HPV Vaccine

Earlier this summer (2006), Merck pharmaceutical received FDA approval to
market the first Human Papillomavirus (HPV) vaccine Gardasil, a genetically
engineered vaccine that helps prevents four types of HPV viruses, including
type 16 infection, one of the most common HPV type viruses implicated in
cervical cancer. Other HPV vaccines are in the pipeline. With the approval
of Gardasil, HPV and its link to cervical cancer was suddenly front page
news around the world with a barrage of media ads marketing the vaccine
heavily for women. The CDC quickly recommended vaccinating all women age
9-26 and even beyond. Overnight women with virtually no risk for cervical
cancer (the vast majority) were suddenly made to feel vulnerable, thus
creating a huge market for the vaccine.

Let me put the issue into much needed perspective. The risk of getting
cervical cancer from HPV has been greatly overstated! Fifty to seventy-five
percent of all people are exposed to HPV in their lifetimes. The virus
clears spontaneously by the immune system within two years in over ninety
percent of all women, posing no risk at all.[1-4] Though the vaccine
undoubtedly has some value for some women, it is unnecessary, and may even
be dangerous, to administer it to millions of girls and women in the North America.

The Numbers Speak for Themselves

There are an average of 9,710 new diagnoses of cervical cancer and 3,700
deaths from the disease in the North America each year, according to the
CDC. Of these new cases, 70 percent are related to HPV. That’s about 6,797
cases per year. Over fourteen types of HPV are associated with cervical
cancer. Gardasil protects against the HPV strains that are implicated in
about 90 percent of cervical cancers, not 100 percent. That further reduces
the number of cases of cervical cancer that might potentially be prevented
with a vaccine to just under 6,200. And the vast majority of these cases
could be prevented with improved nutrition, safe sex, and the kind of
screening and early treatment that is already in place!

The HPV vaccine media blitz has overshadowed the fact that the incidence of
cervical cancer has already decreased dramatically through routine cervical
screening with pap smears and HPV (DNA) testing. For example, the National
Health Service of England reports that the incidence of invasive cervical
cancer fell by 42 percent between 1988 and 1997 in the U.K because of
cervical cancer screening programs. The NHS reports that in 2000, there were
2,424 new cases of invasive cervical cancer, most of which are not fatal.

Abnormal Paps Are Common

Surveys suggest that about four percent of all pap smears will show an
abnormality associated with HPV infection, which is known as atypical
squamous cells of undetermined significance (ASCUS).[5] In the vast
majority, further evaluation will fail to show any abnormality, and no
further action is required. (This occurrence of “false positives” with Pap
smears led to the development of the ThinPrep® Pap Test, which is more
reliable but still not 100 percent accurate.) But five to ten percent of
patients initially diagnosed with ASCUS actually have more worrisome
cellular changes, known as high-grade, which must be followed closely and
treated in some women. [6, 7]

The Department of Pathology, at the University of Alabama in Birmingham
reviewed 39,661 pap and HPV tests from January 1, 2002 to December 31, 2003.
Of these, 12 percent were diagnosed with ASCUS. High risk HPV (DNA) was
detected in only 732 cases! Out of all of these, only six had persistent
abnormal pap smears requiring repeat follow-up; five had evidence of
cellular abnormalities; and four had low-grade cervical dysplasia or
cellular changes associated with HPV. And only one had high-grade dysplasia
(a more worrisome type of cellular change that is associated with a higher
risk of actual cancer down the line if not treated).

The remaining patients all had negative pap smears. In other words, only a
very small percentage of those with high risk HPV were found to have
cervical abnormalities-which are not invasive cervical cancer and are
treatable! [8]

Vaccines Aren’t Entirely Safe

According to the National Vaccine Information Centers (www.909shot.com),
“The FDA allowed Merck to use a potentially reactive aluminum containing
placebo as a control for most trial participants, rather than a
non-reactive saline solution placebo.”[9]

Using a reactive placebo can artificially increase the appearance of safety
of an experimental drug or vaccine in a clinical trial. Gardasil contains
225 mcg of aluminum and, although aluminum adjuvants have been used in
vaccines for decades, they were never tested for safety in clinical trials.
Merck and the FDA did not disclose how much aluminum was in the placebo
6.[10]

Whenever you vaccinate an individual, you’re intervening with their
immunity. And that’s exactly what happened with Gardasil in the clinical
trials. According to the Merck product insert, there was one case of
juvenile arthritis, two cases of rheumatoid arthritis, five cases of
arthritis, and one case of reactive arthritis out of 11,813 Gardasil
recipients. There was also one case of lupus and two cases of arthritis out
of the 9,701 patients who received the aluminum containing placebo.
Investigators dismissed the total of 102 Gardasil and placebo-associated
serious adverse events, including 17 deaths, that occurred during the
clinical trials, claiming that they were unrelated. (It’s also not clear
how many girls received the Hepatitis B vaccine in addition to Gardasil.
Giving a couple vaccines at the same time can increase the risk of adverse
outcomes.)

Regardless, there were 102 adverse events in 21,514 women and children who
received the vaccine or the aluminum containing placebo. This translates to
474 adverse events per 1 million people getting vaccinated. Conservatively
speaking, that’s 14,220 (474 x 30 million) adverse events expected if you
were to give the vaccine as recommended to about 30 million women and
girls-the approximate number of people in the target market for Gardasil.
Is it worth it to make 14,220 girls and women sick in order to possibly
prevent 6,200 cases of HPV-related cervical cancer?

The Bottom Line About HPV Vaccines

Remember, it is not HPV per se that causes the cancer. It’s the immune
system’s inability to fight the virus that is the issue. The rapid,
widespread, and unquestioning acceptance of the HPV vaccine as “the answer”
to cervical cancer prevention speaks volumes about our cultural
misunderstanding of the root causes of health and disease. On his deathbed,
Louis Pasteur, the famous pioneer in the discovery of the role of germs in
disease, said that Antoine Beauchamp, his rival, was correct. It was not
the germ itself that caused disease, it was the environment, which
Beauchamp had claimed all along.

While it is certainly laudable to want to decrease the incidence of
invasive cervical cancer even further, and while this vaccine may be useful
for some high-risk women and girls, it is far too early to subject millions
to yet another vaccine. Especially when there’s so much we can do to shore
up an individual’s immunity safely and effectively.
Gardasil definitely isn’t cost free-it’s a staggering $360 per person. It’s
administered in three shots, which must be given over six months. At this
time, it doesn’t even guarantee immunity for longer than five years.

Gardasil will not eliminate the need for routine pap smears. And whether or
not a woman opts for the vaccine, she should still protect herself from
getting a sexually transmitted disease by using condoms, abstaining from
intercourse, being discerning about her sexual partners, and also making
sure her diet is rich in antioxidant nutrients that help her resist
infections of all kinds.

Rather than relying solely on mass immunization programs that treat
everyone as though they are at equal risk (which clearly isn’t the case),
and which also promote the myth of universal vulnerability, it is far more
prudent to optimize a woman’s nutrition and lifestyle so that her immune
system is functioning optimally in the first place. This is especially true
if she is one of the few who don’t clear HPV rapidly and spontaneously.

Moreover, if a woman has a persistent HPV infection, she has a problem with
her immune system. The bottom line is: The depression of her immune system
is what’s putting her at increased risk for cervical cancer. So while a
vaccine might prevent cancer in one location, disease will manifest in
another area if the root cause isn’t addressed. This is done by looking at
her entire life-body, mind, and spirit.

Money Talks

So who really benefits by vaccinating approximately 30 million girls and
women with a vaccine that costs about $360? Industry analysts point out
that mandating the HPV vaccine for virtually all girls and women will make
Gardasil the blockbuster that Merck needs to boost profits since it was
forced to withdraw its arthritis drug Vioxx. I certainly agree. It is no
secret that medical schools, researchers, the CDC, and even the FDA itself
are increasingly controlled by drug company profits. So is the mainstream
media. To learn the facts about this, I recommend the documentary film
Money Talks: Profits before Patient Safety.

REFERENCES

1. Ho, G.Y., Bierman R., Beardsley, L., et. al., 1998. Natural history of cervicovaginal papillomavirus infection in young women, N Engl J Med,
   338:423-428.
2. Woodman, C.B., Collins, S., Winter, H., et. al., 2001. Natural history of cervical human papillomavirus infection in young women: a longitudinal
   cohort study, Lancet, 357:1831-1836.
3. Nasiell, K., Nasiell, M., Vaclavinkova, V., 1983. Behavior of moderate cervical dysplasia during long-term follow-up, Obstet Gynecol, 61:609-614.
4. Richart, R.M., Barron, B.A., 1969. A follow-up study of patients with cervical dysplasia, Am J Obstet Gynecol, 105:386-393.
5. Davey, D.D., et. al., 2004. Implementation and reporting rates: 2003 practices of participants in the College of American Pathologists
   Interlaboratory Comparison Program in Cervicovaginal Cytology. Arch Pathol Lab Med., 128:1224-1229.
6. Manos, M.M., et. al., 1999. Identifying women with cervical neoplasia: using human papillomavirus DNA testing for equivocal Papanicolaou results,
   JAMA, 281:1605-1610.
7. ASCUS-LSIL Triage Study (ALTS) Group. 2003. Results of a randomized trial on the management of cytology interpretations of atypical squamous
   cells of undetermined significance. Am J Obstet Gynecol. 188:1383-1392.
8. Adams, A., et. al., 2006. Negative colposcopic biopsy after positive Human Papillomavirus DNA testing: false positive HPV results or
   false-negative histologic findings, Am J Clin Pathol. 2006;125(3):413-418.
9. Merck & Co., Inc. 2006. Gardasil [Quadrivalent Human Papillomavirus Types 6,11,16,18 Recombinant Vaccine] product insert. Table 6.
10. Food and Drug Administration. May 18, 2006. FDA Background Document for Vaccines and Related Biological Products Advisory Committee: Gardasil HPV Quadrivalent Vaccine.

DOES YOUR DAUGHTER NEED THE HPV VACCINE?
Dr. Christiane Northrup, M.D.