Roaches… (Blog Re: Ghostwriting/GSK)

[Guest guest]

http://1boringoldman.com/index.php/2010/12/01/roaches/

roaches…

Posted on Wednesday 1 December 2010

For every roach you see, there are a hundred behind the walls.

Yesterday’s article in the New York Times [Drug Maker Wrote Book Under 2

Doctors’ Names, Documents Say] was about Dr. Nemeroff, a person of

specific interest to me, so I jumped on the Nemeroff aspect of the story [a

“quintessential resourceâ€â€¦], but that’s not the real center of things.

That New York Times article was in response to a letter from the Project on

Government Oversight to Dr. Francis , Director of the National Institutes

of Health [POGO Letter to NIH on Ghostwriting Academics]. In that letter, POGO

Executive Director le and Investigator Thacker document five

cases where a Marketing Firm, Scientific Therapeutics Information, ghost wrote

scientific presentations, articles, and books that were published by expert

physicians - all was under the direction of the Pharmaceutical Manufacturer,

GlaxoKline.

Before listing the examples, I just want to highlight how " not okay " all of this

is. We’re used to " marketing " " advertising " in our daily lives. Glossy ads

interrupt our reading and media viewing at every possible juncture - even

popping up on our web pages. But science, particularly medical science, is

something else. Simply put, you don’t want your physician prescribing a

medicine for you to take based on the jillion ad brochures he/she receive every

day designed to increase the manufacturers profits. You want that prescription

to represent the best, safest, unbiased information available for the medical

condition you actually have. That’s why reputable medical journals require

that the researcher display the data that supports the conclusions in detail. So

Scientific Therapeutics Information is a very unusual company indeed - an Ad

Agency for scientific data:



reformatted from http://www.stimedinfo.com/service02.htm

POGO’s first example related to a campaign STI did for GSK’s antidepressant,

Paxil:

According to the documents, GSK began to push sales of Paxil in the early 1990s

with an extensive ghostwriting program run by the marketing firm Scientific

Therapeutics Information (STI). For instance, STI wrote a proposal to organize

GlaxoKline’s Paxil Advisory Board Meeting in 1993 at the Ritz Carlton

Hotel in Palm Beach, Florida. STI chose Dr. Nemeroff of Emory University

as their speaker to lay out the meeting’s agenda and objectives. Dr. Nemeroff

apparently led discussions on how to “evaluate clinical research/promotional

programs†and “generate information for use in promotion/education.â€

[Attachment A]

" What in the hell is the then new Chairman of a Department of Psychiatry doing

leading a marketing strategy meeting for a drug company? " you might ask. But

I’ll restrain myself and stick to the topic. Other than Nemeroff’s presence

in this ambiguous role, for a marketing firm to be involved in a sales strategy

meeting is not that unusual. But the next example goes over the top:

Drs. Dwight and Dennis Charney

NIH funding since FY 2006: $30.6 million

NIH funding FY 2010: $10,929,790

According to the documents, Sally Laden of STI wrote an editorial for Biological

Psychiatry in 2003 for Drs. Dwight , Chairman of the Department of

Psychiatry at the University of Pennsylvania School of Medicine, and Dennis

Charney, then an employee at the NIH and now Dean of Research at the Mt. Sinai

School of Medicine at New York University.

In an email to a GSK employee, Ms. Laden wrote, “Is there a problem with my

invoice for writing Dwight ’ editorial for the [Depression and Bipolar

Support Alliance]’s comorbidity issue to Biological Psychiatry?†[Attachment

B] Yet, when published, the “authors†and Charney only stated, “We

acknowledge Sally K. Laden for editorial support.†[Attachment C]

One might think that these guys just weren’t very good writers and needed

grammatical assistance, until you read the part in red - and realize their

editorial was ghost-written under the direction of the drug company

[GlaxoKline]. POGO’s third example I’ve already covered, STI’s

ghost-writing Drs. Nemeroff and Schatzberg’s book under the direction of

GlaxoKline [a “quintessential resourceâ€â€¦].

In case you haven’t noticed, all of these examples involve GlaxoKline,

Paxil, and Scientific Therapeutics Information. That’s because the documents

were unearthed in suits against GSK involving their antidepressant Paxil.

Here’s another example:

Dr. Yonkers

NIH funding since FY 2006: $6.4 million

NIH funding FY 2010: $1,241,257

In 2002, a GSK employee emailed Dr. Yonkers of Yale School of Medicine, writing,

“Attached please find the poster to be presented at the US Psych Congress.

Please provide feedback.†[Attachment G] Other documents make it clear that

Dr. Yonkers was provided at least one ghostwritten study. For instance, the

cover page for a study on Paxil to be published in Psychopharmacology Bulletin

notes that “Draft I†was prepared by Sally Laden and another STI employee.

The top line of the draft even reminds Dr. Yonkers to remove evidence of STI’s

involvement, stating, “STI Cover Page—To be removed before submission.â€

[Attachment H] When the study was later published, it notes that it was funded

by an “unrestricted educational grant†from GSK, but makes no mention of

STI’s involvement in the paper. [Attachment I]

But it’s this last example that takes the grand prize - Study 329 - a Paxil

drug trial in adolescents conducted at Brown University.

Dr. Keller

NIH funding since FY 2006: $7.0 million

NIH funding FY 2010: $1,341,493

Finally, we would like to turn your attention to Dr. Keller of Brown

University Medical School. In July 2001, Dr. Keller and several colleagues

published a widely read study, called Study 329, on the efficacy of Paxil

(paroxetine) to treat adolescent major depression.[8] Study 329 concluded,

“The findings of this study provide evidence of the efficacy and safety of the

SSRI, paroxetine, in the treatment of adolescent major depression.â€[9]

Study 329, however, was clearly flawed—a mere two years later, the United

Kingdom government warned British physicians to not prescribe Paxil for children

due to fears of potential suicide.[10] In May 2004, our own FDA issued a similar

warning.[11]

In early 2007, the BBC’s investigative program Panorama released a documentary

on Paxil and Study 329.[12] The documentary publicized hundreds of secret emails

from GSK, which were uncovered during litigation, that showed GSK knew years

before the publication of Study 329 that Paxil did not provide efficacy in

treating adolescents for depression.

With regards to Study 329 specifically, the BBC reported online about emails

written by a company hired by GSK to provide PR for Study 329.[13] One email

read, “Originally we had planned to do extensive media relations surrounding

this study until we actually viewed the results.â€[14] Another email read,

“Essentially the study did not really show [Paxil] was effective in treating

adolescent depression, which is not something we want to publicize.â€[15]

[Attachment J] The documentary also noted that Dr. Keller published Study 329

with the help of ghostwriter Sally Laden. In an email to Ms. Laden about Study

329, Dr. Keller wrote, “You did a superb job with this. Thank you very much.

It is excellent. Enclosed are some rather minor changes from me…â€[16] But

before the final draft was released to Dr. Keller, Ms. Laden sent it to GSK for

final approval so that the manuscript “can be released to Keller, MD to

submit for publication….†[Attachment K]

 

In June 2008, former Boston Globe reporter Alison Bass published Side Effects, a

book that documents multiple problems with Dr. Keller’s research used in Study

329. Passages of the book discuss internal documents from Brown University

regarding Dr. Keller’s research on Paxil. The documents were provided to Ms.

Bass by Donna , the former assistant administrator in Brown’s department

of psychiatry. Ms. said that data in Study 329 was changed to satisfy the

study’s sponsor, GSK. According to , “Everybody knew we had to keep

[GlaxoKline] happy and give them the results they wanted.â€[17]

Even Brown University’s student newspaper, The Brown Daily Herald, published

an exposé on Dr. Keller’s research and Study 329.[18] Dr. Keller refused to

respond to questions from the paper. An editorial that accompanied this story

stated, “We do believe that [Dr. Keller’s] actions directly affect the

integrity of the University.â€[19] Yet, despite the multiple public

revelations, Brown University has done nothing.

POGO searched the NIH Reporter database of grants and was surprised to find

that, despite all the repetitive controversy, Dr. Keller is still receiving NIH

grants.  Currently, he is the primary investigator on two NIH grants, with

funding in 2010 of $1,341,493. Over the last five years, the NIH has given Dr.

Keller $7 million in grants.[20]

In this last example, as bad as it is, the POGO letter only calls it " flawed. "

It wasn’t just flawed, it was jury-rigged, dry-labbed, whatever term one uses

to say the data was altered to fit the conclusion - by GSK? by Keller? by STI?

all of the above? who knows?  Outright fraud for sure…

I opened with " For every roach you see, there are a hundred behind the walls "

for obvious reasons. This is an example of a practice that is surely more

widespread than just this instance demonstrates. Thacker has his work cut

out for him, and he’s just the guy to do it.

The campaign of GSK to promote Paxil by disguising their advertisments as hard

science published by identified experts while controlling the content through a

professional marketing firm is more than just sleaze. The results were harmful

to their customers - birth defects, suicides, addiction - genuinely bad things

[so much for the old Hippocratic Oath " Do no harm " ]. And the story reads like an

old Greek Tragedy written with Aristotle’s formula from his Poetics. There’s

a character flaw in the main character, apparent in the opening scene that

festers and grows, ultimately bringing his tragic downfall at the end of the

story. That would, of course, apply to Dr. Nemeroff who began by leading a sales

strategy meeting and ended up a paid shill for GSK, bringing colleagues down

with him. But it also applies to GSK and STI who started with a marketing

strategy and ended up participating in corrupted research and fraud.

This is a rotten story, among untold others. How will they ferret out the

others? I’d start by looking for academics with absurdly long cv’s. I’d

look for big-time grant getters, particularly ones who do drug or device trials.

And I’d look for academics who give a lot of promotional talks, AKA CME

presentations. But mostly, there’s a culture, particularly in Psychiatry, of

giving people like this a bye because they bring in money to their Institutions.

The solution is easy. Dry up the money, even if the NIH has to declare a

moratorium on all drug/device trials. If we don’t do that, the NIH/NIMH will

simply go away. And, to state the obvious, our patients deserve better…

Says the American Psychiatric Association [recent past President: Alan

Schatzberg]:



I paid my dues to the APA for a lot of years, so I feel I earned my right to

rebut this silly Statement from the APA:



Unrestricted Grants from Pharmaceutical Companies were Charlie Nemeroff’s

special area of expertise. He always makes this claim - that they come with no

strings attached, no control. He got them by the bucketful while he was at Emory

and used them for all kinds of perks - Grand Rounds speakers, sending residents

to conferences, etc. The loophole is simple. They didn’t have to have any

control, any strings. He was a willing co-conspirator already. They didn’t

even have to say " you scratch my back and I’ll scratch yours. " They were both

already scratching, and simply having someone like him in charge of an academic

department was worth plenty, no matter what he did with the money. This was how

he kept himself so popular - deep pockets from " unrestricted grants. " This

argument isn’t evidence, it’s an indictment. I expect Schatzberg worked the

same scam.



And so the reviewers made suggestions and they were acted on [probably by STI's

writers]. They were playing it straight, but the point is that Nemeroff and

Schatzberg didn’t write it. Whether the ghost-writing was pay-back to Charlie

and Alan for their continued support, or a way to get primary care docs writing

more scripts, or as a way to be loved by the recipients for the freebie - it

doesn’t matter. They signed their names to a book they didn’t write and the

reader didn’t know that. If I found a Faulkner manuscript in my attic

and published it with my name as author, it wouldn’t matter that it was a good

book when they took back my Pulitzer Prize when my deceit was exposed.

This statement by the APA is very " Charlie. " I don’t know Alan Schatzberg, but

I’ve been around and heard a ton about Charlie Nemeroff. He’s no fool.

Plausible deniability is his middle name. Of course he has an explanation for

everything. He always does. I expect partner Schatzberg is equally facile with

excuses. Maybe GSK didn’t exercise any rights of approval. But the point is

that Nemeroff and Schatzberg didn’t write the book, Sally Laden and Diane

Coniglio of STI wrote the book. ly, from all that has transpired, these two

doctors didn’t need to be watched over by the drug companies, particularly

Charlie. He was already leading their marketing meetings. He was one of them…

STI chose Dr. Nemeroff of Emory University as their speaker to lay out

the meeting’s agenda and objectives. Dr. Nemeroff apparently led discussions

on how to “evaluate clinical research/promotional programs†and “generate

information for use in promotion/education.†[Attachment A]

Sent via BlackBerry by AT & T

[Guest guest]

http://1boringoldman.com/index.php/2010/12/01/roaches/

roaches…

Posted on Wednesday 1 December 2010

For every roach you see, there are a hundred behind the walls.

Yesterday’s article in the New York Times [Drug Maker Wrote Book Under 2

Doctors’ Names, Documents Say] was about Dr. Nemeroff, a person of

specific interest to me, so I jumped on the Nemeroff aspect of the story [a

“quintessential resourceâ€â€¦], but that’s not the real center of things.

That New York Times article was in response to a letter from the Project on

Government Oversight to Dr. Francis , Director of the National Institutes

of Health [POGO Letter to NIH on Ghostwriting Academics]. In that letter, POGO

Executive Director le and Investigator Thacker document five

cases where a Marketing Firm, Scientific Therapeutics Information, ghost wrote

scientific presentations, articles, and books that were published by expert

physicians - all was under the direction of the Pharmaceutical Manufacturer,

GlaxoKline.

Before listing the examples, I just want to highlight how " not okay " all of this

is. We’re used to " marketing " " advertising " in our daily lives. Glossy ads

interrupt our reading and media viewing at every possible juncture - even

popping up on our web pages. But science, particularly medical science, is

something else. Simply put, you don’t want your physician prescribing a

medicine for you to take based on the jillion ad brochures he/she receive every

day designed to increase the manufacturers profits. You want that prescription

to represent the best, safest, unbiased information available for the medical

condition you actually have. That’s why reputable medical journals require

that the researcher display the data that supports the conclusions in detail. So

Scientific Therapeutics Information is a very unusual company indeed - an Ad

Agency for scientific data:



reformatted from http://www.stimedinfo.com/service02.htm

POGO’s first example related to a campaign STI did for GSK’s antidepressant,

Paxil:

According to the documents, GSK began to push sales of Paxil in the early 1990s

with an extensive ghostwriting program run by the marketing firm Scientific

Therapeutics Information (STI). For instance, STI wrote a proposal to organize

GlaxoKline’s Paxil Advisory Board Meeting in 1993 at the Ritz Carlton

Hotel in Palm Beach, Florida. STI chose Dr. Nemeroff of Emory University

as their speaker to lay out the meeting’s agenda and objectives. Dr. Nemeroff

apparently led discussions on how to “evaluate clinical research/promotional

programs†and “generate information for use in promotion/education.â€

[Attachment A]

" What in the hell is the then new Chairman of a Department of Psychiatry doing

leading a marketing strategy meeting for a drug company? " you might ask. But

I’ll restrain myself and stick to the topic. Other than Nemeroff’s presence

in this ambiguous role, for a marketing firm to be involved in a sales strategy

meeting is not that unusual. But the next example goes over the top:

Drs. Dwight and Dennis Charney

NIH funding since FY 2006: $30.6 million

NIH funding FY 2010: $10,929,790

According to the documents, Sally Laden of STI wrote an editorial for Biological

Psychiatry in 2003 for Drs. Dwight , Chairman of the Department of

Psychiatry at the University of Pennsylvania School of Medicine, and Dennis

Charney, then an employee at the NIH and now Dean of Research at the Mt. Sinai

School of Medicine at New York University.

In an email to a GSK employee, Ms. Laden wrote, “Is there a problem with my

invoice for writing Dwight ’ editorial for the [Depression and Bipolar

Support Alliance]’s comorbidity issue to Biological Psychiatry?†[Attachment

B] Yet, when published, the “authors†and Charney only stated, “We

acknowledge Sally K. Laden for editorial support.†[Attachment C]

One might think that these guys just weren’t very good writers and needed

grammatical assistance, until you read the part in red - and realize their

editorial was ghost-written under the direction of the drug company

[GlaxoKline]. POGO’s third example I’ve already covered, STI’s

ghost-writing Drs. Nemeroff and Schatzberg’s book under the direction of

GlaxoKline [a “quintessential resourceâ€â€¦].

In case you haven’t noticed, all of these examples involve GlaxoKline,

Paxil, and Scientific Therapeutics Information. That’s because the documents

were unearthed in suits against GSK involving their antidepressant Paxil.

Here’s another example:

Dr. Yonkers

NIH funding since FY 2006: $6.4 million

NIH funding FY 2010: $1,241,257

In 2002, a GSK employee emailed Dr. Yonkers of Yale School of Medicine, writing,

“Attached please find the poster to be presented at the US Psych Congress.

Please provide feedback.†[Attachment G] Other documents make it clear that

Dr. Yonkers was provided at least one ghostwritten study. For instance, the

cover page for a study on Paxil to be published in Psychopharmacology Bulletin

notes that “Draft I†was prepared by Sally Laden and another STI employee.

The top line of the draft even reminds Dr. Yonkers to remove evidence of STI’s

involvement, stating, “STI Cover Page—To be removed before submission.â€

[Attachment H] When the study was later published, it notes that it was funded

by an “unrestricted educational grant†from GSK, but makes no mention of

STI’s involvement in the paper. [Attachment I]

But it’s this last example that takes the grand prize - Study 329 - a Paxil

drug trial in adolescents conducted at Brown University.

Dr. Keller

NIH funding since FY 2006: $7.0 million

NIH funding FY 2010: $1,341,493

Finally, we would like to turn your attention to Dr. Keller of Brown

University Medical School. In July 2001, Dr. Keller and several colleagues

published a widely read study, called Study 329, on the efficacy of Paxil

(paroxetine) to treat adolescent major depression.[8] Study 329 concluded,

“The findings of this study provide evidence of the efficacy and safety of the

SSRI, paroxetine, in the treatment of adolescent major depression.â€[9]

Study 329, however, was clearly flawed—a mere two years later, the United

Kingdom government warned British physicians to not prescribe Paxil for children

due to fears of potential suicide.[10] In May 2004, our own FDA issued a similar

warning.[11]

In early 2007, the BBC’s investigative program Panorama released a documentary

on Paxil and Study 329.[12] The documentary publicized hundreds of secret emails

from GSK, which were uncovered during litigation, that showed GSK knew years

before the publication of Study 329 that Paxil did not provide efficacy in

treating adolescents for depression.

With regards to Study 329 specifically, the BBC reported online about emails

written by a company hired by GSK to provide PR for Study 329.[13] One email

read, “Originally we had planned to do extensive media relations surrounding

this study until we actually viewed the results.â€[14] Another email read,

“Essentially the study did not really show [Paxil] was effective in treating

adolescent depression, which is not something we want to publicize.â€[15]

[Attachment J] The documentary also noted that Dr. Keller published Study 329

with the help of ghostwriter Sally Laden. In an email to Ms. Laden about Study

329, Dr. Keller wrote, “You did a superb job with this. Thank you very much.

It is excellent. Enclosed are some rather minor changes from me…â€[16] But

before the final draft was released to Dr. Keller, Ms. Laden sent it to GSK for

final approval so that the manuscript “can be released to Keller, MD to

submit for publication….†[Attachment K]

 

In June 2008, former Boston Globe reporter Alison Bass published Side Effects, a

book that documents multiple problems with Dr. Keller’s research used in Study

329. Passages of the book discuss internal documents from Brown University

regarding Dr. Keller’s research on Paxil. The documents were provided to Ms.

Bass by Donna , the former assistant administrator in Brown’s department

of psychiatry. Ms. said that data in Study 329 was changed to satisfy the

study’s sponsor, GSK. According to , “Everybody knew we had to keep

[GlaxoKline] happy and give them the results they wanted.â€[17]

Even Brown University’s student newspaper, The Brown Daily Herald, published

an exposé on Dr. Keller’s research and Study 329.[18] Dr. Keller refused to

respond to questions from the paper. An editorial that accompanied this story

stated, “We do believe that [Dr. Keller’s] actions directly affect the

integrity of the University.â€[19] Yet, despite the multiple public

revelations, Brown University has done nothing.

POGO searched the NIH Reporter database of grants and was surprised to find

that, despite all the repetitive controversy, Dr. Keller is still receiving NIH

grants.  Currently, he is the primary investigator on two NIH grants, with

funding in 2010 of $1,341,493. Over the last five years, the NIH has given Dr.

Keller $7 million in grants.[20]

In this last example, as bad as it is, the POGO letter only calls it " flawed. "

It wasn’t just flawed, it was jury-rigged, dry-labbed, whatever term one uses

to say the data was altered to fit the conclusion - by GSK? by Keller? by STI?

all of the above? who knows?  Outright fraud for sure…

I opened with " For every roach you see, there are a hundred behind the walls "

for obvious reasons. This is an example of a practice that is surely more

widespread than just this instance demonstrates. Thacker has his work cut

out for him, and he’s just the guy to do it.

The campaign of GSK to promote Paxil by disguising their advertisments as hard

science published by identified experts while controlling the content through a

professional marketing firm is more than just sleaze. The results were harmful

to their customers - birth defects, suicides, addiction - genuinely bad things

[so much for the old Hippocratic Oath " Do no harm " ]. And the story reads like an

old Greek Tragedy written with Aristotle’s formula from his Poetics. There’s

a character flaw in the main character, apparent in the opening scene that

festers and grows, ultimately bringing his tragic downfall at the end of the

story. That would, of course, apply to Dr. Nemeroff who began by leading a sales

strategy meeting and ended up a paid shill for GSK, bringing colleagues down

with him. But it also applies to GSK and STI who started with a marketing

strategy and ended up participating in corrupted research and fraud.

This is a rotten story, among untold others. How will they ferret out the

others? I’d start by looking for academics with absurdly long cv’s. I’d

look for big-time grant getters, particularly ones who do drug or device trials.

And I’d look for academics who give a lot of promotional talks, AKA CME

presentations. But mostly, there’s a culture, particularly in Psychiatry, of

giving people like this a bye because they bring in money to their Institutions.

The solution is easy. Dry up the money, even if the NIH has to declare a

moratorium on all drug/device trials. If we don’t do that, the NIH/NIMH will

simply go away. And, to state the obvious, our patients deserve better…

Says the American Psychiatric Association [recent past President: Alan

Schatzberg]:



I paid my dues to the APA for a lot of years, so I feel I earned my right to

rebut this silly Statement from the APA:



Unrestricted Grants from Pharmaceutical Companies were Charlie Nemeroff’s

special area of expertise. He always makes this claim - that they come with no

strings attached, no control. He got them by the bucketful while he was at Emory

and used them for all kinds of perks - Grand Rounds speakers, sending residents

to conferences, etc. The loophole is simple. They didn’t have to have any

control, any strings. He was a willing co-conspirator already. They didn’t

even have to say " you scratch my back and I’ll scratch yours. " They were both

already scratching, and simply having someone like him in charge of an academic

department was worth plenty, no matter what he did with the money. This was how

he kept himself so popular - deep pockets from " unrestricted grants. " This

argument isn’t evidence, it’s an indictment. I expect Schatzberg worked the

same scam.



And so the reviewers made suggestions and they were acted on [probably by STI's

writers]. They were playing it straight, but the point is that Nemeroff and

Schatzberg didn’t write it. Whether the ghost-writing was pay-back to Charlie

and Alan for their continued support, or a way to get primary care docs writing

more scripts, or as a way to be loved by the recipients for the freebie - it

doesn’t matter. They signed their names to a book they didn’t write and the

reader didn’t know that. If I found a Faulkner manuscript in my attic

and published it with my name as author, it wouldn’t matter that it was a good

book when they took back my Pulitzer Prize when my deceit was exposed.

This statement by the APA is very " Charlie. " I don’t know Alan Schatzberg, but

I’ve been around and heard a ton about Charlie Nemeroff. He’s no fool.

Plausible deniability is his middle name. Of course he has an explanation for

everything. He always does. I expect partner Schatzberg is equally facile with

excuses. Maybe GSK didn’t exercise any rights of approval. But the point is

that Nemeroff and Schatzberg didn’t write the book, Sally Laden and Diane

Coniglio of STI wrote the book. ly, from all that has transpired, these two

doctors didn’t need to be watched over by the drug companies, particularly

Charlie. He was already leading their marketing meetings. He was one of them…

STI chose Dr. Nemeroff of Emory University as their speaker to lay out

the meeting’s agenda and objectives. Dr. Nemeroff apparently led discussions

on how to “evaluate clinical research/promotional programs†and “generate

information for use in promotion/education.†[Attachment A]

Sent via BlackBerry by AT & T

[Guest guest]

http://1boringoldman.com/index.php/2010/12/01/roaches/

roaches…

Posted on Wednesday 1 December 2010

For every roach you see, there are a hundred behind the walls.

Yesterday’s article in the New York Times [Drug Maker Wrote Book Under 2

Doctors’ Names, Documents Say] was about Dr. Nemeroff, a person of

specific interest to me, so I jumped on the Nemeroff aspect of the story [a

“quintessential resourceâ€â€¦], but that’s not the real center of things.

That New York Times article was in response to a letter from the Project on

Government Oversight to Dr. Francis , Director of the National Institutes

of Health [POGO Letter to NIH on Ghostwriting Academics]. In that letter, POGO

Executive Director le and Investigator Thacker document five

cases where a Marketing Firm, Scientific Therapeutics Information, ghost wrote

scientific presentations, articles, and books that were published by expert

physicians - all was under the direction of the Pharmaceutical Manufacturer,

GlaxoKline.

Before listing the examples, I just want to highlight how " not okay " all of this

is. We’re used to " marketing " " advertising " in our daily lives. Glossy ads

interrupt our reading and media viewing at every possible juncture - even

popping up on our web pages. But science, particularly medical science, is

something else. Simply put, you don’t want your physician prescribing a

medicine for you to take based on the jillion ad brochures he/she receive every

day designed to increase the manufacturers profits. You want that prescription

to represent the best, safest, unbiased information available for the medical

condition you actually have. That’s why reputable medical journals require

that the researcher display the data that supports the conclusions in detail. So

Scientific Therapeutics Information is a very unusual company indeed - an Ad

Agency for scientific data:



reformatted from http://www.stimedinfo.com/service02.htm

POGO’s first example related to a campaign STI did for GSK’s antidepressant,

Paxil:

According to the documents, GSK began to push sales of Paxil in the early 1990s

with an extensive ghostwriting program run by the marketing firm Scientific

Therapeutics Information (STI). For instance, STI wrote a proposal to organize

GlaxoKline’s Paxil Advisory Board Meeting in 1993 at the Ritz Carlton

Hotel in Palm Beach, Florida. STI chose Dr. Nemeroff of Emory University

as their speaker to lay out the meeting’s agenda and objectives. Dr. Nemeroff

apparently led discussions on how to “evaluate clinical research/promotional

programs†and “generate information for use in promotion/education.â€

[Attachment A]

" What in the hell is the then new Chairman of a Department of Psychiatry doing

leading a marketing strategy meeting for a drug company? " you might ask. But

I’ll restrain myself and stick to the topic. Other than Nemeroff’s presence

in this ambiguous role, for a marketing firm to be involved in a sales strategy

meeting is not that unusual. But the next example goes over the top:

Drs. Dwight and Dennis Charney

NIH funding since FY 2006: $30.6 million

NIH funding FY 2010: $10,929,790

According to the documents, Sally Laden of STI wrote an editorial for Biological

Psychiatry in 2003 for Drs. Dwight , Chairman of the Department of

Psychiatry at the University of Pennsylvania School of Medicine, and Dennis

Charney, then an employee at the NIH and now Dean of Research at the Mt. Sinai

School of Medicine at New York University.

In an email to a GSK employee, Ms. Laden wrote, “Is there a problem with my

invoice for writing Dwight ’ editorial for the [Depression and Bipolar

Support Alliance]’s comorbidity issue to Biological Psychiatry?†[Attachment

B] Yet, when published, the “authors†and Charney only stated, “We

acknowledge Sally K. Laden for editorial support.†[Attachment C]

One might think that these guys just weren’t very good writers and needed

grammatical assistance, until you read the part in red - and realize their

editorial was ghost-written under the direction of the drug company

[GlaxoKline]. POGO’s third example I’ve already covered, STI’s

ghost-writing Drs. Nemeroff and Schatzberg’s book under the direction of

GlaxoKline [a “quintessential resourceâ€â€¦].

In case you haven’t noticed, all of these examples involve GlaxoKline,

Paxil, and Scientific Therapeutics Information. That’s because the documents

were unearthed in suits against GSK involving their antidepressant Paxil.

Here’s another example:

Dr. Yonkers

NIH funding since FY 2006: $6.4 million

NIH funding FY 2010: $1,241,257

In 2002, a GSK employee emailed Dr. Yonkers of Yale School of Medicine, writing,

“Attached please find the poster to be presented at the US Psych Congress.

Please provide feedback.†[Attachment G] Other documents make it clear that

Dr. Yonkers was provided at least one ghostwritten study. For instance, the

cover page for a study on Paxil to be published in Psychopharmacology Bulletin

notes that “Draft I†was prepared by Sally Laden and another STI employee.

The top line of the draft even reminds Dr. Yonkers to remove evidence of STI’s

involvement, stating, “STI Cover Page—To be removed before submission.â€

[Attachment H] When the study was later published, it notes that it was funded

by an “unrestricted educational grant†from GSK, but makes no mention of

STI’s involvement in the paper. [Attachment I]

But it’s this last example that takes the grand prize - Study 329 - a Paxil

drug trial in adolescents conducted at Brown University.

Dr. Keller

NIH funding since FY 2006: $7.0 million

NIH funding FY 2010: $1,341,493

Finally, we would like to turn your attention to Dr. Keller of Brown

University Medical School. In July 2001, Dr. Keller and several colleagues

published a widely read study, called Study 329, on the efficacy of Paxil

(paroxetine) to treat adolescent major depression.[8] Study 329 concluded,

“The findings of this study provide evidence of the efficacy and safety of the

SSRI, paroxetine, in the treatment of adolescent major depression.â€[9]

Study 329, however, was clearly flawed—a mere two years later, the United

Kingdom government warned British physicians to not prescribe Paxil for children

due to fears of potential suicide.[10] In May 2004, our own FDA issued a similar

warning.[11]

In early 2007, the BBC’s investigative program Panorama released a documentary

on Paxil and Study 329.[12] The documentary publicized hundreds of secret emails

from GSK, which were uncovered during litigation, that showed GSK knew years

before the publication of Study 329 that Paxil did not provide efficacy in

treating adolescents for depression.

With regards to Study 329 specifically, the BBC reported online about emails

written by a company hired by GSK to provide PR for Study 329.[13] One email

read, “Originally we had planned to do extensive media relations surrounding

this study until we actually viewed the results.â€[14] Another email read,

“Essentially the study did not really show [Paxil] was effective in treating

adolescent depression, which is not something we want to publicize.â€[15]

[Attachment J] The documentary also noted that Dr. Keller published Study 329

with the help of ghostwriter Sally Laden. In an email to Ms. Laden about Study

329, Dr. Keller wrote, “You did a superb job with this. Thank you very much.

It is excellent. Enclosed are some rather minor changes from me…â€[16] But

before the final draft was released to Dr. Keller, Ms. Laden sent it to GSK for

final approval so that the manuscript “can be released to Keller, MD to

submit for publication….†[Attachment K]

 

In June 2008, former Boston Globe reporter Alison Bass published Side Effects, a

book that documents multiple problems with Dr. Keller’s research used in Study

329. Passages of the book discuss internal documents from Brown University

regarding Dr. Keller’s research on Paxil. The documents were provided to Ms.

Bass by Donna , the former assistant administrator in Brown’s department

of psychiatry. Ms. said that data in Study 329 was changed to satisfy the

study’s sponsor, GSK. According to , “Everybody knew we had to keep

[GlaxoKline] happy and give them the results they wanted.â€[17]

Even Brown University’s student newspaper, The Brown Daily Herald, published

an exposé on Dr. Keller’s research and Study 329.[18] Dr. Keller refused to

respond to questions from the paper. An editorial that accompanied this story

stated, “We do believe that [Dr. Keller’s] actions directly affect the

integrity of the University.â€[19] Yet, despite the multiple public

revelations, Brown University has done nothing.

POGO searched the NIH Reporter database of grants and was surprised to find

that, despite all the repetitive controversy, Dr. Keller is still receiving NIH

grants.  Currently, he is the primary investigator on two NIH grants, with

funding in 2010 of $1,341,493. Over the last five years, the NIH has given Dr.

Keller $7 million in grants.[20]

In this last example, as bad as it is, the POGO letter only calls it " flawed. "

It wasn’t just flawed, it was jury-rigged, dry-labbed, whatever term one uses

to say the data was altered to fit the conclusion - by GSK? by Keller? by STI?

all of the above? who knows?  Outright fraud for sure…

I opened with " For every roach you see, there are a hundred behind the walls "

for obvious reasons. This is an example of a practice that is surely more

widespread than just this instance demonstrates. Thacker has his work cut

out for him, and he’s just the guy to do it.

The campaign of GSK to promote Paxil by disguising their advertisments as hard

science published by identified experts while controlling the content through a

professional marketing firm is more than just sleaze. The results were harmful

to their customers - birth defects, suicides, addiction - genuinely bad things

[so much for the old Hippocratic Oath " Do no harm " ]. And the story reads like an

old Greek Tragedy written with Aristotle’s formula from his Poetics. There’s

a character flaw in the main character, apparent in the opening scene that

festers and grows, ultimately bringing his tragic downfall at the end of the

story. That would, of course, apply to Dr. Nemeroff who began by leading a sales

strategy meeting and ended up a paid shill for GSK, bringing colleagues down

with him. But it also applies to GSK and STI who started with a marketing

strategy and ended up participating in corrupted research and fraud.

This is a rotten story, among untold others. How will they ferret out the

others? I’d start by looking for academics with absurdly long cv’s. I’d

look for big-time grant getters, particularly ones who do drug or device trials.

And I’d look for academics who give a lot of promotional talks, AKA CME

presentations. But mostly, there’s a culture, particularly in Psychiatry, of

giving people like this a bye because they bring in money to their Institutions.

The solution is easy. Dry up the money, even if the NIH has to declare a

moratorium on all drug/device trials. If we don’t do that, the NIH/NIMH will

simply go away. And, to state the obvious, our patients deserve better…

Says the American Psychiatric Association [recent past President: Alan

Schatzberg]:



I paid my dues to the APA for a lot of years, so I feel I earned my right to

rebut this silly Statement from the APA:



Unrestricted Grants from Pharmaceutical Companies were Charlie Nemeroff’s

special area of expertise. He always makes this claim - that they come with no

strings attached, no control. He got them by the bucketful while he was at Emory

and used them for all kinds of perks - Grand Rounds speakers, sending residents

to conferences, etc. The loophole is simple. They didn’t have to have any

control, any strings. He was a willing co-conspirator already. They didn’t

even have to say " you scratch my back and I’ll scratch yours. " They were both

already scratching, and simply having someone like him in charge of an academic

department was worth plenty, no matter what he did with the money. This was how

he kept himself so popular - deep pockets from " unrestricted grants. " This

argument isn’t evidence, it’s an indictment. I expect Schatzberg worked the

same scam.



And so the reviewers made suggestions and they were acted on [probably by STI's

writers]. They were playing it straight, but the point is that Nemeroff and

Schatzberg didn’t write it. Whether the ghost-writing was pay-back to Charlie

and Alan for their continued support, or a way to get primary care docs writing

more scripts, or as a way to be loved by the recipients for the freebie - it

doesn’t matter. They signed their names to a book they didn’t write and the

reader didn’t know that. If I found a Faulkner manuscript in my attic

and published it with my name as author, it wouldn’t matter that it was a good

book when they took back my Pulitzer Prize when my deceit was exposed.

This statement by the APA is very " Charlie. " I don’t know Alan Schatzberg, but

I’ve been around and heard a ton about Charlie Nemeroff. He’s no fool.

Plausible deniability is his middle name. Of course he has an explanation for

everything. He always does. I expect partner Schatzberg is equally facile with

excuses. Maybe GSK didn’t exercise any rights of approval. But the point is

that Nemeroff and Schatzberg didn’t write the book, Sally Laden and Diane

Coniglio of STI wrote the book. ly, from all that has transpired, these two

doctors didn’t need to be watched over by the drug companies, particularly

Charlie. He was already leading their marketing meetings. He was one of them…

STI chose Dr. Nemeroff of Emory University as their speaker to lay out

the meeting’s agenda and objectives. Dr. Nemeroff apparently led discussions

on how to “evaluate clinical research/promotional programs†and “generate

information for use in promotion/education.†[Attachment A]

Sent via BlackBerry by AT & T

[Guest guest]

http://1boringoldman.com/index.php/2010/12/01/roaches/

roaches…

Posted on Wednesday 1 December 2010

For every roach you see, there are a hundred behind the walls.

Yesterday’s article in the New York Times [Drug Maker Wrote Book Under 2

Doctors’ Names, Documents Say] was about Dr. Nemeroff, a person of

specific interest to me, so I jumped on the Nemeroff aspect of the story [a

“quintessential resourceâ€â€¦], but that’s not the real center of things.

That New York Times article was in response to a letter from the Project on

Government Oversight to Dr. Francis , Director of the National Institutes

of Health [POGO Letter to NIH on Ghostwriting Academics]. In that letter, POGO

Executive Director le and Investigator Thacker document five

cases where a Marketing Firm, Scientific Therapeutics Information, ghost wrote

scientific presentations, articles, and books that were published by expert

physicians - all was under the direction of the Pharmaceutical Manufacturer,

GlaxoKline.

Before listing the examples, I just want to highlight how " not okay " all of this

is. We’re used to " marketing " " advertising " in our daily lives. Glossy ads

interrupt our reading and media viewing at every possible juncture - even

popping up on our web pages. But science, particularly medical science, is

something else. Simply put, you don’t want your physician prescribing a

medicine for you to take based on the jillion ad brochures he/she receive every

day designed to increase the manufacturers profits. You want that prescription

to represent the best, safest, unbiased information available for the medical

condition you actually have. That’s why reputable medical journals require

that the researcher display the data that supports the conclusions in detail. So

Scientific Therapeutics Information is a very unusual company indeed - an Ad

Agency for scientific data:



reformatted from http://www.stimedinfo.com/service02.htm

POGO’s first example related to a campaign STI did for GSK’s antidepressant,

Paxil:

According to the documents, GSK began to push sales of Paxil in the early 1990s

with an extensive ghostwriting program run by the marketing firm Scientific

Therapeutics Information (STI). For instance, STI wrote a proposal to organize

GlaxoKline’s Paxil Advisory Board Meeting in 1993 at the Ritz Carlton

Hotel in Palm Beach, Florida. STI chose Dr. Nemeroff of Emory University

as their speaker to lay out the meeting’s agenda and objectives. Dr. Nemeroff

apparently led discussions on how to “evaluate clinical research/promotional

programs†and “generate information for use in promotion/education.â€

[Attachment A]

" What in the hell is the then new Chairman of a Department of Psychiatry doing

leading a marketing strategy meeting for a drug company? " you might ask. But

I’ll restrain myself and stick to the topic. Other than Nemeroff’s presence

in this ambiguous role, for a marketing firm to be involved in a sales strategy

meeting is not that unusual. But the next example goes over the top:

Drs. Dwight and Dennis Charney

NIH funding since FY 2006: $30.6 million

NIH funding FY 2010: $10,929,790

According to the documents, Sally Laden of STI wrote an editorial for Biological

Psychiatry in 2003 for Drs. Dwight , Chairman of the Department of

Psychiatry at the University of Pennsylvania School of Medicine, and Dennis

Charney, then an employee at the NIH and now Dean of Research at the Mt. Sinai

School of Medicine at New York University.

In an email to a GSK employee, Ms. Laden wrote, “Is there a problem with my

invoice for writing Dwight ’ editorial for the [Depression and Bipolar

Support Alliance]’s comorbidity issue to Biological Psychiatry?†[Attachment

B] Yet, when published, the “authors†and Charney only stated, “We

acknowledge Sally K. Laden for editorial support.†[Attachment C]

One might think that these guys just weren’t very good writers and needed

grammatical assistance, until you read the part in red - and realize their

editorial was ghost-written under the direction of the drug company

[GlaxoKline]. POGO’s third example I’ve already covered, STI’s

ghost-writing Drs. Nemeroff and Schatzberg’s book under the direction of

GlaxoKline [a “quintessential resourceâ€â€¦].

In case you haven’t noticed, all of these examples involve GlaxoKline,

Paxil, and Scientific Therapeutics Information. That’s because the documents

were unearthed in suits against GSK involving their antidepressant Paxil.

Here’s another example:

Dr. Yonkers

NIH funding since FY 2006: $6.4 million

NIH funding FY 2010: $1,241,257

In 2002, a GSK employee emailed Dr. Yonkers of Yale School of Medicine, writing,

“Attached please find the poster to be presented at the US Psych Congress.

Please provide feedback.†[Attachment G] Other documents make it clear that

Dr. Yonkers was provided at least one ghostwritten study. For instance, the

cover page for a study on Paxil to be published in Psychopharmacology Bulletin

notes that “Draft I†was prepared by Sally Laden and another STI employee.

The top line of the draft even reminds Dr. Yonkers to remove evidence of STI’s

involvement, stating, “STI Cover Page—To be removed before submission.â€

[Attachment H] When the study was later published, it notes that it was funded

by an “unrestricted educational grant†from GSK, but makes no mention of

STI’s involvement in the paper. [Attachment I]

But it’s this last example that takes the grand prize - Study 329 - a Paxil

drug trial in adolescents conducted at Brown University.

Dr. Keller

NIH funding since FY 2006: $7.0 million

NIH funding FY 2010: $1,341,493

Finally, we would like to turn your attention to Dr. Keller of Brown

University Medical School. In July 2001, Dr. Keller and several colleagues

published a widely read study, called Study 329, on the efficacy of Paxil

(paroxetine) to treat adolescent major depression.[8] Study 329 concluded,

“The findings of this study provide evidence of the efficacy and safety of the

SSRI, paroxetine, in the treatment of adolescent major depression.â€[9]

Study 329, however, was clearly flawed—a mere two years later, the United

Kingdom government warned British physicians to not prescribe Paxil for children

due to fears of potential suicide.[10] In May 2004, our own FDA issued a similar

warning.[11]

In early 2007, the BBC’s investigative program Panorama released a documentary

on Paxil and Study 329.[12] The documentary publicized hundreds of secret emails

from GSK, which were uncovered during litigation, that showed GSK knew years

before the publication of Study 329 that Paxil did not provide efficacy in

treating adolescents for depression.

With regards to Study 329 specifically, the BBC reported online about emails

written by a company hired by GSK to provide PR for Study 329.[13] One email

read, “Originally we had planned to do extensive media relations surrounding

this study until we actually viewed the results.â€[14] Another email read,

“Essentially the study did not really show [Paxil] was effective in treating

adolescent depression, which is not something we want to publicize.â€[15]

[Attachment J] The documentary also noted that Dr. Keller published Study 329

with the help of ghostwriter Sally Laden. In an email to Ms. Laden about Study

329, Dr. Keller wrote, “You did a superb job with this. Thank you very much.

It is excellent. Enclosed are some rather minor changes from me…â€[16] But

before the final draft was released to Dr. Keller, Ms. Laden sent it to GSK for

final approval so that the manuscript “can be released to Keller, MD to

submit for publication….†[Attachment K]

 

In June 2008, former Boston Globe reporter Alison Bass published Side Effects, a

book that documents multiple problems with Dr. Keller’s research used in Study

329. Passages of the book discuss internal documents from Brown University

regarding Dr. Keller’s research on Paxil. The documents were provided to Ms.

Bass by Donna , the former assistant administrator in Brown’s department

of psychiatry. Ms. said that data in Study 329 was changed to satisfy the

study’s sponsor, GSK. According to , “Everybody knew we had to keep

[GlaxoKline] happy and give them the results they wanted.â€[17]

Even Brown University’s student newspaper, The Brown Daily Herald, published

an exposé on Dr. Keller’s research and Study 329.[18] Dr. Keller refused to

respond to questions from the paper. An editorial that accompanied this story

stated, “We do believe that [Dr. Keller’s] actions directly affect the

integrity of the University.â€[19] Yet, despite the multiple public

revelations, Brown University has done nothing.

POGO searched the NIH Reporter database of grants and was surprised to find

that, despite all the repetitive controversy, Dr. Keller is still receiving NIH

grants.  Currently, he is the primary investigator on two NIH grants, with

funding in 2010 of $1,341,493. Over the last five years, the NIH has given Dr.

Keller $7 million in grants.[20]

In this last example, as bad as it is, the POGO letter only calls it " flawed. "

It wasn’t just flawed, it was jury-rigged, dry-labbed, whatever term one uses

to say the data was altered to fit the conclusion - by GSK? by Keller? by STI?

all of the above? who knows?  Outright fraud for sure…

I opened with " For every roach you see, there are a hundred behind the walls "

for obvious reasons. This is an example of a practice that is surely more

widespread than just this instance demonstrates. Thacker has his work cut

out for him, and he’s just the guy to do it.

The campaign of GSK to promote Paxil by disguising their advertisments as hard

science published by identified experts while controlling the content through a

professional marketing firm is more than just sleaze. The results were harmful

to their customers - birth defects, suicides, addiction - genuinely bad things

[so much for the old Hippocratic Oath " Do no harm " ]. And the story reads like an

old Greek Tragedy written with Aristotle’s formula from his Poetics. There’s

a character flaw in the main character, apparent in the opening scene that

festers and grows, ultimately bringing his tragic downfall at the end of the

story. That would, of course, apply to Dr. Nemeroff who began by leading a sales

strategy meeting and ended up a paid shill for GSK, bringing colleagues down

with him. But it also applies to GSK and STI who started with a marketing

strategy and ended up participating in corrupted research and fraud.

This is a rotten story, among untold others. How will they ferret out the

others? I’d start by looking for academics with absurdly long cv’s. I’d

look for big-time grant getters, particularly ones who do drug or device trials.

And I’d look for academics who give a lot of promotional talks, AKA CME

presentations. But mostly, there’s a culture, particularly in Psychiatry, of

giving people like this a bye because they bring in money to their Institutions.

The solution is easy. Dry up the money, even if the NIH has to declare a

moratorium on all drug/device trials. If we don’t do that, the NIH/NIMH will

simply go away. And, to state the obvious, our patients deserve better…

Says the American Psychiatric Association [recent past President: Alan

Schatzberg]:



I paid my dues to the APA for a lot of years, so I feel I earned my right to

rebut this silly Statement from the APA:



Unrestricted Grants from Pharmaceutical Companies were Charlie Nemeroff’s

special area of expertise. He always makes this claim - that they come with no

strings attached, no control. He got them by the bucketful while he was at Emory

and used them for all kinds of perks - Grand Rounds speakers, sending residents

to conferences, etc. The loophole is simple. They didn’t have to have any

control, any strings. He was a willing co-conspirator already. They didn’t

even have to say " you scratch my back and I’ll scratch yours. " They were both

already scratching, and simply having someone like him in charge of an academic

department was worth plenty, no matter what he did with the money. This was how

he kept himself so popular - deep pockets from " unrestricted grants. " This

argument isn’t evidence, it’s an indictment. I expect Schatzberg worked the

same scam.



And so the reviewers made suggestions and they were acted on [probably by STI's

writers]. They were playing it straight, but the point is that Nemeroff and

Schatzberg didn’t write it. Whether the ghost-writing was pay-back to Charlie

and Alan for their continued support, or a way to get primary care docs writing

more scripts, or as a way to be loved by the recipients for the freebie - it

doesn’t matter. They signed their names to a book they didn’t write and the

reader didn’t know that. If I found a Faulkner manuscript in my attic

and published it with my name as author, it wouldn’t matter that it was a good

book when they took back my Pulitzer Prize when my deceit was exposed.

This statement by the APA is very " Charlie. " I don’t know Alan Schatzberg, but

I’ve been around and heard a ton about Charlie Nemeroff. He’s no fool.

Plausible deniability is his middle name. Of course he has an explanation for

everything. He always does. I expect partner Schatzberg is equally facile with

excuses. Maybe GSK didn’t exercise any rights of approval. But the point is

that Nemeroff and Schatzberg didn’t write the book, Sally Laden and Diane

Coniglio of STI wrote the book. ly, from all that has transpired, these two

doctors didn’t need to be watched over by the drug companies, particularly

Charlie. He was already leading their marketing meetings. He was one of them…

STI chose Dr. Nemeroff of Emory University as their speaker to lay out

the meeting’s agenda and objectives. Dr. Nemeroff apparently led discussions

on how to “evaluate clinical research/promotional programs†and “generate

information for use in promotion/education.†[Attachment A]

Sent via BlackBerry by AT & T