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How Minimal Risk Levels Are Set... The following were quotes from the a meeting looking at aluminum in vaccines. This transcript is posted in full (400+ pages) under my Reports/Key Documents link. Within the words spoken at this 2-day meeting was a discussion of how "Minimal Risk Levels" were set at the CDC - what I could only term: Incompetence At Its Best! The discussion on how "safe levels" were determined was provided on pages 172 - 182 of the "aluminum meeting transcripts". Seeing that "we divide by an uncertainty factor" (p. 177) to come up with the "minimal risk level" only further confirmed that these folks, in my opinion, had no valid or substantiated way to determine what was "really safe". "Uncertainty factors" as they stated on p. 177, "become quite a tangled web"... and that "uncertainty factor" was "traditionally 10" (p. 178) but "can go as high as 3,000" (p. 179) - or at least that was where they "stop" .. but, potentially, it looked like it could be even higher than that. Indeed, as the 2-day aluminum meeting was coming to a close and being summarized, the following comment was made by Dr. Theodore Eickhoff of the University of Colorado - I quote: " ... we heard the word "pervasive uncertainty" several times... [p. 151 - day 2 transcript]... What troubles me are the uncertainty factors because they are -- well, just exactly what the name says. They are uncertainty factors and the fact that one conceivably could have 105 since there were five uncertainty factors listed, each one of which has a value of ten, the maximum uncertainty factor, therefore, would be 10 raised to the fifth power or 100,000. ATSDR took a look at that and said that is probably unacceptable and reduced it perhaps somewhat arbitrarily to 103 but we are still dealing with 1,000-fold uncertainty factor... it strikes me as a very imprecise science at best..." [end of quote, emphasis added, Dr. Eickhoff, aluminum transcripts, day 2, p. 156]. Well... one certainly did not need to be an expert in mathematics to realize that was "a rather wide range" [1,000 vs 100,000] for an "uncertainly factor" in a "risk assessment" equation. But it gets worse... What I, personally found “unacceptable” was that instead of considering “all risk factors”, we arbitrarily decided to “reduce the exponent” – in effect – throw out some of the risk factors. If the risk level was considered too high for their calculations, perhaps the risk of the substance itself was too high as well. How was it that “risk assessments” could be “so fluid” based on “what someone thought” as opposed to being based on empirical data! Not only did I question the CDC’s understanding of metal toxicities, but clearly, one could not read this transcript and believe the CDC – or ATSDR (an agency of the CDC) – had much of a clue as to how to set “minimal risk levels” when it came to metals entering the body via vaccines. They stated, I quote: “The largest we can have since we only use the first three uncertainty factors is 1,000”. [aluminum transcripts, emphasis added, p. 179]. Yet, clearly, there was uncertainty in more than three areas when it came to aluminum in the body – I quote: “…we need to know about absorption, distribution, metabolism and elimination. These kinds of data are missing for aluminum or not totally missing but are incomplete for aluminum"... "now the presentations we heard yesterday clearly demonstrated that there are huge gaps in our information about what we know about toxicology of aluminum..." [end of quote, emphasis added, pages 104 and 105, aluminum transcripts, day 2]. …and, then, another uncertainty factor – age! "... we do not seem to have the information on the age related toxicity of aluminum and especially when we are dealing with very young infants... we do not know whether or not there is a difference in susceptibility by age as there are with other metals..." [end of quote, Dr. Halsey, p. 83-84, aluminum transcripts, day 2]. Well, according to my simple first grade type calculation, that put us at five critical uncertainty factors that needed to be considered in the determination of “safe exposure levels”, 1) absorption, 2) distribution, 3) metabolism, 4) elimination, 5) age – and that meant that by their own calculation criteria, the “uncertainty factor” for setting “minimal risk levels” should not be 103, but rather 105 – at minimum – or 100,000, but, for some reason, although none was provided other than what appeared to be “a judgment call”, methods and procedures allowed us to “throw out a few”. I had but one question for the CDC and ATSDR (Agency For Toxic Substances and Disease Registry): Which two of these five variables did you feel was “irrelevant” and hence justified “exclusion from the equation” and allowed one to simply “throw them out”? Absorption? Distribution? Metabolism? Elimination? Age? And given Boyd Haley had testified that testosterone was known to enhance mercury toxicity, what about “gender”? Which variables were irrelevant, keeping in mind that it was known metals had different impacts based on age and keeping in mind issues such as limited bile production in infants, immature blood brain barriers, increases in permeability of the blood brain barrier by metals or vaccine components such as aluminum, immature immune systems that needed to deal with aluminum once it entered the cells, etc. And what about issues like the huge disparity that existed in reference to “duration” of metals in the body (i.e., the CDC stating that the body could rid itself of mercury after a few weeks, verses metal toxicology experts who stated, for example, that the half-life of mercury was 20+ years once it entered the major organs… and clearly, if aluminum accompanied mercury in a vaccination, increased cell permeability would certainly facilitate mercury finding its way into major organs as well. The discussion on the issue of aluminum entering the body’s cells clearly indicated that the CDC had basically no knowledge as to absorption issues! And what about the interaction of metals (i.e., mixing of mercury and aluminum, etc. – or – synergies? Certainly, that, too, - the “additivity” properties of metals - had been raised as an issue during this meeting. And, again, clearly, the CDC appeared to have very little understanding of that, also! 1) Absorption, 2) Distribution, 3) Metabolism, 4) Elimination, 5) Age, 6) Gender 7) Duration, 8) Synergies – 8 “uncertainty factors” – and as such, if ATSDR followed its own guidelines, it would have allocated a factor of 108 as an “uncertainty factor” or 100,000,000 – not 1,000 – in the determination of “minimal risk levels”, but, for some reason, ATSDR felt that even 105 was “probably unacceptable” and as such, per the quote above, the “uncertainty factor” was reduced - perhaps arbitrarily – to 103! Undoubtedly, those I personally considered the “real experts”, people like metals expert Boyd Haley, MMR/Virus expert Andrew Wakefield, world leading immunogeneticist, Hugh Fudenberg who had stated that 5 consecutive flu shots made a person 10 times more likely to get Alzheimer’s, etc., certainly would have “uncertainty factors” of their own they would perhaps want to see included as well. If anything, the list of “uncertainty factors”, in my opinion, could indeed be quite long. My question to ATSDR was the same as that I had for the CDC: Which of these 8 – and potentially much more - “uncertainty factors” were you “comfortable in throwing out” – and why? Perhaps instead of throwing out the “uncertainty factors”, we should be looking at throwing out the substance itself from the vaccine equation – substances like mercury, aluminum and formaldehyde! In reading this transcript, it was painfully evident that neither the CDC nor ATSDR had very much of a clue as to how to set “minimal risk levels” when it came to metals in vaccines. Note that the person from ATSDR who gave the talk on "minimal exposure risk levels and how these were set" - as his opening comment stated - I quote: "We are not doing or we -- this is new to us, anything to do with vaccinations except for maybe the thimerosal incident" [Dr. John Wheeler, Agency For Toxic Substances and Disease Registry, ATSDR", p. 172 of aluminum meeting transcript, emphasis added - very much appears they only started to set "minimal risk levels" for metals in vaccines because of the issue with parents finding out just how much thimerosal there was in vaccines... before that, it does not appear that any "safety levels" were ever set... not surprising given that in over 80 years, not once was there ever a study done to evaluate the safety of mercury in vaccines: So, even he admits he has very little experience in determining "safe levels of exposure" when it came to vaccines… and this was the “expert” the CDC had turned to for explaining how “minimum risk levels” were set for aluminum! That, in and of itself, had raised major red flags for me! Had the CDC brought in ATSDR only as a result of the thimerosal controversy? It certainly was evident that ATSDR had very limited knowledge in setting safety standards as they related to metals for purposes of vaccines – of that – based on the quotes above – there was no doubt!Had exposure levels really been set in the past at the CDC, and if yes, how? And by whom? It certainly appeared to me that “the experts” from ATSDR had been “brought in” to come up with safety levels because perhaps none really had existed! How can this “expert” on “minimal risk levels” make such statements as to “his expertise” or that of his office unless safe levels for exposure had never been made for vaccines in the first place! Indeed, why would “safe levels” ever be set for aluminum if it was totally unregulated by the FDA! Perhaps the website of Dr. Theodore B. Hoekman could help shed some light on the issue of aluminum in vaccines. This was a very interesting quote I had found on this website: “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 the website of Dr. Theodore B. Hoekman, Principal Investigator, Professor of Medical Informatics Basic Science, Faculty of Medicine, Newfoundland and Labrador Centre for Applied Health Research: http://www.luminet.net/~wenonah/hydro/al.htm#toxic]. Thus, if the FDA did not regulate aluminum in vaccines – why would the pharmaceuticals care about this issue if this metal was considered “Generally Regarded As Safe” by the FDA? It was not the CDC’s approval that was necessary for vaccines – it was that of the Food and Drug Administration, FDA – or, as I liked to refer to it – The Failing In Duties Administration! During her presentation on iron overload to the NIH in June 2001, Roberta Crawford had made the following comment – as posted on the Iron Overload Disorder Association – I quote: “Now defining iron deficiency -- so-called "normal" iron levels vary from lab to lab. Most "normal" levels are set too high. Saturation: 12 to 40-45% is reasonable at the present time. Ferritin: 5 to probably 50. As our years of study have shown, we have had to lower these levels several times to be safe… Think about it. If "normal" levels are set artificially high, and your levels fall below that "normal," you are "iron deficient." [end of quote, emphasis added, Roberta Crawford on iron overload, presentation to NIH, June 2001]. Likewise, the same would be true for aluminum and mercury… when had those safety levels last been reviewed and/or modified? I mean, think about it… if safe exposure levels were set “too high”… you would be getting more exposure than you should be and as such, you would be in mercury or aluminum overload land! That seemed like pretty basic information… yet, clearly, even basic information was often not readily available or understood at the CDC. Another very interesting quote – this one relating to actual levels considered “safe exposure” that were currently in place for aluminum – I quote – again from the aluminum transcript: "... the standard of 0.85 milligrams of aluminum per dose set forth in the Code of Federal Regulations, can you tell us where that came from and how that was determined? [Dr. Gerber, National Institute Of Health, p. 46 of aluminum transcripts, emphasis added - note here... this was a person at the NIH and even he did not know the answer to this!] Answer he was given - I quote: "Unfortunately, I could not. I mean, we have been trying to figure that out. We have been trying to figure that out as far as going back in the historical records and determining how they came up with that and going back to the preamble to the regulation. We just have been unsuccessful with that but we are still trying to figure that out." [Dr. Baylor, p. 46, aluminum transcripts, emphasis added - again, note his title: Acting Deputy Director of the Office Of Vaccine Research and Review, and Associate Director for Regulatory Policy at the Center for Biological Evaluation of Research at FDA - thus, here we have a person working in vaccine research and at the FDA who appeared "clueless" as to how aluminum safety exposure standards were determined in spite of having obviously tried to investigate that very issue"!] So, how exactly were those safety standards first determined, and by whom? – two very interesting questions! It seemed to me that neither those in the vaccine business or in government regulation of vaccines had a clue! And given the comment by Dr. Wheeler from ATSDR – an agency that supposedly sets "minimal risk standards"... "We are not doing or we -- this is new to us, anything to do with vaccinations except for maybe the thimerosal incident" (Dr. John Wheeler, Agency For Toxic Substances and Disease Registry, ATSDR", emphasis added, p. 172 of aluminum meeting transcript)... well... again, let me just say that this was not exactly "expert advise" (and I use that term lightly) that I cared to base my child's welfare on... and as such, again, I could not help but think that what we had when it came to metals in vaccines and the safety of these toxins in vaccines was nothing more than "a shot in the dark"! "Perhaps the most important thing that I took away from the last meeting was that those of us who deal with vaccines have really very little applicable background with metals and toxicological research." [Dr. Martin Myers, Director of the National Vaccine Program Office, Department of Health and Human Services, National Vaccine Program Office Workshop on Aluminum In Vaccines, Caribe Hilton International Hotel, San Juan, Puerto Rico, May 11th - 12th, 2000, p. 1, transcripts provided by Eberlin Reporting Service, 14208 Piccadilly Road, Silver Spring, MD, 20906, (301) 460-8369), full transcript is posted under my Reports link]. The above was but a small excerpt from my Book 3 chapter entitled: The Aluminum Connection. |
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