Some Sanity on Merck's Gardasil from Dr. Reichman: Can a vaccine treat my existing HPV infection?

Note from Ilena Rosenthal: The industry scaremongers continue to feed
the frenzy that is putting over $4.5 billion in Merck's coffers this
year... as the evidence of the deaths and other serious complications
unfold.

Gardasil flacks trivialize the reported deaths and repeat the Merck
cervical cancer propaganda, refusing to admit that testing and better
hygiene will also assist in lowering the rates of the many types of
HPV (estimates between 30 and 100). They march around Usenet claiming
if we are cautious about wanting to mass innoculate pre-pubescent
girls, that that means we are "flacking" for the funeral industry and
other cheap propaganda fallacies.

As the new school year is starting around us ... we must be vigilent
that the Vac Machine is NOT the only point of view being spread.

http://ilena-rosenthal.blogspot.com


http://www.msnbc.msn.com/id/20473947/?from=ET

IMPORTANT EXCERPTS:
The study didn't evaluate the long-term progression of HPV infections,
the extent of future abnormalities in cervical cells, or the
development of cervical cancer in these women. There's still a
possibility that the vaccine may diminish the progression to cancer,
but it seems unlikely since it didn't cause the virus to disappear.

Those who have persistent viral infections are a small minority of
women who are then at risk for cervical cancer.

We do know that within two years of HPV exposure (and infection), most
women clear these viruses on their own. Thank goodness for our
cervical “powers of viral destruction.”


Can a vaccine treat my existing HPV infection?
Dr. Judith Reichman shares some answers and explains the vaccine
Health on

By Dr. Judith Reichman


Q: I tested positive for high-risk HPV on my recent Pap smear. I'm
freaked! If I get the HPV vaccine will it help cure me?

A: First, the good news. It's most likely that your body will clear
the virus by itself through your own immune reactions. But the bad
news is that we don't know how to help that process along and the
vaccine won't do it.

A recent article in the Journal of the American Medical Association
(JAMA) detailed a study in which more than 2,000 women between the
ages of 18 to 25 were followed for over a year. These women lived in
Costa Rica and were found, on initial testing, to be positive for
human papilloma virus (HPV). They were divided into two groups: Half
the women got a vaccine that immunizes against HPV 16 and 18, the
other half did not. There are over 30 types of HPV, but only some are
high risk. Type 16 and 18 are found in (and felt to be the cause of)
70 percent of cervical cancers. (The vaccine currently available in
the U.S. is called Gardasil. It's a quadrivalent vaccine because it
protects against four types of HPV: 16, 18, 6 and 11. These last two
types of HPV are not involved in cervical cancer development but do
cause genital warts.)



The women were then followed and tested for viral shedding at 6 and 12
months. The study found that there was no significant difference in
viral clearance (i.e., the virus disappeared) between those who
received immunization after becoming infected with HPV and those who
didn't. The clearance rate of HPV in the women who took the vaccine at
six months was 33.4 percent vs. 31.6 percent in the control group. At
12 months, the rate of continued shedding of the virus was 48.8
percent in the vaccinated group and 49.8 percent in the control group.

The study didn't evaluate the long-term progression of HPV infections,
the extent of future abnormalities in cervical cells, or the
development of cervical cancer in these women. There's still a
possibility that the vaccine may diminish the progression to cancer,
but it seems unlikely since it didn't cause the virus to disappear.

We do know that within two years of HPV exposure (and infection), most
women clear these viruses on their own. Thank goodness for our
cervical “powers of viral destruction.” HPV prevalence is
frighteningly ubiquitous — 50 to 70 percent of sexually active young
adults test positive for one of the HPVs within two years of
initiating sexual activity, especially if they are not consistent in
using condoms. (And even then there can be “oops” occurrences).
Because of its overwhelming prevalence, the current recommendation is
not to test for HPV infection in young adults (under the age of 30).

Those who have persistent viral infections are a small minority of
women who are then at risk for cervical cancer. Finding a persistent
HPV infection in women after the age of 30 should be a signal for
careful follow-up.


Despite this study's results, there are those who feel that it is
worthwhile to give the quadrivalent vaccine (Gardasil) to young women
aged 11 to 26 who have tested positive for one of the high-risk HPVs.
This is because, in theory, the vaccine may provide immunity against
HPV types that these young women were not exposed to and/or infected
with. Whether it is cost-effective to do this, especially in a large
population, is still under discussion.

Dr. Reichman’s Bottom Line: If you are infected with HPV, getting the
HPV vaccine will not help you clear the virus; the vaccine should not
be used to treat current infections.

On Aug 29, 3:45 pm, Ilena Rose wrote:
Note from Ilena Rosenthal: The industry scaremongers continue to feed
the frenzy that is putting over $4.5 billion in Merck's coffers this
year... as the evidence of the deaths and other serious complications
unfold.

Gardasil flacks trivialize the reported deaths and repeat the Merck
cervical cancer propaganda, refusing to admit that testing and better
hygiene will also assist in lowering the rates of the many types of
HPV (estimates between 30 and 100). They march around Usenet claiming
if we are cautious about wanting to mass innoculate pre-pubescent
girls, that that means we are "flacking" for the funeral industry and
other cheap propaganda fallacies.


Ilena continues to trivalize the 250,000 - 290,000 women, who die each
year from Cervical Cancer, while tauting her "7" associated deaths
with the Gardasil vaccine.

It has been estimated that 70% of the 250,000 - 290,000 women who die
of Cervical Cancer each year, could be saved by the Gardasil vaccine,
which protects against the HPV virus.

There has also been NO PROOF, that Ilena Rosenthal's tauted "7"
associated deaths, were actually caused by the vaccine.

Ilena campaigns for screening and testing. . .However testing and
screenings will only find HPV, and Cervical Cancer, it WILL NOT
PREVENT IT!

Ilena's stance is to TREAT the disease, rather than PREVENT it! It is
estimated that 1 in 4 women are infected with the HPV virus, which
Gardasil would protect against .

Ilena Rose wrote:
Note from Ilena Rosenthal: The industry scaremongers continue to feed
the frenzy that is putting over $4.5 billion in Merck's coffers this
year... as the evidence of the deaths and other serious complications
unfold.

Yes, Gardasil has been shown to cause no deaths. If I am incorrect,
please cite your sources.

Gardasil flacks trivialize the reported deaths and repeat the Merck
cervical cancer propaganda, refusing to admit that testing and better
hygiene will also assist in lowering the rates of the many types of
HPV (estimates between 30 and 100).

Evidence please.

They march around Usenet claiming
if we are cautious about wanting to mass innoculate pre-pubescent
girls, that that means we are "flacking" for the funeral industry and
other cheap propaganda fallacies.

Really? Who here is paid by the pharmaceutical companies to say anything?

As the new school year is starting around us ... we must be vigilent
that the Vac Machine is NOT the only point of view being spread.

More importantly, parents must get accurate information. Doctors and the
CDC are some sources of accurate information.

Jeff

...

It has been estimated that 70% of the 250,000 - 290,000 women who die
of Cervical Cancer each year, could be saved by the Gardasil vaccine,
which protects against the HPV virus.

Estimated by whom and why use the word "could"?

On Aug 29, 7:44 pm, edgger wrote:
Estimated by whom and why use the word "could"?

Edgger - I suspect the word "could" reflects on the idea of
protection, IF a girl receives the vaccine. Of course if she does
not, protection "couldn't" really exist then - could it.

Of course if we used screenings and testing for HPV (like some folks
would rather we do) - then PREVENTION AND PROTECTION would be a moot
point, wouldn't it.

I like the article below. It is one of many I have read on the
subject. It actually quotes 75^ protection. But I stick with other
accountings putting it at 70%, just to keep a "conservative" estimate,
so as to not encite the anti-vac folks, any more than they already
are!



Cancer jab 'stops 75% of deaths'

Vaccinating all 12-year-old girls against the virus which causes most
cervical cancers could cut deaths from the disease by 75%, a study
suggests.

GlaxoSmithKline's Cervarix jab targets two strains of the human
papillomavirus.

The firm's findings were presented at the International Papillomavirus
Conference, along with a study on rival jab Gardasil from Sanofi
Pasteur.

Gardasil was found to be effective on more strains of HPV than first
thought.

The idea of finally being able to prevent cases of cervical cancer
with a vaccine is extremely exciting

Dr Anne Szarewski, of Cancer Research UK

For the Cervarix research, a computer model was used to predict the
outcome of vaccinating all 12-year-old girls in the UK - a total of
376,385.

Applied to the whole of the UK on the basis of the latest cervical
cancer figures, it would mean 262 deaths each year, compared with the
current level of around 1,000.

The number of annual cases of the disease would also drop from 2,841
to 682.

The researchers admitted 100% coverage assumed in the study was
unrealistic, but said even if 80% were vaccinated, the number of
deaths would drop by 61%.

Cervarix works by targeting HPV 16 and HPV 18, the two most common
forms of the disease.

It has also been found to be effective at targeting some of the other
most common strains.

Competition

GSK is in fierce competition with Sanofi Pasteur, who are about to see
their vaccine, Gardasil, granted a European licence.

Cervarix is still being developed and will not reach European approval
stage for around another year.

The research into Gardasil, presented at the conference in Prague, the
Czech Republic and funded by Sanofi Pasteur, found it provided
protection against 85% of HPV strains responsible for cervical cancer
- up from 75% shown by previous studies.

Dr Nick Kitchin, medical director at Sanofi Pasteur, said the results
were "very promising".

Dr Anne Szarewski, clinical consultant at Cancer Research UK, said:
"HPV vaccination offers great promise in terms of reducing the number
of cases of cervical cancer and preventing deaths from it.

"Beyond the cases and the deaths, hundreds of thousands of women each
year in the UK suffer anxiety when they have an abnormal smear
result.

"The idea of finally being able to prevent cases of cervical cancer
with a vaccine is extremely exciting."

Story from BBC NEWS: http://news.bbc.co.uk/go/pr/fr/-/2/h...th/5311598.stm

Published: 2006/09/04 09:44:27 GMT

Edgger - Here's another article:


Epidemiology of cancer of the cervix: global and national perspective.


1: J Indian Med Assoc. 2000 Feb;98(2):49-52. Related Articles, Links

Shanta V, Krishnamurthi S, Gajalakshmi CK, Swaminathan R, Ravichandran
K.


Cancer Institute (WIA), Chennai.


Cancer of the uterine cervix is one of the leading causes of cancer
death among women worldwide. The estimated new cancer cervix cases per
year is 500,000 of which 79% occur in the developing countries. Cancer
cervix occupies either the top rank or second among cancers in women
in the developing countries, whereas in the affluent countries cancer
cervix does not even find a place in the top 5 leading cancers in
women. The truncated rate (TR) in the age group 35-64 years in
Chennai, India, is even higher (99.1/100,000; 1982-95) than rate
reported from Cali, Colombia (77.4/100,000, 1987-91). The cervical
cancer burden in India alone is estimated as 100,000 in 2001 AD. The
differential pattern of cervical cancer and the wide variation in
incidence are possibly related to environmental differences.
Aetiologic association and possible risk factors for cervical
carcinoma have been extensively studied. The factors a Sexual and
reproductive factors, socio-economic factors (education and income),
viruses e.g., herpes simplex virus (HSV), human papillomavirus (HPV),
human immunodeficiency virus (HIV) in cervical carcinogenesis and
other factors like smoking, diet, oral contraceptives, hormones, etc.
The accumulated evidence suggests that cervical cancer is preventable
and is highly suitable for primary prevention. Sexual hygiene, use of
barrier contraceptives and ritual circumcision can undoubtedly reduce
cervical cancer incidence. Education, cervical cancer screening of
high risk groups and improvement in socio-economic status can reduce
cervical cancer morbidity and mortality significantly.


PIP: Cancer of the uterine cervix is one of the leading causes of
cancer death among women worldwide. The estimated number of new
cervical cancer cases per year is 500,000, of which 79% occur in
developing countries. Cervical cancer is ranked highest or second-
highest among cancers in women in developing countries, whereas in
affluent countries cervical cancer does not even rate within the top 5
leading cancers in women. The truncated rate in the age group 35-64
years in Chennai, India, is even higher (99.1/100,000; 1982-95) than
the rate reported from Cali, Colombia (77.4/100,000; 1987-91). The
cervical cancer burden in India alone is estimated to reach 100,000 by
2001. The differential patterns of cervical cancer and the wide
variation in incidence are possibly related to environmental
differences. Etiologic associations and possible risk factors for
cervical carcinoma have been extensively studied. The factors a
sexual and reproductive factors; socioeconomic factors (education and
income); viruses (e.g., herpes simplex virus, human papillomavirus,
HIV); and other factors such as smoking, diet, oral contraceptives,
hormones, etc. The accumulated evidence suggests that cervical cancer
is preventable and is highly suitable for primary prevention. Sexual
hygiene, use of barrier contraceptives, and ritual circumcision can
undoubtedly reduce cervical cancer incidence. Education, cervical
cancer screening of high-risk groups, and improvement in socioeconomic
status can reduce cervical cancer morbidity and mortality
significantly.


MeSH Terms:
Adenocarcinoma/etiology
Adenocarcinoma/mortality*
Adult
Carcinoma, Squamous Cell/etiology
Carcinoma, Squamous Cell/mortality*
Cause of Death*
Cross-Sectional Studies
Developing Countries*
Female
Humans
Incidence
India/epidemiology
Middle Aged
Risk Factors
Uterine Cervical Neoplasms/etiology
Uterine Cervical Neoplasms/mortality*


PMID: 11016150 [PubMed - indexed for MEDLINE]

Here's what Planned Parenthood has to say.


Safety of the HPV Vaccine Gardasil

It has come to our attention at Planned Parenthood of Montana that
there is information circulating via email regarding the safety of the
HPV vaccine Gardasil. Below is some information and quick facts for
clarification so that young women are not misinformed about the
vaccine and its potential to save lives.

First, the source of the alert, JudicialWatch, is a conservative think
tank that opposes the use of the HPV vaccine. It's interpretation of
the FDA reports neglects to include the basic disclaimer included on
the FDA VAERS (Vaccine Adverse Events Reporting System) website:

When evaluating data from VAERS, it is important to note that for any
reported event, no cause and effect relationship has been established.
VAERS is interested in all potential associations between vaccines and
adverse events. Therefore, VAERS collects data on any adverse event
following vaccination, be it coincidental or truly caused by a
vaccine. The report of an adverse event to VAERS is not documentation
that a vaccine caused the event.

In addition, VAERS notes: "In some media reports and on some web sites
on the Internet, VAERS reports are presented as verified cases of
vaccine deaths and injuries. Statements such as these misrepresent the
nature of the VAERS surveillance system."

Regarding the safety of Gardasil, the Wall Street Journal followed up
on the JudicialWatch report and provided the following information
regarding the adverse reports including the three deaths:

The new data also show that three female patients who received the
vaccine died. However, Merck, the FDA and the Centers for Disease
Control and Prevention, which helps the FDA monitor vaccine adverse
events, said the deaths were unlikely to have been caused by
Gardasil.
Two of the women were taking birth-control pills and died from blood
clots, a known risk of contraceptive medication, according to the CDC.
The third, a 12-year-old girl, suffered from heart disease and died
from a heart inflammation brought on by the flu, the CDC said.

So far, there have been 1,637 reports of adverse reactions, not an
unusually high number given that two million to three million women
may have received the vaccine. Most of the adverse events involve
minor side effects such as pain at the site of injection, itching and
dizziness. Merck has distributed more than five million doses of
Gardasil in the U.S. since its introduction in June 2006. The vaccine
is administered in three shots over a period of six months.

Karen Riley, a spokeswoman for the FDA, said the agency was closely
monitoring the adverse events associated with Gardasil, including the
pregnancy complications, but "we haven't seen anything at this point
that would suggest we'd make any changes in the product."

We hope this information clarifies some of the concern about Gardasil.
It's critically important that accurate information about vaccines be
presented and that the source of the "concern" be investigated should
a conflict of interest be a consideration.

As with all healthcare issues, Planned Parenthood of Montana makes a
personal commitment to provide its patients with the best- and safest
- health care. We will continue to monitor the FDA and CDC reports
regarding Gardasil and make sure that our friends and patients are
kept well-informed.


http://www.plannedparenthood.org/mon...hpv-vaccine-ga...

This article quotes 493,000 global cases of cervical cancer, with
273,000 deaths.

http://www.emaxhealth.com/103/14596.html

Cervical cancer is the most common cancer in women in low-resource
countries, 85% of the global cervical cancer burden of approximately
493 000 cases and 273 000 deaths being currently found in developing
countries. "Cervical cancer is a major problem for global public
health" said Dr Peter Boyle, Director of IARC.

Screening still a necessity

While new vaccines have been launched recently to prevent infection by
the two major types of Human Papillomavirus (HPV) responsible for
cervical cancer development, cervical cancer prevention will need to
rely on early detection for a number of years before a sizeable
reduction in incidence and mortality is seen from affordable and
efficient immunization campaigns.

All populations not equal for screening tests

For several decades now, it has been known that the Papanicolaou test
("Pap Smear") is a safe, reliable and effective test for detecting
cervical cancer and pre-cancerous lesions. "However, given resources
and logistics, it is impossible at present to introduce the Pap smear
to all parts of the world", said Dr Rengaswamy Sankaranarayanan,
principal author of the study. "On the ground," he added, "in low-
resource settings where cervix cancer is very common, we need a
practical approach to screening and early detection."


For this reason, Dr Sankaranarayanan and colleagues undertook a
randomised controlled trial of a simple technique known as visual
inspection screening, which involves the application of acetic acid
(4%) on the cervix and naked eye inspection for typical acetowhite
coloration of precancerous lesions.

Adapt screening methods to the various settings

In this perspective, "the effort by Sankaranarayanan et al.(1) assumes
enormous public health importance in demonstrating the validity,
efficiency and opportunity of low-tech approaches to cancer
prevention" said Dr Boyle.

This is the largest randomised controlled trial of visual inspection
screening for cervical lesions in a low-resource setting, carried out
in rural India from 2000 to the present, using a low-tech approach.
The scope is wide: over 30 000 women were screened, against
approximately the same number of control women. These results emanate
from a rigorous study, designed to provide strong scientific evidence,
and which has benefited from ethical committees' inputs and approval.

A systematic registration of cancer cases from the entire Dindigul
district by the Dindigul Ambilikkai Cancer Registry (DACR) played an
important role in evaluating the study.

Results

"The study shows a number of important findings with wide-ranging
implications," said Dr Boyle. "There is now evidence from a randomised
trial that screening using visual inspection with 4% acetic acid
(VIA), in the presence of effective treatment for the lesions found,
is effective in reducing incidence and mortality from cervical
cancer."

During the study period, 31 343 women were screened using VIA. Among
these, 1874 women were diagnosed with precancerous lesions, and 72%
received treatment; 167 cervical cancer cases and 83 cervical cancer
deaths were observed compared with 158 cases and 92 deaths in the
control group during 2000-06 ( i.e. women receiving the VIA screening
were 25% less likely to be diagnosed with cervical cancer than those
who did not and were 35% less likely to die from it).

Conclusions

The study concluded that VIA screening, in the presence of good
training and sustained quality assurance, is an effective method for
preventing cervical cancer in developing countries.

"VIA offers a real-time advantage over other screening methods,
particularly in low-resource settings, with the distinct improvement
of diagnosis and rapid treatment at one go, meaning minimal dropouts.
In addition, a range of healthcare personnel can perform it, from the
nurse level up," said Dr Jacob Cherian, Director, Christian Fellowship
Community Health Centre, Ambillikkai, India.

Dr Sankaranarayanan emphasized that "The key to success is providing
highly effective training of personnel and ensuring that quality
control standards at all parts of the procedure are in place."

Recommendations

"While prevailing conditions do differ dramatically between low-
resource nations, it is vital to set up organized screening programs
in the population, parallel to immunization programs, if we want to
have a significant impact on the incidence and mortality from this
common cancer," concluded Dr Esmy, Principal Investigator at the
Christian Fellowship Community Health Centre, Ambillikkai, India.

Acknowledgement

This study was conducted with active collaboration from the Cancer
Institute (WIA), Chennai, the PSG Institute of Medical Sciences,
Coimbatore, and Dindigul district administrative authorities and
health services. The study was supported by a grant from the Bill &
Melinda Gates Foundation through the Alliance for Cervical Cancer
Prevention (ACCP), a group of five international organizations with a
shared goal of working to prevent cervical cancer in developing
countries.

On Aug 29, 10:44 pm, edgger wrote:
It has been estimated that 70% of the 250,000 - 290,000 women who die
of Cervical Cancer each year, could be saved by the Gardasil vaccine,
which protects against the HPV virus.

Estimated by whom and why use the word "could"?

As the vaccine has yet not been shown to prevent any grade 3 lessions
the best surrogate point for cancer and has only been shown to reduce
grade 2 lessions by 17% thats the way you talk. This drugs effect on
cancer rates is unproven. Many experts are advising a wait and see
approach.

Thanks Vince

On Aug 31, 5:08 am, bigvince wrote:

As the vaccine has yet not been shown to prevent any grade 3 lessions
the best surrogate point for cancer and has only been shown to reduce
grade 2 lessions by 17% thats the way you talk. This drugs effect on
cancer rates is unproven. Many experts are advising a wait and see
approach.



I kind of like the following article. . .

Cancer jab 'stops 75% of deaths'

Vaccinating all 12-year-old girls against the virus which causes most
cervical cancers could cut deaths from the disease by 75%, a study
suggests. GlaxoSmithKline's Cervarix jab targets two strains of the
human papillomavirus.

The firm's findings were presented at the International Papillomavirus
Conference, along with a study on rival jab Gardasil from Sanofi
Pasteur.

Gardasil was found to be effective on more strains of HPV than first
thought.

The idea of finally being able to prevent cases of cervical cancer
with a vaccine is extremely exciting

Dr Anne Szarewski, of Cancer Research UK

For the Cervarix research, a computer model was used to predict the
outcome of vaccinating all 12-year-old girls in the UK - a total of
376,385.

Applied to the whole of the UK on the basis of the latest cervical
cancer figures, it would mean 262 deaths each year, compared with the
current level of around 1,000.

The number of annual cases of the disease would also drop from 2,841
to 682.

The researchers admitted 100% coverage assumed in the study was
unrealistic, but said even if 80% were vaccinated, the number of
deaths would drop by 61%.

Cervarix works by targeting HPV 16 and HPV 18, the two most common
forms of the disease.

It has also been found to be effective at targeting some of the other
most common strains.

Competition

GSK is in fierce competition with Sanofi Pasteur, who are about to see
their vaccine, Gardasil, granted a European licence.

Cervarix is still being developed and will not reach European approval
stage for around another year.

The research into Gardasil, presented at the conference in Prague, the
Czech Republic and funded by Sanofi Pasteur, found it provided
protection against 85% of HPV strains responsible for cervical cancer
- up from 75% shown by previous studies.

Dr Nick Kitchin, medical director at Sanofi Pasteur, said the results
were "very promising".

Dr Anne Szarewski, clinical consultant at Cancer Research UK, said:
"HPV vaccination offers great promise in terms of reducing the number
of cases of cervical cancer and preventing deaths from it.

"Beyond the cases and the deaths, hundreds of thousands of women each
year in the UK suffer anxiety when they have an abnormal smear
result.

"The idea of finally being able to prevent cases of cervical cancer
with a vaccine is extremely exciting."

Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/h...th/5311598.stm


Published: 2006/09/04 09:44:27 GMT