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Contaminated Gardasil Vaccine May Be Infectious – Potentially Causing Millions More to Become Sick via Blood Transference – Merck Doctor Admits Contaminant Does Not Belong in the Vaccine

November 11, 2011 By 26 Comments

 

 

 

Press Release

November 11, 2011
By Leslie Carol Botha, Vice-President Public Relations

Gardasil Contaminated with HPV rDNA

In September of this year, SANE Vax Inc. broke the news that 100% of the Gardasil vials tested proved to be contaminated with a recombinant HPV DNA attached to aluminum.  The nonprofit organization contracted with a private lab to run the tests at request of informed physician and medical consumers concerned about HPV vaccine safety and efficacy.  The laboratory informed SANE Vax Inc. that one hundred percent of the thirteen (13) samples of Gardasil™ taken from lots  #1437Z, #1511Z, #0553AA, #NL35360, #NP23400, #NN33070, #NL01490, #NM25110, #NL39620, #NK16180, #NK00140, #NM08120 and #NL13560, currently being  marketed in the U.S.A., Australia, New Zealand, Spain, France, and Poland were found to be positive for HPV rDNA.

In the past month global government health agencies went from demanding that vaccine contamination be investigated – to accepting a universal statement possibly written by Merck – that the agencies were well aware that the ‘presence of DNA fragments was to be expected and did not pose a safety risk. 1.  And life went on as usual.

On October 25, 2011, an advisory panel to the CDC, who actually receives a ‘kick-back’ on Gardasil sales recommended that the vaccine be administered to boys ages 9 to 26 – creating a whole new market for sales and profits.  The recommendation, which falls short of a mandate, means Merck’s Gardasil vaccine could be added to vaccination schedules in pediatricians’ offices across the country.2

Meanwhile – a well-known doctor from Peru, concerned about the safety and efficacy of Gardasil, was scheduled to debate a doctor from Merck at a conference.  Just prior to the scheduled debate, the conference moderator told the audience that the doctor from Merck was in a hurry so he could not stay for the debate regarding the vaccine and instead he would be the first one to address the conferees.

When it was the doctor from Peru’s turn to speak she shared the data and research regarding the contamination of Gardasil with HPV rDNA attached to the aluminum adjuvant. The conference attendees were shocked.

The doctor then accompanied her gynecologist husband to a party for medical professionals and to her great surprise the doctor from Merck was at the gathering.  He of course, was embarrassed to be exposed. When approached by the doctor from Peru he told her that the findings on Gardasil contamination were indeed correct – and the fragments of HPV rDNA did not belong in the vaccine.  And then the ‘good doctor’ tried not to talk to her again that evening.  Perhaps this admission of guilt is the reason he could not or would not debate the vaccination contamination issue?

The Gardasil vaccine controversy reads like a well-scripted science fiction novel since medical professionals and researchers have not yet developed a test to conduct studies on the short-term or long term medical effects of a run-way genetically engineered virus bound to aluminum being injected into the body.

 SANE Vax Inc. Concerns

  • Does the aluminum adjuvant become the carrier for HPV DNA causing said DNA to remain in the blood and/or organs for an extended length of time?
  • Since viral DNA cannot replicate by itself (it needs a host cell) what happens if genetically engineered viral DNA enters a human host cell?
  • How will this now ‘genetically-engineered cell’ replicate?  Will it mutate the host cell leading towards cancer?
  • How will genetically engineered cells affect the reproductive health of future generations?
  • How does the immune system react to the detection of a combination viral DNA and human DNA in what was once a ‘normal’ cell? Will the immune system fight the now genetically engineered human cell?

Can Gardasil Contaminants be Transmitted to Others?

Back in the U.S. Lauren a Gardasil injured teenager – (now adversely affected as long as the purported vaccine’s efficacy – 5 years), was volunteering at a blood drive which left her mother Rosemary, Vice-President of Victim Support wondering ‘If the Gardasil victims are affected by the residue that is in the vaccine, what will it do if they give blood?  Could the recipients of the blood from donors who have had the vaccine be affected by the recombinant HPV DNA?  Can it be transferred via a blood transfusion?’

Rosemary went on to express her concerns to the SANE Vax group that most people who are receiving transfusions are already traumatized and immune-compromised from vehicular or other accidents, surgeries, or poor health conditions.  What will this recombinant HPV DNA virus do to these people?

Gardasil Science Fiction Scenario Unfolds

Let’s add to the unfolding science-fiction scenario. Now that Merck and the government health agencies are aware of the contamination in Gardasil and the ‘good’ doctor’s public admission that the contamination does not belong in the vaccine, what will the pharmaceutical giant do?  What happens if Merck quietly ‘recalls’ contaminated vials of Gardasil and replaces their stockpiles with non-contaminated vials?

How will this affect the millions of adolescents who may have already received the contaminated vaccine? By the time HPV rDNA test protocols are developed – there may no longer be contaminated lots available for study.

Millions could be left wondering what will happen to them as the genetically engineered viral DNA possibly infects more and more host cells in the body. Will they fall victim to a multitude of autoimmune disorders caused by the marauding viral contaminants eroding their immune system? Will their bodies become riddled with ‘cancerous’ cells?   How will the presence of rDNA affect their fertility or the health of future generations?

At this point, no one knows the answers to these questions – and the innocent have truly become human medical experiments.

Take the case of Alexis Wolfe, a teenage girl who became ‘mentally retarded’ post Gardasil vaccination– who is now back in the emergency room, dehydrated – weighing in at 104 pounds and unable to sleep for days. It has been four years since this young girl was vaccinated. Are the genetically engineered viral particles slowly invading every other cell in her body?

Perhaps in the interest of public health and safety vials of the contaminated vaccine should be bought by parents with injured children,  researchers and medical professionals so it is possible to develop tests and study the mechanisms of action of viral contaminants attached to aluminum. The purchase of a vial of Gardasil may well indeed hold the only hope for the victims of a vaccine experiment gone bad.

Source:

1. FDA Information on Gardasil – Presence of DNA Fragments Expected, No Safety Risk
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm276859.htm

2. Gardasil controversy: CDC recommends young boys receive HPV vaccine,
http://www.nj.com/news/index.ssf/2011/10/cdc_recommends_young_boys_rece.html

Filed Under: Gardasil / Silgard, Gardasil / Silgard Injuries, SANE Vax Press Releases, United States, Vaccine Adverse Events Tagged With: , , , , , , ,

FDA Information on Gardasil – Betrayal of the Public Trust?

October 28, 2011 By 14 Comments

By Norma Erickson, President

 

In response to the recent announcement by SANE Vax Inc. of the discovery of genetically modified HPV DNA residue in multiple vials of Gardasil, the FDA posted the following page on their site, FDA Information on Gardasil – Presence of DNA Fragments Expected, No Safety Risk. The FDA lists several ‘key facts’ in an obvious attempt to allay any fears which may have arisen over the discovery of foreign DNA in yet another ‘safe and effective’ vaccine. Unfortunately, these ‘key facts’ raise more questions than answers.

In spite of the fact the FDA claims their mission is, helping the public get the accurate, science-based information they need to use medicines, there are no scientific references and no indication that these ‘key facts’ are anything more than damage control statements. American medical consumers deserve better from an agency funded by taxpayers and entrusted with the mission of being responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices…… (FDA mission statement)

According to the Consumer Justice Group, in the last 27 years, there have been 31 drugs approved ‘safe and effective’ by the FDA which were subsequently withdrawn from the market due to safety concerns not uncovered during clinical trials. No one will ever know the true cost in human suffering resulting from adverse reactions to these 31 FDA approved ‘safe and effective’ medications.

Medical consumers worldwide are not willing to risk their children’s health and perhaps their very lives on a vaccine that ‘might’ prevent cancer 20 to 30 years down the road. Parents are not willing to wait until the adverse events post Gardasil vaccination reaches the same numbers as Vioxx did before the vaccine is withdrawn from the market.

Medical consumers around the world are no longer willing to accept the FDA’s ‘word’ when it comes to HPV vaccines and their children’s health and safety. They are demanding scientific proof of the claims made by the FDA and vaccine manufacturers.

FDA ‘Key Facts,’ and questions raised by SANE Vax Inc. on behalf of medical consumers:

  • Gardasil does contain recombinant HPV L1-specific DNA fragments, but these are not contaminants. DNA encoding the HPV L1 gene is used in the vaccine manufacturing process to produce the virus-like particles that make up the vaccine. The presence of these DNA fragments is expected, is not a risk to vaccine recipients, and is not a safety factor. DNA is the “blueprint” for the majority of living organisms and carries the genetic instructions for how cells function and grow.
    1. Do these ‘expected’ DNA fragments contain plasmid?
    2. Please explain why, if these HPV rDNA fragments are ‘expected,’ why did the manufacturer have to invent a patented process to remove them?
    3. Please provide the DNA sequences of all ‘expected’ HPV DNA fragments in the vaccine.
    4. Provide copies of all scientific studies that prove these DNA fragments are ‘not a risk to vaccine recipients.’
    5. Do the above referenced studies include studies regarding the potential safety concerns of these ‘expected’ DNA fragments being tightly bound to aluminum hydroxyphosphate micro-particles?
  • The vaccine manufacturing process is highly regulated under FDA’s current good manufacturing practice requirements, including inspections conducted by FDA of the manufacturing processes and facilities.
    1. Please publish all reports of FDA inspections of the four manufacturing facilities from which the Gardasil samples tested at Milford Medical Laboratory originated since Gardasil’s FDA approval, including the DNA sequences of the detectable residual HPV DNA molecules and the quantity of total HPV DNA per Gardasil dose.
  • Since the early development of Gardasil, FDA and the manufacturer (Merck and Co., Inc.) have known that after purification of the vaccine, small quantities of residual recombinant HPV L1-specific DNA fragments remain in the vaccine. Gardasil does not contain DNA from other HPV genes or any full-length infectious HPV genomes.
    1. If Merck and Co., Inc. and the FDA knew small quantities of residual recombinant HPV L1-specific DNA fragments remain in Gardasil, why do marketing and information packets from around the world specifically state the vaccine contains ‘no viral DNA’?
    2. Please publish the manufacturer’s dated report, stating the acceptable quantities and the sequences of the residual recombinant HPV L1-specific DNA fragments that remain in the vaccine.
    3. Is the FDA aware that injected naked microbial or viral DNA need not be either full-length or ‘infectious’ to potentially cause a health problem?
  • As it does with all vaccines, FDA continues to monitor the safety of Gardasil. For example, FDA recently evaluated the results of a postmarketing study, which included 189,629 females ages 9 to 26 years, 51% of whom were 9 to 15 years of age to assess the risk for onset of new autoimmune diseases after vaccination with Gardasil. Examples of these types of diseases include juvenile rheumatoid arthritis, lupus, multiple sclerosis, etc. The results of this study showed that there is no elevated risk for onset of new autoimmune disease associated with the use of Gardasil.
    1. Did the 189,629 females selected for postmarketing study include cases reported to VAERS?
    2. Is the FDA aware there are 75 vaccines approved for use in the United States and for the first five years after the approval of HPV vaccines, adverse events reported after HPV vaccinations account for a full 16% of the entire VAERS database? See the analysis here.
    3. Why does this fact not raise a red flag prompting an investigation?
  • FDA also continually reviews all reports of the Vaccine Adverse Event Reporting System after vaccination with Gardasil, and there is no evidence of unusual clinical patterns or high reporting rates of adverse events, including autoimmune diseases.
    1. Is the FDA aware of the fact that out of 75 FDA approved vaccines, adverse injury reports post-HPV vaccination account for the following percentages of VAERS reports for all vaccines?
      • 24% of all life-threatening events
      • 26% of all emergency room visits
      • 25% of all hospitalizations
      • 33% of all extended hospital stays
      • 36% of all disabling events
    2. Why do the above statistics, verifiable here, not raise a red flag requiring investigation?
    3. Did the FDA consider cases of immune-based acute disseminated encephalomyelitis after Gardasil injections (1-7) evidence of unusual clinical patterns? If not, why not?

Medical consumers around the globe are asking the same questions. They will no longer accept semantics games, changing definitions, or public relations statements. Medical consumers demand scientific evidence.

If the FDA is actually protecting the public health, there should be no problem providing scientific documentation answering the questions above. Anything less than full compliance is a betrayal of the public trust, not to mention a violation of the public’s right to informed consent. Notions of equal treatment should be cast aside under the circumstances–can the FDA really support exposing our boys to these significant health risks?

References:

  1. Sutton I, Lahoria R, Tan I, Clouston P, Barnett M. CNS demyelination and quadrivalent HPV vaccination. Mult Scler. 2009; 15:116-9.
  2. Wildemann B, Jarius S, Hartmann M, Regula JU, Hametner C. Acute disseminated encephalomyelitis following vaccination against human papilloma virus.  Neurology. 2009;72:2132-3.
  3. Mendoza Plasencia Z, González López M, Fernández Sanfiel ML, Muñiz Montes JR. Acute disseminated encephalomyelitis with tumefactive lesions after vaccination against human papillomavirus. Neurologia. 2010; 25:58-9.
  4. Chang J, Campagnolo D, Vollmer TL, Bomprezzi R. Demyelinating disease and polyvalent human papilloma virus vaccination. J Neurol Neurosurg Psychiatry. 2010 Oct 9. doi:10.1136/jnnp.2010.214924
  5. DiMario FJ Jr, Hajjar M, Ciesielski T. A 16-year-old girl with bilateral visual loss and left hemiparesis following an immunization against human papilloma virus. J Child Neurol. 2010; 25:321-7.
  6. Balamoutsos G, Bouktsi M, Paschalidou M, Tascos N, Milonas I.  A report of five cases of CNS demyelination after quadrivalent human papilloma virus vaccination: could there be any relationship?  (Abstract No. P297)- Poster Access : www.guthyjacksonfoundation.org/services/download.php?2297.pdf+374
  7. Rossi M, Bettini C, Pagano C. Bilateral papilledema following human papillomavirus vaccination. J Med Cases. 2011; 2:222-4.

 

Filed Under: FDA, Gardasil / Silgard, SANE Vax Press Releases, Vaccine Science Tagged With: , , ,

14 Year old California Girl Dies 14 Days Post-Gardasil Vaccination Family Finds Adolescent Dead in Bed

October 20, 2011 By 13 Comments

Governor Brown Signs Parent’s Worst Nightmare into Law Gives Custody of 12 Year Olds to the State

By Leslie Carol Botha, Vice President Public Relations

The fatality of a 14 year old California girl was entered into the VAERS database on August 23, 2011 – 134 days after her death in April. The latest Gardasil victim died of cardiac arrest 14 days after vaccination.  According to VAERS report # 430780 , the adolescent was vaccinated on March 28, had no other life-threatening illnesses, and received no other vaccinations.

The VAERS write up includes this statement: “Found dead in bed in a.m. by family. Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy. Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death.”

The untimely and sad passing of this innocent previously healthy young girl now marks the 4th death post-HPV vaccination in the state of California. Janny Stokvis, VAERS Analyst for SANE Vax Inc. who found the latest VAERS fatality also reports that there have been 1548 adverse injuries* from Gardasil and Cervarix reported in the state.

California VAERS Reports on Adverse Injuries from HPV 4 Gardasil & HPV 2 Cervarix

Life Threatening – 25
Serious            – 102
Emergency Room/Doctor Visits – 680
Hospitalization – 57
Extended Hospital Stays – 14
Did Not Recover – 249
Disabled – 46
Death – 4:  ages 14, 19, 13, 16

*1 to 10% of the vaccinated population reporting

The Government of California now has Custody of 12 year old Children

SANE Vax Inc. wants to know, “Governor Brown – were you aware of the mounting injuries and deaths of innocent, previously healthy adolescents in the state of California before you signed AB 499 into law last week?”

The bill, sponsored by pharmaceutical giant Merck – the manufacturer of Gardasil, allows health care providers in the state of California to by-pass parental consent giving children as young as 12 years old the ‘power’ to consent to Gardasil without their parents’ knowledge. How many more families will have to find their loved ones dead in their beds – before the governor realizes that the HPV vaccines are posing serious threats to the children of California?

Although the threat to parental informed consent is a huge issue – there are other serious allegations about AB 499 regarding wasteful taxpayer expenditures in a financially disparate state, the relationship between the bill’s sponsor and Merck, and the states prerogative to strip parents of their right and responsibilities.

Was money passed under the table to convince you to sign this bill into law? How can you turn your back on the very parents/families whose rights you have historically defended over your years in office? What happened to responsibility, accountability and government transparency?

SANE Vax Inc. is tired of the rhetoric surrounding the HPV vaccine issue.  Peer-reviewed analysis and studies many of them on the FDA, NCI and CDC web sites point out the dangers of many of the vaccine ingredients including the potential for the HPV vaccines to increase the risk for pre-cancerous lesions if adolescents have been previously exposed to the human papillomavirus and then get vaccinated: 44.6% increase post Gardasil; 32.5% post Cervarix.

In addition, SANE Vax Inc. has spent the last month informing the US, UK, European and Australian medical regulators of a Gardasil contaminant from a genetically engineered HPV DNA virus in 100% of the vials tested.  The lab tests showed that all doses were contaminated with recombinant (genetically modified) DNA fragments firmly attached to the aluminum adjuvant, making it much easier for them to pass into the body’s cells, potentially causing cellular mutations leading to cancer or a wide variety of autoimmune disorders, as well as passing through the blood-brain barrier risk causing strokes, brain damage, encephalitis, meningitis and death – all reactions reported to VAERS after administration of this ‘potentially’ dangerous vaccine.

Until April 2011, all promotional material relating to Gardasil® both prior to and after its licensure, assured medical consumers that there was no viral DNA contaminating this vaccine.

Governor Brown your salary is paid by taxpayers. You are charged with the mission of protecting the health and safety of the citizens of California. Unless you can explain your motives when you signed AB 499 your actions will demonstrate that you violated federal vaccine safety law requiring informed consent by a parent for any vaccine delivered to a child. And you will be remembered as One More Governor who betrayed the trust of your electorate.

Filed Under: Death, Gardasil / Silgard, SANE Vax Press Releases, Vaccine Politics/People Tagged With: , , ,

How Far Will Taxpayer-Sponsored Health Agencies Go To Protect HPV Vaccines?

October 17, 2011 By 2 Comments

By Norma Erickson, President

Rather than address legitimate medical consumers’ concerns about HPV vaccines, government health agencies decide to change the definitions and hope the problems will go away.

28 Feb 2011, SaneVax Inc. published an article titled, Health Care Fraud: HPV ‘vaccines’ are not vaccines at all. This article quoted the definition of ‘vaccine’ from a website sponsored by the Department of Health and Human Services (HHS). On that date, the definition of ‘vaccine’ was, “a product of a weakened or killed microorganism (bacteria or virus) given for the prevention or treatment of an infectious disease.”

Everyone knows infection is not synonymous with an infectious disease. You cannot ‘catch’ cancer from someone else. Therefore, it is not an infectious disease. By the HHS definition, any  injection administered to protect against cancer of any type is not a vaccine.

The SaneVax article went on to quote from a publication entitled, FDA 101: Health Fraud Awareness. This document clearly states, “Health fraud is the deceptive sale or advertising of products that claim to be effective against medical conditions or otherwise beneficial to health, but which have not been proven safe and effective for those purposes.”

It appears the United States Department of Health and Human Services, the agency responsible for oversight of the FDA, agreed with the SANE Vax assessment of HPV ‘vaccines.’ However, instead of addressing the problem of potential fraud the DHHS decided to re-route the original page and alter the definition of vaccine. The DHHS definition of vaccine now reads, “A product that produces immunity therefore protecting the body from the disease. Vaccines are administered through needle injections, by mouth and by aerosol.”

You can verify the change by watching closely after clicking on the following link:

http://www.hhs.gov/nvpo/glossary1.htm (For a brief moment, you will see the original page, before it is re-routed to the new page with the altered definition.)

Much the same thing happened when SANE Vax Inc. reported the discovery of recombinant HPV DNA firmly attached to the aluminum adjuvant in 13 lots of Gardasil from multiple countries around the world.

According to government ‘health’ agencies representing at least thirty countries from around the world, the words “no viral DNA” do not mean what any medical consumer would assume they mean. In spite of the fact ‘no viral DNA’ appears on multiple government ‘health’ agency documents; now, medical consumers are told, “All medicinal products manufactured using recombinant technology may contain small fragments of residual DNA.”

Consider the following excerpts from an FDA document stressing the importance of medical consumers reporting problems with various products regulated by the FDA:

  • Consumers can play an important public health role by reporting to FDA any adverse reactions or other problems with products the agency regulates.
  • The testing that helps to establish the safety of products, such as drugs and medical devices, is typically conducted on small groups before FDA approves the products for sale.
  • Some problems can remain unknown, only to be discovered when a product is used by a large number of people.
  • When problems with FDA-regulated products occur, the agency wants to know about them ……

It appears that ‘knowing’ about a problem and doing something about it are two different things. SaneVax Inc. has reported problems with HPV vaccines to the FDA on multiple occasions. (All correspondence can be viewed here.) Regarding the most recent concern about recombinant (genetically modified) HPV DNA found in Gardasil™ from multiple manufacturing facilities, the FDA completely ignored the fact that the residual HPV DNA is firmly attached to the aluminum adjuvant. Furthermore, FDA officials appeared more concerned with semantics games than asking to examine the detailed genetic sequences contained in the laboratory results. Perhaps if they did, their own laboratories could confirm the Genbank DNA sequences found.

The FDA, CDC, and DHHS all have their salaries paid by American taxpayers. They are charged with the mission of protecting the public’s health and safety. Do these agencies truly believe American medical consumers are so gullible that they will dismiss such an obvious case of misleading and possibly fraudulent marketing of not only one, but two medical interventions that do not meet the definition of ‘vaccine’ being marketed and sold to the world as cancer vaccines?

Do FDA officials really believe medical consumers are naïve enough to accept a proverbial pat on the head from the people they pay to protect their health and safety? The SANE Vax team does not think so. Now that the FDA ‘knows’ about the problem, it is time for them to perform the job they are paid to do.

Give medical consumers scientific documentation proving HPV ‘vaccines’ actually live up to the marketing claims made by the manufacturers. Provide scientific evidence proving residual HPV rDNA firmly attached to an aluminum adjuvant poses no health risk when injected into their children.

Medical consumers world-wide deserve more than altered definitions and semantics games, particularly when their children’s health is at stake. Medical consumers deserve scientific facts. Medical consumers deserve the truth. Anything less deprives them of their right to informed consent.

Filed Under: Government Agencies, SANE Vax Press Releases, Vaccine Politics/People, World News Tagged With: , , ,

Health Authorities Admit Gardasil™ Contains Residual Recombinant HPV DNA

October 14, 2011 By 7 Comments

By Norma Erickson, President

2 September 2011, SANE Vax Inc. posted a letter sent to Dr. Margaret Hamburg, FDA Commissioner, on their website to inform her that recombinant (genetically modified) HPV DNA firmly attached to the aluminum adjuvant had been discovered in Merck’s quadrivalent HPV vaccine, Gardasil™.

In what appears to be a worldwide coordinated response, SANE Vax Inc. and other advocacy groups have received the following replies:

  • 22 September 2011, the European Medicines Agency, via Dr. Abadie said, “The presence of recombinant DNA fragments does not represent a case of contamination and is not considered to be a risk to vaccine recipients. All medicinal products manufactured using recombinant technology may contain small fragments of residual DNA.”
  • 23 September 2011, the Food and Drug Administration (FDA) said, “We have determined that Gardasil is not contaminated with HPV DNA and remains safe and effective….Gardasil does contain recombinant HPV L1 specific DNA fragments. This is expected, since DNA encoding the HPV L1 gene is used in the vaccine manufacturing process to produce the virus-like particles. The presence of these expected DNA fragments, which are inevitable in vaccine production, is not a risk to vaccine recipients, is not harmful, and this DNA is not a contaminant.”
  • 28 September 2011, MedSafe in New Zealand, via email to a local vaccine safety advocate said, “Gardasil is manufactured using recombinant DNA technology so any finding of residual DNA fragments in the vaccine is expected and does not represent contamination.”
  • 7 October 2011, the Queensland Immunisation Program in Australia, via email to an Australian advocate, said, “Gardasil is manufactured using recombinant DNA technology so any finding of residual DNA fragments in the vaccine is expected and does not represent contamination.”

The above statements are all in direct contradiction to the following documentation used on a world-wide basis to either approve, and/or market Gardasil™:

  • From the United Kingdom: HPV vaccines are sub-unit vaccines made from the major protein of the viral-coat or capsid of HPV.Virus-like particles (VLPs) are prepared as recombinant proteins from either yeast or baculovirus infected cells that are derived from a type of moth. VLPs mimic the structure of the natural virus but do not contain any viral DNA.
  • From the FDA: “GARDASIL® is not a live virus vaccine; it contains no viral DNA, and is therefore incapable of causing infection.”
  • From Australia: “GARDASIL contains HPV 6, 11, 16 and 18 L1 VLPs. Each VLP is composed of a unique recombinant L1 major capsid protein for the respective HPV type. Because the virus-like particles contain no viral DNA, they cannot infect cells or reproduce.”
  • From the Gardasil Access Program: “GARDASIL® is not a live virus vaccine; it contains no viral DNA, and is therefore incapable of causing infection.”

To date, all health agencies responding to the SANE Vax announcement of Gardasil™ contamination have completely ignored the fact that the residual HPV DNA is firmly attached to the aluminum adjuvant. Furthermore, no regulatory authority, anywhere, has asked to see the detailed genetic sequences contained in the laboratory results, in order to ask their own laboratories to confirm the Genbank DNA sequences found.

It is important to note that every single time the SANE Vax team communicates with any health ‘authority’ our claims are backed up and referenced with peer-reviewed published scientific studies, data from the manufacturer, or data from government sponsored health agencies. When a response is received, there is no evidence to back up the health agency’s position.

Where does this leave medical consumers? Medical consumers around the world are no longer satisfied with a simple ‘pat on the head’ and ‘assurances’ that vaccines are safe and effective. They demand and deserve scientific proof.

If parents of the Gardasil™ victims had been fully informed of all the risks and limited benefits of Gardasil™, including the presence of recombinant DNA in the vaccine which may cause autoimmune-based disorders, immediate death, or permanent disabilities, they might have been able to make an informed decision. They could have made an informed choice as to whether it was better for their children to risk immediate negative outcomes with a vaccine, or to teach their children about an already proven safe and effective method of controlling cervical cancer, namely regular screening and good gynecological care.

It is time for the manufacturers of HPV vaccines and government health agencies involved to provide scientifically sound proof that residual recombinant HPV DNA firmly attached to an aluminum adjuvant presents no current or future health risk to the children and young adults of the world.

When injecting a healthy population to attempt to control a disease that may occur 40 years down the road in a population that has limited or no access to good gynecological care, there is no excuse for taking on any additional risk involved with vaccination.

Until such time as documented scientific proof is provided, all potentially contaminated vaccines should be withdrawn from the market. Anything less deprives parents around the world of their right to informed consent when making healthcare decisions for their children.

Filed Under: Australasian, European, FDA, Gardasil / Silgard, SANE Vax Press Releases, World News Tagged With: , , ,

Dr. Sin Hang Lee: A case study in ethics don’t pay

October 4, 2011 By 8 Comments

By Norma Erickson, President

SANE Vax Inc. was organized to provide medical consumers with all of the information they need to make informed choices about vaccines, HPV vaccines in particular. Dr. Sin Hang Lee, Director of Milford Medical Laboratory Inc. has been instrumental in our efforts to raise consumer awareness regarding safe and effective cervical cancer prevention and the scientific facts in relation to the international HPV vaccine controversy.

Because of studies submitted to the FDA prior to approval of HPV vaccines indicating there was a substantial increase in pre-cancerous lesions for those who had already been exposed to vaccine-relevant genotypes of HPV before they were injected with Gardasil® or Cervarix®, Dr. Lee agreed to offer his cutting edge technology HPV genotyping test to medical consumers throughout the United States to protect those who were considering HPV vaccination so they could avoid that potential risk. The decision was announced to the public via a BusinessWire Press Release on 20 September 2010.

In the fall of 2010, without Dr. Lee’s knowledge or having an opportunity to defend himself, the newly appointed Chairperson of the Pathology Department at Milford Hospital informed the hospital’s credentialing committee that she was not recommending for approval or supporting Dr. Lee’s application for renewal of his medical staff privileges. For those who do not know, medical staff privileges at a hospital are a major asset to a medical doctor and they establish the relationship that permits among other things, the doctor to practice at a particular hospital.  When medical staff privileges at a hospital are revoked or not renewed, the doctor no longer has permission to practice at the hospital or use its facilities.  The non-renewal of the medical staff privileges, may also adversely affect the doctor’s license to practice medicine. In Dr. Lee’s case, the non-renewal of his medical staff privileges at Milford Hospital is under appeal.

Although Dr. Lee still maintains his medical staff privileges during the appeal, his position as director of the laboratory was summarily terminated along with his employment relationship at Milford Hospital on December 13, 2010 and he has been prevented from using the hospital’s laboratory to continue  his testing and research there ever since that time.  A lawsuit addressing the wrongful termination claim has been brought against the Milford Hospital.

While the hospital-based appeal hearings and the lawsuit are pending, Dr. Lee’s research and testing and the operation of his world class, CLIA certified molecular diagnostic laboratory at the Milford Hospital have all been significantly hindered and obstructed.  Dozens of opportunities for Dr. Lee to test Gardasil samples for contaminants have been lost as the hospital has redirected and/or returned vaccine lots sent to and intended for Dr. Lee back to the senders or other locations.  Dr. Lee and his attorneys are pursuing all available legal remedies to restore the testing laboratory as soon as possible in order to protect the public health, safety and well being.

In addition to his efforts to make sure those who choose to use HPV vaccines are able to protect themselves from a potential increased risk of pre-cancerous lesions due to prior exposure to vaccine-relevant HPV, Dr. Lee also allowed SANE Vax Inc. to offer his HPV DNA sequencing technology to those unfortunate enough to have experienced abnormal pap tests after HPV vaccination. SANE Vax Inc. believes these medical consumers have a right to know what genotypes of HPV are associated with their abnormal cells. If they are vaccine-relevant genotypes, the vaccine did not work for them. If they are not vaccine-relevant genotypes, perhaps the manufacturer targeted the wrong genotypes for their geographic area. Either way, medical consumers have a right to know.

Through the donation of his laboratory facilities, time and effort, Dr. Lee was able to confirm the contamination of Gardasil® with recombinant HPV DNA firmly attached to the aluminum adjuvant contained in the vaccine. This is a man who has dedicated his life to what is best for the medical consumer, no matter what the cost to himself personally.

It is the belief of the SANE Vax team that Dr. Lee has come under fire because of his association with and support for the SANE Vax mission. Therefore, the SANE Vax Board of Directors is beginning a campaign to let those in charge of deciding Dr. Lee’s fate know that we, along with medical consumers around the world, support Dr. Lee.

If you wish to join us to show your support for Dr. Lee and his ability to continue his much needed research, please take a few minutes to send the following three emails to the authorities in charge of determining Dr. Lee’s fate:

#1  Dr. Joe Pelaccia, President and CEO, Milford Medical Hospital

#2  Commissioner Jewel Mullen, Connecticut Department of Public Health

#3  Mr. George Jepsen, Attorney General State of Connecticut

All you need do is copy the linked emails into a new email, add an introductory sentence if you wish, and type your name and state/country after the signature line.

Without the information provided by Dr. Lee and his ongoing research, we feel medical consumers around the world will be deprived of information that is vital to their ability to exercise their right to informed consent when it comes to HPV vaccinations.

Please, take a few minutes and show those in charge of deciding Dr. Lee’s fate that you support his efforts to do what is best for medical consumers.

Filed Under: SANE Vax Press Releases, United States, Vaccine Politics/People Tagged With: , , , , ,

Father of Injured Gardasil Girl Matches Caplan’s Bio-Unethical $10,000 Bet

September 20, 2011 By 10 Comments

By Leslie Carol Botha

September 20, 2011

In a striking move, Australian businessman and father of a Gardasil injured girl, Stephen Tunley matched University of Pennsylvania bioethicist, Dr. Art Caplan’s $10,000 reward for ‘proof of Bachmann vaccine claims.’

Dr. Caplan made headline news after Presidential Candidate Michelle Bachmann, speaking as the mother of three daughters and the foster mother of 23 other adolescent girls publicly called “Gardasil – a potentially dangerous vaccine.’ Bachmann was approached by a mother of a Gardasil injured girl after the Thursday Republican Tea Party debate, and told her daughter was now ‘retarded’ (also known as brain damaged).

Caplan’s response was to place a wager on Bachmann’s ‘incredibly irresponsible falsehood.’

‘If she can produce a case in one week starting today verified by three medical experts that she and I pick of a woman who became ‘retarded’ (her words) due to HPV vaccine I will donate that to a charity of her choice.’ 1.

On Monday, September 19, 2011, SANE Vax Inc. issued a press release on what we feel is a blatant and unprecedented HIPAA violation by exposing a family of an injured child to media scrutiny. 2.

In addition, SANE Vax Inc. emailed an Open Letter to Dr. Caplan, on September 18 stating our objections to his unethical bet.

‘On behalf of the parents of a group of neurologically injured teenage girls after HPV vaccination, we feel obligated to question your ‘bio’-ethics as you challenge Republican presidential candidate Michele Bachmann with a $10,000 bet to prove a claim that a vaccine to prevent cervical cancer caused mental retardation. We represent many parents of teenage girls who have suffered a variety of central nervous system (CNS) dysfunctions, including various degrees of mental ‘retardation’ (impairment) as a sequelae of Gardasil® vaccination injuries. It is hard to believe that as bioethicist you openly instigate violation of the HIPAA law.

‘Now, SANE Vax Inc. challenges you, Dr. Caplan. Prove the vaccine Gardasil® has prevented a single case of cervical cancer. We have not found such a case in the world literature, or in the published clinical trial materials. The endpoints used for evaluating the efficacy of Gardasil® were largely self-reversible precancerous changes, not true cancer as defined in any pathology textbooks.’3.

By Monday morning SANE Vax Inc. President, Norma Erickson received this response.

‘Find the case, present it to michelle bachmann, let the doctors we agree on confirm HPV vaccine as the cause and I pay. You have until thursday.’

Arthur Caplan
Emanuel & Robert Hart Director of
The Center for Bioethics and
Sidney D Caplan Professor of Medical Ethics
University of Pennsylvania
3401 Market St. Suite 320
 

Alerted to the emailed response, Stephen Tunley, researched funding sources for the University of Pennsylvania Bioethics Department and to no one’s surprise found that their primary funding source was none other than the National Institutes of Health.

Outraged, Tunley matched Caplan’s wager – and upped the ante by adding the issue of financial disclosure in the following challenge:

Dear Dr. Caplan

I would like to offer you $10,000 to you to prove that Gardasil did not and does not cause the issues discussed by Ms. Bachman and others. Of course when I win, you might care to donate the monies to SANE Vax. However and unlike your gutless prove it by Thursday deadline – I am happy to keep this offer open for a while.

On a personal note I find it revolting that a ‘bioethicist” would engage in such a bet. Surely your responsibilities are to investigate, consider and approach this with an open mind. But I guess you have long since not been a “real” bioethicist and now are really a ‘vaxapologist!’

One more question: will the $10,000 be sourced from your pockets or from the bioethics centre? As you know, but perhaps many others don’t know, funding for the center comes from a range of sources – including the NIH http://www.bioethics.upenn.edu/funding.shtml, which as we say down-under has ‘skin in the game” by being a co-patent holder for Gardasil and receives royalties from its sale.

A wee bit of conflict of interest and perhaps a challenge for you and your supposed ethics! Interesting that this was not disclosed by you!

So Dr Caplan ‘man up;’ disclose your conflicts and take up the challenge!

Stephen Tunley
Sydney Australia
Father of Chescia Tunley – yet another young woman damaged by Gardasil

The ball is in your court now, Dr. Caplan.

Sources:

1. Bioethicist Offers $10,000 Reward For Proof of Bachmann Vaccine Claims

2. Bioethicists Not So Ethical When It Comes to Gardasil Injuries

3. SANE Vax: Open Letter to Dr. Art Caplan, Bioethicist , University of Pennsylvania

Chesica Tunley’s Story  -
http://sanevax.org/chescia-from-sydney/

Stephen Tunley Writes to CNN
http://sanevax.org/steven-tunley-writes-to-60-minutes/

 

Filed Under: SANE Vax Press Releases, Vaccine Politics/People Tagged With: , , ,

Gardasil Contamination: EMA Steps Up to the Plate, FDA drops the Ball

September 19, 2011 By 8 Comments

By Norma Erickson, President

16 September 2011, in response to an inquiry about SANE Vax’s recent discovery of genetically engineered HPV DNA in Gardasil™[i], the following announcement was broadcast on Tipp.fm radio out of Clonmel, County Tipperary, Ireland:

“The IMB (Irish Medicines Board) and European Medicines Agency (EMA) are aware of the recent communication from Sane Vax and following on from this, the EMA requested the marketing authorisation holder conduct an immediate assessment of the risk of contamination.

The IMB, through its participation in EU Scientific Committees is contributing to the ongoing EU assessment of this issue and will continue to do so at further EU meetings scheduled over the coming week. Any updates on the outcome of these discussions and any recommendations will be highlighted, as appropriate. At present, the balance of risks and benefits for the vaccine remains positive.

The Gardasil vaccine has been licensed for use in the EU since 2006. The IMB together with the EMA continue to monitor the benefit-risk profile of Gardasil.”

This is particularly good news for medical consumers in the 27 countries belonging to the European Union (Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom). An ‘immediate risk assessment’ should mean the marketing authorisation holder must now:

  • Determine the extent of the contamination
  • Determine any potential health risk that could result from HPV rDNA attached to aluminium adjuvant being injected into the human body

The critical issue here is not that the vaccine has residual DNA in it, but that the contaminating HPV DNA is genetically modified and firmly attached to the aluminium adjuvant – making it an unknown quantity as far as potential health risks.

Is recombinant (genetically engineered) HPV DNA, or adventitious DNA, capable of altering human DNA potentially initiating cancer, or a host of autoimmune disorders?

The manufacturer of Gardasil™, Merck, went to great lengths to assure government health authorities around the world there was no viral DNA in the vaccine.[ii] [iii] Merck repeatedly told health authorities that this vaccine only contained virus-like particles manufactured from the L1 protein – NO HPV DNA. Recognizing the potential health risks of residual DNA, government health officials relied on this assurance when they approved the vaccine for use in their countries.

The SANE Vax team believes the solution is simple. Gardasil™ does not meet the specifications the manufacturer put forth to gain approval for the use of their HPV vaccine. Therefore, Gardasil™ use should be discontinued until such time as the manufacturer can either remove all residual HPV DNA from the vaccine, or prove the residual HPV rDNA attached to the aluminium adjuvant poses no health risks when injected into the human body.

SANE Vax Inc would like to thank the EMA and IMB for ‘stepping up to the plate.’ We believe demanding an immediate risk assessment be performed by the authorisation holder is the only reasonable avenue available. Medical consumers around the globe will be watching and anxiously awaiting the outcome of your investigations into this matter.

SANE Vax Inc notified the FDA about the discovery of HPV rDNA contaminants in Gardasil™ before anyone else was informed.[iv] Why does this government agency remain strangely silent regarding the contamination of Gardasil™? Has the Food and Drug Administration in the United States ‘dropped the ball’?

Could it be that since the FDA failed to require the manufacturer to test for, evaluate and quantify the risks of residual recombinant HPV DNA in Gardasil™ before granting approval for marketing the vaccine, they just decided to take their toys and go home?

Medical consumers deserve better than that.

Filed Under: SANE Vax Press Releases Tagged With: , , , , , ,

Bioethicists Not So Ethical When It Comes to Gardasil Injuries

September 19, 2011 By 7 Comments

Dr. Caplan et al., we are not willing to gamble with patient’s lives…..
However, you and some of your associates are apparently willing to do just that. 

 

 

By Leslie Carol Botha, Vice-President Public Relations
Janny Stokvis - Researcher and VAERS Analyst

September 18, 2011

Time to get this story straight: – University of Pennsylvania bioethicist, Dr. Art Caplan1.recently committed what SANE Vax views as an unprecedented HIPAA violation by offering a $10,000 reward for ‘proof of Bachmann vaccine claims.’

Forcing a family to disclose their child’s health records publicly, in front of a maniacal witch burning media network out to get Presidential Candidate Michelle Bachmann, is unethical, immoral, unprofessional and unwarranted. Obviously the news of Gardasil contamination and Bachmann’s reference to the vaccine as potentially dangerous has dug a knife deep into the heart of the Pharma industrial beast.

Now, the beast thinks it can raise its ugly head publicly demanding this family sacrifice a child’s privacy to save Bachmann’s political face.  Outrageous.

According to Forbes Magazine, ‘University of Pennsylvania bioethicist Art Caplan is so confident that Michele Bachmann’s claim that a young girl was made mentally retarded by injections of the Gardasil vaccine against human papilloma virus is false that he is offering to donate $10,000 to the charity of Bachmann’s choice if she can produce such a patient.

‘Caplan, who has made the offer via Twitter, to the Minneapolis Star Tribune, on the radio stations WTVN and WOR, also proposes that Bachmann should donate $10,000 to the charity of his choice if such a patient can be produced. He says her campaign hasn’t responded. He writes:

‘If she can produce a case in one week starting today verified by three medical experts that she and I pick of a woman who became ‘retarded’ (her words) due to HPV vaccine I will donate that to a charity of her choice.’ 2.

Charity of Bachmann’s choice?  Dr. Caplan, you should be writing a check to the victim’s family to cover the medical costs incurred by the contaminated vaccine.  In fact, the entire industry better get their checkbooks ready – because families are lining up ready to speak out and be counted.

In addition to Caplan, ‘another bioethicist, Steven Miles of the University of Minnesota, has offered $1,000 if a patient whose brain was damaged by an HPV vaccine can be produced. The bioethicists are making a pretty safe bet, because the odds of finding a reputable medical expert who will say a case of mental disability was caused by Gardasil is close to nil.’ 2.

Define ‘reputable’ – one who is paid to be beholden to Merck?   Sirs, you are doing the 23,388 adversely injured adolescents and the 102 families whose daughters and sons have died HPV post-vaccination a disgraceful disservice with your pompous attitudes.

SANE Vax Inc. believes that Caplan and Miles are violating HIPAA’s (Health Insurance Portability and Accountability Act) Patient Privacy Act guaranteeing privacy rights under federal law by focusing the media’s biased pharmaceutical spotlight on innocent families forcing them into the media limelight to disclose their adolescent’s medical history to the public. 3.

All this mother in Florida did was take advantage of the opportunity to let Bachmann know there is a problem with Gardasil.  Where is the crime in that?  All Bachmann did was publicly report what the mother told her…why should she be raked over the coals…unless of course there is something to hide?

Why not focus on a girl whose mother has already spoken out on the issue to try and find the cause of her brain damage.  That is what ‘mental retardation’ is isn’t it?

Hobart Indiana mother Amy Pingel has been very vocal in her efforts to get media attention to the fact that Gardasil can cause serious side effects, including seizures, neurological problems and even paralysis.  She believes her daughter is proof.

Her daughter, Zeda was a normal, healthy 13-year-old who loved her family, her friends and her phone. She once was a popular cheerleader and A-B student, who texted and talked tirelessly. Now, she is silent. She is strapped to her wheelchair, her head leaning against a head rest, her eyes wandering, seemingly sightless. She can neither walk, eat, nor speak.4.

Research vs. Rebuttal

If indeed, these bioethicists were ethical, they would be doing the research instead of using their ‘authority’ to refute the claim.

Instead, SANE Vax Inc. has gathered research for them since their arrogance is standing in the way of bioethics.

According to VAERS – the following reports have been listed for HPV, HPV2 & HPV 4 and ‘mental disorders.’ This is an estimated 1 to 10% of the vaccine-injured population reporting.

VAERS Analysis HPV, HPV2, HPV4 –
U.S. & Foreign		 HPV4
U.S. Only
Acute Disseminated Encephalomyelitis (ADEM)

21

7
Encephalitis

53

27
Demyelination

60

28
Psychotic Disorder

14

5
Abnormal Behaviour

49

41
Cognitive Disorder

22

19
Mental Status Changes

41

38
Nuclear Magnetic Resonance Imaging Brain Abnormal

132

95
Speech Disorder

90

67
Myelitis Transverse

30

21
Facial Palsy

138

105

 

Encephalitis is known to be an infection that involves inflammation of the brain that can cause mental retardation. 5.

According to Wikipedia – Encephalomyelitis is a general term for inflammation of the brain and spinal cord, describing a number of disorders including:

Acute disseminated encephalomyelitis or postinfectious encephalomyelitis, a demyelinating disease of the brain and spinal cord, possibly triggered by vaccination or viral infection;  Encephalomyelitis disseminata, a synonym for multiple sclerosis;  and Myalgic encephalomyelitis, a syndrome involving inflammation of the central nervous system with symptoms of muscle pain and fatigue; the term has sometimes been used interchangeably with chronic fatigue syndrome 6.

The following peer-reviewed studies point out the links between Encephalitis and HPV Vaccines:

Demyelinating disease and polyvalent human papilloma virus vaccination
J Neurol Neurosurg Psychiatry doi:10.1136/jnnp.2010.214924

Since its inception, the polyvalent vaccine against the human papilloma virus (HPV), Gardasil, has generated some controversies as a temporal relationship between the administrations of the vaccine and the development of a few autoimmune diseases, such as acute disseminated encephalomyelitis (ADEM), multiple sclerosis (MS) and Guillain–Barre syndrome have been reported. We encountered two cases whose initial presentation of CNS demyelination followed in close time relationship the administration of Gardasil vaccine and we discuss their possible association.
http://jnnp.bmj.com/content/early/2010/10/08/jnnp.2010.214924.extract

Meningococcal and Human Papilloma Virus Vaccine Associate Recurrent Acute Disseminated Enchephalomyelitis
Juan Carlos Muniz, MD, Stanley Krolczyk, DO, RPH; Lise Casady, ARNP, University of South Florida
http://www.mscare.org/cmsc/images/pdf/2008cmscabstracts-posters53.pdf

A report of five cases of CNS demyelination after quadrivalent human papilloma virus vaccination: could there be any relationship?
26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) & 15th Annual Conference of Rehabilitation in MS (RIMS) 13.10.2010 – 16.10.2010
http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=116417&XNSPRACHE_ID=2&XNKONGRESS_ID=126&XNMASKEN_ID=900

Acute disseminated encephalomyelitis with tumefactive lesions after vaccination against human papillomavirus
Neurología. 2010;25(1):58-69
http://www.elsevier.es/sites/default/files/elsevier/pdf/295/295v25n01a13148580pdf001_2.pdf

Bilateral Papilledema Following Human Papillomavirus Vaccination Case Report
J Med Cases • 2011;2(5):222-224

http://www.journalmc.org/index.php/JMC/article/viewFile/256/203

Acute Disseminated Encephalomyelitis Following Vaccination Against Human Papilloma Virus
American Academy of Neurology, Neurology 2009;72:2132–2133.

Wildemann et al. present a case of aggressive acute disseminated encephalomyelitis (ADEM) following immunization with the polyvalent human papillomaviruses (HPV) vaccine. The time between vaccine exposure and onset of illness provides evidence for a cause-effect relationship.

The author goes on to note “…it is important to monitor the occurrence of immune-mediated diseases that are occurring after vaccination with Gardasil®”
http://www.neurology.org/content/74/10/864.2.full.html

 

Gentlemen – it is high time you acknowledge there is a problem with the HPV vaccines.  Medical consumers know it, and researchers and medical professionals are aware. Get your checks ready because we are coming to collect.

 

Sources:

1. Art Caplan http://www.med.upenn.edu/apps/faculty/index.php/g275/p11072

2. Bioethicist Offers $10,000 Reward For Proof of Bachmann Vaccine Claims http://www.forbes.com/sites/matthewherper/2011/09/15/bioethicist-offers-10000-reward-for-proof-of-bachmann-vaccine-claims/

3.HHS Health Information Privacy
http://www.hhs.gov/ocr/privacy/

4. WISH TV Indianapolis, GOP debate puts questions over HPV vaccine back in the spotlight – 1 Hoosier mom blames daughter’s illness on vaccine

Filed Under: Gardasil/Silgard Vaccine, SANE Vax Press Releases, Science & Medicine, Vaccine Injury Reporting, VAERS Tagged With: , , , , ,

Infectious Disease News report misleading as to the efficacy of Cervarix vaccine against anal cancer

September 8, 2011 By Leave a Comment

By Norma Erickson and Stephen Tunley

In a recent article in Infectious Disease News[1]commenting on the research published in the latest issue of Lancet Oncology[2], Jason Harris reported:

“There were 27 diagnosed HPV-related anal cancers in the vaccine group vs. 85 diagnoses in the control group, for a vaccine efficacy of 68.2% (95%GI, 51.4-79.7). For cervical cancer, researchers observed 28 diagnoses in the vaccine group compared with 116 in the control group. Vaccine efficacy against cervical HPV 16 was 75.8% (95% CI, 63.8-84.2).

For HPV 18, there were 20 diagnosed anal cancers in the vaccine group compared with 45 in the control group. Vaccine efficacy was 55.5% (95% CI, 25.2-74.2). [emphasis added]

Let us be clear, the research study showed no such thing as prevention of actual cancers and definitely not anal cancers, only HPV infections. There is a significant difference between HPV infection and cancer!

In particular, a review of page 6 of the study by Kreimer et al.,² published in Lancet Oncology reveals that:

“In the full cohort, vaccine efficacy against anal HPV 16/18 infection detected 4 years after vaccination was 62.0% (95% CI47.1-73.1) and the corresponding cervical vaccine efficacy was 76.4% (67.0-83.5); p for interaction by anatomical site was 0.031: table 2). Vaccine efficacy against anal HPV 16 was 68.2% (51.4-79.7); 27 events in the HPV group vs 45 events in the control group…..[emphasis added]

Thus, the Lancet Oncology paper clearly states that HPV vaccination was protective against HPV infections and NOT against anal cancer. This is also clear from the title of the Lancet Oncology study, “Efficacy of a bivalent HPV 16/18 vaccine against anal HPV 16/18 infection among young women: a nested analysis within the Costa Rica Vaccine Trial.”

If the HPV vaccine did indeed prove protective against anal cancer, it is more than likely the authors would have indicated so somewhere in their manuscript!

Noteworthy, the commentary on the Kreimer et al. study² published in the same issue of Lancet Oncology, by former lead researcher on both Cervarix and Gardasil clinical trials, is very important. In this commentary Dr. Diane Harper states that although the HPV vaccine Cervarix may prevent HPV infections associated with anal cancers, the overall benefit of prophylactic HPV vaccination against anal cancer in the heterosexual male population remains unknown. This is because efficacy trials are lacking and anal cancer incidence is rare (2 cases per 100,000 population).[3] Furthermore, the end-stage precancerous HPV-related anal cancer lesions (AIN3 lesions) have a relatively low rate of malignant transformation in immunocompetent patients and, according to Harper, many people with AIN3 die with it, not of it.³

This type of poor and misleading reporting by Infectious Disease News¹ is very disappointing. The use of just two words – anal cancers – changes the implications of the research by Kreimer et al.² completely. What follows if such errors are not corrected is that the two words get repeated by others and perpetuated to the point where scientific fiction replaces the facts. Soon a vaccine against a virus becomes a cure for cancer – just like that.

One would think, or at least hope, reporters and journal editors responsible for ensuring the accuracy of scientific information would not allow such glaring errors in reporting. However, the Infectious Disease News commentary by Jason Harris¹ shows this is not the case. One has to wonder how many of such far from innocuous inaccuracies have been published in the past by a journal which:

“strives to be the global, definitive information source for ID professionals by delivering timely, accurate, authoritative and balanced reports on clinical issues, socioeconomic topics and industry developments, as well as presenting clinically relevant information on medical therapies for the benefit of the patient[4][5]” [emphasis added]

The Infectious Disease News website states:

“Article review process: All articles posted on InfectiousDiseaseNews.com are reviewed by the Chief Medical Editor and Executive Editor, who are solely responsible for deciding upon their acceptance, rejection or need for revision, based upon their appropriateness to the mission of the publication. All staff-written news reports are sent to quoted sources for verification of media accuracy. Quotes and other information in staff-written news reports are verified for accuracy with sources prior to publication. Excluded from this policy are InfectiousDiseaseNews.com website-first articles, which are not sent to sources to facilitate the rapid dissemination of this news.”⁴

So here’s the rub, if you want accuracy, don’t read the website-first articles. Indeed, it appears rapid dissemination of inaccuracy is more important than dissemination of accuracy!

SANE Vax asks, why is this allowed? Perhaps in answering this question one should also ask the following: Who does such inaccurate reporting profit?

Infectious Disease News appears to have a prestigious editorial board.[6] Chief Medical Editor, Dr. Paul Volberding is widely considered one of the world’s leading AIDS experts. In 1990, Dr. Volberding co-chaired the Sixth International Conference on AIDS, held in San Francisco, and has served on the international advisory committee for all subsequent international conferences. He is currently chief of the medical service at the San Francisco Veterans Affairs Medical Center, and principal investigator and co-director of USCF’s Center for AIDS Research. He is also the co-editor of The Medical Management of AIDS, the most widely used textbook of HIV medicine.[7] Bottom line, Dr. Volberding of all people should know the difference  between a vaccine that prevents a viral infection-related cancer and a vaccine that merely prevents a viral infection!

One cannot help but noting Dr. Volberding’s financial disclosure in which he declares that he serves as the scientific advisor to an impressive range of pharmaceutical companies, including: Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Ortho Biotech, Pfizer/Agouron, Shire and Schering. In addition, Dr. Volberding is also on a speakers’ bureau for Gilead, GlaxoSmithKline, Ortho Biotech and Schering.6 Finally, according to the Infectious Disease News Article review process quoted above 4, Dr Volberding as the Chief Editor is solely responsible (together with the Executive Editor) for deciding upon the acceptance of papers, “based upon their appropriateness to the mission of the publication”.

All of the above leads to a disturbing possibility that the commentary on the study by Kremier et al. as presented in Infectious Disease News, was designed to provide an outcome that supports the promotion of Cervarix, manufactured by GlaxoSmithKline, as a cure for anal cancers.

Where are the peer review and safeguards to maintain scientific accuracy and protect medical consumers from this type of pharmaceutical biased propaganda? Where are the voices of regulatory authorities who are supposed to keep this type of thing from occurring again and again?

 

Sources:

[1] Harris J. Targeting HPV 16/18 shows promise in cancer risk reduction. Infectious Disease News, 2011, http://www.infectiousdiseasenews.com/article/86993.aspx

[2] Kreimer AR, Gonzalez P, Katki HA, et al. Efficacy of a bivalent HPV 16/18 vaccine against anal HPV 16/18 infection among young women: a nested analysis within the Costa Rica Vaccine Trial. Lancet Oncology, Sep 2011;12(9):862-870

[3] Harper DM, Vierthaler SL. Who should be targeted for vaccination against anal cancer? Lancet Oncology, 2011:12(9):828-829

4 Infectious Disease News, Editorial Policy and Philosophy, Mission Statement. http://www.infectiousdiseasenews.com/aboutus.aspx#contact

5 Infectious Disease News, Meet the Editorial Board, http://www.infectiousdiseasenews.com/MeetBoard.aspx

6 University of California, San Francisco, Paul A. Volberding, MD, Director; http://hivinsite.ucsf.edu/InSite?page=ab-01-01-02

 

Filed Under: SANE Vax Press Releases Tagged With: , , , , , , ,
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