TIMELINE FOR PEDIATRIC  BIPOLAR DISORDER

         Disease Creation       Pharmaceutical Funding        Research Fraud     Heavily Drugged Children

—————————————————————————————————->

After this first section, please refer to second part of this post at the bottom of the page which is the expansive timeline on the creation of child bipolar that has led to the devastating psychiatric standard of drugging children with several dangerous psychiatric drugs at a time, including antipsychotics.

Some key psychiatrists show up prominently in this timeline and some of the promotion of various psychotropic drugs appear to follow the pharmaceutical research funding.

If you have data on clinical research being altered to support funding as opposed to science, or have any other information on unethical or criminal acts by the researchers involved that is not listed in this timeline, please let us know. Your information could potentially save a lot of children in the future. Also, if you know of anything missing in this timeline that you feel should be added, please email to BevMacPhee@gmail.com
————————————————————————————————–

 Pediatric Bipolar Psychiatric Guidelines Exposed
as a drug marketing opportunity and a CRIME AGAINST HUMANITY

 

By Bev MacPhee

Below is my personal view based upon the vast amount of data below. Psychiatrists, major pharmaceutical companies and a medical journal publisher acted together to create the controversial pediatric Bipolar psychiatric guideline that calls for children, as young as two-years-old, to be dangerously drugged for multiple mental disorders and with several categories of psychiatric drugs at a time Like many, I feel this action and the resultant harm from such severe drugging to be a crime against humanity.

Per the International Criminal Court, “Crimes against humanity” is defined as a widespread or systematic attack directed against any civilian population, with knowledge of the attack, and includes: “inhumane acts of a similar character intentionally causing great suffering or serious bodily or mental injury.” To me, the scheme to put nearly a million children on antipsychotics, often mixed with a cocktail of other mind-altering drugs, fits the definition.

The data below appears to reveal how Joseph Biederman. a highly-influential psychiatric researcher at Harvard University and Massachusetts General Hospital, spearheaded a 400% increase in the diagnosis of Pediatric Bipolar Disorder from 1994 to 2003. and then helped to create the psychiatric drugging guideline by way of very questionable research, for this disorder that was officially approved in 2005.

In addition to the 2005 Bipolar Treatment Guidelines were the heavy promotion of pediatric Bipolar in medical journals, continuing medical education courses and in the media. Here is the resultant number of US children and adolescents by age who were being prescribed antipsychotics and other psychotropic as of 2013:

Antipsychotics     0-5 Years                 27,343

Breakdown:
0-1 Years                654
2-3 Years                3,760
4-5 Years                24,363

6-12 Years             359,882
13-17 Years           490,272

Grand Total           0-17 Years               830,836 US Children on antipsychotics

http://www.cchrint.org/psychiatric-drugs/children-on-psychiatric-drugs

 

The following data will also reveal, through court documents and media accounts, the role of a major drug company in funding the research and creating the studies, and a publisher that owns the medical journal [Journal of the American Academy of Child and Adolescent Psychiatry] that publishes child psychiatric guidelines and is known for having a subsidiary company that writes alleged medical research articles while having its paid-off researchers sign on as the study authors.

You will see Biederman’s role in creating Pediatric Bipolar Disorder and how it turned the drug, Risperdal, into a gold mine for Johnson & Johnson Pharmaceuticals. He was not the first psychiatrist to label children as Bipolar, as debates about the diagnosis of Bipolar (BP) in children can be traced back to the 1950s.  Yet, it was not until early 1994 and 1995 that articles by psychiatrists Joseph Biederman, Barbara Geller and Janet Wozniak seemed to increase the diagnoses.

The rest of the story is below in more detail with documents linked:

With the surge of articles from Biederman et al, as to the diagnosis of Bipolar Disorder in children and adolescents, came the need to set down standards in which to diagnosis it.

“Due to the lack of research of Bipolar Disorder in children and adolescents, in 1994 many of the treatments were drawn from adult literature. At that time, children and adolescents were diagnosed with Bipolar disorder based on the same criteria used for adults as outlined in DSM-IV (American Psychiatric Association [APA], 1994b). The general consensus of the then available data was sufficient to suggest that Bipolar disorder with onset before the age of 18 years is essentially the same disorder as that in adults, but further studies were needed to clarify the long-term course and outcome of the early-onset forms, especially for those with very early onset”.  http://www.bpso.org/practice.htm

In 1994, a literature review was done that was used to develop the initial draft of the manuscript for the guidelines . (Practice Parameters for the Assessment and Treatment of Children and Adolescents With Bipolar Disorder).

The National Library of Medicine did the initial search in May 1994, covering the preceding 5-year period. The following topics were reviewed: Bipolar disorder and adolescents (39 articles), Bipolar disorder and children (105 articles), and Bipolar disorder and early onset (21 articles). This search was updated periodically (most recently in December 1995) to identify new articles. . “These practice parameters describe the assessment and treatment of early-onset Bipolar disorder based on scientific evidence regarding diagnosis and effective treatment and on the current state of clinical practice. Biederman was part of the panel of experts where he reviewed and commented on the information in the original draft of the guidelines. His studies on the Child Behavior Checklist in 1995 has been used to distinguish manic children from those with ADHD.”

http://www.ncbi.nlm.nih.gov/pubmed/8682754/

After review by the Committee on Quality Issues, this draft was then distributed to a panel of experts for comment, which just happened to include Dr Joseph Biederman. What a perfect opportunity for Biederman to push his agenda to get more children on psychiatric drugs via a Bipolar Disorder diagnosis.
http://www.jaacap.com/article/S0890-8567(09)63918-6/abstract

The “Practice Parameters for the Assessment and Treatment of Children and Adolescents With Bipolar Disorder”  were published in 1996 with Lithium and Valporic Acid being the drugs of choice to treat it.  The treatment focused on:

(1) amelioration (patient improvement) of acute symptoms;

(2) the prevention of relapse;

(3) the reduction of long-term morbidity; (DEFINITION) and

(4) the promotion of long-term growth and development.

Since there were no medical tests that could be done to determine whether or not a child had Bipolar Disorder, the diagnosis was based on symptoms which were often overlapped with other diseases and made it difficult to determine the Bipolar diagnosis. In order to push his agenda that many children were misdiagnosed with a disease other than Bipolar,  Drs. Biederman et al. [30] I and Wozniak et] in two JAACAP articles report that 16% of a clinical population of children met the criteria for mania primarily by exhibiting chronically irritable mood and describe their use of the Child Behavior Checklist to confirm their diagnoses of Bipolar in these children.

The above situation led to the establishment of the child psychiatric guidelines in 1996, and was pivotal in ensuring that the 400% increase in the diagnosis of Pediatric Bipolar Disorder, was justified due to the all-inclusive efforts of Dr Joseph Biederman. Biederman had stated that in children, Bipolar Disorder could also be present along with diseases such as ADHD.  The development of the guidelines was the first step in promoting that multiple medications could be given simultaneously for the diagnosed disorders.  This was the prompt that Biederman and the pharmaceutical companies needed to create the numerous drugs that would eventually flood the market, all promising to effectively treat Bipolar Disease in children and adolescents. http://www.ncbi.nlm.nih.gov/pubmed/8682754/

 

In 1995/96, Biederman was searching for a pharmaceutical company that would fund him to do clinical trials to prove that children, as young as 2-years-old, could be Bipolar. His first choice was Janssen Pharmaceuticals, Inc., a pharmaceutical subsidiary of Johnson & Johnson. Biederman approached Janssen to do a clinical trial to study Risperdal [generic name Risperidone] in children. The research would cost Janssen $280,000.00  that Biederman wanted for  a research grant, but Janssen refused which angered Biederman so he took his business elsewhere. (1)

As you will read later in this story, in 2002, at the annual American Academy of Child and Adolescent Psychiatry meeting, Biederman gave a presentation, written by Johnson and Johnson, on “Risperdal vs  Placebo  for the Treatment of Conduct Disorder in Children With Mild, Moderate, or Borderline Mental Retardation”.”

,https://clinicaltrials.gov/ct2/show/NCT00266552. As a result of this meeting, guidelines were established for the Child Psychiatric Treatment Standards for other psychiatrists and doctors to use on children.

 

In 1998, Janssen wanted FDA-approval for Risperdal in the treatment of children with disruptive behaviors and who were of sub-average intelligence.  (2 )

They finished this trial of Risperdal and submitted it to the FDA but were turned down. Janssen had originally thought they could get Risperidone approved for treating disruptive kids [Disruptive Behavior Disorder, Conduct Disorder] but had given up on that idea and diverted to the more acceptable Bipolar disorder. (3)

In 1999, The Balanced Mind Parent Network, formerly known as The Child & Adolescent Bipolar Foundation (CABF), started with none other than with Dr. Joseph Biederman on its Scientific Advisory Board. In addition to Biederman, the Scientific Advisory Council included psychiatrists, Karen Wagner, Janet Wozniak, Jean Frazier, Robert Kowatch, Barbara Geller and Melissa DelBello. This group, was receiving funding from several pharmaceutical companies, as a means to promote Pediatric Bipolar and the use of antipsychotics on children to treat it to the media, parents and other doctors and psychiatrists. They also pushed for the eventual Pediatric Bipolar Psychiatric Guidelines where Biederman was a WorkGroup Member and Contributor.

http://www.jaacap.com/article/S0890-8567(09)61467-2/abstract

Between 1995 and 2000, Biederman did different studies for Abbott Laboratories, Bristol-Myers Squibb Company, Cephalon, Inc, and Eli Lilly to name just a few.

In November 1999, Johnson & Johnson marketing executive John Bruins suggested that Biederman had taken business away from Johnson & Johnson after the company turned down the doctor’s request for a $280,000 research grant. (4)

To remedy this situation, Biederman got his $280,000.00 research grant from Johnson and Johnson and his hospital, Massachusetts General Hospital (MGH) got their J&J Center for Pediatric Psychopathology Research Center.  Johnson & Johnson spent $700,000, in one year [2002] alone, to fund the MGH Johnson & Johnson Center for Pediatric Psychopathology with Biederman becoming the Center’s director. The purpose of the center, according to an internal company e-mail contained in court documents, was to “generate and disseminate data supporting the use of Risperdal in children and adolescents.” (5)   However, 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 was said to have written. http://www.nytimes.com/2008/11/25/health/25psych.html?_r=0

Here is important data covered by the Huffington Post:

 

 Annual Report 2002: The Johnson and Johnson Center for Pediatric

.            Psychopathology at the Massachusetts General Hospital

                         Director: Joseph Biederman. MD

An essential feature of the Center is its ability to conduct research satisfying three criteria: a) it will lead to findings that improve the psychiatric care of children; b) it will meet.high levels of scientific quality and c) it will move forward the commercial goals of J&J  (17).

 When you see that Johnson and Johnson paid both Massachusetts General Hospital (MGH)and its child psychiatrist, Joseph Biederman, for a study center  at MGH with a major purpose of moving “forward the commercial goals of J&J,” it certainly appears as though the hospital and psychiatrist (as Director of the Center) were sub-contracted by the pharmaceutical company to promote its drugs.

Furthermore, the research results from the J&J Center at MGH certainly cannot be trusted. As an investigation from US Senator Charles Grassley concluded, Biederman was promising the drug company several positive results of their drugs in children prior to doing the “studies.” Biederman also put children at risk in his experiments as shown by data attached in the previous Grassley link showing that he gave one child in a study of children ages 4-6 years old, 12.5mg of Eli Lilly’s antipsychotic olanzapine while the Mass General Hospital review board only approved a maximum dose of 7.5mg on the children.

In 2000, Johnson and Johnson aimed its efforts directly at selected physicians and state mental health decision makers who were in the best position to advance its marketing interests and its particular aim to affect guideline development. “ One of Janssen’s Key Base Business Goals was to grow and protect the drug’s market share with  child/adolescent patients. Janssen instructed its sales representatives to call on child psychiatrists, as well as mental health facilities that primarily treat children, and to market Risperdal as safe and effective for symptoms of various childhood disorders such as  Attention Deficit Hyperactivity Disorder ( ADHD)), oppositional defiant Disorder ( ODD), Obsessive-Compulsive Disorder (OCD) and Autism.” (6)

With all this new-found data about the urgency to study Pediatric Bipolar even more, came one of the most important part of their plan…how to get it in writing for all to see. In steps Exerpta Medica, a full-service global medical communications agency, who approached Janssen and asked for money to promote Risperdal by ghost-writing articles, having Key Opinion Leaders [KOL] sign onto them and to get them published in their parent company’s’ (Reed Elsevier) journals. (A ghostwriter is a writer who authors books, manuscripts, screenplays, scripts, articles, blog posts, stories, reports, whitepapers, or other texts that are officially credited to another person.)

As a note, Reed Elsevier owns the Journal of the American Academy of Child and Adolescent Psychiatry (JACAAP) that publishes the child psychiatric guidelines. It is also the largest publisher of medical journals which means that they heavily influence how doctors and psychiatrists treat patients.

According to the NY Times  (7)

“As ambitious as Janssen’s plan was, their most successful move came with their union with Dr Joseph Biederman. [he was an Excerpta Medica Key Opinion Leader (KOL) as assistant editor of the Reed Elsevier journal “Biological Psychiatry”] Biederman is well- known in his field and has long been considered a Key -Opinion Leader among his peers.  So it is no surprise that Janssen would select him to deliver a presentation at an American Academy of Child and Adolescent Psychiatry meeting in 2002“ [to help market their product].

“ Janssen wanted approval for Risperdal in the treatment of kids with Disruptive Behaviors, so they drafted a scientific abstract (outline) on Risperdal for Dr. Biederman to sign — as if he were the author — before he presented it at the meeting. It was written by Janssen with Biederman willingly signing on. 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. ([a placebo is a pill or substance that is given to a patient like a drug but that has no physical effect on the patient. ] It should be pointed out that in the deposition that Biederman claimed that he simply reviewed the Janssen study yet he was later listed as Lead Author.”

“In 1994-1995, in about 25 out of every 100,000 visits a child had a Bipolar diagnosis, the number increased to 1,003 per 100,000 by 2002-2003. During the same ten-year period, office visits by adults with a BP diagnosis almost doubled from 905 to 1,679 per 100,000 annually, suggesting that BP diagnoses reported by community-based clinicians have increased across the age span. But the very low base rate of this diagnosis in youth coupled with a rapid rise signaled a major practice change.”

http://capmh.biomedcentral.com/articles/10.1186/1753-2000-4-9#B30

 

The “ Practice Guidelines for the Treatment of Patients With Bipolar Disorder, 2nd Edition”, was published in April 2002. In the guidelines it is stated:

APA practice guidelines are intended to assist psychiatrists in clinical decision making. They are not intended to be a standard of care. The ultimate judgment regarding a particular clinical procedure or treatment plan must be made by the psychiatrist in light of the clinical data presented by the patient and the diagnostic and treatment options available..” http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/Bipolar-watch.pdf

What the write up does not says is that although the judgement for the clinical procedure or treatment plan must come from the physician, but it is totally guided by the pharmaceutical companies who are promoting their drugs as the course of action for Bipolar Diagnosis. As was mentioned above, there were seven (7) drug companies who fully funded unlimited research grants that would affect their take of the antipsychotic drug market enormously.

What was the most important part of the new guidelines that would benefit those drug companies who were funding its studies?

…” The guidelines included multiple types of psychiatric drugs to treat comorbid psychiatric conditions. In other words, different types of drugs such as ADHD and atypical antipsychotics at once. . The quidelines were finished in September 2004 and made official with publication in the American Journal of Child and Adolescent Psychiatry in March 2005). These drugs for children included psychiatry’s most powerful drugs, antipsychotics. http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/Bipolar-watch.pdf

In other words, at the prompting of the drug companies, the psychiatrists declared that more and more kids are Bipolar which leads to the production of more and more drugs.  This is such a huge change from the Guidelines that were established in 1996,  where only two drugs, lithium and Depakote were being used to treat Bipolar Disorder.  Leading psychiatrists created the demand for more drugs, and got paid heavily for promoting it, and the drug companies got rich by meeting the demand of the constantly increasing diagnoses.

…..As a note, this abstract was from a revised study from 1998 : “A Study of the Safety and Effectiveness of Risperidone Versus Placebo for the Treatment of Conduct Disorder in Children With Mild, Moderate, or Borderline Mental Retardation”, https://clinicaltrials.gov/ct2/show/NCT00266552. The purpose of the study is to assess the effectiveness and safety of an oral solution of risperidone (an antipsychotic medication) versus placebo in the treatment of conduct disorder in children with mild, moderate, or borderline mental retardation.

But why would Biederman, who studies Bipolar children, exhume a study of Risperidone in Disruptive Retarded kids to analyze?  The answer comes in the form of internal emails in discovery court documents. (8)

That internal email was to Dr. Biederman about his presenting the data from the 1998 study, at the 2002 American Academy of Child and Adolescent Psychiatry meeting in order to influence a few thousand child psychiatrists in attendance . It was clear in the email that Janssen had done the reanalysis and that Biederman was signing on as the author of record and presenter. (7)

The data in the 1998 trial study for Risperdal to treat disruptive, subnormal intelligence kids,that the FDA disapproved, was re-interpreted for the 2002 AACAP meeting and later published in 2006, with Janssen employee Gahan Pandina listed on the studyThe same data of Risperdal studied on subnormal intelligence disruptive kids was now altered to say that the “[P]reliminary data from open-label trials in children suggest that these agents might be effective in treating pediatric Bipolar disorder.”(8) (16)

You can imagine the frenzy circulating among members of the child psychiatric profession after the above mentioned meeting. Here Biederman spoke about antipsychotics being effective to treat the symptoms of pediatric bipolar while indicating that a broad study had shown this to be true, when in fact, it was re-interpreted data by a drug company from a subnormal intelligence group.

Soon after, the Child and Adolescent Bipolar Foundation (CABF) promted that clinicians who treat children and adolescents with Bipolar Disorder desperately need current treatment guidelines. How convenient was it that Dr. Joseph Biederman was on its Scientific Advisory Board along with numerous other CABF psychiatrists

“So in July 2003, a group of 20 clinicians and CABF members met over a 2-day period to develop these guidelines for the American Academy of Child and Adolescent Psychiatry which approves and publishes child psychiatric treatment standards for other psychiatrists and doctors to use on children. There were four work groups: diagnosis, led by Mary Fristad; comorbidity, led by Boris Birmaher; and treatment, in two groups led by Karen Wagner and Robert Findling, respectively. The authors of the pediatric Bipolar guidelines included Joseph Biederman and his Mass. General Hospital colleague, Janet Wozniak, who were a part of a workgroup.”

 

“The groups met to develop a draft of their sections that was circulated first to the separate work groups and then to the other work group members. Each group presented an overview of its guidelines to the whole group and then submitted its section’s guidelines for further comment and refinement to the members of their group and the other group members. This process went on for approximately 6 months with the guidelines being created by the Child and Adolescent Bipolar Foundation,(CABF) and approved by the American Academy of Child and Adolescent Psychiatry. (AACAP).”  In addition, this project was supported by unrestricted educational grants from Abbott Laboratories, AstraZeneca Pharmaceuticals, Eli Lilly and Company, Forest Pharmaceuticals,Janssen Pharmaceutical, Novartis, and Pfizer.” (9)

 

 

In taking a look at this whole picture, you have Dr Joseph Biederman, well-known psychiatrist and guru of the Bipolar scene, and Key Opinion Leader among his peers, delivering his presentation to American Academy of Child and Adolescent Psychiatry meeting, that stresses the need to study Bipolar to the nth degree.

The Child and Adolescent Bipolar Foundation group (CABF), whose Scientific Advisory Board is made up of other prestigious psychiatrists, stating that they needed specific guidelines to follow and then wanting to write those guidelines themselves. Then being approved by their own organization, the American Academy of Child and Adolescent Psychiatry (AACAP) and then published in the Elsevier-owned, Journal of American Academy of Child and Adolescent Psychiatry .(JAACAP)

Biederman’s affiliation with Elsevier did not stop here. As a matter of fact it was just the beginning of what can only be called, an onslaught of articles written by Biederman and published in Elsevier publications. In a list of 806 studies written by Biederman, more than 1/2 of his studies are published in journals wherein he either has a connection or are from a publisher that was hired by Johnson and Johnson to ghost-write with their Key OLs (which includes Biederman) signing the ghost-written studies. The statistics in this include the following:

381 – 47%  as the number in publications wherein he is connected

440 – 55% is the connected bunch plus additional Elsevier studies wherein we don’t

have connected directly to those Elsevier journal

Studies with Biederman as lead author = 237
107 – 45%  as the number in publications wherein he is connected
132 – 56% is the connected bunch plus additional Elsevier studies wherein we don’t
have connected directly to those Elsevier journal

The number of listed studies above may seem huge, but in reality, the number of study subjects regarding his pediatric Bipolar work was very small and therefore statistically unscientific in their  findings. Here is what others have to say about his studies:

“Legally, physicians may use drugs that have already been approved for a particular purpose for any other purpose they choose, but such use should be based on good published scientific evidence. That seems not to be the case here. Biederman’s own studies of the drugs he advocates to treat childhood Bipolar disorder were, as The New York Times summarized the opinions of its expert sources, so small and loosely designed that they were largely inconclusive.”  (10)

“Over the course of the years between 2000 and 2008, Biederman’s group reported 9 clinical trials [among their 78 articles]. I included this table because I was surprised at how thin it was – seven small open label trials, one retrospective analysis [of someone else’s Janssen financed double blind study], and only one double blind trial of their own. With all the noise they were making, I would’ve expected more”. (11)

In a transcript from a PBS Frontline show on the dramatic increase in the number of kids being diagnosed as Bipolar. (12)

Here is what other doctors have to say about Biederman and his studies:

DAVID SHAFFER, M.D., Chief, Child Psychiatry, Columbia Univ.: “What he did was he took the written criteria for attention deficit disorder and he took the written criteria for Bipolar disorder and he said, “Hey, a lot of these kids that you call ADHD actually fit the criteria for Bipolar disorder,” which I think attracted a whole lot of people. Then all of a sudden, out of nowhere, Bipolar disorder suddenly was being diagnosed left, right and center.”

STEVEN HYMAN, M.D., Fmr. Dir., National Inst. of Mental Health:” The rates of Bipolar diagnoses in children have increased markedly in many communities over the last five to seven years. I think the real question is, are those diagnoses right? And in truth, I don’t think we yet know the answer.”

DAVID SHAFFER, M.D.: “What you’ve got out there is a whole lot of kids who’ve been diagnosed with a condition that hasn’t really attained respectability yet, and they’re receiving medications that have not been fully tested in children.”

Even though Biederman’s study trials on Risperdal were deemed to be so small and loosely designed that they were largely inconclusive,” it didn’t stop him from making a bundle of money from the many drug companies he did business with. Dr Biederman has received research support from Abbott Laboratories, Bristol-Myers Squibb Company, Cephalon, Inc, Eli Lilly and Company, Janssen Pharmaceutica, McNeil Consumer & Specialty Pharmaceuticals, NeuroSearch, New River Pharmaceuticals, Pfizer, Inc, and Shire US, Inc; he serves on speakers’ bureaus for Cephalon, Eli Lilly, McNeil, and Shire and is on advisory boards for Cephalon, Eli Lilly, Janssen, McNeil, Novartis Pharmaceuticals Corporation, and Shire.

Here is a small summary of some of the money he has received just from Johnson and Johnson:

  • 2002: J&J sponsored $224,670 worth of various studies.
  • March 2002: 1,000 doctors attend a $700 CME course given by Biederman,

July 2, 2002: $369,000 for a Risperdal study.

  • July 10, 2002: $55,000 check for Biederman processed.
  • Oct. 21, 2002: KOLs paid $2,500 to attend “National Child and Adolescent Advisory Board.” ( KOL = Key Opinion Leaders)
  • Nov. 12 , 2002: Biederman receives another $200,000 in funding.
  • Dec. 12, 2002: Grant for $181,500 for a Biederman study.
  • 2003 business plan: $1.8 million for a “branded pediatric educational institute” and $2.1 million for KOL advisory boards to gain support for adolescent labeling with the FDA.
  • 2003: Grant money available rises to $300,000
  • 2003: Biederman demands reimbursement for $100,000 of drugs dispensed to him from a pharmacy.
  • 2002/2003: Selling/Marketing and Medical Affairs budget for Mass. General Hospital at $631,000 and $345,000 for 2002 and YTD 2003, respectively.
  • 2003: J&J Pediatric Psychopathology Research Center funds rise to $425,000.

However, it was the large sums that Biederman received that he never reported that landed him in the middle of a Congressional investigation.

“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.”

“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.” (13)

On top of the controversy surrounding Biederman taking money from drug companies and failing to report it, comes other articles that center in on Biederman using children as young four years old, for experiments.

“Dr. Biederman isn’t merely on the take from drug companies, he’s also actively engaged in using children as young as four years old for medical experiments. His current recruitment efforts attempt to round up four- to six-year olds and dose them with Astrazeneca’s Seroquel drug to see what might happen to their brains.”

“This was, perhaps, the same kind of madness that allowed Bayer’s researchers to perform medical experiments on captured Jews in Nazi German’s concentration camps. It is a historical fact that drug companies have routinely used children, blacks, minorities and women for their medical experiments, usually in an effort to create “new marketing opportunities” so they could sell more dangerous prescription medications.” (14)

Is the solution to a child’s “terrible twos ups and downs” to put them on antipsychotics which they feel they should do? How many more crimes against humanity do we need?

I think the following quote from Jacob Azerrad PhD, Clinical Psychologist in Lexington Mass. (60-62) says it best:

“The real scandal perpetrated by Biederman has nothing to do with his consulting fee shenanigans and everything to do with the real life (and death) consequences of the methods now used by modern pediatric psychiatry to tag normal childhood behaviors with diagnoses – like “childhood Bipolar” — and the pediatric medical profession’s complicit acquiescence to such malarkey.  It has been nothing short an epic assault on our children by those who prescribe antipsychotic medications as an antidote to normal childhood behavior.” (15)

References:

3    http://1boringoldman.com/index.php/2011/07/10/trial-93-a-bad-penny/

4     http://www.nytimes.com/2008/11/25/health/25psych.html?_r=0

5    http://articles.philly.com/2008-11-25/business/25255353_1_risperdal-antipsychotic-clinical-trials

6     https://www.justice.gov/opa/pr/johnson-johnson-pay-more-22-billion-resolve-criminal-and-civil-investigations

7   http://www.nytimes.com/2008/11/25/health/25psych.html?_r=0

8).  1 Boring Old Man » trial 93: a very very bad penny…

http://1boringoldman.com/index.php/2011/07/12/trial93-a-veryverybadpe

 

http://www.bpchildren.org/files/Download/TreatmentGuidelines.pdf

10 http://www.nybooks.com/articles/archives/2009/jan/15/drug-companies-doctorsa-story-of-corruption/

11 http://1boringoldman.com/index.php/2011/07/03/Bipolar-kids-biedermania-and-super-angrygrouchycranky-irritability/

12   http://www.pbs.org/wgbh/p

13 http://www.nytimes.com/2008/11/30/opinion/30sun2.html?ref=josephbiederman

14 http://www.naturalnews.com/023408_Dr_Biederman_psychiatric_drugs.html#ixzz3fncwbBxh

15 http://jeffreydachmd.com/defrocking-false-prophets-pediatric-psychiatry/

16   http://www.clinicaltherapeutics.com/article/S0149-2918%2806%2900132-9/abstract

17   This is the  link to the Huffington Post article’s pdf file for the  J&J Pediatric Bipolar Center’s 2002 Annual Report http://webcache.googleusercontent.com/search?q=cache:YueZRkmM200J:highline.huffingtonpost.com/miracleindustry/americas-most-admired-lawbreaker/assets/documents/8/biederman-center-2002-annual-report.pdf+&cd=1&hl=en&ct=clnk&gl=us

 

Practice Parameters for the Assessment and Treatment of Children and Adolescents With Bipolar Disorder (1996)

June 5, 1996

Reprinted with permission of the American Academy of Child & Adolescent Psychiatry andLipincott Williams & Wilkins, publishers.

http://m.thebalancedmind.org/learn/library/practice-parameters-for-the-assessment-and-treatment-of-children-and-adolescents-with-

 

 

————————————————————————————————–
PART 2

                 TIMELINE FOR PEDIATRIC  BIPOLAR DISORDER

         Disease Creation       Pharmaceutical Funding        Research Fraud     Heavily Drugged Children

—————————————————————————————————->

Although this is certainly not an endorsement as this group assists in pushing the expansion of pediatric bipolar and the drugging of children with antipsychotics, this data was taken in part from  http://www.thebalancedmind.org/learn/library/about-pediatric-bipolar-disorder-timeline-english 2009

Mid 19th to the early 20th century – Reports of childhood-onset “circular insanity” or “mania and melancholia” are common in European psychiatric literature.

 

1913 – Kraepelin establishes the modern concept of manic-depressive illness as separate from schizophrenia (“dementia praecox”), and includes the more common form of recurrent severe depression as well as the less common form of alternating periods of mania and depression.

 

1930s – The Freudian psychodynamihttp://www.thebalancedmind.org/learn/library/about-pediatric-bipolar-disorder-timeline-english 2009

c approach to the mind becomes predominant in the United States. The psychoanalytic theory asserts that a classical depressive syndrome could not occur in children before puberty. Doctors characterize such children as suffering from “dysfunctional superego.”

 

1946 – National Institute of Mental Health (NIMH) is established by President Truman in response to large numbers of military discharges and servicemen with psychiatric problems after World War II.

 

1949 – Australian researcher John Cade reports the benefits of lithium to

 

1950 ‘s -Though debates about the diagnosis of bipolar (BP) in children can be traced back to the 1950s [26], and though Gabrielle Carlson published “Bipolar affective disorder in childhood and adolescence” in 1983 [27], the rapid increase in the number of diagnoses of BP did not begin in the US until the mid 1990s [1,28] (see Table 1). While some symptoms now associated with the BP label can be found in previous versions of the DSM in descriptions of disorders such as “unsocialized aggressive reaction of childhood,” “adjustment reaction of childhood,” and “schizophrenic reaction, childhood type,” DSM’s description of BP did not in the past and does not now explicitly address diagnosis of this disorder in childhood.

 

 

1952 – The American Psychiatric Association publishes the first Diagnostic and Statistical Manual (DSM), which includes the diagnosis “manic-depressive reaction.” J.D. Campbell reports on 18 cases of pediatric onset of psychotic mania with strong family history of affective disorders in Journal of Nervous and Mental Disorders. Barton Hall, M.D., in a retrospective review of 2,200 children aged 5-17 seen clinically over many years, announces that manic depression was found in only two, both over age 13.

 

1960s – A handful of articles in the medical literature observe that many adult bipolar patients have been ill since adolescence. Leading psychiatrists insist that to diagnose manic-depression in children, they must meet adult criteria. Young patients are routinely diagnosed as schizophrenic ‘until proven otherwise.’

 

1969 – A Swedish psychiatrist, Dr. Anna-Lise Linell, reports success treating manic depression with lithium in children as young as 6.

 

1970 –“Emotionally disturbed” children are excluded by law from public schools in many states. Children with emotional disabilities are often institutionalized.

 

1970 – Lithium is approved by the FDA to treat mania.

 

1970s – Doctors in Sweden and the U.S. begin using lithium to treat children as young as five with good results. An increasing number of case reports and medical journal articles describe children as young as age three with a continuous pattern of behavior and mood disorder (bipolar is a mood disorder), often in families with history of bipolar illness, whose symptoms improve greatly when treated with lithium.

 

1973 – First use of anticonvulsants in treatment of bipolar disorder.

 

1975 – The National Institute of Mental Health Conference on Depression in Childhood officially recognizes depression in children. Congress enacts the Education for All Handicapped Children Act (now known as the Individuals with Disabilities Education Act (IDEA)) giving all children with disabilities a federally protected civil right to a free appropriate public education that meets their education and related services needs in the least restrictive environment.

 

l979 – National Alliance for the Mentally Ill (NAMI) founded.

 

1980 – Bipolar disorder replaces manic-depressive disorder as a diagnostic term in the Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-III).

 

1980 – Oppositional Defiant Disorder included as a diagnosis in the Diagnostic and Statistical Manual.

 

1980s – Researchers establish differences between adult and early-onset bipolar disorder, but most psychiatrists continue to maintain that pre-pubertal children cannot have the disorder.

 

1980’S early– Gabrielle Carlson et al. observe that bipolar symptomatology in preadolescent children can include severe irritability and emotional liability (as opposed to the classic symptoms that appear in adults and adolescents) [27].

 

1986 – National Depressive and Manic-Depressive Association (National DMDA) founded.

 

1992 – Parent Tomie Burke starts on-line support network BPParents.

 

1993– The FDA approved Risperdal to treat schizophrenia ( J&J)

 

 

…NOTE…The development programs for Risperdal, Zyprexa and Seroquel accelerated with the clinical trials running from the late 1980’s through to 1995.

Atypical antipsychotics Risperdal, Zyprexa and Seroquel all became licensed for schizophrenia  between 1993  and 1997. In 1995, Eli Lilly, then later, other major drug companies, started producing antipsychotics for bipolar.

 

1994 – Childhood mood disorders are included in the DSM IV.

 

The increase in diagnoses seems to begin with early1994 and 1995 articles by Barbara Geller et al., Janet Wozniak et al. and Joseph Biederman et al., which proposed that BP was more prevalent in children than previously thought [11,2931]. When DSM-IV was published in 1994, it contained a new section, “Disorders Usually First Diagnosed in Infancy, Childhood, or Adolescence.” While this section does not specifically mention BP, it does contain the observation that “many disorders included in other sections of the manual have an onset during childhood or adolescence [32].” http://www.capmh.com/content/4/1/9

 

 

Pharmalot reported that “Biederman had received career development grants from the NIH – specifically, the National Institute of Mental Health – between 1994 and 1999 to mentor several individuals as they went about conducting research.” According to Dr. Biederman’s CV, Thomas Spencer, Timothy Wilens, and Jeff Bostic had been aspiring researchers mentored by him.

https://www.facebook.com/democracynow/posts/10202561261205043

 

 

1994- Practice Parameters for the Assessment and Treatment of Children and Adolescents With Bipolar Disorder) are developed.

“Due to the lack of research of Bipolar Disorder in children and adolescents, in 1994 many of the treatments were drawn from adult literature. At that time, children and adolescents were diagnosed with Bipolar disorder based on the same criteria used for adults as outlined in DSM-IV (American Psychiatric Association [APA], 1994b). The general consensus of the then available data was sufficient to suggest that Bipolar disorder with onset before the age of 18 years is essentially the same disorder as that in adults, but further studies were needed to clarify the long-term course and outcome of the early-onset forms, especially for those with very early onset”.  http://www.bpso.org/practice.htm

In 1994, a literature review was done that was used to develop the initial draft of the manuscript for the guidelines . (Practice Parameters for the Assessment and Treatment of Children and Adolescents With Bipolar Disorder).

The National Library of Medicine did the initial search in May 1994, covering the preceding 5-year period. The following topics were reviewed: Bipolar disorder and adolescents (39 articles), Bipolar disorder and children (105 articles), and Bipolar disorder and early onset (21 articles). This search was updated periodically (most recently in December 1995) to identify new articles. . “These practice parameters describe the assessment and treatment of early-onset Bipolar disorder based on scientific evidence regarding diagnosis and effective treatment and on the current state of clinical practice. Biederman was part of the panel of experts where he reviewed and commented on the information in the original draft of the guidelines. His studies on the Child Behavior Checklist in 1995 has been used to distinguish manic children from those with ADHD.”

http://www.ncbi.nlm.nih.gov/pubmed/8682754/

After review by the Committee on Quality Issues, this draft was then distributed to a panel of experts for comment, which just happened to include Dr Joseph Biederman. What a perfect opportunity for Biederman to push his agenda to get more children on psychiatric drugs via a Bipolar Disorder diagnosis.
http://www.jaacap.com/article/S0890-8567(09)63918-6/abstract

1994 Geller et al. report in Journal of American Academy of Adolescent and Child Psychiatry (JAACAP) conversion to BP in 32% of a sample of children with major depression [31].

 

1995– Geller et al. in Journal of Affective Disorders suggested that children and adolescents with rapid-cycling mania characterized by elevated/expansive and/or grandiose mood have BP; the researchers did not use irritability to characterize BP because it also commonly appears in ADHD [29].
Wozniak et al. [11] and Biederman et al. [30] in two JAACAP articles report that 16% of a clinical population of children met the criteria for mania primarily by exhibiting chronically irritable mood and describe their use of the Child Behavior Checklist to confirm their diagnoses of BP in these children.

 

 

http://psychrights.org/Drugs/Biederman/090226JBiedermanDepoTranscript.pdf

 

1995– Dr. Joseph Biederman States:” I approached Janssen in the mid 1990s after I noticed that Risperidone worked for our patients in the paper that we published.  We approached them — I approached them to see if they would be interested to do a clinical trial.  They refused.”

1995 – Trudy Carlson publishes first account of a child’s life with bipolar disorder as The Suicide of My Son.

 

1995 – The following leading psychiatrists published

“Pediatric-Onset Bipolar Disorder: A Neglected Clinical and Public Health Problem,” in Harvard Review of Psychiatry,Vol 3, No. 4, 171-195.

 

 

Ross Baldessarini, M.D., Harvard

Deborah Lipschitz, M.D., Yale

Gianni Faedda, M.D ,Albert Einstein College of Medicine

Trisha Suppes, M.D., Ph.D , University of Texas-Southwestern Medical School  and

Leonardo Tondo, M.D , Institute of Clinical Psychiatry in Italy

 

1995- Nov 9th, The following psychiatrists took the lead in designing and developing  ” These parameters were developed by Jon McClellan, M.D., and John S. Werry, M.D., principal authors, and the Work Group on Quality Issues: William Ayres, M.D., and John Dunne, M.D., Chairs; Members: Elissa Benedek, M.D., Gail Bernstein, M.D., Richard L. Gross, M.D., Robert King, M.D., Henrietta Leonard, M.D., and William Licamele, M.D. AACAP Staff: Mary Graham, Leslie Seigle, Carolyn A. Heier, Michelle E. Wright, and Diane Wiegand, R.N. A draft of these parameters was distributed to the entire AACAP membership for comments. The parameters were approved by the AACAP Council on July 22, 1996.

Reprint requests to AACAP Communications Department, 3615 Wisconsin Ave. N.W., Washington, DC 20016.

© 1997 Published by Elsevier Inc. All rights reserved.

Dr. Allen Francis, Chairman of Dept of Psychiatry, Duke Univ.

Dr. John P Doherty, Prof and Vice-Chairman Psychiatry Cornell Univ.

Dr. David Kahn, Assoc. Clinical Prof of Psychiatry, Columbia Univ.

 

Dr. Francis negotiated with Johnson &Johnson to set forth the Schizophrenia Practice Guidelines ( J-J-J JTXCID1722938-40).  The men established (EKS) Expert Knowledge Systems.  The purpose was to use Johnson &Johnson money to market the guidelines and bring financial benefits to the three doctors.

 

 

1996- July 3, Johnson &Johnson agreed to above strategy of using J&J money to market the Schizophrenia Guidelines .It would allow Janssen to “ Influence states’ governments and providers and build brand loyalty and commitment with large groups of key providers around the country.

 

….NOTE..  “ as early as 1995, ELI Lilly had firmly established bipolar disorder as a target for which it would seek an indication”. a much more interesting target than mania had been.( in medical terminology, an “indication” for a drug refers to the use of that drug for treating a particular disease. )

 

Estimates that 50 percent of all mood disorders might be seen as bipolar disorder rather than depression meant that any drug that took even a relatively small share of this market stood to benefit handsomely.” ( Mania (2008)-p. 193)

 

Basically, Lilly and the other major Pharma co.s started by 1. getting a drug licensed for mania— then preceded to step 2, “ have some academics include the drug in the group of mood stabilizers.”

 

Psychiatrist David Healy points out that that the effusive *bipolar* marketing campaigns by Pharma, which were/are as spurious as they were/are clever depended on academics to make their  disease mongering a very lucrative success.

 

1996 – “Practice Parameters for the Assessment and Treatment of Children and Adolescents With Bipolar Disorder” by Jon McClellan, M.D., and John Werry, M.D.

 

These practice parameters describe the assessment and treatment of early-onset bipolar disorder based on scientific evidence regarding diagnosis and effective treatment and on the current state of clinical practice. Given the scarcity of research on bipolar disorder in children and adolescents, many of the treatment recommendations are drawn from the adult literature. Although the same diagnostic criteria are used as for adults, youth may differ with regard to the developmental presentation of symptoms and comorbid psychiatric disorders. Treatment involves the combination of pharmacotherapy and adjunctive psychosocial interventions. Antimanic agents (primarily lithium or valproic acid) are the mainstays of pharmacotherapy. The treatment focuses on (1) amelioration (patient improvement) of acute symptoms; (2) the prevention of relapse; (3) the reduction of long-term morbidity; and (4) the promotion of long-term growth and development. These parameters were approved by Council of the American Academy of Child and Adolescent Psychiatry on June 5, 1996.

 

 

 

 

1996:  Dr Joseph Biederman  first  named author in article :

“ Attention – deficit hyperactivity disorder and juvenile mania; An overlooked co-morbidity?”  published in ” Journal of the American Academy of Child and Adolescent Psychiatry” 35, 997-1008.

 

1996: Robert Temple, MD; Dir. Office of Drug Evaluation 1..Center for Drug Evaluation and Research at the FDA Sends letter to Timothy R Franson, MD at Eli Lilly for new drug application for Zyprexa  .

 

1996: September; FDA psychiatrist Thomas Laughren, Team Leader Psychiatric Drug Products.. Division of Neuropharmalogical  Drug Products…sends letter to Dr. Paul Leber, director of the Division of Neuropharmacological Drug Products at FDA on Zyprexa’s approval.

 

1996: Zyprexa was approved by the US Food and Drug Administration (FDA) on 6 September 1996.

 

 1997 – The Journal of the American Academy of Child & Adolescent Psychiatry publishes “Child and Adolescent Bipolar Disorder: A Review of the Past 10 Years” by Barbara Geller, M.D. and Joan Luby, M.D., and “Practice Parameters for the Assessment and Treatment of Children and Adolescents With Bipolar Disorder” by Jon McClellan, M.D., and John Werry, M.D.

 

 

“Child and Adolescent Bipolar Disorder: A Review of the Past 10 Years” by Barbara Geller, M.D. and Joan Luby, M.D

 

To provide a review of the epidemiology, phenomenology, natural course, comorbidity, neurobiology, and treatment of child and adolescent bipolar disorder (BP) for the past 10 years. This review is provided to prepare applicants for recertification by the American Board of Psychiatry and Neurology.

The conclusion of this review  data strongly suggest that prepubertal-onset BP is a nonepisodic, chronic, rapid-cycling, mixed manic state that may be comorbid with attention deficit hyperactivity disorder (ADHD) and CD or have features of ADHD and/or CD as initial manifestations. Systematic research on pediatric BP is in its infancy and will require ongoing and future studies to provide developmentally relevant diagnostic methods and treatment.

Late 1990’s : Allen Frances and two other academic psychiatrists were paid by Johnson & Johnson in the late 1990s to write a practice guideline that identified Risperdal, the company’s new atypical antipsychotic, as a preferred treatment for schizophrenia.

 

1998 – Danielle Steel’s book His Bright Light, about her son Nick Traina’s struggle with bipolar disorder, becomes a national best-seller.

 

http://www.capmh.com/content/4/1/9#B47

1998– “ Dr. Rachel Klein argued, as she had in JAACAP in 1998, that it is a mistake to interpret chronic irritability as mania [47]. For irritability or elevated mood to count as a symptom of BP, it must appear in distinct and sustained episodes–not as chronic or rapidly cycling. As Klein put it, episodicity is an absolute necessity of BP.”

 

“Dr. Biederman, however, argued that in its intensity, frequency, and association with “out-of-control aggressive behavior,” the irritability associated with BP is “qualitatively distinct” from the irritability associated with other childhood disorders (such as ADHD or CD). He argued that, much like a neurologist can determine the difference between a seizure associated with petit mal and one associated with temporal lobe epilepsy, so can a properly trained child psychiatrist distinguish between the different types of irritability associated with different diagnoses.”

 

1998–  Janssen wanted FDA-approval for Risperdal in the treatment of children with disruptive behaviors and who were of sub-average intelligence.

They finished this trial of Risperdal and submitted it to the FDA but were turned down. Janssen had originally thought they could get Risperidone approved for treating disruptive kids [Disruptive Behavior Disorder, Conduct Disorder] but had given up on that idea and diverted to the more acceptable Bipolar disorder.

http://1boringoldman.com/index.php/2011/07/10/trial-93-a-bad-penny/

 

 

1998– The following two small studies are typical of Dr. Joseph  Biederman

 

http://www.sciencedirect.com/science/article/pii/S0890856709629774

 

1998- Journal of the American Academy of Child & Adolescent PsychiatryVolume 38, Issue 8, August 1999, Pages 960–965 From the Child Psychiatry Department, Massachusetts General Hospital, Harvard Medical School, Boston Accepted: February 10, 1999;

 

Risperidone Treatment for Juvenile Bipolar Disorder: A Retrospective Chart Review

JEAN A. FRAZIER, M.D.MICHELE C. MEYER, M.D., JOSEPH BIEDERMAN, M.D., JANET WOZNIAK, M.D., TIMOTHY E. WILENS, M.D., THOMAS J. SPENCER, M.D., GRACE S. KIM, M.A.R.,STEPHANIE SHAPIRO, B.A.

 

Objective- To Investigate the effectiveness and tolerability of the atypical neuroleptic risperidone in the treatment of juvenile mania.

Results-Twenty-eight youths (mean SD age, 10.4 3.8 years) with bipolar disorder (25 mixed and 3 hypomanic) who had been treated with risperidone were identified. These children received a mean dose of 1.7 1.3 mg over an average period of 6.1 8.5 months. Using a CGI Improvement score of ≤2 (very much/much improved) to define robust improvement, 82% showed improvement in both their manic and aggressive symptoms, 69% in psychotic symptoms, but only 8% in ADHD symptoms.

Conclusions- Although limited by its retrospective nature, this study            suggests that Risperidone may be effective in the treatment of manic       young people and indicates the need for controlled clinical trials of    Risperidone and other atypical neuroleptics in juvenile    mania. J.Am.Acad. Child Adolesc. Psychiatry, 1999, 38(8):960–965.

——————————————————————————————————————– —

 

1998- Journal of the American Academy of Child & Adolescent Psychiatry, Volume 38, Issue 6, June 1999, Pages 680–685 Risk for Substance Use Disorders [SUD] in Youths With Child- and AdolescentOnset Bipolar Disorder (STUDY)

TIMOTHY E. WILENS, M.D., JOSEPH BIEDERMAN, M.D., RACHAEL B. MILLSTEIN, B.A.,

JANET WOZNIAK, M.D., AMY L. HAHESY, B.A., THOMAS J. SPENCER, M.D.

 

From the Pediatric Psychopharmacology Unit. Child Psychiatric Service. Massachusetts General Hospital, and Harvard Medical School, Boston Accepted 13 November 1998, Available online 13 November 2009

 

Conclusion

Adolescent-onset BPD is associated with a much higher risk for SUD than child-onset BPD, which was not accounted for by conduct disorder or other comorbid psychopathology. Youths with adolescent-onset BPD should be monitored and educated about SUD risk. The identification and treatment of manic symptomatology may offer therapeutic opportunities to decrease the risk for SUD in these high-risk youths.

 

1999- The Balanced Mind Parent Network, formerly known as The Child & Adolescent Bipolar Foundation (CABF), started with none other than with Dr. Joseph Biederman on its Scientific Advisory Board. In addition to Biederman, the Scientific Advisory Council included psychiatrists, Karen Wagner, Janet Wozniak, Jean Frazier, Robert Kowatch, Barbara Geller and Melissa DelBello. This group, was receiving funding from several pharmaceutical companies, as a means to promote Pediatric Bipolar and the use of antipsychotics on children to treat it to the media, parents and other doctors and psychiatrists. They also pushed for the eventual Pediatric Bipolar Psychiatric Guidelines where Biederman was a Work Group Member and Contributor.

http://www.jaacap.com/article/S0890-8567(09)61467-2/abstract

 

1999– Dr. Biederman and Janssen had a contentious relationship. Yet  that same year, Biederman’s group published a positive retrospective study of Risperdal  in the treatment of childhood mania.

 

Taken from Dr. Biederman’s  testimony on basically why he stopped working with  Janssen:

 

http://psychrights.org/Drugs/Biederman/090226JBiedermanDepoTranscript.pdf


Beiderman  Says: “I approached Janssen in the mid 1990s after I noticed that risperidone worked for our patients in the paper that we published. We approached them — I approached them to see if they would be interested to do a clinical trial.  They refused.”

 

Q:  Did Janssen ever — Now, before that time did Janssen ever request that you put together a trial proposal for generally the same type of study? A: All proposals came from me to Janssen, not the other way around

 

Q: In any event, you send out a lot of proposals, some of them are accepted and some of them are denied Right?

A: Correct

 

  1. Janssen happened to deny your first proposal. Right?

A: I think so

 

Q: And did that affect your prescribing practices of Risperdal?

A: Not at all

 

Q: Did it affect your professional relationship with Janssen?

A: Not at all.

 

Q: How long was it between the time that they rejected your first proposal to any suggestion on either side that you would do more research?

A:  I don’t remember. We got funding to do a study of Risperidone  in I believe 2002.

 

Q: I’m handing you Biederman Exhibit 17 4, Doctor, what I want you to do is look at the  e-mail that is the third e-mail on the first page  from John Bruins, who is the Janssen medical science  liaison, to a bunch of people at Janssen Do you see that?

A: Could you point out what you want me  to–?

 

Q: It’s this one right here Dr Joseph Biederman payment” Right?

A: Correct

 

Q: If you go down and look at the second bullet point here, it says “Three or four years ago Janssen HO ,It which I assume means home office, but maybe you know better, “requested that he put together a study to evaluate Risperdal in the child and adolescent population He submitted a thorough and lengthy proposal which amounted to approximately $280,000.  We dragged our heels on his request, which we made, for over a year, He finally received a standard ding letter, By the time I found out

about  it a week later I went to see him, his secretary advised me of his fury The sales representative who called on him and I took an hour of verbal beating.. I have never seen someone so angry” Did I read that reasonably correctly?

A: Yes. This is what the e-mail says

 

Q: Right . Does this refresh your recollection that Janssen requested that you put together a study proposal which you then submitted to them?

A: The way that I recall it happened, it was that I sent a letter; they responded — that I’m interested to do a study. They responded that they wanted a detailed proposal and a budget. But the initiative was from me to them, so the budget — they requested to follow up with a detailed proposal and a budget

 

Q: And they denied that proposal?

A: Yes

 

Q: And you were furious Right?

A: I don’t recall being furious I was disappointed.

 

Dr. Beiderman goes elsewhere to do studies after he was refused by Janssen.

 

Between 1995 and 2000, Biederman did different studies for Abbott Laboratories, Bristol-Myers Squibb Company, Cephalon, Inc, and Eli Lilly to name just a few.

 

1999- November 1999, Johnson & Johnson marketing executive John Bruins suggested that Biederman had taken business away from Johnson & Johnson after the company turned down the doctor’s request for a $280,000 research grant.

http://www.nytimes.com/2008/11/25/health/25psych.html?_r=0

 

To remedy this situation, Biederman got his $280,000.00 research grant from Johnson and Johnson and his hospital, Massachusetts General Hospital (MGH) got their J&J Center for Pediatric Psychopathology Research Center.  Johnson & Johnson spent $700,000, in one year [2002] alone, to fund the MGH Johnson & Johnson Center for Pediatric Psychopathology with Biederman becoming the Center’s director. The purpose of the center, according to an internal company e-mail contained in court documents, was to “generate and disseminate data supporting the use of Risperdal in children and adolescents.”   However, 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 was said to have written. http://www.nytimes.com/2008/11/25/health/25psych.html?_r=0

Here is important data covered by the Huffington Post:

 

 Annual Report 2002: The Johnson and Johnson Center for Pediatric

.            Psychopathology at the Massachusetts General Hospital

                         Director: Joseph Biederman. MD

An essential feature of the Center is its ability to conduct research satisfying three criteria: a) it will lead to findings that improve the psychiatric care ofchildren; b) it will meet.high levels of scientific quality and c) it will move forward the commercial goals of J&J 

http://webcache.googleusercontent.com/search?q=cache:YueZRkmM200J:highline.huffingtonpost.com/miracleindustry/americas-most-admired-lawbreaker/assets/documents/8/biederman-center-2002-annual-report.pdf+&cd=1&hl=en&ct=clnk&gl=us

 

 

 

1999 – 2000 :

 

The Bipolar Child by Demitri Papolos M.D. and Janice Papolos is published

 

ABC News airs a segment of 20/20 on early-onset bipolar disorder in 2000 following the formation of The Child and Adolescent Bipolar Foundation (CABF) http://www.bpkids.org was [now named “The Balanced Mind Parent Network” with the  web site  (www.thebalancedmind.org)].

 

Time magazine runs a cover story on children with BP [15].
CABF included leading psychiatric promoters of child bipolar such as David Fassler on the Board of Directors. It’s Professoinal Advisory Council included psychiatrists Joseph Biederman, Karen Wagner, Janet Wozniak, Jean Frazier, Robert Kowatch, Barbara Geller and Melissa DelBello.

(later in this timeline you will see how they created the child bipolar guidelines)

 

2000- J&J aimed its efforts directly at selected physicians and state mental health decision makers who were in the best position to advance its marketing interests and its particular aim to affect guideline development..

 

2001- Dr. Joseph Biederman publishes a positive trial of Zyprexa in Bipolar kids supported by Eli Lilly.

Mania: A Short History of Bipolar Disorder (Johns Hopkins University Press, 2008

 

David Healy data- Basically, Lilly and the other major Pharma co.s started by  (step 1.) getting a drug licensed for mania— then preceded to (step 2), “ have some academics include the drug in the group of mood stabilizers.”

 

Healy points out that that the effusive *bipolar* marketing campaigns by Pharma, which were/are as spurious as they were/are clever depended on academics to make their  disease mongering a very lucrative success.

 

Healy’s theory is, because it seems no one will say this out right, is that Biederman was motivated solely by $$ to invent childhood bipolar disorder— he thinks he probably sold the idea to Lilly.

 

 

2002- Dr. Biederman published an inconclusive study of Depakote in Bipolar kids supported by Abbott.

 

2002-2005 Janssen funded Biederman’s Johnson &Johnson’s Center for the Study of Pediatric Psychopathology . Johnson & Johnson gave more than $700,000 in just one year to a research center that was headed by Biederman from 2002 to 2005, and some of its research was about Risperdal, the company’s antipsychotic drug.[6] Biederman responded saying that the money did not influence him and that he did not promote a specific diagnosis or treatment

 

Data on Johnson &Johnson’s Center for the Study of Pediatric Psychopathology :

 

http://psychrights.org/Drugs/Biederman/090226JBiedermanDepoTranscript.pdf

 

Per Beiderman, in the transcript: “The J&J Center was centered on understanding the diseases, not the treatment of the diseases. This is a program to treat the condition, pediatric bipolar illness at different ages and to  treat the components of the illness, depression and  ADHD. “

 

Q: And just so the record is clear, can you  tell us what the J&J — the Johnson & Johnson — Center is at Massachusetts General Hospital?

 

A:  The Johnson & Johnson Center was  structured on the basis of an NIH center that has  components, or we call them cores, and focused on  studying the two conditions that we’re interested:  ADl-ID and bipolar illness The center had a core that was neuroimaging, a core that was focused on  genetics, a core that was focused on data analysis  of existing data, a core that we call assessment  that had a core of trained psychometricians to do  structured interviews, and a core that was in product development . There was no treatment in the J&J Center

 

Q: When did the center start?

A: The center, to my recollection, started in 2002  By the way, the center was funded by McNeil and Janssen, not just Janssen

 

Q  Because McNeil, the McNeil-Janssen group makes other drugs that you’re studying for kids Right?

A:  McNeil makes Concerta. We study ADHD and bipolar illness

 

Q: Did you say it was an NIH center before it was a-~

A: No I said it was modeled after centers that the NIH funds .”

 

 

2003- Dr. Rich Leibenluft et al. describe a new syndrome, Severe Mood Dysregulation, (SMD), which aims to bring some conceptual order to the increasingly heterogeneous class of children receiving a BP diagnosis [28,48,49,51].

 

2003- The FDA approved Risperdal to treat bipolar disorder.

 

http://www.capmh.com/content/4/1/9

 

2004-: Dr. Biedrman # 2 author “ Comparative efficacy of atypical antipsychotics for pediatric bipolar disorder; “ Acta Psychiatrica Scandinavia 1110, 50, 29

 

2004- Dr. Biederman #2 author- “ Open trial of atypical  antipsychotics in pre-schoolers with bipolar disorder”, Acta Psychiatrica Scandinavia 1110, 51, 29.

 

NOTE: These trials of Zyprexa and Risperdal , run by MGH/Biederman and his *researchers* were conducted  on children with a mean age of 4 years old. recruited by MGH in its own DTC  ( Direct to Consumer) advertisements alerting parents to the fact that difficult and aggressive behavior in children aged 4 and up might stem from bipolar disorder.

 

NOTE: “Given that it is all but impossible for a short term trial of sedative ages in pediatric states characterized by hyperactivity not to show some rating scale changes that can be regarded as beneficial, the research can only cement the apparent reality of juvenile bipolar disorder into place.’ (D.Healy, “Mania” p. 201)

 

How unscientific,  was this study—??

 

Lay raters were used. Children were NOT interviewed about themselves. the study did NOT use prepubertal age-specific mania items. instead, an instrument designed for studying the epidemiology of ADHD .

 

Despite ALL of the outrageous red flags on this so-called academic research study, Biederman’s *brain fart* (my term :-)- was transformed into a new diagnosis, replete with pharmacological treatment “shown to be effective”

 

The message : Cases of bipolar disorder were being misdiagnosed as ADHD. Given the many children already in the MGH *net* , who do not respond to stimulants— this was a potent message for clinicians looking for another option—

 

Aggressive behavior was determined to be a cardinal sign of bipolar—

 

There are critics, like Barbara Geller , St Louis who took part in NIMH funded study, reported 2002 that “very little was known about the condition”— they set about determining  the first set of criteria for possible bipolar in children-BUT, by the time this study was reported— actually starting in 1996, Biederman and his group published a succession of papers that trumped all reason, science, and humanistic principles !

 

WHY?— $$$ is the only clear motivation for this scourge.

 

Stuart L. Kaplan, MD takes very direct shots at Biederman’s ridiculous excuse for a “clinical study”-in his book, “Your Child Does NOT have bipolar Disorder” -How Bad Science and Good Public Relations Created the Diagnosis. 2011”

 

 

2005  Treatment Guidelines for Children and Adolescents with Bipolar Disorder published (written by a consensus conference of experts convened by the Child and Adolescent Bipolar Foundation (CABF) [now called The Balanced Mind Parent Network] article by Kowatch et al. describing treatment guidelines for children and adolescents with BP published in JAACAP.  Accompanying commentary calls attention to lack of evidence that childhood diagnosis is contiguous with adult BP and critiques some symptoms as difficult to distinguish from developmentally normal childhood behavior [46].

 

[PDF]Treatment Guidelines for Children and Adolescents With …

http://www.bpchildren.org/files/Download/TreatmentGuidelines.pdf

by RA KOWATCH – ‎2005
In the guidelines it is stated:

 

APA practice guidelines are intended to assist psychiatrists in clinical decision making. They are not intended to be a standard of care. The ultimate judgment regarding a particular clinical procedure or treatment plan must be made by the psychiatrist in light of the clinical data presented by the patient and the diagnostic and treatment options available..” http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/Bipolar-watch.pdf

 

What the write up does not says is that although the judgement for the clinical procedure or treatment plan must come from the physician, but it is totally guided by the pharmaceutical companies who are promoting their drugs as the course of action for Bipolar Diagnosis. As was mentioned above, there were seven (7) drug companies who fully funded unlimited research grants that would affect their take of the antipsychotic drug market enormously.

What was the most important part of the new guidelines that would benefit those drug companies who were funding its studies?

…” The guidelines included multiple types of psychiatric drugs to treat comorbid psychiatric conditions. In other words, different types of drugs such as ADHD and atypical antipsychotics at once. . The quidelines were finished in September 2004 and made official with publication in the American Journal of Child and Adolescent Psychiatry in March 2005). These drugs for children included psychiatry’s most powerful drugs, antipsychotics. http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/Bipolar-watch.pdf

In other words, at the prompting of the drug companies, the psychiatrists declared that more and more kids are Bipolar which leads to the production of more and more drugs.  This is such a huge change from the Guidelines that were established in 1996,  where only two drugs, lithium and Depakote were being used to treat Bipolar Disorder.  Leading psychiatrists created the demand for more drugs, and got paid heavily for promoting it, and the drug companies got rich by meeting the demand of the constantly increasing diagnoses.

…..As a note, this abstract was from a revised study from 1998 : “A Study of the Safety and Effectiveness of Risperidone Versus Placebo for the Treatment of Conduct Disorder in Children With Mild, Moderate, or Borderline Mental Retardation”, https://clinicaltrials.gov/ct2/show/NCT00266552.

 

The purpose of the study is to assess the effectiveness and safety of an oral solution of risperidone (an antipsychotic medication) versus placebo in the treatment of conduct disorder in children with mild, moderate, or borderline mental retardation.

 

In addition, this project was supported by unrestricted educational grants from Abbott Laboratories, AstraZeneca Pharmaceuticals, Eli Lilly and Company, Forest Pharmaceuticals,Janssen Pharmaceutical, Novartis, and Pfizer.”

 

 

2006/2009 The FDA approved Risperidone and Aripiprazole for the treatment of irritability associated with autism.

 

http://www.boston.com/yourlife/health/diseases/articles/2007/06/17/backlash_on_bipolar_diagnoses_in_children/

 

2006:  “Dec. 13th. A 4-year-old girl from Hull, Mass., Rebecca, Riley, died on the floor beside her parents’ bed from an overdose of drugs prescribed to treat bipolar disorder and attention deficit hyperactivity disorder. Her death triggered a growing backlash against Dr. Joseph Biederman and his followers.  Rebecca Riley’s parents have been charged with deliberately giving the child overdoses of Clonidine, a medication sometimes used to calm aggressive children. Still, many wondered why a girl so young was being treated in the first place with Clonidine and two other psychiatric drugs, including one not approved for children’s use. Riley’s psychiatrist has said she was influenced by the work of Dr. Biederman and his protege, Dr. Janet Wozniak.

“They are by far the leading lights in terms of providing leadership in the treatment of children who have disorders such as bipolar,” said J. W. Carney Jr., lawyer for Dr. Kayoko Kifuji, a Tufts-New England Medical Center psychiatrist who temporarily gave up her medical license after Riley died on Dec. 13, 2006. “Dr. Kifuji subscribes to the views of the Mass. General team.”

He observed that Biederman’s “research and teaching validates Dr. Kifuji’s work with patients.”

However, Dr. Steven Hyman, who was then director of the mental health institute and is now provost at Harvard University, said he remains very concerned about the growing use of “big gun” antipsychotic drugs such as Zyprexa, Risperdal, and Seroquel on children. In the Massachusetts Medicaid program, the number of people under 18 receiving at least one of the “atypical antipsychotic” drugs rose from 6,943 in 2002 to 9,123 in 2005, a 31 percent jump, before declining to 8,343 in 2006.

Dr. Hyman says that none of the drugs has the approval of the Food and Drug Administration for use in bipolar children, and doctors prescribe them based on their individual judgment.

“We don’t know the first thing about safety and efficacy of these drugs even by themselves in these young ages, let alone when they are mixed together,” said Hyman.

 

2007– JAACAP publishes practice parameter for diagnosis and treatment of BP in children and adolescents. Parameter follows Geller et al. diagnostic criteria more than those proposed by Biederman et al. but warns of difficulty differentiating symptoms from normal childhood behavior and urges periodic revisions of any diagnosis and treatment plan [57].

 

http://www.ncbi.nlm.nih.gov/pubmed/17768268?dopt=Abstract&holding=f1000,f1000m,isrctn

 

2007Archives of General Psychiatry publishes study reporting a 40-fold increase between 1994 and 2003 in the number of office visits in which children (0-19) had a diagnosis of BP [1].

Results:

The estimated annual number of youth office-based visits with a diagnosis of bipolar disorder increased from 25 (1994-1995) to 1003 (2002-2003) visits per 100,000 population, and adult visits with a diagnosis of bipolar disorder increased from 905 to 1679 visits per 100,000 population during this period. In 1999 to 2003, most youth bipolar disorder visits were by males (66.5%), whereas most adult bipolar disorder visits were by females (67.6%); youth were more likely than adults to receive a comorbid diagnosis of attention-deficit/hyperactivity disorder (32.2% vs 3.0%, respectively; P < .001); and most youth (90.6%) and adults (86.4%) received a psychotropic medication during bipolar disorder visits, with comparable rates of mood stabilizers, antipsychotics, and antidepressants prescribed for both age groups.

 

2007- http://www.webmd.com/schizophrenia/news/20070822/fda-oks-risperdal-for-kids-and-teens

FDA OKs Risperdal for Kids and Teens

Risperdal Is First Antipsychotic Drug Approved to Treat Schizophrenia, Bipolar Disorder in Youths

By Miranda Hitti
WebMD Health News

Reviewed by Louise Chang, MD

WebMD News Archive

Aug. 22, 2007 — The FDA today approved the antipsychotic drug Risperdal to treat schizophrenia in teens and bipolar disorder in some youths.

Specifically, Risperdal may be used to treat schizophrenia in adolescents aged 13-17 and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents aged 10-17. “Bipolar disorder I” refers to recurrent episodes of mania and depression.

Risperdal is the first FDA-approved atypical antipsychotic drug to treat either disorder in these age groups. Atypical antipsychotic drugs are newer antipsychotic drugs.

Risperdal is already approved for the treatment of schizophrenia and bipolar disorder in adults, and for irritability associated with autism in kids and teens aged 5-16.

Risperdal’s Pediatric Use

The FDA asked Risperdal’s maker, the drug company Janssen, to study Risperdal’s use in kids and teens with schizophrenia and bipolar disorder.

The FDA made that request because those conditions are “commonly” treated with Risperdal or similar drugs in kids, even though that was an off-label use of those drugs, says Thomas Laughren, MD, who directs the psychiatric products division at the FDA’s Center for Drug Evaluation and Research.

Risperdal’s efficacy at treating schizophrenia in teens was studied in two trials, each lasting six to eight weeks. Patients either took Risperdal or a placebo without knowing which they were taking.

Patients taking Rispderal generally had fewer symptoms, including a decrease in hallucinations, delusional thinking, and other schizophrenia symptoms, according to the FDA.

Risperdal’s efficacy at treating manic or mixed episodes in children or adolescents with bipolar I disorder was demonstrated in a three-week trial. Patients who were experiencing a manic or mixed episode either took Risperdal or a placebo without knowing which they were taking.

Patients taking Risperdal generally had fewer symptoms of their bipolar disorder, including an easing of their elevated mood and hyperactivity.

Drowsiness, fatigue, increase in appetite, anxietynauseadizzinessdry mouth, tremor, and rash were among the most common side effects reported in Risperdal’s pediatric trials.

Laughren notes that data “suggest a signal for some weight gain” in youths taking Risperdal. Janssen is already studying that possibility in a lengthier study. The FDA will do an additional safety review of Risperdal’s pediatric use over the next year.

 

2008-Dr David Healy data- Estimates that 50 percent of all mood disorders might be seen as bipolar disorder rather than depression meant that any drug that took even a relatively small share of this market stood to benefit handsomely.” (Mania (2008)-p. 193)

 

2009-Dr.  Zito et al. report a 10-year trend for Medicaid-insured youth with clinician-reported pediatric bipolar disorder showing a proportional increase in minority youth with this diagnosis from 1997 to 2006 (23% increase in African-American and other minorities and corresponding drop in white youth) [85]. Crystal et al. report that poor children are four times more likely than wealthy children to receive atypical antipsychotics [70].

 

2010– Olfson et. al. report a doubling of the number of privately insured 2-5 year-old children with a psychiatric diagnosis who receive an antipsychotic, and lament the sparseness of non-pharmacological mental health resources [3].

 

 

2013– Number of Children & Adolescents Taking Psychiatric Drugs in the U.S.

 

In addition to the 2005 Bipolar Treatment Guidelines were the heavy promotion of pediatric Bipolar in medical journals, continuing medical education courses and in the media. Here is the resultant number of US children and adolescents by age who were being prescribed antipsychotics and other psychotropic as of 2013:

Antipsychotics     0-5 Years                 27,343

Breakdown:
0-1 Years                654
2-3 Years                3,760
4-5 Years                24,363

6-12 Years             359,882
13-17 Years           490,272

Grand Total           0-17 Years               830,836 kids on antipsychotics

http://www.cchrint.org/psychiatric-drugs/children-on-psychiatric-drugs