HPV Vaccines: Betrayal of the Public Trust?
HPV
Vaccines: Betrayal of the Public Trust?
(But First Personal
Notes From Ed.):
There are so many folks that simply want to believe that products offered by the pharmaceutical
industry are safe, necessary and beneficial as advertised by them. That is simply not
true. They are corporations who have a precious bottom line and with
increasing frequency products are rushed to the market place without
sufficient testing and those Corporations attempt to cover themselves with a
list of possible side effects that cause most people to pause and ask what
the hell is going on.
In the case of Gardasil and Cervarix there should be not only a list
of possible side effects; there should be a list of “collateral damage
reports”. If you have followed these vaccines, their histories, headlines and
the horror tales of those whose lives have been forever altered by them you
would be among the growing number calling for them to be withdrawn from the
marketplace and sent back into testing and proof given that they have such
value as being touted by the Pharma industry for both young women and young
men.
There is no long term projection as to what effects these vaccines are
going to have upon the vaccinated population,
but the growing body of evidence should be enough for serious concern.)
HPV
Vaccines: Betrayal of the Public Trust?
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. 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.
2. 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]
3. 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
Post-Cervarix
Syndrome: Deanna from Margate, Kent, UK
My daughter was a happy, healthy normal teenage girl who
enjoyed school. She had lots of friends and was socially active, going out
and enjoying herself and getting involved at school. Her only health problem
was she was overweight.
In October 2011, Deanna brought home from school a
consent form for the HPV injection. I had a quick look online and just read
about cancer and how all school girls were having it done. I therefore agreed
to give my consent.
Deanna had the 1st injection on the 5th of November 2011. She was fine that
day, but for a few weeks after, she kept saying her arm still hurt. As time
passed this went away. She had her second injection on either the 22ndor
23rd of January
2012. The next day she had flu-like symptoms and was generally not feeling
well. The next day, Deanna had developed a cough, her skin color had changed
and she was very pale; not feeling well at all. By evening we had to take her
to our local A&E.
She was admitted to the hospital with a chest infection
and asthma. Deanna remained in the hospital for 7 nights and was given a
mixture of steroids and antibiotics. After two days of taking the steroids,
Deanna started to develop pains in her ribs and chest. The doctors just said
it was because she had a chest infection. While in the hospital, doctors
referred her to asthma and weight clinics for further appointments.
After Deanna came home, we spent the next 5-6 weeks
going back and forth to doctors, hospital and A&E because the pain she
was having was not going away. It was spreading to other parts of her body:
arms, hands, legs, feet, head, eyes, back and ribs. She was experiencing pain
day and night. She was very unsettled and unable to rest or sleep. Most
nights, she was still awake at 3-4 am. Doctors gave Deanna 6-7 different pain
killers in several different doses. Nothing took the pain away. The inhalers
did not work either.
We waited for months and months to see different
consultants, all doing the same blood tests, examining her and saying there
is nothing they can find wrong. Some of the doctors have said that it is all
in her head. It is particularly depressing for her to think the doctors
believe it is all in her head. She is beginning to believe she will have to
spend the rest of her life in pain. At her age, that is not a pleasant
thought. Doctors have referred her to a mental health unit, but we are still
waiting for an appointment.
Due to Deanna’s health, she was off sick from school for
most of February through October. We have now arranged with the school for
her to attend classes at a later time with the provision that she is able to
sit out of class and rest as needed. The school nurses team is working with
us to help arrange a time-table with the school that suits Deanna’s needs.
She is no longer able to take the bus to and from school due to her pain.
Walking to and from the bus stop is just too much for her.
She no longer participates in any sport due to the
additional pain it causes when she tries to take part. She no longer meets up
with her friends and has slowly lost contact with some of them. Life for
Deanna has changed very much.
Over the last year, Deanna has seen consultants for her
pain, weight, asthma, and eyes. In January 2013, she was finally seen at the
London University College Hospital where they diagnosed her with chronic pain
syndrome. They also gave her medication to help with sleep. For the last 3
weeks Deanna has had some rest, but she is still in constant pain. Our next
appointment is not until August 2013, so nothing is being done about her
pain.
Our family has made many changes to accommodate Deanna’s
needs. I have to take her to and from school. In the early months when she
was off sick, we had family members come to our home to look after Deanna
while we worked. We purchased a new bed, hoping this will help her be a
little more comfortable and perhaps reduce some of the pain. We cut dairy
product out of her diet, which alleviated the asthma symptoms completely. She
is losing weight, even though this is not a symptom. We eat only organic
foods so that no more chemicals go into her body. We are trying to detox her
from the injection. We paid for her to see a homeopath and to have allergy
testing done.
This has been Deanna’s journey so far.
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HPV Vaccines: Betrayal of the Public Trust?
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