Archive for December, 2008

Wyeth Paid For Positive Articles On Their Drugs In Journals

Monday, December 29th, 2008

December 13, 2008

http://www.dbtechno.com/health/2008/12/13/wyeth-paid-for-positive-articles-on-their-drugs-in-journals/

Washington (dbTechno) – According to U.S. Senator Charles Grassley, the pharmaceutical company Wyeth paid to have positive articles written about their drugs in medical journals.

Sen. Grassley is a Republican from Iowa and has been probing into this case for quite some time.

He started by looking into a medical writing company known as DesignWrite.

The company was asked to reveal information on payments that they received from articles on certain drugs such as Prempro.

According to the latest reports from The New York Times, Sen. Grassley has found that Wyeth set up ghost writers to do positive articles on their Prempro drug.

This is scary because it means that scientific journals and such could actually be manipulated.

This could cause doctors to prescribe drugs to patients based on false information.

They had the ghost writers work on the articles, then paid for scientists to put their names on the journals.

This is not the first time pharmaceutical companies have been found to do this either, increasing the problems further.

Whistleblowers sent to mental ward, Chinese paper says

Friday, December 26th, 2008

International Herald Tribune
Monday, December 8, 2008
By Andrew Jacobs
http://www.iht.com/articles/2008/12/08/asia/china.php

BEIJING: Local officials in Shandong Province have apparently found a cost-effective way to deal with gadflies, whistleblowers and all manner of muckraking citizens who dare to challenge the authorities: dispatch them to the local psychiatric hospital.

According to an investigative report published Monday by a state-owned newspaper, public security officials in Xintai city have been institutionalizing residents who persist in their personal campaigns to expose corruption or to protest the unfair seizure of their property. Some people said they were committed up to two years, and several of those interviewed said they had been forced to consume psychiatric medication.

The article, in The Beijing News, said most inmates had been released after they agreed to give up their causes.

Sun Fawu, 57, a farmer seeking compensation for land spoiled by a coal mining operation, said he was seized by the local authorities on his way to petition the central government in Beijing and brought to the Xintai Mental Health Center in October.

During a 20-day stay, he said he was tied to a bed, forced to take pills and given injections that made him numb and woozy. When he told the doctor he was a petitioner, not mentally ill, the doctor reportedly said, “I don’t care if you’re sick or not. As long as you are sent by the township government, I’ll treat you as a mental patient.”

In an interview with the paper, the hospital’s director, Wu Yuzhu, acknowledged that some of the 18 patients brought there by the police in recent years were not deranged, but he had no choice but to take them in. “The hospital also had its misgivings,” he said.

Although China is not known for the kind of systematic abuse of psychiatry that occurred in the Soviet Union, human rights advocates say forced institutionalizations are not uncommon in smaller cities. Robin Munro, the research director of China Labour Bulletin, a rights organization in Hong Kong, said such “an kang” wards – Chinese for peace and health – are a convenient and effective means of dealing with pesky dissidents.

In recent years practitioners of Falun Gong, the banned spiritual movement, have complained of coerced hospitalizations and one of China’s best-known dissidents, Wang Wanxing, spent 13 years in a police-run psychiatric facility under conditions he later described as abusive.

In one recent, well-publicized case, Wang Jingmei , the mother of a man convicted of killing six policemen in Shanghai, was held incommunicado at a mental hospital for five months and only released last Sunday, the day before her son was executed.

The Beijing News story about the hospitalizations in Xintai was notable for the traction it gained in China’s constrained state-run media. Such Communist Party stalwarts as People’s Daily and the Xinhua news agency republished the story, and it was picked up by scores of Web sites. At the country’s most popular portal, Sina.com, it ranked the fifth most-viewed news headline and readers posted more than 20,000 comments by evening. The indignation expressed was universal, with many clamoring for the dismissal of those involved. “They’re no different than animals,” read one post. “No, they’re worse.”

Reached by phone on Monday, a hospital employee said Wu, the hospital director who voiced his misgivings to The Beijing News, was unavailable. The employee, Hu Peng, said local government officials had taken him away for “a meeting” earlier in the day and had also looked through patient records.

Although Hu said the hospital was not authorized to diagnose patients, he nonetheless defended the hospitalizations, saying that all the patients delivered by the Public Security Bureau were certifiably ill. “We definitely would not accept those without mental problems,” he said.

Official Warnings Issued: Eli Lilly’s ADHD drug Strattera Causes Psychoses, Hallucinations, Mania and Agitation

Monday, December 22nd, 2008

http://www.transworldnews.com/NewsStory.aspx?id=69298&cat=10

Stockholm, Sweden 12-01-2008 09:38 GMT (TransWorldNews)

BigPharma’s latest psychostimulant drug is Strattera. Its manufacturer, Eli Lilly, has now changed the label for the drug in Europe to include warnings that Strattera CAUSES “hallucinations, delusional thinking, mania or agitation in children and adolescents without a prior history of psychotic illness or mania … at usual doses”.

 

Please note that Strattera is CAUSING these symptoms – that these “symptoms” seen in children are drug induced, that they in actual fact are signs of drug induced brain dysfunction.

 

It took almost THREE years of foot dragging before the medical authorities in Europe finally decided that Eli Lilly should issue warnings about psychotic reactions in the label for Strattera. But now the warnings are finally out.

 

The story leading up to these warnings can be read in the following article (see also links in the article to background data): The ADHD drug Strattera – actions needed now, from January 2008, http://jannel.se/letter.mhra.strattera.jan08.pdf (See also article about Strattera death at http://jannel.se/Strattera.death2.pdf)

 

The new warnings about the causal role for Strattera in inducing mania, agitation and psychosis with hallucinations, can be read at http://emc.medicines.org.uk/emc/assets/c/html/displaydoc.asp?documentid=14482

 

In the US famous psychiatrists like Dr. Joseph Biederman have convinced doctors that the manic states seen in children receiving ADHD drugs (like Concerta, Adderall and Strattera) are signs of “bipolar disorder” – not signs of drug induced brain dysfunction.

 

This has meant that children in the US, instead of being taken off the dangerous drugs are given the most toxic substances available in psychiatry – neuroleptics (so called antipsychotics like Risperdal, Zyprexa and Abilify).

 

These new warnings in Europe for Strattera, together with all exposures of the fraudulent affairs of Biederman and colleagues, should finally convince doctors about the facts and what needs to be done – that the harmed children need to be taken off the drugs under careful supervision.

 

Janne Larsson

Reporter – investigating psychiatry

Sweden

janne.olov.larsson@telia.com

Psychiatric drugs force queried

Saturday, December 20th, 2008

http://news.bbc.co.uk/2/hi/health/7764512.stm

The practice of forcing psychiatric patients to take medication is not backed by evidence, say UK researchers

Very few rigorous investigations of the use of coerced medication have been done despite it being widespread, the Journal of Advanced Nursing reported.

The dearth of evidence is “unacceptable” and more should be done to find alternatives, the team said.

A spokeswoman for Mind said the threat of forced medication often stopped people seeking help in the first place.

Researchers from the Institute of Psychiatry and City University in London found 14 studies from seven countries on forcing psychiatric inpatients to take medication.
Most of the patients looked at had been admitted involuntarily, and they were slightly more likely to be female and in their 30s, the studies of patients and staff from the UK, USA, Sweden, Finland, Germany, Canada and Denmark, showed.Most had been diagnosed with schizophrenia, bipolar disorder or another psychotic illness.The practice seemed more common in the UK but that is probably because mechanical restraint is used more often in other countries to stop patients harming themselves and others.There was little detail on the events leading up to the coerced medication incidents and “a complete absence” of investigation into alternatives, the researchers said.Early intervention

Study leader Manuela Jarrett, a researcher at the Institute of Psychiatry and registered mental health nurse said she had hoped to find more evidence on the factors that lead up to coerced medication, what constitutes a risk and how long the patient has been on the ward.

“We also need more research into early intervention and whether that can prevent coerced medication.”

“When you stop and think about it, its quite a drastic step.”

She added that hospitals probably had different rates of how often they forced patients to take medication but the figures are not available for monitoring.

The lack of evidence suggests the procedure is taken for granted in psychiatric hospitals, she said.

“We feel that this is unacceptable and more needs to be done to establish sound clinical evidence and viable alternatives to this contentious approach.”

Alison Cobb, senior policy and campaign’s officer at the mental health charity, Mind, said forcing patients to take medication against their will was “extremely distressing” for them.

“Their freedom is taken away and people are often left feeling powerless, frightened and helpless.”

“The threat of coerced medication can discourage people from seeking treatment when they need it and may damage the relationship between patients and mental heath professionals.

“We urgently need to see more studies on this issue, particularly exploring the use of alternative treatments and how to include service users fully in making decisions about treatments.”

Appalling conflicts of interest of prominent psychiatrists

Saturday, December 20th, 2008
The New York Times
November 30, 2008
Editorial

Expert or Shill?
More evidence has emerged of appalling conflicts of interest that throw into doubt the advice rendered and the research performed by two prominent psychiatrists who have received substantial funding from the pharmaceutical industry. The revelations prove, once again, the need for universities and professional societies to crack down on conflicts of interest, and for Congress to pass legislation that will bring hidden conflicts into the open.

Earlier this year, Congressional investigators discovered that Dr. Joseph Biederman, a world-renowned child psychiatrist at Harvard Medical School and Massachusetts General Hospital, had failed to report to Harvard at least $1.4 million in income from drug companies, in violation of the university’s conflict-of-interest guidelines.

Now, internal drug company e-mail and documents that surfaced in a lawsuit have sketched out what looks like an unsavory collaboration between Dr. Biederman and Johnson & Johnson to generate and disseminate data that would support use of an antipsychotic drug, Risperdal, in children, a controversial target group.

The various documents indicate that Dr. Biederman repeatedly asked a Johnson & Johnson subsidiary to fund a research center at Massachusetts General to focus on children and adolescents with bipolar disorders and that the company provided almost $1 million. Disturbingly, one of the center’s publicly stated missions, along with improving the psychiatric care of children, was to “move forward the commercial goals of J.& J.”

The company also drafted a scientific abstract on Risperdal for Dr. Biederman to sign — as if he were the author — before it was presented at a professional meeting. And it sought his advice on how to handle the uncomfortable fact, not mentioned in the abstract, that children given placebos, not just those given Risperdal, also improved significantly.

Dr. Biederman’s work and reputation have helped fuel a huge increase in the use of powerful, risky and expensive antipsychotic medicines in young people, an upsurge that brought a warning recently from a federally appointed panel of experts. Now it is hard to know whether he has been speaking as an independent expert or a paid shill for the drug industry.

Congressional investigators also recently reported that Frederick Goodwin, an influential psychiatrist who has been hosting a popular weekly program on public radio, earned at least $1.3 million by giving marketing lectures for drug makers who potentially stood to benefit from the recommendations he made on the program. He has rightly been removed from the air.

Drugging children with unapproved psychiatric drugs

Saturday, December 13th, 2008

Psychiatry is facing unprecedented exposure for drugging children with unapproved psychotropic drugs, and for ties to drug companies.  In less than a week we’ve seen coverage in the Wall Street Journal, New York Times, USA Today, Boston Globe and LA Times, among others.

From the top down, exposure of psychiatry over the last six months goes like this:

  • Former head of National Institutes of Health and leading mental health talk show host, Fred K. Goodwin, was exposed for not reporting pharmaceutical money to listeners or producers.  He promoted such things as the diagnosis of bipolar disorder in children, which undoubtedly contributed to the continued rise in dangerous and unproven antipsychotic drugs for this use.
  • The infamous Dr. Joe Biederman, Harvard researcher and noted promoter of the Bipolar diagnosis in children was exposed for taking far more money from drug companies than he reported to the University. Yesterday the New York Times reported that internal documents and e-mails between a drug company and Biederman showed him pressuring the drug company to open a research center to “promote the commercial goals of [drug company name deleted].” While Biederman continues to be under investigation, he is credited for helping to fuel the 40 fold increase in the bipolar diagnosis for kids, which of course was accompanied by exploding prescriptions for dangerous, off-label drugs.
  • Then there was the exposure of Karen D. Wagner at the University of Texas Medical Branch in Galveston, who according to US Senator Charles Grassley, failed to disclose tens of thousands of dollars in drug company money while writing guidelines for the drugging of children.  Wagner wrote a chapter of psychiatry’s textbook on psychopharmacology dealing with the treatment of children during this time as well. 

Of course, the editors of the textbook would have gone out of their way to guard against conflicts of interest, right?  That’s what you would think…

Psychopharmacology textbook editors Charles Nemeroff and Alan Schatzburg were both exposed for failing to reveal substantial funding from drug companies.

This isn’t a complete list by any means, but I think you get the picture.  Psychiatry, from top to bottom, is riddled with conflict of interest allegations, and drug companies denying the off-label promotion of their drugs while industry “thought leaders” continue to be found with their hands in the pharmaceutical “cookie jar.”

There is legislation both federally and in the state of Texas to require drug companies to disclose their payments to doctors so that these marketing schemes can be known about up front. Write your own state legislators to introduce and pass legislation to audit psychiatric outcomes, prosecute psychiatric fraud and abuse, and eliminate psychiatrists and psychiatric funding from our schools and communities.

Study: Off-label drugs should be researched for safety

Tuesday, December 9th, 2008

By Rita Rubin, USA TODAY
11/24/2008

Among all the drugs prescribed to treat conditions for which they’re not approved, doctors and patients should be most concerned about antipsychotics and antidepressants, a study suggests today.

This “off-label” prescribing is a legal, common practice that is being questioned in some cases because of inadequate scientific evidence to support its safety and effectiveness.

“Although previous research has highlighted the substantial frequency of off-label drug use without good evidence, we have identified and prioritized specific drugs warranting attention,” the authors of the new study write in the journal Pharmacotherapy.

They list 14 drugs for which needed research into off-label use is most pressing. Three are antipsychotics, six are antidepressants. The researchers considered three factors in devising their list: the volume of off-label use with inadequate evidence, drug safety, and cost and market considerations.

Seroquel, an antipsychotic approved for treating schizophrenia and short-term manic or depressive episodes in bipolar disorder, topped the list. Three out of four times, doctors use the drug off-label, mainly for maintenance therapy for bipolar disease, says senior author Randall Stafford, associate professor of medicine at the Stanford Prevention Research Center.

“It’s not that these off-label uses are necessarily harmful or that these drugs don’t work,” Stafford says. The problem, he says, is that no one can be certain, because needed studies haven’t been done.

The FDA requires drug companies to test their drugs only against conditions for which they’re seeking approval. “Clearly, for many of these off-label uses, the manufacturers are benefiting enormously, and in some cases I think one could argue that off-label use has allowed them to circumvent the regulatory process,” Stafford says. Although the regulatory process is not infallible, he says, “it does provide a level of scrutiny” beyond what the off-label uses have received.

Diedtra Henderson, a spokeswoman for the Pharmaceutical Research and Manufacturers Association, a trade group, said her organization could not comment on off-label prescribing. “That’s nothing being driven by our companies,” she said. “This is an activity that our companies aren’t allowed to do under FDA regulations.”

But according to a paper posted last month by the online journal PLoS Medicine, industry-paid “nationally known, influential academic physicians” help create “buzz” about off-label uses by writing about them for publication or presentation at scientific meetings. The article was written by physician Adriane Fugh-Berman of Georgetown University Medical Center in Washington, D.C., and Douglas Melnick, a preventive medicine doctor in North Hollywood, Calif.

Earlier this month in PLoS Medicine, medical school professor Michael Wilkes and law professor Margaret Johns, both of the University of California, Davis, called for doctors always to inform patients that they want to use a drug off-label, giving them the chance to decide whether they want to take it.

### ### ###

Of course, on-label or off-label use of psychotropic drugs is equally harmful, as you will find once you watch this documentary video:

http://www.cchr.org/#/videos/making-a-killing-introduction

Recognize that the real problem is that psychiatrists fraudulently diagnose life’s problems as an “illness”, and stigmatize unwanted behavior or study problems as  “diseases.” Psychiatry’s stigmatizing labels, programs and treatments are harmful junk science; their diagnoses of “mental disorders” are a hoax – unscientific, fraudulent and harmful. All psychiatric treatments, not just psychiatric drugs, are dangerous, and can cause crime.

Harvard Teaching Hospital Reviewing J&J Ties to Psychiatry Unit

Monday, December 8th, 2008

http://www.bloomberg.com/apps/news?pid=20601087&sid=atN6Se0NVbp0&refer=home

By Rob Waters and Julie Ziegler

Nov. 25 (Bloomberg) — Massachusetts General Hospital will investigate conflicts of interest at a child psychiatry research center it established with funding from Johnson & Johnson, maker of the antipsychotic drug Risperdal.

The hospital, in a statement yesterday, said its grant specified the purpose of the center was scientific and educational, not to promote J&J’s products. Yet the center’s 2002 annual report said it would undertake studies that “will move forward the commercial goals of J&J,” according to documents released in connection with a lawsuit against the company.

The Johnson & Johnson Center for the Study of Pediatric Psychopathology was run by Joseph Biederman, a Harvard University child psychiatrist whose research helped fuel an explosion in the number of children diagnosed with bipolar disorder and treated with antipsychotics. His ties to J&J and other drugmakers were criticized in June by Senator Charles Grassley, an Iowa Republican, who said Biederman failed to disclose most of the $1.6 million he received from the industry from 2000 to 2007.

“I would question how this conduct — the acceptance of money — advances public health,” said Steven Sheller, a Philadelphia attorney who represents the families of children suing J&J in connection with side effects from Risperdal. The hospital is “supposedly interested in public health.”

David Cameron, a spokesman for Boston-based Harvard Medical School, said Harvard isn’t involved with the J&J Center at Massachusetts General, a Harvard teaching hospital.

‘Individually Governed’

“Harvard Medical School does not ‘own’ any of its teaching hospitals,” Cameron said in an e-mail. “While we are affiliated with them through academic appointments, all teaching hospitals are individually governed.”

Biederman didn’t reply to phone messages and e-mails sent to his office.

Massachusetts General, which pledged in June to investigate drug industry payments to Biederman, “takes these allegations very seriously and intends to investigate these issues thoroughly,” said Peggy Slasman, a hospital spokeswoman, in an e-mail yesterday.

The documents were released at a time of fierce debate over the increasing use by children of powerful antipsychotic drugs that can cause weight gain, diabetes and hormonal and neurological effects. Biederman is a leading proponent of the idea that bipolar disorder, once viewed as an adult disease, can begin early in childhood and be treated with drugs. People with bipolar disorder alternate between bouts of depression and mania.

The number of children diagnosed as bipolar increased 40- fold between 1994 and 2003, according to a 2007 study. Sales of drugs used to treat the condition doubled from 2003 to 2006, according to data provided to Bloomberg in 2007 by Wolters Kluwer NV, a prescription-tracking company.

Deposition Battle

Attorneys in a New Jersey state court action against J&J have been battling to depose Biederman to explore the way the company promoted the use of Risperdal. The documents about the doctor and his child psychiatry center at Massachusetts General were released as part of the legal case.

Some plaintiffs allege that J&J promoted Risperdal to patients, including children, for whom it was not approved by U.S. regulators, a practice known as “off-label” prescribing. While doctors are free to prescribe any approved drug to any patient, companies are not allowed to promote drugs for unapproved uses. Drugmakers such as Eli Lilly & Co., the maker of Zyprexa, AstraZeneca Plc, the maker of Seroquel, and J&J are being sued by states and individuals alleging off-label marketing of their antipsychotic treatments.
J&J’s Response

Kara Russell, a spokeswoman for Janssen, the J&J unit that makes Risperdal, said the company promotes the drug and other products only for their approved uses. The company supported the Massachusetts General program “to conduct rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children,” she said in an e-mail yesterday.

The e-mails and internal memos released in the New Jersey lawsuit show Biederman pressed the company for money to establish the center and J&J used the data from center studies to promote Risperdal in children. J&J funded the center from 2002 to 2006.

Biederman “approached Janssen multiple times to propose the creation of a Janssen-MGH center,” according to an e-mail from a J&J executive. The center would “generate and disseminate data supporting the use” of Risperdal in children, the e-mail said. Pediatric use was approved by U.S. regulators in August 2007.

The e-mails released in the lawsuit also show that J&J was closely involved in Risperdal studies undertaken by Biederman and his colleagues at the center.

Generating the Data

In one e-mail, Gahan Pandina, a J&J clinical development executive, sent Biederman a research summary to be presented at a medical conference. The summary listed Biederman as the lead author and concluded that Risperdal “is effective” in treating children with bipolar disorder. In the e-mail, Pandina said he “was able to have our statistics department generate the summary data” and asked Biederman to review, comment and sign a form “as the presenting author.”

The influence Biederman has on other doctors was hinted at in a 2002 e-mail from Pandina, which noted the psychiatrist was “very well received” by a group of 1,000 doctors who paid $700 each for a three-day course on medications for pediatric bipolar disorder. Forming a partnership with Biederman and his program “has the potential of reaching and having a significant impact” on child psychiatrists.

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.

Research Center Tied to Drug Company

Sunday, December 7th, 2008
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.

Kansas psychiatrist Douglas Geenens Disciplined by Kansas Board of Healing Arts

Sunday, December 7th, 2008

This is an overview, in no particular order, of what is publicly known about Douglas Geenens.
Douglas Lee Geenens, D.O., is a Kansas City area physician who specializes in psychiatry and child psychiatry. He has operated mainly in the Overland Park area of Kansas but also was also licensed in Missouri until October 2007.The Kansas Board of Healing Arts suspended his medical license for six months on December 11, 2004 but suspended all but seven days of the suspension. The reason for this disciplinary action was that Dr. Geenens engaged in a social and then sexual relationship with a former patient–the wife of a colleague who had come to him for treatment of “depression and marital issues,” according to the Kansas Board’s Order, which you can see here: http://www.ksbha.org/boardactions/Documents/geenens.pdf

Dr. Geenens married this former patient in Key West, Florida on December 15, 2007.

Dr. Geenens was under investigation by the Missouri State Board of Registration for the Healing Arts but quietly “retired” his license in October 2007 when it was due for renewal. This, according to an official letter from the Board, “closed the Board’s case” against him.

Dr. Geenens was the treating psychiatrist of 13-year-old Matthew Miller, who hanged himself after one week on the Geenens-prescribed antidepressant Zoloft in July 1997. Zoloft is manufactured by the the Pfizer pharmaceutical company. According to a deposition Geenens gave in a lawsuit filed by Miller’s parents against Pfizer, Geenens was (and possibly still is) a highly paid Pfizer speaker, frequently giving promotional talks on Zoloft. See the story here (particularly paragraph 28): http://www.freerepublic.com/focus/f-news/1285024/posts.

Some time between December 2004 and the present, the Kansas Board of Healing Arts re-opened an investigation of Dr. Geenens, due in part perhaps to complaints filed by Citizens Commission on Human Rights, citing his ongoing relationship with the former patient as a continuing violation of rules and regulations governing the conduct of physicians.

On October 29, 2008, the Kansas Board of Healing Arts filed a 23-count disciplinary Petition against Dr. Geenens, seeking to suspend or revoke his license for numerous alleged violations. Twenty of the counts listed in the Petition allege that he prescribed psychiatric drugs without sufficient examinations. It also cites “boundary issues” in connection with improper relationships with patients. In one case, the Petition states that Geenens told a patient, “You need to get a divorce, move to the Plaza and we could have breakfast together.” The document has not yet been published by the Board, but you can see local news about it by searching in the Kansas City Star archives for: “Kansas medical board files disciplinary petition against Leawood psychiatrist” by Alan Bavley, The Kansas City Star, 30 October 2008.