Senator Collins Introduces Pancreatic Islet Cell Transplantation Act of 2003

S. 518. A bill to increase the supply of pancreatic islet cells for research, to provide better coordinate of Federal efforts and information on islet cell transplantation, and to collect the data necessary to move islet cell transplantation from an experimental procedure to a standard therapy; to the Committee on Health, Education, Labor, and Pensions.

Ms. COLLINS. I am pleased to join my colleague from Washington, Senator PATTY MURRAY, as well as my colleague and co-chair of the Senate Diabetes Caucus, Senator JOHN BREAUX, in introducing the Pancreatic Islet Cell Transplantation Act of 2003, which will help to advance tremendously important research that holds the promise of a cure for the more than 1 million Americans with type 1 or juvenile diabetes.

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. Diabetes is a devastating, life-long condition that affects people of every age, race, and nationality. It is the leading cause of kidney failure, blindness in adults, and amputations not related to injury. Moreover, a new study released by the American Diabetes Association last week estimates that diabetes cost the Nation $132 billion last year, and that health care spending for people with diabetes is almost double what it would be if they did not have diabetes.

The burden of diabetes is particularly heavy for children and young adults with type 1, or juvenile diabetes. Juvenile diabetes is the second most common chronic disease affecting children. Moreover, it is one that they never outgrow.

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, and 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.

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 1921. Of the approximately 200 patients who have been treated using variations of the Edmonton Protocol, 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 1 year.

Moreover, the side effects associated with this treatment— which uses more islet cells and a less toxic combination of immunosuppressive drugs than previous, less successful protocols—have been mild and the therapy has been generally well tolerated by most patients.

Unfortunately, long-term use of toxic immunosuppressive drugs, has side effects that make the current treatment inappropriate for use in children. Researcher, however, are working hard to find a way to reduce the transplant recipient's dependence on these drugs so that the procedure will be appropriate for children in the future, and the protocol has been hailed around the world as a remarkable breakthrough and proof that islet transplantation can work. It appears to offer the most immediate chance to achieve a cure for type 1 diabetes, and the research is moving forward rapidly.

New sources of islet cells must be found, however, because, as the science advances and continues to demonstrate promise, the number of islet cell transplants that can be performed will be limited by a 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 legislation we are introducing today will increase the supply of pancreases available for these trials and research. Our legislation will direct the Centers for Medicare and Medicaid Services 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.
Currently, CMS collects performance data from each OPO based upon the number of organs procured for transplant relative to the population of the OPO's service area. 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.

In addition, the legislation establishes an inter-agency committee on islet cell transplantation comprised of representatives of all of the Federal agencies with an active role in supporting this research. The many advisory committees on organ transplantation that currently exist are so broad in scope that the issue of islet cell transplantation—while of great importance to the juvenile diabetes community—does not rise to the level of consideration when included with broader issues associated with organ donation, such as organ allocation policy and financial barriers to transplantation. We believe that a more focused effort in the area of islet cell transplantation is clearly warrented since the research is moving forward at such a rapid pace and with such remarkable results.

To help us collect the data necessary to move islet cell transplantation from an experimental procedure to a standard therapy covered by insurance, our legislation directs the Institute of Medicine to conduct a study on the impact of islet cell transplantation on the health-related quality of life outcomes for individuals with juvenile diabetes, as well as the cost-effectiveness of the treatment.

Diabetes is the most common cause of kidney failure, accounting for 40 percent of new cases, and a significant percentage of individuals with type 1 diabetes will experience kidney failure and become Medicare-eligible before they are age 65. Medicare currently covers both kidney transplants and simultaneous pancreas-kidney transplants for these individuals. To help Medicare decide whether it should cover pancreatic islet cell transplants, our legislation authorizes a demonstration project to test the efficacy of simultaneous islet-kidney transplants and islet transplants following a kidney transplant for individuals with type 1 diabetes who are eligible for Medicare because they have end stage renal disease ESRD.

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 join us as cosponsors.