WASHINGTON - Pediatricians and the Bush administration will likely soon clash with the powerful drug industry over whether medications that are prescribed for children must be tested on kids first.
Many of the drugs that children take have undergone only adult testing, and some pediatricians say clinical trials with children would yield vital information on proper dosages, safety and effectiveness.
The drug industry opposes any government effort to force it to conduct such trials, saying expanded testing would be wasteful, might be unnecessary and could be unethical.
The emerging fight places the Bush administration in the unusual position of supporting more regulation of an important industry. Last month, the administration reiterated its support for the principle that drugs prescribed for children should be clinically tested on young patients just as they are on adults.
The Health and Human Services Department announced it would sponsor clinical trials in children to test 12 popular, off-patent drugs that have been prescribed for youngsters for years but were tested only in adults. Because these drugs no longer enjoy patent protection, it's unlikely that any drug company would conduct such clinical trials on its own.
The medications include azithromycin, an antibiotic; dopamine, a drug commonly used in treating Parkinson's disease but also prescribed for schizophrenia; and heparin, used to slow the blood's clotting ability and reduce the risks of clots.
For years, pediatricians and some parents have been troubled by the relative lack of research data about how prescription drugs affect children. While pharmaceuticals prescribed to adults typically undergo extensive clinical trials in adults before they are marketed, the same drugs often receive little testing on children.
Medical experts say children aren't little adults for whom grownup doses can just be reduced. "That's how you kill children," said Dr. Robert Ward, a neonatologist and clinical pharmacologist at the University of Utah Medical School.
"If you simply scale down the dose by body weight, what it misses is the maturational changes in how the drug is removed from the body. The baby's capacity to remove the drug may be 2 or 3 percent of the capacity of an adult or an older child." A drug can "quickly build up to toxic levels."
Physicians have long had to make educated guesses about how much of a particular drug a child could safely be given. Indeed, some Food and Drug Administration officials have said that doctors writing prescriptions for children are often running little more than uncontrolled experiments.
Tetracycline, an antibiotic, was given to millions of children in the 1960s and 1970s before doctors realized it caused yellowing and malformation of youngsters' teeth, sometimes making teeth so soft and decayed they had to be replaced.
Doctors once gave an anti-bacterial called chloramphenicol to newborns but stopped after observing a pattern of infant deaths. Physicians realized the drug was poisoning the children.
In announcing plans to conduct clinical trials on the 12 drugs, HHS reiterated the administration's goal of passing legislation to require that many drugs be tested in children.
"We think it's not necessary for additional legislation and that it doesn't make sense to establish a statute that says you must test all drugs in children," said Marjorie Powell, assistant senior general counsel of the Pharmaceutical Research and Manufacturers of America. "There well may be drugs you really don't want to test in children for a variety of reasons," such as a medication for prostate cancer.
Lawmakers can't easily ignore the industry's position on the issue. During the 2001-2002 election cycle, pharmaceutical manufacturers contributed $5.7 million to congressional candidates, with nearly 70 percent going to Republicans.
Frank James is a reporter for the Chicago Tribune, a Tribune Publishing newspaper.