HPV Vaccines: Betrayal Of The Public Trust?

HPV Vaccines: Betrayal Of The Public Trust?







Norma Erickson
Activist Post

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):
<blockquote class="tr_bq">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).</blockquote>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.

Source:-
http://www.activistpost.com/2013/03/hpv-vaccines-betrayal-of-public-trust.html