Pediatric Pharm--against

April 15, 2009

Lindsey Webb

And

Shenella Jaigobin

He has been called “the conscience of psychiatry” by Bertram Karon (a Michigan State professor of psychology)

Graduated from Harvard University Worked for two years at the National Institute of Mental

Health (NIMH) Has been a professor at many universities, including

Johns Hopkins University He is the founder and director emeritus of the

International Center for the Study of Psychiatry and Psychology (ICSPP)

• In his new book, “Brain Disabling Treatments in Psychiatry”, Breggin discusses his beliefs on many kinds of psychiatric drugs.

– “Antidepressants cause emotional anesthesia and numbing or sometimes euphoria, providing a fleeting, artificial relief from emotional suffering.”

– “Neuroleptic or antipsychotic drugs disrupt frontal lobe function, causing a chemical lobotomy with apathy and indifference, making emotionally distressed people more submissive and less able to feel.”

– “Stimulants blunt spontaneity and enforce obsessive behaviors in children, making them less energetic, less social, less creative and more obedient.”

Dr. Lawrence Diller, author of Should I Medicate my Child? and Running on Ritalin says, “Unfortunately when parent’s don’t know other choices they turn to medicine first. Too often we underestimate the effectiveness of sound discipline.”

It is easy to medicate a child and harder to change the environment

Most antipsychotics and antidepressants are made for and tested on adults

Drugs that are not proven safe or effective for children are often still prescribed “off-label”

Things that need to be taken into consideration by physician when prescribing drugs to children are general nutritional status, size, maturity of organ function, developmental stage,etc.

Children metabolize some drugs faster than adults—so pound for pound they often require more drugs

Often times the drugs cause mild to severe side effects that doctors treat with more drugs

They become toxic from too many drugs Children can also “outgrow” a drug’s

benefits

Young children still have to go through many stages of brain development

They present the possibility of physiological and even anatomical vulnerability, with possible long-term detrimental effects of the interaction between psychoactive drugs and brain development

“The Medicated Child”

In the case of preschoolers, such developmental phenomena as normal separation anxiety, negativism, developmental hyperactivity, and imaginary playmates obfuscate the usual boundaries of psychopathology at this age.

Because normal development at this age proceeds at a rapid pace, it may be more difficult to separate treatment effectiveness from the process of emotional and behavioral maturation.

Five times as many children and adolescents were prescribed antipsychotics in 2002 than in 1993 through 1995

– In that same period of time, the number of doctor’s visits at which the medications were prescribed jumped from 201,000 to 1,224,000

2007- 389,000 children were on Risperdal

Risperdal prescribed to children has seen a 10 % increase from 2006 to 2007 while there was a 5% decrease prescribed to adults

• Mood Stabilizers– Depakote– Lithium– Tegretol– Neurontin– Lamictal– Topamax

• Typical Antipsychotics Haloperidol (Haldol) Loxapine (Loxitane) Thioridazine (Mellaril) Molindone (Moban) Chlorpromazine (Thorazine)

• Atypical Antipsychotics– Aripiprazol (Abilify)– Clozapine (Clozaril)– Olanzapine (Zyprexa)– Olanzapine/Fluoxetine

(Symbyax)– Risperidone (Risperdal)– Quetiapine (Seroquel)– Ziprasidone (Geodon)

• Anti-anxiety medication– Klonopin– Xanax– Ativan

It is believed that antipsychotic medications help to block excess dopamine in the brain that may be causing symptoms, such as psychosis

They do this by both blocking dopamine receptors and by inhibiting the release of dopamine

Headache Weakness Nausea/Upset

stomach Vomiting Constipation Diarrhea Anxiety Problems with

sleeping Dizziness Sleepiness

Restlessness Rashes Increased salivation Shaking/Tremors Dry mouth Weight gain Increased appetite Inability to control

urination Vision changes Runny nose

Neuroleptic Malignant Syndrome (NMS)

Tardive dyskinesia (TD)

Agranulocytosis High blood sugar Diabetes Strokes Low blood pressure Increased heart rate

and other heart problems

Fainting

Seizures Increased body

temperature Difficulty swallowing Fever Blood clots in the

lungs Liver disease Increased suicidal

thoughts or actions Bleeding problems Mania Low salt levels in the

blood

Antipsychotics have been prescribed to treat aggression, agitation, mood dysregulation, psychosis, self-injury, etc. in adolescents and preschoolers

FDA issued a black-box warning about the development of diabetes in patients receiving antipsychotics

• Commonly prescribed in pediatric patients to treat juvenile bipolar disorder

• Valproate, which is commonly used for bipolar disorder, has been associated with the development of polycystic ovary syndrome in adolescent girls

• Weight gain associated with treatment with certain AEDs may increase the risk of developing endocrine and metabolic problems

On average, one in every twenty to twenty-five children in the United States uses a stimulant to treat ADD/ADHD

Often times antipsychotics are used for ADD/ADHD due to outbursts and disruptive behavior accompanied with the disorder

• Believes that the explosion of Ritalin in 1991 came about with the new education laws that provided services for those with ADD/ADHD

• Parents were looking for a way to help their struggling children in school (IDEA section 504)– Getting an aide– Reduced amounts of work– Unlimited time to take tests

• Long Acting Stimulants– Vyvanse– Adderall XR– Concerta– Daytrana– Focalin XR– Metadate CD– Ritalin LA

• Non-Stimulants– Strattera

• Short/Intermediate Acting Stimulants– Ritalin– Ritalin SR– Methylin ER– Metadate ER– Focalin– Dexedrine– Dextrostat– Adderall

Non-stimulants, such as Strattera, block the reuptake of norepinephrine. This causes a higher level of the neurotransmitter in the brain.

Psychostimulants blocks dopamine transporters that normally allow for dopamine reuptake. This creates an increased level of dopamine in the brain.

• Breggin states that some of the negative physiological side-effects of Ritalin include growth suppression (both in height and weight), tics, skin rashes, nausea, elevated heart rate and blood pressure, headache, stomachache, and psychosis

Some of the negative emotional side effects of Ritalin are sadness, depression, psychotic depression, abnormal thinking, hallucinations, social withdrawal, flattened emotions and emotional instability, and loss of energy

Stimulants such as Ritalin interferes with normal growth-hormone production which can impair and even stunt the growth of the entire body

The impact is so dramatic that researchers have observed that growth-hormone levels can be used as a marker for whether or not children are taking their medication

Parents are told that their children’s bodies will catch up when the stimulant is stopped but nowadays children are kept on stimulants for months or years at a time so there is no opportunity for a growth spurt

Stimulants can cause sudden cardiac arrest or arrhythmias in children

In some cases the child’s heart can show deterioration in the heart similar to chronic cocaine addicts

These stimulants can also cause high blood pressure which can cause strokes

There is great tendency in the medical literature to minimize adverse drug effects in order to support or promote their medication in general

Few, if any sources fully address the brain damage and dysfunction produced by these drugs including strong evidence for stimulant–induced brain shrinkage, cell death, and persistent biochemical changes

A warning to be read in the Adderall and Dexedrine labels reads:

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE.

ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST

BE AVOIDED.

This statement is true for Ritalin and all other stimulants commonly used to treat children

It should also be taken as a warning that all of these drugs cause potentially severe withdrawal reactions

Withdrawal symptoms are generally confused with the behavior that was being treated in the first place (deterioration of the child’s behavior)

Stimulants that “suppress” the behaviors of ADHD often make children more compliant but does so at the expense of their imaginations, creativity, capacity to generate activity and their overall enthusiasm for life

There is no evidence that stimulant drugs actually improve academic performance but do sometimes lead to improved grades because many teachers reward more submissive, unobtrusive behavior with better grades

Prozac is the only antidepressant that has been approved by the FDA for use by children for depression

This being the case, doctors still prescribe other antidepressants to children on an “off-label” basis

SSRI’s Fluoxetine (Prozac) Sertraline (Zoloft) Paroxetine (Paxil) Citalopram (Celexa) Escitalopram

(Lexapro) Fluvoxamine (Luvox)

SNRI’s Venlafaxine (Effexor)

SSRI’s (Selective serotonin reuptake inhibitors) Block the reuptake of serotonin at the

presynaptic nerves, causing a greater amount of serotonin in the brain

SNRI’s (Serotonin-norepinephrine reuptake inhibitors) Block the reuptake of both serotonin and

norepinephrine, causing an increase in both neurotransmitters

One major theme emerging from studies of depression treatment is that SSRIs and other related medications relieve depression only slightly better than placebo pills do

Prozac is recommended as an antidepressant treatment because it showed statistical superiority to placebo pills in 3 out of 15 clinical trials

Those who respond to placebo treatments should have other alternatives examined for them

• “Black box” label warning by the FDA– Antidepressants may

increase the risk of suicidal thinking and behavior in children with Major Depressive Disorder

• Insomnia• Gastrointestinal

disturbances• Serotonin syndrome

• Agitation• Restlessness• Panic attacks• Increased sadness• Extreme increases in

talking or activity• Aggression, violence,

hostility• New or worsened

anxiety• Social withdrawal

There is little information available about the long term effects of SSRI’s

Animal studies suggest that exposure to SSRI’s in infancy leads to excessive fear, anxiety, and substance abuse in adulthood

Client vs. Clinician Ratings of Improvement Children with the disorder may rate their

improvement less than the clinician. What importance is the rating of the clinician? Children’s opinion is being discounted by clinicians by saying that the children are too affected by their disorder to make accurate judgments about their own improvements.

• Active vs. Inert Placebo– Usually when using a placebo in a “double-blind”

study, the participants is given a sugar pill instead of the medication. It is actually quite easy for both clinicians and participants to be able to tell if they are taking the drug or the placebo solely by the presence or absence of side-effects, such as nausea, dry-mouth and dizziness. “As a result, the ‘double-blind’ study is immediately ‘unblinded’ for the those rating outcomes, a fact that seriously compromises any conclusions that can be drawn.”

Time of Measurement Many drug studies are performed over short

periods of time, even though many drugs are prescribed for longer periods of time. The studies do not allow enough time for adequate measures to be taken on the differences between control and experimental groups. Usually, differences between the groups disappear around 16 weeks of using the drugs.

Conflicts of Interest Many of the researchers that are conducting

drug studies that find positive results with drugs are being funded by the pharmaceutical company the produces the drug that is being tested. Obviously, this may skew the results of the studies to favor use of the drug in children.

There have been studies done by respected researchers that show negative information on the effects of psychostimulants that have been largely ignored by the FDA

The FDA relies heavily on information coming from the same academic researchers who have gained funding from pharmaceutical companies.

Heavy marketing by these companies has contributed to the increase in the use of anti-psychotics

Drug companies have little incentive to invest in studies to prove effectiveness and safety for children because physicians are already widely prescribing psychotropics off label to them

The pharmacological action of any psychoactive drug is demonstrated by how it disrupts the normal function of an animal’s brain Which is then applied to the human brain

When the drug companies and the experts get ready to present this information the fact that the drug disrupts normal brain function will be ignored and the drug will be falsely promoted as correcting biochemical imbalances Deliberate deception to make the drugs look positive

Once an agency approves a medication for a particular condition, doctors are free to prescribe it even if it has yet to be approved by the FDA

“Medicating Children”

• In an interview with PBS’s Frontline, told the interviewer that Adderall had the most disingenuous elaborate campaign

• Offered him $100 to listen to someone speak to him about ADD/ADHD funded by Adderall– Incentive to get doctor’s to prescribe their drugs

because it’s fast, easy, and works for everyone– Doctors lose money when they spend time with a

patient• Commercials for these drugs pushes parents to

one-sided thinking: that their child has a biological problem that can only be solved with medication

• Some events in a child's life can trigger acting-out or other symptoms

• Doctors often face time pressures that prevent them from finding out what's going on in kids' lives, knowledge that might suggest alternative treatments

• Insurance coverage rules may encourage the use of antipsychotics as most will reimburse for medications and there is less funding for labor intensive psychotherapy especially for programs such as medicaid

• There are also very few child psychiatrists

American children are the most medicated 1.5 – 2.2 times greater than children in the

Netherlands and in Germany for antipsychotics

3+ times greater for antidepressants

Cognitive Behavioral Therapy

Play Therapy Family Therapy Group Therapy Peer Support Groups Milieu Therapy

Counseling Behavior Modification

Therapy

Therapists are obligated to not take the easy road by abandoning tried and true counseling skills in favor of a quick fix

Current effects of children taking drugs are serious and adverse and we have yet to learn what future outcomes will be like

• About Dr. Peter Breggin (n.d.). Retrieved April 8, 2009, http://www.breggin.com/prbbio.html• ADHD Medications (2008). Retrieved April 9, 2009 from http://www.keepkidshealthy.com/Medicine_Cabinet/adhd_medications.html• Associated Press (2006). Anti-psychotic Drug Use in Kids Skyrockets. Retrieved April 10, 2009 from

http://www.msnbc.msn.com/id/11861986/• Bratter, T.E. (2007). The Myth of ADHD and the Scandal of Ritalin: Helping John Dewey Students Succeed in Medicine-Free College

Preparatory and Therapeutic High School. International Journal of Reality Therapy, 27(1), 4 – 13.• Breggin, P.R. (1995). The Ritalin Fact Book: What Your Doctor Won’t Tell You About ADHD and Stimulant Drugs. Insight on the News,

178 – 188.• Breggin, P.R. (1991). Toxic Psychiatry: Why Therapy, Empathy, and Love Must Replace the Drugs, Electroshock, and Biochemical

Theories of the “New Psychiatry.” New York: St. Martin’s Press.• Child and Adolescent Bipolar Foundation (2002). About Pediatric Bipolar Disorder. Retrieved April 8, 2009 from

http://www.bpkids.org/site/PageServer?pagename=lrn_index_17• Children and Mental Health (n.d.). Retrieved April 11, 2009 from http://www.surgeongeneral.gov/library/mentalhealth/toc.html#chapter3• Children, Adolescents Receiving More Antipsychotic Medications [Electronic version]. (2006). Psychiatry in the News, 36(7), 450.• Elias, M. (2006). New Antipsychotic Drugs Carry Risks for Children. USA Today, 1. Retrieved April 10, 2009, From Academic Search

Premier.• FDA (2005). Atypical Antipsychotic Drugs Information. Retrieved April 9, 2009 from

http://www.fda.gov/CDER/Drug/infopage/antipsychotics/default.htm• Harris, G. (2008). Use of Antipsychotics in Children is Criticized. Retrieved April 8, 2009 from

http://www.nytimes.com/2008/11/19/health/policy/19fda.html?_r=2• Harvard Medical School (2009). Understanding the Risks of Antipsychotic Treatment in Young People. Harvard Mental Health Letter,

25(9), 1 – 3.• Lacramioara, S. & Eugene, A.L. (2007). Ethical Issues in Child Psychopharmacology Research and Practice: Emphasis on Preschoolers.

Psychopharmacology, 191(1), 15 – 26.• Mayes, R. & Erkulwater, J. (2008). Medicating Kids: Pediatric Mental Health Policy and the Tipping Point for ADHD and Stimulants.

Journal of Policy History, 20(3), 309 – 343.• Mayo Clinic Staff (2008). Antidepressants for Children: Explore the Pros and Cons. Retrieved April 9, 2009 from

http://www.mayoclinic.com/health/antidepressants/MH00059• McEvoy, V. (2008). Go Slow on Medicating Children. Retrieved on April 11, 2009 from

http://www.boston.com/news/health/articles/2008/08/11/go_slow_on_medicating_children/treatment.aspx• Meyer, J.S. & Quenzer, L.F. (2005). Psychopharmacology: Drugs, the Brain, and Behavior. Massachusetts: Sinauer Associates, Inc.• Morales, T. (2002). Should I Medicate My Child? Retrieved April 10, 2009 from

http://www.cbsnews.com/stories/2002/08/19/earlyshow/health/health_news/main519084.shtml

• NHS (2008). How Antipsychotics (Probably) Work. Retrieved April 8, 2009 from http://www.nmhct.nhs.uk/pharmacy/moa-neur.htm• NIMH (2009). Antidepressant Medications for Children and Adolescents: Information for Parents and Caregivers. Retrieved April 8, 2009

from http://www.nimh.nih.gov/health/topics/child-and-adolescent-mental-health/antidepressant-medications-for-children-and-adolescents-information-for-parents-and-caregivers.shtml

• Pediatric News and Journals (2009). Retrieved April 8, 2009 from http://pediatrics.about.com/od/newsandjournals/Pediatric_News_and_Journals.htm

• Psychiatric Drug Adverse Reactions (Side Effects) and Medication Spellbinding (2009). Retrieved April 9, 2009 from http://breggin.com/index.php?option=com_content&task=view&id=187&Itemid=93

• Risperidone (2009). Retrieved April 11, 2009 from http://www.drugs.com/pdr/risperidone.html• Russell, K., Dryden, D.M., Liang, Y., Friesen, C., O’Gorman, K., Durec, R., et al. (2008). Risk Factors for Methamphetmine Use in Youth:

A Systematic Review. BMC Pediatrics, 8(48), 1 – 10.• Science Daily (2008). American Kids Most Medicated. Retrieved April 8, 2009 from

http://www.sciencedaily.com/releases/2008/09/080924192437.htm• Science Daily (2008). Risks and Benefits of Antipsychotics in Children and Adolescents. Retrieved April 8, 2009 from

http://www.sciencedaily.com/releases/2008/09/080901205624.htm• Sparks, J.A. & Duncan, B.L. (2004). The Ethics and Science of Medicating Children. Ethical Human Psychology and Psychiatry, 6(1), 25

– 39.• Therapy Styles (2000). Retrieved April 12, 2009 from http://oreilly.com/medical/bipolar/news/therapy_styles.html• Typical Antipsychotics (2009). Retrieved on April 9, 2009 from http://bipolar.about.com/od/glossaryt/g/gl_typicalantip.htm• Watkins, C.E. & Brynes, G. (2006). Ritalin Helps…But What About the Side Effects? Retrieved April 8, 2009 from

http://www.ncpamd.com/Stimulant_Side_Effects.htm• Wyeth Pharmaceuticals, Inc. (2008). About Effexor XR: Depression and Anxiety Disorders. Retrieved April 10, 2009 from

http://www.effexorxr.com/effexor-xr-t