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The Off-Label Use of Adult Drugs: Kids At Risk

A horrible example of a health care system in shambles is the frequent use of off-label use of adult drugs for children. Along those lines, a reader passed along to me a link to this compelling, MUST-READ story about the toxic consequences of adult drugs to our children in last week's New Yorker magazine.

For instance, imagine your child needing stitches after a fall on a jungle gym, a simple procedure and certainly not a life-threatening one. But the ER surgeon, dealing with a screaming child, injects the wound with bupivacaine, a local anesthetic widely used in adults. As the surgeon begins to suture the wound, the child has a seizure and goes into shock. The child is transferred to ICU where a cat scan is taken. Thank God, no brain damage.

A pediatric anesthesiologist and cardiologist, was paged to assist with the emergency. The level of bupivacaine in the child's blood was dangerously high. The boy was intubated and placed on a respirator, then spent several days in intensive care before recovering... from an overdose of bupivacaine.

That surgeon's use of bupivacaine was not unusual, according to that pediatric expert. Why? At least 75 percent of the drugs approved for use in the U.S. have never been given comprehensive pediatric studies. Nevertheless, it's legal for a physician to use ANY FDA-approved drug in whatever way he or she believes is beneficial, and isn't required to inform parents if it hasn't been specifically tested on children. Moreover, there's no single official repository of information about how to calibrate drug dosages for children.

According to a health professional in charge of the FDA's Office of Pediatric Therapeutics calls her agency's approach to pediatric drugs "a passive process." Why? The FDA relies on tracking adverse reaction to pharmaceuticals only through its MedWatch program that collects data merely from voluntary reports sent by patients and doctors. With overwhelming workloads and time commitments, however, few take the time to post feedback.

Folks, Big Pharma will stop at nothing to sell their products when BILLIONS of dollars are at stake. Because they're so focused on profits, urging doctors to prescribe their drugs for as many uses as possible, regardless of their worth, is far more important to them than your health. That's why I'm so focused on my vision to replace this current wreck of a health care system. It's the best in the world for handling emergencies but so lacking in the insights needed to treat the true causes of disease.

The New Yorker January 10, 2005

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