29. Klimt, C. R. and Meinert, C. L.: Design and methods of the University Group Diabetes Program. A study of the effects of hypoglycemic agents on late complications in insulin-independent adult-onset diabetics, abstracted, in Vth Congress of the International Diabetes Federation. Amsterdam, Excerpta Medica International Congress Series No. 74, 1964, p. 150. 30. Klimt, C. R., Meinert, C. L., Bearman, J. E.: The design and methods of cooperative clinical trials. Presented at 7th IBM Medical SymposiumPoughkeepsie, New York, October 1965.

31. Klimt, C. R. and Meinert, C. L.: The design and methods of cooperative therapeutic trials with examples from a study on diabetes, in Lasagna, L. (ed), Clinical Pharmacology, Section 6, Vol. 1, International Encyclopedia of Pharmacology and Therapeutics. Great Britain, Pergamon Press, 1966, pp. 341-373.

32. Klimt, C. R., Meinert, C. L., Ho, I. P., and Briese, F. W.: Study of familial patterns of reported diabetes. Evaluation of questionnaire data. Diabetes 16:40-50, 1967. 33. Klimt, C. R., Meinert, C. L., Miller, M. and Knowles, H. C., Jr.: University Group Diabetes Program (UGDP). A study of the relationship of therapy to vascular and other complications of diabetes, in Butterfield, W.J.H. and Westering, W. V. (eds), Tolbutamide. . . After Ten Years. New York, Excerpta Medica International Congress Series No. 149, 1967, pp. 261–269. 34. Klimt, C. R., et al: Standardization of the oral glucose tolerance test. Report of the Committee on Statistics of the American Diabetes Association. Diabetes 18:299-310, 1969. 35. Klimt, C. R., Knatterud, G. L., Meinert, C. L., and Prout, T. E., The University Group Diabetes Program: A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes, I. Design methods and baseline results. Diabetes 19 (suppl 2): 747-782, 1970. 36. Meinert, C. L., Knatterud, G. L. Prout, T. E., and Klimt, C. R., The University Group Diabetes Program: A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes, II. Mortality results. Diabetes 19 (suppl 2): 787-830, 1970.

37. Klimt, C. R., Miller, M., and Knatterud, G. L., The University Group Diabetes Program: A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes (Initial findings on blood glucose control and mortality), in Reports on Oral Diabetes Therapy Especially With HB 419. Amsterdam, Excerpta Medica, 1971, pp. 131–136. 38. The Coronary Drug Project Research Group: The Coronary Drug Project. Initial findings leading to modifications of its research protocol. JAMA 214:1303-1313, 1970. 39. The Coronary Drug Project Research Group: Control of hyperlipidemia, 4. Progress in drug trials of secondary prevention with particular reference to the Coronary Drug Project, in Jones, R. J. (ed), Atherosclerosis (Proceedings of the Second International Symposium). New York, SpringerVerlag, 1970, pp. 586-595. 40. Knatterud, G. L., Meinert, C. L., Klimt, C. R., Osborne, R. K., and Martin, D. B., The University Group Diabetes Program: Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes, IV. A preliminary report on phenformin results. JAMA 217:777-784, 1971. 41. The University Group Diabetes Program: Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes, III. Clinical implications of UGDP results. JAMA 218:1400-1410, 1971. 42. Klimt, C. R.: The University Group Diabetes Program-A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. Current Medical Dialog 38:1103-1110, 1971.

43. The Coronary Drug Project Research Group: The Coronary Drug Project. Findings leading to further modifications of its protocol with respect to dextrothyroxine. JAMA 220:996-1008, 1972.

44. The Coronary Drug Project Research Group: The natural history of myocardial infarction in the Coronary Drug Project. Prognostic indicators following infarction, on Tibblin, G., Keys, A., Werko, L. (eds), Preventive Cardiology. Stockholm, Almqvist & Wiksell, 1972, pp. 54-64.

45. Prout, T. E.. Knatterud, G. L., Meinert, C. L., and Klimt, C. R., The University Group Diabetes Program: The UGDP controversy-clinical trials versus clinical impressions. Diabetes 21:1035–1040, 1972.

46. Canner, P. L., Berge, K. G., and Klimt, C. R., The Coronary Drug Project Research Group: The Coronary Drug Project. Design, methods, and baseline results (AHA Monograph No. 38). Circulation 47 (suppl 1), 1973. 47. Knatterud, G. L., Klimt, C. R., Osborne, R. K., Meinert, C. L., Martin, D. B., and Hawkins, B. S. The University Group Diabetes Program: A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes, E. Evaluation of phenformin therapy. (Accepted by Diabetes for publication)

48. The Coronary Drug Project Research Group: Prognostic importance of plasma glucose levels after myocardial infarction. (In Preparation) 49. The Coronary Drug Project Research Group: The Coronary Drug Project. Findings leading to discontinuation of the 2.5-mg/day estrogen group. JAMA 226:652-657, 1973.

50. Klimt, C. R., Tominaga, S.: Principles and problems of clinical trials illustrated by findings from the University Group Diabetes Program and the Coronary Drug Project. Japanese J Clin Pharmacol 4:261-276, 1973.

Mr. FLOOD. Mr. Stenzler?

STATEMENT OF CARL STENZLER

Mr. STENZLER. Mr. Chairman, I am Carl Stenzler and I do apologize for the fact that I have only one copy of my statement.

Unfortunately, this diabetes was a problem that I had trouble coping with during the past week and very little work was consummated. So this was started at 5:30 this morning and I regret that I do not have copies with me, but I hope that I can make additional copies if you want them.

I am not unprepared in a knowledgeable sense. I am unprepared in a formal sense. I hope you will bear with me on that score.

I will read my statement.

I wish to thank the members of this distinguished committee for inviting me to speak as chairman of the Diabetes Institute.

Within the last several weeks the Governor encouraged and, through the Department of Health, we created a new nonprofit corporation to replace the temporary committee, Commonwealth of Pennsylvania Committee on Diabetes and Blindness. So I am using what is now in a state of transition, now the Pennsylvania Diabetes Institute, it has a legal structure and hopefully a prepetuity to its stay.

We are of course assuming that Governor Shapp will not remain Governor forever and this is a mechanism to make it as permanent as

we can.

As chairman of the Pennsylvania Diabetes Institute, I represent 25 members selected from the medical profession, the Pennsylvania State Legislature, and concerned laymen from all States. The institute is a permanent, nonprofit corporation that works in cooperation with the Pennsylvania Department of Health.

I am here today to plead the cause of millions of diagnosed, undiagnosed, and potential diabetics in this country today. Indeed, the disease which affects them is so devastating and so little understood that, unless we now fully commit ourselves to dealing with its horrible impact, millions of our citizens will die unnecessary deaths.

There is neither prevention nor cure for the disease. The cause is unknown. Its progressive, ultimately lethal impact on all body functions might be retarded with therapy, but not stopped. In 1969, diabetees mellitus was the eighth cause of death in the United States. Now, it is rated by Dr. George Tokuhata, professor of epidemiol

ogy and biostatistics at the University of Pittsburgh Graduate School of Public Health, as the third cause of death.

Experts disagree as to the direction of even stopgap or palliative therapy, treatment, and control. Early detection and control through insulin therapy neither prevents nor significantly retards the development of such sequential complications as blindness and heart disease.

Unquestionably, diabetes represents in the main a genetic defect, but its nature is unknown. The mechanism of the genetic defect can only be speculated.

Let me sketch the problem a little more fully. Diabetes is a systemic disease that can and does erode virtually every part of the body. In terms of our national health and well-being, it is a clear and present danger which must be heeded. Failure to do so will be at our peril, and at a financial cost to our Nation which cannot, and must not be sustained.

Every diabetic is a candidate for one or several complications: 50 percent of those who live with the disease for 10 to 15 years and 95 percent of those who survive for 25 years will suffer dreadful consequences for their genetic defect.

Ten million diabetics are in jeopardy of blindness, heart disease, kidney failure, stroke, vascular degeneration, hypertension, nervous system breakdown, sexual incompetence, or amputation.

The U.S. Health Service has identified diabetes as a major cause of new blindness. Most ophthalmologists look at diabetes as the first cause of all blindness in the United States.

Almost half of the patients with onset of diabetes under the age of 15 die of kidney disease.

Incidentally, diagnosis of nephropathy is literally a mark of it being fatal. Death is usually anticipated in 5 or 6 years and there is nothing that can be done about it.

Fifty percent of all diabetics blinded by retinopathy will be dead from heart, kidney, or brain disease within 5 to 10 years from onset. Dr. Theodore Cooper, Assistant Secretary for Health at the U.S. Department of Health, Education, and Welfare, recently testified before this committee that 75 percent of all diabetics suffer from terminal heart disease. The National Heart and Lung Institute has identified diabetes as a serious cause of heart disease; and that 65 percent of all heart patients have abnormal carbohydrate tolerance, which frequently leads to manifestation of the diabetes syndrome and can shorten a normal lifespan by as much as 50 percent.

Diabetes is the first cause of male impotence, and a serious cause of female sexual incompetence.

Diabetes is the first cause of pregnancy loss.

Diabetic mothers bear 15 to 20 percent more fetal waste, and three times as many malformed children as their nondiabetic counterparts. Brain damage is not uncommon among children of diabetics.

The life expectance of a diabetic is only two-thirds that of the general population. A diabetic child of 10 years can expect to live only 44 more years as compared with 62 years for a nondiabetic child. At age 30, the diabetic's remaining life may be only 30 years while a nondiabetic can look forward to another 42 years.

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Mortality among diabetics is higher at every age. Death rates are from 5 to 10 times greater in the general population among children and young adults and at least double in later life.

In 1935, there were 500,000 diabetics in the United States. In 1959, there were 2.930,000 diagnosed and undiagnosed diabetics.

In 1975, the American Diabetic Association stated that 10 million Americans, or 1 out of every 20 persons, is diabetic, diagnosed, undiagnosed, and potential. The association also reported that 1 out of every 4 persons is a carrier of the recessive gene that transmits the disease to children or grandchildren. It projects an increase of 1 million persons in the diabetic population every 3 years. Thus, by the year 2000, an additional 10 million persons may become diabetic.

The testimony which follows mine, given by my distinguished colleagues and comembers of the Pennsylvania Diabetes Institute, will clearly demonstrate the specific, devastating effects of diabetes mellitus on those parts of the body which are their specialty. Unfortunately, in the interests of time, experts dealing with all the systemic complications of the disease cannot testify. Therefore, I should like to refer the committee to the statistics detailing these problems attached at the conclusion of my statement.

As a layman, I wish to conclude my description of its devastation by entering into the record a copy of a letter I received from a 40year-old woman with juvenile diabetes. A copy of the letter is attached for your reference. (Read the letter.)

I am here today, on behalf of the institute, to request Federal funds for research into the causes of, and establishment of methods of prevention of, the primary and secondary effects of diabetes.

The Directors of the National Institutes of Health have testified before this committee, indicating not only how much Federal money is allocated to the study or prevention of diabetes, but how little money is allocated. To illustrate, the Director of the National Heart and Lung Institute testified that, for fiscal 1976, $5 million, or one-sixtieth of a budget of $300,000 for his institute was set aside for diabetes. As diabetes is attributed to approximately 25 percent of all heart patient deaths, and 75 percent of all diabetics die from heart disease, this figure is appallingly low.

I recognize that reduction in Federal health funds as proposed in the fiscal 1976 budget may be a necessary response to inflationary pressures. But it renders impossible adequate response to ongoing health programs, and prohibits the stimulation of new and much needed research and prevention of a previously untouched health problem such as diabetes. In fiscal 1964, the cost of health research was 4 percent of the total health cost of $35.9 billion. In fiscal 1974, this cost was still 4 percent of the now-increased $105.8 billion. Although obviously more real dollars were involved in 1974, general inflation rendered this an inadequate response to a growing problem.

I wish to commend this and past administrations for their efforts in health research, and especially, in regards to diabetes. However, I recognize that such attempts were severely limited because of the great lack of information on the subject, the general ignorance as to the nature and extent of medical complications, and the appalling inadequacy of Federal funds allocated for research and prevention.

Given the rapid geometric progression in the size of the diabetic population in this country, we can no longer tolerate this situation and sit idly by.

The Pennsylvania Diabetes Institute proposes that the budget of each National Institute of Health be increased by 3 percent, the funds to be earmarked for diabetes.

I acknowledge, of course, that everyone today is clamouring for more funds, and that inflationary concerns prevent existing moneys from being used with maximum effectiveness. But I must urge this committee to consider the loss of potential incoming revenues from income-producing citizens and the high out-going expenditures to and from the national treasury if funds for preventive research and ongoing complications are not made available.

Federal attention must not only be devoted to people who have already suffered, but to research to prevent others from suffering in the future. I hope that financial incentive can be provided to each of the Institutes so that they can coordinate their efforts. Their competing and conflicting goals and objectives for a small pot of money designed to deal with so vast a problem as our Nation's health must be rationalized and harmonized.

We must now commit ourselves to new, broadened attempts to dealing with a major killer and maimer of our Nation's people. We must reassess our national priorities and give proper, and long overdue consideration to whether or not people live or die.

STATEMENT OF DR. ARNALL PATZ

Mr. FLOOD. Our next witness is Dr. Patz, professor of ophthalmology at Johns Hopkins University School of Medicine.

Dr. PATZ. I am Arnall Patz, M.D., professor of ophthalmology, the Johns Hopkins University School of Medicine, and director of the Diabetic Retinopathy Center of the Johns Hopkins Hospital, Baltimore, Md. I appear before this committee representing the National Society for the Prevention of Blindness as a member of its board of directors and as a member of its public relations and public information committee. I am also here as a member of the Pennsylvania Diabetes Institute.

The diabetic patient, the public at large, and even some members of the medical profession have been lulled into a sense of false security on the assumption that adherence to a special diet and the use of prescribed doses of insulin will permit the individual with diabetes to lead a normal and productive life. Although these measures may control the blood sugar level, damage to small blood vessels throughout the body continues insidiously throughout the lifetime of most diabetic patients. For example, in the eye, damage to blood vessels in the retina affects 80 percent of diabetic patients after 20 years' duration of diabetes and 95 percent of patients having diabetes for 25 years show blood vessel damage in the retina. Fortunately, all of these individuals do not develop severe changes, but enough sustain severe retinal damage that diabetic retinopathy has become the largest cause of blindness in this country in individuals under 60 years of age.

With your permission, I would like to make one additional comment that is not in my written report. On our way up here today Mr.