[ RadSafe ] Re:Public apprehension and regulatory restrictions

Vernig, Peter G. Peter.Vernig at va.gov
Fri Mar 10 12:04:47 CST 2006

I don't usually join into these endless debates but to answer the
question regarding a penalty.

Intravascular brachytherapy, using sources to inhibit the re-narrowing
of coronary arteries was IMO over regulated.  The NRC required that
authorized users have 700 hour of training and experience plus 1 year of
supervised experience.  Essentially the requirements amounted to them
having to be radiation oncologists.

The training and experience requirements for Sr-90 eye applicators is 24
hours.  Somewhat of a coincidence they use the same isotope as the
Novoste Beta Cath and the amounts are not too dissimilar either but the
real similarity is that treatment planning is much simpler than with
most brachytherapy.  With the Beta Cath there is a table entered with
the vessel diameter or balloon diameter and there are only two dwell
times which of course equate to dose.

With the eye applicator it is again, a timed thing.  There are or were a
lot of old applicators out there and a few mistakes on decay
calculations and or some were just omitted and or calibration date not
known or mistaken. Instead of requiring more T & E for the
ophthalmologists the NRC requires that Med Physicist calculate decay.

Yet the NRC was insistent on the T & E for authorized user of the
Novoste IVB.  I submitted a petition for rule making regarding that
which never made it to the NRC because Novoste announced they were
getting out of the business while my higher HQ was sitting on it.

Since drug eluting stents came about IVB use had declined to maybe 25%
or less of its former use.

FDA has not approved DES for treating re-narrowing of the arteries after
angioplasty, only to prevent it.  They are, I think about 90% effective
in prevention.

The Novoste [now Best] Beta Cath is approved to treat re-narrowing but
not to prevent it.

At least partly because of the increased cost of using IVB most
restenosis that is re-narrowing, is treated with DES Off label rather
than IVB which is approved for that treatment.

I believe that the unnecessary added cost of having to have a radiation
oncologist be authorized user has greatly reduced the use of that
effective and approved treatment.  Radiation Oncologists as authorized
users generally want to be paid.  I don't blame them for that, as
authorized users they are responsible for the treatment [read liable] so
it is unfair for them to be responsible and not receive some
compensation for that responsibility/liability.

Is that a penalty?

Any opinions in this e-mail are solely those of the author, and are not
represented as those of the VA Eastern Colorado HCS, the Dept. of
Veterans Affairs, or the US Government.

Peter G. Vernig, Radiation Safety Officer, MS-115, VA Eastern Colorado
Health Care System, 1055 Clermont St. Denver, CO 80220,
peter.vernig at va.gov, Phone= 303.399.8020 x2447; Fax = 303.393.5026,
alternate fax, 303.393.5248

"...whatever is true, whatever is noble, whatever is lovely, whatever is
admirable, if anything is found to be excellent or praiseworthy, let
your mind dwell on these things."

Paul of Tarsus

-----Original Message-----
From: radsafe-bounces at radlab.nl [mailto:radsafe-bounces at radlab.nl] On
Behalf Of jjcohen at prodigy.net
Sent: Friday, March 10, 2006 9:48 AM
To: John Jacobus; parthasarathy k s; Muckerheide, James; Richard L.
Hess; radsafe at radlab.nl
Cc: RuthWeiner at aol.com
Subject: [ RadSafe ] Re:Public apprehension and regulatory restrictions

Is stringent regulatory restriction a reflection of the degree of public
fears, or is it more a contributing factor to greater apprehension? Has
there ever been a penalty for overregulating? How could elevated
limits benefit the regulators?-----
Just a few questions to ponder over the weekend-----   Jerry Cohen

----- Original Message ----- 
From: "John Jacobus" <crispy_bird at yahoo.com>
To: "parthasarathy k s" <ksparth at yahoo.co.uk>; "Muckerheide, James"
<jimm at WPI.EDU>; "Richard L. Hess" <lists at richardhess.com>;
<radsafe at radlab.nl>
Cc: <RuthWeiner at aol.com>
Sent: Tuesday, March 07, 2006 2:43 PM
Subject: [ RadSafe ] Re: No suggestion to change regulatory limits

> Dr. Parthasarathy,
> I believe one of the purposes for performing and
> documenting hormesis studies is to influence the
> regulatory community to elevate regulatory limits.
> The idea being that higher regulatory limits would
> require less expenditures on ALARA programs and
> savings to the utilities using nuclear power and the
> public.  Elevated regulatory limits would also lead to
> the construction of new nuclear power plants as there
> would be reduced public opposition to them.
> --- parthasarathy k s <ksparth at yahoo.co.uk> wrote:
> > Dear John,
> >
> >   Nobody proposed any change in regulatory limits.
> > The radiobiological evidence gives me confidence so
> > that I shall not lose sleep over exposures of a few
> > millisieverts.(Not withstanding genomic instability,
> > bystander effects etc). The quibling over limits as
> > low as 0.15 mSv or 0.25 mSv for the members of the
> > public from waste storage facilities may be
> > laughable. But when I look at the cost evaluation
> > reported by GAO, I believe that all stakeholders
> > including specialists must attempt to arrive at
> > pragmatic limits.
> >   Probably refined radiobiological data give
> > opportunity to spend money unwisely!
> >
> >   Regards
> >   Parthasarathy
> >
> > John Jacobus <crispy_bird at yahoo.com> wrote:
> >   Dr. Parthasarathy, et.al.,
> > So, after all of the reading of papers, reviews and
> > rebuttals, what do you think will come of all this
> > work? Has anyone seen any indication that regulatroy
> > limits will be changed?
> >
> > P.S. Jim, I found the two papers you mentioned in
> > Radio. Environ. Biophys. and will read them later
> > this
> > week.
> >
> >
> +++++++++++++++++++
> "It is not the job of public-affairs officers to alter, filter or
> adjust engineering or scientific material produced by NASA's technical
> staff."
> MICHAEL D. GRIFFIN, NASA administrator.
> -- John
> John Jacobus, MS
> Certified Health Physicist
> e-mail:  crispy_bird at yahoo.com
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