Heartbreaking Heartburn Drug

Gage Stevens was born fussy. His parents took him to a specialist to try to figure out why he cried so much. The doctor said the problem was simply acid reflux, and enrolled Gage in a study she was conducting on the heartburn drug Propulsid.

A few months later, reports CBS News correspondent Sharyl Attkisson, Gage died in his sleep.

His parents were told it was sudden infant death syndrome (SIDS). Nobody told them Propulsid might have been the culprit.

"We were just trying to help our son. That's all. We were just trying to help him," says Gage's mother, Gretchen Stewart.

Gage's parents didn't know that Propulsid had been linked to dozens of deaths, including at least one other baby, before Gage got his first dose. Shortly after Gage died, Propulsid was pulled from the market--linked to more than 300 deaths.

"The anger, it's just...it's so overwhelming that it's a daily thing," said Gage's father, Scott Stevens.

As a result of the CBS News investigation last year, the coroner changed Gage's cause of death from SIDS, instead linking it to his participation in the Propulsid study at the respected Pittsburgh Children's Hospital.

Gage's parents are now suing Pittsburgh Children's Hospital, the doctor who conducted the study, Susan Orenstein, and the maker of Propulsid, Johnson and Johnson.

As CBS News first revealed last year, the study consent form falsely stated that Propulsid was "approved by the FDA" for children. In fact, the US Food and Drug Administration had repeatedly rejected it for pediatric use.

After the CBS News report, the FDA cited Dr. Orenstein for violating federal regulations and good clinical practices. Among other problems, the FDA said there was poor record keeping and that the consent form was coercive and didn't clearly state the risks. And the FDA said Dr. Orenstein failed to report all serious adverse events, including another baby that showed "symptoms of severe intolerance--screaming spells, crying, pulling legs--after each dose."

Even worse, there is now evidence suggesting that Gage never even had the illness that supposedly qualified him for the study. Dr. Orenstein originally did a biopsy and told Gage's parents it confirmed that his esophagus was inflamed due to acid reflux.

But CBS News has now obtained those test results, and they tell a different story: The biopsy was negative. There was "no evidence of...significant inflammation."

So why did Dr. Orenstein put Gage in her study? She won't say. But sources say Dr. Orenstein was having trouble getting enough test subjects. In fact, the 4-year study had dragged out to 7 years by the time Gage was enrolled. Pittsburgh Children's Hospital wouldn't comment, citing the parent's pending lawsuit. In a written statement, the hospital said it remains committed to providing the best and safest treatment to all of its patients.

All of the new disclosures just add to the pain for Gage's parents.

"It just maks it worse. It just makes it worse," said Gretchen.

With all of the problems, you might think the FDA would have banned Dr. Orenstein from future studies, but it didn't. In fact, she doesn't even rate a mention on the FDA's list of doctors who've had serious problems with their studies.

The worst part, say Gage's parents, is not just that so much went wrong. It's that nobody has been able to show them anything has changed because of their son's death.
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