The Children's Amalgam Study is an $11 million study which began in 1997 to prove the "null hypothesis" that mercury amalgam dental fillings do not cause adverse health effects in children. Approximately 500 American Children and 500 Portuguese children are the subjects of the study. The Nuremberg Code, federal regulations (45 CFR 46 et. seq.) and common law require that study subjects or their parents/guardians give informed consent prior to commencing any study with associated risks.
While the American consent forms do disclose that the amalgams contain mercury, they do not disclose that these fillings are 50% elemental mercury. The consent forms do not disclose how much mercury exposure or absorption occurs from the fillings. There is no disclosure of previous study results which have revealed adverse affects to the human body and to animals from mercury amalgams. There is no disclosure of in vitro studies which elicit grave concern for the safety of mercury emitting amalgam dental fillings. A significant number of the child-subjects are poor and/or minority. The subjects receive money for submitting to tests.
The Portuguese consent forms do not disclose that the amalgams contain mercury, nor do they disclose any risks associated with these fillings despite a large body of peerreviewed scientific articles which reveal such risks. These children attend Casa Pia schools which includes orphans and handicapped children. The study investigators from the University of Washington indicate these children have been subjects for other studies in which the University has been involved.
Charlie Brown of Consumers for Dental Choice
discusses the lack of proper informed consent in the Children's Amalgam Trial Studies.
In November 2002, the Portuguese press revealed a decades-long sex abuse scandal at the school. The international press in December 2003 revealed the indictment of 10 high profile Portuguese defendants charged with abuse. School administrators were involved in the facilitation of this abuse. While it is unknown whether any of the child-subjects were also victims of the scandal, the school environment had to be one of duress.
Preliminary results show that the Casa Pia children, as of March 2002, had 4.22 ug/l of mercury in their urine. University of Washington researchers in 1998 published a peerreviewed study showing that dentists with < 4 ug/l of mercury in their urine had adverse neuropsychological and neurobehavioral effects. (While no preliminary results have been revealed for the American children, similar results would be expected.)
This critique finds that the informed consents used in this study are inadequate and invalid under the standards of the Nuremberg Code, federal regulations and common law. Dental therapy was not the primary purpose of this study. Its primary purpose was to justify the continued use of mercury amalgam by dentists even though it was well known that mercury from the amalgam bioaccumulates and has been shown to be the primary source of mercury in the human body.
The purpose of the study is to serve the economic purposes of dentistry.
Since at least March 2002, the investigators have known that the child-subjects have accumulated levels of mercury proven to cause neurological damage. The study must be terminated.Consumers for Dental Choice Critique of the Childrens Amalgam Study Informed Consent Forms
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