ML20046C395
| ML20046C395 | |
| Person / Time | |
|---|---|
| Issue date: | 07/07/1993 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Glenn J SENATE, GOVERNMENTAL AFFAIRS |
| References | |
| CCS, NUDOCS 9308100257 | |
| Download: ML20046C395 (3) | |
Text
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UNITED STATES
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NUCLEAR REGULATORY COMMISSION j
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July 7, 1993 The Honorable John Glenn, Chairman Committee on Governmental Affairs United States Senate Washington, DC 20510
Dear Mr. Chairman:
This refers to the letters sent to you by the individuals identified by initials in the enclosure and forwarded to the U. S. Nuclear Regulatory Commission.
Each letter writer was contacted by telephone to obtain additional information.
Since the letters were also forwarded to the U. S.
Food and Drug Administration (FDA) for review, NRC and FDA coordinated efforts to contact each letter writer, to minimize duplication of effort and inconvenience to the letter writers.
NRC collected information regarding NRC authority over the incidents and the applicability of NRC regulations, including the medical treatment facility, year of treatment, and radiation treatment device (also in the enclosure), as well as potential concerns about administration error.
The FDA collected additional patient incident information, which can be found in the FDA's Product Problem Reporting Program (PRP) reports.
We obtained our information from the letters and telephone conversations with the individual writers.
Based on this, only two of the patient incidents, described in the letters and discussed in greater detail below, involved material covered by the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974 (Public Law 93-438).
In neither of these two cases involving cobalt-60 (Co-60) teletherapy did the patient or family allege that there were errors made during the delivery of the radiation therapy treatments.
Both patients were treated for cancer more than 20 years ago, while they were teenagers.
The first individual said she developed breast cancer seventeen years after the initial radiation treatment and underwent surgery and additional radiation treatment.
This individual believes, based on current medical knowledge relating the first radiation treatments to increased risk of breast cancer, that she should have been monitored more aggressively for breast cancer, and that the second radiation therapy was inappropriate because of her earlier radiation treatments and risks.
This individual is advocating increased public awareness, for both patients and physicians, of the increased risks for breast cancer after radiation treatments for Hodgkin's disease. We have communicated her concerns to the American College of Radiology and the American Cancer Society, which are in the best positions to develop information to provide to cancer patients.
According to the patient's wife, the second individual was treated for fibrosarcoma of the thoracic spine. The vertebra was removed and extensive radiation treatments given in 1966.
The patient's wife did not believe there 9308100257 930707 I
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~ The Honorable John Glenn '
were any errors in his radiation treatments.
She stated that the patient believed that his digestive tract, lower intestine, and kidneys were never the same after the treatment.
The patient survived for 26 years, following radiation treatment, before dying in 1992. According to the discussions with the patient's wife, surgeons treating him a few years ago for kidney problems told him that he had extensive scar tissue in his abdomen as a result of the radiation treatments.
Both the patient and his wife recognized that without the radiation therapy treatments, he would not have lived 26 years.
The patient's wife believed her husband's story would be useful in your probe of the effects of radiation treatments.
NRC did not find any evidence of misadministrations in either case. There were no allegations of either treatment errors or equipment failures.
Both therapies were completed long before (i.e., in 1966 and 1971) NRC had a misadministration rule (1980) and would not have required either reporting to NRC or notification of the patient.
For the patients receiving treatment delivered by linear accelerators (five of the seven reported cases), FDA is providing copies of the letters, and information gathered, to the appropriate State Regulatory Authority in the States in which the therapy occurred.
The trend in the incidents reported reflects the fact that the majority of radiation therapies are not regulated by NRC either because the devices do not contain byproduct material or the therapy treatment was received in an Agreement State.
Sincerely, P+
adesH.Taxior fecutive Director for Operations
Enclosure:
Summary of Treatment Device and Facility Information, by Writer cc:
Senator William V. Roth, Jr.
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SUMMARY
OF TREATMENT DEVICE AND FACILITY INFORMATION, BY WRITER TREATMENT THERAPY TREATMENT WRITER RESIDENCE YEAR DEVICE FACILITY Patient Treated with NRC-Regulated Device ARR Batavia, OH 1971 Cobalt-60 Mercy Hospital Pittsburgh, PA EWL Springfield, OH 1966 Cobalt-60 Ohio State University Hospital Patient Treated with non-NRC-Reaulated Device BD Orlando, FL 1989 LINAC Orlando Regional Medical Center Orlando, FL DE Parrish, AL 1991 LINAC Baptist Medical Center: (Princeton)
Birmingham, AL JS Cassopolis, MI 1985 LINAC South Bend Memorial Hospital South Bend, IN NS Concord, Twp, OH 1992 LINAC East Side Radiology Willoughby Hills, OH ETW Blue Springs, MO 1988 LINAC University of Kansas Medical Center Enclosure
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