FDA and HPV — when did they know the truth? This is Fraud Folks!!
FDA and HPV — when did they know the truth?
Cynthia A. Janak
Cynthia A. Janak
December 12, 2007
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>
Self-limiting-Function: adjective Date: 1863, : limiting oneself or itself; especially of a disease : SELF-LIMITED Function: adjective Date: 1845, : limited by one’s or its own nature; specifically : running a definite and limited course self — limited disease>
What I am going to do is quote segments of this document and highlight what I consider is important to the average person. I know this is going to be long but to summarize would be an injustice to the authors of this document.
VI. Statement of the basis for disagreement with the present classification status
[21 CFR § 860.123(a)(5) ]
The basis of this reclassification request is that the present regulatory classification of HPV DNA tests as devices intended for use in identifying and typing HPV infection to stratify women at risk for cervical cancer, thus assigned to class III, requiring submission and approval of PMAs , is no longer appropriate because continued designation of low-to-moderate risk HPV DNA test devices as class III devices contradicts the current understanding of HPV infection and its relationship to the development of cervical cancer. Based on new scientific information published in the past 15 years, it is now generally agreed that identifying and typing HPV infection does not bear a direct relationship to stratification of the risk for cervical cancer. Most acute infections caused by HPV are self-limiting [1, 4-7]. It is the persistent HPV infection that may act as a tumor promoter in cancer induction [8-11]. Identifying and typing HPV is an important tool for following patients with persistent HPV infection. Repeated sequential transient HPV infections, even when caused by “high-risk” HPVs, are characteristically not associated with high risk of developing squamous intraepithelial lesions, a precursor of cervical cancer.
A woman found to be positive for the same strain (genotype) of HPV on repeated testing is highly likely suffering from a persistent HPV infection and is considered to be at high risk of developing precancerous intraepithelial lesions in the cervix. It is the persistent infection, not the virus, that determines the cancer risk.
The FDA has accepted the above interpretation of current medical science, as reflected in its March 31, 2003 announcement on approval of the Digene HC2 High-Risk HPV DNA Test while making the following public statements on record [I] :
“The FDA today approved expanded use of a laboratory test to detect the presence in women of human papillomavirus (HPV), one of the most common sexually transmitted infections .”
“The HPV DNA test does not test for cancer, but for the HPV viruses that can cause cell changes in the cervix . If left untreated, these changes can eventually lead to cancer in some women.”
“Most women who become infected with HPV are able to eradicate the virus and suffer no apparent long-term consequences to their health . But a few women develop a persistent infection that can eventually lead to pre-cancerous changes in the cervix.”
“. . .most infections are short-lived and not associated with cervical cancer.”
The present regulatory control of all HPV DNA in vitro tests as class III devices should be reviewed and the present classification status of this type of devices should be subjected to reclassification according to 21 CFR §860 .3 (c) to conform with the current interpretation by the FDA of medical science on this subject, in the spirit of the Federal Food, Drug, and Cosmetic Act promulgated by the agency to bring safe and effective new technologies to the market timely in a fashion consistent with the least burdensome principles of the FDAMA of 1997.
I paragraph one I quoted, “Based on new scientific information published in the past 15 years, it is now generally agreed that identifying and typing HPV infection does not bear a direct relationship to stratification of the risk for cervical cancer. Most acute infections caused by HPV are self-limiting [1, 4-7]. It is the persistent HPV infection that may act as a tumor promoter in cancer induction [8-11].”
What we have here is proof that there is scientific evidence that has been published in the past 15 years that states that HPV infection does not bear a direct relationship to the forming of cervical cancer. It also tells us that HPV, if allowed to will be taken care of by our own body’s natural processes. “. . .most infections are short-lived and not associated with cervical cancer.” With this being said, why do we need Gardasil when our own body is more than capable of eradicating HPV? What we need is a government policy to assist women with the cost of getting follow-up tests when persistent HPV infection is present. This would make more sense and our government would save so much money on these types of programs instead of $360 each for the Gardasil vaccination.
The other thing is that the FDA took this to be fact on March 31 of 2003. This is way before the 2006 approval of Gardasil. This just proves to me that the FDA knew that Gardasil was not necessary and that a more sensitive type of testing was all that was required.
Dr. Sin Hang Lee, M.D., felt that he had such a device. When I read this I felt like this Dr. was being stonewalled in getting this device approved appropriately by the FDA because it would show that Gardasil was dangerous and not necessary. That would hurt Merck in its requirement for money to pay for the VIOXX settlements.
History of the HPV DNA Nested PCR Application
On October 30, 2006, the undersigned, Sin Hang Lee, M.D., a practicing pathologist wrote a letter  to Dr. Steven I . Gutman, Director, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), Center for Devices and Radiological Health (CDRH), FDA, enclosing the manuscript of a scientific report titled “Human Papillomavirus Genotyping by DNA Sequencing- The Gold Standard HPV Test for Patient Care”  which was submitted to a professional journal to be considered for publication . The purpose of the letter was to inform the FDA that a more sensitive and more specific device is being introduced for detection of HPV in clinical samples and for preparation of materials for HPV genotyping and to request advice and guidance from the agency for making this device available to hospital laboratories at the point of care. With this letter and manuscript, the FDA was informed of the need for a new generation of HPV testing based on new information available because:
1) A sensitive HPV detection device that can provide accurate genotyping information is needed for following patients with persistent infection that is now recognized to be the tumor promoter in cancer induction.
2) A PCR-based HPV detection device with provision for accurate HPV genotyping is more urgently needed now because vaccination with GardasilTM of the women who are already sero-positive and PCR-positive for vaccine-relevant genotypes of HPV has been found to increase the risk of developing high-grade precancerous lesions by 44.6%, according to an FDA VRBPAC Background Document : GardasilTM HPV Quadrivalent Vaccine . May 18, 2006 VRBPAC Meeting. www.fda.izov/ohrms/dockets/ac/06/briefing/2006-4222B3 .
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 , 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  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 , 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 . The median duration of positivity detectable by PCR for a specific HPV type in these young women is 168 days . 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 . 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 . High-grade SIL is often associated with a viral DNA load lower than that observed in less severely affected cells .
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 , 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 verb 1: to form, deposit, or arrange in strata
Squamous — Function: adjective 1 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
All definitions were found at the Merriam-Webster website. http://www.merriam-webster.com
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.
Definition is from the Women’s Health Center a feature of Discovery/Health. http://health.discovery.com/centers/womens/womens.html
Please go to http://www.fda.gov/ohrms/dockets/dockets/07p0210/07p-0210-ccp0001-01-vol1.pdf page 60 document page 58 for all the reference material that was used in this report.
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 <!– var email = ‘cj1951’+’@’; document.write(‘‘); //–> cj1951@<font style=”display:none”><NOSPAM></font>ameritech.net <!– document.write(‘‘); //–>
© Copyright 2007 by Cynthia A. Janak
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