2000 Simpsonwood CDC conference

The 2000 Simpsonwood CDC conference (officially entitled Scientific Review of Vaccine Safety Datalink Information) was a meeting convened in June, 2000, by the Centers for Disease Control, held at the Simpsonwood [1] Methodist retreat and conference center in Norcross, Atlanta, Georgia. Events at the session included a presentation, reviewing data from the Vaccine Safety Datalink, by Dr. Thomas Verstraeten, and a comment on the biologic plausibility and consistency of a possible link between thimerosal and autism from Dr. Loren Koller. In addition to specialists involved in vaccine research, approximately half a dozen public health organisations and pharmaceutical interests were represented, as well as eleven consultants to 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.

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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 data on its toxicity is sparse. It is primarily recognized as a cause of hypersensitivity. Acutely, it can cause neurologic and renal toxicity, including death from overdose."[2] 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 derived from the Vaccine Safety Datalink, that had been conducted by Dr. Thomas Verstraeten.

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.

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.^{[citation needed]}

On January 12, 2001, members of ACIP's vaccine policymaking committee met to discuss claims that children given mercury in vaccines had a much higher rate of autism, attention deficit hyperactivity disorder and other neurodevelopmental disorders.[3]

Embargo

Proceedings were embargoed until June 21, prior to planned publication at ACIP. Publication in the event did not occur until 2003. After the conference, the CDC did not release Dr. Verstraeten's initial findings; instead, further analysis was conducted by Verstraeten and a revised publication was released in 2003.[4]

Criticism of report delays

By the time Verstraeten published the amended study results in 2003, he had gone to work for GlaxoSmithKline.[5] Critics contend that the delay in publication was to afford Verstraeten sufficient time fix the data around what they allege to be the CDC's objective of obscuring the link between thimerosal and autism.[6] Dr. Verstraeten denies the allegations, and has published a substantial account of the matter in the journal Pediatrics.[7] In September 2007, a report of the US Senate's committee on health, education, labor and pensions rejected allegations of impropriety [8].

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:[9]

• 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 products at CBER at the Food and Drug Administration
• 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 Food and Drug Administration'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 American Academy of Pediatricians 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

References

• SafeMinds.org (pdf) - 'Scientific Review of Vaccine Safety Datalink Information' (2000 Simpsonwood CDC conference transcript; July 7-8, 2000)