The document discusses the controversy around diagnosing and treating pediatric bipolar disorder. It notes that powerful psychiatric drugs are being prescribed to very young children for bipolar disorder despite lack of evidence of their effectiveness for this use and serious potential side effects. Pharmaceutical companies have financially supported expanding the diagnosis and use of their drugs off-label in children. Critics argue this has led to overdiagnosis and overprescribing driven more by commercial and social factors than medical science.

1. PEDIATRIC BIPOLAR DISORDER The real deal Or A recent epidemic? Amy Kim

2. TOPICS Treatments Types of treatments Side effects Misdiagnosis/Over-prescribing Dangers of misdiagnosing & over-prescribing How this epidemic started When and why? Pharmaceutical Roles The power of funding Who really benefits?

3. MEDICATIONS Massachusetts’s General Hospital had trial runs on antipsychotic drugs on children with mean age of 4. They were able to recruit these young patients by scaring their parents. Clinicians would tell parents that difficult and aggressive behavior in children might have stemmed from bipolar disorder. There are number of forces that appears to have an increasing number of children and infants being put on these potent drugs without evidence of benefit. Dr. Ellen Leibenluft who is that Clinical Associate Professor of Psychiatry at Georgetown says that “You can easily see why people would feel the need to use medication. But the question is, What medication? We don’t have the data to see what medication to use because we don’t yet know how to think about these children diagnostically.”

4. MEDICATIONS Children who are diagnosed as having bipolar disorder are not treated with stimulants or antidepressants even if they have issues with attention, anxiety or depression because child psychiatrists argued that they make bipolar children much worse. So children who are diagnosed as having bipolar disorder are given much more powerful atypical drugs which lead to much more serious side effects. There is a rampant number of office visits by children diagnosed with bipolar disorder. Thousands of children, as young as two or three are receiving too many medications they don’t need and that cause uncomfortable and sometimes dangerous side effects. The concept that children have bipolar disease and must be treated with adult psychiatric medications has evolved through the marketing efforts of pharmaceutical firms Prescription drugs that are approved by the FDA for bipolar disorder are for the use in adults only, but doctors are able to legally prescribe them to children.

5. MEDICATIONS “ New” classes of drugs to treat bipolar disorder are less specific. Anticonvulsants and atypical antipsychotics are being “rebranded” by pharmaceutical companies to be “mood stabilizers” Makers of antipsychotic drugs such as Lilly, Janssen and Astra-Zeneca, market their drugs as mood stabilizers and not as drugs for manic-depressive disorders. Clinicians and patients are happy to endorse mood stabilizers, despite the lack of evidence that these drugs are effect for this purpose. Children and adolescents who are diagnosed with mental disorders have no known chemical imbalances in the brain. Extremists propose that bipolar disorder and ADHD “do not exist” but are solely social constructions created to control children’s behavior with drugs.

6. MEDICATIONS Mood Stabilizers Lithium Anticonvulsants Antidepressants SSRIs Tricyclics Atypical Antipsychotics Clozapine Olanzapine Aripiprazole Quetiapine Risperidone Ziprasidone

7. MOOD STABILIZERS Mood stabilizers: a psychiatric medication used to treat mood disorders characterized by intense and sustained mood shifts Lithium: mood stabilizing drug, primarily in the treatment of bipolar disorder, where they have a role in the treatment of depression and particularly of mania, both acutely and in the long term Until recently, lithium was the only drug that had evidence of treating symptoms of bipolar disorder. Anticonvulsive Medication: are a family of drugs that depress abnormal nerve activity in the brain, thereby blocking seizures.

8. MOOD STABILIZERS Term “mood stabilizer” has no precise clinical or neuroscientific meaning and are widely used. Anticonvulsants and antipsychotics are now identified as mood stabilizers. It is important to note that any sedative agent can produce some benefits in the treatment.

9. ANTIDEPRESSANTS Antidepressants: a psychiatric medication used for alleviating major depression or dysthymia used alone or in conjunction to anticonvulsants. SSRIs: Selective serotonin reuptake inhibitors or serotonin-specific reuptake inhibitor class of compounds typically used as antidepressants in the treatment of depression, anxiety disorders, and some personality disorders. Tricylcilics: are a class of antidepressant drugs that have been largely replaced by newer antidepressants such as SSRIs

10. ATYPICAL ANTIPSYCHOTICS Atypical antipsychotics: second generation antipsychotics) are a group of antipsychotic drugs used to treat psychiatric conditions. Clozapine Olanzapine(Zyprexa Aripiprazole(Abilify) Quetiapine(Seroquel Risperidone Ziprasidone While Americans prescribe preschoolers drugs such as olanzapine and risperidone, it is rare in other countries for clinicians to prescribe these powerful and aggressive drugs before patients at least reach mid to late teens. Pediatric Bipolar disease is a major reason why atypical antipsychotics are being prescribed to children for long term.

11. ANTICONVULSANTS & ANTIPSYCHOTICS Anticonvulsants are designed to treat epilepsy and atypical antipsychotics are designed to treat schizophrenia. When a child is unnecessarily prescribed antipsychotics and anticonvulsant drugs, mental and physical health may be irrevocably compromised. Patients taking antipsychotic medication show a reduced life expectancy of up to 20 years compared to those not taking medication. Atypical antipsychotics such as Risperdal, a tranquilizing drug with serious and sometimes deadly side effects are being widely prescribed to children. The reason for this is the aggressive efforts made by the drug companies to promote their new class of drugs.

12. SIDE EFFECTS Mood stabilizers Lithium 75 % of users experience side effects. Thyroid abnormalities inhibits re absorption of water leading to excessive urination and thirst. Structural kidney damage disrupts the cardiac conduction system and can cause arrhythmias induce or exacerbate acne, which is a problem for adolescent patients produce a variety of neurological effects, including muscle weakness, tremor, lethargy, cognitive blunting, and headaches blood levels in which, lithium becomes toxic are not much higher than the levels that are necessary for treatment. tremor, nausea and diarrhea, blurred vision, vertigo, confusion, and increased deep tendon reflexes seizures, coma, cardiac arrhythmia, permanent neurological damage, and death

13. SIDE EFFECTS Mood stabilizers Anticonvulsants Weight gain Tremor Dizziness Sedation Headache Nausea Indigestion Bruising Hair loss

14. SIDE EFFECTS Antidepressants Dry mouth Urinary retention Blurred vision Constipation Sedation (can interfere with driving or operating machinery) Sleep disruption Weight gain Headache Nausea Gastrointestinal disturbance/diarrhea Abdominal pain Agitation Anxiety

15. SIDE EFFECTS Atypical Antipsychotics weight gain diabetes diabetic ketoacidosis myocarditi hyperlipidemia sexual dysfunction studies show that there have also been a large number of fatalities relating to atypical antipsychotics in the USA

16. SIDE EFFECTS Peter R. Breggin, MD ( Harvard-trained psychiatrist and former full-time consultant at NIMH , known for efforts to reform the mental health field, including his promotion of caring psychotherapeutic and opposition to overuse of medication) Recent study that found that more children were being given a more toxic antipsychotic drug than a similar adult group. He argues that bipolar children are being medicated more heavily than adults even though these drugs are not approved in children. Another reason why children are given several drugs is so that it is impossible to pinpoint which drugs may be the most responsible for the adverse reactions the child experiences

17. SIDE EFFECTS Peter R. Breggin M.D. says that it will be very difficult for any child to outgrow his or her early behavioral problems and become a normal adult while being overwhelmed with toxic agents for most of his or her childhood. The growing brain is being bathed in substances like antidepressants, stimulants, mood stabilizers, and antipsychotic drugs that cause severe and permanent biochemical imbalances. All these drugs have been shown to distort the shape of the brain cells and in some cases destroy them. The neuroleptic drugs such as risperidone and olanzapine expose child to a commonly irreversible and potentially devastating drug induced neurological injury called tardive dyskinseia. They also cause fatal diabetes, pancreatitis, as well as morbid obesity.

18. TARDIVE DYSKINESEIA Tardive dyskineseia- consist of repetitive and involuntary movements usually caused by side effects of long term or high dosages of antipsychotics. On a study of 118 patients aged 5 – 18 years of age on atypical antipsychotics for atleast 6 months found that 9% had developed tardive dyskinesia.

19. DEPAKOTE In 1995 the drug Depakote was introduced and approved by the FDA. This sedative drug was approved because it produced beneficial effects in acute manic states. It was advertised as a “mood stabilizer” and not a drug for manic-depressive disorder because the advertisement would be illegal due to lack of licensing.

20. SIDE EFFECTS OF DEPAKOTE Serious unexplained weakness with vomiting and confusion or fainting; easy bruising or bleeding, blood in your urine; fever, sore throat, and headache with a severe blistering, peeling, and red skin rash fever, chills, body aches, flu symptoms; urinating less than usual; hallucinations (seeing things that aren't there); extreme drowsiness, lack of coordination; or double vision or back-and-forth movements of the eyes.

21. SIDE EFFECTS OF DEPAKOTE Mild mild drowsiness or weakness; diarrhea, constipation, upset stomach; depression, anxiety, or other emotional changes; tremor (shaking); hair loss weight changes; vision changes; or unusual or unpleasant taste in your mouth.

22. MISDIAGNOSIS European articles from 2006 states that overactivity can also be seen in children with learning disabilities such as mental retardation or Asperger’s syndrome. Asperger’s syndrome is a mild version of autism. Children affected are characterized by social isolation, abnormalities in communication and eccentric behavior such as restrictiveness and repetitiveness during childhood. Bipolar disorder also has many similar symptoms to disorders such as Conduct disorder OCD ODD ADHD and other anxiety related disorders

23. DANGERS OF MISDIAGNOSIS Many children and adolescents who have been labeled with bipolar disorder, now numbering in the millions, are in great emotional pain and are an overwhelming challenge to their families. But in majority of the cases, they are not suffering from bipolar disorder. A child misdiagnosed with a bipolar disorder is denied treatment for their real source of suffering. One of the biggest controversy in psychology these days is the issue of pediatric bipolar disease, which many child psychiatrists now say is being “grossly over diagnosed” Experts from a Harvard Mental Health Letter states that too many will end up being diagnosed when they shouldn’t. The book “ Biplar Children” states that many children diagnosed with bipolar disorder already received diagnosis of ADHD and/or depression. A new drug prescriptions for bipolar disorder are often added to one that they are already taking for ADHD and/or depression.

24. STORY OF REBECCA RILEY

25. REBECCA RILEY 4 year old from Boston, who was diagnosed with bipolar disorder at the age of 2. Family life was viewed as highly dysfunctional She was diagnosed with both ADHD and bipolar disorder Rebecca’s teachers, school nurse, and therapist said that they never saw behavior in Rebecca that fit the diagnosis, such as aggression, mood swings, or hyperactivity. Pharmacist complained that Rebecca’s mother kept making excuses for why her daughter needed more medication.

26. REBECCA RILEY Prescription drugs that are approved by the FDA for bipolar disorder are for the use in adults only, but doctors are able to legally prescribe them to children. School nurse said in the final months of her life, she was so weak like a “floppy doll” Principle had to help her off the bus because the 4 year old girl was shaking so badly. Died from an overdose of prescription drugs Medical examiner said Rebecca died a slow and painful death. Overdose caused organs to shut down, filling the lungs with fluid, and congestive heart failure.

27. WHERE DID IT COME FROM? Until recently, manic-depressive illness was rare and there were only 3300 new cases per year. Bipolar disease now affects 16.5 million people in north America which makes it as common as depression. Until recently bipolar disorder was not detected before adolescence and was thought to be early even as an adolescent onset, but now it seems like many children are detected even as early as preschool. In the past, the youngest admission for manic-depression was at age 17. Now patients can be diagnosed with bipolar disorder at as young as 2. The indicator of the increase of diagnosis of children came with the book called “ The Bipolar Child ” written by Janice and Demitri Papolos. This book sold 70,000 copies in the first 6 months.

28. “ THE BIPOLAR CHILD” After the popularity of this book, many more books were written talking about this new epidemic disease and how the children must be treated aggressively with drugs if they wanted to live a normal life. After the books followed newspapers throughout the country reporting a increasing number of cases of bipolar disorder. -Papolos recommends against the use of the word “no” The story of how Heather Norris was diagnosed with bipolar disorder started with temper tantrums at the age of 18 months. Sherri-Lee Norris (Heather’s mother) brought her to different pediatricians and psychiatrists where she did not get a diagnosis of bipolar disorder. Sherri-Lee Norris brought a copy of the book to her psychiatrist and her daughter Heather was diagnosed with bipolar disorder immediately.

29. JOHN ROSEMOND Earned a masters degree from Western Illinois University and written many popular books on parenting He disagrees with Dr. Demitri Papulos, the author of the book “ The Bipolar Child ” He first addresses that children responding poorly to being told “no” can be normal and diagnostically be nothing. These tantrums and meltdowns in reaction to the word “no” can be cured with regular doses of the word and in the correct combination. Says that “the Papoloses are not helping the epidemic of increasing cases of pediatric bipolar disorder by “pushing” the disease in their so called “bible””

30. PHARMACUETICAL ROLES In the past 10 years, the diagnosis of pediatric bipolar disorder has rapidly increased in North America despite the fact that manic-depressive illness was rarely diagnosed before adolescence. The reason behind the increase in diagnosis happened with the vigorous marketing of pharmaceutical companies. Because companies are not allowed to market pediatric bipolar disorders or their drugs they used the role of academic experts, parent pressure, and technologies. More and more pharmaceutical companies are relying on studies done by academic sources. Relying on these academic studies makes things easier on these companies as opposed to seeking a license from the FDA. More and more pharmaceutical companies are relying on studies done by academic sources. Relying on these academic studies makes things easier on these companies as opposed to seeking a license from the FDA. Drug companies have way too much power in determining how children with psychiatric issues are treated.

31. THE POWER OF MONEY When searching for information over the internet on bipolar disorder in children, people are likely to get a hit for BPChildren.com which is run by a co-author of a bipolar book about children, Juvenile Bipolar Research Foundation (JBRF) which is linked to “ The Bipolar Child” the website for the book by Papolos and Papolos, or bpkids.org, which is a site that in linked to an organization that is supported by unrestricted grants and funds by major pharmaceutical companies. Much of the funding used in the academic studies for these researches come from unrestricted grants from pharmaceutical companies. The claims about the benefits of these treatments used for bipolar disorder may be misleading, but by using patient groups or academic studies, pharmaceutical companies relieve themselves of legal liability.

32. THE POWER OF MONEY The pharmaceutical companies pay for bipolar satellite symposiums, which are meetings or conferences to speak about a certain subjects, at mainstream meetings such as the APA conferences. These symposiums can cost up to $250,000 which makes the price of entry too high for treatment modalities such as psychotherapy. If enough clinicians at the conferences are persuaded by these symposiums, the pharmaceutical companies do not need to submit their data to the FDA to get additional licensing for their medications.

33. WHO REALLY BENEFITS? Many leading researchers have a financial relationship with the manufacturers of the drugs recommended for the treatment of pediatric bipolar disorder which is not illegal but jeopardizes credibility with the public. Peter R. Breggin M.D.,(mentioned earlier) (a Harvard-trained psychiatrist and former full-time consultant at NIMH, known for efforts to reform the mental health field, including his promotion of caring psychotherapeutic and opposition to overuse of medication) calls Joseph Biederman M.D. who is a famous professor of Psychiatry at Harvard Medical School with many followers a “longtime ally to pharmaceutical companies” and comments on his deep financial connections to these companies. states the obvious advantages that the pharmaceutical companies get by promoting these drugs. He states that if most bipolar children get several drugs at once, throughout their childhood, that transforms them from being patients to “cash cows”.

34. MARKETING STRATEGIES The same way that corporations that sell everything from sportswear to automobiles research the needs of their market, pharmaceutical companies attempt to establish the unmet needs of their market. Disease mongering a term used when companies make literature and websites whose goals are to make more people aware of bipolar disorder without advertising their medication. An example of marketing tactic used by pharmaceutical companies is using famous public figures such as celebrities and writers who had bipolar disorder.

35. “ Childhood and adolescence being developmental phases, it is difficult to draw boundaries between phenomena that are part of normal development and others that are abnormal.” (World Health Organization, World Health Report, 2001) “ Childhood bipolar, in my estimation, is nothing more and nothing less than normal toddlerhood in the absence of effective parenting.” -Bose Ravenen, co-author of The Diseasing of America’s Children “ Children with big problems are being given big and bad drugs because no one knows what to do with them.” -Judith Warner

36. CONCLUSIONS The risk of excessive pharmacotherapy, particularly in pre-pubertal children cannot be understated Medication is not always the answer. These medications are very dangerous and almost always come with side effects, short term, long term, or both. Do not believe everything you see. Many of the “research” that is done is funded by pharmaceutical companies, which makes them biased.