We need to question the safety of medication given to our children

Four of every five kids that are hospitalized in the U.S. are treated with drugs that have never been tested for them. They are approved by the Food and Drug Administration only for adults. Outside of the hospital, one-third of all children take such medications.

LOS ANGELES, CA (Catholic Online) - Doctors cannot determine a safe, effective dose due to children metabolizing drugs very differently than adults. For example, the cheap antibiotic chloramphenicol, used in low-income countries, can weaken infants by causing vomiting, low-blood pressure, and impaired heart function in a rare, but often fatal, "gray-baby syndrome."

We tend to act as if kids are the same as adults because the drug trials conducted on children are too few, of poor quality, and usually focus on the importance of fixing disorders in adults, not children.

Children do not have the comprehension and judgment that is needed to give informed consent, so parents, or guardians, must consent for them. Healthy children, also, cannot be enrolled legally in studies that may have more than a minimal risk.

So why don't drug companies test more medications in children? Because of money. Drug companies don't test drugs in children because it is not cost-effective. These companies already sell plenty of adult drugs that are used for children. Also the expense of creating trials for the drugs would not raise their profits.

Instead, adult medicines are gradually finding their way into pediatric practice as more pediatricians experiment with giving the medications to their patients. According to Dr. Florence Bourgeois, of Harvard University, children suffer 59% of disease, however only 12% of the clinical trials are pediatric. Children in poor countries are not likely to have access to properly tested drugs, which makes a case for promoting pharmaceutical-industry leadership in the necessary drug testing.

However, one in three clinical trials funded by the pharmaceutical industry are now being conducted in developing countries, where they are completed cheaper, quicker, and at a higher level of quality than those tested in the U.S. and Europe. A top-level academic medical center, located in India, charges about $1,500 per subject, compared to the $20,000 charged by second-rate centers in the U.S. So pharmaceutical industries conduct their studies abroad because it is in their financial interest to do so.

Nonetheless, the Pediatric report is pleading to motivate the industry to make pediatric drug research worthwhile despite its "small market share." This request ignores the well-known fact that pharmaceutical companies already gain financial rewards for conducting pediatric research.

Pharmaceutical companies are trying to explain that the reluctance to clinical trials comes from claims that each approved drug costs them roughly $800 million to test, with still more studies claiming that the total is $2 billion for each new pill.

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Experts, however, have gone against this statement saying that this figure is fictitious, inflated by the selection of expensive, yet rare and unrepresentative drug studies. According to financial writer Merrill Goozner, author of "The $800 Million Pill: The Truth Behind the Cost of New Drugs," points out that the figure state fails to account for the drug industry's huge tax rebates and uses a badly chosen economic device known as "opportunity cost" that doubled the figure.

Given the history, can we trust the pharmaceutical industry to guide children's medical research? Leadership from the Global Alliance for Vaccines and Immunisation, the World Health Organization, the U.N. Foundation, and the Gates Foundation would be much better, as all these organizations have proved that they can work with the industry to address the need for better medicines. These nonprofits should start and lead new research proposals.

So next time your doctor gives out medication, ask yourself what you would think if most of the drugs your doctor gave you were untested, forcing him or her to guess the correct dosage and medication. Because this is how adult medication given to children is. Remember, the health of the world's children is too important to be simply bought or sold without question.

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