2000 Simpsonwood CDC conference
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The 2000 Simpsonwood CDC conference was a meeting convened in June, 2000, by the Centers for Disease Control, held at the isolated Simpsonwood Methodist retreat and conference center in Norcross, Georgia. Events at the session were highlighted by a presentation regarding vaccine research conducted by Dr. Thomas Verstraeten, and a comment on biologic plausibility and consistency from Dr. Loren Koller. Approximately half a dozen different industry and government groups were represented, whose representatives included eleven consultants from the CDC, a rapporteur (Dr. Paul Stehr-Green), and an epidemiologist, Dr. Phil Rhodes, who was to provide a half hour summary review of the proceedings at the end of the second day.
Discussion of Dr. Verstraeten's vaccine research
The Simpsonwood conference was chaired by Dr. Dick Johnston, who mentioned early in the proceedings that, "There is very limited pharmacokinetic data concerning ethylmercury. There is very limited data on its blood levels. There is no data on its excretion. It is recognized to both cross placenta and the blood-brain barrier." The conference attendees were then apprised over the next two days about the state of research in these areas.
In 1997, the Congress of the United States passed a resolution requiring the Food and Drug Administration (FDA) to review mercury in drugs and biologics. The Simpsonwood conference served the purpose of reviewing findings that resulted from that mandate. Fifty-two representatives from the pharmaceutical industry, the CDC and the FDA gathered at the retreat for two days of discussions, with the main topic of discussion revolving around a presentation regarding statistical research, on reported adverse side effects of vaccines, conducted by Dr. Thomas Verstraeten. Despite requirements to the contrary under federal "Sunshine Laws", no public announcement of the event was made prior to the session, a fact later attributed to the controversial nature of his initial draft findings.
In December, 1998, the FDA called for information from manufacturers about mercury in their products. Subsequently, in 1999, Dr. Verstraeten apprised officials of the CDC and FDA that infants were receiving up to 125 times the mercury exposure considered safe at that time by the Environmental Protection Agency (EPA). The exposure in question was due to the use of mercury as a preservative in vaccines called thimerosal. The vaccine preservative is still used in some thimerosal containing vaccines (TCVs). Despite Verstraeten's 1999 findings, the FDA and CDC have not yet ordered the drug industry to stop using thimerosal as a vaccine preservative, although several other countries have banned TCVs in recent years.
Three vaccines of primary interest were to be discussed, because they are given early in life. These included the hepatitis B vaccine, the DPT vaccine, and the Haemophilus influenza type B vaccine. The MMR vaccine and other non-TCV vaccines, also central to the wider vaccine controversy and related controversies in autism, were not at issue during the meeting. The exact process by which the mercury in TCVs affects cell biology is unknown. However, according to one researcher, Dr. Richard Deth, thimerosal shuts down the detoxifying methylation process when present in the body. A related process affected by mercury is the demethylization of dna, which has the effect of precluding genetic expression, including genetic expression essential for effective immune system response.
Advisory Committee on Immunization Practices
The meeting also served as a prelude to high level government vaccine policy-making meetings, held by the Advisory Committee on Immunization Practices (ACIP), which sets vaccine policy within the US for the CDC. The session was also to serve as the initial meeting of the ACIP work group on thimerosal and immunization. Dr. John Modlin, a faculty member at Dartmouth Medical School, was the chair of the ACIP at the time of the CDC's Simpsonwood conference.
Dr. Walter Orenstein, who gaveled the Simpsonwood conference into session, told attendees the event doubled as the initial meeting of the ACIP work group on thimerosal and immunization, which consisted, at the session, of the five voting members of the committee in attendance, with the group to expand in the two weeks following, prior to the next full ACIP meeding.
On January 12, 2001, members of ACIP's vaccine policymaking committee met to discuss ways to deal with epidemiological statistics showing that children given mercury in vaccines had a much higher rate of autism, attention deficit hyperactivity disorder and other neurodevelopmental disorders.[Salon.com]
Half of the officials involved in discussions held by ACIP were employees or consultants of the drug companies regulated by ACIP.[Salon.com] Efforts to protect vaccine manufacturers from litigation over thiomseral's use have included attachment of a rider to the Homeland Security Act legislation passed in 2002, but which was repealed in 2003. As many as ten different pieces of legislation, containing provisions shielding vaccine makers from potential liability for vaccine injuries, reportedly have been under simultaneous consideration by congress as of late 2005, including provisions in the Biodefense and Pandemic Vaccine and Drug Development Act (BioShield Two) and the Public Readiness and Emergency Preparedness Act (PREPA).
Embargo
Proceedings were embargoed until June 21, prior to planned publication at ACIP. Publication in the event did not occur until 2003.Aftermath
After the conference, the CDC did not release Dr. Verstraeten's findings, although they had been slated for immediate publication. The CDC also told other scientists that Verstraeten's original data had been 'lost' and could not be replicated. CDC handed its database of vaccine records over to a private company, under the supervision of the National Center for Health Statistics, placing it out of reach of Freedom of Information Act requests.
Criticism of report delays
By the time Verstraeten finally published the amended study results in 2003, he had gone to work for GlaxoSmithKline. At the time, he was in the midst of reworking his research results, but the delay in publication caused an apparent conflict of interest. Critics also contend that the delay in publication was to afford Verstraeten sufficient time fix the data around the CDC's objective of obscuring the link between thimerosal and autism.
Conference participants
Among the attendees were the top vaccine specialist from the World Health Organization and representatives of every major vaccine manufacturer, including GlaxoSmithKline, Merck, Wyeth and Aventis Pasteur. A partial list of the participants:
- Dr. Roger Bernier, associate director for science for the CDC's National Immunization Program
- Dr. Mike Blum, from the safety surveillance and epidemiology at Wyeth
- Dr. Vito Caserta, chief medical officer for the Vaccine Injury Compensation Program
- Dr. Bob Chen, chief of vaccine safety and development for the CDC's National Immunization Program
- Dr. Susan Chu, deputy associate director for science for the National Immunization Program
- Dr. John Clements, of the World Health Organization's Expanded Program on Immunization
- Dr. Richard Clover, chair of the department of family and community medicine, University of Louisville, and a member of the ACIP vaccine policy committee
- Dr. Carolyn Deal, acting deputy director of the division of bacterial producst at CBER at the FDA
- Dr. Jose Cordero, deputy director of the National Immunization Program
- Dr. Frank DeStefano, medical epidemiologist in the National Immunization Program, and project director of the Vaccine Safety Datalink
- Dr. Bill Egan, acting director for the FDA's Vaccines Research and Review committee
- Dr. Harry Guess, head of the epidemiology department at Merck Research Laboratories
- Dr. Steve Hadler, an epidemiologist with the National Immunization Program
- Wendy Heaps, a health communications specialist with the National Immunization Program
- Dr. Barbara Howe, head of clinical research group for vaccine development for SmithKline Beecham
- Dr. David Johnson, State public health officer in Michigan, and a member of the ACIP vaccine policy committee
- Dr. Dick Johnston, chair of the Simpsonwood conference
- Dr. Loren Koller, a pathologist and immunotoxicologist from Oregon State University
- Dr. Xavier Kurz, an epidemiologist from Bryssels, representing the European Agency for the Evaluation of Medicinal Products
- Ned Lewis, data manager at the Northern California Kaiser Permanente vaccine study center
- Dr. Alison Mawle, vaccine coordinator for the CDC's National Center for Infectious Diseases
- Dr. John Modlin, a faculty member at Dartmouth Medical School and chairman of the ACIP vaccine policy committee
- Dr. Martin Myers, acting director of the National Vaccine Program
- Dr. Robert Pless, epidemiologiest with the vaccine safety and development branch of the National Immunization Program
- Dr. Douglas Pratt, a medical officer for the FDA's Office of Vaccines
- Dr. Peggy Rennels, pediatric infectious disease specialist at the center of vaccine development, University of Maryland, Baltimore and a member of the ACIP vaccine policy committee and the AAP Committee on Infectious Diseases
- Dr. Phillip Rhodes, statistician for the National Immunization Program
- Dr. Lance Rodewald, associate director for science for the CDC's Immunization Services Division
- Ben Schwartz, of the epidemiology and surveillance division at the National Immunization Program
- Dixie Snyder, the CDC's associate director for science and the executive secretary for ACIP
- Marty Stein, pediatrics department faculty member at University of California, San Diego, co-chair of the American Academy of Pediatrics guidelines on the diagnosis and evaluation for ADHD
- Dr. Ted Staub, global head of biostatistcs and data systems for Aventis Pasteur
- Dr. Thomas Verstraeten, of the EIS office at the National Immunization Program
- Dr. Alex Walker, chair of the epidemiology department at the Harvard School of Public Health
- Dr. Jo White, head of clinical development and research at North American Vaccine
- Dr. Bonnie Word, from State University of New York at Stony Brook, and a member of the ACIP vaccine policy committee
Reference
- [SafeMinds.org] - Transcript of the 2000 Simpsonwood CDC Conference
External links
- [HuffingtonPost.com] - 'ABC Flips: To Now Air 'Killed' Robert Kennedy Jr. Interview. ABC Responds ...' Huffington Post, (June 16, 2005)
- [MSNBC.msn.com] - 'A coverup for a cause of Autism? RFK Jr. explans how ingredient in vaccines may have contributed to spread' (transcript of interview by Joe Scarborough), MSNBC June 22, 2005
- [SafeMinds.org (pdf)] - 'Scientific Review of Vaccine Safety Datalink Information' (complete transcript of conference proceedings, June, 2000)
- [Salon.com] - 'Deadly immunity: When a study revealed that mercury in childhood vaccines may have caused autism in thousands of kids, the government rushed to conceal the data -- and to prevent parents from suing drug companies for their role in the epidemic', Robert F. Kennedy, Jr., Salon.com
- [Skeptico.blogs.com] - 'Robert F. Kennedy Junior’s completely dishonest thimerosal article' (June 20, 2005)
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