I recieved a letter during spring 2009 containing promotion for Gardasil from Sanofi Pasteur MSD where they offered me to buy this vaccine for my teenage daughter. This promotion contained wrong facts and 75 % of its content described how to use my insurance coverage in order to purchase Gardasil at a lowest cost.
In order for you to determine - as a mother / parent - if you want your daughter to have this vaccine, Ive put together information on this site.
My personal opinion is that this vaccine have been approved with too little testings prior to its release. There have also been many serious side effects among the girls/young women who already have received this series of shots. I feel, that including Gardasil in the regular vaccine program for young girls, is based on incorrect facts, tests and information.
By letting Gardasil be included in the regular vaccine program our politicians are showing their approval to let half a generation become test pilots for a drug company. The lenght of its efficiency has not been established yet. Are we supposed to let this half generation contribute to the yearly profit of a drug company when it appears to be the most expensive vaccine ever and needs to be renewed on a regular basis?
Why does not Socialstyrelsen - National Board of Health & Welfare, FDA in USA and other governments all over the world react with the increases of reported side effects and deaths linked to Gardasil?
My concerns are great on behalf of the Swedish population and the lack of commitment from Socialstyrelsen .- National Board of Health & Welfare in this debate and the costs all side effects might cost the taxpayers.
Above mentioned promotional mail and the website www.gardasil.se is reported to Konsumentverket - Swedish Consumer Agency for a misleading promotion and information.
Dok.id. 163127 registrerat 2009-06-29 hos Konsumentverket - Swedish Consumer Agency
HPV vaccines also for boys in USA: http://children.webmd.com/vaccines/news/20100106/new-childhood-vaccine-schedule-now-official?src=RSS_PUBLIC
CDC Ending HPV Vaccine Requirements for Immigrants
http://www.gardasil-talk.com/
Dr Diane Harper, principal investigator (PI) for clinical vaccine trials for Merck (Gardasil) and GlaxoSmithKline
(Cervarix)
Gardasil is associated with serious adverse events, including death. If Gardasil is given to 11 year olds, and the vaccine does not last at least fifteen years, then there is no benefit - and only risk - for the young girl.
http://www.huffingtonpost.com/marcia-g-yerman/an-interview-with-dr-dian_b_405472.html
This is another very good international site:
http://truthaboutgardasil.org/
Sweden starts to give this dangerous vaccine to children of age 9-12 year in January 2010.
Gardasil - A Sad Girl?
What are the ingredients in GARDASIL?
[Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]
The ingredients are proteins of HPV Types 6, 11, 16, and 18, amorphous aluminum hydroxyphosphate
sulfate, yeast protein, sodium chloride, L-histidine, polysorbate 80, sodium borate, and water for injection.
http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf
Recombinant DNA
http://www.youtube.com/watch?v=x2jUMG2E-ic
Virus like particles give, when injected intramuscular to prepubical girls, a 100 times stronger antibody level compared to getting a HPV infection naturally.
The purpose of the genetical manipulation in this vaccine is to pass through the immune system, blood-brain barrier - in order to get as high an efficiency with as little substances as possible.
Simply said:
A town which needs vaccination would need a truckload of substance compared to a cup full of recombinant DNA substances.
When the immune system is penetrated, the human body might suffer from auto immune syndroms - like Guillain Barrés syndrom which starts with numb limbs and might cause paralysis. The autonome nervsystem might also collapse and dyspnoea - difficulty in breathing - might happen. Appr. 5 % dies when suffering from Guillain Barrés syndrom.
Please compare the Swedish product information with the American Patient information which lacks information about Guillan Barrés syndrom.
Scroll down to 4. Eventuella biverkningar (Eventual side effects) in this link:
http://www.fass.se/LIF/produktfakta/artikel_produkt.jsp?NplID=20051216000104&DocTypeID=7&UserTypeID=2
http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf
There are none that can tell what these genetically manipulated vaccines might attract or which course of events that might be triggered in the human body if exposed to certain contaminations in the future.
There are no existing studies made on how 2 nano technically / genetically manipulated vaccines interact with each other in the human body or which side effects that might occur.
I need to point this out since the coming vaccine for the swine flu is manufactured according to the same method as Gardasil.
Just another thought coming to my mind: What happens in my childs body if both Gardasil and the swine flu is injected together or with just a short time in between the shots?
Will there be side effects not known before or worse from what we've seen caused by the Gardasil vaccine?
Are governments / insurance companies around the world prepared to handle all costs that might raise from these genetically manipulated vaccines and the victims they leave behind?
An Early Warning
In 1976 George Wald, Nobel Prize winning biologist and Harvard professor, wrote:
Recombinant DNA technology [genetic engineering] faces our society with problems unprecedented not only in the history of science, but of life on the Earth. It places in human hands the capacity to redesign living organisms, the products of some three billion years of evolution.... It presents probably the largest ethical problem that science has ever had to face. Our morality up to now has been to go ahead without restriction to learn all that we can about nature. Restructuring nature was not part of the bargain.... For going ahead in this direction may be not only unwise but dangerous. Potentially, it could breed new animal and plant diseases, new sources of cancer, novel epidemics.
http://everything2.com/title/Morality+of+Recombinant+DNA
http://www.greens.org/s-r/20/20-01.html
http://www.jstor.org/pss/30131388
Gardasil contains sodium borate which is used in rat poison, pesticides, cleaning detergent and bleach.
http://www.scribd.com/doc/8463346/HPV-Vaccine-Rat-Poison-Chemical-Found-in-Ingredient-List
http://www.jtbaker.com/msds/englishhtml/s3122.htm
http://www.whale.to/vaccine/sodium_borate.html
Gardasil contains polysorbate 80 which causes infertility in mice & humans:
http://www.ncbi.nlm.nih.gov/pubmed/8473002
http://www.whale.to/v/tween_80.html
http://infertility.suite101.com/article.cfm/polysorbate_80_causes_infertility
http://www.ncbi.nlm.nih.gov/pubmed/16400901?dopt=Citation
Very interesting info: Merck - manufacturing Cervarix lists infertility as a autoimmune reaction:
http://www.merck.com/mmhe/sec16/ch186/ch186a.html
In USA 20% of couples struggle with infertility at any given time:
http://www.hmc.psu.edu/healthinfo/i/infertility.htm
Polysorbate 80 in products causing anaphylactoid reactions;
http://www.ingentaconnect.com/content/acaai/aaai/2005/00000095/00000006/art00019;jsessionid=1oas93idk52v4.victoria
Gardasil contains aluminumhydroxiphosfate sulfate - aluminum in vaccine are known to cause neurological damages:
http://www.whale.to/vaccine/Aluminum_in_Vaccines.pdf
http://www.whale.to/v/aluminium_h.html
http://www.whale.to/vaccines/shaw.pdf
“The vaccines we give our children are liquids filled with a host of unknown particles, most of which came from the cells of non-humans: from chickens, monkeys and even from cancer cells. Truly we do not know what we are doing or what are the long-term consequences. All that is known for sure is that vaccines are a very cheap form of public medicine often provided by governments to assure the public that they really do care for the safety of our children.”
http://www.globalresearch.ca/index.php?context=viewArticle&code=GAL20090929&articleId=15452
Gardasil is associated with serious adverse events, including death. If Gardasil is given to 11 year olds, and the vaccine does not last at least fifteen years, then there is no benefit - and only risk - for the young girl says Dr Diana Harper, principal investigator for clinical vaccine trials for Merck and GlaxoSmithKline.
http://www.huffingtonpost.com/marcia-g-yerman/an-interview-with-dr-dian_b_405472.html
Reports reg. Gardasil + side effects ----------->They had no voice. They had no choice.
The most common side effects from GARDASIL are: pain, swelling, itching, bruising, and redness at the injection site, headache, fever, nausea, dizziness, vomiting, fainting, difficulty breathing, wheezing (bronchospasm), hives, rash, swollen glands (neck, armpit, or groin), joint pain, unusual tiredness or weakness, chills, generally feeling unwell, leg pain, shortness of breath, chest pain, aching muscles, muscle weakness, seizure and bad stomach ache.
Full patient information from Merck:
http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf
Gardasil researchers drop bombshell
http://thebulletin.us/articles/2009/10/25/top_stories/doc4ae4b76d07e16766677720.txt
http://www.greensparrow.se/wp/forskare-sagar-gardasil-som-osakert-och-i-stort-satt-verkningslost/
Center (www.NVIC.org) found that there are three to 30 times more serious health problems and deaths reported to VAERS after Gardasil vaccination
http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20090209005358&newsLang=en
Gardasil & Swine flu vaccines, Inconvinient truth;
http://www.nvic.org/NVIC-Vaccine-News/August-2009/Gardasil-Swine-Flu-Vaccines-Inconvenient-Truths.aspx
Gardasil vs Menactra risk report 2009;
http://www.nvic.org/Downloads/NVICGardasilvsMenactraVAERSReportFeb-2009u.aspx
48 deaths since 2006 from Gardasil:
http://www.newsinferno.com/archives/7308
14 year old school girl dies within a cpl of hrs after HPV vaccine:
http://www.dailymail.co.uk/news/article-1216714/Schoolgirl-14-dies-given-cervical-cancer-jab.html
Second girl from Natalie school in 999 drama:
http://www.dailymail.co.uk/news/article-1217076/Second-girl-Natalie-school-999-drama-cervical-jab.html
Partially paralysed:
http://www.dailymail.co.uk/news/article-1214662/GlaxoSmithKline-challenged-safety-Cervarix-anti-cancer-vaccine-left-girl-partially-paralysed.html
Permanent brain damaged;
http://www.naturalnews.com/027188_NaturalNews_cancer_cervical_cancer.html
Always latest listed side effects:
http://www.medications.com/se/gardasil
International Memorial for Vaccine Victims:
http://www.nvic.org/Vaccine-Memorial.aspx
Gardasil Cervical Cancer Vaccine Side Effects Investigation
http://www.personalinjurylawyeramerica.com/medical/gardasil.htm?gclid=CPGwi7Svl50CFcsz3godN3dX3A
Several thousands of girls getting severe side effects from HPV vaccine - it should not have been included in the vaccine programme;
http://www.telegraph.co.uk/health/healthnews/6178045/Two-thousand-schoolgirls-suffer-suspected-ill-effects-from-cervical-cancer-vaccine.html
As early as 2003 FDA archive says HPV is not associated with cervical cancer:"
The FDA news release of March 31, 2003 acknowledges that "most infections (by HPV) are short-lived and not associated with cervical cancer", in recognition of the advances in medical science and technology since 1988. In other words, since 2003 the scientific staff of the FDA no longer considers HPV infection to be a high-risk disease when writing educational materials for the general public whereas the regulatory arm of the agency is still bound by the old classification scheme that had placed HPV test as a test to stratify risk for cervic
"PCR-based HPV detection device with provision for accurate HPV genotyping is more urgently needed now because vaccination with Gardasil of the women who are already sero-positive and PCR-positive for vaccine-relevant genotypes of HPV has been found to increase the risk of developing high-grade precancerous lesions by 44.6%, according to an FDA VRBPAC Background Document : Gardasil HPV Quadrivalent Vaccine. May 18, 2006 VRBPAC Meeting. al cancer in regulating the industry".
Note: FDA removed some reports. ie some links do not work in following articles but read more below:
http://www.naturalnews.com/Report_HPV_Vaccine_0.html
http://www.naturalnews.com/022404.html
http://www.fdareform.org/1723_HPV_HPV_vaccines.html
In this study 76 families were studied for two years with the main focus being the transmission of HPV from parents to infants. Only 2.6% were totally HPV DNA negative.
http://jcm.asm.org/cgi/reprint/43/1/376
If only 2.6% were HPV free we will have 434,404 young women out of 1,000,000 taking the HPV vaccine, who by the time they reach middle age and have families could acquire cervical cancer via a persistent infection with HPV types in the vaccines.
http://www.renewamerica.us/columns/janak/090807
Gardasil was tested only on 1200 girls during prelicensing:
http://www.medicalnewstoday.com/articles/63586.php
24 deaths reported after taking Gardasil in a test group of 25,274:
Deaths in the Entire Study PopulationAcross the clinical studies, 24 deaths were reported in 25,274 (GARDASIL N = 13,686; AAHS Control N
= 11,004, saline placebo N = 584) subjects (9- through 45-year-old girls and women; and 9- through 15-year-old boys). The events reported were consistent with events expected in healthy adolescent and adult
populations. The most common cause of death was motor vehicle accident (4 subjects who received
GARDASIL and 3 AAHS Control subjects), followed by overdose/suicide (2 subjects who received
GARDASIL and 2 subjects who received AAHS Control), and pulmonary embolus/deep vein thrombosis (1
subject who received GARDASIL and 1 AAHS Control subject). In addition, there were 2 cases of sepsis, 1
case of pancreatic cancer, 1 case of arrhythmia, 1 case of pulmonary tuberculosis, 1 case of
hyperthyroidism, 1 case of post-operative pulmonary embolism and acute renal failure, and 1 case of
systemic lupus erythematosus in the group that received GARDASIL.
http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf
June 9 2009 FDA's labeling revision for Gardasil:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm165145.htm
Gardasil Fainting Warning Upgraded:
http://www.yourlawyer.com/articles/read/16633
Germany's Roberth Koch Institute is questioning the effectiveness of the HPV vaccines:
http://www.americanchronicle.com/articles/view/104266
Health authorities may ditch Gardasil and Cervarix:
http://www.gardasilhpv.com/2009/05/health-authorities-may-ditch-gardasil.html
Singapore says no to Gardasil
http://holyhormones.com/puberty/singapore-says-no-to-gardasil-vaccine/
April 2009: more than 1300 reported side effects, May 2009 USA: 16000 reported side effects and 47 deaths after taking Gardasil:
http://www.onlineopinion.com.au/view.asp?article=9112&page=1
2 deaths in Spain after Gardasil:
http://www.brockovichblog.com/2009/03/two_girls_and_spain_takes_down.html
Gardasil ingredient caused sterility in laboratory rats. Merck can't prove if Gardasil is carcinogenic and may be mutagenic:
http://www.infonews.co.nz/news.cfm?l=1&t=0&id=28314
Brittney's warning to other women:
http://www.youtube.com/watch?v=0gCVCP8BFrU
Karen Maynor of New Mexico lost her daughter, Megan Hild to the Gardasil vaccine on November 15, 2008. Megan was a healthy, vital 20-year-old young woman with great aspirations –and no history of previous medical problems. Megan had just finished the second in the series of the Gardasil vaccination in September of 2008. She died in the shower.
Watch Karen Maynor:
http://www.youtube.com/watch?v=Kcpoqo_MNis
UK; Cervarix is included in the vaccine program and have many serious reports of side effects:
http://www.dailymail.co.uk/health/article-1160516/Paralysis-epilepsy-blurred-vision-1-300-girls-reaction-cervical-cancer-vaccine.html
http://endofmen.wordpress.com/2008/01/25/gardasil-vaccine-deaths-in-uk/
http://holyhormones.com/tag/robert-koch-institute/
http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccineRecords.pdf
Blog about Gardasil:
http://translate.google.se/translate_s?hl=sv&q=gardasil+bloggs&um=1&ie=UTF-8&sl=sv&tl=en&tq=gardasil+blog&ei=lfxaSrroG46mnQP8q5DdCQ&sa=X&oi=clir_tip&ct=search_link&resnum=11
More to read:
http://www.judicialwatch.org/gardasil
http://www.yourlawyer.com/articles/read/16633
http://www.naturalnews.com/026293.html
http://www.vaclib.org/news/2006/gardasil.htm
http://www.medications.com/se/gardasil
http://sayingnotovaccines.blogspot.com/2007/07/gardasil-damage-and-death-count-rise.html
http://www.hpvvaccinenotwhatyouthink.info/About_Us.html
http://womenhurtbymedicine.wordpress.com/
http://www.gnhealth.com/gardasil.html
http://www.renewamerica.us/columns/janak/070227
http://www.vaccinerx.com/news/cervical-cancer/gardasil-has-dangerous-side-effects-says-public-interest-group-20070525-293-26.html
http://www.kake.com/news/headlines/39520342.html
http://www.rockymountainnews.com/videos/detail/ashley-story/
http://au.todaytonight.yahoo.com/article/43654/health/gardasil-effects-controversy
http://www.gardasilhpv.com/2009/03/further-post-gardasil-convulsions-send_06.html
http://www.cynthiajanak.com/Gardasil.html
http://www.profitableharm.com/gardasil_cervarix_docs_concerns.html
Link about different types of vaccines:
http://abchomeopathy.com/forum2.php/80669/
Cervical Cancer Facts
There are at least 14 strains of high risk HPV that might cause cervical cancer but the HPV vaccine claims to prevent only against 2 of these strains: HPV 16 and HPV 18
Facts from Swedish Statistic Data Bases:
Among all women who does the regular pap smears and/or participate in the cervical screening programme - 80 % - you find 150 cases per year with the diagnos Cervical cancer - 30 women dies.
All other reports of Cervical cancers appear among the rest - 20% - who doesnt do regular pap smears and/or participate in the cervical screening programme.
1.5 promille, ages 20-44 or 181 women gets the diagnose according to Socialstyrelsens - National Board of Health & Welfare's Data Bases 2007.
A total of 466 were diagnosed with Cevical cancer in Sweden in 2007 according to Socialstyrelsens - National Board of Health & Welfare's Data Bases 2007.
Out of the total population with the diagnose - 162 women died in all ages according to Socialstyrelsens - National Board of Health & Welfare's data bases.
Make sure to check statistics from your own country in order to understand how few that actually die with Cervical cancers and have participated in the cervical screening programme.
In the USA about 7 women per 100,000 contract Cervical cancer. About 2.4 women per every 100,000 die.
About 91% of all cases are with women 40 years of age and older. More than half of the deaths that occur are with women 55 years of age and over.
http://www.youtube.com/watch?v=RZQEUd9Nc7E&feature=related
More than 100 different types of HPV - Human Papilloma Virus - have been identified.Gardasil claims to be effective against 4 strains of HPV's that might cause Cervical cancers or genital warts.
Sanofi Pasteur MSD writes in their promotional letter to me that Cervical cancer is the third most common type of cancer among women in the age group 20-44 which is correct according to Socialstyrelsens data bases. The next sentence describes that a women gets this diagnose every day and that appr. 150 of them will die without mentioning that these figures are included in the total population of women in Sweden. Not in the age group of 20-44.This is misleading; total deaths in all ages were 162 women in 2007.
Does the drug company intentionally use statistics from diff age groups in order to give the reader a wrong perception of the content thus making a ill informed desicion? Is this done to create fear? The company has been fined claiming Gardasil is efficient against other cancers that Cervical cancer:
November 8 2007:
If you tried to search Google prior to October 12 2007 with the word vulva cancer or vaginal cancer you got a sponsored link to the Gardasil homepage listed highest in the result list - even though this vaccine is not approved for any of these diseases. Göran Wennerström's - IGM - conclusion is that the drug company have tried to market this vaccine against diseases its not approved to prevent - so called indication of misinterpretation - which is against common ethics within the drug administration. The company was fined 120 000 SEK.
The company was sorry and explained it must have been a mistake which is something IGM cant accept since a sponsored link in Google search engines must have been activated by the company itself and paid for in order to appear with the link to their homepage.
IGM also points out that Sanofi Pasteur also in the past have been acknowledge to use "indication of misinterpretation" in how theyve been marketing Gardasil. IGM did consider this action as very serious even though the link was quickly removed after IGM decided to fine the company.There is a history of false information to the public from this company . This should lead all to contemplation and a lot of wondering what else the company might withold or mislead consumers regarding Gardasil and its true effect and/or side effects.
September 12 2008
FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal CancersThe U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. These two HPV types cause 70 percent of cervical cancers, and are known to also cause some vulvar and vaginal cancers, but the percentages are not well defined.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116945.htm
The questions that keep coming back into my mind are:
What kind of government allows a drug company to kill with their vaccine and destroy so many young womens life all over the world with no clear studies behind the effectiveness or its side effects in the future.
Especially, considering that its one of the most expensive vaccine ever produced.
Is it just a coincidence that this vaccine is now approved for the same type of cancers that it was fined for in Sweden in 2007??
Is it just a coincidence that Gardasil is not promoted to prevent vulva or vaginal cancers in Sweden due to facts its actually not preventing these cancers at all?
Why market the same vaccine differently in 2 countries when its manufactured in the same way?
Läkemedelsverket - Medical Product Agency in Sweden (same as FDA in USA ) might not accept these claims nor the lack of tests?
Will todays young girls / young women be able to get pregnant in the future when its time for them to consider having a family?
Not even the scientists behind Gardasil have any answers to these questions since no tests have been done regarding fertility after this vaccine.
Thoughts about Gardasil
The costs in Sweden will be appr. 200 million SEK each year but since the longevity of Gardasil is not known there will be significantly higher costs when a renewal of the vaccine is needed.
Since theres no reports available on longevity of Gardasil - none are able to tell which side effects might occur in the future for those participating in the programme. One have to consider not only reported side effects known today but also what might happen within 10-15 years in the human body. Noone can tell if fertility might be effected after taking the series of shots.
Sanofi Pasteur MSD have been fined 120 000 SEK by Infomationsgranskningsmannen -IGM - for unethical promotion of Gardasil in Google search engines.
http://www.lakemedelsvarlden.se/zino.aspx?articleID=11080
Same promotional letter that I got has been directly mailed to underage girls by "mistake":
http://www.aftonbladet.se/kropphalsa/cancer/article3567399.ab
Research Shows Gardasil to be Useless
To further investigate this conclusion, NaturalNews took a closer look at research published in the Journal of the American Medical Association (August, 2007), entitled, "Effect of Human Papillomavirus 16/18 L1 Viruslike Particle Vaccine Among Young Women With Preexisting Infection"
This research sought to determine the usefulness of the HPV vaccine among women who already carry HPV (which includes virtually all women who are sexually active, regardless of their age).
http://www.naturalnews.com/Report_HPV_Vaccine_0.html
http://jama.ama-assn.org/cgi/content/short/298/7/743
US lawyers filed the first two claims on behalf of girls with ailments blamed on Gardasil under a federal program to compensate victims of vaccine-caused illness, The Post has learned.
Both girls got the injections at their middle schools.
One is Jesalee Parsons, now 15, of Oklahoma, who began vomiting the day she got a Gardasil shot and developed pancreatitis, her claim says.
"It makes me mad because they're saying how great it is, but they never mention how many people have been hurt by it," Jesalee told The Post.
http://www.nypost.com/seven/07062008/news/nationalnews/feds_warning_shot_118716.htm?page=0
http://www.digitaljournal.com/article/257045
FDA lists Gardasil as preventive against vulva and vaginal cancer:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm165145.htm
Following conversation with FDA have occured:
Dear Sir's & Madam's.
As a concerned mother Id like to file a complaint regarding how Gardasil was listed on the FDA website to be effective against vulvar and vaginal cancer.
This information will have the effect of intentially misleading the parents of young girls, boys, and young women who are considering taking this vaccine. Gardasil does not prevent HPV related vulvar or vaginal cancers - only cervical cancer.
Sanofi Pasteur MSD in Sweden were promoting Gardasil in the same way that youre currently claiming it to be effective against vulvar and vaginal cancer and they were fined.
http://www.lakemedelsvarlden.se/zino.aspx?articleID=11080
Unless the US product named Gardasil contains other magic components thats excluded in the Swedish / European Gardasil I hereby urge you to change all listings and information you spread about this vaccine.
The way you have listed this you either intentially or unintentially have given misinformation about the vaccine.
I urge you to make correction so that consumers get accurate information on which to base their decisions.
Kind regards
Ann-Britt Axelsdotter
Skickat 2009-06-28
Svar 2009-06-29:
Dear Ann-Britt:
This reply acknowledges the receipt of your e-mail. Your inquiry has
been forwarded to the FDA's Center for Biologics Evaluation and Research
(CBER) for assistance. They will reply directly to you. Response times
may vary. Thank you.
[http://www.fda.gov/BiologicsBloodVaccines/default.htm, email:
ocod@fda.hhs.gov]
Best regards,
Drug Information SH
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
This communication is consistent with 21CFR10.85(k) and constitutes and
informal communication that represents our best judgment at this time
but does not constitute an advisory opinion, does not necessarily
represent the formal position of the FDA, and does not bind or otherwise
obligate or commit the agency to the views expressed.From:
Thank you for your inquiry to the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) concerning Gardasil. Your inquiry has been forwarded to the Center for Biologics Evaluation and Research (CBER) for reply. CBER, one of six centers within FDA, is responsible for the regulation of biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines, allergenic extracts, and cell, tissue and gene therapy products.
We appreciate your concern for the safety of individuals who may take the Gardasil vaccine. Information on Gardasil is available on CBER’s website at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094042.htm. Information on the package insert of Gardasil states "GARDASIL is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine: Cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18 … Not all vulvar and vaginal cancers are caused by HPV, and GARDASIL protects only against those vulvar and vaginal cancers caused by HPV 16 and 18."
The manufacturer is required to provide information including data from clinical trials concerning the safety and effectiveness of the vaccine on the prevention of diseases; this is identified in the package insert. Note that the package insert identifies the prevention of cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18. Vulvar and vaginal cancers may be caused by other factors which Gardasil does not claim to prevent.
Gardasil, manufactured by Merck & Co., Inc., is the only currently licensed Human Papillomavirus Vaccine in the United States.
We hope this information is helpful.
Sincerely,
PHH
Consumer Safety Officer
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Communication, Outreach and Development
Division of Communication and Consumer Affairs
Phone: 301-827-2000
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
From: consumerconcerns@hushmail.com Add contact To: CBER OCOD Consumer Account <ocod@fda.hhs.gov> Date: Tue, 28 Jul 2009 11:02:33 +0200
This message is not encrypted, and is not digitally signed by "consumerconcerns@hushmail.com" <consumerconcerns@hushmail.com>.
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Dear Sir's & Madam's
Thank you for your reply, but the link you provided me with does not work. My question was not answered and my concerns regarding how Gardasil is promoted still remains: How is it possible that the FDA is marketing the same vaccine in the USA as in Sweden, but with different information given? Is not Gardasil the same product whether sold in the USA or in Sweden?
Please send copies on studies that show Gardasil is a preventive for vulva and vaginal cancers caused by HPV 16 & 18. I need to know where all US distributed Gardasil vaccines are manufactured as well.
Thank you for your efforts with my concerns in these matters. Ann-Britt Axelsdotter
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From: CBER OCOD Consumer Account <ocod@fda.hhs.gov> Add contact
To: consumerconcerns@hushmail.com
Date: Mon, 10 Aug 2009 18:03:21 +0200
This message is not encrypted, and is not digitally signed by .
Dear Ms. Axelsdotter:
Thank you for your follow-up inquiry to the Center for Biologics Evaluation and Research (CBER) concerning Gardasil.
Sorry that the link for Gardasil did not work for you. You may want to copy and paste the website into your internet browser to find this information. Here is the link again:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094042.htm. This website provides information on the package insert and FDA press releases concerning Gardasil.
We would like to clarify that FDA is a regulatory agency, and does not market any vaccine in the US or abroad. FDA does regulate the advertizing and labeling of vaccines distributed in the US. Manufacturers may produce vaccines that are approved in the US as well as other countries, and each version of the product would have to comply with the regulations appropriate to the countries where they are distributed. You may want to contact the government of Sweden concerning their requirements. You may also wish to contact the manufacturer concerning the difference between the vaccine licensed in the US and the product distributed in Sweden.
Information on expanded uses for Gardasil to include preventing certain vulvar and vaginal cancers is discussed on CBER’s website at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116945.htm. Information on clinical trials concerning the vulvar and vaginal intraepithelial neoplasia are identified in the package insert. You can also submit a Freedom of Information Act (FOIA) request for information on these clinical trials. When submitting a FOIA request, be as specific as possible with regards to exactly what you would like to obtain. Information on submitting a FOIA request to FDA can be found at http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm.
Gardasil is manufactured and distributed by Merck & Co. Inc., Whitehouse Station, NJ. (USA). You can contact the manufacturer concerning how and where this product is manufactured.
Based on ongoing assessments of vaccine safety information, FDA and CDC continue to find that Gardasil is a safe and effective vaccine. Please note that public health and safety are priorities for FDA and CDC. As with all licensed vaccines, we will continue to closely monitor the safety of Gardasil.
We hope this information is helpful. If you have additional questions, please feel free to call us at 1-800-835-4709.
Sincerely,
PHH
Consumer Safety Officer
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Communication, Outreach and Development
Division of Communication and Consumer Affairs
Phone: 301-827-2000
Bullish future for drug companies:
http://vaccineawakening.blogspot.com/2007/11/canadians-follow-gardasil-money-trail.
http://www.lakemedelsvarlden.se/zino.aspx?articleID=11084
Who's going to be responsible for side effects and future medical costs? Who's getting the profit from these vaccines?
How to protect yourself from HPV
Ask your partner if he / she have had HPV outbursts or genital warts.
Always use condom when you have sex even though HPV is often spread through skin-to-skin contact - not only through the exchange of bodily fluids
Demand the need of your partner to perform real good hygiene since you dont need vaginal / oral / anal penetration to get infected by HPV. Mucus might collect under the foreskin of penis which might cause other infections as well.
Demand condom manufacturer to produce non toxic condoms:
http://www.physiciansforlife.org/content/view/431/36
Use latex or polyutheran condoms if youre sensitive to allergies.
Sperm killing substances might cause the vaginal mucus lining and the urinal tract to get irritated and should be avoided.
Condoms made of lambskin are the oldest type of condoms. These condoms are not effective in preventing HPV transmissions. HPV virus are smaller than sperms and might penetrate the material its made out of - the intestine of a lamb. They're good to use in monogamous relations to prevent pregnancy.
Remember, the more sexpartners you have the bigger chance to get infected with HPV.
USA - VICP - VAERS
If you suffer from side effects and feel you're eligible to compensation:
http://www.hrsa.gov/vaccinecompensation/
The Vaccine Adverse Event Reporting System is a cooperative program for vaccine safety of the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a post-marketing safety surveillance program, collecting information about adverse events (possible side effects) that occur after the administration of US licensed vaccines.
http://vaers.hhs.gov/
Thoughts regarding cancer in general
All human beings have deformed cells being handled by the immune system which sorts them out and and carries them out of our bodies during our whole life.
Our immune systmen is effected by many different things such as stress, environmental poisons, the food we eat, genetics in heredity, sleep and even the thoughts you have. Deformed cells or unwanted cells might start to grow in the human body if your immune system collapse or lowers its defence during a long time.
The human body is able to handle X amount of stress etc which causes deformed cells to grow in the body, ie cancer. If you're diagnosed with cancer you need to remove some of the stressfactors and lead the body into a natural healing process. No matter which kind of treatment you choose this is a must.
The only one responsible is You when it comes to your health condition.I urge you to always be aware of following choices in life: How you choose to live, eat, think and what you expose your body to.
Regarding Cervical cancer and Cervical dysplasia
All women need to understand that tampons do contain bleach and dioxins which might cause cancer. Choose organic products!
Demand more manufacturers to start manufacture more environmentally friendly products.
http://blog.seattlepi.com/realbeauty/archives/146962.asp
http://www.womenanswers.org/womenshealth/womenanswers-org-b1-4478.html
Demand thorough cleaning prior to having sex with your partner.
Make sure your sex partner keep their underwear clean.
http://www.femalepatient.com/html/arc/let/pc/pc_1101.asp
If you care for our children and coming generations please sign this petition:
http://www.naturalnews.com/025646_Gardasil_health_Merck.html
Doctors Warranty of Vaccine Safety
Give this to your doctor to sign when you go for a vaccination:
Doctor’s Warranty of Vaccine SafetyI (Doctor’s name, degree/s)_________________________, _____ am a medical practitioner licensed to practice medicine in ................................ My medical speciality is ________________________.
I have a thorough understanding of the risks and benefits of all the medications that I prescribe for or administer to my patients. In the case of (Patient’s name) ___________________________, age _________, whom I have examined, I find that certain risk factors exist that justify the recommended vaccinations. The following is a list of said risk factors and the vaccinations that will protect against them:
Risk Factor ____________________________________________
Vaccination ___________________________________________
Risk Factor ____________________________________________
Vaccination ___________________________________________
Risk Factor ____________________________________________
Vaccination ___________________________________________
Risk Factor ____________________________________________
Vaccination ___________________________________________
Risk Factor ____________________________________________
Vaccination ___________________________________________
Risk Factor ____________________________________________
Vaccination ___________________________________________
I am aware that vaccines typically contain many of the following:
* Aluminium hydroxide
* Aluminium phosphate
* Ammonium sulfate
* Amphotericin B
* Animal tissues: pig blood, horse blood, rabbit brain
* Dog kidney, monkey kidney,
* Calcium phosphate.
* Chick embryo, chicken egg, duck egg
* Calf (bovine) serum
* Betapropiolactone
* Fetal bovine serum
* Formaldehyde
* Formalin
* Gelatin
* Glycerol
* Human diploid cells (originating from human aborted fetal tissue)
* Hydrolized gelatin
* Mercury (Thimerosal which is 49.6% mercury)
* Monosodium glutamate (MSG)
* Neomycin
* Neomycin sulfate
* Phenol red indicator
* Phenoxyethanol (antifreeze)
* Potassium diphosphate
* Potassium monophosphate
* Polymyxin B
* Polysorbate 20
* Polysorbate 80
* Porcine (pig) pancreatic hydrolysate of casein
* Residual MRC5 proteins
* Sorbitol
* Tri(n)butylphosphate,
* VERO cells, a continuous line of monkey kidney cells, and
* Washed sheep red blood cells
and hereby warrant that these ingredients are safe for injection into the body of my patient. I have thoroughly researched reports to the contrary, such as the reports that Thimerosal causes severe neurological damage, autism and Alzheimer’s disease and that formalin, which is used in the manufacture of over half of all vaccines, causes chemical damage to vaccine proteins and creates reactive chemical groups called carbonyls which can mean that the immune system overreacts once infection occurs and attacks the body in a damaging way. Although I am aware of these reports, I do not find any of them credible.
I am aware that Dr Maurice Hilleman of Merck stated that Merck knowingly distributed millions of vials of polio vaccine that were contaminated with Simian Virus 40 (SV40) [1] and that SV40 is causally linked by some researchers to non-Hodgkin"s lymphoma and mesotheliomas in humans as well as in experimental animals, [2]. I hereby warrant that the vaccines I use in my practice do not contain SV40 or any other live viruses. (Alternately, I hereby warrant that said SV40 virus or other viruses pose no substantive risk to my patient).
Gardasil Vaccine
I am aware that the vaccine may lead to an INCREASE in precancerous lesions in women who already have relevant HPV types and I am aware that Judicial Watch has uncovered FDA reports under the Freedom of Information Act which show that Gardasil led to an increase in the incidence of precancerous lesions by 44.6% in women who had relevant HPV types, [3]. I am aware that by October 2008, over 10,000 adverse reactions, including 27 deaths had been reported to the Vaccine Adverse Event Reporting System about Gardasil. I am aware that cervical cancer usually develops in the late 20s to mid 30s and the protection period of Gardasil is estimated to be 5 years, which means that if my patient gets a first set of shots when she is 10 years old, she will need at least 2-4 additional booster shots to make it through her 30s and in so doing expose herself to the potential side effects of Gardasil over and over again.
I have read the report from Merck which mentions Gardasil was shown to reduce pre-cancers by only 12.2% to 16.5% in the general population and know that my patient will still need to have regular smear tests after she has been vaccinated. I have read information regarding Gardasil thoroughly and do not regard the reports that it causes harm as credible and deem it safe and worthwhile to administer it to my patient.
Flu Vaccine
I am aware that most flu shots contain mercury and I have thoroughly researched the reports which indicate mercury is highly neurotoxic. I am aware that Hugh Fudenberg, MD, an immunogeneticist with nearly 850 papers published in peer review journals, has reported that if an individual had 5 consecutive flu shots between 1970 and 1980 (the years studied), his/her chances of getting Alzheimer’s Disease is 10 times higher than if they had zero, one, or two shots, [4]. I am aware of the reports that flu vaccines were deliberately contaminated with the deadly avian flu virus and distributed to 18 countries by the American company Baxter and that this was believed to be part of a plan to provoke a pandemic, [5]. I am also aware that flu shots do not necessarily protect people against getting the flu, but regard it as worthwhile administering a mercury-containing form of this vaccine to my patient.
In order to protect my patient’s well being, I have taken the following steps to guarantee that the vaccines I will use will contain no damaging contaminants.
STEPS TAKEN: ___________________________________________________________
___________________________________________________________
___________________________________________________________
___________________________________________________________
I have personally investigated the reports made to the VAERS (Vaccine Adverse Event Reporting System) and state that it is my professional opinion that the vaccines I am recommending are safe for administration to a child under the age of 5 years.
The basis for my opinion are itemized on Exhibit A, attached hereto, — "Doctor’s Basis for Professional Opinion of Vaccine Safety." (Please itemize each recommended vaccine separately along with the basis for arriving at the conclusion that the vaccine is safe for administration to a child under the age of 5 years.)
The professional journal articles I have relied upon in the issuance of this Doctor’’s Warranty of Vaccine Safety are itemized on Exhibit B , attached hereto, — "Scientific Articles in Support of Doctor’s Warranty of Vaccine Safety."
The professional journal articles that I have read which contain opinions adverse to my opinion are itemized on Exhibit C, attached hereto, — "Scientific Articles Contrary to Doctor’s Opinion of Vaccine Safety."
The reasons for my determining that the articles in Exhibit C were invalid are delineated in Attachment D , attached hereto, — "Doctor’s Reasons for Determining the Invalidity of Adverse Scientific Opinions."
Hepatitis B Vaccine
I understand that 60 percent of patients who are vaccinated for Hepatitis B will lose detectable antibodies to Hepatitis B within 12 years. I understand that in 1996 only 54 cases of Hepatitis B were reported to the CDC in the 0-1 year age group. I understand that in the VAERS, there were 1,080 total reports of adverse reactions from Hepatitis B vaccine in 1996 in the 0-1 year age group, with 47 deaths reported.
I understand that 50 percent of patients who contract Hepatitis B develop no symptoms after exposure. I understand that 30 percent will develop only flu-like symptoms and will have lifetime immunity. I understand that 20 percent will develop the symptoms of the disease, but that 95 percent will fully recover and have lifetime immunity.
I understand that 5 percent of the patients who are exposed to Hepatitis B will become chronic carriers of the disease. I understand that 75 percent of the chronic carriers will live with an asymptomatic infection and that only 25 percent of the chronic carriers will develop chronic liver disease or liver cancer, 10-30 years after the acute infection.
The following scientific studies have been performed to demonstrate the safety of the Hepatitis B vaccine in children under the age of 5 years.
___________________________________________________________
___________________________________________________________
In addition to the recommended vaccinations as protections against the above cited risk factors, I have recommended other non-vaccine measures to protect the health of my patient and have enumerated said non-vaccine measures on Exhibit D, attached hereto, "Non-vaccine Measures to Protect Against Risk Factors."
I am issuing this Doctor’s Warranty of Vaccine Safety in my professional capacity as the attending physician to (Patient’s name) ________________________________.
Regardless of the legal entity under which I normally practice medicine, I am issuing this statement in both my business and individual capacities and hereby waive any legal immunities from liability lawsuits in the instant case.
I issue this document of my own free will after consultation with competent legal counsel whose name is _____________________________.
__________________________________ (Name of Attending Doctor)
________________________________ (Signature of Attending Doctor)
Signed on this _______ day of ______________ A.D. ________
Witness: _______________________________ Date: _______
Notary Public: __________________________ Date: _______
References:
1. Interview with Dr Maurice Hilleman of Merck at
http://www.youtube.com/watch?v=edikv0zbAlU
2. SV40 is being found in human tumours. See: SV40 Cancer Articles
http://www.sv40foundation.org/Articles.html
3. Judicial Watch Report On the Gardasil Vaccine. See this first 6 pages here. http://uncensored.co.nz/2009/03/27/a-judicial-watch-special-report-exa mining-the-fda%E2%80%99s-hpv-vaccine-records/
The full report is here: http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccineRecor ds.pdf
4. Hugh Fudenberg, MD, is Founder and Director of Research, Neurolmmuno Therapeutic Research Foundation. Information from Dr. Hugh Fudenberg came from transcribed notes of Dr. Fudenberg’s speech at the NVIC International Vaccine Conference, Arlington, VA, US. September, 1997. Quoted with permission. http://www.advancedhealthplan.com/flushots.html
5. ‘Accidental’ Contamination of Vaccine with Live Avian Flu Virus Virtually Impossible http://www.prisonplanet.com/accidental-contamination-of-vaccine-with-l ive-avian-flu-virus-virtually-impossible.html