- Dentala material
- Politik
Det är mer och mer uppenbart att frågan om biverkningar av amalgam är en politisk fråga i USA, inte en vetenskaplig.
Igår publicerades ett dokument på Internet från Office of Management and Budget, OMB.
Det visar strykningar i FDA:s tidigare amalgambeslut år 2009, det som IAOMT fick omprövat i slutet av förra året. Sanningar sagda i granskningskopian från FDA stryks av OMB.
Man ska komma ihåg att OMB saknar medicinsk kompetens.
OMB Changes to FDA Proposed Rule on Amalgam
ADA måste lägga ut mängder av pengar på lobbyverksamhet gentemot federala myndigheter,
http://www.scribd.com/doc/53668158/OMB-Changes-to-FDA-Proposed-Rule-on-Amalgam
Vi får se om det kommer flera reaktioner från USA.
? OMB Changes to FDA Proposed Rule on Amalgam
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46It seems all references to the of the FDA White Paper being a “DRAFT” at any point has
been removed. OMB explains on page 47
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47Consequently, although the term “Draft” suggests that the White Paper will be revised
before being finalized, the Draft White Paper is, in fact, a completed document.
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48Deleted : that exposure to dental amalgam causes systemic diseases
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48Deleted: kidney damage, Parkinson’s disease, Alzheimer’s disease, multiple sclerosis,
amyotrophic lateral sclerosis, autism, and other neurological damage, such as peripheral neuropathies
and tremors . FDA also concluded in the Addendum that prospective clinical studies of dental
amalgam published to date (Refs . 10 through 16) reveal no neurological or renal deficits in children
who first received dental amalgam restorations at ages 6-12 and were followed for 5 or 7 years. FDA
concluded, however, that insufficient data exist regarding the effect of exposure to the mercury in
dental amalgam on health outcomes in children under the age of 6, and in pregnant women and their
developing fetuses, although some studies showed no effect in pregnant women and their developing
fetuses .
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50Delete : <#>Recommends that the labeling state that data are limited regarding long term
outcomes in pregnant women, developing fetuses, nursing infants, children under the age of 6, and
persons with neurological or renal dysfunction .
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51Deleted : B Issues Requiring Special controls In the 2002 proposed rule, FDA identified
risks to health associated with the use of dental amalgam, mercury, and amalgam alloy that it believed
required the imposition of special controls that, in conjunction with the general controls of the act,
would provide reasonable assurance of the safety and effectiveness of the device. The risks identified
were mercury toxicity associated with the improper use and handling of dental amalgam and allergic
reactions
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80Table 1 of this document shows the estimated average annualized costs and other
quantified but not monetized effects of this final rule using both 3-percent and 7-percent annual
discount rates over a 15-year evaluation period. The 15-year evaluation period was selected to
correspond to the typical life of a dental amalgam restoration. FDA has estimated dental amalgam
restorations to last between 10 years and 30 years with a reasonable mean of 15 years.
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81Deleted : known neurotoxicant
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83Deleted : threshold levels. Limited clinical information is available regarding long-term
adverse health utcomes in some potentially vulnerable subpopulations, such as pregnant women,
developing fetuses, nursing infants, children under the age of 6, and persons with neurological or renal
dysfunction. Studies have evaluated
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87“Deleted : Although no causal link between dental amalgam and adverse health effects
has been found, there is
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limited information evaluating the effects of the device on”
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87Deleted : with pre-existing neurological or renal dysfunction and disease). As an
approximation of the total number of this potentially vulnerable sub-population
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90Deleted: information asymmetry. The current market does not provide sufficient
information to ensure that ail potential risks and benefits are considered when using this product
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93Deleted: We do not monetize the potential public health effects of the final rule . The
magnitude of the potential public health effects depend on how dentists react to the recommended
professional labeling . Because the information described in the special controls guidance document is
informative only, and does not encourage or discourage use of dental amalgam, this final rule is
unlikely to have a net effect on the overall use of dental amalgam
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99Deleted : toxicity
COMMENTS AND FDA’S RESPONSES
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55Deleted : while it is universally understood that amalgams release I mercury vapor that
can then be detected in tissues
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55Deleted : available that provide information useful for assessing potential adverse effects
from exposures to dental amalgam mercury vapor . These studies can serve as the basis for using a
biological monitoring approach where comparisons can then be made between urine mercury levels in
well-defined occupational exposures to urine mercury levels from the general population with known
numbers of dental amalgam numbers and/or surfaces . Biological monitoring is an occupational health
tool to assess a worker’s exposure to chemicals and provides more confidence in the exposure
assessment compared to making exposure assessments based on chemical levels in air or foods . For
example, based on a number of occupational studies, strong correlations have been found between
daily, timeweighted air concentrations (which are considerably higher than exposures to dental
amalgam mercury), adverse health outcomes, and urinary mercury levels in workers
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56Deleted: Moreover, as discussed above, FDA has concluded, based on both information
from biological monitoring (urinary mercury levels) and information from air monitoring, that exposures
to mercury vapor from dental amalgam in the general population not occupationally exposed to
mercury vapor are considered to be in the exposure/dose range where associations with adverse
human health effects have not been observed .
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56Deleted : data are limited regarding the long term effects of mercury on certain patient
populations who might be ~I expected to be more sensitive to the mercury in the device
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62Deleted: Other estimates of exposure in subjects with an average number of amalgams
includes 5-9 ug
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62Deleted : (Ref 27),12 ug/day (Ref. 28), < 10 ug/day based on an analysis of 14 studies
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62“Deleted : .7, and 2 .8 ug/day in children, teens, adults, and seniors, respectively (Ref 30)
. Contributing to the wide variation in estimates of daily doses of mercury from dental amalgams are
issues related to problems cited with the
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instruments used to measure mercury vapor in the oral cavity, including whether the small size of
the oral cavity is appropriate for accurately measuring vapor concentrations, and factors such as the
dilution of vapor with inhaled air within the oral cavity”
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62Deleted: inhalation/exhalation rates, analytical quality control and differences in sampling
methodology (Ref 17) .J Because of the difficulties noted in determining a robust estimate of daily
dose of mercury resulting from monitoring of mercury vapor in the oral cavity, FDA is primarily relying
on the biological monitoring assessment of
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63“Deleted : also recognizes that good dental hygiene practices, such as the use of vacuum
pumps and chair-side traps, have greatly reduced the level of mercury to which dental professionals
are exposed . Nevertheless, because there are scientific data showing mercury to be a neurotoxicant,
and because some individuals have a known allergy to mercury, FDA is recommending that the
labeling warn that the device contains mercury, contain a precaution that it should be used with proper
ventilation, and include a contraindication against use in persons with a known allergy to mercury .~
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(Comment) A few comments stated that dental amalgam fillings contribute to the majority of the
mercury body burden in the general population and that mercury levels in the urine are not measures
of mercury body burden, but rather
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represent a combination of the amount of mercury to which an individual has been exposed and
his or her ability to excrete mercury. The comments added that 90 percent of mercury is excreted from
the body through the fecal route, and that low urine mercury levels are not an accurate predictor of
mercury exposure . Some comments stated that data obtained from autopsies demonstrate that high
mercury levels are present in the brain and kidneys, despite dental amalgam mercury
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exposure levels being below safety limits . A few comments noted that mercury passes through
both the umbilical cord and the blood/brain barrier .(Response) FDA recognizes that dental amalgam
contributes to the majority of the body burden of mercury for many people not occupationally exposed
to mercury”
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63Deleted : FDA recognizes that urine and feces are major routes of mercury excretion, but
also recognizes that which excretion route predominates is dependent on the mercury species . The
“90% mercury excreted by the fecal route” relates to excretion of organic methylmercury, and this high
percnt is not the case for inorganic forms of…
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64Deleted : observed, although the authors could not rule out the possibility of a slightly
increased risk of miscarriage. FDA reviewed several recent, wellconducted animal studies designed to
assess mercury vapor exposure (doses that are 2-3 orders of magnitude higher than those
encountered in the general population) on neurological, reproductive, and developmental effects in
pregnant rats and their offspring . One study to assess the effect of exposure to mercury vapor during
gestation (Ref. 35) observed no effects on peripheral, somatosensory, auditory, or visual neurological
functions in offspring exposed prenatally
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68Deleted: Specifically, the recommended labeling statements will help ensure that dentists
are aware of the mercury content of dental amalgam, that the device should not be used in patients
with a known allergy to mercury, and that data are limited regarding long term outcomes in pregnant
women, developing fetuses, nursing infants, children under the age of 6, and persons with
neurological or renal dysfunction .?
