Wednesday, September 29, 2010

What Really Went Wrong with Gardasil

North Hollywood, CA, September 10, 2010 — On September 7, 2010, Shelly Dubois wrote an article for Fortune - on, titled: What’s Wrong with Gardasil. SANE believes that the article discredits the thousands of families, who have suffered deaths and adverse injuries to their daughters in the name of financial numbers and award-winning marketing strategies. 

The article opens with: “There’s a liquid drug that women can get injected into a layer of muscle — three separate times over a six-month period — that can protect them from a kind of cancer. From a scientific perspective, that’s amazing. In terms of public health, it’s a breakthrough.

“But four years after Merck (MRK, Fortune 500) released this would-be top-seller, called Gardasil, it has proven to be a marketplace dud. In Merck’s second quarter, the company reported an 18% year-over-year drop in sales to $219 million and its stock is down nearly 3% to date. Analysts are pointing to Gardasil not as a savior, but as a risk for investors.”

Dubois comments on the reasons why this vaccine has now become a “marketplace dud” stating that Gardasil ran into two major roadblocks: consumer inertia and politics.

1) People are spending less on medicine in general.

2) Some parents aren’t comfortable vaccinating young children against a virus they can only get from having sex.

3) Merck didn’t properly prepare the right doctors.

4) Merck couldn’t counter the bad press.

Although Ms. Dubois does allude to one death from Gardasil she quickly covers her tracks by writing “no one linked Gardasil to the cause of death, but the drug was launched into the fierce debate over vaccine safety.”

It is appalling that the numbers of adverse reactions and deaths to Gardasil were not mentioned in this critique. That is what really went wrong with this vaccine.

The following adverse reactions and deaths have been reported to the Vaccines Advent Reporting System (VAERS) as of 9/2/2010:

Adverse Reactions

Gardasil - 18,461

Cervarix - 426

HPV Vaccines - 137

TOTAL - 19,024


Gardasil 77

Cervarix 4

TOTAL - 81

In March of this year the number of reactions reported stood at 16,000. That means 3,000 more reports were made over the last 6 months - or approx. 125 reports a week. That is what went wrong with Gardasil.
SANE Vax would like to answer the question that Ms. Dubois raises about why girls aren’t completing the vaccines series. “The Centers for Disease Control reported in late August that while 44% of teenagers received the HPV vaccine in 2009, only 27% of them received all three doses of the shot. Unfortunately, there isn’t evidence to support that getting only one shot effectively protects against cancer. So why aren’t women finishing the series?”

According to the 2008 FDA Closing Statement on Gardasil, it was noted that 73.3% of girls receiving the vaccine would develop “new medical conditions.”  Just doing the quick math with only 27% completing the series and 73% getting some kind of “mystery illness’ undiagnosed by doctors - SANE Vax believes that the question answers itself.

What went wrong with Gardasil is not about the financial numbers, marketing strategies, consumer inertia, or politics - it is about destroying the lives of those it was supposed to save.

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, 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, “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.

Thursday, September 23, 2010

Gardasil® - Another Uncontrolled Medical Experiment?

North Hollywood, CA, August 30, 2010 — In 2003, Susan Rako published her groundbreaking book “No More Periods?  The Blessing of the Curse,” stating that ‘manipulating women’s hormonal chemistry for the purpose of menstrual suppression threatens to be the largest uncontrolled experiment in the history of medical science.’ Indeed, within the last decade her prophetic words are ringing true.

S.A.N.E. VAX. Inc. is postulating that the HPV vaccines are the latest uncontrolled medical experiment potentially responsible for 78 reported deaths and 18,900 reported adverse reactions (VAERS).

Although, S.A.N.E. VAX. Inc. concurs that “medical experiment” is a risqué term we feel that it is important to look at the facts surrounding the 2008 and 2010 Gardasil® healthcare provider/patient product inserts.

12/2008 Overall Summary of Adverse Reactions includes: headache, fever, nausea, and dizziness; and local injection site reactions (pain, swelling, erythema, pruritus, and bruising occurred after administration with Gardasil. Syncope has been reported following vaccination with Gardasil and may result in falling with injury; observation for 15 minutes after administration is recommended.  Anaphylaxis has been reported following vaccination with Gardasil.

One and a half years later the 6/2010 USPPI Patient Information about GARDASIL® has a much more extensive list of the most common side effects: pain, swelling, itching, bruising, and redness at the injection site; headache, fever, nausea, dizziness, vomiting, fainting.
The products insert states: “Tell your health care provider if you have any of the following problems because these may be signs of an allergic reaction: difficulty breathing, wheezing (bronchospasm), hives, or rash.

“Tell your health care provider if you have: swollen glands (neck, armpit, or groin), joint pain, unusual tiredness, weakness or confusion; chills, generally feeling unwell, leg pain, shortness of breath, chest pain, aching muscles, muscle weakness, seizure, bad stomach ache, or bleeding or bruising more easily than normal. Contact your health care provider right away if you get any symptoms that concern you, even several months after getting the vaccine. For a more complete list of side effects, ask your health care provider.”

S.A.N.E. VAX. Inc. wants to know what will the litany of adverse reactions look like in another year and a half as injuries and deaths continue to climb? S.A.N.E. VAX. Inc. also is puzzled by the fact that Merck suggests that health care providers have a complete list of side effects, when in most cases they are getting their information from Merck.

Rosemary Mathis, states: “If the 2010 product insert information was available when my daughter Lauren received the vaccine in 2008, the doctor would have known to discontinue the series because of the reactions she was having. Instead, based on my doctor’s advice Lauren received all three injections and got sicker and sicker.

Mathis believes the doctors are not reporting adverse effects to VAERS because the published list from Merck is not correct.  Merck and the CDC classify the symptoms as non-serious, but there are more symptoms that are occurring after Gardasil that are much more serious (paralysis, brain fog, MS, blindness) and they are not listed.

Mathis raises an interesting question: “When young girls have headaches, nausea and dizziness so severe that they cannot function on a daily basis how can that be considered non-serious?”

Indeed, if it was your daughter who was suffering from the above adverse reactions wouldn’t you - as a parent - consider them to be serious?  For that matter, wouldn’t you be appalled if yet another uncontrolled medical experiment put the health and future of your daughter at risk?

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S.A.N.E. VAX, Inc. Formed to Prevent Potential HPV Vaccine Induced Increased Risk of Cancer

North Hollywood, CA, August 16, 2010 — SaneVax, Inc.,, is a non-profit organization, founded to offer affordable highly sensitive HPV testing with specific genotyping by DNA sequencing, for pre- and post vaccination.

According to Chairman of the board, Norma Erickson, the SaneVax mission is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information.

Other organization members include, Leslie Carol Botha, Women’s Health Educator and broadcast journalist; Rosemary Mathis, mother of a daughter injured by the Gardasil vaccination; Freda Birrell, political lobbyist in the UK and Scotland and Janny Stokvis, vaccine researcher. The five women have spearheaded this effort to provide a web site with research articles, studies and data not only on the HPV vaccines - but on eventually on all vaccines marketed in the United States.

Erickson states that the SaneVax team believes in science-based medicine. The primary goal of the organization is to provide the information necessary to assist in making informed decisions regarding vaccination choices. The organization also provides resource referrals to vaccine-injury physicians, medical practitioners, attorneys, and other vaccine-related groups for those unfortunate enough to have experienced vaccine-related injuries.

SANE VAX Inc. will be offering Human papillomavirus (HPV) monitoring test for HPV vaccine users, and will be working in conjunction with Dr. Sin Hang Lee F.R.C.P. (C), FCAP. Dr. Lee has over 50 years’ experience in general/surgical pathology and clinical microbiology and is authorized to practice in the U.S., Canada, and the U.K. Dr. Lee is particularly concerned about the health issues surrounding the HPV vaccines.

There are 283 cases of post-vaccination abnormal pap smears reported to the Vaccine Event Reporting System (VAERS) with more reports of high-risk HPV, cervical lesions and cervical cancer beginning to surface in medical journals.

According to Dr. Lee’s research, HPV 16, one of the two strains of the virus targeted by Gardasil, is not even prevalent in the U.S. HPV 32, 18 and 58 are common strains in some parts of the U.S., but this varies from one location to the next. Lee has also noted that it is a persistent infection with HPV strains that may lead to cervical cancer - not just a one time exposure. He is quick to emphasize that the virus usually passes through women’s bodies within four menstrual cycles.

Pre-testing for HPV is crucial since the May 2008 FDA VRBPAC documents have noted that exposure to HPV prior to vaccination raises the risk of cervical cancer 44.6% for Gardasil and 32.5% for Cervarix. Post-vaccination testing is equally important for those who have suffered adverse reactions to the vaccine.
“Pre and post HPV testing is crucial to identify whether a young woman has already been exposed to HPV - and to try and understand the mechanisms of action causing the injury and death of innocent girls after inoculation,” states Botha. Parents are already expressing interest in HPV testing which costs $50 per test through a national specialty clinical laboratory. Most health insurance companies will reimburse the cost.

The SaneVax site provides the latest news on vaccines, including those currently being developed and tested, with links to scientific studies on their potential safety, efficacy and need. The site also includes a blog, videos, several discussion forums and a physicians’ forum, where doctors representing various medical disciplines, and successfully treating vaccine injuries, can collaborate with each other.

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Gardasil Not Associated with Autoimmune Diseases – Cervarix adds Lymphadenopathy to Adverse Reactions

North Hollywood, CA, September 22, 2010 — According to an article posted on Sept. 3 in Infectious Disease News data was presented at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy showing the quadrivalent human papillomavirus vaccine (Gardasil) did not raise the risk for developing autoimmune conditions. The study was sponsored by Merck and conducted on behalf of the Gardasil Safety Team.

Meanwhile back at the FDA Department of Health and Human Services, a letter was issued to GlaxoSmithKline Biologicals on September 2, 2010, granting “your request to supplement your biologics license application for Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant (Cervarix), to add lymphadenopathy to the Adverse Reactions, Postmarketing Experience section of the full prescribing information.”

S.A.N.E. is asking: “Which one is it boys?”
According to Wikipedia, “lymphadenopathy is a term meaning “disease of the lymph nodes.” It is, however, almost synonymously used with “swollen/enlarged lymph nodes. It could be due to infection, auto-immune disease, or malignancy. Autoimmune etiology includes sarcoidosis, systemic lupus erythematosus, and rheumatoid arthritis all giving a generalized lymphadenopathy.

To date, over 300 events have been reported to the Vaccine Adverse Event Reporting System (VAERS) where the vaccine is HPV or HPV4 (Gardasil) and the symptom is lymphadenopathy.
Norma Erickson, President of S.A.N.E Vax, Inc., referred to the latest Merck funded study on autoimmune diseases as “an outrageous excuse for a scientific study. There are over 60 autoimmune disorders reported to VAERS and the 16 least likely to exhibit (even with Gardasil) were chosen with percentages compiled on only 11 of those – and they were probably randomly sampled.”

On another front – vaccine notables will be gathering at the University of Pennsylvania on Tuesday September 21, 2010 for a Bioethics Conference on The Science, Ethics and Politics of Vaccine Mandates.

Mandating HPV Vaccine will be the topic of an afternoon panel session with Merck Vaccines Senior Director, Health Policy; and representatives from GlaxoSmithKline- Public Policy & Advocacy-Vaccines Division; Columbia University Public Health, and the Children’s Hospital of Pennsylvania.
Diane Harper, MD – Univ. of Missouri-Kansas City School of Medicine, who contributed to the studies of Cervarix and Gardasil worldwide will also be participating in the panel presentation.

Dr. Harper stated in a 2009 Philadelphia Bulletin interview that the “controversial drugs will do little to reduce cervical cancer rates and, even though they’re being recommended for girls as young as nine, there have been no efficacy trials in children under the age of 15.”

Dr. Harper also believes that young girls and their parents should receive more complete warnings before receiving the (HPV) vaccine to prevent cervical cancer, and that the current vaccines should not be mandated.

Parents need to be aware of the sundry and unorthodox messages from pharmaceutical marketeers who influence public policy.  Mixed messages, lack of credible information and motives for profit are a poor excuse for mandating any vaccine.

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