Child Bi-Polar Research Center Tied to Drug Company

[Guest guest]

http://www.nytimes.com/2008/11/25/health/25psych.html?ref=healthNovember 25, 2008Research Center Tied to Drug CompanyBy GARDINER HARRIS

When a Congressional investigation revealed in June that he had earned far moremoney from drug makers than he had reported to his university, Dr. phBiederman, a world-renowned child psychiatrist, said that his "interests aresolely in the advancement of medical treatment through rigorous and objectivestudy."But e-mails and internal documents from & made public in a courtfiling reveal that Dr. Biederman pushed the company to fund a research center atMassachusetts General Hospital whose goal was "to move forward the commercialgoals of J & J," the documents state. The documents also show that & wrote a draft summary of a study that Dr. Biederman, of HarvardUniversity, was said to author.Dr. Biederman's work helped to fuel a 40-fold increase from 1994 to 2003 in thediagnosis of pediatric bipolar disorder and a rapid rise in the use of powerful,risky and expensive antipsychotic medicines in children. Although many of hisstudies are small and often financed by drug makers, Dr. Biederman has had avast influence on the field largely because of his position at one of the mostprestigious medical institutions in the world. & manufactures Risperdal, also known as risperidone, a popularantipsychotic medicine. More than a quarter of Risperdal's use is in childrenand adolescents.Last week, a panel of federal drug experts said that medicines like Risperdalare being used far too cavalierly in children and that federal drug regulatorsmust do more to warn doctors of their substantial risks. Other popularantipsychotic medicines, also referred to as neuroleptics, are Zyprexa, made byEli Lilly; Seroquel, made by AstraZeneca; Geodon, made by Pfizer; and Abilify,made by Bristol-Myers Squibb.Thousands of parents have sued & , AstraZeneca and Eli Lilly,claiming that their children were injured after taking the medicines, whoserisks the companies minimized, the parents claim. As part of the suits,plaintiffs' attorneys have demanded millions of documents from the companies.Nearly all of those documents have been provided under judicial seals, but aselect few that mentioned Dr. Biederman became public after plaintiffs attorneyssought a judge's order to require Dr. Biederman to be interviewed by plaintiffattorneys under oath.In a motion filed two weeks ago, attorneys for the families argued that theyshould be allowed to interview Dr. Biederman under oath because his work hasbeen crucial to the widespread acceptance of pediatric uses of antipsychoticmedicines. To support this contention, the lawyers included more than two dozendocuments, including e-mails from & that mentioned Dr.Biederman. That interview request has yet to be ruled upon.The documents offer an unusual glimpse into the delicate relationship that drugmakers have with influential doctors. In one November 1999 e-mail, Bruins,a & marketing executive, begs his supervisors to approve a$3,000 check to Dr. Biederman in payment for a lecture he gave at the Universityof Connecticut."Dr. Biederman is not someone to jerk around," Mr. Bruins wrote. "He is a veryproud national figure in child psych and has a very short fuse."Mr. Bruins wrote that Dr. Biederman was furious after & rejecteda request that Dr. Biederman had made to receive a $280,000 research grant. "Ihave never seen someone so angry," Mr. Bruins wrote. "Since that time, ourbusiness became non-existant (sic) within his area of control."Mr. Bruins concluded that, unless Dr. Biederman received a check soon, "I amtruly afraid of the consequences."A series of documents described the goals behind establishing the & Center for the study of pediatric psychopathology, for which Dr.Biederman still serves as chief.A 2002 annual report for the center stated that its research must satisfy threecriteria: improve psychiatric care for children, have high standards and "moveforward the commercial goals of J & J," according to court documents."We strongly believe that the center's systematic scientific inquiry willenhance the clinical and research foundation of child psychiatry and lead to thesafer, more appropriate and more widespread use of medications in children," thereport stated. "Without such data, many clinicians question the wisdom ofaggressively treating children with medications, especially those likeneuroleptics, which expose children to potentially serious adverse events."A February 2002 e-mail from s Gharabawi, a & executive,stated that Dr. Biederman approached the company "multiple times to propose thecreation" of the center. "The rationale of this center is to generate anddisseminate 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 Dr. Gahan Pandina, a & executive, to Dr.Biederman included a brief abstract of a study of Risperdal in childrensuffering disruptive behavior disorder. The study was intended to be presentedat the 2002 annual meeting of the American Academy of Child & AdolescentPsychiatry, the e-mail stated."We have generated a review abstract, but I must review this longer abstractbefore passing this along," Dr. Pandina wrote. One problem with the study, Dr.Pandina wrote, is that the children given placebos and those given Risperdalboth improved significantly, "so, if you could, please give some thought to howto handle this issue if it occurs."The draft abstract that Dr. Pandina included in the e-mail, however, stated thatonly the children given Risperdal improved, while those given placebos did not.Dr. Pandina asked Dr. Biederman to sign a form listing himself as author so thecompany could present the study to the conference, according to the e-mail."I will review this morning," Dr. Biederman responded, according to thedocuments. "I will be happy to sign the forms if you could kindly send them tome." The documents do not make clear whether Dr. Biederman approved the finalsummary of the brief abstract in similar form or asked to read the longer reporton the study.Drug makers have long hired professional writers to compose scientific papersand then recruited well-known doctors to list themselves as authors. Thepractice, known as ghostwriting, has come under intense criticism recently, andmedical societies, schools and journals have condemned it.In June, a Congressional investigation revealed that Dr. Biederman had failed toreport to Harvard at least $1.4 million in outside income from & and other makers of antipsychotic medicines.In one example, Dr. Biederman reported no income from & for 2001in a disclosure report filed with the university. When asked by Senator E. Grassley, a Republican of Iowa, to check again, Dr. Biederman said hereceived $3,500. But & told Mr. Grassley that it paid Dr.Biederman $58,169 in 2001.On Monday, J. Cameron, a Harvard spokesman, said the university was stillreviewing Mr. Grassley's allegations against Dr. Biederman. He added that theyhad not seen the drug company documents in question and that the university isnot directly involved in the child psychiatry center at Massachusetts GeneralHospital.Calls to Dr. Biederman were not returned. & did not immediatelycomment or make executives available for comment.

[Guest guest]

The slime eventually floats to the surface. That man has harmed

countless children and looks to have done it all for money and

prestige. His entire profession, minus a few, is also culpable.

To precipitate a holocaust, a hidden holocaust on the unsuspecting

public, it's hard to describe in words. It's so very evil.

Wagner, who took money from GSK and gave a glowing report

on Pasxil/Seroxat with study 329 should go to jail with him.

Jim

Child Bi-Polar Research Center Tied to Drug Company

http://www.nytimes.com/2008/11/25/health/25psych.html?ref=healthNovember 25, 2008Research Center Tied to Drug CompanyBy GARDINER HARRIS

When a Congressional investigation revealed in June that he had earned far moremoney from drug makers than he had reported to his university, Dr. phBiederman, a world-renowned child psychiatrist, said that his "interests aresolely in the advancement of medical treatment through rigorous and objectivestudy."But e-mails and internal documents from & made public in a courtfiling reveal that Dr. Biederman pushed the company to fund a research center atMassachusetts General Hospital whose goal was "to move forward the commercialgoals of J & J," the documents state. The documents also show that & wrote a draft summary of a study that Dr. Biederman, of HarvardUniversity, was said to author.Dr. Biederman's work helped to fuel a 40-fold increase from 1994 to 2003 in thediagnosis of pediatric bipolar disorder and a rapid rise in the use of powerful,risky and expensive antips! ychotic medicines in children. Although many of hisstudies are small and often financed by drug makers, Dr. Biederman has had avast influence on the field largely because of his position at one of the mostprestigious medical institutions in the world. & manufactures Risperdal, also known as risperidone, a popularantipsychotic medicine. More than a quarter of Risperdal's use is in childrenand adolescents.Last week, a panel of federal drug experts said that medicines like Risperdalare being used far too cavalierly in children and that federal drug regulatorsmust do more to warn doctors of their substantial risks. Other popularantipsychotic medicines, also referred to as neuroleptics, are Zyprexa, made byEli Lilly; Seroquel, made by AstraZeneca; Geodon, made by Pfizer; and Abilify,made by Bristol-Myers Squibb.Thousands of parents have sued & , AstraZeneca and Eli Lilly,cla! iming that their children were injured after taking the medicines, who serisks the companies minimized, the parents claim. As part of the suits,plaintiffs' attorneys have demanded millions of documents from the companies.Nearly all of those documents have been provided under judicial seals, but aselect few that mentioned Dr. Biederman became public after plaintiffs attorneyssought a judge's order to require Dr. Biederman to be interviewed by plaintiffattorneys under oath.In a motion filed two weeks ago, attorneys for the families argued that theyshould be allowed to interview Dr. Biederman under oath because his work hasbeen crucial to the widespread acceptance of pediatric uses of antipsychoticmedicines. To support this contention, the lawyers included more than two dozendocuments, including e-mails from & that mentioned Dr.Biederman. That interview request has yet to be ruled upon.The documents offer an unusual glimpse into the delicate relationship that drugm! akers have with influential doctors. In one November 1999 e-mail, Bruins,a & marketing executive, begs his supervisors to approve a$3,000 check to Dr. Biederman in payment for a lecture he gave at the Universityof Connecticut."Dr. Biederman is not someone to jerk around," Mr. Bruins wrote. "He is a veryproud national figure in child psych and has a very short fuse."Mr. Bruins wrote that Dr. Biederman was furious after & rejecteda request that Dr. Biederman had made to receive a $280,000 research grant. "Ihave never seen someone so angry," Mr. Bruins wrote. "Since that time, ourbusiness became non-existant (sic) within his area of control."Mr. Bruins concluded that, unless Dr. Biederman received a check soon, "I amtruly afraid of the consequences."A series of documents described the goals behind establishing the & Center for the study of pediatr! ic psychopathology, for which Dr.Biederman still serves as chief.< BR>A 2002 annual report for the center stated that its research must satisfy threecriteria: improve psychiatric care for children, have high standards and "moveforward the commercial goals of J & J," according to court documents."We strongly believe that the center's systematic scientific inquiry willenhance the clinical and research foundation of child psychiatry and lead to thesafer, more appropriate and more widespread use of medications in children," thereport stated. "Without such data, many clinicians question the wisdom ofaggressively treating children with medications, especially those likeneuroleptics, which expose children to potentially serious adverse events."A February 2002 e-mail from s Gharabawi, a & executive,stated that Dr. Biederman approached the company "multiple times to propose thecreation" of the center. "The rationale of this center is to generate anddisseminate da! ta 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 Dr. Gahan Pandina, a & executive, to Dr.Biederman included a brief abstract of a study of Risperdal in childrensuffering disruptive behavior disorder. The study was intended to be presentedat the 2002 annual meeting of the American Academy of Child & AdolescentPsychiatry, the e-mail stated."We have generated a review abstract, but I must review this longer abstractbefore passing this along," Dr. Pandina wrote. One problem with the study, Dr.Pandina wrote, is that the children given placebos and those given Risperdalboth improved significantly, "so, if you could, please give some thought to howto handle this issue if it occurs."The draft abstract that Dr. Pandina included in the e-mail, however, stated ! thatonly the children given Risperdal improved, while those given placebos did not.Dr. Pandina asked Dr. Biederman to sign a form listing himself as author so thecompany could present the study to the conference, according to the e-mail."I will review this morning," Dr. Biederman responded, according to thedocuments. "I will be happy to sign the forms if you could kindly send them tome." The documents do not make clear whether Dr. Biederman approved the finalsummary of the brief abstract in similar form or asked to read the longer reporton the study.Drug makers have long hired professional writers to compose scientific papersand then recruited well-known doctors to list themselves as authors. Thepractice, known as ghostwriting, has come under intense criticism recently, andmedical societies, schools and journals have condemned it.In June, a Congressional investigation revealed that Dr. Biederman had failed toreport to Harvard at least $1.4 million in outside income from so! n & and other makers of antipsychotic medicines.In one example, Dr. Biederman reported no income from & for 2001in a disclosure report filed with the university. When asked by Senator E. Grassley, a Republican of Iowa, to check again, Dr. Biederman said hereceived $3,500. But & told Mr. Grassley that it paid Dr.Biederman $58,169 in 2001.On Monday, J. Cameron, a Harvard spokesman, said the university was stillreviewing Mr. Grassley's allegations against Dr. Biederman. He added that theyhad not seen the drug company documents in question and that the university isnot directly involved in the child psychiatry center at Massachusetts GeneralHospital.Calls to Dr. Biederman were not returned. & did not immediatelycomment or make executives available for comment.