A hospital study designed to test a heartburn drug on children is blamed for the death of a 9-month-old boy, a Coroner recently ruled. Gage Stevens died in November 1999. His death was initially blamed on sudden infant death syndrome (SIDS). It was later learned that the boy’s death may have been caused by an experimental drug he was taking called Propulsid. The drug has been associated with heart rhythm abnormalities and 80 deaths, though the FDA said it could not prove the drug caused any deaths. The baby’s parents, Scott Stevens and Gretchen Stewart, said they signed a consent form at the hospital that incorrectly said the FDA approved the drug for infants. In a statement, children’s hospital officials admitted the form was wrong. They said it told parents the drug was approved because officials believe approval was imminent. They also said the form listed the drugs potential side effects and risks, including heart rhythm problems. Gage, who suffered from heartburn and chronic diarrhea, had been enrolled in the study for 6 months before he died. He was participating in a clinical trial to determine the safety of the drug to treat gastroesophageal reflux in children. The hospital halted the trial after the FDA told officials of a possible link between the drug and Gage’s death. The coroner who initially signed Gage’s death certificate, stating that he died as a result of SID’S (Sudden Infant Death Syndrome), later revised the cause of death. This was only after being contacted by CBS evening news and reviewing additional information from the baby’s family and the FDA. Where do you start with so many possible Health Outrages within one continual medical disaster?
