[Congressional Record Volume 148, Number 124 (Thursday, September 26, 2002)]
[Extensions of Remarks]
[Page E1660]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




           PANCREATIC ISLET CELL TRANSPLANTATION ACT OF 2002

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                     HON. GEORGE R. NETHERCUTT, JR.

                             of washington

                    in the house of representatives

                     Wednesday, September 25, 2002

  Mr. NETHERCUTT. Mr. Speaker, on behalf of the Congressional Diabetes 
Caucus I am pleased to introduce the Pancreatic Islet Cell 
Transplantation Act of 2002.
  I know first-hand about the difficulty involved in managing this 
disease, as my daughter was diagnosed with diabetes when she was six. 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 100 patients 
who have been transplanted using variations of this protocol, nearly 80 
percent remain insulin independent beyond two 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. As of January 2002, there were 68 islet transplantation 
centers around the world.
  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 has 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, 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 plans to continue their 
research in the future.
  The Pancreatic Islet Cell Transplantation Act of 2002 contains three 
provisions that I believe will help to 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. Currently, OPOs do not receive credit from the 
Centers for Medicare and Medicaid Services (CMS), towards their 
certification, for pancreases retrieved and used for research or islet 
transplantation. The OPOs do receive credit for pancreases retrieved 
and used for whole pancreas transplants. 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.
  Ultimately, the goal is to expand the human clinical trials, 
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 towards this goal.
  I encourage all of my colleagues to join with me in supporting this 
important legislation.

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