Re: no subject received Wed, 16 Oct 2002 14:56:28 -0500
From: Terry J DuBose (tjdubose@juno.com)
Tue Oct 22 21:57:53 2002
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Dr. Smeltzer, this is exactly the argument we (as liaison from the SDMS
to the AIUM Bioeffects Committee) made last year when taking the issues
of 3D entertainment studios and the public sale of Doppler fetal
monitors before the committee. We made the argument that proud new
parents would be purchasing these little Doppler monitors as soon as they
found out they were pregnant... and be spending HOURS searching for the
little bugger's heart beat, not realizing that they would not be able to
find it until probably 12+ weeks... if then. Who knows how much
sonic/heat energy would be deposited under those circumstances?
The basic response was that the FDA has limited resources and this was/is
not a real problem when compared to what the FDA has to do overall.
I am convinced that the corporate culture in Washington DC would like
nothing better than to break the back of mainstream medicine... let the
pharmaceuticals and equipment manufacturers sell to anyone... regardless
of their education or skill. That's the "free market" at it's best.
>From their point of view, any oversight is socialism, and needs to be
stamped out. "Caveat Emptor" and it is just the public's stupidity if
they are taken in by charlatans... reguardless of the results on their
long term health.
Peace, Terry J DuBose
---------------------------------------------------
On Tue, 22 Oct 2002 20:57:32 -0500 "James S. Smeltzer"
---------------------------------------------------
<gaperina@mindspring.com> writes:
--
---------------------------------------------------
> Philippe,
>
> My personal opinion is that the issue is heat. The MI does not
> aggregate total heat transfer to the patient or any object presumed
> to
> be an embryo. Here opinion ends.
>
> The heat flux to and out of an embryo depends on the conditions, the
>
> energy delivered, the energy absorbed and the tissue perfusion. It
> depends on time only to the extent that an equilibrium flux rate is
> not
> achieved at a temperature safe for the embryo. If you insonate a
> larger
> field, which happens to be an entire embryo, at MI power levels
> proven
> safe for a sub sample of the field (2-D sonography), you do not
> necessarily provide safe (Nonteratogenic) power (equilibrium
> temperature) to the embryo.
>
> I stand absolutely on the fact that there is a pioneer (or from the
> embryo's point of view - guinea pig) risk as long as actual
> monitored
> and measured experience with an actual drug or modality in human
> embryos
> does not preclude any measurable increase in problems - theoretical
> considerations and animal experiments aside.
>
> I stand absolutely on the fact that thalidomide was proven safe in
> two
> species before given to women who were pregnant (not legally in the
> US,
> thanks to the FDA which prefers to let Asian and European fetuses be
>
> used as post-marketing guinea pigs).
>
> I stand absolutely on the fact that heat is a proven teratogenesis
> in
> humans.
>
> I will state categorically that women who subject their embryos to
> "cute" 3-D shows are subjecting them to unknown risks.
>
> I will state categorically that early 3-D embryonic sonography
> necessarily exposes the early embryo to more sound energy than is
> necessary to document a heart beat and crown-rump length, and are,
> therefore, inherently violating the ALARA principle.
>
> Besides these facts, the rest is conjecture.
>
> Jim
>
> -------------------------
> > [From: Philippe Jeanty. MD, PhD;
> -------------------------
> > [Address: jeanty@TheFetus.net;
> -------------------------
> > [To: Multiple recipients of list ULTRASOUND;
> > [Date: Tuesday, October 22, 2002 01:55:14 PM
> >Hey Jim....
> >Are these comment documented evidences or personal opinions ?
> >Do folks who use 3D expose the fetus longer then folks who do not ?
>
> what is
> >the average time of exposure in your environment ? What typical
> values
> of MI
> >and TI do you have on your images ?
> >
> >I would think that the issue is way more complex then your note let
> it
> >appear, and that your note, by simplifying too much may give a
> distorted
> >view to reality.
> >
> >Would you possibly reconsider the statements you made ?
> >
> > -----Original Message-----
> >From: ultrasound@obgyn.net [mailto:ultrasound@obgyn.net]
> On Behalf Of
> >James S Smeltzer MD
> >Sent: Monday, October 21, 2002 10:19 PM
> >To: Multiple recipients of list ULTRASOUND
> >Subject: Re: no subject received Wed, 16 Oct 2002 14:56:28
> -0500
> >
> >At 02:59 PM 10/16/2002 -0500, you wrote:
> >>Hi my name in Fabiola savinovich and I am 29 weeks pregnant. i
> would
> like
> >>to know were in MIami can I get a 3D ultrasound performed. Thanks
> >>
> >
> >Hi Fabiola!
> >
> >Usually a 3-D ultrasound does not obtain more information about
> your
> baby
> >than a skilled examiner gets with a regular ultrasound. It does
> deliver
> >more total energy to the baby. We know this is heat. We also know
>
> that
> >heat is a known cause of birth defects in the first 3 months
> inside.
> Right
> >now lots of women are using their babies as guinea pigs to see if
> this
> is
> >enough heat to be a problem or not. Once a few million women have
> had
> this
> >test and had follow-up on their babies we may know that it is safe.
>
> Then
> >again we may know that it is risky.
> >
> >If you or the baby's father have some problems with the development
> of
> the
> >skeleton or certain physical deformities that might be inherited,
> then
> this
> >may be a better test for you despite this potential risk.
> Otherwise I
> >would talk the unknown risk and benefits over with your doctor. In
>
> general
> >it is usually wise to let someone else use their baby as a guinea
> pig
> and
> >avoid exposing your baby to unknown and new things until they are
> known
> to
> >be safe, unless they are the best possible medical alternative for
> some
> >other reason.
> >
> >Jim Smeltzer, MD
>
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<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN">
Dr. Smeltzer, this is exactly the argument we (as liaison from the SDMS to
the AIUM Bioeffects Committee) made last year when taking the issues
of 3D entertainment studios and the public sale of Doppler fetal monitors
before the committee. We made the argument that proud new parents would be
purchasing these little Doppler monitors as soon as they found out they
were pregnant... and be spending HOURS searching for the little bugger's heart
beat, not realizing that they would not be able to find it until probably 12+
weeks... if then. Who knows how much sonic/heat energy would be deposited
under those circumstances?
The basic response was that the FDA has limited resources and this was/is
not a real problem when compared to what the FDA has to do overall.
I am convinced that the corporate culture in Washington DC would like
nothing better than to break the back of mainstream medicine... let the
pharmaceuticals and equipment manufacturers sell to anyone... regardless of
their education or skill. That's the "free market" at it's best.
>From their point of view, any oversight is socialism, and needs to be stamped
out. "Caveat Emptor" and it is just the public's
stupidity if they are taken in by charlatans... reguardless of the results on
their long term health.
Peace, Terry J DuBose
---------------------------------------------------
---------------------------------------------------
On Tue, 22 Oct 2002 20:57:32 -0500 "James S. Smeltzer" <
---------------------------------------------------
> Philippe,
>
> My personal opinion is that the issue
is heat. The MI does not
> aggregate total heat transfer to the
patient or any object presumed
> to
> be an embryo. Here
opinion ends.
>
> The heat flux to and out of an embryo depends on
the conditions, the
>
> energy delivered, the energy absorbed and
the tissue perfusion. It
> depends on time only to the extent that
an equilibrium flux rate is
> not
> achieved at a temperature safe
for the embryo. If you insonate a
> larger
> field, which happens
to be an entire embryo, at MI power levels
> proven
> safe for a
sub sample of the field (2-D sonography), you do not
> necessarily
provide safe (Nonteratogenic) power (equilibrium
> temperature) to the
embryo.
>
> I stand absolutely on the fact that there is a pioneer
(or from the
> embryo's point of view - guinea pig) risk as long as
actual
> monitored
> and measured experience with an actual drug
or modality in human
> embryos
> does not preclude any measurable
increase in problems - theoretical
> considerations and animal
experiments aside.
>
> I stand absolutely on the fact that
thalidomide was proven safe in
> two
> species before given to
women who were pregnant (not legally in the
> US,
> thanks to the
FDA which prefers to let Asian and European fetuses be
>
> used as
post-marketing guinea pigs).
>
> I stand absolutely on the fact
that heat is a proven teratogenesis
> in
> humans.
>
> I will state categorically that women who subject their embryos to
> "cute" 3-D shows are subjecting them to unknown risks.
>
>
I will state categorically that early 3-D embryonic sonography
>
necessarily exposes the early embryo to more sound energy than is
>
necessary to document a heart beat and crown-rump length, and are,
>
therefore, inherently violating the ALARA principle.
>
> Besides
these facts, the rest is conjecture.
>
> Jim
>
> -------------------------
>
> [From: Philippe Jeanty. MD, =
> -------------------------
>
PhD;=20
> -------------------------
>
> > [Address: jeanty@TheFetus.net;
>
> [To: Multiple recipients of list
ULTRASOUND;
> > [Date:
Tuesday, October 22, 2002 01:55:14 PM
> >Hey Jim....
> >Are
these comment documented evidences or personal opinions ?
> >Do folks
who use 3D expose the fetus longer then folks who do not ?
>
>
what is
> >the average time of exposure in your environment ? What
typical
> values
> of MI
> >and TI do you have on your
images ?
> >
> >I would think that the issue is way more
complex then your note let
> it
> >appear, and that your note,
by simplifying too much may give a
> distorted
> >view to
reality.
> >
> >Would you possibly reconsider the statements
you made ?
> >
> > -----Original Message-----
>
>From: ultrasound@obgyn.net [mailto:ultrasound@obgyn.net]
> On Behalf Of
> >James S Smeltzer MD
>
>Sent: Monday, October 21,
2002 10:19 PM
>
>To: Multiple recipients of
list ULTRASOUND
>
>Subject: Re: no subject
received Wed, 16 Oct 2002 14:56:28
> -0500
> >
> >At
02:59 PM 10/16/2002 -0500, you wrote:
> >>Hi my name in Fabiola
savinovich and I am 29 weeks pregnant. i
> would
> like
>
>>to know were in MIami can I get a 3D ultrasound performed.
Thanks
> >>
> >>
> >>
> >
>
>Hi Fabiola!
> >
> >Usually a 3-D ultrasound does not
obtain more information about
> your
> baby
> >than a
skilled examiner gets with a regular ultrasound. It does
>
deliver
> >more total energy to the baby. We know this is
heat. We also know
>
> that
> >heat is a known
cause of birth defects in the first 3 months
> inside.
>
Right
> >now lots of women are using their babies as guinea pigs to see
if
> this
> is
> >enough heat to be a problem or
not. Once a few million women have
> had
> this
>
>test and had follow-up on their babies we may know that it is safe.
>
> Then
> >again we may know that it is risky.
>
>
> >If you or the baby's father have some problems with the
development
> of
> the
> >skeleton or certain physical
deformities that might be inherited,
> then
> this
> >may
be a better test for you despite this potential risk.
> Otherwise
I
> >would talk the unknown risk and benefits over with your
doctor. In
>
> general
> >it is usually wise to let
someone else use their baby as a guinea
> pig
> and
>
>avoid exposing your baby to unknown and new things until they are
>
known
> to
> >be safe, unless they are the best possible medical
alternative for
> some
> >other reason.
> >
>
>Jim Smeltzer, MD
>
>
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