News Update 15 July 2013
The Japanese government
has officially stopped recommending the Human Papillomavirus vaccines and has
begun warning its citizens against taking the shot.
Standard Digital reports:
In effect, the Japanese Ministry of Health is
saying quite categorically that it has no faith in Gardasil and Cervarix… While
the vaccines will remain freely available in the country, Japanese medical
institutions are now required by law to inform young girls or their parents
that the government does not recommend the vaccines any longer because of their
associated adverse effects. [emphasis added]
The U.S. Food and Drug
Administration (FDA) has approved two HPV vaccines: Merck’s Gardasil and
GlaxoSmithKline’s Cervarix. The two vaccines raked in over $2 billion in profits just last year.
Back in February, Judicial Watch sued the U.S. Department of
Health and Human Services for documents requested under the Freedom of
Information Act (FOIA) in regard to the HPV vaccine and the government’s
National Vaccine Injury Compensation Program (VICP).
When the information was
finally received, it revealed that of 200 claims filed, the U.S. government has
paid out nearly $6 million in damages to 49 HPV vaccine victims through VICP —
and more than half the claims are still awaiting evaluation.
The Japanese government has officially stopped recommending the Human Papillomavirus vaccines and has begun warning its citizens against taking the shot.
Standard Digital reports:
In effect, the Japanese Ministry of Health is
saying quite categorically that it has no faith in Gardasil and Cervarix… While
the vaccines will remain freely available in the country, Japanese medical
institutions are now required by law to inform young girls or their parents
that the government does not recommend the vaccines any longer because of their
associated adverse effects. [emphasis added]
The U.S. Food and Drug
Administration (FDA) has approved two HPV vaccines: Merck’s Gardasil and
GlaxoSmithKline’s Cervarix. The two vaccines raked in over $2 billion in profits just last year.
Back in February, Judicial Watch sued the U.S. Department of
Health and Human Services for documents requested under the Freedom of
Information Act (FOIA) in regard to the HPV vaccine and the government’s
National Vaccine Injury Compensation Program (VICP).
When the information was
finally received, it revealed that of 200 claims filed, the U.S. government has
paid out nearly $6 million in damages to 49 HPV vaccine victims through VICP —
and more than half the claims are still awaiting evaluation.
As I reported before, reading through official HPV vaccine adverse claims documents is like reading a novel called Every Parent’s Worst Nightmare. HPV vaccine side effects reported so far include a whole barrage of adverse reactions such as Guillain-Barre syndrome, seizures, severe pain, fatigue syndrome, tremors, infertility, spontaneous miscarriage and even death.
To date, at least 47
girls and women have died after taking HPV vaccines. The shot has also been
linked to full-blown cervical cancer and outbreaks of the very
genital warts it is supposed to
help protect from in the first place. - See more at: http://www.riseearth.com/2013/07/japan-stops-hpv-vaccines-citing-adverse_15.html#sthash.TwnMt581.dpuf
----------------------------- NOW READ THIS
------------------------
Norma Erickson
Last week, multiple news articles reported 44% of American parents
refusing Gardasil or Cervarix for their children. Between 2008 and 2010,
the percentage of parents concerned about the safety of these two vaccines
nearly quadrupled. As of 2010, only 32% of eligible girls were vaccinated
against HPV. What is wrong with this picture?
Excerpts from national news sources, March 18-22, 2013:
- USA Today The percentage of parents who say they won’t have
their teen daughters vaccinated against the human papillomavirus
increases, even though physicians increasingly recommend the vaccinations.
Concerns about safety and side effects for the human papillomavirus (HPV)
vaccine have increased among parents: 16% cited these fears as the main
reason they did not have their daughters vaccinated in 2010, up from 5% in
2008…
- Medpage Today Parents increasingly say they are worried about
the safety of the human papillomavirus (HPV) vaccine and don’t intend to
vaccinate their teen daughters… But there is no similar pattern for two
other vaccines aimed at adolescents…
- CNN Health Concerns of mothers and fathers about the safety
of the HPV vaccine grew each year, from 4.5% in 2008 to 16.4% in 2010… The
number of parents who said they would not vaccinate their children for HPV
increased from 38.9% in 2008 to 43.9% in 2010. The main concern was
safety.
- CBS News One of the main reasons parents said they didn’t
want their children vaccinated against HPV was because of safety concerns.
- Bloomberg The number of girls who received either injection
(Gardasil or Cervarix) rose to about one-third in 2010 from 16 percent in
2008…
- FiercePharma A growing share of U.S. parents say they won’t
vaccinate their daughters… And that leaves Merck’s Gardasil and GSK’s
Cervarix with a shrinking market.
- The New York Times …suggesting, the need for interventions beyond
clinical recommendations like possibly ‘state and federally
designed social marketing campaigns’… Without brushing aside the need
to address safety concerns, the increasing rates of HPV vaccine refusal
suggest that widespread vaccination will require more than marketing
campaigns. Medical professionals need to look for ways to tell a
better story to parents and teens about HPV, vaccination and cancer. (emphasis
added)
Taxpayer funded social marketing campaigns? Look for ways to ‘tell
a better story’ to parents? Who are these people kidding? What happened to
investigative journalism? What happened to fact-finding? What happened to fair
and balanced journalism?
Has no one considered the possibility that the 43.9% of parents
refusing this particular vaccine might have some valid concerns?
When will people realize
there is a huge difference between ‘increasingly concerned about the safety’
and ‘increasingly aware of the potential risks’? After all, this would not be
the first time a prescription medication approved by the FDA as ‘safe and
effective’ turned out to be nothing of the sort. Will HPV vaccines be next?
HPV vaccination programs
worldwide are based on two assumptions. First, HPV vaccines will prevent
cervical cancer and save lives. Second, HPV vaccines will pose no risk of
serious side effects. Therefore, it would make sense to vaccinate as many
pre-adolescent girls as possible to reduce the worldwide burden of cervical
cancer. What happens if both of these assumptions are not based on factual
evidence?[1]
Medical Consumers Want
to Know:
1.
Since HPV vaccines have
never been shown to prevent cervical cancer, why are they being promoted as
cervical cancer vaccines?1
2.
Since the majority of
HPV infections and a great proportion of abnormal lesions associated with
cervical cancer development clear spontaneously without medical treatment, how
can these factors be used as ‘end-points’ during clinical trials to reliably
predict the number of cervical cancer cases that could be prevented by HPV
vaccines?1
3.
How can the clinical
trials make an accurate estimate of the risk associated with HPV-vaccines if
they are methodologically biased to produce false negatives?1
4.
Why are HPV vaccines
marketed so aggressively in developed countries, when 85.5% of annual cervical
cancer cases and 87.9% of annual cervical cancer deaths occur in developing
countries?[2]
5.
How can passive adverse
event monitoring systems (voluntary reporting with no penalty for failure to
report), such as those used by most vaccine surveillance systems world-wide,
allow the medical regulatory agencies to make accurate estimates on the real
frequency of HPV-vaccine related adverse reactions?
6.
How can accurate
estimates of the real frequency of HPV-vaccine related adverse reactions be
made if appropriate follow-up and thorough investigations of suspected vaccine
reactions are not conducted?
The FDA granted Merck’s
HPV vaccine, Gardasil, fast track approval in June of 2006, despite the fact
that this HPV vaccine failed to meet the FDA criteria for fast track approval.[3] FDA approval of GSK’s HPV vaccine,
Cervarix, followed shortly after in January 2007.
According to The New York Times, the CDC Advisory
Committee on Immunization Practices recommended adding HPV vaccines to the
immunization schedule in the U.S. despite the fact that 64% of the advisory
committee members had potential conflicts of interest which were either never
disclosed or left unresolved at the time they voted. 3% of the members actually
voted on matters they had been barred from considering by ethics officers. News
like this certainly does little to enhance the level of public trust.
Is it possible for the
FDA to objectively monitor the safety and efficacy of HPV vaccines? One has to
wonder since Congress tightened the rules on outside consulting after similarly
undisclosed conflicts of interest were discovered within advisory committees
at the FDA.
As if this is not
enough, the United States Department of Health and Human Services, via the
National Institutes of Health, Office of Technology Transfer receives royalties
on each HPV vaccine sold worldwide. This happens because technologies used in
the production of HPV vaccines were developed at NIH and subsequently patented
by them. For three of the last five years, HPV vaccines based on recombinant
papillomavirus capsid proteins have ranked #1 based on royalties from product
sales.[4]
Marketing Gardasil to
the public under these circumstances is a typical case of unconstrained
government self-dealing. The major patent holder (National Cancer
Institute/NCI), the regulator (FDA) and the vaccination policy maker (CDC) are
all divisions of the Department of Health and Human Services (DHHS). These
self-dealings typically benefit some administrators, not the government or tax
payers. For example, Dr. Julie Gerberding, as the Director of the CDC, approved
the use of Gardasil for cervical cancer prevention as a public health policy is
now the president of Merck’s Vaccine division promoting the sales of Gardasil.
How much revenue is
generated for the NIH from international sales of HPV vaccines? In November
2010, Dr. Eric Suba submitted a Freedom of Information Request to the Office of
Government Information Services to discover the amount. It seems the financial
details of the partnership between the NIH, Merck and GlaxoSmithKline are
exempt from disclosure. (Read the response he received here.) Apparently,
transparency in government does not apply to the top 20 revenue producing
patent(s) developed at taxpayer expense. Why is the public not allowed to share
in celebrating the success of products they financed?
Three Strikes for
Gardasil?
1.
September
2011: Recombinant HPV
DNA L1 protein fragments, possibly attached to the aluminum adjuvant, were
discovered in 100% of Gardasil samples tested. There was no subsequent
investigation. The FDA simply declared the ‘expected’ presence of residual DNA
is not a safety factor. No documentation was provided.
2.
The fact that HPV vaccines
were approved by governments worldwide based on manufacturers’ assertions that
the vaccines contained ‘no viral DNA’ was completely ignored.[5], [6] The possibility of recombinant HPV DNA
fragments being attached to aluminum adjuvant particles was also ignored.
3.
August
2012: One of the
antigens used in Gardasil was discovered in central nervous system samples from
two girls who died after being vaccinated with Gardasil. No cause of death was
identified upon autopsy in either case.[7] HPV-16 L1 gene DNA fragments of vaccine
origin apparently attached to aluminum adjuvant particles were also discovered
in post mortem blood and spleen samples of a girl who died 6 months after
Gardasil injections.[8], [9]
4.
February
2013: It was discovered
that the naked HPV 16 L1 gene fragments bound to aluminum particles by ligand
exchange in Gardasil have acquired a non-B conformation. This conformational
change may have stabilized the HPV 16 gene fragments in Gardasil preventing
their normal enzymatic degradation in vaccine recipients.[10], [11] Non-B DNA conformations and their
relationship to diseases has been studied since the 1960’s. Based on current
scientific knowledge, the human genetic consequences of these non-B DNA
structures are approximately 20 neurological diseases, approximately 50 genomic
disorders and several psychiatric diseases.[12], [13] The impact of injected foreign non-B
DNA on human health is totally unknown.
Why have none of these
discoveries sparked a single investigation in any country? Why is no one
concerned when genetically modified viral DNA fragments are found in vaccines
that are reported to have no viral DNA? Why is no one worried about those viral
DNA fragments being attached to aluminum (a known toxin) possibly creating a
new chemical compound of unknown toxicity?
Why are no red flags
raised when those viral DNA fragments attached to aluminum acquire a non-B
conformation – something known to be associated with multiple debilitating
diseases? Anyone with an ounce of common sense should demand to know why those
charged with approval, recommendation and safety monitoring of these vaccines
appear to be utterly unconcerned about the future health implications of any
one of these discoveries, much less all three of them.
What kind of ‘expert’
advice is being given to YOUR government health officials?
Israel’s Advisory
Committee on Infectious Diseases and Inoculations held a teleconference on 30
January 2013, to discuss the proposed introduction of HPV vaccines into the
country’s school inoculation program among other issues. The official transcript of that meeting, dated 11
February 2013, provides some interesting insights for medical consumers who
question HPV vaccine safety.
Ron Dagan, MD, is Professor of Pediatrics and
Infectious Diseases at the Ben-Gurion University of the Negev in Beer-Sheva,
Israel, and Director of the Pediatric Infectious Disease Unit at the Soroka
University Medical Center, also in Beer-Sheva. An active researcher and
international lecturer, Dr. Dagan’s work focuses on new conjugate vaccines. His
expert advice to Israel’s Advisory Committee regarding potential HPV vaccine
implementation is as follows (translation provided-emphasis added):
We are dealing with injections, some of which
given in 3 [separate] doses, which are delivered to teenage girls. Many
side effects are to be expected. During the week following the vaccine
delivery of the injections many serious events which are not related/linked
to the vaccination are expected: fainting, deaths and convulsions/fits.
This needs to be taken into account. Even if it is not rational, if
these events happen in class they may damage the general perception/status of
the vaccinations. This is happening all over the world all the time. We
have already dealt with a similar issue in relation to the delivery of MMT with
TD and Polio and we have accepted the nurse’s proposal to split these between
grades 1 and 2. The nurses are suitable to make recommendations to the
committee in relation to this issue. In relation to the side effects,
we need to be prepared in advance and not simply react after the fact. I
propose we consult with the English representatives as to how they’ve gone
about this. We must prepare for the delivery of the new vaccine. The nurses
need to know they are going about this in the way they are most comfortable
with (/have the most control over/familiarity with).
If this is an example of
the expert advice vaccination programs are based on, it’s no wonder medical
consumers are questioning HPV vaccine safety, efficacy and need. Many side
effects are to be expected? Fainting, deaths, convulsions and fits occurring
during the week following vaccination – yet not related to the vaccine?
Preparing in advance for side effects? Consulting with other countries to see
how they handled the problem? Are countries around the world being offered
similar expert advice?
So, what will it take to
solve the HPV vaccine uptake problem?
Parental concerns about
HPV vaccine safety are not going to go away in response to social media
campaigns. Teaching medical professionals to ‘tell a better story’ is not going
to make parents change their mind about Gardasil, Cervarix, or any future HPV vaccine.
Platitudes and unsubstantiated reassurances are no longer sufficient.
The time has come for
government health authorities to make HPV vaccine manufacturers prove their
claims or pull their products from the market. Medical consumers want scientifically
proven facts – Safe, Affordable, Necessary and Effective – nothing less is
acceptable.
References:
[1] HPV vaccines and cancer prevention, science versus activism,
Tomljenovic et al 2013
[2] WHO/ICO Information Centre on HPV and
Cervical Cancer (HPV Information Centre). Human Papillomavirus and Related Cancers in World. Summary
Report 2010.
[3] Too
fast or not too fast: the FDA’s approval of Merck’s HPV vaccine Gardasil.
Tomljenovic/Shaw 2012
[6] Detection of human papillomavirus (HPV) L1 gene DNA possibly
bound to particulate aluminum adjuvant in the HPV vaccine Gardasil®Lee
2012
[7] Death after Quadrivalent Human Papillomavirus (HPV)
Vaccination: Causal or Coincidental? Tomljenovic/Shaw 2012
[8] Detection of human papillomavirus L1 gene DNA fragments in
postmortem blood and spleen after Gardasil® vaccination—A case reportLee
2012
[9] Death after Quadrivalent Human Papillomavirus (HPV)
Vaccination: Causal or Coincidental? Tomljenovic/Shaw 2012
[10] Topological conformational changes of human papillomavirus
(HPV) DNA bound to an insoluble aluminum salt—A study by low temperature PCR,
Lee 2013
[11] Gardasil: New Study Brings More Safety Questions to Light,
Erickson 2013
[13] Non-B
DNA Conformations, Genomic Rearrangements, and Human Disease,
Bacolla/Wells 2013
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