Big Pharma’s Next Big Thing: Antipsychotic Medicines for Preschoolers | BNET

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Big Pharma’s Next Big Thing: Antipsychotic Medicines for Preschoolers

By Jim  | September 1, 2010

Dr. Joan Luby, the preschool depression researcher at the center of a New

York Times article that failed to mention her past research was funded by

& (JNJ), Shire (SHPGY) and AstraZeneca (AZN), is currently

testing the antipsychotic Risperdal on autistic children aged 30 months to 5

years old, according to the ClinicalTrials.gov database. Although the study is

not funded by Janssen, the unit of J & J that makes Risperdal, it nonetheless

typifies a new field of drug research: The use of mood-altering pharmaceuticals

on the very, very young.

The NYT piece investigated the development of preschool depression as a

diagnosis. Slate, like me, found it surprising that the author did not believe

Big Pharma’s interest in the field was relevant. Minyanville thought the same

thing. Such research is controversial. In November 2008, the FDA said

antipsychotic drugs were over-used in children and that more should be done to

discourage doctors from treating unruly kids with powerful drugs.

Luby — who also believes that certain antidepressants may be effective in

children, according to this press release — is just one researcher looking at

extending the use of antipsychotics to very young kids. Here’s a study on

Lithium vs. Risperdal in kids aged 7 and up. And here’s a similar trial on

kids aged 6 and up. GlaxoKline (GSK) is currently testing Paxil on

7-year-olds despite that medicine’s well-document propensity to trigger

suicides in young patients.

The reason the FDA has warned against use of these drugs in kids is twofold:

First, many of these products are not approved for use in children. Risperdal

— the product in the Luby study of 30-month olds — is only approved for use

in autistic children older than 5; and for schizophrenics older than 13. Eli

Lilly (LLY)’s competing antipsychotic Zyprexa is not indicated for anyone

below the age of 13.

Second, drug companies generally do all their tests on the more robust bodies of

adults. Relying on those results to use drugs in children is therefore a bit of

a crapshoot. Here’s an anecdotal history:

Risperdal can cause boys to grow breasts, the FDA heard in 2008.

The FDA put a “black box†warning on GSK’s Paxil because the drug triggers

suicides in children. One of GSK’s researchers is a convicted criminal who

faked her results.

Likewise, Pfizer (PFE) was cited by the FDA for giving kids overdoses of Geodon

in its pediatric drug trials

And AstraZeneca just paid nearly $200 million to settle 17,500 lawsuits claiming

Seroquel (another antipsychotic) is linked to diabetes.

Luby did not immediately return two messages requesting comment. In her defense,

it’s worth knowing that she’s also studying non-drug intervention —

therapy, basically — for young children with depression.

Sent via BlackBerry by AT & T

[Guest guest]

http://m.bnet.com/blog/drug-business/big-pharma-8217s-next-big-thing-antipsychot\

ic-medicines-for-preschoolers/5624

Big Pharma’s Next Big Thing: Antipsychotic Medicines for Preschoolers

By Jim  | September 1, 2010

Dr. Joan Luby, the preschool depression researcher at the center of a New

York Times article that failed to mention her past research was funded by

& (JNJ), Shire (SHPGY) and AstraZeneca (AZN), is currently

testing the antipsychotic Risperdal on autistic children aged 30 months to 5

years old, according to the ClinicalTrials.gov database. Although the study is

not funded by Janssen, the unit of J & J that makes Risperdal, it nonetheless

typifies a new field of drug research: The use of mood-altering pharmaceuticals

on the very, very young.

The NYT piece investigated the development of preschool depression as a

diagnosis. Slate, like me, found it surprising that the author did not believe

Big Pharma’s interest in the field was relevant. Minyanville thought the same

thing. Such research is controversial. In November 2008, the FDA said

antipsychotic drugs were over-used in children and that more should be done to

discourage doctors from treating unruly kids with powerful drugs.

Luby — who also believes that certain antidepressants may be effective in

children, according to this press release — is just one researcher looking at

extending the use of antipsychotics to very young kids. Here’s a study on

Lithium vs. Risperdal in kids aged 7 and up. And here’s a similar trial on

kids aged 6 and up. GlaxoKline (GSK) is currently testing Paxil on

7-year-olds despite that medicine’s well-document propensity to trigger

suicides in young patients.

The reason the FDA has warned against use of these drugs in kids is twofold:

First, many of these products are not approved for use in children. Risperdal

— the product in the Luby study of 30-month olds — is only approved for use

in autistic children older than 5; and for schizophrenics older than 13. Eli

Lilly (LLY)’s competing antipsychotic Zyprexa is not indicated for anyone

below the age of 13.

Second, drug companies generally do all their tests on the more robust bodies of

adults. Relying on those results to use drugs in children is therefore a bit of

a crapshoot. Here’s an anecdotal history:

Risperdal can cause boys to grow breasts, the FDA heard in 2008.

The FDA put a “black box†warning on GSK’s Paxil because the drug triggers

suicides in children. One of GSK’s researchers is a convicted criminal who

faked her results.

Likewise, Pfizer (PFE) was cited by the FDA for giving kids overdoses of Geodon

in its pediatric drug trials

And AstraZeneca just paid nearly $200 million to settle 17,500 lawsuits claiming

Seroquel (another antipsychotic) is linked to diabetes.

Luby did not immediately return two messages requesting comment. In her defense,

it’s worth knowing that she’s also studying non-drug intervention —

therapy, basically — for young children with depression.

Sent via BlackBerry by AT & T

[Guest guest]

http://m.bnet.com/blog/drug-business/big-pharma-8217s-next-big-thing-antipsychot\

ic-medicines-for-preschoolers/5624

Big Pharma’s Next Big Thing: Antipsychotic Medicines for Preschoolers

By Jim  | September 1, 2010

Dr. Joan Luby, the preschool depression researcher at the center of a New

York Times article that failed to mention her past research was funded by

& (JNJ), Shire (SHPGY) and AstraZeneca (AZN), is currently

testing the antipsychotic Risperdal on autistic children aged 30 months to 5

years old, according to the ClinicalTrials.gov database. Although the study is

not funded by Janssen, the unit of J & J that makes Risperdal, it nonetheless

typifies a new field of drug research: The use of mood-altering pharmaceuticals

on the very, very young.

The NYT piece investigated the development of preschool depression as a

diagnosis. Slate, like me, found it surprising that the author did not believe

Big Pharma’s interest in the field was relevant. Minyanville thought the same

thing. Such research is controversial. In November 2008, the FDA said

antipsychotic drugs were over-used in children and that more should be done to

discourage doctors from treating unruly kids with powerful drugs.

Luby — who also believes that certain antidepressants may be effective in

children, according to this press release — is just one researcher looking at

extending the use of antipsychotics to very young kids. Here’s a study on

Lithium vs. Risperdal in kids aged 7 and up. And here’s a similar trial on

kids aged 6 and up. GlaxoKline (GSK) is currently testing Paxil on

7-year-olds despite that medicine’s well-document propensity to trigger

suicides in young patients.

The reason the FDA has warned against use of these drugs in kids is twofold:

First, many of these products are not approved for use in children. Risperdal

— the product in the Luby study of 30-month olds — is only approved for use

in autistic children older than 5; and for schizophrenics older than 13. Eli

Lilly (LLY)’s competing antipsychotic Zyprexa is not indicated for anyone

below the age of 13.

Second, drug companies generally do all their tests on the more robust bodies of

adults. Relying on those results to use drugs in children is therefore a bit of

a crapshoot. Here’s an anecdotal history:

Risperdal can cause boys to grow breasts, the FDA heard in 2008.

The FDA put a “black box†warning on GSK’s Paxil because the drug triggers

suicides in children. One of GSK’s researchers is a convicted criminal who

faked her results.

Likewise, Pfizer (PFE) was cited by the FDA for giving kids overdoses of Geodon

in its pediatric drug trials

And AstraZeneca just paid nearly $200 million to settle 17,500 lawsuits claiming

Seroquel (another antipsychotic) is linked to diabetes.

Luby did not immediately return two messages requesting comment. In her defense,

it’s worth knowing that she’s also studying non-drug intervention —

therapy, basically — for young children with depression.

Sent via BlackBerry by AT & T

[Guest guest]

http://m.bnet.com/blog/drug-business/big-pharma-8217s-next-big-thing-antipsychot\

ic-medicines-for-preschoolers/5624

Big Pharma’s Next Big Thing: Antipsychotic Medicines for Preschoolers

By Jim  | September 1, 2010

Dr. Joan Luby, the preschool depression researcher at the center of a New

York Times article that failed to mention her past research was funded by

& (JNJ), Shire (SHPGY) and AstraZeneca (AZN), is currently

testing the antipsychotic Risperdal on autistic children aged 30 months to 5

years old, according to the ClinicalTrials.gov database. Although the study is

not funded by Janssen, the unit of J & J that makes Risperdal, it nonetheless

typifies a new field of drug research: The use of mood-altering pharmaceuticals

on the very, very young.

The NYT piece investigated the development of preschool depression as a

diagnosis. Slate, like me, found it surprising that the author did not believe

Big Pharma’s interest in the field was relevant. Minyanville thought the same

thing. Such research is controversial. In November 2008, the FDA said

antipsychotic drugs were over-used in children and that more should be done to

discourage doctors from treating unruly kids with powerful drugs.

Luby — who also believes that certain antidepressants may be effective in

children, according to this press release — is just one researcher looking at

extending the use of antipsychotics to very young kids. Here’s a study on

Lithium vs. Risperdal in kids aged 7 and up. And here’s a similar trial on

kids aged 6 and up. GlaxoKline (GSK) is currently testing Paxil on

7-year-olds despite that medicine’s well-document propensity to trigger

suicides in young patients.

The reason the FDA has warned against use of these drugs in kids is twofold:

First, many of these products are not approved for use in children. Risperdal

— the product in the Luby study of 30-month olds — is only approved for use

in autistic children older than 5; and for schizophrenics older than 13. Eli

Lilly (LLY)’s competing antipsychotic Zyprexa is not indicated for anyone

below the age of 13.

Second, drug companies generally do all their tests on the more robust bodies of

adults. Relying on those results to use drugs in children is therefore a bit of

a crapshoot. Here’s an anecdotal history:

Risperdal can cause boys to grow breasts, the FDA heard in 2008.

The FDA put a “black box†warning on GSK’s Paxil because the drug triggers

suicides in children. One of GSK’s researchers is a convicted criminal who

faked her results.

Likewise, Pfizer (PFE) was cited by the FDA for giving kids overdoses of Geodon

in its pediatric drug trials

And AstraZeneca just paid nearly $200 million to settle 17,500 lawsuits claiming

Seroquel (another antipsychotic) is linked to diabetes.

Luby did not immediately return two messages requesting comment. In her defense,

it’s worth knowing that she’s also studying non-drug intervention —

therapy, basically — for young children with depression.

Sent via BlackBerry by AT & T