new news related to the foreign bribery allegations & violations of the Foreign Corrupt Practices Act regarding AstraZeneca since Nov. 2011. So this news coming out of Serbia appears to be straight out of a John Grisham Novel. We have a Huge Multinational Corporation, Bribery, Corruption, and now a principle Doctor @ the center of the allegations found hanging in the forest. There has to be a very dark and seedy under belly to this story that has yet to be revealed. Makes even a hardened Cynic begin to wonder?

also @ b92 BELGRADE -- The family of former director of the Serbian Institute of Oncology and Radiology Nenad Borojević "still does not believe that he had taken his own life".

Doctor accused of cancer drugs fraud

commits suicide
 Via b92 

Nenad Borojević, former head of the Institute of Radiology and Oncology in Belgrade, was found hanged in a forest in the city's Košutnjak neighborhood, it was announced.
According to reports, he committed suicide.

It was announced that the police would release a statement detailing the suicide, "and its motives".

Borojević was undergoing trial, but was released from custody for the duration of the court process. He was forbidden to leave his place of residence and was fitted with an electronic surveillance bracelet to monitor his movements.

Borojević and eight others were facing justice accused of, from 2007 until 2009, colluding with pharmaceutical companies to supply them in advance with information on the amount of needed cytostatic drugs, and on public procurement plans for the purchase of the said medication.

At the start of the trial, Borojević denied that he accepted bribes from the companies, and also rejected the prosecution's claim that he headed the group that rigged tenders called to purchase cancer treatment drugs.

The anti-corruption case was tried by the Special Court in Belgrade. Among those accused was the former head of the Pediatric Oncology Ward of the Institute, Zoran Bekić.

IM: Death of ex-Oncology Institute head was suicide


BELGRADE -- The family of former director of the Serbian Institute of Oncology and Radiology Nenad Borojević "still does not believe that he had taken his own life". 
A file photo of Nenad Borojević

                                            A file photo of Nenad Borojević

This is despite a statement on Thursday by Interior Minister Ivica Dačić, who said that "the first analysis point to suicide".

Borojević was found dead, hanging from a tree in a forest-park in Belgrade.

Marko Kastratović, one of Borojević's lawyers, told Tanjug on Thursday that the family had not yet received a police report about his death, or a report by the investigating judge and they did not believe he had killed himself.

“Everything is still open to doubt, and there also are some new circumstances that I cannot speak about at the moment, because it rests with the family to decide. They will decide whether and when to disclose the information to the public,” said Kastratović.

Dačić said earlier today that the investigation into the Borojević's death in Košutnjak was underway and that the body had been sent for autopsy, but the first analysis indicated that he had committed suicide.

However, while the criminal proceedings against Borojević have now been annulled, the proceedings concerning forfeiture of property suspected to have been acquired through criminal acts will be continued against his successors.

Before his death, Borojević was on trial before the Belgrade special court, on charges of unlawfully acquiring RSD 11.2mn through malpractices in connection with procurement of cancer treatment drugs.

He was granted provisional release pending trial with the prohibition of leaving Belgrade and was wearing electronic bracelets by way of which his movements were monitored.

The Prosecutor's Office for Organized Crime charged Borojević and another eight defendants with making illegal arrangements with officials of pharmaceutical companies concerning getting information about the consumption of cytostatics and the relevant public procurement procedures in advance.

Background Story:

November 2011

AstraZeneca Indicted In Serbia For Alleged Bribery

AstraZeneca PLC said Monday in a securities filing that it was criminally indicted in Serbia for alleged bribery.

Drago Prvulovic/Agence France-Presse/Getty Images
The sign of the British pharmaceutical company AstraZeneca is pictured at the plant in Lund, Sweden, on March 2, 2010.
The indictment, which according to the filing was served in August, accuses local AstraZeneca employees of having “made allegedly improper payments to physicians” at the Institute of Oncology and Radiology of Serbia.
In the filing, the company said it has filed a number of procedural motions to dismiss the charges.
“We intend to vigorously defend the matter and have filed a number of pending preliminary procedural objections that ask the Serbian criminal court to dismiss the indictment,” Tony Jewell, an AstraZeneca spokesman, said in an email. “This case is still in preliminary stages, so we are not in a position, at this time to comment further or to predict the outcome.”
The disclosure was made when AstraZeneca reported third-quarter earnings on Oct. 27; the Financial Times reported it (sub req) at the time. Monday’s filing, the 6-K required of foreign issuers, was a bundle of press releases made by the company during October.
Last year, the director of the Institute—as well as several others, including a business unit manager in AstraZeneca’s Belgrade office—were arrested in an alleged bribery scheme that involved favoring some pharmaceutical companies’ products when purchasing cancer-treatment medicine.
The pharmaceutical industry is already staring at an industry-wide probe in the U.S. into alleged foreign bribery. AstraZeneca was one of several companies that disclosed it was being investigated for possible violations of the Foreign Corrupt Practices Act, which bars companies and individuals from bribing foreign officials to get or keep business.
Johnson & Johnson settled in April, agreeing to pay $70 million to U.S. authorities. In itslatest annual report, AstraZeneca said it’s cooperating with U.S. authorities on the probe, and it couldn’t predict the scope, duration or outcome of the investigation.
(Correction: The highest-ranking person AstraZeneca person arrested was a business unit manager, not the head of the Belgrade office.)

Wednesday, January 11, 2012

The Texas J&J Risperdal Trial Begins - just the tip of the criminal TMAP & Teen-Screen iceberg

The Texas J&J Risperdal Trial Begins - just the tip of the TMAP & TeenScreen iceberg

 1 Boring Old Man blog has been writing with unbridled enthusiasm and dogged persistence about the pharmaceutical industry criminal collusion & corruption that has enveloped & consumed psychiatry, medicine, research, & scholastic institutions over the past several decades. This past week he informed his readers he was off to Texas to bear witness to the coined "TMAP Trial" for himself. 

I strongly suggest you take the time to read Mickey's blog to become informed and empowered by the wisdom and knowledge he generously gifts the reader. He has invited us all to share his ring side seat to quite possibly one of the most important social policy trials of our times.

A background to the TMAP Journey...

Of course we know that the J&J Risperdal trial highlighted in this post & below is just one small piece of a much larger and darker puzzle of targeted malfeasance for profit by one of the most powerful industries in the world today. This is simply one more step in a long & arduous journey toward bringing back some integrity and justice to America; and our once trusted; yet now hopelessly lost & corrupted health care system.
State attorney general sued drug company
Abbott: state paid excessively to Johnson & Johnson for Risperdal
Austin Statesman
By Tim Eaton
Jan.8, 2012
Texas Attorney General Greg Abbott is pitted against one of the largest multinational pharmaceutical companies in a trial starting this week that could bring the state more than $1 billion one of its largest potential awards since a multibillion-dollar tobacco settlement in 1998. Abbott is charging that Johnson & Johnson Inc., its wholly owned subsidiary Janssen Pharmaceutical LLC and five other related companies defrauded the state in a "sophisticated marketing scheme" that caused the Texas Medicaid Program to pay too much for Janssen’s schizophrenia drug Risperdal, the lawsuit says. The state also questions the companies’ marketing practices and alleges that the companies misled state health officials about the drug’s effectiveness, the risk of side effects and its suitability for pediatric use. The trial is scheduled to begin 9 a.m. today in Judge John Dietz’s 250th state District Court in Travis County…
Texas got involved with Risperdal litigation about six years ago, when Abbott’s office joined a lawsuit filed by corporate whistle-blower Allen Jones, who is a former employee of the office of the inspector general of Pennsylvania. Jones has questioned the process for how Risperdal was approved in Texas and how that information was used by other states in their approval processes. Jones filed suit in 2004 after his investigation in Pennsylvania led him to examine the companies’ track record in Texas. As a whistle-blower plaintiff, he alleged that the companies overcharged the states and overstated the drug’s effectiveness…
The lawsuit says that Johnson & Johnson and its subsidiaries employed suspect tactics in order to sell Risperdal in the public sector, which promised to be especially lucrative. Eighty-five percent of Risperdal’s revenue was projected to come from the public sector, because schizophrenic adults tend to be poor and uninsured. "Understanding the need to obtain significant government buy-in to achieve their financial goals for Risperdal, defendants set their sights on a state with one of the largest Medicaid populations in the country — Texas," according to the filing by the state and Jones. But getting a state like Texas to put a drug on a list of preferred medications — which the companies ultimately accomplished — can be a tremendous undertaking.
The lawsuit discusses the challenge for the companies to persuade decision-makers in Texas’ public medical agencies to make the move — despite what it said was evidence that the drug is more expensive and no more effective than older medications, the state and Jones say in their lawsuit. Johnson & Johnson and the related companies even created a special business unit called the Public Health Systems and Reimbursement Department designed to push the drug in the public sector, the lawsuit says. The companies also had to navigate the Texas Medicaid Program’s cost-savings measures, and to do so the companies employed a campaign that included misrepresentations about the drug’s effectiveness and superiority over other drugs, the state alleges.
The state’s case outlines allegations of kickbacks — "money going directly to key decision-makers," the lawsuit says — paid more than a decade ago to several doctors employed by the state’s Health and Human Services Commission to give Risperdal preference over other antipsychotic drugs. Jones’ lawsuit claims that Risperdal became part of the treatment plan because of the drug companies’ "improper influence" over Dr. Steven Shon, the former medical director for behavioral health at the Department of State Health Services. Shon had served as a paid Janssen consultant and traveled the country promoting the Texas plan… Jones’ legal team also charged that the company perfected its marketing skills in Texas before reaching out to the other states in which it pushed for expanded Risperdal prescriptions…

Friday, January 6, 2012

AstraZeneca Seroquel - More evidence tying Seroquel use to the development of Diabetes and related conditions

AstraZeneca Seroquel - More evidence tying Seroquel use to the development of Diabetes and related conditions

 A new abstract has been published once again showing the direct correlation between the use of anti-psychotic drugs and the onset of diabetes & related conditions (causation). Of course, we know from some of the very limited public release of AstraZeneca internal documents related to the Seroquel litigation; that AstraZeneca was well aware of these inherent adverse health risks related to Seroquel long ago ( background here astrazeneca-suppressed-drug-test-data ) , but instead of conducting further investigation and studies into these damaging and deadly relevant risk factors; they chose to bury the adverse data instead, and then turn Seroquel over to their marketing/sales department to make it the multi-billion dollar a year block buster it eventually became. 

In fact, the main hang up that has been so publicly touted in the Seroquel Litigation is that the plaintiff law firms haven't provided accepted expert medical testimony that Seroquel is a leading contributor to the onset of diabetes and related conditions to the court. That appears to be no longer a significant problem considering the new dear doctor letter  and studies showing the connection conclusively.

Studies have already shown that atypical anti-psychotics (Seroquel) have a much higher risk for metabolic disorders than the older anti-psychotics drugs (abstract of study here -> Atypical Antipsychotic Drugs and Diabetes Mellitus in the US Food and Drug Administration Adverse Event Database : Conclusions: In the AERS database, lower associations with DRAEs were seen for haloperidol, aripiprazole and ziprasidone, and higher associations were seen for olanzapine, risperidone, clozapine and quetiapine. Our findings support differential risk of diabetes across atypical anti-psychotics, reinforcing the need for metabolic monitoring of patients taking anti-psychotics.)

Yet, this newest study that isn't even differentiating between older anti-psychotics and the newer atypical anti-psychotics is showing a more significant correlation between the use of these drugs and the onset or development of diabetes and related conditions. ( you can reasonably imagine if they had only conducted this study using a-typical anti-psychotic drugs, the prevalence numbers would be much higher than are being portrayed in the abstract below) . This is vitally important health information that has been buried for far to long from the public and users of these drugs. 

The evidence is now showing that no longer can greedy pharmaceutical giants like AstraZeneca hide the reality of what they have done. There is no longer any doubt that they placed profits before patient safety in one of the most detestable crimes of our times. No more excuses, injured parties demand trials, they demand no more hidden secrets, no more backroom pay to play deals...the injured parties and the public have a right to know, & they have a right to justice.


From The Journal Of Clinical Psychiatry

Prediabetes in Patients Treated With Antipsychotic Drugs
[Abstract] [Full Text] Posted 12/27/11

 Prediabetes in Patients Treated With Antipsychotic Drugs

Prediabetes in Patients Treated With Antipsychotic Drugs
J Clin Psychiatry
Copyright 2011 Physicians Postgraduate Press, Inc.
 Background: In 2010, the American Diabetes Association (ADA) proposed that individuals with fasting glucose level of   100–125 mg/dL (5.6–6.9 mmol/L) or glucose level of 140–199 mg/dL (7.8–11.0 mmol/L) 2 hours after a 75-g oral glucose tolerance test or hemoglobin A1c 5.7%–6.4% be classified as prediabetic, indicating increased risk for the emergence of diabetes mellitus. At the same time, the ADA formulated guidelines for the use of metformin for the treatment of prediabetes.
Objective: To determine the prevalence of prediabetes in a cohort of psychiatrically ill adults receiving antipsychotics and to compare the clinical and metabolic features of prediabetic patients with those of patients with normal glucose tolerance and those with diabetes mellitus.
Method: The 2010 ADA criteria were applied to a large, consecutive, single-site European cohort of 783 adult psychiatric inpatients (mean age: 37.6 years) without a history of diabetes who were receiving antipsychotics. All patients in this cross-sectional study underwent measurement of body mass index (BMI), waist circumference, oral glucose tolerance test, and fasting insulin and lipids from November 2003 through July 2007.
Results: 413 patients (52.8%) had normal glucose tolerance, 290 (37.0%) had prediabetes, and 80 (10.2%) had diabetes mellitus. The fasting glucose and/or hemoglobin A1c criteria were met by 89.7% of prediabetic patients. A statistically significant intergroup gradient from normal glucose tolerance to prediabetes and from prediabetes to diabetes mellitus was observed for waist circumference, triglycerides, fasting insulin levels, and frequency of metabolic syndrome (P = .02 to P < .0001). Only 19/290 prediabetic patients (6.6%) met the 2010 ADA criteria for treatment with metformin.
Conclusions: Prediabetes is highly prevalent in adults treated with antipsychotic drugs and correlates with markers of increased intraabdominal adiposity, enhanced lipolysis, and insulin resistance. Criteria for using metformin to prevent the emergence of diabetes mellitus may need to be revised for this population.


                         Or we can continue to do nothing...allow corporate greed to go unchecked, and have our population do the above instead

Thursday, January 5, 2012

AstraZeneca Seroquel - NEW DEAR DOCTOR WARNING LETTER - Dec. 2011 - but wasn't their litigation defense based on their claim that Seroquel doesn't cause diabetes?

AstraZeneca Seroquel - NEW DEAR DOCTOR WARNING LETTER - Dec. 2011 - but wasn't AstraZeneca's litigation defense based on their dubious claim that Seroquel doesn't cause diabetes?

 From the MHRA

 Seroquel (quietapine) - 23 December 2011
 Information on weight gain, hyperglycaemia, and metabolic riskPDF file (opens in new window) (208Kb)

Dear Doctor

Re: quetiapine and quetiapine prolonged release Summary Product Characteristics update
We are continuously monitoring the safety of our products and the Summary of Product Characteristics (SmPC) is updated frequently to accommodate the most up to date information regarding our products. Section 4.4 Special Warnings and Precautions of the quetiapine and quetiapine prolonged release SmPCs was updated recently to reflect the most up to date information on weight gain, hyperglycaemia and metabolic risk.

In agreement with the MHRA, AstraZeneca is providing the following information to prescribers to highlight the labelling text relating to metabolic parameters. We have also added a citation for guidelines on how to monitor patients that are taking atypical antipsychotics in line with good practice as recommended by MHRA.

Update to information in the “Special warnings and precautions” section of the label on weight gain, hyperglycaemia and metabolic risk:

Weight gain has been reported in patients who have been treated with quetiapine, and should be monitored and managed as clinically appropriate as in accordance with utilised antipsychotic guidelines*.

Hyperglycaemia and/or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases (see section 4.8). In some cases, a prior increase in body weight has been reported which may be a predisposing factor. Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines. Patients treated with any antipsychotic agent including quetiapine, should be observed for signs and symptoms of hyperglycaemia, (such as polydipsia, polyuria, polyphagia and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control. Weight should be monitored regularly.

Metabolic Risk:
Given the observed changes in weight, blood glucose (see hyperglycemia) and lipids seen in clinical studies, there may be possible worsening of the metabolic risk profile in individual patients, which should be managed as clinically appropriate.

Reg Office AstraZeneca UK Limited,
2 Kingdom Street, London, W2 6BD,
Reg No 03674842
AstraZeneca UK Limited is a subsidiary
company of AstraZeneca PLC
DOP: November 2011 545607 - 1551204

Existing information on other metabolic parameters include the following:

Increases in triglycerides, LDL and total cholesterol, and decreases in HDL cholesterol have been observed in clinical trials with quetiapine. Lipid changes should be managed as clinically appropriate.
Please see Section 4.4 of the SmPC “Special warnings and precaution for use” for further details.
*Antipsychotic guidelines relevant to UK include the following. Prescribers are encouraged to check for updates to relevant guidelines on a regular basis.

National Institute for Health and Clinical Excellence. Core intervention in the treatment and management of schizophrenia in primary and secondary care (update). Clinical guideline 82. 2009
Should you have any questions regarding the above information please contact our Medical Information Department on 01582 836836.

Yours faithfully,
Catriona McMahon BSc MBChB FRCA MFPM
Medical & Regulatory Affairs Director
AstraZeneca UK Marketing Company

Somehow this newest dear doctor warning letter doesn't quite jive with what AstraZeneca was actually doing & claiming while feverishly promoting the drug Seroquel

 From the highly regarded 1boringoldman blog

Drugmaker Paid Psychiatrist Nearly $500,000 to Promote Antipsychotic, Despite Doubts About Research
Propublica and Chicago Tribune
by Christina Jewett, ProPublica, and Sam Roe
Nov. 11, 2009
Dr. Michael ReinsteinChanile Hayes came under Dr. Michael Reinstein’s care after suffering a nervous breakdown. Hayes went from 140 pounds to nearly 300 in two years after taking Seroquel, a drug that Reinstein was paid to promote by its manufacturer, AstraZeneca. Executives inside pharmaceutical giant AstraZeneca faced a high-stakes dilemma. On one hand, Chicago psychiatrist Dr. Michael Reinstein was bringing the company a small fortune in sales and was conducting research that made one of its most promising drugs look spectacular. On the other, some worried that his research findings might be too good to be true.
In an e-mail, an AstraZeneca executive says Reinstein should get careful treatment because of his potential worth to the company.As Reinstein grew irritated with what he perceived as the company’s slights, a top executive outlined the scenario in an e-mail to colleagues. "If he is in fact worth half a billion dollars to (AstraZeneca)," the company’s U.S. sales chief wrote in 2001, "we need to put him in a different category." To avoid scaring Reinstein away, he said, the firm should answer "his every query and satisfy any of his quirky behaviors."
Putting aside its concerns, AstraZeneca would continue its relationship with Reinstein, paying him  $490,000 over a decade to travel the nation promoting its best-selling antipsychotic drug, Seroquel. In return, Reinstein provided the company a vast customer base: thousands of indigent, mentally ill residents in Chicago-area nursing homes. During this period, Reinstein also faced accusations that he overmedicated and neglected patients who took a variety of drugs. But his research and promotional work went on, including studies and presentations examining many of the antipsychotics he prescribed on his daily rounds.
The AstraZeneca payments, filed as exhibits in a federal lawsuit, highlight the extent to which a leading drug company helped sustain one of the busiest psychiatrists working in local nursing facilities. In an interview and in response to written questions, Reinstein said industry payments he has received for speeches and other engagements have had no bearing on his research results or patient care. He said he does not "accept any money from corporations to study their medications. This eliminates any possible conflicts of interest."
But he does receive money from the Uptown Research Institute, a for-profit business that conducts industry and federally funded studies on psychotropic drugs to help mentally ill patients. Reinstein’s office in Uptown is adjacent to the research institute, which is owned by John Sonnenberg, a clinical psychologist who describes Reinstein as "a mentor of mine" and "brilliant." Sonnenberg said drugmakers and others pay his institute to do research, and the group, in turn, pays Reinstein a consulting fee "under $2,000 a month" and has for many years…
This next clip about Reinstein’s use of Clozaril is much worse and should be read in toto [In Chicago’s Nursing Homes, a Psychiatrist Delivers High-Risk Meds, Cut-Rate Care]. There are plenty of other equally disturbing reports about Reinstein and Sonnenberg. Just google michael reinstein md. And in spite of Sonnenberg’s denials, this is clearly a shared enterprise with a fabricated separation to deflect conflict of interest charges. It’s kind of hard to see how John Sonnenberg can run a 52 site multinational clinical trial from a Chicago store-front, but this is the very Agency in charge of the Lurasidone D1050231 Trial that I’ve been discussing – the one that Drs. Meltzer and Potkin are so excited about.

Back to the Main Event:
So, looking back to the table of changes for the clinical trial of Latuda® [D1050231], it should make sense. John Sonnenberg and his Uptown Research Institute conducted the clinical trial for Dainippon Sumitomo Pharma. In 2009 Dainippon Sumitomo Pharma acquired Sepracor and created Sunovion in early 2010. In the meantime, Dr. Reinstein and Uptown Research were the focus of a lot of negative and embarrassing attention, being included in suits against AstraZeneca’s Seroquel. Here, I’m back to guessing again, but I suspect that Sunovion needed to sanitize D1050231 and distance themselves from Reinstein and Sonnenberg, so they brought in Quintiles to clean things up and help them with their FDA process and other things. So Dr. Herbert Y. Meltzer was not the Principal Investigator of the clinical trial like he said in the video. He was a Principle Investigator of the Vanderbilt site, one of fifty-two sites. The Study Principal Investigator was John Sonnenberg PhD operating out of that Chicago store-front next to and affiliated with a major dangerous pill mill operated by Dr. Michael Reinstein [that needs shutting down yesterday]. I doubt that anyone reading the article in the American Journal of Psychiatry pictured that store-front as the research facility behind the article [or Dr. Reinstein as a psychiatric consultant]…

Addendum: Perhaps you recall Dr. Reinstein’s Seroquel Pamphlet on Diabetes from long ago:

Wednesday, January 4, 2012

Federal Judge subverts justice once again - Is Bayer Yaz going to be the next AstraZeneca Seroquel

We used to have something very unique in America that separates us from humanity's dark history of tyrannical dictatorships, elitist tyrannies, unbending theocracies, military tribunals, & oppressive oligarchies; it was called the rule of law and a system of equal justice determined by the masterful safe guard called a jury of our peers. That cherished and endangered safe guard of the common citizenry is now being supplanted within our judicial system with politically appointed judges with tainted partition agendas that serve those powerful few that have in turn gifted them their positions. 

The injured parties in the Bayer YAZ litigation better be paying very close attention & start applying some firm pressure upon their law firms right now; before they are the next injured parties sold down the river for an insulting settlement offer by these ambulance chaser law firms that are looking out for themselves and bottom lines first & foremost. Oh yeah, their injured clients a very distant second, if at all..most of these law firms headed to these secretive backroom dealing only see you the injured party as a number, a dollar sign, a meal ticket, and easy pay day. 

You are not a real person, an actual face, or a feeling human being that has suffered an injustice & injury by blatant corporate malfeasance to them. You are just simply a numbers calculation, one of many nameless & faceless thousands they intend to use as bargaining chips for profit . 

 Just ask the injured Seroquel litigants! We have been on the receiving end of the misinformation tread mill, felt the total disregard for our concerns and inquiries, and been bullied by these same law firms and court system you're relying upon to seek justice & to serve your best interest.  It's many of the same law firms, the same secret backroom scam, and more than likely end up being the same unjust results coming for the YAZ victims down the proverbial pike very soon.... 

Say it ain't so! Please say it ain't so: trials canceled, judges forcing settlement negotiations, delays, delays, & more delays... and to think the same mediator hired gun appointed (or shall we say anointed) to this litigation that directed the scandalous miscarriage of justice in the AstraZeneca Seroquel litigation. 

This surely means more shady secret back room deals with no injured party oversight or reasonable knowledge of the goings on..Tort litigation has become a corrupted cookie cutter process of monetary deal making that richly rewards both attorney firm greed & unscrupulous/recklessness corporate behavior; while leaving the actual injured parties with insulting token settlements and zero justice. But more than than this, it's hides the truth and inherent dangers of drug products from the general public. 

As with the AstraZeneca Seroquel litigation; Bayer will for all intent & purpose end up walking away from this litigation with a scant slap on the wrist **while admitting no wrong doing and profiting beyond imagination** and to think, with all those product dangers & the pertinent information to be hidden from the general public's knowledge base forever. 

This same crooked play book is now being used over and over again...and no one is standing up to confront all the greed serving beastly players from bottom to top of this members only club. This is none other than a corrupt elitist government sanctioned miscarriage of justice..what some call to BIG to be held accountable, and others call pay to play. What it's not, is about equal justice or receiving your rightful day in court before a jury of your peers, specially when a huge corporation with forethought and great malice recklessly causes you serious bodily harm from using their unsafe product.


From fiercepharma

Judge calls off Yaz trial, orders suits into mediation

The first Yaz trial won't open as scheduled. A federal judge delayed the bellwether patient lawsuit, set for trial next week, and appointed a special master to mediate instead. And this special master is well versed in pharma liability litigation: It's George Washington law professor Stephen Saltzburg, who handled mediation in 26,000 Seroquel lawsuits.

Judge David Herndon, who's overseeing litigation over Bayer's birth control pills, had promised in the fall to press for settlements after the bellwether trials wrapped up. But in an order filed Dec. 31, Herndon abandoned his previous plan in favor of mediation, saying this alternative will "better serve" plaintiffs and defendants in these cases. Herndon ordered both sides to meet with Saltzburg "without delay" and negotiate in good faith.

The order not only put the first Yaz trial—Kerry Sims v. Bayer—on hold, but also put the rest of the bellwether trials in limbo. Herndon is presiding over thousands of suits claiming Bayer contraceptives Yaz and Yasmin caused dangerous blood clots, and the drugmaker didn't adequately warn patients of the risks. Bayer maintains the pills are safe and effective when used as directed.
Lawyers aren't the only ones debating the drugs' safety. A range of studies have turned in conflicting results on their safety risks, with some highlighting substantial increase in clotting risks and others finding no increase. In December, an FDA advisory panel reviewed the data, and the group recommended labeling changes to clarify the potential risk of blood clots. The committee backed the drugs' risk-benefit profile, however, with a 15-11 vote.

- get Judge Herndon's order (PDF)


If your wondering how all these defective & harmful drugs are getting approved to market; there this interesting article today over at Pharmalot you should read. & read here concerning YAZ

Different drug for a different use than Seroquel no doubt...but the hidden data, corporate hanky panky, and ingrained corruption up and down the profiteering chain link connections are eerily similar..