Strattera: Psych Drug DEATHS As UK State Secrets

AboutLawsuits.com has:

Strattera Liver Injury Reports Continue To Be Received By FDA

And Before you even Read it, ...... We have 1 question:

How many people have actually DIED, or had their liver and kidneys Blown out..... from Undiagnosed, Untreated, ADHD?

Here's 2 keepers from the above.

"The bolded warning indicates that the medication should be discontinued in patients who develop jaundice, which involves a yellowing of the skin or whites of the eyes, or who have laboratory evidence of liver injury while taking Strattera."

"Drug induced liver injury is the most common reason for acute liver failure in the United States. A drug may cause chemical damage to liver cells which can result in serious injury to the liver and may cause death. Signs of liver damage may include nausea, jaundice, vomiting, bleeding, abdominal pain or mental confusion. Kidney failure may also be present in some cases."

Mental Confusion? Isn't this stuff peddled to make people Unconfused?


drugawareness.org links to Sepp Hasslberger at newmediaexplorer.org who has: (from Oct 2008)

Strattera Adverse Effects: UK Medicines Agency Refuses To Act

"Janne Larsson, an investigator and reporter in Sweden, has obtained information about adverse event reports on Eli Lilly's ADHD drug Strattera, using the Swedish freedom of information laws. The data, coming from both the FDA's adverse reaction database and from reports to the UK's Medicines agency, shows numerous adverse effects and scores of deaths by suicide.

Yet the agency, even after repeated prodding by Larsson to initiate action, has refused to budge or even acknowledge that there is a problem. MHRA apparently accepts the drug's producer Eli Lilly's data rather than its own and the FDA's adverse event reports."

Hasslberger's article has Larsson claiming MHRA "cannot verify the source" of false info regarding Strattera deaths, when it was the Manufacturer itself - Eli Lilly - which Provided that info, ..... To MHRA.

Hasslberger also brings us This report from Janne Larsson:

Suicides and Psychiatric Drugs: A Report Based On Data From The National Board Of Health And Welfare In Sweden. On pg 9:

"Better sources of information are the unpublished clinical trials of psychiatric drugs done by pharmaceutical companies, and the important studies done by independent researchers.

A number of these studies show that antidepressants and neuroleptics increase the risk of suicidal behaviour and directly cause effects that lead to suicide."

As the old Scot in Braveheart said: (right after they cauterized his arrow wound shut with red hot steel): "Shoore and That'll Wake you up in the Morning"

And in This letter from Janne Larsson to Professor Kent Woods: Chief Executive MHRA:

"Add to this the staggering number of adverse events reported internationally for Strattera (the majority for children) Lilly has told the MHRA: During this reporting period, a total of 23,132 spontaneous adverse event reports of atomoxetine [Strattera], representing 58,048 adverse events, were collected by the MAH [Market Authorization Holder; Eli Lilly] [5] This covered the period from November 2002 to March 2006. The number of persons who have experienced suicidality in connection with Strattera treatment has now reached 965 (PSUR 9, p. 106). Up to November 2007 (PSUR 9, Annex 16) there were also 513 case reports about mania, psychosis or hallucinations in connection with Strattera treatment.

Furthermore:

Strattera - 10,998 Adverse "Psychiatric Reactions" reported In Less Than 3 Years

"These agencies, responsible for protecting the public from harmful drugs and for "appropriate treatment", consider a document reviewing the "suicidal and self-injurious behaviour" caused by a psychiatric drug in the category of state secrets, and that it would be "an actionable breach of confidence" to let the public know about these data."

State Secrets? "an actionable breach of confidence?" STATE SECRETS?

Orwell's 1984 is now 25 years behind us in Western Civilization's rear view mirror.

Again: How many people have actually DIED, or had their liver and kidneys Blown out, ..... from Undiagnosed, Untreated, ADHD?

In the pre Public/Private cooperation CHANGE AGENT days Before 'Mental Health' became such a Lucrative obsession, ..... those Untreated ADHD-ers became carpenters, bricklayers, plumbers etc. (I.E. people who actually Contributed to society) Rather than crippled wards, or full time residents of the Granite Orchard, in our Brave New, One World Disorder, National Socialist, For Profit/Non Profit, Non-$cience, State.

FDA: Agency Whistleblowers Seek Presidential Intervention

NYT Gardiner Harris has:

Dissidents At FDA Complain Of Inquiry

In an escalating war between FDA Scientists who complained of Intimidation BY FDA Brass, and FDA Brass themselves, yet another shot has been fired.

This time, After the Dissidents went to the US House with a pile of Documents which launched a letter from the House To FDA Commish von Eschenbach, it appears that the Dissidents may have been Counter Attacked By FDA Brass: whom They accuse of launching a criminal Investigation against them in retaliation, ...... for complaining.

"Heidi Rebello, an F.D.A. spokeswoman, said she could neither confirm nor deny the existence of a criminal investigation."

The Dissidents are asking President Obama to Intervene immediately.

HR 5605: Physicians Payments Sunshine Act Of 2008

It looks like Pharma with their Multi Billion Dollar Psych Hustle MAY be needing some consoling, because HR 5605 might be a WIN for America.

Red Orbit has:

Doctors Gifts Must Be Disclosed Under New Measure

"Kohl said he was confident the legislation, called the Physician Payment Sunshine Act, would pass in the current Democratic-led Congress."

Having to Actually Disclose all that Grease they've been spreading around might leave Pharma themselves Diagnosably 'Clinically Depressed'. And then They would have be subjected to their Own Antidepressing, Antipsychoticing Chemical horrors, with perhaps a side order of Forced ECT (1) 'Treatments'.

The Prescription Project has:

What the Sunshine Act Means.

Downside? 2 More years till it kicks in.

"Where will reports be published?

On a public, searchable website, no later than September 30, 2011."

Here's the text of HR 5605: LINK

In Sept 2007 S. 2029 was a Senate proposal to address the problem.

Being libertarian We're addicted to the adage that America needs JUST 1 MORE LAW:

'No new law may be passed without 1st Revoking 6 existing laws.'

Congress could haply Continue pork-barreling America for another 29 years before that law would even Lipstick their piggie bank. However: given the LETHAL corruption in Academic and Corporate Medicine today - Especially Psychiatry - HR 5605 appears to be desperately needed, and until Constitutionally Mandated Inalienable Rights/Real Free Markets blow that LETHAL Psychiatric Corruption clean Out of medicine, We'll (reluctantly) Endorse this proposed can of Life Saving Tire Patch.

We're reluctant only in that HR 5605 doesn't go far enough. With the Hundreds of Billions in Pharma's cash boxes: $Million Dollar Fines are barely a slap on the wrist.


But then, ..... Rome wasn't built in a day.

ADHD Meds Can Cause Hallucinations In Some Kids

Reuters has:

ADHD Drugs Can Cause Hallucinations In Some Kids

Here; we find kids with no previous hallucianatory tendencies being 'Mental Healthed' into believing that bugs, worms and snakes were crawling on them. Ms Steenhyusen's article further reports that one 7 year old girl started running very fast and then just fell down: explaining that she had run into a wall: which remained invisible to everyone else. But at least she's now 'Mentally Healthy'.

Web MD has:

ADHD Drugs: Hallucinations Not Uncommon

Here we find a 12 year old boy with cerebral palsy being poisoned with methylphenidate, and 2 hours later believing he was surrounded by roaches. The 'Mental Health' roaches disappeared immediately upon discontinuation of their Diagnosing Ideate's 'Medication'.

LA Times has:

ADHD Drugs Cause Hallucinations In Some Kids In which:

FDA adverse events compiled from reports (almost 8% of kids 4-17 have been 'Diagnosed' Already) revealed 800 cases of psychosis or mania, and symptoms of psychosis surfaced with Every ADHD drug tested.

So if Your kid is 'Incurably Mentally Ill' (at least until the GD Treatment is Out of their system) in any of 4 BILLABLE Flavors:

DSM-IV-TR Billing Code: 314.00: Attention Deficit Hyperactivity Disorder
Predominantly Inattentive Type
DSM-IV-TR Billing Code: 314.01: Attention Deficit Hyperactivity Disorder
Combined Type
DSM-IV-TR Billing Code: 314.01: Attention Deficit Hyperactivity Disorder
Predominately Hyperactive-Impulsive Type
DSM-IV-TR Billing Code: 314.9: Attention Deficit Hyperactivity Disorder NOS
Not Otherwise Specified (That's right, just yank it out your Billing Code DSM Butt)

You, ...... May be Forced to have a TAX FUNDED Ideate Diagnose them and 'Treat' them to Strattera, (1) Ritalin, or Concerta (2)..... unless you WANT Child Protective Services to steal your kid for 'Medical Neglect', ..... and house them in a State Facility where he/she can be Brain Damaged with Antipsychotics, Antidepressents and Anticonvulsants, ...... and subjected to physical and sexual abuse as Dr Kreszewski discovered in Oklahoma. (backstory)

Here's more on the CPS Child Stealing Racket from: Emmasmith.org, who ALSO have an Aircraft Carrier size bee in Their Constitutional Bonnet: replete with numerous Court case listings in case Your family has been savaged by them. See Dr Fred Baughman on the Myth Of ADHD, and: adhdfraud.org and ablechild.org. Then bookmark Emmasmith - or better still Screen Capture it - and be Ready to go to the mat with CPS, because You may Need to.

PS: SSRI Update:

Recently there's been news of Former French President Chirac being poodled by his own poodle: which was on Prozac. See the Advertisements from Lilly, Pfizer and Novartis on Their campaign for Your doggie Fed Reserve IOUs at The Bonkers Institute For Nearly Genuine Research.

Drug Sales Rep: Gwen Olsen Video

05:15: "The Revolving Door"

"Show me a sane man and I will cure him for you."

Carl Gustav Jung, psychiatrist and psychologist, who praised both Hitler and Musolini

And check this Catholic Culture Book review of a recent biography of Carl Jung.

Zyprexa: More From US DOJ

For those who want More on the Eli Lilly/Zyprexa action, here's More from the USDOJ

LINK

US v. Eli Lilly and Company

Food & Drug Administration Criminal

United States v. Eli Lilly and Company, Cr. No. 09-020 (E.D. Pa.)

Most Recent Update 1/22/09 (See end of document)

1/16/09 Update:
On January 15, 2009, the Assistant Attorney General for the Civil Division and Acting United States Attorney in Philadelphia announced a criminal information and a civil settlement involving pharmaceutical company Eli Lilly and Company. The case involves off-label marketing of Eli Lilly’s drug Zyprexa for uses other than what the Food and Drug Administration approved. The company is charged with one count of distributing misbranded drugs with inadequate directions for use. A plea agreement signed by Eli Lilly admits the company’s guilt to the criminal charge of misbranding. Specifically, Eli Lilly admits that between Sept. 1999 and March 31, 2001, the company promoted Zyprexa in elderly populations as treatment for dementia, including Alzheimer’s dementia. Eli Lilly has agreed to pay a $515 million criminal fine and to forfeit an additional $100 million in assets. A civil settlement has been reached between Eli Lilly, the United States and relators, in which Eli Lilly will pay up to $800 million to the federal government and the states to resolve False Claims Act claims by Medicaid and other federal programs and agencies including TRICARE, the Federal Employees Health Benefits program, Department of Veterans Affairs, Bureau of Prisons and the Public Health Service Entities. The federal government will receive approximately $438 million from the civil settlement. The state Medicaid programs and the District of Columbia will share up to approximately $361 million of the civil settlement, depending on the number of states that participate in the settlement. The qui tam relators will receive $78 million from the federal share of the settlement amount. A Corporate Integrity Agreement (CIA) between Eli Lilly and the Office of Inspector General of the Department of Health and Human Services requires 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 Eli Lilly send doctors a letter notifying them about the global settlement; and that the company post on its website information about payments to doctors, such as honoraria, travel or lodging. Eli Lilly 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.

The announcement was issued in a DOJ Press Release (1/15/09).

The following documents are attached:

Information

Plea Agreement

Government's Memorandum for Entry of Plea and Sentencing

Corporate Integrity Agreement

Civil Settlement

1/22/09 Update:

The entry of plea and sentencing hearing in this matter will be held before the Honorable Robert F. Kelly on Friday, January 30, 2009, at 10:00 a.m. in Courtroom 11B, 11th floor of the United States District Court, United States Courthouse, 601 Market Street, Philadelphia, Pennsylvania. The case has been assigned the criminal docket number 09-020.

Zyprexa: Drug Sales Rep Video

Zyprexa: The US DOJ Release: 1/15/09

http://www.usdoj.gov/opa/pr/2009/January/09-civ-038.html

FOR IMMEDIATE RELEASE
Thursday, January 15, 2009
WWW.USDOJ.GOV
CIV
(202) 514-2007
TDD (202) 514-1888
Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-label Promotion of Zyprexa

$515 Million Criminal Fine Is Largest Individual Corporate Criminal Fine in History; Civil Settlement up to $800 Million

American pharmaceutical giant Eli Lilly and Company today agreed to plead guilty and pay $1.415 billion for promoting its drug Zyprexa for uses not approved by the Food and Drug Administration (FDA), the Department of Justice announced today. This resolution includes a criminal fine of $515 million, the largest ever in a health care case, and the largest criminal fine for an individual corporation ever imposed in a United States criminal prosecution of any kind. Eli Lilly will also pay up to $800 million in a civil settlement with the federal government and the states.

Eli Lilly agreed to enter a global resolution with the United States to resolve criminal and civil allegations that it promoted its antipsychotic drug Zyprexa for uses not approved by the FDA, the Department said. Such unapproved uses are also known as "off-label" uses because they are not included in the drug’s FDA approved product label.

Assistant Attorney General for the Civil Division Gregory G. Katsas and acting U.S. Attorney for the Eastern District of Pennsylvania Laurie Magid today announced the filing of a criminal information against Eli Lilly for promoting Zyprexa for uses not approved by the FDA. Eli Lilly, headquartered in Indianapolis, is charged in the information with promoting Zyprexa for such off-label or unapproved uses as treatment for dementia, including Alzheimer’s dementia, in elderly people.

The company has signed a plea agreement admitting its guilt to a misdemeanor criminal charge. Eli Lilly also signed a civil settlement to resolve civil claims that by marketing Zyprexa for unapproved uses, it caused false claims for payment to be submitted to federal insurance programs such as Medicaid, TRICARE and the Federal Employee Health Benefits Program, none of which provided coverage for such off-label uses.

The plea agreement provides that Eli Lilly will pay a criminal fine of $515 million and forfeit assets of $100 million. The civil settlement agreement provides that Eli Lilly will pay up to an additional $800 million to the federal government and the states to resolve civil allegations originally brought in four separate lawsuits under the qui tam provisions of the federal False Claims Act. The federal share of the civil settlement amount is $438 million. Under the terms of the civil settlement, Eli Lilly will pay up to $361 million to those states that opt to participate in the agreement.

Under the Food, Drug, and Cosmetic Act (FDCA), 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 Zyprexa, also known by the chemical name olanzapine, in Sept. 1996 for the treatment of manifestations of psychotic disorders. In March 2000, FDA approved Zyprexa for the short-term treatment of acute manic episodes associated with Bipolar I Disorder. In Nov. 2000, FDA approved Zyprexa for the short term treatment of schizophrenia in place of the management of the manifestations of psychotic disorders. Also in Nov. 2000, FDA approved Zyprexa for maintaining treatment response in schizophrenic patients who had been stable for approximately eight weeks and were then followed for a period of up to eight months. Zyprexa has never been approved for the treatment of dementia or Alzheimer’s dementia.

The criminal information, filed in the Eastern District of Pennsylvania, alleges that from Sept. 1999 through at least Nov. 2003, Eli Lilly promoted Zyprexa for the treatment of agitation, aggression, hostility, dementia, Alzheimer’s dementia, depression and generalized sleep disorder. The information alleges that Eli Lilly’s management created marketing materials promoting Zyprexa for off-label uses, trained its sales force to disregard the law and directed its sales personnel to promote Zyprexa for off-label uses.

The information alleges that beginning in 1999, Eli Lilly expended significant resources to promote Zyprexa in nursing homes and assisted-living facilities, primarily through its long-term care sales force. Eli Lilly sought to convince doctors to prescribe Zyprexa to treat patients with disorders such as dementia, Alzheimer’s dementia, depression, anxiety, and sleep problems, and behavioral symptoms such as agitation, aggression, and hostility.

The information further alleges that the FDA never approved Zyprexa for the treatment of dementia, Alzheimer's dementia, psychosis associated with Alzheimer's disease, or the cognitive deficits associated with dementia.

The information also alleges that building on its unlawful promotion and success in the long-term care market, Eli Lilly executives decided to market Zyprexa to primary-care physicians. In Oct. 2000, Eli Lilly began this off-label marketing campaign targeting primary care physicians, even though the company knew that there was virtually no approved use for Zyprexa in the primary-care market. Eli Lilly trained its primary-care physician sales representatives to promote Zyprexa by focusing on symptoms, rather than Zyprexa’s FDA approved indications.

The qui tam lawsuits alleged that between Sept. 1999 and the end of 2005, Eli Lilly promoted Zyprexa for use in patients of all ages and for the treatment of anxiety, irritability, depression, nausea, Alzheimer’s and other mood disorders. The qui tam lawsuits also alleged that the company funded continuing medical education programs, through millions of dollars in grants, to promote off-label uses of its drugs, in violation of the FDA’s requirements.

"Off-label promotion of pharmaceutical drugs is a serious crime because it undermines the FDA’s role in protecting the American public by determining that a drug is safe and effective for a particular use before it is marketed," said Gregory G. Katsas, Assistant Attorney General for the Civil Division. "This settlement demonstrates the Department’s ongoing diligence in prosecuting cases involving violations of the Food, Drug, and Cosmetic Act, and recovering taxpayer dollars used to pay for drugs sold as a result of off-label marketing campaigns."

"When pharmaceutical companies ignore the government’s process for protecting the public, they undermine the integrity of the doctor-patient relationship and place innocent people in harm’s way," said acting U.S. Attorney for the Eastern District of Pennsylvania, Laurie Magid. "Off-label marketing created unnecessary risks for patients. People have an absolute right to their doctor’s medical expertise, and to know that their health care provider’s judgment has not be clouded by misinformation from a company trying to build its bottom line."

The global resolution includes the following agreements:

• A plea agreement signed by Eli Lilly admitting guilt to the criminal charge of misbranding. Specifically, Eli Lilly admits that between Sept. 1999 and March 31, 2001, the company promoted Zyprexa in elderly populations as treatment for dementia, including Alzheimer’s dementia. Eli Lilly has agreed to pay a $515 million criminal fine and to forfeit an additional $100 million in assets.
• A civil settlement between Eli Lilly, the United States and various States, in which Eli Lilly will pay up to $800 million to the federal government and the states to resolve False Claims Act claims and related state claims by Medicaid and other federal programs and agencies including TRICARE, the Federal Employees Health Benefits Program, Department of Veterans Affairs, Bureau of Prisons and the Public Health Service Entities. The federal government will receive $438,171,544 from the civil settlement. The state Medicaid programs and the District of Columbia will share up to $361,828,456 of the civil settlement, depending on the number of states that participate in the settlement.
• The qui tam relators will receive $78,870,877 from the federal share of the settlement amount.
• A Corporate Integrity Agreement (CIA) between Eli Lilly 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 Eli Lilly send doctors a letter notifying them about the global settlement; and that the company post on its website information about payments to doctors, such as honoraria, travel or lodging. Eli Lilly 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.

"OIG’s Corporate Integrity Agreement will increase the transparency of Eli Lilly’s interactions with physicians and strengthen Eli Lilly’s accountability for its compliance with the law," said Department of Health and Human Services Inspector General Daniel R. Levinson. "This historic resolution demonstrates the Government’s commitment to improve the integrity of drug promotion activities."

In addition to the $1.415 billion criminal and civil settlement announced today, Eli Lilly previously agreed to pay $62 million to settle consumer protection lawsuits brought by 33 states. The state consumer protection settlements were announced on Oct. 7, 2008.

"Today's announcement of the filing of a criminal charge and the unprecedented terms of this settlement demonstrates the government's increasing efforts aimed at pharmaceutical companies that choose to put profits ahead of the public's health," said Special Agent-in-Charge Kim Rice of FDA's Office of Criminal Investigations. "The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the safeguards of the drug approval process and recklessly promote drugs for uses for which they have not been proven to be safe and effective."

"The illegal scheme used by Eli Lilly significantly impacted the integrity of TRICARE, the Department of Defense's healthcare system," said Ed Bradley, Special Agent-in-Charge, Defense Criminal Investigative Service. "This illegal activity increases patients’ costs, threatens their safety and negatively affects the delivery of healthcare services to the over nine million military members, retirees and their families who rely on this system. Today’s charges and settlement demonstrate the ongoing commitment of the Defense Criminal Investigative Service and its partners in law enforcement to investigate and prosecute those that abuse the government's healthcare programs at the expense of the taxpayers and patients."

"This case should serve as still another warning to all those who break the law in order to improve their profits," said Patrick Doyle, Special Agent-in-Charge of the Office of Inspector General for the Department of Health and Human Services in Philadelphia. "OIG, working with our law enforcement partners, will pursue and bring to justice those who would steal from vulnerable beneficiaries and the taxpayers."

The civil settlement resolves four qui tam actions filed in the Eastern District of Pennsylvania: United States ex rel. Rudolf, et al., v. Eli Lilly and Company, Civil Action No. 03-943 (E.D. Pa.); United States ex rel. Faltaous v. Eli Lilly and Company, Civil Action No. 06-2909 (E.D. Pa.); United States ex rel. Woodward v. Dr. George B. Jerusalem, et al., Civil Action No. 06-5526 (E.D. Pa.); and United States ex rel. Vicente v. Eli Lilly and Company, Civil Action No. 07-1791 (E.D. Pa.). All of those cases were filed by former Eli Lilly sales representatives.

The criminal case is being prosecuted by the U.S. Attorney’s Office for the Eastern District of Pennsylvania and the Office of Consumer Litigation of the Justice Department’s Civil Division. The civil settlement was reached by the U.S. Attorney’s Office and the Commercial Litigation Branch of the Justice Department’s Civil Division.

This matter was investigated by the FDA’s Office of Criminal Investigations, the Defense Criminal Investigative Service and the Department of Health and Human Services Office of Inspector General.

Assistance was provided by representatives of FDA’s Office of Chief Counsel and the National Association of Medicaid Fraud Control Units.

The Corporate Integrity Agreement was negotiated by the Office of Inspector General of the Department of Health and Human Services.

Eli Lilly's guilty plea and sentence is not final until accepted by the U.S. District Court.

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09-038