| Cervical
Cancer Vaccine -- A Shameful Example of How Medical Research is Taking
Dangerous Short-Cuts
-By Nicholas Regush
Whenever you see or hear the word "breakthrough" in a medical news report,
duck for cover. Chances are someone’s imagination is hard at work.
The latest medical frenzy involved a vaccine aimed at cervical cancer.
The
study was published in the November 21 issue of The New England Journal
of
Medicine (NEJM).
The Reuters News Agency provided this lead: "A vaccine against a cervical
cancer-causing virus can protect young women from infection - a success
researchers hope will eventually allow them to prevent many cases of cervical
cancer."
The virus referred to is the human papillomavirus (HPV).
Reuters quoted Dr. Christopher P. Crum of Brigham and Women’s Hospital
in
Boston as saying: "This is a great study."
Let’s move on.
CBSNews.com’s headline asked the question: "Major Cancer Breakthrough?"
Then the report proceeded to quote researchers in this manner: "It’s really
the
first time that a vaccine has been shown to prevent directly a pre-cancerous
condition and indirectly a cancerous condition." That quote was attributed
to
Dr. Carol Brown, a gynacologic oncologist at Memorial Sloan Kettering
Cancer Center in New York.
Over at the New York Times, at least the headline was more circumspect:
"Experimental Vaccine Appears To Prevent Cervical Cancer." The "deck" or
the line underneath the main headline might have read this way: "Appearances
Can Be Deceiving." However, the Times chose to report: "The vaccine works
by making people immune to a sexually transmitted virus [human
papillomavirus] that causes many cases of the disease."
The Times quoted Dr. Laura A. Koutsky of the University of Washington in
Seattle, the study’s director, as saying: "These are tremendous results."
The Chicago Tribune bought the study too. Its lead paragraph referred to
the
fact that "after decades of failure," scientists showed early success in
preventing human papilloma infection, "which is linked to cervical cancer."
Really?
First, Some Background And A Question Raised
Cervical cancer, arising in the lining of the cervix, affects about 13,000
women
in the U.S. each year. About 4,000 die. Worldwide, a half million get the
disease and 225,000 die.
Back in the 1970s, herpes simplex virus (HSV) was proposed as the
sexually-transmitted cause of cervical cancer, based mostly on population
studies that showed a correlation of the disease with HSV DNA. That
approach shifted to HPV in the 1980s, and over the years population studies
set the pace for the now well-accepted view that cervical cancer is strongly
related to the transmission of HPV.
This is a group of more than 100 viruses, about 30 of which are said to
be
linked to cervical cancer. Of these 30 or so, HPV-16 is said to be found
in 50
percent of cervical cancers. HPV-18 accounts for another 20 percent.
In addition to the population studies that link HPV to cervical cancer,
there is,
for example, research showing that HPV viral DNA can be found integrated
in
the genetic structure of cervical cancers.
Back in 1992, however, a question was raised about the dominant and
increasingly entrenched theory that HPV causes cervical cancer. It came
from
Peter Duesberg and Jody Schwartz, molecular biologists at the University
of
California at Berkeley.
Among the various issues they raised about the acceptance of HPV as the
cause of cervical cancer was their fundamental concern that there was a
lack
of consistent HPV DNA sequences and consistent HPV gene expression in
tumors that were HPV-positive. They instead suggested that "rare
spontaneous or chemically induced chromosome abnormalities which are
consistently observed in both HPV and HSV DNA-negative and positive
cervical cancers induce cervical cancer."
In short, Duesberg and Schwartz were pointing to the possibility that
"carcinogens may be primary inducers of abnormal cell proliferation rather
than HPV or HSV." And here’s the key point: "Since proliferating cells
[cancer
cells dividing wildly] would be more susceptible to infection than resting
cells,
the viruses would just be indicators rather than causes of abnormal
proliferation."
The concept they raised back in 1992 is still relevant today; only science
has
gone on to assume that causation of cervical cancer has been well
established. Even the National Cancer Institute (NCI) says that "direct"
causation has not been demonstrated; however, the NCI and just about
everyone else works with the principle that it has been established. Lip
service is paid to other possible factors that may be involved in cervical
cancer such as environmental conditions, including smoking. Even dietary
factors -- particularly low levels of Vitamin A and folate -- have been
suggested as associated with a risk for cervical cancer.
But once a vaccine to prevent HPV infection is raised as a weapon to prevent
cervical cancer, then it’s pretty clear that the medical Establishment
has gone
all the way in accepting a theory. And it’s also quite evident in some
of the
comments listed above that have been made to reporters.
The headline to the accompanying editorial to the study in the NEJM screams
out:
"The Beginning of the End for Cervical Cancer?"
This editorial is more or less an ode to the research published.
But the published research doesn’t necessarily deserve any praise. Why?
Because the study is a disgrace.
A Worthless Study
When I first reviewed the study, I couldn’t believe the NEJM was putting
this
research on such a high footing -- and that includes the embarrassing
editorial.
Essentially this is what the study is about: Of 2,392 young women who were
entered into the study, 859 were excluded from the final data analysis
-- some
for technical reasons and the vast majority because they were actually
found
to be infected with HPV-16 before getting the vaccine.
Of 1,533 women who remained, half were given the vaccine and half the
placebo shot.
The results were as follows: No one who was vaccinated developed an
HPV-16 infection or a precancerous growth. Of those who received the
placebo shot, 41 women became infected with HPV-16, and nine of them had
precancerous cervical growths.
On the surface, at least interesting for an early study. But those results
became the focus of great jubilation.
But I’ll tell you this: It doesn’t take a rocket scientist to see that
the study’s
methodology is flawed to such a degree that it doesn’t even deserve to
be
published in some throwaway journal. But then again, the NEJM has, of late,
become a depository for bad science.
Still, given that the entire world of health journalism seems to have piled
on
the bravos for this study and just about every vaccine specialist has come
out
of the woodwork to applaud yet another vaccine effort, I figured that I
would
seek out someone who has the guts to face up to the bilge that masquerades
as science. I therefore got hold of Howard Urnovitz, who is a scientist
dealing
in molecular issues and a regular contributor to redflagsweekly.com.
His first reply was that "this is a poorly designed study that fits all-too-well
into
the legacy of medical incompetence called vaccine research."
Here is what Urnovitz had to say, pretty well reaching the same conclusions
that I reached upon careful review of this study:
"These investigators initially enrolled 2,392 women to take part in the
study.
Immediately, 36 percent were disqualified primarily because they had
detectable HPV markers, according to the study’s authors, who determined
HPV-detectability by either antibody or PCR testing. In other words, the
study
selected for women who showed some sort of robust natural immunity that
kept them from expressing the HPV markers.
Then the study used a cancer detection method which is known to be
inaccurate, with a rate of false negative test results that ranges from
1
percent to 93 percent, despite the fact that it is the only test currently
available in the United States to screen women for signs of cervical cancer.
(A
false negative result means that women who have cervical cancer or
precancerous tissues are not being identified when they have a Pap smear.)"
The women in this study are only monitored for HPV infection if they show
a
positive Pap smear. But since even the CDC recognizes that the Pap test
produces a wide range of false negative results, the HPV study’s foundation
--
the Pap test -- is so unreliable that the rest of the study is rendered
highly
suspect.
"Also, the HPV test is poorly designed. A positive result was defined as
any
PCR signal that exceeded the background PCR level associated with an
HPV-negative sample of human DNA. This is a risky protocol because PCR
tests are plagued with false positive reactions (a positive signal that
is not a
true detection of the target). Since the authors show no data or reference
to
data on a secondary test that confirms the gene sequence of a positive
signal, they cannot conclude that they are measuring HPV."
So here is what the study really amounts to. Again, I’ll defer to Urnovitz
because he lays it very cleanly on the line:
"The proper conclusion of this study should be: Administration of this
HPV-16
vaccine reduced the incidence of an uncharacterized PCR signal from a poorly
defined cohort which was strongly biased toward a natural immunity.
Finally, press suggestions or those from the authors that young girls will
soon
be given a vaccine to prevent cervical cancer are ridiculously premature.
As an aside (make of it what you will), given the great new honesty in
medicine these days, it was noted in the NEJM that "some co-authors on
the
study are with Merck Research Laboratories which developed the vaccine
and provided the funding."
Red Flags Weekly November 25, 2002
source:
Mercola Website.
DR. MERCOLA'S COMMENT:
Wouldn’t it be nice if we could just get a shot, or in the future just
eat a
plant that is reengineered to contain a vaccine that would rid of us
cancer? Of course it would.
Unfortunately that is not the way our bodies were designed. Cancer
prevention is not as simplistic as taking a vaccination. Maintaining a
high level of immune integrity is the key, and this is done through the
basics of emotional balancing, optimized nutrition, avoidance of toxins,
proper sleep, exercise and hydration.
This research is clearly another deceptive ploy by Merck to generate
revenue for their vaccine division in exchange for the delusional hope
that a vaccine will reduce the risk of cancer.
Nicholas Regush writes an excellent review on this topic, which he is
quite familiar with as a result of his review of the literature on HHV6
for
his worthwhile book The Virus Within.
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