Are Children Taking Untested Drugs?
It's not just drugs. It's also devices such as surgical instruments and artificial organs, as well as new products for diagnosing diseases. Physicians are prescribing, performing surgeries, and diagnosing for their pediatric patients using drugs, devices and test methods that were never tested in children! It's true.
It's true, but there's an explanation... sort of. Most medical advances benefit adults. Because adults comprise the largest segment of the population, it should not be any surprise that most medical research advances the care of adult conditions, diseases, and health. Most clinical trials are designed, therefore, to test new ways of treating adults. They must be designed to adequately prove the safety and effectiveness of the new idea, but are designed as efficiently as is feasible. As a result, the study population is often limited to adults (because that is the population for which the new idea is expected to be used) and children are often specifically excluded from the study. So are pregnant women, but that's another story.
What's the big deal, then? The big deal is that many drugs, for example, are eventually used by physicians on children, often in lower doses. Physicians are not prohibited from prescribing any drug they think will help a patient, including those that have not been tested for a particular disease or condition, unless there is some reason to believe the drug would be harmful. Of course, the physician keeps an especially close eye on the child's reaction to and progress on the drug, but she cannot be sure there will be no unexpected side effects in her pediatric patient because children were never included in the clinical trials of the drug.
If a drug is developed for a childhood disease or condition, then it is always tested in children. The most significant reason for not including children in clinical trials of drugs intended to address predominantly adult medical issues is to avoid subjecting a particularly vulnerable population (children) to what may be uncomfortable or even harmful effects of a new drug during the clinical trial.
It's ironic how our desire to protect children from harm in clinical trials may actually cause more harm down the road when these very same drugs are used on children without the benefit of information learned from clinical research.
-Joe
Related Topics: Clinical Trials: Concerns for Women, Children and Genetic Privacy, Pint-Size Patients Need Pint-Size Prescriptions
It's true, but there's an explanation... sort of. Most medical advances benefit adults. Because adults comprise the largest segment of the population, it should not be any surprise that most medical research advances the care of adult conditions, diseases, and health. Most clinical trials are designed, therefore, to test new ways of treating adults. They must be designed to adequately prove the safety and effectiveness of the new idea, but are designed as efficiently as is feasible. As a result, the study population is often limited to adults (because that is the population for which the new idea is expected to be used) and children are often specifically excluded from the study. So are pregnant women, but that's another story.
What's the big deal, then? The big deal is that many drugs, for example, are eventually used by physicians on children, often in lower doses. Physicians are not prohibited from prescribing any drug they think will help a patient, including those that have not been tested for a particular disease or condition, unless there is some reason to believe the drug would be harmful. Of course, the physician keeps an especially close eye on the child's reaction to and progress on the drug, but she cannot be sure there will be no unexpected side effects in her pediatric patient because children were never included in the clinical trials of the drug.
If a drug is developed for a childhood disease or condition, then it is always tested in children. The most significant reason for not including children in clinical trials of drugs intended to address predominantly adult medical issues is to avoid subjecting a particularly vulnerable population (children) to what may be uncomfortable or even harmful effects of a new drug during the clinical trial.
It's ironic how our desire to protect children from harm in clinical trials may actually cause more harm down the road when these very same drugs are used on children without the benefit of information learned from clinical research.
-Joe
Related Topics: Clinical Trials: Concerns for Women, Children and Genetic Privacy, Pint-Size Patients Need Pint-Size Prescriptions
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