Gardasil, Teenage Girls, Guillain-Barré Syndrome and Statistical Analysis

Don’t Shoot the Sentries

While I served as the Colorado Women’s Chamber of Commerce President, I was chosen to attend a leadership development program called 50 for Colorado. In one of the weekly sessions, Chief Justice of the Colorado Supreme Court, Luis D. Rovira spoke to the group about the importance of listening to all sides of an issue before coming to a conclusion. Additionally he addressed the need to be willing to change a position based on new information. He called the program, “Don’t Shoot The Sentries.”

Justice Rovia described generally accepted public opinion as being like a group encampment, its members huddling around the communal fires, acting as the nucleus of established knowledge.  Everyone in that central group is relatively content that their worldview is the correct one, the right one. However, every encampment posts sentries at the edge of the group to warn of encroachment or danger. These individuals see and hear things that the folks in the comfortable center are not aware of yet.  The sentries shout warnings into the center about new conditions at the edge — new people, new ideas, new situations, disturbing the peace of the encampment. Some encampments value peace of mind more than new information and shoot the sentry.

The point of his story was, no matter how comfortable you are in your current belief do not shoot the sentry for shouting new information and opinion. In Justice Rovia’s experience, many of the extreme messages that have come from the edges of society, are eventually accepted as truths in the center of the cultural encampment. For over 15-years, of all the 50-weeks of classes, lectures and field trips, this is the one lesson I have held closely. I listen to all sides of an issue, I never belittle, let alone shoot a sentry, and when presented with a compelling argument or statement with cited facts, I am perfectly willing to change my opinion.

That is why I value comments that don’t agree with my current view.

A comment to a recent Blog, Urgent Warning about Gardasil stated:

“Guillain-Barré Syndrome (GBS) occurs in 1 or 2 out of every 100,000 teenage girls regardless of vaccination status. There has been no indication that HPV vaccination increases that rate; and given that over 25 million doses of the HPV vaccine have now been given to teen girls, simple statistics ought to tell you that pure coincidence will see the onset of GBS within a week or so in some subset of that population. Unless you are wedded to the idea that correlation DOES mean causation, then you need better evidence that it is the vaccine…like evidence that the rate of onset has gone up.”

RE: Guillain-Barré Syndrome (GBS) occurs in 1 or 2 out of every 100,000 teenage girls regardless of vaccination status.

Primary research sources, the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Center for Disease Control (CDC), and secondary research sources, such as WebMD, wrongdiagnosis.com, and CureResearch.com, all use the phase, About 1 or 2 people out of 100,000 develop Guillain-Barré Syndrome (GBS) each year(1). The term, People indicates GENERAL POPULATION — male, female, the very old, and the very young. I have not yet found separate GBS incident rates for teenage girls in any of the data sets released by US governmental agencies, but I’m still researching as I think it would be a helpful baseline to have for future comparison. All the sources refer to GBS as a rare autoimmune disorder destroying nerve function leading to weakness and paralysis. Every one of the Governmental and private GBS sources referenced the same citation for the” 1 or 2 people out of 100,000” figure:

(1.)Shy ME (2008). Guillain-Barré syndrome section of Peripheral neuropathies. In L Goldman, D Ausiello, eds., Cecil Textbook of Medicine, 23rd ed., pp. 2802–2816. Philadelphia: Saunders Elsevier.

RE: “There has been no indication that HPV vaccination increases that rate; and given that over 25 million doses of the HPV vaccine have now been given to teen girls, simple statistics ought to tell you that pure coincidence will see the onset of GBS within a week or so in some subset of that population. Unless you are wedded to the idea that correlation DOES mean causation, then you need better evidence that it is the vaccine…like evidence that the rate of onset has gone up.”

That thought process would indeed be persuasive IF the US Governmental agencies collected, analyzed and released such data annually. Such, however is not the case.

It must be noted that the ‘Cecil Textbook of Medicine, 23rd edition’ given as the common cited source for the “1 or 2 people out of 100,000 develop GBS each year” was published in 2007, with footnotes referencing the US Census Bureau, Population Estimates, 2004 and US Census Bureau, International Data Base, 2004.

The US Government conducts a national population census every 10 years, the next being due in 2010. Historically, it has taken about four years before the census figures are correlated and released to the general public. Once those figures are released, medical researchers can then begin to analyze the incident rates of various diseases against those numbers to determine percentage of population affected, and any changes in incident rate from previous censuses.

So lets think about this process of statistical data collection, analysis, and reporting for a moment.

Both Federal agencies and private health organizations are, in 2009, referring to a dataset gathered in 2000, analyzed and released as a sited source in 2007.

The next US population census will be gathered in 2010, correlated and released to the general public by 2014. At that time, medical researchers can examine trending changes in the incidences of GBS in the general public, and if the data is available as a subset, extrapolate the number of GBS cases reported in relation to teen girls. At that time investigators could look for causal factors in any increase in the incidence of GBS in that population. If that avenue of research is pursued, and if the HPV-vaccine Gardasil is tracked as a possible factor in the increase of reported teen girl GBS cases, there will probably be an asterisk on the report data.

The FDA announced the approval of the HPV-vaccine, Gardasil June 8, 2006 so the first full year of data couldn’t be complied until mid-2007. Medical researchers will have approximately three and a half years of Gardasil deployment data to examine. They will, of course, know the total number of Gardasil does delivered, and hopefully when the teen girls’ incidences of GBS presented within the Gardasil shot series — first, second or third. So sometime between 2014 and 2017, trusted source reference material should be able indicate a causal relationship of the impact of the Gardasil vaccine to GBS incidences in teen girls, cast doubt, or completely negate the supposition. We won’t know until then. It won’t be until the 2020 census data released some time in 2024 that medical researchers can determine the full effect thirteen years of the HPV-vaccine, Gardasil has had on a generation of young America women.

RE: simple statistics ought to tell you that pure coincidence will see the onset of GBS within a week or so in some subset of that population.

There is no such thing as simple statistics. Statistical analysis depends on the type and veracity of the data gathered. A data set, which relates the Garasil injection to onset of GBS in teenage girls, has not yet been gathered, or analyzed by anyone in the US government. One cannot draw a valid statistical conclusion about data that has not yet been collected and correlated. That is supposition, not statistical analysis. One of the reasons people are referring to “raw, unanalyzed VAERS data” is that it is the only data the US government has made available.

If you have current (2007—2009) GBS/Gardasil statistical data from Great Britain or the EU governments, please share it. In the issue of unintended consequences concerning Gardasil, I want to be proven wrong in every one of my suppositions. It is my greatest hope that the HPV-vaccine, Gardasil is as safe and effective as the Merck commercial says it is.

I am always accepting new news from the Senteries.

PG

Author: H. Sandra Chevalier-Batik

I started the Inconvenient Woman Blog in 2007, and am the product of a long line of inconvenient women. The matriarchal line is French-Canadian, Roman Catholic, with a very feisty Irish great-grandmother thrown in for sheer bloody mindedness. I am a research analyst and author who has made her living studying technical data, and developing articles, training materials, books and web content. Tracking through statistical data, and oblique cross-references to find the relevant connections that identifies a problem, or explains a path of action, is my passion. I love clearly delineating the magic questions of knowledge: Who, What, Why, When, Where and for How Much, Paid to Whom. My life lessons: listen carefully, question with boldness, and personally verify the answers. I look at America through the appreciative eyes of an immigrant, and an amateur historian; the popular and political culture is a ceaseless fascination. I have no impressive initials after my name. I’m merely an observer and a chronicler, an inconvenient woman who asks questions, and sometimes encourages others to look at things differently.