KANSAS CITY, KAN. ? A U.S. Senate inquiry has put a Kansas University professor under scrutiny over his role in promoting a heartburn medication for pediatric use, despite concerns that use in children could cause serious side effects and even death.

Dr. Paul Hyman, a professor of pediatric gastroenterology at the KU Medical Center, was a champion of the drug Propulsid during the 1980s and 1990s – before his 2002 arrival at KU.

At question is whether pharmaceutical giant Johnson & Johnson used Hyman’s research to promote the drug for consumption by children, despite safety concerns and even though the federal Food and Drug Administration hadn’t approved Propulsid for pediatric use.

Hyman declined an interview request Tuesday. But through the university, he issued a seven-paragraph statement to the Journal-World explaining his involvement with the drug’s promotion.

He denied putting children at risk or advocating an inappropriate use of the medication. KU officials, in an accompanying statement, said they had questioned Hyman and saw no reason to take action.

“My commitment is to the children suffering from digestive disorders,” Hyman said in his statement. “I have never compromised their health at the request of a funding source and I never will.”

Times report

The Senate inquiry follows an investigation by The New York Times published last month. That story was based, in part, on internal company documents obtained by the newspaper.

Sens. Charles Grassley, R-Iowa, and Max Baucus, D-Mont., both ranking members of the Senate Finance Committee, sent a letter last week to Johnson & Johnson requesting information about the company’s promotion of the drug. They set a July 28 deadline for the information.

• Statement from Dr. Paul Hyman (doc)

According to The Times, the senators specifically asked for information on money paid to Hyman and American Pseudo-Obstruction and Hirschprung’s Society, which Hyman served as chief medical adviser and which advocated the use of Propulsid in children. Johnson & Johnson gave $1 million to the group during the late 1980s and 1990s, the Times reported.

The letter also asked for information on $450,000 paid to the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, which also advocated the use of Propulsid.

Neither senator returned phone messages from the Journal-World on Tuesday.

The concerns over Propulsid, which first was approved by the Food and Drug Administration in 1993, surfaced in the mid-1990s, the Times reported.

Last year, Johnson & Johnson settled lawsuits over the drug’s use that claimed 300 people died and as many as 16,000 were injured from taking the drug.

Johnson & Johnson pulled the drug from the market in 2000 amid concerns about its safety.

Book deal

Hyman told The Times he thought risks from the drug were minimal. He received sponsorship for his research on rare pediatric intestinal diseases from Jansen Pharmaceutica, which later was acquired by Johnson & Johnson.

He also was put on the Propulsid advisory board and gave a presentation in 1997 on the drug to 240 doctors at a Johnson & Johnson seminar, The New York Times reported.

Some of the research conducted under the Jansen sponsorship involved Propulsid, Hyman said, but some did not. He said he had reported his “positive experiences” with Propulsid, and that the money from Jansen had “no strings attached.”

After Hyman’s research indicated Propulsid was useful in children’s digestive problems, Jansen Pharmaceutica paid for 10,000 copies of a textbook on digestive disorders edited by Hyman.

“There was no influence on the book from any outside corporate source,” Hyman said. “The book does contain some references on the research on Propulsid to that time (in a section I did not write), but that comprised only a small part of the entire book.”

KU officials said they had met with Hyman to discuss the story and the inquiry. They said they were satisfied with his explanation of events, though they are continuing to monitor the situation.

“We responded prudently when The New York Times report surfaced and met with Dr. Hyman,” Chet Johnson, chairman of KU’s pediatric department, said Tuesday. “He has responded to our questions and we see no reason for action at this time. However, we continue to monitor the situation, consistent with the high ethical standards we demand for our researchers and clinical practitioners.”