Questions Regarding DR. Saenger's Radiation Experiment at the University of Cincinnati

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at the University of Cincinnati Senator Gravel, January 3, 1972, ..' ANIMAL DATA AND BASIS FOR TRYING ' THIS THERAPY Your letter refers repeatedly (pages-3: 5,' 6, 9) tothe which justifies human experimentation. You state (page 3) that, "In the opinion ofthe Committee, the team at Cincinnati had abundant bases in the liter a - ture for undertaking this studytt. Later (page 6) you state that,since 1942, the rev have been alluding to the "bibliography'' dated November 30,1971 You apparently are A survey of those titles suggests that many concern c.) measurement of radiation effects other than cancer Only a few of them see5 t o conc vanced, disse nina ted tumorstt wi which is what Dr. Saenger decided t o do, according palliation and therapy. ern the treatment of t'adla. Would you please ifidicate ex z ct ly which ofthe S6 references report on experiments elsewhere, on either humans or other an in als,in which the treat - ment of malignant, d is scn in a ted turnors was the purenergy sources? Which of these st t ; dies were complete prior to1960, when Dr. Saenger began his own ex peri - b. You rcfer (page 6) to current efforts elsewhere using whole-or-partial-body radiation to control prostate " . Where are these experiments going on, and who is conducting then? Is this external or

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-. - body radiation if the cancer is disseminated of Phosphorus-32 for prostate cancer. external or internal radiation, and what is the of the breast with widespread metastases to bone. Was this external or internal radiation, and what is the mean whole-body exposure in rads? - ...e. Bibliography item 1 5 5 (1956) concerns the use of _. radioactive Phosphorus and Testosterone in the .. . trcatnent of metastic lesions in bone from breast and prostate. What was the mean whole-body exf. You state (page 11) that tlsometype of partial or whole-body radiation is u s e d in more than 42 difto your letter, a list is not available, where did the information cone from: Do you mean by !'usedft, 11 . FOLLOT!-UP STUDIES TO DE TE WINE EFFECTS : the Cincinnati group reported results showing an extension of days over untrezted patients in cach of the tunor categories'!. Without sone specification herc, this inportact Saenger's papers or reports does he present this

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or-partial-body irradiation, or completely untreated .Hoy many patients, if any, experienced a n increase : ..! A d ecr e ase in activity and %e 11- b e ing "1 '$4 ..* You state (page 8) that about 29% of the patients felt a reduction of pain and tumor-size following Dr. Saenger's treatment. For how long did these of D r . Saenger's reports can I find this important You state (page 8) that about 29% of the patients experienced PO improvenent or change following Dr. Saenger's treatnent. Is it thc position of the Am xi can Colleze of Radiology that .the whole-body irradiation treat zen t helped as nany (298) as not (29%)? Or are there other factors besides this special tre a tmnt which may account for these redata on pain and tumor reductioa? .' How many autopsies have been performed on the deCONTROL CRCUPS TO DETER.JIISE FELPFULSESS OR EARXFULNESS a. You state (page 10) that Dr. Saenger has rio specific control groups or randonizcd saxples, but that "Tho literature contains sufficient studies of similar patients and comparable sized samples treated by other methods to allow basic coq ari sons of tumor Dr. Saenger must have assembled and thoroughly , studied this literature in order t o make the comparison of survival times which you report (page S) and to conclude that his treatment is promising.

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I would like a list of the studies which Dr: . Saenger is using for comparison and control. Would you make me a.copy? "one o r more types of treatment" both before and --. Prior to Dr. Saenger's treatment, how many of his 82 pati cnt s had themselves already had 1. localized,prophylactic irradiation of the How many of his82patients received any of those You state (page 8)that the mixture of treatments single whole-body radiation therapy. If the primary purpose of Dr. Saenger's work i s t o advance cancer theragy and notto procure Fmnan data for the Department of Defense, asthe ACR con- ' tends (page ll), which was doomed t o give ttclouily't and "blurred" results ? To vh t extent could nore useful information about the therapeutic effects treatmeiit of advanced disse nina tcd tun or s be obtai ned from laboratory animal experiments?

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V. TRICKERY, PURPOSE, RISK a. According tothe AEC's 1968 booklet, Your Bod and body lethal dose for 50% of exposed mamnals ranges from about 100to1000 rads...500 rads is thought t o i 4 .------ ___A _ _ - A single i dose exposure between 5 0 and 400 rad s is victim (of such a dose) may show signs of (tired blood', and a somevfiat lowered disease resistance, with consequent shortened life expectancy... What basis, if any, exists for disputing these You quote (page 8) Dr. Saenger as stating that his range creates "no greater risk than many present To what degree would "present form of chemotherapy" constitute the sane risk to a he zl thy person a s would a single dose of 200 - 300rads of whole-body To what extent is it correct to say that chemotherapy has unequivocally helped dozens or hundreds or thousands of cancer pati ect s ? condition had been thought t o be stable died within marrow function was found t o be subnormal, and "thus rel a table to radiation syndrone". To what extent would such results indicate warning pati cnt s about possible lethal effects from Dr. e . You state (page 7) that all the patients were told the radiation treatment would be attempted Itto prolong 150-300 rads might prolong life ? What basis is there for supposing that

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and then "becoming pr act i car ' i n 1969. Could y ~ up lease provide a year-by-year list (11 who received bone-marrow transplants, and the Altogether, how many of the82patients received . - ,.. entries) showing the number of patients that year There seems t o be quite a variation in when the fron imnediately after raciiation, tothe same day, What used t o determine the timing, and what deter - mines it now? Can delay kill a patient ? are certainly no greater than those experienced by patients treated either by surgery or by any of the syst c nic drugs now being used clinically on dis - Wo are not comparing disc on fort. ?'!hat is a tissue is the voluntary and informed choke 5y patients to endure cxtra discomfort and risk in return for someI do not understand thy the patients were notin - formed about the possible side - effects ; Doctors commonly offer warnings to thc irp ari cnt ssb out the biotic s,penicillin, etc. even though the effects cm be subjectively induced. Is it ap.proved medical prac - tice for doctors not to warn patients about unpleasant

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patients were told that the experiments might have military as well as clinical significance. What ,. i. You state (page 6) that 24 patients were rejected and treatment. What was the basis for rejection ? Were they too sick to risk the extra ordeal ? sham irradiation treatment". What vas the thera - I was the reason for this change in policy ? eutic purpose of this ? HOW many of the82patients k. You suggest (page 3) that referral just to Dr. Saenger's papers prepared for t h e Department of Defense might produce misleading conclusions about the real pur?ose of his work. You supplied a list of all his papers and presentations ; Is it correct to infer from their titles that there is only one about the effects of his treatment on helping cancer vic times (1967), and in that paper, he says he 1. You state (page 3) that "bepartnent of Defense funds were used only to support the laboratory and psychological studies,but not the trez t nen torc are of the patient " .Later (page 6) you state that only October 8,1971) it has been stated that the DOj) E already spent $ S50,000 on this work, vhich comes t o $10,000 per patient. What accounts for this cost