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The Centers for Disease Control and The National Immunization Program

 

The Centers for Disease Control and The National Immunization Program

 

 Scientific Review of Vaccine Safety Datalink Information
      National Immunization Program - Centers for Disease Control
      Simpsonwood Conference Center in Atlanta, Georgia
.
      
Transcript of June 7-8, 2000 **

 "The number of dose related relationships are linear and statistically significant.  You can play with this all you want.  They are linear.  They are statistically significant. " Bill Weil, M.D., Liaison to the American Academy of Pediatrics **

 

 Thimerosal Vaccine Safety Datalink Study
      Thomas Verstraeten, Robert Davis, Frank DeStefano
      Phase I - February 29, 2000

"I do not wish to be the advocate of the anti-vaccine lobby and sound as if I am 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 and unpleasant theory."  Dr. Thomas Verstraeten, lead author in VSD study, in an e-mail to Dr. Robert Chen, Chief of CDC/Immunization Safety Branch

 

   Advisory Committee on Immunization Practices

The Advisory Committee on Immunization Practices (ACIP) consists of 15 experts in fields associated with immunization, including, but not limited to, vaccine manufacturers and their paid consultants.

The Committee develops written recommendations for the routine administration of vaccines to the pediatric and adult populations, along with schedules regarding the appropriate periodicity, dosage, and contraindications applicable to the vaccines.  ACIP is the only entity in the federal government which makes such recommendations.

The process of how recommendations are developed through working groups, the potential for conflicts of interest and the issuing of waivers for individuals with a financial conflict of interest are explained in testimony by Dixie E. Snider, M.D., M.P.H., the Associate Director for Science at the Centers for Disease Control and Prevention before the Committee on Government Reform U.S. House of Representatives on June 14, 2000:

"To ensure a thorough review of available information, the ACIP often appoints working groups to assist in the development of drafts of recommendations. Working groups generally consist of ACIP members and CDC staff and may include ex-officio members, liaison representatives and other consultants with immunization expertise. Working groups present these drafts for deliberation by the full Committee at regularly scheduled meetings of the ACIP. Only the full committee of the ACIP may issue ACIP recommendations, after a vote approving those recommendations is taken. A vote may be taken when a quorum of at least seven eligible ACIP members are present. Eligible voters are those members who do not have a conflict of interest. If there are not seven eligible voting members present, the Executive Secretary of the Committee can appoint the ex officio members as voting members, as provided in the Charter for this Committee."

"Federal advisory committees inherently have members who may have potential financial conflicts of interest because, as I've mentioned, the members are chosen for service based on their expertise in the areas in which advice is sought by the government. Experts in the vaccine field frequently have affiliations with, or may be engaged in research conducted by, academic institutions or other institutions which may receive funding from vaccine manufacturers. Physicians in private practice who are considered experts often do consultancies, work for managed care organizations involved in clinical trials, and/or accept honoraria for lectures given at scientific meetings sponsored by manufacturers. This professional experience which contributes toward the development of their immunization expertise also may result in potential conflicts of interest. Congress has recognized the need for service on federal advisory committees by these experts and has provided for waivers of the conflict of interest prohibitions under 18 U.S.C. § 208 when the need for the individual's services outweighs the potential for a conflict of interest created by the financial interest involved."

  ACIP - Minutes of Meetings

October 2000 to present

  ACIP - Transcripts of Meetings

June 21, 2000 and June 22, 2000 - In this two day meeting, Dr. Thomas Verstraeten discussed the Thimerosal/VSD study and some of its findings. 

However, the more troubling findings of early datasets were not discussed at this two day meeting.  It is interesting to note the findings he discussed at this public meeting and the closed door meeting held at Simpsonwood are quite different from the findings in his confidential draft of February 29, 2000.  

Dr. Verstraeten's paper of February 29, 2000 showed a 2.48 relative risk increase (a 248 percent increase) of autism in children who had received the mercury laced vaccines (see graph 3 at the top of page 15 of the above report). 

Even more troubling than the first written, yet unpublished, analysis of February 29, 2000 by Dr. Verstraeten and the CDC is the initial analysis which has been dubbed "Generation Zero" and was apparently never compiled into a formal report.  In this analysis, done in November  and December of 1999, CDC researchers found a relative risk of 11.35 for autism for those infants with >25 mcg exposure at one month.  In other words, children exposed to thimerosal levels as low as those found in the flu vaccine of today were over 11 times more likely to acquire a neurodevelopmental disorder.

These results were so disquieting to the CDC they apparently felt the need to revise the data by including younger infants (not yet diagnosed) and pulled in data from a financially faltering Massachusetts HMO that dramatically under reported autism rates (due to a poorly designed database) and used these "new" calculations in the second and third drafts of this report.  Internal e-mails from the Centers for Disease Control in Atlanta, obtained by SafeMinds under FOIA, appear to confirm this suspicion.

All of these numerical permutations dramatically decreased the relationship of Thimerosal to the risk of neurodevelopmental disorders, including autism. Unfortunately for millions of children around the world, the published analysis of the VSD (Vaccine Safety Datalink) data had eliminated the risk, never informing others of their initial findings that were of great significance.  Sadly, this version would be repeatedly cited by other authors in many medical publications and news stories over the next few years, even today.  The various manipulations the dataset went through over the course of 4 years prior to publication is discussed in detail in the science section of this website.

In the November 5, 2003 issue of Pediatrics, Verstraeten, et al published data based upon the manipulated figures from the VSD study as discussed above.

Ironically, even Neal Halsey, M.D., a staunch supporter of the National Vaccine Program, and former Chairman of the CDC Advisory Committee on Immunization Practices (ACIP), raised credibility issues as evidenced in his December 17, 2003 letter to Pediatrics. 

In February 2004, Geier and Geier published a letter to the editor in Pediatrics which detailed the serious errors in the Verstraeten study.

Most telling is the letter from Dr. Verstraeten himself to Pediatrics about the allegation that his study "cleared" thimerosal.

Congressman David Weldon, M.D. (R-FL) has also detailed his concerns about the credibility of the these studies and suspected statistical cover-ups in his letter to Judy Gerberding, M.D., Director of the Centers for Disease Control, in his letter to her dated October 31, 2003.  Congressman Weldon stated:

“I am very concerned about activities that have taken place in the National Immunization Program (NIP) in the development of this study, and I believe the issues raised need your personal attention.”

“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.”

To date, there has been no corrective action taken at the CDC by Dr. Gerberding, in fact, the pattern of behavior continues to be reflected the their ongoing studies and published papers.

 

 Nomination to the National Toxicology Program

The National Toxicology Program (NTP) was established in 1978 by the Department of Health and Human Services (DHHS) to coordinate toxicological testing programs within the Department, strengthen the science base in toxicology; develop and validate improved testing methods; and provide information about potentially toxic chemicals to health regulatory and research agencies, the scientific and medical communities, and the public.

The NTP is an interagency program consisting of relevant toxicology activities of the National Institutes of Health's National Institute of Environmental Health Sciences (NIH/NIEHS), the Centers for Disease Control and Prevention's National Institute for Occupational Safety and Health (CDC/ NIOSH), and the Food and Drug Administration's National Center for Toxicological Research (FDA/NCTR)NTP's mission is to evaluate agents of public health concern by developing and applying tools of modern toxicology and molecular biology.

 

Do you STILL think it should be in vaccines?

 

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