`Public Health Sciences Stewart A. Farber Consulting Services March 13, 1995 March 8, 1995 Mr. Steven Klaidman Advisory Committee on Human Radiation Experiments 1726 M St., NW Suite 600 Washington, DC 20036 RE: Nasopharyngeal Radium Irradiation - Initial Radiation Experiments Performed by DOD on 7,613 Navy and Army Air Force Military Personnel during 1944-45 Dear Mr. Klaidman: This letter is being written to reiterate my earlier communications with the Advisory Committee during July 1994, and to follow-up my discussions with your during the past week about the above issue not being handled in an ethical and responsible manner. In response to my recent calls to your office, on March 2, 1995, we discussed that to date the Advisory Committee has not seriously reviewed this issue as a human radiation experiment in its initial use by the Navy and Army Air Force. The facts of this _____ have been clearly presented in numerous communications which I have directed to the Advisory Committee and other branches of government as noted below. These communications include my 7/1/94 News Release documenting that 7,613 veterans received radium irradiation in two human experiments conducted by the U.S. Navy and the Army Air Force, my invited testimony to a Hearing before the Subcommittee on Clean Air and Nuclear Regulation of the Committee on Environment and Public Works of the U.S. Senate ("Assessing the Effects of Nasal Radium Treatments". S. Hrg. 103-822, August 29, 1994 chaired by Sen. Joseph Lieberman (D-CT)), my _____ letter (5 pages plus 9 Attachments, explaining the history and basis for concern regarding nasal radium irradiation) to the DOE Radiation Experiments Hotline (Inquiry CPM12, dated Jan. 12, 1994), and my letter-to-the-editor of the New England Journal of Medicine ("Radium Exposure in U.S. Military Personnel", Jan. 2, 1992, Vol. 326, No. 1, pp. 71-72 co-authored with Dr. Alan Ducatman, M.C., presently Director of Occupational and Environmental Medicine at W. Virginia School of Medicine). Dr. Ducatman also testified as a "public" witness at the 8/29/94 Senate Hearing on Radium Irradiation Health Effects. As we recently discussed, the lack of consideration to date by the Advisory Committee to the 7,613 Military Personnel who were part of a human radiation experiment in 1944-45 appears to highlight an inconsistent and illogical approach to the mission of the Advisory Committee. This failure by the Advisory Committee to duly review the implications of radium experiments on military personnel coupled with the future of the Navy, Air Force, CDC, VA, and HHS to comment to taking any _____ steps to even provide notice to irradiated veterans (see S. Hrg. 103-822 responses to Sen. Lieberman's hearing and post-hearing questions) regarding potential ___ 19 Stuart Street ___ 111.1 Airport Road ___ Pawtucket RI _____ ___ Warren, VT 05674 (401) 727-4947 (502) 496-3356 Voice/FAX 1 S. Farber to S. Klaidman-Advisory Committee March 8, 1995 Page 2 of 7 effects on their health as required by law (given the likelihood of harm documents to scientific study of this issue (See Sandler, 1982 study "Neoplasms Following Childhood Radium Irradiation of the Nasopharynx", published in the Journal of the National Cancer Institute) represents a serious failure by the U.S. Government to behave in a honest and ethical manner regarding human radiation experiments investigation and follow-up and the likely significant effects on health (both malignant and non-malignant) of veterans from nasal radium irradiation. EXPERIMENTAL NATURE OF INITIAL ARMY AIR FORCE AND NAVY RADIUM IRRADIATION STUDIES This point was discussed in some detail in the News Release which I authored and sent to you earlier (see Submarine Survivors Group, News Release dated 7/1/94) and I will only briefly review the _____ as presented earlier. As noted in this 7/1/94 News Release, U.S. Government sponsored "human radiation experiments" involved 7,613 veterans (732 submariners and 6,881 Army Air Force trainees) who received nasal radium irradiation during 1944-45. These experiments are clearly documented in several medical journal reports published in the open medical literature by participating Navy and Army Air Force physicians found during my research. (See Annals of Otology, 1945 for Army Air Force Experimental program description, and Haines, 1945 for description of Navy human radiation experimental program). Further, based on the latest National Academy of Sciences risk factors (see Appendix __ Attached dated 3/8/9_ and App. I to my written testimony to the 8/29/94 Senate Hearing for _____ from BEIR-V Report) for radium nasopharyngeal irradiation as practiced in this country, the predicted health impact due to malignant brain tumors alone for radium nasal irradiation procedure as delivered in the U.S. equates to one brain cancer death per 7,400 Person-Years of follow-up (for the standard protocol of four 10 minute or three 12 minute irradiations applied bilaterally). Since 7,613 military personnel were treated with radium primarily from May 1944 until April 1945 (when the 6,881 Army Air Force personnel were irradiated) this equates to approximately 381,000 PY of followup. This PY total divided by 1 brain cancer excess death (per the National Academy of Sciences) per 7,400 PY (see App. 1) equates to a prediction of 51 4 excess brain cancer deaths expected in a population of 7,613 veterans treated. These two miliary radium irradiation experiments during 1944-45, were much to _____ in scope to prove the radium nasal irradiation technique safe. Nevertheless, despite only two to six months of followup, and the absence of a control group (other than 66 men in the Eighth Air Force in England who had a positive history of aerotitis with excessive nasopharyngeal lymphoid tissue who were not treated) these studies were the basis for the Navy, and Air Force adopting radium nasal irradiation as a 'standard medical treatment' used on veterans from that time forward. It is worth noting that at the start of the Navy research and Army Air Force "Radium Aerotitis Control Program" there was no standard treatment protocol. As noted in the Army's published paper (see p. 654, Annals of Otology, 1945) the radium applicators were inserted into the nasopharynx and allowed to remain in place for 6.6 minutes per irradiation (Radium dosage 1 gm 20 seconds). Later in the program, based on initial results, the Army physicians increased the irradiation time to 8.5 minutes to each nostril (1 gm 25 seconds). As stated by the Army report (p. 656, Annals Otology, 1945). Public Health Sciences 19 Stuart Street - Pawtucket, RI 02860 (401) 727-4947 2 S. Farber to S. Klaidman-Advisory Committee March 8, 1995 Page 3 of 7 "With these applicators (Note: standard 50 mg. Ra-226 _____ monel metal commercial irradiator manufactured by the Radium Chemical Corporation, NY, NY) 8.5 minutes' exposure is the maximum that may be given with safety. Careless timing or otherwise increasing this dosage will result in undesirable reactions. (Note: Concern was that longer irradiations would lead to beta burns or ulceration of the nasopharynx or nasal mucous membranes). Highlighting the experimental nature of the initial radium irradiation studies performed by the military, the Navy (See Haines, 1946) radium irradiation experimental test protocol varied from eight minute per treatment up to 10 minutes per treatment (___ longer per treatment than the 8.5 minutes judged "the maximum that may be given with safety by the Army Air Force physicians) using the identical monel metal 50 mg. commercial___dium nasal irradiator. At the same time, private nonmilitary hearing loss clinics associated ___deafness prevention programs in children starting in 1943 (see Sandler, 1982) employed a protocol whereby the same radium irradiators were being left in place for 12 minutes per treatment 41% greater radiation exposure per irradiation than the 8.5 minutes judged "the maximum that may be given with safety" by the Army Air Force physicians). In addition the cited Army Air Force experiment determined that: "As a rule, a course of three treatments is given at intervals of not less than 25 - 30 days. It is inadvisable to shorten the intervals between treatment because undesirable reactions may occur." (p. 656, Annals Otology, 1945) The Navy protocol as to how much time should elapse before repeat irradiation treatments are given was to have successive treatments at intervals of about one month, (see p. 353, Haines, 1946). Reflecting that radium irradiation was not an established clinical practice at the time, the standard treatment protocol for children at the time by private physicians (see p. 4, Sandler, 1982) notes that: "The applicators were left in place an average of 12 minutes. Treatments were generally given three times at 2-week intervals." Accordingly, it is clear that the Navy and Army initial studies were not just using an "established clinical practice" as the DOD representatives maintained at the time of the 8/29/94 Senate hearing (since their irradiation protocols differed between the Navy and Army, and differed markedly from what was being used to treat children at the time) but were researching and determining in their first experiments what was "the maximum (individual duration of exposure and spacing between irradiation treatments) that may be given with safety". They were clearly conducting experiments. It is now possible to estimate that radium irradiation of the nasopharynx was subsequently used by the Navy and Army on more than 25,000 veterans following the initial experiments in 1944-45. Further, following W.W. II at least 200,000 members of the general public, mostly children under 6 years of age received radium nasalpharyngeal irradiation during the 1950s for otitis media related ear and hearing problems. Public Health Sciences 19 Stuart Street - Pawtucket, RI 02860 (401) 727-4947 3 S. Farber to S. Klaidman-Advisory Committee March 8, 1995 Page 4 of 7 Executive Order #12891 mandates that any "human radiation experiment" such as these initial radium irradiation experiments be reviewed by the Advisory Committee on Human Radiation Experiments to consider whether: "..appropriate medical follow-up was conducted; and "if the experiments' design and administration met the ethical and scientific standards, including standards of informed consent that prevailed at the time of the experiments and that exist today." The experimental nature of the initial military radium nasal irradiations is proven beyond any doubt by a quote from Dr. Haines, who at the time was a Navy Captain at the Medical Research Department of the U.S. Submarine Base in Groton, CT researching problems with otitis media in submariners. Navy Dr. Haines authored the paper "Aerotitis Media in Submariners" (see Haines, 1946) after completing his initial experiments using radium applicators. As Dr. Haines wrote (see Haines, 1946, p. 368): "The present study attempted to discover the causes and effects of aerotitis media and to find the best means of prediction, prevention, and treatment." Of 6,149 Navy trainees evaluated 732 received a course (four ten minute irradiations on average, in each nostril) of radium irradiation. Navy Capt. Haines in his introduction to the cited report wrote: "Merely another clinical study would not meet the need. In view of the fact that we had a rich source of material, and since every condition necessary for rigid experimental control was available, we felt it possible to meet rigorous research criteria, and thus to provide a fairly definitive study on the causes, effects, prediction, and treatment of the disorder. The present report describes aerotitis media as it appears in submariners, and recounts the experiments by which we attempted to understand it and _____ its effects." (Note: added emphasis not in original) (see Haines, 194_, p. 347) That the Navy and Army representatives testifying at the 8/29/94 Senate hearing continue to maintain that the initial experiments cited above were "established clinical practice" highlights how the facts are being blatantly ignored. It is time to face the facts of this matter and deal with them honestly. As noted in (Farber and Ducatman, 1992): "The military personnel involved have a right to know of their exposure; they may be at increased risk for head and neck neoplasms. In addition, submariners in the nuclear navy may have pursued later careers at civilian and defense-related nuclear facilities from which epidemiological reports suggest an increased prevalence of brain cancer without a clear relation to dose. The radiation dose to the head and neck during the use of radium applicators will have been higher than virtually all occupational exposures. Inclusion of such therapeutically treated people may therefore compound ongoing studies of brain and other head and neck cancers at nuclear facilities. Public Health Sciences 19 Stuart Street - Pawtucket, RI 02860 (401) 727-4947 4 S. Farber to S. Klaidman-Advisory Committee March 8, 1995 Page 5 of 7 For these reasons, we encourage people who may have been exposed to identify themselves, and we suggest that formal programs for the identification and medical surveillance of such people are needed. COMPARISON OF RADIUM IRRADIATED EXPERIMENTAL VETERAN COHORT VS. OTHER HUMAN RADIATION EXPERIMENTS REVEALED TO DATE Recent AP news reports on 2/10/95 from U.S. DOE cited the first "hard estimate" of the scope of Cold War era human radiation testing performed by DOE or its predecessor agencies including the Atomic Energy Commission. The Energy Department said that about 9000 people were used in 154 documented experiments according to Ellyn Weiss, director of DOE's Office of Human Radiation Experiments. As has been widely reported many of these DOE sponsored "experiments" involved tracer amounts of radioactivity used to study metabolic pathways or the results of medical treatments and response of experimental subjects to treatment for their health problems. Doses in this type experiment were typically in the 1 to 100 milliRem range of total exposure to target organs. Of note, the 7,613 person Navy and Army radium experimental cohort identified above is approximately equal in size to the 9,000 subjects of all other DOE sponsored human radiation experiments. It is likely the overall effect on cancer cases derived above (51 excess brain cancer deaths alone "expected" among the 7,613 veterans subject to radium irradiation, exposed to typical contact doses to the nasopharynx of 1000.000 milliRem based on dose response relationships derived by the National Academy of Sciences) greatly exceeds all cancers "expected" in the DOE reported experimental population given than the majority of DOE experimental subjects received trivial radiation doses by comparison. Of note, the CDC's Dr. James M. Smith, Chief of the CDC's Radiation Studies Branch, national Center for Environmental Health, in his testimony about the radium exposed population on 8/29/94 erroneously dismissed the significance of the Sandler, 1982 study (as did the Department of the Navy in its 1992 response published in the New England Journal of Medicine to the Farber, 1992 letter) by claiming it was negated by another study carried out in the Netherlands and published in 1989 (See Verduijn, 1989). In realty the Verduijn study involved average radiation doses to individuals studied of from one-quarter to one-sixth that delivered in U.S. practice. Accordingly, the U.S. National Academy of Sciences cites only the Sandler 1982 study in deriving a 5.3 fold excess (3 cases observed, 0.57 "expected") of brain cancer mortality (i.e.; one cancer death per 7,400 PY) among the average child who received a typical course of radium treatments in the U.S. By contrast, the CDC states in its 8/29/94 testimony before the Senate Subcommittee that: "...the limited studies that have been done are inconclusive with regard to health risk from nasopharyngeal radium irradiation...A study is likely to be difficult and complex. Therefore, it is very important that a feasibility study be undertaken before any resources are committed to a comprehensive study." When Senator Lieberman tried to question the CDC representative on 8/29/94 about the average level of exposure in the CDC's Hanford Thyroid Disease Study (a retrospective study of 3000 persons exposed in the 1940s and 1950s to radioactive iodine emissions from the Public Health Sciences 19 Stuart Street - Pawtucket, RI 02860 (401) 727-4947 5 S. Farber to S. Klaidman-Advisory Committee March 8, 1995 Page 6 of 7 Hanford Nuclear Facility in Washington State) vs. the level of radiation exposure of radium nasal irradiation subjects, he asks the question of Dr. Smith: Sen. Lieberman: "But we've heard estimates as high as 400,000 for people exposed in the radium rod treatment. I assume also just by way of comparison, that generally speaking, the exposure was more diffuse (i.e., _____)...to the people of Hanford than (that received by individuals who were treated with radium) rods. The CDC response to this important question highlights how the CDC prefers not to face the facts of this situation: "Dr. Smith: "Perhaps a better term than diffuse would be prolonged. Because those emissions (from Hanford) occurred over a period of a few years, as opposed to treatments like this (from radium nasal irradiation), which are more acute." As is well established, a given large total radiation dose delivered over time (i.e. fractionated over years) results in less likely biological effect than an acute dose. In reality the effective dose delivered from the typical course of radium nasal irradiation likely exceeds the effective dose delivered to the average member of the cohort being following for iodine exposure to the thyroid. In addition, should a thyroid tumor develop from iodine exposure, thyroid cancer is fatal in less than 5% of cases diagnosed vs. brain cancer being fatal in close to 100% of cases diagnosed. Accordingly, the Hanford Thyroid Disease Study mandated by Congress and being conducted by the Fred Hutchinson Cancer Research Center, Seattle, WA under contract to the U.S. Centers for Disease Control at a cost of about $20,000,000 is a lesser source of excess risk to the general population exposed than the radium nasal irradiation experiment on the first 7,613 veterans irradiated. Accordingly, were the CDC to perform even a simple feasibility study on the likelihood of a study of 3,000 members of the general population around Hanford due to iodine thyroid dose yielding a clear dose- response relationship vs. that likely in the radium irradiation case, it would have been obvious the Hanford Study is much less likely to yield any meaningful information as to the effects of radiation exposure in health. Accordingly, the CDC is squandering U.S. taxpayer research dollars on iodine studies from Hanford while ignoring a potentially valuable study in the case of the radium nasal irradiation experiments. SUMMARY In summary, 7,613 veterans clearly meet the definition of "human radiation experiments" under the definitions provided Executed Order 12891 of Jan. 18, 1994. Since these two experiments involved intentional irradiation of 7,613 adult submariner and aviator trainees sufficient to shrink lymphoid tissue after intense contact exposures to the nasopharynx averaging 2,000 Rad and had not been classified as 'common and routine clinical practices...involving incidental exposures to ionizing radiation' (per Executive Order 12891) as of the date these experiments were conducted, these irradiated veterans must be included among those human radiation experiments slated for in-depth review by the Human Radiation Interagency Working Group. Public Health Sciences 19 Stuart Street - Pawtucket, RI 02860 (401) 727-4947 6 S. Farber to S. Klaidman-Advisory Committee March 8, 1995 Page 7 of 7 In reality the number of Navy personnel treated with radium nasal irradiation in total is now suspected as numbering at least 15,000. In addition no fewer than 10,000 Army Air Force personnel also received the radium treatment to shrink hypertrophied adenoids and lymphoid tissue in the Eustachian tube. The first 7,661 servicemen used as subjects for a radium irradiation experiment in 1944-45 by the Navy and Army are likely to suffer increased rates of brain cancer (51 deaths predicted, based on BEIR V, NAS risk estimates for nasal radium irradiation as practiced in the US). The predicted brain cancer deaths expected from this one DOD radiation experiment would dwarf all expectation of cancer impacts from the 9,000 so-called experimental subjects of 154 "experiments" reported by DOE to date. Of note regarding this _____ radium experimental treatment of veterans (a treatment subsequently used as an "established medical treatment" on no fewer than 200,000 children for otitis media in the 1950s): . The radioactivity used (radium-226) was a "natural" radioisotope and not "byproduct" or source material supplied by DOE or its predecessor agencies. . The radium irradiators were supplied by a private company, not DOE or its predecessor agencies including the AEC. . The initial radium irradiation experimental subjects do not fit the mold of experimental subjects popularized in extensive media coverage last year. These were not indigent patients, poor _____, or retarded patients, treated in secret by made scientists, but the "best and the brightest" of US servicemen. Experimental subjects were submariners, combat aviators and later some test pilots. Some of the early high performance jet pilots and astronauts are likely to have been treated. Sen. John Glenn potentially received this treatment as did former Pres. Bush (as a Navy pilot in W.W.II) and Mrs. Bush (as a military dependent in W.W.II). Both President and Mrs. Bush developed thyrotoxicosis or Graves disease in the 1980s, a disease now casually linked to nasal radium treatments based on the Sandler, 1982 study (9 fold excess risk for Graves disease, a non-malignant thyroid disorder, linked to pituitary gland irradiation). . The initial experiments were not secret but performed openly and reported in the open medical literature in 1945 and 1946. The early studies and experiments done with radium have been ignored to date by the Presidents Advisory Committee on Human Radiation Experiments and this oversight should be quickly corrected. Very truly yours, Stewart Farber Attachment - Appendix: (Estimation of Radium Nasal Irradiation Health Effects) Public Health Sciences 19 Stuart Street - Pawtucket, RI 02860 (401) 727-4947 7 S. Farber to Human Radiation Advisory Committee Appendix I Page 1 of 4 March 8, 1995 Appendix I Estimation of Radium Nasal Irradiation Health Effects In Military Experimental Cohort Dose Response Relationship Cited by BEIR-V Report The fifth, and latest report prepared by the National Academy of Sciences, National Research Council's committee on the Biological Effects of Ionizing Radiation (BEIR) published in 1990 is titled "Health Effects of Exposure to Low Levels of Ionizing Radiation" (BEIR V Report). This series of reports has been prepared to advise the U.S. Government on the health consequences of radiation exposure. Congress in 1863 granted a charter to the National Academy of Sciences as a private, nonprofit "society of distinguished scholars dedicated to the furtherance of science and technology and to their use for the general welfare." The Academy has a mandate that requires it to advise the federal government on scientific and technical matters. In preparing updated Reports on a given subject as the status of scientific knowledge advances with time, the BEIR Report series represents the best expert consensus standard of risk from ionizing radiation that exists at the time a report is issue. In the section of the BEIR-V Report dealing with Radiogenic Cancer at Specific Sites, Brain and Nervous System" the BEIR committee cites and accepts as sufficiently 'powerful' for cancer risk estimation of the Brain and Nervous System only the epidemiological study (see Sandler, 1982, see Bibliography) of the health outcome of the typical radium nasal irradiation 'treatment'. This one study of the health outcome of using the monel metal radium nasopharyngeal applicator ("Crowe-Burnam technique) as developed and popularized by two Johns Hopkins University Hospital physicians) remains today the only basis to estimate potential health risk for radium nasal irradiation as delivered in the U.S. Based on this one study (Sandler, 1982 published in the Journal of the National Cancer Institute, a dose response relationship is stated by the committee for nasal irradiation: As the BEIR-V committee report states (see National Research Council, 1990, p 311): "Similarly, 3 of 904 patients treated with radium implants in the nasopharynx and follows for an average of 25 years after treatment were observed to develop brain tumors (Added note not in BEIR report: these were brain tumor deaths not cases versus none in 2,021 controls; on the basis of an estimated average dose to the brain of 0.15-0.4 Gy (15 Rem to 40 Rem) and an expectation of 0.57 brain tumors, the excess in this series has been calculated to range from 3.4 +/- 2.4 to 9.0 +/- 6.4 cases/10,000 PYGy for doses of 0.4 Gy and 0.15 Gy, respectively." While not immediately obvious, the above two BEIR-V committee stated factors for brain cancer risk are actually identical as noted below in factoring out the range of doses estimated by the BEIR committee for the typical course of radium nasal irradiation. It is not necessary to concern oneself with the average dose delivered to an average individual receiving the radium nasal irradiation procedure, if one is only trying to calculate how many brain cancer deaths would be "predicted" based on the Sandler, 1982 study in following any given one group of individuals irradiation in a similar manner using radium nasal applicators. Factoring out the unnecessary (and somewhat confusing to the average reader) expression in this simplifying case for energy deposition or 'does' (which is noted above in By (Gray), where 1 Gray =1 J/kg (jouiekg) = 100 Rad)) simplifies the excess risk factor expression and allows simple calculation of how many 'excess' brain cancer deaths would be 'expected' in any cohort of radium irradiated individuals. Public Health Sciences 19 Stuart Street - Pawtucket, RI 02860 (401) 727-4947 8 S. Farber to Human Radiation Advisory Committee Appendix I Page 2 of 4 March 8, 1995 The conversion of the BEIR-V cited 'excess' brain cancer risk factor is noted below TABLE 2 BEIR-V Cited Risk Factor (p.311.BEIR-V)Derived Simplified Equivalent Risk Factor 3.4 brain cancer deaths/10,000 PYGy1 'excess' brain cancer death per 0.4 By/treatment = per 7,400 PY of follow-up 9.0 brain cancer deaths/10,000 PYGy1 'excess' brain cancer death per 0.15 By/treatment = per 7,400 PY of follow-up The above BEIR-V cited risk factors both equate to 1 'excess' brain cancer death per 7,400 PY Person-Years (PY) of follow-up if we are assessing the effect of an 'average' protocol three 12 minute or four 10 minute nasal irradiations by a 50 mg monel irradiator) only on brain cancer excess risk. Prediction Of Brain Cancer Excess Risk On A Cohort Of 7,613 Individuals Who Received Radium Nasal Irradiation As a point of comparison, and to have some reasonable point of reference as to the significance of the health risk of nasal radium irradiation from brain cancer alone, we can calculate what would be predicted in terms of health effects (using the BEIR-V radium risk factor above for brain cancer deaths alone) in an epidemiological study of a randomly selected cohort of 7,613 individuals who received radium nasal irradiation (the size of the initial Navy and Army Air Force experiments cohorts). Thus, if 7,613 radium nasal irradiation individuals (P=7,613 were followed for 50 years (Y = 50) after receiving radium nasal irradiation (the years of follow-up which have occurred since the Navy and Army Air Force cohorts were irradiated in an initial experiment during 1944-45) one would calculate the following number of brain cancer deaths predicted among these two equally sized cohorts based on the BEIR-V Committee's risk factor for radium nasal irradiation: Table 3 Predicted Excess Brain Cancer Deaths (Group Size P=7,613; Followed for Y-50 years) For Radium Nasopharyngeal Irradiation of Initial Navy and Army Experimental Cohort (1944-45) Excess Brain Cancer Deaths = = (P)(Y) (BEIR-V Risk Factor (For Radium Nasal Irradiated Individuals (where P = Number of persons = of Group size P, follows for 7,613) Y years each on average) (Y = Average Years of follow-up = 50) (BEIR-V Risk Factor = 1/7,400) = (7,613)(50)(1/7,400) = = 51.4 excess brain cancer deaths Public Health Sciences 19 Stuart Street - Pawtucket, RI 02860 (401) 727-4947 9 S. Farber to Human Radiation Advisory Committee Appendix I Page 3 of 4 March 8, 1995 There are likely to be many other non-malignant health impacts of radium nasal irradiation in this radium treated cohort based on the Sandler, 1980 study other than excess brain cancer. These include the observed 9 fold higher risk of thyrotoxicosis (hyperthyroidism due to enlarged thyroid, often referred to as Graves disease) noted in the Sandler, 1980 report. The elevated rate of thyrotoxicosis due to radium nasal irradiation is suspected as being due to pituitary irradiation from the radium procedure sufficient to interfere with normal hormonal balance controlled by the pituitary and the hypothalamus interactions, which are master glands of the human endocrine system. The Sandler 1982 study is admitted only one study of 904 individuals who received radium nasal irradiation for whom the researchers attempted to determine health outcome after 25 years by looking at health statistics available. However, the health impacts suggested by this one study clearly can not be ignored. A larger, more comprehensive epidemiological study evaluating the health effects of radium nasopharyngeal irradiation on the health of the estimated 40,000 veterans population and on a representative cross section of the 200,000 members of the public who received this 'treatment' is clearly long overdue. This issue can no longer be ignored by the medical, public health, and governmental bodies that have responsibilities in these matters. The scientific/epidemiological data which currently exists as to level of risk to the health and well being of the overall cohort of no fewer than 40,000 veterans of the Navy and Army Air Force treated with radium from W.W.II through the late 1960s and no fewer than 200,000 members of the U.S. general public by private physicians demands expanded evaluation and _____ follow-up immediately. This risk estimated noted in Table 3 above does not hinge on any sudden realization of the significance of the Sandler, 1982 study results by the BEIR-V committee in 1990. The risk documented by the Sandler, 1982 study have apparently been overlooked, ignored, or misrepresented by almost every governmental and private group which has reviewed the study's conclusion since it was published, including the Department of the Navy, Bureau of Medicine and Surgery in mid-1991 when the Navy was drafting an official response to the Farber, 1992 letter published in the New England Journal of Medicine, recent testimony to the Senate Clear Air and Nuclear Regulation Subcommittee of the Environment and Public Works Committee by governmental representatives from the CDC, Army, and Navy, and in press releases in October 1994 by Johns Hopkins Hospital about this issue. This institutional and governmental denial cannot be allowed to continue since it flies in the face of present knowledge, and ignores the human needs of so many people to have this issue properly studied and prudent advisories issued for media surveillance and followup. Public Health Sciences 19 Stuart Street - Pawtucket, RI 02860 (401) 727-4947 10 S. Farber to Human Radiation Advisory Committee Appendix I Page 4 of 4 March 8, 1995 Bibliography Annals of Otology, Rhinology, and Laryngology, (Misc. authors), "The use of Radium in the Aero___ Control Program of the Army Air Forces", Vol. 54, pp. 650-724, 1945 Executive Order 12891, The White House, Office of the Press Secretary, Jan. 15, 1994 Farber, S., and Ducatman, A.M., "Radium Exposure in U.S. Military Personnel' The New England Journal of Medicine, Vol. 326, No. 1, pp. 71-72, Jan. 2, 1992. Haines, H.L., and Harris, J.D., "Aerotitis Media in Submariners", Annals of _____, Rhinology, and Laryngology, Vol. 55, pp. 347-71, 1946 Matanoski, G.M., Research Grant Summary: "Health Consequences of Nasopharyngeal Radium Exposure", p. 24, appearing in "Research Into the Biological Effects of Ionizing Radiation in the Bureau of Radiological Health, U.S. Dept. HHS, Public Health Service, Food and Drug Administration, Bureau of Radiological Health, HHS Publication (FDA) 80-8125, dated July ____) National Research Council, National Academy of Sciences, Committee on the Biological Effects of Ionizing Radiation, "Health Effects of Exposure to Low Levels of Ionizing Radiation (BEIR V Report, pp. 310-312, (Radiogenic Cancer at Specific Sites: Brain and Nervous System) Washington, DC, 1990 Sandler, D.P., Matanoski, G.M., Comstock, G.W., and Mitchell, T, "Health Consequences of Nasopharyngeal Radium Exposure", The Johns Hopkins University, School of Hygiene and Public Health, p. 15-24, appearing in "Symposium on Biological Effects, Imaging Techniques, and Dosimetry of Ionizing Radiations, held Rockville, MD, June 6-8, 1979, U.S. Dept. HHS, Public Health Service, Food and Drug Administration, Bureau of Radiological health, HHS Publication (FDA) 80-8126, dated July 1980 Sandler, D.P., Comstock, G.W., and Matanoski, G.M., "Neophasms Following Childhood Radium Irradiation of the Nasopharynx, Journal of the National Cancer Institute, Vo. 68, pp. 3-8, 1982 Veruijn, PG, Hayes, RB, et.al., "Mortality after nasopharyngeal radium irradiation for eustachian tube dysfunction", Annals Otology, Rhinology, Laryngology, Vol. 98, pp. 839-44, ____. Warlick, Steven B., CDR, MC, USN, Internal review paper: "Nasopharyngeal Irradiation with Radium: Its Use in U.S. Submarines and a Review of the Literature", prepared for the Department of the Navy, Bureau of Medicine and Surgery, Washington, DC. as technical basis for Navy comments included in a response to Letter-to-the- Editor, "Radium Exposure in U.S. Military Personnel", 1/2/92 New England Journal of Medicine (see Farber, 1992 above),June 6, 1991 Public Health Sciences 19 Stuart Street - Pawtucket, RI 02860 (401) 727-4947 11