Battle over drugs hits crescendo

[Guest guest]

New Freedom Commission's medication guideline is taking a beating. This is the

drugging guideline recommended after Teenscreen any other screening takes place.

This guideline was exported to 16 other states. I will send a better version

strait from the paper later.

http://www.statesman.com/search/content/news/stories/local/12/23/23mhmrdrugs.htm\

l

Battle over drugs hits crescendo

Lawsuit claims state official who pushed drug was rewarded.

By Embry, Corrie MacLaggan

AMERICAN-STATESMAN STAFF

Saturday, December 23, 2006

Texas Attorney General Greg Abbott's effort to recoup public money spent on

prescription drugs in state mental health programs highlights the growing cost

of those drugs, the emotional debate about how to treat mental illness and the

pharmaceutical industry's role in creating support among experts for its

products.

Abbott has joined a lawsuit alleging that the makers of a schizophrenia medicine

called Risperdal misrepresented the benefits of their drug so the state would

purchase it for patients in public mental health programs instead of

anti-psychotic drugs that cost less and were just as effective. The drug became

part of a much-celebrated treatment plan not only used in Texas facilities but

also exported to 16 states.

MOST POPULAR STORIES

a.. Boy dies after being shot with a pellet gun

b.. Texas decides to tweak its running game in time for Alamo

c.. Austin officer fired in use-of-force case

d.. Two die in Northwest Austin fire

e.. Heavy hail-producing storms expected this afternoon

" We believe Texas has been defrauded of some money, and we're going to be

looking to get our money back, " Abbott said this week.

Texas is the first state to go after drug companies accused of improperly

influencing state officials who decided to adopt the treatment plan. The case is

not only about the hundreds of millions of dollars Texas spent on one drug. It

also raises questions about the role powerful drug companies play in crafting

state decisions about how to treat mental illness.

Abbott would not say how much money Texas could gain from the lawsuit.

Melsheimer, a Dallas attorney for Pennsylvania whistle-blower

, said Texas has paid hundreds of millions of dollars for Risperdal since

2000. is teaming up with Abbott to sue six drug companies.

" We certainly believe that (the treatment plan) was essentially a marketing

scheme masquerading as medical science, " Melsheimer said.

The lawsuit filed asks that receive an unspecified percentage of

what the state recovers.

State officials defended the drug plan. It is " firmly grounded in the latest

research and science, " said Goodman, a spokeswoman for the Health and

Human Services Commission.

Representatives for Janssen, the New Jersey company that makes Risperdal, have

not responded to requests for comment, and two Texas scholars involved with the

development of the treatment plan said university lawyers told them not to speak

to reporters.

The plan at issue was developed in the 1990s as state officials sought a

standard process for treating schizophrenia, major depression and bipolar

disorder. The development of such guidelines has become common in medicine in

the past 20 years, said Dr. Rosenheck, director of the Northeast Program

Evaluation Center in the federal Department of Veterans Affairs.

" There's been movement among academic doctors to make the information available

in a simple form and to encourage people to follow the evidence, " said

Rosenheck, a psychiatry professor at the Yale School of Medicine. " These

guidelines are there not just to tell you what's a good thing to do, but to

increase the likelihood that doctors will do it. "

The advent of new mental health drugs spurred the state's $5.6 million project

to develop the treatment plan, known as the Texas Medication Algorithm Project,

or TMAP. The Wood Foundation, founded by a former executive at

& Inc., gave $1.8 million to the project. Janssen is a

subsidiary of & , and both companies are defendants in the

lawsuit.

The first two phases of the project, including a four-month trial at 16 clinic

sites, produced surprisingly positive results, with good patient response,

according to American-Statesman accounts at the time.

But ' lawsuit claims that Risperdal became part of the treatment plan

because of drug companies' " improper influence " over Dr. Shon, the former

medical director for behavioral health at the Department of State Health

Services. The lawsuit says the companies pushed Risperdal by giving state

officials around the country trips, perks and speaking fees.

Shon, who lost his state job after Abbott's investigation of ' claims, has

served as a paid Janssen consultant and traveled the country promoting the Texas

plan. He denies the allegations in the lawsuit, however.

" I didn't personally benefit from this project, " he said.

Doctors treating patients in state-run mental health programs are required to

follow the protocol, which is still in use, unless they document why they should

not. Risperdal is one of five drug options in the initial treatment options for

schizophrenia.

In 1997, the year the protocol was developed, 7,314 people in state hospitals,

state schools and mental health community centers were treated with Risperdal

for at least one day, according to the health department. In the 2006 budget

year, 21,537 people were treated with the drug.

One of the states that copied Texas' treatment plan was Pennsylvania. says

in his lawsuit that, while working for the state inspector general in

Pennsylvania, he looked into allegations of impropriety in the adoption of the

program there. One of the drug companies' representatives revealed payments made

to Shon, the lawsuit says.

says his supervisors in Pennsylvania sought to limit his investigation and

told him drug companies " write checks to politicians on both sides of the

aisle, " and they eventually removed him as lead investigator on the case.

left the inspector general's office in 2004, the same year he filed the

lawsuit against Texas. In the process, he became a hero of sorts to people

suspicious of the ways medicines are used to treat mental illness. Abbott could

take on the same status as the case develops.

Jerry Boswell, president of the Citizens Commission on Human Rights of Texas, a

mental health watchdog organization, commended the attorney general for taking

on drug companies Boswell says have pushed certain drugs on a " captive

audience " : Medicaid and Medicare patients.

" This is going on all over the nation, and we can be proud that Texas is the

first one to take the bull by the horns . . . to put a stop to this fraud, "

Boswell said.

Defenders of the Texas plan often grumble privately that is propped up by

the Church of Scientology and that Boswell's commission was co-founded by that

church. Although his commission was indeed co-founded by the church, Boswell

said, that's a red herring.

" is not a Scientologist, and he is not doing this on behalf of Scientology

or any other cause other than the truth, " Melsheimer said.

A two-part study funded by the National Institute of Mental Health emboldened

Risperdal's critics when the first part was published in 2005. It concluded that

an older, less expensive drug called perphenazine performed as well in treating

schizophrenia as Risperdal and three other newer drugs.

" There was the general belief that risperidone and the newer drugs were superior

and had less side effects than the older drugs, " said Yale's Rosenheck, who

worked on the study. It and " several other independent government studies in the

last three years have led me and some other people to question whether those

conclusions are warranted. "

But Goodman, with the state health commission, said the new drugs " make it

possible for people with serious mental health issues to control their symptoms

and avoid the side effects that kept them from having normal lives. Yes, there,

are still side effects with the new drugs. There are side effects with all

drugs. "

Rosenheck, who is familiar with the Texas protocol but said he is not an expert

in it, said its development came at a time when doctors and scholars had great

hope for powerful new drugs.

" The people that did TMAP are quite highly respected, " he said. " I think it was

developed out of the current beliefs that were widespread in the profession.

I've been surprised the way it's been linked to commercial purposes. There are

lots of promotional activities that many of us are aware of and wince at, but

TMAP was never one of them. "

Still, the attention to the Texas system comes at a time of heightened scrutiny

surrounding medicine's relationship with pharmaceutical companies.

Two former editors of the New England Journal of Medicine wrote books recently

voicing concerns about the drug industry's role in determining medical

treatment.

' lawsuit, in fact, says the Texas program was only one piece of a

Risperdal marketing effort that also spanned continuing education programs,

speakers bureaus, advisory boards and trade publications.

" We don't for a minute believe that Janssen was the only company out there that

was doing things this way, " said Siegal, one of ' attorneys.

Mental health drugs in Texas

1950s: First anti-psychotic drugs are introduced.

1990s: Anti-psychotic drugs considered to have fewer side effects are

introduced.

1997: Texas Medication Algorithm Project, or TMAP, a drug treatment plan, is

developed by a panel of health experts and state officials.

1999: Texas Legislature requires the state mental health program to follow TMAP

protocol.

Late 1990s-early 2000s: Texas mental health official Dr. Shon travels

around the country speaking about TMAP.

Sixteen other states eventually adopt the protocol.

2003: President Bush's New Freedom Commission on Mental Health recommends TMAP.

2004: After questioning drug company payments to state officials, is

fired from his job as an investigator at the Pennsylvania inspector general's

office.

2004: Because the drug protocol used by many states originated in Texas,

files lawsuit in County District Court against & and some

subsidiaries.

The lawsuit is sealed from public view because of protections that

whistle-blowers such as are granted.

October 2006: Shon is forced by superiors to retire from the Texas health

department after officials learn of findings of a Texas attorney general

investigation into whether Shon was unduly influenced by drug companies.

December 2006: Texas joins ' lawsuit. The lawsuit is opened to the public.

Sources: Office of Comptroller Carole Keeton Strayhorn, Health and Human

Services Commission, lawsuit

jembry@... ; 445-3654; cmaclaggan@... ; 445-3548

FAIR USE NOTICE: This may contain copyrighted material. Such material is made

available for educational purposes, to advance understanding of human rights,

democracy, scientific, moral, ethical, and social justice issues, etc. 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]

New Freedom Commission's medication guideline is taking a beating. This is the

drugging guideline recommended after Teenscreen any other screening takes place.

This guideline was exported to 16 other states. I will send a better version

strait from the paper later.

http://www.statesman.com/search/content/news/stories/local/12/23/23mhmrdrugs.htm\

l

Battle over drugs hits crescendo

Lawsuit claims state official who pushed drug was rewarded.

By Embry, Corrie MacLaggan

AMERICAN-STATESMAN STAFF

Saturday, December 23, 2006

Texas Attorney General Greg Abbott's effort to recoup public money spent on

prescription drugs in state mental health programs highlights the growing cost

of those drugs, the emotional debate about how to treat mental illness and the

pharmaceutical industry's role in creating support among experts for its

products.

Abbott has joined a lawsuit alleging that the makers of a schizophrenia medicine

called Risperdal misrepresented the benefits of their drug so the state would

purchase it for patients in public mental health programs instead of

anti-psychotic drugs that cost less and were just as effective. The drug became

part of a much-celebrated treatment plan not only used in Texas facilities but

also exported to 16 states.

MOST POPULAR STORIES

a.. Boy dies after being shot with a pellet gun

b.. Texas decides to tweak its running game in time for Alamo

c.. Austin officer fired in use-of-force case

d.. Two die in Northwest Austin fire

e.. Heavy hail-producing storms expected this afternoon

" We believe Texas has been defrauded of some money, and we're going to be

looking to get our money back, " Abbott said this week.

Texas is the first state to go after drug companies accused of improperly

influencing state officials who decided to adopt the treatment plan. The case is

not only about the hundreds of millions of dollars Texas spent on one drug. It

also raises questions about the role powerful drug companies play in crafting

state decisions about how to treat mental illness.

Abbott would not say how much money Texas could gain from the lawsuit.

Melsheimer, a Dallas attorney for Pennsylvania whistle-blower

, said Texas has paid hundreds of millions of dollars for Risperdal since

2000. is teaming up with Abbott to sue six drug companies.

" We certainly believe that (the treatment plan) was essentially a marketing

scheme masquerading as medical science, " Melsheimer said.

The lawsuit filed asks that receive an unspecified percentage of

what the state recovers.

State officials defended the drug plan. It is " firmly grounded in the latest

research and science, " said Goodman, a spokeswoman for the Health and

Human Services Commission.

Representatives for Janssen, the New Jersey company that makes Risperdal, have

not responded to requests for comment, and two Texas scholars involved with the

development of the treatment plan said university lawyers told them not to speak

to reporters.

The plan at issue was developed in the 1990s as state officials sought a

standard process for treating schizophrenia, major depression and bipolar

disorder. The development of such guidelines has become common in medicine in

the past 20 years, said Dr. Rosenheck, director of the Northeast Program

Evaluation Center in the federal Department of Veterans Affairs.

" There's been movement among academic doctors to make the information available

in a simple form and to encourage people to follow the evidence, " said

Rosenheck, a psychiatry professor at the Yale School of Medicine. " These

guidelines are there not just to tell you what's a good thing to do, but to

increase the likelihood that doctors will do it. "

The advent of new mental health drugs spurred the state's $5.6 million project

to develop the treatment plan, known as the Texas Medication Algorithm Project,

or TMAP. The Wood Foundation, founded by a former executive at

& Inc., gave $1.8 million to the project. Janssen is a

subsidiary of & , and both companies are defendants in the

lawsuit.

The first two phases of the project, including a four-month trial at 16 clinic

sites, produced surprisingly positive results, with good patient response,

according to American-Statesman accounts at the time.

But ' lawsuit claims that Risperdal became part of the treatment plan

because of drug companies' " improper influence " over Dr. Shon, the former

medical director for behavioral health at the Department of State Health

Services. The lawsuit says the companies pushed Risperdal by giving state

officials around the country trips, perks and speaking fees.

Shon, who lost his state job after Abbott's investigation of ' claims, has

served as a paid Janssen consultant and traveled the country promoting the Texas

plan. He denies the allegations in the lawsuit, however.

" I didn't personally benefit from this project, " he said.

Doctors treating patients in state-run mental health programs are required to

follow the protocol, which is still in use, unless they document why they should

not. Risperdal is one of five drug options in the initial treatment options for

schizophrenia.

In 1997, the year the protocol was developed, 7,314 people in state hospitals,

state schools and mental health community centers were treated with Risperdal

for at least one day, according to the health department. In the 2006 budget

year, 21,537 people were treated with the drug.

One of the states that copied Texas' treatment plan was Pennsylvania. says

in his lawsuit that, while working for the state inspector general in

Pennsylvania, he looked into allegations of impropriety in the adoption of the

program there. One of the drug companies' representatives revealed payments made

to Shon, the lawsuit says.

says his supervisors in Pennsylvania sought to limit his investigation and

told him drug companies " write checks to politicians on both sides of the

aisle, " and they eventually removed him as lead investigator on the case.

left the inspector general's office in 2004, the same year he filed the

lawsuit against Texas. In the process, he became a hero of sorts to people

suspicious of the ways medicines are used to treat mental illness. Abbott could

take on the same status as the case develops.

Jerry Boswell, president of the Citizens Commission on Human Rights of Texas, a

mental health watchdog organization, commended the attorney general for taking

on drug companies Boswell says have pushed certain drugs on a " captive

audience " : Medicaid and Medicare patients.

" This is going on all over the nation, and we can be proud that Texas is the

first one to take the bull by the horns . . . to put a stop to this fraud, "

Boswell said.

Defenders of the Texas plan often grumble privately that is propped up by

the Church of Scientology and that Boswell's commission was co-founded by that

church. Although his commission was indeed co-founded by the church, Boswell

said, that's a red herring.

" is not a Scientologist, and he is not doing this on behalf of Scientology

or any other cause other than the truth, " Melsheimer said.

A two-part study funded by the National Institute of Mental Health emboldened

Risperdal's critics when the first part was published in 2005. It concluded that

an older, less expensive drug called perphenazine performed as well in treating

schizophrenia as Risperdal and three other newer drugs.

" There was the general belief that risperidone and the newer drugs were superior

and had less side effects than the older drugs, " said Yale's Rosenheck, who

worked on the study. It and " several other independent government studies in the

last three years have led me and some other people to question whether those

conclusions are warranted. "

But Goodman, with the state health commission, said the new drugs " make it

possible for people with serious mental health issues to control their symptoms

and avoid the side effects that kept them from having normal lives. Yes, there,

are still side effects with the new drugs. There are side effects with all

drugs. "

Rosenheck, who is familiar with the Texas protocol but said he is not an expert

in it, said its development came at a time when doctors and scholars had great

hope for powerful new drugs.

" The people that did TMAP are quite highly respected, " he said. " I think it was

developed out of the current beliefs that were widespread in the profession.

I've been surprised the way it's been linked to commercial purposes. There are

lots of promotional activities that many of us are aware of and wince at, but

TMAP was never one of them. "

Still, the attention to the Texas system comes at a time of heightened scrutiny

surrounding medicine's relationship with pharmaceutical companies.

Two former editors of the New England Journal of Medicine wrote books recently

voicing concerns about the drug industry's role in determining medical

treatment.

' lawsuit, in fact, says the Texas program was only one piece of a

Risperdal marketing effort that also spanned continuing education programs,

speakers bureaus, advisory boards and trade publications.

" We don't for a minute believe that Janssen was the only company out there that

was doing things this way, " said Siegal, one of ' attorneys.

Mental health drugs in Texas

1950s: First anti-psychotic drugs are introduced.

1990s: Anti-psychotic drugs considered to have fewer side effects are

introduced.

1997: Texas Medication Algorithm Project, or TMAP, a drug treatment plan, is

developed by a panel of health experts and state officials.

1999: Texas Legislature requires the state mental health program to follow TMAP

protocol.

Late 1990s-early 2000s: Texas mental health official Dr. Shon travels

around the country speaking about TMAP.

Sixteen other states eventually adopt the protocol.

2003: President Bush's New Freedom Commission on Mental Health recommends TMAP.

2004: After questioning drug company payments to state officials, is

fired from his job as an investigator at the Pennsylvania inspector general's

office.

2004: Because the drug protocol used by many states originated in Texas,

files lawsuit in County District Court against & and some

subsidiaries.

The lawsuit is sealed from public view because of protections that

whistle-blowers such as are granted.

October 2006: Shon is forced by superiors to retire from the Texas health

department after officials learn of findings of a Texas attorney general

investigation into whether Shon was unduly influenced by drug companies.

December 2006: Texas joins ' lawsuit. The lawsuit is opened to the public.

Sources: Office of Comptroller Carole Keeton Strayhorn, Health and Human

Services Commission, lawsuit

jembry@... ; 445-3654; cmaclaggan@... ; 445-3548

FAIR USE NOTICE: This may contain copyrighted material. Such material is made

available for educational purposes, to advance understanding of human rights,

democracy, scientific, moral, ethical, and social justice issues, etc. 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]

New Freedom Commission's medication guideline is taking a beating. This is the

drugging guideline recommended after Teenscreen any other screening takes place.

This guideline was exported to 16 other states. I will send a better version

strait from the paper later.

http://www.statesman.com/search/content/news/stories/local/12/23/23mhmrdrugs.htm\

l

Battle over drugs hits crescendo

Lawsuit claims state official who pushed drug was rewarded.

By Embry, Corrie MacLaggan

AMERICAN-STATESMAN STAFF

Saturday, December 23, 2006

Texas Attorney General Greg Abbott's effort to recoup public money spent on

prescription drugs in state mental health programs highlights the growing cost

of those drugs, the emotional debate about how to treat mental illness and the

pharmaceutical industry's role in creating support among experts for its

products.

Abbott has joined a lawsuit alleging that the makers of a schizophrenia medicine

called Risperdal misrepresented the benefits of their drug so the state would

purchase it for patients in public mental health programs instead of

anti-psychotic drugs that cost less and were just as effective. The drug became

part of a much-celebrated treatment plan not only used in Texas facilities but

also exported to 16 states.

MOST POPULAR STORIES

a.. Boy dies after being shot with a pellet gun

b.. Texas decides to tweak its running game in time for Alamo

c.. Austin officer fired in use-of-force case

d.. Two die in Northwest Austin fire

e.. Heavy hail-producing storms expected this afternoon

" We believe Texas has been defrauded of some money, and we're going to be

looking to get our money back, " Abbott said this week.

Texas is the first state to go after drug companies accused of improperly

influencing state officials who decided to adopt the treatment plan. The case is

not only about the hundreds of millions of dollars Texas spent on one drug. It

also raises questions about the role powerful drug companies play in crafting

state decisions about how to treat mental illness.

Abbott would not say how much money Texas could gain from the lawsuit.

Melsheimer, a Dallas attorney for Pennsylvania whistle-blower

, said Texas has paid hundreds of millions of dollars for Risperdal since

2000. is teaming up with Abbott to sue six drug companies.

" We certainly believe that (the treatment plan) was essentially a marketing

scheme masquerading as medical science, " Melsheimer said.

The lawsuit filed asks that receive an unspecified percentage of

what the state recovers.

State officials defended the drug plan. It is " firmly grounded in the latest

research and science, " said Goodman, a spokeswoman for the Health and

Human Services Commission.

Representatives for Janssen, the New Jersey company that makes Risperdal, have

not responded to requests for comment, and two Texas scholars involved with the

development of the treatment plan said university lawyers told them not to speak

to reporters.

The plan at issue was developed in the 1990s as state officials sought a

standard process for treating schizophrenia, major depression and bipolar

disorder. The development of such guidelines has become common in medicine in

the past 20 years, said Dr. Rosenheck, director of the Northeast Program

Evaluation Center in the federal Department of Veterans Affairs.

" There's been movement among academic doctors to make the information available

in a simple form and to encourage people to follow the evidence, " said

Rosenheck, a psychiatry professor at the Yale School of Medicine. " These

guidelines are there not just to tell you what's a good thing to do, but to

increase the likelihood that doctors will do it. "

The advent of new mental health drugs spurred the state's $5.6 million project

to develop the treatment plan, known as the Texas Medication Algorithm Project,

or TMAP. The Wood Foundation, founded by a former executive at

& Inc., gave $1.8 million to the project. Janssen is a

subsidiary of & , and both companies are defendants in the

lawsuit.

The first two phases of the project, including a four-month trial at 16 clinic

sites, produced surprisingly positive results, with good patient response,

according to American-Statesman accounts at the time.

But ' lawsuit claims that Risperdal became part of the treatment plan

because of drug companies' " improper influence " over Dr. Shon, the former

medical director for behavioral health at the Department of State Health

Services. The lawsuit says the companies pushed Risperdal by giving state

officials around the country trips, perks and speaking fees.

Shon, who lost his state job after Abbott's investigation of ' claims, has

served as a paid Janssen consultant and traveled the country promoting the Texas

plan. He denies the allegations in the lawsuit, however.

" I didn't personally benefit from this project, " he said.

Doctors treating patients in state-run mental health programs are required to

follow the protocol, which is still in use, unless they document why they should

not. Risperdal is one of five drug options in the initial treatment options for

schizophrenia.

In 1997, the year the protocol was developed, 7,314 people in state hospitals,

state schools and mental health community centers were treated with Risperdal

for at least one day, according to the health department. In the 2006 budget

year, 21,537 people were treated with the drug.

One of the states that copied Texas' treatment plan was Pennsylvania. says

in his lawsuit that, while working for the state inspector general in

Pennsylvania, he looked into allegations of impropriety in the adoption of the

program there. One of the drug companies' representatives revealed payments made

to Shon, the lawsuit says.

says his supervisors in Pennsylvania sought to limit his investigation and

told him drug companies " write checks to politicians on both sides of the

aisle, " and they eventually removed him as lead investigator on the case.

left the inspector general's office in 2004, the same year he filed the

lawsuit against Texas. In the process, he became a hero of sorts to people

suspicious of the ways medicines are used to treat mental illness. Abbott could

take on the same status as the case develops.

Jerry Boswell, president of the Citizens Commission on Human Rights of Texas, a

mental health watchdog organization, commended the attorney general for taking

on drug companies Boswell says have pushed certain drugs on a " captive

audience " : Medicaid and Medicare patients.

" This is going on all over the nation, and we can be proud that Texas is the

first one to take the bull by the horns . . . to put a stop to this fraud, "

Boswell said.

Defenders of the Texas plan often grumble privately that is propped up by

the Church of Scientology and that Boswell's commission was co-founded by that

church. Although his commission was indeed co-founded by the church, Boswell

said, that's a red herring.

" is not a Scientologist, and he is not doing this on behalf of Scientology

or any other cause other than the truth, " Melsheimer said.

A two-part study funded by the National Institute of Mental Health emboldened

Risperdal's critics when the first part was published in 2005. It concluded that

an older, less expensive drug called perphenazine performed as well in treating

schizophrenia as Risperdal and three other newer drugs.

" There was the general belief that risperidone and the newer drugs were superior

and had less side effects than the older drugs, " said Yale's Rosenheck, who

worked on the study. It and " several other independent government studies in the

last three years have led me and some other people to question whether those

conclusions are warranted. "

But Goodman, with the state health commission, said the new drugs " make it

possible for people with serious mental health issues to control their symptoms

and avoid the side effects that kept them from having normal lives. Yes, there,

are still side effects with the new drugs. There are side effects with all

drugs. "

Rosenheck, who is familiar with the Texas protocol but said he is not an expert

in it, said its development came at a time when doctors and scholars had great

hope for powerful new drugs.

" The people that did TMAP are quite highly respected, " he said. " I think it was

developed out of the current beliefs that were widespread in the profession.

I've been surprised the way it's been linked to commercial purposes. There are

lots of promotional activities that many of us are aware of and wince at, but

TMAP was never one of them. "

Still, the attention to the Texas system comes at a time of heightened scrutiny

surrounding medicine's relationship with pharmaceutical companies.

Two former editors of the New England Journal of Medicine wrote books recently

voicing concerns about the drug industry's role in determining medical

treatment.

' lawsuit, in fact, says the Texas program was only one piece of a

Risperdal marketing effort that also spanned continuing education programs,

speakers bureaus, advisory boards and trade publications.

" We don't for a minute believe that Janssen was the only company out there that

was doing things this way, " said Siegal, one of ' attorneys.

Mental health drugs in Texas

1950s: First anti-psychotic drugs are introduced.

1990s: Anti-psychotic drugs considered to have fewer side effects are

introduced.

1997: Texas Medication Algorithm Project, or TMAP, a drug treatment plan, is

developed by a panel of health experts and state officials.

1999: Texas Legislature requires the state mental health program to follow TMAP

protocol.

Late 1990s-early 2000s: Texas mental health official Dr. Shon travels

around the country speaking about TMAP.

Sixteen other states eventually adopt the protocol.

2003: President Bush's New Freedom Commission on Mental Health recommends TMAP.

2004: After questioning drug company payments to state officials, is

fired from his job as an investigator at the Pennsylvania inspector general's

office.

2004: Because the drug protocol used by many states originated in Texas,

files lawsuit in County District Court against & and some

subsidiaries.

The lawsuit is sealed from public view because of protections that

whistle-blowers such as are granted.

October 2006: Shon is forced by superiors to retire from the Texas health

department after officials learn of findings of a Texas attorney general

investigation into whether Shon was unduly influenced by drug companies.

December 2006: Texas joins ' lawsuit. The lawsuit is opened to the public.

Sources: Office of Comptroller Carole Keeton Strayhorn, Health and Human

Services Commission, lawsuit

jembry@... ; 445-3654; cmaclaggan@... ; 445-3548

FAIR USE NOTICE: This may contain copyrighted material. Such material is made

available for educational purposes, to advance understanding of human rights,

democracy, scientific, moral, ethical, and social justice issues, etc. 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]

New Freedom Commission's medication guideline is taking a beating. This is the

drugging guideline recommended after Teenscreen any other screening takes place.

This guideline was exported to 16 other states. I will send a better version

strait from the paper later.

http://www.statesman.com/search/content/news/stories/local/12/23/23mhmrdrugs.htm\

l

Battle over drugs hits crescendo

Lawsuit claims state official who pushed drug was rewarded.

By Embry, Corrie MacLaggan

AMERICAN-STATESMAN STAFF

Saturday, December 23, 2006

Texas Attorney General Greg Abbott's effort to recoup public money spent on

prescription drugs in state mental health programs highlights the growing cost

of those drugs, the emotional debate about how to treat mental illness and the

pharmaceutical industry's role in creating support among experts for its

products.

Abbott has joined a lawsuit alleging that the makers of a schizophrenia medicine

called Risperdal misrepresented the benefits of their drug so the state would

purchase it for patients in public mental health programs instead of

anti-psychotic drugs that cost less and were just as effective. The drug became

part of a much-celebrated treatment plan not only used in Texas facilities but

also exported to 16 states.

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" We believe Texas has been defrauded of some money, and we're going to be

looking to get our money back, " Abbott said this week.

Texas is the first state to go after drug companies accused of improperly

influencing state officials who decided to adopt the treatment plan. The case is

not only about the hundreds of millions of dollars Texas spent on one drug. It

also raises questions about the role powerful drug companies play in crafting

state decisions about how to treat mental illness.

Abbott would not say how much money Texas could gain from the lawsuit.

Melsheimer, a Dallas attorney for Pennsylvania whistle-blower

, said Texas has paid hundreds of millions of dollars for Risperdal since

2000. is teaming up with Abbott to sue six drug companies.

" We certainly believe that (the treatment plan) was essentially a marketing

scheme masquerading as medical science, " Melsheimer said.

The lawsuit filed asks that receive an unspecified percentage of

what the state recovers.

State officials defended the drug plan. It is " firmly grounded in the latest

research and science, " said Goodman, a spokeswoman for the Health and

Human Services Commission.

Representatives for Janssen, the New Jersey company that makes Risperdal, have

not responded to requests for comment, and two Texas scholars involved with the

development of the treatment plan said university lawyers told them not to speak

to reporters.

The plan at issue was developed in the 1990s as state officials sought a

standard process for treating schizophrenia, major depression and bipolar

disorder. The development of such guidelines has become common in medicine in

the past 20 years, said Dr. Rosenheck, director of the Northeast Program

Evaluation Center in the federal Department of Veterans Affairs.

" There's been movement among academic doctors to make the information available

in a simple form and to encourage people to follow the evidence, " said

Rosenheck, a psychiatry professor at the Yale School of Medicine. " These

guidelines are there not just to tell you what's a good thing to do, but to

increase the likelihood that doctors will do it. "

The advent of new mental health drugs spurred the state's $5.6 million project

to develop the treatment plan, known as the Texas Medication Algorithm Project,

or TMAP. The Wood Foundation, founded by a former executive at

& Inc., gave $1.8 million to the project. Janssen is a

subsidiary of & , and both companies are defendants in the

lawsuit.

The first two phases of the project, including a four-month trial at 16 clinic

sites, produced surprisingly positive results, with good patient response,

according to American-Statesman accounts at the time.

But ' lawsuit claims that Risperdal became part of the treatment plan

because of drug companies' " improper influence " over Dr. Shon, the former

medical director for behavioral health at the Department of State Health

Services. The lawsuit says the companies pushed Risperdal by giving state

officials around the country trips, perks and speaking fees.

Shon, who lost his state job after Abbott's investigation of ' claims, has

served as a paid Janssen consultant and traveled the country promoting the Texas

plan. He denies the allegations in the lawsuit, however.

" I didn't personally benefit from this project, " he said.

Doctors treating patients in state-run mental health programs are required to

follow the protocol, which is still in use, unless they document why they should

not. Risperdal is one of five drug options in the initial treatment options for

schizophrenia.

In 1997, the year the protocol was developed, 7,314 people in state hospitals,

state schools and mental health community centers were treated with Risperdal

for at least one day, according to the health department. In the 2006 budget

year, 21,537 people were treated with the drug.

One of the states that copied Texas' treatment plan was Pennsylvania. says

in his lawsuit that, while working for the state inspector general in

Pennsylvania, he looked into allegations of impropriety in the adoption of the

program there. One of the drug companies' representatives revealed payments made

to Shon, the lawsuit says.

says his supervisors in Pennsylvania sought to limit his investigation and

told him drug companies " write checks to politicians on both sides of the

aisle, " and they eventually removed him as lead investigator on the case.

left the inspector general's office in 2004, the same year he filed the

lawsuit against Texas. In the process, he became a hero of sorts to people

suspicious of the ways medicines are used to treat mental illness. Abbott could

take on the same status as the case develops.

Jerry Boswell, president of the Citizens Commission on Human Rights of Texas, a

mental health watchdog organization, commended the attorney general for taking

on drug companies Boswell says have pushed certain drugs on a " captive

audience " : Medicaid and Medicare patients.

" This is going on all over the nation, and we can be proud that Texas is the

first one to take the bull by the horns . . . to put a stop to this fraud, "

Boswell said.

Defenders of the Texas plan often grumble privately that is propped up by

the Church of Scientology and that Boswell's commission was co-founded by that

church. Although his commission was indeed co-founded by the church, Boswell

said, that's a red herring.

" is not a Scientologist, and he is not doing this on behalf of Scientology

or any other cause other than the truth, " Melsheimer said.

A two-part study funded by the National Institute of Mental Health emboldened

Risperdal's critics when the first part was published in 2005. It concluded that

an older, less expensive drug called perphenazine performed as well in treating

schizophrenia as Risperdal and three other newer drugs.

" There was the general belief that risperidone and the newer drugs were superior

and had less side effects than the older drugs, " said Yale's Rosenheck, who

worked on the study. It and " several other independent government studies in the

last three years have led me and some other people to question whether those

conclusions are warranted. "

But Goodman, with the state health commission, said the new drugs " make it

possible for people with serious mental health issues to control their symptoms

and avoid the side effects that kept them from having normal lives. Yes, there,

are still side effects with the new drugs. There are side effects with all

drugs. "

Rosenheck, who is familiar with the Texas protocol but said he is not an expert

in it, said its development came at a time when doctors and scholars had great

hope for powerful new drugs.

" The people that did TMAP are quite highly respected, " he said. " I think it was

developed out of the current beliefs that were widespread in the profession.

I've been surprised the way it's been linked to commercial purposes. There are

lots of promotional activities that many of us are aware of and wince at, but

TMAP was never one of them. "

Still, the attention to the Texas system comes at a time of heightened scrutiny

surrounding medicine's relationship with pharmaceutical companies.

Two former editors of the New England Journal of Medicine wrote books recently

voicing concerns about the drug industry's role in determining medical

treatment.

' lawsuit, in fact, says the Texas program was only one piece of a

Risperdal marketing effort that also spanned continuing education programs,

speakers bureaus, advisory boards and trade publications.

" We don't for a minute believe that Janssen was the only company out there that

was doing things this way, " said Siegal, one of ' attorneys.

Mental health drugs in Texas

1950s: First anti-psychotic drugs are introduced.

1990s: Anti-psychotic drugs considered to have fewer side effects are

introduced.

1997: Texas Medication Algorithm Project, or TMAP, a drug treatment plan, is

developed by a panel of health experts and state officials.

1999: Texas Legislature requires the state mental health program to follow TMAP

protocol.

Late 1990s-early 2000s: Texas mental health official Dr. Shon travels

around the country speaking about TMAP.

Sixteen other states eventually adopt the protocol.

2003: President Bush's New Freedom Commission on Mental Health recommends TMAP.

2004: After questioning drug company payments to state officials, is

fired from his job as an investigator at the Pennsylvania inspector general's

office.

2004: Because the drug protocol used by many states originated in Texas,

files lawsuit in County District Court against & and some

subsidiaries.

The lawsuit is sealed from public view because of protections that

whistle-blowers such as are granted.

October 2006: Shon is forced by superiors to retire from the Texas health

department after officials learn of findings of a Texas attorney general

investigation into whether Shon was unduly influenced by drug companies.

December 2006: Texas joins ' lawsuit. The lawsuit is opened to the public.

Sources: Office of Comptroller Carole Keeton Strayhorn, Health and Human

Services Commission, lawsuit

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