[NOTE: Addresses and phone numbers have been made current in this copy from that at time of press release]
Radium Experiment Assessment Project
1285 Wood Ave., Bridgeport, CT 06604
FOR IMMEDIATE RELEASE Contact: Stewart Farber, MSPH- Director (203) 397-2625
Dan Burnstein, Esq.- President- Center for Atomic Radiation Studies, Inc. (617) 256-3661
582 BALTIMORE SCHOOLCHILDREN IN HUMAN RADIATION EXPERIMENT
BY JOHNS HOPKINS FOUND BY GOVERNMENT TO HAVE
CANCER MORTALITY RISK 8 TIMES ITS' LIMIT FOR MEDICAL NOTICE -
PRESIDENT OFFERS ANOTHER 'APOLOGY' BUT NO ACTION
Registry Of Baltimore Radiation Experiment Subjects AnnouncedBy
Independent Scientist Credited With Forcing Advisory Committee On Human Radiation Experiments To Face Health Risk Of Nasal Radium Irradiation Experiments
A human radiation experiment involving Nasal Radium Irradiation (NRI) carried out by Johns Hopkins Hospital on 582 third grade Baltimore schoolchildren from 1948 to 1954 funded by the federal government has been ignored in a recent Implementing Report [see Bibliography, Appendix 1- US Government, 1997 ] issued by the Clinton Administration. Excess head and neck cancer mortality risk to Baltimore children had been estimated by the President's Advisory Committee on Human Radiation Experiments (ACHRE) as being more than 8 times higher than its' own threshold for medical notice and follow-up, and 10 times higher than its' calculated cancer risk in experiments with NRI treated veterans carried out from 1944-1946. The Administration has proposed to make at least 7,600 veterans treated in NRI experiments reviewed by ACHRE eligible for health screening under the Department of Veterans Affairs' Ionizing Radiation Program, but children at higher risk treated in Baltimore have been ignored. The Hopkins experiment has major public health implications to the no less than 571,000 children and young adults estimated by the U.S. Centers for Disease Control to have been treated with NRI across the U.S. as 'standard medical practice'.
Announcement Of Central Clearinghouse For Nasal Radium Irradiation Experimental Subjects - The Radium Experiment Assessment Project, a private non-profit public health initiative devoted to:
-- Outreach & Identification of NRI treated individuals
-- Public Awareness of potential health risks
-- Encouraging "right-to-know" initiatives
-- Promoting proper medical surveillance and follow-up for treated individuals
-- Research and documentation of known facts of NRI
requests that any person who participated in the government sponsored NRI experiment conducted in Maryland by Johns Hopkins Hospital and School of Public health during 1948 - 1954 to contact it as noted below. Individuals receiving Nasal Radium Irradiation (insertion of radioactive rods through the nose to irradiate and shrink adenoids) in a series of what were typically 3 to 4 'treatments' of about twelve minutes duration, usually about 2 to 4 weeks apart in an experiment on Baltimore 3rd graders selected during the fall and winter of 1948 and fall of 1949 and followed through 1954 for hearing ability, or in other 'hearing loss prevention' programs in Maryland conducted from about 1943 into the 1960s, are invited to contact the Radium Experiment Assessment Project to request a registration form, fact sheet, and annotated bibliography. Treated individuals are invited to:
a) Call the REAP Hotline at (203) 397-2625 [updated]
b) E-mail: firstname.lastname@example.org
c) Write: Radium Experiment Assessment Project
Center for Atomic Radiation Studies, Inc.
1285 Wood Ave.
Bridgeport, CT 06604
Nasal Radium Irradiation - A Domestic Nagasaki?-Brain cancer mortality excess risk predicted among NRI treated children in any given sized group would exceed total all site cancer mortality observed in epidemiological studies of a similar number of survivors of the atomic bombing of Hiroshima and Nagasaki [based on the National Academy of Sciences (NAS) risk factor for NRI treated children derived from a health risk study conducted at Johns Hopkins completed in 1979]. Based on excess brain cancer risk derived from an epidemiological study conducted at Johns Hopkins (Sandler, 1982 ), the NAS analysis equated to 8.8 estimated excess cancer deaths per 1,000 treated children over their lifetimes. The Advisory Committee on Human Radiation Experiments in its Final Report to the President, ignored the National Academy of Sciences risk estimate, and came up with its own estimate of 4.35 excess brain cancers fatalities per 1,000 children treated with NRI, and 8.4 excess cancers of the head and neck per 1,000 children treated with NRI [based on calculations, totally ignoring then current epidemiological studies conducted at Johns Hopkins suggesting a higher risk]. Nevertheless, the ACHRE excess cancer risk estimates would still predict approximately equal cancer mortality in NRI treated children as in the survivors of the atomic bombing of Hiroshima and Nagasaki. [See Appendix I for details of this
Excess cancer mortality ( brain cancer mortality 5.3 times normal per National Academy of Sciences review) and non-malignant thyroid disorders excess risk ( 8.6 times normal) documented in 1979 NRI study conducted at Johns Hopkins School of Public Health misrepresented by Johns Hopkins epidemiologist in letter to Maryland residents as part of 1996 follow-up study of longer term health effects on earlier studied cohort. [See Appendix III for details]
Friday , July 25, 1997
Pawtucket, RI -
A "human radiation experiment" involving 582 Baltimore third graders carried out by Johns Hopkins University School of Medicine using Nasal Radium Irradiation (NRI) to shrink adenoids in an experiment funded by the federal government conducted from 1948 to 1954 has been ignored in recent actions by the Clinton Administration [see US Government, 1997] said a public health scientist with the Radium Experiment Assessment Project today.
"Nasal Radium Irradiation of third grade experimental subjects in Baltimore by Johns Hopkins under Research Grant B-19 [see Attachment 6] during 1948 to 1949, resulted in an average radiation dose to the nasopharynx, base of the brain, and other vital structures in the head and neck of NRI treated children which significantly exceeded the radiation dose to these same anatomical structures received by the survivors of the atomic bombing of Hiroshima and Nagasaki",
said Stewart Farber, M.S. Public Health, Director of the Radium Experiment Assessment Project.
"Unfortunately, NRI was casually used on more than 500,000 children during the period 1946 to the 1960s, after it became a common, although ill-advised , clinical practice. NRI use was criticized by many national ENT specialists as early as 1948 because it delivered radiation doses to the lymphoid tissue in the nasopharynx and pharynx [since certain hospitals such as Johns Hopkins for some years routinely treated a child's tonsils after every tonsillectomy] that were normally reserved in every other area of medicine for the treatment of malignant conditions where the short term benefit justified a long-term risk of malignancy or other health effects",
RADIUM EXPERIMENT ASSESSMENT PROJECT
CLEARINGHOUSE FOR EXPERIMENTAL SUBJECTS
A comprehensive and complete epidemiological study and outreach program is needed immediately to determine what are the real health impacts of NRI procedure on health and to ensure that experimental NRI treated subjects get proper medical notice, follow-up, and treatment where necessary.
"We are dealing with a major domestic public health issue whose impact as to excess cancer mortality and cancer incidence is likely to exceed the total cancer impact observed among the survivors of Hiroshima and Nagasaki. [see below and Appendix I for documentation]. The time for evasive or inaccurate statements by the Administration in its recent Implementing Report on the recommendations of the Advisory Committee on Human Radiation Experiments, private medical institutions, the Navy, Veteran's Department, and Centers for Disease Control is long past"
said Stewart Farber, Director of REAP. Farber, a public health and radiation risk assessment scientist who first highlighted the need for a central government registry for military personnel treated with nasal radium irradiation issue in a letter ["Radium Exposure in U.S. Military Personnel"] to the medical and scientific community in 1992 (see Farber, 1992) in the New England Journal of Medicine, has testified twice before Congress on nasal radium irradiation experiments and NRI's later 'standard medical use' on what the CDC has finally been forced to admit is at least 500,000 children and more than 10,000 submariners and aviators.
The Radium Experiment Assessment Project, as one of more than thirty radiation experimental subject and victims' rights groups have joined with the Task Force on Radiation and Human Rights to demand Congressional Oversight Hearings on the "Implementation Plan" announced by the Administration in its wishful "Building Public Trust" report.
"The fact that an issue as significant as NRI experiments on children, with major public health implications on a total population of at least 500,000 NRI treated children in the U.S., could be ignored by the Clinton Administration after review by ACHRE, while earlier falling through the cracks of the system designed to protect U.S. public health and safety, indicts the process by which radiation health risks are analyzed and responded to in this country", said Farber.
In regard to radium nasopharyngeal irradiation, a meaningful and comprehensive medical notice, and follow-up of the Baltimore experimental subjects treated by Johns Hopkins during 1948 to 1954 as well all NRI treated individuals treated across the U.S. needs to be initiated immediately" he states.
As a first step in this process, and given the failures of government and private institutions to act responsibly, the Radium Experiment Assessment Project is requesting that any person who received nasal radium irradiation as part of the Human Radiation Experiment Research Grant B-19 conducted by Johns Hopkins University School of Medicine and School of Hygiene and Public Health on third grade schoolchildren in Baltimore city schools from July 1948 to November 1954, or any other NRI treated individual desiring a registration form, fact sheet, and annotated bibliography to contact REAP by:
a) Calling: Stewart Farber, MS Public Health, Director of REAP at: (802) 496-3356
b) E-mailing: email@example.com
c) Writing: Radium Experiment Assessment Project
172 Old Orchard Way
Warren, VT 05674
ESTIMATED RISK OF BRAIN CANCER IN NRI TREATED CHILDREN EXCEEDS OVERALL CANCER RISK OF ATOMIC BOMB SURVIVORS
"Further, based on the latest National Academy of Sciences risk factors for brain cancer mortality following nasopharyngeal radium irradiation (NRI) treatment of children as practiced in this country [see Appendix I for detailed documentation of this point based on the National Academy of Sciences, Biological Effects of Ionizing Radiation- BEIR-V Report], the predicted health impact due to brain cancer mortality alone from NRI on an equal sized group of radium treated children would exceed the excess cancers from all causes observed among 79,856 A-bomb survivors studied in detailed epidemiological studies. Based on the BEIR-V Report risk estimates citing a research study carried out at the Johns Hopkins University, School of Public Health completed in 1979 and published in the Journal of the National Cancer Institute (Sandler, 1982), nasal radium irradiation is not just equivalent to a domestic 'Nagasaki Up The Nose' of at least 571,000 Americans [according to the lowest estimates of the NRI treated population recently published by the U.S. Centers for Disease Control, see Mellinger-Birdsong, 1996] but actually is likely to exceed the excess cancer mortality from all causes seen among both the Hiroshima and Nagasaki A-bomb survivors", said Farber.
The Advisory Committee on Human Radiation Experiments (ACHRE) was established by Presidential Executive Order #12891 in January 1994 to investigate "human radiation experiments" conducted the federal government or by private institutions with government funding. ACHRE was forced by private scientists and citizen initiatives [see Bibliography: Farber, 1994(a) - Farber, 1995(d)] to evaluate the experimental use of nasal radium irradiation which revealed one human radiation experiment involving 582 third grader children in Baltimore and in two others involving 7,613 military personnel (see Haines, 1946 and Annals of Otol., 1945). These initial experimental studies on children and veterans using sealed radium applicators to shrink lymphoid tissue met the definition of a "human radiation experiments" as defined by Executive Order #12891 establishing the Human Radiation Interagency Working Group. [See Appendix II].
"Since these three studies involved intentional irradiation of Baltimore schoolchildren and adult submariner and aviator trainees sufficient to shrink lymphoid tissue after intense contact exposures to the nasopharynx averaging 2,000 Rad (see Farber, 1992) 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 experiments had to be included among those human radiation experiments which received in-depth review by the Human Radiation Interagency Working Group" said Farber.
These early military and civilian nasal radium irradiation experiments conducted in Baltimore reviewed by the ACHRE were too limited in scope and duration to prove the technique safe but became the basis for private physicians and the Department of Defense adopting nasal radium irradiation as a 'standard medical treatment' for childhood middle ear problems (otitis media), or inability to equalize pressure in planes and submarines, that led to its subsequent use on more than 500,000 children and 10,000 veterans after W.W. II. 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."
RECENT (IN)ACTIONS BY THE CLINTON ADMINISTRATION
After 17 months of delay, the White House recently released a report detailing the Clinton Administration's planned actions [and failures to act] in response to an "independent" Advisory Committee on Human Radiation Experiments (ACHRE) Final Report recommendations on Cold War-era radiation experiments issued in 1995. ACHRE's recommendations and their implementation by the Human Radiation Interagency Working Group (IWG) [see Appendix II for makeup] in the IWG report "Building Public Trust" were claimed by President Clinton to detail the steps the US Government would take to finally "right the wrongs of the past inflicted on unknowing citizens" . The 4,000 human radiation experiments reviewed by ACHRE were carried out or funded by the U.S. Government primarily through the Department of Defense (DOD) and Department of Energy (DOE, or its predecessor agencies) and were conducted at numerous major medical institutions, including Johns Hopkins Hospital. One experiment conspicuous by its absence from the Clinton Administration's Implementing Report was performed on 582 third graders in the Baltimore public schools who were part of an experiment conducted by Johns Hopkins involving the insertion of metal rods with a sealed capsule of radium-226 termed a Nasopharyngeal Radium Applicator or 'radium rod' used to shrink lymphoid tissue at the opening of the Eustachian tube.
"The Johns Hopkins NRI experiment has been deliberately overlooked as to any medical notice or follow-up action by the federal government despite ACHRE's earlier determination that children in this Hopkins radiation experiment had the greatest cancer mortality risk of any experiment it examined for which people were still alive and might benefit from medical notice and follow-up",
said Dan Burnstein, Esq., President of the Center for Atomic Radiation Studies, Inc. The details as to excess cancer risk for head and neck cancers being 8.4 times the ACHRE threshold for medical notice and follow-up for which people were still alive and might benefit from medical notice and follow-up are included as Appendix II. Although widely criticized on medical and ethical grounds, the ACHRE had maintained in its Oct. 1995 report to the President that of the 4,000 experiments it reviewed involving hundreds of thousands of test subjects: "There is no subject of biomedical experiments for whom there is a need to provide active notice and medical follow-up".
"The conflicts of interest, hypocrisy, shoddy ethics, and agenda science underlying the recommendations by ACHRE and the recent report by the Clinton Administration to do nothing regarding active medical notice and follow-up of NRI experimental subjects is most clearly demonstrated in that these 'independent committee members' and the IWG completely ignored even the NRI experiment conducted by Johns Hopkins on 582 Baltimore schoolchildren which was the only experiment examined by ACHRE which exceeded their own threshold for notice",
said Stewart Farber, MSPH, Director of the Radium Experiment Assessment Project. ACHRE's own calculation of excess cancer mortality risk [See Appendix II for details] for this experimental group of children who were selected from Baltimore public schools for an experiment to study 'the efficiency of nasopharyngeal [radium] irradiation [NRI] in the prevention of deafness in children' in Research Grant No. B-19 carried out at Johns Hopkins University School of Medicine and School of Public Health from July 1948 until November 1954 exceeded ACHRE's arbitrary threshold for medical notice and follow-up by more than a factor of 8. This human radiation experiment conducted under Research Grant No. B-19 by Johns Hopkins involved 582 children who were 3rd graders in Baltimore city schools, average age 8.5 years at the time, which would make these individuals about 57 years of age at present. Third graders were screened and selected for this experiment during the fall and winter of 1948-49 and the fall of 1949. 291 were treated with nasal radium applicators, and 291 were treated with "blank" nasal radium applicators as control subjects.
"This recent failure by the U.S. Government in its "Building Public Trust- Actions to Respond to the Report of the Advisory Committee on Human Radiation Experiments" to even mention NRI treated children in Project B-19 and to overrule the ACHRE's outrageous failure to meet its obligations by recommending medical notice and follow-up for the 582 nasal radium experimental subjects at Johns Hopkins is a breach of the Presidential Executive Order which established ACHRE in January 1994, and an insult to the American people and the public health mandates of this issue",
according to Farber.
After the ACHRE report issued in late 1995 recommended against any notification of 582 experiment NRI subjects treated as children by Johns Hopkins or 7,661 veterans treated in early NRI experiments by the Department of Defense in the Army Air Force and Navy submarine service, the Radium Experiment Assessment Project (REAP) was organized as a project of the Center for Atomic Radiation Studies, Inc. (CARS), a Brookline, Mass. based 501 (c)(3) non-profit organization devoted to increasing public understanding of issues related to radiation through greater availability of reliable, objective information. REAP was established to research the NRI issue, promote public awareness of its potential health risks, encourage public 'right-to-know' initiatives, and promote proper medical surveillance and follow-up recommendations for treated individuals based on full consideration of the current scientific research and medical knowledge about this treatment. A description of the Radium Experiment Assessment Project - Background & Goals is include as Attachment 1.
REVIEW OF EXCESS HEALTH RISKS TO NRI TREATED CHILDREN
Included as Appendix II is a review of the excess cancer risk to NRI treated children based on:
1) A more detailed discussion of the review of the excess cancer mortality risk to Baltimore children treated with NRI by the Presidents' own Advisory Committee (ACHRE) which calculated an elevated excess brain cancer mortality over the lifetime of NRI treated children (4.35 fatal brain cancers per 1000 individuals) and an estimated excess head and neck cancer mortality in children (8.4 fatal head and neck cancers per 1000 individuals) vs. a threshold for medical monitoring and notification of 1 per 1000 treated individuals.
2) Newly published epidemiological studies (Verduijn, 1996) which report findings as to excess cancer incidence which were ignored by the Human Radiation Experiments Interagency Working Group in its recent Implementing Report issued by the White House. The Verduijn, 1996 report noted: "A statistically significant difference was noted only for cumulative all-site cancer incidence with the exposed having twice as many verified cancers as the nonexposed." Children in this, the largest study ever conducted of the effects of NRI on the health of children, followed 2,510 NRI treated children in the Netherlands who received average radiation exposure 3.5 times lower than received on average in children treated with NRI in the Hopkins experimental programs.
BOTH PUBLIC AND PHYSICIANS BEING MISLED AS TO RISK OF NRI BY GOVERNMENT AND PRIVATE MEDICAL INSTITUTIONS
Included as Appendix III is a review of recent examples of how both the public and the medical profession are either receiving no information or distorted information about the health risks of NRI as presently known. These examples include:
1) Failure of the ACHRE to recommend medical notice and follow-up to the experimental NRI third grade schoolchildren treated at by Johns Hopkins University School of Medicine in Grant No. B-19 starting in 1948. This action in which Dr. Ruth Faden of Johns Hopkins , as chair of the ACHRE, voted against medical notice and follow-up for the schoolchildren treated in Baltimore raises a serious question about conflict of interest and questionable ethical behavior by the Chairperson of the ACHRE. At a minimum, Dr. Faden should have recused herself from a vote on whether to provide medical notice and follow-up to NRI experimental subjects treated by Hopkins rather that actively opposing such notice.
2) 1996 NRI Study Subjects in Maryland Given False Information About NRI Health Risks- Epidemiological researchers including Dr. Genevieve M. Matanoski, M.D., Dr. P.H. a public health professor at Johns Hopkins School of Public Health contacted earlier epidemiological study subjects (studied during 1977 to 1979, see Sandler, 1980 and Matanoski, 1980) in a letter during early 1996 as part of a follow-up study forced to be conducted by recent U.S. Senate Hearings and public advocacy efforts related to potential NRI health risks. The 1996 follow-up study subjects contacted by Johns Hopkins' researchers were falsely told that there were "almost identical illness rates" between nasal radium treated and untreated groups in the original study while one of the 1996 letter signers (Dr. Genevieve Matanoski) had authored a research summary in 1979 (see Matanoski, 1980- copy enclosed) that stated just the opposite:
"There was an overall statistically significant increase in benign and malignant tumors of the head and neck among the irradiated patients compared to the nonirradiated.. Although there were no thyroid tumors, there was a statistically significant increase in other thyroid diseases (a combination of hyperplasia, nodular goiter, and thyrotoxicosis) and of thyrotoxicosis alone." -- Matanoski, 1980
This recent attempt by Johns Hopkins to placate current public concerns based on inaccurate claims regarding, and even apparent denial of, the actual findings of their own original research on NRI health effects on cancer and other nonmalignant conditions is reprehensible and should be rebuked and investigated by the scientific community and the U.S. Congress as a case of scientific fraud on a major public health issue..
PUBLIC RIGHT-TO-KNOW POTENTIAL HEALTH RISKS OF NRI
"The ACHRE 'recommendations' and the recent White House report totally ignoring the issue of NRI experiments on children and the risk of elevated brain cancer and head and neck cancers deserves to be condemned because it is not based on an honest review of health risks as presently known. Recent failures to act by the federal government deny radium exposed children like myself, now 50 years old on average, the basic information we need to seek appropriate medical screening in following up on potential health problems as a result of unusual head and neck irradiation carried out on young children. Medical screening is vital so that health problems can, to the extent possible, be minimized related to thyroid disorders, hormonal problems, and various other life threatening impacts such as benign or malignant tumors now linked to nasal radium irradiation",
said Fran Kenneally, a 50 year old woman treated eight times with nasal radium irradiation as a 6 to 8 year old child in the 1950s. Fran Kenneally suffered six miscarriages and gave birth to a brain damaged son before being diagnosed with a pituitary tumor at age 37 in 1984. Had Fran known of the high radium irradiation dose to the pituitary and health effects reviewed in the unpublished Sandler, 1980 report which documented a high rate of thyroid problems suspected as being related to pituitary irradiation and hormonal dysfunction, her hormonal problems would probably have led to much earlier detection of her pituitary tumor which caused a lifetime of suffering, said Stewart Farber. Fran testified before Congress at a Senate Hearing on "Assessing the Effects of Nasal Radium Treatments" [S. Hrg 103-822, August 29, 1994] and later served on a panel of experts and NRI stakeholders at a CDC/VA sponsored workshop held in September 1995 on "The Public Health Response to Nasal Radium Irradiation".
"It appears", said Fran , that "even the so called 'Public Health Response to Nasal Radium Irradiation' workshop held in Sept. 1995 was a self-serving attempt by government bureaucracies such as the CDC and VA to appear to the general public, treated veterans, and interested political interests as if were acting in good faith to consider the broad public health implications of NRI on the 571,000 to 2,617,000 NRI treated children estimated at the CDC/VA Workshop as receiving nasal radium treatments. In reality, the CDC, VA and various medical institutions are trying to obscure this issue under a cloud of statistical double talk and deliberate deception while suppressing open consideration of the suggested risks of nasal radium irradiation on treated children.."
When President Clinton accepted the Final Report and recommendations of the Advisory Committee on Human Radiation Experiments in a ceremony at the White House he stated:
"Our greatness is measured not only in how we....do right but also [in] how we act when we know we've done the wrong thing; how we confront our mistakes, make our apologies, and take action."
October 3, 1995
"Sadly, the actions of the US Government regarding the nasal radium irradiation experiment on Baltimore schoolchildren during 1948 to 1954 conducted by Johns Hopkins, judged by the ACHRE to exceed the Advisory Committee's own threshhold for medical notice and follow-up by a factor of more than 8, makes a mockery of the President's admirable rhetoric. Hypocritical apologies by the White House to past victims of our government's unethical actions in some of its human experiments research cannot substitute for meaningful actions to really right the wrongs of the past. In the case of nasal radium experiments on third grade schoolchildren in Baltimore, the government has clearly not confronted its mistakes, has made no apology, and has taken no action"
according to the Radium Experiment Assessment Project's Stewart Farber.