[Congressional Record Volume 149, Number 35 (Wednesday, March 5, 2003)]
[Senate]
[Pages S3166-S3167]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Ms. COLLINS (for herself, Mrs. Murray, Mr. Breaux, and Mr. 
        Miller):
  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

[[Page S3167]]

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.
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