Vote! Leave the Black Box warnings alone!

[Guest guest]

http://www.pharmalot.com covers the pharmaceutical industry and is a

fairly new service of the The Star-Ledger of New Jersey.

Vote " Leave the Black Box warnings alone! " here:

http://www.pharmalot.com/2007/07/fda-wont-rule-out-repealing-black-box-w

arning-on-antidepressants

FDA Won't 'Rule Out' Repealing Black Box Warning On Antidepressants

July 7th, 2007

By Ed Silverman

That's what Tom Laughren, the FDA official who oversees psychiatric

drugs, says may happen if CDC data on suicides in 2005, which will be

released at year's end, is compelling.

The potential flip-flop comes amid growing noise by some psychiatrists

that the agency's Black Box warnings in 2004 that antidepressants are

somehow linked to suicide in youngsters may be scaring some docs,

parents and teenagers.

As evidence, some psychiatrists cite a recent study in The Journal of

American Psychiatry, which found the number of scrips for pediatric

depression, ages 5 to 18, fell more than 50 percent between 2003 and

2005. At the same time, the number of teen suicides jumped a record 18

percent between 2003 and 2004, the most recent year for which data

exist.

" If I had known how much the label would rattle parents, I wouldn't have

voted for it, " Gail Griffith, who was the patient representative on the

FDA panel that recommended the warnings, tells Newsweek.

For his part, Laughren notes that the study reflected " only one year of

data, " but updated CDC may be revealing. " If the rates are up again,

it's likely we'll go back to the board of advisers, " he tells the weekly

mag, which notes the FDA has repealed only one Black Box warning in its

history, on the acid-reflux medication Prilosec, which was withdrawn in

2003. " But I wouldn't rule it out, " he adds. " The evidence is very

compelling. "

For the " rest of the story " , see here: http://tinyurl.com/3yehvo

And here: www.psychsearch.net/child_suicides.pdf

About Pharmalot

Ed Silverman is a prize-winning journalist who has covered the

pharmaceutical industry for The Star-Ledger of New Jersey, one of the

nation's largest daily newspapers, for the past 12 years. During that

time, he has closely followed a variety of topics of concern to those

who work for, and with, pharmaceutical manufacturers - drug development;

mergers and acquisitions; regulatory oversight; safety and pricing

controversies, and marketing issues.

Prior to joining The Star-Ledger, Silverman spent six years at New York

Newsday and previously worked at Investor's Business Daily, among other

newspapers. He has a master's degree in journalism from New York

University and a bachelor's degree in accounting from Binghamton

University. Although tethered to his laptop, Silverman lives in suburban

New Jersey with his wife, three children and one sizeable labrador

retriever.

[Guest guest]

http://www.pharmalot.com covers the pharmaceutical industry and is a

fairly new service of the The Star-Ledger of New Jersey.

Vote " Leave the Black Box warnings alone! " here:

http://www.pharmalot.com/2007/07/fda-wont-rule-out-repealing-black-box-w

arning-on-antidepressants

FDA Won't 'Rule Out' Repealing Black Box Warning On Antidepressants

July 7th, 2007

By Ed Silverman

That's what Tom Laughren, the FDA official who oversees psychiatric

drugs, says may happen if CDC data on suicides in 2005, which will be

released at year's end, is compelling.

The potential flip-flop comes amid growing noise by some psychiatrists

that the agency's Black Box warnings in 2004 that antidepressants are

somehow linked to suicide in youngsters may be scaring some docs,

parents and teenagers.

As evidence, some psychiatrists cite a recent study in The Journal of

American Psychiatry, which found the number of scrips for pediatric

depression, ages 5 to 18, fell more than 50 percent between 2003 and

2005. At the same time, the number of teen suicides jumped a record 18

percent between 2003 and 2004, the most recent year for which data

exist.

" If I had known how much the label would rattle parents, I wouldn't have

voted for it, " Gail Griffith, who was the patient representative on the

FDA panel that recommended the warnings, tells Newsweek.

For his part, Laughren notes that the study reflected " only one year of

data, " but updated CDC may be revealing. " If the rates are up again,

it's likely we'll go back to the board of advisers, " he tells the weekly

mag, which notes the FDA has repealed only one Black Box warning in its

history, on the acid-reflux medication Prilosec, which was withdrawn in

2003. " But I wouldn't rule it out, " he adds. " The evidence is very

compelling. "

For the " rest of the story " , see here: http://tinyurl.com/3yehvo

And here: www.psychsearch.net/child_suicides.pdf

About Pharmalot

Ed Silverman is a prize-winning journalist who has covered the

pharmaceutical industry for The Star-Ledger of New Jersey, one of the

nation's largest daily newspapers, for the past 12 years. During that

time, he has closely followed a variety of topics of concern to those

who work for, and with, pharmaceutical manufacturers - drug development;

mergers and acquisitions; regulatory oversight; safety and pricing

controversies, and marketing issues.

Prior to joining The Star-Ledger, Silverman spent six years at New York

Newsday and previously worked at Investor's Business Daily, among other

newspapers. He has a master's degree in journalism from New York

University and a bachelor's degree in accounting from Binghamton

University. Although tethered to his laptop, Silverman lives in suburban

New Jersey with his wife, three children and one sizeable labrador

retriever.

[Guest guest]

http://www.pharmalot.com covers the pharmaceutical industry and is a

fairly new service of the The Star-Ledger of New Jersey.

Vote " Leave the Black Box warnings alone! " here:

http://www.pharmalot.com/2007/07/fda-wont-rule-out-repealing-black-box-w

arning-on-antidepressants

FDA Won't 'Rule Out' Repealing Black Box Warning On Antidepressants

July 7th, 2007

By Ed Silverman

That's what Tom Laughren, the FDA official who oversees psychiatric

drugs, says may happen if CDC data on suicides in 2005, which will be

released at year's end, is compelling.

The potential flip-flop comes amid growing noise by some psychiatrists

that the agency's Black Box warnings in 2004 that antidepressants are

somehow linked to suicide in youngsters may be scaring some docs,

parents and teenagers.

As evidence, some psychiatrists cite a recent study in The Journal of

American Psychiatry, which found the number of scrips for pediatric

depression, ages 5 to 18, fell more than 50 percent between 2003 and

2005. At the same time, the number of teen suicides jumped a record 18

percent between 2003 and 2004, the most recent year for which data

exist.

" If I had known how much the label would rattle parents, I wouldn't have

voted for it, " Gail Griffith, who was the patient representative on the

FDA panel that recommended the warnings, tells Newsweek.

For his part, Laughren notes that the study reflected " only one year of

data, " but updated CDC may be revealing. " If the rates are up again,

it's likely we'll go back to the board of advisers, " he tells the weekly

mag, which notes the FDA has repealed only one Black Box warning in its

history, on the acid-reflux medication Prilosec, which was withdrawn in

2003. " But I wouldn't rule it out, " he adds. " The evidence is very

compelling. "

For the " rest of the story " , see here: http://tinyurl.com/3yehvo

And here: www.psychsearch.net/child_suicides.pdf

About Pharmalot

Ed Silverman is a prize-winning journalist who has covered the

pharmaceutical industry for The Star-Ledger of New Jersey, one of the

nation's largest daily newspapers, for the past 12 years. During that

time, he has closely followed a variety of topics of concern to those

who work for, and with, pharmaceutical manufacturers - drug development;

mergers and acquisitions; regulatory oversight; safety and pricing

controversies, and marketing issues.

Prior to joining The Star-Ledger, Silverman spent six years at New York

Newsday and previously worked at Investor's Business Daily, among other

newspapers. He has a master's degree in journalism from New York

University and a bachelor's degree in accounting from Binghamton

University. Although tethered to his laptop, Silverman lives in suburban

New Jersey with his wife, three children and one sizeable labrador

retriever.

[Guest guest]

http://www.pharmalot.com covers the pharmaceutical industry and is a

fairly new service of the The Star-Ledger of New Jersey.

Vote " Leave the Black Box warnings alone! " here:

http://www.pharmalot.com/2007/07/fda-wont-rule-out-repealing-black-box-w

arning-on-antidepressants

FDA Won't 'Rule Out' Repealing Black Box Warning On Antidepressants

July 7th, 2007

By Ed Silverman

That's what Tom Laughren, the FDA official who oversees psychiatric

drugs, says may happen if CDC data on suicides in 2005, which will be

released at year's end, is compelling.

The potential flip-flop comes amid growing noise by some psychiatrists

that the agency's Black Box warnings in 2004 that antidepressants are

somehow linked to suicide in youngsters may be scaring some docs,

parents and teenagers.

As evidence, some psychiatrists cite a recent study in The Journal of

American Psychiatry, which found the number of scrips for pediatric

depression, ages 5 to 18, fell more than 50 percent between 2003 and

2005. At the same time, the number of teen suicides jumped a record 18

percent between 2003 and 2004, the most recent year for which data

exist.

" If I had known how much the label would rattle parents, I wouldn't have

voted for it, " Gail Griffith, who was the patient representative on the

FDA panel that recommended the warnings, tells Newsweek.

For his part, Laughren notes that the study reflected " only one year of

data, " but updated CDC may be revealing. " If the rates are up again,

it's likely we'll go back to the board of advisers, " he tells the weekly

mag, which notes the FDA has repealed only one Black Box warning in its

history, on the acid-reflux medication Prilosec, which was withdrawn in

2003. " But I wouldn't rule it out, " he adds. " The evidence is very

compelling. "

For the " rest of the story " , see here: http://tinyurl.com/3yehvo

And here: www.psychsearch.net/child_suicides.pdf

About Pharmalot

Ed Silverman is a prize-winning journalist who has covered the

pharmaceutical industry for The Star-Ledger of New Jersey, one of the

nation's largest daily newspapers, for the past 12 years. During that

time, he has closely followed a variety of topics of concern to those

who work for, and with, pharmaceutical manufacturers - drug development;

mergers and acquisitions; regulatory oversight; safety and pricing

controversies, and marketing issues.

Prior to joining The Star-Ledger, Silverman spent six years at New York

Newsday and previously worked at Investor's Business Daily, among other

newspapers. He has a master's degree in journalism from New York

University and a bachelor's degree in accounting from Binghamton

University. Although tethered to his laptop, Silverman lives in suburban

New Jersey with his wife, three children and one sizeable labrador

retriever.

[Guest guest]

Thanks for the tiny url. We all voted and fwd-ed. Terry

- Vote! Leave the Black Box warnings alone!

http://www.pharmalot.com covers the pharmaceutical industry and is a

fairly new service of the The Star-Ledger of New Jersey.

Vote " Leave the Black Box warnings alone! " here:

http://tinyurl.com/3c9pzn

FDA Won't 'Rule Out' Repealing Black Box Warning On Antidepressants

July 7th, 2007

By Ed Silverman

That's what Tom Laughren, the FDA official who oversees psychiatric

drugs, says may happen if CDC data on suicides in 2005, which will be

released at year's end, is compelling. The potential flip-flop comes

amid growing noise by some psychiatrists that the agency's Black Box

warnings in 2004 that antidepressants are somehow linked to suicide in

youngsters may be scaring some docs, parents and teenagers.

As evidence, some psychiatrists cite a recent study in The Journal of

American Psychiatry, which found the number of scrips for pediatric

depression, ages 5 to 18, fell more than 50 percent between 2003 and

2005. At the same time, the number of teen suicides jumped a record 18

percent between 2003 and 2004, the most recent year for which data

exist.

" If I had known how much the label would rattle parents, I wouldn't have

voted for it, " Gail Griffith, who was the patient representative on the

FDA panel that recommended the warnings, tells Newsweek.

For his part, Laughren notes that the study reflected " only one year of

data, " but updated CDC may be revealing. " If the rates are up again,

it's likely we'll go back to the board of advisers, " he tells the weekly

mag, which notes the FDA has repealed only one Black Box warning in its

history, on the acid-reflux medication Prilosec, which was withdrawn in

2003.

" But I wouldn't rule it out, " he adds. " The evidence is very

compelling. "

For the " rest of the story " , see here: http://tinyurl.com/3yehvo

And here: www.psychsearch.net/child_suicides.pdf

About Pharmalot

Ed Silverman is a prize-winning journalist who has covered the

pharmaceutical industry for The Star-Ledger of New Jersey, one of the

nation's largest daily newspapers, for the past 12 years. During that

time, he has closely followed a variety of topics of concern to those

who work for, and with, pharmaceutical manufacturers - drug development;

mergers and acquisitions; regulatory oversight; safety and pricing

controversies, and marketing issues.

Prior to joining The Star-Ledger, Silverman spent six years at New York

Newsday and previously worked at Investor's Business Daily, among other

newspapers. He has a master's degree in journalism from New York

University and a bachelor's degree in accounting from Binghamton

University. Although tethered to his laptop, Silverman lives in suburban

New Jersey with his wife, three children and one sizeable labrador

retriever.

[Guest guest]

Thanks for the tiny url. We all voted and fwd-ed. Terry

- Vote! Leave the Black Box warnings alone!

http://www.pharmalot.com covers the pharmaceutical industry and is a

fairly new service of the The Star-Ledger of New Jersey.

Vote " Leave the Black Box warnings alone! " here:

http://tinyurl.com/3c9pzn

FDA Won't 'Rule Out' Repealing Black Box Warning On Antidepressants

July 7th, 2007

By Ed Silverman

That's what Tom Laughren, the FDA official who oversees psychiatric

drugs, says may happen if CDC data on suicides in 2005, which will be

released at year's end, is compelling. The potential flip-flop comes

amid growing noise by some psychiatrists that the agency's Black Box

warnings in 2004 that antidepressants are somehow linked to suicide in

youngsters may be scaring some docs, parents and teenagers.

As evidence, some psychiatrists cite a recent study in The Journal of

American Psychiatry, which found the number of scrips for pediatric

depression, ages 5 to 18, fell more than 50 percent between 2003 and

2005. At the same time, the number of teen suicides jumped a record 18

percent between 2003 and 2004, the most recent year for which data

exist.

" If I had known how much the label would rattle parents, I wouldn't have

voted for it, " Gail Griffith, who was the patient representative on the

FDA panel that recommended the warnings, tells Newsweek.

For his part, Laughren notes that the study reflected " only one year of

data, " but updated CDC may be revealing. " If the rates are up again,

it's likely we'll go back to the board of advisers, " he tells the weekly

mag, which notes the FDA has repealed only one Black Box warning in its

history, on the acid-reflux medication Prilosec, which was withdrawn in

2003.

" But I wouldn't rule it out, " he adds. " The evidence is very

compelling. "

For the " rest of the story " , see here: http://tinyurl.com/3yehvo

And here: www.psychsearch.net/child_suicides.pdf

About Pharmalot

Ed Silverman is a prize-winning journalist who has covered the

pharmaceutical industry for The Star-Ledger of New Jersey, one of the

nation's largest daily newspapers, for the past 12 years. During that

time, he has closely followed a variety of topics of concern to those

who work for, and with, pharmaceutical manufacturers - drug development;

mergers and acquisitions; regulatory oversight; safety and pricing

controversies, and marketing issues.

Prior to joining The Star-Ledger, Silverman spent six years at New York

Newsday and previously worked at Investor's Business Daily, among other

newspapers. He has a master's degree in journalism from New York

University and a bachelor's degree in accounting from Binghamton

University. Although tethered to his laptop, Silverman lives in suburban

New Jersey with his wife, three children and one sizeable labrador

retriever.

[Guest guest]

Thanks for the tiny url. We all voted and fwd-ed. Terry

- Vote! Leave the Black Box warnings alone!

http://www.pharmalot.com covers the pharmaceutical industry and is a

fairly new service of the The Star-Ledger of New Jersey.

Vote " Leave the Black Box warnings alone! " here:

http://tinyurl.com/3c9pzn

FDA Won't 'Rule Out' Repealing Black Box Warning On Antidepressants

July 7th, 2007

By Ed Silverman

That's what Tom Laughren, the FDA official who oversees psychiatric

drugs, says may happen if CDC data on suicides in 2005, which will be

released at year's end, is compelling. The potential flip-flop comes

amid growing noise by some psychiatrists that the agency's Black Box

warnings in 2004 that antidepressants are somehow linked to suicide in

youngsters may be scaring some docs, parents and teenagers.

As evidence, some psychiatrists cite a recent study in The Journal of

American Psychiatry, which found the number of scrips for pediatric

depression, ages 5 to 18, fell more than 50 percent between 2003 and

2005. At the same time, the number of teen suicides jumped a record 18

percent between 2003 and 2004, the most recent year for which data

exist.

" If I had known how much the label would rattle parents, I wouldn't have

voted for it, " Gail Griffith, who was the patient representative on the

FDA panel that recommended the warnings, tells Newsweek.

For his part, Laughren notes that the study reflected " only one year of

data, " but updated CDC may be revealing. " If the rates are up again,

it's likely we'll go back to the board of advisers, " he tells the weekly

mag, which notes the FDA has repealed only one Black Box warning in its

history, on the acid-reflux medication Prilosec, which was withdrawn in

2003.

" But I wouldn't rule it out, " he adds. " The evidence is very

compelling. "

For the " rest of the story " , see here: http://tinyurl.com/3yehvo

And here: www.psychsearch.net/child_suicides.pdf

About Pharmalot

Ed Silverman is a prize-winning journalist who has covered the

pharmaceutical industry for The Star-Ledger of New Jersey, one of the

nation's largest daily newspapers, for the past 12 years. During that

time, he has closely followed a variety of topics of concern to those

who work for, and with, pharmaceutical manufacturers - drug development;

mergers and acquisitions; regulatory oversight; safety and pricing

controversies, and marketing issues.

Prior to joining The Star-Ledger, Silverman spent six years at New York

Newsday and previously worked at Investor's Business Daily, among other

newspapers. He has a master's degree in journalism from New York

University and a bachelor's degree in accounting from Binghamton

University. Although tethered to his laptop, Silverman lives in suburban

New Jersey with his wife, three children and one sizeable labrador

retriever.

[Guest guest]

Thanks for the tiny url. We all voted and fwd-ed. Terry

- Vote! Leave the Black Box warnings alone!

http://www.pharmalot.com covers the pharmaceutical industry and is a

fairly new service of the The Star-Ledger of New Jersey.

Vote " Leave the Black Box warnings alone! " here:

http://tinyurl.com/3c9pzn

FDA Won't 'Rule Out' Repealing Black Box Warning On Antidepressants

July 7th, 2007

By Ed Silverman

That's what Tom Laughren, the FDA official who oversees psychiatric

drugs, says may happen if CDC data on suicides in 2005, which will be

released at year's end, is compelling. The potential flip-flop comes

amid growing noise by some psychiatrists that the agency's Black Box

warnings in 2004 that antidepressants are somehow linked to suicide in

youngsters may be scaring some docs, parents and teenagers.

As evidence, some psychiatrists cite a recent study in The Journal of

American Psychiatry, which found the number of scrips for pediatric

depression, ages 5 to 18, fell more than 50 percent between 2003 and

2005. At the same time, the number of teen suicides jumped a record 18

percent between 2003 and 2004, the most recent year for which data

exist.

" If I had known how much the label would rattle parents, I wouldn't have

voted for it, " Gail Griffith, who was the patient representative on the

FDA panel that recommended the warnings, tells Newsweek.

For his part, Laughren notes that the study reflected " only one year of

data, " but updated CDC may be revealing. " If the rates are up again,

it's likely we'll go back to the board of advisers, " he tells the weekly

mag, which notes the FDA has repealed only one Black Box warning in its

history, on the acid-reflux medication Prilosec, which was withdrawn in

2003.

" But I wouldn't rule it out, " he adds. " The evidence is very

compelling. "

For the " rest of the story " , see here: http://tinyurl.com/3yehvo

And here: www.psychsearch.net/child_suicides.pdf

About Pharmalot

Ed Silverman is a prize-winning journalist who has covered the

pharmaceutical industry for The Star-Ledger of New Jersey, one of the

nation's largest daily newspapers, for the past 12 years. During that

time, he has closely followed a variety of topics of concern to those

who work for, and with, pharmaceutical manufacturers - drug development;

mergers and acquisitions; regulatory oversight; safety and pricing

controversies, and marketing issues.

Prior to joining The Star-Ledger, Silverman spent six years at New York

Newsday and previously worked at Investor's Business Daily, among other

newspapers. He has a master's degree in journalism from New York

University and a bachelor's degree in accounting from Binghamton

University. Although tethered to his laptop, Silverman lives in suburban

New Jersey with his wife, three children and one sizeable labrador

retriever.