First, I want to say thank you to everyone reading my articles. Your emails
show me your curiosity and concern about what is happening in the world today
warms my heart.
In my last article about Gardasil I quoted a document that I found on the FDA
website called the "Reclassification Petition for Human Papillomavirus (HPV)
DNA, Nested Polymerase Chain Reaction (PCR) Detection" published March 7,
2007.
What I have done is read all 68 pages of this document. What I am going to
show you is that the FDA knew back in 2003 that a HPV is not the actual cause
of cervical cancer. The actual cause is a "persistent HPV infection
that may act as a tumor promoter in cancer induction [8-11].
I want you to take note of "persistent HPV infection" and "self-limiting."
These terms are stated throughout the document and very important to what I am
going to show you. Here are the definitions. At the end of the document I will
have further definitions of some of the terms that are used in this document.
Persistent-Function: adjective Etymology: Latin persistent-,
persistens, present participle of persistere Date: 1826, 1:
existing for a long or longer than usual time or continuously: as a:
retained beyond the usual period persistent leaf>
Without a response from Dr . Gutman or from the OIVD, the petitioner
submitted a S 10k application (K063649) on December 7, 2006, identifying
Hybrid Captures 2(hc2) High-Risk HPV DNA Test (Digene hc2) manufactured by
Digene Corporation, 1201 Clopper Road, Gaithersburg, MD 20878 as the predicate
device.
A letter dated January 9, 2007 from the FDA in response to the K063649
submission, signed by Sally A. Hojvat, M.Sc., Ph.D., Director, Division of
Microbiology Devices, OIVD [3], stating:
"We have determined that your type of device is classified as a class III
device by the approval order for the VRAPAP Human Papillomavirus DNA detection
Kit dated December 23, 1988" and "Section 515(a)(2) of the Act requires a
class III device to have an approved PMA before it can be legally marketed,
unless the device is reclassified."
On January 18, 2007, the petitioner submitted a Request for Evaluation
of Automatic Class III Designation under Section 513(f)(2) of the FDCA (the
Act), but was advised by the Office of Device Evaluation on February 22,
2007 to withdraw the 513(f)(2) submission and resubmit this petition under
Section 513(f) .
Historically, HPV testing [15] was introduced to compensate for the poor
sensitivity and specificity of the Pap smear cytology often used as a
diagnostic tool for borderline precancerous lesions. The only FDA approved
Digene Hybrid Capture 2 (HC2) assay is commonly used to determine if a
cervicovaginal lavage sample harbors "high-risk" HPVs [16], as an adjunctive
test for evaluation of the cytologically borderline cases [17-19] .
However, it is now recognized that persistent infection of a "high-risk" HPV,
not the HPV virus itself, is the pivotal promoter in causing cervical
precancerous lesions and cancer [7-10] . Most of HPV infections, even
caused by "high-risk" genotypes, are transient with normal Pap cytology in
sexually active young women [1, 3-6]. In 93% of the initially infected
women, the same viral type is not detected upon re-examination four menstrual
cycles later [20]. The median duration of positivity detectable by PCR for
a specific HPV type in these young women is 168 days [21]. Multiple
"high-risk" HPV infections do not constitute a higher risk for the development
of cervical neoplasia when compared with single high-risk HPV infection [22].
For the development and maintenance of a high-grade squamous intraepithelial
lesion (SIL), the risk is greatest in women positive for the same genotype of
HPV on repeated testing [7-9]. Viral load is not a useful parameter to predict
high-grade SIL [23]. High-grade SIL is often associated with a viral DNA load
lower than that observed in less severely affected cells [24].
I am going to run some numbers for you. If 93% of the women that are infected
receive the Gardasil vaccine it could increase the risk of cervical cancer by
44.6%. Presently, 50,000 women are diagnosed with cervical cancer a year in
developed countries. This means if you increase that number by 44.6% you will
have 82,956 women that could be at risk of being diagnosed with cervical
cancer in the industrial nations of the world. These numbers are staggering.
This could mean that 32,956 additional women will have to go through the
horrors of cervical cancer. This also means that their families will have to
watch as their mother, sister, grandmother, aunt or friend goes through the
procedures necessary because of the disease. I would not wish this on my worst
enemy.
...PCR-based HPV DNA tests have not been introduced into the clinical
laboratories for assisting patient management in the U.S.A. due to the present
FDA regulatory control by which this "type of device is classified as a class
III device by the approval order for the VIRAPAP Human Papillomavirus DNA
detection Kit dated December 23, 1988 [2, 3] . The regulatory arm of the
FDA has resorted to invoking an approval order issued before the HPV PCR
technology was developed to block all PCR-based HPV DNA detection assays
by assigning them a class III status, requiring PMA submission for their
approval. The burden put on the industry in fulfilling the requirements for
a PMA submission to clear a qualitative HPV DNA detection assay at the FDA is
enormous...
Here Dr. Lee is trying to get approval of a new device that is more accurate
but in my opinion the FDA is trying to stonewall his efforts and continue with
a device that is outdated. Is the FDA trying to tell us that our scientists
are so inept that they cannot invent something better in 19 years??? Could
this be because Gardasil is the fatted calf of Merck? These are the questions
that I have.
As a result, few or no manufacturers are willing to invest in PMA
submissions in order to introduce a PCR-based technology for HPV DNA
detection. Assigning a class III classification and requiring PMA
application for a new HPV DNA detection device can only serve to suffocate
new technologies that may compete with the outdated inaccurate
FDA-endorsed Digene HC2 assay. The major reason for which the PCR-based
HPV DNA detection device should not be classified into its present class III
classification is to remove the regulatory roadblock for the FDA to allow the
introduction of "safe and effective new technologies to the market quickly"
as promulgated in a statement made by former FDA commissioner Mark B
McClellan, M .D. Ph.D.
(1) The summary of the current scientific data by the National Cancer
Institute (NCI) in its official document labeled Fact Sheet on HPV,
reviewed and updated on 06/08/2006 [66], further supports the
conclusions that even the so-called "high-risk" HPV genotypes pose only a low
risk to the impairment of human health and that HPV assays are adjunctive
or additional in nature to the Pap test and biopsy, the two pivotal in vitro
tests to screen and diagnose precancerous cervical conditions. The relevant
paragraphs in this NCI document supporting these conclusions are quoted as
follows .
"Most HPV infections occur without any symptoms and go away without any
treatment over the course of a few years. However, HPV infection sometimes
persists for many years, with or without causing cell abnormalities. "
"Some types of HPV are referred to as "low-risk" viruses because they rarely
develop into cancer. HPV types that are more likely to lead to the development
of cancer are referred to as "high-risk. " Both high-risk and low-risk types
of HPV can cause the growth of abnormal cells, but generally only the
high-risk types of HPV may lead to cancer. Sexually transmitted,
high-risk HPVs include types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59,
68, 69, and possibly a few others. These high-risk types of HPV cause
growths that are usually flat and nearly invisible, as compared with the warts
caused by types HPV-6 and HPV-11 . It is important to note, however, that
the majority of high-risk HPV infections go away on their own and do not cause
cancer . "
"Having many sexual partners is a risk factor for HPV infection.
Although most HPV infections go away on their own without causing any type of
abnormality, infection with high-risk HPV types increases the chance that mild
abnormalities will progress to more severe abnormalities or cervical cancer.
Still, of the women who do develop abnormal cell changes with high-risk
types of HPV, only a small percentage would develop cervical cancer if the
abnormal cells were not removed. Studies suggest that whether a woman
develops cervical cancer depends on a variety of factors acting together with
high-risk HPVs . The factors that may increase the risk of cervical cancer in
women with HPV infection include smoking and having many children . "
" What tests are used to screen for and diagnose precancerous cervical
conditions? A Pap test is the standard way to check for any cervical cell
changes. A Pap test is usually done as part of a gynecologic exam. The U. S.
Preventive Services Task Force guidelines recommend that women have a Pap test
at least once every 3 years, beginning about 3 years after they begin to have
sexual intercourse, but no later than age 21 .
Because the HPV test can detect high-risk types of HPV in cervical cells, the
FDA approved this test as a useful addition to the Pap test to help health
care providers decide which women with ASC-US need further testing, such as
colposcopy and biopsy of any abnormal areas. (Colposcopy is a procedure in
which a lighted magnifying instrument called a colposcope is used to examine
the vagina and cervix. Biopsy is the removal of a small piece of tissue for
diagnosis.) In addition, the HPV test may be a helpful addition to the Pap
test for general screening of women age 30 and over . "
Here are some of items of interest from the above statement from the National
Cancer Institute.
"Most HPV infections occur without any symptoms and go away without any
treatment over the course of a few years" I found this to be interesting
because even the National Cancer Institute believes, for the most part, that
HPV will just go away. Interesting. Monitoring the HPV seems to be the most
evasive way to go. Injecting our bodies with more chemicals will just damage
our fragile immune system.
This next item is of significance. Here is a list of "high-risk HPVs
include types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 69, and
possibly a few others." Gardasil only addresses two, 16 and 18. What about
the rest of them? Don't they count? They are all high-risk types.
This last one is my favorite. "many sexual partners is a risk factor for
HPV infection." Even the National Cancer Institute sees that having many
sexual partners is hazardous to your health. Here is another instance of where
abstinence is best in preventing disease. Should not our schools be teaching
abstinence instead of condom use? My answer is yes! Preventing HPV is a
really good reason in my opinion.
What I have quoted above has been taken from the first 27 pages of the
document. There are 68 pages to this document and I will inform you about the
rest of the contents in a later article. It is a very interesting read.
Here are the definitions to some of the more technical terms.
Stratification — Function: noun Date: circa 1617, 1 a:
the act or process of
stratifying — Function: verb Inflected Form(s):
strat•i•fied; strat•i•fy•ing Etymology: New Latin stratificare,
from stratum + Latin -ificare -ify Date: 1661, transitive
verb1: to form, deposit, or arrange in
strata
Squamous — Function: adjective1 a : covered with or
consisting of scales b : of, relating to, or being a stratified
epithelium that consists at least in its outer layers of small scalelike cells
Intraepithelial- Function: adjective: occurring in or
situated among the cells of the epithelium
Epithelium-Function: noun: a membranous cellular tissue
that covers a free surface or lines a tube or cavity of an animal body and
serves especially to enclose and protect the other parts of the body, to
produce secretions and excretions, and to function in assimilation
Squamous intraepithelial lesion (SIL). This change is considered
precancerous. SIL changes are divided into two categories: low-grade SIL and
high-grade SIL.
Low-grade SIL refers to early changes in the size, shape and number
of cells on the surface of the cervix. Most of these lesions return to
normal on their own without treatment. Others, however, may continue to grow
or become increasingly abnormal in other ways and develop into a high-grade
lesion.
Other terms for low-grade SIL are mild dysplasia or cervical intraepithelial
neoplasia 1 (CIN 1). According to the National Cancer Institute, these
precancerous changes occur most often in women ages 25 to 35, but can appear
in other age groups, as well.
Generally, your health care professional will recommend a diagnostic test as
a follow-up if your test is categorized as low-grade SIL/CIN I, including
colposcopy and biopsy.
High-grade SIL. Cells in this category look very different from
normal cells and are less likely to return to normal without treatment and
more likely to develop into cancer. These abnormal cellular changes are
still confined to the surface of the cervix only and still are considered
precancerous changes. High-grade SIL is most common in women age 30 to 40,
but can occur in other age groups, as well.
Other terms for high-grade SIL are moderate or severe dysplasia (CIN 2 or
CIN 3) carcinoma in situ.
Follow up for high-grade SIL/CIN 2 or CIN 3 involves additional procedures,
including biopsy, to determine the degree of abnormality and rule out
invasive cancer.
I hope that you found the information that I presented today to be most
informative in making your decision in regards to being vaccinated with
Gardasil.
May your God bless you and you are in my prayers.
Cynthia Janak is a freelance journalist, mother of three, foster mother of
one, grandmother of five, business owner, Chamber of Commerce member. Her
expertise is as an administrative professional. Her specialties are adoptee
and genealogy research and research journalism. Hobbies: Writing prose,
crocheting, Conservative Studies, and rehabbing houses. You can contact
Cynthia Janak at
cj1951@ameritech.net