June 29, 2010
By Cynthia A. Janak
For those of you who have come to this article for the first time I would suggest that you start at the beginning of this series. All the information that was presented to the FDA on March 12th of 2010 starts with the information about HPV. My feelings are that it is best to get the whole story and not just part. Anyway, I want to thank you for being here.
Before I continue I want to share with you something new that I found on the FDA website. Boy, I find such things when I am looking for something else. It could be the hand of God leading me to this stuff. But anyway on to what I found.
On May 19th of 2008 the FDA had a meeting with the Infectious Disease Society of America (IDSA). The title of the presentation was “Immunization Before the Next Pandemic? Risks, Benefits and Pathways. The presenter was Jesse L. Goodman, MD, MPH, Director, Center for Biologics Evaluation and Research, IDSA, Washington, DC.(1)
I found the whole presentation interesting and I wish that they would have had the whole transcript of this presentation but the slides tell the story. The slides that caught my interest were slides 32 and 33 that are titled “Detecting Rare Adverse Events: some simple math”. Dr. Goodman mentions the impracticality of large trials. This is what he states on the slide. (I want to note here that the presentation was about a pandemic but this section mentions large clinical trials.)
Even impractically large trials will often fail to confirm small increases in events which may be significant when applied to a large population
What this tells me is that they know that the adverse events of a drug or vaccine are not truly known until given to a large population. This brings to mind what Dr. Diane Harper said about the HPV vaccines. “Giving it to 11-year-olds is a great big public health experiment,” (2)