Senators Ask Drug Giant to Explain Grants to Doctors

[GerryDaypray]

http://www.nytimes.com/2005/07/06/bu...gewanted=print



Senators Ask Drug Giant to Explain Grants to Doctors
By STEPHANIE SAUL
The Senate Finance Committee yesterday began an inquiry into whether Johnson & Johnson used educational grants to promote the pediatric use of its former heartburn medication, Propulsid, even as internal company concerns mounted during the 1990's about the drug's safety in some children.

The inquiry follows a June 10 article in The New York Times describing how, despite growing evidence linking the drug to heart problems and deaths, the company helped pay for a physician's book recommending Propulsid's use in children and gave grants to pediatric gastroenterology organizations that favored such use.

Johnson & Johnson withdrew Propulsid in 2000 after reports of 80 heart-related deaths and 341 injuries among patients taking the medication.

In a letter yesterday to the company's chief executive, William C. Weldon, Senators Charles E. Grassley and Max Baucus cited the article and requested information and documents disclosing who received the grants, the amount of those grants and their purpose.

Mr. Grassley, an Iowa Republican who is the committee chairman, and Mr. Baucus, its senior Democrat, from Montana, said the committee had decided to expand an inquiry, begun June 9, into how pharmaceutical companies sometimes use physician education seminars and research grants to discuss using drugs to treat conditions beyond those approved by the Food and Drug Administration.

Such efforts can be legal under federal drug laws, but critics say the activities too often go beyond education and instead promote the off-label use of drugs.

The F.D.A. approved Propulsid in 1993 for the treatment of nighttime heartburn in adults. Because the drug was never approved for use in children, the company could not directly market it for pediatric use. But by 1998, more than half a million prescriptions were being written annually to treat digestive problems in children.

The company agreed last year to pay up to $90 million to settle lawsuits that claimed 300 people died and as many as 16,000 were injured from taking the drug.

A Johnson & Johnson spokesman, Jeffrey J. Leebaw, said yesterday that the company had not yet seen the letter from the senators and, therefore, could not comment. But "Johnson & Johnson marketed Propulsid only for its approved indication," Mr. Leebaw said.

The senators specifically asked for information about Johnson & Johnson payments to Dr. Paul Hyman, a pediatric gastroenterologist currently affiliated with the University of Kansas, as well as two organizations: the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition and the American Pseudo-Obstruction and Hirschsprung's Society.

Dr. Hyman was among the first doctors to treat children experimentally with Propulsid in 1984 and received financing for some of his work from the company. Johnson & Johnson also helped publish and distribute his book on childhood digestive disorders. In an interview for the June article, Dr. Hyman said that while Propulsid had some serious risks, dangerous side effects were rare.

Johnson & Johnson gave $1 million during the late 1980's and 1990's to the American Pseudo-Obstruction and Hirschsprung's Society, a support group for parents of children with unusual digestive diseases for which Propulsid was a treatment.

Dr. Hyman was a chief medical adviser to the group, which shifted some of its focus away from the rare diseases and toward common childhood acid reflux with financing from Johnson & Johnson, according to the Times article.

The company also donated $450,000 to the North American Society for Pediatric Gastroenterology Hepatology and Nutrition. In a report in 1999, the group concluded that Propulsid "has a place in pediatric therapeutics." The report's lead author later said that Johnson & Johnson's money had no influence on the group's conclusions.

Senators Grassley and Baucus asked the company to answer questions by July 28.

[Cyndee]

:-( We need a 'smiley' for puking.

[elisa]

Will this "smiley" do?

[Cyndee]

Originally Posted by elisa

Will this "smiley" do?

that is definitely a good smiley--wonder if paxilprogress can add it to the list! I've added it to my own computer! Thanks

[scotty]

The news continues to come out on Big Pharma influence. This is a good thing!! They can no longer operate behind the scenes without all of us watching.
How about this one?? Seems appropriate since we're talking about GI!!

[rdjanis]

The way Pharms throws money around to promote the meds is truly disgusting. I think any docs that participate in this type of thing should lose their damn license!

[Delynbetter]

I worked in the pharmacy of the medical school and watched as new drugs were tested before they came on the market. Retrovir was the first one that we kept records of...or at least the first one during my employment there.

Big Pharma did pay the school for their testing, but the school was honest. The medical school had a lot of us watching over every aspect of the study. Results were not given by just one physician or one department. The patients were interviewed by both the physicians and the pharmacists.

I believe this is the way that all studies should be done, with many inputs and confirmation of results from various sources. But without actual copies of the results we'll never know how many people actually oversaw the testing and results. It's frustrating.

[Cyndee]

Laurie--thanks for the pukeface. I guess I'm collecting smiley faces that are puking! They will sure come in handy. ha!