10 Years Later, Glaxo Still Haunted by Faked Studies of Paxil in Kids

[Guest guest]

http://www.bnet.com/blog/drug-business/10-years-later-glaxo-still-haunted-by-faked-studies-of-paxil-in-kids/5545

10 Years Later, Glaxo Still Haunted by Faked

Studies of Paxil in Kids

By Jim

| August 19, 2010

A crooked doctor who faked data in a GlaxoKline

(GSK) study of the antidepressant Paxil

in children is

expected to plead guilty to criminal charges today, causing

groans among GSK’s senior management as the company hopes to fend

off a different criminal investigation into whether it manipulated

clinical data on its diabetes drug, Avandia.

The two cases are technically completely separate, but they’re

both about data manipulation. GSK has been accused of sitting on

data showing risks on both drugs; and the

FDA previously shut down one of GSK’s factories where both drugs

were made.

Thus, the expected guilty plea of Dr. Carmen

Palazzo today is a reminder to managers everywhere that

cutting ethical corners can cause unwanted chickens to return to

their roosts, even years later.

Palazzo

was indicted in 2007 on 40 counts of defrauding Medicare and

Medicaid at her New Orleans clinic, and 15 counts of conducting

fraudulent clinical trials. The charges followed an FDA

accusation that she had enrolled 26 children in studies of

Paxil for obsessive-compulsive disorder and major depressive

disorder. She included children in the trial — which was given the

cutesey nickname “Kiddie-Sads-Present and Lifetime” — who did not

have the diagnoses being studied. GSK gave her more than $5,000

for each child she enrolled.

At trial, Palazzo

was convicted on 39 counts of healthcare fraud and was sentenced

to 87 months in prison and forfeiture of $655,000. The

clinical trial fraud charges were thrown out, but prosecutors

appealed and won a

ruling this year reinstating those charges. That appears to

be the reason Palazzo is reappearing in court to make a plea.

The use of Paxil in children became extremely controversial after

it emerged that GSK

knew for 15 years, but didn’t tell anyone until 2006, that

the drug may carry a risk for suicide. The drug now carries a black-box

warning for suicide risk in children.

The business lesson here is that bad decisions often have lengthy

lives as well as unintended consequences: the Palazzo episode

started in 2000, when GSK first approached Palazzo to do the

studies. Ten years later, that lousy choice is still on GSK’s

agenda as the FDA

decides whether its maneuvering on Avandia data is worthy of

referral to criminal prosecutors.

Related:

The

FDA Strikes Back: Criminal Probe of Glaxo Seeks to Chill Data

Manipulation

Glaxo

Is Testing Paxil on 7-Year-Olds Despite Well Known Suicide

Risks

Glaxo,

Paxil and the Catholic Sex Abuse Cover-Up: Drug Implicated in

Priest’s Suicide

Jagged

Little Pill: When Drug Companies “Forget” to Mention Suicide

Risks

“CASSPER”

Was GSK’s Friendly Ghostwriting Program on Paxil

[Guest guest]

http://www.bnet.com/blog/drug-business/10-years-later-glaxo-still-haunted-by-faked-studies-of-paxil-in-kids/5545

10 Years Later, Glaxo Still Haunted by Faked

Studies of Paxil in Kids

By Jim

| August 19, 2010

A crooked doctor who faked data in a GlaxoKline

(GSK) study of the antidepressant Paxil

in children is

expected to plead guilty to criminal charges today, causing

groans among GSK’s senior management as the company hopes to fend

off a different criminal investigation into whether it manipulated

clinical data on its diabetes drug, Avandia.

The two cases are technically completely separate, but they’re

both about data manipulation. GSK has been accused of sitting on

data showing risks on both drugs; and the

FDA previously shut down one of GSK’s factories where both drugs

were made.

Thus, the expected guilty plea of Dr. Carmen

Palazzo today is a reminder to managers everywhere that

cutting ethical corners can cause unwanted chickens to return to

their roosts, even years later.

Palazzo

was indicted in 2007 on 40 counts of defrauding Medicare and

Medicaid at her New Orleans clinic, and 15 counts of conducting

fraudulent clinical trials. The charges followed an FDA

accusation that she had enrolled 26 children in studies of

Paxil for obsessive-compulsive disorder and major depressive

disorder. She included children in the trial — which was given the

cutesey nickname “Kiddie-Sads-Present and Lifetime” — who did not

have the diagnoses being studied. GSK gave her more than $5,000

for each child she enrolled.

At trial, Palazzo

was convicted on 39 counts of healthcare fraud and was sentenced

to 87 months in prison and forfeiture of $655,000. The

clinical trial fraud charges were thrown out, but prosecutors

appealed and won a

ruling this year reinstating those charges. That appears to

be the reason Palazzo is reappearing in court to make a plea.

The use of Paxil in children became extremely controversial after

it emerged that GSK

knew for 15 years, but didn’t tell anyone until 2006, that

the drug may carry a risk for suicide. The drug now carries a black-box

warning for suicide risk in children.

The business lesson here is that bad decisions often have lengthy

lives as well as unintended consequences: the Palazzo episode

started in 2000, when GSK first approached Palazzo to do the

studies. Ten years later, that lousy choice is still on GSK’s

agenda as the FDA

decides whether its maneuvering on Avandia data is worthy of

referral to criminal prosecutors.

Related:

The

FDA Strikes Back: Criminal Probe of Glaxo Seeks to Chill Data

Manipulation

Glaxo

Is Testing Paxil on 7-Year-Olds Despite Well Known Suicide

Risks

Glaxo,

Paxil and the Catholic Sex Abuse Cover-Up: Drug Implicated in

Priest’s Suicide

Jagged

Little Pill: When Drug Companies “Forget” to Mention Suicide

Risks

“CASSPER”

Was GSK’s Friendly Ghostwriting Program on Paxil

[Guest guest]

http://www.bnet.com/blog/drug-business/10-years-later-glaxo-still-haunted-by-faked-studies-of-paxil-in-kids/5545

10 Years Later, Glaxo Still Haunted by Faked

Studies of Paxil in Kids

By Jim

| August 19, 2010

A crooked doctor who faked data in a GlaxoKline

(GSK) study of the antidepressant Paxil

in children is

expected to plead guilty to criminal charges today, causing

groans among GSK’s senior management as the company hopes to fend

off a different criminal investigation into whether it manipulated

clinical data on its diabetes drug, Avandia.

The two cases are technically completely separate, but they’re

both about data manipulation. GSK has been accused of sitting on

data showing risks on both drugs; and the

FDA previously shut down one of GSK’s factories where both drugs

were made.

Thus, the expected guilty plea of Dr. Carmen

Palazzo today is a reminder to managers everywhere that

cutting ethical corners can cause unwanted chickens to return to

their roosts, even years later.

Palazzo

was indicted in 2007 on 40 counts of defrauding Medicare and

Medicaid at her New Orleans clinic, and 15 counts of conducting

fraudulent clinical trials. The charges followed an FDA

accusation that she had enrolled 26 children in studies of

Paxil for obsessive-compulsive disorder and major depressive

disorder. She included children in the trial — which was given the

cutesey nickname “Kiddie-Sads-Present and Lifetime” — who did not

have the diagnoses being studied. GSK gave her more than $5,000

for each child she enrolled.

At trial, Palazzo

was convicted on 39 counts of healthcare fraud and was sentenced

to 87 months in prison and forfeiture of $655,000. The

clinical trial fraud charges were thrown out, but prosecutors

appealed and won a

ruling this year reinstating those charges. That appears to

be the reason Palazzo is reappearing in court to make a plea.

The use of Paxil in children became extremely controversial after

it emerged that GSK

knew for 15 years, but didn’t tell anyone until 2006, that

the drug may carry a risk for suicide. The drug now carries a black-box

warning for suicide risk in children.

The business lesson here is that bad decisions often have lengthy

lives as well as unintended consequences: the Palazzo episode

started in 2000, when GSK first approached Palazzo to do the

studies. Ten years later, that lousy choice is still on GSK’s

agenda as the FDA

decides whether its maneuvering on Avandia data is worthy of

referral to criminal prosecutors.

Related:

The

FDA Strikes Back: Criminal Probe of Glaxo Seeks to Chill Data

Manipulation

Glaxo

Is Testing Paxil on 7-Year-Olds Despite Well Known Suicide

Risks

Glaxo,

Paxil and the Catholic Sex Abuse Cover-Up: Drug Implicated in

Priest’s Suicide

Jagged

Little Pill: When Drug Companies “Forget” to Mention Suicide

Risks

“CASSPER”

Was GSK’s Friendly Ghostwriting Program on Paxil

[Guest guest]

http://www.bnet.com/blog/drug-business/10-years-later-glaxo-still-haunted-by-faked-studies-of-paxil-in-kids/5545

10 Years Later, Glaxo Still Haunted by Faked

Studies of Paxil in Kids

By Jim

| August 19, 2010

A crooked doctor who faked data in a GlaxoKline

(GSK) study of the antidepressant Paxil

in children is

expected to plead guilty to criminal charges today, causing

groans among GSK’s senior management as the company hopes to fend

off a different criminal investigation into whether it manipulated

clinical data on its diabetes drug, Avandia.

The two cases are technically completely separate, but they’re

both about data manipulation. GSK has been accused of sitting on

data showing risks on both drugs; and the

FDA previously shut down one of GSK’s factories where both drugs

were made.

Thus, the expected guilty plea of Dr. Carmen

Palazzo today is a reminder to managers everywhere that

cutting ethical corners can cause unwanted chickens to return to

their roosts, even years later.

Palazzo

was indicted in 2007 on 40 counts of defrauding Medicare and

Medicaid at her New Orleans clinic, and 15 counts of conducting

fraudulent clinical trials. The charges followed an FDA

accusation that she had enrolled 26 children in studies of

Paxil for obsessive-compulsive disorder and major depressive

disorder. She included children in the trial — which was given the

cutesey nickname “Kiddie-Sads-Present and Lifetime” — who did not

have the diagnoses being studied. GSK gave her more than $5,000

for each child she enrolled.

At trial, Palazzo

was convicted on 39 counts of healthcare fraud and was sentenced

to 87 months in prison and forfeiture of $655,000. The

clinical trial fraud charges were thrown out, but prosecutors

appealed and won a

ruling this year reinstating those charges. That appears to

be the reason Palazzo is reappearing in court to make a plea.

The use of Paxil in children became extremely controversial after

it emerged that GSK

knew for 15 years, but didn’t tell anyone until 2006, that

the drug may carry a risk for suicide. The drug now carries a black-box

warning for suicide risk in children.

The business lesson here is that bad decisions often have lengthy

lives as well as unintended consequences: the Palazzo episode

started in 2000, when GSK first approached Palazzo to do the

studies. Ten years later, that lousy choice is still on GSK’s

agenda as the FDA

decides whether its maneuvering on Avandia data is worthy of

referral to criminal prosecutors.

Related:

The

FDA Strikes Back: Criminal Probe of Glaxo Seeks to Chill Data

Manipulation

Glaxo

Is Testing Paxil on 7-Year-Olds Despite Well Known Suicide

Risks

Glaxo,

Paxil and the Catholic Sex Abuse Cover-Up: Drug Implicated in

Priest’s Suicide

Jagged

Little Pill: When Drug Companies “Forget” to Mention Suicide

Risks

“CASSPER”

Was GSK’s Friendly Ghostwriting Program on Paxil