Health: Research Center Tied to Drug Company

[Guest guest]

November 25, 2008

Research Center Tied to Drug Company By GARDINER

HARRIS<http://topics.nytimes.com/top/reference/timestopics/people/h/gardiner_har\

ris/index.html?inline=nyt-per>

http://www.nytimes.com/2008/11/25/health/25psych.html?em

 

When a Congressional investigation revealed in June that Dr. Joseph

Biederman, a world-renowned child psychiatrist, had earned far more money

from drug makers than he had reported to his university, he said that his

interests were " solely in the advancement of medical treatment through

rigorous and objective study. "

 

But e-mail messages and internal documents from Johnson & Johnson made

public in a court filing reveal that Dr. Biederman pushed the company to

finance a research center at Massachusetts General

Hospital<http://topics.nytimes.com/top/reference/timestopics/organizations/m/mas\

sachusetts_general_hospital/index.html?inline=nyt-org>,

in Boston, with a goal to " move forward the commercial goals of J. & J. " The

documents also show that the company prepared a draft summary of a study

that Dr. Biederman, of Harvard, was said to have written.

 

Dr. Biederman's work helped to fuel a fortyfold increase from 1994 to 2003

in the diagnosis of pediatric bipolar

disorder<http://health.nytimes.com/health/guides/disease/bipolar-disorder/overvi\

ew.html?inline=nyt-classifier>and

a rapid rise in the use of powerful, risky and expensive antipsychotic

medicines in children.

 

Although many of his studies are small and often financed by drug makers,

Dr. Biederman has had a vast influence on the field largely because of his

position at one of the most prestigious medical institutions.

 

Massachusetts General said in a statement Monday that it took the

accusations related to the research center " very seriously " and intended " to

investigate these issues thoroughly. "

 

Johnson & Johnson makes a popular antipsychotic medicine called Risperdal,

or risperidone. More than a quarter of its use is in children and

adolescents.

 

Last week, a panel of federal drug experts said that medicines like

Risperdal were being used too cavalierly in children and that regulators

must do more to warn doctors of their substantial risks. Other popular

antipsychotic medicines, also referred to as neuroleptics, are Zyprexa, made

by Eli Lilly; Seroquel, made by AstraZeneca; Geodon, made by Pfizer; and

Abilify, made by Bristol-Myers Squibb.

 

Thousands of parents have sued AstraZeneca, Eli Lilly and Johnson & Johnson,

claiming that their children were injured after taking the medicines; they

also claim that the companies minimized the risks of the drugs.

 

As part of the lawsuits, plaintiffs' lawyers have demanded millions of

documents from the companies. Nearly all have been provided under judicial

seals, but a select few that mentioned Dr. Biederman became public after

plaintiffs' lawyers sought a judge's order to require Dr. Biederman to be

interviewed by them under oath.

 

In a motion filed two weeks ago, lawyers for the families argued that they

should be allowed to interview Dr. Biederman under oath because his work had

been crucial to the widespread acceptance of pediatric uses of antipsychotic

medicines. To support this contention, the lawyers included more than two

dozen documents, among them e-mail messages from Johnson & Johnson that

mentioned Dr. Biederman. A judge has yet to rule on the request.

 

The documents offer an unusual glimpse into the delicate relationship that

drug makers have with influential doctors.

 

In a November 1999 e-mail message, John Bruins, a Johnson & Johnson

marketing executive, begs his supervisors to approve a $3,000 check to Dr.

Biederman as payment for a lecture he gave at the University of

Connecticut<http://topics.nytimes.com/top/reference/timestopics/organizations/u/\

university_of_connecticut/index.html?inline=nyt-org>.

 

 

" Dr. Biederman is not someone to jerk around, " Mr. Bruins wrote. " He is a

very proud national figure in child psych and has a very short fuse. "

 

Mr. Bruins wrote that Dr. Biederman was furious after Johnson & Johnson

rejected a request that Dr. Biederman had made for a $280,000 research

grant. " I have never seen someone so angry, " Mr. Bruins wrote. " Since that

time, our business became non-existant (sic) within his area of control. "

 

Mr. Bruins concluded that unless Dr. Biederman received a check soon, " I am

truly afraid of the consequences. "

 

A series of documents described the goals behind establishing the Johnson &

Johnson Center for the study of pediatric psychopathology, where Dr.

Biederman serves as chief.

 

A 2002 annual report for the center said its research must satisfy three

criteria: improve psychiatric care for children, have high standards and

" move forward the commercial goals of J. & J., " court documents said.

 

" We strongly believe, " the report stated, " that the center's systematic

scientific inquiry will enhance the clinical and research foundation of

child

psychiatry<http://topics.nytimes.com/top/news/health/diseasesconditionsandhealth\

topics/psychiatry_and_psychiatrists/index.html?inline=nyt-classifier>and

lead to the safer, more appropriate and more widespread use of

medications in children.

 

" Without such data, many clinicians question the wisdom of aggressively

treating children with medications, especially those like neuroleptics,

which expose children to potentially serious adverse events. "

 

A February 2002 e-mail message from Georges Gharabawi, a Johnson & Johnson

executive, said Dr. Biederman approached the company " multiple times to

propose the creation " of the center. " The rationale of this center, " the

message stated, " is to generate and disseminate data supporting the use of

risperidone in " children and adolescents.

 

Documents show that Johnson & Johnson gave the center $700,000 in 2002

alone. Massachusetts General said in its statement on Monday that grant

agreements indicated the center " was for scientific and educational purposes

only and not for purposes of promoting, directly or indirectly, the products

of Johnson & Johnson and its affiliates. "

 

A statement Monday from Janssen Pharmaceutica, a unit of Johnson & Johnson,

said it helped finance the research center in 2002 " with an objective to

conduct rigorous clinical trials to clarify appropriate use and dosing of

Risperdal in children. "

 

A June 2002 e-mail message to Dr. Biederman from Dr. Gahan Pandina, a

Johnson & Johnson executive, included a brief abstract of a study of

Risperdal in children with disruptive behavior disorder. The message said

the study was intended to be presented at the 2002 annual meeting of the

American Academy of Child and Adolescent Psychiatry.

 

" We have generated a review abstract, " Dr. Pandina wrote, " but I must review

this longer abstract before passing this along. "

 

One problem with the study, Dr. Pandina wrote, is that the children given

placebos and those given Risperdal both improved significantly. " So, if you

could, " Dr. Pandina added, " please give some thought to how to handle this

issue if it occurs. "

 

The draft abstract that Dr. Pandina put in the e-mail message, however,

stated that only the children given Risperdal improved, while those given

placebos did not. Dr. Pandina asked Dr. Biederman to sign a form listing

himself as the author so the company could present the study to the

conference, according to the message.

 

" I will review this morning, " responded Dr. Biederman, according to the

documents. " I will be happy to sign the forms if you could kindly send them

to me. " The documents do not make clear whether he approved the final

summary of the brief abstract in similar form or asked to read the longer

report on the study.

 

Drug makers have long hired professional writers to compose scientific

papers and then recruited well-known doctors to list themselves as the

author. The practice, known as ghostwriting, has come under intense

criticism recently, and medical societies, schools and journals have

condemned it.

 

In June, a Congressional investigation revealed that Dr. Biederman had

failed to report to Harvard at least $1.4 million in outside income from

Johnson & Johnson and other makers of antipsychotic medicines.

 

In one example, Dr. Biederman reported no income from Johnson & Johnson for

2001 in a disclosure report filed with the university. When asked by Senator

Charles E.

Grassley<http://topics.nytimes.com/top/reference/timestopics/people/g/charles_e_\

grassley/index.html?inline=nyt-per>,

an Iowa Republican who is leading the Congressional inquiry, to check again,

Dr. Biederman said he had received $3,500. But Johnson & Johnson told Mr.

Grassley that it paid $58,169 to Dr. Biederman in 2001.

 

A Harvard spokesman, David J. Cameron, said Monday that the university was

still reviewing Mr. Grassley's accusations against Dr. Biederman. Mr.

Cameron added that the university had not seen the drug company documents in

question and that it was not directly involved in the child psychiatry

center at Massachusetts General.

 

Calls to Dr. Biederman were not returned.

Copyright 2008<http://www.nytimes.com/ref/membercenter/help/copyright.html>

The

New York Times Company <http://www.nytco.com/>

 

 

 

[Guest guest]

And another reason I have chosen to object to some of the new 'cutting edge' of

medications that are also used for 'off label' treatments. I have a disability

that literally rendered me a guinea pig and to which I directly blame a result

of said condition to significantly worsen to the point of having to file for

disability.

 

I worked pharmacy and the alternative field for years. I've pulled OFF of the

shelves meds the average person is not informed adequately if at all the reasons

for the discontinuation of a medication that had been touted as 'safe' when in

fact had caused death or permanent damage.

 

I personally know a shrink who sits on the board of the company who manufactures

Viagra.

This has nothing to do with his practice but his lecture circuit certainly was a

very nice package.

 

I was placed on drugs that are mentioned in this article for PAIN. I can tell

you first hand how percentages of sales of medications designed for a condition

are also being used for other conditions and I ended up in an ER because I was

given an antipsychotic for 'sleep'. I did not sleep . I hallucinated to the

point my husband who works at our ER had to take me for a heavy sedation because

of one of those drugs.

 

 I now have a doctor I finally brown bagged my medications and dumped them out

on the table and asked him 'do you see a problem here? I believe my self to be

toxic at this point with medications I have no need for because you fear

treating what I have even at the risk of my sanity......'.......he no longer

sees me and I now take 4 medications in stead of 14.

 

Blood pressure

Blood Sugar

Diuretic

1 pain med.

 

and I can think again. Thank the drug companies and the greed of egoists because

the truth of the matter is the 'dollar' is what is important.

 

The doctor who did his Viagra 'tour' also received kick backs from the company

who manufactures geodon and therefore almost all of his patients were placed on

that medication.

 

That is where having a front seat in the pharmaceutical field comes in handy.

Written on precription pads we could always tell when a major company had

targeted an area . It is also the reason I refused to try Lyrica until more info

is made available.

 

This pisses me off . It did when I worked and it does so now.

 

Evie

 

 

 

--- On Tue, 11/25/08, Butch Owen <butchowen wrote:

 

Butch Owen <butchowen

Health: Research Center Tied to Drug Company

, ATFE2

Tuesday, November 25, 2008, 10:35 AM

 

November 25, 2008

Research Center Tied to Drug Company By GARDINER

HARRIS<http://topics.nytimes.com/top/reference/timestopics/people/h/gardiner_har\

ris/index.html?inline=nyt-per>

http://www.nytimes.com/2008/11/25/health/25psych.html?em

 

When a Congressional investigation revealed in June that Dr. Joseph

Biederman, a world-renowned child psychiatrist, had earned far more money

from drug makers than he had reported to his university, he said that his

interests were " solely in the advancement of medical treatment through

rigorous and objective study. "

 

But e-mail messages and internal documents from Johnson & Johnson made

public in a court filing reveal that Dr. Biederman pushed the company to

finance a research center at Massachusetts General

Hospital<http://topics.nytimes.com/top/reference/timestopics/organizations/m/mas\

sachusetts_general_hospital/index.html?inline=nyt-org>,

in Boston, with a goal to " move forward the commercial goals of J. &

J. " The

documents also show that the company prepared a draft summary of a study

that Dr. Biederman, of Harvard, was said to have written.

 

Dr. Biederman's work helped to fuel a fortyfold increase from 1994 to 2003

in the diagnosis of pediatric bipolar

disorder<http://health.nytimes.com/health/guides/disease/bipolar-disorder/overvi\

ew.html?inline=nyt-classifier>and

a rapid rise in the use of powerful, risky and expensive antipsychotic

medicines in children.

 

Although many of his studies are small and often financed by drug makers,

Dr. Biederman has had a vast influence on the field largely because of his

position at one of the most prestigious medical institutions.

 

Massachusetts General said in a statement Monday that it took the

accusations related to the research center " very seriously " and

intended " to

investigate these issues thoroughly. "

 

Johnson & Johnson makes a popular antipsychotic medicine called Risperdal,

or risperidone. More than a quarter of its use is in children and

adolescents.

 

Last week, a panel of federal drug experts said that medicines like

Risperdal were being used too cavalierly in children and that regulators

must do more to warn doctors of their substantial risks. Other popular

antipsychotic medicines, also referred to as neuroleptics, are Zyprexa, made

by Eli Lilly; Seroquel, made by AstraZeneca; Geodon, made by Pfizer; and

Abilify, made by Bristol-Myers Squibb.

 

Thousands of parents have sued AstraZeneca, Eli Lilly and Johnson &

Johnson,

claiming that their children were injured after taking the medicines; they

also claim that the companies minimized the risks of the drugs.

 

As part of the lawsuits, plaintiffs' lawyers have demanded millions of

documents from the companies. Nearly all have been provided under judicial

seals, but a select few that mentioned Dr. Biederman became public after

plaintiffs' lawyers sought a judge's order to require Dr. Biederman to

be

interviewed by them under oath.

 

In a motion filed two weeks ago, lawyers for the families argued that they

should be allowed to interview Dr. Biederman under oath because his work had

been crucial to the widespread acceptance of pediatric uses of antipsychotic

medicines. To support this contention, the lawyers included more than two

dozen documents, among them e-mail messages from Johnson & Johnson that

mentioned Dr. Biederman. A judge has yet to rule on the request.

 

The documents offer an unusual glimpse into the delicate relationship that

drug makers have with influential doctors.

 

In a November 1999 e-mail message, John Bruins, a Johnson & Johnson

marketing executive, begs his supervisors to approve a $3,000 check to Dr.

Biederman as payment for a lecture he gave at the University of

Connecticut<http://topics.nytimes.com/top/reference/timestopics/organizations/u/\

university_of_connecticut/index.html?inline=nyt-org>.

 

 

" Dr. Biederman is not someone to jerk around, " Mr. Bruins wrote.

" He is a

very proud national figure in child psych and has a very short fuse. "

 

Mr. Bruins wrote that Dr. Biederman was furious after Johnson & Johnson

rejected a request that Dr. Biederman had made for a $280,000 research

grant. " I have never seen someone so angry, " Mr. Bruins wrote.

" Since that

time, our business became non-existant (sic) within his area of control. "

 

Mr. Bruins concluded that unless Dr. Biederman received a check soon, " I

am

truly afraid of the consequences. "

 

A series of documents described the goals behind establishing the Johnson &

Johnson Center for the study of pediatric psychopathology, where Dr.

Biederman serves as chief.

 

A 2002 annual report for the center said its research must satisfy three

criteria: improve psychiatric care for children, have high standards and

" move forward the commercial goals of J. & J., " court documents

said.

 

" We strongly believe, " the report stated, " that the center's

systematic

scientific inquiry will enhance the clinical and research foundation of

child

psychiatry<http://topics.nytimes.com/top/news/health/diseasesconditionsandhealth\

topics/psychiatry_and_psychiatrists/index.html?inline=nyt-classifier>and

lead to the safer, more appropriate and more widespread use of

medications in children.

 

" Without such data, many clinicians question the wisdom of aggressively

treating children with medications, especially those like neuroleptics,

which expose children to potentially serious adverse events. "

 

A February 2002 e-mail message from Georges Gharabawi, a Johnson & Johnson

executive, said Dr. Biederman approached the company " multiple times to

propose the creation " of the center. " The rationale of this

center, " the

message stated, " is to generate and disseminate data supporting the use of

risperidone in " children and adolescents.

 

Documents show that Johnson & Johnson gave the center $700,000 in 2002

alone. Massachusetts General said in its statement on Monday that grant

agreements indicated the center " was for scientific and educational

purposes

only and not for purposes of promoting, directly or indirectly, the products

of Johnson & Johnson and its affiliates. "

 

A statement Monday from Janssen Pharmaceutica, a unit of Johnson & Johnson,

said it helped finance the research center in 2002 " with an objective to

conduct rigorous clinical trials to clarify appropriate use and dosing of

Risperdal in children. "

 

A June 2002 e-mail message to Dr. Biederman from Dr. Gahan Pandina, a

Johnson & Johnson executive, included a brief abstract of a study of

Risperdal in children with disruptive behavior disorder. The message said

the study was intended to be presented at the 2002 annual meeting of the

American Academy of Child and Adolescent Psychiatry.

 

" We have generated a review abstract, " Dr. Pandina wrote, " but I

must review

this longer abstract before passing this along. "

 

One problem with the study, Dr. Pandina wrote, is that the children given

placebos and those given Risperdal both improved significantly. " So, if

you

could, " Dr. Pandina added, " please give some thought to how to handle

this

issue if it occurs. "

 

The draft abstract that Dr. Pandina put in the e-mail message, however,

stated that only the children given Risperdal improved, while those given

placebos did not. Dr. Pandina asked Dr. Biederman to sign a form listing

himself as the author so the company could present the study to the

conference, according to the message.

 

" I will review this morning, " responded Dr. Biederman, according to

the

documents. " I will be happy to sign the forms if you could kindly send

them

to me. " The documents do not make clear whether he approved the final

summary of the brief abstract in similar form or asked to read the longer

report on the study.

 

Drug makers have long hired professional writers to compose scientific

papers and then recruited well-known doctors to list themselves as the

author. The practice, known as ghostwriting, has come under intense

criticism recently, and medical societies, schools and journals have

condemned it.

 

In June, a Congressional investigation revealed that Dr. Biederman had

failed to report to Harvard at least $1.4 million in outside income from

Johnson & Johnson and other makers of antipsychotic medicines.

 

In one example, Dr. Biederman reported no income from Johnson & Johnson for

2001 in a disclosure report filed with the university. When asked by Senator

Charles E.

Grassley<http://topics.nytimes.com/top/reference/timestopics/people/g/charles_e_\

grassley/index.html?inline=nyt-per>,

an Iowa Republican who is leading the Congressional inquiry, to check again,

Dr. Biederman said he had received $3,500. But Johnson & Johnson told Mr.

Grassley that it paid $58,169 to Dr. Biederman in 2001.

 

A Harvard spokesman, David J. Cameron, said Monday that the university was

still reviewing Mr. Grassley's accusations against Dr. Biederman. Mr.

Cameron added that the university had not seen the drug company documents in

question and that it was not directly involved in the child psychiatry

center at Massachusetts General.

 

Calls to Dr. Biederman were not returned.

Copyright

2008<http://www.nytimes.com/ref/membercenter/help/copyright.html>

The

New York Times Company <http://www.nytco.com/>