And in December, the Food and Drug Administration began requiring companies to test almost all new medicines in young people. The testing is necessary, experts say, because 80 percent of all medicines used in children have not been adequately researched in them. For children and their families, the boom in pediatric testing has brought a chance of improved treatments, but also the ethical dilemmas that accompany medical research. Enrolling children in medical experiments is a delicate business. In some cases, healthy youngsters are study subjects, raising questions about whether they are being exposed to risks without possible benefit.
Some studies pay children to enroll.
Although the money is typically designated to cover expenses, it may include a profit. The same applies to physicians. There is enormous opportunity for profit now because of the explosion of drug testing in children. That opportunity extends to the pharmaceutical companies, who under the 1997 law can delay generic competition in exchange for pediatric testing. The law has meant hundreds of millions of dollars in additional profits for the makers of such blockbuster drugs as Claritin, the allergy medicine, and Prozac, the antidipressant.