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Return To Book 3 Table Of Contents The Failing In Duties Administration…Or… FDA… In looking at the many issues that now seemed to surround “autism”, I could not help but wonder about the guidelines that existed for the protection of the public. Dental amalgam use had started in America in approximately 1830. “Silver” fillings – were really about fifty percent mercury – mercury being the biggest component in “silver” fillings. Yet, mercury was among the top three most toxic substances known to man. By 1840, already those in science were sounding warning bells as to the dangers of mercury fillings – warning bells that obviously had been filed with the FDA but had basically been kept within the walls of the FDA – the very agency – I thought – whose job it was to ensure public safety in these matters. Yet, even though those warning bells were still being sounded – indeed – by those in the dental industry itself – those who seemed to know the most about these issues – still – the FDA’s position in terms of the public’s “need to know” had been one of “we just need to inform the dentist”. But who was supposed to inform the consumer? Would that be left to the dentist? Given history had shown dentists who had raised these issues with their patients had in some cases lost their licenses for doing so, how “motivated” would a dentist be in addressing these issues with consumers? And what dentist would open himself up to such huge liability issues by even bringing up the issue of the dangers of mercury in dental amalgams? The following was but one example of many dockets that had been filed with the FDA by the dental industry in attempts to warn the public of the dangers of mercury in dental amalgams. Indeed, the International Academy of Oral Medicine and Toxicology had apparently provided funds for the video done by the University of Calgary team, capturing the effects of low- level mercury exposure on neurons. In a docket filed with the FDA Dental Devices Branch, by the International Academy Of Oral Medicine And Toxicology, docket no. 01N-0067, filed April 22, 2002, by Michael F. Ziff, D.D.S. [doctor of dental surgery] and Executive Director of the International Academy Of Oral Medicine And Toxicology, the following statements were made: “In 1998, USFDA ruled that mercury and its compounds are NOT Generally Recognized As Safe (GRAS) and eliminated them from Over The Counter (OTC) products. [FR 63(77):19799-19802, 22 April 1998]. By first accepting Dental Mercury as a Class I safe and effective dental device and now proposing acceptance into Class II, USFDA is acting contradictory to its own precedent. Is USFDA taking the position that Dental Mercury is the only non-toxic form of mercury known?… Comment Position: Against USFDA’s failure to require consumer notification of the ingredients in dental amalgam (Full Disclosure). In its Proposed Rules [FR 67(34):7620-7630, 20 February 2002], USFDA states “the clinician would be made aware of all materials he/she is placing” (p. 7627) and “FDA is recommending a consistent label that will allow interested consumers of dental amalgam to easily obtain necessary information that may result in mercury exposure avoidance.” (P. 7628) Yet, even though mercury is scientifically acknowledged to be highly toxic and USFDA acknowledges consumer exposure to amalgam mercury, the Guidance Document contains no requirement that the consumer be provided with Full Disclosure. This omission is clearly not in the best interest of protection of the consumer, nor in protection of clinicians from potential medico-legal jeopardy. USFDA requires that the clinician be informed, which is actually the responsibility of OSHA and NIOSH. The responsibility of USFDA is to the consumer.” [emphasis added - end of quote from docket no. 01N-0067, filed with the FDA on April 22, 2002, by Michael F. Ziff, D.D.S. [doctor of dental surgery] and Executive Director of the International Academy Of Oral Medicine And Toxicology] In other words, the USFDA is taking the position that “dentists” should be informed of the dangers of mercury – given it would be considered a “work hazard”. But, - correctly - the International Academy Of Oral Medicine And Toxicology was stating that this responsibility to inform “dentists” as to the dangers of mercury in the workplace was the responsibility of OSHA (Occupational Safety And Health Administration) and NIOSH (National Institute For Occupational Safety And Health). In other words, USFDA is doing someone else’s job – rather than doing its own! OSHA and NIOSH should be “informing” dentists as to the dangers of mercury in the workplace. USFDA had a responsibility – not to dentists – but to consumers – and, as clearly stated in the above referenced docket, the USFDA was not acting in the best interest of the consumer by failing to warn consumers of the dangers of mercury in dental amalgams! The fact that this docket stated information could be readily made available to “interested consumers” was also a complete joke! If I knew not of this even “being an issue” – how would I even know to ask or have “an interest” in this issue? Given that the FDA was also the agency responsible for approving vaccinations – and the dangers of mercury in vaccinations had never been investigated, nor had the overall dangers of mercury been made “public knowledge” via any “public information literature” or “public announcements” by this agency, there could be no doubt that this agency had completely failed in its responsibilities to the consumer – in more ways than one! Not once, in my lifetime, had I ever seen any documentation from the FDA to the public on the potential dangers of mercury and/or aluminum in vaccines or of dental amalgams. If it was the responsibility of the FDA to inform the consumer, why had the FDA not mandated that consumers be informed and given this literature – if it even existed – automatically – upon each and every visit to the dentist or doctor’s office? No studies on the dangers of mercury… no long term studies on vaccination safety issues… no regulation of aluminum… no mandate to inform the consumer… no nothing… and, I suspected… no studies on the danger of excess iron in prenatal vitamins, baby formulas and baby foods, etc.… Criminal acts … or total incompetence… take your pick… neither let the FDA “off the hook” in terms of its complete and total failure to meet its responsibilities and protect the public in this matter! Given this appeared to be a “willful omission” on the part of the USFDA, I suspected that attorneys for the mercury poisoned would argue this fell more in the realm of “criminal acts” than simply “total incompetence” – although the case could certainly be made – for both! The FDA… The FDA… The FDA… an agency so closely tied to the pharmaceutical industry and the dental industry – an agency that appeared to be not an “administrator” of healthcare issues but rather – provided simply a “rubber stamp approval” based on little or no long term - independent - scientific research! Clearly, this had been where the system – had completely “broken down” – and as such, also in my opinion – perhaps hundreds of millions worldwide had now apparently been “Fortified, Drugged and/or Annihilated” – courtesy – again in my opinion - of the FDA! In my opinion, what we were witnessing here – was the “Twin Tower disaster of healthcare” – only this disaster was of much greater proportions impacting - every nation, every city, every household - every person and, this disaster had the potential to rock and change the world like never before. As the “Twin Tower” disaster of 9/11 in New York had shown us how vulnerable we were to acts of violence – so too, had – again in my opinion – incompetence - at the FDA – shown us how vulnerable we were – not only as a nation – but as a human race – to “acts of incompetence in healthcare management”. Clearly, when it came to issues of the safety of mercury in dental amalgams, the safety of iron in the body, the safety of vaccines, in general the FDA had failed miserably in its responsibilities to not only me, but to every taxpayer – and as such, I now found myself with a very sick child – and my entire family – not only my son - had been held so very captive – to “autism”, as I suspected were many other families captive to Alzheimer’s, schizophrenia, bipolar, depression, Parkinson’s, diabetes, and on and on and on! To leave the shackles of autism behind would involve much more than working at “saving Zachary”. To leave the shackles of this disaster behind meant we had to leave the “rubble” of the FDA behind too – and start over! The answer was not in congressional hearings with no apparent desire to get to the truth – given a single subpoena had yet to be issues in these matters – nor was it in hiding from the truth, denying the issues or making supplements “prescription only” – the answer – in my opinion – was in setting “minimal standards” of safety based on long-term – independent - studies in all these issues and in overhauling – The Food and Drug Administration – an agency that now left a nauseating and very bad taste in the mouths of many! Warning bells… warning bells… warning bells… sounding everywhere… sounded by parents of children with autism… and sounded by those in the dental industry involved in matters of public safety as it related to oral dental health and safety… sounding, it seemed, in many divisions at the FDA… Warning bells… warning bells… warning bells… sounding everywhere at the FDA… but failing to be heard! But, it appeared that dental amalgams and mercury detox might be tied to, much more. Already, Boyd Haley, metals expert, had stated that mercury and aluminum reacted together to produce unknown toxicities. And now, another person, obviously knowledgeable in the effects of mercury was raising concerns, too – Michael Ziff, D.D.S. and Executive Director of the International Academy Of Oral Medicine And Toxicology. Sam Ziff, Michael Ziff, D.D.S., Mats Hanson, Ph.D. had written a guide entitled Dental Mercury Detox, Bio Probe, Inc., Publisher, ISBN 0-941011-05-4 (http://www.bioprobe.com) which stated the following – again, I quote: “Any exercise or activity that causes sweating serves the desired purpose of inducing the excretion of toxins and heavy metals through the skin.” [end of quotation – emphasis added - Sam Ziff, Michael Ziff, D.D.S., Mats Hanson, Ph.D, Dental Mercury Detox, p.51]. If indeed toxins were excreted via the skin, that certainly could help explain the rise in skin cancers, could it not? Aluminum was a toxin in the body… and a toxin found in antiperspirants. Antiperspirants worked by blocking pores, thus preventing what appeared to be a natural process of excreting toxins via the skin. This excerpt seemed to indicate that toxins could be excreted through the skin. But what about toxins on the skin – such as aluminum – that had not been ingested or injected into the body? Aluminum was found in many, many products to treat skin rashes as well as in cosmetics, genetically-engineered foods, and multiple food products on grocery store shelves, vaccines for both humans and animals, many household products, and on and on and on. Given aluminum was a known gene mutant, did it not stand to reason that – perhaps – just perhaps – aluminum in so many forms - could have “something” to do with the rise in skin cancer or cancer overall? I also wondered if somehow the sun’s heat – in excess - could trigger a bad reaction in the skin involving toxins. I had always been very, very careful to protect Zachary’s skin, and now, was more thankful than ever that he had pretty well always worn long sleeves and a hat – even in the summer. Perhaps the effects of aluminum were also, at least in part, to blame for what we were seeing in botulism. Botulism resulted when young children – usually under age two or so – were given honey. The following were a few quotes from an article I had found on the Internet relating to botulism. This article, entitled, “Honey and Infant Botulism - Honey not safe for babies, parents told” by Andrew Gilligan, available at http://users.westnet.gr/~cgian/honey.htm, stated the following – and again, I quote: “HONEY, regarded as one of the purest foods in existence, has been declared unsuitable for babies and there are also fears that honey made from the pollen of genetically-engineered crops could endanger people's health. Warnings that babies under 12 months should not be given honey are beginning to appear on commercially-produced brands… bees can pick up mutant pollen from "transgenic" crops - crops altered to carry foreign genes - with potentially serious effects on human health… Millions of pounds have been spent over the past decade by companies "reinventing nature" - mixing plants' natural genes with others to boost yields or increase resistance to insects and disease. Some of these added genes are toxic to humans as well as insects; others can cause violent allergic reactions. Genetically-altered pollen "could pose problems to man who consumes honey as a food", the study says. The paper's authors, Colin Eady, David Twell and Keith Lindsey, warn: "As ever-increasing numbers of genetically-engineered crop plants are being approved for release experiments, it is vital that the potential problems associated with the expression of transgenic products in pollen are addressed." [end of quote – emphasis added, Honey and Infant Botulism - Honey not safe for babies, parents told” by Andrew Gilligan, http://users.westnet.gr/~cgian/honey.htm, source quoted: UK News Electronic Telegraph, Sunday 18 May 1997, Issue 723]. Had the “safety” of no product containing this known gene mutant been evaluated – at all? From what I could find, it appeared that once again, long-term studies were not performed. Perhaps this was because the FDA did not consider a known gene mutant to be a potential danger! “Aluminum has been exempted from tesitng for safety by the FDA under a convoluted logic wherein it is classified as GRAS. (Generally Regarded As Safe.) It has never been tested by the FDA on its safety and there are NO restrictions whatever on the amount or use of aluminum.” [end of quote, emphasis added: Aluminum Toxicity information compiled and submitted by Frank Hartman and available at: http://www.luminet.net/~wenonah/hydro/al.htm#toxic, the website of Dr. Dr. Theodore B. Hoekman]. Mercury and aluminum… both toxins in and of themselves… and… when combined – as in vaccines – increased to “unknown toxicities”… hum… Were there any scientists at the FDA who knew and/or reviewed even “the basics” or was this simply really an agency run by bureaucrats that could perhaps more accurately be called - the Fast Drug Approval agency – a mere puppet controlled of the pharmaceutical industry? It certainly appeared that as in the case of the safety of mercury and the overall safety of vaccines, when it came to aluminum we had all been “Fooled and Deceived Again” – courtesy of the FDA! As I thought about genetic engineering and the fact that B17 was a rather “unknown” vitamin with potential benefits in preventing cancer - according to more and more in science - I certainly found this all very interesting in view of the fact that this vitamin was found in the seeds of many fruits and we were now a society moving to “seedless fruits” via “genetic engineering”. Hum… very interesting indeed! The more I read, the more it was evident that aluminum was – potentially - as huge a problem as mercury – as experts appeared to have indicated in the Puerto Rico meeting of 2000 – transcripts of which had been obtained by the US Autism Ambassador and submitted as official testimony on behalf of the public to Dan Burton for the December 10, 2002 government reform hearings and also given to several other key legislators. Legislators were now being given substantial information showing the dangers of mercury (Simpsonwood meeting transcripts) and aluminum (Puerto Rico meeting transcripts). The question was – how long would it take them to act on this information - and make it public – information that had now – also been shared with many parents of children with autism via online discussion groups and autism newsletters providing links for the downloading of these reports – reports – that surely – would also find their way – to many attorneys involved in vaccine injury lawsuits! The government had attempted to seal vaccine injury lawsuits – although unsuccessfully. How long would it take for the government to own up to the fact that it knew of the dangers of these substances – as clearly indicated in these reports – attended by many from government agencies including the NIH, CDC, FDA, etc. as well as by the pharmaceutical industry! Warning bells… warning bells… warning bells… in the form of higher and higher statistics in so many disorders… perhaps the most telling of all… childhood cancers… in the form of cries from desperate parents of children with autism… the cries of so many… looking for answers! Warning bells… warning bells… warning bells… sounding everywhere… yet failing to be heard! More and more warning bells… and now… not only were these warnings auditory… they were very much in visual medium too… The effects of mercury on neurons had been captured on video by the University of Calgary team that had very clearly, without a doubt, shown that even low level mercury exposure resulted in the devastation of neurons – shrinking them to about half their original size – also impacting future neuronal growth and leading to “neurofibrillary tangles” – one of the “hallmarks” of Alzheimer’s - as well. In their video, these researchers had also made comments relating to lesions found in the brains of persons with Alzheimer’s. Indeed, in the article published by the University of Calgary team, the following comment was made: “A similar in vivo molecular lesion was observed in brains of 80% of Alzheimer’s disease (AD) patients, but was not seen in brains from age-matched control patients” [7] [end of quote, emphasis added: Christopher C. W. Leong, Naweed I. Syed andFritz L. Lorscheider, Faculty of Medicine, University of Calgary, Retrograde Degeneration Of Neurite Membrane Structural Integrity Of Nerve Growth Cones Following In Vitro Exposure To Mercury, by, published in NeuroReport, Vol 12, No. 4 26 March 2001, ISSN: 0959-4965.] The reference [7] alluded to in their article by the University of Calgary team was as follows: Pendergrass JC, Haley BE, Vimy MJ et al. Neurotoxicity 18, 315-324 (1997) [end of quotes]. Of course, as with all science, there was the usual “disclaimer” that “we do not know for sure” if these things were related and so, of course, more study was necessary. I, for one, was certainly in favor of “more study” – especially of “independent” study! Similar “brain lesions”… neurofibrillary tangles… If it looked like a duck, walked like a duck… quacked like a duck… In so much of this, I could not help but be overwhelmed at what appeared to be incompetence on so many levels when it came to issue of the safety in dental amalgams, vaccines, food products, prescription and over-the-counter products, etc. With all the tax dollars that had been poured into agencies that were supposed to protect the public, and yet, appeared to failed miserably in that role… and the billions more poured into “research” – although, I would argue that was very “selective” research – looking at everything “but mercury and or vaccines overall” as a possible cause to autism, I could not help but feel so completely betrayed by a system I had so trusted – for myself – for my family – and for my son – who now lived a daily battle with – autism! No… that battle was not limited to my son… it was a battle my entire family now lived with – every single day! What I now saw as total incompetence on so many levels – had proved devastating to my entire family – and to many other families as well – families that now spanned well beyond “just autism”. There was no doubt in my mind that society now faced some very difficult issues. The question was – would it now be strong enough to address those issues? With fifty percent of us heading for Alzheimer’s and untold millions heading for cancer, stroke and so many other disorders that now appeared to play into this we had no choice but to address these issues – now. There was no time left for games. What I had once seen as a solid, stable healthcare system – was, in my opinion – nothing but a house of cards – with “the children of autism” now holding that all powerful - “trump card”- a card so powerful that it – literally – in my opinion - had the potential to collapse and topple not only one of the most powerful industries known to man, but many of the most powerful government agencies known to man also! The autistic child… once the forgotten child… now the key to so much! |
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