Statements on Introduced Bills and Joint Resolutions - S. 2158

STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

By Ms. COLLINS (for herself, Mrs. MURRAY, Mr. WARNER, Mr. BINGAMAN, Mr. ALLEN, Mr. FEINGOLD, Mr. COCHRAN, Mr. LAUTENBERG, Mr. HAGEL, Mr. REED, Mr. SMITH, Mr. ENSIGN, and Mr. DEWINE):

S. 2158. A bill to amend the Public Health Service Act to increase the supply of pancreatic islet cells for research, and to provide for better coordination of Federal efforts and information on islet cell transplantation; to the Committee on Health, Education, Labor, and Pensions.

Ms. COLLINS. Mr. President, I am pleased to join my colleague from Washington, Senator PATTY MURRAY, in introducing the Pancreatic Islet Cell Transplantation Act of 2004, which will help to advance tremendously important research that holds the promise of a cure for the more than one million Americans with Type 1, or juvenile diabetes. The legislation is similar to the bipartisan bill, S. 518, which we introduced last year and which attracted 52 cosponsors.

As the founder and co-chair of the Senate Diabetes Caucus, I have learned a great deal about this serious disease and the difficulties and heartbreak that it causes for so many Americans and their families as they await a cure. The burden of juvenile diabetes is particularly heavy for children and young people. It is the second most common disease affecting children. Moreover, it is one that they never outgrow.

In individuals with juvenile diabetes, the body's own immune system attacks the pancreas and destroys the islet cells that produce insulin. As a consequence, people with juvenile diabetes require daily insulin injections for survival. 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 conditions such as kidney failure, blindness or amputation, as well as a dramatic reduction in their quality of life.

Thankfully, there is good news for people with diabetes. We have seen some tremendous breakthroughs in diabetes research in recent years, and I am convinced that diabetes is a disease that can be cured, and will be cured in the near future.

We were all encouraged by the development of the "Edmonton Protocol," an experimental treatment developed at the University of Alberta involving the transplantation of insulin-producing pancreatic islet cells, which has been hailed as the most important advance in diabetes research since the discovery of insulin in 1920. Pancreatic islet cell transplantation has been performed on nearly 300 individuals to date, and the majority of them no longer need to take insulin to stay alive. Significant research questions, however, remain to be answered if we are to make certain that the procedure is appropriate for everyone who suffers from juvenile diabetes.

There are also non-scientific barriers to expanding islet cell transplantation, and the Pancreatic Islet Cell Transplantation Act of 2004 addresses some of them. We were extremely pleased that a key component of S. 518 was included in the Medicare reform bill signed into law last year. That provision authorized a Medicare demonstration project to test the efficacy of pancreatic islet cell transplants for individuals with juvenile diabetes who are eligible for Medicare because they have end-stage renal disease.

The legislation we are introducing today includes the remaining two provisions from last year's legislation that were not included in the Medicare bill. These two provisions are intended to increase the supply of pancreata for islet cell transplantation and to improve the coordination of federal efforts and information regarding islet cell transplantation.

There currently are only about 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. To increase the supply of available pancreases, our legislation will direct the Centers for Medicare and Medicaid Services (CMS) to grant credit to organ procurement organizations (OPOs)-for the purposes of their certification-for pancreases harvested and used for islet cell transplantation and research. While CMS considers a pancreas to have been procured for transplantation if it is used for a whole organ transplant, the OPO receives no credit towards its certification if the pancreas is procured and used for islet cell transplantation or research. Our legislation will therefore give the OPOs an incentive to step up their efforts to increase the supply of pancreases donated for this purpose.

Finally, to provide a more focused effort in the are of islet cell transplantation, our legislation requires the Diabetes Mellitus Interagency Coordinating Committee at the National Institutes of Health to include in its annual report an assessment of the Federal activities and programs related to islet cell transplantation and to make recommendations for legislative or administrative actions that might increase the supply of pancreases available for islet cell transplantation.

Islet cell transplantation offers real hope for people with diabetes. Our legislation, which is strongly supported by the Juvenile Diabetes Research Foundation (JDRF), addresses some of the specific obstacles to moving this research forward as rapidly as possible, and I urge all of my colleagues to sign on as cosponsors.