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Was baby treated for ailment he didn't have?

Monday, July 09, 2001

By Byron Spice, Science Editor, Post-Gazette

Results of a biopsy have raised questions about whether 9-month-old Gage Stevens of Munhall, who died in 1999 while receiving an experimental drug therapy for acid reflux, even had the disorder for which he was being treated.

Gage died on Nov. 24, 1999. Allegheny County Coroner Dr. Cyril H. Wecht would later rule that his death was sudden, unexpected and with symptoms consistent with a heart arrhythmia. Irregular heartbeat is a side effect of Propulsid, a heartburn medication that had been prescribed to Gage as part of a study directed by Dr. Susan Orenstein, a gastroenterologist at Children's Hospital.

But a biopsy performed when Gage entered the study in May 1999 failed to show signs of significant inflammation or other hallmarks of gastroesophageal reflux.

Acid reflux and inflammation of the esophagus can be diagnosed in several ways, but a biopsy usually is considered a definitive diagnosis, said Anthony D'Amico, an attorney for Gage's parents, Scott Stevens and Gretchen Stewart. So D'Amico said he was surprised by the results of the biopsy report, which he obtained during the discovery process for a lawsuit the family filed against Orenstein and Janssen Pharmaceuticals, the maker of Propulsid.

Officials at Children's Hospital refused to comment about what factors were considered in enrolling Gage in the "infantile esophagitis" trial, citing the pending lawsuit.

Joe Dominick, the chief deputy coroner, said signs of gastroesophageal reflux "are not necessarily something we're going to see at autopsy." The coroner's report instead relied on the boy's medical records, which described a significant clinical history of acid reflux.

No one disputes that the infant was fussy, often cried and threw up a lot. Those symptoms convinced Gage's pediatrician to refer him to Orenstein, who then enrolled him in her study, D'Amico noted.

Gastroesophageal reflux is a troublesome issue in infants. Reflux itself is as natural as a burp and simply refers to the backflow of acidic stomach contents into the esophagus. The problem comes when the sphincter that normally limits backflow doesn't work right and reflux occurs excessively, leading to inflammation of the esophagus. In addition to heartburn, excessive reflux can cause infants to avoid food, fail to thrive and increase the risk of sudden infant death syndrome.

An estimated four out of every 10 children under 18 months of age suffer from gastroesophageal reflux. Most outgrow it, but some have cases that persist for years. Last year, researchers at Allegheny General Hospital found evidence that the disease is linked to a genetic abnormality.

Doctors not only worry about distinguishing between normal and abnormal reflux in infants, but also struggle along with parents with the fact that no effective treatment exists.

Orenstein's federally sponsored study was an attempt to find such a treatment, though there were reasons to be cautious in using Propulsid, or cisapride. Heart arrhythmias were known to be a side effect of Propulsid in adult patients; rhythm disturbances and one sudden death had already been reported in infants prior to Gage joining Orenstein's study.

In addition to Propulsid, Gage also had been administered Tagamet, an acid-reducing medication. D'Amico said that combining the two drugs was known to increase the risk for heart arrhythmias.

Janssen withdrew Propulsid from the market last summer.

The study consent form that Gage's parents signed said that Propulsid had been approved by the U.S. Food and Drug Administration for use in children, which was false.

Children's has acknowledged that the consent form was erroneous and, in a statement, said it had taken steps to ensure the accuracy of all such forms used by its clinical investigators.

"For example, we have reinforced our existing policy that requires a member of the hospital's Institutional Review Board (which oversees all experiments involving humans) to investigate and re-confirm any representations relating to a study drug's FDA approval in a consent form," the statement said. "Also, all investigators are provided formal training and certification on issues of regulatory requirements related to clinical trials."

In April 2000, FDA representatives began a review of Orenstein's procedures in the study and concluded that she had failed to report all unanticipated problems in the study subjects.

Though her annual reports had noted that no subject had withdrawn because of an adverse reaction, her records showed that one subject "exhibited symptoms of severe intolerance (screaming spells, crying, pulling legs) after each dose of study drug, which resolved after withdrawal from the study," according to a May 2000 FDA letter to Orenstein.

The letter also noted problems with the consent form, including "coercive" elements that suggested patients not in the study would not receive the same quality of care as those enrolled.

But these and other problems cited in the letter were not deemed significant enough to merit sanctions. Instead, the FDA officials made suggestions and left it to Orenstein to take corrective action.

Mike Laffin, a Children's Hospital spokesman, said Orenstein declined to comment.

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