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Introduction
Chapter I: pre-1999
There's Mercury In Vaccines?
Chapter II: 1999-2000
Simpsonwood
Chapter III: 2001
IOM: Biologically Plausible
Chapter IV: 2001-2002
CDC World Travel
Chapter V: 2003
It's Rotten In Denmark
Chapter VI: 2004
IOM slams the door (quickly)
Epilogue: present day
Better science, better kids, and a DJ
Chapter V: 2003
It's Rotten in Denmark
"Mercury is hazardous to humans. Its use in medicinal products is undesirable, unnecessary and should be minimized or eliminated entirely. Manufacturers of vaccines and thimerosal, (an ethlymercury compound used in vaccines), have never conducted adequate testing on the safety of thimerosal. The FDA has never required manufacturers to conduct adequate safety testing on thimerosal and ethlymercury compounds...Thimerosal used as a preservative in vaccines is likely related to the autism epidemic. This epidemic in all probability may have been prevented or curtailed had the FDA not been asleep at the switch regarding injected thimerosal and the sharp rise of infant exposure to this known neurotoxin. Our public health agencies' failure to act is indicative of institutional malfeasance for self-protection and misplaced protectionism of the pharmaceutical industry" - Mercury In Medicine: Taking Unnecessary Risks, Committee On Government Reform, U.S. House of Representatives, May 21, 2003
The Mercury In Medicine report, from Chairman Burton's Committee on Government Reform, was released in May 2003, and provided a scathing indictment of the Federal Health bureaucracy and their inexplicable complacency regarding mercury and vaccines. Despite the entire report being publicly available in the Congressional Record, it has gotten little publicity.
While the Mercury In Medicine report was certainly not welcome by CDC, they knew that by the Fall of 2003 the pendulum would swing back towards exonerating Thimerosal with the near simultaneous release of four separate studies between September and November in four separate medical journals that would provide the basis for "proof" that vaccines and autism are unrelated as cited by the IOM six months later in their 2004 report. Three of those studies, in Pediatrics, The Journal of the American Medical Association, and The American Journal of Preventative Medicine, would be based on the Danish data, and one study, also in Pediatrics, would be the data finally released by CDC of their analysis of the VSD.
For practicing Doctors, medical journals are their primary source of information from the outside world. For pediatricians, tasked with administering the lengthy U.S. Immunization Schedule, Pediatrics, the Journal of the American Academy of Pediatrics, is their trusted source of information. We believe few pediatricians are remotely aware of the conflicts, limitations, and manipulation that the published studies were subjected to, and that few realize many of the published authors were CDC employees or SSI employees, a Danish vaccine manufacturer. Because Pediatrics is the trusted source of information for Doctors, and because the two Pediatrics studies are most often cited regarding "proof", we will focus our time analyzing these two.
In September 2003, Pediatrics published Thimerosal and the Occurrence of Autism: Negative Ecological Evidence From Danish Population-Based Data. Thimerosal was removed from Danish vaccines in 1992, and the study showed that not only did autism rates not go down after its removal, they actually went up. The study's lead other, Kristeen Madsen, had been one of the Danish researchers Dr. Diane Simpson reached out to early on in her world travel of 2001. This study was highly flawed for the following reasons (read SafeMinds' critique here):
- The data as it was captured was blatantly obscured. The study looked at data between 1970-2000. In 1995, the Danish registry added "Outpatient Clinics" to their count of autism cases. It turns out that Outpatient Clinics are where 93% of Danish children are diagnosed with autism, so the number of autism cases before 1995 did not include the clinics. More surprising, the authors even note this in the study: "since 1995 outpatient activities were registered as well...the proportion of outpatient to inpatient activities was about 4 to 6 times as many outpatients as inpatients...this may exaggerate the incidence rates."
Exaggerate the incidence rates? It is the equivalent of doing a study on "Divorce Rates in North America" and counting Mexico and Canada only for the first few years, then adding in the United States, and noting that divorce rates went up. As a SafeMinds critique of the study noted, "Therefore, their purported increase after 1994 can be explained entirely by the registration of an existing autism population that did not require hospitalization." To compound the problem, Denmark also changed the diagnostic code they used, to the more universal ICD10 code, beginning in 1993, which would have further raised the rates.
Dr. Madsen, in his communications with Dr. Diane Simpson two years earlier, actually noted this discrepancy in Danish data in an email exchange:
Dr. Simpson: "Did they [autism rates] increase after 1993??"
Dr. Madsen: "Yes but not very dramatically and there could be more reasons for that. First of all we had a change from ICD8 to ICD10 in 1994 and furthermore our outpatient clinics were registered in our surveillance from 1995."
- The rates of autism in Denmark and the number of vaccines and amount of mercury received in children are markedly lower than the U.S. Danish children receive 75% less Thimerosal than American children, they receive immunizations when they are older, and the U.S. autism rate is TEN TIMES the rate of Denmark (Denmark is 1 in 1,600, U.S. is 1 in 166). As an example, here is an email exchange back in 2001 discussing data from Great Britain between Dr. Verstraeten, the author of the CDC's internal analysis, and Robert Chen. Dr. Verstraeten notes that the British numbers will probably not be helpful because the Thimerosal received by British children is too low relative to American children: "The maximum exposure is indeed relatively low...it may not be worth doing this after all." Denmark's Thimerosal was as low or lower than Britain, but they proceeded with the study anyway.
- The study authors were conflicted, and the conflicts were not reported in the study, as they should have been. Of the seven co-authors of the study, three had received direct funding from the CDC on vaccine-safety related projects. One of the authors, Poul Thorsen, was a CDC employee. And, two of the authors were employees of Statens Serum Institute, a Danish vaccine manufacturer. Here's SSI's Annual Report. Interestingly, page 28 shows that sales of vaccine products to the U.S. were particularly high in 2002. None of these conflicts are mentioned anywhere in the study.
- CDC actual wrote a letter to Pediatrics recommending publication of the study. This letter, written prior to the official date of submission, reveals how involved in the study CDC was (remember, one of their employees was a co-author). Jose Cordero, Director of the Division of the CDC responsible for developmental disabilities, oversees the CDC's efforts to fight autism. He notes, "its findings provide one strong piece of evidence that thimerosal is not causally linked to autism." Dr. Cordero, too, had seen the Generation Zero data and attended the meeting in Simpsonwood.
Two months later, Dr. Vestraeten's data, which began with a panic in late 1999 ('It just won't go away"), was published in Pediatrics titled Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organizations. Perhaps most frustrating about this study is that it is often referenced as "proof" that vaccines do not cause autism when it was actually a neutral-outcome study, as Dr. Verstraeten himself noted, in a letter to Pediatrics:
"Surprisingly, however, the study is being interpreted now as negative [where 'negative' implies no association was shown between Thimerosal and autism] by many...The article does not state that we found evidence against an association, as a negative study would. It does state, on the contrary, that additional study is recommended, which is the conclusion to which a neutral study must come...A neutral study carries a very distinct message: the investigators could neither confirm nor exclude an association, and therefore more study is required."
This study was highly flawed for the following reasons (read SafeMinds' critique here):
- The data was manipulated to remove the strong correlation between mercury and autism. As Chapter II discussed, the initial analysis using Vaccine Safety Datalink data (VSD) showed a high correlation between Thimerosal and autism, called "Generation Zero." The CDC used many techniques to dumb-down the numbers including removing comparisons to children who had received no Thimerosal, lowering the age of children available for the analysis, and including a bankrupt HMO, with notoriously faulty data systems, in their final round of analysis. This HMO helped neutralize the findings reviewed at Simpsonwood. As SafeMinds reported:
"The general drift of their design changes was clear, to reduce the statistical power through conscious manipulation of statistical methods, data classifications, and samples."
- Dr. Verstraeten, the study's author, had been an employee of Glaxo SmithKline for more than 2 years by the time the study was published. This blatant conflict, with a study author employed by a company being sued by parents for Thimerosal in vaccines, was never noted in the Pediatrics study.
- Even with all the manipulation, the study was still a neutral outcome study.Many people would be surprised to know that the study itself cites a correlation between Thimerosal-containing vaccines and both "tics" and "language delay." Beyond that, the study neither proves nor disproves an association between Thimerosal and autism and recommends that more work needs to be done.
What's Egregious About This Time Period?
1.  CDC and SSI employees were the primary study authors of studies that would exonerate their own policies (CDC) and products (SSI).
2.  Conflicts of the study authors were never cited in any of the studies published.
3.  CDC knew about the limitations of the Danish data, but moved towards publication any way, with a senior official actually lobbying Pediatrics for publication.
4.  CDC manipulated evidence of a correlation between Thimerosal and autism from their own VSD data, despite the overwhelming evidence of "Generation Zero" and the data presented at Simpsonwood.
5.  We have never proven, using American data, that Thimerosal didn't cause the autism epidemic, yet "proof" is often cited of exactly that.
Where is the Evidence?
1.  Email from Simpson to Madsen: "It would mean a great deal to us"
June 12-13, 2001
Communication between Dr. Diane Simpson, Deputy Director of the National Immunization Program for CDC, and Kreesten Madsen, a Danish scientist.
This email is important for a number of reasons. Firstly, it is the first communication between CDC and the Danish Dr. Madsen, who would later co-author the Pediatrics study in September 2003 exonerating Thimerosal. It shows that CDC is looking anywhere to try and find data and that the heads of the National Immunizations Program, like Dr. Simpson, are leading the charge.
Dr. Simpson: "Our primary question is: did the rates increase dramatically from the late 1980's into the 1990s as they did here in the United States. A quick answer to that question would mean a great deal to us here!!!"
Secondly, Dr. Madsen highlights an issue that would be manipulated to form the basis for the 2003 Pediatrics study: outpatient clinics, where the majority of Danish children are diagnosed with autism, were not included in the Danish registry until 1995. This administrative change forms the basis for the studies put forth by CDC regarding the "proof" in Denmark that Thimerosal does not cause autism.
Dr. Madsen: "To the best of my knowledge - no, the rates did not increase dramatically in the late 1980's..."
Dr. Simpson: "Did they increase after 1993??"
Dr. Madsen: "Yes, but not very dramatically and there could be more reasons for that...and furthermore our outpatient clinics were registered in our surveillance from 1995."
Source: FOIA filing by parents.
2.  Email from Verstraeten to Chen: "Not worth doing"
June 26, 2001
Communication between Dr. Thomas Verstraeten, head of internal analysis of CDC Vaccine Safety Data and Dr. Robert Chen, Director of Vaccine Safety, CDC.
This email is important for two reasons:
It shows that CDC rejected British data because the amount of Thimerosal British children received through vaccines was too low relative to American children to generate a fair comparison. Yet, the same issue existed in Denmark, and the studies were done anyway, as CDC was more "frantic" to find data to exonerate Thimerosal.
It shows that CDC was using grant money to influence where studies were done. After expressing disappointment over the British numbers, Dr. Verstraeten notes that maybe the money can be given to "Harald in Sweden." CDC controlled the funds for the research that was done.
As Dr. Verstraeten writes:
"The maximum exposure [in Britain] is indeed relatively low...my estimate is that you need at least >50 [mcg of mercury] by 3 months or >100 by 6 months to see an effect if there is one which you barely make...I hate to say this, but given these concerns, it may not be worth doing this after all. On the other hand, maybe the grant can be given to Harald in Sweden..."
Source: FOIA filing by parents.
3.  Letter From Cordero to Pediatrics
December 10, 2002
Dr. Cordero, Director of the CDC's National Center on Birth Defects and Developmental Disabilities, to Pediatrics in support of publication of the Danish study exonerating Thimerosal.
Dr. Cordero, who had been privy to the Generation Zero data and was present at the Simpsonwood meeting, encouraged Pediatrics to publish the Danish study, despite its fatal flaws, and noted "its findings provide one strong piece of evidence that thimerosal is not causally linked to autism."
Source: FOIA filing by parents.
4.  Criticisms of Danish Studies
2002-2003
Soon after their publication, many helpful criticisms of the Danish studies were released, including:
SafeMinds analysis of the network of Danish researchers and the CDC available here
SafeMinds analysis of the Pediatrics study available here
SafeMinds analysis of the Journal of American Medical Association study available here
5.  Criticisms of CDC's Study in Pediatrics
2002-2003
Soon after their publication, many helpful criticisms of the CDC's Study in Pediatrics were released including:
SafeMinds detailed analysis of the manipulation of data by the CDC available here
SafeMinds analysis of "Generation Zero" VSD data available here
Dr. Mark Geier's letter to Pediatrics available here
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