Gage Stevens fussed, cried and vomited often. Nothing his pediatrician recommended [...] worked. 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. Six months later [...] he was dead.
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. 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?
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From "Kids as guinea pigs" by Dawn MacKeen
Gage Stevens fussed, cried and vomited often. Nothing his pediatrician recommended [...] worked. 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. Six months later [...] he was dead.
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. 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?
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.
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.
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.
In March, Jaansen Pharmaceutical pulled Propulsid off the market. Researchers are supposed to meet a high ethical bar in experimenting on children. With adults, a scientist may conduct a study that has tremendous risk and little therapeutic benefit, as long as the research is expected to yield valuable scientific information. Under federal regulations, children generally must benefit from participation in a study. If they don't, the study should pose minimal risk. In most cases, the experimental drug should be no more dangerous than other treatments for the child's condition.
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