Dr. Edward Yazbak, a pediatrician, referred to CDC’s epidemiological studies “just a distraction. They hope to bury evidence of the dangers of vaccines. At the same time, they have waged a misinformation campaign in making claims that skyrocketing Autism/ASD rates are due to better diagnostics.”
An email exchange (2001) between Dr. Verstraeten, Dr. Chen and Dr. Elizabeth Miller (a consultant epidemiologist to the WHO, previously headed the UK Immunisation Department for 15 years) discussed the national differences in infants’ exposure to thimerosal. They all acknowledged that the U.S. vaccination schedule exposes American infants to much higher doses of thimerosal than babies in Europe, including the U.K. They further acknowledged that Danish babies’ exposure to thimerosal does not come close to the exposure of U.S. babies – Danish babies received 75% less thimerosal than U. S. babies. That difference in exposure to mercury-laced vaccines renders the Danish studies non-comparable to U.S. children, and, therefore of no value toward ascertaining the risk posed by thimerosal-laced vaccines.
CDC officials disregarded the incompatibility of Danish vs. U.S. infants’ exposure to 75% higher doses of thimerosal; despite the incongruity, they chose Denmark as a population study comparator.
CDC officials selected a Danish network of scientists who were either employed by the Danish vaccine manufacturer, Statens Serum Institut (SSI), or worked at institutions closely connected to SSI, such as the Danish Epidemiology Science Center, and Aarhus University. The details of how the studies’ results were premeditated are revealed in internal CDC email correspondence .
The Danish studies were crafted to deliver “proof of innocence” to offset Dr. Verstraeten’s evidence documenting a disturbing Thimerosal-autism risk; and they were crafted to refute Dr. Wakefield’s suggestion of an autism-MMR connection.
CDC disregarded the scientific reservations about comparing “apples to pears”
Dr. Verstraeten expressed concern about scientific dishonesty in an email (dated July 14, 2000) addressed to Harvard professor, Dr. Philippe Grandjean, an expert in heavy metals toxicity, (copies addressed to Chen, DeStefano, and four other CDC scientists) he stated:
“many experts looking at this thimerosal issue, do not seem bothered to compare apples to pears… I do not wish to be the advocate of the anti-vaccine lobby and sound like being convinced that thimerosal is or was harmful, but at least I feel we should use sound scientific argumentation and not let our standards be dictated by our desire to disprove an unpleasant theory.”
CDC officials sought to obtain reports that would provide the appearance of scientific evidence that thimerosal, the mercury-based vaccine additive is safe, the MMR is safe, and that vaccines do not cause autism.
Dr. Diane Simpson, the CDC official tasked with obtaining proof to offset Dr. Verstraeten’s demonstrated thimerosal-autism risk, traveled to Denmark in 2001 where she met with a network of Danish scientists. CDC provided tens of millions of dollars in grants to a Danish team at the University of Aarhus in Denmark; the management of the grants was entrusted to psychiatrist Poul Thorsen, who had been a CDC “visiting scientist” in 1990.
At Thorsen’s recommendation, Simpson recruited Kreesten Madsen, a doctoral candidate, who was listed as the lead author on several pivotal Danish studies. However, the principal scientist who co-authored those studies was, in fact Thorsen.
Beyond the continued influence of fraudulent CDC and CDC-sponsored Danish epidemiological studies, Thorsen was a participant in a pivotal Working Group of the American Psychiatric Association (APA), which led to the controversial re-defining of the criteria for an autism diagnosis in the DSM-5, psychiatry’s diagnostic “bible”; the new DSM-5 criteria reduced the autism prevalence rate substantially.
In another email addressed to Dr. Chen (2001), Dr. Verstraeten expressed serious doubts about the reliability of the UK General Practice Research Database (GPRD) which numerous authors have continued to rely on, to support the claim that there is “no evidence of a causal association between thimerosal and autism”.
“I think two issues are important in assessing the potential strength of the GPRD study:.1. Maximum exposure and 2. Unbiased controls.
I’m not sure if the GPRD is that reliable that you can be sure that low exposure is really low exposure and not underascertainment in the database. I hate to say this, but given these concerns, it may not be worth doing this after all. On the other hand, maybe the [WHO] grant can be given to Herald in Sweden to do a follow-up of the DTaP trial.” (June 26, 2001)
Dr. Verstraeten’s criticism of the GPRD alarmed Dr. Miller who expressed her concern (in an email to Chen): “Do I have to give my GPRD grant money from WHO back”?
The CDC VSD study (1999) led by Dr. Verstraeten, underwent a series protocol manipulations and statistical tricks aimed at eliminating the 7.6 relative increased risk of autism from exposure to thimerosal.
During a four year “evolution”, the study’s original conclusion – an increased risk factor of 7.6 – a risk that Dr. Verstraetn had indicated in 1999 – “it just won’t go away” – was systematically reduced at each phase in a series of 5 protocol modifications – even after his departure from CDC for GSK in June 2001. In phase 2, infants’ exposure to Thimerosal was compared at 3 months rather than 1 month – when infants are their most vulnerable; the original 400,000 records from the 4 HMOs, were reduced to 124,170 records from 2 HMOs, with the addition of records from the Harvard Pilgrim HMO – which used different diagnostic codes than the other two – (and whose records’ accuracy was in doubt.)
These changes reduced the relative risk to 2.48. In phase 3, the age criteria of the children included, was changed from (0 to 6 years) to (0 to 3). A cut off at age 3 eliminated a significant number of children who were subsequently diagnosed, but not counted in the study. This was acknowledged by Dr. Coleen Boyle in an internal email to Dr. Frank DeStefano (April, 2000):
“For me the big issue is the missed cases — and how this relates to exposure. Clearly there is gross underreporting… Considering that the average age of diagnosis of autism in the VSD database was 44 to 49 months it is easy to see that almost half of the children in the database were too young to be diagnosed.”
This dubious cut-off resulted in reducing the relative risk 1.69. A manuscript was submitted for publication but was rejected by the journal Epidemiology. Two more “modifications” wiped the risk out of existence. The study was then submitted for publication to Pediatrics (2003). The study’s illegitimate, manipulated findings exonerating Thimerosal were widely publicized.
In October 2003, Congressman Dave Weldon, MD raised serious concerns in a letter to CDC Director, Julie Gerberding, citing specific issues undermining the scientific integrity of the CDC Pediatric study, and CDC’s undue influence on the IOM report:
“I found a disturbing pattern which merits a thorough, open, timely, and independent review by researchers outside of the CDC, HHS, the vaccine industry, and others with a conflict of interest in vaccine related issues (including many in University settings who may have conflicts)… A review of these documents leaves me very concerned that rather than seeking to understand whether or not some children were exposed to harmful levels of mercury in childhood vaccines in the 1990s there may have been a selective use of the data to make the associations in the earliest study disappear.
Furthermore, the lead author of the article, Dr. Thomas Verstraeten worked for the CDC until he left over two years ago to work in Belgium for GlaxoSmithKline (GSK) a vaccine manufacturer facing liability over TCVs [thimerosal containing vaccines]. In violation of their own standards of conduct, Pediatrics failed to disclose that [serious conflict of interest].
“In reviewing the study there are data points where children with higher exposures to the neuortoxin mercury had fewer developmental disorders. This demonstrates to me how excessive manipulation of data can lead to absurd results.” [Highlight added]
Internal email correspondence reveal a culture at CDC that is intent on shielding vaccines and the childhood vaccination schedule at any cost. That culture was the subject of a follow up letter by Congressman Weldon to CDC Director, Dr. Julie Gerberding (January 2004):
“For too long, those who run our national vaccination program have viewed those who have adverse reactions, including those with severe adverse reactions, as the cost of doing business… It appears to me not only as a Member of Congress but also as a physician that some officials within the CDC’s NIP may be more interested in a public relations campaign than getting to the truth about thimerosal.”
Public distrust in government vaccine safety pronouncements is validated in documented evidence showing that CDC-sponsored published reports are the product of scientific fraud, in violation of legally mandated, ethical requirements, and malfeasance by high level CDC officials.
In 2011, Poul Thorsen was indicted by a federal grand jury on 22 criminal counts of forgery, money laundering, embezzlement, among others, whereupon he fled the country to Denmark and remains a fugitive from justice. In 2012, Thorsen was added to the Office of Inspector General’s “Most Wanted” list of criminals.
At the very least, Thorsen’s documented criminal actions clearly call into question the validity of those CDC-sponsored Danish epidemiological reports whose inordinate influence continues to permeate the vaccine literature and vaccination policies. Yet, the academic community, and the medical journals – with the exception of Nature Online – have maintained a deafening silence – even as the evidence of fraud and criminality by the principal scientist of the Danish studies was laid bare.
What was also laid bare in internal correspondence is that CDC officials colluded with Thorsen’s Danish team in deception and fraud in the preparation of autism research studies for publication.
In January 2011, BMJ Editor-in-chief, Dr. Fiona Godlee, reignited and intensified the campaign against Andrew Wakefield, by launching an unprecedented assault that declared his research to be “fraudulent”, and Dr. Wakefield guilty of “elaborate fraud.”
Was the timing of BMJ assault a coincidence?
The BMJ assault was launched at the very moment that conclusive evidence of far-reaching, elaborate scientific fraud was uncovered in CDC internal documents. These documents also provided the US Inspector General with evidence of elaborate criminal actions committed by Poul Thorsen, MD, PhD (dubbed “Master Manipulator” in a book by James Grundvig, 2016). Thorsen was the principal investigator of the pivotal CDC-commissioned Danish studies that declared that neither thimerosal nor the MMR posed a risk of autism. CDC relies on those studies to dismiss evidence of serious risks posed by the MMR and thimerosal for young children.
Whereas Poul Thorsen’s extensive fraud and malfeasance was substantiated by evidence; Dr. Godlee’s charge of fraud against Andrew Wakefield was made without a shred of evidence.
Internal correspondence document that the CDC commissioned Danish studies were designed and manipulated to provide the pre-determined exoneration of Thimerosal as a causative trigger for autism. The authors delivered the “evidence” that CDC sought (and paid millions to obtain) in its effort to quell public suspicions that an autism epidemic has been triggered by (a) vaccines laced with mercury (thimerosal) and/or (b) the combined measles/mump/ rubella (MMR) vaccine.
The six Danish studies are:
- Madsen KM, Hviid A, Vestergaard M, Schendel D, Wohlfahrt J, Thorsen P, Olsen J, Melbye M, New England Journal of Medicine, 2002;
- Hviid A, Stellfeld M, Wohlfahrt J, JAMA 2003;
- Madsen KM, Lauritsen, MB, Pedersen CB, Thorsen P, Plesner AM, Andersen PH and Mortensen PB, Pediatrics, 2003;
- Stehr-Green P, Tull P, Stellfeld M, Mortenson PB, Simpson D. American Journal of Preventive Medicine, 2003;
- Larsson HJ, Eaton WW, Madsen KM, Vestergaard M, Olesen AV, Agerbo E, Schendel D, Thorsen P, Mortensen PB. American Journal of Epidemiology, 2005;
- Lauritsen MB, Jørgensen M, Madsen KM, Lemcke S, Toft S, Grove J, Schendel DE, Thorsen P. Journal of Autism and Developmental Disorders 2010
The foundation for CDC’s public assurances that “conclusive” evidence shows that vaccines, with or without mercury are safe, relies on invalid, fraudulent studies.
The authors of the “the definitive Madsen MMR Study” sent a letter to the editor-in-chief of The New England Journal of Medicine (2002) to persuade him to accept their study for publication. They emphasized the political value of their study and claimed their study refuted Wakefield and provided strong support for the MMR vaccine program:
“It has been suggested that the measles-mumps-rubella (MMR) vaccine may cause autism.
If true, this could jeopardize the MMR vaccine program in children.
The debate was initiated by research in Britain [Wakefield] provided suggestive evidence of an association between the MMR vaccine and autism…
In addition, Uhlmann recently published a study where they found measles in the gut in patients with developmental disorders but not I controls. So far, no study has had sufficient power to address the topic.. Our study gave no support for an association between MMR vaccination and autism or autism-like conditions.” [Emphasis added]
Evidently, the editor, Dr. Jeffrey Drazen, was persuaded and the article was published in the NEJM (2002). Dr. S. Suissa, an epidemiologist at McGill University, questioned the statistical analysis in this large population-based epidemiological study. However, his letter to the editor was not published. In 2004, Gary Goldman, PhD and F. Edward Yazbak, MD submitted their detailed scientific critique of the same study; their critique was not published in the NEJM; it was published in the Journal of American Physicians and Surgeons.
The emails document how the Danish studies were manipulated to exonerate the MMR vaccine and thimerosal in vaccines. They misclassified children, masked the association of autism, and deleted portions of the data. This constitutes fraud.
Principal CDC insiders who colluded with Thorsen in deception and fraud include:
Dr. Coleen Boyle, Director of National Center for Birth Defects & Developmental Disabilities [Boyle was the lead investigator of the Congressional investigation of Agent Orange in 1984-1987. She and her team reported, “no association” between the defoliant dioxin and the inventory of cancers and autoimmune diseases that sickened tens of thousands of US troops. Her exoneration of Agent Orange deprived those veterans of getting compensated].
Dr. Marshalyn-Yeargin-Allsopp, Head of Developmental Disabilities Branch; Dr. Joanne Wojcik, Procurement and Grants Office, CDC; Epidemiologist, Dr. Diana Schendel, was the senior CDC scientist directly involved in the Danish project. She was Thorsen’s longtime girlfriend who co-authored more than three dozen studies with Thorsen, including the “definitive” NEJM (2002) study. In 2009, she was officially reprimanded for the conflict that her intimate relationship posed. In 2014, she moved to Denmark, taking a position in the epidemiology department at Aarhus University.
Internal correspondence provides a record showing that the authors knew that the results that they reported in the Pediatrics (2003) were contradicted by the data from the Danish Psychiatric registry. The actual data confirmed that following the removal of thimerosal in 1992, the “incidence and prevalence” rate of autism in Denmark decreased.
The study, “Thimerosal and the Occurrence of Autism”, was published in the journal Pediatrics, (2003). The first named author was Madsen; however the principal investigator was psychiatrist Poul Thorsen and a team of six co-authors at Aarhus University. The study was presented as an analysis of the Danish Psychiatric Registry from 1971 – 2000. The ostensible, stated purpose of the study was to determine whether the removal of Thimerosal from children’s vaccines in Denmark (in 1992) decreased the incidence of autism.
The report they submitted for publication claimed that the prevalence of in autism in Denmark increased after thimerosal was removed from childhood vaccines in 1992. Figure 1 in the published report in Pediatrics shows a 20-fold increase in autism. The authors stated:
“From 1991 until 2000 the incidence (of autism) increased and continued to rise after the removal of thimerosal from vaccines, including increases among children born after the discontinuance of thimerosal …The discontinuation of thimerosal-containing vaccines in Denmark in 1992 was followed by an increase in the incidence of autism. Our ecological data do not support a correlation between thimerosal-containing vaccines and the incidence of autism.”
Despite the implausibility of such a correlation, no one within the medical establishment questioned or critically examined this study or any of the Danish epidemiological studies. The first detailed critique of the Madsen / Thorsen Pediatrics study (2003) was by Mark Blaxill; it was posted on Safe Minds, September 2003. Blaxill, who is a business analyst, not a medical scientist, identified inconsistencies with the previous study (NEJM, 2002) by the same Danish authors who used the same Danish dataset.
Blaxill’s analysis showed that the claimed findings in the Pediatrics report were invalidated by their biased methodology. Blaxill identified the scientifically illegitimate methods the authors used to arrive at their predetermined CDC-commissioned “findings” exonerating vaccines and thimerosal. He did so – even without the benefit of the incriminating internal CDC documentsthat provide evidence of fraud.
- Inconsistent inclusion criteria: Prior to 1993, only inpatient autism cases were reported in the Danish registry; representing only 10% of autism cases. Following the removal of Thimerosal from childhood vaccines in 1992, patients from a large Copenhagen outpatient clinic were added. But the authors excluded these cases from the report. In 1995, a new Danish registry was introduced to include all outpatients. These existing, previously unregistered patients were counted by the investigators as new—thereby artificially increasing the number of reported autism cases significantly.
- Inconsistent diagnostic criteria: In 1994, Denmark changed the diagnostic criteria for autism from “psychosis proto-infantilis” to the more commonly used “childhood autism” to determine a diagnosis. The diagnostic criteria require autism to be identified before a child is three years old. But the authors misrepresented newly registered outpatient cases – many of who were children between the ages of 7 and 9 as “newly diagnosed.”
- Deletion of data: The authors also deleted the entire year 2001 data for seven year old children from the final published report. This constitutes flagrant research fraud. Blaxill also invalidated the Danish mercury vaccine exposure experience as not a proper comparator:
“The context for the early mercury exposures was completely different in Denmark when compared to any other country, and particularly compared to the U.S. and U.K., where autism rates are being watched most closely. The Danish report describes a different world of vaccine exposures and ignores exposures that are present today that were not present in Denmark in the 1970s. Autism onset has been reliably associated with exposure to viruses.
In the cases where increasing thimerosal exposures have accompanied autism increases, numerous additional confounders were present that were not present in Denmark. Between 1970-92, the only childhood vaccine given in Denmark until 5 months of age was the monovalent pertussis vaccine. In the United States in the 1990s, children were exposed to multiple doses of diphtheria, pertussis, tetanus, polio, hepatitis B and haemophilus influenza B (Hib) vaccines before five months of age.
In the United Kingdom, injections before age 5 months included multiple doses of meningitis C, polio, diphtheria, tetanus, Hib, and pertussis vaccines. Increasing autism rates there were accompanied by earlier thimerosal exposures due to schedule changes, new exposures to MMR and Hib vaccines, and stringent on-time compliance procedures. Denmark did not administer thimerosal-containing Rho D immunoglobulin during pregnancy.”
This is the pivotal study that CDC has relied on as “scientific evidence” of the innocence of thimerosal. The only in-depth critical analyses of the Madsen/ Thorsen Danish studies has been by vaccine safety advocacy groups, independent scientists, and alternative news sources. But these valid critiques analyzing the methodology of the Danish studies did not make it into “high impact” journals where the Danish studies were published. The independent analyses were ignored by the medical establishment and by the media as well.
By burying the criticism, this study not only “enjoyed a prolonged period of acceptance: It influenced the outcome of the IOM Immunization Safety Review Committee of February 9, 2004 and helped sabotage the MMR litigation in the United Kingdom.”
In 2014, a review by a group of independent scientists examined the six studies that CDC continues to cite as evidence in support of its claim, that there is “no relationship between thimerosal-containing vaccines and autism rates in children”, was published in Biomed Research International. Dr. Brian Hooker and colleagues identified more than 165 published studies that refute CDC’s claim that thimerosal is safe.
Of these 165 studies, 16 studies specifically examined the effects of Thimerosal on infants / children. Among the adverse effects, the studies documented following exposure to Thimerosal, include: one death, 4 allergic reactions, 5 malformations, 6 autoimmune reactions, 8 developmental delay, 9 neurodevelopmental disorders, including tics, speech delay, language delay, ADHD, and autism.
CDC’s childhood vaccination policy rests on the denial of the existence of evidence documenting safety hazards posed by the vaccines in the CDC Vaccination Schedule. CDC uses its influence with the gatekeepers of “high impact” medical journals, who reject scientific studies that contradict the sacrosanct vaccine safety mantra. Although a body of scientific studies documenting serious vaccine-related ill effects, has accumulated in the scientific literature, CDC and those “high impact” journal editors invoke their authority to declare: “there is no evidence of a risk from thimerosal or MMR”.
WMP NOTE: This concludes Part Five. Part Six of the seven-part series will be entitled: A Foolish Faith in Authority.
Previously published articles: Sharav’s Introduction to the full article, L’affaire Wakefield: Shades of Dreyfus & BMJ’s Descent into Tabloid Science, outlines her well-researched and documented belief that, “Public health officials and the medical profession have abrogated their professional, public, and human responsibility, by failing to honestly examine the iatrogenic harm caused by expansive, indiscriminate, and increasingly aggressive vaccination policies.” Part One focuses on how the Centers for Disease Control and Prevention (CDC) and the vaccine industry control vaccine safety assessments, control the science of vaccines and control the scientific and mass channels of information about vaccines. In Part Two Ms. Sharav interprets the complex web of internal CDC documents, revealing how key CDC studies and CDC-commissioned studies were shaped by use of illegitimate methods. Part Three takes a closer look at the Brighton Collaboration and the extraordinary influence these stakeholders have in the business of vaccines and their power to control the science and research and manipulate reports to further their own interests. Focusing on the HPV vaccine, in Part FourMs. Sharav explores how a global network of government/academic and industry stakeholders can suppress information about genuine scientific findings and, when needed, engage in corrupt practices to thwart the airing of information about vaccine safety issues.
More about the author: Vera Sharav is a Holocaust survivor and a fierce critic of the medical establishment. This article was originally published at www.ahrp.org. Stat news recently published an article about her and her work.