Two separate articles from the June 1, 2002 issue of the British Medical Journal deal with the subject of "Off-Label" drug prescriptions for children. Off-Label means the usage of a drug for a purpose other than that which it was approved and licensed for. Off-Labeling also applies when drugs are used in a population that the drug was never tested on. Such is the case in many drugs that were never tested on children but are commonly prescribed for them.
One of the two articles looks at a study in Germany and makes a chilling opening statement. "Between 35% and 90% of the drugs prescribed to hospitalized children are either not licensed for children's use or are prescribed outside the terms of their product license (off label prescribing). Subsequent adverse reactions are more likely than with licensed products." Their comments were, "We found that 13.2% of prescriptions for a representative group of children in primary care in Germany were off label." The article attributed 75% of the off label usage to lack of information about the usage of the drugs.
The second article dealt with the same problem in the United States. The opening statement in that article included a comment about how a new drug could come to the market in the US. "Until recently, the drug need only to have been studied in the adult male population. Yet once a drug is approved it may be prescribed by a physician for any population or disease state desired." To attempt to change this situation a law was passed, the FDA Modernization Act of 1997 (FDAMA), which provided that manufacturers of drugs under patent could seek a six month patent extension for performing studies leading to labeling in children. This meant that if the drug companies performed studies on children there could be six additional months of patent protection worth millions or billions in revenue.
The moral dilemma of such studies is that children are not of legal age to volunteer themselves for such drug testing. In the past most studies were performed on healthy male volunteers. Submitting healthy children by their parents or guardians carries ethical questions not present in adult volunteers. Unfortunately, as the article points out that some drug companies wait until the patent is close to expiration before deciding on whether or not to initiate studies on children. Often the decision is based solely on the expected profit potential the drug may carry for the extra six months of patent protection. This means that these drugs were used on children for an extended period of time without any studies to justify the usage.