Follow-Up RE: Infamous Endorsement of Anthrax Vaccine for Children
Following dissemination of our Infomail, Infamous Endorsement of Anthrax Vaccine for Children, AHRP was asked by one recipient, what evidence existed to show that the anthrax vaccine has caused disability and death.
This is an important, legitimate question that deserves clarification and citation to evidence which we want to share with all our Infomail readers.
Military studies of the anthrax vaccine have provided very little information about adverse effects. However, as Meryl Nass, MD, a recognized expert on anthrax and biological weapons, points out, a June, 2007 report by the General Accounting Office [GAO-07-787R ] states (on page 4, last paragraph):
"Officials from the VHC Network [Vaccine Healthcare Centers] and CDC [Center for Disease Control] estimate that between 1 and 2 percent of immunized individuals may experience severe adverse events, which could result in disability or death. Some of these events may occur coincidentally following immunization, while others may truly be caused by immunization."
Dr. Nass also refers to a slide from a Vaccine Healthcare Center presentation, which states that the anthrax vaccine poses a risk of "Severe AE [Adverse Events]....of 1-2%"
She notes, "There are no good studies of incidence or prevalence of severe adverse events to point to, but this is what the CDC and military Vaccine Healthcare Centers acknowledged from their own experience with vaccine reactions.
The 2002-2007 CDC-directed, five center anthrax vaccine clinical trial enrolled 1564 subjects initially, followed them over 43 months, and reported 229 serious adverse events to VAERS.
A preliminary 2008 report in the Journal of the American Medical Association (JAMA ) provided the total Adverse effect number, as 229, but without a breakdown by the type of adverse event:
"During the 7 months of participation summarized here, there were 51 SAEs reported among 47 subjects of the 1005, including 3 deaths. Using World Health Organization causality assessment criteria, the data and safety monitoring board concluded after a blinded review that none of these 51 SAEs was related or possibly related to the study agent. Since enrollment began, there have been 229 SAEs in the entire 1563 participant cohort involving 186 participants, with 7 deaths." [emphasis added]
Four years have passed since CDC completed this major trial, yet no final report has ever been published.
Disclosure: Dr. Nass is a board member of The Aliiance for Human Research Protection.
Thank You AHRP
See Also:
http://lindseyshistoryblog.blogspot.com/2010/05/gulf-war-syndrome-forced-anthrax.html
The only time I am aware of that final reports of completed trials are not published is when the results are not positive---
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ReplyDeleteORIGINAL INDUSTRY INSIDER commented;
Bill, an old rule of thumb used to be for FDA to do a 20% audit of the total patient enrollment, and then to get to that 20% they would, for the sake of efficiency audit the highest enrolling site. This could be problematic if the patients are not evenly distributed across sites.
Let say if you have have a 500 patient trial and you have 40 investigators enrolling 10 patients/site, and two investigators enrolling 50 patients/site. FDA would audit the two high enrolling sites to get their 20% (100 patients), and the remaining 40 sites would go untouched. Thus, in reality, only 4.8% of the total number of sites would be audited.
Usding this algorithm, you can see how it is easy for FDA to miss problems."
And this mess is Whose fault?
"Suppose you were an idiot. And suppose you were a member of Congress. But I repeat myself."
Mark Twain