Gene Therapy to Treat Disease - Biotechnology and Your Health: Pharmaceutical Applications - page 94

PRO OR CON ?
Children in Clinical Trials
Should new medical treatments be tested on children? This is
not a simple question. Adults, protected by all the federal
rules about how clinical trials should be handled, are generally
considered capable of giving or withholding consent to participate
in a trial, after being informed of the potential risks and benefits.
Children under the age of 18 are thought to be too immature
to understand what they are being told and to judge the risks.
Therefore, their parents or guardians must give consent for them,
but some people question whether the parents of a sick child
can make an objective decision about such an issue. Parents may
want to believe that the doctor knows best and would not suggest
that a child take part in a trial if it were not in the child's best
interest. Children are also seen as too fragile to withstand the
risks of experimental treatments, so for many years, children
were not included in studies of new drugs. However, because
drugs were not tested on young people, no one really knew if a
particular drug was safe and effective for children. Children are
not just small adults. They may have distinct ways of absorbing
and removing drugs from their bodies. The amount of the drug
given and the timing of its administration may be inappropriate,
even if a child's size is taken into account. In addition, some
diseases appear more often or have a different pattern in
children. In 1998, the FDA and the NIH began to require that
children be included in clinical trials if the treatment was
intended to be used in children. The inclusion of children has to
be scientifically and ethically justified and parental consent
must be sought and obtained. In addition, unless a child's
participation in a trial is essential to his or her welfare, the
American Academy of Pediatrics recommends that a child's
refusal to participate be respected.