[Congressional Record Volume 148, Number 108 (Thursday, August 1, 2002)]
[Senate]
[Pages S7914-S7915]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Ms. COLLINS (for herself and Mrs. Murray):
  S. 2849. A bill to increase the supply of pancreatic islet cells for 
research, to provide better coordination 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. Mr. President, I am pleased to join my colleague from 
Washington, Senator Murray, in introducing the Pancreatic Islet Cell 
Transplantation Act of 2002 which will help to advance important 
research that holds the promise of a cure for the more than one 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, diabetes costs the nation more than 
$105 billion a year, one out of every ten health care dollars, in 
health-related expenditures.
  The burden of diabetes is particularly heavy for children and young 
adults with 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 70 patients who have been treated using variation of the 
Edmonton Protocol over the past two years, 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 
two years.
  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. Researchers, 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 juvenile 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, OPS, 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 warranted 
since the research is moving forward at such a rapid pace and with such 
remarkable results.
  And finally, 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 for individuals with juvenile

[[Page S7915]]

diabetes as well as the cost-effectiveness of the treatment.
  Islet cell transplantation offers real hope for people with juvenile 
diabetes. Our legislation, which is strongly supported by the Juvenile 
Diabetes Research Foundation, addresses some of the specific obstacles 
to moving this research forward as rapidly as possible, and I urge all 
of our colleagues to join us in sponsoring it.
                                 ______