Pfizer - Lustral Zoloft issues prosecutor's manual in criminal cases

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http://www.nj.com/news/ledger/index.ssf?/base/news-

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Star-Ledger

Pfizer issues prosecutors a manual to defend drug Zoloft is not

culprit in

violence, firm says Thursday, August 05, 2004 BY ED SILVERMAN

As controversy mounts over the safety of antidepressant pills, one

drug

maker has been fighting back in an unusual way -- distributing a

" prosecutor's manual " in criminal cases.

In cases around the country, Pfizer has offered a playbook to help

prosecutors challenge claims that its Zoloft drug is the culprit

behind

violent crimes instead of the defendants on trial. The information

given to

prosecutors includes medical literature and legal arguments.

The Pfizer manuals provide a rare look at the lengths to which drug

makers

sometimes go to defend products that are under attack. Although first

created a decade ago, their existence is only now coming to light as

part of

the widening controversy over antidepressants.

Some of the medicines are blamed by some medical experts for

suicides and

other violent acts. Moreover, the drugs have spawned accusations

that drug

makers have withheld crucial clinical-trial data about the rate of

suicidal

behavior among patients.

" The company may be within their rights to distribute this manual,

but it's

certainly going to appear ill-advised to send information at a time

when

they're accused of hiding data, " said Arthur Caplan of the Center for

Bioethics at the University of Pennsylvania.

Next month, a Food and Drug Administration panel will meet to review

clinical-trial data for antidepressants. And a congressional

subcommittee

will hold a hearing to review the FDA's handling of antidepressants

and to

grill several drug-company executives.

A spokeswoman for Pfizer, which maintains Zoloft is safe and

effective, told

The Star-Ledger manuals are distributed to prosecutors only on " rare "

occasions. The manual, she said, includes medical literature, package

inserts or other information a prosecutor may find " useful. "

The manuals are not widely available. Pfizer has so far successfully

argued

in various courts the playbooks, also known as " Litigation Manuals, "

are

confidential. That has prevented the public from seeing the

contents, but

some details have been divulged in lawsuits filed in California over

the

safety of Zoloft.

The court documents, quoting the manual itself, said it is " designed

to

assist criminal prosecutors in cases in which a defendant alleges

that his

wrongful, violent conduct should be excused because when he

committed the

violent act, he was taking the antidepressant medicine that is

marketed

under the brand name Zoloft. "

Pfizer, the New York-based drug maker that employs about 5,500

people in New

Jersey, has good reason to defend the drug. Last year, Zoloft

generated $3.1

billion in sales.

Legal experts said Pfizer and other drug makers are not only within

their

rights to distribute manuals, but actually should do so in order to

protect

themselves. That is because a crime blamed on an antidepressant

could lead

to expensive civil lawsuits, they said.

" I've not heard of this before, but it's definitely not unusual for

a drug

company, or any company, to anticipate potential liability and do

some risk

prevention, " said Bloom, a professor at Boston College Law

School and

a former prosecutor.

" If I'm the corporate counsel at Pfizer, it's really in my interest

to make

sure the prosecutor is successful, " he added. " And if they are

presenting

prosecutors with knowingly false information, the defense should

present

witnesses of their own. It's the adversary system. "

The Pfizer manual is the subject of a tussle in a South Carolina

murder case

that is being closely watched because Zoloft is being blamed for the

crime.

In 2001, a 12-year-old boy named Pittman was charged with

killing his grandparents while on Zoloft.

Defense attorneys are seeking a court order that would force the

prosecutor

to submit the manual. The prosecutor, who couldn't be reached for

comment

due to an extended illness, has so far refused to disclose materials

received from Pfizer.

Such manuals have turned up before. Eli Lilly has distributed one

for its

Prozac antidepressant, although a Lilly spokesman said the company

referred

to them as notebooks.

Two months ago, the same South Carolina prosecutor acknowledged

receiving a

manual about Paxil, which is made by Glaxokline, but wouldn't

reveal

the contents. Defense attorneys have asked a judge to order the

prosecutor

to make it available.

A Glaxo spokeswoman denied that the company provided a manual. She

described

it as " a collection of primarily publicly available materials, "

although she

said she was unable to offer details about the information that was

not

publicly available.

Ed Silverman can be reached at (973) 392-1542 or esilverman@s....

FAIR USE NOTICE: This may contain copyrighted (C ) material the use

of which

has not always been specifically authorized by the copyright owner.

Such

material is made available for educational purposes, to advance

understanding of human rights, democracy, scientific, moral,

ethical, and

social justice issues, etc. It is believed that this constitutes

a 'fair

use' of any such copyrighted material as provided for in Title 17

U.S.C.

section 107 of the US Copyright Law. This material is distributed

without

profit.

[Guest guest]

..

http://www.nj.com/news/ledger/index.ssf?/base/news-

16/1091683380116820.xml

Star-Ledger

Pfizer issues prosecutors a manual to defend drug Zoloft is not

culprit in

violence, firm says Thursday, August 05, 2004 BY ED SILVERMAN

As controversy mounts over the safety of antidepressant pills, one

drug

maker has been fighting back in an unusual way -- distributing a

" prosecutor's manual " in criminal cases.

In cases around the country, Pfizer has offered a playbook to help

prosecutors challenge claims that its Zoloft drug is the culprit

behind

violent crimes instead of the defendants on trial. The information

given to

prosecutors includes medical literature and legal arguments.

The Pfizer manuals provide a rare look at the lengths to which drug

makers

sometimes go to defend products that are under attack. Although first

created a decade ago, their existence is only now coming to light as

part of

the widening controversy over antidepressants.

Some of the medicines are blamed by some medical experts for

suicides and

other violent acts. Moreover, the drugs have spawned accusations

that drug

makers have withheld crucial clinical-trial data about the rate of

suicidal

behavior among patients.

" The company may be within their rights to distribute this manual,

but it's

certainly going to appear ill-advised to send information at a time

when

they're accused of hiding data, " said Arthur Caplan of the Center for

Bioethics at the University of Pennsylvania.

Next month, a Food and Drug Administration panel will meet to review

clinical-trial data for antidepressants. And a congressional

subcommittee

will hold a hearing to review the FDA's handling of antidepressants

and to

grill several drug-company executives.

A spokeswoman for Pfizer, which maintains Zoloft is safe and

effective, told

The Star-Ledger manuals are distributed to prosecutors only on " rare "

occasions. The manual, she said, includes medical literature, package

inserts or other information a prosecutor may find " useful. "

The manuals are not widely available. Pfizer has so far successfully

argued

in various courts the playbooks, also known as " Litigation Manuals, "

are

confidential. That has prevented the public from seeing the

contents, but

some details have been divulged in lawsuits filed in California over

the

safety of Zoloft.

The court documents, quoting the manual itself, said it is " designed

to

assist criminal prosecutors in cases in which a defendant alleges

that his

wrongful, violent conduct should be excused because when he

committed the

violent act, he was taking the antidepressant medicine that is

marketed

under the brand name Zoloft. "

Pfizer, the New York-based drug maker that employs about 5,500

people in New

Jersey, has good reason to defend the drug. Last year, Zoloft

generated $3.1

billion in sales.

Legal experts said Pfizer and other drug makers are not only within

their

rights to distribute manuals, but actually should do so in order to

protect

themselves. That is because a crime blamed on an antidepressant

could lead

to expensive civil lawsuits, they said.

" I've not heard of this before, but it's definitely not unusual for

a drug

company, or any company, to anticipate potential liability and do

some risk

prevention, " said Bloom, a professor at Boston College Law

School and

a former prosecutor.

" If I'm the corporate counsel at Pfizer, it's really in my interest

to make

sure the prosecutor is successful, " he added. " And if they are

presenting

prosecutors with knowingly false information, the defense should

present

witnesses of their own. It's the adversary system. "

The Pfizer manual is the subject of a tussle in a South Carolina

murder case

that is being closely watched because Zoloft is being blamed for the

crime.

In 2001, a 12-year-old boy named Pittman was charged with

killing his grandparents while on Zoloft.

Defense attorneys are seeking a court order that would force the

prosecutor

to submit the manual. The prosecutor, who couldn't be reached for

comment

due to an extended illness, has so far refused to disclose materials

received from Pfizer.

Such manuals have turned up before. Eli Lilly has distributed one

for its

Prozac antidepressant, although a Lilly spokesman said the company

referred

to them as notebooks.

Two months ago, the same South Carolina prosecutor acknowledged

receiving a

manual about Paxil, which is made by Glaxokline, but wouldn't

reveal

the contents. Defense attorneys have asked a judge to order the

prosecutor

to make it available.

A Glaxo spokeswoman denied that the company provided a manual. She

described

it as " a collection of primarily publicly available materials, "

although she

said she was unable to offer details about the information that was

not

publicly available.

Ed Silverman can be reached at (973) 392-1542 or esilverman@s....

FAIR USE NOTICE: This may contain copyrighted (C ) material the use

of which

has not always been specifically authorized by the copyright owner.

Such

material is made available for educational purposes, to advance

understanding of human rights, democracy, scientific, moral,

ethical, and

social justice issues, etc. It is believed that this constitutes

a 'fair

use' of any such copyrighted material as provided for in Title 17

U.S.C.

section 107 of the US Copyright Law. This material is distributed

without

profit.

[Guest guest]

..

http://www.nj.com/news/ledger/index.ssf?/base/news-

16/1091683380116820.xml

Star-Ledger

Pfizer issues prosecutors a manual to defend drug Zoloft is not

culprit in

violence, firm says Thursday, August 05, 2004 BY ED SILVERMAN

As controversy mounts over the safety of antidepressant pills, one

drug

maker has been fighting back in an unusual way -- distributing a

" prosecutor's manual " in criminal cases.

In cases around the country, Pfizer has offered a playbook to help

prosecutors challenge claims that its Zoloft drug is the culprit

behind

violent crimes instead of the defendants on trial. The information

given to

prosecutors includes medical literature and legal arguments.

The Pfizer manuals provide a rare look at the lengths to which drug

makers

sometimes go to defend products that are under attack. Although first

created a decade ago, their existence is only now coming to light as

part of

the widening controversy over antidepressants.

Some of the medicines are blamed by some medical experts for

suicides and

other violent acts. Moreover, the drugs have spawned accusations

that drug

makers have withheld crucial clinical-trial data about the rate of

suicidal

behavior among patients.

" The company may be within their rights to distribute this manual,

but it's

certainly going to appear ill-advised to send information at a time

when

they're accused of hiding data, " said Arthur Caplan of the Center for

Bioethics at the University of Pennsylvania.

Next month, a Food and Drug Administration panel will meet to review

clinical-trial data for antidepressants. And a congressional

subcommittee

will hold a hearing to review the FDA's handling of antidepressants

and to

grill several drug-company executives.

A spokeswoman for Pfizer, which maintains Zoloft is safe and

effective, told

The Star-Ledger manuals are distributed to prosecutors only on " rare "

occasions. The manual, she said, includes medical literature, package

inserts or other information a prosecutor may find " useful. "

The manuals are not widely available. Pfizer has so far successfully

argued

in various courts the playbooks, also known as " Litigation Manuals, "

are

confidential. That has prevented the public from seeing the

contents, but

some details have been divulged in lawsuits filed in California over

the

safety of Zoloft.

The court documents, quoting the manual itself, said it is " designed

to

assist criminal prosecutors in cases in which a defendant alleges

that his

wrongful, violent conduct should be excused because when he

committed the

violent act, he was taking the antidepressant medicine that is

marketed

under the brand name Zoloft. "

Pfizer, the New York-based drug maker that employs about 5,500

people in New

Jersey, has good reason to defend the drug. Last year, Zoloft

generated $3.1

billion in sales.

Legal experts said Pfizer and other drug makers are not only within

their

rights to distribute manuals, but actually should do so in order to

protect

themselves. That is because a crime blamed on an antidepressant

could lead

to expensive civil lawsuits, they said.

" I've not heard of this before, but it's definitely not unusual for

a drug

company, or any company, to anticipate potential liability and do

some risk

prevention, " said Bloom, a professor at Boston College Law

School and

a former prosecutor.

" If I'm the corporate counsel at Pfizer, it's really in my interest

to make

sure the prosecutor is successful, " he added. " And if they are

presenting

prosecutors with knowingly false information, the defense should

present

witnesses of their own. It's the adversary system. "

The Pfizer manual is the subject of a tussle in a South Carolina

murder case

that is being closely watched because Zoloft is being blamed for the

crime.

In 2001, a 12-year-old boy named Pittman was charged with

killing his grandparents while on Zoloft.

Defense attorneys are seeking a court order that would force the

prosecutor

to submit the manual. The prosecutor, who couldn't be reached for

comment

due to an extended illness, has so far refused to disclose materials

received from Pfizer.

Such manuals have turned up before. Eli Lilly has distributed one

for its

Prozac antidepressant, although a Lilly spokesman said the company

referred

to them as notebooks.

Two months ago, the same South Carolina prosecutor acknowledged

receiving a

manual about Paxil, which is made by Glaxokline, but wouldn't

reveal

the contents. Defense attorneys have asked a judge to order the

prosecutor

to make it available.

A Glaxo spokeswoman denied that the company provided a manual. She

described

it as " a collection of primarily publicly available materials, "

although she

said she was unable to offer details about the information that was

not

publicly available.

Ed Silverman can be reached at (973) 392-1542 or esilverman@s....

FAIR USE NOTICE: This may contain copyrighted (C ) material the use

of which

has not always been specifically authorized by the copyright owner.

Such

material is made available for educational purposes, to advance

understanding of human rights, democracy, scientific, moral,

ethical, and

social justice issues, etc. It is believed that this constitutes

a 'fair

use' of any such copyrighted material as provided for in Title 17

U.S.C.

section 107 of the US Copyright Law. This material is distributed

without

profit.

[Guest guest]

..

http://www.nj.com/news/ledger/index.ssf?/base/news-

16/1091683380116820.xml

Star-Ledger

Pfizer issues prosecutors a manual to defend drug Zoloft is not

culprit in

violence, firm says Thursday, August 05, 2004 BY ED SILVERMAN

As controversy mounts over the safety of antidepressant pills, one

drug

maker has been fighting back in an unusual way -- distributing a

" prosecutor's manual " in criminal cases.

In cases around the country, Pfizer has offered a playbook to help

prosecutors challenge claims that its Zoloft drug is the culprit

behind

violent crimes instead of the defendants on trial. The information

given to

prosecutors includes medical literature and legal arguments.

The Pfizer manuals provide a rare look at the lengths to which drug

makers

sometimes go to defend products that are under attack. Although first

created a decade ago, their existence is only now coming to light as

part of

the widening controversy over antidepressants.

Some of the medicines are blamed by some medical experts for

suicides and

other violent acts. Moreover, the drugs have spawned accusations

that drug

makers have withheld crucial clinical-trial data about the rate of

suicidal

behavior among patients.

" The company may be within their rights to distribute this manual,

but it's

certainly going to appear ill-advised to send information at a time

when

they're accused of hiding data, " said Arthur Caplan of the Center for

Bioethics at the University of Pennsylvania.

Next month, a Food and Drug Administration panel will meet to review

clinical-trial data for antidepressants. And a congressional

subcommittee

will hold a hearing to review the FDA's handling of antidepressants

and to

grill several drug-company executives.

A spokeswoman for Pfizer, which maintains Zoloft is safe and

effective, told

The Star-Ledger manuals are distributed to prosecutors only on " rare "

occasions. The manual, she said, includes medical literature, package

inserts or other information a prosecutor may find " useful. "

The manuals are not widely available. Pfizer has so far successfully

argued

in various courts the playbooks, also known as " Litigation Manuals, "

are

confidential. That has prevented the public from seeing the

contents, but

some details have been divulged in lawsuits filed in California over

the

safety of Zoloft.

The court documents, quoting the manual itself, said it is " designed

to

assist criminal prosecutors in cases in which a defendant alleges

that his

wrongful, violent conduct should be excused because when he

committed the

violent act, he was taking the antidepressant medicine that is

marketed

under the brand name Zoloft. "

Pfizer, the New York-based drug maker that employs about 5,500

people in New

Jersey, has good reason to defend the drug. Last year, Zoloft

generated $3.1

billion in sales.

Legal experts said Pfizer and other drug makers are not only within

their

rights to distribute manuals, but actually should do so in order to

protect

themselves. That is because a crime blamed on an antidepressant

could lead

to expensive civil lawsuits, they said.

" I've not heard of this before, but it's definitely not unusual for

a drug

company, or any company, to anticipate potential liability and do

some risk

prevention, " said Bloom, a professor at Boston College Law

School and

a former prosecutor.

" If I'm the corporate counsel at Pfizer, it's really in my interest

to make

sure the prosecutor is successful, " he added. " And if they are

presenting

prosecutors with knowingly false information, the defense should

present

witnesses of their own. It's the adversary system. "

The Pfizer manual is the subject of a tussle in a South Carolina

murder case

that is being closely watched because Zoloft is being blamed for the

crime.

In 2001, a 12-year-old boy named Pittman was charged with

killing his grandparents while on Zoloft.

Defense attorneys are seeking a court order that would force the

prosecutor

to submit the manual. The prosecutor, who couldn't be reached for

comment

due to an extended illness, has so far refused to disclose materials

received from Pfizer.

Such manuals have turned up before. Eli Lilly has distributed one

for its

Prozac antidepressant, although a Lilly spokesman said the company

referred

to them as notebooks.

Two months ago, the same South Carolina prosecutor acknowledged

receiving a

manual about Paxil, which is made by Glaxokline, but wouldn't

reveal

the contents. Defense attorneys have asked a judge to order the

prosecutor

to make it available.

A Glaxo spokeswoman denied that the company provided a manual. She

described

it as " a collection of primarily publicly available materials, "

although she

said she was unable to offer details about the information that was

not

publicly available.

Ed Silverman can be reached at (973) 392-1542 or esilverman@s....

FAIR USE NOTICE: This may contain copyrighted (C ) material the use

of which

has not always been specifically authorized by the copyright owner.

Such

material is made available for educational purposes, to advance

understanding of human rights, democracy, scientific, moral,

ethical, and

social justice issues, etc. It is believed that this constitutes

a 'fair

use' of any such copyrighted material as provided for in Title 17

U.S.C.

section 107 of the US Copyright Law. This material is distributed

without

profit.