[Congressional Record (Bound Edition), Volume 149 (2003), Part 4]
[Extensions of Remarks]
[Pages 5098-5099]
[From the U.S. Government Publishing Office, www.gpo.gov]




                 PANCREATIC ISLET CELL TRANSPLANTATION

                                 ______
                                 

                     HON. GEORGE R. NETHERCUTT, JR.

                             of washington

                    in the house of representatives

                         Tuesday, March 4, 2003

  Mr. NETHERCUTT. Mr. Speaker, I am pleased to introduce the Pancreatic 
Islet Cell Transplantation Act of 2003.
  I know first-hand about the difficulty involved in managing this 
disease, as my daughter was diagnosed with diabetes when she was 6. I 
have hope in the rapid pace of research in this area and believe that 
one day soon there will be a cure for my daughter and the millions of 
Americans with diabetes. The legislation we are introducing today is an 
important step toward this goal.
  It is a promising time for research on diabetes, and those suffering 
from the disease and their families are filled with hope. One of the 
most exciting recent advances, and the focus of this legislation, is 
pancreatic islet cell transplantation. Many have hailed the 
breakthrough in this area as the most important advance in diabetes 
research since the discovery of insulin in 1921.
  In 2000, researchers in Edmonton, Canada, were successful in 
isolating islets from donor pancreases and transplanting those cells 
into a person with diabetes through an injection. These injected islets 
then begin to function and produce insulin, and this procedure appears 
to offer the most immediate cure for diabetes. This procedure has 
become known as the Edmonton Protocol and of the approximately 200 
patients who have been transplanted using variations of this protocol, 
nearly 80 percent remain insulin independent beyond 2 years. The 
research is moving forward quickly, and researchers around the world 
are trying to replicate and expand on this success and make it 
appropriate for children.
  I am proud that exciting advances are underway in the State of 
Washington. Recently, a clinical research team at the JDRF Center for 
Human Islet Transplantation in Seattle performed the first three human 
islet transplants in the Northwest. All of these individuals were 
suffering the effects of advanced diabetes complications prior to 
receiving the transplant,

[[Page 5099]]

and all three have now achieved critical post-transplant success in the 
management of their blood sugar levels. I am heartened to know that the 
Seattle program team plans to continue its research in the future.
  The Pancreatic Islet Cell Transplantation Act of 2003 contains four 
provisions that I believe will help move this research forward. The 
first section of the bill provides a regulatory incentive to organ 
procurement organizations (OPOs) to procure additional pancreases. One 
of the major challenges in promoting research on and transplantation of 
islet cells is the shortage of pancreases. Approximately 2,000 
pancreases are donated each year, and only approximately 500 of those 
donated are available for use in islet cell transplants. Clearly, this 
is not nearly a large enough supply considering that millions of 
Americans have diabetes. While OPOs do receive credit from CMS for 
pancreases retrieved and used for whole pancreas transplants, they do 
not receive credit for pancreases retrieved and used for islet cell 
transplantation. This creates a disincentive for OPOs to retrieve 
pancreases for research or islet transplantation. My legislation 
attempts to provide an incentive to OPOs by directing CMS to provide 
credit to OPOs for pancreases retrieved and used for research and islet 
transplantation.
  The second section of this legislation creates a federal inter-agency 
committee to coordinate efforts in the area of islet transplantation 
and to make recommendations to the Secretary of Health and Human 
Services on regulations and policies that would advance this exciting 
area of research.
  The goal of the human clinical trials is to demonstrate success over 
a longer period of time, and move islet cell transplantation from an 
experimental procedure to standard therapy covered by insurance and 
appropriate for all individuals with diabetes. The third section of 
this legislation directs the Institute of Medicine to conduct a study 
on clinical outcomes and comprehensive cost-utility analysis that will 
be important in moving toward this goal.
  The fourth section of this bill creates a Medicare demonstration 
project. A significant percentage of individuals with type I diabetes 
has kidney failure and becomes Medicare eligible before the age of 65. 
Insufficient data exists to determine the efficacy of a simultaneous 
islet-kidney transplant or an islet transplant after a kidney 
transplant for individuals with type I diabetes. By directing the 
Secretary of HHS to create a demonstration project to test Medicare 
coverage for individuals with type I diabetes, we can assess the value 
of simultaneous islet-kidney transplants or islet transplant after a 
kidney transplant.
  I encourage all of my colleagues to join with me in supporting this 
important legislation.

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