ML20044B498
| ML20044B498 | |
| Person / Time | |
|---|---|
| Issue date: | 03/02/1992 |
| From: | Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Marcus C LA CITY HARBOR UCLA MEDICAL CENTER, TORRANCE, CA |
| Shared Package | |
| ML20044B499 | List: |
| References | |
| FOIA-93-133 NUDOCS 9203200384 | |
| Download: ML20044B498 (2) | |
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e UNITED sTbTes f.
NUCLEAR REGULATOh V COMMISSION
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YVAsHINo ton, o. c. 20555 h!AR 2 1992 Carol S. Marcus, 4.D., Ph.D.
Ifuelear Medicine Outpatient Clinic
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Bldg. A-13 Harbor. UCLA 1000 West Carson Street Torrance, CA 90509
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Dear Jr. Marcus:
During the course of the recent Advisory Committee of the Medical Use of isotopes (ACHUI)meetingheldonNovember 7 1991, you made several coments regarding the incident at Tripler Arrqy Medical Center and stated that the patient had concealed her pregnancy.
Spacifically, tne following are quotes from your statements that are part of the oublic record (p. 258 of the proceedings transcript):
1.
"She hid her pregnsney from three physicians; her physician on the island, and the endocrinologist at Tripler, and t1e nuclear medicine phy s ician. "
2.
"I don't know whether she-hid the pregnarcy because she wa r whether she was afraid she wouldn't be 3.
"This was a complicating thing in the whole investigation, that I think really helped in having the accident occur, that she hid it so very, very effectively."
We reviewed both your initial report dated July 4,1990, and the Nuclear
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Regulatory Comission (NRC) inspection report sumary dated August 3,1990.
The NRC investigation of the incident did not include any communication with the patient's personal physician on Truk, nor are We aware of any information which indicated that the patient hid her pregnancy from her physician.
- Also, there are several references in both these reports that the endocrinologist's secretary was awar y patient was pregnant.
In your report, you stated that "His' and the sdc;0r jsecretary realized that the patient was pregnant, retary told t e lealth coordinator in Truk to ha he se scheduled after the baby was born." The secretary did not inform Of.1 bout the i
birth of the baby on June 1st. Although the patient did nos volunt the fact that she was nursing when she arrived at Tripler, this does not imply that sh'e concealed that she was nursing. The patient did inform the nuclear medicine technologist that she was nursing when the scan was perforced op June 21, 1990.
i Because the evidence does not support the fact that slie concealed her pregnancy, the NRC will submit a correction to the public record to be included with the transcript of the ACMUI meeting.
If, however, you have further information 1
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not currently available to us that would support the fact that'she deliberately-concealed her pregnancy, please provide.us with such information.by March 15, 1992, in order that we may consider it prior to correcting the record.
Sincerely, P
Richard E. Cunningham, Director i
Division of Industrial and Medical Nuclear Safety, NHSS Office of Nuclear. Material. Safety J
and Safeguards t
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j sun s sanax mu cn z uttu. outs inuss tes ocates nnensiot UCIA SCHOOL OF MEDICINE HARBOR - UCIA MEDICAL CENTER DEPARTMENT OF RADIOLoCY March 10, 1992 1000 CARSON STREET TORRANCE, CALIFORNIA 90500
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' Richard E.
Cunningham Director, Div. of Indust. rial and Medical Safety, NMSS O.S. Nuclear Regulatory Commission Washington, DC 20555
Dear Dick:
This letter is in answer to your letter of 2 March 92 concerning the Tripler incident.
The patient, is a nurse, and was told repeatedly (I think it waT5~ tiiiies ) befo're that she should not be pregnant or breast-feeding when given I-131.
she hid the pregnancy from three physiciansb I cannot prove that it.
It is hard to imagine a ysician dum but can only infer enough to order I-131 on a known pregnant patient, a ough I don't know anything about her physician on Truk or what the standards for a practltioner in that country might be.
I spoke with the health gare worker fro Truk who knew about the regnancy and so informed Dr.-g retar the first time he. request went through.
I spo <e o or Iso, and he was not told of the pregnancy problem.
He w s no involved in this first attempt at scheduling at all.
I trul think that the " girls" got together and stopped th' test and tha probably neither physician knew; certainly tlid not.
When the second request for the procedure weit t roug1, the baby had not yet been born.
I do not know if it was the same health care worker on Truk that passed it alon (I think i was) but it went out anyway.
I do not know if ur.
secretary remembered about the or wnether she assumed the baby had been born,or whether pregnancy ht about it at all. This is not a secretar job, and lucky break.y's she thoug There is no catching the problem the first time was a
.a that an abysician, especially a competent endocrinologist like w
Or lllll1B giFwould have taken a pregnant patient off replacement w nh' he r hypothyroidism to coincide with delivery, syn arou,
unless he did not kne she wa regnant.
No way.
The patient could have talked to en she got to Tripler or could have sent a message to aim ore when the order came through to stop the replacement synthroid and she was going into her 9th month.
It is very strange to me that she did nots she could have done it through the health care worker.
4 Informatica in this record was deleted in acc;rtna with the Fredxn of information Act, exemptions __d F01A _fird3 nwm
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ex March 10, 1992 Richard E.
Cunningham Page The patient could have told the Nuclear Medicine physician or a technologist that she was breast-feeding, but did not.
She had a serum D-HCG drawn and did not mention she had given birth just a short time before.
Of course she admitted to the nuclear medicine technologist that she was breast-feeding after_the scan---it was impossible to deny.
Did you see that scan?
As I recall, all you saw was two extremely radioactive breasts and everything else in the image was negligible by comparison.
She told the nuclear medicine physician that she knew she shouldn't be breast-feeding, Why but that she thought that 11 hours1.273148e-4 days <br />0.00306 hours <br />1.818783e-5 weeks <br />4.1855e-6 months <br /> of waiting would be enough.
didn't she ask?
The nuclear medicine people were there, were competent, and were very nice.
Yes, they were busy that day, but it would have been easy to ask the question.
Someone has to be with the patient to administer the dose.
It is easy to ask then.
Remember, this is a young lady who has had metastatic disease and who has been saved by excellent medical management at Tripler, despite the difficulties of dealing with another country that is very backward.
She might have been very fearful of recurrent metastasis, and afraid she would not be cared for if she admitted the pregnancy / lactation.
This is certainly a reasonably likely scenario.
I would also like to point out that I had at least two meetings with physicians at Tripler where no one else from NRC was with me, and I had ' several other meetings with physicians at Tripler in which other NRC representatives were present but we spoke briefly, technically, and professionally,.
t none of the NRC people understo uch of anything except who understood some of it because is a good nuclear me icine technologist and a pretty savvy woman and mother.
In addition, I had telephone conversations with several individuals f rom Tripler before I lef t for Hawaii, and no one from NRC was in on those conversations.
I therefore do not think it is of any importance what the NRC inspection a rt summary said.
The NRC inspection team, with the exception o and me, were not capable of doing this job.
They were out of
.,eir element completely and were in the dark.
The first question they asked when I arrived was,"What does the thyroid gland sp?"
At least they were honest.
Your wouldn't send me in to troualeshoot a reactor accident; why send them into a highly complex medical care delivery system?
I cannot comment on the accuracy and completeness of their report, because no one from NRC ever sent me a copy to review.
Why didn't you?
I disagree completely with your statement that "the evidence does not support the fact that she concealed her pregnancy";
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March 10, 1992 Richard E. Cunningham Page that there is much evidence suggesting that in fact she did.
I still tind it amazing that NRC had already made up its mind about wanting to " kill" Tripler before my or the NRC report was in or before this complex case was discussed.
(It never has been satisfactorily discussed).
The inspectors from Region V were obviously feeling this pressure throughout' the inspection.
Such prejudice is grossly inappropriate.
I expect that things would of have been quite dif f erent if it had been Bethesda Naval instead Tripler Army. Hospital.
As far as your third quotation of mine goes, it doesn't make sense as written and there probably is a transcription error in the second line.
However, I still believe that she hid her pregnancy ar n I left Tripler, I assumed it was because the Later I realized that I was probably ver app ying e wrong set o Itural values, and that more likely it was fear of not being cared for.
I had no idea I would be expected to " prove" this.
You sent me out as a medical consultant.
I am not a detective or a public With 5 and her baby back on Truk, prosecutor.
neither I nor anyone crediole trom'NRC ever talked to her; I have had to make certain probablistic assumptiens.
Why does it even matter?
There is, I
- think, no doubt that the two Tripler physicians did not know about the pregnancy, and it is highly probable that L lan did not know, either.
There is no doubt thatl
.she shouldn't be pregnant or breast-feeding.
y )e is very shy.
or very dumb.
The point is that commun ca ton lled to take place despite numerous prior caveats and ample opportunity, and that is why such occurances are so rare:
the system works almost all the time.
Before NRC considers " submit (ting) a correction to the public record to be included with the transcript of the ACMUI meeting.",
how has NRC " proved" that she did NOT conceal her pregnancy and lactztion?
You haven't.
I believe she concealed her pregnancy, probably by design but possibly by being shy or dumb.
Concealment nonetheless.
on what basis can you dispute this? And what is your motivation to attemot to do so?
By the way, did you write this letter or did someone write it for you?
I have never known you to be rude, but I received this on 9 March '92 and the " deadline" for you to receive my answer is March 15th or you intend to incorrectly " correct" the public record.
Considering the fact that the ACMUI meeting was 7-8 Nov. 91, what took you so long, and wh Because someone is hoping I won't make the deadline? y rush ma?
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March 10, 1992 Richard E.
Cunningham Page You may not want to follow the advice you pay me so well(!) to produce; that is your privilege.
But to try to discredit it, without any evidence whatsoever, because it does not fit the propaganda construct that your staff would like to arrange, is blatant unethical behavior.
It is my' opinion, and that of other professionals in the field, that NRC s behavior in the Tripler incident was contemptible.
The fact that your staff is in the process of concocting a regulation about pregnancy and lactation, which is absolutely unnecessary and out of your jurisdiction anyway, appears to be the cause of this attempt to change the
'l public record.
After all, if the public record did not fit, why l
not change it so that it does? The same staff has performed in the i
same unethical manner with the Q/M Rule, the Immediately Effective 1
Interim Final Rule, the ACNP/SNM Petition, the Syncor suit, and j
Abnormal Occurrences Reports to Congress.
I have known you for 22 years, Dick.
I have disagreed with you numerous times, but I have never seen you stoop to this.
Would you please fix this mess before it goes any further?
Sincerely,
.' Carol S.
Marcus, Ph.D.,
M.D.
Ji r ec to r, Nuclear Med. OutpE~P Clinic and Assoc. Prof. of Radiological Sciences UCLA cc:
Hugh Thompson, Deputy EDO Barry Siegel, M.D.,
Chair, ACMUI William Parler, Designated Agency Ethics Official CSM:sfd
.