From: Phillip Windham [phillipb7@earthlink.net] Sent: Monday, September 04, 2006 7:27 PM To: Dockets, FDA Subject: RE: Summary of Serious Deficiencies in the Children's AmalgamStu dies of Bellinger et al and De Rouen et al I sent the documentation for Docket No. 2006N-0352 that was the purpose that I compiled the information for that was true for all of my documentation see included: ----- Original Message ----- From: Gornick, Mary Ann To: phillipb7@earthlink.net Sent: 9/1/2006 10:59:32 AM Subject: RE: Summary of Serious Deficiencies in the Children's AmalgamStu dies of Bellinger et al and De Rouen et al Dear concerned citizen, We received your email regarding the upcoming September 6-7 meeting on dental amalgam. If you would like your comments to be publicly available, please resend your email to the following docket, which has been established for this meeting. Docket No. 2006N-0352 Please remember that the docket is open to the public, so be mindful of any personal information you include in your email. To submit comments, resend your email to FDADockets@oc.fda.gov and reference Docket Number 2006N-0352 or visit http://www.fda.gov/dockets/ecomments , select "Docket Search," type in Docket Number 2006N-0352 under "Docket ID," and then follow instructions provided. __________________________ Michael E. Adjodha Executive Secretary Dental Products Panel DHHS/FDA/CDRH/ODE Mail Stop: HFZ-480 Room: 9200 Corp., 330L Phone: 301-827-5283, ext. 123 Fax: 301-480-3002 E-mail: michael.adjodha@fda.hhs.gov _____________________________ ------------------------------------------------------------------------------ From: Phillip Windham [mailto:phillipb7@earthlink.net] Sent: Tuesday, August 22, 2006 8:25 PM To: Adjodha, Michael E Subject: Summary of Serious Deficiencies in the Children's Amalgam Studies of Bellinger et al and De Rouen et al B. Windham, Research Director and President, DAMS International, berniew1@earthlink.net 850-878-9024 Comments on Children's Amalgam Study one: "Neurological and Renal Effects of Dental Amalgam in Children", D.C. Bellinger et al, JAMA, April 10, 2006 The study design was not a serious effort to determine amalgam safety. The study was an unethical use of a known highly toxic substance on children who were not fully informed or in a position to understand the implications. But the author's interpretation of results is also questionable. It is known from thousands of studies and millions of tests by medical labs that those with amalgam get significantly higher mercury exposure than those without, that mercury accumulates in the brain and major organs proportionately to the number of amalgam fillings, and commonly causes chronic degenerative neurological conditions later in life. http://www.home.earthlink.net/~berniew1/indexa.html Thus the ethics in the exposure to a group of children to higher levels of a very neurotoxic substance such as mercury is highly questionable. This study was not a serious test of the safety of amalgam since the exposure was to children with no previous amalgam fillings at relatively low levels of exposure for a very limited period of time. The mean number of restored amalgam surfaces in the mouth of the amalgam group at the end of the study was only 4 amalgam surfaces. And while the urine mercury level in the amalgam group was 50% higher than the non-amalgam group, this is a much lower differential than most studies of groups or either children or adults with and without amalgams. For more details see: www.home.earthlink.net/~berniew1/comments.html Children's Amalgam Study 2: Preliminary Comments on "Neurobehavioral Effects of Dental Amalgam in Children", T. A. De Rouen, et al, JAMA, April 19, 2006 In justifying the study design the author's state on page 1 that "there is little or no evidence concerning health effects of low level mercury exposure from amalgam, especially in children". In fact, there are over 3,000 peer-reviewed studies in the medical literature(3) that were submitted by parties in the FDA amalgam docket to the FDA (4), that document the mechanisms by which mercury(from amalgam) commonly causes over 30 chronic health conditions. And there are hundreds are peer-reviewed studies and clinical studies that document that many thousands of patients with these conditions have improved after amalgam replacement(2). While it is clear that hundreds of thousands (or millions) of children have had their health adversely affected by mercury, since there are multiple exposure mechanisms it's not clear the extent to which dental amalgam is responsible (7). But the main problem with the study design appears to be the choice of what conditions were tested for and the kinds of tests that were used. In describing why the chosen conditions were tested for and in what manner, the authors stated on page 2 of the study that the target organs for elemental mercury exposure from amalgam were identified to be the renal system and neurological functions(memory, attention/concentration, and motor/visuomotor). Actually, while there is documentation in the medical literature of many other types of health effects, there is little evidence in the literature on common renal effects.(1,2,3). And there are other types of health effects that have been well documented in the literature to be more commonly caused by mercury than attention or memory(though these also have been documented to be commonly caused by mercury exposure). The referenced analysis shows that the basic assumptions that the authors say they based their study design on were not valid, and the study does not demonstrate what it has been suggested to demonstrate. For details and references, see: www.home.earthlink.net/~berniew1/comments.html