S.A.N.E Vax, INC Supports Bachmann Gardasil/Mental Retardation Charge

Monday, 19 September 2011 As of June 2011 there have been 68 deaths related to the HPV Gardasil vaccine were reported to VAERS. At the Republican Presidential Candidate debate, Michele Bachmann stepped on a hornet's nest when she strongly criticized Rick Perry for issuing an Executive Order mandating Texas school girls to be vaccinated with Merck's HPV vaccine, Gardasil.

Controversy has swirled around this vaccine since Merck's aggressive unethical marketing tactics were uncovered in 2007. These included pay offs to public officials. See: Merck Lobbies States to MANDATE cervical-cancer vaccine forschoolgirls and Merck Payola Pays Off: Texas Governor Orders STD Vaccine for ALL girls

Bachmann called Perry's use of the Executive Order an abuse of his executive power.

Indeed, mandatory vaccination against HPV is unsupportable HPV is not communicable in a school setting--it is communicated only by sexual contact. The condition Human Papilloma Virus (HPV) is present in 50% of the sexually active population. HPV does NOT automatically develop into cancer in the overwhelming majority of the population. HPV is mostly benign--no treatment needed.

Furthermore, early detection of pre-cancerous cervical cells is readily accomplished by routine PAP smears--which sexually active women in the US routinely have. And pre-cancerous cervical condition is eminently treatable.

Therefore, cervical cancer does not pose a major danger for all children--therefore, the risk from the vaccine itself is not justifiable.

Indeed, the Texas legislature had overruled (then) Governor Perry's Executive Order because it was unsupportable.

Bachmann correctly noted that the HPV vaccine poses serious risks of harm: As of June 22, 2011 there have been a total 68 deaths reported to the Vaccine Adverse Event Reporting System (VAERS) related to Gardasil.

As of June 22, 2011, approximately 35 million doses of Gardasil® were distributed in the U.S. and VAERS received a total of 18,727 of which 8% were deemed serious.

The following HPV-linked injuries have been reported to VAERS (estimated at 1% to 10% of injuries linked to vaccines)

Bachmann stated that Merck “made millions of dollars because of this mandate;” and that Governor Perry had received thousands of dollars in campaign contributions from Merck. She also noted that “the governor’s former chief of staff was the chief lobbyist for this drug company.” http://www.politico.com/news/stories/0911/63329.html#ixzz1YPZbncRy

First among the hornets to attack Bachmann is none other than bioethicist Art Caplan who came to Rick Perry's and Merck's defense.

Ironically, when Rick Perry entered the race for Republican Presidential candidate, on August 15, 2011, he acknowledged in an Iowa radio call-in show his mistake in issuing that Gardasil Executive Order: "I readily stand up and say I made a mistake on that. "

Art Caplan is the director of the Bioethics Center at the University of Pennsylvania, which has beenn criticized for its copious pharmaceutical industry funding. Oblivious to the reports of vaccine-related encephalitis, cognitive disorder, and more, Caplan challenged Bachmann with a $10,000 bet to prove her claim that the vaccine to prevent cervical cancer caused mental retardation.

Mental retardation can be caused by encephalitis, an infection involving inflammation of the brain as well as autoimmune inflammatory diseases involving the central nervous system.

Below, the organization SANE challenges Art Caplan with peer-reviewed published reports of harm from the HPV vaccine.

Subject: Challenge Issued to Republican Presidential Candidate, Michelle Bachmann

On behalf of the parents of a group of neurologically injured teenage girls after HPV vaccination, we feel obligated to question your ‘bio’-ethics as you challenge Republican presidential candidate Michele Bachmann with a $10,000 bet to prove a claim that a vaccine to prevent cervical cancer caused mental retardation. We represent many parents of teenage girls who have suffered a variety of central nervous system (CNS) dysfunctions, including various degrees of mental ‘retardation’ (impairment) as a sequelae of Gardasil® vaccination injuries. It is hard to believe that as bioethicist you openly instigate violation of the HIPAA law.

Do you accept the standard medical teaching that mental retardation may be the sequelae of an inflammatory pathology of the brain, namely encephalitis, in the surviving patients1? We do. If you do not, please cite some peer-reviewed, published studies to support your argument.

The SANE Vax team has found seven reports published in various peer-reviewed medical journals, documenting HPV vaccination as the most likely cause of a hitherto poorly understood and probably autoimmune-based inflammatory disease involving the central nervous system, including various parts of the brain 2-8.

The authors, reviewers and editors of these articles all felt that a highly unusual CNS pathology following Gardasil® vaccination needs to be brought to the attention of the world’s medical community because the inflammatory pathology and its pathogenesis cannot be easily explained; it is apparently autoimmune-based.

This letter is to inform you that SANE Vax Inc., representing parents whose daughters have been injured by the Gardasil® vaccination, have reported to the FDA that the currently marketed Gardasil® is probably 100% contaminated by recombinant HPV DNA firmly bound to amorphous aluminum hydroxyphosphate sulfate adjuvant9.

This HPV DNA/aluminum complex may mediate an immunotoxic reaction leading to some of the inflammatory neurodegenerative disorders observed in the Gardasil® victims, similar to the mechanism observed in experimental animals10.

We suggest you visit the CDC HPV Vaccine VAERS Reports site to see the prevalence of various sequelae after the patients recovered from the acute phase of CNS injuries.

Now, SANE Vax Inc. challenges you, Dr. Caplan. Prove the vaccine Gardasil® has prevented a single case of cervical cancer. We have not found such a case in the world literature, or in the published clinical trial materials. The endpoints used for evaluating the efficacy of Gardasil® were largely self-reversible precancerous changes, not true cancer as defined in any pathology textbooks.

At least two proven invasive cervical cancers developed shortly after HPV vaccination have been reported in medical literature. According to the report, one of the young patients had received a full course of HPV vaccination when she was enrolled in a clinical trial for which the subjects must be pre-screened to be cytology-negative before enrollment. The HPV-found in her cancer was HPV-3111, subsequently recognized as a vaccine-relevant genotype due to “cross reaction” and “cross protection”.

How would you, Dr. Caplan, justify the vaccination from the standpoint of a bioethicist when the vaccine may have actually accelerated an undetectable precancerous change associated with a vaccine-relevant HPV to a clinical invasive cancer with lymphatic invasion?

Signed on behalf of the Board of Directors, SANE Vax Inc. Leslie Carol Botha, Vice President of Public Relations Janny Stokvis, Vice President of Research Rosemary Mathis, Vice President of Victim Support Freda Birrell, Secretary Linda Thompson, Treasurer

You’ve disposed of my percentages of young girls seriously harmed by HPV vaccines based on an error in my methodology.

AERs are reported to Government Regulators on a voluntary basis, and very few of them are actually reported.

http://www.ncbi.nlm.nih.gov/pubmed/16689555

“Drug Saf. 2006;29(5):385-96.
Under-reporting of adverse drug reactions : a systematic review.
Hazell L, Shakir SA.
Source
Drug Safety Research Unit, Southampton, UK.
Abstract
The purpose of this review was to estimate the extent of under-reporting of adverse drug reactions (ADRs) to spontaneous reporting systems and to investigate whether there are differences between different types of ADRs. A systematic literature search was carried out to identify studies providing a numerical estimate of under-reporting. Studies were included regardless of the methodology used or the setting, e.g. hospital versus general practice. Estimates of under-reporting were either extracted directly from the published study or calculated from the study data. These were expressed as the percentage of ADRs detected from intensive data collection that were not reported to the relevant local, regional or national spontaneous reporting systems. The median under-reporting rate was calculated across all studies and within subcategories of studies using different methods or settings. In total, 37 studies using a wide variety of surveillance methods were identified from 12 countries. These generated 43 numerical estimates of under-reporting. The median under-reporting rate across the 37 studies was 94% (interquartile range 82-98%). There was no significant difference in the median under-reporting rates calculated for general practice and hospital-based studies. Five of the ten general practice studies provided evidence of a higher median under-reporting rate for all ADRs compared with more serious or severe ADRs (95% and 80%, respectively). In comparison, for five of the eight hospital-based studies the median under-reporting rate for more serious or severe ADRs remained high (95%). The median under-reporting rate was lower for 19 studies investigating specific serious/severe ADR-drug combinations but was still high at 85%. This systematic review provides evidence of significant and widespread under-reporting of ADRs to spontaneous reporting systems including serious or severe ADRs. Further work is required to assess the impact of under-reporting on public health decisions and the effects of initiatives to improve reporting such as internet reporting, pharmacist/nurse reporting and direct patient reporting as well as improved education and training of healthcare professionals.
PMID: 16689555 [PubMed - indexed for MEDLINE]

And based upon that, I’ll stick with my 6 out of every 100 number. Thank you for helping me refine this issue into better documented and clearer focus.

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