Rhonda Robinson Rhonda Robinson is a mother of nine, and grandmother of 16, who believes the single most powerful force in America today is a vigilant mother, unafraid to nurture and protect her children. Still married to her high school sweetheart, Rhonda is a homeschooling mother by day, and a speaker, weekly newspaper columnist, and freelance writer by night (actually, really early morning before anyone is up—but it’s still dark out, so that counts.) Spanning 20 years of homeschooling and childbirth, Rhonda has gained over 572 pounds and lost 500, nursed a total of 17 years, and changed at least 29, 952 diapers, and rocked over 5,000 miles of tearful terrain. She holds a Master’s degree in laundry and speaks fluent toddler. View all articles | Contact author

Let’s play a quick game of “What if?”, shall we? Let’s begin with a plausible, but fictional scenario.

What if… a young mother in her seventh month of pregnancy begins to experience signs of labor? The pulling sensation deep in her back that seems to come and go suddenly becomes more frequent, and painful, with each passing hour.

Frightened, and concerned for the life of their child, the couple makes arrangements for their other children and rush to the hospital.

The eager but apprehensive parents wait in a small, cold emergency room, tucked behind a curtain. The long wait seemed to help; the signs of birth begin to subside.

At last the doctor arrives, and with a quick check she confirms their fear and warns that the baby could come early; too early. In an effort to stop the premature birth the doctor prescribes a medication that is intended to correct the imbalance of the hormones that is creating this crisis.

Thankful for the strides in modern medicine she takes a dose, then makes arrangements for a follow-up appointment.

What the doctor may not know however, is that not only has this drug not been proven effective in stopping premature labor, but has been known in clinical trials to have serious adverse side effects such as actually causing premature labor and death.

Would the FDA approve such a drug?

“What if”…it has?

The names of such drugs are common household words like Paxil and Zoloft. They are commonly used for depression, and the FDA has now acknowledged what they have known for over a year; they are ineffective in treating children, and can cause the very tragedy they are supposed to prevent.

Although the FDA has not approved any antidepressant other than Prozac for children, the practice of “off-label” prescriptions is common.

Which means doctors can prescribe a drug for something other than what the FDA has approved it for. Thus, children aged 1 to 17 now account for seven percent of anti-depressant prescriptions.

As absurd as it sounds, children and adolescents suffering from depression are being prescribed drugs in which suicide and self-harm is considered a side effect.

This “side-effect” was the drug companies' dirty little secret until the New York attorney general brought suit against GlaxoSmithKline. GSK, a major drug company that makes Paxil, was accused of fraud for concealing negative clinical trial results (it was shown to be ineffective in children and induced suicidal thoughts). The company agreed in a settlement to make public both negative and positive results of its trials.

New York achieved through the courts what the FDA either could not or would not, concerning public safety and patient informed consent.

According to an Associated Press report, a Glaxo spokeswoman said the sales reps were not allowed to speak with doctors about the clinical-trial results. The company claimed it would be considered promoting off-label prescriptions.

Whatever the excuse, the result is still the same. Doctors have been denied the necessary information in which to make life and death decisions.

Just this month, over a year after the UK banned these and other antidepressants for use in treating children with depression, the FDA has finally acknowledged the serious side effects and has issued its strongest warning.

A bold black box carries the somber warning that this drug can “increase the risk of suicidal thinking and behavior” in children and adolescents with major depressive disorder and other psychiatric disorders, who take them.

There will also be medication guides given to patients and parents that include the warning with each new prescription and refill.

The ruling came down after last month’s hearings, when FDA officials heard testimony from drug companies, a panel of experts, and grieving parents who lost their children to these “side effects.”

One mother from Laytonsville, Md., whose 12-year-old daugher hanged herself last January, told the FDA, "The blood of these children is on your hands." She said, "Candace's death was entirely avoidable had we been given the appropriate warnings."

For this mother, and far too many others, the game of “what if” will undoubtedly be played in their minds for years to come.

Copyright 2004 Rhonda Robinson

Published in The Regional