FW: Illegal marketing of Psych Drug Zyprexa - Lilly expected to Pay $1.4 billion to settle criminal and civil charges

[Guest guest]

From: Psych News

[mailto:psych_news@...]

Sent: Wednesday, January 14, 2009 1:29 PM

Psych News

Subject: Illegal marketing of Psych Drug Zyprexa - Lilly expected to Pay

$1.4 billion to settle criminal and civil charges

" Lilly

has been accused of a years-long scheme to persuade doctors to prescribe

Zyprexa to two categories of patients — children and the elderly — for whom the

drug was not federally approved and in whom its use was especially risky. "

Letter to the

editor: letters@...

New

York Times

Lilly Said to Be Near

$1.4 Billion U.S. Settlement on Drug

By GARDINER HARRIS

January 14, 2009

Eli Lilly, the drug company, is expected to agree as soon as Thursday to pay

$1.4 billion to settle criminal and civil charges that it illegally marketed

its blockbuster antipsychotic drug Zyprexa for unauthorized use in patients

particularly vulnerable to its risky side effects.

The amount of the settlement is a record sum for so-called corporate

whistleblower cases, which are federal lawsuits prompted by tips from company

employees or former employees. Details of the agreement were provided by people

involved in the negotiations.

Among the charges, Lilly has been accused of a years-long scheme to persuade

doctors to prescribe Zyprexa to two categories of patients — children and the

elderly — for whom the drug was not federally approved and in whom its use was

especially risky.

In one marketing effort, the company urged geriatricians to use Zyprexa to

sedate unruly nursing home patients so as to reduce “nursing time and effort,”

according to court documents. Like other antipsychotics, Zyprexa increases the

risks of sudden death, heart failure and life-threatening infections like

pneumonia in elderly patients with dementia-related psychosis.

The company also pressed pediatricians and family practice doctors to treat

disruptive children with Zyprexa, court documents show, even though the

medicine’s tendency to cause severe weight gain and metabolic disorders is

particularly pronounced in children. Over the last decade, Zyprexa’s use in

children has soared.

The case is being prosecuted by the United States Attorney’s Office for the

Eastern District of Pennsylvania. Hartman, a spokeswoman for the

office, declined to comment.

Sekson, a Lilly

spokeswoman, said she could not comment on the status of the Zyprexa

negotiations. Last fall, the company, anticipating a settlement, had set aside

$1.4 billion for that purpose.

Lilly executives have for years insisted that the company’s Zyprexa marketing

efforts were legal and appropriate. When asked whether she could repeat those

assurances, Ms. Sekson said, " It would be inappropriate for me to comment

further right now. "

It could not be confirmed on Wednesday whether the company will acknowledge

wrongdoing as part of the settlement. Without a settlement, Lilly risks being

barred from participating in the federal Medicaid and Medicare programs — a

huge part of its business — even though such bans almost unheard of for big

drug makers because their products are considered so essential.

In the United States, most of Zyprexa’s sales are paid for by government

programs because so many of those taking Zyprexa are indigent or disabled.

Zyprexa had sales of $4.8 billion in 2007, making it the biggest seller by far

for Lilly, whose revenue that year was $18.6 billion. Depending on dosage, the

drug can cost as much as $25 for a daily pill.

The settlement may have little impact on how doctors actually use Zyprexa,

because physicians are free to prescribe drugs as they see fit. But it is

because drug makers are barred from promoting drugs for uses not specifically

approved by the Food and Drug Administration that Lilly has been charged.

Zyprexa has F.D.A. approval only for the treatment of schizophrenia and the

mania and agitation associated with bipolar disorder.

Just about every major drug company in recent years has pleaded guilty or is

under investigation for urging doctors to use medicines beyond their approved

uses. The Zyprexa case and others were brought by former drug company employees

using a Civil War-era whistleblower law to claim that the companies defrauded

government health programs. The former employees usually share in the recovery.

The Zyprexa settlement is the largest such recovery in history, surpassing the

$900 million fine that Tenet Healthcare paid in 2006 to resolve whistleblower

claims that it improperly billed Medicare. In 2001, TAP Pharmaceutical agreed

to pay $875 million to resolve criminal and civil charges related to pricing

and marketing of its cancer drug, Lupron.

But while the fines in such cases involving drug makers have been substantial,

they generally recover only a fraction of the costs associated with unapproved

drug uses.

Zyprexa, for instance, has generated more than $39 billion in sales since its

approval in 1996, making it one of the biggest-selling drugs in the world. As

much as half of Zyprexa’s use is estimated to be for unapproved or “off label”

use, the $1.4 billion fine — punishment for years of illegal marketing efforts

— represent less than one year of off-label sales of the drug.

And despite mounting concern about Zyprexa’s risks and the negative publicity

surrounding the legal case, sales were $3.5 billion for the first nine of 2008,

2 percent higher than in the first nine months of 2007.

Zyprexa was initially received as a significant advance over an earlier

generation of antipsychotics. But a series of landmark studies in recent years

have cast doubt on that long-held view and suggested that Zyprexa is no better

than older drugs that sell for far less.

A government study published in September, for instance, found that Zyprexa was

no more effective in children than an older medicine but caused more serious

side effects. Indeed, the children receiving Zyprexa gained so much weight

during the study that a safety monitoring panel ordered that they be taken off

the drug.

In December 2006, The New York Times published articles detailing hundreds of

internal Lilly documents and e-mail messages among top company managers that

showed how the company sought for years to downplay Zyprexa’s tendency to cause

severe weight gain and metabolic disorders, including diabetes, while promoting

unapproved uses.

One 2000 e-mail message, for instance, described how a group of diabetes

doctors that Lilly had retained to consider potential links between Zyprexa and

diabetes had warned the company that “unless we come clean on this, it could

get much more serious than we might anticipate.”

The government’s case will remain sealed until at least Thursday, when a judge

is expected to approve the settlement. People involved in the negotiations say

that prosecutors pressed for a resolution in the waning days of the Bush

Administration to avoid having to get another set of approvals from new bosses

at the Justice Department in Washington.

While the settlement is intended to resolve all pending government claims, it

is unclear whether all states, which are parties to the case through the

federal-state Medicaid program, have agreed to terms.

Some of the claims and evidence in the government’s case are similar to those

made in a pending California state whistleblower lawsuit in which Jaydeen

Vicente, a former Lilly sales representative, described years of what she said

were illegal Zyprexa marketing efforts.

Ms. Vicente claimed, for instance, that Lilly paid kickbacks to doctors who

prescribed large amounts of Zyprexa by hiring them to educate other doctors

through a “speaker’s program” or by sending doctors to posh resorts where they

were trained to be speakers.

“The speaking engagements were frequently a mere sham,” Ms. Vicente’s lawsuit

states. “Lilly-paid speakers were even paid to give pointless presentations to

their colleagues at the healthcare facility with which they were affiliated.”

The drug industry continues to hire tens of thousands of doctors to serve as

part-time marketing representatives, although medical schools and societies

increasingly frown on the practice.

Ms. Vicente was hired in 2000 to join a 160-person “Long Term Care” sales team

that focused on nursing homes “despite the lack of any clinical trials or

F.D.A. approval for the use of Zyprexa in the elderly,” the lawsuit states.

Ms. Vicente and other Lilly sales representatives distributed a Lilly study

contending that elderly patients who were prescribed the drug “required fewer

skilled nursing staff hours than patients prescribed other competing

medications” and reduced “caregiver distress,” the lawsuit states. Zyprexa

often induces sleep in patients.

“In truth, this was Lilly’s thinly-veiled marketing of Zyprexa as an effective

chemical restraint for demanding, vulnerable and needy patients,” the lawsuit

states.

In October, Lilly agreed to pay $62 million to 32 states and the District of

Columbia to settle consumer protection claims related to Zyprexa. It paid

Alaska $15 million and agreed to pay $1.2 billion to 31,000 Zyprexa plaintiffs.

Some private Zyprexa claims remain unresolved.

Source: http://www.nytimes.com/2009/01/15/business/15drug.html?pagewanted=1 & _r=1 & ref=business

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TeenScreen. Petition: http://www.petitiononline.com/TScreen/petition.html

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[Guest guest]

While I feel this is good news, I would also caution that it is very likely anyone using drugs manufactured by this outfit will be helping pay this settlement since I suspect the company will be hiking already outlandishly high prices even more. ~~Ruth

Illegal marketing of Psych Drug Zyprexa - Lilly expected to Pay $1.4 billion to settle criminal and civil charges

"Lilly has been accused of a years-long scheme to persuade doctors to prescribe Zyprexa to two categories of patients — children and the elderly — for whom the drug was not federally approved and in whom its use was especially risky."

Letter to the editor: lettersnytimes

New York TimesLilly Said to Be Near $1.4 Billion U.S. Settlement on DrugBy GARDINER HARRISJanuary 14, 2009Eli Lilly, the drug company, is expected to agree as soon as Thursday to pay $1.4 billion to settle criminal and civil charges that it illegally marketed its blockbuster antipsychotic drug Zyprexa for unauthorized use in patients particularly vulnerable to its risky side effects.The amount of the settlement is a record sum for so-called corporate whistleblower cases, which are federal lawsuits prompted by tips from company employees or former employees. Details of the agreement were provided by people involved in the negotiations.Among the charges, Lilly has been accused of a years-long scheme to persuade doctors to prescribe Zyprexa to two categories of patients — children and the elderly — for whom the drug was not federally approved and in whom its use was especially risky.In one marketing effort, the company urged geriatricians to use Zyprexa to sedate unruly nursing home patients so as to reduce “nursing time and effort,†according to court documents. Like other antipsychotics, Zyprexa increases the risks of sudden death, heart failure and life-threatening infections like pneumonia in elderly patients with dementia-related psychosis.The company also pressed pediatricians and family practice doctors to treat disruptive children with Zyprexa, court documents show, even though the medicine’s tendency to cause severe weight gain and metabolic disorders is particularly pronounced in children. Over the last decade, Zyprexa’s use in children has soared.The case is being prosecuted by the United States Attorney’s Office for the Eastern District of Pennsylvania. Hartman, a spokeswoman for the office, declined to comment.

Sekson, a Lilly spokeswoman, said she could not comment on the status of the Zyprexa negotiations. Last fall, the company, anticipating a settlement, had set aside $1.4 billion for that purpose.Lilly executives have for years insisted that the company’s Zyprexa marketing efforts were legal and appropriate. When asked whether she could repeat those assurances, Ms. Sekson said, "It would be inappropriate for me to comment further right now."It could not be confirmed on Wednesday whether the company will acknowledge wrongdoing as part of the settlement. Without a settlement, Lilly risks being barred from participating in the federal Medicaid and Medicare programs — a huge part of its business — even though such bans almost unheard of for big drug makers because their products are considered so essential.In the United States, most of Zyprexa’s sales are paid for by government programs because so many of those taking Zyprexa are indigent or disabled. Zyprexa had sales of $4.8 billion in 2007, making it the biggest seller by far for Lilly, whose revenue that year was $18.6 billion. Depending on dosage, the drug can cost as much as $25 for a daily pill.The settlement may have little impact on how doctors actually use Zyprexa, because physicians are free to prescribe drugs as they see fit. But it is because drug makers are barred from promoting drugs for uses not specifically approved by the Food and Drug Administration that Lilly has been charged.Zyprexa has F.D.A. approval only for the treatment of schizophrenia and the mania and agitation associated with bipolar disorder.Just about every major drug company in recent years has pleaded guilty or is under investigation for urging doctors to use medicines beyond their approved uses. The Zyprexa case and others were brought by former drug company employees using a Civil War-era whistleblower law to claim that the companies defrauded government health programs. The former employees usually share in the recovery.The Zyprexa settlement is the largest such recovery in history, surpassing the $900 million fine that Tenet Healthcare paid in 2006 to resolve whistleblower claims that it improperly billed Medicare. In 2001, TAP Pharmaceutical agreed to pay $875 million to resolve criminal and civil charges related to pricing and marketing of its cancer drug, Lupron.But while the fines in such cases involving drug makers have been substantial, they generally recover only a fraction of the costs associated with unapproved drug uses.Zyprexa, for instance, has generated more than $39 billion in sales since its approval in 1996, making it one of the biggest-selling drugs in the world. As much as half of Zyprexa’s use is estimated to be for unapproved or “off label†use, the $1.4 billion fine — punishment for years of illegal marketing efforts — represent less than one year of off-label sales of the drug.And despite mounting concern about Zyprexa’s risks and the negative publicity surrounding the legal case, sales were $3.5 billion for the first nine of 2008, 2 percent higher than in the first nine months of 2007.Zyprexa was initially received as a significant advance over an earlier generation of antipsychotics. But a series of landmark studies in recent years have cast doubt on that long-held view and suggested that Zyprexa is no better than older drugs that sell for far less.A government study published in September, for instance, found that Zyprexa was no more effective in children than an older medicine but caused more serious side effects. Indeed, the children receiving Zyprexa gained so much weight during the study that a safety monitoring panel ordered that they be taken off the drug.In December 2006, The New York Times published articles detailing hundreds of internal Lilly documents and e-mail messages among top company managers that showed how the company sought for years to downplay Zyprexa’s tendency to cause severe weight gain and metabolic disorders, including diabetes, while promoting unapproved uses.One 2000 e-mail message, for instance, described how a group of diabetes doctors that Lilly had retained to consider potential links between Zyprexa and diabetes had warned the company that “unless we come clean on this, it could get much more serious than we might anticipate.â€The government’s case will remain sealed until at least Thursday, when a judge is expected to approve the settlement. People involved in the negotiations say that prosecutors pressed for a resolution in the waning days of the Bush Administration to avoid having to get another set of approvals from new bosses at the Justice Department in Washington.While the settlement is intended to resolve all pending government claims, it is unclear whether all states, which are parties to the case through the federal-state Medicaid program, have agreed to terms.Some of the claims and evidence in the government’s case are similar to those made in a pending California state whistleblower lawsuit in which Jaydeen Vicente, a former Lilly sales representative, described years of what she said were illegal Zyprexa marketing efforts.Ms. Vicente claimed, for instance, that Lilly paid kickbacks to doctors who prescribed large amounts of Zyprexa by hiring them to educate other doctors through a “speaker’s program†or by sending doctors to posh resorts where they were trained to be speakers.“The speaking engagements were frequently a mere sham,†Ms. Vicente’s lawsuit states. “Lilly-paid speakers were even paid to give pointless presentations to their colleagues at the healthcare facility with which they were affiliated.â€The drug industry continues to hire tens of thousands of doctors to serve as part-time marketing representatives, although medical schools and societies increasingly frown on the practice.Ms. Vicente was hired in 2000 to join a 160-person “Long Term Care†sales team that focused on nursing homes “despite the lack of any clinical trials or F.D.A. approval for the use of Zyprexa in the elderly,†the lawsuit states.Ms. Vicente and other Lilly sales representatives distributed a Lilly study contending that elderly patients who were prescribed the drug “required fewer skilled nursing staff hours than patients prescribed other competing medications†and reduced “caregiver distress,†the lawsuit states. Zyprexa often induces sleep in patients.“In truth, this was Lilly’s thinly-veiled marketing of Zyprexa as an effective chemical restraint for demanding, vulnerable and needy patients,†the lawsuit states.In October, Lilly agreed to pay $62 million to 32 states and the District of Columbia to settle consumer protection claims related to Zyprexa. It paid Alaska $15 million and agreed to pay $1.2 billion to 31,000 Zyprexa plaintiffs. Some private Zyprexa claims remain unresolved.

Source: http://www.nytimes.com/2009/01/15/business/15drug.html?pagewanted=1 & _r=1 & ref=business

28,083 Signatures Against TeenScreen. Petition: http://www.petitiononline.com/TScreen/petition.html Video:

If you would rather not receive the latest news via this e-mail line, please send a message toPsych_Newspsychsearch (DOT) net with "UNSUBSCRIBE ME" in the subject line.

[Guest guest]

While I feel this is good news, I would also caution that it is very likely anyone using drugs manufactured by this outfit will be helping pay this settlement since I suspect the company will be hiking already outlandishly high prices even more. ~~Ruth

Illegal marketing of Psych Drug Zyprexa - Lilly expected to Pay $1.4 billion to settle criminal and civil charges

"Lilly has been accused of a years-long scheme to persuade doctors to prescribe Zyprexa to two categories of patients — children and the elderly — for whom the drug was not federally approved and in whom its use was especially risky."

Letter to the editor: lettersnytimes

New York TimesLilly Said to Be Near $1.4 Billion U.S. Settlement on DrugBy GARDINER HARRISJanuary 14, 2009Eli Lilly, the drug company, is expected to agree as soon as Thursday to pay $1.4 billion to settle criminal and civil charges that it illegally marketed its blockbuster antipsychotic drug Zyprexa for unauthorized use in patients particularly vulnerable to its risky side effects.The amount of the settlement is a record sum for so-called corporate whistleblower cases, which are federal lawsuits prompted by tips from company employees or former employees. Details of the agreement were provided by people involved in the negotiations.Among the charges, Lilly has been accused of a years-long scheme to persuade doctors to prescribe Zyprexa to two categories of patients — children and the elderly — for whom the drug was not federally approved and in whom its use was especially risky.In one marketing effort, the company urged geriatricians to use Zyprexa to sedate unruly nursing home patients so as to reduce “nursing time and effort,†according to court documents. Like other antipsychotics, Zyprexa increases the risks of sudden death, heart failure and life-threatening infections like pneumonia in elderly patients with dementia-related psychosis.The company also pressed pediatricians and family practice doctors to treat disruptive children with Zyprexa, court documents show, even though the medicine’s tendency to cause severe weight gain and metabolic disorders is particularly pronounced in children. Over the last decade, Zyprexa’s use in children has soared.The case is being prosecuted by the United States Attorney’s Office for the Eastern District of Pennsylvania. Hartman, a spokeswoman for the office, declined to comment.

Sekson, a Lilly spokeswoman, said she could not comment on the status of the Zyprexa negotiations. Last fall, the company, anticipating a settlement, had set aside $1.4 billion for that purpose.Lilly executives have for years insisted that the company’s Zyprexa marketing efforts were legal and appropriate. When asked whether she could repeat those assurances, Ms. Sekson said, "It would be inappropriate for me to comment further right now."It could not be confirmed on Wednesday whether the company will acknowledge wrongdoing as part of the settlement. Without a settlement, Lilly risks being barred from participating in the federal Medicaid and Medicare programs — a huge part of its business — even though such bans almost unheard of for big drug makers because their products are considered so essential.In the United States, most of Zyprexa’s sales are paid for by government programs because so many of those taking Zyprexa are indigent or disabled. Zyprexa had sales of $4.8 billion in 2007, making it the biggest seller by far for Lilly, whose revenue that year was $18.6 billion. Depending on dosage, the drug can cost as much as $25 for a daily pill.The settlement may have little impact on how doctors actually use Zyprexa, because physicians are free to prescribe drugs as they see fit. But it is because drug makers are barred from promoting drugs for uses not specifically approved by the Food and Drug Administration that Lilly has been charged.Zyprexa has F.D.A. approval only for the treatment of schizophrenia and the mania and agitation associated with bipolar disorder.Just about every major drug company in recent years has pleaded guilty or is under investigation for urging doctors to use medicines beyond their approved uses. The Zyprexa case and others were brought by former drug company employees using a Civil War-era whistleblower law to claim that the companies defrauded government health programs. The former employees usually share in the recovery.The Zyprexa settlement is the largest such recovery in history, surpassing the $900 million fine that Tenet Healthcare paid in 2006 to resolve whistleblower claims that it improperly billed Medicare. In 2001, TAP Pharmaceutical agreed to pay $875 million to resolve criminal and civil charges related to pricing and marketing of its cancer drug, Lupron.But while the fines in such cases involving drug makers have been substantial, they generally recover only a fraction of the costs associated with unapproved drug uses.Zyprexa, for instance, has generated more than $39 billion in sales since its approval in 1996, making it one of the biggest-selling drugs in the world. As much as half of Zyprexa’s use is estimated to be for unapproved or “off label†use, the $1.4 billion fine — punishment for years of illegal marketing efforts — represent less than one year of off-label sales of the drug.And despite mounting concern about Zyprexa’s risks and the negative publicity surrounding the legal case, sales were $3.5 billion for the first nine of 2008, 2 percent higher than in the first nine months of 2007.Zyprexa was initially received as a significant advance over an earlier generation of antipsychotics. But a series of landmark studies in recent years have cast doubt on that long-held view and suggested that Zyprexa is no better than older drugs that sell for far less.A government study published in September, for instance, found that Zyprexa was no more effective in children than an older medicine but caused more serious side effects. Indeed, the children receiving Zyprexa gained so much weight during the study that a safety monitoring panel ordered that they be taken off the drug.In December 2006, The New York Times published articles detailing hundreds of internal Lilly documents and e-mail messages among top company managers that showed how the company sought for years to downplay Zyprexa’s tendency to cause severe weight gain and metabolic disorders, including diabetes, while promoting unapproved uses.One 2000 e-mail message, for instance, described how a group of diabetes doctors that Lilly had retained to consider potential links between Zyprexa and diabetes had warned the company that “unless we come clean on this, it could get much more serious than we might anticipate.â€The government’s case will remain sealed until at least Thursday, when a judge is expected to approve the settlement. People involved in the negotiations say that prosecutors pressed for a resolution in the waning days of the Bush Administration to avoid having to get another set of approvals from new bosses at the Justice Department in Washington.While the settlement is intended to resolve all pending government claims, it is unclear whether all states, which are parties to the case through the federal-state Medicaid program, have agreed to terms.Some of the claims and evidence in the government’s case are similar to those made in a pending California state whistleblower lawsuit in which Jaydeen Vicente, a former Lilly sales representative, described years of what she said were illegal Zyprexa marketing efforts.Ms. Vicente claimed, for instance, that Lilly paid kickbacks to doctors who prescribed large amounts of Zyprexa by hiring them to educate other doctors through a “speaker’s program†or by sending doctors to posh resorts where they were trained to be speakers.“The speaking engagements were frequently a mere sham,†Ms. Vicente’s lawsuit states. “Lilly-paid speakers were even paid to give pointless presentations to their colleagues at the healthcare facility with which they were affiliated.â€The drug industry continues to hire tens of thousands of doctors to serve as part-time marketing representatives, although medical schools and societies increasingly frown on the practice.Ms. Vicente was hired in 2000 to join a 160-person “Long Term Care†sales team that focused on nursing homes “despite the lack of any clinical trials or F.D.A. approval for the use of Zyprexa in the elderly,†the lawsuit states.Ms. Vicente and other Lilly sales representatives distributed a Lilly study contending that elderly patients who were prescribed the drug “required fewer skilled nursing staff hours than patients prescribed other competing medications†and reduced “caregiver distress,†the lawsuit states. Zyprexa often induces sleep in patients.“In truth, this was Lilly’s thinly-veiled marketing of Zyprexa as an effective chemical restraint for demanding, vulnerable and needy patients,†the lawsuit states.In October, Lilly agreed to pay $62 million to 32 states and the District of Columbia to settle consumer protection claims related to Zyprexa. It paid Alaska $15 million and agreed to pay $1.2 billion to 31,000 Zyprexa plaintiffs. Some private Zyprexa claims remain unresolved.

Source: http://www.nytimes.com/2009/01/15/business/15drug.html?pagewanted=1 & _r=1 & ref=business

28,083 Signatures Against TeenScreen. Petition: http://www.petitiononline.com/TScreen/petition.html Video:

If you would rather not receive the latest news via this e-mail line, please send a message toPsych_Newspsychsearch (DOT) net with "UNSUBSCRIBE ME" in the subject line.

[Guest guest]

You are totally correct…. The costs will be passed on but the use

will also diminish as the truth of these poisons are exposed.  Court

settlements since they set a precedence can have a heavy effect on future

attempts to lie by advertisers regardless of product.  Many of these drugs are

reboxed and remarketed under different names and for different reasons

definitely not a good thing!

Dennis

From:

no-forced-vaccination

[mailto:no-forced-vaccination ] On Behalf Of putney1963@...

Sent: Thursday, January 15, 2009 11:54 AM

no-forced-vaccination

Subject: Re: FW: Illegal marketing of Psych Drug

Zyprexa - Lilly expected to Pay $1.4 billion to settle criminal and civil

charges

While I feel this is good news, I would also

caution that it is very likely anyone using drugs manufactured by this outfit

will be helping pay this settlement since I suspect the company will be hiking

already outlandishly high prices even more. ~~Ruth

Illegal marketing of Psych Drug Zyprexa - Lilly expected to Pay

$1.4 billion to settle criminal and civil charges

" Lilly

has been accused of a years-long scheme to persuade doctors to prescribe

Zyprexa to two categories of patients — children and the elderly — for whom the

drug was not federally approved and in whom its use was especially risky. "

Letter

to the editor: letters@...

New York Times

Lilly Said to Be Near $1.4 Billion U.S. Settlement on Drug

By GARDINER HARRIS

January 14, 2009

Eli Lilly, the drug company, is expected to agree as soon as Thursday to pay $1.4

billion to settle criminal and civil charges that it illegally marketed its

blockbuster antipsychotic drug Zyprexa for unauthorized use in patients

particularly vulnerable to its risky side effects.

The amount of the settlement is a record sum for so-called corporate

whistleblower cases, which are federal lawsuits prompted by tips from company

employees or former employees. Details of the agreement were provided by people

involved in the negotiations.

Among the charges, Lilly has been accused of a years-long scheme to persuade

doctors to prescribe Zyprexa to two categories of patients — children and the

elderly — for whom the drug was not federally approved and in whom its use was

especially risky.

In one marketing effort, the company urged geriatricians to use Zyprexa to

sedate unruly nursing home patients so as to reduce “nursing time and effort,â€

according to court documents. Like other antipsychotics, Zyprexa increases the

risks of sudden death, heart failure and life-threatening infections like pneumonia

in elderly patients with dementia-related psychosis.

The company also pressed pediatricians and family practice doctors to treat

disruptive children with Zyprexa, court documents show, even though the

medicine’s tendency to cause severe weight gain and metabolic disorders is

particularly pronounced in children. Over the last decade, Zyprexa’s use in

children has soared.

The case is being prosecuted by the United States Attorney’s Office for the

Eastern District of Pennsylvania. Hartman, a spokeswoman for the

office, declined to comment.

Sekson, a Lilly spokeswoman, said she could not comment on the status

of the Zyprexa negotiations. Last fall, the company, anticipating a settlement,

had set aside $1.4 billion for that purpose.

Lilly executives have for years insisted that the company’s Zyprexa marketing

efforts were legal and appropriate. When asked whether she could repeat those

assurances, Ms. Sekson said, " It would be inappropriate for me to comment

further right now. "

It could not be confirmed on Wednesday whether the company will acknowledge

wrongdoing as part of the settlement. Without a settlement, Lilly risks being

barred from participating in the federal Medicaid and Medicare programs — a

huge part of its business — even though such bans almost unheard of for big

drug makers because their products are considered so essential.

In the United States, most of Zyprexa’s sales are paid for by government

programs because so many of those taking Zyprexa are indigent or disabled. Zyprexa

had sales of $4.8 billion in 2007, making it the biggest seller by far for

Lilly, whose revenue that year was $18.6 billion. Depending on dosage, the drug

can cost as much as $25 for a daily pill.

The settlement may have little impact on how doctors actually use Zyprexa,

because physicians are free to prescribe drugs as they see fit. But it is

because drug makers are barred from promoting drugs for uses not specifically

approved by the Food and Drug Administration that Lilly has been charged.

Zyprexa has F.D.A. approval only for the treatment of schizophrenia and the

mania and agitation associated with bipolar disorder.

Just about every major drug company in recent years has pleaded guilty or is

under investigation for urging doctors to use medicines beyond their approved

uses. The Zyprexa case and others were brought by former drug company employees

using a Civil War-era whistleblower law to claim that the companies defrauded

government health programs. The former employees usually share in the recovery.

The Zyprexa settlement is the largest such recovery in history, surpassing the

$900 million fine that Tenet Healthcare paid in 2006 to resolve whistleblower

claims that it improperly billed Medicare. In 2001, TAP Pharmaceutical agreed

to pay $875 million to resolve criminal and civil charges related to pricing

and marketing of its cancer drug, Lupron.

But while the fines in such cases involving drug makers have been substantial,

they generally recover only a fraction of the costs associated with unapproved

drug uses.

Zyprexa, for instance, has generated more than $39 billion in sales since its

approval in 1996, making it one of the biggest-selling drugs in the world. As

much as half of Zyprexa’s use is estimated to be for unapproved or “off labelâ€

use, the $1.4 billion fine — punishment for years of illegal marketing efforts

— represent less than one year of off-label sales of the drug.

And despite mounting concern about Zyprexa’s risks and the negative publicity

surrounding the legal case, sales were $3.5 billion for the first nine of 2008,

2 percent higher than in the first nine months of 2007.

Zyprexa was initially received as a significant advance over an earlier

generation of antipsychotics. But a series of landmark studies in recent years

have cast doubt on that long-held view and suggested that Zyprexa is no better

than older drugs that sell for far less.

A government study published in September, for instance, found that Zyprexa was

no more effective in children than an older medicine but caused more serious

side effects. Indeed, the children receiving Zyprexa gained so much weight

during the study that a safety monitoring panel ordered that they be taken off

the drug.

In December 2006, The New York Times published articles detailing hundreds of

internal Lilly documents and e-mail messages among top company managers that

showed how the company sought for years to downplay Zyprexa’s tendency to cause

severe weight gain and metabolic disorders, including diabetes, while promoting

unapproved uses.

One 2000 e-mail message, for instance, described how a group of diabetes

doctors that Lilly had retained to consider potential links between Zyprexa and

diabetes had warned the company that “unless we come clean on this, it could

get much more serious than we might anticipate.â€

The government’s case will remain sealed until at least Thursday, when a judge

is expected to approve the settlement. People involved in the negotiations say

that prosecutors pressed for a resolution in the waning days of the Bush

Administration to avoid having to get another set of approvals from new bosses

at the Justice Department in Washington.

While the settlement is intended to resolve all pending government claims, it

is unclear whether all states, which are parties to the case through the

federal-state Medicaid program, have agreed to terms.

Some of the claims and evidence in the government’s case are similar to those

made in a pending California state whistleblower lawsuit in which Jaydeen

Vicente, a former Lilly sales representative, described years of what she said

were illegal Zyprexa marketing efforts.

Ms. Vicente claimed, for instance, that Lilly paid kickbacks to doctors who

prescribed large amounts of Zyprexa by hiring them to educate other doctors

through a “speaker’s program†or by sending doctors to posh resorts where they

were trained to be speakers.

“The speaking engagements were frequently a mere sham,†Ms. Vicente’s lawsuit

states. “Lilly-paid speakers were even paid to give pointless presentations to

their colleagues at the healthcare facility with which they were affiliated.â€

The drug industry continues to hire tens of thousands of doctors to serve as

part-time marketing representatives, although medical schools and societies

increasingly frown on the practice.

Ms. Vicente was hired in 2000 to join a 160-person “Long Term Care†sales team

that focused on nursing homes “despite the lack of any clinical trials or

F.D.A. approval for the use of Zyprexa in the elderly,†the lawsuit states.

Ms. Vicente and other Lilly sales representatives distributed a Lilly study

contending that elderly patients who were prescribed the drug “required fewer

skilled nursing staff hours than patients prescribed other competing

medications†and reduced “caregiver distress,†the lawsuit states. Zyprexa

often induces sleep in patients.

“In truth, this was Lilly’s thinly-veiled marketing of Zyprexa as an effective

chemical restraint for demanding, vulnerable and needy patients,†the lawsuit

states.

In October, Lilly agreed to pay $62 million to 32 states and the District of

Columbia to settle consumer protection claims related to Zyprexa. It paid

Alaska $15 million and agreed to pay $1.2 billion to 31,000 Zyprexa plaintiffs.

Some private Zyprexa claims remain unresolved.

Source: http://www.nytimes.com/2009/01/15/business/15drug.html?pagewanted=1 & _r=1 & ref=business

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TeenScreen. Petition: http://www.petitiononline.com/TScreen/petition.html

Video:

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[Guest guest]

You are totally correct…. The costs will be passed on but the use

will also diminish as the truth of these poisons are exposed.  Court

settlements since they set a precedence can have a heavy effect on future

attempts to lie by advertisers regardless of product.  Many of these drugs are

reboxed and remarketed under different names and for different reasons

definitely not a good thing!

Dennis

From:

no-forced-vaccination

[mailto:no-forced-vaccination ] On Behalf Of putney1963@...

Sent: Thursday, January 15, 2009 11:54 AM

no-forced-vaccination

Subject: Re: FW: Illegal marketing of Psych Drug

Zyprexa - Lilly expected to Pay $1.4 billion to settle criminal and civil

charges

While I feel this is good news, I would also

caution that it is very likely anyone using drugs manufactured by this outfit

will be helping pay this settlement since I suspect the company will be hiking

already outlandishly high prices even more. ~~Ruth

Illegal marketing of Psych Drug Zyprexa - Lilly expected to Pay

$1.4 billion to settle criminal and civil charges

" Lilly

has been accused of a years-long scheme to persuade doctors to prescribe

Zyprexa to two categories of patients — children and the elderly — for whom the

drug was not federally approved and in whom its use was especially risky. "

Letter

to the editor: letters@...

New York Times

Lilly Said to Be Near $1.4 Billion U.S. Settlement on Drug

By GARDINER HARRIS

January 14, 2009

Eli Lilly, the drug company, is expected to agree as soon as Thursday to pay $1.4

billion to settle criminal and civil charges that it illegally marketed its

blockbuster antipsychotic drug Zyprexa for unauthorized use in patients

particularly vulnerable to its risky side effects.

The amount of the settlement is a record sum for so-called corporate

whistleblower cases, which are federal lawsuits prompted by tips from company

employees or former employees. Details of the agreement were provided by people

involved in the negotiations.

Among the charges, Lilly has been accused of a years-long scheme to persuade

doctors to prescribe Zyprexa to two categories of patients — children and the

elderly — for whom the drug was not federally approved and in whom its use was

especially risky.

In one marketing effort, the company urged geriatricians to use Zyprexa to

sedate unruly nursing home patients so as to reduce “nursing time and effort,â€

according to court documents. Like other antipsychotics, Zyprexa increases the

risks of sudden death, heart failure and life-threatening infections like pneumonia

in elderly patients with dementia-related psychosis.

The company also pressed pediatricians and family practice doctors to treat

disruptive children with Zyprexa, court documents show, even though the

medicine’s tendency to cause severe weight gain and metabolic disorders is

particularly pronounced in children. Over the last decade, Zyprexa’s use in

children has soared.

The case is being prosecuted by the United States Attorney’s Office for the

Eastern District of Pennsylvania. Hartman, a spokeswoman for the

office, declined to comment.

Sekson, a Lilly spokeswoman, said she could not comment on the status

of the Zyprexa negotiations. Last fall, the company, anticipating a settlement,

had set aside $1.4 billion for that purpose.

Lilly executives have for years insisted that the company’s Zyprexa marketing

efforts were legal and appropriate. When asked whether she could repeat those

assurances, Ms. Sekson said, " It would be inappropriate for me to comment

further right now. "

It could not be confirmed on Wednesday whether the company will acknowledge

wrongdoing as part of the settlement. Without a settlement, Lilly risks being

barred from participating in the federal Medicaid and Medicare programs — a

huge part of its business — even though such bans almost unheard of for big

drug makers because their products are considered so essential.

In the United States, most of Zyprexa’s sales are paid for by government

programs because so many of those taking Zyprexa are indigent or disabled. Zyprexa

had sales of $4.8 billion in 2007, making it the biggest seller by far for

Lilly, whose revenue that year was $18.6 billion. Depending on dosage, the drug

can cost as much as $25 for a daily pill.

The settlement may have little impact on how doctors actually use Zyprexa,

because physicians are free to prescribe drugs as they see fit. But it is

because drug makers are barred from promoting drugs for uses not specifically

approved by the Food and Drug Administration that Lilly has been charged.

Zyprexa has F.D.A. approval only for the treatment of schizophrenia and the

mania and agitation associated with bipolar disorder.

Just about every major drug company in recent years has pleaded guilty or is

under investigation for urging doctors to use medicines beyond their approved

uses. The Zyprexa case and others were brought by former drug company employees

using a Civil War-era whistleblower law to claim that the companies defrauded

government health programs. The former employees usually share in the recovery.

The Zyprexa settlement is the largest such recovery in history, surpassing the

$900 million fine that Tenet Healthcare paid in 2006 to resolve whistleblower

claims that it improperly billed Medicare. In 2001, TAP Pharmaceutical agreed

to pay $875 million to resolve criminal and civil charges related to pricing

and marketing of its cancer drug, Lupron.

But while the fines in such cases involving drug makers have been substantial,

they generally recover only a fraction of the costs associated with unapproved

drug uses.

Zyprexa, for instance, has generated more than $39 billion in sales since its

approval in 1996, making it one of the biggest-selling drugs in the world. As

much as half of Zyprexa’s use is estimated to be for unapproved or “off labelâ€

use, the $1.4 billion fine — punishment for years of illegal marketing efforts

— represent less than one year of off-label sales of the drug.

And despite mounting concern about Zyprexa’s risks and the negative publicity

surrounding the legal case, sales were $3.5 billion for the first nine of 2008,

2 percent higher than in the first nine months of 2007.

Zyprexa was initially received as a significant advance over an earlier

generation of antipsychotics. But a series of landmark studies in recent years

have cast doubt on that long-held view and suggested that Zyprexa is no better

than older drugs that sell for far less.

A government study published in September, for instance, found that Zyprexa was

no more effective in children than an older medicine but caused more serious

side effects. Indeed, the children receiving Zyprexa gained so much weight

during the study that a safety monitoring panel ordered that they be taken off

the drug.

In December 2006, The New York Times published articles detailing hundreds of

internal Lilly documents and e-mail messages among top company managers that

showed how the company sought for years to downplay Zyprexa’s tendency to cause

severe weight gain and metabolic disorders, including diabetes, while promoting

unapproved uses.

One 2000 e-mail message, for instance, described how a group of diabetes

doctors that Lilly had retained to consider potential links between Zyprexa and

diabetes had warned the company that “unless we come clean on this, it could

get much more serious than we might anticipate.â€

The government’s case will remain sealed until at least Thursday, when a judge

is expected to approve the settlement. People involved in the negotiations say

that prosecutors pressed for a resolution in the waning days of the Bush

Administration to avoid having to get another set of approvals from new bosses

at the Justice Department in Washington.

While the settlement is intended to resolve all pending government claims, it

is unclear whether all states, which are parties to the case through the

federal-state Medicaid program, have agreed to terms.

Some of the claims and evidence in the government’s case are similar to those

made in a pending California state whistleblower lawsuit in which Jaydeen

Vicente, a former Lilly sales representative, described years of what she said

were illegal Zyprexa marketing efforts.

Ms. Vicente claimed, for instance, that Lilly paid kickbacks to doctors who

prescribed large amounts of Zyprexa by hiring them to educate other doctors

through a “speaker’s program†or by sending doctors to posh resorts where they

were trained to be speakers.

“The speaking engagements were frequently a mere sham,†Ms. Vicente’s lawsuit

states. “Lilly-paid speakers were even paid to give pointless presentations to

their colleagues at the healthcare facility with which they were affiliated.â€

The drug industry continues to hire tens of thousands of doctors to serve as

part-time marketing representatives, although medical schools and societies

increasingly frown on the practice.

Ms. Vicente was hired in 2000 to join a 160-person “Long Term Care†sales team

that focused on nursing homes “despite the lack of any clinical trials or

F.D.A. approval for the use of Zyprexa in the elderly,†the lawsuit states.

Ms. Vicente and other Lilly sales representatives distributed a Lilly study

contending that elderly patients who were prescribed the drug “required fewer

skilled nursing staff hours than patients prescribed other competing

medications†and reduced “caregiver distress,†the lawsuit states. Zyprexa

often induces sleep in patients.

“In truth, this was Lilly’s thinly-veiled marketing of Zyprexa as an effective

chemical restraint for demanding, vulnerable and needy patients,†the lawsuit

states.

In October, Lilly agreed to pay $62 million to 32 states and the District of

Columbia to settle consumer protection claims related to Zyprexa. It paid

Alaska $15 million and agreed to pay $1.2 billion to 31,000 Zyprexa plaintiffs.

Some private Zyprexa claims remain unresolved.

Source: http://www.nytimes.com/2009/01/15/business/15drug.html?pagewanted=1 & _r=1 & ref=business

28,083 Signatures Against

TeenScreen. Petition: http://www.petitiononline.com/TScreen/petition.html

Video:

If you

would rather not receive the latest news via this e-mail line, please send a

message to

Psych_News@...

with " UNSUBSCRIBE ME " in the subject line.

[Guest guest]

I totally agree with you--NOT a good thing. Very dangerous, as a matter of fact. ~~Ruth

Illegal marketing of Psych Drug Zyprexa - Lilly expected to Pay $1.4 billion to settle criminal and civil charges

"Lilly has been accused of a years-long scheme to persuade doctors to prescribe Zyprexa to two categories of patients — children and the elderly — for whom the drug was not federally approved and in whom its use was especially risky."

Letter to the editor: lettersnytimes

New York TimesLilly Said to Be Near $1.4 Billion U.S. Settlement on DrugBy GARDINER HARRISJanuary 14, 2009Eli Lilly, the drug company, is expected to agree as soon as Thursday to pay $1.4 billion to settle criminal and civil charges that it illegally marketed its blockbuster antipsychotic drug Zyprexa for unauthorized use in patients particularly vulnerable to its risky side effects.The amount of the settlement is a record sum for so-called corporate whistleblower cases, which are federal lawsuits prompted by tips from company employees or former employees. Details of the agreement were provided by people involved in the negotiations.Among the charges, Lilly has been accused of a years-long scheme to persuade doctors to prescribe Zyprexa to two categories of patients — children and the elderly — for whom the drug was not federally approved and in whom its use was especially risky.In one marketing effort, the company urged geriatricians to use Zyprexa to sedate unruly nursing home patients so as to reduce “nursing time and effort,†according to court documents. Like other antipsychotics, Zyprexa increases the risks of sudden death, heart failure and life-threatening infections like pneumonia in elderly patients with dementia-related psychosis.The company also pressed pediatricians and family practice doctors to treat disruptive children with Zyprexa, court documents show, even though the medicine’s tendency to cause severe weight gain and metabolic disorders is particularly pronounced in children. Over the last decade, Zyprexa’s use in children has soared.The case is being prosecuted by the United States Attorney’s Office for the Eastern District of Pennsylvania. Hartman, a spokeswoman for the office, declined to comment.

Sekson, a Lilly spokeswoman, said she could not comment on the status of the Zyprexa negotiations. Last fall, the company, anticipating a settlement, had set aside $1.4 billion for that purpose.Lilly executives have for years insisted that the company’s Zyprexa marketing efforts were legal and appropriate. When asked whether she could repeat those assurances, Ms. Sekson said, "It would be inappropriate for me to comment further right now."It could not be confirmed on Wednesday whether the company will acknowledge wrongdoing as part of the settlement. Without a settlement, Lilly risks being barred from participating in the federal Medicaid and Medicare programs — a huge part of its business — even though such bans almost unheard of for big drug makers because their products are considered so essential.In the United States, most of Zyprexa’s sales are paid for by government programs because so many of those taking Zyprexa are indigent or disabled. Zyprexa had sales of $4.8 billion in 2007, making it the biggest seller by far for Lilly, whose revenue that year was $18.6 billion. Depending on dosage, the drug can cost as much as $25 for a daily pill.The settlement may have little impact on how doctors actually use Zyprexa, because physicians are free to prescribe drugs as they see fit. But it is because drug makers are barred from promoting drugs for uses not specifically approved by the Food and Drug Administration that Lilly has been charged.Zyprexa has F.D.A. approval only for the treatment of schizophrenia and the mania and agitation associated with bipolar disorder.Just about every major drug company in recent years has pleaded guilty or is under investigation for urging doctors to use medicines beyond their approved uses. The Zyprexa case and others were brought by former drug company employees using a Civil War-era whistleblower law to claim that the companies defrauded government health programs. The former employees usually share in the recovery.The Zyprexa settlement is the largest such recovery in history, surpassing the $900 million fine that Tenet Healthcare paid in 2006 to resolve whistleblower claims that it improperly billed Medicare. In 2001, TAP Pharmaceutical agreed to pay $875 million to resolve criminal and civil charges related to pricing and marketing of its cancer drug, Lupron.But while the fines in such cases involving drug makers have been substantial, they generally recover only a fraction of the costs associated with unapproved drug uses.Zyprexa, for instance, has generated more than $39 billion in sales since its approval in 1996, making it one of the biggest-selling drugs in the world. As much as half of Zyprexa’s use is estimated to be for unapproved or “off label†use, the $1.4 billion fine — punishment for years of illegal marketing efforts — represent less than one year of off-label sales of the drug.And despite mounting concern about Zyprexa’s risks and the negative publicity surrounding the legal case, sales were $3.5 billion for the first nine of 2008, 2 percent higher than in the first nine months of 2007.Zyprexa was initially received as a significant advance over an earlier generation of antipsychotics. But a series of landmark studies in recent years have cast doubt on that long-held view and suggested that Zyprexa is no better than older drugs that sell for far less.A government study published in September, for instance, found that Zyprexa was no more effective in children than an older medicine but caused more serious side effects. Indeed, the children receiving Zyprexa gained so much weight during the study that a safety monitoring panel ordered that they be taken off the drug.In December 2006, The New York Times published articles detailing hundreds of internal Lilly documents and e-mail messages among top company managers that showed how the company sought for years to downplay Zyprexa’s tendency to cause severe weight gain and metabolic disorders, including diabetes, while promoting unapproved uses.One 2000 e-mail message, for instance, described how a group of diabetes doctors that Lilly had retained to consider potential links between Zyprexa and diabetes had warned the company that “unless we come clean on this, it could get much more serious than we might anticipate.â€The government’s case will remain sealed until at least Thursday, when a judge is expected to approve the settlement. People involved in the negotiations say that prosecutors pressed for a resolution in the waning days of the Bush Administration to avoid having to get another set of approvals from new bosses at the Justice Department in Washington.While the settlement is intended to resolve all pending government claims, it is unclear whether all states, which are parties to the case through the federal-state Medicaid program, have agreed to terms.Some of the claims and evidence in the government’s case are similar to those made in a pending California state whistleblower lawsuit in which Jaydeen Vicente, a former Lilly sales representative, described years of what she said were illegal Zyprexa marketing efforts.Ms. Vicente claimed, for instance, that Lilly paid kickbacks to doctors who prescribed large amounts of Zyprexa by hiring them to educate other doctors through a “speaker’s program†or by sending doctors to posh resorts where they were trained to be speakers.“The speaking engagements were frequently a mere sham,†Ms. Vicente’s lawsuit states. “Lilly-paid speakers were even paid to give pointless presentations to their colleagues at the healthcare facility with which they were affiliated.â€The drug industry continues to hire tens of thousands of doctors to serve as part-time marketing representatives, although medical schools and societies increasingly frown on the practice.Ms. Vicente was hired in 2000 to join a 160-person “Long Term Care†sales team that focused on nursing homes “despite the lack of any clinical trials or F.D.A. approval for the use of Zyprexa in the elderly,†the lawsuit states.Ms. Vicente and other Lilly sales representatives distributed a Lilly study contending that elderly patients who were prescribed the drug “required fewer skilled nursing staff hours than patients prescribed other competing medications†and reduced “caregiver distress,†the lawsuit states. Zyprexa often induces sleep in patients.“In truth, this was Lilly’s thinly-veiled marketing of Zyprexa as an effective chemical restraint for demanding, vulnerable and needy patients,†the lawsuit states.In October, Lilly agreed to pay $62 million to 32 states and the District of Columbia to settle consumer protection claims related to Zyprexa. It paid Alaska $15 million and agreed to pay $1.2 billion to 31,000 Zyprexa plaintiffs. Some private Zyprexa claims remain unresolved.

Source: http://www.nytimes.com/2009/01/15/business/15drug.html?pagewanted=1 & _r=1 & ref=business

28,083 Signatures Against TeenScreen. Petition: http://www.petitiononline.com/TScreen/petition.html Video:

If you would rather not receive the latest news via this e-mail line, please send a message toPsych_Newspsychsearch (DOT) net with "UNSUBSCRIBE ME" in the subject line.

[Guest guest]

I totally agree with you--NOT a good thing. Very dangerous, as a matter of fact. ~~Ruth

Illegal marketing of Psych Drug Zyprexa - Lilly expected to Pay $1.4 billion to settle criminal and civil charges

"Lilly has been accused of a years-long scheme to persuade doctors to prescribe Zyprexa to two categories of patients — children and the elderly — for whom the drug was not federally approved and in whom its use was especially risky."

Letter to the editor: lettersnytimes

New York TimesLilly Said to Be Near $1.4 Billion U.S. Settlement on DrugBy GARDINER HARRISJanuary 14, 2009Eli Lilly, the drug company, is expected to agree as soon as Thursday to pay $1.4 billion to settle criminal and civil charges that it illegally marketed its blockbuster antipsychotic drug Zyprexa for unauthorized use in patients particularly vulnerable to its risky side effects.The amount of the settlement is a record sum for so-called corporate whistleblower cases, which are federal lawsuits prompted by tips from company employees or former employees. Details of the agreement were provided by people involved in the negotiations.Among the charges, Lilly has been accused of a years-long scheme to persuade doctors to prescribe Zyprexa to two categories of patients — children and the elderly — for whom the drug was not federally approved and in whom its use was especially risky.In one marketing effort, the company urged geriatricians to use Zyprexa to sedate unruly nursing home patients so as to reduce “nursing time and effort,†according to court documents. Like other antipsychotics, Zyprexa increases the risks of sudden death, heart failure and life-threatening infections like pneumonia in elderly patients with dementia-related psychosis.The company also pressed pediatricians and family practice doctors to treat disruptive children with Zyprexa, court documents show, even though the medicine’s tendency to cause severe weight gain and metabolic disorders is particularly pronounced in children. Over the last decade, Zyprexa’s use in children has soared.The case is being prosecuted by the United States Attorney’s Office for the Eastern District of Pennsylvania. Hartman, a spokeswoman for the office, declined to comment.

Sekson, a Lilly spokeswoman, said she could not comment on the status of the Zyprexa negotiations. Last fall, the company, anticipating a settlement, had set aside $1.4 billion for that purpose.Lilly executives have for years insisted that the company’s Zyprexa marketing efforts were legal and appropriate. When asked whether she could repeat those assurances, Ms. Sekson said, "It would be inappropriate for me to comment further right now."It could not be confirmed on Wednesday whether the company will acknowledge wrongdoing as part of the settlement. Without a settlement, Lilly risks being barred from participating in the federal Medicaid and Medicare programs — a huge part of its business — even though such bans almost unheard of for big drug makers because their products are considered so essential.In the United States, most of Zyprexa’s sales are paid for by government programs because so many of those taking Zyprexa are indigent or disabled. Zyprexa had sales of $4.8 billion in 2007, making it the biggest seller by far for Lilly, whose revenue that year was $18.6 billion. Depending on dosage, the drug can cost as much as $25 for a daily pill.The settlement may have little impact on how doctors actually use Zyprexa, because physicians are free to prescribe drugs as they see fit. But it is because drug makers are barred from promoting drugs for uses not specifically approved by the Food and Drug Administration that Lilly has been charged.Zyprexa has F.D.A. approval only for the treatment of schizophrenia and the mania and agitation associated with bipolar disorder.Just about every major drug company in recent years has pleaded guilty or is under investigation for urging doctors to use medicines beyond their approved uses. The Zyprexa case and others were brought by former drug company employees using a Civil War-era whistleblower law to claim that the companies defrauded government health programs. The former employees usually share in the recovery.The Zyprexa settlement is the largest such recovery in history, surpassing the $900 million fine that Tenet Healthcare paid in 2006 to resolve whistleblower claims that it improperly billed Medicare. In 2001, TAP Pharmaceutical agreed to pay $875 million to resolve criminal and civil charges related to pricing and marketing of its cancer drug, Lupron.But while the fines in such cases involving drug makers have been substantial, they generally recover only a fraction of the costs associated with unapproved drug uses.Zyprexa, for instance, has generated more than $39 billion in sales since its approval in 1996, making it one of the biggest-selling drugs in the world. As much as half of Zyprexa’s use is estimated to be for unapproved or “off label†use, the $1.4 billion fine — punishment for years of illegal marketing efforts — represent less than one year of off-label sales of the drug.And despite mounting concern about Zyprexa’s risks and the negative publicity surrounding the legal case, sales were $3.5 billion for the first nine of 2008, 2 percent higher than in the first nine months of 2007.Zyprexa was initially received as a significant advance over an earlier generation of antipsychotics. But a series of landmark studies in recent years have cast doubt on that long-held view and suggested that Zyprexa is no better than older drugs that sell for far less.A government study published in September, for instance, found that Zyprexa was no more effective in children than an older medicine but caused more serious side effects. Indeed, the children receiving Zyprexa gained so much weight during the study that a safety monitoring panel ordered that they be taken off the drug.In December 2006, The New York Times published articles detailing hundreds of internal Lilly documents and e-mail messages among top company managers that showed how the company sought for years to downplay Zyprexa’s tendency to cause severe weight gain and metabolic disorders, including diabetes, while promoting unapproved uses.One 2000 e-mail message, for instance, described how a group of diabetes doctors that Lilly had retained to consider potential links between Zyprexa and diabetes had warned the company that “unless we come clean on this, it could get much more serious than we might anticipate.â€The government’s case will remain sealed until at least Thursday, when a judge is expected to approve the settlement. People involved in the negotiations say that prosecutors pressed for a resolution in the waning days of the Bush Administration to avoid having to get another set of approvals from new bosses at the Justice Department in Washington.While the settlement is intended to resolve all pending government claims, it is unclear whether all states, which are parties to the case through the federal-state Medicaid program, have agreed to terms.Some of the claims and evidence in the government’s case are similar to those made in a pending California state whistleblower lawsuit in which Jaydeen Vicente, a former Lilly sales representative, described years of what she said were illegal Zyprexa marketing efforts.Ms. Vicente claimed, for instance, that Lilly paid kickbacks to doctors who prescribed large amounts of Zyprexa by hiring them to educate other doctors through a “speaker’s program†or by sending doctors to posh resorts where they were trained to be speakers.“The speaking engagements were frequently a mere sham,†Ms. Vicente’s lawsuit states. “Lilly-paid speakers were even paid to give pointless presentations to their colleagues at the healthcare facility with which they were affiliated.â€The drug industry continues to hire tens of thousands of doctors to serve as part-time marketing representatives, although medical schools and societies increasingly frown on the practice.Ms. Vicente was hired in 2000 to join a 160-person “Long Term Care†sales team that focused on nursing homes “despite the lack of any clinical trials or F.D.A. approval for the use of Zyprexa in the elderly,†the lawsuit states.Ms. Vicente and other Lilly sales representatives distributed a Lilly study contending that elderly patients who were prescribed the drug “required fewer skilled nursing staff hours than patients prescribed other competing medications†and reduced “caregiver distress,†the lawsuit states. Zyprexa often induces sleep in patients.“In truth, this was Lilly’s thinly-veiled marketing of Zyprexa as an effective chemical restraint for demanding, vulnerable and needy patients,†the lawsuit states.In October, Lilly agreed to pay $62 million to 32 states and the District of Columbia to settle consumer protection claims related to Zyprexa. It paid Alaska $15 million and agreed to pay $1.2 billion to 31,000 Zyprexa plaintiffs. Some private Zyprexa claims remain unresolved.

Source: http://www.nytimes.com/2009/01/15/business/15drug.html?pagewanted=1 & _r=1 & ref=business

28,083 Signatures Against TeenScreen. Petition: http://www.petitiononline.com/TScreen/petition.html Video:

If you would rather not receive the latest news via this e-mail line, please send a message toPsych_Newspsychsearch (DOT) net with "UNSUBSCRIBE ME" in the subject line.

[Guest guest]

Well, I guess it's better than nothing... But there is a niggling

question that remains: How does one come to " Settle criminal charges " ?

Aren't criminal charges something that are brought by the State or

Federal governments? How come all the petty drug users/pushers in jail

didn't get to " settle " their cases?

Shouldn't these people, who are guilty of much bigger crimes, be

pursued and punished with more than monetary resolutions? Shouldn't

the individual persons, within Eli Lilly, responsible for colluding to

harm the people who took the drugs and got ill or died from them be

held responsible? How do they get to hide behind some corporate shield

for crimes so heinous? These people are mass murderers, in effect. And

they get to buy their way out of real punishment? How come? Life isn't

a game of Monopoly where you get to buy your way out of jail... is it?

I mean, a lot of people got hurt and died because of their callous

(careless would be too soft a word to use here)actions. How is this

" settlement " justice? If I were one of the victims or related to them,

I would not feel very 'settled' about this outcome. These monsters

basically get a slap on the wrist (granted, the slap on the pocketbook

may smart a bit, but not all that much for such a big drug company,

especially when compared to their executives and others getting some

good, long prison terms...) and get to go free and see what other

monstrous crimes they can get away with. They'll just have to be a bit

more careful about covering their tracks in the future. And that

shouldn't be much of a problem either. Look at all the neat lessons

they must have learned from going through this lawsuit. They know what

clues to cover up next time...

" Settle a criminal charge... " that just does not sound good to me...

[Guest guest]

Well, I guess it's better than nothing... But there is a niggling

question that remains: How does one come to " Settle criminal charges " ?

Aren't criminal charges something that are brought by the State or

Federal governments? How come all the petty drug users/pushers in jail

didn't get to " settle " their cases?

Shouldn't these people, who are guilty of much bigger crimes, be

pursued and punished with more than monetary resolutions? Shouldn't

the individual persons, within Eli Lilly, responsible for colluding to

harm the people who took the drugs and got ill or died from them be

held responsible? How do they get to hide behind some corporate shield

for crimes so heinous? These people are mass murderers, in effect. And

they get to buy their way out of real punishment? How come? Life isn't

a game of Monopoly where you get to buy your way out of jail... is it?

I mean, a lot of people got hurt and died because of their callous

(careless would be too soft a word to use here)actions. How is this

" settlement " justice? If I were one of the victims or related to them,

I would not feel very 'settled' about this outcome. These monsters

basically get a slap on the wrist (granted, the slap on the pocketbook

may smart a bit, but not all that much for such a big drug company,

especially when compared to their executives and others getting some

good, long prison terms...) and get to go free and see what other

monstrous crimes they can get away with. They'll just have to be a bit

more careful about covering their tracks in the future. And that

shouldn't be much of a problem either. Look at all the neat lessons

they must have learned from going through this lawsuit. They know what

clues to cover up next time...

" Settle a criminal charge... " that just does not sound good to me...

[Guest guest]

Well, I guess it's better than nothing... But there is a niggling

question that remains: How does one come to " Settle criminal charges " ?

Aren't criminal charges something that are brought by the State or

Federal governments? How come all the petty drug users/pushers in jail

didn't get to " settle " their cases?

Shouldn't these people, who are guilty of much bigger crimes, be

pursued and punished with more than monetary resolutions? Shouldn't

the individual persons, within Eli Lilly, responsible for colluding to

harm the people who took the drugs and got ill or died from them be

held responsible? How do they get to hide behind some corporate shield

for crimes so heinous? These people are mass murderers, in effect. And

they get to buy their way out of real punishment? How come? Life isn't

a game of Monopoly where you get to buy your way out of jail... is it?

I mean, a lot of people got hurt and died because of their callous

(careless would be too soft a word to use here)actions. How is this

" settlement " justice? If I were one of the victims or related to them,

I would not feel very 'settled' about this outcome. These monsters

basically get a slap on the wrist (granted, the slap on the pocketbook

may smart a bit, but not all that much for such a big drug company,

especially when compared to their executives and others getting some

good, long prison terms...) and get to go free and see what other

monstrous crimes they can get away with. They'll just have to be a bit

more careful about covering their tracks in the future. And that

shouldn't be much of a problem either. Look at all the neat lessons

they must have learned from going through this lawsuit. They know what

clues to cover up next time...

" Settle a criminal charge... " that just does not sound good to me...

[Guest guest]

Well, I guess it's better than nothing... But there is a niggling

question that remains: How does one come to " Settle criminal charges " ?

Aren't criminal charges something that are brought by the State or

Federal governments? How come all the petty drug users/pushers in jail

didn't get to " settle " their cases?

Shouldn't these people, who are guilty of much bigger crimes, be

pursued and punished with more than monetary resolutions? Shouldn't

the individual persons, within Eli Lilly, responsible for colluding to

harm the people who took the drugs and got ill or died from them be

held responsible? How do they get to hide behind some corporate shield

for crimes so heinous? These people are mass murderers, in effect. And

they get to buy their way out of real punishment? How come? Life isn't

a game of Monopoly where you get to buy your way out of jail... is it?

I mean, a lot of people got hurt and died because of their callous

(careless would be too soft a word to use here)actions. How is this

" settlement " justice? If I were one of the victims or related to them,

I would not feel very 'settled' about this outcome. These monsters

basically get a slap on the wrist (granted, the slap on the pocketbook

may smart a bit, but not all that much for such a big drug company,

especially when compared to their executives and others getting some

good, long prison terms...) and get to go free and see what other

monstrous crimes they can get away with. They'll just have to be a bit

more careful about covering their tracks in the future. And that

shouldn't be much of a problem either. Look at all the neat lessons

they must have learned from going through this lawsuit. They know what

clues to cover up next time...

" Settle a criminal charge... " that just does not sound good to me...

[Guest guest]

Agreed. ~~Ruth

Re: FW: Illegal marketing of Psych Drug Zyprexa - Lilly expected to Pay $1.4 billion to settle criminal and civil charges

Well, I guess it's better than nothing... But there is a nigglingquestion that remains: How does one come to "Settle criminal charges"?Aren't criminal charges something that are brought by the State orFederal governments? How come all the petty drug users/pushers in jaildidn't get to "settle" their cases?Shouldn't these people, who are guilty of much bigger crimes, bepursued and punished with more than monetary resolutions? Shouldn'tthe individual persons, within Eli Lilly, responsible for colluding toharm the people who took the drugs and got ill or died from them beheld responsible? How do they get to hide behind some corporate shieldfor crimes so heinous? These people are mass murderers, in effect. Andthey get to buy their way out of real punishment? How come? Life isn'ta game of Monopoly where you get to buy your way out of jail... is it?I mean, a lot of people got hurt and died because of their callous(careless would be too soft a word to use here)actions. How is this"settlement" justice? If I were one of the victims or related to them,I would not feel very 'settled' about this outcome. These monstersbasically get a slap on the wrist (granted, the slap on the pocketbookmay smart a bit, but not all that much for such a big drug company,especially when compared to their executives and others getting somegood, long prison terms...) and get to go free and see what othermonstrous crimes they can get away with. They'll just have to be a bitmore careful about covering their tracks in the future. And thatshouldn't be much of a problem either. Look at all the neat lessonsthey must have learned from going through this lawsuit. They know whatclues to cover up next time..."Settle a criminal charge..." that just does not sound good to me...

[Guest guest]

Agreed. ~~Ruth

Re: FW: Illegal marketing of Psych Drug Zyprexa - Lilly expected to Pay $1.4 billion to settle criminal and civil charges

Well, I guess it's better than nothing... But there is a nigglingquestion that remains: How does one come to "Settle criminal charges"?Aren't criminal charges something that are brought by the State orFederal governments? How come all the petty drug users/pushers in jaildidn't get to "settle" their cases?Shouldn't these people, who are guilty of much bigger crimes, bepursued and punished with more than monetary resolutions? Shouldn'tthe individual persons, within Eli Lilly, responsible for colluding toharm the people who took the drugs and got ill or died from them beheld responsible? How do they get to hide behind some corporate shieldfor crimes so heinous? These people are mass murderers, in effect. Andthey get to buy their way out of real punishment? How come? Life isn'ta game of Monopoly where you get to buy your way out of jail... is it?I mean, a lot of people got hurt and died because of their callous(careless would be too soft a word to use here)actions. How is this"settlement" justice? If I were one of the victims or related to them,I would not feel very 'settled' about this outcome. These monstersbasically get a slap on the wrist (granted, the slap on the pocketbookmay smart a bit, but not all that much for such a big drug company,especially when compared to their executives and others getting somegood, long prison terms...) and get to go free and see what othermonstrous crimes they can get away with. They'll just have to be a bitmore careful about covering their tracks in the future. And thatshouldn't be much of a problem either. Look at all the neat lessonsthey must have learned from going through this lawsuit. They know whatclues to cover up next time..."Settle a criminal charge..." that just does not sound good to me...

[Guest guest]

Agreed. ~~Ruth

Re: FW: Illegal marketing of Psych Drug Zyprexa - Lilly expected to Pay $1.4 billion to settle criminal and civil charges

Well, I guess it's better than nothing... But there is a nigglingquestion that remains: How does one come to "Settle criminal charges"?Aren't criminal charges something that are brought by the State orFederal governments? How come all the petty drug users/pushers in jaildidn't get to "settle" their cases?Shouldn't these people, who are guilty of much bigger crimes, bepursued and punished with more than monetary resolutions? Shouldn'tthe individual persons, within Eli Lilly, responsible for colluding toharm the people who took the drugs and got ill or died from them beheld responsible? How do they get to hide behind some corporate shieldfor crimes so heinous? These people are mass murderers, in effect. Andthey get to buy their way out of real punishment? How come? Life isn'ta game of Monopoly where you get to buy your way out of jail... is it?I mean, a lot of people got hurt and died because of their callous(careless would be too soft a word to use here)actions. How is this"settlement" justice? If I were one of the victims or related to them,I would not feel very 'settled' about this outcome. These monstersbasically get a slap on the wrist (granted, the slap on the pocketbookmay smart a bit, but not all that much for such a big drug company,especially when compared to their executives and others getting somegood, long prison terms...) and get to go free and see what othermonstrous crimes they can get away with. They'll just have to be a bitmore careful about covering their tracks in the future. And thatshouldn't be much of a problem either. Look at all the neat lessonsthey must have learned from going through this lawsuit. They know whatclues to cover up next time..."Settle a criminal charge..." that just does not sound good to me...

[Guest guest]

Agreed. ~~Ruth

Re: FW: Illegal marketing of Psych Drug Zyprexa - Lilly expected to Pay $1.4 billion to settle criminal and civil charges

Well, I guess it's better than nothing... But there is a nigglingquestion that remains: How does one come to "Settle criminal charges"?Aren't criminal charges something that are brought by the State orFederal governments? How come all the petty drug users/pushers in jaildidn't get to "settle" their cases?Shouldn't these people, who are guilty of much bigger crimes, bepursued and punished with more than monetary resolutions? Shouldn'tthe individual persons, within Eli Lilly, responsible for colluding toharm the people who took the drugs and got ill or died from them beheld responsible? How do they get to hide behind some corporate shieldfor crimes so heinous? These people are mass murderers, in effect. Andthey get to buy their way out of real punishment? How come? Life isn'ta game of Monopoly where you get to buy your way out of jail... is it?I mean, a lot of people got hurt and died because of their callous(careless would be too soft a word to use here)actions. How is this"settlement" justice? If I were one of the victims or related to them,I would not feel very 'settled' about this outcome. These monstersbasically get a slap on the wrist (granted, the slap on the pocketbookmay smart a bit, but not all that much for such a big drug company,especially when compared to their executives and others getting somegood, long prison terms...) and get to go free and see what othermonstrous crimes they can get away with. They'll just have to be a bitmore careful about covering their tracks in the future. And thatshouldn't be much of a problem either. Look at all the neat lessonsthey must have learned from going through this lawsuit. They know whatclues to cover up next time..."Settle a criminal charge..." that just does not sound good to me...

[Guest guest]

VERY well put!  It is bittersweet to see these types of stories… 

And it is important that we continue to push the information out… this is where

we win… education.

From: no-forced-vaccination

[mailto:no-forced-vaccination ] On Behalf Of putney1963@...

Sent: Thursday, January 15, 2009 5:27 PM

no-forced-vaccination

Subject: Re: Re: FW: Illegal marketing of Psych

Drug Zyprexa - Lilly expected to Pay $1.4 billion to settle criminal and civil

charges

Agreed. ~~Ruth

Re: FW: Illegal marketing of Psych Drug

Zyprexa - Lilly expected to Pay $1.4 billion to settle criminal and civil

charges

Well, I guess it's better than nothing... But

there is a niggling

question that remains: How does one come to " Settle criminal

charges " ?

Aren't criminal charges something that are brought by the State or

Federal governments? How come all the petty drug users/pushers in jail

didn't get to " settle " their cases?

Shouldn't these people, who are guilty of much bigger crimes, be

pursued and punished with more than monetary resolutions? Shouldn't

the individual persons, within Eli Lilly, responsible for colluding to

harm the people who took the drugs and got ill or died from them be

held responsible? How do they get to hide behind some corporate shield

for crimes so heinous? These people are mass murderers, in effect. And

they get to buy their way out of real punishment? How come? Life isn't

a game of Monopoly where you get to buy your way out of jail... is it?

I mean, a lot of people got hurt and died because of their callous

(careless would be too soft a word to use here)actions. How is this

" settlement " justice? If I were one of the victims or related to

them,

I would not feel very 'settled' about this outcome. These monsters

basically get a slap on the wrist (granted, the slap on the pocketbook

may smart a bit, but not all that much for such a big drug company,

especially when compared to their executives and others getting some

good, long prison terms...) and get to go free and see what other

monstrous crimes they can get away with. They'll just have to be a bit

more careful about covering their tracks in the future. And that

shouldn't be much of a problem either. Look at all the neat lessons

they must have learned from going through this lawsuit. They know what

clues to cover up next time...

" Settle a criminal charge... " that just does not sound good to me...

[Guest guest]

VERY well put!  It is bittersweet to see these types of stories… 

And it is important that we continue to push the information out… this is where

we win… education.

From: no-forced-vaccination

[mailto:no-forced-vaccination ] On Behalf Of putney1963@...

Sent: Thursday, January 15, 2009 5:27 PM

no-forced-vaccination

Subject: Re: Re: FW: Illegal marketing of Psych

Drug Zyprexa - Lilly expected to Pay $1.4 billion to settle criminal and civil

charges

Agreed. ~~Ruth

Re: FW: Illegal marketing of Psych Drug

Zyprexa - Lilly expected to Pay $1.4 billion to settle criminal and civil

charges

Well, I guess it's better than nothing... But

there is a niggling

question that remains: How does one come to " Settle criminal

charges " ?

Aren't criminal charges something that are brought by the State or

Federal governments? How come all the petty drug users/pushers in jail

didn't get to " settle " their cases?

Shouldn't these people, who are guilty of much bigger crimes, be

pursued and punished with more than monetary resolutions? Shouldn't

the individual persons, within Eli Lilly, responsible for colluding to

harm the people who took the drugs and got ill or died from them be

held responsible? How do they get to hide behind some corporate shield

for crimes so heinous? These people are mass murderers, in effect. And

they get to buy their way out of real punishment? How come? Life isn't

a game of Monopoly where you get to buy your way out of jail... is it?

I mean, a lot of people got hurt and died because of their callous

(careless would be too soft a word to use here)actions. How is this

" settlement " justice? If I were one of the victims or related to

them,

I would not feel very 'settled' about this outcome. These monsters

basically get a slap on the wrist (granted, the slap on the pocketbook

may smart a bit, but not all that much for such a big drug company,

especially when compared to their executives and others getting some

good, long prison terms...) and get to go free and see what other

monstrous crimes they can get away with. They'll just have to be a bit

more careful about covering their tracks in the future. And that

shouldn't be much of a problem either. Look at all the neat lessons

they must have learned from going through this lawsuit. They know what

clues to cover up next time...

" Settle a criminal charge... " that just does not sound good to me...