DOE1.960219.000

MEDICAL INFORMATION SHEETS

RADIATION THERAPY FOR ACNE

RADIATION THERAPY FOR ASTHMA

BIRTHMARKS AND RADIATION

USE OF X-RAYS FOR BURSITIS

FLUOROSCOPY FOR SHOE-FITTING

RADIOACTIVE IODINE FOR DIAGNOSTIC AND THERAPEUTIC USES

RADIOPHOSPHORUS AND ITS MEDICAL USES

X-RAYS FOR RINGWORM

MEDICAL USES OF RADIOACTIVE ISOTOPES

MEDICAL, USES OF RADIUM

RADIATION THERAPY FOR SINUS CONDITIONS

THIOURACILS IN MEDICINE

IRRADIATION OF THE THYMUS GLAND - .

X-RAY THERAPY FOR WARTS

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DOE1.960219.001a

Synopsis:

Radiation, in the form of roentgen rays (now called x-rays), was used in the United States for the treatment of acne as early as 1902. Acne treatment by radiation continued until almost 1960.

What causes acne? Acne is the result of overactivity in the sebaceous glands (oil-producing glands located at the base of hair follicles) followed by an idammation of the hair follicles. Irradiation of these glands reduced their secretions and the inflammatory process. The beneficial results obtained fiom radiation therapy were attributed to shrinkage of the sebaceous glands and the reduction in oils that were produced. A comparison of acne treatments by vaccine, hormonal therapy, and split- doses of radiation showed that radiation produced the most favorable results. However, excess radiation could also produce skin burns, and physicians became increasingly concerned about potential side effects of radiation.

The treatment of acne with x-rays was discontinued over time in favor of less toxic and more effective drug therapy, hygiene (facial washing), and dietary restrictions.

References:

Miskjian, H. G. "X-Rays in the Treatment of Acne Vulgaris." Ohio State Medical Jotrriial, December 194 1, pp. 1177-1 179.

Kline, Paul R. and Gahan, Emanuel. "Unilateral Roentgen Irradiation in the Treatment of Acne Vulgaris." Archives of Dermatology and S'hilology, August 1942, pp. 207-2 10.

Pasieczny, T. and Grant, Peter. "Preliminary and Short Reports: A Comparison in the Treatment of Acne Vulgaris." m e Journal of InvestigatGe Dermatology, February 195 1, pp. 7 1-74

Way, Stuart C. "X-Rays vs. Other Modalities in the Treatment of Acne Vulgaris." American Medical Association Archives of Dermatology, January 1960, pp. 103-1 09.

Prepared September, 1994 By the Office of Human Radiation Experiments of the Department of Energy

L.. DOEl.960219.001 b

Synopsis:

The therapeutic effect of radiation in the management of allergic diseases, especially asthma, was investigated by medical doctors in 1906. Probably the first systematic treatment of asthma by x-rays in this country was practiced at the Mayo Clinic in 193 1. Thousands of children and adults with asthma were treated with radiation from x-rays or radium during the 1930s and 1940s.

Why was radiation used to treat asthma? Hypertrophied (swoIlen) and infected lymphoid tissues (adenoids) were frequently found in children suffering from bronchial asthma. Such asthmatic children were usually sensitive to one or more airborne allergens as well. The infected tissue served as a focus when the children were exposed to bacteria (colds) and often contributed to the asthmatic episode. Radiation therapy was effective in reducing tissue mass, and therefore was thought to be a valuable and effective treatment in selected cases of asthma in children in whom some or all attacks were precipitated by respiratory infections.

Children with asthma of over two years duration were treated with x-ray or radium irradiation of the nasopharynx (nose and throat). Radiation treatments were typically administered in a series of three irradiations lasting six to ten minutes every few weeks. If a second series was required, it was generally given six to twenty-four months later. Since there was no marked difference in results between the patients treated with radium and those treated with x-rays, a combination of both was often used. Improvement for periods from six months to four years was noted in 80 percent of those treated with no particular tendency to recurrence.

The use of radiation therapy for the treatment of asthma was discontinued by about 1960 in favor of less toxic and more effective drug therApy.

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References:

Hull, Wayne M. et al. "The Therapeutic Value of Roentgen Treatment in Chronic Asthma." American Journal of Roentgenolou, February 1943, pp. 227-233.

Cohen, Victor L. and Fisher, Wilbur J. "An Evaluation of Radium Treatment to the Nasopharynx in Asthmatic Children." Jotrrnal of Aljergy, September 1949, pp. 328-334.

Spain, W. C. and Weymuller, E. A. "Irradiation of the Nasopharynx: Its Importance in the Treatment of Bronchial Asthma in Children Between One and Sixteen Years of Age." Annals of Western Medicine and Surgery, October 1949, pp. 346-350.

Mueller, Harry L. and Flake, Carlyle G. "Irradiation of the Nasopharynx in Children with Infectious Asthma." New England Jozrrnal of Medicine, June 12, 1952, pp. 924-927.

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Rackernam, Francis M. "The Management of Asthma. " m e Medicat Clinics of North America, September 195 pp. 1305-13 1 1

Sheldon, John M. "A Rounded Approach to Asthma Therapy." Seminar Report of the Merck Sharp and Dohmc Winter 1959, pp. 22-28.

Prepared September, I994 By the ODce of Huniaii Radiation Experiments of the Deparhient of Energy

Synopsis:

The term 'birthmarks' or nevi encompasses a wide variety of colored or non-colored malformations of the skin. A family of birthmarks ranging range in color from pink to deep purple are related to the capillary system. This group of birthmarks includes the common portwine and strawberry stain marks. During the 1940s a variety of treatments was employed to eradicate or decrease the size of these marks. Radium treatment was commonly and successfblly used in the case of strawberry birthmarks and the deeper type associated with this group. However, radium treatment was found to have little effect on the portwine stain type of birthmark. The success of this therapy was found to be directly related to age, Therefore, radiation therapy was most commonly used in younger patients. Radon seed implantation was recommended as an alternative treatment for both strawberry marks and the deeper marks. Seeds had the advantage of reduced medical follow-up. Birthmarks other than those of this family were found to be relatively insensitive to radiation and were most frequently treated by surgery, cauterizing with electricity, or freezing with carbon dioxide.

Today, radiation has been replaced with newer methods for treating birthmarks. The laser has replaced radiation as a more safe and effective therapy.

References:

Watson, William. "Blood and Lymph Vessel Tumors. " Surgery, GynecoZogy, and Obstetrics, November 1940, pp. 569-588.

Bailey, Wilbur and Kiskadden, William. "Treatment of Birthmarks." California and Western Medicine, November 1943, pp. 265-268.- .-

Hodge, Harry M. "Birthmarks. '' Mississippi Valley Medical Jozrrnd, May 195 1 , pp. 76-78.

Berkow, Robert (ed). 7he MerckMamal of Diagnosis and Treatment, 1987.

Prepared September, 1994 By the OfJice of Human Radiation Experiments of the Deparfmenf of Eilergv

. . DOE1.960219.001d

Synopsis:

The bursa is a sac-like cavity filled with fluid at locations in the body where friction occurs, such as where tendons or muscles pass over bones of the shoulder, elbow, knee, and heel. The bursa aids movement and prevents friction between the moving parts. Bursitis is an inflammation of the bursa. The causes of bursitis are thought to be trauma, overuse, infection, arthritis, or gout. Bursitis was treated with rest, splints, heat, physical therapy and surgery. Local injections of anesthetics such as novocain into the joint were also used to treat bursitis.

X-ray therapy was used by physicians to treat bursitis during the 1940s and 1950s. It was considered to be a common and acceptable practice of that era. Radiation reduced tissue mass, which made bursitis less painful. The use of x-ray therapy.for the treatment of bursitis was discontinued by about 1960 in favor of less-toxic and more-effective drug therapy (anti-inflammatory agents, steroids, pain medication), aspiration of the joint, surgery, and other conservative measures (such as rest, splinting, and exercise).

References:

Weinberg, Tobias B. "Arthritis and Para-Arthritis Treated with the Roentgen Ray." The American Joicrnal of Roentgenology and Radium Therapy, March 1940, pp. 4 16-424.

Abel, Martin S . and Lomhoff, Irving I. "The Treatment of Bursitis and Peritendonitis Calcarea of the Shoulder Joint by Roentgen Therapy." PeFnzanente Foicndatioii Medical Bulletin, July 1949, pp. 90-93.

Lattomus, W. W. and Hunter, L. M. "Roentgen Therapy of Subdeltoid Bursitis." Delaware State Medical Journal, July 1949, pp. 115-1 17.

N e 6 Floyd E. and Anderson, C. Max. W e of Ultraviolet Blood Irradiation in the Treatment of Bursitis and Tendinitis Calcarea." American Jorcrtial of Surgery, June 195 1, pp. 622-628.

Mann, Lawrence S . "Treatment of Subdeltoid Bursitis with Roentgen Therapy." Journal of the International College of Surgeons, September 1952, pp. 385-388.

Garber, Robert L. "Some Observations on Roentgen Therapy of Bursitis and Peritendinitis Calcarea of the Shoulder. 'I n e Ohio Stale Medical Joirrnal, October 1952, pp. 91 8-9 19.

Shoss, M. and Otto, T. G. "Roentgen Therapy of Subdeltoid Tendinitis and Bursitis." Missozrri Medicine, November, 1955 pp. 855-863.

The MerckManuuI of Diagnosis and Xkerapy, Fifteenth Edition, 1987, pp. 1267-1268.

Prepared September, 1994 By the Office of Human Radiation Experiments of the Department of Energy

DOEl.960219.001e .- .

Synopsis:

Fluoroscopy was a common practice during the 1940s and 1950s in many shoe stores and department stores (particularly those specializing in children's shoes) for measuring foot size and supplementing other usual methods of shoe-fitting. So-called "x-ray shoe fitters" were considered to be a modern and harmless application of x-ray technology. These devices consisted of an x-ray tube housed in a case lined with lead or steel and containing a fluorescent screen. The unit was equipped with an opening for the customer's feet and three viewing openings through which the customer, clerk, and one other person could observe the screen. A push-button automatic timer, which could be set for any predetermined time, was included on most installations. In actual use, exposure times were found to vary from 5 to 45 seconds, although 25 seconds appeared to be the most popular setting. Repeated exposures could be made by releasing and pushing the button. Later models were equipped with three separate switches providing three different intensities -- one for men, one for women, and one for children.

Excessive use of fluoroscopy devices, however, was found, in some cases, to cause skin burns and abnormal foot growth in children. A series of studies were begun in 1949 to determine radiation exposures received by customers, clerks, and other persons from the x-ray shoe-fitting units. Radiation doses to feet, leakage through the walls of the cabinet, and scattering from the opening in which the customer placed his feet were measured. Recommendations were made to add more lead shielding, to educate store employees about the potential harmfbl effects of radiation, and to minimize use of fluoroscopy devices and viewing times to minimize the potential for radiation injury to customers and employees.

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The use of the shoe-fitting fluoroscopes was mostly discontinued by about 1960, because it was I

recognized that such devices were not actually needed to properly fit people with shoes, and that the potential risks of radiation exposure exceeded the benefits.

References:

Hempelmann, L. H. "Potential Dangers in the Uncontrolled Use of Shoe-Fitting Fluoroscopes. I' New England Jozrrnal of Medicine, September 1, 1949, pp. 335-336.

Williams, Charles R. "Rgdiation Exposures from the Use of Shoe-Fitting Fluoroscopes. I' New EngZand JournaZ ofMedicine, September 1, 1949, pp. 333-335.

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Bumstead, H. E. and Spolyar, Louis W. "Are the Shoe Fitting Fluoroscopes a Health Hazard to the Public in Indiana?" Journal of the Indiana Medical Association, May 195 1, pp. 376-378.

Dyson, E. D. "Shoe-Fitting X-Ray Fluoroscopes: Radiation Measurements and Haz'ards. " British Medical Journal, August 4, 1956, pp. 269-272.

Prepared September, 1994 By the O f f e of Human Radiation Experiments of the Department of Energy

. a DOEl.960219.001f \

RADIOACTIVE, IODINE FOR DIAGNOSTIC AND THE~RAPEUT

Synopsis:

Nuclear medicine has found its earliest application in the study, diagnosis, and treatment of the thyroid gland and thyroid disorders. The affinity of the thyroid for iodine permits the use of radioisotopes as both a diagnostic tool and as a therapeutic agent. Radioactive iodine (1-131 and other isotopes of iodine) has been used in medical applications since the early 1940s, when it became available in commercial quantities. By the mid 1 9 5 0 ~ ~ nuclear medicine procedures using radioiodine had gained wide acceptance within the medical community.

Radioactive iodine is used to diagnose hyperthyroidism, such as Toxic Goiter, Graves' Disease, or Basedow's Disease and to evaluate problems after the surgical removal of the thyroid. I- 13 1 is used also in the diagnosis of cancer of the thyroid.

As a therapy radioactive iodine has proven to be the most effect artificial radioisotope. Initially reported as'a treatment for hyperthyroidism in 1942,I-13 1 remains a principle therapy today. There has been no proven increase in tumors, leukemia, or cancer with this therapy in young patients. However, the treatment is avoided with pregnant or breast-feeding women. Radioactive iodine therapy avoids the potential side effects associated with chemical medications.

Two approaches have been used with radioactive iodine as treatment for thyroid cancers. I- 13 1 may be used alone to provide concentrated internal radiation to the cancer without serious damage to surrounding tissues posed by external radiation such as radium or x-ray treatment. Radioactive iodine may be also used in conjunction with surgery. In this case total or partial removal of the thyroid is routinely followed by treatment with radioactive iodine. .

References:

Wasserman, Louis Robert and Loevinger, Robert. "Use of Radioactive Isotopes in Medicine. 'I Advances in Internal Medicine, Volume IV, 1950, pp. 77- 160.

Gordon, E. S. and Albright, E. C. "Treatment of Thyrotoxicosis with Radioactive Iodine." The Joiirnal of the American Medical Association, July 29, 1950, pp. 1 129- 1 132.

Curtis, George M. "Iodhe in the Atomic Age." Journal of the American Pharmaceutical Association, October 1951, pp. 479-487.

King, E. R. "Present Status of Radioiodine in Thyroid Disease." Medical Annals of the District of Columbia, September 1956, pp. 473-484.

Domnitz, J. et. al. "The Evaluation of 1-13 1 Therapy of Grave's Disease." Archives of Internal Medicine, August 1960, pp. 194-204.

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Rosenthal, D. J. and Lawrence, J. H. "The Use of Radioactive Isotopes in Medicine." Medical Clinics of North America, September 1956, pp. 15 15- 1543.

Berkow, Robert(Ed). The Merck Manual of Diagnosis and Treatment, 1987. I

Prepared September, I994 By the O f f e of Human Radiation Experiments of the Department of Energy

t -' " DOEl.960219.001 g

DIOPHOSPHO USES \ *

Synopsis:

Radioactive phosphorus (P-32) was first produced in cyclotron at Berkeley in 1936. Medical applications were found for P-32 in the diagnosis and treatment of a wide variety of disorders, including acute and chronic leukemia, Hodgkin's disease, polycythemia vera, eye tumors, and various other forms of cancer. It was also used to reduce the pain of bone cancer and bone metastases from other forms of cancer. Radiophosphorus was administered either orally or intravenously in both diagnostic and therapeutic amounts.

The most successfbl medical application of P-32 was the treatment of polycythemia vera, a condition in which there is an increase above the normal level of red cells in the blood. Symptoms of this disorder are weakness, headache, light-headedness, visual disturbances, fatigue, and shortness of breath. Since the cause of polycythemia vera is not well established, treatment seeks to reduce the severity of symptoms rather than eliminate the disease entirely. The treatment is well tolerated by most patients and requires little follow-up once the disease is controlled. However, P-32 therapy is also associated with an increased incidence of acute leukemic transformation. For this reason P-32 treatment has generally been discontinued in favor of other standard chemotherapy regimens. An alternative, radioactive strontium-89-chloride, was recently approved as an agent for reduction of pain from bone cancer.

References:

Erf, Lowell A. et. al. "Radioplio.Sphorus--- An Agent for the Satisfactory Treatment of Polycythemia and Its Associated Manifestations." Antials of InternalMedicirie, October 1943, pp. 587-60 1.

Warren, Shields, "The Retention of Radioactive Phosphorus in Leukemic Patients." Cancer Research, December 1943, pp. 872-876.

Warren, Shields. "The Therapeutic Use of Radioactive Phosphorus." The American Joztrnal of Medical Sciences, June 1945, pp. 701-711.

Erf, Lowell A. "Radiopbosphorus as the Treatment of Choice in Primary Polycythemia." American Journal of Medicine, October 1946, pp. 362-366.

(coniinited on oiher side)

Doan, C. A. et. al. "Radioactive Phosphorus, P-32: A Six-Year Clinical Evaluation of Internal Radiation Therapy." Journal of Laboratory and Clinical Medicine, August 1947, pp. 943-969.

-Friedell, H. L. and Storaashi; J. P. "The Therapeutic Application of Radioactive Phosphorus with Special Reference to the Treatment of Primary Polycythemia and Chronic Myeloid Leukemia." Journal of Clinical Investigation, November 1949, pp. 1308- 1323.

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Cooper, William M. "Clinical Experiences in the Use of Radioactive Phosphorus." American Practitioner, October 1951, pp. 852-854.

D u q , Jr., B. J. et. al. "Radiophosphorus (P-32) in Diagnosis and Treatment." New York State Journal of Medicine, March 1, 1952, pp. 551-554.

Abbatt, J. D. et. al. "Recent Advances in the Treatment of Polycythemia Vera." The Practitioner, March 1952, pp. 243-248.

Harmon, J. B. "Treatment of Polycythemia with Radioactive Phosphorus." British Medical Jour;aZ, April 16, 1955, pp. 930-934.

Berkow, Robert, Ed. n e Merck Maniral of Diagnosis and Treatment, 1 987, pp. 1 13 8- 1 14 1 .

Prepared September, 1994 By the OfJice of Human Radiation Experiments of ihe Department of Energy

DOE1.960219.001 h

Synopsis:

Ringworm is a fingus infection affecting the skin on various parts of the body. The type of ringworm (tinea capitis) that affects the head and scalp is particularly difficult to cure and can become epidemic in younger children. X-ray treatment for ringworm was first advocated in Europe in 1904 and the procedure was standardized in 1907. X-ray treatment was improved during the early part of the century and became a generally accepted practice among dermatologists during the ringworm epidemic of the 1940s and 1950~~ both in the United States and in England. The procedure was considered to be painless and harmless, and was therefore recommended for unrestricted use. As late as 1956, x-ray treatment for hair removal was still practiced as a method to treat ringworm, particularly in the most stubborn cases. New oral and topical anti-fingal ointments have replaced X-rays and have reduced treatment for ringworm to approximately two to four weeks.

References:

Lewis, G. M. et. al. "Measure to Prevent and Control an Epidemic of Ringworm of the Scalp." New York State Joitrnal ofMedicine, June 15, 1944, pp. 1327-1333.

Pendergrass, Eugene P. and Mahoney, Francis. "A Consideration of Roentgen Therapy in Producing Temporary Depilation for Tinea Capitis." Radiology, April 1948, pp. 468-475.

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Brain, R. et. al. "Treatment offingworm of the Scalp." BritishMedical Joitrnnl, April 17, 1948, pp. 723-726.

Beare, J. Martin and Cheeseman, E. A. "Tinea Capitis: Review of 1004 Cases." The British Journal of Dermatology, May 1951, pp. 165-186.

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Crossland, Paul. "Therapy of Tinea Capitis." California Medicine, May 1956, pp. 35 1-353.

. Prepared September, I994 By the OfJice of Human Radiation Experiments of the Department of Etzergy

DOEl.9602 19.001 i

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Synopsis:

Radioactive materials (radioisotopes) have been used in medicine for the diagnosis and treatment of cancer and various other medical conditions since their discovery in 1895. All radioactive isotopes emit rays (or energy) which give them their special value to medicine. These rays are generally used to destroy or alter the fbnction of cells in an effort to eliminate the medical condition. Physicians use radioactive isotopes with caution and carehlly select the isotope used according to the type of energy it emits, its decay rate and radioactive lifetime, natural metabolism in the body, and other useful chemical properties.

Radium was used primarily in the treatment of tonsillitis, chronic ear infections, birthmarks, acne, thymus conditions, ringworm, warts, and various cancers. Radium needles were used to treat oral tumors. Radium has been generally discontinued in favor of other approaches.

Radioactive iodine is used in the treatment of overactive thyroid glands, thyroid cancers, and heart disease (chest pain and congestive heart failure). Radioactive iodine is also used to identie the sites of new cancers that have spread from the thyroid gland. It is still one of the most widely used isotopes in modern nuclear medicine.

Radioactive phosphorus was used to treat polycythemia vera (the excessive production of red blood cells), leukemia, Hodgkin's disease, eye tumors, and various other cancers, and to reduce pain associated with bone cancer.,

Radioactive cobalt has been used to treat various cancers (such as bladder, breast, cervix, lung, mouth, throat) as an external source of gamma rays.

Other radioactive isotopes used in the diagnosis and treatment of disease include those of the elements: iron, copper, zinc, chromium, carbon, potassium, sodium, nitrogen, beryllium, magnesium, arsenic, sulfur, yttrium, calcium, technetium, rhenium, strontium, and gold.

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Care is taken in the use of radioisotopes to maximize radiation dose to cancer cells while minimizing dose to normal tissues.

References:

Low-Beer, Bertram V. A., et al. "The Therapeutic Use of Artificially Produced Radioactive Substances." Radiology, November 1942, pp. 573-597.

Isotopes Branch, U. S . Atomic Energy Commission. "The Isotope Distribution Program. ' I Science, August 29, 1947, pp. 175- 179.

Krusen, Frank H. "Atomic Energy in Medical Practice." n e Medical Clinics of North America, September 25, . 1947, pp. 972-98 1.

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"Atomic Energy in Clinical Medicine." General Practice Clinics, Septembe, 1949, pp. 43 5-492.

"Benefits from Atomic Energy." General Practice Clinics, October 1949, pp. 493-548.

Loutit, J. F. "Current Therapeutics: Radioactive Isotopes." The Practitioner, January 1950, pp. 77-82.

Barnes, Allan C. et al. "The Use of Radioactive Cobalt in the Treatment of Carcinoma of the Cervix." American Journal of Obstetrics and Gynecology, November 1950, pp. 11 12- 1 120.

Lampe, Isadore. "Medical Applications of Radiations and Radioactivity. I' Indiatrial Medicine and Surgery, May 1951, pp. 221-226.

Looney, William B. "The Initial Medical and Industrial Use of Radioactive Materials (1 91 5-1 940), American Journal of Roentgenology and Radium Therapy, November 1954, pp. 83 8-848.

Perryman, C. Richard and Evans, John C. "The Advantages and Disadvantages of Cobalt 60 Teletherapy." The Pennsylvania Medical Journal, October 1956, pp. 1236-1239.

Burkell, C. C. and Watson, T. A. "Some Observations on the Clinical Effects of Cobalt-60 Telecufie Therapy." The American Journal of Roentgenology arid Radium Therapy, November 1956, pp. 895-904.

Koeck, George P. "Cobalt Radiotherapy." The Journal of the Medical Sociew of New Jersey, November 1956, pp. 544-547.

Prepared September, I991 By the OfJice of Human Radiation Experiments of the DeparMent of Energy

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Synopsis:

Radium was first used as a medical therapeutic agent in North America in about 1904. Dissolved radium in water was thought to have some medicinal quality. Gamma radiation fiom radium sources was used both internally and externally, primarily for treatment of cancers such as those of the brain, larynx, esophagus, stomach, rectum, breast, bladder, testicles, prostate, cervix, ovary, uterus, and also for diffise cancers such as Hodgkin's disease, lymphosarcoma, and leukemia. Radiation from radium was also used to treat other non-malignant medical conditions and growths, such as goiters, enlarged thymus gland, thyroid disorders, nasal polyps, eye infections, and certain bone disorders.

Radium tubes were used extensively during the 1950s and 1960s for the treatment of chronic tonsillitis and enlarged adenoids, and for reduction of lymphoid tissue following tonsillectomy and/or adenoidectomy, reduction of thymus gland (to prevent crib death), acute and chronic ear infections (otitis media), ear trauma (aerotitis media) suffered by World War I1 pilots and Navy divers, birthmarks, acne, ringworm of the scalp, and various hearing disorders (mild tone deafness in children).

The anticipated effect of radium therapy was a slow reduction in the mass of tissue, so that the tissue flattened and became thinner. Tissue folds, pits, or crevices opened and shrank after exposure to radiation. This made radium the treatment of choice by some physicians for conditions where inflamed or swollen tissues were problematic. Radiation therapy was generally given in a series of three or four treatments over two weeks, and was repeated, if necessary, after six months. -

Since gamma radiation originated from external radium sources, the skin usually received the highest dose. The use of radium rods, needles, and seeds avoided skin exposure, and allowed the radiation to be applied internally, and then be completely removed from the patient. However, side effects such as tissue scaring and increased incidence of thyroid cancer were associated with radium therapy. Therefore, the use of radium as a therapeutic agent was discontinued before 1960 in favor of less toxic and more effective treatments, such as antibiotics and surgery.

References:

Charteris, Alexander A. and Thomson, John. "The Radium Beam Therapy Unit at the Western Infirmary, Glasgow." British Journal of Radioiogy, December 1939, pp. 692-695.

Shaw, Dwight B. "Radium." Mississippi Valley Medical Journal, January 1939, pp. 67-68.

Cipollaro, Anthony C. "Dangers Incident to the Indiscriminate Use of Radium Compounds or Radon in the Treatment of Cutaneous Diseases." Journal of the American Medical Association, December 7 , 1940, pp. 1996- 1998.

Perry, Gentz. "The Practical and Economic Phases of X-ray and Radium Therapy. 'I Illinois Medical Journal, March 1940, pp. 247-250.

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Simpson, Frank E. "History of Radium Therapeutics." Illinois Medical Joiirnal, June 1940, pp. 598-604. -

"Medical Uses of Radium. I' British JownaI of RadioIogy, January 194 1, pp. 1 - 10.

"Medical Uses of Radium." British Jotirnal of Radiology, February 1942, pp. 56-62.

Fricke, Robert E. "Annual Report for 1942 of the Section on Radium Therapy." Proceedings of the Staff Meetings of the Mayo C h i c , October 20, 1943, pp. 396-399.

"Medical Uses of Radium." British Jozrrnal of RadioIogv, March 1944, pp. 96-100.

Fricke, Robert E. and Bowing, Harry H. "Annual Report of the Section on Radium Therapy for 1944." Proceedings of the StaflMeetings of the Mayo C h i c , December 12, 1945, pp. 473-478.

Fricke, Robert E. and Bowing, Harry H. "Annual Report of the Section on Radium Therapy for 1946." Proceedings of the StaflMeetings of the Mayo Clinic, October 29, 1947, pp. 505-508.

Martin, Charles L. "Low Intensity Radium Element Needles." Janeway Lecture 1949. American Journal of Roentgenology and Radium nerapy, October 1949, pp. 467-492.

Morrison, Wallace. "Radium and the Lymphoid Tissue of the Nasopharynx and Pharynx.'' Archives of OtoIaryngoIogy, September, 1949, pp. 300-308.

Fricke, Robert E. and Van Herik, Martin. "Report on Radium Therapy for. 1950." Proceedings of StafMeetings of theMayo C h i c , August 1, 1951, pp. 306-308.

Fricke, Robert E. and Van Herik, Martin. "Report on Radium Therapy for 195 1 .I' Proceedings of StaffMeetings of theMay0 Clinic, August 13, 1-952, pp. 337-340. .

Quimby, Edith H. "The Background of Radium Therapy in the United States, 1906-1956." American Journal of RoentgenoIogy, March 1956, pp. 443-450.

Raloff, Janet. "Reassessing Radium's Risks. I' Science News, September 10, 1994, pp. 1 72- 1 73.

Prepared September, I994 By the ODce of Human-Radiation Experiments of the Department of Energy

DOEl.960219.001 k

Synopsis:

During the 1940s and 195Os, radiation was considered an acceptable therapy for relief of sinus I

blockages and infections. X-rays from cathode-ray tubes and gamma radiation from radium tubes were used as radiation sources. The most notable effect of roentgen (x-ray) therapy for sinus problems was the relief of pain and headache. This relief of pain was often accompanied by a noticeable increase in sinus discharge, so it was thought that the effect of x-ray therapy on the sinuses was a reduction in the swelling of the tissues and release of mucous buildup. Roentgen therapy was generally not used as the sole therapeutic agent in cases of acute sinusitis but as an adjunct therapy, especially in regard to relief of symptoms. Thus, it was believed that symptomatic relief was evidence of the effectiveness of this type of treatment.

Severe side-effects, such as scarring and the increased incidence of head and neck tumors were eventually associated with radiation therapy for sinus conditions. The treatment of sinus conditions with x-rays was discontinued by 1960 in favor of less toxic and more effective drugs, medications, and surgery.

References:

Williams, Henry L. and Popp, Walter C. "Roentgen Therapy for Acute Sinusitis." Annals of Otology, Rhinology, and Laryngology, September 1940, pp. 749-754.

Freund, E. Martin. "Sinusitis in Children and Infants." Nau York State Jotirnal of Medicine, July 1, 1952, pp. 1660- 1662.

Schenck, Samuel George and Seldowitz, Morton. "Sinobronchitis in Children." Mississippi Valley Medical Journal, November 1952, pp. 177- 180.

Van Alyea, 0. E. "Recent Trends in the Non-Surgical Management of Nasal Sinusitis." The Eye, Ear, Nose and Throat Monthly, August 1956, pp. 489-492.

Prepared September, I994 By the O f f e of Human Radiation Experiments o j the Department of Energy

DOEl.960219.0011

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Synopsis:

Thiouracil , medically known as "Deracil," and similar compounds have been used to treat thyroid disorders since the early 1940s. This class of compounds provides a non-radioactive alternative therapy to radioactive iodine or surgical removal of the thyroid in cases of thyroid cancer.

Hyperthyroidism is a family of disorders including Graves' disease, Basedow's disease, and Plummer disease, and is characterized by an excess production of thyroid hormones. Common signs of hyperthyroidism are goiter, tremor, and moist skin. The most frequent symptoms are nervousness, increased activity, increased sweating, increased sensitivity to heat, fatigue, increased appetite, and weight loss. The most common treatment for hyperthyroidism is radioactive iodine. However, radioactive iodine is not advised for pregnant women or breast-feeding mothers. In these cases, thiouracils are the medication of choice to return the thyroid hormone levels to normal. Surgical removal of the thyroid may be avoided by stabilizing and maintaining the patient on thiouracil medication and synthetic thyroid hormone.

The first successfbl reports of thiouracil appeared in the medical literature in 194 1. Thiouracil was replaced by less toxic medications having similar chemical structures. Today the compound propylthiouracil is used with minimal adverse effects. Potential side effects are nausea and loss of taste. Thiouracils have also been used to treat angina pectoris (a severe, constricting pain in the chest usually associated with coronary disease) and congestive heart failure.

.

-

- .- References:

Hettig, Robert. "Recent Advances in Treatment of Leukemias and Lymphomas. Texas State Journal of Medicine, November 1947, pp. 439-445.

King, B. T. and Roselline, L. J. "Treatment of Acute Thyroiditis with Thiouracil." Journal of the American Medical Association, September 22, 1945, pp. 267-268.

Rinkoff, Solomon and Tandatnick, Joseph. "Report on Thiouracil Therapy in 26 Case of Thyrotoxicosis." Journal of the NationalMedicaI Association, November 1945, pp. 188-191.

Lahey, F. H. et. al. "Thiouracil -- Its Use in the Preoperative Treatment of Severe Hyperthyroidism." Surgery, Gynecology, and Obstetrics, October 1945, pp. 425-439.

Berkow, Robert (ed.). n e Merck Manual of Diagnosis and Treatment, 1987.

Budavari, Susan (ed.). The Merck Index, 1989.

Prepared September, 1994 By the Office of Human Radiation Ejcperiments of the Department of Energy

DOE 1.9602 1 9.001 m .

c Y

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Synopsis:

The exact purpose and function of the thymus gland was relatively unknown in the 1940s. However, a number of experienced medical doctors thought that an enlarged thymus, particularly in newborns and young children, caused stridor (noisy respiration caused by obstruction of the airway), shortness of breath, suffocating spells, cyanosis (bluish coloration of the skin due to insufficient oxygen in the blood), and crib death. In many cases, physicians treated the enlarged thymus glands with x-rays or gamma rays from radium sources in an effort to shrink the gland and prevent blockage of the airway.

By 1949, it was believed that irradiation of the thymus gland was justified only after a carefbl search had eliminated other possible causes for the symptoms. During the mid-l950s, the usefdness of thymus reduction by radiation was questioned and is no longer practiced. In addition, an increased incidence of thyroid cancer in adults has been associated with their irradiation of the thymus gland as children.

References:

"Thymus -- A Symposium." Bulletirflancouver Medical Association, November 1943, pp. 34-42.

Peters, M. Vera. "The Results of Irradiation of the Human Thymus Gland." Journal of the American Medical Women's Association, March 1948, pp. 87-91.

Moss, Arthur J. and Litman, NeXN. "The Thymus Gland: Present Concept of Its Importance in Pediatric Practice." Annals of Western Medicine and Surgery, October 1949, pp. 3 57-359.

Silverman, Frederic N. "Thymic Irradiation: A Historical Note." American Journal of Roentgenology, September 1960, pp. 562-564.

Prepared September, I994 By the Office of Human Radiation Experiments of the Department of Eqergy

a

P DOEl.960219.001n

Synopsis:

Warts are a commonly occurring skin growth caused by a virus. Several different types of therapies have been used over time for the treatment of warts on the hands and feet. During the last 50 years, these therapies have included surgical excision, freezing, burning, treatment with acids and other chemicals, and x-rays. During the 1940s and 1950s, x-ray therapy provided a better-than-average method for removing warts. X-ray therapy was thought to be clean, pain-free, and requiring only one or two treatments to remove the warts. As late as 1956, x-ray therapy was still the treatment of choice by some physicians.

As with other radiation therapies for non-malignant skin growths, the treatment of warts with x-rays was discontinued in favor of less toxic and more effective chemical treatment.

References:

Wright, Wayne L. "Plantar Wart Therapy." United States NmalMedical Bidletin, 1949, pp. 707-709.

Hellier, F. F. "The Treatment of Warts with X-Rays: Is Their Action Physical or Psychological?" British Journal ofDennatology, May 1951, pp. 193-194.

Wright, Wayne. "Verruca Plantaris. I' California'Medicine, June 1955, pp. 450-453.

Reeves, Robert J. and Jackson, Murray T. "Roentgen Therapy of Plantar Warts." The American Journal of Roentgenology and Radirim i%eFapy, November 1956, pp. 977-978.

Prepared September, 1994 By the Office of Human Radiation Experiments of the Department of Energy

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Attachment

--. CONSOLIDATED LIST OF HUMAN RADIATION EXPERIMENTS

A number of human radiation experiments have been identified from the.recent document search efforts in additiort t o those previously described in the 1986 Markey Report, of purpose, numbers of subjects, radioisotopes, degree of severity, dates and placcs, the following are given as examples:

A1 though these experiments reprcsent a broad spectrum in terms

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.1. Iron Metabolism in fluman Pregnancy as Studied with the Radioactive Isotope Fe-59 a

- -

Iron-59 ingestion studies eere conducted at the Vanderbilt University Hospital 'during the years 1942-1949 :\to determine the absorption of iron during

Researchers also studied iron-59 distribution in fetal tissues and transfer rates from the women to fetuses. women ingested tracer amounts of Fe-59, and 466 of these women were studied during return visits to Vanderbilt b*?tween 1947 and 1950. The journal article in American Journa? o f Obstetrics and Gyneco?ogy, vol 61, 1951, pp 477-486, notes that the 466 women received single doses ranging from 1.8 to 120 mg of Fe-59.- Another articJe located in the American Journa? o f €pidemio?ogy, vol 90, 1969, pp 1-10 notes that the fetal radiation doses have been estimated as 5 - 15 cGy (rad). The early studies were funded by the Nutrition Foundation; the Rockefeller Foundation, and the State of Tennessee. Follow-up studies to determine long-term health effects in children born to these mothers were funded by theSPublic Health Service and the Atomic Energy Commission. Radiation.doses to maternal blood were estimated to be about 0.2 rad. A small increase in cancer incidence was observed in these children (3 cases in 634 exposed children compared to none in 655 comparison children).

. pregnancy. One group of 819 healthy pregnant

L

2. Uptake of Iodine-131 i,n Thyroids. of Psychiatric Patients

Iodine-131 was injected 'into hospital patients to study the thyroid gland and investigate new methods for treating thyroid cancer.

psychiatric patients with radioiodine" to supply base1 ine 'nformation about normal thyroids. Sixty-five of the human subjects were patients from the Langley. Porter C1 inic for' mental diseases. whether any abnormal th,yroid function existed in patients with mental disorders. No abnormal thyroid function was found, so this group constituted a normal thyroid control group. The Atomic Energy Commission partially funded this work, and the research is described by Dr. Robert Stone in a progress report of the University of Cal iforrtia Radiation Laboratory for the period July 1, 1949 to April 15, 1950.. The results were published as "Thyroid function in Mental Disease Measured with Radioiodine, 1-131,'' in the American Journal o f Psychiatry 106:561-572.

A laboratory report to .:-. the. Atomic Energy Commission describes the "problem of investigating

They were studied to determine

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3. Distribution o f Chlorine-38, Sodium-24, and Bromine-82 in Extracellular

The total volume of extracellular fluids in 15 humans was studied at Brookhaven National Laboratory during the period 1952 to 1953. Five chronically i l l hospital patients were injected with C1-38 and Na-24, prepared . at the Brookhaven Reactor. Ten other patients were injected with C1-38 and Br-82. Total radiation doses were planned so that the weekly dose limit of 0.3 rep (0.3 rad) would not be exceeded. times post-injection and counted for radioactivity. consideBd-to be "normal" subjects for purposes o f this study. funded by the Atomic Energy Commission, and was reported in BNL-1326, "Chl oride, Bromide, Sodi urn, and Sucrose Spaces in Humans, 'I by 3. L. Gambl e, Jr., J .S . Robertson, C.A. Hannigan, 'C.G. Foster, and L.E. Farr, dated February 4, 1953, Reference is made in the text to three other related studies in normal human subjects to determine extracellular fluid volumes.

4. Neonatal Iodine-131 Uptake Studies

Ilniversi ty o f Tennessee, 'Memphis, Van Middlesworth. Commission to check for hypothyroidisn. microcuries, with' maximum doses about 60 rep in newborns. There was informed consent, but signed records are not available. Seven male infants (one white and six.black) were included in the study. Journa7 of Diseases o f Chi7dren, 1951, pp 439-442, by Van Middlesworth describes. the experiment.

A journal article (Journal o f Nuclear Medicine vol 4, 1963, p 162) mentions a study conducted by the State University of Iowa, supported in part by grants from Atomic Energy Commission Biology and Medical Division (AT(ll-1)291) and the American Cancer Society (T-159C). 1-131 intramuscular radioiodine to study thyroidal uptake. Eight newborns received oral radioiodine. Scientists included R.T. Morrison, J.A. Birbeck, T.C. Evans, and J.I. Routh. .

Studies using iodine-131 in newborns are cited in the following: - .. ... vol -.17, .1956, p 503, E.E. Martmer, K.E. Conigan, H.P. Charbendeau, and A. Sosini'and Pediatrics vol 26, 1969, p 771.' The first article notes that Martmer et a1 reported in 1956 on the tyroid uptake of 1-131 in 65 premature and 5 term infants (aged 1 to 63 days). The infants received a 5 microcurie oral dose'. Ogborn, et al, where the radioiodine uptake in the thyroid of 28 newborns (3 t o 7.5 days old) was studied. The infants received a dose of 5 microcuries. This appears to be the same study; It is not known if Atomic Energy

Fluids of Chronically I11 Patients

Blood samples were drawn at various

This work was The patients were

Funded by Atomic Energy Dosage of iodine-131 was 1-2

d An article in the AMA American

,.

Seventeen newborn infants received 1 uc

Pediatrics,

The second article cites a second study in 1960 reported by

Commi ssi on sponsored' the study

5.

Studies were condqcted at the University of .Iowa during 1953 on the uptake iodine-131 in human embryo thyroids. Dosages o f 100 t o 200 microcuries of

. . Uptake of Radioiodine in Human Embryos

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1-131 were given to pregnant women scheduled for therapeutic abortion. aborted embryos were sectioned and autoradiographed. thyroid uptake at four weeks, nearly one month sooner than was previously known. of radioiodine across the placental barrier. study was also useful for determining the amount of radioiodine that could be given to pregnant women and the time it could be given in terms of protecting the unborn child. This work appears to have been funded by the Atomic Energy Commission. The work is reported in the Monthly Status and Progress Report of the Commission's Division of Biology and Medicine-for the month of June 1953.

The The human embryos showed

The information gained from this

'

This finding was important to medicine in understanding transmission

The number of subjects is not known.

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6. Strontium Injection Studies

During the Strontium Metabolism meeting at the Atomic Energy Commission, Division of Biology and Medicine on January 27, 1954, a discussion was held on pathological changes produced by strontium. Dr. Joseph Hamil ton mentioned that Dr. Friedell administered 10 millicuries o f strontium-89 to a patient,

. which was considered to be 'labout a lethal dose." This evoked a "searching of minds" for cases of accidental exposure in humans and a number of such instances were recall ed.

The Health Division Progress Report, November 20-December 20, 1954 (Los Alamos) mentions the intravenous injection of strontium-89 to study distribution of strontium among serum proteins. 'The summary does not state whether this study was human or animal, or whether it is related to the study noted in the above paragraph.

For perspective, in June 1993, the U.S. Food and Drug Administration approved the injection of strontium-89-chloride for palliation of painful .bone metastases.

7. Plutonium Ingestion Study

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The approved dosage is 4 millicuries.

On May 13, 1946, six male employees of the Metallurgical Laboratory o f the .. Manhattan Engineer District in Chicago drank a water solution containing 400

documented in a June 26, 1946, memorandum from E.R. Russell to J.J. Nickson (Director of the Health Division at the Metallurgical Laboratory). The purpose of this study was t o investigate the gastrointestinal absorption and fecal excretion rate of ingested plutonium. results to improve' the interpretation of plutonium exposure and bioassay data collected from occupationally exposed persons. experiment was entirely voluntary, and the amounts of plutonium were

, sufficiently low as t o be barely detectable in urine and feces with instrumentation available in 1946. alive in 1994.

...: counts. per minute (about 0.18 nanocuries) of plutonium-239. The study is

Scientists also hoped to use

Participation in this

,

At least two of the subjects were still

3

8. Tulane Studies

--. -. A series of metabolic experiments were conducted at Charity Hospital and Tulane University. The primary focus of the experiments was to investigate the role of electrolytes in congestive heart failure patients. The total number of subjects studied is not well known and some may have participated more than once. pub1 ished. Approximately 269 subjects were included in the study, although some of these subjects may, have participated in more than one study. Radioisotopes used included: mercury-203,205, chlorine-36, sodium-22,24,

to examine the radiation effects on the human subjects. The radioisotope studies examined retention times, excretion rates, biologic decay rates, and a variety of other physiological parameters.

9.

Follow-up journal. articles describing the studies have been . I

- - - . rubidi-urn-86, and potassium-39,42. One subject received only X-ray radiation

Uptake of Tritiated Thymidine by Tumors in Cancer Patients

In 1962, tritiated (H-3) thymidine, a DNA synthesis tracer, was injected into four cancer patients scheduled for surgery. studied in tumors and in normal cells. The study also examined the tumor cell proliferation process. Tissue was remved from the tumor and from normal skin for comparison. Results confirmed previous results .in experimental animals: that tumor cell s do not necessarily pro1 i ferate' faster than normal cell s . The study was a joint project o f the Northwestern University Medical School, the Veterans Administration Research Hospital, and the Argonne National . Laboratory, with funding from the Atomic Energy Commission. may have been one of the principal scientists.. Other participating scientists include G. C. Henegar, W . E. Kisieleski, and H. Lisco. The study is reported in "Uptake of Tritiated Thymidine by Human Tumors In Vivo," Laboratory I n v e s t i g a t i o n vol 11, no. 5, May 1962, pages 360-364. (From series Tritiated Thymidine. Injection Experiment, Argonne National Laboratory.)

The rate of tritium uptake was

- Dr. R. Baserga

10. Effect of Oral or Injected Ph~sphorus-32 on Hemoglobin Met.abolism in Patients with Polycythemia Vera

This study was conducted by the Health Division o f the Metallurgical

at the University o f Minnesota (one patient). dosage of 15-40 millicuries P-32, and two patients were injected with undetermined amounts of P-32 in a study of the metabolism of hemoglobin metabolisi in man. These experiments took place between October, 1944, and June, 1945. Hemolytic Effect of Radiation," by S. Schwartz, E.J. Katz, L.M. Porter, L.O. Jacobson, and C.J. Watson, in Report CH-3760, Metallurgical Laboratory, Chicago, July 10, 1946 (National Archives, Argonne Collection). This report does not address whether patient benefit was expected or observed.

. . . :Laboratory at the University of Chicago Hematology Clinic (six patients) and Five patients received an oral .

Five o'f the case descriptions are reported in "Studies of the

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11. Arsenic-76 Biodistribution and Excretion Studies

---. Twelve hospital patients were injected intravenously in 1947 with As-76, as potassium arsenite, to study the uptake, retention, distribution, and excretion of arsenic. The study was conducted by the Argonne National Laboratory in 1947, in Chicago. The subjects included five males and seven females hospitalized with leukemia, Hodgkin's disease, polycythemia vera, melanocarcinoma, and carcinoma of the parotid, and ranged in age from 18 to

' . 67. Amounts of As-76 administered were 0.5 to 13.8 millicuries. The study was reported in "Arsenic-76 Preliminary Studies," a progress report, by

- - - Dr. W-&-Neal, Dr. L.O. Jacobson, H. Ducoff, and T. Kelly, Argonne National Laboratory, Biology Division, June 1, 1947 (Part of CH-3830, National Archives, Argonne Collection).

. . 12. Colloidal Gold-198 Studies at Oak Ridge

The Seventh Annual Report of the Oak-Ridge Institute o f Nuclear Studies (June 30, 1953), described the administration of colloidal gold-198. The experiment was conducted in the hope of having a therapeutic effett on two individuals who had cancer of the live?. Several other human subjects with advanced cancer were injected with coiioidal Au-198, shortly before their death, to study the metabolism and biodistribution of colloidal gold. A report on these experiments results was published in Cancer 6(2), March 1953.

13. C1 inical Experiments on. Use o f Lutetium-177, Yttrium-90, GoldL198, Iodine-131, Gall ium.67, Gallium-72, and Strontium-85 at Oak Ridge

The Sixth through Ninth annual reports of the Oak Ridge Institute of Nuclear Studies (June 30, 1955) describe the early clinical use o f injected lutetium-177, yttrium-90, gold-198, iodine-131, gallium-67, gallium-72, and strontium-85; Cancer 7:856-866, 1954 (gold-198), and in Radio7ogy 63:251-257, 1954 (colloidal P-32). therapeutic properties of various radioisotopes for treating cancer. cases, a therapeutic benefit to the patient was hoped for. However, there . were also a number of metabolic studies that were conducted using terminally

. ..-..jjl. cancer patients to determine the biodistribution and retention of different radiqisotopes, and their rates of . excretion from the body. studies were supported by the Atomic Energy Commission and are considered to. be pioneering studies in the development of the field of nuclear medicine.

14. Decompression Sickness Studies using Radioactive Gases

Human subjects breathed air tagged with' radioactive nitrogen and argon gases. Nitrogen uptake was then monitored. 'These experiments took pl ace during the 1980's at Lawrence Livermore National Laboratory.

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Some of the work was reported in Radio7ogy 61(4):534-613, 1953;

In many The purpose of these studies was'to investigate the

These

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15. In-Vivo Calibration Studies Using Humans Administered Niobium-92m, Barium-133, and Strontium-85 at Lawrence Livermore National Laboratory (and other DOE 1 aboratories)

Subjects in the United Kingdom were injected with radioactive barium or strontium, or inhaled radioactive niobium, and then were whole-body or chest- counted at Lawrence Livermore National Laboratory and other DOE sites in the U.S. for in-vivo counting equipment*and to intercalibrate the various U.S. and British in-vivo counting centers. Several studies t ook place during the period -1-978-1989, H.E. Palmer 'at Pacific Northwest Laboratory and H. L. Anderson at Lawrence Livermore National Laboratory were two of the principal scientists for the study.

The purpose of these studies was to develop accurate calibration factors

. . 16. Ozone Effects on Overall and'Regiona1 Lung Function

Human subjects inhaled radioactive nitrogen or carbon didxide to determine : . I functional changes that might be caused by low concentration3 of ozone from . smog. contract from the Department of Energy (DOE) from 1977 to 1978.

17. ' Technetium-99 In-Vivo Counting Experiments

Subjects weie injected with technetium-99 microspheres and then placed in the who1 e-body counter at Lawrence Livermore National Laboratory to determine *whether technetium-99 could be used to calibrate in-vivo counting equipment for direct measurements of plutonium-239 in workers accidentally exposed to plutonium.

.. /

..--. . The study was performed by the University o'f Washington under a

. 1

18. Calibration Studies on Los Alamos Firemen Ingesting Radionuclides

Firemen at the Los Alamos National Laboratory ingested small amounts of radioactive materials and participated in a study to calibrate the HUMCO I1 1 iquid scintillation counter and compare results with measurements made on earl ier versions of whole-body counters.

.:+inc-65 (1 microcurie) was administered orally to humans and four animal species. scintillation human-body counter (HUMCO I) and a sodium iodide gamma-ray spectrome!er., The study was intended to examine the effects o f fallout from atomic testing and activation products.

The in-vivo time changes were observed using the liquid .

19. Retention and Excretion o f Iodine-131 in Man

A series of studies were performed 1.0 measure the biological retention half- times in man and their excretion from the body using ultra-high-sensitive 1 iquid scintillation counte'rs. administered, and rates of retention and excretion were measured using the

press release notes a study in which 26 people ingested 8 microcuries of

Tracer amounts of radioisotopes were

whole-body,counting equipment. A summary from the May 16, 1994 Los Alamos -i ,

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iodine-131. The i n t e n t of t h e s tudy was t o determine how long t h e body r e t a i n e d t h e iodine-131. body r a d i a t i o n coun te r . Another r e p o r t , LAMS-2455, Biological and Medical Research Group (H-4) of the . Health .Division - Semiannual Report January Through June 1960, conta ins a r e p o r t of t he i n j e c t i o n of 28 s u b j e c t s w i t h r a d i o a c t i v e iodine-131. These persons were then placed in t h e whole-body coun te r .

20. Experiments t o Study Coordination and Psychomotor Responses Af t e r Exposure t o External Pene t r a t ing Radiation .

The s u b j e c t s were then placed i n Los Alamos' whole-

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Experiments were performed on human sub jec t s t o determine coord ina t ion and psychomotor responses before and a f t e r ex terna l r a d i a t i o n i n human sub jec t s a s p a r t o f a l a r g e r p r o j e c t c a l l e d NEPA (Nuclear Energy f o r t h d Propulsion of ,

Energy Commission p r o j e c t . recommended a wide range of human experimentation designed t o determine how p i l o t s would be a f fec ted by t h e r a d i a t i o n exposure . they would experience while f l y i n g a!#nuclear-powered a i r c r a f t . Much of t h e proposed human experimentation was no t c h r i e d o u t ; however, t h e r e a r e some documents p e r t a i n i n g t o l imi ted . s t u d i e s on the effects of r a d i a t i o n oti neurosensory func t ion . This work was conducted a t ' the M.D. Anderson Hospital i n Houston, Texas, dur ing t h e period 1950 t o 1952.

21 . S tud ie s of 60-Hertz Exposure Ef fec t s on Human Function

-a

--- A j r c r a f t ) --._ ;! The development of nuc lear r e a c t o r s was a j o i n t Air Force/Atomic In 1949, t h e p r o j e c t ' s medical'-advisory committee

(Memorandum from C. S. Shoup t o Kenneth Kasschau, March 12, 1952). . .

S t u d i e s on t h e e f f e c t s of non-ionizing electromagnet ic f i e l d r a d i a t i o n were conducted on humans t o determine e f f e c t s on t h e ca rd iovascu la r system. Recording senso r s were a t tached t o the ches t and arm t o measure t h e e lec t rocard iogram (ECG), h e a r t r a t e , blood p res su re , r e s p i r a t i o n , and oxygen s a t u r a t i o n . o r a magnetic f i e l d exposure group. f a c i l i t y for a pe r iod of t h r e e hours . ( a l t e r n a t i n g 45 cyc le s ) , . and t h e magnetic f i e l d s t r e n g t h was t o be 200 m i l l i g a u s .

not been determined whether t h e s e experiments a c t u a l l y took p l a c e , Documentation from DOE/Oak Ridge Operations inc ludes approvals from DOE and from the.Departrnent of Health and Human Serv ices (DHHS), with assurance of

S u b j e c t s were assigned a t random t o e i t h e r a sham exposure group The s u b j e c t s were t o s i t i n t h e exposure

Exposures were t o be i n t e r m i t t e n t '

These experiments were t o have been conducted by t h e Midwest . ...'?- Research I n s t i t u t e i n conjunct ion with Oak Ridge National Laboratory. I t has

compliance with DHHS regu la t ions and documents.

22. Human Radiat ion Experiments a t Vanderbil t Univers i ty on the Metabolism

Human r a d i a t i o n experiments were conducted a t Vanderbil t Un ive r s i ty under Cont rac t AT-(40-1)-2402 with t h e Atomic Energy Commission. There a r e many supplements t o t h i s c o n t r a c t t h a t i nd iv idua l ly s p e c i f y t h e t y p e of s t u d i e s

Radioisotopes of

t o L be. conducted. These. s t u d i e s ranged i n scope from the- performance of accura te

measurements, q u a n t i f i c a t i o n of i so topes and i s o t o p i c metabolism, t h e <

* .

absorp t ion of r a d i o a c t i v e i so topes in adu l t and f e t a l t i s s u e s , t h e e f f e c t s of i o d i n e on t h e t h y r o i d during therapy , and o t h e r s t u d i e s . occur red from 1958 t o 1978.

These s t u d i e s - \.

23. -Human Fetal S t u d i e s on 'Protein and Lipid Metabolism Using H-3' and C-14

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Tritium (H-3) and carbon-14 t r a c e r s t u d i e s were conducted by t h e Los Alamos Heal th Divis ion i n co l l abora t ion w i t h t h e Chicago Lying-In Hospi ta l and Argonne Cancer Research Hospi ta l . Subjec ts included f i v e women undergoing t h e r a p e u t i c a b o r t i o n s a t t h e Chicago Lying-In Hospi ta l . These s t u d i e s showed t h a t . c k o l s s t e r o l , f a t t y a c i d s , and tissue p ro te ins were synthes ized i n t he human fetus and very small amounts t r a n s f e r r e d ac ross t h e p l acen ta l b a r r i e r . O r a l l y adminis tered cho le s t e ro l was 1.abeled with t r i t i u m (H-3) ( a dose of e i t h e r 10 mic rocur i e s o r 50 microcuries) and was found- in t h e f e t a l p a r t of the p lacenta .

-The'Fel a t h e r a t e s of cho le s t e ro l b iosynthes is from ace ta l s - l -carbon-14 and from var ious o t h e r s u b s t r a t e s i n a l l f e t a l organs and c e r t a i n maternal t i s s u e s were a l s p determined. A summary of th is work is descr ibed i n t h e 1954 LA-1889 Annual Report, Biomedical Research Group, Health Divis ion; t h e 1957 Annual Reports of t h e Los Alamos Health Division; A n n u a l Report, Biomedical Research Group, Health Div is ion LA-1690 1953, 2nd the H-Division Progress Report July 20 - August 20, 1'954. Gould, Leroy, O k i t a , Kabvara, Keegan, and Bergenstal p a r t i c i p a t e d , i n th is s tudy . Gould and Leroy appear t o have been t h e p r inc ipa l s c i e n t i s t s f o r t h e s t u d y s e r i e s . Another document, H-Division Progress Report , February 20 - March 20,.1955, noted t h a t 34 s u b j e c t s received carbon-14 l a b e l e d a c e t a t e a s p a r t of t h e same s tudy. ' A c o l l a b o r a t i v e s tudy between LASL and the U n i v e r s i t y . cf Chicago examined cho le s t e ro l metabolism i n coronary p a t i e n t s . A t l e a s t two s u b j e c t s rece ived an o ra l dose of t r i t i um- labe led c h o l e s t e r o l . Two p a t i e n t s

annual r epor t no te s t h a t 10 s u b j e c t s a t Argonne and s u b j e c t s and c o n t r o l s i n S a n t a Fe a l s o r ece ived t r i t i u m - l a b e l e d c h o l e s t e r o l . u s ing t r i t ium-labe led cho le s t e ro l (33.8 microcuries) and carbon-14-labeled c h o l e s t e r o l (4.24 microcur ies ) was p a r t o f t h i s s e r i e s . rheumatoid a r t h r i t i s received an i n j e c t i o n t o determine t h e percentaqe of '

Carbon-14-labeled a c e t a t e was i n j e c t e d a l s o (100 microcur ies ) .

,

Leroy, Davison, and Gould conducted t h e s t u d i e s , - .

/died (from t h e i r d i s e a s e ) and t i s s u e samples were analyzed a t LASL. The 1953

Another t r a c e r s tudy

One male with ch ron ic

u r i n a r y s t e r o i d s de r ived from c h o l e s t e r o l . (This work i s r epor t ed in The :.L. Journa7 o f C7 inica7 Endocrino andJetabo7ism, "Evaluation of Tritium

CfioKstero l a s a Tracer i n M a 3 a r o l d WWU3Et.m a l , Gordon - Gould, March 1957, volume 17, number 3 ) .

24. S tud ie s on Human Exposure t o Neutron Radiation

Human s u b j e c t s i r r a d i a t e d with neutrons were evaluated by count ing t h e i r . a c t i v a t e d sodium-24 a t Los Alamos. National Laboratory (summary i n t h e 1957 A n n u a l Report of t h e Los Alamos Heal th Divis ion) .

-

a

DRAFT

25. S tud ie s on I n j e c t e d Sodium-22, Potassium-42, Rubidium-86, Cesium-132, . Cesium-134, and Cesium-137.

- -L.

The r ad io i so topes Na-22, K-42 , Rb-86, Cs-134, and Cs-137 were admi.nistered t o human s u b j e c t s and measured 'over time in t h e h u m a n body-counter. The' r e t e n t i o n p a t t e r n s f o r most were followed for about one yea r ; i n one man, t h e r e t e n t i o n p a t t e r n o f cesium was followed f o r about two yea r s . This study may have been a c o l l a b o r a t i o n w i t h the Argonne Cancer Hospital i n Chicago. A

~ summary of t h i s work i s descr ibed i n t h e 1957 Annual Report o f t he 'Los Alamos Health' Divis ion. 1959 --&c.ember 1959. . (The, number of sub jec t s i s , n o t . known from t h e summary).

See a l s o t h e Group H-4 Semiannual Report, LAMS-2445 Ju ly - - -

Another Los Alamos document, Biological and Medical Research Group (H-4) of t h e Health D i v i s i o n - Annua l Report , LAMS-2780, J u l y 1961 through June 1962, d e s c r i b e s q n experiment where potassium-40 and cesium-137 were measured in 58.

Anderson i s c i t e d as t h e researcher . ' T b s e s u b j e c t s may not have been "dosed." F i f t y con t ro l sub jec t s a r e c i t e d i n Bio logica l and Medical hesearch Group (H-4) of t h e Health Divis ion - A n n u a l Report , LA-3132-MS, July 1963 - June 1964. The r e sea rche r f o r this s tudy was Dean.

-c'oritrxl s u b j e c t s .

\

A s t u d y was made a t t h e Los Alamos National Laboratory o f t h e whole-body r e t e n t i o n of Cs-137 i n 3 male s u b j e c t s given 0.3 microcuries o f Cs-137. (approximately 30 t imes t h e cesium-137 body burden due t o f a l l o u t ) . This s tudy i s repor ted by t h e Biological and Medical Research Group (H-4) of t h e

' Health Divis ion, i n t h e Annual Report LA-3432-MS, f o r J u l y 1964 through June 1965. Other Los Alamos documents t h a t may conta in p e r t i n e n t information a r e (Bio logica l and Medical Research,Group (H-4) of t h e Health Div is ion - . Semiannual Report, LAMS-2627, January through June 1961; and Biological and ' Medical Research Group (H-4) of t h e Health Divis ion - Annual Report , LA-3132- . MS, J u l y 1963 - June 1964. The 1964 annual r e p o r t notes 0.3 microcuries of cesium-137 adminis te red o r a l l y t o two sub jec t s . Four s u b j e c t s were used in t r a c e r s t u d i e s .

Cesium-132 r e t e n t i o n was measured in fou r human sub jec t s who were in j ec t ed in t r avenous ly a t Los Alamos National Laboratory during 1962 t o 1963. This experiment was conducted t o determine the shor t - te rm r e t e n t i o n component of

An account of t h i s s tudy i s given in t h e annual r epor t o f the Bio logica l and Medical Research Group (H-4) of t h e Health Divis ion (LAMS- 3034) , J u l y 1962 through June 1963.

'

L

,

..:.-cesium, i n t h e body.

26. Detefmination of t h e Survival Time of Red Blood Ce l l s by Chromiurn-51 Labeling .

A s t u d y was conducted by Los Alamos National Laboratory i n about 1957 t o de te rmine t h e s u r v i v a l t imes of c i r c u l a t i n g blood e ry th rocy te s ( r ed blood c e l l s ) i n hea l thy and d iseased s u b j e c t s . Thir ty- two human ( 7 well and 25 i l l ) subjects received in t ravenous i n j e c t i o n of samples of t h e i r own red blood c e l l s t h a t had been previous ly removed and tagged with r a d i o a c t i v e Cr-51. A f t e r tagging , the red c e l l s were in j ec t ed back i n t o t h e s u b j e c t ' s body, and t h e person was counted i n t h e human body-counter. Half-t imes f o r the surv iva l

9

. .

DRAFT

--. -.

o f t h e ch'romium t a g were determined. ob ta ined from the s u b j e c t s and counted t o determine exc re t ion r a t e s . s t u d y may have been a co l l abora t ion with t h e Argonne Cancer Hospi ta l in Chicago. Los Alamos Heal th Divis ion.

Large volumes o f u r i n e were a l so This

A summary o f t h i s work i s descr ibed i n t h e 1957 Annual Report of t h e

27. Absorption o f Iodine-131 and Uptake o f Sodium-24 in Human Subjec ts

One . s u b j e c t cu taneous ly absorbed 10 microcuries o f sodium-24 (palm). s u b j e c t rece ived 51 microcuries of iodine-131 on t h e palm.

iodine-131) . were used f o r these experiments. Biologicalpand Medical Research Group (H-4) of t h e Health Div is ion -

Another The. same i so topes - w e r e - m l l y inges t ed (0.18 microcuries o f sodium-24 o r 0.14 microcur ies of

I t i s not c l e a r from t h e summary whether t h e same two sub jec t s These a r e descr ibed i n document LAMS-2526,

* . semiannual: Report J u l y Through December 1960) .. . -.

28. Retent ion ' o f 1 0 d i n e ~ l 3 1 . i n ' s u b j e c t s ' w i t h Inflammatory Liver Disease . . r-

Ten norm%l s u b j e c t s and 18 persons s u f f e r i n g from var ious (but mostly inflammatbry) hepatic d i sease were in j ec t ed in t ravenous ly w i t h 10 microcuries o f I -131-labeled ,rose bengal. The t i m z - a c t i v i t y curves f o r 1-131 were determined using t h e arm counter a t Los Alamos National Laboratory. r e t e n t i o n curve was found t o b e a b e t t e r measurement of func t ion than t h e c l e a r a n c e rate i t s e l f by rose bengal dye exc re t ion techniques. r e p o r t e d by t h e Bio logica l and Medical Research Group (H-4) o f the Health Div i s ion , Semiannual Report LAMS-2455, January through June, 1960.

.

The blood.

This study i s -i

29. The Fate o f Radon Ingested by Man

Two male s u b j e c t s , on two occasions received an o r a l dosage o f about one mil 1 icurie of radon d isso lved i n 100 ml o f water . The s tudy occur red , i n Rochester , New York. man", Hea7th Physics, Vol 11, 1965, pp. 465-476.

Information loca ted i n "The Fate of Radon Ingested by

30. Pre l iminary Human Experiment on Inhaled Zirconium-89 . @

.':'-Prel-i.minary i n h a l a t i o n s t u d i e s using an act ive smoke conta in ing t h e 81-hour Zr-89 were completed i n 1945 (Progress Report f o r t h e Month o f October 1945, Lawrence Berkeley Laboratory, Dr. Joseph G . Hamil t on Records). Energy Commission funded the s tudy ( con t r ac t W-7405-eng-48A) f o r t h e Un ive r s i ty of C a l i f o r n i a . The work occurred a t the Divis ions o f Radiology and Medicine, Un ive r s i ty of Cal i fo rn ia .Medical School, San Franc isco , and the Div i s ion o f Medical Physics and Crocker Laboratory, Univers i ty o f Ca l i fo rn ia , Berkeley, The purpose o f the experiment was t o determine the degree o f r e t e n t i o n by the lungs of very f ine ly d iv ided a c t i v e smoke suspended in a i r . The r e s u l t s showed t h a t almost 100 pe rcen t of t h e inhaled a c t i v i t y ( t o t a l a c t i v i t y inhaled - 2,430.counts p e r second, o r about 0.5 microcur ies ) was r e t a ined wi th in t h e lungs and upper r e s p i r a t o r y t rac t .

The Atomic

. Only one human sub jec t was used ("one o f us").

Only 32 percent o f t he t o t a l a c t i v i t y was exc re t ed . The

DRAFT L

r e p o r t notes t h a t f u t u r e s t u d i e s using the s h o r t - l i v e d zirconium iso tope in humans were planned f o r t h e near u ture .

31. Radium a s an Experimental Therapy f o r Trea t ing Mental Disorders .

P a t i e n t s of a s t a t e mental hosp i t a l were i n j e c t e d w i t h radium a s an experimental t he rapy f o r mental d i so rde r s . The experiment appears t o have been conducted i n Elg in , I l l i n o i s , a t t h e Elgin S t a t e Hospital between 1931 and 1933. Document i n d i c a t e t h a t 70 t o 450 micrograms of radium-226 were i n j e c t e d . This experiment occurred p r i o r t o t h e es tab l i shment of t h e Atomic

1 a t e r c o l l e c t e d r eco rds and attempted t o l o c a t e t h e sub jec t s . be l i eved t h a t i f t h e p a t i e n t s could be loca ted and body content measurements made i n t h e - l 9 5 0 s , a v a l i d r e t e n t i o n curve f o r radium in humans over severa l

measuremen'ts. This information was useful f o r r a d i a t i o n p ro tec t ion guide1 i n e s f o r a lpha p a r t i c l e emi t t e r s . The records conta in information regarding radium c o n t e n t p f t h e l o c a t e d s u b j e c t s , medical information r e l a t i n g t o t h e s u b j e c t s ' admissior t ' to the h o s p i t a l , p e r i o d i c medical examination r e s u l t s and causes of

.dea th and 'death c e r t i f i c a t e s f o r deceased s u b j e c t s . (Records from t h e S e r i e s Elgin S t a t e Hospi$al Records, Center f w Human Radiobiology).

32. D i s t r i b u t i o n of Zinc in Normal Blood'and Organs Using Zinc-65

Researchers i n Boston adminis tered r ad ioac t ive zinc-65 t o a 67 year -o ld person s u f f e r i n g from myelogenous leukemia, and t o a hea l thy cont ro l s u b j e c t . The in ten t was t o determine white c e l l z inc-65 con ten t and t h e d i s t r i b u t i o n of zinc in normal blood and organs, Analysis occurred over a long per iod of t ime t o t r a c k z inc-65 r e t e n t i o n . Pr inc ipa l s c i e n t i s t s included John G . Gibson, Znd, Bert L . Va l l ee , Rex G . F luhar ty , and 3. Eugene Nelson. The experiment occurred i n September 1947, and experimental informateion was presented a t t h e Fourth I n t e r n a t i o n a l Cancer Research Congress. I n j e c t i o n s ranged from two mg p e r day t o " f a r i n excess of th is amount." This s tudy may o r may not have been funded by Department of Energy predecessors agencies .

A summary conta ined i n t h e May 16, 1994, news r e l e a s e sugges ts t h a t Los Alamos

(Refer t o LAMS-2526, Biological and Medical Research Group (H-4) o f t h e Health Div is ion - Semiannual Report J u l y Through December 1960). summary,.two people swallowed zinc-65 ch lo r ide a s part of a s tudy of t h e long- term r e t e n t i o n of t h e compound. The s t u d i e s were conducted by C . R . Richmond, J.E. Furchner, and W.H. Langham f o r a period o f one t o two y e a r s . Two s u b j e c t s (not known i f the'same two) were used t o s tudy the e f f e c t s of d i f f e r i n g l e v e l s of z inc in t h e d i e t on t h e absorp t ion of o r a l l y adminis tered z inc-65 . J . E . Furchner, C . R . Richmmd, and F . A . Traf ton conducted t h i s s tudy . See a lso Bio logica l and Medical Research Group (H-4) o f t he Heal th Divis ion - Annual Report , LAMS-2780.,- July 1961 through June 1962; and Group H-4 Semiannual Repofl, ~ A M S - 2 4 4 s u l y 1959-T-l)ecember 1959. This c i t a t i o n notes an o r a l dose of 0.76 microcuries o f zinc-65 t o two s u b j e c t s - t h i r d and fou r th i n t h e experiment s e r i e s by Furchner.

-& 3q LA.* - a ( 7 0 0 6 ?I) - P$$&! ---. * e W + + q d - -

- - - Energy-hmmi s s i o n o r Argonne National Laboratory. Argonne National Laboratory Researchers

- _-- decades co.uld be cons t ruc ted . Argonne National Laboratory,made a1 1 1 a t e r

- - . - - .

L

.

...'i has'.documentation on t h i s experiment, and may have conducted t h e experiment.

According t o th is

L

11

DRAFT

Another Los Alamos citation (Biological and Medical Research Group (H -4 ) of the Health Division - Semiannual Report, LACIS-2627, January through June 1961) notes iodine-131 studies by Furchner involving 17 subjects. provided also notes that zi.nc-65 was given to a terminal leukemia.patient, a 15-year old girl.

33. Clinical Testing of a Line-Scanning Proportional Counter Camera Using

--L-. The summary .

Injected Iodine-125 and Technetium-99m

Diagnostic dosages of 1-125 and Tc-99m were administered to selected patients

images obtained with the two radioisotopes with the camera were evaluated and compared. certain aspects of this study were experimental, and the objective was development of instrumentation and techniques for evaluating human thyroids. An-estimatbd 100 subjects were studied (medical chart rev-iiiw still pending). This study occurred from August 27, 1975 to September 29, 1977. The protocol was apprpved by Oak Ridge Associated Universities (ORAU)/Oak Ridge National Laborato'ry (ORNL) Institutional Review Board (IRB).

34. Radium Injection Experiment

About 440 micrograms (440 microcuries) of radium-226 were injected into the

unknown, but it is likely that the experiment took place in Berkeley or San' Francisco prior t o 1945. As much as 11.4 micrograms Ra-226 were retained in the subject's body at time of death, many years after injection. The record

. i s found in the Joseph G. Hamilton Record Collection, Lawrence Berkeley Laboratory. Another record located in the same collection is a partial memorandum from someone in the Army Service Forces, U.S. Engineer Office, Oak Ridge, to the file regarding tolerance values for radium and plutonium.

35. Metabolism of 'Calcium and Radiostrontium in Infants

- - - referred t o the Oak Ridge Hospital for thyroid evaluation. The quality of the

Although these subjects were evaluated for pre-existing disease,

- --- -

L - - - - .

body of a human subject. The date and location of this experiment are d

Experiments on calcium and radiostrontium metabolism were conducted. by Jean and Justine Burg for 2-1/2 years (1960 to 1962) at Crocker Laboratory,

. .::.,.Berkeley, Cal i forni a. The experiment appears t o have examined cal ci um metabolism in three infants, with strontium as a tracer. Diapers were obtained a.nd calcium was counted through excretion; retention was also . *

recorded.

36. Cal ifornium-252 Cancer Radiotherapy Program

Cal ifornium-252 was implanted into tumors of 18 terminal whose clinical condition precluded cwative intent. experiments would show feasibility o f Cf-252 implants in cancer therapy. These experiments occurred .about 1971, passi bly at Brookhaven National Laboratory, the University of Pennsylvania, Columbia University, the

Agreements were reached with Christie Hospital and United Oxford Hospitals,

Calcium intake was also recorded (from milk and other foods),

volunteer. patients, It was hoped that these

University of Cincinnati, or Memorial Sloan-Kettering Cancer Center. -i

12

L DRAFT

both i n Great B r i t a i n , f o r t he Cf-252 loan program, f o r use in cancer r a d i o t herapy . 37. Asta t ine-211 and Iodine-131 I n j e c t i o n s

Eight human subjects were i n j e c t e d with t h e 7-hour ha l f -1 i f e a lpha-emi t te r At-211. compare iod ine w i t h a s t a t i n e (both a r e halogens) . in tended t o s tudy t h e uptake of o r a l l y adminis tered a s t a t ine -211 by t h e

conducted a t t h e Un ive r s i ty of C a l i f o r n i a Hospital during e a r l y 1954. The p r i n c i p a l r e s e a r c h e r seems t o have been Dr. Joseph Hamilton. a re : Dr. Rusted, Dr. Bel l , Dr, David E. Brown, Dr. William A. R e i l l y (Di rec to r ) , ' b r . S e a r l s , Dr. Edmiston, and Dr. McCorkle, Pa tho log i s t s a l so

- -- p a r t i c i p a t g d :

George Watson (Hahnemann Hospi ta l ) .-

---

Three of t h e same s u b j e c t s a l s o rece ived i n j e c t i o n s of 1-131 t o I t appears t h a t researchers

- - - - ' t hy ro id i n p a t i e n t s with var ious thy ro id d i s o r d e r s . These experiments were

Others mentioned

N . Malamud; Wilfred E. Toreson, S t u a r t Lindsay, Warren Bostick, ' A. Johnson, '3. V i s a l l i , and M. J. Aguilar (Univers i ty o f C a l i f o r n i a Hospi ta l ) ;*

-

P !: - - 38. Total'-,Body Neutron Act iva t ion Analysis /'. ' - - . \I,

Approximately 40 t o 50 females w i t h k n w n bone-wasting d i s e a s e and 25 c h r o n i c a l l y i l l a d u l t s su f f e r ing from kidney f a i l u r e received a uniform low f l u x high energy neutron exposure. s tudy , which occurred from 1969 t o 1973, poss ib ly a t Univers i ty Hospi ta l , Un ive r s i ty of Washington, S e a t t l e .

39. Study of Chromium-51-1 abeled Blood i n Normal Volunteer Sub jec t s

The Atomic Energy Commission funded this L

L

Chromium-51 was used t o t a g red blood c e l l s , whichewere then i n j e c t e d i n normal volunteers i n q u a n t i t i e s equal t o those used c l i n i c a l l y in blood volume de te rmina t ions . The est imated number of vo lunteers was about 50. These s t u d i e s l e d t o the use of adenine as a blood p rese rva t ive . These s t u d i e s may have involved f o r e i g n human s u b j e c t s i n Bangkok, Thailand. The Universi ty of Washington, S e a t t l e , may have conducted t h e s tudy.

. -40. . . . . I ron-55 . . . and Iron-59 I n j e c t i o n S tudies i n Normal and Anemic Subjec ts ..- . . ... Los Alamos has documentation (Biological and Medical Research Group (H-4) of t h e Heal th Div is ion - Annual Report , LAMS-2780, J u l y 1961 through June 1962) r e g a r d i n g t h e o r a l admin i s t r a t ion o f 0.275 microcuries of i ron-59 t o 20 men and 30 women. Dr. Clarence Lushbaugh i s c i t e d a s t h e r e sea rche r . Another document, Group H-4 Semiannual Report , LAMS-2445 J u l y 1959 - December 1959, i n d i c a t e s t h a t 0 .5 t o 0.7 microcuries of i ron-59 were given o r a l l y t o 66 persons , inc luding one 7-month pregnant woman. by p e r i o d i c measurements i n t he whole body-counter a t LANL. de te rmine t h e pe rcen t r e t en t ion . o f t h e adminis tered dose. a r e c i t e d a s r e sea rche r s .

The Richland C o l l e i t i o n , Bate numbers 8759 t o 8760 i n d i c a t e t h a t iron-55 and i ron -59 were i n j e c t e d i n t o about 20 normal and about 60 t o 80 d iseased

These people were then s tudied The i n t e n t was t o

Lushbaugh and Hale

13

I DRAFT j

(anemic) s u b j e c t s . Approximately 5 t o 10 microcur ies were i n j e c t e d . The Atomic Energy Commission- sponsored s t u d i e s l e d t o a phys io?ogic - - -. c l a s s i f i c a t i o n o f red c e l l production.

. 41. - Ingest ion o f Iodine-131' i n Milk by Hanford Employees

Eight GE/Hanford workers ingested iodine-131 in milk in o r d e r t o determine t h e .uptake of iodine-131 i n t h e thy ro id . The m i l k was drawn from a cow t h a t had been f ed f ive microcur ies o f iodine-131. This experiment occurred i n Richland Washington,

42. Effects of X-Rays on Mi tos i s of Human Skin

An experiment was conducted a t Los Alamos National Laboratory on the ' effe ,c ts

i ncl uded korman Know1 an and Louis Hempelmann. Report , LAMS-790; August 20 - September' 20, 1948.

- - .- - - -

.- ' ___ gf-X-yays-on the m i t o t i c a c t i v i t y o f human skin. Principal. scientists (From H - D i v i s i on Progress

.*- - - . ' 43. Metibolism of Carbon-14-labeled Chelat ing Agent - *

L - - . - I '

Some human s u b j e c t s received t h e c h e l a t :fig agent CaEDTA in t ramuscular ly , o r a l l y , and cu taneous ly f o r a metabolic s tudy. . ( 7 h e Journa7 o f Laboratory and C7inica7 Medicine, "The Metabolism o f 'C-14 Labeled Ethylenediaminetetra-acetic

volume 43). Document found a t Los Alamos. .These metabol ic s t u d i e s a r e c i t e d i n ano the r Los Alamos document, t h e 1953 annual r e p o r t . . *

44. S t r o n t i um-85 (Los A1 amos Records)

Los Alamos annual r e p o r t (Biological and Medical Research Group (H-4) of t h e Heal th Divis ion - Annual Report, LAMS-2780, J u l y 1961 through June 1962) c i t e s an o r a l dose of 1.07 microcuries of s t ront ium-85 given t o three males. Furchrier i s c i t e d a s the researcher . abso rp t ion of 70 microcur ies of s t ront ium-85 in 2 s u b j e c t s . c i t e d a s t h e r e sea rche r .

Acid i n Human Beings", Harry Foreman, Theodore T. T r u j i l l o , April, 1954, . d

.- This same r e p o r t a l s o c i t e s cutaneous Van D i l l a is

. ..--- 45.''-3odine-131 S t u d i e s (Los Alamos)

Two s t u d i e s by Lushbaugh a r e mentioned. One involves the admin i s t r a t ion of 0.5 microcur ies of iodine-'131 t o two women, one a d u l t , and one i n f a n t . The o t h e r i s t h e i n j e c t i o n of 0 .7 microcuries o f iodine-131 i n e i g h t sub jec t s . The Biological and Medical Research Group (H-4) o f t h e Health Divis ion -

1964 con ta ins an a b s t r a c t of an

vol 9, 1963, pp 1325 - 1331) c i t e s a thy ro id metabolism s tudy EiTET&en and a d u l t s using nanocurie doses o f ' iodine-125 and iodine-131. Another document, Group H-4 Semiannual Report, LAMS-2445 J u l y 1959 - December 1959, c i t e s a .

metabolism i n ch i ld ren and a d u l t s Van written by Van D i l l a @e27 f7+ Ph sics: 'J

s t u d y where pat ients received iodine-131 o r a l l y t o s tudy t h y r o i d uptake, d

*i 4

DRAFT L

--L.

L

retention, and function (counting occurred in the whole body-counter). This study was also a Lushbaugh study.

46. RaLa Experiments

The 1953 annual report (Los Alamos) mentions an absorption study of barium- 140/lanthanum-140 (RaLa) in humans. Foreman is cited as the researcher.

47. Thyroidal Deposition of Iodine-131 in Man, Rat, and Dog, From Milk and Nonmi 1 k Sources I ,

This study was located by Idaho in a Hea'lth Physics article, vol 9, 1963, 'pp' 1249 - 1252 (Idaho was not involved). The study involved the ingestion of iodine-131 in water solution and cow"s milk in 11 adult humans. Rats and dogs were studied also. The experiment was conducted by New York State Veterinary. Coll ege and Cornel 1 University, under contract, with the Atomic Energy Commission. and J.R. Georgi . 48. Sunshine Studies: . Strontium-90 and Calcium-45 Injections in 'Terminal I Cancer Patients

One part of Project Sunshine. under Atomic Energy Commission Contract A-930-1- 1656 involved the evaluation of strontium metabolism in relation to calcium in humans. Arthur R. Schulert was the principal scientist for this portion. Dr. Daniel Laslo and associates from the Division of Neoplastic Diseases, Montef iore Hospital, New York, assisted with the study. .Researchers administered strontium-85 and calcium-45 simultaneously and intravenously to terminal cancer patients. The report does not state the amounts injected. Observation occurred from three days to three months. From the data presented, it appears that ten patients received 'injections. A large variety of body tissues were analyzed for each isotope for each patient after autopsy. Doses ranged from 10.1 to 108.5 microcuries for strontium-85'and from 15.2 to 88 microcuries for calcium-45. .

The Hamilton Collection

- - .-

Principal researchers may have been C. I. Comar, R.A. Wentworth,

. - . ... . ... .:. . , .-.

The Department of Energy has identified descriptions of various radiation experiments i i l the Joseph Hamilton Collection. being redacted. completed,. these 'documents will be released to pub1 ic reading rooms.

These documents are currently As soon as the Privacy Act redaction process has been

15

DOEl.960219.003 NAVAL MEDICAL RESEARCH INSnsUTE

NATIONAL NAVAL MLDICAL CICNTER

BETHESOA 14. MARYLANO

D r . William Sir1 Donner Laboratory of Medical Physics Univeroity of California Berkeley, California

Dear Dr. Siri:

I enjoyed viriting your laboratory greatly and should have written sooner to thank you. You were mort generous with your time, aud extremely helpful.

I am convinced that progrerr in the field of body cmnposition rtudies vill be greatly hastened by exchange of ideas betveen workers in the field and I hope ve can continue to compare notes.

As far as our VOrk here goer, we have decided that setting up methods for both body water and body den8ity in human subjects is too ambitious a proJectvith the facilities and time available, and are therefore are working with B%Abelled urea as a mehrure of body vater i n mtients, with an aim to try to find conrtant ratios between this rpace, radiorulfate space, and red c e U nuso. I n animals we are repeating mme of Face's earlier vork on body water Y E . body fat.

more constant relationship between body denrity snd body water or extracellular vater. a conrtant relatiourhip does exist, I am confident they w i l l support construction of a chamber l ike yours here at Betherds. Eave you tried radiosulfattf

suing a lees direct line of approach. We

I m particularly interested to learn if you have found any

If I can convince the Navy (and rysclf) that

If you get East be rure to come by for a visit.

With beat regarda,

Sincerely yours,

, . I

DOEl.960219.004

hfarch 5, 1985 M-3, Part I

CHAPTER 1. INTRODUCTION

1.01 DEFINITIONS

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a. “R&D (Research and Development)” in the Department of Medicine and Surgery includes the investigation and refinement of biomedical problems and hypotheses related to human health, diseases, defects, and handicaps as well as the systematic study and refinement of problems and hypotheses related to the delivery of health care.

b. “Research” is the testing of concepts by the scientific method of hypothesis formulation, systematic and recorded collec- tion of relevant data, and interpretation of the results in terms of the hypothesis.

c. “Development” is the application of research to practical ends with the intent of producing useful devices or techniques rather than the testing‘ of concepts. It can involve nonroutine evaluation of new or existing devices and techniques and may employ the scientific method. The output includes the initial formulation of products, whether devices or techniques, correction of defective products, and improvement of existing products.

d. “Principal investigator” is the individual who is accountable for the proposal, performance, and culmination of a research or development project.

e. “Co-principal investigator” is one of two or more principal investigators who share equally in the accountability for a project.

f. “Cooperating investigator” is the person at any one VA facility who is accountable for the facility’s participation in a study that involves two or more facilities.

g. “Collaborating investigator” is any other investigator who participates in a project; generally persons are considered as “collaborating” if they will be included as joint authors of the final presentation of the project.

h. “Project” is a coherent unit of research or development that is proposed, pursued, and reported as a separate activity. Its scope is larger than that of a single experiment but may be smaller than that of an individual’s scientific activity over a long period. As a unit, the project can be considered the work that will produce one or more published papers, formal reports, or completed devices or techniques.

i. “Program” includes one or more projects clearly related to one another. Thus, there is the program of an investigator or of a medical center as well as the program of cardiovascular research and the cooperative research program. A single project may be included in more than one program.

j. “Intramural research or development” is that performed by VA employees or appointees (including those serving without compensation), generally within VA facilities.

k. “Extramural research or development” is that performed by investigators not in the employ of the VA but financed by the VA.

1. “Cooperative s h d y ” is a project or program of research or development conducted at two or more health care facilities using a common protocol so that data obtained at all participating facilities can be treated as though from a single source.

m. “Collaborative study” is a project or program of research or development conducted at two or more health care facilities; i t does not require a common protocol.

n. “Affiliated institution” generally refers to an academic institution that has a relationship with a VA medical center docu- mented by a Memorandum of Affiliation in conformance with M-8, “Academic Affairs,” Part I, Chapter 2, Appendix 2A. In addition, special purpose affiliations documented by a memorandum of understanding approved by the Director of the appro- priate R&D service, VA Central Office, may be developed in R&D areas such as health services or rehabilitation research and

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March 5. 1985 M-3, Part I

development. Such special affiliations will be designated as “HSR&D Field Programs” or “Rehab R&D affdiations” and the specially affiliated institution will be termed “HSR&D-affdiated” or “Rehab R&D-affiated” institution, as appropriate.

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1.02 PRINCIPLES AND OBJECTIVES OF THE RESEARCH AND DEVELOPMENT PROGRAM

a. The primary mission of the Department of Medicine and Surgery-to provide high quality medical care to veteran-patients- is served by the R&D pro- in three ways:

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(1) The production of new knowledge, techniques, or products leading to improved prevention, diagnosis, treatment, and control of disease, as well as correction of, or compensation for, defects. These R&D products benefit veteran-patients and human- . ity in general.

(2) The attraction and retention of a high quality professional staff that improves the care of the VA’s patients.

(3) The provision of a stimulating intellectual environment necessary for the educational programs in VA health care facilities .-__---- as well as serving in support of subparagraphs ( I ) and (2) above.

b. These objectives can be attained only through research and development of high quality. The program, therefore, constantly strives to achieve excellence.

c. The results of pevelopment and of directly applied research, including clinical studies, can have an immediate effect on patient care. Such applications, however, depend upon research commonly called basic. Scientists performing basic studies also advise and assist other staff members in pursuing their research.

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1.03 POLICIES

a. Staff members of health care facilities are encouraged to engage in R&D programs consistent with the best interests of .. L -- patient care.

b. Research and development are conducted as intramural activities when this is feasible. Extramura.! research may be supported through contracts when this is the best or only means to achieve the program’s objectives and when such support is allowed by law and VA policy. The VA does not make grants for extramural research and developmept.

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c. The VA R&D program encourages free exchange of scientific, technical, and medical information both within and outside the VA. (See M-1, pt. 1, par. 9.66a.) In keeping with this policy, VA investigators are encouraged to report their work at profes- sional meetings and in scientific, technical, and medical publications, and to participate in the activities of their professional organizations. While the importance of the free exchange of information is acknowledged, one must understand that presenta- tions and publications identified with the VA reflect upon the agency. Accordingly, presentations or publications that are to enjoy the support of and identification with the agency must be, and are, subject to appropriate review for quality prior to dissemination. In reporting research, the law and agency policies regarding patient information disclosures must be observed.

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d. VA funds may be used to support the exchange of technical information. Such means of exchange include, but are not limited to publications, conferences, and other professional meetings. .

e. The VA recognizes the important role of research in the basic biomedical and related sciences and of basic scientists in advancing health care. Scientists, whether clinicians or not, whose work is of high quality and relevant to the VA’s mission and who contribute to related functions of the health care facilities, may be supported in their research.

f. Physicians, dentists, and nurses cannot receive salaries or special pay, where applicable, from R&D funds except with the express prior approval of the Chief Medical Director. Written request(s) for exception, with justification for i t , shall be submitted by the facility Director through the ACMD/R&D (Assistant Chief Medical Director for Research and Development).

J . . \ g. The VA and/or i t investigators can accept financial support froin governmental and nongovernmental organizations for research and/or development in accordance with VA policies and programs. Such funding must use fiscal mechanisms prescribed L