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Article #103

& RFD sci.med.toxicology (Was: Re: Composite BIS-GMA tox. art. (Was: Re: BEWARE ULF'S MERCURY FIGS.))

#103
From: Brian Sandle
Date: Wed, 10 Jan 1996 00:00
403 lines
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Hali J. Kaufman (ms2thdr@ids.net) wrote:
: In article <4c99hq$7n6@nms.telepost.no>, reiersol@telepost.no (Dagfinn
: Reiersol) wrote:
: 
: > bsandle@southern.co.nz (Brian Sandle) wrote:
: > 
: > 
: > >My composites still have a hot, angry taste after several years. I keep
: > >my tongue away but the taste leaks around the left side of it where the
: > >fillings are.
: > 
: > Something very odd is going on here. I've never heard ANYONE complain
: > about this before. Has anyone else heard of this kind of problem?
: 
: I've never heard of something like that.  My guess may be that there is
: some significant leakage around these composites, and If there were
: amalgams previously placed and not completely removed there could be some
: ionic transfer (maybe?) amongst the different materials.  I don't know but
: whomever the original problem has originated from should seek some dental
: guidance instead of just "tasting" since there could be some decay under
: these composites as well.
: 
: -- 
: If you never try to do something, you will never know if you can do it.
: 
: Hali J. Kaufman, DMD
: Newport, RI

Firstly might I mention the RFD for a group sci.med.toxicology. The
notice has not been on sci.med.dentistry or sci.med.occupational. I am
posting this there with the excellent long article about how iatrogenics
is a major cause of death which has just been on sci.med.dentistry only,
(plus a reply from me of an NIH gopher article which is perhaps the part
somewhat more relevant to sci.med.occupational as well as to filling
tox.). It is interesting that the article was partly from chance and I
worry a little about separating toxicology out of the main groups.
Multiple posting sends only one copy around the world, and it is only
read once, though the RFD seemed to go out to groups at several times
with several downloads, consequently. Did many bother to go to
news.groups to see any discussion?

At the stage I had these fillings placed I was wanting to know about
whether there were alternatives to amalgam ones. I discussed mercury
removal with the dentist and he was very careful to remove all the
mercury. 

The two teeth were sore to chew on and I feel that may have been because
I had been persuaded away from fluoride toothpaste by the anti-fluoride
wave. Had I started using calcium fluoride 1% nutritional powder earlier
I may not have had the pain. It was called a Schuesslers salt.

The dentist could not tell me the formulation of the Tetric fillings he
used, though I later found it out from another dentist who supplied the
instruction sheet to me.

In the process of trying to find out about the fillings I spoke to Dr
Mike Godfrey who is listed as being involved in the amalgam conference
recently advertised. He said Tetric had been found useful for some
people. 

In an older article of his he advises biocompatibility testing before
placement of fillings and says that that might show that it is possible
to tolerate even one of the following less compatible materials. This old
list of his I provide for interest and I would be interested to see it
updated.

He wrote:

**********************************************************************
                 Do not, if possible,      |   More compatible 
                 have any of the           |   materials are:
                 following materials       |   
                 used in your teeth.       |
                 They have been shown      |
                 to have low               | 
                 biocompatibility and      |
                 could make your           |
                 condition worse:          |
                                           |
Composites:      P10, P30, Herculite,      |   Adaptic II, Concept,
                 Bisfil, Distalite,        |   Durafil, Occlusion,
                 Radio-opaque Heliomolar.  |   Opalux,
                                           |   Radiolucent Heliomolar
                                           |
Glass-ionomers:  Ceramcore, Ketac Bond.    |   Cerachem, Ceramfil,
                                           |   Ketac Cem.
                                           |
Cements:         Ames, Ceramco cement,     |   Biomer Caulk,
                 Scotchbond, I.R.M.,       |   Dicor cement, Durelon,
                 T.cement.                 |   Flecks PC, PCA cement
                                           |
Precious Crowns: Noble M,                  |   Stern's 2713,
                 Artian sympathet 20,      |   Jelenko O, Noble J,
                 Bio C, Bio H, Choice,     |   SMG-2.
                 Englehard, Vista.         |
                                           |
Non Precious                               |
Crowns:          Biocast, Rexillium III,   |
                 Ultimate.                 |
                                           |
Ceramic:         Cerestore                 |   Di Cor.
                                           |
Bases:           Dycal                     | 

**********************************************************************

He also said the list will change as more materials come onto the market.
I question as to whether they will be stronger at the expense of
biocompatibilty.

So it is surprising that you, Hali, have not found any patients having
problems.

The taste is weird and horrific and it has been of the same character
since the beginning, though after 3 years it has decreased somewhat and
I can almost bear it without having to put myself into psychological
detachment. I do not believe it to be bacterial, consequently. Also I
have had an xray, though because of surface soreness to floss in between
the teeth after the fillings were placed. That seems to be relieved by
Colgate Toothpaste with sodium monofluorophosphate. Perhaps you saw my
article about that.


In contrast to the Tetric taste the taste of amalgams is a minor salty
taste.

What did you think about the loss of such a large proportion of the mass
of a composite when the soluble components are eluted from the open
structure with a solvent, also the killing of cells by the non-eluted
composite?

I should probably have had the fillings changed back to amalgam. I was
hoping that the taste would go away sooner. I liked the better bite,
though, and as I have asked before I wonder how often that is part of
'amalgam removal recovery'? Also I see that the newer amalgams are much
more mercury emitting, according to Dagfinn.

***********************************************************************
In message-ID: <0099BFA0.93B64940@Msu.oscs.montana.edu>
From: gmt1810@Msu.oscs.montana.edu (Mark Tarka)
Newsgroups: sci.med.dentistry
Subject: Adverse drug reactions/events
Date: Sat, 06 Jan 1996 09:19:43
Organization: Montana State University
Lines: 151

JAMA, July 5, 1995 -- Vol. 274, No. 1, pp. 29 et seq., has this
abstract/summary preceeding the the article "Incidence of Adverse Drug
Events and Potential Adverse Drug Events":

      OBJECTIVES. -- To assess incidence and preventability of adverse
    drug events (ADEs) and potential ADEs.  To analyze preventable
    events to develop prevention strategies.
      DESIGN. -- Prospective cohort study.
      PARTICIPANTS. -- All 4031 adult admissions to a stratified random
    sample of 11 medical and surgical units in two tertiary care
    hospitals over a 6-month period.  Units included two medical and
    three surgical intensive care units and four medical and two
    surgical general care units.
      MAIN OUTCOME MEASURES.
      METHODS. -- Incidents were detected by stimulated self-report by
    nurses and pharmacists and by daily review of all charts by nurse
    investigators.  Incidents were subsequently classified by two
    independent reviewers as to whether they represented ADEs or
    potential ADEs and as to severity and preventability.
      RESULTS. -- Over 6 months, 247 ADE's and 194 potential ADE's were
    identified.  Extrapolated event rates were 6.5 ADE's and 5.5 ADE's
    per 100 nonobstetrical admissions, for mean numbers per hospital per
    year of approximately 1900 ADE's and 1600 potential ADEs.  Of all
    ADEs, 1% were fatal (none preventable), 12% life-threatening, 30%
    serious, and 57% significant.  Twenty-eight percent were judged
    preventable.  Of the life-threatening and serious ADEs, 42% were
    preventable, compared with 18% of significant ADEs.  Errors
    resulting in preventable ADEs occurred most often at the stages of
    ordering (56%) and administration (34%); transcription (6%) and
    dispensing errors (4%) were less common.  Errors were much more
    likely to be intercepted if the error occurred earlier in the
    process:  48% at the ordering stage vs 0% at the adminsitration
    stage.
      CONCLUSION. -- Adverse drug events were common and often
    preventable; serious ADEs were more likely to be preventable.  Most
    resulted from errors at the ordering stage, but many also occurred
    at the administration stage.  Prevention strategies should target
    both stages of the drug delivery process.

I believe, that the foregoing is a true and correct rendition of the
original; readers are urged to access the original text.

Now, I had responded to Dave Lambert's post (based on this article) with
the statements that the year of publication was missing, as well as
baseline information (e.g. the number of individuals involved in the
study.  I rashly predicted some 400 patient fatalities per 100000
_practitioners_.  I was in error.

Given the numbers in the quoted text (supra...a favorite lawyer's
term... from the Latin...above), I would have to revise (i.e.
"refigger") my estimate.

(441 ADEs)(1 fatal ADE/100 ADEs)(12 months/year)
------------------------------------------------ = 2.188e-3 fatal/pt-yr
     (4031 patients)(6 months)

That's 0.002188 deaths per patient-year.

My analysis was related to the murders per 100,000 people in the state
of New York:  12.5, according to the World Almanac and Book of Facts
1991, Pharos Books: New York, 1990, page 848.

By the numbers given in the cited article, 0.002188 deaths per
patient-year times 100,000 yields 218 deaths per 100,000 patients per
year.  This is 18 times the murder rate in the state of New York for
1990.  My initial estimate of 400 deaths per 100,000 was too high, but
not excessively so.  Another analysis based upon the abstract gives an
annual death rate of 35 (1%) per (1900 + 1600) or 1000 per 100,000.

The article itself uses an analogy:  iatrogenic injuries are four times
the
annual automobile fatality rate and account for for more deaths than all
other
accidents combined.

This ain't no joke, folks.  Dave views this problem from the perspective
of a
practitioner who has to make decisions "in the trenches".  I, on the
other
hand, see this as an overall problem, arising from the generic medicine
man's
desire to prosper; that is, a cumulative effect coming as the result of
individual actions over a period of time (consider the flagellum of a
multiflagellate  single-celled organism -- uncoordinated action of a part
results in random movement of the whole).

A quick survey of MEDLINE's most recent volume (1990 - present) shows

     1990 32 matches to the search "adverse drug reactions" (ADRs)
     1991 71 matches
     1992 82 matches
     1993 113
     1994 109 (this year shows an article about the FDA
               encouraging reporting of ADRs)
     1995 80

There were also 7 matches for the phrase "adverse drug events". 
According to the article referenced above, the change in terms allows
more incidents to be reported/recorded under the guidelines of WHO.  To
my untrained eyes, the numbers reach a peak, and decline after action by
the FDA.  This is perhaps an example of cause and effect as applied to
large populations (the medical profession is caught between the patient
pool and the FDA, more so if the public gets wind of the problem of ADEs
and ADRs).  I know, I've tracked the exponential increase in articles
related to pollution by simply counting the number of annual
publications listed the the New York Times indices at the library;
finally, as the public became increasingly aroused, the clean-up began. 
The same for the number of articles about the Civil War (noting that the
numbers had significantly declined, then shot upwards on the
assassination of Lincoln).  Simply, the pulse-beat of some population of
individuals.

What's interesting, though, is that I see what seems to be no more than
handwaving about amelioration of the problem, other than movement along
the lines of using computer data bases to monitor such things as
inappropriate drug combinations, patient/customer sensitivities, etc. 
While I haven't had the time to read fully the article of focus here
(nor the accompanying article and editoral), or any of the articles
associated with this topic I do have questions I would appreciate
answers to, or comments about:

1.  Are the various software programs available for the practitioners
(med or dent) based upon human or animal studies, or both, or perhaps
only on reported incidents from hospitals, clinics, private practice? 

2.  Does anyone know of any active reasearch funded by the NIH or FDA
(or other agency) in the area of testing on an individual bases (e.g.
chairside) for possible adverse reactions to medication combinations
_before_  new medication is actually used?

3.  What is the situation in countries which permit the usage of drugs
not permitted for distribution in this country (I recall an abstract
referring to action in Germany, ca. 1988)?

Overall, it would seem that unless a large number of the people using
some given mix of drugs react adversely a significant part of the time
to the addition of a new medication, then the use of software to screen
potential drug interactions would be based on possibilities and not the
actual fact that there will be a problem.  This would be another layer
of defensive practice methods, which could (and probably does) lead to
some doctors and dentists blindly selecting patients who are "safe",
discarding [potential] "unsafe" patients, while still proporting to
adhere to the oldest and most endearing of the public relations phrases
of the discipline.  I'm just speculating here, "what-if" type of
thinking.

My interest in this topic comes only because the lack of a date in a
literature citation caught my attention, and I mean to start no new line
of discussion in this newsgroup.  But I really would appreciate any
comments on question two, above (I am a grad student, analytical
chemistry).




     Mark     gmt1810@msu.oscs.montana.edu


**********************************************************************

Mark, this does not answer your question, but it's perhaps related.

From the NIH gopher.



**********************************************************************
 9.  EFFECTS AND SIDE EFFECTS OF DENTAL RESTORATIVE MATERIALS

                      National Institutes of Health,
               Office of Medical Applications of Research,
                Technology Assessment Conference Statement
                           August 26-28, 1991


This statement was originally published as:
     Effects and side effects of dental restorative materials.  Technol
     Assess Conf Statement; 1991 Aug 26-28.  Bethesda (MD):  National
     Institutes of Health, Office of Medical Applications of Research;
     [1991]:(9):18.
For making bibliographic reference to the statement in the electronic
form displayed here, it is recommended that the following format be
used:
     Effects and side effects of dental restorative materials.  NIH
     Technol Assess Statement Online 1991 Aug 26-28 [cited year month
     day]; (9):18.

[many lines from this 36kbyte report deleted]
The evidence suggests that other restorative materials such as casting
alloys, composites, glass ionomers, and ceramics can induce local
reactions in some individuals.  The incidence appears to be low based on
the number of case reports in the literature and results from dental
patient questionnaires.  Systemic toxicity of these non-amalgam
restorative materials also appears to be low.

The paucity of reports of systemic toxicity with the use of dental
restorative materials could be due to a true "biological inertness" of
the materials or could be due to other factors.  For example, symptoms
resulting from dental treatment might be reported to medical rather than
dental personnel, with the correlation between dental restorative
materials and systemic effects thereby being missed. The amount of
potentially toxic residues released from restorations may be too low to
cause a clinically detectable effect.  In addition, clinical effects
might develop over months or years rather than immediately after
restoration or become manifest in tissues rendered more susceptible by
other disease.  Furthermore, most previous studies of restorative
materials have involved subjective questionnaires rather than objective
physiological and laboratory measurements. Tooth restorative materials
generally have not been studied in properly designed longitudinal
studies.

In summary, very few patients appear to be at risk of developing a local
toxic or allergic reaction in response to the placement of restorations.
Even when such reactions occur, they may not be clinically significant.

[many more interesting lines deleted]

CONCLUSIONS AND RECOMMENDATIONS

Conclusions

Current dental restorative materials can be used effectively for
restoring teeth for functional or esthetic reasons.  Virtually all
restorative materials have components with potential health risks.
However, there is no scientific evidence that currently used restorative
materials cause significant side effects.  Available data do not justify
discontinuing the use of any currently available dental restorative
materials or recommending their replacement.

Although mercury vapor is released from dental amalgam, the quantities
released are very small and do not cause verifiable adverse effects on
human beings.  While there is no scientific evidence that existing
dental restorative materials are not safe, it must be recognized that
the supporting data are incomplete.


Recommendations

 1.  Manufacturers of all restorative materials should provide an insert
     or "stickers" listing the constituents used to formulate each
     material.  This information should be referenced in each patient's
     chart.
 2.  Dentists should install devices to recover waste amalgam residues
     in their offices for recycling to reduce environmental
     contamination.

 3.  A specific Food and Drug Administration program should be
     established for reporting and investigating adverse reactions to
     dental restorative materials.

[more lines including panel members' names deleted]
**********************************************************************

Brian Sandle. Shell to snail? bsandle@southern.co.nz
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From: bsandle@southern.co.nz (Brian Sandle)
Subject: & RFD sci.med.toxicology (Was: Re: Composite BIS-GMA tox. art. (Was: Re: BEWARE ULF'S MERCURY FIGS.))
Date: 1996/01/10
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