Senate Finance Committee Begins Investigation of Johnson & Johnson Educational Grants

The Senate Finance Committee on Tuesday began an investigation into whether Johnson & Johnson awarded educational grants to promote pediatric use of the heartburn medication Propulsid, despite internal company concerns in the 1990s about the safety of the treatment in some children, the New York Times reports (Saul, New York Times, 7/6). A June 10 Times article examined the history of Propulsid, which J&J removed from the U.S. market in 2000 after FDA received reports of 80 deaths and 341 serious heart problems in patients who took the medication.

In 1998, Propulsid had more than $1 billion in sales, and about 20% of infants in neonatal care units received the medication as a treatment for acid reflux. Later that year, after FDA raised concerns over the efficacy of Propulsid in children in clinical trials, the agency and J&J negotiated revisions to warnings on the label of the medication (New York Times, 6/10).

In a letter to J&J CEO William Weldon on Tuesday, committee Chair Chuck Grassley (R-Iowa) and ranking member Max Baucus (D-Mont.) cited the Times article and asked for information and documents related to grant recipients, amounts and purposes. The senators said that the committee had decided to expand an investigation that began June 9 into how pharmaceutical companies in some cases use physician education seminars and research grants to discuss off-label uses of medications. They asked J&J to respond to their questions by July 28.

The senators also asked for information related to Paul Hyman -- a pediatric gastroenterologist at the University of Kansas and a member of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition and the American Pseudo-Obstruction and Hirschsprung's Society, a support group for the parents of children with rare digestive diseases. Hyman, one of the first physicians to treat children with Propulsid experimentally in 1984, received financial support from J&J for some of his research. J&J also helped publish and distribute a book that Hyman wrote about childhood digestive diseases.

In addition, J&J in the late 1980s and 1990s awarded $1 million to APHS, where Hyman served as chief medical adviser. According to the Times, APHS "shifted some of its focus away from the rare diseases" for which Propulsid was a treatment "and toward common childhood acid reflux with financing" from J&J.

J&J also awarded $450,000 to NASPGHAN, which concluded in a 1999 report that Propulsid "has a place in pediatric therapeutics," although researchers maintain that the funds did not influence their conclusion.

Jeffery Leebaw, a J&J spokesperson, said that the company has not reviewed the letter from the senators and declined to comment. He added that J&J "marketed Propulsid only for its approved indication" (New York Times, 7/6).

"It makes no sense that financially conflicted physicians" who receive funds from the pharmaceutical industry "should be developing educational materials and practice guidelines," Jerome Kassirer, an author and professor at Tufts University School of Medicine, writes in a Boston Globe opinion piece.

He concludes, "Extracting medicine from industry's educational ventures will be painful, but probably less painful than inappropriate and more costly medical care or the opprobrium of a disenchanted public" (Kassirer, Boston Globe, 7/6).