FDA Can No Longer Attest to Safety of Mercury Amalgam

[Yvonne Johnson]

>>>Subject: FDA Can No Longer Attest to Safety of Mercury Amalgam Date:
>>>Tue, 27 Mar 2007 02:17:11 EDT
>>>
>>>Hi Friends,
>>>
>>>Here is a message from Bob Reeves an Attorney from KY about Charlie
>>>Brown's
>>>e-mail.
>>>
>>>Mary Ann Newell
>>>
>>>
>>>FDA Can No Longer Attest to Safety of Mercury Amalgam
>>>
>>>
>>>This is an excerpt from the Reply brief Charlie Brown prepared and filed
>>>in
>>>MOMS vs FDA, with Johann Wehrle's able assistance. The FDA's attorney in
>>>a
>>>footnote in a related matter stated that these quotes are out of context.
>>>I
>>>have reviewed them in context and the FDA argument is untenable. I think
>>>you
>>>will enjoy reading this.
>>>Having developed this kind of ammo, Charlie has a really good chance of
>>>winning this case. Bob
>>>FDA’s Admission: Can No Longer Attest to Safety of Mercury Amalgam
>>>After thirty years of bureaucratic double talk and calculated efforts to
>>>sidestep its legal responsibility by failing to classify mercury amalgam
>>>dental
>>>implants, the Food and Drug Administration comes before this Court with a
>>>long-overdue admission: It doesn’t know whether this primitive device
>>>– a remnant
>>>of pre-Civil War technology – is safe or not.
>>>In its brief FDA admits – not once, but five times – to problematic
>>>issues
>>>about the safety of the mercury-based dental implants it is charged with
>>>regulating. FDA advises this Court that no scientific clarity exists
>>>regarding the
>>>safety of mercury amalgam:
>>>Ø Admission: “there is a lack of conclusive evidence regarding
>>>the
>>>health effects of mercury fillings†(FDA brief, p. 18);
>>>Ø Admission: “constantly changing scientific evidence†exists
>>>on
>>>mercury amalgam (Id., p. 39);
>>>Ø Admission: “complex issues and intense disagreement [exist]
>>>about the
>>>scientific evidence regarding mercury and its potential health effectsâ€
>>>(Id.,
>>>pp. 40-41);
>>>Ø Admission: “the complexity of the issue and the lack of
>>>conclusive
>>>scientific evidence on the health effects of dental amalgams†(Id., p.
>>>41);
>>>Ø Admission: “the lack of … definitive scientific evidence.â€
>>>(Id., p.
>>>41).
>>>Inexorable to pleas, Panels, and petitions, FDA insists it may keep
>>>amalgam
>>>unclassified.
>>>Nonsense. FDA must classify this mercury amalgam device as a III and
>>>write a
>>>premarket approval regulation. 21 U.S.C. § 360c(c)(2)(C) could not be
>>>clearer: A preamendment implant, of which amalgam is one, “shall be
>>>classified in
>>>class III unless the Secretary determines that [a III] is not necessary
>>>to
>>>provide reasonable assurance of safety and effectiveness.†FDA having
>>>admitted
>>>that it is unable to provide such reasonable assurance, amalgam must be a
>>>III.
>>>
>>>******************************************************************************
>>>*******************
>>>******************************************************************************
>>>****
>>>And this is what the FDA said in a FOOTNOTE:
>>>
>>>4 Petitioners’ statement that the FDA is “unable to attest to
>>>amalgam’s
>>>safety,â€
>>>see Application at 2, relies on statements taken out of context from
>>>respondent’s brief
>>>and mischaracterizes the agency’s position. In classifying a medical
>>>device,
>>>the agency
>>>must “weigh[] any probable benefit to health from the use of the device
>>>against any
>>>probable risk of injury or illness from such use.†21 U.S.C. §
>>>360c(a)(2)(C).
>>>At the
>>>time the FDA issued its proposed rule to classify EAADM in class II, the
>>>agency
>>>explained that the scientific evidence at that time demonstrated that the
>>>probable
>>>benefits of EAADM outweighed any probable risks, given the “overall
>>>lack of
>>>valid
>>>scientific evidence that persons whose carious teeth are treated with
>>>dental
>>>amalgam
>>>experience any adverse health effects, other than a very small number of
>>>people who
>>>are hypersensitive to mercury.†See 67 Fed. Reg. 7,620, 7,627 (Feb. 20,
>>>2002)
>>>(proposed rule). The 2006 advisory panel did not change the FDA’s
>>>conclusion
>>>that
>>>there is no evidence that dental amalgams cause health problems in the
>>>general
>>>population. See App. at 152; see also U.S. Br. at 12-13. The FDA
>>>continues to
>>>review
>>>emerging scientific evidence to determine whether there is new
>>>information
>>>that would
>>>alter the agency’s conclusion (and therefore might affect the final
>>>classification of
>>>EAADM). As the agency explained in its brief, however, there still is
>>>“no
>>>conclusive
>>>evidence that dental amalgams have adverse health effects.†See U.S.
>>>Br. at
>>>41.
>>>
>>>
>>>Bob
>>>Robert E. Reeves
>>>REEVES LAW OFFICE
>>>167 West Main St., Suite 1310
>>>Lexington, KY 40507
>>>O) 859-226-0700, Fax-0711
>>>
>>>
>>>
>>>
>>>
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>>
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