To determine if a drug is safe and effective, it must be tested in clinical trials, or rigorous scientific studies involving large groups of patients. The gold standard of drug testing is the controlled double-blind study: Volunteers are randomly sorted into a group that receives the experimental treatment, and a group that gets a placebo. Neither the subjects nor the researchers know who is in which group, until the end, which is why these studies are said to be "double blind."

Most drugs prescribed for children have been tested on and approved for adults, but not kids. The medical community has pushed hard to change this. Drugs affect small, young bodies differently than grown ones. Doctors are allowed to prescribe medication for patients "off-label" -- for purposes that have not specifically been approved. But many doctors say it is bad medicine simply to halve the dose of an adult drug and give it to a child. Inevitably, they say, kids will be put at risk. Either we limit and monitor the danger in a clinical trial, or experiment on the pediatric population at large through widespread off-label use.

"One could speculate that there are more deaths through the use of Propulsid off-label than through the use in research studies," says Dr. Robert Nelson, associate professor of pediatrics at the Medical College of Wisconsin in Milwaukee. "If doing research could mean that we could reduce the amount of deaths outside the studies, then that could be for the good for the children."

It was the widespread off-label prescription of Propulsid that prompted gastroenterologist Susan Orenstein to study the drug. She was skeptical of the pediatric community's embrace of the medication, which was routinely prescribed to children with GERD. She recruited 100 infants to be in a double-blind study: One group would get Propulsid; one group would get Tagamet, a top-selling drug for adults that blocks the production of acid; one group would get both drugs, and one group would receive a placebo.

"Rather than an investigator like this being portrayed as pushing the envelope, at times they can be pushing the brakes on things," says Dr. Donald Fischer, the medical director of Children's Hospital at Pittsburgh who oversees research there.

Gage initially ended up in the placebo group. When he failed to improve, his mother told researchers. In July, three months after he entered the study, they put him on Propulsid and Tagamet.

Gastroesophageal reflux disease can range from a minor annoyance -- a "spitty" baby -- to a serious illness. Stomach acid can come up to the esophagus and spill into the trachea, narrowing the airways and making it difficult to breathe. Children's Hospital officials say Gage was very sick, while his family contends that he would have eventually outgrown the condition, as many children do without prescription drugs.

In March, Jaansen Pharmaceutical pulled Propulsid off the market. "If [Orenstein] hadn't been doing this, and this child hadn't been in a study and was one of the thousands of patients getting it in the community, I'm not sure a red flag would have been raised," Fischer says.

But it is hard to imagine that Gage's family would find solace in this. On Mother's Day, almost a year after her baby was enrolled in the study, Gretchen Stewart struggled painfully to make sense of the loss, the family's attorney said.

The need for pediatric research is clear -- until it's on the back of your child. "Do you want to sacrifice your son or daughter for the next two or three generations?" asks Adil Shamoo, vice president of Citizens for Responsible Care and Research and professor of biochemistry at the University of Maryland School of Medicine in Baltimore. "I wouldn't. I would do a lot of things in my life but not this, not precious children to be used as guinea pigs."