Wednesday, Jul 9, 2008
The death of a 9-month-old boy rekindles an agonizing debate: Should powerful drugs be tested on children?
May 31, 2000 | No matter how Gretchen Stewart held her 3-month-old son, she couldn't console him. Gage Stevens fussed, cried and vomited often. Nothing his pediatrician recommended, including switching his formula, worked either. Finally, Gage's doctor told his mother about a specialist at Pittsburgh Children's Hospital who was testing the anti-heartburn drug Propulsid on children with Gage's condition. Maybe that would help, she recalls him saying.
Gage was enrolled in the study on May 11, 1999. Six months later, his grandmother gave him his nightly dose of medication and tucked him into bed. By morning, he was dead.
His family believes his participation in the drug study killed him. The local coroner seems to agree. Last month, Gage had the unfortunate honor of receiving a second death certificate. Instead of sudden infant death syndrome, originally listed as the cause of death last November, it now reads "cisapride [Propulsid] and cimetidine [Tagamet] prescribed therapy" and "trial drug study." After reexamining the case, Cyril Wecht, the Allegheny County, Penn., medical examiner, concluded that Gage died from cardiac arrhythmia -- or heartbeat abnormalities -- a side effect of Propulsid.
The death of Gage Stevens, who suffered from a relatively common condition, gastroesophageal reflux disease (GERD), has reopened the issue of whether it is right to test powerful drugs on children. While the death of 18-year-old Jesse Gelsinger brought criticism to the field of gene therapy -- and prompted Department of Health and Human Services Secretary Donna Shalala last week to announce increased federal monitoring of medical research -- Gage's death takes the debate to a deeper, more troubling level.
Should babies who can't even say "Mama," let alone decide to participate in a medical experiment, become pawns in the high-stakes game of drug research? Or is the death of a child simply the price that must be paid to determine if a drug is safe and effective for widespread use?
"One way we feel comfortable about research is telling each other, these people know the risks and they choose," says Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania Medical Center. "We can't feel as good about allowing experiments on children."
Most drugs are tested extensively on adults before the Food and Drug Administration approves them for general sale. Once a drug is on the market, a doctor may prescribe it for any patient, even a child. It is generally believed that only about one-fourth of medicines prescribed for children have been approved specifically for kids.
Amid growing concerns over the inadequacy of pediatric drug testing, federal legislation was passed three years ago to promote studies on kids. Since then, the number of vaccines and pediatric medicines in development has skyrocketed -- and so have the number of kids on the frontlines of research. Gage Stevens may be the first casualty of this new era.
There is no way to prove posthumously that Gage died because of heart problems, as the medical director of Children's Hospital and other experts point out. His case is also complicated by problems in the study protocol. The researchers led Gage's parents to believe that Propulsid was FDA-approved for kids, when it wasn't. According to the family's lawyer, the second page of the "informed consent" document noted that there had been deaths as a result of taking this medication, but said most of those occurred when Propulsid was mixed with an antibiotic. In fact, Propulsid had been linked to at least 80 deaths and 341 heart rhythm abnormalities. Nineteen of the deaths were patients under 19 years old.
"If there had been anything that had been conveyed to Gretchen to show that there was remotely a risk that her baby would have died, she would have not participated in the study," says Anthony D'Amico, an attorney for Gage's family. Children's Hospital has suspended the Propulsid study. The manufacturer has pulled the drug off the market.
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