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Secrecy. This study received widespread publicity in the 1970's. We responded to all questions about it at the time, including an open press conference. The study resulted in 13 published papers, nine DASA reports and 24 scientific presentations.

What about the status of total body irradiation and partial body irradiation since 1971? It is apparently a common misunderstanding that the use of these methods of treatment for therapy has been discontinued. This statement is incorrect.

Doses. Our doses were at a low level of 100 to 200 rads total volume. I might state there that in the documents that you have there is a typo. It says, 300. It should be 200. And up to 300 rads partial body radiation between 1960 and 1970.

In other centers, doses now range from 600 to 1,200 rads in single or divided doses of total body and with sequential hemibody radiation in these same dose ranges.

Fractionation, that is the splitting of these doses over a period of several days, has replaced single large doses of, say, 1,200 rads, because of the complication of radiation pneumonitis.

Among the solid tumors treated during these two decades have been cancers of the breast, prostate, lung, colon, and some sarco

mas.

At the University of Cincinnati Department of Radiation Oncology, from 1979 on, total and partial body radiation were administered to adults and children for leukemias, lymphomas, cancers of the breast, prostate, and neuroblastoma.

Nationally, uses of total body and partial body irradiation have grown steadily since 1970 and are used more widely today than ever before.

To conclude this presentation of several decades, I speak to you as a survivor of cancer, having been treated with radiation and surgery.

Our work has contributed significantly to the better treatment of patients with far advanced cancer and to our better understanding of the effect of radiation on humans in a time when nuclear warfare once again seems possible.

Thank you.
Mr. BRYANT. Thank you, Dr. Saenger.
[The prepared statement of Dr. Saenger follows:]

Statement of Eugene L. Saenger, M. D.

Before the House Judiciary Committee
Subcommittee on Administrative Law and Governmental

Relations
April 11, 1994
Cincinnati, Ohio

E.L. Saenger, M.D.

April 11, 1994

SUMMARY

Several important points are presented summarizing our work:

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a One purpose of the study was the treatment of patients with far advanced for whom the goal was the relief of pain, shrinkage of cancer and improvement in well being.

b.

A second purpose was to study the systemic effects of radiation on the patient.

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Treatment was given only if benefit to the patient was anticipated.

d Patients were chiefly from the Cincinnati-General Hospital. Selection was made only based on the presence of advanced cancer and where no other therapy was considered to be as or more efficacious than that currently available chemotherapy. Race, IQ, or socioeconomic standing were not selection factors.

e.

Treatment was paid for by Cincinnati General Hospital and the National Institutes of Health. No Department of Defense funds were used for treatment or patient care or decisions regarding therapy or patient reimbursement.

f. Patients were told that the treatment might help them and were cautioned that it might not. Some patients chose not to be treated.

There was nothing secret about our work. There was nothing secret as to its being conducted. There was nothing secret about the findings obtained.

E.L. Saenger, M.D.

April 11, 1994

I am Eugene L. Saenger, M. D. of Cincinnati. It is a privilege for me to speak before this distinguished sub-committee of the Judiciary Committee of the U.S. House of Representatives to present a summary of our work on the treatment of far advanced cancer and the effects of wide field radiation therapy, work which I was privileged to direct and the results of which I am proud. The participation and support of the highly qualified physicians, allied scientists and associated health professionals is gratefully acknowledged. My Curriculum Vitae is attached. (See Appendix 1)

I am a graduate of Walnut Hills High School, Harvard College, 1938, cum laude and University of Cincinnati, College of Medicine 1942. My training in Radiology was at Cincinnati General Hospital completed in 1945. I am a Diplomate of the American Board of Radiology and the American Board of Nuclear Medicine.

My major appointments at University of Cincinnati College of Medicine include rising from Assistant Professor of Radiology to Professor of Radiology from 1949-1987 and Professor Emeritus since then. I was the founder and director of (what continues today) the Eugene L. Saenger Radioisotope Laboratory from 1950 to 1987. I was Radiology Therapist at Children's Hospital from 1947 to 1987.

I have given over 40 guest and invited lectures in the U.S. and elsewhere. I have received the De Hevesy Nuclear Pioneer Award of the Society of Nuclear Medicine and the Gold Medal of the Radiological Society of North America and the Daniel Drake Award of the University of Cincinnati College of Medicine, these being the highest honors of these organizations.

My consultant appointments to my government encompass both domestic and international service, and include among others requests from the Department of Justice; Department of Energy; Environmental Protection Agency; Department of Health and Human Services; National Institutes of Health; Department of Defense; Food and Drug Administration: International Atomic Energy Agency; Oak Ridge Affiliated Universities; Surgeon General of the Air Force; the U. S. Public Health Service and numerous government administered hospitals. Additionally, I was proud to serve my country as an officer in the United States Army, attaining the rank of Major prior to my honorable discharge.

My principal appointments at the University of Cincinnati College of Medicine range from Assistant Professor of Radiology in 1949 rising to Professor, and from 1987, the rank of Professor Emeritus. I am a member of 29 medical and scientific societies and the Founding President of the Society for Medical Decision Making. In addition to being an honorary member of the National Council on Radiation Protection and Measurement (NCRP), I delivered the Sixth Lauriston Taylor Lecture--the highest honor of this organization. The NCRP is an organization chartered by Congress that develops recommendations for radiation safety used by Federal Agencies for protection of the public.

E.L. Saenger, M.D.

April 11, 1994

With my colleagues, I am the author of 187 publications in the scientific literature, the majority being in refereed journals.

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Several important points are presented summarizing our work:

A One purpose of the study was the treatment of patients with far advanced cancer for whom the goal was the relief of pain, shrinkage of cancer and improvement in well being.

B. A second purpose was to study the systemic effects of radiation on the patient.
с Treatment was given only if benefit to the patient was anticipated.

D. Patients were chiefly from the Cincinnati General Hospital. Selection was based only on the presence of advanced cancer and where no other therapy was considered to be as or more efficacious than then available chemotherapy. Race, IQ, or socioeconomic standing were not selection factors.

E Treatment was paid for by Cincinnati General Hospital and the National Institutes of Health. No Department of Defense funds were used for treatment or patient care or decisions regarding therapy or patient reimbursement.

F. Patients were told that the treatment might help them and were cautioned that it might not. Some patients chose not to be treated.

G There was nothing secret about our work. There was nothing secret as to its being conducted. There was nothing secret about the findings obtained.

11.

What Was The Purpose of The Total Body Irradiation (TBI)/Partial Body Irradiation (PBI) Study:

The primary goal of the study was to improve the treatment and general clinical management by increasing, if possible, survival of patients with advanced cancer and palliation of symptoms. (Palliation is treatment directed at relief but not cure.) In addition, observations and laboratory tests were carried out to seek effects of radiation on cancer patients and on the changes that could be ascribed to radiation.

The palliative effects of TBI were considered to be at least equal to and very likely to be superior to the chemotherapy available in the period from 1960 - 1970. Also the treatment methods

E.L Saenger, M.D.

April 11, 1994

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