June 6, 2008
Researchers Fail to Reveal Full Drug Pay
by GARDINER HARRIS and BENEDICT CAREY
The Sunday New York Times
Child Experts Fail to Reveal Full Drug Pay
A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given Congressional investigators.
NY Times photos, right: top: Senator Charles E. Grassley pushed three experts in child psychiatry at Harvard to expose their income from consulting fees. bottom: Dr. Joseph Biederman belatedly reported at least $1.6 million in consulting fees.
By failing to report income, the psychiatrist, Dr. Joseph Biederman, and a colleague in the psychiatry department at Harvard Medical School, Dr. Timothy E. Wilens, may have violated federal and university research rules designed to police potential conflicts of interest, according to Senator Charles E. Grassley, Republican of Iowa. Some of their research is financed by government grants.
Like Dr. Biederman, Dr. Wilens belatedly reported earning at least $1.6 million from 2000 to 2007, and another Harvard colleague, Dr. Thomas Spencer, reported earning at least $1 million after being pressed by Mr. Grassley's investigators. But even these amended disclosures may understate the researchers' outside income because some entries contradict payment information from drug makers, Mr. Grassley found.
In one example, Dr. Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with the university. When asked recently to check again, he reported receiving $3,500. But Johnson & Johnson told Mr. Grassley that it paid him $58,169 in 2001, Mr. Grassley found.
The Harvard group's consulting arrangements with drug makers were already controversial because of the researchers' advocacy of unapproved uses of psychiatric medicines in children.
In an e-mailed statement, Dr. Biederman said, "My interests are solely in the advancement of medical treatment through rigorous and objective study," and he said he took conflict-of-interest policies "very seriously." Drs. Wilens and Spencer said in e-mailed statements that they thought they had complied with conflict-of-interest rules.
John Burklow, a spokesman for the National Institutes of Health, said: "If there have been violations of N.I.H. policy - and if research integrity has been compromised - we will take all the appropriate action within our power to hold those responsible accountable. This would be completely unacceptable behavior, and N.I.H. will not tolerate it."
The federal grants received by Drs. Biederman and Wilens were administered by Massachusetts General Hospital, which in 2005 won $287 million in such grants. The health institutes could place restrictions on the hospital's grants or even suspend them altogether.
Alyssa Kneller, a Harvard spokeswoman, said in an e-mailed statement: "The information released by Senator Grassley suggests that, in certain instances, each doctor may have failed to disclose outside income from pharmaceutical companies and other entities that should have been disclosed."
Ms. Kneller said the doctors had been referred to a university conflict committee for review.
Mr. Grassley sent letters on Wednesday to Harvard and the health institutes outlining his investigators' findings, and he placed the letters along with his comments in The Congressional Record.
Dr. Biederman is one of the most influential researchers in child psychiatry and is widely admired for focusing the field's attention on its most troubled young patients. Although many of his studies are small and often financed by drug makers, his work helped to fuel a controversial 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder, which is characterized by severe mood swings, and a rapid rise in the use of antipsychotic medicines in children. The Grassley investigation did not address research quality.
Doctors have known for years that antipsychotic drugs, sometimes called major tranquilizers, can quickly subdue children. But youngsters appear to be especially susceptible to the weight gain and metabolic problems caused by the drugs, and it is far from clear that the medications improve children's lives over time, experts say.
In the last 25 years, drug and device makers have displaced the federal government as the primary source of research financing, and industry support is vital to many university research programs. But as corporate research executives recruit the brightest scientists, their brethren in marketing departments have discovered that some of these same scientists can be terrific pitchmen.
To protect research integrity, the National Institutes of Health require researchers to report to universities earnings of $10,000 or more per year, for instance, in consulting money from makers of drugs also studied by the researchers in federally financed trials. Universities manage financial conflicts by requiring that the money be disclosed to research subjects, among other measures.
The health institutes last year awarded more than $23 billion in grants to more than 325,000 researchers at over 3,000 universities, and auditing the potential conflicts of each grantee would be impossible, health institutes officials have long insisted. So the government relies on universities.
Universities ask professors to report their conflicts but do almost nothing to verify the accuracy of these voluntary disclosures.
"It's really been an honor system thing," said Dr. Robert Alpern, dean of Yale School of Medicine. "If somebody tells us that a pharmaceutical company pays them $80,000 a year, I don't even know how to check on that."
Some states have laws requiring drug makers to disclose payments made to doctors, and Mr. Grassley and others have sponsored legislation to create a national registry.
Lawmakers have been concerned in recent years about the use of unapproved medications in children and the influence of industry money.
Mr. Grassley asked Harvard for the three researchers' financial disclosure reports from 2000 through 2007 and asked some drug makers to list payments made to them.
"Basically, these forms were a mess," Mr. Grassley said in comments he entered into The Congressional Record on Wednesday. "Over the last seven years, it looked like they had taken a couple hundred thousand dollars."
Prompted by Mr. Grassley's interest, Harvard asked the researchers to re-examine their disclosure reports.
In the new disclosures, the trio's outside consulting income jumped but was still contradicted by reports sent to Mr. Grassley from some of the companies. In some cases, the income seems to have put the researchers in violation of university and federal rules.
In 2000, for instance, Dr. Biederman received a grant from the National Institutes of Health to study in children Strattera, an Eli Lilly drug for attention deficit disorder. Dr. Biederman reported to Harvard that he received less than $10,000 from Lilly that year, but the company told Mr. Grassley that it paid Dr. Biederman more than $14,000 in 2000, Mr. Grassley's letter stated.
At the time, Harvard forbade professors from conducting clinical trials if they received payments over $10,000 from the company whose product was being studied, and federal rules required such conflicts to be managed.
Mr. Grassley said these discrepancies demonstrated profound flaws in the oversight of researchers' financial conflicts and the need for a national registry. But the disclosures may also cloud the work of one of the most prominent group of child psychiatrists in the world.
In the past decade, Dr. Biederman and his colleagues have promoted the aggressive diagnosis and drug treatment of childhood bipolar disorder, a mood problem once thought confined to adults. They have maintained that the disorder was underdiagnosed in children and could be treated with antipsychotic drugs, medications invented to treat schizophrenia.
Other researchers have made similar assertions. As a result, pediatric bipolar diagnoses and antipsychotic drug use in children have soared. Some 500,000 children and teenagers were given at least one prescription for an antipsychotic in 2007, including 20,500 under 6 years of age, according to Medco Health Solutions, a pharmacy benefit manager.
Few psychiatrists today doubt that bipolar disorder can strike in the early teenage years, or that many of the children being given the diagnosis are deeply distressed.
"I consider Dr. Biederman a true visionary in recognizing this illness in children," said Susan Resko, director of the Child and Adolescent Bipolar Foundation, "and he's not only saved many lives but restored hope to thousands of families across the country."
Longtime critics of the group see its influence differently. "They have given the Harvard imprimatur to this commercial experimentation on children," said Vera Sharav, president and founder of the Alliance for Human Research Protection, a patient advocacy group.
Many researchers strongly disagree over what bipolar looks like in youngsters, and some now fear the definition has been expanded unnecessarily, due in part to the Harvard group.
The group published the results of a string of drug trials from 2001 to 2006, but the studies were so small and loosely designed that they were largely inconclusive, experts say. In some studies testing antipsychotic drugs, the group defined improvement as a decline of 30 percent or more on a scale called the Young Mania Rating Scale - well below the 50 percent change that most researchers now use as the standard.
Controlling for bias is especially important in such work, given that the scale is subjective, and raters often depend on reports from parents and children, several top psychiatrists said.
More broadly, they said, revelations of undisclosed payments from drug makers to leading researchers are especially damaging for psychiatry.
"The price we pay for these kinds of revelations is credibility, and we just can't afford to lose any more of that in this field," said Dr. E. Fuller Torrey, executive director of the Stanley Medical Research Institute, which finances psychiatric studies. "In the area of child psychiatry in particular, we know much less than we should, and we desperately need research that is not influenced by industry money."
To learn more about the marketing deceptions used by the pharmaceutical companies and how the evidence has been and is being purposely misconstrued, see this discussion that begins with excerpts from the already classic video of Tom Cruise on the Today Show.
October 4, 2008
Top Psychiatrist Didn’t Report Drug Makers’ Pay
By GARDINER HARRIS
One of the nation’s most influential psychiatrists earned more than $2.8 million in consulting arrangements with drug makers from 2000 to 2007, failed to report at least $1.2 million of that income to his university and violated federal research rules, according to documents provided to Congressional investigators.
The psychiatrist, Dr. Charles B. Nemeroff of Emory University, is the most prominent figure to date in a series of disclosures that is shaking the world of academic medicine and seems likely to force broad changes in the relationships between doctors and drug makers.
In one telling example, Dr. Nemeroff signed a letter dated July 15, 2004, promising Emory administrators that he would earn less than $10,000 a year from GlaxoSmithKline to comply with federal rules. But on that day, he was at the Four Seasons Resort in Jackson Hole, Wyo., earning $3,000 of what would become $170,000 in income that year from that company 17 times the figure he had agreed on.
The Congressional inquiry, led by Senator Charles E. Grassley, Republican of Iowa, is systematically asking some of the nation’s leading researchers to provide their conflict-of-interest disclosures, and Mr. Grassley is comparing those documents with records of actual payments from drug companies. The records often conflict, sometimes starkly.
“After questioning about 20 doctors and research institutions, it looks like problems with transparency are everywhere,” Mr. Grassley said. “The current system for tracking financial relationships isn’t working.”
The findings suggest that universities are all but incapable of policing their faculty’s conflicts of interest. Almost every major medical school and medical society is now reassessing its relationships with drug and device makers.
“Everyone is concerned,” said Dr. James H. Scully Jr., the president-elect of the Council of Medical Specialty Societies, whose 30 members represent more than 500,000 doctors.
Dr. Nemeroff is a charismatic speaker and a widely admired scientist who has written more than 850 research reports and reviews. He was editor in chief of the influential journal Neuropsychopharmacology. His research has focused on the long-term mental health risks associated with child abuse as well as the relationship between depression and cardiovascular disease.
Dr. Nemeroff did not respond to calls and e-mail messages seeking comment. Jeffrey L. Molter, an Emory spokesman, wrote in an e-mail statement that the university was “working diligently to determine whether our policies have been observed consistently with regard to the matters cited by Senator Grassley.”
The statement continued: “Dr. Nemeroff has assured us that: ‘To the best of my knowledge, I have followed the appropriate university regulations concerning financial disclosures.’ ” On Friday night, Emory announced that Dr. Nemeroff would “voluntarily step down as chairman of the department, effective immediately, pending resolution of these issues.”
Mr. Grassley began his investigation in the spring by questioning Dr. Melissa P. DelBello of the University of Cincinnati after The New York Times reported her connections to drug makers. Dr. DelBello told university officials that she earned about $100,000 from 2005 to 2007 from eight drug makers, but AstraZeneca alone paid her $238,000 during the period, Mr. Grassley found.
Then in early June, the senator reported to Congress that Dr. Joseph Biederman, a renowned child psychiatrist at Harvard Medical School, and a colleague, Dr. Timothy E. Wilens, had reported to university officials earning several hundred thousand dollars each in consulting fees from drug makers from 2000 to 2007, when in fact they had earned at least $1.6 million each.
Then the senator focused on Dr. Alan F. Schatzberg of Stanford, president-elect of the American Psychiatric Association, whose $4.8 million in stock holdings in a drug development company raised concerns.
Mr. Grassley has sponsored legislation called the Physician Payment Sunshine Act, which would require drug and device companies to publicly list payments to doctors that exceed $500. Several states already require such disclosures.
As revelations from Mr. Grassley’s investigation have dribbled out, trade organizations for the pharmaceutical industry and medical colleges have agreed to support the bill. Eli Lilly and Merck have announced that they would list doctor payments next year even without legislation.
The National Institutes of Health have strict rules regarding conflicts of interest among grantees, but the institutes rely on universities for oversight. If a university fails, the agency has the power to suspend its entire portfolio of grants, which for Emory amounted to $190 million in 2005, although the agency rarely takes such drastic measures.
Dr. Nemeroff was the principal investigator for a five-year $3.9 million grant financed by the National Institute of Mental Health for which GlaxoSmithKline provided drugs.
Income of $10,000 or more from the company in any year of the grant a threshold Dr. Nemeroff crossed in 2003, 2004, 2005 and 2006, records show would have required Emory to inform the institutes and take steps to deal with the conflict or to remove Dr. Nemeroff as the investigator.
Repeatedly assured by Dr. Nemeroff that he had not exceeded the limit, Emory did nothing.
“Results from N.I.H.-funded research must not be biased by any conflicting financial interests,” John Burklow, a spokesman for the health institutes, said in the kind of tough statement that in the past has rarely been followed by real sanctions. “Officials at Emory are investigating the concerns.”
“Failure to follow N.I.H. standards” on conflict of interest, Mr. Burklow continued, “is very serious, and N.I.H. will take all appropriate action to ensure compliance.”
In 2004, Emory investigated Dr. Nemeroff’s outside consulting arrangements. In a 14-page report, Emory’s conflict of interest committee detailed multiple “serious” and “significant” violations of university procedures intended to protect patients.
But the university apparently took little action against Dr. Nemeroff and made no effort to independently audit his consulting income, documents show.
Universities, too, can benefit from the fame and money the deals can bring a point Dr. Nemeroff made in a May 2000 letter stamped “confidential” that he sent to the dean of Emory’s medical school. The letter, which was part of a record from a Congressional hearing, addressed Dr. Nemeroff’s membership on a dozen corporate advisory boards (some of the companies’ names have since changed).
“Surely you remember that Smith-Kline Beecham Pharmaceuticals donated an endowed chair to the department and that there is some reasonable likelihood that Janssen Pharmaceuticals will do so as well,” he wrote.
“In addition, Wyeth-Ayerst Pharmaceuticals has funded a Research Career Development Award program in the department, and I have asked both AstraZeneca Pharmaceuticals and Bristol-Meyers [sic] Squibb to do the same. Part of the rationale for their funding our faculty in such a manner would be my service on these boards.”
Universities once looked askance at professors who consulted for more than one or two drug companies, but that changed after a 1980 law gave the universities ownership of patents discovered with federal money.
The law helped give birth to the biotechnology industry and led to the discovery of dozens of life-saving medicines. Consulting arrangements soon proliferated at medical schools, and Dr. Nemeroff who at one point consulted for 21 drug and device companies simultaneously became a national model.
He may now become a model for a broad reassessment of industry relationships. Many medical schools, societies and groups are considering barring doctors from giving lectures on drug or device marketing.
For all his fame in the world of psychiatry, Dr. Nemeroff has faced ethics troubles before. In 2006, he blamed a clerical mix-up for his failing to disclose that he and his co-authors had financial ties to Cyberonics, the maker of a controversial device that they reviewed favorably in a journal he edited.
The Cyberonics paper led to a bitter e-mail exchange between Dr. Nemeroff and Claudia R. Adkison, an associate dean at Emory, according to Congressional records. Dr. Adkison noted that Cyberonics had not only paid Dr. Nemeroff and his co-authors but had also given an unrestricted educational grant to Dr. Nemeroff’s department.
“I can’t believe that anyone in the public or in academia would believe anything except that this paper was a piece of paid marketing,” Dr. Adkison wrote on July 20, 2006.
Two years earlier, unknown to the public, Emory’s conflict of interest committee discovered that Dr. Nemeroff had made more serious blunders, including failing to disclose conflicts of interest in trials of drugs from Merck, Eli Lilly and Johnson & Johnson.
His continuing oversight of a federally financed trial using GlaxoSmithKline medicines led Dr. Adkison to write Dr. Nemeroff on July 15, 2004, that “you must clearly certify on your annual disclosure form that you do not receive more than $10,000 from GSK.”
In a reply dated Aug. 4, Dr. Nemeroff wrote that he had already done so but promised again that “my consulting fees from GSK will be less than $10,000 per year throughout the period of this N.I.H. grant.”
When he sent that letter, Dr. Nemeroff had already earned more than $98,000 that year from GlaxoSmithKline. Three weeks later, he received another $3,844.56 for giving a marketing talk at the Passion Fish Restaurant in Woodbury, N.Y.
From 2000 through 2006, Dr. Nemeroff earned more than $960,000 from GlaxoSmithKline but listed earnings of less than $35,000 for the period on his university disclosure forms, according to Congressional documents.
Sarah Alspach, a GlaxoSmithKline spokeswoman, said via e-mail that “Dr. Nemeroff is a recognized world leader in the field of psychiatry,” and that the company requires its paid speakers to “proactively disclose their financial relationship with GSK, and we believe that healthcare professionals are responsible for making those disclosures.”
November 22, 2008
Popular Radio Host Has Drug Company Ties
By GARDINER HARRIS
An influential psychiatrist who served as the host of public radio’s popular “The Infinite Mind” program earned at least $1.3 million between 2000 and 2007 giving marketing lectures for drug makers, income not mentioned on the program.
The psychiatrist and radio host, Dr. Frederick K. Goodwin, is the latest in a series of doctors and researchers whose ties to drug makers have been uncovered by Senator Charles E. Grassley, a Republican from Iowa. Dr. Goodwin, a former director of the National Institute of Mental Health, is the first media figure investigated.
Dr. Goodwin’s radio programs have often touched on subjects important to the commercial interests of the companies for which he consults. In a program broadcast on Sept. 20, 2005, Dr. Goodwin warned that children with bipolar disorder who are left untreated could suffer brain damage, a controversial view. “But as we’ll be hearing today,” Dr. Goodwin reassured his audience, “modern treatments mood stabilizers in particular have been proven both safe and effective in bipolar children.”
That very day, GlaxoSmithKline paid Dr. Goodwin $2,500 to give a promotional lecture for its mood stabilizer drug, Lamictal, at the Ritz Carlton Golf Resort in Naples, Fla. Indeed, Glaxo paid Dr. Goodwin more than $329,000 that year for promoting Lamictal, records given Congressional investigators show.
In an interview, Dr. Goodwin said that Bill Lichtenstein, the program’s producer, knew of his consulting activities but that neither he nor Mr. Lichtenstein thought that “getting money from drug companies could be an issue. In retrospect, that should have been disclosed.”
But Mr. Lichtenstein said that he was unaware of Dr. Goodwin’s financial ties to drug makers and that he called Dr. Goodwin earlier this year “and asked him point-blank if he was receiving funding from pharmaceutical companies, directly or indirectly, and the answer was, ‘No.’”
“The fact that he was out on the stump for pharmaceutical companies was not something we were aware of. It would have violated our agreements,” Mr. Lichtenstein said in an interview.
Margaret Low Smith, vice president of National Public Radio, said that N.P.R. will remove “The Infinite Mind” from its satellite radio service next week, the earliest possible date. Ms. Smith said that had N.P.R. been aware of Dr. Goodwin’s financial interests, it would not have aired the program.
Sarah Alspach, a spokeswoman for Glaxo, said, “We continue to believe that healthcare professionals are responsible for making disclosures to their employers and other entities, in this case National Public Radio and its listeners.”
“The Infinite Mind” is a weekly program that has won more than 60 journalism awards over 10 years and bills itself as “public radio’s most honored and listened to health and science program.” It has more than one million listeners in more than 300 radio markets. Mr. Lichtenstein said that the last original program aired in October, that reruns have been airing since and that “the show is going off the air.”
The program has received major underwriting from the National Institutes of Health and the National Science Foundation, both of which have policies requiring grantees to disclose and manage conflicts of interest. Mr. Grassley wrote letters to both agencies asking whether disclosure rules were followed for the grants. Spokespeople for both agencies said they were cooperating with the investigation.
Mr. Grassley is systematically asking some of the nation’s leading researchers and doctors to provide their conflict-of-interest disclosures, and Mr. Grassley is comparing those documents with records of actual payments from drug companies. The records often conflict, sometimes starkly.
In October, Mr. Grassley revealed that Dr. Charles B. Nemeroff of Emory University, one of the nation’s most influential psychiatric researchers, earned more than $2.8 million in consulting arrangements with drug makers from 2000 to 2007, failed to report at least $1.2 million of that income to his university and violated federal research rules. As a result, the National Institutes of Health suspended a $9.3 million research grant to Emory and placed restrictions on other grants, and Dr. Nemeroff relinquished his chairmanship of Emory’s psychiatry department.
In June, the senator revealed that Harvard University’s Dr. Joseph Biederman, whose work has fueled an explosion in the use of powerful antipsychotic medicines in children, had earned at least $1.6 million from drug makers between 2000 and 2007, failed to report most of this income to his university, and may have violated federal and university research rules.
Mr. Grassley’s investigation demonstrates how deeply pharmaceutical commercial interests reach into academic medicine, and it has shown that universities are all but incapable of policing these arrangements. As a result of these revelations, almost every major medical school and medical society is now reassessing its relationships with drug and device makers.
“We know the drug companies are throwing huge amounts of money at medical researchers, and there’s no clear-cut way to know how much and exactly where,” Mr. Grassley said. “Now it looks like the same thing is happening in journalism.”
Mr. Grassley has proposed legislation that would require drug makers to publicly post all payments of $500 or more made to doctors. Eli Lilly and Merck have promised to begin posting such payments next year.
Dr. Goodwin has authored an influential textbook on bipolar disorder and is an adjunct professor at George Washington University. In an extensive interview, Dr. Goodwin blamed a changing ethical environment for any misunderstandings between himself and Mr. Lichtenstein about his consulting arrangements.
“More than 10 years ago when he and I got involved in this effort, it didn’t occur to me that my doing what every other expert in the field does might be considered a conflict of interest,” Dr. Goodwin said.
He defended the views he expressed in many of his radio programs and said that, because he consults for so many drug makers at once, he has no particular bias.
“These companies compete with each other and cancel each other out,” he said. This view is dismissed by industry critics, who say that experts who consult widely for drug makers tend to minimize the value of non-drug or older drug treatments.
In the fine print of a study he authored in 2003, Dr. Goodwin reported consulting or speaking for nine drug makers. Mr. Grassley only asked for payment information from Glaxo. Dr. Goodwin said that in recent years Glaxo paid him more than other companies.
He said that he has never given marketing lectures for antidepressant medicines like Prozac, so he saw no conflict with a program he hosted in March titled “Prozac Nation: Revisited” that he introduced by saying, “As you will hear today, there is no credible scientific evidence linking antidepressants to violence or to suicide.”
That same week, Dr. Goodwin earned around $20,000 from Glaxo, which for years suppressed studies showing that its antidepressant, Paxil, increased suicidal behaviors.
Tom Rosenstiel, director of the Project for Excellence in Journalism, said that although concerns about media bias are growing, few people believe that journalists take money from those they cover. Disclosures like those surrounding Dr. Goodwin could change that, “so this kind of thing is very damaging,” Mr. Rosenstiel said.
November 25, 2008
Research Center Tied to Drug Company
By GARDINER HARRIS
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, 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 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.
“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 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, 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.