Disgraced FDA Official Goes Back to Big Pharma

[Guest guest]

http://www.alternet.org/healthwellness/72513/?page=entire

Disgraced FDA Official Goes Back to Big Pharma

By Martha Rosenberg, AlterNet

Posted on January 8, 2008, Printed on January 9, 2008

http://www.alternet.org/story/72513/

As a 33-year-old Wall Street insider known for recommending hot medical stocks,

physician Gottlieb was a surprising choice for FDA deputy commissioner for

medical and scientific affairs, an appointment named in 2005.

" Gottlieb has an orientation which belies the goal of the FDA, " said Dr. Jerome

Kassirer, former editor of The New England Journal of Medicine.

" The appointment comes out of nowhere, " said former FDA Commissioner

Kennedy.

" Anything but a reassuring signal, " said Time magazine.

As critics feared, soon after assuming the number two FDA position, Gottlieb had

to recuse himself from resource planning for a possible bird flu epidemic

because of financial ties to Roche and Sanofi-Aventis. He also had to bow out of

work related to Eli Lilly, Proctor & Gamble and five other drug companies.

When three people in a multiple sclerosis drug trial lost blood platelets and

one died, he called stopping the study " an overreaction " because the disease,

not the drug, might be to blame.

And when FDA scientists rejected Pfizer's osteoporosis drug candidate Oporia,

forecast to earn $1 billion a year, underlings received accusatory emails from

Gottlieb.

His on-to-Wall-Street approach succeeded in rushing Chantix, Pfizer's

stop-smoking drug, varenicline, to the market, but a string of suicides and the

violent death of Dallas musician Albrecht in 2006 left many asking if

that was such a good thing.

" The truth is, the FDA's required trials reveal limited information, " Gottlieb

wrote presciently in an op-ed in the Chicago Tribune in 2005. " In many cases, it

is only after ... drugs are on the market for many years and given to thousands

of patients that their true benefits [sic] are revealed. "

Gottlieb even trashed the definitive Women's Health Initiative (WHI) study that

found that hormone replacement therapy (HRT) was bad for women's health saying

the results " were rushed to print with a cleverly orchestrated PR blitz. "

Now that he's left the FDA, Gottlieb is helping sell Lilly's osteoporosis drug

Evista which the company was convicted in 2005 of marketing, off label, for

anti-cancer and heart disease purposes.

In an angry December op-ed in the Wall Street Journal, Gottlieb wrote that since

Evista has now been approved to reduce the risk of developing some breast

cancers, doesn't that transform Lilly's " speech 'crime,' by some measures, into

a public service? "

Penalizing Lilly's off-label promotion of Evista may have proved " fatal " for

" patients and doctors who rely on the latest clinical information to make hard

decisions, " Gottlieb said, implying physicians are lost without input from drug

reps with Bachelor of Science degrees.

But of course this is not the first time Lilly has had " free speech " problems.

In October, the FDA told Lilly to stop falsely claiming that antidepressant

Cymbalta produced " significantly less pain interference with overall

functioning " and start mentioning its side effect of liver toxicity.

And documents from its Viva Zyprexa campaign show Lilly marketed the atypical

antipsychotic for off label use among elderly patients though an increased risk

of death in older patients is a warning on its own label.

Nor is Evista a misunderstood wonder drug.

Launched in 1998 to disappointing results, Justice Department documents reveal

Lilly brand managers decided to market off label uses for Evista to boost sales.

And when 20 million women quit HRT in the early 2000's, marketing Evista

(raloxifene), a selective estrogen receptor modulator (SERM), as a kind of

anti-estrogen or good estrogen made sense.

Like HRT, researchers hinted Evista was an all purpose, youth giving drug, not

just for preventing and treating osteoporosis but also for reducing the risk of

some types of breast cancer and heart attack, stroke or other cardiovascular

problems in at risk patients.

Dr. Barrett-Connor, head of epidemiology at the University of

California, San Diego called a 2002 Evista study, " exciting because it offers

new hope in treating heart disease, the biggest killer of women, while at the

same time strengthening their bones. "

Barrett-Connor also assured the public that hormone therapy had " no significant

effect on the risk for stroke among postmenopausal women with coronary disease "

in an article in the American Heart Association's journal, Circulation, in 2001,

paid for by hormone maker Wyeth-Ayerst Research.

Unfortunately, Evista is a little too much like HRT, which, contrary to what

appeared in Circulation, causes a 26 percent increased risk of breast cancer, 29

percent increased risk of heart attack, 41 percent increased risk of stroke, and

100 percent increased risk of blood clots according to WHI figures.

Not only does Evista cause lethal blood clots -- its warning label says

" Increased risk of Venous Thromboembolism and Death From Stroke " -- it increases

the risk of ovarian cancer according to some clinicians.

" Evista induces ovarian cancer in both mice and rats, " wrote Dr. S.

Epstein, professor of environmental medicine at the University of Illinois

School of Public Health in the Chicago Tribune in 1998. " Furthermore,

carcinogenic effects were noted at dosages well below the recommended

therapeutic level. "

In 2001 scientists at the University of Southern California also found Evista

stimulated the growth of ovarian cancer cells.

" In breast and uterine cancer it does not appear to be a problem; in ovarian

cancer it may stimulate the cells, " said Dr. son, a professor of

obstetrics and gynecology, referring to laboratory studies.

Evista advertising is also like HRT, relying on ageism, sexism and

fear-mongering to sell itself with the patronizing tag line, Protect Her Bones

Protect Her Breasts, and a female model symbolically covering her breasts with

her arms.

No, off label marketing of Evista is not a public service. But Gottlieb's

departure from the FDA might be.

© 2008 Independent Media Institute. All rights reserved.

View this story online at: http://www.alternet.org/story/72513/

[Guest guest]

http://www.alternet.org/healthwellness/72513/?page=entire

Disgraced FDA Official Goes Back to Big Pharma

By Martha Rosenberg, AlterNet

Posted on January 8, 2008, Printed on January 9, 2008

http://www.alternet.org/story/72513/

As a 33-year-old Wall Street insider known for recommending hot medical stocks,

physician Gottlieb was a surprising choice for FDA deputy commissioner for

medical and scientific affairs, an appointment named in 2005.

" Gottlieb has an orientation which belies the goal of the FDA, " said Dr. Jerome

Kassirer, former editor of The New England Journal of Medicine.

" The appointment comes out of nowhere, " said former FDA Commissioner

Kennedy.

" Anything but a reassuring signal, " said Time magazine.

As critics feared, soon after assuming the number two FDA position, Gottlieb had

to recuse himself from resource planning for a possible bird flu epidemic

because of financial ties to Roche and Sanofi-Aventis. He also had to bow out of

work related to Eli Lilly, Proctor & Gamble and five other drug companies.

When three people in a multiple sclerosis drug trial lost blood platelets and

one died, he called stopping the study " an overreaction " because the disease,

not the drug, might be to blame.

And when FDA scientists rejected Pfizer's osteoporosis drug candidate Oporia,

forecast to earn $1 billion a year, underlings received accusatory emails from

Gottlieb.

His on-to-Wall-Street approach succeeded in rushing Chantix, Pfizer's

stop-smoking drug, varenicline, to the market, but a string of suicides and the

violent death of Dallas musician Albrecht in 2006 left many asking if

that was such a good thing.

" The truth is, the FDA's required trials reveal limited information, " Gottlieb

wrote presciently in an op-ed in the Chicago Tribune in 2005. " In many cases, it

is only after ... drugs are on the market for many years and given to thousands

of patients that their true benefits [sic] are revealed. "

Gottlieb even trashed the definitive Women's Health Initiative (WHI) study that

found that hormone replacement therapy (HRT) was bad for women's health saying

the results " were rushed to print with a cleverly orchestrated PR blitz. "

Now that he's left the FDA, Gottlieb is helping sell Lilly's osteoporosis drug

Evista which the company was convicted in 2005 of marketing, off label, for

anti-cancer and heart disease purposes.

In an angry December op-ed in the Wall Street Journal, Gottlieb wrote that since

Evista has now been approved to reduce the risk of developing some breast

cancers, doesn't that transform Lilly's " speech 'crime,' by some measures, into

a public service? "

Penalizing Lilly's off-label promotion of Evista may have proved " fatal " for

" patients and doctors who rely on the latest clinical information to make hard

decisions, " Gottlieb said, implying physicians are lost without input from drug

reps with Bachelor of Science degrees.

But of course this is not the first time Lilly has had " free speech " problems.

In October, the FDA told Lilly to stop falsely claiming that antidepressant

Cymbalta produced " significantly less pain interference with overall

functioning " and start mentioning its side effect of liver toxicity.

And documents from its Viva Zyprexa campaign show Lilly marketed the atypical

antipsychotic for off label use among elderly patients though an increased risk

of death in older patients is a warning on its own label.

Nor is Evista a misunderstood wonder drug.

Launched in 1998 to disappointing results, Justice Department documents reveal

Lilly brand managers decided to market off label uses for Evista to boost sales.

And when 20 million women quit HRT in the early 2000's, marketing Evista

(raloxifene), a selective estrogen receptor modulator (SERM), as a kind of

anti-estrogen or good estrogen made sense.

Like HRT, researchers hinted Evista was an all purpose, youth giving drug, not

just for preventing and treating osteoporosis but also for reducing the risk of

some types of breast cancer and heart attack, stroke or other cardiovascular

problems in at risk patients.

Dr. Barrett-Connor, head of epidemiology at the University of

California, San Diego called a 2002 Evista study, " exciting because it offers

new hope in treating heart disease, the biggest killer of women, while at the

same time strengthening their bones. "

Barrett-Connor also assured the public that hormone therapy had " no significant

effect on the risk for stroke among postmenopausal women with coronary disease "

in an article in the American Heart Association's journal, Circulation, in 2001,

paid for by hormone maker Wyeth-Ayerst Research.

Unfortunately, Evista is a little too much like HRT, which, contrary to what

appeared in Circulation, causes a 26 percent increased risk of breast cancer, 29

percent increased risk of heart attack, 41 percent increased risk of stroke, and

100 percent increased risk of blood clots according to WHI figures.

Not only does Evista cause lethal blood clots -- its warning label says

" Increased risk of Venous Thromboembolism and Death From Stroke " -- it increases

the risk of ovarian cancer according to some clinicians.

" Evista induces ovarian cancer in both mice and rats, " wrote Dr. S.

Epstein, professor of environmental medicine at the University of Illinois

School of Public Health in the Chicago Tribune in 1998. " Furthermore,

carcinogenic effects were noted at dosages well below the recommended

therapeutic level. "

In 2001 scientists at the University of Southern California also found Evista

stimulated the growth of ovarian cancer cells.

" In breast and uterine cancer it does not appear to be a problem; in ovarian

cancer it may stimulate the cells, " said Dr. son, a professor of

obstetrics and gynecology, referring to laboratory studies.

Evista advertising is also like HRT, relying on ageism, sexism and

fear-mongering to sell itself with the patronizing tag line, Protect Her Bones

Protect Her Breasts, and a female model symbolically covering her breasts with

her arms.

No, off label marketing of Evista is not a public service. But Gottlieb's

departure from the FDA might be.

© 2008 Independent Media Institute. All rights reserved.

View this story online at: http://www.alternet.org/story/72513/

[Guest guest]

http://www.alternet.org/healthwellness/72513/?page=entire

Disgraced FDA Official Goes Back to Big Pharma

By Martha Rosenberg, AlterNet

Posted on January 8, 2008, Printed on January 9, 2008

http://www.alternet.org/story/72513/

As a 33-year-old Wall Street insider known for recommending hot medical stocks,

physician Gottlieb was a surprising choice for FDA deputy commissioner for

medical and scientific affairs, an appointment named in 2005.

" Gottlieb has an orientation which belies the goal of the FDA, " said Dr. Jerome

Kassirer, former editor of The New England Journal of Medicine.

" The appointment comes out of nowhere, " said former FDA Commissioner

Kennedy.

" Anything but a reassuring signal, " said Time magazine.

As critics feared, soon after assuming the number two FDA position, Gottlieb had

to recuse himself from resource planning for a possible bird flu epidemic

because of financial ties to Roche and Sanofi-Aventis. He also had to bow out of

work related to Eli Lilly, Proctor & Gamble and five other drug companies.

When three people in a multiple sclerosis drug trial lost blood platelets and

one died, he called stopping the study " an overreaction " because the disease,

not the drug, might be to blame.

And when FDA scientists rejected Pfizer's osteoporosis drug candidate Oporia,

forecast to earn $1 billion a year, underlings received accusatory emails from

Gottlieb.

His on-to-Wall-Street approach succeeded in rushing Chantix, Pfizer's

stop-smoking drug, varenicline, to the market, but a string of suicides and the

violent death of Dallas musician Albrecht in 2006 left many asking if

that was such a good thing.

" The truth is, the FDA's required trials reveal limited information, " Gottlieb

wrote presciently in an op-ed in the Chicago Tribune in 2005. " In many cases, it

is only after ... drugs are on the market for many years and given to thousands

of patients that their true benefits [sic] are revealed. "

Gottlieb even trashed the definitive Women's Health Initiative (WHI) study that

found that hormone replacement therapy (HRT) was bad for women's health saying

the results " were rushed to print with a cleverly orchestrated PR blitz. "

Now that he's left the FDA, Gottlieb is helping sell Lilly's osteoporosis drug

Evista which the company was convicted in 2005 of marketing, off label, for

anti-cancer and heart disease purposes.

In an angry December op-ed in the Wall Street Journal, Gottlieb wrote that since

Evista has now been approved to reduce the risk of developing some breast

cancers, doesn't that transform Lilly's " speech 'crime,' by some measures, into

a public service? "

Penalizing Lilly's off-label promotion of Evista may have proved " fatal " for

" patients and doctors who rely on the latest clinical information to make hard

decisions, " Gottlieb said, implying physicians are lost without input from drug

reps with Bachelor of Science degrees.

But of course this is not the first time Lilly has had " free speech " problems.

In October, the FDA told Lilly to stop falsely claiming that antidepressant

Cymbalta produced " significantly less pain interference with overall

functioning " and start mentioning its side effect of liver toxicity.

And documents from its Viva Zyprexa campaign show Lilly marketed the atypical

antipsychotic for off label use among elderly patients though an increased risk

of death in older patients is a warning on its own label.

Nor is Evista a misunderstood wonder drug.

Launched in 1998 to disappointing results, Justice Department documents reveal

Lilly brand managers decided to market off label uses for Evista to boost sales.

And when 20 million women quit HRT in the early 2000's, marketing Evista

(raloxifene), a selective estrogen receptor modulator (SERM), as a kind of

anti-estrogen or good estrogen made sense.

Like HRT, researchers hinted Evista was an all purpose, youth giving drug, not

just for preventing and treating osteoporosis but also for reducing the risk of

some types of breast cancer and heart attack, stroke or other cardiovascular

problems in at risk patients.

Dr. Barrett-Connor, head of epidemiology at the University of

California, San Diego called a 2002 Evista study, " exciting because it offers

new hope in treating heart disease, the biggest killer of women, while at the

same time strengthening their bones. "

Barrett-Connor also assured the public that hormone therapy had " no significant

effect on the risk for stroke among postmenopausal women with coronary disease "

in an article in the American Heart Association's journal, Circulation, in 2001,

paid for by hormone maker Wyeth-Ayerst Research.

Unfortunately, Evista is a little too much like HRT, which, contrary to what

appeared in Circulation, causes a 26 percent increased risk of breast cancer, 29

percent increased risk of heart attack, 41 percent increased risk of stroke, and

100 percent increased risk of blood clots according to WHI figures.

Not only does Evista cause lethal blood clots -- its warning label says

" Increased risk of Venous Thromboembolism and Death From Stroke " -- it increases

the risk of ovarian cancer according to some clinicians.

" Evista induces ovarian cancer in both mice and rats, " wrote Dr. S.

Epstein, professor of environmental medicine at the University of Illinois

School of Public Health in the Chicago Tribune in 1998. " Furthermore,

carcinogenic effects were noted at dosages well below the recommended

therapeutic level. "

In 2001 scientists at the University of Southern California also found Evista

stimulated the growth of ovarian cancer cells.

" In breast and uterine cancer it does not appear to be a problem; in ovarian

cancer it may stimulate the cells, " said Dr. son, a professor of

obstetrics and gynecology, referring to laboratory studies.

Evista advertising is also like HRT, relying on ageism, sexism and

fear-mongering to sell itself with the patronizing tag line, Protect Her Bones

Protect Her Breasts, and a female model symbolically covering her breasts with

her arms.

No, off label marketing of Evista is not a public service. But Gottlieb's

departure from the FDA might be.

© 2008 Independent Media Institute. All rights reserved.

View this story online at: http://www.alternet.org/story/72513/

[Guest guest]

http://www.alternet.org/healthwellness/72513/?page=entire

Disgraced FDA Official Goes Back to Big Pharma

By Martha Rosenberg, AlterNet

Posted on January 8, 2008, Printed on January 9, 2008

http://www.alternet.org/story/72513/

As a 33-year-old Wall Street insider known for recommending hot medical stocks,

physician Gottlieb was a surprising choice for FDA deputy commissioner for

medical and scientific affairs, an appointment named in 2005.

" Gottlieb has an orientation which belies the goal of the FDA, " said Dr. Jerome

Kassirer, former editor of The New England Journal of Medicine.

" The appointment comes out of nowhere, " said former FDA Commissioner

Kennedy.

" Anything but a reassuring signal, " said Time magazine.

As critics feared, soon after assuming the number two FDA position, Gottlieb had

to recuse himself from resource planning for a possible bird flu epidemic

because of financial ties to Roche and Sanofi-Aventis. He also had to bow out of

work related to Eli Lilly, Proctor & Gamble and five other drug companies.

When three people in a multiple sclerosis drug trial lost blood platelets and

one died, he called stopping the study " an overreaction " because the disease,

not the drug, might be to blame.

And when FDA scientists rejected Pfizer's osteoporosis drug candidate Oporia,

forecast to earn $1 billion a year, underlings received accusatory emails from

Gottlieb.

His on-to-Wall-Street approach succeeded in rushing Chantix, Pfizer's

stop-smoking drug, varenicline, to the market, but a string of suicides and the

violent death of Dallas musician Albrecht in 2006 left many asking if

that was such a good thing.

" The truth is, the FDA's required trials reveal limited information, " Gottlieb

wrote presciently in an op-ed in the Chicago Tribune in 2005. " In many cases, it

is only after ... drugs are on the market for many years and given to thousands

of patients that their true benefits [sic] are revealed. "

Gottlieb even trashed the definitive Women's Health Initiative (WHI) study that

found that hormone replacement therapy (HRT) was bad for women's health saying

the results " were rushed to print with a cleverly orchestrated PR blitz. "

Now that he's left the FDA, Gottlieb is helping sell Lilly's osteoporosis drug

Evista which the company was convicted in 2005 of marketing, off label, for

anti-cancer and heart disease purposes.

In an angry December op-ed in the Wall Street Journal, Gottlieb wrote that since

Evista has now been approved to reduce the risk of developing some breast

cancers, doesn't that transform Lilly's " speech 'crime,' by some measures, into

a public service? "

Penalizing Lilly's off-label promotion of Evista may have proved " fatal " for

" patients and doctors who rely on the latest clinical information to make hard

decisions, " Gottlieb said, implying physicians are lost without input from drug

reps with Bachelor of Science degrees.

But of course this is not the first time Lilly has had " free speech " problems.

In October, the FDA told Lilly to stop falsely claiming that antidepressant

Cymbalta produced " significantly less pain interference with overall

functioning " and start mentioning its side effect of liver toxicity.

And documents from its Viva Zyprexa campaign show Lilly marketed the atypical

antipsychotic for off label use among elderly patients though an increased risk

of death in older patients is a warning on its own label.

Nor is Evista a misunderstood wonder drug.

Launched in 1998 to disappointing results, Justice Department documents reveal

Lilly brand managers decided to market off label uses for Evista to boost sales.

And when 20 million women quit HRT in the early 2000's, marketing Evista

(raloxifene), a selective estrogen receptor modulator (SERM), as a kind of

anti-estrogen or good estrogen made sense.

Like HRT, researchers hinted Evista was an all purpose, youth giving drug, not

just for preventing and treating osteoporosis but also for reducing the risk of

some types of breast cancer and heart attack, stroke or other cardiovascular

problems in at risk patients.

Dr. Barrett-Connor, head of epidemiology at the University of

California, San Diego called a 2002 Evista study, " exciting because it offers

new hope in treating heart disease, the biggest killer of women, while at the

same time strengthening their bones. "

Barrett-Connor also assured the public that hormone therapy had " no significant

effect on the risk for stroke among postmenopausal women with coronary disease "

in an article in the American Heart Association's journal, Circulation, in 2001,

paid for by hormone maker Wyeth-Ayerst Research.

Unfortunately, Evista is a little too much like HRT, which, contrary to what

appeared in Circulation, causes a 26 percent increased risk of breast cancer, 29

percent increased risk of heart attack, 41 percent increased risk of stroke, and

100 percent increased risk of blood clots according to WHI figures.

Not only does Evista cause lethal blood clots -- its warning label says

" Increased risk of Venous Thromboembolism and Death From Stroke " -- it increases

the risk of ovarian cancer according to some clinicians.

" Evista induces ovarian cancer in both mice and rats, " wrote Dr. S.

Epstein, professor of environmental medicine at the University of Illinois

School of Public Health in the Chicago Tribune in 1998. " Furthermore,

carcinogenic effects were noted at dosages well below the recommended

therapeutic level. "

In 2001 scientists at the University of Southern California also found Evista

stimulated the growth of ovarian cancer cells.

" In breast and uterine cancer it does not appear to be a problem; in ovarian

cancer it may stimulate the cells, " said Dr. son, a professor of

obstetrics and gynecology, referring to laboratory studies.

Evista advertising is also like HRT, relying on ageism, sexism and

fear-mongering to sell itself with the patronizing tag line, Protect Her Bones

Protect Her Breasts, and a female model symbolically covering her breasts with

her arms.

No, off label marketing of Evista is not a public service. But Gottlieb's

departure from the FDA might be.

© 2008 Independent Media Institute. All rights reserved.

View this story online at: http://www.alternet.org/story/72513/