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.

Vera Hassneer Sharav

Subject: Challenge Issued to Republican Presidential Candidate, Michelle Bachmann

 S.A.N.E. VAX, INC

Dear Dr. Caplan:

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? 

 

Yours respectfully,

Norma Erickson, President
ANE Vax, Inc.

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 

   

References:

1)    Palmer RJ, Finley KH. Sequelae of encephalitis; report of a study after the California epidemic. Calif Med. 1956 Feb;84(2):98-100.

2)    Sutton I, Lahoria R, Tan I, Clouston P, Barnett M. CNS demyelination and quadrivalent HPV vaccination. Mult Scler. 2009; 15(1):116-119.

3)    Wildemann B, Jarius S, Hartmann M, Regula JU, Hametner C. Acute disseminated encephalomyelitis following vaccination against human papilloma virus. Neurology. 2009 Jun 16;72(24):2132-3. Neurology. 2009 Jun 16;72(24):2132-3.

4)   Mendoza Plasencia Z, González López M, Fernández Sanfiel ML, Muñiz Montes JR. Acute disseminated encephalomyelitis with tumefactive lesions after vaccination against human papillomavirus Neurologia. 2010 Jan-Feb;25(1):58-9.

5)    Chang J, Campagnolo D, Vollmer TL, Bomprezzi R. Demyelinating disease and polyvalent human papilloma virus vaccination. J Neurol Neurosurg Psychiatry. 2010 Oct 9. doi:10.1136/jnnp.2010.214924

6)   DiMario FJ Jr, Hajjar M, Ciesielski T. A 16-year-old girl with bilateral visual loss and left hemiparesis following an immunization against human papilloma virus. J Child Neurol. 2010 Mar;25(3):321-7.

7)   Balamoutsos G, Bouktsi M, Paschalidou M, Tascos N, Milonas I.  A report of five cases of CNS demyelination after quadrivalent human papilloma virus vaccination: could there be any relationship?  (Abstract No. P297)- Poster Access : www.guthyjacksonfoundation.org/services/download.php?2297.pdf+374

8)   Rossi M, Bettini C, Pagano C. Bilateral papilledema following human papillomavirus vaccination. J Med Cases. 2011: 2:222-224.

9)   http://www.businesswire.com/news/home/20110906005422/en/SANE-Vax-Reports-Human-Papillomavirus-HPV-DNA

10) Marichal T, Ohata K, Bedoret D, Mesnil C, Sabatel C, Kobiyama K, Lekeux P, Coban C, Akira S, Ishii KJ, Bureau F, Desmet CJ. DNA released from dying host cells mediates aluminum adjuvant activity. Nat Med. 2011 Jul 17;17(8):996-1002.

11) Beller U, Abu-Rustum NR. Cervical cancers after human papillomavirus vaccination.  Obstet Gynecol. 2009 Feb;113(2 Pt 2):550-2.

 

  See also, the following peer-reviewed studies point out the links between Encephalitis and HPV Vaccines:

Demyelinating disease and polyvalent human papilloma virus vaccination
J Neurol Neurosurg Psychiatry doi:10.1136/jnnp.2010.214924

Since its inception, the polyvalent vaccine against the human papilloma virus (HPV), Gardasil, has generated some controversies as a temporal relationship between the administrations of the vaccine and the development of a few autoimmune diseases, such as acute disseminated encephalomyelitis (ADEM), multiple sclerosis (MS) and Guillain–Barre syndrome have been reported. We encountered two cases whose initial presentation of CNS demyelination followed in close time relationship the administration of Gardasil vaccine and we discuss their possible association.
http://jnnp.bmj.com/content/early/2010/10/08/jnnp.2010.214924.extract

Meningococcal and Human Papilloma Virus Vaccine Associate Recurrent Acute Disseminated Enchephalomyelitis
Juan Carlos Muniz, MD, Stanley Krolczyk, DO, RPH; Lise Casady, ARNP, University of South Florida
http://www.mscare.org/cmsc/images/pdf/2008cmscabstracts-posters53.pdf

A report of five cases of CNS demyelination after quadrivalent human papilloma virus vaccination: could there be any relationship?
26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) & 15th Annual Conference of Rehabilitation in MS (RIMS) 13.10.2010 - 16.10.2010
http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=116417&XNSPRACHE_ID=2&XNKONGRESS_ID=126&XNMASKEN_ID=900

Acute disseminated encephalomyelitis with tumefactive lesions after vaccination against human papillomavirus
Neurología. 2010;25(1):58-69
http://www.elsevier.es/sites/default/files/elsevier/pdf/295/295v25n01a13148580pdf001_2.pdf

Bilateral Papilledema Following Human Papillomavirus Vaccination Case Report
J Med Cases • 2011;2(5):222-224
http://www.journalmc.org/index.php/JMC/article/viewFile/256/203

Acute Disseminated Encephalomyelitis Following Vaccination Against Human Papilloma Virus
American Academy of Neurology, Neurology 2009;72:2132–2133.

Wildemann et al. present a case of aggressive acute disseminated encephalomyelitis (ADEM) following immunization with the polyvalent human papillomaviruses (HPV) vaccine. The time between vaccine exposure and onset of illness provides evidence for a cause-effect relationship.

The author goes on to note “…it is important to monitor the occurrence of immune-mediated diseases that are occurring after vaccination with Gardasil®”
http://www.neurology.org/content/74/10/864.2.full.html