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By NHF President, Maureen Salaman Gordon

The year was 1961, a time of great darkness in conventional adult psychiatry (the darkness of ignorance is only now just beginning to lift). This is a true story.

Julie was not quite two years old when her father became concerned about her behavior. She fought with her little brother, wasn't quite getting the right potty training, and openly defied her parents. Normal behavior under most standards, considering her age. However, for a psychiatrist trained in the use of drugs, not child behavior, it was enough to prescribe a heavy tranquilizer with dangerous side effects.

She might never have discovered the terrible secret if her father hadn't recorded it in her baby book. He wrote, Unusual fussiness and irritability. Much sibling quibbling. It has regressed to bedwetting. Definite signs of psychological insecurity. Dr. Ames prescribed a tranquilizer of the promazine type (phenothiazine). The reaction created spastic movements (dyskinesia), eye rolling (oculogyric), and general tremors.

Julie was admitted to the hospital when she lost motor control of her body. Her neck lost its support of its head, which lolled onto her shoulder, her eyes rolled back uncontrollably, she slurred her words, her hands shook, she had trouble walking, and she had facial tics. She was lucky she didn't die or end up brain damaged. She was in the hospital two days before the effects of the drug wore off and she started to regain normal function.

More reasons to reject pharmaceuticals for our kids

Only now, almost forty years later, is the FDA and conventional medicine admitting that their policies of promoting dangerous prescription drugs have been victimizing our kids.

 We have had a decades-lone experimentation with our children, admits Dianne Murphy, FDA pediatric drug specialist, in a November 1999 article in USA Today.

According to widely cited statistics, 80 percent of prescriptions written for children involve medications approved only for adult use. Adverse drug reactions account for more than 100,000 deaths each year, according to some reports. And at least half a million American children are taking prescription and antidepressants that have not been determined to be safe or effective in children.

Why children kill

There are 3-4 million children and adolescents suffering from depression and obsessive-compulsive disorder in the US, according to a number of sources. Despite the fact that there are a number of concerns about prescribing antidepressants to youths, doctors have been prescribing them for children, with some 580,000 children and adolescents being prescribed SSRIs (selective serotonin reuptake inhibitors) such as Prozac, Paxil, and Zoloft in 1996.

The use of Prozac alone went from 41,000 ages 6-12 in 1995 to 203,000 in 1996. Though shocked by bizarre shottings in schools, few Americans have noticed how many shooters are among the six million kids now on psychotropic drugs.

Kip Kinkel, a 15-year-old youth who killed his parents and killed two and wounded 22 of his fellow students at Thurston High School in Oregon, was taking Prozac.

Eric Harris, one of the shooters at Columbine High in Littleton, CO, was under the influence of Luvox (fluvoxamine), an anti-depressant medication. The potential side effects of Luvox are listed in the manufacturer's warning. Frequent adverse effects include manic reaction and psychotic reaction. Symptoms of mania include delusions of grandeur, intense irritability, rages and delusional thoughts.

Ann Blake Tracy, PhD, author of Prozac: Panacea or Pandora? has been studying the violent, dark side of SSRI drugs for ten years. She has researched 32 murder/suicides involving women and their children. She found that in 24 of 32 cases a SSRI drug was involved.

A report issued in 1995 by the Drug Enforcement Agency warned that Ritalin, commonly prescribed for Attention Deficit Hyperactivity Disorder (ADHD), shares many of the pharmacological effects of cocaine. Some experts believe Ritalin can cause psychotic reactions resulting in suicide and violent behavior toward others.

Most medicines are administered to children lacking manufacturer's recommendations -- in other words, by the seat of their pants. Except for a relatively small number of therapies for infections and childhood diseases, physicians can only guess on dosages for children, increasing the likelihood of dangerous, even deadly, side effects. How many parents do you think are told this by their doctor? How many find out too late?

Drug makers put profit before safety

The lack of clinical data on drug safety and efficacy in children goes back to the long-held belief that it is unethical to enroll infants and small children in clinical trials before obtaining adult test data documenting safety and effectiveness.

This line of thinking was changing by 1977 when the American Academy of Pediatrics (AAP) asserted that the exclusion of children from trials was more unethical than testing because it forced physicians to prescribe drugs for children based on inadequate information. The FDA responded in 1979 by adding a pediatric use section to the indications section of the label in an attempt to encourage manufacturers to provide additional dosing information.

However, few drug manufacturers were willing to invest in added testing for very small patient populations. Not surprising when you consider that pharmaceutical sales for adults in the United States run about $70 billion a year, while those for children account for a mere $3.5 billion. The figures are even smaller for pediatric use of medications to treat degenerative and potentially fatal conditions such as arthritis, cancer, AIDS, cardiorenal problems and depression. Through the 1980s little changed. Most drugs remained pediatric orphans, with three quarters of medications offering inadequate information on their use for children.

The situation prompted FDA to issue a revised rule in 1994, offering an alternative method to support pediatric use information. It specified that when the course of a disease is similar in adults and children sponsors may submit data from controlled clinical trials in adults, together with testing to show  effectiveness in pediatric populations.

The new policy has generated about 400 efficacy supplements. Unfortunately, about 75 percent of them proved to be inadequate, offering minor word changes and unanalyzed literature reviews. The continued lack of pediatric data prompted government officials to try again.

In August 1997 Congress gave the FDA the right to require manufacturers to conduct studies and supply data to document the safety and effectiveness of pediatric uses for all new and existing medications that are likely to be used in children or for those that offer meaningful therapeutic benefits over existing treatments. The requirement was never mandated. There was too much complaining by the manufacturers to risk losing the tax base.

Although they naturally support the concept of developing more drugs for children, thus increasing their profit margin, they object strongly to a government mandate that they conduct studies or label a product in a specific way. Drug makers' excuses include concern that added information requirements could slow or side-track the development of new therapies for adults, that regulators did not fully appreciate the difficulties of developing pediatric formulations, and that the proposal contradicts emerging international policies -- all deemed more important than the safety of our children.

Trying once again, last year an FDA rule required companies seeking approval of new products to do pediatric studies if their drugs will be taken by children. Adding an economic incentive (one they will understand), if companies do pediatric studies requested by the FDA (they have to be bribed to do the right thing?), dederal legislation grants them an additional six months of profit exclusivity before  generic forms of their drugs enter the market. Several makers of antidepressants have studies under way. None of the drugs are close to winning approval for use with children.

What's wrong with this picture?

While the Feds and the FDA walk on eggshells to avoid incurring the wrath or disapproval of pharmaceutical companies, children are being victimized by helpless doctors and parents who deed into the propaganda that drugs are the only solutions to their medical and behavioral problems.

Prescribing medicine is a two-edged sword. Doctors and parents expect the drugs to help a child recover from his illness. However, the specter of side effects, some of which can be serious or even deadly, is always present.

A 1998 Canadian study of 1,545 children under 17 years old who experienced drug side effectrs found that antibiotics are the number-one cause, specifically amoxicillin and ampicillin, which caused 24% of all drug reactions. Vaccines were second at 19%. Antibiotics found to be troublesome included Ceclor, sulfamethoxazole-trimethoprim (Septra, Bactrim), erythromycin, penicillin, cloxacillin, and erythromycin/sulfisoxazole.

Serious side effects from pharmaceuticals designed for adults is a serious issue. The tip of the iceberg are antiviral AIDS drugs which damage childrens' hearing, cause seizures and cardiac arrest, asthmatic children whose growth is stunded by inhaling high doses of cortico steroids; and children becomming  irritable, confused, delirious and even hallucinatory after their parents applied a topical over-the-counter dyphenhydramine product (brand names include Caladryl, Ziradryl and chain drugstores brands like  CVS's Calohist) over large areas of skin.

In December, doctors at a Tennessee hospital gave 200 infants the antibiotic erythromycin as a precaution when they were exposed to whooping cough. Seven of the infants because ill with pyloric stenosis, in which a muscle at the bottom of the stomach enlarges, blocking food from passing to the small intestine, requiring surgical treatment. All the affected babies were under three weeks of age.

Precaution is no excuse for giving antibiotics that pose serious risks to infants, especially to babies so young. Newborns are also sometimes given erythromycin when the mother has tested positive for chlamydia.

Have you ever seen the hot pink diaper rash of a fungus infection on a baby that's being treated with antibiotics? The overkill is appalling.

Dr. Jonathan Wright did biopsies on children with asthma. He found that in those who were given antibiotics before five years of age, the cilia in the intestine was severely impaired, compromising digestion and creating allergic reactions.

Even the American Journal of Pediatrics admits that chronic ear infections are caused by food allergies. Dr. Wrignt claims that if you give children the age of four antibiotics  they will have asthma before the age of five or six, and 50 percent will have epileptic seizures. Incidences of asthma in children under four years of age have increased in the last decade by 160 percent.

Many drugs are approved without pediatric testing and even then manufacturers do testing for correct dosages only after the drugs are approved.

It behooves all of us to insist that  natural medicines continue to be studied and embraced, and that man-made chimicals have no place in our lives and the lives oand health of our children. We must demand that pharmaceutical companies be held accountable for their propaganda and that our freedom of medical choice  be honored.


Adult Medication is Used on Young Without Testing. USA Today, November 30, 1999

American Family Physician, p.1734, November 15, 1998.

Antibiotic Tied to Seven Newborns' Stomach Disorder. Bynum, Russ, Associated Press, December 17, 1999.

Antidepressant Makers Study Kids' Market, Wall Street Journal, v. CCXXIIX, n. 66, p. 81 April 4, 1997

Columbine Shooter Was Prescribed Anti-Depressant, CNN

Interactive, April 29, 1999

Doping Our Kids, Bresnahan, David M.,, April 9, 1999

Drug Reactions, Pediatrics for Parents, May 1999.

Effect of Asthma and Its Treatment on Growth: Four Year Follow-Up of Cohort of 

Children from General Practices in Tayside, Scotland, McCowan, C., et al.,

British Medical Journal, 316, 7132, 668(1), February 28, 1998.

Website of the

Pediatric Antiviral AIDS Therapy Damages Hearing in Children, AIDS Weekly Plus, October 26, 1998

The Pediatric Drug Development Challenge, Pharmaceutical Technology, v. 22, n. 8, p. 12, August 1998.

Warning about Topical Analgesic, HealthFacts, v. 22, n. 10, p. 2(1), October 1997.

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