|
The Incredible "White Washing" Of the CDC Thimerosal Study Population Sample... As I read the complete transcript of the Simpsonwood meeting discussing the CDC thimerosal study by Verstraeten, Davis and DeStefano that resulted in the document entitled: Thimerosal VSD Study - Phase I, and having taken at least the basics in statistics, there was something that very much stood out for me when it came to the CDC study looking at the possible link between vaccines and neurodegeneration. That "something" was the fact that the population sample used clearly was NOT even close to being representative of children who would have been exposed to vaccines and in all likelihood have gone on to develop autism. Clearly, I was not the only person seeing major issues with this study... and the several "follow up studies" done on this issue. A letter written in Oct. 2003 to the CDC by US Congressman Dave Weldon - who was also a DOCTOR - outlined the many, many "concerns" he had with what appeared to be nothing less than "data manipulation" that resulted in the "disappearance" of the earlier autism-vaccine link. But, there were many, many issues I saw as very "troubling" in this whole "study"... some of my issues, Dr. Weldon had raised, others, he had not. Yet, in reading this 262 page transcript, these issues had very much "stood out" for me. Let me explain the reasons for which, in my opinion, the Thimerosal study by Verstraeten, Davis and DeStefano that resulted in the document entitled: Thimerosal VSD Study - Phase I, used a population that I can only describe as "white washed" and therefore, truly not a good sample to capture the true extent of the potential problem with vaccines. The database used was a COMPUTERIZED database that looked at BILLING DATA provided by HMOs., etc. I knew that in my personal case, this would never have captured my son in the population sample. From what I could understand of this report, it very much looked like billing codes were the primary thing looked at, as were "diagnosis" for things such as ADHD, etc. In the case of my son, I took him to a pediatrician for an initial assessment - and only a notation was made in his records that he showed signs of autism. There was obviously nothing in the billing that would have indicated that his visit to the pediatrician in early April of 2000 was to discuss the possibility of autism with a pediatrician. The reason I knew that for a fact was because Blue Cross Blue Shield ended up calling my husband and I to find out what that visit was for. We had just left corporate America and had also applied for our own insurance via Blue Cross Blue Shield - apart from our employer - and therefore, BCBS wanted to know "the specifics" about this visit for Zachary - as it could very much impact their willingness to insure us - and clearly it did. We had applied for insurance almost 6 weeks earlier. The normal process was supposed to take approximately 2 weeks. It had taken close to 6 weeks due to backlogs. When I honestly told BCBS that this was a visit because I suspected autism in my son, within 2 days, we received the final answer to our request for personal insurance - BCBS could cover everyone - except Zachary! We replied "thanks, but no thanks" ... But, this experience certainly demonstrated several things as they related to the thimerosal study. 1. Given "billing data" was used, I very much suspected persons without medical insurance would not have even have shown up in their "data" or population sample as no data would have gone to an HMO, etc. for billing purposes. It was estimated that 11 - 12% of children in the US did not have health insurance according to US Census data: http://www.census.gov/Press-Release/www/2002/cb02-127.html 2. Unless the billing information provided "something" to indicate the problem was autism or an autism spectrum disorder, again, that information would have been missed. In my case, that would definitely have been true since the doctor had simply put a "hand-written notation" in Zachary's records, and the insurer had to call to find out what the visit was for in the first place. But, there were other reasons for which this population sample may very, very much underestimate the scope of the problem. 3. The data used looked at billing codes. It looked at billing data. Billing data was just that... billing data... and often, it was inaccurate. Having worked with databases in the past, I knew how often codes were simply wrong and/or inaccurate. You simply could not, in my opinion, use a database intended for billing to determine the impact of vaccines on children. These data were NOT INTENDED for such a study and as such, in my opinion, that in itself, provided for many, many issues in terms of the accuracy of the data! The simple fact was that if I was a data entry clerk and did not remember the code for a certain thing, but I remembered that the billing for that was say $150.00, then using any code that billed "150.00 would have resolved the issue from a "billing perspective". As such, the accuracy of "billing data" being used for a study to determine an autism-vaccine link, in my opinion, was highly questionable! 4. Particularly troubling to me, however, was what I saw as "white washing of the population sample" via the automatic elimination from the study of specific children. Clearly, over 25% of the probable sample was ELIMINATED from the study. Page 34 of the Simpsonwood meeting transcripts states: "... there was quite a large group, about 25%, that we excluded because of congenital or perinatal disorders..." The fact that 25% of children appeared to experience and/or be born with "some kind of problem" in this nation should be reason enough for concern, in my opinion. Add that 25% to the 12% or so of children known to be uninsured, and clearly, close to 37% of the "real life" population sample was missing from this study - and those "left over" - could certainly be considered among the "healthiest" in terms of who was allowed to participate in the study - hardly representative of the US population given this study indicated that 25% of children had some type of problem very early on! Yet, surely these children had been vaccinated - so, why exclude them from the study given they were perhaps the "most susceptible" to vaccine injury! "Congenital disorders" would have excluded children who had disorders such as Down Syndrome (the genetic but not hereditary condition) ... yet a dual diagnosis of DS and autism was "no longer rare" according to work done at the Cleveland Clinic and discussed at the National Down Syndrome Society conferences, both past and present. http://www.ndss.org/ndssmedia/pdf/Conference_brochure.pdf (see section for Bonnie Patterson). In fact, according to some studies, if you have Down Syndrome you may be up to 10 times more likely than the "general population" to also have autism (refer to paper on Redefining The Role of Insulin posted in full on this website). Thus, according to the "criteria" set in the Simpsonwood study, those who may be the most "at risk" for autism, were completely excluded from the study under the "perinatal clause"! Excluded from this study were children who had not only "congenital" ("born with") problems but also children who had problems during the "perinatal period". Well... what exactly was the "perinatal period"? "Perinatal medicine" as defined by an online dictionary was the period started from week 28 in gestation to day 28 after birth - I quote: "The branch of medicine dealing with the foetus and infant during the
perinatal period. The I could not help but ask: Why go back to week 28 of gestation and exclude any child whose mother experienced a problem during pregnancy? Could it be because these children were perhaps most "at risk" for autism and given we really did not want to see "a link" between autism and vaccines, we chose to exclude as many "risks" as possible that would show a link between autism and vaccines? Why would a study looking at the effects of thimerosal go back to week 28 of gestation in determining who would or would not be included in the population sample? Week 28 was a critical point in pregnancy... that was when mothers showed signs of gestational diabetes, Rh factor incompatibility, etc. As such, any child of a mother who would have experienced gestational diabetes, or Rh factor incompatibility - requiring a Rhogam shot at week 28 of gestation - a shot laced with mercury - for the mother, any child born with a "problem" at birth (i.e., jaundice, etc.), any child experiencing breathing problems at birth, or early in life, any infant with cardiac, respiratory or CNS (i.e., mental retardation, etc.,) problems would most likely have been excluded from this study. Yet, these were often the very issues seen in children that went on to develop autism. That "little glucose bottle" Zachary had been given at birth because he was "low on glucose" had always bothered me since I had discovered he had autism. Clearly, this was a sign of problems with insulin even though I did not have "gestational diabetes"... a sign from DAY 1. Were children of mothers with gestational diabetes excluded from this study? Gestational diabetes was certainly considered a serious perinatal condition given it led to increases in birth defects and perinatal deaths - as indicated on this link - and as such, these were considered "high-risk pregnancies": http://www.co.hennepin.mn.us/commhlth/chpubs/2003/CHSNeedsAssessment/Diabetesfinal.pdf Note that both gestational diabetes and Rh factor incompatibility were considered "high risk pregnancies". Thus, as a parent of a child with autism who was born "low on glucose" - a clear sign of a problem with insulin, I certainly would take issue with this study if it had excluded children of mothers with gestational diabetes - especially since I had learned from several other mothers of children with autism that their children were also "low on glucose" at birth! For a whole lot more on the role of insulin in these disorders, please read the research paper I have written and posted in full on this website on Redefining The Role of Insulin: Could It Play A Major Role In Metal Detoxification? In discussions with other parents of children with autism, I had also learned some children appeared to have low levels of iron at birth. Given iron and insulin modulated one another... that was not surprising to me (more on that in book 3). Unfortunately, children seen as "anemic" - and hence believed to be low on iron - could be given iron supplements when in fact the problem was not one of "too little iron" but "too much". This link explained how one could have "iron overload" in spite of appearing to be "anemic" via blood tests. Thus, "low blood iron" at birth, in my opinion, was but another sign of a problem and perhaps another "marker" for susceptible children. When the body had "too much iron", iron was put into "storage" instead of going to the production of blood... and as such, the body appeared to "hide" iron. As such, one certainly could appear to have "low iron" at birth, when indeed the problem was "too much iron"... and remember, iron and insulin modulated each other. Zachary was born "low on glucose". DS, another disorder I felt was very much tied to this was a disorder involving one of the worst free radicals known to man... one that had to do with IRON - again, more on all this in "book 3"! http://www.ironoverload.org/anemia.htm Most don't know it... but iron and insulin modulate one another... insulin absolutely plays a role in these disorders and prenatal vitamins are LOADED with iron... up to almost 100 times what the body needs each day... iron is VERY toxic... and the body has no good mechanism for riding itself of iron... so...trip up iron levels... you are going to trip up INSULIN because IRON AND INSULIN MODULATE EACH OTHER! For a whole lot more on the role of iron in these disorders, please read the research paper I have written and posted in full on this website on Redefining The Role of Insulin: Could It Play A Major Role In Metal Detoxification? Also excluded from this study were infants born prematurely because their systems would have been "more susceptible" to vaccines as again, clearly indicated in the Simpsonwood transcripts. Children who were premature were often vaccinated on a different schedule. Yet, Dr. Verstraeten himself stated in the Simpsonwood meeting - I quote: "I can see some very premature children also getting vaccinated"... (p. 153 of Simpsonwood transcripts). Obviously, these children, being more susceptible in the first place, could very well have gone on to have "an event" that would have increased the statistical significance had they been included in this study! Thus, children who would have been among the "most susceptible" to vaccine injury, were excluded from the study, even though, clearly, according to Dr. Verstraeten himself, many very premature were also getting vaccinated... Also excluded were infants who died... death and autopsy reports were excluded - even though, clearly, the VAERS database indicated vaccines often played a role in childhood deaths, SIDS, and/or abnormal breathing patterns. See: http://www.909shot.com/Articles/gnssids.htm or http://thinktwice.com/sids.htm Also excluded were children who had not received 2 polio shots. I did not understand this "condition/criteria" given the polio vaccine DID NOT contain mercury and as such, it should be a non-issue in a study that was supposed to be looking at THIMEROSAL... unless the scientists believed this could be a way of seeing if something else was the problem - like the polio shot... something that did not have mercury in it. If a "non-thimerosal" containing shot was going to be included in this study, why was it not the MMR instead of the polio shot because, clearly, parents were associating the MMR with autism also. Thus, why take polio and not look at the MMR instead? The study stated that this "polio criteria" was to determine "dates for participation in the HMO program". Well, clearly, there were "date data" available to determine that in databases... given billing information had to include "date of service" and as such, using the "polio criteria" in my opinion, was a totally bogus criteria... the study could have simply looked at "dates themselves". Also excluded were children who had received hepatitis B immunoglobulins. Note the reason for excluding these children as stated on p. 32 of the Simpsonwood report - I quote: "Those would be vaccinated for hepatitis B and would have a higher likelihood of the outcomes"... That exclusion was very troubling to me... it very much appeared to be saying that we specifically excluded these kids because if they had this shot, they would be more likely to have neurodegeneration... so, let's not include them! Note also that the study underrepresented the effects of Hepatitis B in children because that data was generally not available and as such, the data was very much incomplete in this respect. Note that Hepatitis B is the first shot usually given to infants... often before they left the hospital... and it certainly did contain mercury and it certainly did appear to cause death in infants according to information in the VAERS database! Often the information from the hospital records appeared to not make it to the pediatrician's office and hence, the issue with the accuracy of the Hepatitis B data in this study. Refer to: http://www.vaccinationnews.com/DailyNews/2003/July/09/HepatitisBVaccine9.htm Also excluded were children participating in vaccine studies... for new vaccines... as indicated by Dr. Gerber's comments at the Simpsonwood meeting - again, I quote: "...it seems to me that during the time that this study was done, 1992 - 1997, at least at Northern California Kaiser, there was a substantial number of children involved in vaccine trials. The vaccines that those children would have received would not have shown up in the CPT coding. " Dr. Gerber, p. 232 Note also, that as clearly indicated in the Simpsonwood meeting, many children were simply not old enough yet to be diagnosed! (p. 38 of Simpsonwood transcripts). There were also issues with codes themselves. For example, a child could be said to be diagnosed with ADHD and then, later "not confirmed". Well, given that ADHD was usually confirmed around age 8 - 10, it would make sense that this "diagnosis" would not have been confirmed... perhaps the doctor was simply indicating that there was a problem. The lack of a "confirmed ADHD diagnosis" did not mean that a problem did not exist anyway... and as such, in my opinion, "lack of confirmation" did not equal "lack of a problem or issue"... even though that appeared to be "how the data were interpreted" in this "study". Note also another interesting comment... I quote: ... "the heavier babies in this cohort are more likely to have the outcome, and that is statistically significant..." (p. 46 of Simpsonwood transcript). That was very interesting to me... heavier babies... hum.. was an insulin problem at play here? It was also a known fact that mothers who had heavier babies were more likely to develop diabetes later in life: Refer to: http://www.co.hennepin.mn.us/commhlth/chpubs/2003/CHSNeedsAssessment/Diabetesfinal.pdf My son was very, very heavy/big... always "off the growth charts"... he CONSTANTLY wanted to eat... so much so, that this was very much discussed with his pediatrician, who referred to him as "the moose". Casein/milk proteins... were believed to act as natural opiates in children with autism... certainly helping to explain why children like Zachary wanted to eat constantly... they were getting a "drug high" from their milk! Yet, again, according to the Simpsonwood meeting, it appeared that children who had "feeding problems" were excluded (see p. 98 of Simpsonwood transcripts). Needless to say, there was very little doubt that children who develop autism had "feeding problems"... as clearly evidenced by overeating, vomiting, diarrhea, selective food choices, etc., in these children. Yet, children with "feeding problems" appeared to again have been excluded from the study! Note also that unless a mother "raised a concern", children would not have been included in the population... it was often up to the mother to "see the problems" and have the child looked at... and unfortunately, many, many children went quite a while before they were "diagnosed" - as clearly indicated in the Simpsonwood meeting. Again, I quote: "There is no routine screening of children, so it is only if the mothers bring their children for a problem that we will be able to pick it up."( p. 49 of Simpsonwood transcript). "I work in the Early Intervention Program and I wish you were right, but in a study that we have done in Michigan, we think that there is less than 40%, probably less than 30%, of the kids who are eligible in terms of delay that are in fact referred for evaluation. Even then, we don't know how many of those are getting treated..." (Dr. Weil, Simpsonwood meeting transcripts, p. 137). Also, children who "dropped out of the HMO for some reason" were not included in the study. Could these be children whose parents saw a problem and went to a DAN! (Defeat Autism Now!) doctor, etc. instead? Again, I see a huge issue with not including these children in the population sample. As I looked at this "population sample", clearly, in my opinion, there was much too much "white washing" of the initial population. It clearly was not even close to representative of the "population" in general. As clearly stated by those attending the Simpsonwood meeting - I quote: "the kids you choose to let into your analysis can have a great effect on what happens eventually..." (p. 96 of Simpsonwood transcripts)... and... "As a whole, the group was pretty unanimous, in fact we were unanimous, in saying that additional research is needed." Dr. Stehr-Green, Simpsonwood transcripts, p. 252) The Simpsonwood meeting occurred in June of 2000. Note that on November 15 of that same year - 2000 - Walt Orenstein, Director of the National Immunization Program at the CDC, attended a meeting again, on the safety of vaccines and when the FDA's Dr. Susan S. Ellenberg proposed conducting larger trials, Walt Orenstein clearly indicated he was "not in favor of expanded studies"... not surprising given the concerns raised in Simpsonwood about "the study that should never have been done in the first place" ... and the "white-washing" of the original population sample! "... so what I will present to you is the study that nobody thought we should do".... (Dr. Verstraeten, Simpsonwood transcripts, p. 31) If "nobody thought we should do this study", obviously, that meant we - at the CDC - did not want to find a link between autism and vaccines. As such, again, I can only conclude that the above "exclusions" had been done in order NOT to find a link between autism and vaccines. As clearly indicated by Dr. Clement representing the World Health Organization, it very much appeared the "outcome" of this study" could have been "predicted"... and so, perhaps we should never have done this study in the first place! Again, if you don't want to see "a link", in my opinion, you will do what you can in order "not to see a link"! "I am really concerned that we have taken off like a boat going down one arm of the mangrove swamp at high speed, when in fact there was not enough discussion really early on about which way the boat should go at all. And I really want to risk offending everyone in the room by saying that perhaps this study should not have been done at all, because the outcome of it could have, to some extent, been predicted and we have all reached this point now where we are left hanging, even though I hear the majority of consultants say to the Board that they are not convinced there is a causality direct link between Thimerosal and various neurological outcomes... I wonder how on earth you are going to handle it from here." (Dr. Clements, representing Expanded Program on Immunizations, WHO (World Health Organization), Geneva, Simpsonwood transcripts, p. 247) But, again, remember this quote: "As a whole, the group was pretty unanimous, in fact we were unanimous, in saying that additional research is needed." Dr. Stehr-Green, Simpsonwood transcripts, p. 252) So, 51 persons left a meeting saying they were "unanimous" in their belief that more studies were needed. Yet, I had found something else that was very troubling. Below was a link regarding a November 2000 meeting in a story done by Reuters, on Thursday, Nov 16th, entitled: FDA, NIH, CDC reconsider system for ensuring vaccine safety, during which Walt Orenstein (who had headed the Simpsonwood Meeting in June where the thimerosal study was discussed and this "unanimous" statement had been made) was asked about "expanded studies"... and stated he was "not in favor of expanded studies"... Note that "additional studies" were already supposed to be underway according to the Simpsonwood transcripts in order to better look at or confirm "the signal" received in the thimerosal study. Had these studies been completed and confirmed the problem - perhaps to a greater extent than originally thought? I could not help but wonder. How could 51 people state that "more studies were needed" and yet, Walt Orenstein, at a meeting 5 months later, stated that he was "not in favor of expanded studies"? Call me crazy... but, "I smelled a rat"! http://archive.mail-list.com/hbv_research/msg01771.html In my opinion, there could be no doubt that the CDC Thimerosal study used a very "white washed population"... and still... they had received "a signal" of a problem in terms of the correlation between vaccines and neurodegneration... I now suspected had the CDC used a more representative population sample... perhaps that "signal" would have been something more in the order of a - "tornado warning"! The Simpsonwood Transcript revealed something else, I found very interesting... something I thought could be another significant piece to this puzzle... When it came to the issue of vaccines and autism, certainly, in my opinion, the pieces were starting to fall very much into place... and the picture being revealed was disturbing indeed! |
|