FDA warns Glaxo about Paxil TV ads

[Guest guest]

Too little too late but it's something. And again, from a business

source, not a medical source. It's amazing how little about ADs is

found in the medical sections compared to the business sections. What

does that tell us???

2nd UPDATE:FDA Asks GlaxoKline To Stop PaxilCR TV Ad

06-11-04 02:09 PM EST

By Mohammed Hadi

Of DOW JONES NEWSWIRES

NEW YORK (Dow )--The U.S. Food and Drug Administration asked

GlaxoKline PLC (GSK) to stop certain advertisements for the

controlled- release version of its anxiety treatment Paxil because

they are too broad and are misleading about safety issues.

The request was made public just over a week after New York Attorney

General Eliot Spitzer filed a lawsuit against Glaxo over the alleged

concealment of data that would challenge the safety and efficacy of

Paxil when given to children.

In a letter to Glaxo posted on the FDA's Web site Thursday, the FDA

said a TV ad for Paxil Controlled-Release is " false or misleading "

because it suggests that the drug can be used by a broader range of

patients than it is actually approved for and implies that the drug is

safer than actually demonstrated.

" The TV ad suggests that anyone experiencing anxiety, fear or self-

consciousness in social or work situations is an appropriate candidate

for Paxil CR, " the agency said.

Instead, Paxil CR, is approved for social anxiety disorder, or SAD,

which is different than the " lesser degrees of performance anxiety or

shyness that do not generally require psychopharmacological treatment,

" the FDA wrote.

The FDA also charged that the advertisement excludes information on

certain side effects, and distract viewers with " compelling and

attention-grabbing visuals " while risk information is presented. The

company was given until June 23 to respond to the FDA in writing.

Last Tuesday, Spitzer filed a lawsuit accusing Glaxo of " repeated and

persistent fraud, " and alleging that Glaxo hid the fact that in some

of its trials involving children Paxil failed to show better efficacy

than a placebo, or a dummy pill, and in some cases was more likely to

cause suicidal thinking.

Glaxo, the suit says, " had done several studies and only one of which

generated the affirmative results they wanted to use in promoting the

drug. " The suit continues: Their " efforts to suppress the other

studies was harmful and improper to the doctors who where making

prescribing decisions and it violated the law. "

In a press release Thursday, Glaxo said it has made data available to

health- care professionals " through publication in peer-reviewed

journals, poster presentations at scientific meetings, and medical

letters to physicians. "

However, the company plans to make summaries of safety and efficacy

data from the clinical studies of Paxil in adolescents and children

available on its Web site.

The company also noted that Paxil has not been approved in Europe or

North America for the treatment of children under the age of 18, and

said it is company policy not to promote off label use of any of its

drugs.

A Glaxo spokeswoman said the advertisement the FDA is asking the

company to stop airing last appeared on May 9 and won't run again.

" That was just our media schedule, and it was unrelated to this (FDA

letter), " said Leone, spokeswoman for Glaxo. " We had no

forewarning of this letter. "

She said the company submits all of its direct-to-consumer ads to the

FDA prior to having them air, and did so in the case of the ad in

question.

" Our point of view is that we acted responsibly because we submitted

the campaign to the FDA for review prior to airing and then we did

modify the proposed commercial in an attempt to address their comments

before it aired, " Leone said. " We incorporated their comments. " She

couldn't say exactly what those comments were.

She said the company disagrees with the FDA letter. However, Glaxo

will work with the FDA to make " appropriate revisions " for future

commercials.

-By Mohammed Hadi, Dow Newswires; 201-938-2007

Dow Newswires

06-11-04 1409ET

Copyright © 2004 Dow & Company, Inc. .

[Guest guest]

Too little too late but it's something. And again, from a business

source, not a medical source. It's amazing how little about ADs is

found in the medical sections compared to the business sections. What

does that tell us???

2nd UPDATE:FDA Asks GlaxoKline To Stop PaxilCR TV Ad

06-11-04 02:09 PM EST

By Mohammed Hadi

Of DOW JONES NEWSWIRES

NEW YORK (Dow )--The U.S. Food and Drug Administration asked

GlaxoKline PLC (GSK) to stop certain advertisements for the

controlled- release version of its anxiety treatment Paxil because

they are too broad and are misleading about safety issues.

The request was made public just over a week after New York Attorney

General Eliot Spitzer filed a lawsuit against Glaxo over the alleged

concealment of data that would challenge the safety and efficacy of

Paxil when given to children.

In a letter to Glaxo posted on the FDA's Web site Thursday, the FDA

said a TV ad for Paxil Controlled-Release is " false or misleading "

because it suggests that the drug can be used by a broader range of

patients than it is actually approved for and implies that the drug is

safer than actually demonstrated.

" The TV ad suggests that anyone experiencing anxiety, fear or self-

consciousness in social or work situations is an appropriate candidate

for Paxil CR, " the agency said.

Instead, Paxil CR, is approved for social anxiety disorder, or SAD,

which is different than the " lesser degrees of performance anxiety or

shyness that do not generally require psychopharmacological treatment,

" the FDA wrote.

The FDA also charged that the advertisement excludes information on

certain side effects, and distract viewers with " compelling and

attention-grabbing visuals " while risk information is presented. The

company was given until June 23 to respond to the FDA in writing.

Last Tuesday, Spitzer filed a lawsuit accusing Glaxo of " repeated and

persistent fraud, " and alleging that Glaxo hid the fact that in some

of its trials involving children Paxil failed to show better efficacy

than a placebo, or a dummy pill, and in some cases was more likely to

cause suicidal thinking.

Glaxo, the suit says, " had done several studies and only one of which

generated the affirmative results they wanted to use in promoting the

drug. " The suit continues: Their " efforts to suppress the other

studies was harmful and improper to the doctors who where making

prescribing decisions and it violated the law. "

In a press release Thursday, Glaxo said it has made data available to

health- care professionals " through publication in peer-reviewed

journals, poster presentations at scientific meetings, and medical

letters to physicians. "

However, the company plans to make summaries of safety and efficacy

data from the clinical studies of Paxil in adolescents and children

available on its Web site.

The company also noted that Paxil has not been approved in Europe or

North America for the treatment of children under the age of 18, and

said it is company policy not to promote off label use of any of its

drugs.

A Glaxo spokeswoman said the advertisement the FDA is asking the

company to stop airing last appeared on May 9 and won't run again.

" That was just our media schedule, and it was unrelated to this (FDA

letter), " said Leone, spokeswoman for Glaxo. " We had no

forewarning of this letter. "

She said the company submits all of its direct-to-consumer ads to the

FDA prior to having them air, and did so in the case of the ad in

question.

" Our point of view is that we acted responsibly because we submitted

the campaign to the FDA for review prior to airing and then we did

modify the proposed commercial in an attempt to address their comments

before it aired, " Leone said. " We incorporated their comments. " She

couldn't say exactly what those comments were.

She said the company disagrees with the FDA letter. However, Glaxo

will work with the FDA to make " appropriate revisions " for future

commercials.

-By Mohammed Hadi, Dow Newswires; 201-938-2007

Dow Newswires

06-11-04 1409ET

Copyright © 2004 Dow & Company, Inc. .

[Guest guest]

Too little too late but it's something. And again, from a business

source, not a medical source. It's amazing how little about ADs is

found in the medical sections compared to the business sections. What

does that tell us???

2nd UPDATE:FDA Asks GlaxoKline To Stop PaxilCR TV Ad

06-11-04 02:09 PM EST

By Mohammed Hadi

Of DOW JONES NEWSWIRES

NEW YORK (Dow )--The U.S. Food and Drug Administration asked

GlaxoKline PLC (GSK) to stop certain advertisements for the

controlled- release version of its anxiety treatment Paxil because

they are too broad and are misleading about safety issues.

The request was made public just over a week after New York Attorney

General Eliot Spitzer filed a lawsuit against Glaxo over the alleged

concealment of data that would challenge the safety and efficacy of

Paxil when given to children.

In a letter to Glaxo posted on the FDA's Web site Thursday, the FDA

said a TV ad for Paxil Controlled-Release is " false or misleading "

because it suggests that the drug can be used by a broader range of

patients than it is actually approved for and implies that the drug is

safer than actually demonstrated.

" The TV ad suggests that anyone experiencing anxiety, fear or self-

consciousness in social or work situations is an appropriate candidate

for Paxil CR, " the agency said.

Instead, Paxil CR, is approved for social anxiety disorder, or SAD,

which is different than the " lesser degrees of performance anxiety or

shyness that do not generally require psychopharmacological treatment,

" the FDA wrote.

The FDA also charged that the advertisement excludes information on

certain side effects, and distract viewers with " compelling and

attention-grabbing visuals " while risk information is presented. The

company was given until June 23 to respond to the FDA in writing.

Last Tuesday, Spitzer filed a lawsuit accusing Glaxo of " repeated and

persistent fraud, " and alleging that Glaxo hid the fact that in some

of its trials involving children Paxil failed to show better efficacy

than a placebo, or a dummy pill, and in some cases was more likely to

cause suicidal thinking.

Glaxo, the suit says, " had done several studies and only one of which

generated the affirmative results they wanted to use in promoting the

drug. " The suit continues: Their " efforts to suppress the other

studies was harmful and improper to the doctors who where making

prescribing decisions and it violated the law. "

In a press release Thursday, Glaxo said it has made data available to

health- care professionals " through publication in peer-reviewed

journals, poster presentations at scientific meetings, and medical

letters to physicians. "

However, the company plans to make summaries of safety and efficacy

data from the clinical studies of Paxil in adolescents and children

available on its Web site.

The company also noted that Paxil has not been approved in Europe or

North America for the treatment of children under the age of 18, and

said it is company policy not to promote off label use of any of its

drugs.

A Glaxo spokeswoman said the advertisement the FDA is asking the

company to stop airing last appeared on May 9 and won't run again.

" That was just our media schedule, and it was unrelated to this (FDA

letter), " said Leone, spokeswoman for Glaxo. " We had no

forewarning of this letter. "

She said the company submits all of its direct-to-consumer ads to the

FDA prior to having them air, and did so in the case of the ad in

question.

" Our point of view is that we acted responsibly because we submitted

the campaign to the FDA for review prior to airing and then we did

modify the proposed commercial in an attempt to address their comments

before it aired, " Leone said. " We incorporated their comments. " She

couldn't say exactly what those comments were.

She said the company disagrees with the FDA letter. However, Glaxo

will work with the FDA to make " appropriate revisions " for future

commercials.

-By Mohammed Hadi, Dow Newswires; 201-938-2007

Dow Newswires

06-11-04 1409ET

Copyright © 2004 Dow & Company, Inc. .

[Guest guest]

Too little too late but it's something. And again, from a business

source, not a medical source. It's amazing how little about ADs is

found in the medical sections compared to the business sections. What

does that tell us???

2nd UPDATE:FDA Asks GlaxoKline To Stop PaxilCR TV Ad

06-11-04 02:09 PM EST

By Mohammed Hadi

Of DOW JONES NEWSWIRES

NEW YORK (Dow )--The U.S. Food and Drug Administration asked

GlaxoKline PLC (GSK) to stop certain advertisements for the

controlled- release version of its anxiety treatment Paxil because

they are too broad and are misleading about safety issues.

The request was made public just over a week after New York Attorney

General Eliot Spitzer filed a lawsuit against Glaxo over the alleged

concealment of data that would challenge the safety and efficacy of

Paxil when given to children.

In a letter to Glaxo posted on the FDA's Web site Thursday, the FDA

said a TV ad for Paxil Controlled-Release is " false or misleading "

because it suggests that the drug can be used by a broader range of

patients than it is actually approved for and implies that the drug is

safer than actually demonstrated.

" The TV ad suggests that anyone experiencing anxiety, fear or self-

consciousness in social or work situations is an appropriate candidate

for Paxil CR, " the agency said.

Instead, Paxil CR, is approved for social anxiety disorder, or SAD,

which is different than the " lesser degrees of performance anxiety or

shyness that do not generally require psychopharmacological treatment,

" the FDA wrote.

The FDA also charged that the advertisement excludes information on

certain side effects, and distract viewers with " compelling and

attention-grabbing visuals " while risk information is presented. The

company was given until June 23 to respond to the FDA in writing.

Last Tuesday, Spitzer filed a lawsuit accusing Glaxo of " repeated and

persistent fraud, " and alleging that Glaxo hid the fact that in some

of its trials involving children Paxil failed to show better efficacy

than a placebo, or a dummy pill, and in some cases was more likely to

cause suicidal thinking.

Glaxo, the suit says, " had done several studies and only one of which

generated the affirmative results they wanted to use in promoting the

drug. " The suit continues: Their " efforts to suppress the other

studies was harmful and improper to the doctors who where making

prescribing decisions and it violated the law. "

In a press release Thursday, Glaxo said it has made data available to

health- care professionals " through publication in peer-reviewed

journals, poster presentations at scientific meetings, and medical

letters to physicians. "

However, the company plans to make summaries of safety and efficacy

data from the clinical studies of Paxil in adolescents and children

available on its Web site.

The company also noted that Paxil has not been approved in Europe or

North America for the treatment of children under the age of 18, and

said it is company policy not to promote off label use of any of its

drugs.

A Glaxo spokeswoman said the advertisement the FDA is asking the

company to stop airing last appeared on May 9 and won't run again.

" That was just our media schedule, and it was unrelated to this (FDA

letter), " said Leone, spokeswoman for Glaxo. " We had no

forewarning of this letter. "

She said the company submits all of its direct-to-consumer ads to the

FDA prior to having them air, and did so in the case of the ad in

question.

" Our point of view is that we acted responsibly because we submitted

the campaign to the FDA for review prior to airing and then we did

modify the proposed commercial in an attempt to address their comments

before it aired, " Leone said. " We incorporated their comments. " She

couldn't say exactly what those comments were.

She said the company disagrees with the FDA letter. However, Glaxo

will work with the FDA to make " appropriate revisions " for future

commercials.

-By Mohammed Hadi, Dow Newswires; 201-938-2007

Dow Newswires

06-11-04 1409ET

Copyright © 2004 Dow & Company, Inc. .