Tuesday, July 12, 2011

Pharmaceutical Corporate Corruption in an Elitist Government – AstraZeneca Seroquel & Who’s Not Looking Out For You…conflicts of interest alert


Pharmaceutical Corporate Corruption in an Elitist Government – AstraZeneca Seroquel & Who’s Not Looking Out For You…conflicts of interest alert

Seroquel was approved by the FDA in 1997. So let’s do a little fuzzy math 
adding up the number of years Seroquel has been on the market 1997 – 2011 = 14 years. 
we can guess-timate that it starts out as a billion dollar a year drug and
is now a 5+ billion dollar a year drug = which in a low ball guess-timation 
ball parks out @ some where in the neighborhood of 30 – 50 billion dollars 
in total revenue. (THAT'S NOT CHUMP CHANGE)
 
Now we’ll factor in a 520 million dollar fine paid to the federal government
& another 86 million to the States for their criminal off label marketing
and fraud charges. (Remember, AstraZeneca in this sweet heart deal admitted No Guilt
or any Wrong Doing)
 
Add in another 1 billion they are spending on their super dream team legal efforts
& the few hundred million they are offering to settle tens of thousands of civil 
litigation claims for the hidden and buried serious damage seroquel has caused 
to our citizenry. We can round up into the roughly 2 billion dollar range. 
 
So when you take away 2 billion from between 30 & 50 billion in profitable sales; 
you can see clearly that corporate crime pays quite handsomely. 
Now it’s not even over…that patent is still running and the profits keep piling up in
mountain sized piles of cash…..
 
place that in a context that this is just one drug out of hundreds that have used 
these same horrendous criminal tactics to make countless billions. 
Does anyone have to even wonder why we have an unsustainable financial 
health crisis in America? 
 
We are being fleeced and burdened with unsafe drugs causing untold major health 
consequences for patients, while we are paying through the nose at the same time.
Talk about running the ultimate con game and crime syndicate.
 
So you would think our government representatives would want to do something
about this correct! What if they are very much part of the problem and crimes?
What solutions do we have then? 
 
from bloomberg news
 
Strong double-digit sales growth at CER for Crestor, Symbicort and Seroquel XR. 
Crestor and Seroquel franchise sales now exceed $5 billion each for the
full year.


We are losing the war on drugs because of people in high office whose hands are deep in the pockets of the maker of OxyContin, Purdue Pharma!
Eric Holder, our current Attorney General, went from prosecuting bad guys to shielding them. In 2001, Darrell McGraw Jr., the longtime Democratic attorney general of the state of West Virginia, filed a civil case against Purdue Pharma alleging that the privately held pharmaceutical company had engaged in "coercive and deceptive" marketing of OxyContin.
McGraw further charged that Purdue had used misleading advertisements and had promoted the inappropriate use of OxyContin for minor pain. His lawsuit further stated that Purdue had offered doctors free trips to “pain management” seminars where the firm pitched the drug as safe and effective for treating minor pain – without mentioning the drug was supposed to be used only for severe pain and easily abused.
McGraw also alleged that Purdue had told “pharmacists that they can get in trouble if they do not fill prescriptions, even if they believe someone may be an abuser of the drug.” He maintained that the firm’s underhanded practices had caused users in West Virginia to become addicted to the drug.
And he noted that while Purdue’s annual sales revenue from OxyContin had surpassed $1 billion, the state of West Virginia was saddled with the cost of treating people who had become addicted due to misuse of the drug -- encouraged by Purdue Pharma.
The lawsuit was a big worry to Purdue -- very specifically they had a lot to lose financially. This suit was a serious threat to the corrupt drugmaker, and they eventually called in Eric Holder, an attorney working for Covington and Burling in Washington, DC to cover up their deceptive deeds.
The morning the case was to go to trial, in November 2004, Holder helped negotiate a settlement. Working in the judge’s chambers in West Virginia, he put together an agreement under which the firm would have to pay $10 million over four years into drug abuse and education programs in West Virginia -- and Purdue Pharma would not have to admit any wrongdoing!
Eric Holder managed to keep the criminal activity of Purdue Pharma quiet since there would be no trial and no documents or testimony to be made public. Did Holder's "hands in the pockets of Purdue Pharma" allow this epidemic of OxyContin death and addiction throughout the country to perpetuate? Many people think it did.



Financial disclosure statements filed with the U.S. Office of Government Ethics show that Eric Holder Jr., Jeh Johnson, Ronald Kirk and Tom Vilsack reaped the profits from being Am Law 100 partners. (Hat Tip: Politico.)
Holder, Obama's nominee for attorney general, made $3.3 million at Covington & Burling last year, a number that includes deferred compensation. The AG-to-be (barring an unexpected senatorial rejection) stands to earn between $1 million and $5 million from Covington as part of a separation agreement with the firm.
Holder also will receive a repayment of anywhere between $500,000 and $1 million from Covington's capital account. Politico reports that Covington's retirement plan also might pay Holder nearly $500,000. If confirmed as AG, Holder's annual salary would be $196,700. Holder previously served as deputy attorney general at Main Justice during the Clinton administration.

from Covington & Burling

Covington has one of the world's most active and respected Pharmaceutical Litigation and Investigations Practices, with over 110 firm lawyers engaged in this work.  Drawing on the expertise of the firm's pre-eminent FDA regulatory practice, our litigators have helped guide some of the world's leading pharmaceutical companies through all aspects of difficult investigations and lawsuits.  Covington represents more pharmaceutical companies in more criminal and civil investigations by federal and state government agencies, including high-profile congressional inquiries -- such as the Food & Drug Administration, the Department of Justice, Congress, and State Attorneys General -- than any firm in the country.  Our litigation experience is broad, encompassing many areas including, suits under the False Claims Act, product liability litigation, patent litigation, pricing and antitrust litigation, litigation with federal agencies, and insurance coverage disputes.

Pharmaceutical Investigations
As investigations often precede litigation, our firm has deep experience serving as national coordinating counsel, handling document-intensive litigation, working with experts, and managing multi-jurisdictional and class action proceedings for pharmaceutical manufacturers.  The firm regularly advises pharmaceutical clients on a wide array of enforcement and regulatory proceedings, including the Anti-Kickback Statute, the Medicaid rebate statute, the Prescription Drug Marketing Act, the False Claims Act, the Stark physician referral statute, and state anti-fraud and consumer protection laws. With the assistance of our offices in London and Brussels, we also handle investigations under the Foreign Corrupt Practices Act.

In addition to Executive branch investigations, Covington has also assisted numerous pharmaceutical manufacturers in preparing for high-profile congressional inquiries.  We have a team of lawyers with experience on both sides of the aisle in the House and the Senate.  Covington’s team of former government lawyers, includes a Deputy Associate Attorney General, a U.S. Attorney (EDNY), two Assistants to White House Counsel, eight AUSA's (including one from Boston), two DOJ Civil Fraud Section Attorneys, and three DA's.  Through our numerous legislative representations, we have developed a deep appreciation of the benefits of being forthcoming in these investigations, the value of developing a positive relationship with both majority and minority staff and educating them on the substance of their inquiries, and the importance of effectively preparing witnesses for congressional hearings. Our lawyers are also experienced at handling the public relations and media relations challenges that often accompany political investigations, including preparing and implementing "crisis management" plans that dovetail with our legal strategies. 

The Practical Law Company (PLC) ranked Ethan Posner, Mark Lynch, and Geoffrey Hobart as being leading lawyers in the Pharmaceutical Fraud & Abuse Investigations field.  These rankings reflect our lawyers' superior industry knowledge and proven ability to protect clients' interests in a broad range of investigations and related litigation.

Pharmaceutical Litigation
Covington is one of the most active firms in the country on a broad range of pharmaceutical litigation.  Our litigators draw on the expertise of the firm's preeminent Food and Drug Practice, which comprises 40 lawyers, including two who served as Chief Counsel of the Food and Drug Administration.  Our lawyers serve as regulatory and legislative counsel for numerous manufacturers and also industry groups such as PhRMA (Pharmaceutical Research and Manufacturers of America); CHPA (Consumer Healthcare Products Association); EFPIA (European Federation of Pharmaceutical Industries and Associations); NPC (National Pharmaceutical Council); and AHI (Animal Health Institute).

False Claims Act: In today's world, government investigations often proceed in tandem with private class actions and qui tam lawsuits under the False Claims Act. We have experience with investigations alleging wrongdoing during clinical research, violations of the Prescription Drug Marketing Act, billing fraud, kickbacks and violations of the Stark self-referral law, and violations of good manufacturing practices.  We represent companies in all phases of an investigation, from subpoena compliance to trial.  Our experience includes handling the private class actions that arose out of two of the largest health care matters in history -- the cases involving overbilling allegations against National Medical Enterprises/Tenet Healthcare Corporation and SmithKline Beecham Clinical Laboratories.

Products Liability Litigation: Covington has defended many product liability claims on behalf of clients in the food, drug, and chemical industries, and has played a central role in defending against actions seeking to establish new scientific theories of causation and novel theories of liability.  We presently serve as national coordinating counsel for Hoffmann-La Roche in Accutane product liability litigation; national coordinating counsel in all pharmaceutical products liability litigation for the Consumer Healthcare Products Association (CHPA), the Washington, DC based trade association for nonprescription drug manufacturers; and we are responsible for economic injury cases involving OxyContin.

Patent Litigation: The firm successfully combines its regulatory and antitrust expertise in handling Hatch-Waxman and other patent cases and associated antitrust litigation. Representative litigation work includes: coordinating Monsanto's litigation of several cases involving interrelated biotechnology patents, as well as antitrust and trade secret issues; defending SmithKline Beecham against claims of patent infringement; defending GlaxoSmithKline for alleged patent antitrust violations; prosecuting suits for patent infringement on behalf of clients such as Key Pharmaceuticals, Caliper Life Sciences, and Monsanto Company; and a pending ANDA case for Johnson & Johnson.

Pricing and Antitrust Litigation: We have successfully litigated many complex civil and criminal antitrust and consumer protection matters, including nationwide class actions, consolidated multidistrict cases, short-fuse preliminary injunction proceedings, and appeals up through the U.S. Supreme Court.  Our experience encompasses jury and bench trials in state and federal courts and before administrative agencies. Representative matters include: Boehringer Ingelheim in pending Canadian import litigation; GlaxoSmithKline and Purdue Pharma in patent/antitrust litigation; a major Rx client in a Department of Justice criminal grand jury investigation; Warner-Lambert in the In re Brand Name Prescription Drugs Antitrust Litigation; and, related state court lawsuits.  We also serve as antitrust counsel to the National Pharmaceutical Council, Consumer Healthcare Products Association, Pharmacogenetics Working Group (EU and US scientific representatives from 22 major pharmaceutical companies), and well over a dozen other trade associations in the food and drug area and related fields.

Litigation with Federal Agencies: Our litigators have extensive experience representing pharmaceutical manufacturers that challenge FDA actions and those that intervene to defend agency actions.  For example, we have both overturned FDA decisions denying pediatric exclusivity to our clients and defended FDA decisions granting pediatric exclusivity.  We also have deep expertise in handling "reverse" Freedom of Information Act cases, where manufacturers assert their interests in the confidentiality of proprietary information sought by competitors, watch-dog groups or others.

Insurance: The firm has a leading national practice in litigating insurance coverage disputes for policyholders, and has handled many cases for pharmaceutical manufacturers both in court trials and in private arbitrations, including both domestic and international proceedings.  We recovered approximately $1.5 billion in coverage for Dow Corning breast implant liabilities, and are currently representing several major pharmaceutical manufacturers in confidential arbitrations seeking coverage for major product liability cases.

Representative Matters

  • Lead counsel to Pfizer on numerous investigations into physician interaction practices and the marketing and promotion of various prescription drugs by the Department of Justice, multiple state Attorneys General, Congress and the Securities and Exchange Commission.
  • Lead counsel to GlaxoSmithKline in a Department of Justice investigation into physician payments, sales and marketing issues and good manufacturing practices, as well in federal and state lawsuits challenging AWP drug pricing.
  • Lead counsel to Boehringer Ingelheim in the Canadian import antitrust litigation.
  • Representation of Procter & Gamble Pharmaceuticals, Inc. in a California antitrust and unfair competition case challenging a contract authorizing the sale of an "authorized generic" version of P&GP's Macrobid.
  • National coordinating counsel for Hoffmann-La Roche and Roche Laboratories Inc. -- Covington managed all aspects of a nationwide lawsuit alleging that Accutane causes depression, psychosis, suicide, violence, and other psychiatric side effects. Covington also managed all political aspects of this controversy. Drawing on the substantial experience of our lawyers in dealing with the House Energy and Commerce Committee, we worked closely with the committee staff over an 18-month period to provide documents and other requested information. The Committee ultimately held a day-long hearing in December 2002, and we prepared company executives to testify, including Roche's President and CEO, George Abercrombie.
·  Lead counsel to Purdue Pharma in OxyContin® antitrust and consumer protection class actions.
·  Lead counsel to Johnson & Johnson in an investigation by the Department of Justice into alleged off-label promotion and managed care relationships.
  • ·  Lead counsel to InterMune and Medicis in Department of Justice investigations of alleged off-label marketing and promotion.

Accolades

  • PLC Cross-border Super League
    • Ranked 1st in the Life Sciences Regulatory Super League (2004-2011)
    • Ranked 1st in the Life Sciences Industry Super League (2005-2009)
  • PLC - Life Sciences, Which Law Firm?  (2006-2009)
    • Leading: Government Enforcement & Investigations, USA
    • Highly Recommended: Product Liability, England
    • Recommended: Product Liability, USA
http://www.scribd.com/doc/39692892/Public-Financial-Disclosure-Report-Eric-Holder




Public Financial Disclosure Report Eric Holder

Sunday, July 10, 2011

Discontinuation of Quetiapine (SEROQUEL) From an NIMH-Funded Trial Due to Serious Adverse Events


 Do the benefits outweigh the risk? The Grim Sleeper above wants you to believe they do!

I happened to come across this study of quetiapine (seroquel) copy & pasted below. This information should be sounding off alarm bells and raising grave concerns over a drug that has been continually approved for ever expanding indications by the FDA. It should be stated that we (the citizens of America) have stood idol & watched as a drug assault upon America has transpired based on at best questionable clinical trial study data that in many cases is not only skewed; but controlled, manipulated, & directly funded by AstraZeneca.

  This all has the evidenced appearance to be nothing short of a colossal marketing campaign masked as legitimate scientific data/endeavors. Please check out what AstraZeneca has in the pipeline for Seroquel as that patent clock continues to tick down -->U.S.National Institutes of Health:Clinical trials:quetiapine (Seroquel); and then take a moment to ask yourself how a dangerous and powerful anti-psychotic drug has become one of the most prescribed and profitable drugs in America (worth multiple billions of dollars in sales and profit each year) ? 

It is definitely not because we have had an explosive epidemic of psychosis or that some unknown pathogen is causing a massive schizophrenia outbreak. 

It is no mistake many tens of thousands of users have been stricken with serious and debilitating preventable conditions from ingesting Seroquel. No expense has been spared by AstraZeneca in the marketing of this drug at every level possible; from the Representative offices of Washington DC, to your main street doctors office & and virtually every place in-between.  

As you read this study below conducted by the National Institute of Mental Health, you should ask yourself how this same government could be approving the use of this drug in younger & younger children & in many more less serious health conditions (yes, they are even now trialing this drug on toddlers and it's being used regularly off label in children as young as 2 years old).  

You may come to the conclusion from reading this article, other posting on this blog, or by doing your own research, that this madness must stop! If you are that person; I can only say that it will not stop until you stand up and make it stop. Please make your voice heard!

------------------------------------------------------------------------------------------------------------------------

Discontinuation of Quetiapine From an NIMH-Funded Trial Due to Serious Adverse Events

DILIP V. JESTE, M.D., HUA JIN, M.D., SHAHROKH GOLSHAN, Ph.D., SUNDER MUDALIAR, M.D., DANIELLE GLORIOSO, M.S.W., IAN FELLOWS, M.S.
La Jolla, Calif., HELENA KRAEMER, Ph.D.
Stanford, Calif., and STEPHAN ARNDT, Ph.D.
Iowa City, Iowa

To the Editor: We have been conducting a 5-year study, funded by the National Institute of Mental Health, to compare four commonly used atypical antipsychotics (aripiprazole, olanzapine, quetiapine, and risperidone) in middle-aged and older patients with psychotic symptoms for whom a treating clinician has recommended an atypical antipsychotic. In this Institutional Review Board-approved protocol, we use equipoise-stratified randomization which allows the patients and their physicians to exclude up to two of these antipsychotic agents that are not acceptable to them. The treating physician chooses the dosage and duration of treatment. The detailed study design is described elsewhere (2). We report the results of an unplanned interim analysis recommended by our Data and Safety Monitoring Board, which led to the discontinuation of quetiapine from the study. It includes the first 294 of the proposed 450 subjects to be enrolled. Sixty-one subjects dropped out prior to data collection and were excluded from analysis. Diagnoses for the remaining 233 patients were as follows: schizophrenia (32%); bipolar disorder (11%); and psychosis associated with dementia (24%), with depression (11%), with posttraumatic stress disorder (16%), or not otherwise specified (6%).
There were 79 Food and Drug Administration-defined serious adverse events (3) that occurred in 57 of the 233 study subjects while they were taking their randomly assigned drugs (Table 1). Among the patients taking quetiapine, 38.5% had serious adverse events relative to 19.0% in other groups ({chi}2=9.56, df=1, p=0.002), providing a relative risk of 2.0 (confidence interval=1.3–3.1). All pairwise differences involving quetiapine were significant. Using Mantel-Haenszel tests to account for the equipoise-stratified randomization and pooling the other drug groups, the quetiapine group exhibited higher rates of serious adverse events ({chi}2=5.63, df=1, p=0.022). (Pairwise differences using Mantel-Haenszel analysis did not reach significance.) Of the serious adverse events with quetiapine, 29.7% (11/37) were rated as "probably" or "possibly" related to the medication. For other drugs, 21.1% (9/42) of the serious adverse events were rated as "probably" or "possibly" related to the medication. Of the individual types of medical serious adverse events, rates of pneumonia were higher with quetiapine than with other drugs combined (p=0.011, Fisher’s exact).

View this table:[in this window]
[in a new window]


A multivariate logistic regression analysis for all serious adverse events was performed, 

covarying for age, prior antipsychotic treatment, and medical burden. 
The overall difference in the proportion of serious adverse events among the four drug groups 
remained similar in all analyses. 
Likewise, differences in length of treatment did not seem to be responsible for differential rates 
of serious adverse events, since there was no significant difference between quetiapine and other 
drugs regarding the duration the subjects continued to take their randomly assigned medication.



Footnotes
Dr. Jeste reports that AstraZeneca, Bristol-Myers Squibb, Eli Lilly, and Janssen donated quetiapine, aripiprazole, olanzapine, and risperidone, respectively, for this NIMH-funded study.
Drs. Jin, Golshan, Mudaliar, Kraemer, and Arndt and Ms. Glorioso and Mr. Fellows report no competing interests.
Supported in part by grants from NIMH (R01 MH64722, T32 MH019934, and P30 MH080002) and the Department of Veterans Affairs.

Saturday, July 9, 2011

AstraZeneca - Seroquel - paying corrupt doctors to destroy your health - Reject the seroquel settlement offer

AstraZeneca Seroquel - paying corrupted doctors to market seroquel & destroy your health - Reject the seroquel settlement offer - Bad Drug - Bad Offer - Demand Justice

Stories like the following from soulful sepulcher blog have played out over and over again in the sleazy marketing of the drug Seroquel. It's no mistake that you were harmed by this drug; AstraZeneca knew it was dangerous, knew it was unsafe, & knew about the devastating side effects. They simply covered it up, and then went about buying off doctors & advocacy groups to mass market this drug to the detriment of your health.

This is no crazed conspiracy therory; this is evidenced and documented fact that AstraZeneca does not want replayed over and over again before the American Public & to Juries in court rooms across America. This reported settlement offer is nothing more than a scam and cheap ploy to avoid any reasonable accountability for their criminal wrong doing & to keep you the injured party from receiving any rational semblance of justice.

-------------------------------------------------

In Biederman's public shadow, Melissa Del Bello was also investigated by Senator Grassley: AstraZeneca and Seroquel, big pharma, big bucks

In the wake of the Biederman sanction by Mass General, there has been a flurry of discussion again regarding Senator Grassley's 2008 investigation of drug company payments to doctors. The focus has been mostly on Biederman, Wilens and Spencer due to their pocketing and non-disclosures of $1 million a piece.

In the shadows, lurking in the background though is another pharma money taker and that is Melissa Del Bello who sits on the conflicted(pharma income) KOL Scientific Advisory board with Biederman et al at C.A.B.F. Child Adolescent Bipolar Foundation,and "Professor of Psychiatry and Pediatrics, Vice Chair of Clinical Research, Co-Director, Division of Bipolar Disorders Research, University of Cincinnati College of Medicine, Ohio". Grassley refers to these treatment guidelines in his speech.


The United States Committee on Finance
Grassley floor statement on drug company payments to doctors
Floor Statement of U.S. Senator Chuck Grassley of Iowa
Pharma Payments to Doctors
Wednesday, April 2, 2008

"Since last summer, I have been investigating dozens of physicians to see if they are reporting their outside income to their universities. These physicians are at public and private universities and are working at institutions of higher learning across the United States.

Today, I am going to report on the actions of one physician to explain how industry payments to medical experts can affect medical practice.

Last summer, The New York Times ran an article about several drugs called atypical antipsychotics.

These drugs are very powerful, and the New York Times reported that they are widely prescribed for children.

In the case of Seroquel, this drug became widely prescribed to treat children for bipolar disorder in 2005. And it is important to examine this drug because we have paid billions of taxpayer dollars for Seroquel in the last few years.

This happened after a group of experts decided that drugs like Seroquel worked in kids and published new guidelines in The Journal of the American Academy of Child and Adolescent Psychiatry.

But this panel based its guidelines on a single inconclusive study from 2002.

Paid for by Astra Zeneca, the study concluded that kids did well on Seroquel, even though half of them dropped out of the study because of bad side effects.

The lead author of this study was Dr. Melissa Del Bello, a professor at the University of Cincinnati.

After reading about this story, I sent a letter to the University of Cincinnati and asked to see Dr. Del Bello's reports of outside income.

I found out that Dr. Del Bello received over $100,000 from Astra Zeneca in 2003, the year after she did the study.

The following year, the company paid her over $80,000. These payments were for lectures, consulting fees, service on advisory boards, and reimbursements for travel-related costs.

After the university sent me these records, I asked Astra Zeneca to account for money that the company had sent to Dr. Del Bello.

The numbers didn't add up. Between 2005 to 2007, Dr. Del Bello reported about $100,000 in outside income to her university.

But I found out that Astra Zeneca had paid her over $238,000-that's a big difference.And the money keeps dribbling in.

Just last week, Astra Zeneca reported to me that they had discovered an additional $1800 in payments to Dr. Del Bello. Who knows if we will ever know the full amount.

So her own university, which is supposed to be monitoring her conflicts of interest, didn't even know about the additional payments.

It seems to me that they did what many universities around the country do-they trusted their faculty to provide accurate information.

Even worse, I found out that Dr. Del Bello receives grant money from the National Institutes of Health. And according to federal regulations, universities are supposed to monitor conflicts of interest when their researchers receive NIH grants.

Obviously, the university is engaged in the practice of "trust but did NOT verify."

Another interesting thing happened while I was looking into Dr. DelBello.

According to the letter I received from the University of Cincinnati, Dr. Del Bello failed to report other money that she received from big drug companies.

It turns out that Dr. DelBello had a company which she established for "personal financial purposes.

AstraZeneca, the maker of Seroquel, paid MSZ Associates Inc., an Ohio Corporation,over $60,000.
And where do you think is the address for MSZ Associates? You got it, the Department of Psychiatry at the University of Cincinnati.

This situation is unfortunate on so many levels.

It is unfortunate for the University of Cincinnati that relied on the representations of its faculty; it is unfortunate for patients who once believed that their doctor was not for sale; and itis unfortunate that we are in a day and age where a bill promoting transparency for millions and millions of dollars going from big drug companies to American doctors is necessary.

This is just one example of a doctor who has been receiving large amounts of money from drug companies.

In this area, as in many others, a little bit of sunshine will go a long way.

The fact that a physician can promote a drug to other doctors and receive NIH funding,while hiding a very clear conflict of interest, is disturbing. And that's why we need this bill.

Because nobody is watching this money and it is having a bad effect on medical practice.Before closing I also want to say that the University of Cincinnati has and continues to be very cooperative in this investigation and it is greatly appreciated. I yield the floor."
-Senator Charles Grassley, 2008



C-Span video library

Watch, listen or read the captions of Grassley's floor statement in 2008 on drug company payments to doctors, including the remarks above regarding Melissa Del Bello.








For more in-depth reading related to this topic, I would highly recommend you go over to the 1 Boring Old Man Blog to read his expert and thoughtful commentary on seroquel and the horrendous corruption that has enveloped modern day psychiatry.

Sunday, July 3, 2011

AstraZeneca continues to mass market Seroquel despite safety concerns & sordid history - it's still raining profits from this storm cloud of deceit

People Magazine June 20, 2011


AstraZeneca continues to mass market Seroquel despite safety concerns & sordid history - it's still raining profits from this storm cloud of deceit


Get Off of My Cloud

  

From: Counterpunch.org/MarthaRosenberg

Seroquel's Toll

By MARTHA ROSENBERG  
January 24, 2011

Even though AstraZeneca's antipsychotic Seroquel is the fifth best-selling medication in the US according to drugs.com, exceeded only by Lipitor, Nexium, Plavix and Advair diskus, its safety, effectiveness, clinical trial and promotion records are highly checkered.

An original backer, psychiatrist Richard Borison, was sentenced to a 15-year prison sentence in 1998 for a pay-to-play Seroquel research scheme.

Its US medical director Wayne MacFadden had sexual affairs with two different women involved with Seroquel research, say published reports.

Chicago psychiatrist Michael Reinstein received $500,000 from AstraZenenca and wrote 41,000 prescriptions for Seroquel reports the Chicago Tribune and ProPublica.

Psychiatrist Charles Nemeroff who left Emory University in disgrace after a Congressional investigation for unreported pharma income, promoted Seroquel in continuing medical education courses according to the web site of psychiatrist Daniel Carlat.

Florida child psychiatrist Jorge Armenteros was chairman of the FDA committee responsible for recommending Seroquel approvals while a paid AstraZeneca speaker himself, said the Philadelphia Inquirer in 2009.

Psychiatrist Charles Schulz' high profile pro-Seroquel presentations are suspected of being colored by his AstraZeneca income says the Minneapolis Star Tribune.

And unexplained Iraq and Afghanistan troop deaths are linked to Seroquel reported the Associated Press in August.

Originally approved for schizophrenia in 1997, Seroquel has subsequently been approved for bipolar disorder, for some groups of kids and as an add-drug for depression. This "indications creep" has mostly flown below the public's radar. Seroquel expansion to treat children in late 2009, for example, was noted as a mere "label change" on the FDA web site. Hello?

Even without its depression indication, Seroquel is big business for AstraZeneca, earning $4.9 billion in sales in 2009. It is the drug that North Carolina's Medicaid spends the most on: $29.4 million per year, reports the Charlotte News and Observer.

But now, as AstraZeneca rolls out its "Still Trying to Get Ahead of Your Depression" campaign, there are new questions about Seroquel's safety and effectiveness.

According to an FDA warning letter, an AstraZeneca sales representative during an unsolicited sales call on January 3, 2008 sold Seroquel as a treatment for major depressive disorder to a physician before it was approved for MDD, an infraction which is illegal.

Once Seroquel was approved for depression (as an add-on treatment to an antidepressant for patients with major depressive disorder who not have an adequate response to antidepressant therapy), its leave-behind sheets drew another FDA warning letter.

AstraZeneca implied patients would achieve "remission" from depression with Seroquel XR (extended release) as opposed to with an antidepressant alone, says FDA -- a claim not backed up by clinical experience.

Seroquel's effect on depression has only been demonstrated in two, six-week trials FDA further said and six weeks is "not a long enough time period to adequately assess remission." (It was approved...why?)

Also the case study of "Catherine F." depicted in leave-behind sheets is inaccurate says FDA because it suggests Seroquel alleviates "symptoms of sadness and loss of interest when this has not been demonstrated by substantial evidence or substantial clinical experience." (It was approved...why?)

Even AstraZeneca's own briefing to the FDA committee in 2009 admits a "failed study" in which both Seroquel and Lexapro "failed to differentiate from placebo" which is Clinical Trial for "didn't work."

Nor did AstraZeneca adequately disclose Seroquel risks says FDA which include increased mortality in elderly patients with dementia-related psychosis, suicidality, neuroleptic malignant syndrome, hyperglycemia and diabetes mellitus, hyperlipidemia, weight gain and other serious side effects.

In fact, in addition to risks like cataracts, seizures and increases in blood pressure in children and adolescents, already on the Seroquel label, FDA asked AstraZeneca to add the "risk of EPS and withdrawal syndrome in neonates" a few months ago: movement disorders which can affect mothers' babies if the mothers are taking Seroquel and stop.

But the FDA might also look at what the government's other hand is doing. In May the Office of the Army Surgeon General's final report on the findings of its Pain Management Task Force unabashedly hawks Seroquel for an unapproved use.

"Physicians should consider these medications for sleep disorders," says the 163-page report," listing Ambien and Seroquel (quetiapine) "for nightmares" even though Seroquel has never been approved for insomnia, sleep disorders or "nightmares."

Maybe the government will send itself a warning letter.