108th Congress

Pancreatic Islet Cell Transplantation Act of 2004

H.R. 3858, S. 2158

Background

Diabetes is a devastating, lifelong condition that affects people of every age, race, and nationality, including approximately 16 million Americans. It is the leading cause of kidney failure, blindness in adults, and amputations unrelated to injury. Moreover, diabetes costs the Nation more than $105 billion a year, 1 out of every 10 health care dollars, in health-related expenditures. In individuals with juvenile diabetes, the body’s immune system attacks the pancreas and destroys the islet cells that produce insulin. While the discovery of insulin was a breakthrough in the treatment of people with diabetes, it was not a cure. People with juvenile diabetes face the constant threat of developing life-threatening complications as well as a drastic reduction in their quality of life.

In 2001, researchers in Edmonton, Alberta, Canada, building on years of research, reported that they had developed methods for harvesting pancreatic islet cells and transplanting these insulin-producing cells into patients with a drug treatment protocol that allowed the majority to become insulin independent. Of the approximately 70 patients who have been treated using a variation of the Edmonton Protocol during the past 2 years, all have seen the reversal of their life-disabling hypoglycemia, and nearly 80 percent have maintained normal glucose levels without insulin shots for more than 2 years.

Because of the serious shortage of pancreases available for islet cell transplantation, new sources of islet cells must be found. Only a few thousand cadaveric pancreases are donated annually, and of these only a portion are available for islet transplants. The supply of cadaveric donor islets is only sufficient to establish insulin independence in approximately 250 transplant recipients per year in the United States, a number far less than the estimated 1 million individuals with Type 1 diabetes. Moreover, most patients require islet cells from two pancreases for the procedure to work effectively.

Provisions of the Legislation/Impact on NIH

H.R. 3858, the Pancreatic Islet Cell Transplantation Act of 2004, was introduced by Representative George R. Nethercutt, Jr. (R-WA) on February 26, 2004. H.R. 3858 would permit pancreases obtained by organ procurement organizations for the purposes of islet cell transplantation or research to be counted toward that organization’s certification.

The bill would also require the Diabetes Mellitus Interagency Coordinating Committee to include an assessment of the Federal activities and programs related to pancreatic islet cell transplantation in its annual report. The Committee would also evaluate 1) the adequacy of Federal funding for taking advantage of scientific opportunities relating to pancreatic islet cell transplantation, 2) current policies and regulations affecting the supply of pancreases for islet cell transplantation, 3) the effect of xenotransplantation on advancing pancreatic islet cell transplantation, 4) the effect of United Network for Organ Sharing policies regarding pancreas retrieval and islet cell transplantation, 5) the existing mechanisms to collect and coordinate outcomes data from existing islet cell transplantation trials, 6) implementation of multiagency clinical investigations of pancreatic islet cell transplantation, and 7) recommendations for such legislation and administrative actions as the Committee considers appropriate to increase the supply of pancreases available for islet cell transplantation.

Status and Outlook

H.R. 3858 was introduced on February 26, 2004, and was referred to the House Energy and Commerce Subcommittee on Health.

Companion measure S. 2158, the Pancreatic Islet Cell Transplantation Act of 2004, was introduced by Senators Susan M. Collins (R-ME) and Patty Murray (D-WA) on March 2, 2004. S. 2158 was referred to the Senate Committee on Health, Education, Labor and Pensions. No further action has occurred on this legislation.