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70. Adolescents without private insurance usually can receive ACIP-recommended vaccines for free or at low
cost through the federal Vaccines for Children (VFC) program or a state-base vaccine program.
71. The federal and state governments established these programs to help minors without insurance to find
affordable vaccines. Ironically, because of the way these programs are set up, low-income families with female
minors without insurance may have an easier time getting the HPV vaccine than those who are privately insured.
72. The National Institute of Health has patents on papillomavirus vaccine technology. Doctor Douglas Lowy is
the inventor of this technology. The National Institute of Health has licensed the technology to both Merck and
GlaxoSmithKline, the two companies developing commercial HPV vaccines.
73. According to Douglas Robert Lowy the inventor of the HPV vaccine, at the CCR/TEDCO Technology
Showcase on September 25, 2007 from his own views and not those reflected by the Center for Cancer
Research National Cancer Institute and National Institute of Health, on page 7 the Systemic Virus Like Particles
is Protective in 3 Animal Papillomavirus Models: Skin (rabbits) and Oral Muscosa (cows & Dogs). The protection
is prophylactic, not therapeutic. (Exhibit A attached to this Complaint include the September 25, 2007 Showcase
of Dr. Douglas R. Lowy personal assessment on papillomavirus vaccine technology that he invented)
74. Doctor Lowy states in diagram from CCR/TEDCO Technology Showcase on September 25, 2007 on page 2
adapted from Schiffman & Castle, New England Journal of Medicine that most infections clear spontaneously,
and eliminating cancer risk for that infection. Cervical precancer lesion begin to appear late 20’s to mid 30’s
while cervical cancer start around early 30’s to early 50’s.
75. Cervical cancer was never identified in the study as being a female childhood disease nor is there any
reference of any public health crisis or threat regarding HPV in children.
76. Doctor Lowy states in diagram from CCR/TEDCO Technology Showcase on September 25, 2007 on page 2
adapted from Schiffman & Castle, New England Journal of Medicine that lifetime incidence of genital HPV
infection > (is less than) 80% in U.S. and that persistent infection with a high-risk HPV, especially HPV 16 or 18,
is the single most important risk factor for progression to precancer and cancer.
77. Doctor Lowry presentation at the CCR/TEDCO Technology Showcase on September 25, 2007 on page 8
rest the conclusion from NCI Early Phase Clinical HPV16 Li VLP Vaccine Trials on the ideal that the antibody
titers achieved in people are similar to those that protect animals against experimental viral challenge.
78. Doctor Lowy presented Outstanding Medical Issues at the CCR/TEDCO Technology Showcase on
September 25, 2007 on page 12 provides questions like, Will the vaccine continue to have an excellent safety
profile after it has been given to hundreds of thousands of people? How long will the vaccine remain highly
protective? Will there be a need for booster vaccinations? Will the vaccine be effective in boys/men? (Exhibit B
attached to this Complaint include the September 25, 2007 Showcase of Dr. Douglas R. Lowy personal
assessment on papillomavirus vaccine technology that he invented)
79. The safety of this vaccine for children and its life long efficacy as a cancer preventive for this population are
unproven and even questionable by the inventor. The clinical trials were fare too short to demonstrate the
vaccine prevents the HPV from transforming into cancer.
80. According the CDC website on HPV “the vast majority of males and females infected with HPV viruses suffer
no ill effects. In most healthy people, the immune system fights off the virus. Only 2.2% of women who contract
the types of virus that can cause cervical cancer actually develop the disease. Regular Pap tests can usually
detect the cancer early enough to cure it.”
81 According DHHS Federal Regulations Code, TITLE 45 PUBLIC WELFARE DEPARTMENT OF HEALTH AND
HUMAN SERVICES PART 46 PROTECTION OF HUMAN SUBJECTS Revised June 23, 2005 - Effective June 23,
2005 subpart D Additional Protections for Children Involved as Subjects in Research 46.402 under Definitions,
Defines a children as (a) Children are persons who have not attained the legal age for consent to treatments or
procedures involved in the research, under the applicable law of the jurisdiction in which the research will be
conducted.
82. The definitions in §46.402: (b) Assent means a child's affirmative agreement to participate in research. Mere
failure to object should not, absent affirmative agreement, be construed as assent. (c) Permission means the
agreement of parent(s) or guardian to the participation of their child or ward in research.
83. DHHS code states that in section §46.404 Research not involving greater than minimal risk. HHS will conduct
or fund research in which the IRB finds that no greater than minimal risk to children is presented, only if the IRB
finds that adequate provisions are made for soliciting the assent of the children and the permission of their
parents or guardians, as set forth in §46.408.
84. The definitions in §46.102 of subpart A shall be applicable to this subpart as well. In addition, as used in this
subpart: (d) Research means a systematic investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable knowledge. Activities, which meet this definition,
constitute research for purposes of this policy, whether or not they are conducted or supported under a
program, which is considered research for other purposes. For example, some demonstration and service
programs may include research activities.
85. The definitions in §46.102 of subpart A shall be applicable to this subpart as well. In addition, as used in this
subpart: (g) IRB means an institutional review board established in accord with and for the purposes expressed
in this policy. (h) IRB approval means the determination of the IRB that the research has been reviewed and
may be conducted at an institution within the constraints set forth by the IRB and by other institutional and
federal requirements.
86. The definitions in §46.102 of subpart A shall be applicable to this subpart as well. In addition, as used in this
subpart: (i) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or tests.
87. Over 9,000 adverse reactions to the HPV experimental vaccine were reported to the FDA via the Vaccine
Adverse Event Reporting System (VAERS) included over 300 serious life threatening reactions and over 20
deaths which represents a greater danger then the actual disease of cervical cancer in Washington DC . Eight
female died in Washington DC of Cervical cancer in 2007. Over 40 women who received the vaccine while
pregnant, 18 experienced side effects ranging from spontaneous abortion to fetal abnormities.

88. Side effects published by Merck Corporation did warn the public about potential pain, fever, nausea,
dizziness and itching after receiving the HPV vaccine. Over 70% of the adverse reactions reported are typical
side effects to vaccinations. However, other more serious side effects reported include paralysis, Bells Palsy,
Guillain-Barre Syndrome, and seizures, what are not expect encounters during a routine physical or
psychological examination or test. (A true and correct copy of the Merck & CO., Inc Efficacy Report of Gardasil is
attached to this complaint as Exhibit C.)

89. Bells Palsy, Guillain-Barre Syndrome, paralysis and seizures are life-threatening illnesses that are seriously
beyond minimum risk. The potential harm to life has exceeded the potential health benefit for many children who
now suffer conditions were avoidable.

90. Governmental guidelines and organizations were made to report suspected adverse reactions (VAERS) from
medicine and medical treatments to submit on expedited basis, reports of unexpected or serious expected
adverse medicine reaction reports.
91. Detailed Information about the HPV vaccine adverse reaction by the government Vaccine Adverse Events
Reporting System (VAERS) which is apart of the Federal government Department of Health and Human Services
government.
92. The U.S. government (VAERS) records demonstrated that many children were exposed substantially to life
threatening harm and disability caused by using the HPV vaccine than receiving any benefit from the vaccine
causing deprivation of liberty with present and later opportunities in life.
93. Victims suffered from following illness after being injected with Merck’s HPV vaccine Gardasil: Dyspnoea is
difficult or labored breathing; shortness of breath. Syncope is the technical term for fainting. The immediate
cause of loss of consciousness is failure of oxygen supply to the brain, because of failure of adequate blood
flow, due in turn to a severe fall in blood pressure. Vasovagal syncope is Vagal attack a paroxysmal condition
marked by slow pulse, a fall in blood pressure, and sometimes by convulsions, thought to be the result of
sudden stimulation of the vagus nerve mediated through receptors located in the carotid sinus, the aortic arch,
or the heart. A demyelinating disorder associated with transverse myelopathy and optic neuritis. Also called
Devic's disease. Devic's disease, also known as Devic's syndrome, neuromyelitis optica (NMO), or optic-spinal
MS, is an autoimmune, inflammatory disorder in which a person's own immune system attacks myelin of the
neurons of the optic nerves and spinal cord. Blood clot is blood that has been converted from a liquid to a solid
state also called a thrombus. The process by which a blood clot forms is termed coagulation. A blood clot, or
thrombus, is stationary within a vessel or the heart. If it moves from that location through the bloodstream, it is
referred to as an embolus. Blindness is Loss of useful sight. Blindness can be temporary or permanent. Damage
to any portion of the eye, the optic nerve, or the area of the brain responsible for vision can lead to blindness.
The definitions were arrived by using Medterms.com from medicine.net. (A true and correct copy of the VAERS
LINE LIST REPORT is attached to this complaint as Exhibit D) << Back Page Next Page>>