Vaccine Safety and Safety Surveillance

             Painting of a Friend by Chris 2007

On Good Morning America, in an interview for an ABC news story on Gardasil, Dr. Jacques Moritz, Director of Gynecology at Saint Lukes-Roosevelt Hospital in New York City was quoted as saying that:
 
"He would not offer the Gardasil vaccine to patients when good cervical cancer screening techniques and treatments exist. He has also chosen not to have his 11 year-old daughter get the HPV shot because of his concerns."
 
In the same news story, Dr. Timothy Johnson, ABC news Chief Medical Editor, said with regard to endorsing Gardasil inoculations:
"I'm taking a pass on this one."
 
 A video of the feature story and accompanying article are available at :
 
 
 
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On August 19, 2009, the CDC/FDA jointly published the first post-licensure safety report on Gardasil. 
The paper was a summary of reports to the Vaccine Adverse Events Reporting System (VAERS) following receipt of Gardasil. In the report, they admit:
  • 68% of the reports came from Merck and 89% of those reports had insufficient information for medical review.
  • "VAERS data need to be interpreted with caution " because cases are underreported, reports can be  incomplete and inconsistent in quality, there is a lack of standard case definitions and coding and they are unable to establish causality.
  • The rate of Adverse Events Following Immunization ( AEFI ) was determined by dividing an underreported number of cases by an inflated denominator  based on the number of doses of vaccine distributed, not the number of doses actually used. 
Based on flawed data and incorrect calculations, the CDC determined that most AEFI rates were not greater than background rates except for syncope and venous thromboembolic events. 

(B.A. Slade, L.Leidel, C. Vellozzi, E.J. Woo, W. Hua, A. Sutherland, H.S.A.Izurieta, R. Ball, N. Miller, N. M. Braun, L.E. Markowitz, and J. Iskander. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. The Journal of the American Medical Association, 302 (7):750-757,2009.)

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How can this degree of inadequacy be tolerated?

How can the CDC/FDA earn the public's trust with research like this?

Why after more than 20 years does the CDC continue to use a safety surveillance system that is so limited and inadequate?

Why after all of these years is there still no follow up with the victims or their families, even in reported cases of death?

Why is there no standardized list of adverse symptoms or pre and post injection investigations?

Why are there no statistical analyses of death-period allocations to test the "coincidental death" hypothesis? 

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Critical comments on the FDA/CDC report:



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"But the net benefit of the HPV vaccine to a woman is uncertain. Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened. ... When weighing evidence about risks and benefits, it is also appropriate to ask who takes the risk, and who gets the benefit....If other matters weigh in, such as profit for a company or financial or professional gains for physicians or groups or physicians, the balance is easily skewed. The balance will also tilt if the adverse events are not calculated correctly."
 
Quoted from: C. Haug. The Risks and Benefits of HPV Vaccination. Journal of the American Medical Association, 302 (7): 795-796, August 19, 2009.
 
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To date, there are no long term safety or efficacy studies and no studies of the interaction between Gardasil and other vaccines like Menactra or birth control pills. The pre-licensure clinical studies that were done have been broadly criticized for failing to have a true control group, for testing fewer than 1200 girls 16 years and younger and for lack of efficacy data for this population. 

A report by Dr. David Ayoub and the Prairie Collaborative for Immunization Safety: 

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An analysis by the National Vaccine Information Center compared Gardasil to another vaccine, Menactra,  which is administered in the same age population. They found a much higher incidence of serious adverse health events from Gardasil than Menactra. In addition, the FDA/CDC safety surveillance report cited above states, "The VAERS reporting rate for qHPV (Gardasil) is triple the rate for all other vaccines combined..."

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