107th Congress

PANCREATIC ISLET CELL TRANSPLANTATION ACT OF 2002
S. 2849

Background

Diabetes is a devastating, life-long condition that affects people of every age, race, and nationality, affecting approximately 16 million Americans. It is the leading cause of kidney failure, blindness in adults, and amputations not related 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 landmark breakthrough in the treatment of people with diabetes, it is not a cure. People with juvenile diabetes face the constant threat of developing devastating, life-threatening complications as well as a drastic reduction in their quality of life.

In 2001, researchers in Edmonton, Canada, building on years of research, reported that they had developed methods for harvesting islets and transplanting these insulin-producing pancreatic islet cells into patients with a drug treatment protocol that allowed the majority to become insulin-dependent. The National Institutes of Health (NIH) along with the Juvenile Diabetes Research Foundation (JDRF) are supporting expanded trials of islet transplantation to replicate and build upon the Edmonton advance, which has been hailed as the most important advance in diabetes research since the discovery of insulin in 1921. Of the approximately 70 patients who were treated using a variation of the Edmonton Protocol over the past 2 years, all have seen a reversal of their life-disabling hypoglycemia, and nearly 80 percent have maintained normal glucose levels without insulin shots for more than 2 years.

New sources of islet cells will need to be found because of the serious shortage of pancreases available for islet cell transplantation. There currently are only 2,000 pancreases donated annually and, of these, only about 500 are available each year for islet cell transplants. Moreover, most patients require islet cells from two pancreases for the procedure to work effectively.

The goal of the legislation would be to increase the supply of pancreases available for these trials and research. The legislation would direct the Centers for Medicare and Medicaid Services to grant credit to organ procurement organizations for the purposes of their certification-for pancreases harvested and used for islet cell transplantation and research.

Provisions of the Legislation/Impact on NIH

S. 2849 was introduced on August 1, 2002, by Senators Susan M. Collins (R-ME) and Patty Murray (D-WA) to 1) increase the supply of pancreatic islet cells for research, 2) provide better coordination of Federal efforts and information on islet cell transplantation, and 3) collect the data necessary to move islet cell transplantation from an experimental procedure to a standard therapy. In addition, to encourage organ donation, the bill would require the establishment of a U.S. Department of Health and Human Services Interagency Committee on Islet Cell Transplantation. This committee would include representatives from the National Institute on Diabetes and Digestive and Kidney Diseases (to serve as chairperson); the National Institute of Allergy and Infectious Diseases; the National Institute of Environmental Health Sciences; the Health Resources and Services Administration; the Centers for Medicare and Medicaid Services; the U.S. Department of Defense; the U.S. Department of Veterans Affairs; the National Aeronautics and Space Administration; and other agencies and NIH representatives as deemed appropriate by the chairperson and Secretary of Health and Human Services (HHS).

This coordinating committee would be responsible for 1) conducting a study and reporting the results of the adequacy of Federal research funding for research on islet cell transplantation, 2) current policies and regulations affecting the supply of pancreases, 3) investigating the effect of xenotransplantation on advancing islet cell transplantation the effect of United Network for Organ Sharing variances on pancreas retrieval and transplantation, and 4) reviewing the existing mechanisms to collect and coordinate outcome data from existing islet cell transplantation trials. The Secretary of HHS is also directed to commission the Institute of Medicine to conduct a study on the impact of islet cell transplantation on the health-related quality of life for individuals with juvenile diabetes and the cost-effectiveness of the treatment. Such sums as may be necessary would be authorized for these activities.

Status and Outlook

S. 2849 was introduced on August 1, 2002, and was referred to the Committee on Health, Education, Labor and Pensions. No further action has occurred.