Testing Medications: Who's Being Left Out?
Children get sick, just like adults do. But many times the only medications doctors can prescribe for children have never been tested in children. Why is that? And how could this prescription practice affect you and your family?
The Process of Testing Drugs
When drug companies wish to manufacture and market a new drug, they must first receive approval from the United States Food and Drug Administration (FDA). This is done by submitting scientific evidence proving that the drug is safe and effective.
That evidence is collected in experiments, usually first conducted in test tubes and laboratory animals, and then in human studies called "clinical trials." Clinical trials take several years and cost millions of dollars to conduct.
The data collected during clinical trials is summarized in detail on an approved drug's labeling. While much of it may seem like medical "mumbo-jumbo" to the average layperson, it is often vital information for a treating physician.
Why Some Groups Are Left Out
Historically, certain segments of the population have been largely omitted from clinical trials of new drugs. These groups include children, women of childbearing potential, and elderly people.
There are several reasons for this:
Safety is a concern in all clinical trials, but it can be of particular concern with regard to populations who may be more vulnerable to adverse effects from drugs—such as children, developing fetuses in pregnant women, and elderly people.
There is the argument that duplicating expensive trials in different populations may not be cost-effective for the company footing the bill.
Some experts argue that it's unethical to expose certain groups of people to the risk associated with taking an experimental drug. And in the case of children, it's been argued that it's unethical to enroll them in clinical trials when they're not old enough to consent.
Robert Ward, MD, FAAP, past chairman of the American Academy of Pediatrics' Committee on Drugs, refutes that argument by asking if enrolling children in trials, when appropriate, is any less ethical than treating them with drugs that haven't been specifically tested in children.
"It is interesting to consider what is more ethical—testing drugs in children with the assent of older children and the informed permission of their parents, or simply treating children with medications that physicians think will be safe and effective but that haven't been extensively tested," Dr. Ward says.
The Challenge for Doctors
Thus, doctors are faced with a bit of a conundrum when prescribing medications to certain patients. To many doctors, that's cause for concern. The lack of testing means a lack of knowledge regarding clinical effect, proper dosing, and potential side effects.
For example, while antidepressants are widely used in children and adolescents, there have been few studies in that age group, and certain antidepressants have been linked to an increased risk of suicide.
Children, many experts point out, are not simply "little adults." You can't just cut a drug dose in half and expect it to work the way it works in an adult. Similarly, geriatricians reject the argument that elderly people respond predictably to the same drugs shown to be safe and effective in younger adults.
Efforts to Improve the Situation
Fortunately, changes are being made to improve the situation. Since the mid-1990s, the FDA has proposed several rules to encourage the inclusion of children, women of childbearing potential, and elderly people in clinical trials of new drugs.
Perhaps most significantly, Congress passed a legislative provision in 1997 (which was renewed in early 2002) that grants a six-month extension on the patents of drugs produced by companies that test their drugs in children.
This financial incentive helps offset the cost of extra testing and is an "honorable 'quid pro quo' that works for everybody," according to Jeff Trewhitt, spokesperson for the Pharmaceutical Research and Manufacturers of America.
What You Can Do
In the meantime, your best bet, as always, is to be an informed consumer. Whenever you or your child is prescribed a medication, ask your doctor and pharmacist if the drug was specifically tested in your age group and what are the potential risks associated with the drug.
It's important to remember that a drug that hasn't been tested in a certain population isn't necessarily dangerous to that population and not taking the drug to treat a condition may be riskier than taking it. In many cases, doctors may have substantial experience using that drug to treat people in that population and, if so, they should be able to tell you how the drug has worked in their experience.
American Academy of Pediatrics
Center for Drug Evaluation and Research
US Food and Drug Administration
College of Family Physicians of Canada
Testimony: Robert Ward, MD, FAAC, Past Chairman of the AAP's Drug Committee, to the United States Senate Committee on Health, Education, Labor and Pensions; May 8, 2001. American Academy of Pediatrics website. Available at: http://www.aap.org/advocacy/washing/testimonymay8thBWard.htm .
Last reviewed January 2009 by
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