What Every Parent Should Know About Gardasil
Take Back Your Health
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Gardasil, the new human papillomavirus (HPV) vaccine that has been heavily advertised by its manufacturer, Merck, and
possibly made mandatory for girls entering the sixth grade, has been criticized as being untested, unproven, and even
unsafe by countless in the medical field.
Diane M. Harper, a lead researcher, scientist, physician, professor and former director of the Gynecologic Cancer
Prevention Research Group at the Norris Cotton Cancer Center at Dartmouth Medical School who spent 20 years
developing the vaccine for human papillomavirus says the HPV vaccine is not for younger girls, and that it is "silly" for
states to be mandating it for them. Internationally recognized as a pioneer in the field, Harper does not believe there
has been adequate studies documenting the vaccine’s safety for young girls saying, "Giving it to 11-year-olds is a great
big public health experiment.” [1]
The following information has been gathered to help parents understand what the vaccine is said to protect against and
why the controversy exists surrounding the Merck vaccine.
HPV Alone Insufficient to Cause Cancer
According to the National Cancer Institute, Human papillomaviruses (HPVs) are a group of more than 100 viruses.
Some types of HPV are associated with certain types of cancer. These are called "high-risk" oncogenic or carcinogenic
HPVs. Of the more than 100 types of HPV, over 30 types can be passed from one person to another through sexual
contact. About 6 million new genital HPV infections occur each year in the United States. Most HPV infections occur
without any symptoms and go away without any treatment. [2]
In the majority of women with cervical cancer, HPV is also present; however, it is unknown whether it is the HPV that
actually caused the cancer or whether the cancerous cells supply the body with a breeding ground for certain HPV
strains. During discussions at the FDA, however, it was admitted that HPV alone is insufficient to cause cancer, meaning
that additional factors must be present for cancer to appear.
Dr. Elizabeth Unger of the Centers for Disease Control stated, "So it is believed that infection alone is insufficient to
cause cancer, and additional factors are required for neoplasia. There are certainly lots of questions about HPV
infection…" [3]. The prominent medical text book, Cancer: Principles & Practice of Oncology whose editors include Dr.
Vincent DeVita, Jr. who was President of the National Cancer Institute and Dr. Steven Rosenberg, Chief of Surgery at
the National Cancer Institute agrees. According to this text, "HPV infection is not sufficient for cervical carcinogenesis.”
[4]
A study estimating the American population prevalence of HPV infection published in the Feb 28, 2007 edition of the
Journal of the American Medical Association found that only 3.4% of women aged 14—59 yrs were infected with one of
the HPV types in Gardasil and only 2% were infected with one of the two types that are in the vaccine and are associated
with cervical cancer. [5]
The Center for Disease Control states the prevalence of the types of infections with HPV (6, 11, 16 or 18, the types
prevented by Gardasil), at under 1.6 percent. Although HPV is certainly widespread in the population, the vast number
of people who contract it "will not have any symptoms and will clear the infection on their own" to quote the Centers for
Disease Control. In fact, approximately 90% of women with new HPV infections clear the infection within 2 years. [6]
An infection that almost always causes no symptoms and clears up on its own is hardly a cause for alarm, still less for a
campaign of mandatory vaccination aimed at schoolchildren. There have been calls for the universal vaccination of
American males as well; however, the CDC states that it does not yet know if the vaccine is effective at all in boys or
men.
What is Cervical Cancer?
Cervical cancer is cancerous growth in tissues of the cervix (the organ connecting the uterus and vagina). It is usually a
slow-growing cancer that may not have symptoms but can be found with regular Pap tests (a procedure in which cells are
scraped from the cervix and looked at under a microscope). According to the American Cancer Society, between 1955
and 1992, the number of cervical cancer deaths in the United States dropped by 74%, in large part due to the increased
use of the screening test and condoms. The death rate continues to go down by about 4% per year. Half of the cases of
cervical cancer occur between the ages of 35 and 45. It is rare under age 20. [7]
The American Cancer Society also reports that cervical cancer is responsible for about 1% of cancer deaths per year.
Some claim that this low number is due to effectiveness of routine Pap screening, which results in the detection and
treatment of pre-cancerous lesions so that they never get to the cancer stage. Nutritional deficiencies, especially vitamin
A and folate, mineral deficiency (zinc, selenium, calcium and iron), smoking, and birth control use have been shown to
be associated with cervical cancer.
HPV infection is highly associated with cervical cancer, yet there remains debate as to whether the virus actually causes
cancer. Some cervical cancers don't have associated HPV, and most people infected with HPV do not get cancer, so HPV
cannot be the full cause of cancer. Some researchers and FDA scientists wonder if the abnormal cells (cancerous or pre-
cancerous) may simply be a friendly environment for viruses to grow around, so the virus infection may occur after the
changes that cause cancer rather than the other way around. Smoking has more to do with the progression of HPV
infection to cervical cancer than any other single factor. Smokers with HPV go on to develop cervical cancer much more
frequently than infected non-smokers. [8]
The vast majority of abnormal Pap tests do not equate to cancer. Even abnormal Pap tests showing pre-cancerous cells of
the CIN (cervical intraepithelial neoplasia) II grade clear by themselves with no treatment 40% of the time. Treatment
of pre-cancers has limited the progression to cancer to only 1%. This means that Gardasil is coming out at a time when
cervical cancer is already on the decline. [8]
Cancer data show that lawmakers looking to force pre-teen girls to take Gardasil, the lone vaccine on the market, are
targeting the wrong age group. Middle-school girls inoculated with the vaccine will be no older than 18 when they pass
Gardasil's five-year window of proven effectiveness -- more than a decade before the typical cancer patient contracts
HPV, according to a Washington Times article. [9] Moreover, the Gardasil monograph states: "efficacy of the vaccine in
this age group [9—13 yr olds] has not been demonstrated". Due to the unknown duration of efficacy in older women, the
benefit of Gardasil to 9—13 year olds is even more dubious. [10]
Infectious disease specialists and cancer pathologists say the incubation period for HPV becoming cancer is 10 to 15 years
-- meaning the average cervical cancer patient, who is 47, contracted the virus in her 30s and would not be protected by
Gardasil taken as a teen. [11]
Does the Vaccine Work?
It must be recognized that all human studies submitted to the FDA were done by or financed by the drug manufacturer.
These studies have limited to no independent scientific review. In fact, it takes a formal Freedom of Information Act
request to obtain the exact study reports and statistical analyses that the drug manufacturer gave to the FDA. Gardasil
is Merck's first big drug development since the highly-publicized Vioxx scandal. The basis for many Vioxx lawsuits is
that Merck withheld information that clearly showed the dangers of the drug but pushed for its release anyway. The
Vioxx scandal also revealed that the FDA may not be so trustworthy either. FDA insiders exposed how the agency
deliberately ignored abundant test information showing that Vioxx was dangerous to cardiac patients. The systemic
failure of the FDA to weigh the risks and protect the public without undue influence of the manufacturers was brought to
light by Vioxx but it has not yet led to any meaningful changes at the agency.
In spite of thousands of Vioxx liability suits still unresolved, Gardasil has gotten fast track FDA approval. The FDA
approved the drug through their “priority review process” which takes six months or less and is used for medication with
the “potential to provide significant health benefits.” There is no question that clinical trials have proven effective in
preventing certain strains of HPV infection, however, given the lack of proper research, it seems all too soon to be
approving a drug that could also potentially cause long-term harm to our children.
Since HPV is found in connection with most cervical cancers, the theory was that a vaccine against HPV would prevent
cervical cancer. However, the vaccine studies couldn't demonstrate this, simply because there were no cases of cervical
cancer in the vaccinated group or in the group that received placebo shots. So they used a substitute measure (a
'surrogate marker') for cancer. They compared abnormal pre-cancerous Pap results in people who were vaccinated versus
not vaccinated.
The vaccine is nearly 100% effective in preventing four types of HPV infection. Two of the four subtypes included in the
vaccine are currently responsible for 70% of cervical cancer. So we would expect a 70% reduction in precancerous Pap
results, right? Pre-cancerous Paps only went down by 12% to 45%, depending on which population was studied. [12]
Why didn't the vaccine cause a 70% reduction in pre-cancers in the general population?
Moira Terese Dolan, M.D. states, “Gardasil's reduction of pre-cancers by 12.2% to 16.5% in the general population
would mean that instead of 30 to 40 cases of cancer per million, there would only be 26 - 35 cancers. So it would take
vaccination of a million girls to prevent cancer in 4 to 5 girls. About 37% die from cervical cancer, so that would prevent
1 to 2 deaths. So $360 million in vaccine would prevent 1 to 2 deaths.” [13] This statistic does not take into account the
potential deaths (3 already reported to the Vaccine Adverse Event Reporting System) that the vaccine could actually
cause.
Cervical cancer is generally a slow-growing tumor, and the test period for Gardasil was not a lengthy one. Therefore it is
not surprising that not a single case of cervical cancer occurred in the test groups during the clinical trials. In the trials,
the development of genital warts and CIN (cervical intraepithelial neoplasia) were used as "stand-ins" for cervical cancer
- but that is not the same thing as truly demonstrating the prevention of cervical cancer.
Even the FDA has been forced to admit that. The best they can do now is side-step the issue by saying, "It is believed
that prevention of cervical precancerous lesions is highly likely to result in the prevention of these cancers.” [14] So,
are we now mandating vaccines for half the population based on an unproven premise that is 'believed' to be 'highly
likely'? Where is the science in that?
Unfortunately, this is all conjecture. In the Merck studies the follow up was too short and the numbers too few to prove
prevention of cervical cancer.
What are the Side Effects?
Documents obtained from the U.S. Food and Drug Administration under the provisions of the Freedom of Information
Act, detail 1,637 reports of adverse reactions to Gardasil reported to the Vaccination Adverse Reporting System
(VAERS). [15] Three deaths are seemingly related to the vaccine although the FDA’s spokesperson stated that these
deaths were probably unrelated. One physician’s assistant reported that a female patient “died of a blood clot three
hours after getting the Gardasil vaccine.” Two other reports, on girls 12 and 19, reported deaths due to heart problems
and/or blood clotting. [16]
As of May 11, 2007, the 1,637 adverse vaccination reactions reported to the FDA via VAERS included 371 serious
reactions. Of the 42 women who received the vaccine while pregnant, 18 experienced side effects ranging from
spontaneous abortion to fetal abnormities. [17]
Side effects published by Merck & Co. warn the public about potential pain, fever, nausea, dizziness and itching after
receiving the vaccine. Indeed, 77% of the adverse reactions reported are typical side effects to vaccinations. But other
more serious side effects reported include paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures.
So far more than 40 cases of Guillain-Barre syndrome - a dangerous immune disorder that causes tingling, numbness
and even paralysis of the muscles have been reported in girls who have received the HPV vaccine. [18]
VAERS is a passive surveillance system and depends upon voluntary reporting of serious health problems following
vaccination, even though safety provisions in the National Childhood Vaccine Injury Act of 1986 mandated that health
care providers report vaccine adverse events. There have been estimates that fewer than 10 percent, even as low as 1 to 4
percent, of adverse events which occur after prescription drug or vaccine use are ever reported to government adverse
event reporting systems. [19] [20] [21] [22]
"If only 1 to 4 percent of all adverse events associated with Gardasil vaccination are being reported to VAERS, there
could have been up to 38,000 health problems after Gardasil vaccination in 2006 which were never reported," said
National Vaccine Information Center President Barbara Loe Fisher. "How many girls are really having short-term
health problems associated with getting this vaccine that could turn into long-term neurological or immune system
disorders? And how many will go on to develop fertility problems, cancer or damage to their genes, all of which Merck
admits in its product insert that it has not studied at all? We just don't know enough to be mandating Gardasil for
anyone, much less vulnerable 11 to 12 year old girls entering puberty." [23]
The new HPV vaccine components include aluminum phosphate, sodium chloride, L-histidine, polysorbate and sodium
borate. Exposure to borax may impair fertility or cause damage to an unborn child. (there were 5 reported cases of
babies born with congenital birth defects to women who had the vaccine within 30 days of becoming pregnant.), aluminum
is implicated as a cause of brain damage, a suspected factor in Alzheimer’s Disease, dementia, seizures, comas, and
allergic skin reactions, and polysorbate is known to cause cancer in animals. [24]
Political Ties
As if all of the side effects, lack of science, ability to detect pre-cancerous changes through routine Pap tests, and
successful treatment options for cervical cancer weren’t enough of a reason to question Gardasil, we also know that
there are some very questionable ties between Merck lobbyists and influential government officials. Texas Gov. Rick
Perry used executive privilege in February to bypass his legislature and mandate the vaccine in his state for girls
entering the sixth grade. Vaccine opponents accused Perry of alleged conflicts of interest between the vaccine’s maker,
Merck & Co., and some of Perry’s past and present staff, as well as between Women In Government (WIG), a group of
women legislators who are promoting the vaccine in their home states. Shortly after Perry’s mandate the Texas Medical
Association and the American Academy of Pediatrics publicly stated that they were opposed to the order saying it's too
early to mandate the vaccine, which was approved for use last June. [25] [26]
Perry’s chief of staff Deirdre Delisi met with the governor's budget director and three members of his office for an "HPV
Vaccine for Children Briefing" on Oct. 16. That same day, Merck & Co.'s political action committee donated $5,000 to
Perry and a total of $5,000 to eight state lawmakers. [27] According to the San Antonio Express News, Merck donated
$50,000 to a Republican Governors Association fundraising dinner hosted by Perry. Apparently Merck has donated the
same amount to this dinner annually for the past six years. [28]
Mike Toomey, Perry's former chief of staff and Delisi's predecessor, lobbies for Merck. According to Delisi's calendar,
she met with Toomey three times in the six months before the order was issued. One meeting happened in August, on
the same day two other Perry staffers met with a different Merck lobbyist for a "Merck HPV Vaccine update." [29]
Delisi is a member of Women In Government as is Indiana Sen. Connie Lawson, R-Indianapolis, who introduced a bill
that would have required Indiana girls to receive the vaccine.
WIG has admitted that Merck is a sponsor of their organization. However, both WIG and Merck have declined to say
how much money that sponsorship entails. Previously, Lawson told the Fort Wayne Daily News that Merck paid for
“scholarships” for various WIG activities. Since then, that newspaper also discovered through WIG newsletters posted on
cached pages of the group’s Web site that scholarships from sponsors go to compensate legislators for transportation,
lodging and their attendance at various educational seminars, such as regional and national meetings the group regularly
holds. One of those meetings occurred over a three-day period in November 2005, and was attended by Delisi and Perry’s
wife, Anita Perry. The event was called the “HPV & Cervical Cancer Summit: New Opportunities for Partnerships and
Prevention.” [30]
Anita Perry, who was billed on the event’s agenda as dedicated to “improving childhood immunization rates serving as
the state’s immunization education spokesperson,” was the keynote speaker at the seminar’s opening gala dinner.
Another speaker during the three-day event was Laura Koutsky, chair of the steering committee for Merck Research
Laboratories Phase III Prophylactic HPV vaccine trials. She was listed on the agenda as a principle investigator in
several HPV related studies and a member of the American Social Health Association National HPV Scientific Advisory
Committee. Another speaker was a researcher who serves as a consultant to Merck, and still another was one with
connections to Digene, the manufacturer of the screening test for HPV. A top official from Merck's vaccine division also
sits on Women in Government's business council. [31]
The state of Texas is not alone in its apparent influence by Merck & Co. In Virginia, for example, Merck, a longstanding
contributor to political campaigns in the state, has spent nearly $40,000 in contributions over the past two years. It has
also hired Williams Mullen Strategies, a prominent lobbying firm, to spearhead the company's efforts to persuade
lawmakers in Richmond to vote for a mandatory vaccine. On the team is Sandra D. Bowen, a well-known Richmond
lobbyist and Cabinet secretary under two governors. [32] Del. Phil Hamilton, R-Newport reported a donation of $1,000
from Merck just weeks before he introduced the bill mandating Gardasil. That brings his total from Merck to $10,000
over the past decade. [33]
Newsday has reported that in New York State, Merck laid out more than half a million dollars in lobbying costs and
donations to key officials. Between 1999 and 2006, Merck donated $106,000 ($33,400 to Democratic accounts and $72,600
to Republican accounts). [34]
Conclusion
With very little scientific data, questionable efficacy and safety issues, political influences, and very little to no danger
from HPV infection, it seems very clear that Gardasil has no business in our children or in medical offices for that
matter. There are 25 states considering some form of mandatory vaccination for school age girls, with several other
countries doing the same. With billions of dollars in the balance our children’s lives are at stake. My hope is that this
article created an awareness of the issues at hand and that you will share this information with as many people you know
so that no more young girls have to suffer needlessly.
References:
1. Cindy Bevington, Fort Wayne Daily News (Indiana), March 14, 2007, Researcher Blasts HPV Marketing
http://www.kpcnews.com/articles/2007/03/21/online_features/hpv_vaccine/hpv01.txt Accessed June 2007
2. National Cancer Institute
http://www.cancer.gov/cancertopics/factsheet/Prevention/HPV-vaccine Accessed June 2007
3. Dr. Elizabeth Unger. See Minutes from: FDAVaccines and Related Biological Products Advisory Committee,
November 28, 2001, p. 21 available here:
http://www.fda.gov/ohrms/dockets/ac/cber01.htm#Vaccines%20&%20Related%20Biological
4. Vincent T. Devita, Jr., et al., editors, Cancer Principles & Practice of Oncology, 6th edition, volume2, p. 1523
5. Dunne EF, Unger ER, Sternberg M, et al. Prevalence of HPV infection among females in the United States.
JAMA. 2007;297:813-819.
6. Ho GY, Bierman R, Beardsley L, et al. Natural history of cervicovaginal papillomavirus infection in young women.
N Engl J Med. 1998;338:423-428.
7. Amercian Cancer Society http://www.cancer.
org/docroot/CRI/content/CRI_2_4_1X_What_are_the_key_statistics_for_cervical_cancer_8.asp Accessed June 2007
8. Medical Accountability Network http://site.mawebcenters.com/medicalaccountabilitynetwork/essay_gardasil.html
Accessed June 2007
9. Lopes G, Dolan CM, Forced Cure Targets Wrong Age Group. The Washington Times. February 26, 2007
10. Gardasil Monograph http://www.merckfrosst.ca/assets/en/pdf/products/GARDASIL_1055-a_10_06-E.pdf
Accessed June 2007
11. Lopes G, Dolan CM, Forced Cure Targets Wrong Age Group. The Washington Times. February 26, 2007
12. Gardasil Monograph http://www.merckfrosst.ca/assets/en/pdf/products/GARDASIL_1055-a_10_06-E.pdf
Accessed June 2007
13. Medical Accountability Network http://site.mawebcenters.com/medicalaccountabilitynetwork/essay_gardasil.
html Accessed June 2007
14. FDA http://www.fda.gov/fdac/features/2006/506_cervical.html Accessed June 2007
15. Judicial Watch http://www.judicialwatch.org/archive/2007/GardasilVAERSReports.pdf Accessed June 2007
16. Judicial Watch http://www.judicialwatch.org/archive/2007/GardasilVAERSDeaths.pdf Accessed June 2007
17. Judicial Watch http://www.judicialwatch.org/archive/2007/GardasilVAERSReports.pdf Accessed June 2007
18. Cindy Bevington, Fort Wayne Daily News (Indiana), March 14, 2007, Researcher Blasts HPV Marketing
http://www.kpcnews.com/articles/2007/03/21/online_features/hpv_vaccine/hpv01.txt Accessed June 2007
19. Scott HD, Rosenbaum SE et al. Rhode Island physicians’ recognition and reporting of adverse drug reactions. RI
Med J 1987; 70:311-316.
20. Rosenthal S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events.
Am J Public Health 1995; 85:1706-9.
21. Braun M. Vaccine adverse event reporting system (VAERS): usefulness and limitations. John’s Hopkins
Bloomburg School of Public Health. www.vaccinesafety.edu/VAERS.htm
22. Food and Drug Administration, Center for Drug Evaluation and Research. The clinical impact of adverse event
reporting. MedWatch. October 1996.
23. National Vaccine Information Center, February 21, 2007
http://www.krnv.com/Global/story.asp?S=6117829&nav=8faR Accessed June 2007
24. Gajdova et al - "Delayed effects of neonatal exposure to Tween 80 on female reproductive organs in rats." Food
Chem Toxicol 31(3):183-90 (1993) Institute of Preventive and Clinical Medicine, Limbova, Bratislava.
25. Elliot, J. Panel votes to block HPV vaccine requirement. Houston Chronicle. Feb. 22, 2007 http://www.chron.
com/disp/story.mpl/special/07/legislature/4571812.html Accessed June 2007
26. Ackerman, T. TEXAS: Doctors Say Perry's Inoculation Mandate Is Premature, Houston Chronicle. February 08,
2007
27. Childs, D. Political Intrigue in Merck's HPV Vaccine Push. ABC News. Feb. 22, 2007
http://abcnews.go.com/Health/story?id=2890402&page=1&CMP=OTC-RSSFeeds0312 Accessed June 2007
28. Scharrer, G, Bureau, A. Merck says GOP gift wasn't tied to governor's executive order, San Antonio Express
News. February 27, 2007 http://www.mysanantonio.com/news/politics/stories/MYSA022807.05A.Merck.34b5501.html
Accessed June 2007
29. Peterson, LA. Vaccine Meeting, Merck Donation Coincide, ABC News. February 21, 2007
http://abcnews.go.com/US/WireStory?id=2894214&page=1 Accessed June 2007
30. Cindy Bevington, Fort Wayne Daily News (Indiana), Questions surround advocacy group's connection to drug
firms. February 11, 2007
31. Cindy Bevington, Fort Wayne Daily News (Indiana), Questions surround advocacy group's connection to drug
firms. February 11, 2007
32. Gardner, A. Drugmaker Assists In Pushing for Mandate For HPV Vaccination, The Washington Post. February
11, 2007 http://www.washingtonpost.com/wp-dyn/content/article/2007/02/10/AR2007021001279_pf.html Accessed June 2007
33. Editorial, Merck donations cloud debate, The Virginian-Pilot. February 15,
http://content.hamptonroads.com/story.cfm?story=119438&ran=116081&tref=rss Accessed June 2007
34. Kerr, K. Merck gave NY pols $500,000 as it pressed for laws mandating its vaccine for cervical cancer, Newsday.
March 9, 2007
possibly made mandatory for girls entering the sixth grade, has been criticized as being untested, unproven, and even
unsafe by countless in the medical field.
Diane M. Harper, a lead researcher, scientist, physician, professor and former director of the Gynecologic Cancer
Prevention Research Group at the Norris Cotton Cancer Center at Dartmouth Medical School who spent 20 years
developing the vaccine for human papillomavirus says the HPV vaccine is not for younger girls, and that it is "silly" for
states to be mandating it for them. Internationally recognized as a pioneer in the field, Harper does not believe there
has been adequate studies documenting the vaccine’s safety for young girls saying, "Giving it to 11-year-olds is a great
big public health experiment.” [1]
The following information has been gathered to help parents understand what the vaccine is said to protect against and
why the controversy exists surrounding the Merck vaccine.
HPV Alone Insufficient to Cause Cancer
According to the National Cancer Institute, Human papillomaviruses (HPVs) are a group of more than 100 viruses.
Some types of HPV are associated with certain types of cancer. These are called "high-risk" oncogenic or carcinogenic
HPVs. Of the more than 100 types of HPV, over 30 types can be passed from one person to another through sexual
contact. About 6 million new genital HPV infections occur each year in the United States. Most HPV infections occur
without any symptoms and go away without any treatment. [2]
In the majority of women with cervical cancer, HPV is also present; however, it is unknown whether it is the HPV that
actually caused the cancer or whether the cancerous cells supply the body with a breeding ground for certain HPV
strains. During discussions at the FDA, however, it was admitted that HPV alone is insufficient to cause cancer, meaning
that additional factors must be present for cancer to appear.
Dr. Elizabeth Unger of the Centers for Disease Control stated, "So it is believed that infection alone is insufficient to
cause cancer, and additional factors are required for neoplasia. There are certainly lots of questions about HPV
infection…" [3]. The prominent medical text book, Cancer: Principles & Practice of Oncology whose editors include Dr.
Vincent DeVita, Jr. who was President of the National Cancer Institute and Dr. Steven Rosenberg, Chief of Surgery at
the National Cancer Institute agrees. According to this text, "HPV infection is not sufficient for cervical carcinogenesis.”
[4]
A study estimating the American population prevalence of HPV infection published in the Feb 28, 2007 edition of the
Journal of the American Medical Association found that only 3.4% of women aged 14—59 yrs were infected with one of
the HPV types in Gardasil and only 2% were infected with one of the two types that are in the vaccine and are associated
with cervical cancer. [5]
The Center for Disease Control states the prevalence of the types of infections with HPV (6, 11, 16 or 18, the types
prevented by Gardasil), at under 1.6 percent. Although HPV is certainly widespread in the population, the vast number
of people who contract it "will not have any symptoms and will clear the infection on their own" to quote the Centers for
Disease Control. In fact, approximately 90% of women with new HPV infections clear the infection within 2 years. [6]
An infection that almost always causes no symptoms and clears up on its own is hardly a cause for alarm, still less for a
campaign of mandatory vaccination aimed at schoolchildren. There have been calls for the universal vaccination of
American males as well; however, the CDC states that it does not yet know if the vaccine is effective at all in boys or
men.
What is Cervical Cancer?
Cervical cancer is cancerous growth in tissues of the cervix (the organ connecting the uterus and vagina). It is usually a
slow-growing cancer that may not have symptoms but can be found with regular Pap tests (a procedure in which cells are
scraped from the cervix and looked at under a microscope). According to the American Cancer Society, between 1955
and 1992, the number of cervical cancer deaths in the United States dropped by 74%, in large part due to the increased
use of the screening test and condoms. The death rate continues to go down by about 4% per year. Half of the cases of
cervical cancer occur between the ages of 35 and 45. It is rare under age 20. [7]
The American Cancer Society also reports that cervical cancer is responsible for about 1% of cancer deaths per year.
Some claim that this low number is due to effectiveness of routine Pap screening, which results in the detection and
treatment of pre-cancerous lesions so that they never get to the cancer stage. Nutritional deficiencies, especially vitamin
A and folate, mineral deficiency (zinc, selenium, calcium and iron), smoking, and birth control use have been shown to
be associated with cervical cancer.
HPV infection is highly associated with cervical cancer, yet there remains debate as to whether the virus actually causes
cancer. Some cervical cancers don't have associated HPV, and most people infected with HPV do not get cancer, so HPV
cannot be the full cause of cancer. Some researchers and FDA scientists wonder if the abnormal cells (cancerous or pre-
cancerous) may simply be a friendly environment for viruses to grow around, so the virus infection may occur after the
changes that cause cancer rather than the other way around. Smoking has more to do with the progression of HPV
infection to cervical cancer than any other single factor. Smokers with HPV go on to develop cervical cancer much more
frequently than infected non-smokers. [8]
The vast majority of abnormal Pap tests do not equate to cancer. Even abnormal Pap tests showing pre-cancerous cells of
the CIN (cervical intraepithelial neoplasia) II grade clear by themselves with no treatment 40% of the time. Treatment
of pre-cancers has limited the progression to cancer to only 1%. This means that Gardasil is coming out at a time when
cervical cancer is already on the decline. [8]
Cancer data show that lawmakers looking to force pre-teen girls to take Gardasil, the lone vaccine on the market, are
targeting the wrong age group. Middle-school girls inoculated with the vaccine will be no older than 18 when they pass
Gardasil's five-year window of proven effectiveness -- more than a decade before the typical cancer patient contracts
HPV, according to a Washington Times article. [9] Moreover, the Gardasil monograph states: "efficacy of the vaccine in
this age group [9—13 yr olds] has not been demonstrated". Due to the unknown duration of efficacy in older women, the
benefit of Gardasil to 9—13 year olds is even more dubious. [10]
Infectious disease specialists and cancer pathologists say the incubation period for HPV becoming cancer is 10 to 15 years
-- meaning the average cervical cancer patient, who is 47, contracted the virus in her 30s and would not be protected by
Gardasil taken as a teen. [11]
Does the Vaccine Work?
It must be recognized that all human studies submitted to the FDA were done by or financed by the drug manufacturer.
These studies have limited to no independent scientific review. In fact, it takes a formal Freedom of Information Act
request to obtain the exact study reports and statistical analyses that the drug manufacturer gave to the FDA. Gardasil
is Merck's first big drug development since the highly-publicized Vioxx scandal. The basis for many Vioxx lawsuits is
that Merck withheld information that clearly showed the dangers of the drug but pushed for its release anyway. The
Vioxx scandal also revealed that the FDA may not be so trustworthy either. FDA insiders exposed how the agency
deliberately ignored abundant test information showing that Vioxx was dangerous to cardiac patients. The systemic
failure of the FDA to weigh the risks and protect the public without undue influence of the manufacturers was brought to
light by Vioxx but it has not yet led to any meaningful changes at the agency.
In spite of thousands of Vioxx liability suits still unresolved, Gardasil has gotten fast track FDA approval. The FDA
approved the drug through their “priority review process” which takes six months or less and is used for medication with
the “potential to provide significant health benefits.” There is no question that clinical trials have proven effective in
preventing certain strains of HPV infection, however, given the lack of proper research, it seems all too soon to be
approving a drug that could also potentially cause long-term harm to our children.
Since HPV is found in connection with most cervical cancers, the theory was that a vaccine against HPV would prevent
cervical cancer. However, the vaccine studies couldn't demonstrate this, simply because there were no cases of cervical
cancer in the vaccinated group or in the group that received placebo shots. So they used a substitute measure (a
'surrogate marker') for cancer. They compared abnormal pre-cancerous Pap results in people who were vaccinated versus
not vaccinated.
The vaccine is nearly 100% effective in preventing four types of HPV infection. Two of the four subtypes included in the
vaccine are currently responsible for 70% of cervical cancer. So we would expect a 70% reduction in precancerous Pap
results, right? Pre-cancerous Paps only went down by 12% to 45%, depending on which population was studied. [12]
Why didn't the vaccine cause a 70% reduction in pre-cancers in the general population?
Moira Terese Dolan, M.D. states, “Gardasil's reduction of pre-cancers by 12.2% to 16.5% in the general population
would mean that instead of 30 to 40 cases of cancer per million, there would only be 26 - 35 cancers. So it would take
vaccination of a million girls to prevent cancer in 4 to 5 girls. About 37% die from cervical cancer, so that would prevent
1 to 2 deaths. So $360 million in vaccine would prevent 1 to 2 deaths.” [13] This statistic does not take into account the
potential deaths (3 already reported to the Vaccine Adverse Event Reporting System) that the vaccine could actually
cause.
Cervical cancer is generally a slow-growing tumor, and the test period for Gardasil was not a lengthy one. Therefore it is
not surprising that not a single case of cervical cancer occurred in the test groups during the clinical trials. In the trials,
the development of genital warts and CIN (cervical intraepithelial neoplasia) were used as "stand-ins" for cervical cancer
- but that is not the same thing as truly demonstrating the prevention of cervical cancer.
Even the FDA has been forced to admit that. The best they can do now is side-step the issue by saying, "It is believed
that prevention of cervical precancerous lesions is highly likely to result in the prevention of these cancers.” [14] So,
are we now mandating vaccines for half the population based on an unproven premise that is 'believed' to be 'highly
likely'? Where is the science in that?
Unfortunately, this is all conjecture. In the Merck studies the follow up was too short and the numbers too few to prove
prevention of cervical cancer.
What are the Side Effects?
Documents obtained from the U.S. Food and Drug Administration under the provisions of the Freedom of Information
Act, detail 1,637 reports of adverse reactions to Gardasil reported to the Vaccination Adverse Reporting System
(VAERS). [15] Three deaths are seemingly related to the vaccine although the FDA’s spokesperson stated that these
deaths were probably unrelated. One physician’s assistant reported that a female patient “died of a blood clot three
hours after getting the Gardasil vaccine.” Two other reports, on girls 12 and 19, reported deaths due to heart problems
and/or blood clotting. [16]
As of May 11, 2007, the 1,637 adverse vaccination reactions reported to the FDA via VAERS included 371 serious
reactions. Of the 42 women who received the vaccine while pregnant, 18 experienced side effects ranging from
spontaneous abortion to fetal abnormities. [17]
Side effects published by Merck & Co. warn the public about potential pain, fever, nausea, dizziness and itching after
receiving the vaccine. Indeed, 77% of the adverse reactions reported are typical side effects to vaccinations. But other
more serious side effects reported include paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures.
So far more than 40 cases of Guillain-Barre syndrome - a dangerous immune disorder that causes tingling, numbness
and even paralysis of the muscles have been reported in girls who have received the HPV vaccine. [18]
VAERS is a passive surveillance system and depends upon voluntary reporting of serious health problems following
vaccination, even though safety provisions in the National Childhood Vaccine Injury Act of 1986 mandated that health
care providers report vaccine adverse events. There have been estimates that fewer than 10 percent, even as low as 1 to 4
percent, of adverse events which occur after prescription drug or vaccine use are ever reported to government adverse
event reporting systems. [19] [20] [21] [22]
"If only 1 to 4 percent of all adverse events associated with Gardasil vaccination are being reported to VAERS, there
could have been up to 38,000 health problems after Gardasil vaccination in 2006 which were never reported," said
National Vaccine Information Center President Barbara Loe Fisher. "How many girls are really having short-term
health problems associated with getting this vaccine that could turn into long-term neurological or immune system
disorders? And how many will go on to develop fertility problems, cancer or damage to their genes, all of which Merck
admits in its product insert that it has not studied at all? We just don't know enough to be mandating Gardasil for
anyone, much less vulnerable 11 to 12 year old girls entering puberty." [23]
The new HPV vaccine components include aluminum phosphate, sodium chloride, L-histidine, polysorbate and sodium
borate. Exposure to borax may impair fertility or cause damage to an unborn child. (there were 5 reported cases of
babies born with congenital birth defects to women who had the vaccine within 30 days of becoming pregnant.), aluminum
is implicated as a cause of brain damage, a suspected factor in Alzheimer’s Disease, dementia, seizures, comas, and
allergic skin reactions, and polysorbate is known to cause cancer in animals. [24]
Political Ties
As if all of the side effects, lack of science, ability to detect pre-cancerous changes through routine Pap tests, and
successful treatment options for cervical cancer weren’t enough of a reason to question Gardasil, we also know that
there are some very questionable ties between Merck lobbyists and influential government officials. Texas Gov. Rick
Perry used executive privilege in February to bypass his legislature and mandate the vaccine in his state for girls
entering the sixth grade. Vaccine opponents accused Perry of alleged conflicts of interest between the vaccine’s maker,
Merck & Co., and some of Perry’s past and present staff, as well as between Women In Government (WIG), a group of
women legislators who are promoting the vaccine in their home states. Shortly after Perry’s mandate the Texas Medical
Association and the American Academy of Pediatrics publicly stated that they were opposed to the order saying it's too
early to mandate the vaccine, which was approved for use last June. [25] [26]
Perry’s chief of staff Deirdre Delisi met with the governor's budget director and three members of his office for an "HPV
Vaccine for Children Briefing" on Oct. 16. That same day, Merck & Co.'s political action committee donated $5,000 to
Perry and a total of $5,000 to eight state lawmakers. [27] According to the San Antonio Express News, Merck donated
$50,000 to a Republican Governors Association fundraising dinner hosted by Perry. Apparently Merck has donated the
same amount to this dinner annually for the past six years. [28]
Mike Toomey, Perry's former chief of staff and Delisi's predecessor, lobbies for Merck. According to Delisi's calendar,
she met with Toomey three times in the six months before the order was issued. One meeting happened in August, on
the same day two other Perry staffers met with a different Merck lobbyist for a "Merck HPV Vaccine update." [29]
Delisi is a member of Women In Government as is Indiana Sen. Connie Lawson, R-Indianapolis, who introduced a bill
that would have required Indiana girls to receive the vaccine.
WIG has admitted that Merck is a sponsor of their organization. However, both WIG and Merck have declined to say
how much money that sponsorship entails. Previously, Lawson told the Fort Wayne Daily News that Merck paid for
“scholarships” for various WIG activities. Since then, that newspaper also discovered through WIG newsletters posted on
cached pages of the group’s Web site that scholarships from sponsors go to compensate legislators for transportation,
lodging and their attendance at various educational seminars, such as regional and national meetings the group regularly
holds. One of those meetings occurred over a three-day period in November 2005, and was attended by Delisi and Perry’s
wife, Anita Perry. The event was called the “HPV & Cervical Cancer Summit: New Opportunities for Partnerships and
Prevention.” [30]
Anita Perry, who was billed on the event’s agenda as dedicated to “improving childhood immunization rates serving as
the state’s immunization education spokesperson,” was the keynote speaker at the seminar’s opening gala dinner.
Another speaker during the three-day event was Laura Koutsky, chair of the steering committee for Merck Research
Laboratories Phase III Prophylactic HPV vaccine trials. She was listed on the agenda as a principle investigator in
several HPV related studies and a member of the American Social Health Association National HPV Scientific Advisory
Committee. Another speaker was a researcher who serves as a consultant to Merck, and still another was one with
connections to Digene, the manufacturer of the screening test for HPV. A top official from Merck's vaccine division also
sits on Women in Government's business council. [31]
The state of Texas is not alone in its apparent influence by Merck & Co. In Virginia, for example, Merck, a longstanding
contributor to political campaigns in the state, has spent nearly $40,000 in contributions over the past two years. It has
also hired Williams Mullen Strategies, a prominent lobbying firm, to spearhead the company's efforts to persuade
lawmakers in Richmond to vote for a mandatory vaccine. On the team is Sandra D. Bowen, a well-known Richmond
lobbyist and Cabinet secretary under two governors. [32] Del. Phil Hamilton, R-Newport reported a donation of $1,000
from Merck just weeks before he introduced the bill mandating Gardasil. That brings his total from Merck to $10,000
over the past decade. [33]
Newsday has reported that in New York State, Merck laid out more than half a million dollars in lobbying costs and
donations to key officials. Between 1999 and 2006, Merck donated $106,000 ($33,400 to Democratic accounts and $72,600
to Republican accounts). [34]
Conclusion
With very little scientific data, questionable efficacy and safety issues, political influences, and very little to no danger
from HPV infection, it seems very clear that Gardasil has no business in our children or in medical offices for that
matter. There are 25 states considering some form of mandatory vaccination for school age girls, with several other
countries doing the same. With billions of dollars in the balance our children’s lives are at stake. My hope is that this
article created an awareness of the issues at hand and that you will share this information with as many people you know
so that no more young girls have to suffer needlessly.
References:
1. Cindy Bevington, Fort Wayne Daily News (Indiana), March 14, 2007, Researcher Blasts HPV Marketing
http://www.kpcnews.com/articles/2007/03/21/online_features/hpv_vaccine/hpv01.txt Accessed June 2007
2. National Cancer Institute
http://www.cancer.gov/cancertopics/factsheet/Prevention/HPV-vaccine Accessed June 2007
3. Dr. Elizabeth Unger. See Minutes from: FDAVaccines and Related Biological Products Advisory Committee,
November 28, 2001, p. 21 available here:
http://www.fda.gov/ohrms/dockets/ac/cber01.htm#Vaccines%20&%20Related%20Biological
4. Vincent T. Devita, Jr., et al., editors, Cancer Principles & Practice of Oncology, 6th edition, volume2, p. 1523
5. Dunne EF, Unger ER, Sternberg M, et al. Prevalence of HPV infection among females in the United States.
JAMA. 2007;297:813-819.
6. Ho GY, Bierman R, Beardsley L, et al. Natural history of cervicovaginal papillomavirus infection in young women.
N Engl J Med. 1998;338:423-428.
7. Amercian Cancer Society http://www.cancer.
org/docroot/CRI/content/CRI_2_4_1X_What_are_the_key_statistics_for_cervical_cancer_8.asp Accessed June 2007
8. Medical Accountability Network http://site.mawebcenters.com/medicalaccountabilitynetwork/essay_gardasil.html
Accessed June 2007
9. Lopes G, Dolan CM, Forced Cure Targets Wrong Age Group. The Washington Times. February 26, 2007
10. Gardasil Monograph http://www.merckfrosst.ca/assets/en/pdf/products/GARDASIL_1055-a_10_06-E.pdf
Accessed June 2007
11. Lopes G, Dolan CM, Forced Cure Targets Wrong Age Group. The Washington Times. February 26, 2007
12. Gardasil Monograph http://www.merckfrosst.ca/assets/en/pdf/products/GARDASIL_1055-a_10_06-E.pdf
Accessed June 2007
13. Medical Accountability Network http://site.mawebcenters.com/medicalaccountabilitynetwork/essay_gardasil.
html Accessed June 2007
14. FDA http://www.fda.gov/fdac/features/2006/506_cervical.html Accessed June 2007
15. Judicial Watch http://www.judicialwatch.org/archive/2007/GardasilVAERSReports.pdf Accessed June 2007
16. Judicial Watch http://www.judicialwatch.org/archive/2007/GardasilVAERSDeaths.pdf Accessed June 2007
17. Judicial Watch http://www.judicialwatch.org/archive/2007/GardasilVAERSReports.pdf Accessed June 2007
18. Cindy Bevington, Fort Wayne Daily News (Indiana), March 14, 2007, Researcher Blasts HPV Marketing
http://www.kpcnews.com/articles/2007/03/21/online_features/hpv_vaccine/hpv01.txt Accessed June 2007
19. Scott HD, Rosenbaum SE et al. Rhode Island physicians’ recognition and reporting of adverse drug reactions. RI
Med J 1987; 70:311-316.
20. Rosenthal S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events.
Am J Public Health 1995; 85:1706-9.
21. Braun M. Vaccine adverse event reporting system (VAERS): usefulness and limitations. John’s Hopkins
Bloomburg School of Public Health. www.vaccinesafety.edu/VAERS.htm
22. Food and Drug Administration, Center for Drug Evaluation and Research. The clinical impact of adverse event
reporting. MedWatch. October 1996.
23. National Vaccine Information Center, February 21, 2007
http://www.krnv.com/Global/story.asp?S=6117829&nav=8faR Accessed June 2007
24. Gajdova et al - "Delayed effects of neonatal exposure to Tween 80 on female reproductive organs in rats." Food
Chem Toxicol 31(3):183-90 (1993) Institute of Preventive and Clinical Medicine, Limbova, Bratislava.
25. Elliot, J. Panel votes to block HPV vaccine requirement. Houston Chronicle. Feb. 22, 2007 http://www.chron.
com/disp/story.mpl/special/07/legislature/4571812.html Accessed June 2007
26. Ackerman, T. TEXAS: Doctors Say Perry's Inoculation Mandate Is Premature, Houston Chronicle. February 08,
2007
27. Childs, D. Political Intrigue in Merck's HPV Vaccine Push. ABC News. Feb. 22, 2007
http://abcnews.go.com/Health/story?id=2890402&page=1&CMP=OTC-RSSFeeds0312 Accessed June 2007
28. Scharrer, G, Bureau, A. Merck says GOP gift wasn't tied to governor's executive order, San Antonio Express
News. February 27, 2007 http://www.mysanantonio.com/news/politics/stories/MYSA022807.05A.Merck.34b5501.html
Accessed June 2007
29. Peterson, LA. Vaccine Meeting, Merck Donation Coincide, ABC News. February 21, 2007
http://abcnews.go.com/US/WireStory?id=2894214&page=1 Accessed June 2007
30. Cindy Bevington, Fort Wayne Daily News (Indiana), Questions surround advocacy group's connection to drug
firms. February 11, 2007
31. Cindy Bevington, Fort Wayne Daily News (Indiana), Questions surround advocacy group's connection to drug
firms. February 11, 2007
32. Gardner, A. Drugmaker Assists In Pushing for Mandate For HPV Vaccination, The Washington Post. February
11, 2007 http://www.washingtonpost.com/wp-dyn/content/article/2007/02/10/AR2007021001279_pf.html Accessed June 2007
33. Editorial, Merck donations cloud debate, The Virginian-Pilot. February 15,
http://content.hamptonroads.com/story.cfm?story=119438&ran=116081&tref=rss Accessed June 2007
34. Kerr, K. Merck gave NY pols $500,000 as it pressed for laws mandating its vaccine for cervical cancer, Newsday.
March 9, 2007
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Steve Tullius, D.C.
