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Infant's death raises alarms on who's used in drug trials

Thursday, April 27, 2000

By Ellen Mazo, Post-Gazette Staff Writer

A second look at the death of a 9-month-old Munhall boy has put the spotlight on a federally-approved practice of using children in clinical drug trials.

 
Scott Stevens and Gretchen Stewart -- "Little did we know that Gage was basically a guinea pig." (Martha Rial, Post-Gazette) 

Gage E. Stevens, a participant in a Children's Hospital study on the use of the drug Propulsid for gastroesophageal reflux, died asleep in his crib on Nov. 24.

Finding no indications of drug overdoses or foul play, Dr. Cyril Wecht, Allegheny County coroner, initially determined that the infant had died of Sudden Infant Death Syndrome, or SIDS.

Gage had been part of the Propulsid trial conducted by Children's gastroenterologist Dr. Susan Orenstein. While Propulsid, which also is known as cisapride, had not been approved by the Food and Drug Administration for use in treating infants and young children, it had been approved for adults.

Orenstein had run the clinical trial with 100 children since 1994.

Wecht said that toxicology reports initially sent up no red flags, but after a review of the case, he ruled yesterday that the cause of death was cardiac arrhythmia, a noted Propulsid side effect.

A month ago, Janssen Pharmaceutica, the Titusville, N.J.-based manufacturer, announced it would pull the drug from the market this summer, and that use of it as of May 1 would be limited to those who met strict clinical guidelines.

Gage is the only child in the clinical trial from this area to have died. The study at Children's is one of several around the country; the FDA reported that 19 children under the age of 19 who were treated with Propulsid have died.

"This drug has been widely prescribed by pediatricians and pediatric specialists for the treatment of gastroesophageal reflux in children and infants due to its efficacy and presumed safety based on the adult data," Children's Hospital said in the statement.

Maybe so, said the baby's mother, Gretchen Stewart, 27, "but little did we know that Gage was basically a guinea pig, and they never told us that [Propulsid] causes dangerous side effects, or there had been deaths."

 
  Gage E. Stevens, a participant in a Children's Hospital study on the use of the drug Propulsid for gastroesophageal reflux, died asleep in his crib on Nov. 24.

Stewart, a cardiac nurse at Mercy Hospital, said she was never comfortable with the SIDS ruling. She and her husband, Scott Stevens, accepted it, however, until two months ago when she read an Associated Press story in the Pittsburgh Post-Gazette that described the frightening health issues raised by parents whose children were prescribed Propulsid for reflux.

Stewart called the FDA. She called the coroner's office. She kept asking questions.

In the meantime, the FDA sent out an advisory acknowledging the "known risk of rare -- but serious -- cardiac events associated with the drug."

The FDA said it would hold a public advisory committee meeting this month to discuss the drug's safety. The meeting was never held because Janssen said it would voluntarily pull Propulsid from the market.

Gage, who weighed 5 pounds, 7 ounces at birth, had shown signs of reflux within a month of his birth. A symptom of reflux, which occurs when stomach acid backs up into the esophagus, is excessive throwing up.

While not a life-threatening condition in and of itself, reflux can lead to malnourishment or cause permanent damage to the esophagus.

Doctors say that most babies outgrow the problem by their first birthday. But Stewart said that Orenstein was adamant that Propulsid was the best treatment for their child. The drug acts as a peristalsis, helping propel food through the system.

The FDA-approved double-blind study, which ultimately included 100 children, meant that some children received a placebo; others, Propulsid only; a third group, Tagamet, or cimetidine, which inhibits the production of stomach acids; and a fourth group, Propulsid and Tagamet.

Gage was a part of the fourth group. Canada recently warned on its drug labels that there is a contraindication in the use of Tagamet and Propulsid together.

Stewart and Stevens, 31, a computer programmer, said they were unaware of any major problems and signed the consent form for their son's participation. The consent form said that Propulsid was FDA-approved for use in infants.

That was wrong.

"The language was added because, at the time, it was widely believed by pediatric gastroenterologists around the country that cisapride approval was imminent because of the manufacturer's sponsorship of pediatric studies and the apparent efficacy and safety," Children's Hospital said in a statement.

Stewart said that if they had known of the previous deaths, they never would have consented.



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