Gardasil vaccination: Evaluating the risks versus benefits

Gardasil vaccination: Evaluating the risks versus benefits








(NaturalNews) All drugs are associated with some risks of adverse
reactions and vaccines are no exception. In weighing risks versus
benefits, one has to keep in mind that vaccines represent a special
category of drugs since they are generally given to healthy individuals.
If there are uncertain benefits from a vaccine, only a small level of
risk of harmful effects may be acceptable. If the benefits are certain,
then a greater risk of side effects may be tolerated. Here I review
the current evidence which indicates that the former case applies to
Gardasil, the quadrivalent human papillomavirus (qHPV) vaccine:

1) The efficacy of Gardasil in preventing cervical cancer has not been
demonstrated and the marketing campaign has been misleading. The
efficacy of Gardasil remains unsubstantiated since the vaccine hasn't
been adequately tested on the primary age group to which it is currently
given.

Merck promoted Gardasil primarily as a vaccine against cervical cancer,
rather than promoting it as a vaccine against HPV infection or
sexually transmitted diseases.

According to recent reports published in two highly respected scientific journals, Nature Biotechnology and Journal of American Medical Association (JAMA):

"Most genital infections are asymptomatic and resolve spontaneously,
but the virus can persist and cause precancerous lesions that can
become malignant over the subsequent 20-30 years." (Nature Biotechnology, 2007 2)

"So how should a parent, physician, politician, or anyone else decide
whether it is a good thing to give young girls a vaccine that partly
prevents infection caused by a sexually transmitted disease (HPV
infection), an infection that in a few cases will cause cancer 20 to 40
years from now? (JAMA, 2009 3).

The fact is that malignant cervical cancer takes decades to develop and
yet the longest clinical trial on Gardasil was only four years in
duration. In other words, Gardasil was never shown to prevent cervical cancer
[emphasis added]. Furthermore, in all clinical trials conducted by
Merck the cervical intraepithelial neoplasia (CIN) 2/3 precancerous
lesion was used as the efficacy endpoint for evaluating the Gardasil.
What is the problem with using the CIN 2/3 lesion as the standard for
efficacy? First, if the marketing claim for Gardasil is that the
vaccine "protects against cervical cancer" then cervical cancer should
have been used as the endpoint for efficacy, not a surrogate marker
such as a CIN 2/3 precancerous lesion [emphasis added]. Second, in the
natural course of cervical cancer, only a small fraction of the CIN 2
lesions will progress to CIN 3 lesions and only a small fraction of CIN
3 lesions will eventually progress to cervical cancer. Furthermore,
even CIN 3 lesions are heterogeneous (there are early small lesions and
old advanced lesions and we do not know what proportion of the small
lesions, which serve as clinical endpoints in current studies, would
persist to become large, advanced CIN3 lesions). Therefore, in any
female population (and that includes those who have undergone Gardasil
clinical trials) there are many more CIN 2 lesions than a combination of
CIN 3 lesions and cervical cancers. As a result, the vast majority of
the "CIN 2/3 or worse" cases used for evaluation of efficacy, and
listed in Merck's report to FDA Vaccines and Related Biological
Products Advisory Committee (VRBPAC Background Document on Gardasil HPV
Quadrivalent Vaccine , must have been CIN 2 lesions.

In a review of the literature from 1950-1992, it was noted that 60
percent of CIN 1 lesions regressed, 30% persisted, 10 percent
progressed to CIN 3, and only 1 percent progressed to invasive cancer.
The corresponding approximations for CIN 2 were 40 percent, 40 percent,
20 percent, and 5 percent, respectively. The likelihood of CIN 3
regressing was 33 percent and that of progressing to invasive cancer
was greater than 12 percent.

The author of the study, Andrew G Ostor, MD, from the Departments of
Obstetrics and Gynaecology and Pathology, University of Melbourne noted:

"It is obvious from the above figures that the probability of an
atypical epithelium becoming invasive increases with the severity of
the atypia, but does not occur in every case. Even the higher degrees
of atypia may regress in a significant proportion of cases. As
morphology by itself does not predict which lesion will progress or
regress, future efforts should seek factors other than morphological to
determine the prognosis in individual patients."

The above remark leads us to a third reason why a surrogate
morphological marker is not an adequate endpoint for assessing the
efficacy of cervical cancer vaccines:

"CIN 2 is not a true biologic entity but an equivocal diagnosis of
pre-cancer, representing an admixture of HPV infection and pre-cancer.
The existence of CIN 2 biopsy results as a clinical entity may be the
consequence of the inaccuracies of colposcopy and colposcopically
directed biopsy, which could result in less than-perfect representation
of the underlying disease state."

Furthermore, the same report by the National Cancer Institute (NCI 9) states that:

"That CIN2 is the least reproducible of all histopathologic diagnoses may in part reflect sampling error."

Finally, according to second report by the NCI 10:

"Approximately 40 percent of undiagnosed CIN 2 will regress over two
years." (this also precisely corroborates the findings of the study by
Ostor)

Gardasil is marketed as the vaccine that prevents cervical cancer. This
statement is incorrect. Based on the above NCI findings, we can
conclude that the data presented in the VRBPAC Background Document on
Gardasil HPV Quadrivalent Vaccine 8 only supports the claim that
Gardasil can prevent "an equivocal diagnosis of pre-cancer,
representing an admixture of HPV infection and pre-cancer" - about half
of which are self-reversing to normal cases and not reflect actual
cervical cancer.

There was yet another important oversight in assessing the efficacy of
Gardasil. Most cervical cancers are believed to be linked to infection
with genital HPV types 6, 11, 16, and 18 2 3 11. According to NCI, the
only reliable HPV genotyping method is a "PCR system with short target
sequences" or alternatively, "'sentinel-base' genotyping by PCR."
Ironically, these HPV genotyping methods were never used to determine
the HPV type associated with precancerous lesions in the clinical trials
for evaluation of the efficacy of Gardasil to prevent type-specific
HPV infections.

2) Cervical cancer is a rare disease in developed countries which
invalidates the recommendations for universal immunization with any HPV
vaccine. The incidence of cervical cancer has dropped substantially
since implementation of regular Pap screening procedures. Currently, in
the US, the death rate from cervical cancer (2.4/100,000 women) is
lower than the rate of reported serious adverse events, including
death, from Gardasil (3.34/100,000 doses distributed)

The severity of cervical cancer should not be undermined. Advanced
cervical cancer is a deadly disease, especially in areas where the
resources and infrastructure to fully implement

Papanicolaou (Pap) smear tests are limited such as Latin America,
Africa, India and South Asia. In the past four decades, industrialized
countries such as the US, have cut cervical cancer mortality and
incidence rates by 74 percent largely through the use of the Pap smear
2.

Thus, as noted by Diane Harper, MD, Professor and Vice Chair,
Obstetrics and Gynecology, Community and Family Medicine and
Informatics and Personalized Medicine, who conducted the phase 2 and
phase 3 trials for Gardasil, authoring their publications, in developed
countries such as the US, which have regular Pap screening programs in
place, the HPV vaccine will do little to decrease the already very
small cancer rate. In fact, Harper noted that if women who are
vaccinated stop going for Pap smears, the incidence rate for cervical
cancer would increase.

Based on L1-encoded virus-like particles, Gardasil should protect
against the HPV genotypes 16 and 18, which are thought to account for
70 percent of cervical cancers. Since Gardasil does not even claim to
protect against all cases of cervical cancer but only those "caused by
HPV strains 16 & 18", it does not replace the need for a regular
pap smear.

More crucially, however, for deciding whether a risk of adverse effects
from the HPV vaccine is worth taking, much depends on the perceived
benefit from the vaccine relative to that risk. If benefits are indeed
substantial, then many individuals would be willing to accept the risk.
However, if the benefit of the vaccine has not been demonstrated and
is in fact only speculative, and if a majority of those women who are
persistently infected with HPV are not likely to develop cancer
providing they are adequately screened, then most reasonably they will
only be willing to accept very small risk of harm from the vaccine. Data
from clinical safety trials argue against small risks from Gardasil
vaccination. In a paper published in JAMA, Slade et al. (2009) 11
report that from June 1, 2006, through December 31, 2008, the US
Vaccine Adverse Event Reporting System (VAERS) received 424 reports of
adverse reaction following receipt of Gardasil amongst which, 772 (6.2
percent) were serious, including 32 deaths. Given the overall reporting
rate of 53.9 reports per 100, vaccine doses distributed, the estimated
rate of reported serious adverse events from Gardasil is 3.34/100 doses
distributed. This rate is higher than the death rate from cervical
cancer in the US which stands at 2.4/100 women (according to CDC
statistics, 15).

Harper poses an important question 14:

"Would a parent accept such a rate of serious adverse events if the
same cancer prevention can occur with continued Pap screening? Is there
any acceptable level of risk of serious adverse events, including
death, to prevent genital warts?" [emphasis added]

The later claim was in reference to one of the vaccine's other claimed benefits.

3) Most HPV infections are benign and resolve spontaneously without causing cervical cancer

According to Harper 16:

"70 percent of all HPV infections resolve themselves without treatment
within a year. Within two years, the number climbs to 90 percent. Of
the remaining 10 percent of HPV infections, only half will develop into
cervical cancer."
These numbers are consistent with those above quoted from Nature Biotechnology:

"Most genital infections are asymptomatic and resolve spontaneously,
but the virus can persist and cause precancerous lesions that can
become malignant over the subsequent 20-30 years."

In addition, in a recent JAMA editorial, Charlotte Haug, MD, PhD, emphasized:

"The virus does not appear to be very harmful because almost all HPV
infections are cleared by the immune system. In a few women, the HPV
infection persists, and some women may develop precancerous cervical
lesions and eventually cancer. It is currently impossible to predict in
which women this will occur and why. Likewise, it is impossible to
predict exactly what effect vaccination of young girls and women will
have on the incidence of cervical cancer 20 to 40 years from now."

Thus, again, there appears to be little rationale in support of universal immunization with any HPV vaccine.

(Note from SaneVax: Are the benefits of Gardasil vaccination worth the
risks? Take a good look at the following in-depth study, then decide
for yourself.)

http://sanevax.org/news-blog/wp-content/uploads/2011/02/Gardasil-vacc...



Source:-
http://www.naturalnews.com/031454_Gardasil_risks.html