Overstated Claims Hurt: Cymbalta Ad Is Skewered

[Guest guest]

Paragraph 9: “If it is ‘good promotional practice’ to promote Cymbalta as

alleviating pain in depression based on a meager and borderline statistically

significant effect over placebo, then I suppose good promotional practice is

being followed.” - Psychology Professor Glen Spielmans

From Pharmalot:

http://www.pharmalot.com/2008/01/overstated-claims-hurt-cymbalta-ad-is-skewered/\

#more-11099

Overstated Claims Hurt: Cymbalta Ad Is Skewered

January 3rd, 2008 9:26 am By Ed Silverman

One night while watching TV, Glen Spielmans noticed a ‘Depression Hurts’ ad,

which is part of the marketing campaign for Lilly’s Cymbalta, and was struck by

what he saw. “I thought the claim that Cymbalta not only alleviated depression

but also physical pain for depressed patients was a bit on the incredible side,

so I thought I’d see if their claims were supported by data,” he tells us.

And so the psychology professor at Metropolitan State University in St. ,

Minnesota, conducted a meta-analysis of five published studies that examined

Cymbalta and pain relief in depressed patients. What did he find? Overstated

claims, he says, as well as incomplete reporting - Lilly, he argues, didn’t

provide summaries of all relevant data in three of their trials, which runs

counter to the drugmaker’s contention that it maintains a transparent policy

toward disclosing all clinical trial data.

“The results indicate a very small and statistically nonsignificant analegesic

effect…Additionally, some of the relevant data on (Cymbalta’s) effects have not

been reported fully, making it likely that the obtained results reflect an

overestimate of its true impact on painful physical symptoms in depression,” he

wrote in Psychotherapy and Psychosomatics (here’s the study). “Based upon the

currently available evidence, the marketing of (Cymbalta) as an antidepressant

with analgesic properties for people with depression does not appear to be

adequately supported.”

“This is misleading advertising,” says Spielmans.

A Lilly spokeswoman wrote back to say the drugmaker follows “good promotional

practices and promote our products based on claims that we can support from our

data,” and that Lilly discloses publicly all research that is “significant,”

whether favorable or unfavorable.” She didn’t specifically address his charge,

though, that some summaries weren’t disclosed at the time he conducted his

research.

The spokeswoman also maintains “clinical trial results show Cymbalta is

effective in treating the broad range of depression symptoms, including the

painful physical symptoms.” However, she didn’t contend that Cymbalta has a

clinically significant impact on treating pain in depressed patients.

The Lilly spokeswoman then criticized Spielmans’ analysis, charging he

misinterpreted and, therefore, excluded certain scales. “He also mixed clinical

trials that had very different study designs that normally would not be grouped

together in such a study,” she writes. “In addition, Dr. Spielmans chose to

analyze only five of the nine publicly available duloxetine trials in depressed

patients with pain data.”

For his part, Spielmans tells us that he “did not mix studies with drastically

different designs. Each study in the meta-analysis examined the effects of

(Cymbalta) versus placebo and/or paroxetine (Paxil) in treating pain in patients

with depression. This criticism is not valid. It would appear that Lilly has not

read my meta-analysis. As stated in my article, two studies were excluded from

analysis because they failed to provide sufficient data. I believe that two

studies have been published since my meta-analysis went to press. That adds up

to nine studies.

“If it is ‘good promotional practice’ to promote Cymbalta as alleviating pain in

depression based on a meager and borderline statistically significant effect

over placebo, then I suppose good promotional practice is being followed.”

Despite such criticisms, Lilly’s Cymbalta advertising garnered an ‘All-Stars

Large Pharma Marketing Team’ award from Medical Marketing & Media. You can read

about that here.

Hat tip to WSJ Health Blog and Furious Seasons

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

transmittal 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.

________________________________________________________________________________\

____

Never miss a thing. Make your home page.

http://www./r/hs

[Guest guest]

Paragraph 9: “If it is ‘good promotional practice’ to promote Cymbalta as

alleviating pain in depression based on a meager and borderline statistically

significant effect over placebo, then I suppose good promotional practice is

being followed.” - Psychology Professor Glen Spielmans

From Pharmalot:

http://www.pharmalot.com/2008/01/overstated-claims-hurt-cymbalta-ad-is-skewered/\

#more-11099

Overstated Claims Hurt: Cymbalta Ad Is Skewered

January 3rd, 2008 9:26 am By Ed Silverman

One night while watching TV, Glen Spielmans noticed a ‘Depression Hurts’ ad,

which is part of the marketing campaign for Lilly’s Cymbalta, and was struck by

what he saw. “I thought the claim that Cymbalta not only alleviated depression

but also physical pain for depressed patients was a bit on the incredible side,

so I thought I’d see if their claims were supported by data,” he tells us.

And so the psychology professor at Metropolitan State University in St. ,

Minnesota, conducted a meta-analysis of five published studies that examined

Cymbalta and pain relief in depressed patients. What did he find? Overstated

claims, he says, as well as incomplete reporting - Lilly, he argues, didn’t

provide summaries of all relevant data in three of their trials, which runs

counter to the drugmaker’s contention that it maintains a transparent policy

toward disclosing all clinical trial data.

“The results indicate a very small and statistically nonsignificant analegesic

effect…Additionally, some of the relevant data on (Cymbalta’s) effects have not

been reported fully, making it likely that the obtained results reflect an

overestimate of its true impact on painful physical symptoms in depression,” he

wrote in Psychotherapy and Psychosomatics (here’s the study). “Based upon the

currently available evidence, the marketing of (Cymbalta) as an antidepressant

with analgesic properties for people with depression does not appear to be

adequately supported.”

“This is misleading advertising,” says Spielmans.

A Lilly spokeswoman wrote back to say the drugmaker follows “good promotional

practices and promote our products based on claims that we can support from our

data,” and that Lilly discloses publicly all research that is “significant,”

whether favorable or unfavorable.” She didn’t specifically address his charge,

though, that some summaries weren’t disclosed at the time he conducted his

research.

The spokeswoman also maintains “clinical trial results show Cymbalta is

effective in treating the broad range of depression symptoms, including the

painful physical symptoms.” However, she didn’t contend that Cymbalta has a

clinically significant impact on treating pain in depressed patients.

The Lilly spokeswoman then criticized Spielmans’ analysis, charging he

misinterpreted and, therefore, excluded certain scales. “He also mixed clinical

trials that had very different study designs that normally would not be grouped

together in such a study,” she writes. “In addition, Dr. Spielmans chose to

analyze only five of the nine publicly available duloxetine trials in depressed

patients with pain data.”

For his part, Spielmans tells us that he “did not mix studies with drastically

different designs. Each study in the meta-analysis examined the effects of

(Cymbalta) versus placebo and/or paroxetine (Paxil) in treating pain in patients

with depression. This criticism is not valid. It would appear that Lilly has not

read my meta-analysis. As stated in my article, two studies were excluded from

analysis because they failed to provide sufficient data. I believe that two

studies have been published since my meta-analysis went to press. That adds up

to nine studies.

“If it is ‘good promotional practice’ to promote Cymbalta as alleviating pain in

depression based on a meager and borderline statistically significant effect

over placebo, then I suppose good promotional practice is being followed.”

Despite such criticisms, Lilly’s Cymbalta advertising garnered an ‘All-Stars

Large Pharma Marketing Team’ award from Medical Marketing & Media. You can read

about that here.

Hat tip to WSJ Health Blog and Furious Seasons

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

transmittal 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.

________________________________________________________________________________\

____

Never miss a thing. Make your home page.

http://www./r/hs

[Guest guest]

Paragraph 9: “If it is ‘good promotional practice’ to promote Cymbalta as

alleviating pain in depression based on a meager and borderline statistically

significant effect over placebo, then I suppose good promotional practice is

being followed.” - Psychology Professor Glen Spielmans

From Pharmalot:

http://www.pharmalot.com/2008/01/overstated-claims-hurt-cymbalta-ad-is-skewered/\

#more-11099

Overstated Claims Hurt: Cymbalta Ad Is Skewered

January 3rd, 2008 9:26 am By Ed Silverman

One night while watching TV, Glen Spielmans noticed a ‘Depression Hurts’ ad,

which is part of the marketing campaign for Lilly’s Cymbalta, and was struck by

what he saw. “I thought the claim that Cymbalta not only alleviated depression

but also physical pain for depressed patients was a bit on the incredible side,

so I thought I’d see if their claims were supported by data,” he tells us.

And so the psychology professor at Metropolitan State University in St. ,

Minnesota, conducted a meta-analysis of five published studies that examined

Cymbalta and pain relief in depressed patients. What did he find? Overstated

claims, he says, as well as incomplete reporting - Lilly, he argues, didn’t

provide summaries of all relevant data in three of their trials, which runs

counter to the drugmaker’s contention that it maintains a transparent policy

toward disclosing all clinical trial data.

“The results indicate a very small and statistically nonsignificant analegesic

effect…Additionally, some of the relevant data on (Cymbalta’s) effects have not

been reported fully, making it likely that the obtained results reflect an

overestimate of its true impact on painful physical symptoms in depression,” he

wrote in Psychotherapy and Psychosomatics (here’s the study). “Based upon the

currently available evidence, the marketing of (Cymbalta) as an antidepressant

with analgesic properties for people with depression does not appear to be

adequately supported.”

“This is misleading advertising,” says Spielmans.

A Lilly spokeswoman wrote back to say the drugmaker follows “good promotional

practices and promote our products based on claims that we can support from our

data,” and that Lilly discloses publicly all research that is “significant,”

whether favorable or unfavorable.” She didn’t specifically address his charge,

though, that some summaries weren’t disclosed at the time he conducted his

research.

The spokeswoman also maintains “clinical trial results show Cymbalta is

effective in treating the broad range of depression symptoms, including the

painful physical symptoms.” However, she didn’t contend that Cymbalta has a

clinically significant impact on treating pain in depressed patients.

The Lilly spokeswoman then criticized Spielmans’ analysis, charging he

misinterpreted and, therefore, excluded certain scales. “He also mixed clinical

trials that had very different study designs that normally would not be grouped

together in such a study,” she writes. “In addition, Dr. Spielmans chose to

analyze only five of the nine publicly available duloxetine trials in depressed

patients with pain data.”

For his part, Spielmans tells us that he “did not mix studies with drastically

different designs. Each study in the meta-analysis examined the effects of

(Cymbalta) versus placebo and/or paroxetine (Paxil) in treating pain in patients

with depression. This criticism is not valid. It would appear that Lilly has not

read my meta-analysis. As stated in my article, two studies were excluded from

analysis because they failed to provide sufficient data. I believe that two

studies have been published since my meta-analysis went to press. That adds up

to nine studies.

“If it is ‘good promotional practice’ to promote Cymbalta as alleviating pain in

depression based on a meager and borderline statistically significant effect

over placebo, then I suppose good promotional practice is being followed.”

Despite such criticisms, Lilly’s Cymbalta advertising garnered an ‘All-Stars

Large Pharma Marketing Team’ award from Medical Marketing & Media. You can read

about that here.

Hat tip to WSJ Health Blog and Furious Seasons

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

transmittal 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.

________________________________________________________________________________\

____

Never miss a thing. Make your home page.

http://www./r/hs

[Guest guest]

Paragraph 9: “If it is ‘good promotional practice’ to promote Cymbalta as

alleviating pain in depression based on a meager and borderline statistically

significant effect over placebo, then I suppose good promotional practice is

being followed.” - Psychology Professor Glen Spielmans

From Pharmalot:

http://www.pharmalot.com/2008/01/overstated-claims-hurt-cymbalta-ad-is-skewered/\

#more-11099

Overstated Claims Hurt: Cymbalta Ad Is Skewered

January 3rd, 2008 9:26 am By Ed Silverman

One night while watching TV, Glen Spielmans noticed a ‘Depression Hurts’ ad,

which is part of the marketing campaign for Lilly’s Cymbalta, and was struck by

what he saw. “I thought the claim that Cymbalta not only alleviated depression

but also physical pain for depressed patients was a bit on the incredible side,

so I thought I’d see if their claims were supported by data,” he tells us.

And so the psychology professor at Metropolitan State University in St. ,

Minnesota, conducted a meta-analysis of five published studies that examined

Cymbalta and pain relief in depressed patients. What did he find? Overstated

claims, he says, as well as incomplete reporting - Lilly, he argues, didn’t

provide summaries of all relevant data in three of their trials, which runs

counter to the drugmaker’s contention that it maintains a transparent policy

toward disclosing all clinical trial data.

“The results indicate a very small and statistically nonsignificant analegesic

effect…Additionally, some of the relevant data on (Cymbalta’s) effects have not

been reported fully, making it likely that the obtained results reflect an

overestimate of its true impact on painful physical symptoms in depression,” he

wrote in Psychotherapy and Psychosomatics (here’s the study). “Based upon the

currently available evidence, the marketing of (Cymbalta) as an antidepressant

with analgesic properties for people with depression does not appear to be

adequately supported.”

“This is misleading advertising,” says Spielmans.

A Lilly spokeswoman wrote back to say the drugmaker follows “good promotional

practices and promote our products based on claims that we can support from our

data,” and that Lilly discloses publicly all research that is “significant,”

whether favorable or unfavorable.” She didn’t specifically address his charge,

though, that some summaries weren’t disclosed at the time he conducted his

research.

The spokeswoman also maintains “clinical trial results show Cymbalta is

effective in treating the broad range of depression symptoms, including the

painful physical symptoms.” However, she didn’t contend that Cymbalta has a

clinically significant impact on treating pain in depressed patients.

The Lilly spokeswoman then criticized Spielmans’ analysis, charging he

misinterpreted and, therefore, excluded certain scales. “He also mixed clinical

trials that had very different study designs that normally would not be grouped

together in such a study,” she writes. “In addition, Dr. Spielmans chose to

analyze only five of the nine publicly available duloxetine trials in depressed

patients with pain data.”

For his part, Spielmans tells us that he “did not mix studies with drastically

different designs. Each study in the meta-analysis examined the effects of

(Cymbalta) versus placebo and/or paroxetine (Paxil) in treating pain in patients

with depression. This criticism is not valid. It would appear that Lilly has not

read my meta-analysis. As stated in my article, two studies were excluded from

analysis because they failed to provide sufficient data. I believe that two

studies have been published since my meta-analysis went to press. That adds up

to nine studies.

“If it is ‘good promotional practice’ to promote Cymbalta as alleviating pain in

depression based on a meager and borderline statistically significant effect

over placebo, then I suppose good promotional practice is being followed.”

Despite such criticisms, Lilly’s Cymbalta advertising garnered an ‘All-Stars

Large Pharma Marketing Team’ award from Medical Marketing & Media. You can read

about that here.

Hat tip to WSJ Health Blog and Furious Seasons

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

transmittal 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.

________________________________________________________________________________\

____

Never miss a thing. Make your home page.

http://www./r/hs