FDA Accused of Silencing Vioxx Warnings

[Guest guest]

" ........A " picture is emerging of an agency that can't see

the

forest for the

trees, " Grassley said. " Merck knew it had trouble on its hands and

took

action. At the same time, instead of acting as a public watchdog,

the Food

and Drug Administration was busy challenging its own expert and

calling his

work 'scientific rumor.'.............. "

http://news./news?

tmpl=story & cid=534 & u=/ap/20041008/ap_on_he_me/fda_vio\

xx_worries & printer=1

By DIEDTRA HENDERSON, AP Science Writer

WASHINGTON - The Food and Drug Administration (news - web sites)

silenced

one of its drug experts who raised safety concerns weeks before

Merck & Co.

yanked the blockbuster drug Vioxx due to increased risks for heart

attack

and strokes, the chairman of the Senate Finance Committee said

Thursday.

Dr. J. Graham, associate director for science in the FDA

(news - web

sites) Drug Center's Office of Drug Safety, told Senate

investigators he

faced stiff resistance within the regulatory agency to his findings.

" Dr. Graham described an environment where he

was 'ostracized,' 'subjected

to veiled threats' and 'intimidation,' " Sen. Chuck Grassley, R-Iowa,

said in

a statement after Finance Committee investigators interviewed the

researcher

Thursday.

Graham told The Associated Press that Grassley's characterization was

accurate. Raising safety concerns within the agency is " extremely

difficult, " the 20-year employee said, declining further comment.

In a prepared statement, the FDA said it " values open discussion and

frank

exchange about scientific and medical issues " and subjects its

scientists to

" more rigorous " scrutiny than typical scientific peer reviews. The

Government Accountability Office, an investigative arm of Congress,

already

has been asked to look into whether the FDA muzzled another staffer

who

linked antidepressants to raising the odds of children suffering

suicidal

tendencies. When Merck voluntarily pulled Vioxx from the market on

Sept. 30,

the GAO was asked to roll the FDA's handling of that controversy

into its

inquiry.

That report is not expected for months. Grassley's committee is one

of three

in Congress also scrutinizing the FDA's actions.

A " picture is emerging of an agency that can't see the forest for the

trees, " Grassley said. " Merck knew it had trouble on its hands and

took

action. At the same time, instead of acting as a public watchdog,

the Food

and Drug Administration was busy challenging its own expert and

calling his

work 'scientific rumor.' "

Graham was lead author on a research project that studied the

records of

1.39 million Kaiser Permanente patients, including 40,405 treated

with

Pfizer's Celebrex and 26,748 treated with Vioxx. The study found

that high

doses of Vioxx, known as rofecoxib, tripled risks of heart attacks

and

sudden cardiac death.

The research team's original conclusion said that high doses of

Vioxx should

not be prescribed or used.

Graham, scheduled to present those findings in late August during an

epidemiology conference in France, said he ran into resistance when

the FDA

reviewed his abstract.

" I think the recommendation about high dose rofecoxib is unnecessary

and

particularly problematic since FDA funded this study and 's

travel to

France to present it, " Anne E. Trontell, deputy director of the

FDA's Office

of Drug Safety, wrote in an Aug. 12 e-mail.

The internal e-mail exchange was released by Grassley.

In the e-mail, Trontell suggested that Graham defer his presentation

in

favor of a journal article so dissenting scientists - including

within the

FDA - could comment.

She also said Merck should be alerted before the findings became

public " so

they can be prepared for extensive media attention that this will

likely

provoke. "

Others within the agency suggested Graham's conclusion was too

strongly

worded, given the FDA had not added such warnings to Vioxx labels.

" I've gone about as far as I can without compromising my deeply held

conclusions about this safety question, " Graham replied in an Aug. 13

e-mail.

The FDA said such discussions are typical before scientific findings

are

published.

The conclusion Graham presented in France was revised: " This and

other

studies cast serious doubt on the safety " of Vioxx doses higher than

25 mg.

per day.

The FDA said that Graham decided to revise his abstract

conclusion. " He did

so voluntarily, " the agency said.

In testimony before a congressional panel in mid-September,

Mosholder, an FDA epidemiologist, said his bosses asked him to soften

recommendations about antidepressants.

Mosholder's analysis pointed to increased suicidal thoughts and

behaviors

among children taking antidepressants well before federal advisers

pushed

for strident warnings on the drugs. He suggested preferential use of

Prozac,

the only drug approved to treat depressed children and - according

to his

review - the one with the lowest risk.

His supervisors within the FDA told him to suggest that children use

such

medications " with caution, " Mosholder told the Congressional panel.

Dr. Seligman, acting director of the FDA's Office of Drug

Safety, said

the agency did not pressure Mosholder to change his conclusion.

___

On the Net:

FDA: http://www.fda.gov/

[Guest guest]

" ........A " picture is emerging of an agency that can't see

the

forest for the

trees, " Grassley said. " Merck knew it had trouble on its hands and

took

action. At the same time, instead of acting as a public watchdog,

the Food

and Drug Administration was busy challenging its own expert and

calling his

work 'scientific rumor.'.............. "

http://news./news?

tmpl=story & cid=534 & u=/ap/20041008/ap_on_he_me/fda_vio\

xx_worries & printer=1

By DIEDTRA HENDERSON, AP Science Writer

WASHINGTON - The Food and Drug Administration (news - web sites)

silenced

one of its drug experts who raised safety concerns weeks before

Merck & Co.

yanked the blockbuster drug Vioxx due to increased risks for heart

attack

and strokes, the chairman of the Senate Finance Committee said

Thursday.

Dr. J. Graham, associate director for science in the FDA

(news - web

sites) Drug Center's Office of Drug Safety, told Senate

investigators he

faced stiff resistance within the regulatory agency to his findings.

" Dr. Graham described an environment where he

was 'ostracized,' 'subjected

to veiled threats' and 'intimidation,' " Sen. Chuck Grassley, R-Iowa,

said in

a statement after Finance Committee investigators interviewed the

researcher

Thursday.

Graham told The Associated Press that Grassley's characterization was

accurate. Raising safety concerns within the agency is " extremely

difficult, " the 20-year employee said, declining further comment.

In a prepared statement, the FDA said it " values open discussion and

frank

exchange about scientific and medical issues " and subjects its

scientists to

" more rigorous " scrutiny than typical scientific peer reviews. The

Government Accountability Office, an investigative arm of Congress,

already

has been asked to look into whether the FDA muzzled another staffer

who

linked antidepressants to raising the odds of children suffering

suicidal

tendencies. When Merck voluntarily pulled Vioxx from the market on

Sept. 30,

the GAO was asked to roll the FDA's handling of that controversy

into its

inquiry.

That report is not expected for months. Grassley's committee is one

of three

in Congress also scrutinizing the FDA's actions.

A " picture is emerging of an agency that can't see the forest for the

trees, " Grassley said. " Merck knew it had trouble on its hands and

took

action. At the same time, instead of acting as a public watchdog,

the Food

and Drug Administration was busy challenging its own expert and

calling his

work 'scientific rumor.' "

Graham was lead author on a research project that studied the

records of

1.39 million Kaiser Permanente patients, including 40,405 treated

with

Pfizer's Celebrex and 26,748 treated with Vioxx. The study found

that high

doses of Vioxx, known as rofecoxib, tripled risks of heart attacks

and

sudden cardiac death.

The research team's original conclusion said that high doses of

Vioxx should

not be prescribed or used.

Graham, scheduled to present those findings in late August during an

epidemiology conference in France, said he ran into resistance when

the FDA

reviewed his abstract.

" I think the recommendation about high dose rofecoxib is unnecessary

and

particularly problematic since FDA funded this study and 's

travel to

France to present it, " Anne E. Trontell, deputy director of the

FDA's Office

of Drug Safety, wrote in an Aug. 12 e-mail.

The internal e-mail exchange was released by Grassley.

In the e-mail, Trontell suggested that Graham defer his presentation

in

favor of a journal article so dissenting scientists - including

within the

FDA - could comment.

She also said Merck should be alerted before the findings became

public " so

they can be prepared for extensive media attention that this will

likely

provoke. "

Others within the agency suggested Graham's conclusion was too

strongly

worded, given the FDA had not added such warnings to Vioxx labels.

" I've gone about as far as I can without compromising my deeply held

conclusions about this safety question, " Graham replied in an Aug. 13

e-mail.

The FDA said such discussions are typical before scientific findings

are

published.

The conclusion Graham presented in France was revised: " This and

other

studies cast serious doubt on the safety " of Vioxx doses higher than

25 mg.

per day.

The FDA said that Graham decided to revise his abstract

conclusion. " He did

so voluntarily, " the agency said.

In testimony before a congressional panel in mid-September,

Mosholder, an FDA epidemiologist, said his bosses asked him to soften

recommendations about antidepressants.

Mosholder's analysis pointed to increased suicidal thoughts and

behaviors

among children taking antidepressants well before federal advisers

pushed

for strident warnings on the drugs. He suggested preferential use of

Prozac,

the only drug approved to treat depressed children and - according

to his

review - the one with the lowest risk.

His supervisors within the FDA told him to suggest that children use

such

medications " with caution, " Mosholder told the Congressional panel.

Dr. Seligman, acting director of the FDA's Office of Drug

Safety, said

the agency did not pressure Mosholder to change his conclusion.

___

On the Net:

FDA: http://www.fda.gov/

[Guest guest]

" She also said Merck should be alerted before the findings became

public " so

they can be prepared for extensive media attention that this will

likely

provoke. "

And that my friends is the FDA in a nutshell!! Don't worry about the

public safety, just make sure the Drug companies are given advance

warning to they can call in the spin doctors. At least Merck pulled

the drug on their own, since we know that the FDA would have taken

YEARS to present this information.

[Guest guest]

" She also said Merck should be alerted before the findings became

public " so

they can be prepared for extensive media attention that this will

likely

provoke. "

And that my friends is the FDA in a nutshell!! Don't worry about the

public safety, just make sure the Drug companies are given advance

warning to they can call in the spin doctors. At least Merck pulled

the drug on their own, since we know that the FDA would have taken

YEARS to present this information.