The Honorable José Luis Moreno Ocampo

International Criminal Court 
Office of the Prosecutor 
Communications 
Post Office Box 19519 
2500 CM The Hague 
THE NETHERLANDS

To the Honorable Prosecutor Ocampo,

We are requesting you authorize an investigation by the International Criminal Court (ICC) proprio motu into a crime against humanity under Article 7 of the Rome Statute directed at those responsible for the design, funding, execution, analysis, and publication of an unethical scientific experiment conducted on hundreds of children.  The experiment exposed the children to significant amounts of mercury, a deadly poison, in order to justify the use of dental amalgam fillings, and the results were used to promote the use of mercury fillings on millions of additional children throughout the world.

The perpetrators of this experiment and the principle targets of ICC’s investigation would be the following:

a)  A team of scientific researchers based at the University of Lisbon, Portugal, and at the University of Washington, Seattle, Washington, United States of America,

b) Norman Braveman, PhD, project coordinator, at the National Institute of Dental and Cranial Facial Research (NIDCR), which is a part of the National Institute of Health, based in the state of Maryland, United States of America,

c) NIDCR itself, as the institution that provided the funding and coordination of the unethical scientific research project, and

d) Casa Pia, a state-owed orphanage system located in Lisbon, Portugal, where the experimental child-subjects were all obtained.  Many of them were exposed to mercury over a seven-year period, with no attempt afterwards to follow-up or monitor them for possible long-term health consequences or to offer them safe removal of the mercury amalgam fillings and heavy metal detoxification. At Casa Pia, about 500 children who had been dentally uncared-for and neglected, were enticed into the experiment in 1997. Half of them received dental amalgam fillings, which are 50% mercury, for their cavities, and the other half of them received composite, plastic resin-based fillings, which do not contain mercury.

e) New England Research Institute (NERI), and researchers working for it and in collaboration with it, for conducting a similar experiment on children in community clinics in Boston, Massachusetts, and in Farmington, Maine, both in the United States of America.

The atrocities committed by these institutions were enacted upon approximately 1000 children in the U.S. and Portugal, and the documents enclosed herein prove that this shameful experiment involving mercury and vulnerable children merits investigation by the ICC.

Jurisdiction

Portugal ratified the Rome Statute in February of 2002.  While the crimes discussed commenced with the study’s design and funding in August 1996, and with the induction of children into the programs in Portugal and in the U.S. in 1997, they continued well after 2002, making the two studies, known together as the Children Amalgam Trials (CATs), eligible under the submission guidelines for ICC investigation.

Because Portugal ratified the Rome Statute, the portion of the CATs that used children at Casa Pia in Lisbon, may be particularly amenable to the investigations and actions of the ICC. As you know, the U.S. has not ratified the Rome Statute, but there are many individuals and institutions in the U.S. who are willing to submit evidence and testify regarding these matters, and their involvement will help forge a just and appropriate outcome.

Background on the Amalgam Issue

The dangers of amalgam fillings have been known since they were first introduced as a dental product in the 1830s.  The American Society of Dental Surgeons, the predecessor to the American Dental Association, made its members pledge not to use mercury because of its known toxicity, and over the past century, government officials, scientists, dentists, consumers, and others have continued to raise serious concerns about the threats dental mercury poses to humans and to the environment at large.

In recent decades, the technical ability to measure mercury vapor has improved dramatically, and over twenty years ago, it was demonstrated that amalgams are an unstable mixture of mercury and four other metals, that they give off mercury constantly, and that they release mercury much faster when a person is chewing food or brushing teeth. Additional factors, such as the presence of other dental metals and the grinding of the teeth at night, can greatly increase the release of mercury from the amalgams.

Based on animal studies and human autopsy studies, it is now also known that dental amalgams are typically the greatest personal source of mercury in a person’s environment, more than air, water, and food, including fish, combined. Hundreds of studies have emerged since the 1990’s showing the role that mercury from dental amalgams can play in neurological, auto-immune, endocrine, digestive, reproductive, and cardiovascular disorders. In fact, amalgams are being recognized scientifically as a significant cause of illness and death.

However, those individuals and institutions committed to the defense of dental amalgams have been unwilling to concede defeat in the scientific argument.  Perhaps they feel that they would be professionally disgraced for having been wrong on such an important issue and that organizations such as the American Dental Association (ADA) would be destroyed by a complete loss of all of credibility. They might also be worried that the dental division of the US Food and Drug Administration (FDA) would face similar humiliation. Whatever their reasoning is, the amalgam argument has become a high stakes battle for everyone involved.

Yet, it is absolutely horrific that vulnerable children were enlisted as pawns in this battle.

Background for the Children Amalgam Trials (CATs) including Casa Pia

The two studies comprising the CATs were initiated for NIDCR, a part of the US National Institutes of Health, by Norman Braveman, PhD, who was the “project coordinator” for both studies. Over time, NIDCR spent about $11 million on the CATs.

For the study involving 500 children at the Casa Pia orphanage system in Lisbon, it appears that NIDCR and Braveman provided funding directly to University of Washington Professor Timothy DeRouen, PhD, and to other researchers, and not to the University of Washington itself. Investigators at the University ofWashington had previously partnered with the University of Lisbon, and they had also used Casa Pia children for human experimentation before, but no official role for the University of Washington is described in Casa Pia study results that were published in the Journal of the American Medical Association (JAMA) onApril 19, 2006. It is nearly certain that both of the Universities would have had to review and approve the Casa Pia study in their Institutional Review Board processes, but the JAMA paper makes no such mention of such a review.

The publication of the results for both the Casa Pia and the NERI/ New England studies were trumpeted out to the public in a multi-million dollar media publicity blitz on the same day they were published, with the message “amalgams are safe for children” being repeated in every newspaper, radio, and TV broadcast.  It is unclear whether the NIDCR or some other source funded and coordinated the highly sophisticated public relations campaign, but it is clear that the real purpose of the expensive and elaborate experiment on human children was to provide the fuel for this eventual public relations blitz and to provide a basis for continuing the dental amalgam mercury cover-up by the ADA and its allies, rather than to have a reasonable evaluation of all of the scientific research available.

Ironically, the April 19, 2006 edition of JAMA that featured the Children’s Amalgam Study also featured an editorial by Herbert Needleman, MD, who cautioned, “It is predictable that some outside interests will expand the modest conclusions of these studies to assert that use of mercury amalgam in dentistry is risk free. That conclusion would be unfortunate and unscientific."

Needleman’s apprehension about the possible propagandistic use of the Children’s Amalgam Studies was right on target. The launching and execution of the publicity blitz on April 19, 2006, the same day the research was published, showed an obvious disregard of the cautionary warnings of Needleman and of other experts on children’s health. The PR blitz demonstrated that an unfolding scientific fraud was reaching a new climax. Critics of the use of amalgam mercury in dentistry know that, based on the state of our scientific knowledge in the mid-1990s, the Children’s Amalgam Studies should have never been undertaken; amalgam should just have been banned – for children and for everyone else - at that time. Further aspects of this are provided in the evidence included herein and cited below.

We believe this evidence builds a case for a violation of Article 7 under the Rome Statute, as what happened is a crime against humanity that impacted and continues to impact children around the globe.

Discussion of some of the evidence provided

Consent Forms

The 1995 grant written for the CATs explicitly states, “The general purpose of the trial is to investigate the possible relationship between low dose exposure to mercury vapor from dental amalgam restorations and the occurrence of specific health conditions in children.”

The grant also openly notes, “Experimental studies on animals, and biopsy observations in humans based on occupational exposure to organic mercury can affect the immune system to produce a nephritic syndrome…In humans, signs and symptoms associated with mercury intoxication from elemental mercury include tremor, ataxia, personality change, loss of memory, insomnia, fatigue, depression, headaches, irritability, slowed nerve conduction, weight loss, appetite loss, psychological distress, and gingivitis.”

Thus, the wording of the grant itself concedes that at the time of the studies, numerous reports about potential health hazards caused by mercury had been recognized. In spite of this knowledge, the “informed consent” forms used in the study deceivingly excluded information about the previously known dangers of mercury exposure to humans. The Portuguese consent forms did not even disclose that amalgam fillings contain mercury, the known neurotoxin serving as the central focus of investigation for the study.  Obviously, the forms were uninformative and deceptive and, in New England, the children were given gifts and cash incentives to entice them to enroll in the experiment.

The Nuremberg Code establishes that subjects of human experimentation or their parents/legal guardians must provide “informed” consent before the initiation of any study.  As such, “informed” consent requires subjects and/or their parents/legal guardians to be made adequately aware of any possible risks.

Deception is clear with regards to the “informed” consent forms used in the Children’s Amalgam Study, and the documents included herein demonstrate the crime against humanity that occurred through the use of these misleading consent forms.

Molestation of Child-Subjects

In 2002, it was revealed that the children of the Casa Pia Orphanage were victims of an organized pedophile ring. The scandal came to light when one of the former child victims sued his abuser.   

Portuguese judiciary police officials estimated that at least 128 children, from among the 600 surveyed, (among the 4,600 pupils enrolled in Casa Pia at the time), had been sexually abused. However, even when the sex abuse scandal broke in 2002, the Children’s Amalgam Study continued. And even after seven people were convicted in 2010, and the Casa Pia molestation case was over, some aspects of the CATs continued.

To make matters worse, top administrators at Casa Pia, who were supposedly monitoring and protecting the interests of orphaned children throughout the period of the Casa Pia study, were found to be participants of the sexual abuse scandal.  Some of them are appealing their convictions, hoping to avoid jail time. Their abuse of their power and authority as administrators brings into question the ability of these individuals to make ethical and moral decisions on behalf of their wards in the orphanage, especially with regard to their participation in this study and the reporting of adverse health impacts suffered by the child subjects.

Issues with the Science Itself

Lack of Medical Evaluation

Other than the collection of urine and the measurement of mercury levels in the urine and the (later) evaluation of urinary porphyrin profiles, the CATs largely relied on “self-reporting” of health problems by the children’s parents or guardians. Clearly, if the parents and guardians were uninformed about the possible side effects (fatigue, anxiety, depression, difficulty learning) of mercury exposure, they were not likely to competently report on such possible signs and symptoms of mercury’s effects.

Further, at Casa Pia, one medical doctor signed the “informed consent” forms for all 100 orphans enrolled in the study (since they had no parents).  Whereas it would appear that he was the one expected to self-report “sentinel events” of health issues for these children, it seems that he also had an incentive to cover up and minimize the reporting of such sentinel events in order to avoid discovery that the children were being harmed.  Indeed, the sex abuse scandal that erupted at Casa Pia in 2002 revealed that the medical doctor who signed for the CAT studies was one of the officials charged with sexual abuse of the children at Casa Pia.

It should be noted as well that two of the children in the amalgam group at Casa Pia died during the course of the study.  Although one died from a gunshot, supposedly accidental, Chief Investigator DeRouen said that he knew of no autopsy results from either of these deaths and that he did not even know if any autopsies had even been done on the deceased; his excuse being that they did not have access to any of the medical records. Such a statement by Timothy DeRouen shows how poorly the health status of these children was being monitored! 

Another indication of the corruption involved in this study is that none of the children appear to have been removed from the study, as a precaution, because of any reported sentinel health events (and there were some sentinel health events reported).  This fact again suggests that there was no serious effort to protect these children.

Glossing over the meaning of the urine mercury test data

A thoughtful look at the urine mercury concentrations shown in Figure 2 of the Casa Pia study shows the urinary mercury concentration dropped after the second year in the amalgam group. Since there is no reason for mercury body burden to be dropping – the number of amalgam fillings in the teeth of these children is the same, or increasing, as time goes on – the drop in urinary mercury concentration means only one thing: after the second year, the children were losing their ability to excrete mercury through their kidneys.

This kidney problem was particularly true for the boys. Thus, had the publicity blitz been honest, it would have warned the public that “amalgams in children expose them to mercury, which can especially harm boys’ kidney function and their ability to excrete mercury.”

Incompleteness of the CAT studies as of April 19, 2006

More evidence that the publicity campaign launched on April 19, 2006 was harmful propaganda is that the toxicology part of the Casa Pia study had not been completed at the time, and the immune function part of the NERI study had not been completed either.

James S. Woods, PhD, a leading scientist on the Portuguese team, was there on the team to analyze the urinary porphyrin results, which were meant to give a far more accurate picture of mercury body burden than urinary mercury would. Yet, critics noticed that the April 19, 2006 Casa Pia report in JAMA had no mention of any results of an analysis of the urinary porphyrins by Woods.

Leo Cashman, of Dental Amalgam Mercury Solutions (DAMS, a non-profit group), telephoned Woods in July 2006, and Woods claimed that he had not even begun to analyze the porphyrin data.  Thus, a study whose purpose was to look at mercury toxicity had not even been completed in one of its most significant aspects, but a public relations blitz had meanwhile been launched to proclaim that amalgam had been shown to be safe for children.    

Similarly, Bruce Shenker, PhD, reached by telephone by Leo Cashman, conceded to Leo that he had not yet completed his portion of the study.  This is particularly significant in light of the fact that in 2002, Shenker had co-authored a study which had found “growing evidence that heavy metals in general and mercurial compounds, in particular, are toxic to the human immune system.”

J.S. Woods knew the immorality of the Casa Pia experiment and the immorality of dental amalgam

J.S. Woods ranks among one of the well-published mercury scientific researchers of our time, and he has published research on the susceptibility of certain sub-populations of the general population to mercury. In March, 2009, Woods spoke at a meeting of the International Academy of Oral Medicine and Toxicology (IAOMT) where he gave a superb presentation on the various genes that create susceptibility to mercury in children or adults, causing such problems as inattention, mood disorders, memory problems, and depression.

“Such polymorphisms lower the threshold of certain neurological functions that are affected by mercury…and autism, ADHD, and depression are all associated with mercury exposure,” he told the IAOMT.

Another susceptible population to mercury problems is boys, according to Wood’s published research.

Boys are less able to excrete mercury, he had found, and the data he used in this research was from the Casa Pia study. 

In spite of this evidence and his published research, when questioned about the Casa Pia study he had co-authored, Woods would not renounce the conduct of the Casa Pia study and the propagandistic way it was used. But he seemed embarrassed and ashamed when questioned out the Casa Pia study.

A study of the Casa Pia data revealed health problems in a subset of the amalgam child subjects

Analyzing the data independently, researchers Mark Geier, MD, and David Geier, claim to have uncovered abnormal porphyrin profiles, indicative of adverse health effects, within certain subjects of the amalgam subjects at Casa Pia – the same kind of harm that James Woods had warned could happen among vulnerable subsets within the population. This raises an important question: Did Woods and other investigators sift through the porphyrin data, discover the truth, and then cover up the ugly truth by the way they diluted the data in their group analysis?

No warnings of future health problems

While the CAT studies began unethically, they also ended unethically because of long-term threats to the health of the child-subjects, who are now young adults. This is because, just as they received no helpful information about possible symptoms at the onset of the study, the children who had been in the amalgam group received no cautionary warnings about the possibility of future health repercussions after the study was completed.

Specifically, these children, now heading into their reproductive years, were not warned that mercury is a reproductive toxin, one that can produce loss of libido (a common symptom), infertility, miscarriages, and birth defects. Multiple sclerosis often occurs in young females in their twenties or thirties. Other auto-immune diseases that can be encountered are lupus, asthma, and allergies because of the immune-disrupting effects of mercury.  In addition to immune dysfunction, digestive problems, fungal overgrowths, depression, and myriad other mental and neurological disorders can occur as the long-term result of having mercury in the mouth. The leading causes of death, heart disease and cancer, are also linked to mercury exposure; we can show all of this in abundant detail. Among the sickest people who come to us for help and information are those who have had amalgams since childhood.

Partly due to the publicity blitz and largely due to the denial of the organizations promoting an unsafe medical practice, the typical medical doctor dismisses any patient question about the amalgam-mercury connection, as does the typical dentist. Thus, the former Casa Pia mercury experiment subject is likely to suffer from some or many of the health problems listed above with no idea that his/her participation in the childhood research project could be causing the symptoms.  

Should the former subject of the experiment have their fillings removed, when the fillings become old and deteriorated (and they do not last forever!) he or she is most likely unaware that unsafe amalgam removal very often sets into motion a much more severe state of mercury poisoning.  This can take the form of more severe issues such as multiple sclerosis or other auto-immune or neurological disorders. Whether the old amalgams are removed and replaced by composite fillings or – horribly - by more amalgams, the unsafe amalgam removal by a conventional dentist is likely to be disastrous, pushing the unsuspecting patient into a health crisis. We help people deal with these crises all the time and we know the problem well.

The US Food and Drug Administration magnified the gruesomely unethical Children’s Amalgam Studies

In the U.S., the Food and Drug Administration (FDA) has a Center for Devices and Radiological Health (CDRH) whose dental division is in charge of regulating dental materials, including amalgams, for safety and effectiveness. In early August, 2009, after 30 years of dragging its feet, delaying, and making excuses, the FDA dental division finally classified the “encapsulated amalgam” product.  The only way that amalgams can be sold today is in the encapsulated form, so this was their ultimate classification of the amalgam product. FDA’s so-called “amalgam rule” was a total travesty:  Some had hoped that there would be a special curb on amalgams for women of child bearing age, or pregnant women, or children, but there was not even a requirement for the dentist to tell the patient that there is mercury in amalgam fillings.  This “oversight” is reminiscent of the Casa Pia lack of informed consent.

To make it worse, the FDA downplayed the warnings that manufacturers are supposed to provide to the dentists on the product warning label.  The FDA’s “guidance document” to these manufacturers basically said “get rid of the warnings about placing amalgams in children, and replace them with the claim that the Children Amalgam Trails have shown that amalgams do not harm children.”

Of all the hundreds of studies that the FDA could have cited for special mention, the FDA handpicked one – the CATs – and elevated it above all the others, claiming that it had established amalgams as safe for children. Thus, FDA took the corrupt scientific process of Casa Pia and magnified it a million times, allowing for the harm of millions of children, not just hundreds. Was this the plan for the CATs all along?

Note that this was done by FDA after it had been explicitly warned about the deficiencies and evidence of wrongdoing in the CAT studies. FDA knew about the shabby informed consent, the scientific incompleteness, the boys losing their kidney function after two years, and the sexual abuse scandal. None of this phased the FDA, and it embraced the CATs and elevated them above all else.

Conclusion

The documents following this letter exhibit a substantial foundation for an investigation into crimes against humanity enacted by the Timothy DeRouen and his research team and co-authors, the National Institute of Dental and Cranial Facial Research (NIDCR) of the National Institute of Health in the United States, and Norman Braveman, PhD, the NIDCR’s CAT project coordinator, and the Casa Pia Orphanage in Lisbon, Portugal, and its top administrator, deputy administrator, and medical doctor.

If the ICC sees fit to include the New England branch of the CAT, we know that many in the US are prepared to assist in the investigation of Sonja McKinlay, PhD, and Felicia Trachtenberg, PhD, of New England Research Institute, NERI itself, David Bellinger, PhD, and other responsible investigators there.

Secondary targets of investigation would be other institutions, such as the University of Washington, University of Lisbon, University of Rochester, Harvard University, and others who failed in their duties to provide the necessary institutional review, at the very least. Investigation of these powerful institutions would be a healthy signal that no institution is too rich, too powerful, or too well-connected to be challenged and scrutinized on the world stage.

The experimental abuse of the children at Casa Pia is something that all people of the world can understand and abhor, and the abuse of the children at Casa Pia is a sign of the large-scale corruption that is still occurring worldwide as children have mercury placed into their mouths with no warning to them or their parents or legal guardians.

We at DAMS are prepared to work with ICC attorneys and investigators by sharing additional details and evidence of serious wrongdoing at Casa Pia, the harmful effects of the corrupt science, and the tragedy of how it is being used. We urge you to investigate and charge those responsible for subjecting children to an abusive experiment that significantly exposed them to mercury, a deadly poison.

Respectfully submitted on behalf of DAMS, INC (Dental Amalgam Mercury Solutions), a non-governmental organization by...

Kelly Gallagher - The Mouth Of Hope

Anita Vasquez - Tibau
P.O. Box 664
Newport Beach CA 92661 USA