Gardasil: An Open Letter To The Republican Candidates For The Presidency. Join The Campaign For The Answers And Protect The Young Women Of This Nation From The Unholy Pharmaceutical/Politico Alliance.
Escalate The Gardasil HPV Dialog. Write The Republican Candidates at the campaign sites, Face Book Pages and their local/state media outlets; engage them, challenge them to honor their oaths of office and serve the will of the people. The issue is on the table and being discussed openly as a political matter, the Genie let out of the bottle by Rick Perry and the fire fueled by Michele Bachmann. It is time to seize the moment and turn the issue from a political sound bite contest to a clearly focused debate on the need to deal with the corruption behind the issue and need to recall/remove the vaccine from the market place for at least a full retesting and a real opportunity to put the candidate’s feet to the fire on the related political/moral issues involved. They want the Presidency; we want our questions answered! LETTER TO THE CANDIDATES Dear Candidate, (Fill In The Name) Americans understand the unholy, corrupt, corrosive, and criminal; alliance that exists between Pharmaceutical Lobbies and our elected officials, Federal and State and the medical profession that has contributed to the low regard for all concerned. We despise the political stance taken by most of our “leaders” whole priorities are: (1) Get Elected, (2) Get Re-Elected, (3) Spin out of campaign rhetoric and promise, (4) ignore : your oath of office, the laws of this land, the people’s needs and will and the truth. We are not arguing or asking you to speak to the easy, popular, “high road” of declaring that government mandating HPV/Gardasil vaccination of America’s young women is dead wrong. We’ll grant you that safe position. What we are asking you to address as a candidate for the highest elected office in this nation, is the fact that the Gardasil Vaccine has multiple contaminations and is dangerous, having crippled, maimed and killed young women in the nation to the extent that the casualties cannot be sloughed off as acceptable “collateral damage”. We are asking you to speak to doing the right thing. Can you commit to: (1) Taking no campaign money from the Pharmaceutical Industry? (2) Can you call for the recall/withdrawal of Gardasil from the market place demanding a full retesting of the vaccine with public input? (3) Can you support a Congressional Investigation of the roles of the FDA, CDC and the NCI in the safe certification process and subsequent denial of the harm done thus far? (4) Can you; will you support a Congressional investigation of Merck Pharmaceutical and manner in which they have marketed the product and manipulated the media, Government Agencies and elected leaders in peddling a fraud-filled campaign of necessity of mandatory universal vaccination of all of America’s young women and attempted to sell the same idea and product to address genital warts in our men? (5) Are you willing; will you participate in exposing the corruption in the marketing of this product and hold legally and financially accountable all responsible for the fraud, misrepresentations and blatant disregard of Gardasil’s value and the harm visited upon too many young women of this nation? (6) Are you willing; will you call for the maximum financial compensation for those women and families ruined by Gardasil? We ask you to be a part of the solution to problem born greed, perpetuated by influence peddling and executed in the most arrogant of manners, and not a part/party to the perpetuation and cover up of the problems with the Gardasil Vaccine. Respectfully, Ed. Dickau ccs: Michele Bachmann Herman Cain Newt Gingrich Jon Huntsman Ron Paul Rick Perry Mitt Romney Rick Santorum The entirety of this post can be sent to you for your use and or editing for use by contacting ed.dickau@gmail.com This letter will be sent to each candidate at his/her campaign site as well as their Face Book wall. Gardasil: An Open Letter To The Republican Candidates Each candidate has had their letter posted in preparation for the Facebook communications. Each candidate has been sent the full letter at their campaign sites with a like to their online copy and the complete Camus Café Post. Each candidate was also sent this link… Additional Face Book Comment Can Be Entered at these Links  THE CONTACT SOURCE LIST MATERIALS: MICHELE BACHMANN HERMAN CAIN NEWT GINGRICH JON HUNTSMAN RON PAUL RICK PERRY MITT ROMNEY RICK SANTORUM ADDITIONAL POSTS: It is time that everyone contacts The FDA and deliver the message that we want Gardasil recalled, retested and Merck Pharmaceutical Company investigated as regards its manufacturing process and marketing of this product, at least. ADDITIONAL SOURCES  |
ADDENDUM The FDA Drops The Ball (PDF) (PDF) February 14, 2011 FOR IMMEDIATE RELEASE Philadelphia, Pennsylvania, United States of America (Free-Press-Release.com) February 14, 2011 -- “A pap smear never harmed anyone,"says Dr. Diane Harper, lead developer of Gardasil®, the HPV vaccine manufactured by Merck Pharmaceuticals. In this segment we delve deeper into that and other statements made by Dr. Harper. She also was involved heavily in the development of Cervarix®, the HPV Vaccine manufactured by GlaxoSmithKline. In this segment some interesting comments pertain to both HPV vaccines. In our first segment, Harper made some startling clarifications about the use of Gardasil® in boys and men, and how, "Unfortunately, the FDA has given Merck a blanket approval to use Gardasil® in males 9-26." She further admitted neither Gardasil® nor Cervarix® would cure or treat a current diagnosis of HPV, but that some have hypothesized that these vaccinated people instead may "react poorly" to these vaccines. When asked to clarify her statement about pap smears, she stated, “The best way to prevent cervical cancer is with routine Pap screening starting at age 21 years. Vaccination Cannot Prevent As Many Cervical Cancers As Can Pap Screening. Pap screening with vaccination does NOT lower your chances of cervical cancer - Pap screening and vaccination lowers your chances of an abnormal Pap test. Gardasil® is associated with GBS [Guillian-Barre Syndrome] that has resulted in deaths. Pap screening using a speculum and taking cells from the cervix is not a procedure that results in death.” She further tells us,"Gardasil® can be offered along with Cervarix® as an option to prevent abnormal Pap test results in those women who can make an informed decision about how much they value this benefit compared to the rare risk of GBS. If a woman has no access to Pap screening, receiving HPV vaccines may help reduce cervical cancer IF the vaccines last long enough. At this time, Gardasil® is proven to last for at least 5 years, and Cervarix® for at least 8.5 years. Health policy analyses show that there will be no reduction in cervical cancer unless the vaccine lasts at least 15 years." In our time with Dr. Harper, we learned that she feels that those who participate in male with male sex may have some protection against anal cancer. However, she also states that in order for Gardasil® or Cervarix ® to truly make a difference, they must be effective for at least 15 years. At this time, neither HPV vaccine fits this description. She also admits there is the connection of serious side effects and deaths with these vaccines. In fact, we asked Harper if she had a statement she would like to make to those who have suffered side effects. She replied, “Please push for full disclosure in consent forms so that parents and potential vaccinated persons can weigh the benefits and risks of the HPV vaccination from their own perspective. Having federal funding to researchers to aid in setting up full disclosure consent forms will help the process of decision making." We then asked about the possible side effects that can be caused by Gardasil®, and her response was, “The side effects are many; most require only time to reverse. For the severe autoimmune demyelinating diseases, working with a neurologist is often helpful.” However, when we asked her how much time she thought it would take for these side effects to wear off, as some of those affected are approaching three and four years of being injured, Harper stated, “I do not know of a time frame in which the side effects will wear off.” This interview has raised some serious questions. If the HPV vaccines need to be last a minimum of fifteen years in order to be effective and lower the incidence of cervical cancer in women, why are they being so heavily marketed when the developer states Gardasil® lasts five years and Cervarix® lasts just over eight? In our next segment, Dr.Harper will go into detail about the use of placebos in the HPV vaccines, and if there was one used in the HPV vaccine trials. Richmond, Virginia, United States of America(Free-Press-Release.com) February 7, 2011 -- When even one of the developers of a vaccine recognizes and discloses its dangers and limitations, shouldn't the FDA and CDC listen? Truth About Gardasil recently had the opportunity to discuss Gardasil®, the HPV vaccine manufactured by Merck Pharmaceuticals, with one of its lead developers, Dr. Diane Harper. In this first installment of our interview, Dr.Harper sets the record straight on several questions surrounding this supposed "miracle vaccine". Harper, a Medical Doctor who is internationally known as a clinician and researcher, also earned a Master's Degree in Public Health (MPH). She is probably most well known for her role in the development of Gardasil® and in the readying of this vaccine for its public release. She helped in every phase from recruiting trial participants to providing medical care during the trial to collecting specimens and interpretation of the final data. There has been much controversy and debate about Gardasil® from its very beginning. Questions have been raised not only about its safety, but also the advertisements and marketing plan by Merck. Gardasil® started out being marketed to young women ages 9 to 26, as cervical cancer prevention in the "One Less" campaign. According to neontommy.com, Merck won awards for this by "creating a market out of thin air". Since then, the FDA has granted approval to not only market it to boys of the same age range, but has given permission to add anal cancer to the list of diseases that Gardasil® can prevent. . See Gardasil's Marketing Raises Ethical Issues Harper says, “It has been a plan for Merck from the beginning". When we asked her about this she stated, “Unfortunately, the FDA has given Merck a blanket approval to use Gardasil® in males and females 9-26 years old without making it clear to parents or males/females that the only data for male cancer preventions is in MSM (gay men) NOT in heterosexual men". She goes on to say, "For men who have sex with men, there is a benefit to using Gardasil in the prevention of anal intraepithelial neoplasia grade 2 and 3. However, in the case of heterosexual men, this was never tested, and there is no penile cancer prevention seen in heterosexual men". Harper also tells us that for people who have a current diagnosis of HPV , "Neither Gardasil® nor Cervarix® will cure or treat the current HPV, so there is no reason to vaccinate for current disease. A previous diagnosis of HPV does not preclude the use of one of the vaccines - data show similar efficacies in those with past HPV as those who are HPV naive. The reasons for adverse reactions are not clear. There is a remote immune hypothesis that someone with a large HPV infection may react poorly to a HPV vaccine, but this is hypothetical and theoretical". When we asked Harper about these adverse reactions, and if there was a chance specifically of developing auto-immune conditions, she said, "After getting Gardasil®, yes". The question about whether people with an auto- immune condition were excluded from the trials, Harper stated , "Getting an autoimmune disease from a vaccine is very different than having an autoimmune disease first and then being vaccinated. Gardasil®/Merck is now undertaking trials to vaccinate women with auto immune diseases". We questioned her further about the risks versus benefits of the HPV vaccines, and how long these "benefits" would last, as well as her infamous statement, "A pap smear never harmed anyone". The answers to those questions and many more will appear in the next segment on our conversation with Dr. Diane Harper. From: Freda Birrell – East Lothian, Scotland Secretary, Sane Vax Inc – www.sanevax.org Dear Member, Information was sent to you recently in connection with the genetically modified residue, attached to the adjuvant, which was found in 13 vials of Gardasil from the following countries: New Zealand, Australia, France, Spain, Poland and the USA. It has just come to my attention through colleagues in Ireland that the Irish Medicine Board (IMB) has issued a statement as follows – see attachment above which confirms that the email received came from the radio station which made reference to rDNA being discovered in Gardasil: Statement from the IMB in this regard The IMB and European Medicines Agency (EMA) are aware of the recent communication from Sane Vax and following on from this, the EMA requested the marketing authorisation holder conduct an immediate assessment of the risk of contamination. The IMB, through its participation in EU Scientific Committees is contributing to the on going EU assessment of this issue and will continue to do so at further EU meetings scheduled over the coming week. Any updates on the outcome of these discussions and any recommendations will be highlighted, as appropriate. At present, the balance of risks and benefits for the vaccine remains positive. The Gardasil vaccine has been licensed for use in the EU since 2006. The IMB together with the EMA continue to monitor the benefit-risk profile of Gardasil. First of all I am so glad that the EMA has requested the marketing authorization holder to conduct an immediate assessment of the risk of contamination. That is very important and also to know that this will be discussed fully at further EU meetings to be scheduled over the coming week. That is extremely reassuring and I look forward to hearing the outcome of these discussions. I have been advised by Dr Sin Hang Lee that he would be more than happy to discuss his findings and present the hard data to representatives on the Committee for Medicinal Products for Human Use (CHMP) (probably the Chairman would wish to do this) and if considered appropriate a representative from the Environment and Public Health Committee as well. As I am sure you will understand, all Dr Lee would request is a signed assurance that you and/or your members would not disclose his proprietary methodology or data to anyone outside of the appropriate government representatives and their scientific advisors. The electropherogram raw data on each sample will be made available with the understanding that they are proprietary data for regulatory authority viewing only as they are the property of Dr Lee’s laboratory. He would be happy to answer questions regarding his methodology and the potential health impacts of this discovery. He also would be happy to put you in touch with Professor Colin MacKenzie and Professor Birgit Henrich of the Institute of Medical Microbiology and Virology and Center for Biological and Medical Research, Heinrich-Heine-University, Duesseldorf, Germany if you wish to discuss his techniques. Should you wish to verify his credentials, some of his peer-reviewed published articles are listed at the end of this communication. This would give you the opportunity to hear how this contamination was discovered, to be able to ask any questions of Dr Lee and to then be able to decide how best to deal with this important matter. However, the last few words in the IMB statement above are strange to say the least “the balance of risks and benefits for the vaccine remains positive”. How that statement can be made when the full investigation into the rDNA discovery in Gardasil has not yet been determined is of great concern. – Almost like saying well we know the answer before there has been any official investigation into this. The reasons I say this are: The adjuvant that boosts the immune response that activates the immune system is linked to the DNA which provokes the inflammatory response; Antibodies will be produced but as there is a contamination within the adjuvant then this in itself could produce other antibodies targeted against the DNA which could go on to cause any number of autoimmune conditions; I believe the pharmaceutical company did not know this contamination was there and therefore is in no position to say one way or another if it will cause harm; If they are sure it will not cause any harm then could their research findings on this particular issue be submitted to you as well as to all the European countries which make up the EU; If they do have these research findings then they must have known for a period of time that the contamination was present; One thing that is certain, and we do not have to prove this now, is that many thousands of girls have been badly harmed after vaccination with Gardasil and sadly there have also been those who have died. I personally believe that the pharmaceutical company can no longer say that Gardasil is safe and effective. As they denied any viral contamination in the vaccine from the concept of this programme, then they are not able now to say that Gardasil did not cause the deaths and autoimmune disorders which have been experienced around the globe. This is just not an American or European issue; it stretches to the other side of the world as well. I thank you again for taking this matter seriously and do hope that you will consider speaking with the scientist who made the discovery. It appears that the pharmaceutical company did not know about this contamination in the Gardasil vaccine, otherwise they would have had to disclose this fact. In their own words they made it clear from the start ‘the HPV vaccines do not include any viral DNA’. With best wishes Yours sincerely Freda Birrell – East Lothian, Scotland Secretary, Sane Vax Inc – www.sanevax.org References: 1. Lee S H, Vigliotti VS, Vigliotti JS, Pappu S. Routine human papillomavirus genotyping by DNA sequencing in community hospital laboratories. Infect Agent Cancer 2007; 2:11. 2. Lee S H, Vigliotti VS, Pappu S. Human papillomavirus (HPV) infection among women in a representative rural and suburban population of the United States. Inter J Gyn Ob. 2009; 105:210-214. 3. Lee S H, Vigliotti VS, Pappu S. Molecular tests for human papillomavirus (HPV), Chlamydia trachomatis and Neisseria gonorrhoeae in liquid-based cytology specimen. BMC Women’s Health 2009; 9:8. 4. Lee S H, Vigliotti VS, Vigliotti JS, Pappu S. Validation of human papillomavirus genotyping by signature DNA sequence analysis. BMC Clin Pathol 2009; 9:3. 5. Lee S H, Vigliotti VS, Pappu S. Signature sequence validation of human papillomavirus type 16 (HPV-16) in clinical specimens. J Clin Path. 2010;63:235-239. 6. Lee SH. Guidelines for the use of molecular tests for the detection and genotyping of human papilloma virus from clinical specimens. In series Methods in Molecular Biology, volume Diagnosis of Sexually Transmitted Diseases. C. MacKenzie and B. Henrich, Eds. J. Walker, Series Ed. Humana Press. In Press 2011. 7. Lee SH. From human papillomavirus to cervical cancer. Obstet Gynecol 2010; 116:1221-2. (see attached copy) 8. Schiffman M, Wentzensen N. From human papillomavirus to cervical cancer. In Reply to a Letter to the Editor. Obstet Gynecol 2010; 116:1221-2. Dr. Lee provided several attachments that are available upon request as they cannot be posted here. Email sanevax@charter.net to request attachments. As of June 2011 there have been 68 deaths related to the HPV Gardasil vaccine were reported to VAERS.  Bachmann called Perry's use of the Executive Order an abuse of his executive power. Indeed, mandatory vaccination against HPV is unsupportable HPV is not communicable in a school setting--it is communicated only by sexual contact. The condition Human Papilloma Virus (HPV) is present in 50% of the sexually active population. HPV does NOT automatically develop into cancer in the overwhelming majority of the population. HPV is mostly benign--no treatment needed. Furthermore, early detection of pre-cancerous cervical cells is readily accomplished by routine PAP smears--which sexually active women in the US routinely have. And pre-cancerous cervical condition is eminently treatable. Therefore, cervical cancer does not pose a major danger for all children--therefore, the risk from the vaccine itself is not justifiable. Indeed, the Texas legislature had overruled (then) Governor Perry's Executive Order because it was unsupportable. Bachmann correctly noted that the HPV vaccine poses serious risks of harm: As of June 22, 2011 there have been a total 68 deaths reported to the Vaccine Adverse Event Reporting System (VAERS) related to Gardasil. As of June 22, 2011, approximately 35 million doses of Gardasil® were distributed in the U.S. and VAERS received a total of 18,727 of which 8% were deemed serious. The following HPV-linked injuries have been reported to VAERS (estimated at 1% to 10% of injuries linked to vaccines) (More…) Le Café Politique De Camus De Café: Vaccine Issues Again! SaneVax ...lecafpolitiquedecamusdecaf.blogspot.com/.../vaccine-issues-again-sa... - Cached Oct 12, 2010 – Vaccine Issues Again! SaneVax Discovers Vulnerable Girls in United States Targeted for HPV Vaccination. SaneVax Discovers Vulnerable Girls ... S.A.N.E. Vax, Inc. Announces Medical Consumers Start Letter ...gamutnews.com/.../s-a-n-e-vax-inc-announces-medical-consumers-start-lett... Jun 14, 2011 – Jun. 14, 2011 (Business Wire) -- The SaneVax Team is pleased to announce multiple groups of concerned citizens worldwide including victims ... …Dr. Mark Schiffman is a senior investigator at the National Cancer Institute (NCI) and the official medical monitor of the HPV vaccine clinical trial leading to the Food and Drug Administration (FDA) approval of the HPV vaccine for sales to prevent cervical cancer. The letter to him states medical consumers will hold him accountable for supplying the post-licensure monitoring survey results, specifically “to publish the HPV genotypes which are causing precancerous and cancerous cytologic changes in the women who have been immunized by the HPV vaccines, under the brand names of Gardasil and Cervarix.” Based on the VAERS Reports, a significant number of post-vaccinated women are now developing cervical precancerous and cancerous lesions. The letter further stated that Dr. Schiffman must know that the HPV vaccines currently being marketed were approved by the FDA under the Fast Track Drug Development Programs, using “CIN 2/3, AIS, or worse by histology – with virology to determine the associated HPV type” as the surrogate endpoint in the evaluation of the efficacy of the vaccine to prevent cervical cancer… http://sanevax.org/news-blog/2011/07/gardasil-smoking-gun/ Well, I am at it again. I am asking why the 11 year old Hispanic boy was included in the study. I was amazed at what I found as to what is presently available to me in regards to this topic. I went to http://clinicaltrials.gov to find my answers. This was a real learning experience as to who are excluded but the vaccine is a one size fits all and administered to all even those that would have been excluded from the study. This article is going to be a little long but the summary at the end will be well worth the wait. Trust me it sure will at least in my opinion. The trials I am going to reference are on my favorite product Gardasil® by Merck. Here is the first study. The eligibility requirements are a little long. I want to focus on Gardasil® (V503) but the eligibility for REPEVAX ™ is important also. This study has been completed. First Received on February 19, 2010. Last Updated on June 22, 2011 Eligibility Ages Eligible for Study: 11 Years to 15 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: Yes Criteria Inclusion criteria:
Exclusion Criteria:
Human Papilloma Virus (HPV) Type-Specific Antibody This study is enrolling participants by invitation only. First Received on September 20, 2010. Last Updated on September 24, 2010 Eligibility Genders Eligible for Study: Both Accepts Healthy Volunteers: No Sampling Method: Non-Probability Sample Study Population This will be limited to subjects who were enrolled into IMPAACT P1047 and who completed the scheduled vaccine doses for their designated arm. Criteria Inclusion Criteria:
Exclusion Criteria:
Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting This study is currently recruiting participants. Verified on February 2011 by University of Pittsburgh First Received on August 11, 2010. Last Updated on February 24, 2011 Eligibility Ages Eligible for Study: 18 Years to 26 Years Genders Eligible for Study: Male Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria:
Exclusion Criteria:
Mother — Daughter Initiative (MDI) in Cervical Cancer Prevention This study is currently recruiting participants. Verified on June 2011 by Jhpiego First Received on March 23, 2010. Last Updated on June 21, 2011 Further study details as provided by Jhpiego: Primary Outcome Measures:
The aim of the study to assess whether we can fully vaccinate (all 3 doses),50% of girls aged 9 -13 in the participating districts, in an 18-month period. This corresponds to 4000 girls in Thailand and 4000 in Phillipines.The study will seek to understand if this level of population coverage (50%), can be achieved through encouraging women that receive cervical cancer screening to bring in their daughters or relatives for vaccination. Secondary Outcome Measures:
Data on mother's knowledge of the vaccine, and intention to have their daughters vaccinated will be collected for a period of 1 year (or when the target number of 700 women/guardians is reached, whatever comes first). Data will be collected on:
Programmatic data will be collected for the duration of the project, including but not limited to:
Eligibility Ages Eligible for Study: 9 Years to 13 Years Genders Eligible for Study: Female Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria:
Exclusion Criteria:
A Study of V503 Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006 AM1) This study is ongoing, but not recruiting participants. First Received on January 11, 2010. Last Updated on June 22, 2011 Further study details as provided by Merck: Primary Outcome Measures:
Secondary Outcome Measures:
Eligibility Ages Eligible for Study: 12 Years to 26 Years Genders Eligible for Study: Female Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Participants Age 12 to 15 Years:
Participants Age 16 to 26 Years:
Exclusion Criteria: All participants:
Participants Age 16 to 26 Only:
Sorry it was so long but it was important to have all the details without omission. First I am going to give you my favorite comments made in the criteria. Inclusion criteria:
Exclusion Criteria:
Let me summarize my favorites the way I see them. To be included in the studies you better be in good health. They do not want you to have anything wrong with you while they are conducting the studies. You may have a "New Medical Condition" later but you need to be healthy now. You and your mother's willingness to participate in this vaccination study are very important also. They really do not want anyone that is not on board 100% now do they. Even though they will be giving this vaccine to everyone you are excluded because you are allergic to something in the vaccine. That may includesulfonamide. (Ref: article, section: 11-year-old Hispanic male). Also, your allergy to any food or medicine is important so you cannot be allowed to participate for your own good. For your own protection they do not want you to have any history or current condition that would cause you harm or jeopardize their study outcome but it is all for your protection. It doesn't matter that people with your conditions will probably be given the vaccination anyway. They just do not want to cause you harm except for maybe a "New Medical Condition." They are going to be testing to see how the immune system reacts so to protect you, you need a strong immune system and no autoimmune disorders. You do not need to concern yourself that the vaccine will be administered to others without consideration for these medical issues. So to everyone that is going to be receiving and/or administering the vaccine I want to assure you that the vaccine is safe for everyone except if they have a reaction to a yeast product or a previous dose of the HPV vaccine. On behalf of the vaccine manufactures I want to thank you for your participation in this study. Don't call us. We will call you. Interests: I am a board member of the Truth About Gardasil and have no other affiliations with any other group. © Cynthia A. Janak |
No comments:
Post a Comment