Federal Activity
Centers for Disease Control (CDC) - Historic Overview
Thimerosal Exposure via Vaccines & Current Activity
to Close Vaccine Safety Research Gaps

This information is from: http://www.safeminds.org/government-affairs/federal-activity-cdc.html

Ten years ago the Public Health Service (PHS) and the American Academy of Pediatrics (AAP) first announced that thimerosal should be removed from vaccines and took an  appropriate position of caution.  Their statement in part to practitioners is below:

“…because any potential risk is of concern, the Public Health Service (PHS), the American Academy of Pediatrics (AAP), and vaccine manufacturers agree that thimerosal-containing vaccines should be removed as soon as possible.”

From then to now, government agencies tasked with protecting the public  have failed to take aggressive action to get the mercury out and protect our nation’s children and have instead focused their energies on avoiding or hiding the truth that is before them, and in doing so undercut the public’s trust while continuing to put babies at risk for mercury injury.

Through the federal Freedom of Information Act (FOIA), and other similar requests, SafeMinds has gained access to documents relevant to the issue of mercury in medicine. Congress mandated the FDA and other health agencies under its purview to establish levels of heavy metals in pharmaceutical agents in the 1997 FDA Modernization Act. The Food and Drug Administration (FDA) and Centers for Disease Control (CDC) were then obliged to study the issue of thimerosal (mercury containing preservative in vaccines) toxicity. Their troubling findings were discussed at a meeting in June 2000 at the Simpsonwood Resort in Norcross, Georgia.  Comments as reported by the Detroit news have been distilled into a short form here along with other pertinent highlights of this landmark meeting.

During this time period, the CDC continued to do their epidemiological studies on Thimerosal toxicity from vaccines in children. Their first analysis (and from all indications the most accurate of their efforts) obtained by SafeMinds under the Freedom of Information Act must have been, as documented in the Simpsonwood transcript, terribly disturbing to them. It showed a 2.48% increased risk of neurodevelopmental disorders in children who had received the mercury laced vaccines (see graph 3 at the top of page 15 of the above report).

Following their initial review, the CDC revised the data by including younger infants (not yet diagnosed) and pulled in data that knowingly and 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 the Freedom of Information Act (FOIA), appear to confirm this suspicion.

The addition of this knowingly flawed data allowed for a revised, and inaccurately lower, rate of neurodevelopmental disorders/injury secondary to Thimerosal/vaccine exposure. The original unreleased and unpublished version of the VSD Thimerosal Analysis found that exposure to mercury via vaccines created the risk of neurological and renal impairment (Verstraeten et al).

Documents obtained through FOIA led to the landmark 2003 Congressional Report Mercury in Medicine, Taking Unnecessary Risks.  Findings and recommendations in this report, with respect to the Centers for Disease Control, were in part:

·         The CDC failed in their duty to be vigilant as new vaccines containing thimerosal were approved and added to the immunization schedule. When the Hepatitis B and Haemophilus Influenzae Type b vaccines were added to the recommended schedule of childhood immunizations, the cumulative amount of ethylmercury to which children were exposed nearly tripled.

·         The CDC’s failure to state a preference for thimerosal-free vaccines in 2000 and again in 2001 was an abdication of their responsibility. As a result, many children received vaccines containing thimerosal when thimerosal-free alternatives were available.

·         The CDC in general and the National Immunization Program in particular are conflicted in their duties to monitor the safety of vaccines, while also charged with the responsibility of purchasing vaccines for resale as well as promoting increased immunization rates. Greater collaboration and cooperation between federal agencies responsible for safeguarding public health in regard to heavy metals is needed.

·         To date, studies conducted or funded by the CDC that purportedly dispute any correlation between autism and vaccine injury have been of poor design, under-powered, and fatally flawed. The CDC s rush to support and promote such research is reflective of a philosophical conflict in looking fairly at emerging theories and clinical data related to adverse reactions from vaccinations. 

Access by independent researchers to the Vaccine Safety Datalink (VSD) database is needed for independent replication and validation of CDC studies regarding exposure of infants to mercury-containing vaccines and autism. The current process to allow access remains inadequate.  A more integrated approach to mercury research is needed. There are different routes that mercury takes into the body, and there are different rates of absorption. Mercury bioaccumulates; the Agency for Toxic Substances and Disease Registry (ATSDR) clearly states: This substance may harm you. Studies should be conducted that pool the results of independent research that has been done thus far, and a comprehensive approach should be developed to rid humans, animals, and the environment of this dangerous toxin. 

·         Congress should enact legislation that prohibits federal funds from being used to provide products or pharmaceuticals that contain mercury, methylmercury, or ethylmercury unless no reasonable alternative is available.

Subsequent to the Mercury in Medicine report, the Institute of Medicine (IOM) issued the controversial 2004 Immunization Safety Review: Vaccines and Autism.  This report based its conclusions almost entirely on five epidemiologic studies, which would miss the association with autism in a genetically acceptable subset of children.  This study is often used by the CDC in their response to the vaccine concerns as the basis for thimerosal’s safety and continued use in vaccines such as the flu shot.

In 2001 the Institute of Medicine concluded "exposure to thimerosal-containing vaccines could be associated with neurodevelopmental disorders.''  and  recommended that children not be given mercury-containing vaccines.   The IOM 2001 also recommended that several biological and clinical studies be conducted to determine whether thimerosal could cause neurodevelopmental disorders such as autism.  However, the 2004 IOM report narrowed its focus solely to autism and was largely comprised of epidemiological studies from Denmark of poor design with lead investigators having conflicts of interests with vaccine manufacturers with some studies receiving funding from vaccine manufacturers.  The Verstraeten study was the only U.S. study to be included in the IOM’s 2004 report, of which the lead investigated stated in April 2004 to Pediatrics  “The bottom line is and has always been the same: an association between thimerosal and neurological outcomes could neither be confirmed nor refuted, and therefore, more study is required.”   Former Congressman and doctor, Dave Weldon (FL) went on the record regarding the flaws of the IOM’s 2004 report. 

Today the vaccine safety debate continues with safety concerns escalating and confidence in immunization declining.  The vaccine concerns that many in the autism community, as well as scientific community, have voiced are not anti-vaccine in nature and are instead, focused on closing vaccine-safety research gaps that public health policy has not addressed. Leaving research gaps unaddressed has resulted in the continued erosion of public confidence in the national vaccination program and inconsistent vaccine court rulings both for and against vaccine induced autism. The question of a link, however, has been answered by the court in that awards for vaccine induced autism have been made. Gaps in science must be closed to allow the Vaccine Injury Compensation Program to have the fullest scientific understanding of vaccines and any associated adverse events leading to injury available during award deliberations and to provide more consistent rulings in future.

During the last two Institute of Medicine (IOM) meetings on various goals contained in the "Review of Priorities in the National Vaccine Plan," Dr. Louis Z. Cooper, professor emeritus of pediatrics at the College of Physicians and Surgeons of Columbia University and former president of the American Academy of Pediatrics (AAP), has repeatedly criticized some of CDC’s vaccine-related spending priorities of $300 billion on vaccine promotion, while spending only $20 million on vaccine safety research.   Specifically, he’s noted that to date, vaccine safety research has been “done on the cheap”.  Consequently, scientists testifying before the IOM and comments from the public indicated that a great deal is unknown regarding the effect of vaccination on total health outcomes beyond the decline in rates for a handful of infectious diseases.

With the new Administration, it is possible that the Federal agencies are finally getting serious about addressing vaccine safety problems.  The NVAC Vaccine Safety Working Group is seeking public comment on their draft report on the draft ISO Scientific Agenda. An opportunity to submit written comments is now available. You can view the Federal Register notice requesting comments from the public. In addition to general comments, NVPO is seeking input on any additional gaps not addressed in the ISO Scientific Agenda nor the NVAC Vaccine Safety Working Group draft report, and/or prioritization criteria and its application to the ISO Scientific Agenda. The deadline to receive comments is 5 p.m. on May 13, 2009. Public comments will be given in their entirety to and summarized for the NVAC Vaccine Safety Working Group. All comments will be made public. Please do not include any sensitive information you do not want made public.

SafeMinds Directors Sallie Bernard and Vicky Debold participated in the NVAC Writing Group meeting held in February.  The Writing Group consisted of individuals and members of groups with a primary interest in vaccine-related issues, state and local public health and immunization officials, pediatricians, and federal officials. The Writing Group has published a draft joint statement and draft documents on Gaps in the Research Agenda and Criteria for Assessing ISO Research, which address questions around immunization of special populations, specific diseases which might be caused by vaccination, and the health effect of vaccination practices.

Encouragingly, the Writing Group acknowledged the public’s strong desire to study total health outcomes as they relate to the full vaccination schedule. Their consensus recommendation asked that an independent expert panel be convened to review strengths and weaknesses, ethical issues and feasibility of study designs with consideration to be given to research on vaccinated vs. unvaccinated populations. The inclusion of autism as a desired outcome was also recommended along with the need for transparency and broad public and stakeholder involvement in the review process.

Despite the progress made by the Salt Lake City Writing Group, much more is needed to understand potential adverse effects from vaccines. SafeMinds will be attending the March 16 meeting and submit a comprehensive analysis of needed vaccine safety reforms for the upcoming NVPO stakeholder meetings that will focus on the following points:

·         The proposed prioritization scheme for the CDC’s ISO vaccine safety research is sound, however, CDC’s vested interests in vaccine promotion precludes their ability to conduct unbiased vaccine safety research. Vaccine safety research must be overseen by an independent agency, conducted by unbiased researchers and assure parent stakeholder involvement in all aspects of research.

·         The CDC’s ISO lacks the budget and infrastructure to conduct adequate safety research and relies on the flawed and deficient VAERS and VSD databases to detect adverse effects. The funding of safety research must increased and based on sound datasets capturing all potential adverse events.

·         In the interest of transparency, the unrestricted use of CDC’s VAERS and VSD datasets should be made available to outside, independent scientists immediately in a manner that preserves patient privacy.

·         The CDC’s ISO studies vaccine safety only after it has been licensed, relegating safety as secondary to vaccine promotion. Vaccine safety policy should ensure that comprehensive research is transparent to the public and conducted to examine the effects of the total vaccination schedule, not just individual vaccines, before licensure.

·         In fulfilling its Congressional charter to make vaccines as safe as possible, NVPO must ensure that a comprehensive program of vaccine safety research is initiated through the establishment of the expert panel, as recommended by the Writing Group. This panel would be charged with identifying science on health outcomes in vaccinated versus unvaccinated populations. Additionally, this science requires more than one study of on the effects of a single vaccine; it requires an array of cell, animal and human studies with multiple endpoints, from immunological alterations to metabolic dysregulation to brain changes, especially in sensitive subpopulations.

·         The treatment of our children as guinea pigs in the ever expanding and untested vaccine schedule is unethical. Billions of dollars are spent to license, promote and pay for vaccinations, while the CDC shamefully spends only about $20 million annually for safety research. At a minimum, vaccine safety should have the same priority as vaccine development and promotion. The US government needs a “Safety First” agenda for vaccines.

·         Scientists, like Dr. Wakefield, have been endless persecuted for conducting safety research whose findings are viewed as unfavorable by those with vested interests in vaccine uptake. The US government must support scientists currently engaged in much needed safety research; they must not be persecuted for conducting research that closes acknowledged vaccine safety research gaps.

Simpsonwood & Related Documents
This information is from:

http://safeminds.org/government-affairs/foia/simpsonwood.html

Congress mandated the FDA and other health agencies under its purview to establish levels of heavy metals in pharmaceutical agents in the 1997 FDA Modernization Act. The FDA and CDC were then obliged to study the issue of Thimerosal toxicity. Their troubling findings were discussed at a meeting in June 2000 at the Simpsonwood Resort in Norcross, Georgia. The transcript of this meeting, obtained by SafeMinds under the Freedom of Information Act (FOIA) is available here.

Comments as reported by the Detroit news have been distilled into a short form here along with other pertinent highlights of this landmark meeting.

During this time period, the CDC continued to do their epidemiological studies on Thimerosal toxicity from vaccines in children. Their first analysis (and from all indications the most accurate of their efforts) obtained by SafeMinds under the Freedom of Information Act must have been, as documented in the Simpsonwood transcript, terribly disturbing to them. It showed a 2.48% increased risk of neurodevelopmental disorders in children who had received the mercury laced vaccines (see graph 3 at the top of page 15 of the above report).

Following their initial review, the CDC revised the data by including younger infants (not yet diagnosed) and pulled in data that knowingly and 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 the Freedom of Information Act (FOIA), appear to confirm this suspicion.

The addition of this knowingly flawed data allowed for a revised, and inaccurately lower, rate of neurodevelopmental disorders/injury secondary to Thimerosal/vaccine exposure.