Showing posts with label mystery illness. Show all posts
Showing posts with label mystery illness. Show all posts

Tuesday, September 6, 2011

SANE Vax Inc. Announces the Discovery of Viral HPV DNA Contaminant in Gardasil

By Norma Erickson, President


Phone calls from mothers with children who have experienced adverse events after HPV vaccination is part of the everyday routine for members of the SANE Vax team. This one was different. A sexually naïve 13 year old girl from Toronto had developed acute juvenile rheumatoid arthritis within 24 hours after the third Gardasil™ injection. Two years later, her blood was tested by a local clinical laboratory and found to be positive for HPV DNA.

Local physicians could provide no explanation. Human papillomavirus is an epithelial virus which does not survive in the blood stream for long. HPV only thrives on skin and mucosal membranes. They could not explain why HPV was in her blood instead of HPV antibodies.

Desperate for answers, her mother called SANE Vax to see if there was any research available that might shed some light on her daughter’s situation. Not having any contradictory information available, the SANE Vax team agreed to contact some experts for their professional opinion.

Many phone calls and much research later, the only option left was to try to determine whether Gardasil could have been the possible source of HPV in the girl’s blood.

Dr. Sin Hang Lee, a pathologist at the Milford Hospital pathology laboratory well-known for using cutting-edge DNA sequencing for molecular diagnoses,[i] was initially contracted to examine a single sample of Gardasil for possible contamination. This sample tested positive for recombinant viral HPV-11 and viral HPV-18 residues, both of which were firmly attached to the aluminum adjuvant.

In order to understand the possible implications of such contamination, medical consumers must understand the following definitions:

There is no such thing as an independently ‘live virus’. Any and all viruses must be embedded in a host cell in order to reproduce.
‘Wild DNA’ is any DNA found in nature.
‘Viral DNA’ is any DNA isolated or derived from the genome of a virus.
‘Recombinant DNA’ is a DNA that has been artificially attached to DNA from another species or a man-made DNA construct, in other words, genetically modified.
‘Recombinant DNA,’ also known as genetically modified DNA, is considered a biohazard.[ii] [iii]
‘DNA residue’ is left-over DNA in a final product after the product has been purified to remove the DNA.
Any DNA can be adsorbed (attached) to aluminum adjuvant.
‘Mutagenesis’ is the formation or development of a genetic mutation. Gardasil has not been evaluated for mutagenesis.[iv]
‘Carcinogenesis’ is the initiation of cancer formation. Gardasil has not been evaluated for carcinogenesis.⁴
Concerned that recombinant DNA, if present, might have triggered some of the autoimmune-based inflammatory disorders and malignant tumors observed among children/young women after receiving Gardasil™ vaccinations, medical professionals and vaccine safety advocates from the United States, Australia, New Zealand, Spain, France, and Poland donated samples of Gardasil™ currently distributed in their countries to be examined.

In all, 13 different lot numbers were tested by Dr. Sin Hang Lee. One hundred percent of the samples were found to be contaminated with viral HPV DNA residues, firmly attached to the aluminum adjuvant.

At the time of Gardasil™ approval, both Merck and the FDA represented that there was no viral DNA in the vaccine.[v] [vi] [vii] Both the FDA and Merck knew, or should have known, that any residual recombinant HPV DNA left in the vaccine could pose a health risk to any medical consumer injected with Gardasil™.[viii] [ix]

Medical consumers need the answers to the following questions:

If recombinant HPV DNA attached to aluminum adjuvant enters a person’s blood, how long will it remain there?

What autoimmune-related disorders could result from this contamination?
Is it possible for this contamination to initiate gene mutations which may lead to cancer?
What genetic changes (mutagenesis) could occur should the residual HPV DNA enter and begin reproducing in a human cell?
SANE Vax believes the FDA should have required Merck to test for, evaluate and quantify the risks of residual recombinant HPV DNA in Gardasil™ before granting approval for marketing the vaccine. SaneVax believes the FDA should require every lot of Gardasil™ be tested for residual HPV DNA prior to shipment.

It is time for the manufacturer and the FDA to do their jobs. It is time to disclose the health impacts contaminant viral HPV DNA may have unleashed on unsuspecting medical consumers around the globe.

SANE Vax Inc. has sent a letter to Dr. Margaret Hamburg, FDA Commissioner to inform her of the contamination and request FDA investigation into the extent of HPV DNA contamination in the Gardasil HPV4 vaccine currently on the market. It was also requested that the FDA take appropriate actions to ensure public safety regarding future shipments.

Anything less than immediate action is not acceptable.


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[i] DNA sequencing for molecular diagnoses

[ii] Potential Biohazards of Recombinant DNA

[iii] POLICY ON THE USE OF BIOHAZARDOUS AGENTS AND RECOMBINANT DNA IN

RESEARCH AND TEACHING LABORATORIES AT THE UNIVERSITY OF NORTH

CAROLINA AT GREENSBORO

[iv] Gardasil: Highlights of Prescribing Information

[v] Developing an HPV vaccine to prevent cervical cancer and genital warts

[vi] Gardasil (Human Papillomavirus Vaccine) Questions and Answers – Gardasil, June 8, 2006, FDA

[vii] VRBPAC Briefing Document, FDA, 17 Nov 2010,see section 3.2, page 12

[viii] History, precedent, and progress in the development of mammalian cell culture systems for preparing vaccines: safety considerations revisited.

[ix] In vivo study of hepatitis B vaccine effects on inflammation and metabolism gene expression.

Tuesday, July 5, 2011

Partnering for HPV Vaccine Introduction, Part I: Questions Unanswered

Despite unanswered questions about HPV vaccine efficacy and duration of protection, nine 'partner' organizations chose to proceed making plans for worldwide distribution of Gardasil and Cervarix prior to FDA approval. What is wrong with this picture?


PRLog (Press Release) – Jul 05, 2011 – On 5 October 2005, eight months prior to FDA approval of the HPV vaccine Gardasil, the Pan American Health Organization (PAHO, a regional office of the World Health Organization) sponsored a meeting in Washington D.C. The theme of this meeting was, Partnering for HPV Vaccine Introduction. According to the final report issued after this meeting,1 its purpose was to, “accelerate and strengthen the dialogue between invited partner agencies regarding their interests and plans related to the introduction of Human Papillomavirus (HPV) vaccines.”

Of course, both potential vaccine suppliers, Merck and GlaxoSmithKline, were ‘invited.’ In addition to the potential suppliers, representatives from the following ‘partnering agencies’ were in attendance:

• The Pan American Health Organization (PAHO)
• The World Health Organization (WHO)
• The International Union Against Cancer (UICC)
• The American Cancer Society (ACS)
• The United States Agency for International Development (USAID)
• The United States National Cancer Institute (NCI)
• The United States Centers for Disease Control and Prevention (CDC)
• Program for Appropriate Technology in Health (PATH)
• The Bill and Melinda Gates Foundation

After a brief introduction, representatives of PAHO outlined the activities their organization had already conducted in preparation for the introduction of the yet to be approved HPV vaccines. Then, Merck and GSK each made a brief presentation regarding their respective-proposed HPV vaccines, Gardasil and Cervarix.

The presentations made by Merck and GlaxoSmithKline raised the following questions from their ‘partnering agencies’:

• Question 1: How would vaccine efficacy be assessed in young children in the absence of CIN lesions?

• Question 2: How will the issue of consent for HPV vaccine trials in adolescents be handled?

• Question 3: What is the duration of protection conferred by these vaccines?

• Question 4: What level of antibody is actually protection?

According to the final report on this meeting, published by PAHO, the answers given to these questions were sketchy at best. That may be understandable, considering HPV vaccines had not yet been approved by the FDA. However, it is not acceptable for these questions to remain unanswered five years post-FDA approval.

SaneVax Inc. has the following concerns regarding the above-stated questions:

Question 1: Although both vaccine suppliers indicated they were ‘conducting immune-bridging studies,’ the question posed has still not been answered. There is no adequate reliable method of testing HPV vaccine efficacy to this day. Using CIN lesions is not reliable, considering they frequently reverse on their own, without medical intervention. Efficacy against vaccine-relevant HPV genotypes could theoretically be tested via DNA sequencing, but that option is not readily available to medical consumers.

Question 2: Both vaccine suppliers indicated they required consent from the parent, or legal guardian, as well as permission from the subject when trials were conducted with participants below the legal age of consent. This clearly was not the case in India, April 2009, when clinical trials were halted because of alleged ethics violations including boarding school administrators being allowed to give consent for all of the girls attending their school, and other consent forms being returned with a thumbprint (clearly indicating the person granting consent could not read the consent form).2

Question 3: The answer provided by both vaccine suppliers then (information on duration of protection is unavailable at this time), is similar to the one they give today. Both vaccines have been approved for nearly five years. One of the suppliers is already talking about the potential need for a booster shot to maintain protection. Duration of protection is still unknown.

Question 4: The answer given at the time by the vaccine suppliers was, “There are currently no established serologic correlates of protection.” What that means is no matter how many antibodies are produced and circulating in a vaccinated person’s bloodstream, no one knows if you are protected. Serologic correlates have still not been established.

Three of the four questions posed at the meeting are basic questions that should have been answered prior to FDA approval of either HPV vaccine. There must be a reliable way to determine efficacy and antibody level required for protection with any vaccine. These should be determined prior to marketing. Every vaccine carries some risk for some people. If efficacy cannot be determined with accuracy you have nothing left but risk.

Duration of protection should also be well established prior to marketing for the same reason efficacy needs to be determined. No one can logically determine if a vaccine is cost effective when they do not know the duration of protection.

One has to wonder why nine prestigious organizations, responsible for the health and well-being of millions of people, would agree to stand behind and promote any vaccine that could not clearly and scientifically demonstrate the answers to very basic questions regarding the product’s efficacy.

There are only a couple of options available to medical consumers to determine HPV vaccines’ efficacy. One, wait 20 or more years to see if HPV vaccines actually make an impact on cervical cancer rates; or two, demand post licensure monitoring that includes HPV DNA sequencing to find out if the vaccines are actually making an impact on vaccine-relevant genotypes of HPV.

The SaneVax Team votes for – No adequate post-licensure monitoring – No marketing!

Sources:
1. Partnering For HPV Vaccine Introduction, Final Report: Visit http://www.paho.org/English/AD/FCH/IM/HPVMtg-FinalReport ... for details.
2. "Human Smears" by Madhavi Tata, visit http://www.outlookindia.com/article.aspx?277351 for details

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SaneVax believes only Safe, Affordable, Necessary & Effective vaccines and vaccination practices should be offered to the public. Our primary goal is to provide scientific information/resources for those concerned about vaccine safety, efficacy and need.

Spinning the Spin Part II: Marketing Scientific Research & Studies

Fewer girls develop cervical abnormalities after HPV vaccine.
FOR IMMEDIATE RELEASE

PRLog (Press Release) – Jun 28, 2011 – My father, once a pharmaceutical packaging salesman and now an Alzheimer’s nursing home patient whose mental clarity declined rapidly post- flu vaccination – once told me ‘never believe in everything that is advertised.’ Truer advice was never given. Perhaps that is when I started questioning the marketing on products about women’s health, always reading between the lines and doing my own research.

Over the last 30 years – marketing and advertising has taken hold of the world. Consumers are continually bombarded with sales pitches for everything from the latest and greatest technological toys to medications and vaccines. Marketing campaigns for women’s health products are orchestrated with as much flare and fanfare as a formal event. 1. Gardasil was no exception.

In 2006, the HPV vaccine Gardasil was introduced to a public generally unaware of Human Papillomavirus or its supposed threat to adolescent girls and women. However, the public was quickly informed of the ‘dangers’ of the virus when Merck Pharmaceutical Company launched an aggressive One Less Girl to get Cervical Cancer advertising campaign – with an awarding-winning jingle that had adolescent girls dancing in their living rooms – determined to become one less victim of cervical cancer.

According to Neon Tommy, the campaign was successful. Merck’s marketing techniques earned Gardasil a “pharmaceutical brand of the year” award from Pharmaceutical Executive for its ‘savvy disease education,’ and creating ‘a market out of thin air.” 2.

OK – so as medical consumers we get the promotion of products….but when did scientific research sell out to marketing companies and the media?

How Women are Viewed by the Pharma/Medical Complex

In order to understand why this latest HPV vaccine uncontrolled medical experiment has been conducted on adolescent girls and now boy’s ages 9 to 26, it is important to recognize the social/political context of how women are perceived by the medical industry.

In their recently updated book, For Her Own Good: Two Centuries of the Experts Advice to Women by Barbara Ehrenreich and Deidre English expose the reasons for medical experiments on women.

“Since the nineteenth century, “experts” have been telling women how to take care of themselves. Generations of highly respected mainstream physicians have proclaimed most aspects of women’s lives an indication of weakness, from menstruation (illness requiring seclusion) to pregnancy (a disabling disease), to reading or intense conversation (a hazard to women’s health). Even domesticity, the prescription for a safe environment for women, became a domain for legions of “scientific” experts…. Yet experts continue to use pseudo-science to tell women how to live."

Ehrenreich and English write in the book’s introduction:

No matter how many degrees the experts dangle in front of you, no matter how many studies they cite, dig deeper, value your own real-life experiences, and think for yourself.3.

So when Reuters and CNBC.com and other world press picked up the story out of Australia (Ian Frazer country) this past week: Fewer girls develop cervical abnormalities after HPV vaccine 4. The SANE Vax team immediately started investigating.

According to Julia Brotherton, an epidemiologist with the Victorian Cytology Service Registries and lead author of the paper; "This data ... shows a reduction in the number of very young woman with high grade cervical lesions diagnosed since the vaccine program started."

However, mid-way through the article, Associate Professor Karen Canfell, an epidemiologist with the Cancer Council of New South Wales commented that "The study looked at overall trends, and we cannot be absolutely certain that the drop in cervical abnormalities in the youngest age group was due to HPV vaccination."

Norma Erickson, president of SANE Vax, Inc. immediately found the flaw in the data used in the study and commented, “Both groups showed less than 1% cervical abnormalities – which is statistically accurate across the board.

How can anyone state a reduction from 0.8% to 0.42% is a significant reduction? Technically, I will admit it is almost a 50% reduction but in 1,000 girls – that would be a reduction from 8 with abnormal cells to 4 with abnormal cells….which pap smears would catch a whole lot cheaper than paying $300,000 to vaccinate the same thousand girls – not to mention they still need pap screening regardless of vaccination status.”

Diane Harper as well as many other researchers in the field – have stated that it will be at least 20 years before it is known whether or not the HPV vaccines will have impacted the worldwide cervical cancer rates.

Professor Ian Frazer, Director of the Diamantina Institute for Cancer, Immunology and Metabolic Medicine in Australia and creator of the HPV vaccine – stated in an Australian newspaper article titled God’s Gift to Women, “HPV vaccines should eventually eliminate a number of epithelial cancers and reduce the annual burden of cancer deaths globally by 5%–10%.” 5.

It is truly unfortunate, that instead of utilizing an already proven, safe and effective means of reducing cervical cancer risk; the medical marketing ‘experts’ at Merck, the FDA, CDC, and NCI decided to ‘re-educate’ medical consumers and push a vaccine that has not been scientifically proven safe, affordable, necessary, or effective. Perhaps, it is not medical consumers that need to be ‘re-educated’ - Perhaps it is time for the medical ‘experts’ to learn - if medications/vaccinations are not Safe, Affordable, Necessary and Effective, medical consumers do not want them.

Sources:

1. Susan Rako MD - http://www.susanrako.com/article5.htm

2. Neon Tommy: http://www.neontommy.com/2010/01/gardasils-broadreaching ...

3. For Her Own Good: Two Centuries of the Experts Advice to Women: http://www.isbnlib.com/preview/1400078008/For-Her-Own-Go ...

4. Fewer girls develop cervical abnormalities after HPV vaccine: http://www.cnbc.com/id/43433951

5. God’s Gift to Women: The Human Papillomavirus http://holyhormones.com/wp-content/uploads/downloads/2010/07/HPV-Fraser-Imm-20061.pdf

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SaneVax believes only Safe, Affordable, Necessary & Effective vaccines and vaccination practices should be offered to the public. Our primary goal is to provide scientific information/resources for those concerned about vaccine safety, efficacy and need.

Saturday, January 29, 2011

SaneVax Introduces One More Cervarix Girl: Lara from Wales

Lara’s story is but another in the line of tragedies following GlaxoSmithKline’s “Armed for Life” marketing campaign for Cervarix. Unfortunately, she has joined the group of 'One More Injured or Gone After HPV Vaccination.'

PRLog (Press Release) – Jan 28, 2011 – Prior to Cervarix, Lara was every mother’s dream child. She didn’t cry, finished her bottles in the blink of an eye and was always smiling. As she grew, she began to remind people of the “energizer bunny.” She was always on the go, participating in every physical activity she could find. Lara rode bicycles, roller skated, played football, basketball, hockey, and rode horses. She enjoyed walking on the beach, surfing and swimming. Lara was constantly surrounded by friends and admirers of all ages. On top of all this, at only 13 years old, Lara knew what she wanted to do with her life – she was going to become a forensic pathologist. She worked very hard in school and her performance record showed it. In short, she was a girl who would make any mother proud.

Enter Cervarix. On 13 October 2008, Lara received her first injection of the HPV vaccine Cervarix. The day went without incident. Lara had no adverse reaction. Unfortunately, that was not the case with her second injection.

Shortly after her second jab, 17 November 2008, Lara started feeling very ill. She had a high temperature, sore throat, headaches, joint pain, and extreme tiredness. It seemed all of her energy was gone. Lara’s mom took her to the GP who put her on some medication to control the symptoms and sent her home. After a few weeks, she was able to go back to school.

Even though the package insert for Cervarix clearly states that further injections should not take place when an adverse reaction is experienced, Lara was administered the third and final injection on 31 March 2009. Shortly after, her perfect world began to fall apart. Lara woke up the morning after her third injection not feeling well. Her symptoms began with a very high temperature and difficulty walking. She lost her voice. Being the responsible student she was, she tried valiantly to attend classes. After three days, she could no longer handle it and had to stay home.

That was only the beginning of Lara’s new medical conditions. She started to experience extreme sensitivity to light. For days, she would have to sit in a darkened room because light hurt her eyes so badly. Things started to smell unusual, she began to lose her hair, had terrible headaches, and neck pain. Lara had trouble walking. Her legs just would not do what she wanted them to do. At times, she could not even keep her balance when she was sitting down. Probably the most disturbing symptom was the unexplained weight loss.
When Lara started losing weight, her mom put her on a high calorie diet. In spite of all Lara ate, she still lost 3 stones (42 pounds) over the next few months. Lara is living a nightmare.

During this time, Lara was taken to eight different doctors at two different hospitals. Lara has been admitted to the hospital several times, but no one seemed to know what was happening to her. Frequently, she was prescribed painkillers, told she must have a virus and sent home. At various other times, her mom was told she was bulimic, just seeking attention, on drugs, or that it was all in her head. At least once, her mom was accused of being paranoid, the equivalent of Munchausen by proxy. Lara has now been diagnosed with CFS/ME, chronic fatigue syndrome/myalgic encephalomyelitis. Although there are many potential causes of this condition, one recognized possible cause is a vaccine-reaction.

Lara’s mom has been forced to watch as her daughter’s life is being ripped away. She has watched as her daughter transformed from the healthy, happy creature you see in the photo above, to a mere shadow of her former self. Mom has had to sit by and listen as her daughter cries out in pain, even in her sleep. Mom is forced to watch her daughter try to complete her education at home because she was too ill to attend regular classes for an entire year. Worst of all, mom has had to face the unspeakable agony of hearing her daughter ask why the doctors cannot ‘put her down’ like they do animals when they are in pain.

Today, Lara is back in school but can only attend about half of the time. Sometimes, her mother has to physically carry her to school because she collapses on the way. Her teachers have agreed to modify her schedule and concentrate on classes that lead her toward her goal of becoming a forensic pathologist. Lara is still determined to reach her goal. She is just having an extremely difficult time doing it.

Lara has stopped socializing. She lives in self-imposed isolation. She is frustrated that she cannot just live her life the way it was. Every day her mother wonders what the future really holds for her beautiful young daughter. She faces every day in fear of losing her pride and joy.

Lara’s mom wants to tell everyone, “Do not take the huge step of vaccinating your child with Cervarix without doing your research. You need to know the potential risks, as well as the potential benefits before you decide. You can always vaccinate, but once it is done -- you cannot change your mind.”

The SaneVax team believes everyone considering HPV vaccination needs to know things like this are possible. That is why we have partnered with TruthAboutGardasil (visit http://truthaboutgardasil.org) and ThinkExist Productions (visit http://onemoregirlfilm.com) to produce a documentary called “One More Girl.” This documentary will provide a place for girls like Lara and their families to tell their stories. It will also expose the truth behind the approval of HPV vaccines, their deceptive marketing practices and the political pressure to make these vaccines mandated around the world despite ongoing questions about their safety and efficacy.

Please, take a few minutes to watch the documentary trailer below. This information must be made public before any more girls join the group Lara and so many others around the world have joined – the group comprised of “One More Girl Injured or Gone after HPV Vaccination.” We need your help to make it possible.

Learn more about the ‘One More Girl’ documentary here: http://www.kickstarter.com/projects/1995527181/one-more- ...

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SaneVax believes only Safe, Affordable, Necessary & Effective vaccines and vaccination practices should be offered to the public. Our primary goal is to provide scientific information/resources for those concerned about vaccine safety, efficacy and need.

Tuesday, September 28, 2010

Lancet Article Recognizes Impact Social Advocacy Groups Have on HPV Vaccination Programs

North Hollywood, CA, September 27, 2010 — In the August 2010 issue of The Lancet, an article titled: The India HPV-vaccine suspension by Heidi J Larson, Pauline Brocard, Geoffrey Garnett of the Institute for Global Health, Imperial College London noted the impact global advocacy groups concerned about the safety and efficacy of the HPV vaccines has had on the success of immunization programs worldwide.

According to the authors, “We need to find new ways to engage the public, early on, in health research and in the design and delivery of health programmes. That approach includes taking the time to listen to societal concerns, public emotions, and politics that can derail programmes or research.”

The efforts of SAMA, India’s Resource Group for Women and Health, http://www.samawomenshealth.org/ were cited in the article for their well-designed efforts to force the Indian government to halt the HPV vaccination trials until an independent inquiry of the deaths and adverse injuries to Indian girls was conducted.  A panel of medical professionals was gathered - without representation by members of SAMA or the other 68 social and political organizations that pressured the Indian government. According to The Hindu, India’s national newspaper “…Information on the demonstration project and licensing of two vaccines to prevent cervical cancer has been exempted from public disclosure under Section 8 of the Right to Information Act, 2005.” (8/09/10)

However, the damage has been done - and global efforts by groups around the world questioning whether the vaccine is safe, necessary and effective is mounting daily, according to Norma Erickson, Chairman of the Board for S.A.N.E Vax, http://sanevax.org/. “Never before has a global community come together to create a world-wide movement putting pressure on the media, governments and the pharmaceutical companies demanding for an independent study into the safety and efficacy of Gardasil/Silgard and Cervarix.”

In the face of a dictum issued by the U.S. Health and Human Services Secretary, Kathleen Sebelius who stated in the February 2010 issue of Readers Digest, “There are groups out there that insist that vaccines are responsible for a variety of problems despite all scientific evidence to the contrary. We have reached out to media outlets to try to get them to not give the views of these people equal weight in their reporting to what science has shown and continues to show about the safety of vaccines;” the public outcry in the United States is rising - affecting the numbers of girls getting vaccinated.

Alicia Capilla, founder of AAVP; Association of Affected Young Women by HPV Vaccine, in Spain agrees. “I can tell you that the work we have done in Spain has decreased HPV vaccination uptake numbers.”

The Mothers’ Alliance Ireland (MAI) has spent almost a decade researching the HPV/cervical cancer link and is now actively protesting mandatory vaccination of adolescent girls. MAI and concerned mothers from various counties throughout Ireland have written letters to the media, passed out information leaflets, held public meetings and contacted public health officials and politicians protesting this legislation.

The Lancet article states: As far as these groups were concerned, their arguments were evidence-based. Some of the points made by the advocacy groups and a member of parliament are generally reasonable: calling for increased funds for health, maximising investment in priority health issues, ensuring the safety of health interventions, communicating clearly and honestly any risks, and conducting ethical processes in research.”

The article concludes with the statement, “We might not always understand them, but we cannot ignore them.” This statement can be flipped to the other side… the social advocacy groups may not always understand the pharmaceuticals and government’s motives - but the evidence based research and the increasing numbers of adversely injured and the deaths will not be ignored.