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You are here: Home / NEWS . . . . . . . . / Government Agencies / Testimony against mandatory human papillomavirus (HPV) vaccination of young girls for cervical cancer prevention

Testimony against mandatory human papillomavirus (HPV) vaccination of young girls for cervical cancer prevention

May 12, 2011 By Norma 6 Comments

By Sin Hang Lee, M.D. Pathologist, Milford, Connecticut
Before the DC Department of Health Budget Committee meeting on May 5, 2011

Summary of testimony:

I am a medical doctor practicing hospital pathology for more than 50 years. My residency included training in the1960’s in the laboratory created by Dr. George Papanicolaou in New York Hospital. Using Pap smear to detect precancerous changes for early treatment in the U.S. has reduced the incidence of cervical cancer from 44 in 100,000 women in 1947 to about 5 in 100,000. Now, cervical cancer is a rare disease in the U.S. most among women who have no regular gynecologic health care, especially among new immigrants and the underprivileged. The average cervical cancer patient is about 54 years old. 

I have also introduced a reliable HPV test to further improve the accuracy of Pap smear screening because now we know that HPV infection is a necessary, but not a sufficient cause for cervical cancer.

Mass vaccination of young women for cervical cancer prevention is not cost-effective because all vaccinated women still need post-vaccination Pap cytology screening for possible precancer development since not all cancer-causing HPV genotypes are targeted for protection by Gardasil. Gardasil has not been proven to be an effective vaccine in reducing cervical cancer incidence in clinical trials. The immunity generated by Gardasil vaccination in protection against HPV infection lasts about 4 years. A vaccinated 6th grade student would lose her immunity against HPV infection at 10th grade. The safety and efficacy of the HPV vaccine have not been tested on young girls below age 15.

Because of the nature of the HPV vaccines, Gardasil is associated with high frequencies of allergic/anaphylactic reactions. In fact, it is estimated the rate of anaphylaxis in young women after Gardasil vaccination was 5 to 20 times higher than that identified in comparable school-based vaccination programs. Some of the reactions may be serious, including permanent disability or possible death.

The benefit of mass HPV vaccination for cervical cancer prevention does not outweigh its risk. Supportive evidence is presented as follows. 

(1) Cervical cancer is very preventable by Papanicolaou (Pap) smear screening

Cervix cancer is rare in this country today because most women get regular Pap tests – American Cancer Society [1].

Testimony on Cervical Cancer by Nancy C. Lee, M.D., the then Associate Director for Science, National Center for Chronic Disease and Health Promotion, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services before the House Committee on Commerce, Subcommittee on Health and Environment
March 16, 1999, contains the following passages [2]:

“The main purpose of cervical cancer screening is to find precancerous lesions, treat them, and cure them, so that these women do not go on to be diagnosed with cervical cancer.”

“Cervical cancer occurs at an average age of 54; however, cervical intraepithelial neoplasia (or CIN), the precursor lesion to cervical cancer, most often occurs in much younger women. For a woman with CIN, her likelihood of survival is almost 100 percent with timely and appropriate treatment. The fact that CIN occurs at a younger age tells us that it usually takes a substantial amount of time for cervical cancer to develop.”

In 1947, the incidence of cervical cancer in the U.S. was 44 per 100,000 women, as high as in many underdeveloped countries today. Pap smear screening has reduced the incidence of cervical cancer in the U.S. to the lowest in the world. According to the CDC/NCI Cancer Progress Review dated October 16, 2002, the mortality of cervical cancer continued to decline from 1969 to 1999 for all age groups. The age-adjusted death rate per 100,000 standard population was 2.8 for cervical cancer, compared with 56.5 for lung cancer, 27.1 for breast cancer and 20.9 for colorectal cancer in year 2000 [3].  

In the U.S., immigrant and underprivileged women who face a multitude of barriers to Pap screening and cervical cancer treatment are the major victims of cervical cancer [4].  It is safe to say that the mainstream American women under regular care of their gynecologists do not die of cervical cancer.

(2) HPV testing increases the power to screen out women with high-risk HPV persistent infection

The current etiologic model for the development of invasive cervical cancer highlights infection with high-risk HPV types as a necessary, but not sufficient, cause of cervical cancer. This model also incorporates the role of co-factors, such as smoking, nutritional deficiencies, oral contraceptive (OC) use, and parity status in the development of cancer [5]. A schematic diagram summarizes the three conceptual stages of cervical carcinogenesis after HPV infection is initiated. The precancerous cell changes, including the cervical intraepithelial neoplasia (CIN) lesions, are mostly self-reversible [6]. In 93% of initially infected women the same viral type could not be detected four menstrual cycles later [7]. The median duration of a detectable specific HPV type is 168 days [8]. In its P03-26 News release dated March 31, 2003, the FDA officially stated “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 [9]”  The risk of persistent HPV infection can be successfully followed and managed with an appropriate HPV DNA testing [10, 11].

Based on the existent Pap cytology and HPV screening programs available, mass HPV vaccination of young females contributes very little in further reducing cervical cancer morbidity and mortality in this country. HPV-vaccinated women must continue their regular Pap cytology and HPV screening. The public health policy should focus on offering regular quality gynecological care to all women, including education and screening for cervical precancerous changes.  

(3) HPV vaccine is associated with higher rates of side effects than other childhood vaccines

Genital human papillomavirus (HPV) infection is common, but most infections are confined in the epithelium of the cervix without inducing an effective systemic immune response. This defective immune response facilitates viral persistence, a key feature of high-risk HPV infection. HPV L1 virus-like particle (VLP) vaccines are delivered by intramuscular injection. The highly immunogenic vaccines can elicit high levels of L1-specific serum neutralizing antibodies and immune memory [12]. High levels of L1-neutralizing antibodies are needed to protect against subsequent type-specific HPV infections. However, the highly immunogenic VLPs may also cause more allergy/anaphylaxis in the vaccinated persons. The estimated rate of anaphylaxis in young women after human papillomavirus (HPV) vaccination was significantly higher – 5 to 20 fold – than that identified in comparable school-based vaccination programs [13]. The updated VAERS-reported side effects of HPV vaccines, some resulting from allergy/anaphylaxis, are copied as follows: https://www.sanevax.org/

 

Updated VAERS Reports – HPV Vaccines
Description  Total Female    Male Unknown
Disabled 714 709 1 4
Deaths 94 78 2 14
Abnormal Pap Smear 376 376 N/A N/A
Cervical Cancer 41 41 N/A N/A
Life Threatening 422 412 7 3
Emergency Room Visit 8,733 8,562 93 78
Hospitalized 2,159 2,126 21 12
Extended Hospital Stay 195 193 32 37
Did Not Recover 4,346 4,273 36 37
Adverse Events  21,634  20,866  315 453

 

Comments: Because of the nature of the VLPs, HPV vaccines are associated with higher frequencies of allergy/anaphylaxis reactions than other childhood vaccines. Some of the reactions may be serious, including permanent disability and possible death.

4) Safety and efficacy of HPV vaccine have not been tested among young females below age 15

The quadrivalent vaccine clinical trials against human HPV infection were reported in the FUTURE I and FUTURE II studies.

FUTURE I Study Group. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med. 2007 May 10;356(19):1928-43 [14].

In this series, 5455 women between the ages of 16 and 24 years who had had a lifetime number of no more than four sex partners were studied at 62 study sites in 16 countries.

  • FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915-27. [15]

In this series, 12,167 women between the ages of 15 and 26 years who had had a lifetime number of no more than four sex partners were studied at 90 study sites in 13 countries.

Comments: The FDA has recently rejected approval of Gardasil for women between the ages of 27 and 45 because the efficacy of the vaccine has not been studied in this age group.

http://www.fiercevaccines.com/story/fda-rejects-mercks-gardasil-women-over-27/2011-04-07

By the same reasoning, since the safety and efficacy of the quadrivalent HPV vaccine are totally unknown in women younger than age 15, the vaccine should not be used for women younger than age 15 without additional clinical data. 

5) The quadrivalent HPV vaccine has not been proven as an effective cervical cancer vaccine in any age group 

The endpoint adopted for efficacy evaluation of Gardasil in the clinical trial was cervical intraepithelial neoplasia 2/3 (CIN2/3) or adenocarcinoma in situ (AIS), not cervical cancer [16] as summarized in the FUTURE I [14] and FUTURE II [15] as follows.

 

FUTURE I Clinical Trial Data

 

Table 3

Cervical Lesions with any HPV type According to grade of lesion

 

Total              Vaccine    Placebo             % Efficacy (95%CI)

CIN grade 1              2713               277                 363                 25(12-36)

CIN grade 2              2723               102                 116                 13(<0-34)

CIN grade 3              2723                  79                    72                  -9(<0-22)

AIS                              2723                    1                      6               83(<0-100)

 

 

 

FUTURE II Clinical Trial Data

 

Table 3

Cervical Lesions with any HPV type According to grade of lesion

 

Total       Vaccine          Placebo         % Efficacy (95%CI)

CIN grade 2              6087               149                 192                 22(3-38)

CIN grade 3              6087               127                 161                 21(<0-38)

AIS                              6087                   5                  83                 7(<0-84)

As stated in an NCI report [Castle PE, Stoler MH, Solomon D, Schiffman M. The relationship of community biopsy-diagnosed cervical intraepithelial neoplasia grade 2 to the quality control pathology-reviewed diagnoses: an ALTS report. Am J Clin Pathol. 2007;127:805-815.]:

―.. CIN2 is not a true biologic entity but an equivocal diagnosis of precancer, representing an admixture of HPV infection and percancer. The existence of CIN2 biopsy results as a clinical entity may be the consequence of the inaccuracies of colposcopy and colposcopically directed biosy….. That CIN2 is the least reproducible of all histopathologic diagnoses may in part reflect sample error, ie, the biopsy procedure could make a CIN 1 of HPV infection appear worse by sampling the lesional area diagonally..”

In another NCI report [Castle PE, Schiffman M, Wheeler CM, Wentzensen N, Gravitt PE. Impact of improved classification on the association of human papillomavirus with cervical precancer. Am J Epidemiol. 2010 Jan 15;171(2):155-63.], it was stated:

 “… there is an increasing recognition that CIN 2 is an equivocal diagnosis of precancer, an admixture of HPV infections by both carcinogenic and noncarcinogenic HPV and misclassified CIN 3. Approximately 25%–50% of CIN 2 will regress within a year or 2 years. Although CIN 3 is a better surrogate for invasive potential, it is increasingly clear that it too is heterogeneous. Only a third of CIN 3/carcinoma in situ diagnosed in women with a median age in the late 30s invaded over 30 years…”

Comments: The data in FUTURE I AND FUTURE II studies only demonstrated that HPV vaccine, Gardasil, may be effective in reducing the risk of “not a true biologic entity” lesion (CIN2) and a “heterogeneous” lesion (CIN3). Cervical cancer was not used as an endpoint for evaluation in the clinical trials.

6) The duration of immunity after HPV vaccination is about 4 years

According to NCI Factsheet Human Papillomavirus (HPV) Vaccines

http://www.cancer.gov/cancertopics/factsheet/prevention/HPV-vaccine

                 How long do the vaccines protect against infection?

The duration of immunity after HPV vaccination is not yet known. Phase III clinical trials have shown that Gardasil and Cervarix can provide protection against HPV16 for 4 years.

Comments: If young girls are HPV-vaccinated at 12 years of age, by age 16 when sexual activity starts, the immunity induced by the vaccine against type-specific HPV infection will disappear. 

Related

Filed Under: Government Agencies, HPV, United States Tagged With: testimony opposing mandatory Gardasil vaccination

Comments

  1. Sandy L says

    May 14, 2011 at 1:17 pm

    This excellent Summary of Testimony is both relevant and enlightening.
    ETHICAL ASPECTS REGARDING DEVELOPING COUNTRIES
    Excerpt from the testimony:
    “Based on the existent Pap cytology and HPV screening programs available, mass HPV vaccination of young females contributes very little in further reducing cervical cancer morbidity and mortality in this country. HPV-vaccinated women must continue their regular Pap cytology and HPV screening. The public health policy should focus on offering regular quality gynecological care to all women, including education and screening for cervical precancerous changes”.

    In the case of developing countries it is ethically questionable that mass vaccination be promoted, when it is known that there are often poor resources regarding screening, monitoring and gynecological care in general.

    PRE-TESTING IS NECESSARY
    It is crucial to test for HPV before vaccination. It is stated in FDA VRBPAC documents that exposure to HPV prior to vaccination with Gardasil increases cervical cancer risk by 44.6% and by 32.5% for Cervarix.

    With this in mind and the knowledge that most women are exposed to HPV, it is difficult to understand the logic regarding FDA’s refusal regarding promotion of Gardasil for older women in US, yet granting permission for Canada.

    MONITORING AND HPV GENOTYPING
    Differences in types of HPV virus strains have been found between countries and regions.

    Vaccine monitoring should include investigation of the HPV genotypes which cause cervical precancerous lesions and cancers after introduction of HPV vaccination programs. This will indicate the effectiveness of the vaccines.

    DNA sequencing-based methods should be employed for reliable HPV genotyping.

    WILL HPV VACCINES INCREASE THE RISK OF CANCER?
    The manufacturer of Gardasil, Merck, specifies in the package insert that the vaccine has not been tested for carcinogenic properties. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111263.pdf
    “13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
    GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity”.

    Replacement, a normal phenomenon in virology, will occur: Virus strains which are removed by the vaccine are replaced by new ones. Immunologist Charlotte Haug, editor of The Journal of the Norwegian Medical Association stated in a presentation at 1st Nordic Gynecologic Meeting on HPV Vaccine:

    “ If the vaccine is effective, viral replacement will take place. The question is whether the strains replacing HPV 16/18 will cause more or less disease”.

    (The incorrect term “cancer vaccines” which is sometimes used for HPV vaccines may be tragically burdened with ironic truth).

    REPORTING OF ADVERSE EVENTS
    Adverse events which are registered in VAERS, although significantly more than those associated with other childhood vaccines, still represent less than 10 per cent of the actual numbers.
    The reporting of adverse events is formulated as such in the package insert:
    “ To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or VAERS at 1-800-822-7967 or www. vaers.hhs.gov”.

    The fact that contact information is given first for the manufacturer is unsatisfactory and may potentially influence statistics for adverse events.

    FALSE PLACEBO
    It is important to note that during clinical trials of Gardasil more than 90% of the ‘placebo’ subjects received an aluminum-containing placebo.
    This obscures the true rate of adverse experiences because aluminum is toxic.
    Using the toxic placebo during trials makes Gardasil appear to be safer than it really is.

    CO-ADMINISTRATION INCREASES RISK OF ADVERSE EVENTS
    There is no empirical evidence to show that giving Gardasil in combination with any other vaccine is safe. Over 80 percent of Gardasil adverse event reports to VAERS involve co-administration with one or more vaccines. Co-administration with Menactra appears to be especially risky.

    NEW MEDICAL CONDITION ACQUIRED BY 73 PER CENT OF THE VACCINATED
    Information regarding clinical trials reveals that 73.3% of participants who received Gardasil acquired a new medical condition.

    CONGENITAL ABNORMALITIES
    The approval letter from FDA to Merck, which refers to an agreement between Merck and the Norwegian authorities:
    http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm111283.htm

    Quote from section 3:
    “You have committed to conduct a study in collaboration with the Norwegian Government, if GARDASIL ® is approved in the European Union and the Government of Norway incorporates HPV vaccination into its national guidelines, to assess the impact of HPV vaccination on the following in Norway:
    The long-term burden of HPV disease including the incidence of HPV 6/11/16/18-related cervical disease;
    a. The long-term burden of HPV disease caused by types other than HPV 6/11/16/18;
    b. The overall incidence of cervical HPV disease;
    c. The incidence of HPV-related cancers and pre-cancers (CIN 2/3, AIS and cervical cancer; VIN 2/3 and vulvar cancer; and VaIN 2/3 and vaginal cancer);
    d. The interaction between administration of GARDASIL ® and pregnancy outcomes, especially congenital anomalies, by linking the vaccination registry with the Medical Birth Registry”.
    It is unknown whether Gardasil will increase the risk of congenital abnormalities.

    BLOOD CLOTS
    Hormonal contraceptives and Gardasil are separately suspected of causing increase in risk for blood clots. It is relevant to ask whether the combination may magnify this risk.
    The package insert for Gardasil only mentions oral contraceptives with respect to immune response, not to safety:
    “Use of hormonal contraceptives or lack of use of hormonal contraceptives among study participants did not alter immune response in the per protocol efficacy (PPE) population”.
    http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm179549.htm
    “Thromboembolic disorders (blood clots) have been reported to VAERS in people who have received Gardasil. Most of these individuals had risk factors for blood clots such as use of oral contraceptives which are known to increase the risk of clotting”.
    It appears that in the case of blood clots resulting after taking both Gardasil and oral contraceptives, one may risk that both manufacturers blame each other. This could possibly minimize possibility for legal compensation for injury.
    POSSIBLE BRAIN DAMAGE
    Polysorbate 80/Tween 80 is an emulgent which renders the blood-brain barrier more porous and is present in certain injections in connection with drug targeting. When it is desirable for specific drugs, for example chemotherapeutic or psychiatric drugs to gain contact with brain tissue and act locally, polysorbate 80 is included in order to facilitate passage of the drugs through the barrier and into the brain tissue.
    This characteristic of polysorbate 80 is extremely undesirable regarding Gardasil, when it may facilitate passage of toxic aluminium through the blood-brain barrier and into the brain tissue.
    ALUMINIUM
    Along with 150 microgram polysorbate 80 in Gardasil recipients will receive other substances resulting in a total of 675 microgram aluminium and 105 microgram sodium borate, both highly toxic substances when injected. Aluminium is also controversial with regard to numerous other potential adverse events:
    http://www.ncbi.nlm.nih.gov/pubmed/19004564
    Excerpt from the above link: “This case has highlighted potential dangers associated with aluminium-containing adjuvants and we have elucidated a possible mechanism whereby vaccination involving aluminium-containing adjuvants could trigger the cascade of immunological events which are associated with autoimmune conditions including chronic fatigue syndrome and macrophagic myofasciitis”.
    CONCLUSION
    Regarding HPV vaccines there is no evidence that possible benefits outweigh the considerable risks.

    Reply

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  3. Kyle Nopeman says:
    May 15, 2011 at 7:48 am

    Я извиняюсь, но, по-моему, Вы не правы. Я уверен. Пишите мне в PM, обсудим….

    By Sin Hang Lee, M.D…..

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    […] It can be excellent to bear in mind that the sooner the warts are treated, the less severe they will become and much simpler to get rid of. Also, maintaining a strong immune program and staying healthy are crucial, given that the ailment is viral. While this medical condition is uncomfortable and embarrassing, the availability of a lot of cures nowadays makes it much more manageable and bearable though as noted there are no cures for genital warts. Related BlogsTestimony against mandatory human papillomavirus (HPV) vaccination of young girls for cervical cance… […]

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