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VASP Collects and Publishes Valuable Data and Results Suppression of Reports Leads to Resignation The VASP continued collecting valuable data, which have been At the beginning of 2001 and again in 2002, after one and two published or presented at various conferences; I received co- years of shingles data collection, I submitted manuscripts for authorship credit on some of these papers.** I considered it a review by my superiors and subsequent approval for publication privilege to be a part of the team, which included three others in by the CDC. These manuscripts discussed preliminary data our local office: a project director and two research assistants. describing potential deleterious effects of the Universal Varicella In January 2000, I was encouraged when my earlier suggestion Vaccination Program. (The biological mechanism supporting to collect cases of shingles (herpes zoster) was adopted and added these observations had already been explained in the scientific to the chickenpox data collection. In retrospect, we should have and medical journal literature; see references in Appendix 4 of my been collecting shingles cases from the onset of the project in complete paper at http://www.MedicalVeritas.com/ order to have a consistent methodology for determining baseline FULLNEXUS.pdf.) Unlike previous analyses of the positive incidence rates that could be used in year-to-year comparisons. aspects of vaccination, these manuscripts were treated very Numerous studies dating from as early as 1965 had alluded to a differently. By October 2002, I felt that I could no longer conduct potential link between the two diseases: that a decrease in research objectively; and with the submitted manuscripts still chickenpox incidence could give rise to an increase in shingles pending formal review, I resigned from the VASP, citing my (see summary of references in Appendix 1 of my complete paper _ ethical compromise. at http://www.MedicalVeritas.com/FULLNEXUS pdf). In my letter of resignation, I stated: "Whenever research data and information concerning potential adverse effect ciated PART Il: Vaccine Causes a Rash of Controversy: with a vaccine used in human populations are suppressed and/or CDC Requests a Special Study be misrepresented by health authorities, not Conducted only is this most disturbing, it goes Up to this point, everything seemed to against all accepted scientific norms be going well. I was receiving positive and dangerously compromises feedback, and a letter from the LACDHS My manuscri pts discussed professional ethics." commended all of our efforts. However, preliminary data describing things began to change when the CDC Notice to "Cease and Desist" asked our project to conduct an potential deleterious effects from Publication additional study among middle-school of the Universal Varicella Following my resignation, I (7th-8th grade) students to determine the A A submitted final versions of four percentage who had not had Vaccination Program. manuscripts that had been awaiting chickenpox—in other words, those who review for the past one to two years were considered still susceptible to the during my employment to both the disease. Surveys were provided to each LACDHS and the CDC, notifying them school, asking the relevant questions in of pending publication and making order to allow computation of the percentage of susceptible students —_ inquiry as to whether other individuals desired authorship credit. by age and race. With the approval of the project director, an When there was no response, I submitted the manuscripts for additional question was added to the survey, inquiring if the student ublication. All four manuscripts were peer reviewed and had ever had shingles and, if so, the age at which the outbreak published in Vaccine, a medical journal based in the UK and occurred. This was intended to provide some baseline data on known throughout Europe.'*”’ shingles incidence among children and adolescents in the Antelope Following the acceptance of the first three manuscripts," I Valley region. received a letter from the Los Angeles County legal department After analysing several thousand questionnaires, I wrote a on behalf of the LACDHS, requesting that I "cease and desist" manuscript that addressed varicella susceptibility as well as the ublication in a medical journal. My attorney filed a response incidence of shingles. To my surprise the CDC claimed that the citing the possibility of litigating based on state and federal False study was not designed to determine shingles incidence, and Claims Acts and calling upon Dr Philip R. Krause, lead research neither the LACDHS nor the CDC expressed interest in publishing investigator at the FDA's Center for Biologic Evaluation and or discussing the results pertaining to shingles. The manuscript Research, to testify as an expert witness in support of my findings. discussing varicella susceptibility was published word for word as The "cease and desist" issue appeared to have ended with no further I had written it, with only minor changes to a few sentences.’ The response forthcoming from the LA County legal department. remainder of the manuscript on shingles was simply discarded. ann in An and Qlien Adthacta Danutatinn VASP Collects and Publishes Valuable Data and Results The VASP continued collecting valuable data, which have been published or presented at various conferences; I received co- authorship credit on some of these papers.** I considered it a privilege to be a part of the team, which included three others in our local office: a project director and two research assistants. In January 2000, I was encouraged when my earlier suggestion to collect cases of shingles (herpes zoster) was adopted and added to the chickenpox data collection. In retrospect, we should have been collecting shingles cases from the onset of the project in order to have a consistent methodology for determining baseline incidence rates that could be used in year-to-year comparisons. Numerous studies dating from as early as 1965 had alluded to a potential link between the two diseases: that a decrease in chickenpox incidence could give rise to an increase in shingles (see summary of references in Appendix 1 of my complete paper at http://www.MedicalVeritas.com/FULLNEXUS pdf). My manuscripts discussed preliminary data describing potential deleterious effects Py ee Oe BW ee eT CDC Intervenes and Slurs Author's Reputation However, prior to publication of the fourth manuscript and after Thad received a letter of acceptance from the editor of Vaccine, the CDC attempted to block publication of this manuscript by calling the Life Sciences editor of Elsevier, which oversees publication of Vaccine. Again my attorney intervened, asking the CDC if it served on the editorial board of Vaccine. After a year's delay, the manuscript was finally released for print publication in May 2005. The basic analysis for this manuscript had been outlined in 2001 while I was serving as research analyst.'* The CDC next attempted to slur my reputation by stating that I was merely a "data manager having no input into the studies". In reality, I was responsible for submitting the background material No Follow-up Allowed on Recurring Shingles Cases While preparing another annual report, I had identified 10 cases where individuals reported a second case of shingles. I computed the incidence of recurrent shingles in the same manner as had been done in another peer-reviewed article and requested permission from my superiors to conduct a telephone interview with each of these 10 cases to assess whether or not they had some pre-existing or underlying condition that might have suppressed their immune system. Despite our calling 10,000 parents/caregivers of children with chickenpox, no permission was granted to contact these 10 individuals. Further, this analysis was also deleted from the annual report without explanation. JUNE — JULY 2007 NEXUS = 21 : of the Universal Varicella Vaccination Program. www.nexusmagazine.com