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August 20, 2018

A Historical Overview—Pre-1999 to 2006 Chapter 2

Chapter II: 1999-2000

“the number of dose related relationships [between mercury and autism] are linear and statistically significant. You can play with this all you want. They are linear. They are statistically significant.” – Dr. William Weil, American Academy of Pediatrics. Simpsonwood, GA, June 7, 2000

“the number of dose related relationships [between mercury and autism] are linear and statistically significant. You can play with this all you want. They are linear. They are statistically significant.” – Dr. William Weil, American Academy of Pediatrics. Simpsonwood, GA, June 7, 2000

“Forgive this personal comment, but I got called out at eight o’clock for an emergency call and my daughter-in-law delivered a son by c-section. Our first male in the line of the next generation and I do not want that grandson to get a Thimerosal containing vaccine until we know better what is going on. It will probably take a long time. In the meantime, and I know there are probably implications for this internationally, but in the meanwhile I think I want that grandson to only be given Thimerosal-free vaccines.” – Dr. Robert Johnson, Immunologist, University of Colorado, Simpsonwood, GA, June 7, 2000

“But there is now the point at which the research results have to be handled, and even if this committee decides that there is no association and that information gets out, the work has been done and through the freedom of information that will be taken by others and will be used in other ways beyond the control of this group. And I am very concerned about that as I suspect that it is already too late to do anything regardless of any professional body and what they say…My mandate as I sit here in this group is to make sure at the end of the day that 100,000,000 are immunized with DTP, Hepatitis B and if possible Hib, this year, next year and for many years to come, and that will have to be with thimerosal containing vaccines unless a miracle occurs and an alternative is found quickly and is tried and found to be safe.” – Dr. John Clements, World Health Organization, Simpsonwood, GA, June 7, 2000

Soon after the joint statement by the AAP and Public Health Service was released, all hell broke loose, and the CDC moved into damage control mode, where they remain today, seven years later. (Here’s a great article from the Hepatitis Control Report on the panic.) Parents of autistic children began to compare the symptoms of autism to the symptoms of mercury poisoning, and a feisty Congressman from Indiana with an autistic grandson, Dan Burton, started using his pulpit as head of the Committee on Government Reform to ask very tough questions. By August, two months after the joint statement, his committee was in a full-scale investigation of conflict in vaccine policy, which the CDC knew.

Shockingly, CDC received letters in July and September 1999 from Merck and SmithKline Beecham, respectively, letting CDC know that full production of Thimerosal-free vaccines for Hepatitis B and DTaP could be made available almost immediately. To SmithKline, CDC responded with a tepid letter thanking them for the offer, but not taking them up on it. Thimerosal would remain in the vaccines on the Childhood Immunization Schedule for three more years, into late 2002, before Thimerosal-free vaccines were finally available for all vaccines, as this letter from FDA to Congressman Dave Weldon demonstrates. CDC’s inexplicable complacency in the face of the July 1999 statement to switch over to Thimerosal-free vaccines was highlighted in this March 2006 article by Robert F. Kennedy Jr in the Huffington Post.

As part of the FDA Modernization act that spurred the joint statement, FDA was required to commission the Institute of Medicine to review the impact of mercury in vaccines. The IOM’s study began in late 1999 with an expected publication date in 2001. For the CDC, the walls were starting to close in, particularly for the man responsible for both vaccine development and vaccine safety, Dr. Robert Chen. The knowledge of a looming IOM review spurred CDC to take matter into their own hands.

Soon after the AAP statement a young CDC epidemiologist, Dr. Thomas Verstraeten, was given the task of comparing neurodevelopmental outcomes of children exposed to Thimerosal using the CDC’s internal database, the Vaccine Safety Datalink (VSD). CDC hoped to run their own analysis, establish no relationship between Thimerosal and autism, give the analysis to the IOM, and close this chapter for good. By November of 1999, just 5 months after the joint statement, Dr. Verstraeten was in a near panic as the data he was analyzing was showing a clear, unassailable, ugly truth: there was a statistically significant relationship between the amount of mercury children were receiving through their vaccines and autism. No matter how he tried to run the numbers, he wrote, the association “just won’t go away.”

In June of 2000, six months after Dr. Verstraeten’s analysis revealed a clear correlation, the CDC commissioned a private meeting at the Simpsonwood Conference Center in Atlanta, GA, with representatives from the CDC, other health organization (WHO, FDA) and representatives of vaccine manufacturers to share some startling news: despite six full months of trying to dumb down the data, CDC’s analysis was still showing a statistically significant relationship between neurodevlopmental disorders, especially autism, and Thimerosal children received through their vaccines.

The Simpsonwood meeting set that stage for the way the CDC has conducted themselves ever since: control the damage, bury the data, and ensure that the National Immunization Program never misses a beat. The candor and incriminating statements of the Simpsonwood attendees is at times breathtaking, as some of the above quotes demonstrate, and a whole website could be devoted to analyzing the words of the participants. A great summary of the Simpsonwood meeting is available through this excellent article written by Dr. Russell Blaylock. The transcript from the meeting was stamped with the words “Do Not Copy or Release” and “Confidential”, but was obtained by parents through FOIA.

What’s Egregious About This Time Period?

1. Dr. Verstaeten’s analysis of the CDC’s VSD showed a clear and unassailable relationship between Thimerosal received and neurodevelopmental disorders. Recent emails now show how Dr. Verstraeten began the complex task of managing the relationship down and the advice he received in doing so. By the time his work was actually published in Pediatrics, almost 3 years later, the data had been manipulated to the point of showing no association between Thimerosal and autism. For an explanation of how the CDC removed the association, click here.

2. In the midst of the controversy surrounding Thimerosal, CDC was given the opportunity to switch to Thimerosal-free versions of Hepatitis B and DTaP immediately following the joint statement by two vaccine manufacturers in the Fall of 1999 and chose not to.

3. The Simpsonwood meeting was unprecedented: a secret meeting convened by a public government agency (CDC) that also included vaccine manufacturers. Why were vaccine manufacturers involved in policy decision and reviewing data that could potentially make them liable for billions in damages? No document more clearly demonstrates the inability of public health officials to put our children first than the Simpsonwood transcript.

Where is the Evidence?

1. Simpsonwood Transcript
June 7-8, 2000, Simpsonwood Conference Center, Atlanta, GA

This transcript, at 238 pages, is a challenging read, and Dr. Blaylock’s article is a great place to start. The scope of the transcript is breathtaking, as it shows the wide range of concerns, very few of which have anything to do with the safety of children, that the individuals responsible for US vaccine policy wrestled with as they were confronted with data unassailably linking thimerosal from vaccines and damaged children. Perhaps Dr. Robert Chen of CDC summed it up best towards the end of the meeting, setting the stage for a cover-up now in its seventh year:

 “We have been privileged so far that given the sensitivity of information, we have been able to manage to keep it out of, let’s say, less responsible hands…”

Source: FOIA filing by parents.

2. Verstraeten CDC Internal Email: “It Just Won’t Go Away”
December 17, 1999, Written by Dr. Thomas Verstraeten, CDC, and sent to Dr. Robert Davis and Dr. Frank Destefano, title, CDC.

Dr. Verstraeten was responsible for the preliminary analysis of the CDC’s Vaccine Safety Datalink to determine if a relationship existed between Thimerosal and autism. The “It” in Dr. Verstraeten’s subject line of “It just won’t go away” is the correlation between Thimerosal and autism. Dr. Verstraten also notes that “all the harm is done in the first month.”

Dr. Verstraeten’s email is a working email describing the analysis he is doing with references to spreadsheets that contain specific data. Not until a recent FOIA was that data available which you can now see here. This new information, through the data known as “Generation Zero”, highlights just how extreme the correlations were between Thimerosal and neurodevelopmental disorders.

As one example, on the first page of the spreadsheet, if you look under the “2990” category for autism, it shows a 7.62 incidence for children who receive the largest mercury dose in month 1, called “HgCat1 (3)”, a highly statistically-significant correlation.

Source: FOIA filing by parents

3. Verstraeten CDC Internal Email: “Disprove an Unpleasant Theory”
July 14, 2000, Written by Dr. Thomas Verstraeten, CDC, and sent to Dr. Phillipe Grandjean

This email was written one month after the Simpsonwood secret meeting. Dr. Verstraeten, as the lead CDC epidemiologist analyzing the Generation Zero data showing a high correlation between mercury and autism, was very frustrated by the focus of participants in the Simpsonwood meeting on managing information, liability, and reputations, rather than the science and data at hand. He complains:

“Unfortunately, I have witnessed how many experts, looking at this thimerosal issue, do not seem bothered to compare apples to pears at the best and insist that if nothing is happening in these studies [referring to some old science on other types of mercury exposure] then nothing should be feared of thimerosal.

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.”

Source: SafeMinds

4. Merck and Smithkline letters, 1999: We can be thimerosal-free today
July 7, 1999 and July 31, 1999, Letters sent from vaccine manufacturers to the CDC.

These letters were only recently acquired through parent filings of FOIA. Merck wrote:

“Beginning in early September 1999…the Company believes it could provide sufficient thimerosal-free vaccine.”

SmithKline wrote:

“SB is in a position to to supply…the only DTPa vaccine that does not use Thimerosal as a preservative in enough quantities to supply the estimated U.S. market needs for the remainder of 1999.”

CDC responded to SmithKline:

“[The CDC NIP staff] has communicated this updated information regarding your supply to the 64 immunization projects. CDC also plans to monitor DTaP ordering patterns and continue to provide the States with a choice among currently licensed brands of DTaP vaccines.”

Translation: Although we just said mercury should be removed from vaccines quickly, we are not going to take you up on your offer to do just that. Robert F. Kennedy’s recent article on this letter exchange helps capture the outrage many feel.

Source: FOIA filing by parents.

5. Boyle CDC Internal Email: “What happens if you do this?”
April 25, 2000, Written by Dr. Coleen Boyle, Acting Assistant Director for Science to Dr. Frank Destefano, title, CDC.

Dr. Boyle wrote this email after reviewing the Verstraeten analysis in an internal CDC meeting. By this time, CDC had begun to manipulate the data in order to reduce the correlation between mercury and childhood disorders, although the correlation was still strong enough for the Simpsonwood meeting to take place two months later.

Dr. Boyle’s questions reveal much about the nature of the manipulation. She writes:

“Since most of the dx’s [diagnosis] are generally not picked up until the 2nd or 3rd year of life had you considered eligibility criteria of at least 18 months or 2 years?? What happens if you do this?”

What Dr. Boyle is noting is that the current analysis CDC is doing includes children as young as six months of age in their analysis, who have no chance of being diagnosed with autism yet, which allows the relative incidence level to decline. The average age of autism diagnosis is estimated to be 4. So, a reasonable cutoff for any analysis trying to find autism incidence would be 2 1/2 or 3 (rather than the 18 months Dr. Boyle mentions), not 6 months old. The only reason to include 6 month-olds in the analysis of the incidence of an autism diagnosis is to lower the incidence and exonerate Thimerosal. She continues:

“For me the big issue is the missed cases – and how this relates to exposure. Clearly there is a gross underreporting.”

Dr. Boyle is pointing out the limitations of the CDC’s analysis. The CDC relied on two large West Coast HMOs to get data on the number of patients with an autism diagnosis. CDC maintained the internal data on the vaccines these children received and put the two sets of information together to establish if those receiving more mercury had higher rates of autism. The problem is that HMOs materially underreport the number of cases of autism relative to national averages because many parents go outside of their HMO to get the diagnosis and to seek treatment for their children.

CDC had considerably lower incidence levels to start with based on their data source. They lowered the age they were looking at, before children can receive an autism diagnosis, to lower the incidence even further, and they still had a material correlation strong enough to warrant an emergency meeting in Simpsonwood.

Source: FOIA filing by parents.

6. Letter From FDA to Congressman Dave Weldon, M.D. (R-FL)

June 18, 2003, Letter from the FDA confirming the actual expiration dates of Thimerosal-containing vaccines for children to Congressman Dave Weldon, M.D. (R-FL)

This letter refutes the often-reported fallacy that Thimerosal was removed from children’s vaccines in 1999. In fact, Thimerosal-containing vaccines were in the market with expiration dates as late as September 2002, as this letter explicitly states. (It’s also worth noting that the FDA has no mechanism for tracking vaccines on the shelf, so its plausible that vaccines were in the supply chain well past their expiration dates.)

Today, the timing of the removal of Thimerosal is becoming even more murky, as CDC has recently placed Influenza vaccine on the recommended schedule, the vast majority of which are loaded with mercury, as this UPI article, “Mercury Creeps Back In”, notes.

Merck appears to have contributed to this misunderstanding, with this press release in 1999, which was extremely misleading. As this Los Angeles Times article in 2005 noted:

“Drug maker Merck & Co. continued to supply infant vaccine containing a mercury-based preservative for two years after declaring that it had eliminated the chemical.

In September 1999, amid rising concern about the risks of mercury in childhood vaccines, Merck announced that the Food and Drug Administration had approved a preservative-free version of its hepatitis B vaccine.

“Now, Merck’s infant vaccine line,” the company’s press release said, “is free of all preservatives.”

But Merck continued to distribute vaccine containing the chemical known as thimerosal, along with the new product, until October 2001, according to an FDA letter sent in response to a congressional inquiry.

The thimerosal-containing supplies had expiration dates in 2002.”

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