What Every Parent Should Know About the HPV Vaccine
Steve Tullius, DC
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.cancerorg/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, 2007
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