OT: Harvard's Biederman and ties to J&J

[Guest guest]

Joe " pedi bipolar genes " Biederman caught with cleft foot in the

cookie jar again and Harvard/Mass General still won't terminate him.

http://www.pharmalot.com/2008/11/harvards-biederman-and-his-ties-to-

jj/

Harvard's Biederman And His Ties To J & J

9 Comments

By Ed Silverman // November 24th, 2008 // 3:19 pm

Last June, when a Congressional investigation revealed Harvard

University's ph Biederman had earned far more money from

drugmakers than he had reported to the school, the world-renowned

child psychiatrist insisted his " interests are solely in the

advancement of medical treatment through rigorous and objective

study. " (Back story).

Now, e-mails and internal & documents made public in

a court filing reveal Biederman pushed the drugmaker to fund a

research center at Massachusetts General Hospital, and the point

was " to move forward the commercial goals of J & J, " according to the

documents, The New York Times reports. The documents also show J & J

wrote a draft summary of a study that Biederman was said to author

(here are the documents; this is a Word document, folks).

Biederman's work helped to fuel a 40-fold increase from 1994 to 2003

in the diagnosis of pediatric bipolar disorder and a rapid rise in

the use of powerful, risky and expensive antipsychotics in children,

the Times writes. Many of his studies are small and often financed by

drugmakers, but Biederman has had outsized influence because of his

position at one of the world's most prestigious medical institutions.

J & J makes Risperdal and more than a quarter of its use is in children

and adolescents.

Last week, a panel of federal drug experts noted that meds such as

Risperdal are prescribed improperly and the FDA must do more to warn

doctors of the risks (back story). Other popular antipsychotics

include Lilly's Zyprexa, Pfizer's Geodon, AstraZeneca's Seroquel, and

Bristol-Myers Squibb's Abilify. Numerous lawsuits filed against J & J

and other drugmakers over these issues.

Plaintiffs' attorneys have demanded untold numbers of documents, and

nearly all are under judicial seals, but a select few mentioning

Biederman became public after a judge's order was sought to require

Biederman to be deposed. Biederman argued he shouldn't be deposed

because he is actively cooperating with the US Senate Finance

Committee investigation (here is the deposition order).

In a motion filed two weeks ago, attorneys for the families argued

they should be allowed to interview Biederman under oath because his

work has been crucial to the widespread acceptance of pediatric usage

of antipsychotics, the Times writes. To support this contention, the

lawyers included more than two dozen documents, including e-mails

from J & J that mentioned Biederman.

The documents, the Times correctly notes, offer an unusual glimpse

into the delicate relationship between drugmakers and influential

doctors. In one November 1999 e-mail, Bruins, a J & J marketing

exec, begs his supervisors to approve a $3,000 check to Biederman in

payment for a lecture he gave at the University of Connecticut. " Dr.

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

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

(click e-mail to enlarge)

Bruins also wrote that Biederman was furious after J & J rejected a

request Biederman had made to receive a $280,000 research grant. " I

have never seen someone so angry, " Bruins wrote. " Since that time,

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

He concluded that, unless Biederman received a check soon, " I am

truly afraid of the consequences. "

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

Center for the Study of Pediatric Psychopathology, where Biederman is

still chief. A 2002 annual report for the center stated that its

research must satisfy three criteria: improve psychiatric care for

children, have high standards and " move forward the commercial goals

of J & J, " according to court documents.

" We strongly believe that the center's systematic scientific inquiry

will enhance the clinical and research foundation of child psychiatry

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

medications in children, " the report stated. " 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. "

In a February 2002 e-mail, s Gharabawi, a J & J exec, wrote that

Biederman approached the company " multiple times to propose the

creation " of the center. " The rationale of this center is to generate

and disseminate data supporting the use of risperidone in " children

and adolescents, the e-mail stated. & gave the center

$700,000 in 2002 alone, documents show.

A June 2002 e-mail from Gahan Pandina, another J & J exec, to Biederman

included a brief abstract of a study of Risperdal in children

suffering disruptive behavior disorder. The study was intended to be

presented at the 2002 annual meeting of the American Academy of Child

& Adolescent Psychiatry, the e-mail stated.

" We have generated a review abstract, but I must review this longer

abstract before passing this along, " Pandina wrote. One problem with

the study, Pandina wrote, is that the children given placebos and

those given Risperdal both improved significantly, " so, if you could,

please give some thought to how to handle this issue if it occurs. "

The draft abstract that Pandina included in the e-mail, however,

stated that only the children given Risperdal improved, while those

given placebos did not. Pandina asked Biederman to sign a form

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

the conference, according to the e-mail.

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

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

send them to me. " The documents, the Times writes, do not make clear

whether Biederman approved the final summary of the brief abstract in

similar form or asked to read the longer report on the study. This

would be an example of ghostwriting, by the way.

In June, a Congressional investigation revealed that Biederman failed

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

and other makers of antipsychotics. For instance, Biederman reported

no income from J & J for 2001 in a disclosure report filed with the

university. When asked by Senator Chuck Grassley of the finance

committee to check again, Biederman said he received $3,500. But J & J

told Grassley it paid Biederman $58,169 in 2001 (back story).

On Monday, Cameron, a Harvard spokesman, told the Times the

university is still reviewing the allegations against Biederman, and

they had not seen the documents in question and that the university

is not directly involved in the child psychiatry center at

Massachusetts General Hospital. Calls to Biederman were not returned,

the Times writes, and J & J did not immediately comment or make

executives available for comment.