Re: NRC's Patient Release Rule

[carol marcus <csmarcus@ucla.edu>]

At 08:49 AM 10/28/99 -0500, you wrote:
>A recent RADSAFE posting asked how the NRC came to relax its rules on
>releasing patients with I-131 in their systems.  The answer is not
>pretty, but perhaps it will be helpful to those who want to understand
>how regulatory decisions really get made.  I was an NRC lawyer from 1975
>until a month ago, but what I am describing is public information.
>
>The Riverside incident in the mid-1970's alerted the NRC to the fact
>that it was hospitals, not nuclear power plants, where members of the
>public were actually suffering harm from radiation in the U.S.  Some 400
>patients were overexposed at Riverside because of an error in
>calculating the decay of the source.  In the aftermath of that event,
>the NRC Commissioners established, over strong NRC staff protest, the
>rule that required misadministrations to be reported to the NRC and the
>patient.
>
>After the failure of repeated NRC staff efforts to get the Commission to
>repeal or water down aspects of Part 35, the staff realized that there
>was a better way to accomplish this goal:  to arrange for the proposal
>to be submitted nominally by a member of the regulated community.  Then
>the NRC staff could go through the motions of evaluating the proposal
>and forward it to the Commissioners, ostensibly as a request from the
>interested public.  
>
>Dr. Carol Marcus has alleged in print, many times, that the former head
>of the NRC's medical section, Mr. Richard Cunningham, assigned an NRC
>staff member, Mr. Norman McElroy, to work with her in drafting such a
>petition.  See for example her letter of November 9, 1992, to the NRC
>docket in PRM-20-20, PRM-35-10, etc., responding to my letter to the
>docket of October 31, 1992:
>
>"Mr. Crane's naiveté concerning the first Petition I wrote in June,
>1989, with Mr. McElroy's help, is surprising.  Mr. Cunningham instructed
>Mr. McElroy to help me write the petition.  I didn't know how to write
>regulatory language, and it was Mr. McElroy's job to help me do that. 
>NRC had written some very poor quality and dangerous regulations in
>1987, and Mr. Cunningham realized that the language had to be fixed, and
>asked us to do it together.  It was an 'inside' job from the start."
>
>When the Commission became aware of this, it put in place a new rule,
>barring such assistance to petitioners by the NRC staff.  Mr. McElroy,
>the unfortunate staff member who had allegedly worked with Dr. Marcus,
>left the NRC, an apparent scapegoat.
>
>To judge from Dr. Marcus's account, if it is accurate -- and I see no
>reason to doubt that it is -- old practices died hard.  According to the
>same letter quoted above, she received a telephone call late in 1990
>from Mr. Hal Peterson, then of the NRC staff.  The NRC had recently
>amended 10 CFR Part 20, and a question had arisen whether its 100
>millirem standard for exposures to the general public had the effect of
>amending Part 35 as well.  To quote Dr. Marcus:
>
>"My Petition was written at the request of Hal Peterson, who was
>embarrassed at the uncorrected errors in 10 CFR Part 20, and who urged
>me to 'write a petition YESTERDAY'.  At the time, the new Part 20 was
>supposed to go into effect 1 Jan 92, and we did not have many months to
>waste.  I argued at the time that I did not want to write another
>petition (I wonder why?), but he insisted it was the only option open,
>and that is how I spent Christmas Eve, 1990.  It was hastily done, and
>recommended honoring the methodology of NCRP no. 37, getting rid of the
>'30 mCi rule' for all radionuclides other than I-131, and retaining the
>5 mSv maximum for members of the public from patient sources....Much
>later, after discussing the issues at leisure in much more detail with
>members of NRCP, ACNP, SNM, and NRC, I wrote an addendum covering the
>'30mCi" issue.  Do to the fact that the '30mCi' value was embarrassingly
>based on a naive mistake by the AEC in the early 1950's and never fixed
>thereafter, and due also to the fact it is not mentioned anywhere in
>NRCP no. 37 (nor should it have been), I made a scientifically valid
>case for a 'default' value of I-131 patient discharge which came out to
>33 mCi.  However, there is excellent reason to raise that number,
>especially for athyreotic carcinoma patients with normal renal
>function.  NRCP no. 37 lists limits of 50 mCi for certain home
>situations and 80 mCi for even more restrictive home situations.  Mr.
>Crane should familiarize himself with these qualifiers, because he is
>obviously unfamiliar with these long-accepted concepts.  NRCP no. 37 is
>the law in California; the '30 mCi rule" does not exist here.  We in
>California try to base our policies on scientifically valid health
>physics."
>
>In my comments to the NRC on the petition, I stressed the special
>character of I-131, which made it more dangerous than other commonly
>used radiopharmaceuticals, and highlighted the danger to the public from
>vomitus.  (I also pointed out that the NRC staff, by Dr. Marcus's
>account, was passing judgment on what was actually its own proposal.) 
>To quote my letter of October 31, 1992:
>
>"In addition, one of the most common effects of I-131 treatment is
>nausea. ... As an inpatient, one is instructed to call the nurses'
>station at the first sign of nausea, so that appropriate medication may
>be given.  Vomiting presents problems for hospital Radiation Safety
>departments, because they must enter the radiologically contaminated
>room in order to clean up.  Consider, however, how much worse it would
>be if the patient is at home, vomiting, and unprotected family members,
>rather than Radiation Safety personnel with rubber gloves and other
>protective gear, are having to clean up, probably without thinking for a
>moment, under the stress of the situation, of the radiological
>implications. ... What about the patient, traveling home by public
>transportation....?"
>
>I also pointed to the then recent report in the New York Times that a
>World Health Organization team was finding unexpected childhood thyroid
>cancer deaths near Minsk among children exposed to radioiodines from
>Chernobyl, and suggested that this was "not the time for the NRC to be
>approving regulatory changes that will have the effect of exposing
>American children to more I-131."  (In her reply, Dr. Marcus
>sarcastically criticized me for "quoting such incontrovertibly superb
>scientific sources as the New York Times for data on childhood thyroid
>cancer near Chernobyl.")
>
>Concerns similar to mine were expressed by the health authorities of six
>states.  New York State drew attention to the dangers of exposure from
>vomitus, and it expressed concern about releasing any patient after a
>dose of more than 80 mCi.  (This number may have come from the same
>source cited by Dr. Marcus.)  But when the NRC issued the proposed rule,
>it was as though those six states and I had never filed comments at
>all.  There was no identification of the special character of I-131 as
>an issue; no mention of vomitus; and -- this was no surprise -- no
>mention of the issue of whether the NRC staff had played a role in
>inspiring the petition.
>
>I filed comments once again, making all these points, quoting the
>comments of the six states, and adding that it was discouraging to feel
>that if one's comments went counter to the NRC staff's proposal, they
>would simply be ignored.  I pointed out the disparity between the
>proposed rule and the International Basic Safety Standards to which the
>United States nominally subscribes.  I pointed to a comment from NIH,
>which said that it knew that despite all precautionary warnings, its
>I-131 patients frequently went right to the airport and boarded planes
>after their release.  If that was a problem under the 30 mCi limit, how
>much worse would it be if that limit was lifted? 
>
>But all these comments were ignored once again, and when the
>Commissioners received the NRC staff memorandum ostensibly analyzing the
>comments, and proposing a final rule for the Commission's adoption, none
>of these issues were addressed.  Apparently, the NRC staff was confident
>that no Commissioner or Commissioner's assistant would bother to read
>the actual comments filed.  As far as the Commissioners knew, the issue
>for them to decide was an easy one:  whether the exposure level to
>members of the public should be 100 millirem or 500.  The Commissioners
>voted their approval, and the final rule duly went forth.
>
>As a result, the Commissioners approved a major deregulation of I-131
>treatments without, I suspect, fully appreciating what they were doing. 
>They had not been told of the concerns of New York and other states;
>they knew nothing of the risk of vomitus; they did not understand that
>I-131 was in a class by itself; and they did not realize that Dr.
>Marcus's petition was, by her own account, filed only because the NRC
>staff demanded it. 
>
>The NRC staff paper, and all the filings in the docket, are publicly
>available; I am revealing no secrets here.  By the way, all the comments
>that I filed, on the petition and the proposed rule, I wrote on my own
>time, and submitted in my capacity as a private citizen.  I had been a
>thyroid cancer patient, receiving two outpatient and five inpatient
>treatments, and being aware of just what extraordinary precautions
>hospitals take with their I-131 patients, I thought it was the height of
>irresponsibility to enact a regulatory change that would allow patients
>with large doses of I-131 in them to walk out the door.  But I might has
>well have saved the money I spent on stamps.
>
>The recent reports on RADSAFE of patients vomiting up I-131, and of
>passengers on a city bus walking through the vomit, should come as no
>surprise.  Not only were such problems predictable, they were predicted.
>
>Last month, shortly after my retirement from the NRC, I happened to meet
>a senior physician at one of the great medical centers in the east. 
>Without signaling my own views, I asked him what he thought of the NRC's
>patient release rule.  Without hesitation, he answered:  "Probably the
>biggest mistake the NRC has made in 35 years."
>
>Peter Crane
>pgcrane@erols.com
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>

Dear Radsafers:

Peter Crane is confusing a number of details, and telling only selective
parts of the truth in others.  Other of his statements, such as the efforts
of the NRC staff to help physicians, are dead wrong.  Only Norman McElroy
tried to do the right thing.  Dick Cunningham tried somewhat, and so did
Hugh Thompson, but the Office of General Counsel fought them to the ground,
and they felt they could't do too much without getting into trouble
themselves.  Norman McElroy was fired for trying to do the right thing, and
Dick Cunningham was later removed from his position and shelved until he
retired.  Thompson virtually abandoned the "Medical" Program in order to
politically survive until his early retirement.

The true origin of the "relaxing" of NRC's regulations for patient discharge
is an embarrassing story for NRC.  I think most Nuclear Medicine physicians
assumed that the 30 mCi standard was based on the 500 mrem maximum dose to
members of the general public; certainly I assumed this in my younger days.
When NRC changed 10 CFR Part 20 to drop public doses from 500 mrem to 100
mrem, I was afraid that huge numbers of patients would be forced to stay
isolated in hospitals because of a standard 5x more stringent than
previously.  Initially, I was concerned about DIAGNOSTIC doses of
radioactive material.  You will recall that NRC's regulation at the time
referred to 30 mCi of ANY radionuclide, or a default mR/hr reading.  

The new Part 20 at 20.1301(c) provides for a petition mechanism to maintain
the 500 mrem limit for an individual member of the public; NRC foresaw the
advisability of granting exceptions to the 100 mrem standard.  You may
recall that the 500 mrem standard was not lowered because there was any
evidence of hazard at 500 mrem, but because it was possible in most cases to
get the number down to 100 mrem, and for overkill safety reasons, the LNT
supporters thought it was good (i.e. NCRP and ICRP).  Using NRC's own
"1301(c) Petition" mechanism, I sought to avoid a terribly inappropriate
problem.  

When I reviewed NCRP no. 37, which is a license condition for all California
licensees, I realized that the highly simplistic equation in Appendix I.
could be expanded by inserting disease group and individual patient data so
that somewhat realistic absorbed dose calculations could be made for members
of the non-patient public.  In fact, the more one added compartmentalization
data, shielding data (both from the patient and for the exposed public
member, whose whole body dose is much less than the skin dose), and
realistic times of exposure and distances of exposure, the more accurate
one's calculations became.  After the main petition was submitted, I went
back and looked at the I-131 case and couldn't figure out where in the world
the "30 mCi" had come from.  NCRP no. 37 pooh-poohs the "30 mCi" number, but
did not give its origin.  (The NRC originally applied the "30 mCi" to I-131;
only in 1987, I think it was, was it applied to ALL radionuclides.)  Don
Cool admitted that no one at NRC had any idea where it came from or what it
was based on; we had a completely arbitrary and capricious standard with no
scientific basis at all.  It certainly had nothing to do with the 500 mrem
limit.  A few years later, I ran into an older individual who told me that
some AEC guy made this "back of the envelope" estimate, and made some really
bad medical mistakes in doing so, but the older individual was loath to
correct the AEC guy because he thought that the standard might be even lower
as a result; 30 mCi was silly enough.

At that point I amended my petition to attempt to bring science into
standards, a nearly impossible undertaking at NRC.  The most malevolent
schemes were undertaken by the Office of General Counsel and certain staff
individuals after that.  Remember---NRC ASKED me to submit my petition.  You
may recall that the new Part 20 was initially delayed for some months
because NRC has neglected to change the numbers of the sections, and both
old and new Part 20 had the same numbers, and that would have been very
confusing because Agreement States were using the old Part 20 for up to 3
years after the new Part 20 came out.  When the new Part 20 was delayed for
renumbering, the Office of General Counsel threw out my petition because it
referred to a rule that did not exist!  It took going to Thompson, as I
recall, to crush the sleaze of OGC who were doing this.  It took, in the
end, 7 years of war with NRC staff and management before the rule went
through, and even then it wasn't right (it is perfect in California,
however).  First, the EDO gave the petition a "low priority" and NRC staff
was told to bury it.  Commissioner E. Gail de Planque resurrected it and
gave it to a different group, but that group, and its leader, could not do
the math (e to the minus x, and logarithms, were beyond NRC's competence).
I was told that NRC was putting out a contract to perform the calculations,
and I begged the leader (Don Cool) not to do that; it would take too long
and use up our User Fees.  I said that I would do all the calulations for
him within 2 weeks.  With a little help from Oak Ridge with some specific
gamma ray constants I didn't have, I got all the calculations in on time.
Then Cool let out a contract anyway; he said NRC didn't have the math
ability to "check my numbers".  Incompetent?  Stalling?  Both?  When a
Proposed Rule came out, it was preposterous, and I had a meeting with
Chairman Ivan Selin to discuss it.  Ivan has a Ph.D. in EE and an Sc.D.in
mathematics, and besides, he's really bright.  He knows nothing about
medicine or pharmacy, but when he went over the math, he was very
embarrassed.  He said that "We didn't do our homework."  I told him NRC
COULDN'T do its homework, but Ivan insisted it would be corrected.  However,
the staff simply stalled until Ivan left, and put out a pretty bad rule with
a really bad reg guide (dumb math, among other things) when Jackson came in.
She was much easier to fool than Ivan.

So what really happened after all this?  The standard ended up being set
where it should have been all along, at 500 mrem.  The only reason the
standard was "relaxed" is that NRC's medical requirements were inconsistent
with Part 20 limits to begin with.

As far as the Riverside incident is concerned, this had nothing to do with
anything I ever wrote.  I don't know why Peter is dragging that up here; he
is mistaken.  The Riverside incident showed the need for high standards of
competence among physicians and physicists who perform radiation therapy.
NRC is still being criticized by many that physicist qualifications are a
joke, and often techs ("dosimetrists") do therapy calculations.  This merely
insures a steady stream of mistakes, so that NRC can justify its program.
If standards were high, mistakes would be fewer.  Anyway, one regulation
fixed the thing that caused Riverside, and it never happened again.

My first petition was nicknamed "The Radiopharmacy Petition", and it was
written because NRC has restricted the use of appropriate drugs for
appropriate patients, had virtually exterminated the practice of pharmacy,
and was demanding compliance with requirements that were REALLY harmful to
workers, and morbid and possibly fatal to patients.  When 3 patients were
denied drugs and procedures that their primary care physicians and nuclear
medicine physicians thought necessary, and all 3 cases were
life-threatening, it became necessary to change the regs and license
conditions.  NRC asked for this petition because it was getting really
scared, but did not know how to fix the mess it had made. For example, NRC
recognized the practice of pharmacy in its regs, but denied it in every
license as a license condition (fraud).  In one critical patient's case, the
FDA begged the NRC to permit a therapy drug to be used for an unlabeled
indication which was nevertheless the standard of practice, and NRC refused.
The nuclear medicine physician was threatened with possible prison by the
NRC individual in Region V. if he dared treat his patient!  The patient's
physicians then changed the patient's diagnosis to one on the package
insert.  While this is a felony, the FDA railed against NRC at a public
meeting that is was pretty bad that NRC's ridiculous requirements required
physicians to commit a felony, and that it was NRC that was guilty, not the
physicians.  Eventually, after 5 years of warfare with certain staff
individuals and certain members of the Office of General Counsel, the
"Radiopharmacy Rule" went through.  Not surprisingly, the NRC started
playing "death by licensing" games again.  In the Proposed Part 35, the vile
licensing NUREG goes right back to the dangerously stupid 1987 requirement
of FDA-approved or accepted drugs and only labeled indications for therapy.
Obviously the staff never learns, the management never learns, and the
Commissioners have no idea what's going on.

These are the types of things that led the NAS-IOM to condemn NRC's
"Medical" Program completely, and recommend that Congress remove NRC's
statutory authority in this area.  Medicine and pharmacy decisions should
remain in the hands of State Boards of Medicine and Pharmacy; NRC has zero
talent or competence here, and no one needs its opinion.  The fact that NRC
has nearly killed some patients, and has prevented many patients from
getting the procedure of choice for their medical condition, means that NRC
is not only useless---it's downright dangerous.  The NAS-IOM stated that all
a Rad Health entity needs to do is establish high qualifications for
Authorized Users, and require that medical practices be set up to comply
with the numerical (but not the baloney paperwork) standards of 10 CFR Part
20.  As long as the radiation doses to workers, members of the non-patient
public, and the environment are met (and NRC states that in Nuclear Medicine
they surely are met), none of the other junk is needed.  This is a
PERFORMANCE STANDARD.  Whatever you are doing, you meet the numerical safety
standards.  As far as patients are concerned, this is under State Boards who
use board-certified specialists to advise on all cases of possible
negligence or malpractice.  Having served as a consultant to the California
Medical Board, I know that this works.  Having served as an advisor and
consultant to the NRC officially for 4 years, and unofficially for some
years before that, I can say unequivocally that the NRC system does not work
at all.

And that, Peter, is what really happened.

Ciao, Carol

Carol S. Marcus, Ph.D., M.D.
<csmarcus@ucla.edu>


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