[Senate Hearing 106-304]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 106-304


 
                CONQUERING DIABETES: ARE WE TAKING FULL
                      ADVANTAGE OF THE SCIENTIFIC
                      OPPORTUNITIES FOR RESEARCH?

=======================================================================


                                HEARING

                               before the

                               PERMANENT
                     SUBCOMMITTEE ON INVESTIGATIONS

                                 of the

                              COMMITTEE ON
                          GOVERNMENTAL AFFAIRS
                          UNITED STATES SENATE

                       ONE HUNDRED SIXTH CONGRESS

                             FIRST SESSION



                               __________

                            OCTOBER 14, 1999

                               __________

      Printed for the use of the Committee on Governmental Affairs


                                


                      U.S. GOVERNMENT PRINTING OFFICE
 61-160 cc                   WASHINGTON : 2000
------------------------------------------------------------------------------
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                   COMMITTEE ON GOVERNMENTAL AFFAIRS

                   FRED THOMPSON, Tennessee, Chairman
WILLIAM V. ROTH, Jr., Delaware       JOSEPH I. LIEBERMAN, Connecticut
TED STEVENS, Alaska                  CARL LEVIN, Michigan
SUSAN M. COLLINS, Maine              DANIEL K. AKAKA, Hawaii
GEORGE V. VOINOVICH, Ohio            RICHARD J. DURBIN, Illinois
PETE V. DOMENICI, New Mexico         ROBERT G. TORRICELLI, New Jersey
THAD COCHRAN, Mississippi            MAX CLELAND, Georgia
ARLEN SPECTER, Pennsylvania          JOHN EDWARDS, North Carolina
JUDD GREGG, New Hampshire
             Hannah S. Sistare, Staff Director and Counsel
      Joyce A. Rechtschaffen, Minority Staff Director and Counsel
                 Darla D. Cassell, Administrative Clerk

                                 ------                                

                PERMANENT SUBCOMMITTEE ON INVESTIGATIONS

                   SUSAN M. COLLINS, Maine, Chairman
WILLIAM V. ROTH, Jr., Delaware       CARL LEVIN, Michigan
TED STEVENS, Alaska                  DANIEL K. AKAKA, Hawaii
GEORGE V. VOINOVICH, Ohio            RICHARD J. DURBIN, Illinois
PETE V. DOMENICI, New Mexico         MAX CLELAND, Georgia
THAD COCHRAN, Mississippi            JOHN EDWARDS, North Carolina
ARLEN SPECTER, Pennsylvania
          K. Lee Blalack, II, Chief Counsel and Staff Director
      Linda J. Gustitus, Minority Chief Counsel and Staff Director
                     Mary D. Robertson, Chief Clerk


                            C O N T E N T S

                                 ------                                
Opening statements:
                                                                   Page
    Senator Collins..............................................     1
    Senator Edwards..............................................    10
    Senator Levin................................................    14

                               WITNESSES
                       Thursday, October 14, 1999

Phillip Gorden, M.D., Director, National Institute of Diabetes 
  and Digestive and Kidney Diseases, National Institutes of 
  Health.........................................................     5
Ryan Dinkgrave, Livonia, Michigan, on behalf of the Juvenile 
  Diabetes Foundation............................................    17
Pam Fernandes, Needham, Massachusetts............................    18
Gordon Jump, Coto de Caza, California............................    20
William H. Fuller, Jr., Virginia Beach, Virginia.................    23
C. Ronald Kahn, M.D., Executive Vice President and Director, 
  Joslin Diabetes Center, Boston, Massachusetts, and Former 
  Chairman, Diabetes Research Working Group......................    26
Edward H. Leiter, Ph.D., Senior Staff Scientist, The Jackson 
  Laboratory, Bar Harbor, Maine..................................    30
Senator Spencer Abraham, a U.S. Senator from the State of 
  Michigan.......................................................    33
Jeffrey A. Bluestone, Ph.D., Director, Ben May Institute for 
  Cancer Research, University of Chicago, Chicago, Illinois......    34

                     Alphabetical List of Witnesses

Abraham, Hon. Spencer:
    Testimony....................................................    33
    Prepared statement...........................................    33
Bluestone, Jeffrey A. Ph.D.:
    Testimony....................................................    34
    Prepared statement...........................................    89
Dinkgrave, Ryan:
    Testimony....................................................    17
    Prepared statement...........................................    62
Fernandes, Pam:
    Testimony....................................................    18
    Prepared statement...........................................    65
Fuller, William H. Jr.:
    Testimony....................................................    23
    Prepared statement...........................................    73
Gorden, Phillip, M.D.:
    Testimony....................................................     5
    Prepared statement...........................................    45
Jump, Gordon:
    Testimony....................................................    20
    Prepared statement...........................................    68
Kahn, C. Ronald, M.D.:
    Testimony....................................................    23
    Prepared statement with attached charts......................    75
Leiter, Edward H., Ph.D.:
    Testimony....................................................    30
    Prepared statement...........................................    86

                                Exhibits

* May Be Found In The Files of the Subcommittee


 1. Chart: ``Increasing Deaths Due to Diabetes''................    93

 2. Chart: ``Diabetes: Research Investment vs. Medicare Costs''.    94

 3. Chart: ``Diabetes Research as Fraction of NIH Total''.......    95

 4. Chart: ``Rising Prevalence of Diabetes in the U.S.''........    96

 5. ``The Family's Guide To Diabetes,'' Web site of Ryan 
  Dinkgrave, Livonia, Michigan...................................    97

 6. a. Conquering Diabetes--A Strategic Plan for the 21st 
  Century, A Report of the Congressional-Established Diabetes 
  Research Working Group, 1999...................................     *
 6. b. Summary of the Report and Recommendations of the 
  Congressionally-Established Diabetes Research Working Group....   100

 7. Charts presented by Dr. C. Ronald Kahn:
      a. ``Increasing Deaths Due To Diabetes''..................   115
      b. ``The Economic Impact of Diabetes is Staggering''......   116
      c. ``The Economics of Diabetes''..........................   117
      d. ``Goals of the DRWG Plan''.............................   118
      e. ``Components of the DRWG Strategic Plan''..............   119
      f. ``Budget Recommendations''.............................   120

 8. Statement for the Record of the American Diabetes 
  Association....................................................   121

 9. Statement for the Record of the American Association of 
  Diabetes Educators.............................................   130

10. Statement for the Record of Arnauld E. Nicogossian, M.D., 
  Associate Administrator, Office of Life and Microgravity 
  Sciences and Applications, National Aeronautics and Space 
  Administration.................................................   134

11. Diabetes Overview, National Diabetes Information 
  Clearinghouse (NIDDK)..........................................   137

12. The Vision of Pam Fernandes, Diabetes Forecast, September 
  1999...........................................................   153


                   CONQUERING DIABETES: ARE WE TAKING
                    FULL ADVANTAGE OF THE SCIENTIFIC
                      OPPORTUNITIES FOR RESEARCH?

                              ----------                              


                       THURSDAY, OCTOBER 14, 1999

                                       U.S. Senate,
                Permanent Subcommittee on Investigations,  
                  of the Committee on Governmental Affairs,
                                                    Washington, DC.

    The Subcommittee met, pursuant to notice, at 9:30 a.m., in 
room SD-628, Dirksen Senate Office Building, Hon. Susan M. 
Collins, Chairman of the Subcommittee, presiding.
    Present: Senators Collins, Levin, and Edwards.
    Also attending: Senator Abraham.
    Staff present: K. Lee Blalack, Chief Counsel and Staff 
Director; Mary D. Robertson, Chief Clerk; Kirk E. Walder, 
Investigator; Elizabeth Hays, Staff Assistant; Ryan Blalack, 
Intern; Leslie Bell, Minority Congressional Fellow; Priscilla 
Hanley and Felicia Knight (Senator Susan M. Collins); Butch 
Burke (Senator Ted Stevens); Anne Bradford (Senator Fred 
Thompson); Laurie Armstrong (Senator John Edwards); Allison 
Dehosky and Erin Quay (Senator Arlen Specter); and Natacha 
Blain (Senator Richard Durbin).

              OPENING STATEMENT OF SENATOR COLLINS

    Senator Collins. The Subcommittee will please come to 
order.
    Good morning. Today the Permanent Subcommittee on 
Investigations is holding an oversight hearing to examine the 
impact that diabetes has on Americans, and to determine whether 
Federal funding for diabetes research is sufficient to take 
advantage of the unprecedented opportunities for progress 
toward better treatments, prevention and ultimately a cure.
    Diabetes is a devastating condition that affects people of 
every age, race and nationality. Sixteen million Americans 
suffer from diabetes, and about 800,000 new cases are diagnosed 
each year. Moreover, diabetes frequently goes undiagnosed. Of 
the 16 million Americans with diabetes, an estimated 5.4 
million do not realize that they have the disease, with the 
result that its serious consequences go untreated.
    Diabetes is one of our Nation's most costly diseases, both 
in human and economic terms. It is the fifth deadliest disease 
in the United States, and kills almost 200,000 Americans 
annually. As this chart illustrates,\1\ while the death rate 
for other common life-threatening diseases, like cardiovascular 
disease and stroke, has declined in recent years, the death 
rate due to diabetes has actually increased by 30 percent since 
1980.
---------------------------------------------------------------------------
    \1\ See Exhibit No. 1, which appears in the Appendix on page 93.
---------------------------------------------------------------------------
    Diabetes is also the leading cause of kidney failure; 
blindness in adults; and amputations not related to injury. It 
is a major risk factor for heart disease, stroke, birth 
defects, and shortens life expectancy by up to 15 years.
    In addition to the human toll of diabetes, this disease 
costs the Nation in excess of $105 billion annually in health-
related expenditures. At present, more than one out of every 
ten health care dollars and about one out of every four 
Medicare dollars are spent each year treating people with 
diabetes.
    Indeed, taxpayers spend more than $40 billion a year 
treating people with diabetes through various programs such as 
Medicare, Medicaid, Veterans and Federal employees health 
programs. In stark contrast, only about 3 percent of the budget 
of the National Institutes of Health is devoted to research on 
diabetes and its complications.
    This second chart illustrates the huge disparity between 
the cost of treating just Medicare patients and the amount of 
the Federal investment in diabetes research.\1\ If we looked at 
all Federal programs, the disparity would be even greater.
---------------------------------------------------------------------------
    \1\ See Exhibit No. 2, which appears in the Appendix on page 94.
---------------------------------------------------------------------------
    What is particularly alarming to me is that the inadequate 
investment in research has occurred at a time when the 
percentage of Americans with known diabetes has increased 
dramatically. The number of diagnosed cases of diabetes has 
almost doubled since 1970. This trend is only expected to 
accelerate in the 21st Century as our population ages. Unless 
dramatic changes occur and occur soon, the number of Americans 
with diabetes will climb to 23 million over the next 10 years.
    There currently is no way to prevent or cure diabetes, and 
available treatments have had only limited success in 
controlling its devastating consequences. The problem is made 
all the more complex because diabetes is not a single disease. 
Rather, it occurs in several forms and has complications that 
affect virtually every system of the body.
    Children with type 1 diabetes face a lifetime of daily 
finger pricks to check their blood sugar levels, daily insulin 
shots, and the possibility of complications such as kidney 
failure and blindness which can be disabling and even deadly. 
Older Americans with type 2 diabetes can also be disabled by 
the multiple complications of this serious disease.
    Recently I had the opportunity to meet a courageous 8-year-
old boy from North Yarmouth, Maine. His name is Nathan 
Reynolds, and he epitomizes for me why it is so important to 
accelerate our fight against diabetes.
    Nathan is an active young child. He enjoys school, biking, 
swimming, baseball, and collecting old coins. He was diagnosed 
with diabetes in December 1997, a diagnosis that has forever 
changed his life and the life of his family.
    He has had to learn how to draw his blood, something his 4-
year-old brother reminds him to do before every meal. He has to 
check his blood sugar level and give himself an insulin shot. 
What to me is saddest of all, is that Nathan can never take a 
day off from his diabetes. It does not matter if it is his 
birthday, it does not matter if it is Christmas, he still has 
to take those shots every single day.
    The fact that diabetes, once diagnosed, is a lifelong 
condition, was underscored by a 65-year-old man who recently 
wrote to me that he estimated he had given himself 76,000 
insulin shots since he was first diagnosed with diabetes at age 
15; 76,000 shots.
    The good news for children like Nathan and our witnesses 
today is that promising research is underway that may lead to 
medical breakthroughs for those with both type 1 and type 2 
diabetes. The next decade holds tremendous promise for diabetes 
research. Improvements in technology and the general growth in 
scientific knowledge have created unprecedented opportunities 
for medical advances that should lead to better treatments, 
prevention, and ultimately a cure for children like Nathan.
    Earlier this year, the congressionally sponsored Diabetes 
Research Working Group issued its report entitled ``Conquering 
Diabetes: A Strategic Plan for the 21st Century.'' \1\ The 
report details the magnitude of the problem and provides a 
comprehensive plan for NIH-funded diabetes research.
---------------------------------------------------------------------------
    \1\ Exhibit No. 6.a. is retained in the files of the Subcommittee.
---------------------------------------------------------------------------
    In the report, the Working Group finds that many scientific 
opportunities are not being pursued due to insufficient 
funding, lack of appropriate mechanisms, and a shortage of 
trained researchers. The report also concludes that the current 
funding, level of effort, and scope of diabetes research falls 
far short of what is needed to capitalize on these 
opportunities; and, further, that the funding level is far 
short of what is required to make progress on this complex and 
difficult problem. The report recommends funding of $827 
million for diabetes research at NIH in fiscal year 2000.
    Last week, I am pleased to report, the Senate approved a 
Labor-HHS appropriations bill increasing funding for NIH by $2 
billion, a very positive development. Senator Breaux, who 
serves as co-chair with me of the Diabetes Caucus in the 
Senate, helped me win passage of an amendment to that bill 
calling for increased support for diabetes research in 
accordance with the recommendations of the Diabetes Research 
Working Group. The unanimous Senate vote for this amendment 
sends a strong and clear signal that diabetes research is a 
high priority for the U.S. Senate.
    Diabetes has been underfunded in the past, and it is 
imperative that we ensure that sufficient resources are 
available to take full advantage of the extraordinary 
opportunities we have to better understand and ultimately 
conquer this devastating disease.
    This morning's hearing is intended to examine the effects 
that diabetes and its resulting complications have had on 
Americans of all ages in both human and economic terms. We will 
also hear from researchers who will talk about the scientific 
opportunities available in diabetes research and the work that 
they are doing to find better treatments, a means of 
prevention, and ultimately a cure.
    I would note that I am particularly proud that The Jackson 
Laboratory in Bar Harbor, Maine, have been leaders in this 
research.
    Finally, we will discuss future funding levels for diabetes 
research, and how we can be helpful in ensuring that NIH does 
complete the commitment that the Senate has underscored must be 
kept. I very much look forward to the testimony of our 
witnesses today, and to learning more about this critically 
important issue of public health.
    Due to the time constraints of this hearing, the 
Subcommittee was unable to invite everyone affected by this 
issue to present oral testimony. We have already received two 
written statements, one from the American Diabetes Association 
and the other from NASA, making the Subcommittee aware of 
NASA's ongoing contributions to biomedical research and in 
particular diabetes research. I must say that I personally was 
unaware of NASA's contributions in this area, and I appreciated 
their providing us with this testimony.
    Without objection, these statements and any others that the 
Subcommittee receives in the next 10 days will be included in 
our printed hearing record.\1\
---------------------------------------------------------------------------
    \1\ See Exhibits No. 8-10, which appears in the Appendix on page 
121-134.
---------------------------------------------------------------------------
    Before proceeding to our first witness, I want to take the 
opportunity to say that the order of witnesses for this 
morning's hearing is not what I had originally planned. We had 
originally planned to have the administration's representative 
testify on the last panel, so that he would have the 
opportunity to hear and to respond to the concerns raised by 
diabetes patients, their families, and by some of the leading 
scientists in the field of diabetes research.
    The Department of Health and Human Services liaison, 
however, informed the Subcommittee that they would ``not 
allow'' Dr. Gorden to testify unless he testified first and on 
a panel of his own. I want to make very clear that I realize 
this was not Dr. Gorden's decision and I certainly do not hold 
him personally accountable for the ill-advised policy by the 
Department of Health and Human Services, but I want to say for 
the record that I think HHS's policy in this regard is both 
unfortunate and very arrogant.
    It seems to me that it suggests that the Clinton 
Administration does not want to be held accountable for its 
decisions. And, moreover, I would think that NIH would be 
concerned and HHS would be concerned that this policy only 
serves to reinforce criticisms voiced by the Institute of 
Medicine and others, that NIH is not sufficiently involving 
patients and their families, the ones who have the most at 
stake, in the process of setting research priorities. I 
understand that research allocation decisions should be made on 
the basis of sound science, but also it clearly should take 
into account the human toll of the disease.
    I do want to again say I realize this is not Dr. Gorden's 
fault and it is not his policy, but I did want to express for 
the record my strong disagreement with HHS's decision and its 
policy in this matter. I also understand that Dr. Gorden is 
going to try to remain for the duration of the hearing so that 
he can do what our intention was, and that is hear the 
testimony of the other witnesses, and I want to express my 
personal appreciation for his willingness to do so.
    Having said that, our first witness this morning is Dr. 
Phillip Gorden. He serves as the Director of the National 
Institute of Diabetes and Digestive and Kidney Diseases, which 
is part of the National Institutes of Health. Dr. Gorden began 
his career at NIH in 1966 as a senior investigator in the 
Clinical Endocrinology Branch of the NIDDK. Dr. Gorden became 
the Director of the National Institute of Diabetes and 
Digestive and Kidney Diseases in 1986. We very much look 
forward to hearing his testimony.
    Dr. Gorden, under our Subcommittee rules, we have to swear 
in each and every witness, so I am going to ask that you stand, 
pursuant to Rule 6.
    [Witness sworn.]
    Senator Collins. Thank you very much. You may proceed.

   TESTIMONY OF PHILLIP GORDEN, M.D.,\1\ DIRECTOR, NATIONAL 
   INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES, 
                 NATIONAL INSTITUTES OF HEALTH

    Dr. Gorden. Senator Collins, I would like to first assure 
you that I will be available to you throughout the entire 
course of your hearing.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Gorden appears in the Appendix on 
page 45.
---------------------------------------------------------------------------
    With your permission I would like to add just one brief 
personal note to express, on behalf of the Department and the 
NIH, our sincere appreciation to Dr. Kahn for his work in 
chairing the Diabetes Research Working Group, and to all the 
members of that committee who worked so hard to put their 
report together. In addition, I would appreciate if you would 
let the record of this Subcommittee show that we extend our 
congratulations to him on the marriage of his daughter, Stacy 
Anne, which took place only 4 days ago.
    Thank you very much for that.
    Senator Collins. He does indeed have a lot to be proud of. 
Thank you.
    Dr. Gorden. Madam Chairman, I am very pleased to have the 
opportunity to testify this morning as the Director of the 
National Institute of Diabetes and Digestive and Kidney 
Disease, which has lead responsibility for diabetes research at 
the National Institutes of Health and within the Department of 
Health and Human Services. I very much appreciate the 
opportunity to tell you about the Department's efforts to 
combat diabetes, with emphasis on our biomedical research 
program.
    As you have mentioned, in both human and economic terms, 
diabetes is an extremely costly disease. It is widely 
recognized as one of the leading causes of death and disability 
in the United States and throughout the world. Diabetes affects 
an estimated 16 million Americans, about half of whom do not 
know they have the disease and are not being appropriately 
treated for it. Approximately 800,000 people are diagnosed with 
diabetes each year, including both genders, the young, the old, 
all races and ethnic groups, the rich and the poor.
    Although diabetes occurs most often in older individuals, 
it is one of the most common chronic disorders in children in 
the United States. About 120,000 children and teenagers younger 
than age 19 have diabetes. Both type 1 and type 2 diabetes are 
associated with the eye, kidney and peripheral nerve 
complications, as well as heart attack and stroke.
    According to the American Diabetes Association, diabetes 
and its complications cost an estimated $98 billion annually. 
Though there are several interventions currently available to 
help reduce the burden of this disease, there are no methods to 
cure it or to prevent its onset.
    The Department has a multifaceted agenda to combat 
diabetes. Diabetes is an important trans-NIH research area 
because the disease and its complications affect multiple organ 
systems. The scientific direction of the broad NIH diabetes 
research program has been recently augmented by recommendations 
we have received from a special trans-NIH symposium on diabetes 
scientific opportunities and challenges, as well as by the 
identification of scientific opportunities and needs in the 
strategic plan developed by the congressionally established 
Diabetes Research Working Group.
    NIH diabetes research is complemented by programs of the 
Centers for Disease Control and Prevention, the Indian Health 
Service, and other parts of the Department. We have also 
established productive collaborations with the American 
Diabetes Association and the Juvenile Diabetes Foundation 
International, as well as the biotechnology and pharmaceutical 
industries.
    Remarkable advances in both fundamental and clinical 
science are having an enormous positive effect on diabetes 
research and treatment. These include rapid advances in 
genetics and genomics, new discoveries of mechanisms to 
manipulate the immune system, a major new understanding of cell 
communication, and key advances in clinical science, such as 
blood pressure and lipid control, which are crucial to the 
treatment of diabetes.
    Two major clinical trials have demonstrated that the 
complications of diabetes can be ameliorated or prevented 
through close control of blood glucose levels. These important 
clinical results, coupled with the demonstrated efficacy of 
laser photocoagulation in treating diabetic eye disease, and 
the use of drugs such as ACE inhibitors in ameliorating the 
kidney disease of diabetes, all represent major steps forward 
in our continued quest for more effective treatment, and 
ultimately, prevention and cure of the disease.
    In type 1 diabetes, we are pursuing multiple research 
avenues in the search for underlying causes of this disease, 
together with new treatment and prevention strategies. We are 
searching for clues to what causes the body to attack and 
destroy its insulin-producing cells, the hallmark of type 1 
diabetes.
    We are also embarking on a new and exciting initiative to 
restore insulin-producing capacity through islet cell 
transplantation. This research is propelled by a remarkable 
study in primates, showing that both insulin-producing islet 
cells and kidneys can be transplanted using a highly selective 
method to control for immune rejection of the transplant.
    We have also a major clinical trial aimed at preventing or 
delaying the onset of type 1 diabetes in individuals at risk, 
and we are seeking to develop more effective ways to achieve 
good glucose control.
    In type 2 diabetes, we are gaining new insights into the 
mechanism of insulin action, which provides new therapeutic 
options to combat the body's resistance to insulin, a 
characteristic abnormality of this disease. We also have a 
major research initiative on obesity, a serious risk factor for 
type 2 diabetes.
    In fundamental research, the discovery of the obesity gene 
and its protein product, leptin, in mice have provided new 
insight into mechanisms of obesity and both the control of 
eating disorders and energy regulation. The fundamental 
observations underlying this discovery were made at The Jackson 
Laboratory years ago. These findings have now spearheaded the 
discovery of at least five different genetic defects in humans 
that lead to obesity, and may provide new insight into the 
interrelationship between obesity and type 2 diabetes.
    We have also launched a major clinical trial in which drug 
and lifestyle interventions are being studied to see whether 
they can delay or prevent the onset of type 2 diabetes. Over 50 
percent of the patients in the trial are from minority 
populations who suffer disproportionately from the high burden 
of this disease. A second multicenter clinical trial is 
designed to study the health benefits of long-term weight loss 
in type 2 diabetic patients. Furthermore, the National Heart, 
Lung and Blood Institute has inaugurated a major clinical trial 
to determine whether glucose control can augment the beneficial 
effects of blood pressure and cholesterol control in 
ameliorating the vascular disease of diabetes that leads to 
heart attack and stroke.
    Madam Chairman, I am grateful for the opportunity to share 
with you some examples of our efforts and progress in combating 
diabetes. I have tried to underscore today that we understand 
the great burden that diabetes places on families, patients and 
communities. A number of those individuals are here with us 
today to demonstrate that even further.
    At the same time, I want to share my feeling of 
encouragement and hope. I believe that our strong national 
programs hold the essential key to curing this disease. We have 
important programs under way, but much more remains to be done. 
I am very pleased to answer any questions that you may have.
    Senator Collins. Thank you very much, Dr. Gorden. I am 
going to direct your attention to Exhibit 3.\1\ And if I could 
have Exhibit 3 put up, also, I believe it is in the notebook 
before you if it is not clear from the chart.
---------------------------------------------------------------------------
    \1\ See Exhibit No. 3, which appears in the Appendix on page 95.
---------------------------------------------------------------------------
    Dr. Gorden, as I mentioned in my opening statement, I am 
concerned that only about 3 percent of NIH's budget has been 
devoted to research on diabetes and its complications. 
Moreover, if you look at this chart, you can see that the 
percentage has actually declined over the past 20 years, at the 
same time that the death rate from diabetes has actually 
increased by 30 percent.
    Now, I understand that there is no universally agreed-upon 
method for determining the appropriate level of research 
funding, but it seems to me that this is an awfully small 
investment when you consider that this is a disease that 
affects about 6 to 7 percent of the population, accounts for 10 
percent of all health care expenditures and about 25 percent of 
our Medicare budget.
    Your institute is the lead institute for diabetes research. 
What percentage of your budget is dedicated to diabetes 
research? I realize there is diabetes research going on in 
other institutes, as well, but you are the primary one.
    Dr. Gorden. In NIDDK, we fund approximately 60 to 65 
percent of what is coded as diabetes research across the 
National Institutes of Health. Those funds constitutes about 27 
percent of the total budget for NIDDK.
    Senator Collins. Overall in NIH it is about 3 percent of 
the research dollars; is that correct?
    Dr. Gorden. If you were to express the entire NIH budget, 
which is a very large figure, as a denominator against almost 
anything else as a numerator, you will come out with a 
relatively small figure in terms of a specific disease.
    What I would like to emphasize, and what I think is by far 
and away the most important, is the part that starts in fiscal 
year 1997, when we began to see the increased appropriations 
for NIH, for which we are enormously grateful to the Congress. 
I believe that what you are seeing now is the benefit of that 
being translated into research on diabetes. From 1997 there is 
an upward trend and I think that is what we are really focused 
on this morning.
    Senator Collins. Did you request an increase in your budget 
as part of the budget process going through OMB that the 
administration presented to Congress?
    Dr. Gorden. We basically request what the OMB permits us to 
request, which turns out to be the administration's budget. 
That request was at a level of approximately a 2.1 percent 
increase over fiscal year 1998. And this was the budget that 
NIH presented, as well as the one my individual institute, as 
well as all the other institutes, presented in our testimony to 
the Congress this past spring.
    Senator Collins. So essentially the administration tells 
you what you are to request for a budget, as opposed to your 
putting forth what you believe would be the ideal budget to 
meet the needs and to take advantage of the scientific 
opportunities?
    Dr. Gorden. It is a rather complex process. At some point 
in time we may be asked to present a professional judgment 
budget, as we were by Senator Specter last year. The formal 
process then goes through a number of iterations, and in the 
end we present the administration's consolidated budget.
    Senator Collins. Did you agree with the administration's 
proposal to request a budget that would provide an increase for 
NIH of only 2.5 percent?
    Dr. Gorden. I think that it is important that we adhere to 
some common format in terms of our budgetary presentation. In 
the context of adhering to that format, I agree with the 
process. I would obviously prefer, on a personal level, to see 
our level go higher.
    Senator Collins. Let me ask you what may be an easier 
question for you to answer, and one that puts you less on the 
spot. Do you agree with the findings of the Diabetes Research 
Working Group that diabetes research has been underfunded, and 
thus we have not been able to take advantage of scientific 
opportunities? Maybe it is not an easier question, I do not 
know.
    Dr. Gorden. I think we need to put in context the fact that 
the Working Group points out the enormous opportunities in 
diabetes research that are open to us. They were dealing with a 
specific disease and making recommendations on a specific 
disease.
    Both at NIDDK and across NIH, we must take those 
recommendations and put them in the context of everything that 
we do, which is also reflective of language that we receive 
from the Senate and from the House which underscores the 
multiplicity of diseases that our research combats. We have to 
place the recommendation of the Diabetes Research Working Group 
in context across NIH based on all of the considerations and 
recommendations that are coming to us.
    I think that in each disease area we may have concerns 
about underfunding, and it is difficult to know exactly how one 
places one of these relative to another. This is really the 
issue that we face in terms of implementation strategies. I 
think in terms of recommendations, that this is the way it 
should be.
    Senator Collins. The Senate has increased funding for NIH 
by 13 percent, a far stronger investment than that proposed by 
the administration. If the 13 percent figure goes through, what 
funding level would you envision would be provided for diabetes 
research? Would we be able to approach the $827 million 
recommended by the Working Group?
    Dr. Gorden. In the example that you gave, the NIH would 
receive a 13 percent increase for all the diseases within its 
mission, but the Working Group calls for over an 80 percent 
increase for diabetes research alone. We have to deal in some 
way with the difference between a 13 percent increase and an 80 
percent increase.
    Another issue that I think is a little complicated, when 
one strictly talks in budget terms rather than scientific 
terms, is that we were involved with the Working Group's 
recommendations from its very outset. Because the Congress 
provided us with a very generous budget in fiscal year 1999, we 
were able to jump-start some initiatives and lay some of the 
footprints for many of the Working Group's recommendations 
across the highest priority areas.
    When we talk about science, we can talk in logical terms 
about what is started and what needs to be completed. When we 
try to translate that into total dollar terms, it becomes a 
little bit more complicated in terms of how we express it.
    Senator Collins. I guess my concern, Dr. Gorden, is the 
Senate has gone on record very strongly in favor of the Working 
Group's recommendations. The report language in the 
appropriations bill is equally strong. We provided a 13 percent 
increase, which I hope will survive in conference. The Senate's 
goal is to double NIH spending over the next 5 years. There are 
many of us who have cosponsored a resolution in support of 
that.
    I want to know how we are going to get there. I want to 
know what NIH thinks, whether you are committed to implementing 
the recommendations of the Working Group, whether NIH shares 
the commitment of the Senate to providing the necessary 
research dollars to conquer this devastating disease.
    I am pleased that we are on the up-tick, but when you look 
at the impact of this disease versus the resources that we are 
now putting in it, it is just a huge disparity. And when I 
visit with scientists, I am so excited about the research that 
is underway. When I talk to children and adults who have this 
disease and I see the impact on their lives, I want a 
breakthrough, and I am convinced we have got to be willing to 
invest to get there.
    So I guess what I want to hear from you is, what is the 
extent of NIH's commitment? Do you agree with the Working 
Group? Do you have a plan for following the Working Group's 
recommendations? Are you going to put in the resources that 
Congress clearly wants you to put in, that this eminent group 
of scientists and patients have come up with an excellent plan 
for achieving? What are your intentions? What is your plan?
    Dr. Gorden. Senator, I want to emphasize what has happened 
with this up-tick, and I am absolutely confident that it is 
going to continue. We very much support the recommendations. 
They are scientifically very sound and solid. We are actively 
involved in implementation strategies, and implementation 
strategies are mechanisms to actually place these 
recommendations into operation.
    We receive a broad recommendation. We have to translate 
that into an implementation strategy. We are in the process of 
making those translations now, as we anticipate over the next 
possibly 2 weeks to receive an appropriation. At that time I 
think we will be prepared to move forward in implementing many 
of the recommendations from the Diabetes Research Working 
Group.
    Plans are afoot, certainly within NIDDK. NIDDK is involved 
in working with the other institutes to canvass their plans and 
also to stimulate the efforts that have been proposed by the 
Working Group so that they can be translated across NIH. There 
is no question that the momentum is there, and we are very 
excited about moving forward. We share this feeling of 
excitement about the research opportunities that exist.
    Senator Collins. From my perspective, it has been Congress 
that keeps pushing NIH in this direction. It was Congress that 
established the Diabetes Research Working Group. It was 
Congress that has given the increases to NIH, despite the 
administration requesting increases this year that wouldn't 
even have kept pace with inflation.
    And I want to yield to my colleague for some questions 
before I wrap up a couple more areas I want to talk to you 
about, but I want to send a very strong message that we need 
you as partners in this fight and we admire NIH. I respect the 
incredible caliber of scientists and research that you are 
doing. But we need to make a commitment to getting this job 
done, and it can't be just the Congress pushing, pushing, 
pushing. We need a commitment from NIH that puts diabetes 
research as a priority.
    Senator Edwards, welcome.

              OPENING STATEMENT OF SENATOR EDWARDS

    Senator Edwards. Thank you, Madam Chairwoman.
    Good morning, Dr. Gorden.
    Dr. Gorden. Good morning, sir.
    Senator Edwards. And I apologize, I missed the beginning of 
your testimony and I listened to just your answers to the most 
recent series of questions, and I may be being repetitive but I 
am not sure I understood your answer.
    Are you saying that NIH is committed to following the 
Working Group's recommendations?
    Dr. Gorden. I am saying that the scientific opportunities 
that are being proposed by the Working Group are opportunities 
that the NIH is pursuing to implement.
    Senator Edwards. So the answer is, you are committed to 
following the recommendations; is that what you are saying?
    Dr. Gorden. We are committed to following the scientific 
recommendations of the Working Group.
    Senator Edwards. One of the issues that has been raised by 
some of my folks back in North Carolina, for example, Dr. John 
Busey, who you may know is a diabetes researcher there, has to 
do with the number of proposals that are made for conducting 
research in the area of diabetes and the percentage of those 
proposals that are accepted by NIH.
    First of all, in the area of diabetes, do you have any idea 
about what percentage of the proposals that are made to do 
research in that area are in fact accepted by NIH?
    Dr. Gorden. In general, we talk about the number of awards 
for grants, which is the largest expenditure that NIH makes 
across the board. With the very generous support that we have 
received from the Congress in the last 2 fiscal years, we now 
have an award rate of about 33 percent across NIH. That is the 
proportion of eligible grant applications that are actually 
awarded.
    The same is generally true for diabetes. In other words, 
our award rate for diabetes-related grants would be in the same 
range as they would be in our institute for digestive disease 
or kidney-related grants or nutrition-related grants, and that 
is generally the same across NIH. We fund about one-third of 
the grant applications we receive, and that is driven by the 
peer review system. That system evaluates the scientific 
quality of each individual grant, which is really the bedrock 
of NIH support of fundamental science.
    Senator Edwards. Well, my concern is the anecdotal stories 
I hear, and I hear what you are saying about the percentages, 
indicate that some of the young researchers become very 
discouraged in this area because they do a lot of work, they 
make these proposals, their proposals are rejected.
    And I guess ultimately what you and I both need to be 
concerned about is making sure that we are able to attract and 
retain good researchers, particularly, since we are here 
talking about diabetes today, in the area of diabetes. Do you 
have any ideas or thoughts about how to deal with that?
    Dr. Gorden. Yes. I have been watching this for some time 
now, and I believe there is nothing more positive to the 
community and to young investigators or people who are 
contemplating biomedical science as a career, as what has been 
provided to NIH over the last 2 fiscal years. These 
investigators are encouraged by the commitment on the part of 
the Congress to double the NIH budget.
    Those are very powerful statements to young investigators 
who are looking for the interest and the importance of a 
biomedical research career. They now are seeing that this may 
be really a viable and secure future for them to pursue, in the 
sense that resources are going to be available. In my view, 
nothing has been a more powerful statement for young 
investigators.
    In addition to that, we have got to ensure that the young 
investigators, in diabetes research in particular, have the 
human infrastructure in place to actually reach the full 
implementation of all of these recommendations that have been 
made. That will require furthering the human infrastructure, a 
goal that we have set. We have set out to establish new kinds 
of research career mechanisms; to enhance clinical 
investigation, which is an area that is particularly put upon 
in the last few years. But, the increased resources that are 
actually flowing into biomedical research in general have had 
an enormously positive effect on young people.
    Senator Edwards. Well, I think I just will point out, and I 
think you recognize it is critically important that we attract 
and retain talented people to do research in these areas.
    Dr. Gorden. I agree completely, Senator.
    Senator Edwards. In terms of the importance of diabetes 
research, do you agree with the basic premise that although 
stroke and heart disease at least superficially appear to cause 
more deaths, more premature deaths than diabetes, that diabetes 
is often an underlying cause of both stroke and heart disease?
    Dr. Gorden. Yes, that is true.
    Senator Edwards. And so sometimes the importance of 
diabetes, at least if you only look at the superficial 
information, is underestimated.
    Dr. Gorden. That is absolutely true.
    Senator Edwards. So whatever we can do in the way of 
diabetes research and prevention of diabetes also has a direct 
impact on premature deaths caused by stroke and heart disease?
    Dr. Gorden. Absolutely. I would like to add that, for 
instance, we met recently with the American Heart Association, 
which has decided to make diabetes one of its major risk 
factors. If you recall, hypertension, cholesterol and smoking 
have been key risk factors for their public relations campaign. 
Now diabetes is added to that.
    Although diabetics have benefited tremendously from the 
same interventions that have decreased mortality in heart 
disease and stroke, quantitatively they have not benefited as 
much, and we have got to find the reason for that. What is that 
additional increment of risk that diabetics have, that is 
related to diabetes per se in some way? We are not certain what 
that risk is.
    Now, if you are a diabetic and you smoke, this is really 
bad. If you are anybody and you smoke, it is really bad. But if 
you are a diabetic and you are hypertensive, that is a very bad 
situation. These things all are additive and are synergistic, 
really, as risk factors.
    In our prevention studies, we are trying very hard to 
reduce this other layer of risk, and trying to find what it is 
about diabetes that creates this additional risk for 
cardiovascular disease, which as you point out are heart attack 
and stroke. This is a very important objective in this whole 
enterprise.
    Senator Edwards. Thank you, Dr. Gorden. We appreciate very 
much the work you do at NIH. I think it is critically 
important.
    I would just emphasize what Senator Collins said just a few 
moments ago, which is, we believe it is so important that the 
diabetes research that needs to be done is focused on, that the 
Working Group's recommendations are in fact implemented. In my 
State of North Carolina diabetes is an enormous problem, and 
for a variety of reasons. So we would just like to see you 
continue the up-tick that you show on your chart, and would 
like very much to see the recommendations of the Working Group 
followed.
    Dr. Gorden. Thank you, sir.
    Senator Edwards. Thank you, Dr. Gorden.
    Senator Collins. Thank you, Senator.
    Dr. Gorden, I just have a couple more questions for you. 
Since diabetes has complications that affect virtually every 
system in the body, it is not surprising that other institutes 
at NIH are also involved in diabetes research. One concern that 
I have heard from scientists and from advocates for the 
diabetes community is that there is insufficient collaboration 
among the institutes in planning diabetes research.
    What are your plans to improve collaborative efforts so 
that you do have the most bang for the buck, you do have a 
synergistic effect of your research?
    Dr. Gorden. I think this is a very important issue. I think 
that this new emphasis on both collaboration with other 
institutes and trans-NIH support is fueled by several things.
    We created one model in the special appropriation of the 
Balanced Budget Act of 1997, which was a special appropriation 
for type 1 diabetes. Though NIDDK is the principal 
administrator of that initiative at NIH, it is clearly a trans-
NIH effort. We have achieved that by working through the 
Diabetes Mellitus Coordinating Committee. We have also done it 
by working directly with the institute directors in planning 
the initiatives to go forward.
    We have taken that model now and have used the increased 
appropriations that you see in fiscal year 1998 and 1999 to 
propel the momentum in other institutes. When we take the 
Working Group's plan and their recommendations, we now can look 
at a spreadsheet and see which recommendations apply most 
directly to which institutes. We now can communicate directly 
with those institutes and work with them.
    For instance, within the last several weeks we had a 
workshop with the National Institute of Neurological Diseases 
and Stroke. Neuropathy of diabetes has been recognized as an 
area that has been underfunded and under-researched. Therefore, 
we are prepared to join with them to create a major initiative 
in fiscal year 2000 to address this problem.
    Similar initiatives are under way with the National Heart, 
Lung and Blood Institute on macrovascular heart attack and 
stroke. We have a program that we have inaugurated with them. 
They have joined with us in our major effort to combat obesity 
in a clinical trial.
    These are just a few of the examples of things that are 
moving forward, and at a much greater rate and momentum than in 
the past. I feel very comfortable and confident about the 
collaborative trans-NIH effort for all of these important 
initiatives, because the essence is that each institute has 
both resources and expertise, and we need both of those. We 
need the resources and the expertise that they bring to the 
table. That is what we are trying to maximally take advantage 
of in our program development.
    Senator Collins. The final issue I want to discuss with you 
concerns reports, very disturbing reports that we are starting 
to see more type 2 diabetes in teenagers. In fact, just last 
week when I was in Maine, a dietician came up to me and told me 
that she is seeing an increase in her practice of diabetic 
teenagers who are type 2 rather than type 1.
    What is NIH doing to combat that disturbing trend, and do 
you have any research underway, perhaps related to life style 
issues, that you could share with us?
    Dr. Gorden. This is a very important issue, and we plan to 
move forward with an initiative in fiscal year 2000 to address 
this. We want to both define the magnitude of this problem and 
to define the issues involved in this. We believe that they are 
similar issues to those occurring in adults with diabetes, but 
we think that there may be other issues as well.
    There are issues of obesity in children, which has been an 
increasing issue in the last 10 years. The increases in obesity 
and diabetes are interrelated. These cases of obesity are 
occurring primarily in minority populations, particularly 
Native Americans and Hispanic populations. There are obviously 
reasons.
    Our basic research in genetics and other areas will 
continue in an attempt to define this in a more fundamental 
way, but we must address this as a public health emergency 
quickly, and try to do those things that are going to help 
ameliorate the problem. That is what we plan to do, initially 
working through the more basic scientific avenues in terms of 
the broad area of fundamental science, which is going to 
ultimately address this problem. We have got to do something 
about it quickly as a public health issue. It is a major 
problem. We are very concerned about it.
    Senator Collins. That development to me shows how complex 
this issue is. We not only need to be doing research focused on 
a cure which I feel so strongly about, we also need education 
efforts to help people manage their diabetes better. We need to 
work on treatment, prevention, and the cure, and I hope that 
your research will pay attention to all three of those goals.
    I want to thank you very much for being with us today, and 
again I appreciate your willingness to stay and hear from our 
witnesses. I think we will all learn a great deal from them. 
Thank you, Dr. Gorden.
    Dr. Gorden. Thank you very much, Senator Collins.
    Senator Collins. I am now going to call on Senator Levin, 
who is our Ranking Minority Member of the Subcommittee, who has 
a great deal of commitment to this issue. We also have one of 
his constituents with us today to help us better understand 
this devastating disease. And I would like to, before we call 
on our next panel of witnesses, call on Senator Levin for his 
opening statement and any comments he might want to make in 
introducing his constituent.

               OPENING STATEMENT OF SENATOR LEVIN

    Senator Levin. Madam Chairman, let me thank you first of 
all for holding this hearing. It is a very important hearing in 
the battle against diabetes. You have taken a leadership role 
here which is critically important to the health of the Nation, 
and I commend you for doing it. It is a really important cause 
that you have taken the leadership of here. Thank you, for all 
of us, for doing so.
    As we all know, diabetes is a pernicious disease that 
affects people of all ages, and in addition to the ill effects 
that it creates on its own, it causes a variety of other 
debilitating medical problems such as heart attack, stroke, 
kidney failure, blindness, and circulatory failure which can 
lead to amputation. And all of these complications makes 
diabetes the sixth deadliest disease in the United States. It 
annually affects 16 million people, about a third of whom are 
undiagnosed. It kills about 200,000 people a year.
    Diabetes afflicts 120 million people worldwide, and the 
World Health Organization estimates that this number will 
skyrocket to 300 million within the next 25 years. A new case 
of diabetes is diagnosed every 40 seconds. It is the leading 
cause of kidney failure, adult blindness, and nontraumatic 
amputations. People with diabetes are two to four times more 
likely to have a heart attack or stroke. Life expectancy of 
people with diabetes averages 15 years less than that of people 
without diabetes.
    Those are the facts that we have to contend with and try to 
change. In my home State of Michigan, almost 400,000 people 
have been diagnosed with diabetes. Medical experts believe 
another 204,000 have the disease but don't yet know it. We have 
the fifth highest rate of incidence of diabetes in the country, 
in my State of Michigan.
    The financial cost can be overwhelming. Until recently, 
Medicare would not pay for one of the basic management tools, 
an insulin pump, and I want to commend our Chairman for her 
efforts in getting that policy changed.
    We have many witnesses today. One of them is a constituent 
of mine that we are very proud of, Ryan Dinkgrave from Livonia, 
Michigan, Stevenson High School, 16 years old. At his young age 
he has already made a major contribution in the fight against 
diabetes. He has raised public awareness of this disease, and 
now wears an insulin pump.
    He has told us, first, that the emergency medical personnel 
in his home city were not trained or authorized in the use of 
advanced life support methods relative to diabetes. Today, 
advanced life support is part of the training of their 
emergency medical personnel, and this life support includes the 
use of an injectable hormone which stimulates the liver to 
release glucose.
    Ryan has been very active in educating the people about 
diabetes in other ways. He has created a Web site called ``The 
Family's Guide to Diabetes.'' He has been interviewed on 
national television. He has helped raise funds for diabetes 
research, and we are very proud of the effort and 
accomplishments of this young man. We are very delighted that 
he is here with us today, with his dad, I understand. I want to 
welcome you, Ryan. I wish I could stay for your testimony. I 
have read your statement, however, and it is a very eloquent 
and moving statement.
    I have to return to another hearing, and the Chairman 
understands the kind of complications that we have in our 
senatorial lives. And I thank her again for her leadership, for 
allowing me to make my opening statement at this time, and to 
introduce Ryan to the Subcommittee.
    And finally, Madam Chairwoman, I would ask unanimous 
consent that a hard copy of Ryan's Web site be inserted in the 
record. It is a very clever Web site. It will be particularly 
attractive to young people. Web sites do that generally, but 
specifically this Web site is designed in a very creative way 
which will be specifically attractive to young people. So I 
would ask, Madam Chairman, that we make a hard copy of this Web 
site as part of our record.\1\
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    \1\ See Exhibit No. 5, which appears in the Appendix on page 97.
---------------------------------------------------------------------------
    Senator Collins. Without objection.
    Senator Levin. And, again, my thanks to you for your 
leadership.
    Senator Collins. Thank you, Senator Levin.
    I am delighted to join Senator Levin in welcoming our next 
panel of witnesses this morning. He has already introduced 
Ryan, so I will proceed to introduce the other witnesses.
    Pam Fernandes is from Needham, Massachusetts; Gordon Jump 
from Coto de Caza, California; and William Fuller, Jr., of 
Virginia Beach, Virginia.
    Ms. Fernandes was diagnosed with type 1 diabetes at an 
early age but did not realize the profound effect that diabetes 
would have on her life until she had a physical shortly before 
starting college. Despite her efforts to control her diabetes 
for the last 20 years, she unfortunately has lost her sight. In 
spite of the hardships that diabetes has imposed on her life, 
Ms. Fernandes has become an international tandem cycling 
champion and a recognized para-olympic athlete. We are very 
pleased to have her with us today.
    We will then hear from Gordon Jump, who most of you 
probably recognize from his role on the television series 
``WKRP in Cincinnati.'' You might also, however, recognize him 
as the lonely but ever-ready Maytag repairman. In real life, 
however, Mr. Jump has type 2 diabetes, and he will give us his 
perspective of living with this disease.
    Now, the sports fans out there will undoubtedly recognize 
our next witness, William Fuller, who played in four pro bowls 
during his 13 years as an NFL defensive lineman. Mr. Fuller is 
a former board member of the Juvenile Diabetes Foundation, who 
first got involved with this cause after his father 
unfortunately died from diabetes-related illness. Mr. Fuller 
hosts several fund-raising events sponsored by the Juvenile 
Diabetes Foundation, including the ``Sack the Quarterback'' 
promotion.
    So we are very delighted to have all four of our witnesses 
here with us today. They span different ages, obviously. They 
have different experiences. And we really appreciate their 
willingness to come forward and help better educate the 
Subcommittee, and indeed the entire Senate, on the implications 
of living with diabetes.
    Now, as I explained to Dr. Gorden, pursuant to the 
Subcommittee rules, we do need to swear you in. At this point I 
would ask that you all stand and raise your right hands.
    [Witnesses sworn.]
    Senator Collins. Thank you. Ryan, since you are the 
youngest, you get to go first, so we will ask that you proceed 
with your testimony.

TESTIMONY OF RYAN DINKGRAVE,\1\ LIVONIA, MICHIGAN, ON BEHALF OF 
                THE JUVENILE DIABETES FOUNDATION

    Mr. Dinkgrave. Madam Chairman and Members of the 
Subcommittee, thank you for giving me the opportunity to 
testify this morning on behalf of the Juvenile Diabetes 
Foundation International. As is already stated, my name is Ryan 
Dinkgrave. I am 16 years old and a student at Stevenson High 
School. I hope to attend college at the University of Michigan 
and eventually find success in a career field which I enjoy.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Dinkgrave appears in the Appendix 
on page 62.
---------------------------------------------------------------------------
    I was diagnosed with juvenile or type 1 diabetes when I was 
in the fifth grade, just over 6 years ago. It was one of the 
scariest things that has ever happened to me. My pediatrician 
said that my constant thirst and exhaustion were because I had 
diabetes. I also lost weight, experienced frequent sluggishness 
and other common symptoms of diabetes. I had no clue what 
diabetes was, and I really didn't want to know, but we 
proceeded directly to the hospital. That day was the first of 
my 6-year experience of trying to live with diabetes.
    I was in the hospital for almost a week, and I left with no 
idea what to expect. It turned out that having diabetes meant 
my whole life was to be turned upside down and changed in every 
way. No longer could I just eat what I would like or when I 
would like, no longer could I really do anything without 
planning for so many possible situations related to having 
diabetes, such as low blood sugar that could lead to an insulin 
reaction or high blood sugar that could lead to severe health 
complications.
    I began trying to manage my diabetes with two shots a day, 
which eventually became three shots a day and then four. Along 
with the shots came blood glucose tests four, five, sometimes 
six times a day. These tests involve pricking my finger to draw 
a drop of blood.
    Along with these daily efforts came worries about what 
could happen if my blood sugars were not kept in good control: 
Heart problems, kidney problems, nerve damage, vision problems, 
blindness, amputations--the list seemed like an impossible 
thing to avoid. My life would certainly never be the same.
    Last November, after doing insulin injections for over 5 
years, I switched to a more advanced type of insulin therapy 
called the insulin pump. This is a device that is about the 
size of a pager, which administers insulin through a tube that 
goes into my body and has to be moved to a new location every 2 
days. While it has allowed me more freedom, better blood sugar 
control, and possibly a longer life, it is still not perfect 
and living with diabetes is still, at best, very difficult. 
Until there is a cure, nothing will satisfy those who struggle 
to live daily with this disease.
    A common misperception about diabetes is that one with 
diabetes is healthy. This is because people with diabetes often 
have no outwardly visible characteristics of the disease, 
especially teens and children with diabetes. There is no 
physical evidence of the organ damage and future health 
concerns of somebody who has diabetes.
    Look at any teenager or child with diabetes. They look just 
like anyone else their age. Put 100 kids in a line, and you 
cannot possibly pick out who has diabetes or who does not. It 
is because of this that many people do not realize the severity 
of diabetes and the urgency for a cure, until it is too late 
and complications of the disease have set in.
    I personally have had to struggle a lot with diabetes, both 
emotionally and physically. I have to worry about future health 
concerns, and every moment of every day I must be aware of my 
condition and treat it. I have had three seizures due to low 
blood sugar. I know that this scared me and my parents like 
never before with how serious and trying these events have 
been.
    I have done a lot to help spread out information and 
awareness on diabetes, and work with others, diabetics and 
doctors and what not, like myself. About 3\1/2\ years ago I 
started a Web site called ``The Family's Guide to Diabetes'' at 
diabetes.cbyc.com for children and teens with diabetes. It was 
created basically to fill what I thought was a need for a way 
for people with common situations to exchange information and 
experiences.
    Through the site, and through my speaking to doctors, 
families and others about diabetes, I have been able to 
exchange a lot of this information and learn about how others 
live with diabetes. Also, I have participated in JDF's Walk to 
Cure Diabetes for each of the past 5 years. In fact, this year 
my group, Team Ryan, raised a new high of $4,000 which will go 
to support curing diabetes through JDF's $75 million research 
budget.
    This past summer I was the Michigan representative for the 
JDF Children's Congress here in Washington, D.C. The JDF 
Children's Congress allowed 100 children and teens with 
diabetes to explain to Congress and the Nation how diabetes 
impacts us and the need for increased research funding for a 
cure.
    I learned at the Children's Congress about the Diabetes 
Research Working Group report that indicated there are many 
high-quality diabetes research projects that are not being 
conducted solely due to a lack of funding. On behalf of all the 
children and teens with diabetes, I urge you to ensure that 
this funding be made available so we can find a cure as quickly 
as possible.
    Thank you very much for allowing me the opportunity to 
testify, and I would be pleased to answer any questions.
    Senator Collins. Thank you very much, Ryan.
    Ms. Fernandes.

     TESTIMONY OF PAM FERNANDES,\1\ NEEDHAM, MASSACHUSETTS

    Ms. Fernandes. Good morning. My name is Pam Fernandes. I am 
from Needham, Massachusetts. Thank you for the opportunity to 
speak with you today about diabetes, a disease which plagues 
our Nation. Today some people will give you statistics relating 
to diabetes. These numbers will give you a sense of the 
overwhelming breadth of the problem. Through my story, I hope 
to give you a sense of the tragic depth of the problem.
---------------------------------------------------------------------------
    \1\ The prepared statement of Ms. Fernandes appears in the Appendix 
on page 65.
---------------------------------------------------------------------------
    Thirty-four years ago I was diagnosed with type 1 diabetes. 
At the age of 4, my understanding was quite simplistic: Two 
painful injections a day, urine tests, and no treats. Through 
my childhood and early adolescence I tried desperately to 
understand the disease that made me different from every other 
kid.
    When I was 18, at the very time in my life when options 
should have been endless, diabetes threw me a curve. I went to 
visit my eye doctor 2 weeks before leaving for college. He told 
me I had a few small hemorrhages, nothing to be worried about, 
but that I should see a specialist when I arrived in Boston.
    Two weeks after arriving in Boston, I got the news that I 
was going blind. The day I walked into that doctor's office 
began 8 of the most painful and difficult years of my life. 
After laser surgery and five eye operations, I was declared 
legally blind. I was just 21 years old.
    One week before my 22nd birthday, I started dialysis 
treatments. You see, diabetes had also affected my kidneys. I 
lived on a machine for 5 years, and although everyone said I 
was doing remarkably well with the treatments, I never felt 
worse in my life. I couldn't really imagine any kind of future 
with each day being so emotionally and physically painful.
    After more than 30 operations and two episodes of 
respiratory arrest, I made a life-changing decision. In 1987 I 
received a kidney transplant. The first year was difficult, but 
soon I rediscovered the Pam that was vibrant, alive and 
tenacious.
    About the time life began looking up for me, my family was 
hit with an unthinkable tragedy. My oldest brother, Mark, died 
from complications of his diabetes. He also had kidney disease, 
which led to his failing health. One of the most difficult 
things about Mark's death was watching my parents cope with the 
loss of a child. Diabetes had taken the life of a 32-year-old 
man who had a wife and a young girl.
    In 1992 I was invited to ride on the back of a tandem 
bicycle. Little did I realize that that would both change my 
life and open doors that I never dreamed imaginable. I rode 
recreationally for about a year to stay fit and have fun. I got 
involved with American Diabetes Association Tour de Cures, bike 
rides designed to raise money to support diabetes education and 
research. I am very happy to have been invited to be the 
national spokesperson for the American Diabetes Association 
Tour de Cures for the next 2 years.
    Bike racing entered my life in 1993. I attended a camp for 
cyclists with disabilities held at the U.S. Olympic Training 
Center. This was one of the most empowering weeks of my life, 
and I decided to give bike racing a try. In 1994 I won a silver 
medal at the World Championships for Disabled Cyclists in 
Belgium. At the 1996 Atlanta Paralympic Games I won a bronze 
medal. I have earned over 12 national championship titles.
    I was surprised to find out that I was the only diabetic 
athlete on the disabled cycling team. I also learned that I was 
the only transplant recipient to ever have competed at the 
Paralympic Games. As if these recognitions were not enough, I 
have also been recognized through many awards, including being 
named U.S. Olympic Committee Athlete of the Year.
    I am, in many regards, a very lucky girl. This disease 
hasn't been kind to me, but so far I have come out ahead. I am 
a living example of how far we have come with research, by the 
mere fact that I am here talking with you today and that I am 
doing what I am doing. I am also a very sad reminder of how far 
we have yet to go. My story speaks well to the power of the 
human spirit, but how many setbacks can one spirit endure?
    Unfortunately, I am not the rule but the exception. Many 
people with diabetes don't have the determination, the desire, 
the knowledge, the opportunity or the family support to succeed 
as I have. That is why it is so important for you as our 
Congressmen to understand our disease and to help us by 
supporting the research that will help us find better treatment 
options and ultimately the cure.
    I learned some very poignant lessons my first few trips to 
Washington. I learned the enormous responsibility that our 
Congress has as it relates to our Nation's health. I also 
learned that there is nothing between me and the cure to my 
disease but money. We have no lack of researchers. We have no 
lack of desire. What we have is a lack of money.
    Diabetes must become a national priority. Right now there 
are over 16 million people in the United States with diabetes. 
In the coming years that number will go up because diabetes 
isn't going away.
    With the diligence of the Diabetes Research Working Group, 
we have identified extraordinary scientific opportunities. We 
must find the means to support this research. We must find that 
$827 million. Diabetes and its complications are a financial 
drain on our country, not to mention the human toll that it 
takes.
    My mom and I made a pact when my brother Mark died. I told 
her that I would never give up. She knew that I was a fighter 
and a survivor. But the sad fact is that I probably will 
succumb to this disease, because like it or not, it has got a 
pretty good track record of shortening people's lives.
    For as long as I am able, I promise that I will do what I 
can to stop diabetes. Please make that same commitment today. 
We need your support, your understanding and your wisdom. 
Together we can fight this disease, diabetes. Together we can 
win the battle, but it will take all of us to do what we can.
    Thank you for your time and interest in our disease.
    Senator Collins. Thank you very much for your testimony.
    Mr. Jump.

     TESTIMONY OF GORDON JUMP,\1\ COTO DE CAZA, CALIFORNIA

    Mr. Jump. Madam Chairman, Members of your Subcommittee, my 
thanks for the opportunity to address you.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Jump appears in the Appendix on 
page 68.
---------------------------------------------------------------------------
    About 20 years ago I found that I am a type 2 diabetic. For 
5 years I lived in a state of denial. Sooner or later, though, 
you have to come to grips with the fact that you have a chronic 
illness. When you finally acquire the gumption to take 
advantage of the educational programs offered by many of the 
hospitals, you will encounter a term that you do not usually 
associate with disease, and the term is ``manage.'' You must 
learn to manage your disease.
    Managing diabetes, a disease with few overt signs and 
symptoms, is not really an easy task. Self-discipline, almost a 
dirty word today, is the most important part of disease 
management for the diabetic. Carefully monitoring diet, 
exercise, body changes, medication, requires a diligence that 
most of us just simply do not possess. In order to simply 
survive we have to spend money, and lots of it, to keep the 
disease under control.
    We discover that diabetes is not just a single disease to 
be treated. Diabetes affects the cardiovascular system, the 
nervous system, neuropathy, affects your feet, your legs, and 
ultimately other parts of your body. Your eyes can be affected 
to the point of blindness. Lack of circulation in your limbs 
can cause you to require amputation. You are in a constant 
struggle with life and death, actually.
    In the case of type 2 diabetes, onset is usually at the 
time of life when the person is most productive. This is also 
the time when you are under the most stress: Climbing the 
corporate ladder, struggling with teenagers at home, and going 
through divorce or being downsized, maybe even going through a 
midlife crisis, whatever that is. It is rather like the chicken 
and the egg thing: Which comes first, the stress or the 
diabetes?
    The American Diabetes Association has done a tremendous job 
in bringing the standard of awareness to a much higher level, 
but I am sure they would agree that the standard of awareness 
is not nearly high enough. The ADA has also provided tremendous 
support to physicians in providing educational services on the 
disease and its management to their patients.
    In the 20 years since I was diagnosed, I have suffered a 
number of health problems, several of which can be directly 
attributed to diabetes. For the first 8 years or 10 years of my 
condition, I simply had to take pills, watch my diet, and saw 
my endocrinologist when I felt I should, which in the case of 
most diabetics was never enough.
    By the time I had acquired enough sense to seriously 
consider doing something to maintain my health, my health was 
already all bad. I had high blood pressure, four-digit 
triglycerides, cholesterol numbers that would scare even an 
actor. Not only did I go on insulin, but I needed a lot of 
other medications: Pills for my heart, high blood pressure, 
triglycerides, cholesterol, digestion, and it goes on and on.
    Sometimes a severe and sudden change in someone's eyes 
gives a physician a clue that diabetes may be the ultimate 
diagnosis for an individual. I have worn glasses for many years 
and often had to have my prescription changed. It wasn't too 
long ago I woke one morning and I realized that I was seeing 
double; was not anything that I had had to drink or eat.
    After a number of tests had been made to assess the 
situation, I was finally fitted with glasses that made it 
possible for me to function. It was a frightening time for me, 
not knowing whether my sight would ever be restored to single 
vision again. Vision problems, including blindness, is another 
of the complications of diabetes.
    This past June, I underwent angioplasty. The triglycerides 
and the cholesterol, all spoken of as being part of diabetes, 
had finally spoken. My blocked artery was discovered much the 
same way my diabetes was discovered, during a physical exam 
administered during the month of May. It was not the best time 
for me to have a procedure that could turn into a situation 
that might incapacitate me for several days, because my 
daughter was about to get married in the month of June.
    The angiogram disclosed an artery that was approximately 95 
percent occluded. At the very least it would require a stint or 
angioplasty, and at the worst, bypass surgery. Fortunately, 
while the artery's shape and placement did not allow for the 
emplacement of a stint, an angioplasty seems to have been 
successful.
    Being afflicted with diabetes is not something that I would 
wish on my worst enemy. How much money will be needed for basic 
research to conquer this insidious disease, I really do not 
know. How much is the disease itself costing the country in the 
form of Medicare, Medicaid, disability and other county, State 
and Federal programs? I really do not know.
    I calculated what I thought would be the cost of the most 
basic diabetic supplies for an insulin-dependent type 2 
diabetic for 1 month. Assuming checking the blood sugar only 
twice a day, using one test strip each time, it would run about 
$1.34 per day. Two sterile alcohol swabs to help you with that, 
16 cents a day. And 20 units per day of insulin, and that is 
very, very minimal, $4.20 daily. The cost of 1 month's basic 
supplies would be somewhere around $184.20. Now, this figure 
also assumes that no other medications are required, and it 
does not account for doctor's visits, transportation, or the 
other things, the miscellaneous things, that are involved with 
the disease.
    I calculated that the cost of my medications--that is not 
including doctor, hospital, extra glasses, or other devices--if 
I had no insurance, the cost for 1 month would be around 
$733.20. Even with insurance, I manage to pay more than $200 
per month. The standard co-pay for a prescription is $10. 
However, because of the price of some medications, the co-pay 
can be as much as eight times that amount. For example, one 
medication without insurance help would cost $149.50 a month, 
and another is $111.82 for 1 month's supply.
    I think about the monetary cost of this disease and wonder 
how people who are struggling to live on Social Security can 
possibly do an adequate job of caring for themselves, even with 
Medicare. I know there are other programs that help some, but 
the gap is still way too wide. If it was one disease that 
remained as one, perhaps it would be sufficient to allow the 
drug companies to take their time to seek out a cure.
    Diabetes takes its toll in the day-to-day wear and tear 
that it afflicts on the human body in the form of heart 
disease, amputations caused by wounds that won't heal, eyes 
that lose their sight, financial burdens, and sundry other 
complications. The final blow it administers is the worst of 
all: A parent with type 2 diabetes finds out that his or her 
child has been diagnosed with the disease, and the cycle begins 
all over again.
    I say let us break that cycle. Let us put type 2 diabetes 
out to pasture with smallpox, polio, whooping cough, and 
dyptheria. And let us find the research necessary and fund the 
research necessary to find a cure. And I ask Congress to make 
that money available so that can be accomplished.
    My thanks to you, Senator, and to those other members of 
the Senate who see the insidiousness of the disease, know the 
importance of its cure for the financial well-being of our 
Nation, and are willing to do something about it. Thank you.
    Senator Collins. Thank you, Mr. Jump. Mr. Fuller.

    TESTIMONY OF WILLIAM H. FULLER, JR.,\1\ VIRGINIA BEACH, 
                            VIRGINIA

    Mr. Fuller. Chairman Collins and Members of the 
Subcommittee, thank you for inviting me to testify today 
regarding diabetes research, an issue I care deeply about.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Fuller appears in the Appendix on 
page 73.
---------------------------------------------------------------------------
    In 1991, I was in my fourth year of NFL football as a 
defensive lineman with the Houston Oilers. After playing spot 
duty for the first years, I was finally getting my long overdue 
chance at being a starter. Having played 2 years in the old 
U.S. Football League and 3 years with the Oilers, I had already 
made more money than I could ever imagine.
    This success had enabled me to buy my mother and father 
their first house, complete with a satellite dish so that they 
could watch me play anywhere in the United States, this after 
living in apartments our entire life. I was the first person in 
the Fuller family lineage to graduate from college. I had been 
married for 5 years, and had a beautiful wife and two young 
daughters.
    It should have been one of the better periods in my 
football career, or life for that matter, but that was not the 
case, for I was seriously considering retirement. You see, back 
in my home town of Chesapeake, Virginia, a totally different 
story was unfolding. The people I owed the most gratitude for 
my success were suffering, suffering because of diabetes.
    My father had type 2 diabetes. His diabetes had already 
caused him to have a leg amputated while I was in college. It 
also caused his kidneys to fail, and he had to be hooked to a 
dialysis machine 3 days a week for 3 hours each visit. And now, 
to make matters worse, he was losing his eyesight.
    At 6 feet 3 and 260 pounds, I knew it was getting harder 
and harder for my mother to take care of him. She also took 
care of my sister, who cannot hear as the result of a bout with 
spinal meningitis when she was a baby. Until I left for college 
on a football scholarship, it had always just been the four of 
us.
    My wife suggested I get a nurse to help my mother take care 
of him, but mom kept saying they were fine and no need for me 
to worry. She promised to let me know if things got too tough, 
but on a recent trip home a neighbor informed me that my father 
had fallen down in the bathroom and my mother had to call the 
neighbor to help get him up.
    I told my father my thoughts of quitting football so I 
could return home and help out. If he could have gotten up and 
punched me, I think he would have. I remember it as being one 
of the few times I had ever seen my father cry. He told me how 
proud he was of the man I had become, and no matter what 
happened, to promise not to quit because of his situation. He 
said that my quitting football would do more harm to him than 
diabetes ever could. I did not believe that, but we decided to 
get some help for my mother, and I promised not to quit, a 
promise that was made even tougher because of the Oilers' 
insistence that players live and train in Houston year round.
    It was during that same time that I met a gentleman named 
Milton Slocum at a charity event. He informed me of his 
business as a publicist and marketing agent for several of the 
Houston Rockets. We agreed to meet the next day. We met, and 
basically I told him the story I just told you. When he asked 
me specific questions about diabetes, I honestly could not 
answer them. All I knew, that it was a horrible disease that 
was wreaking havoc on my father, and it had something to do 
with the fact that his body was not producing enough insulin.
    The next week Milton scheduled a meeting with the Juvenile 
Diabetes Foundation. It was a meeting that would forever change 
my life. I later served 6 years on JDF's International Board of 
Directors, and currently serve on its Board of Chancellors. I 
walked into JDF's office as a helpless and hopeless young man 
with a lot of questions. I walked out with many answers to my 
basic questions, but more importantly, I walked out with hope, 
hope that research would lead to a cure.
    Through my annual celebrity golf classic and the ``Sack the 
Quarterback'' promotion, we have raised over $1 million toward 
this important research. I have learned a lot about this 
disease. I now know that there are over 60 million people with 
diabetes, and that many of them are children. To watch my 
father, my hero, suffer and eventually succumb to diabetes was 
very tough, but I cannot imagine the pain if this disease were 
to attack one of my four daughters.
    However, over the years I have met many parents that are 
dealing with this nightmare on a daily basis. I cannot imagine 
having to give my 2-year-old daughter an insulin injection, or 
having to realize the possibilities of blindness, amputation, 
or diabetic comas that she or any of my daughters could face 
for the rest of their lives.
    In almost 20 years of playing college and pro football, I 
have learned a lot about teamwork. I sincerely believe that the 
team of researchers at the National Institutes of Health, JDF 
and other organizations are on the right track to find a cure. 
I am proud to be part of that team.
    Every team needs leaders, and Congress, and the NIH, if 
they provide the funding to support all diabetes research 
opportunities, have the capability of leading the way to a 
cure. We are ever so close to our Super Bowl--that is a cure 
for diabetes.
    I thank you for your time, and may God bless you all.
    Senator Collins. Thank you very much, Mr. Fuller.
    I must say I had a series of questions to ask each of you, 
but I think your testimony speaks for itself. You have put the 
human face on this devastating disease. Your testimony is so 
eloquent and so moving that anything I could ask you would be 
superfluous. It is why I wanted Dr. Gorden to stay. It is why 
this report is so critical, because it says ``conquering 
diabetes.'' It is why the increased research is just so vital. 
Your stories are so moving, your courage so inspirational, that 
I just want to pledge to you that I accept Ms. Fernandes' 
challenge to fight for a cure for this disease and to keep 
fighting until we have achieved that goal.
    Ryan, I want to say to you how much I appreciate the 
efforts that you are making to reach out to other kids and to 
teens with diabetes through your Web site. You are absolutely 
right that most people do not understand how serious this 
disease is.
    And that is why all of your testimony is so important, 
because you have each eloquently described either your own 
struggle, or in the case of Mr. Fuller, his father's struggle 
with this devastating disease. You have put the human face on 
it. We can talk about the statistics, we can look at the 
charts, but until we hear from you first-hand and what it has 
meant to your lives and your family's lives, that is what we 
need to provide the momentum for the cure.
    I just want to thank each of you for your eloquence, for 
speaking out, for caring enough, for your involvement, and for 
being here today. You are why we are here, and I just want to 
assure you of my personal commitment to keep up the fight. So I 
accept your challenge, Ms. Fernandes, and again, thank you for 
your courage and thank you for speaking out. Thank you for your 
good work.
    I would now like to call our final panel of witnesses this 
morning, and I am sure our final panel, which are distinguished 
scientists, have also been moved by what they have just heard, 
and if anything will redouble their efforts. They are all such 
leaders in their fields.
    Dr. Ronald Kahn is the former chairman of the 
congressionally mandated Diabetes Research Working Group. He 
was the chairman of the group that produced this very important 
report. He is also executive vice president and director at the 
world-renowned Joslin Diabetes Center in Boston.
    Dr. Edward Leiter is the senior staff scientist at The 
Jackson Laboratory in Bar Harbor, Maine. Dr. Leiter took me 
around the lab a few months ago and told me of the very 
exciting research. I became aware of Jackson Lab's role when I 
was visiting the Juvenile Diabetes Center, Research Center, at 
Harvard Medical School earlier this year, and all the mice they 
were using of course came from Jackson Lab.
    Finally, we have Dr. Jeffrey A. Bluestone, who is the 
director of the Ben May Institute for Cancer Research at the 
University of Chicago in Chicago, Illinois.
    I am very pleased to have three such distinguished 
researchers and scientists who really are on the cutting edge 
of diabetes research with us today. As I have explained 
previously, our rules do require that everybody be sworn in. 
Makes more sense when we are having an investigative 
Subcommittee, where we are worried that people won't tell the 
truth, but we do have to apply it across the board, so if you 
would, please stand.
    [Witnesses sworn.]
    Senator Collins. Thank you. Dr. Kahn, I would like to start 
with you, and again I want to welcome all of you to the 
Subcommittee.

TESTIMONY OF C. RONALD KAHN, M.D.,\1\ EXECUTIVE VICE PRESIDENT 
 AND DIRECTOR, JOSLIN DIABETES CENTER, BOSTON, MASSACHUSETTS, 
      AND FORMER CHAIRMAN, DIABETES RESEARCH WORKING GROUP

    Dr. Kahn. Thank you, Chairman Collins, and I also want to 
thank you personally and this Senate Subcommittee for giving me 
a chance to present this report of the Diabetes Research 
Working Group to you today. As you are aware, the Diabetes 
Research Working Group or DRWG, as we came to call it, was 
created in response to a request by the House and the Senate to 
evaluate the current state of diabetes research in the United 
States and to develop a strategic plan for the Nation as to how 
best to proceed making progress against this disease.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Kahn with attached charts appears 
in the Appendix on page 75.
---------------------------------------------------------------------------
    The DRWG consisted of 16 members representing the 
scientific and medical community, the JDF, the ADA, minority 
populations that are disproportionately affected, and others 
who have interest in this disease. We had tremendous support 
from the NIH, in particular from NIDDK, from Dr. Gorden's 
office and Carol Feld, who is here at these hearings, and from 
a number of other individuals that all deserve a lot of credit 
and thanks.
    Now, what is diabetes, and why was it so important that 
this Diabetes Research Working Group was deemed necessary? As 
you have already stated, diabetes is a very complex disease. 
Furthermore, it is not a single disease but rather a group of 
diseases which affect a large number of people.
    The two major forms of diabetes, type 1, the insulin-
dependent form of diabetes, which used to be called the 
juvenile-onset form and type 2, the adult onset form, often 
called non-insulin-dependent diabetes, although it too may 
require insulin therapy. These two forms affect 16 million 
Americans, as has been mentioned already.
    It is estimated that over 700,000 people, mostly children 
and young adults, have type 1 diabetes. And as individuals age, 
diabetes becomes even more common. In fact, if we all live to 
be 80--and we all hope to live to be 80--17 percent of the 
people in this room will have diabetes. As a result of these 
two forces, the type 1 and the type 2, about 800,000 new cases 
of diabetes are diagnosed each year.
    In addition, there are many other forms of diabetes. Some 
are rare, but some are quite common. For example, gestational 
diabetes is a form of diabetes that occurs during pregnancy and 
affects over 5 percent of all women in the United States who 
become pregnant.
    As we have already also heard, diabetes spares no one. We 
have heard from Ryan, and my neighbor Avi Robbins who is about 
the same age. We have heard in the House and in the Congress 
from Nicole Johnson, last year's Miss America. We know it from 
our parents and our grandparents and our grandchildren, from 
one coast to the other. Everyone is at risk.
    The risk is particularly high in minority populations of 
the United States. African Americans, Hispanics, Native 
Americans and Asian Americans not only represent some of the 
fastest growing segments of our population, but they are 
particularly vulnerable to diabetes and its complications. 
Among these groups, the Pima Indians of Arizona have the 
highest incidence of diabetes in the world. Over 50 percent of 
the adults have diabetes in that indian tribe.
    Not only does living with diabetes present many day-to-day 
challenges, but as has already been said, affects virtually 
every tissue of the body with long-term and severe damage.
    Diabetic eye disease is the most common cause of blindness 
in working age adults. Diabetic kidney disease accounts for 42 
percent of end-stage renal disease, that is, patients requiring 
dialysis or transplantation. It is the fastest growing cause of 
end-stage renal disease. Stroke and heart disease are increased 
two to four times, as you have already said yourself, and this 
is especially increased in women who normally are protected 
from these vascular problems, at least in the premenopausal age 
group.
    Diabetes affects the nervous system, leading to impaired 
sensation, pain, and slow digestion, impotence and many other 
problems. The rate of congenital malformations in offspring of 
diabetic women is increased three- to four-fold, and more than 
half of the lower limb amputations in the United States are 
secondary to diabetes.
    As has already been said also, diabetes is the sixth 
leading cause of death in the United States, but in fact in 
some of these minority populations it is the third leading 
cause of death.
    Now, as you have already shown, and one of the surprising 
findings even to the members of the DRWG is that despite all of 
our knowledge and despite all of our efforts, since 1980 the 
age-adjusted death rate due to diabetes has increased by 30 
percent, while the death rate from other common diseases such 
as stroke and cardiovascular disease has fallen.
    Of course these are only statistics. We have already heard 
from a number of individuals today about the very personal 
impact of this disease. In our report we had five personal 
profiles, including one from Pam Fernandes, who presented 
today. I am sad to tell you that one of the individuals who was 
discussed in our report, Jerrold Weinberg of Detroit, actually 
passed away from the time the report was being prepared to the 
time we were able to present. He died at the age of 39 from 
complications of this disease.
    The economic impact of diabetes is also staggering. The 
cost of diabetes to the Nation has been estimated at $105 
billion annually, and some estimates have gone as high as $130 
billion. Somewhere between 10 and 14 percent of all U.S. health 
care dollars are spent for people with diabetes. One of every 
four Medicare dollars pays for health care of people with 
diabetes.
    Next chart, please. Another striking finding of the DRWG 
was that while health care costs for each person in the United 
States affected with diabetes average $6,560 annually, the 
current investment in diabetes research is only about $30 per 
person affected per year. That is, less than one-half of 1 
percent of the cost of the disease is invested in R&D in an 
attempt to reduce the burden caused by diabetes. This is a very 
small investment for a disease that affects 6 to 7 percent of 
the population and accounts for 10 to 14 percent of all health 
care dollars.
    With these facts in mind, the strategic plan created by the 
Diabetes Research Working Group had multiple goals. We felt 
that it was important to understand the causes of diabetes and 
the causes of its complications; to develop methods to prevent 
and treat diabetes, and to prevent and treat diabetic 
complications, methods to reduce the impact of diabetes in 
minority populations; and to develop the research 
infrastructure and to train investigators to do the necessary 
research to achieve these goals; and of course, very 
importantly, to translate these research findings into clinical 
practice.
    In developing an approach to this plan, I took some advice 
that was given to me by Lee Iacocca, who is a strong supporter 
of diabetes research through his own foundation and supports 
diabetes research at the Joslin as well. And he said, ``Just 
imagine you are in the year 2010, and you would like to look 
back and see what you have accomplished in the area of 
diabetes. Then, given these goals, what would you have to do 
over the next decade to at least have some chance of 
accomplishing them?''
    And so this was the challenge to the committee, and this is 
what led to this 140-page Research Strategic Plan that you have 
before you today.
    There are three major components of the DRWG's strategic 
plan:
    Extraordinary opportunities, these were areas that we 
viewed as rapidly expanding and important areas of research, 
where increased investment or development of new approaches 
would significantly speed research.
    Special needs for special problems was an area that we felt 
was equally important, but these were more focused areas of 
research, usually targeted to specific populations or specific 
complications or some cases specific methodological approaches.
    And then, finally, resources and infrastructural needs. 
This was, of course, the plan for increasing research manpower 
and technology, as well as the infrastructural elements 
required for diabetes research.
    In this plan, all in all, there are 88 recommendations in 
16 different categories, and I would just like to briefly talk 
about a couple of these today.
    Perhaps one of the most exciting areas in all of research 
today is in the area of genetics, and the genetics of diabetes 
and its complications. If we identify the genes for diabetes 
and its complications, we may someday be able to predict and 
prevent the disease. Understanding the genetics will also give 
us the opportunity to develop new therapies that are directed 
at the true, central problem of the disease.
    The DRWG proposes several initiatives in the area of 
genetics, including the creation of a national consortium for 
the study of the genetics of diabetes. One of the goals of this 
consortium would be to develop a diabetes DNA chip. In fact, I 
brought this actual DNA chip to show you. The little square in 
the center of this black holder is the DNA chip that we are 
using in my laboratory and is being used in other laboratories 
to try to identify some of the genes that might be altered in 
diabetes.
    We believe that with the proper investment in research, 
within a decade a diabetes-specific chip could be developed, 
that when exposed to DNA from a few drops of blood, would tell 
us who is likely to develop diabetes, which of the diabetic 
patients are most likely to develop which complications, and 
perhaps even who would respond best to each specific treatment 
approach.
    A second area that we will hear I am sure more about from 
Dr. Bluestone is the area of autoimmunity and the beta cell. 
This holds the key to type 1 diabetes, since type 1 diabetes is 
an autoimmune disease that destroys the insulin-producing beta 
cells. Important progress has been made in this area over the 
past several years, including identifying some of the genes 
involved in predisposing to type 1 diabetes, some of the 
components of the beta cell that are attacked; developing 
markers for detection of pre-diabetes; and demonstrating the 
critical importance of tight glucose control for reducing 
diabetes complications.
    But there remain many challenges which are critical if we 
are to conquer this disease, and in the DRWG report we describe 
a program to intensify research to understand the immunologic 
basis of type 1 diabetes; to develop optimal strategies for 
blocking the immune destruction; for expanding research in the 
area of transplantation as therapy, which will require solving 
critical issues such as, where do we get enough islet cells to 
treat the hundreds of thousands, or perhaps eventually 
millions, of people who could benefit from this treatment; and 
how do we protect these transplanted cells from immunologic 
rejection?
    Other extraordinary opportunities that are listed in the 
report include an area of basic research called cell signaling 
and cell communication. This is a very important area, because 
we believe that in this area will be the keys for understanding 
type 2 diabetes; and type 2 diabetes, after all, does account 
for 90 percent of all of the patients with this disease.
    Obesity, another critical area of extraordinary 
opportunities. Research in animal models, such as has been done 
at The Jackson Laboratory and in other laboratories, has 
pointed the way to the great opportunities here that need to be 
approached in our studies for humans with this disease.
    And, finally, the area of clinical research and clinical 
trials which must be applied to develop evidence-based medicine 
to approach this disease.
    The DRWG has also made special recommendations, in our 
special needs for special problems area, regarding the eye, 
kidney and nerve complications as well as the cardiovascular 
complications, which is the major killer of people with 
diabetes.
    In these areas we must define exactly how and why does 
diabetes enhance the atherosclerotic process or these other 
vascular problems. Why do women with diabetes tend to be at 
special risk and lose their vascular protection? What are the 
factors that occur in diabetic patients, that lead them to be 
at increased risk of dying after a heart attack, and how can we 
develop therapies to enhance their survival? And can we develop 
better specific, noninvasive techniques to identify the 
presence of diabetic complications, predict their progression, 
and assess their response to therapy?
    We also describe basic and clinical research programs to 
better understand the impact of diabetes in the young, in the 
old, in women, and in minority populations.
    As I have already indicated, the current investment in 
diabetes research is small, and indeed far too small to provide 
the resources needed to begin to address the research plan. As 
requested by Congress, therefore, the DRWG has developed 
budgetary recommendations to accompany this plan. You will see 
that the recommendations call for a 5-year step-up in the 
research budget for diabetes, from the current level of about 
$443 million to, as you have pointed out, $827 million for the 
year 2000, and actually rising to $1.6 billion by the year 
2004.
    Let me point out to this Subcommittee and to this group 
that these numbers were not arbitrarily chosen. They were based 
on a planning process, a detailed planning process that took 15 
months, and we believe describe what is realistically needed to 
bring diabetes research to a point where there would be at 
least a reasonable chance that we could accomplish a number of 
the goals that we have set forth over the next 10 years. In the 
full report, this detailed budget is outlined in a project-by-
project and institute-by-institute manner.
    Finally, I would like to point out that the members of the 
Diabetes Research Working Group do not believe that diabetes 
research should necessarily be funded by taking resources from 
other important biomedical research needs. We understand the 
problems that NIH faces. We are very supportive of NIH, the 
Director of NIH, Dr. Varmus, the Director of NIDDK, Dr. Gorden, 
and we recognize the many challenges that must be faced in 
utilizing their precious resources.
    But we would like to use the analogy that like the 
military, which must be prepared to fight a battle on at least 
two fronts, the NIH and the biomedical research community must 
be prepared to fight a battle of human disease, not just on two 
fronts, but on many fronts at once, and this will require a 
significant investment both immediately and in the long term.
    The DRWG is convinced that there is both great urgency and 
unprecedented opportunities in diabetes research. We are 
convinced that taking action now will save thousands of men and 
women and children from severe consequences of diabetes. We 
have done the first part of the job by developing the report, 
and we applaud and are delighted by the support of the Senate 
and its recommendation to support this. We now ask the U.S. 
Government and the NIH to give its continuing support to allow 
us to do the research that will be required to conquer this 
dread disease. Thank you.
    Senator Collins. Thank you, Dr. Kahn. Dr. Leiter.

     TESTIMONY OF EDWARD H. LEITER, PH.D.,\1\ SENIOR STAFF 
      SCIENTIST, THE JACKSON LABORATORY, BAR HARBOR, MAINE

    Mr. Leiter. Madam Chairman, I wish to begin by commending 
you and the other Senator co-sponsors of the recently passed 
sense of the Senate resolution calling to the attention of the 
American people the impact that diabetes has on our population 
and urging increased support for diabetes research, education 
and early treatment.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Leiter appears in the Appendix on 
page 86.
---------------------------------------------------------------------------
    I am a senior staff scientist at The Jackson Laboratory, a 
world center for mammalian genetics, and my research focus has 
been mouse genetic models of both type 1, insulin dependent, 
and type 2, non-insulin dependent, diabetes. Now, the fact that 
there are different forms of diabetes underscores the genetic 
complexity of the diseases, but there is something in common, 
and unfortunately we have heard about that commonality. Those 
are the complications of kidney failure, blindness, heart 
disease and stroke, and amputations.
    I have a personal family reason for being interested in 
both type 1 and type 2 diabetes. My grandfather had type 2 
diabetes and my uncle, Frank Black of Los Angeles, California, 
has been struggling valiantly with his type 1 diabetes since 
first diagnosis in 1942. So it is concern for my uncle, for the 
millions of Americans who now fight with their diabetes, and 
for those Americans that will develop diabetes, that leads me 
to give you my comments.
    We now know that most cases of type 1 diabetes in humans 
represents an autoimmune disease, wherein a rogue immune system 
turns against the body in which it resides. We have an 
excellent mouse model, the NOD mouse, for autoimmune insulin 
dependent diabetes. One of the most important lessons we have 
learned from the NOD mouse is that autoimmune diabetes is a 
preventable disease. This finding, along with similar findings 
in another animal model, provided the impetus for NIH to 
initiate clinical trials to prevent type 1 diabetes from 
developing in young adults deemed at high risk.
    One of the most exciting recent developments in my 
laboratory comes from the close relative of the NOD mouse. Like 
the NOD mouse, this relative seems to have just the right 
genetic program to develop type 1 diabetes. It doesn't. Why?
    It seems that the insulin-producing beta cells of this 
mouse are unusually resistant to immune-mediated injury. With 
support from the American Diabetes Association and the Juvenile 
Diabetes Foundation, we are working very hard to try and 
decipher or understand the factor that is protecting these beta 
cells. We hope that these findings can be extrapolated to make 
human islets more resistant to damage by a rogue immune system.
    Of equal importance in my research are the mouse models of 
obesity in type 2 diabetes that I am developing. Such new 
models are of tremendous importance in the testing of 
pharmaceutical compounds to be used in the treatment of human 
type 2 diabetes. For example, these mice are helping us 
identify genetic targets that respond favorably to a given 
pharmaceutical compound, as well as identifying the genetic 
makeup of individuals that would suffer adverse side effects if 
they were treated with a comparable anti-diabetes drug.
    I would like to add some thoughts about the recommendations 
made to Congress by the Diabetes Research Working Group. 
Obviously, as a recipient of NIH funding to do my own diabetes 
research, and having participated in the development of the 
DRWG recommendations, I am biased in my hope that the 
recommendations could be implemented by the NIH.
    Although considerably more NIH funds have been designated 
for diabetes-related research in the past year or two than ever 
before, research dollars that are allocated are still 
inadequate to fund all the meritorious investigator-proposed 
grant applications in the areas identified by the Diabetes 
Research Working Group. I have personally served in NIH peer 
review panels evaluating diabetes research, and have observed 
that the competition for grant funding today is so stringent 
that many scientific avenues that could be explored are not 
being explored.
    Indeed, if the discoverers of insulin, Drs. Frederick 
Banting and Charles Best, were to apply for an NIH grant today, 
providing only their interesting hypothesis that the pancreas 
made a substance that might control blood sugar, I am fairly 
convinced that their application would be turned down. Why? The 
answer is that with NIH's rather limited resources devoted to 
diabetes research, only those investigators receive funding who 
can demonstrate with preliminary studies that the hypothesis 
they are proposing to test is correct.
    This review process assures the Congress and the American 
taxpayers that their monies are being wisely spent by the NIH. 
However, it also means that the process of scientific 
discovery, which often moves by trial and error, and sometimes 
even serendipity, on the road to getting an ``eureka,'' is not 
being promoted to its fullest extent. Thus, progress on the 
path to better therapies and an eventual prevention of diabetes 
is not as rapid as it might be if all the Diabetes Research 
Working Group recommendations could be implemented.
    So, in closing, let me thank the Subcommittee and 
especially the Senator from my own State of Maine, Senator 
Collins, for inviting my comments. We are now in an 
unparalleled age of discovery in molecular genetics in both 
mice and in humans.
    The Human Genome Project, which the Congress has so wisely 
supported, will provide a genetic blueprint on which a massive 
structure of new knowledge will be built. This new knowledge 
will certainly contain the key to new therapies not only to 
control diabetes but more importantly, as Dr. Kahn has 
suggested, to identify individuals at risk to develop this 
devastating disease, and thereby permit interventions to 
prevent diabetes from happening. This is a reality now in my 
mouse models. Let us work to make it a reality in the human 
family as well.
    Senator Collins. Thank you very much, Dr. Leiter.
    I notice that the other Senator from Michigan, Senator 
Abraham, who has been a leader in the fight against diabetes, 
has also arrived, and I wanted to give the Senator the chance 
to either join us at the dias or to make any statement if he 
would like.
    Senator Abraham. I don't think it would hurt to sit here.
    Senator Collins. That would be great. Senator Abraham was a 
cosponsor of an amendment that I offered last week to the 
Labor-HHS bill, supporting the recommendations for $827 million 
in funding by the Working Group, and we have worked very 
closely on diabetes research issues. So I asked him if he would 
like to join us today, and I appreciate the fact that you have 
been able to stop by.

  OPENING STATEMENT OF SENATOR SPENCER ABRAHAM, A U.S SENATOR 
                   FROM THE STATE OF MICHIGAN

    Senator Abraham. Senator Collins, thank you very much, both 
for inviting me and for giving me a moment. I will not detract 
too long from the panel's efforts because we really want to 
hear from experts at these events.
    We had a hearing in my committee, or actually a markup on a 
bill, downstairs in the Judiciary Committee, so I couldn't be 
here as early as I had wanted and I have to head on back, but I 
did want to just congratulate you and thank you for the 
leadership you have demonstrated on these issues in our State 
as well as the other States.
    We have obviously a lot of folks who are in various ways 
incapacitated by diabetes. In our own family, both my wife's 
mother and father are diabetics who take regular insulin 
injection, so it is not an issue that doesn't have its impact 
even on us here in the Senate.
    And so I just want to thank you for the leadership. I fully 
support the efforts you have engaged in to try to both draw 
more attention to this disease, as well as to try to focus more 
of the Federal Government's efforts on trying to combat it. We 
appreciate all who have been part of this.
    Of course, we have a Michigan witness. I missed his 
testimony, but I had a chance to say ``hi'' to Ryan, and I want 
to welcome him and his family to the Senate. We appreciate 
having our constituents down to participate, but in particular 
when they bring important messages like he has today.
    So I just thank you very much, and I will let you return to 
the hearing, but I really appreciate very much an opportunity 
to speak out in support of your efforts.
    The prepared statement of Senator Abraham follows:
                 PREPARED STATEMENT OF SENATOR ABRAHAM
    Madam Chair, I am proud to speak today on the importance of funding 
for diabetes research.
    Diabetes affects the lives of 15.7 million Americans, with 
approximately 2,200 newly diagnosed cases a day. High levels of funding 
are vital in developing a cure for this disease, which is why I 
strongly support an increase of 45 percent in funding within the Fiscal 
Year 2000 NIH budget for diabetes research, bringing funding levels to 
a total of $827 million.
    Diabetes affects almost every aspect of daily life. Imagine having 
your schedule being dictated by a regime of specialized diet, blood 
sugar checks, and insulin shots. Now, imagine being a kid and having to 
endure the countless doctors visits, injections, and tests. Or, not 
being able to attend a sleep-over, play a sport, or even enjoy the 
Halloween candies passed out during class. Imagine, instead of enjoying 
the freedom and spontaneity of being a kid, having your life revolve 
around a disease.
    This year, I was proud to be a Honorary Co-Chair for the JDF 
Children's Congress. The JDF is dedicated to discovering a cure for 
diabetes and the accompanying complications through the support of 
medical research. The Children's Congress provided a way for kids with 
diabetes to come to Washington and not only get an opportunity to meet 
their peers, but to educate their Senators and Representatives about 
coping with this disease.
    Our children face this disease with a courage beyond their years, 
but it is our responsibility to make sure that someday they won't have 
to. Today we have the privilege of hearing the testimony of a young 
constituent of mine, and one of this year's delegates of the Children's 
Congress. Ryan Dinkgrave is only 16 years old but has lived with 
diabetes since the fifth garde. I would like to take this opportunity 
to commend Ryan for his achievements in promoting diabetes awareness. 
He has created a Web site called the ``Families Guide to Diabetes'' for 
families to learn about coping with the disease. In addition, during 
this year's Juvenile Diabetes Foundation's (JDF) Walk to Cure Diabetes, 
Ryan's group, ``Team Ryan'' raised an event-record $4,000. All of us 
can learn from Ryan's courage and dedication.
    It is vital that we continue to fund diabetes research so we can 
someday find a way to cure this debilitating disease. I want to commend 
Senator Collins for her work to educate government and the public about 
this disease and the need for increased funding. I was proud to vote 
for her amendment to the Labor, Health and Human Services, Education 
appropriations bill, which calls upon Congress to raise awareness of 
the devastating impact of diabetes and instructs NIH to increase 
funding levels to that which has been recommended by the 
Congressionally-mandated Diabetes Research Working Group. Her 
amendment, which passed overwhelmingly, demonstrates, beyond a shadow 
of a doubt, the strong commitment in the Senate to finding a cure for 
diabetes and improving the lives of those affected by this disease.

    Senator Collins. Thank you, and thank you for your support 
in this area. I want to let you know that Ryan did a terrific 
job. You can be very proud of him and the efforts that he is 
making.
    Senator Abraham. Thank you.
    Senator Collins. Thank you. Dr. Bluestone, if you would 
proceed.

TESTIMONY OF JEFFREY A. BLUESTONE, PH.D.,\1\ DIRECTOR, BEN MAY 
INSTITUTE FOR CANCER RESEARCH, UNIVERSITY OF CHICAGO, CHICAGO, 
                            ILLINOIS

    Mr. Bluestone. Good morning, Chairman Collins. My name is 
Jeffrey Bluestone. I am the Chairman of the Committee on 
Immunology at the University of Chicago, and also the Director 
of the Juvenile Diabetes Foundation Islet Transplant Center at 
the University of Chicago and University of Minnesota.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Bluestone appears in the Appendix 
on page 89.
---------------------------------------------------------------------------
    But I am addressing you today mostly as a Ph.D. basic 
scientist at the University of Chicago, on behalf of myself and 
other scientists, both basic and clinical colleagues of mine, 
all of us in continued pursuit for the cure for diabetes and 
other debilitating autoimmune diseases. All of these diseases 
depend very much on the Federal Government's support and your 
efforts and others for the basic and clinical research funds 
that we use.
    In my short presentation, I hope to impart to you my 
personal sense of optimism. I believe we are really on the 
precipice of making dramatic changes in the way we treat 
autoimmune diseases and diabetes, and with your help I feel 
that we have a chance of turning the corner quickly to fight 
these autoimmune diseases such as type 1 diabetes.
    I thought I might share with you some of my own research 
and why I think that we are indeed at a time to be very 
optimistic. My laboratory has focused for a number of years on 
the basic processes that determine why immune cells respond or 
don't respond to tissues, self tissues, foreign bacteria, or 
viruses. We have used organ transplantation as a model to try 
to understand how to reeducate, train the immune system not to 
recognize self tissue and not to recognize transplants of 
kidneys, livers, and most prominently in our recent research, 
islet cells from other individuals.
    What we have learned in the last 10 years, quite 
dramatically actually, is that type 1 diabetes is indeed an 
autoimmune disease, a disease caused by the T cells in the 
body's ability to recognize and target and kill the very beta 
cells that are critical for insulin production. And, as Dr. 
Leiter pointed out, the animal models that have been developed 
and exploited at The Jackson Laboratory has made our work very 
easy in trying to understand better the basic processes of this 
disease.
    And perhaps the most dramatic observations that we have 
made in the last 10 years is that the T cells, the cells that 
are most prominently involved in the destruction of the islet 
cell of the pancreas, are very much regulatable. We have 
learned that the T cell works like a lock-and-key mechanism, 
where each T cell recognizes a protein uniquely, and the T 
cells that recognize the insulin-producing beta cells are not 
the same as the T cells that recognize a virus or a bacteria.
    We have also learned that the process of T reactivity is a 
multi-step process, in which not only is there recognition of 
the tissue but then subsequent exposure to other signals that 
determine whether the T cell gets turned on or turned off. 
These fundamental observations have changed the way we have 
thought about how we are going to manipulate or alter the T 
cells responsible for generating immune responses against 
autoimmune diseases in self tissue.
    What we have learned is that our basic processes of immune 
intervention that we have used over the past 2 decades, which 
have had extraordinary success in treating autoimmune disease 
to some extent, but more often kidney transplants and liver 
transplants, that these are sledgehammers. These are drugs that 
suppress the whole immune response. They have worked very well, 
but they lead to many complications and toxicities. They 
require treatment for the whole life of the individual who has 
the transplant or the disease, and although they have been very 
successful, they beg for more sophisticated and targeted 
approaches.
    And what we have learned is that we can now develop drugs 
against these lock-and-key mechanisms on the T cells, the drugs 
against the receptor itself that recognizes the islet cell, as 
well as drugs against these other molecules that are necessary 
for signaling a competent immune response. I think there is a 
tremendous amount of excitement and enthusiasm in the community 
that some of these drugs, when combined in appropriate ways, 
will lead to what we call immune tolerance, the ability to 
treat with drugs for a short period of time and reeducate or 
train the immune system so it does not recognize any more its 
self tissues, like in the pancreas, and that we can 
subsequently do islet transplantation in a setting in which the 
islet cells will not be rejected.
    It is these exciting new approaches to the treatment of 
immune disorders that actually led the NIH and the JDF and, as 
you mentioned earlier on, a very concerted effort among 
different institutes to put together what I think is an 
exciting, bold new initiative. It is called the Immune 
Tolerance Network.
    It is a 7-year project funded, as I said, by the NIH and 
the JDF--I have been fortunate to be asked to lead this 
effort--in which over 70 investigators from around the world 
will be putting their energies towards trying to study not just 
diabetes, a very important area in islet transplantation, but 
other autoimmune diseases like lupus and multiple sclerosis and 
rheumatoid arthritis, to work with kidney transplantation as 
well, and even allergy and asthma, to try and understand common 
mechanisms in regulating all of these diseases and common 
approaches, as I say, redefine and reeducate the immune system, 
such that we can now avoid the attack of these terrible T 
cells.
    This effort, which has just begun--yesterday I closed a 
meeting of the 70 investigators, our first--is supported by 
$140 million from the NIH and the JDF over the next 7 years. It 
is a tremendous opportunity. I feel a tremendous amount of 
pressure, in fact, to make a difference in this thing.
    It is a testament to the confidence of you in the Senate, 
to the research community, that we really are now putting these 
kinds of dollars in, and I truly believe that we need to 
continue to do that, and we need to do that because the basic 
research underpinnings that have gotten us here today don't 
just stop, that we need to keep moving on, to come up with new 
ideas and new opportunities. Genetic research is going to have 
tremendous impact, as well.
    So there is no doubt that the recent scientific 
developments represent remarkable progress in our understanding 
of human disease. We have new tools now, those little chips 
that Dr. Kahn brought today--which may now give us a fresh 
approach to the treatment of diabetes and related diseases.
    I urge the Congress and the NIH to implement the 
recommendations of the Diabetes Research Working Group. I sit 
before you today full of enthusiasm and optimism. I am 
confident that 50 years from now, when we look back at the turn 
of the century, it will not be remembered as a time when we 
argued over managed care and how to redefine our public health 
system. It will be regarded as a golden age of biology that 
marked the beginning of the end for so many diseases. And like 
the industrial revolution at the end of the last century, the 
biological revolution will be remembered as a time of 
innovation and discovery, when diseases like diabetes are only 
a memory. Thank you.
    Senator Collins. Thank you very much, doctor.
    Dr. Leiter, first I want to again commend you and the other 
two scientists here today for your excellent work and 
commitment in this area. I was struck by your testimony that if 
the two inventors of insulin, Dr. Banting and Dr. Best, I 
believe the names were, were to apply today for an NIH grant to 
support their theory, that you do not believe they would be 
funded based on what they would be going to NIH with.
    That suggests to me the magnitude of the problem, and that 
there are many meritorious projects out there that we are just 
not funding, and that we may be missing the chance for a 
tremendous breakthrough. Is that what you are trying to tell us 
by using that example? That is a startling statement.
    Mr. Leiter. Things have improved dramatically over the last 
2 years, as your diagram and the testimony of Dr. Gorden have 
indicated, so with the funding of one in three applications 
now, that really is a very positive step. But still, within the 
one out of three that gets funded, there is probably one out of 
three in there that is deemed excellent but not outstanding.
    The peer review panel, just to ensure that NIH is going to 
get what it hopes to get, which is a real positive outcome, 
will send the investigator back a message, ``Get us some more 
preliminary data and come back, and let's then reevaluate your 
hypothesis to see how close to the scientific truth it really 
is.'' And if we can just get that second out of three grants 
funded, progress will be moved forward because the scientist 
will not be frustrated, will not be scraping.
    Thank goodness for the Juvenile Diabetes Foundation and the 
American Diabetes Foundation. If you are from Maine or Michigan 
or some other cold weather State, jump starting in winter time 
is a very common concept. Well, these two private organizations 
have jump started scientific research in diabetes in this 
country, and it is through their efforts that many of these one 
out of three grants are not lying fallow but actually some of 
that preliminary data is being obtained.
    I know Director Varmus is aware of the problem, I know 
NIDDK is trying to remedy the problem, how to fund innovation 
at the same time as NIH is putting its money on sure things. So 
it is certainly a problem that is being tackled at the 
governmental levels. They are aware of it, they are trying to 
deal with it, but certainly it will be helped out if the 
Diabetes Research Working Group recommendations, at the funding 
level you and your co-sponsors have supported in the Senate, 
were to become reality.
    Senator Collins. I appreciate your mentioning the terrific 
support provided by the Juvenile Diabetes Foundation and the 
American Diabetes Association. I am so impressed with their 
advocacy and their commitment to research, and I know that Dr. 
Bluestone, also the project that you described involved some 
funding, some private funding, as well.
    I guess that leads me to a question for Dr. Bluestone, 
which is, how well does it work to have private funding in 
addition to NIH funding? Are there problems with merging the 
funding streams, or are you able to handle the combination of 
private and public dollars without any problems?
    Mr. Bluestone. I can speak about the JDF Foundation, which 
I have had the most experience with, which may actually be a 
pioneer in this area, I believe. What they have done is, they 
have actually partnered very effectively with the NIH. They 
have taken advantage of tremendous talent in the NIH and the 
review process identifying outstanding research opportunities, 
and helped to support research.
    One of our grants is basically an NIH-funded grant that at 
the time in the early 1990's had to be cut because of 
administrative cuts due to budget restrictions. The JDF came in 
and restored that cut so we could do all the research that we 
had hoped to do. So it has been an exceptional partnership, I 
believe.
    More recently, the ability of the JDF to actually help in 
getting the tolerance network going, contributing 10 percent of 
the money actually that is going towards this network, was 
actually an extraordinary opportunity. Again, they did it in an 
incredibly productive way, by not trying to fund separately or 
fund independently, solely, but here to partner with the NIH 
and put the money together. So if the JDF could be used as a 
role model in this, it would be very good for all of us.
    Senator Collins. Thank you.
    Dr. Kahn, I want to get back to one of the key issues that 
has been before us, and again I want to salute you for 
excellent work. You made a very important point, which is, the 
budget numbers recommended by the Working Group are not plucked 
out of a hat. They are not arbitrary. They are tied to a 
planning process and to achieving specific goals, and that to 
me is the strength of your report.
    What has been NIH's reaction to your good work, to the 
funding levels? Are you satisfied with the reaction? And I 
realize I may be putting you in a little bit of a difficult 
spot. Maybe, though I am very pleased that Dr. Gorden has 
stayed for the hearing, I should have him go away for this 
part.
    Dr. Kahn. No, that is fine. But yes, I think that as you 
gathered from Dr. Gorden's testimony, they are caught in a bind 
in a sense that they have many initiatives brought to them and 
a limited budget.
    I think that NIDDK actually should be commended for, as Dr. 
Gorden pointed out, jump starting a number of things in this 
report. NIAID, the National Institute on Allergy and Infectious 
Disease, in this program that is partly through that institute 
and partly through NIDDK, and the JDF has also jump started 
some of the initiatives related to the autoimmunity. So there 
has been actually some very positive response by a number of 
institutes and institute directors, and attempts to use some of 
the existing funding to pick, if you will cherry pick some of 
the ideas from this report to see if they could not be jump 
started.
    Clearly, however, with the existing levels of funding that 
are available, the type of effort that we hoped could be 
achieved cannot be achieved. It will take a significant 
increase in diabetes research funding to achieve this, in part 
because these efforts really require a multidisciplinary, 
multifaceted approach. You heard from Dr. Bluestone that this 
immunology initiative alone is going to be $140 million over 7 
years, and we believe that our genetics initiative could be in 
the range of $100 million over 7 or 8 years, or maybe even 
more.
    So each of these initiatives, if we really want to 
concentrate and maximize the scientific opportunity, will take 
a very significant investment. Of course, we can do something 
with half that amount or a third that amount, but it will be 
half as much or a third as much. You cannot get the whole 
process for part of the price.
    So I think that NIH has made some efforts to actually use 
its resources to do this, but I think that they will be greatly 
enabled by, hopefully by the legislation or the recommendations 
that you have made and that have been passed by the Senate. And 
I think that that would allow the full magnitude of the report 
to really have its maximal impact.
    Senator Collins. I think that is a very important point, 
because given the state of the research, we really do need this 
infusion of funds and we need it now, if we are going to 
achieve the goals. And that is one reason I want to hold this 
hearing today, to try to give momentum and try to frankly put 
some pressure on NIH to keep pushing forward in this area, 
since I think it is very clear there is very strong 
congressional support for doing so.
    Dr. Bluestone, you gave a very lucid explanation of how the 
type 1 diabetes autoimmune--of the fact that it is an 
autoimmune disease. As I have read more about type 1 diabetes, 
it seems to me that islet cell transplantation has tremendous 
promise, but I do not understand how we are going to prevent 
the body from attacking the transplanted cells. Or at one point 
I thought, ``Why don't we just transplant pancreases? Why don't 
we?''
    I mean, maybe that is an option, but it seems to me you 
always have the problem of turning off whatever is causing the 
host body to attack the islet cells all over again. Is that 
part of your work? It sounds like that is part of the focus, is 
to figure out how, without using the kinds of powerful anti-
immune system drugs that cause so many other problems, we can 
tackle that issue.
    Mr. Bluestone. Yes. It is actually worse than that. The 
transplant has two problems. The first problem is what you 
said, which is, the autoimmune response which was ongoing in 
the patient before you put in the islets is still ongoing. The 
second problem is, you have now taken islet cells from another 
individual, like when you take a kidney, and you have that so-
called allo response, the foreign response, as well. So there 
are two responses you have to deal with. In kidney 
transplantation we only have to deal with one; in liver 
transplantation, only one.
    So you are right, it is a tremendous challenge, but the 
things that I was talking about, the ability to understand the 
basic mechanism by which the T cell recognizes both the 
autoimmune and the alloimmune response, is exactly what we are 
targeting right now. And what is very exciting is the fact that 
the transplant gives you is an opportunity to intervene just at 
the point when the T cell is just about to recognize the 
tissue.
    In an autoimmune patient, there is now data that at 6 
months of age there are already signs in the type 1 diabetic of 
an immune response against the pancreas, and it is progressive, 
so that by 6, 7, 8, and 10 years old it is to late, the patient 
is diabetic. With the transplant, we know when the transplant 
is going in, and we can now try to manipulate the immune 
response precisely at that time, which I think will give us a 
tremendous advantage.
    Finally, the only other point that I would make is that we 
do do pancreas transplants right now, and in fact they are 
rather successful. But one of the great opportunities in islet 
transplantation is the opportunity to be able to not only 
manipulate the islet cells so that when they go in they are 
less likely to be rejected, which is difficult in pancreas to 
do, but also the cost and morbidity associated with surgery and 
clinical care will be avoided.
    And then, finally, of course, are great opportunities led 
by places like the Joslin to try to create the ability to grow 
these cells, so that even though there are only about 4,000 
pancreases a year, that we might be able to treat the millions 
of people who are going to be able to take advantage of the 
technology.
    Senator Collins. And, as you pointed out in your testimony, 
the work you are doing also has implications for other 
autoimmune diseases like multiple sclerosis, I think you said.
    Mr. Bluestone. Yes. It is actually true that there is great 
opportunities. When I talk about this in public, I talk about 
Teflon and the space program. I truly believe that the outcomes 
of these kinds of research are often serendipity and 
unanticipated, and there is, from cancer to AIDS to the various 
autoimmune diseases, these are processes that are dealt with by 
the immune system over and over and over again.
    And what we have learned is that immune disorders really 
affect many diseases and dozens of diseases now, so I am 
optimistic that the basic research done in the area of diabetes 
will almost certainly have implications for many of these other 
diseases.
    Senator Collins. Dr. Leiter, you mentioned in your 
testimony that you are working with the NOD mouse to try to 
identify predictors, I believe, so that we could identify young 
people who are at risk for type 1 diabetes. Could you explain 
more about that research? That very much interests me, because 
perhaps if we can intervene at an earlier age, we can prevent 
some of the devastating consequences of diabetes, or figure out 
eventually how to switch off the cell that is causing the 
problem.
    Mr. Leiter. The basic approach that we have to predicting 
what the genetic makeup is for a program to get diabetes is 
marriage. We heard Dr. Kahn has just had a daughter married, 
and let us see, Mr. Jump I think just had his daughter married. 
Well, we choose different husbands and wives for NOD.
    The NOD mouse is really a replicate of just one single 
human being at risk to get insulin-dependent diabetes. So 
depending who we call in as a marriage partner, we come up with 
different genetic combinations that will lead us toward 
diabetes or away from diabetes. And sometimes, to our 
amazement, if we choose a certain marriage partner, the kind of 
diabetes that ensues may not be the same kind of autoimmune 
diabetes that the NOD has.
    So we see all kinds of complex intermixtures, telling us 
once again that genetically there are all kinds of ways to get 
diabetes. But with regard to pre-diagnosis, there is one major 
factor that tells us that the mouse really could get diabetes 
if the genetic program would allow it, and those are genes 
which tell the teachers of the T cells that Dr. Bluestone was 
talking about. There is a certain genetic component that tells 
these teachers of the T cells how to teach.
    And in humans at high risk for insulin-dependent diabetes, 
we can see that there are certain similarities between their 
instructional genes or T cell education and what the NOD mouse 
has. So genetically that is the first thing we look for, for an 
autoimmune genetic bad education, and that is true in humans as 
well. So there is a major genetic component in the mouse and in 
humans for type 1, and they are in the same place genetically.
    But after that, you really are limited to some of the 
immunologists' and the clinicians' tools, and that is, you look 
in the blood. You could either do what Dr. Bluestone might do, 
and pull out some T cells and show them something that the beta 
cell makes and ask, ``Do you recognize this, and if so, would 
you attack it or will you let it go?'' And if that recognition 
is there without letting it go, then you already know that 
mouse is on the road to developing type 1 diabetes and you darn 
well better think about doing something early if you want to 
stop that, and that is what Dr. Bluestone and his 70 other 
scientists are working on doing.
    The other thing you can do is measure antibodies. If the 
beta cell is being attacked by the T cells, then signs of the 
destruction are antibodies against beta cell components like 
insulin and other components. So if you see this combination of 
a major genetic component that leads to a bad education of the 
T cells, so they do not tolerate the way they should, so 
teaching tolerance is missing; if you see that the Beta cells 
are being attacked, as reflected by these immune signposts, and 
you could also do a glucose tolerance test, those would be 
signs in a mouse or a human that it is time for some sort of 
intervention.
    And that, of course, is what NIH is working with the JDFI 
and the ADA to develop, just the right kinds of interventions.
    Senator Collins. Thank you. I am fast reaching the end of 
my scientific knowledge. Once I get past the T cells and the 
beta cells and the islets, I am really on thin ice, but 
fortunately we can rely on the experts.
    Dr. Kahn, I had one other area that I wanted to raise with 
you. I think we heard from our panel of people coping with 
diabetes a very important point. Ryan mentioned it. In fact, 
all of them mentioned it, one way or the other.
    And that is that there is a common misperception about how 
serious diabetes is, and that the public does not understand 
how serious the disease is and how devastating the consequences 
can be. Ryan points out that if you take a classroom of 
students, you cannot tell who has diabetes and who does not by 
looking at them. Mr. Fuller talked about when he first learned 
his father had diabetes, he knew it had something to do with 
insulin and that was about it. Mr. Jump talked about that he 
was in denial at first about his own diabetes. Ms. Fernandes 
did not realize the risks of going blind at first.
    I think that part of the challenge that we face is the lack 
of public awareness about the severity of diabetes. Do you 
think that that lack of public understanding has contributed to 
the fact that diabetes research has been so severely 
underfunded?
    Dr. Kahn. That is a very tough question. I definitely would 
start off by agreeing with your perception, and by the 
perception that has been stated, that too many people believe 
that diabetes is not a serious disease, and it obviously is a 
very serious disease.
    I would actually say that the problem in a certain way is 
greater in the area of type 2 diabetes than type 1 diabetes. In 
type 1 diabetes, we are more sensitive to the fact that these 
are young children, that their life styles and their growing up 
period of their life is very disrupted with management of this 
disease. Their parents are obviously distraught, and they have 
to help manage this disease. And of course we talk about a 
lifetime of disease.
    We are perhaps a little less sympathetic to the older 
person who has diabetes, but who is equally devastated, and who 
may have in fact many more complications because of their age. 
They may already have heart disease or have kidney disease or 
have other chronic, debilitating diseases that only make the 
situation for them that much more complex. And Mr. Jump gave us 
some idea of even for an individual like himself, how many 
different medications and how many different monitorings he has 
to do.
    And both of these, even type 2 more than type 1, seem to be 
so silent. The type 2 diabetic individual, we have heard that 
as many as a third to a half of them don't even know they have 
the disease. And yet they are, during this period of silence, 
actually at risk for developing complications. Many times they 
present first with some of the complications, the neuropathy, 
the retinopathy, and so forth.
    I don't know if public awareness is the rate-limiting step 
in our research funding, because I think that obviously the ADA 
and the JDF have both done a lot to increase public awareness 
about this disease. But I think that it is perhaps one factor 
that has given somewhat less pressure or tension on this 
disease than on AIDS or cancer, which are such rapid 
devastating diseases. Here we have a slow and devastating 
disease.
    And I think that we need to be aware that because it is 
slow and because it looks like not much is going on, does not 
mean that not a lot is going on. And so I think that we do have 
to be cognizant of the fact that more people die of diabetes 
each year, by a factor of several fold, than die of AIDS, and 
more people will have diabetes complications of various sorts 
than many other diseases which are much more high profile.
    So I think that there is a need to realize how important 
this is. The economic impact I think also speaks to this. It 
tells you that there is a very big public health burden as well 
as a personal health burden. So I think that there are plenty 
of reasons that we should be more attentive to this disease. I 
think that Congress' initiatives, both on the House and the 
Senate side, have been tremendously helpful.
    And I hope that with this and with more funding for NIH, 
that institute directors like Dr. Gorden will have more 
resources to put into this disease, because I know that they 
would like to. He cannot say that but we can say that. He would 
like to do it, we would like him to do it, and I think that 
what he needs is a green light from you to go ahead.
    Senator Collins. And that he has.
    I want to thank you very much for your testimony today. I 
am trying to do my part to promote awareness of diabetes, not 
only through this hearing, but also today the Senate Diabetes 
Caucus which I chair is holding a free screening for Senate 
employees and for Senators. It is going to be held in the 
nurse's station on the first floor between the Hart and Dirksen 
Senate Buildings, and I encourage anyone to take advantage of 
the free screening today. I am going to do it myself, although 
having learned a lot about diabetes, I must say I am a little 
bit nervous about what the results may be.
    In all seriousness, I do want to thank all of our witnesses 
today. Again, I want to thank you for your dedication to 
diabetes research, for the excellent work that you are doing in 
your labs, for the exciting research that you have underway.
    I hope that I will be able to hold another hearing 5 years 
from now, if the voters of the State of Maine have the judgment 
to send me back for a second term, and that I will be able to 
hear of the exciting breakthroughs that you have accomplished 
because we have given you the resources that you need to 
achieve the goals set out in the Working Group's report. So I 
want to thank you very much for sharing your experience with us 
today.
    I want to thank all of our witnesses today for coming 
forward and sharing their unique perspectives. I particularly 
want to thank the people with diabetes who testified today. I 
think that it is so important that we do put the human face on 
this very serious disease, and without their very eloquent and 
moving testimony, this hearing would have been far different. 
So I want to thank particularly our second panel for coming 
forward today.
    I want to thank Dr. Gorden as well, and to assure him that 
he has the very strong support of Congress, he has that green 
light that Dr. Kahn referred to. I am very committed to 
continuing the fight against diabetes. We have learned a great 
deal today, and I think we have learned there is reason for 
great hope and optimism, that indeed the research is at a stage 
where we can see breakthroughs happening.
    It is very exciting what is going on, and I think that as 
long as NIH works with Congress to fully fund the 
recommendations of the Diabetes Research Working Group, that we 
will make the kinds of breakthrough that are going to allow us 
eventually to prevent and cure diabetes, as well as giving 
improved treatments and improved quality of life for those who 
are suffering from the disease right now.
    I also want to thank my staff, which has worked very hard 
on this hearing. Priscilla Hanley, of my personal staff, has 
worked very closely with me on all the initiatives I have 
undertaken for diabetes, as well as the members of the 
Subcommittee staff, particularly Lee Blalack, Elizabeth Hays, 
Mary Robertson, and Justin Tatram.
    I also want to thank again the American Diabetes 
Association and the Juvenile Diabetes Foundation for the 
expertise that they have provided me. I am going to continue 
the fight, as well, and I thank you very much for your 
contributions.
    The Subcommittee is now adjourned.
    [Whereupon, at 11:57 a.m, the Subcommittee was adjourned.]

                            A P P E N D I X

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