FDA Information on Gardasil - Betrayal of the Public Trust?
In response to the recent announcement by SANE Vax Inc. of the discovery of genetically modified HPV DNA residue in multiple vials of Gardasil, the FDA posted the following page on their site, FDA Information on Gardasil – Presence of DNA Fragments Expected, No Safety Risk. The FDA lists several ‘key facts’ in an obvious attempt to allay any fears which may have arisen over the discovery of foreign DNA in yet another ‘safe and effective’ vaccine. Unfortunately, these ‘key facts’ raise more questions than answers. In spite of the fact the FDA claims their mission is, helping the public get the accurate, science-based information they need to use medicines, there are no scientific references and no indication that these ‘key facts’ are anything more than damage control statements. American medical consumers deserve better from an agency funded by taxpayers and entrusted with the mission of being responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices…... (FDA mission statement) According to the Consumer Justice Group, in the last 27 years, there have been 31 drugs approved ‘safe and effective’ by the FDA which were subsequently withdrawn from the market due to safety concerns not uncovered during clinical trials. No one will ever know the true cost in human suffering resulting from adverse reactions to these 31 FDA approved ‘safe and effective’ medications. Medical consumers worldwide are not willing to risk their children’s health and perhaps their very lives on a vaccine that ‘might’ prevent cancer 20 to 30 years down the road. Parents are not willing to wait until the adverse events post Gardasil vaccination reaches the same numbers as Vioxx did before the vaccine is withdrawn from the market. Medical consumers around the world are no longer willing to accept the FDA’s ‘word’ when it comes to HPV vaccines and their children’s health and safety. They are demanding scientific proof of the claims made by the FDA and vaccine manufacturers. FDA ‘Key Facts,’ and questions raised by SANE Vax Inc. on behalf of medical consumers: · Gardasil does contain recombinant HPV L1-specific DNA fragments, but these are not contaminants. DNA encoding the HPV L1 gene is used in the vaccine manufacturing process to produce the virus-like particles that make up the vaccine. The presence of these DNA fragments is expected, is not a risk to vaccine recipients, and is not a safety factor. DNA is the "blueprint" for the majority of living organisms and carries the genetic instructions for how cells function and grow.
Medical consumers around the globe are asking the same questions. They will no longer accept semantics games, changing definitions, or public relations statements. Medical consumers demand scientific evidence. If the FDA is actually protecting the public health, there should be no problem providing scientific documentation answering the questions above. Anything less than full compliance is a betrayal of the public trust, not to mention a violation of the public’s right to informed consent. References: 1. Sutton I, Lahoria R, Tan I, Clouston P, Barnett M. CNS demyelination and quadrivalent HPV vaccination. Mult Scler. 2009; 15:116-9. 2. Wildemann B, Jarius S, Hartmann M, Regula JU, Hametner C. Acute disseminated encephalomyelitis following vaccination against human papilloma virus. Neurology. 2009;72:2132-3. 3. Mendoza Plasencia Z, González López M, Fernández Sanfiel ML, Muñiz Montes JR. Acute disseminated encephalomyelitis with tumefactive lesions after vaccination against human papillomavirus. Neurologia. 2010; 25:58-9. 4. Chang J, Campagnolo D, Vollmer TL, Bomprezzi R. Demyelinating disease and polyvalent human papilloma virus vaccination. J Neurol Neurosurg Psychiatry. 2010 Oct 9. doi:10.1136/jnnp.2010.214924 5. DiMario FJ Jr, Hajjar M, Ciesielski T. A 16-year-old girl with bilateral visual loss and left hemiparesis following an immunization against human papilloma virus. J Child Neurol. 2010; 25:321-7. 6. Balamoutsos G, Bouktsi M, Paschalidou M, Tascos N, Milonas I. A report of five cases of CNS demyelination after quadrivalent human papilloma virus vaccination: could there be any relationship? (Abstract No. P297)- Poster Access : www.guthyjacksonfoundation.org/services/download.php?2297.pdf+374 7. Rossi M, Bettini C, Pagano C. Bilateral papilledema following human papillomavirus vaccination. J Med Cases. 2011; 2:222-4. Judicial Watch Uncovers FDA Records Detailing 26 New Reported Deaths in Gardasil |
Rick Perry's decision to administer Gardasil to teen-age girls in his state to ward off a sexually transmitted disease that has been linked to cervical cancer. The evidence continues to mount, however, that Gardasil vaccinations are risky – especially ... See all stories on this topic »-WND.com Healthy Living: Gardasil Vaccination (Human Papilloma Virus) for Males WABI The HPV4 vaccine (Gardasil, Merck) protects against 4 types of HPV that account for 70% of cervical cancer and 90% of genital warts. The vaccine for boys is administered in exactly the same way as for girls. A series of 3 injections over 6 months is ... See all stories on this topic » Gardasil Policy May Grow Coverage Without Reversing Sales Slide BusinessWeek s Gardasil vaccine after a US panel recommended it be given to boys to reduce transmission of a virus that causes cervical cancer, insurance executives said. The policy endorsed by the Centers for Disease Control and Prevention's immunization committee ... See all stories on this topic » Merck: Stronger but Vigilant Wall Street Journal By PETER LOFTUS Merck & Co. said its third-quarter profit jumped from a year-earlier period that was weighed down by a legal charge, while revenue rose 8% on strong sales of diabetes drugs and the Gardasil cervical-cancer vaccine. ... See all stories on this topic » READER'S VIEWS: Thoughts on politics and STDs Culpeper Star Exponent After reading the front page last week about the STD outbreak in Culpeper County schools and being boiling mad, I thought how much this is a ploy to further the Gardasil agenda in Virginia and further erode our parental rights! Gov. ... See all stories on this topic » Merck profits soar as Januvia, Gardasil sales impress Pharma Times Merck & Co's third-quarter net income has rocketed thanks to lower charges and strong sales of a number of key drugs, notably the diabetes drugs Januvia and Janumet and the cervical cancer vaccine Gardasil. Net income came in at $169 billion, ... See all stories on this topic » HPV Vaccine Protection Against Anal Disease in Men Medscape But, in a 2010 interview, Dr. Palefsky told Medscape Medical News that study's data are "strongly suggestive" of cancer prevention and that Gardasil has proven effectiveness against warts, which is a protection that is highly meaningful to MSM. ... See all stories on this topic » Class action against manufacturer of Gardasil cancer vaccine French Tribune A class action against the manufacturer of the cervical cancer vaccine Gardasil – which is distributed by company CSL in Australia – is being led by a 28-year-old Melbourne-based woman, Naomi Snell. Snell is leading the class action against the ... See all stories on this topic »- Student Health Center answers your questions The Scribe We offer Hepatitis A and B, Meningococcal, Tdap (tetanus, diphtheria, and pertussis, Gardasil, MMR (measles, mumps, rubella), and influenza. Why is it important to receive these vaccinations? According to the Centers for Disease Control and Prevention, ... See all stories on this topic » Gardasil: Unsafe at Any Age HULIQ Pharmaceutical company Merck has attempted to expand the use of Gardasil to older women, but the FDA has put up a roadblock. Gardasil, the vaccine used to prevent HPV in young women under 25 years of age is once again in the spotlight. ... See all stories on this topic » Gardasil (Cervical Cancer) - Analysis and Forecasts to 2020 PR Newswire (press release) NEW YORK, Oct. 18, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue: GlobalData's pharmaceuticals report, "Gardasil (Cervical Cancer) - Analysis and Forecasts to 2020" provides Gardasil ... See all stories on this topic » HPV jab: doctors call for teenage girls to be given more effective vaccine ... The Guardian Doctors are pressing the Department of Health to switch from using Cervarix to usingGardasil to immunise teenage girls against cervical cancer because Gardasil protects against more strains of the cancer causing virus HPV. ... See all stories on this topic »-The Guardian Feds contine to ignore mounting Gardasil bodycount Washington Examiner (blog) Both healthy, athletic young women suddenly dropped dead shortly after receiving their final injection of Gardasil, a vaccine developed by Merck to protect girls and young women from cervical cancer caused by the human papilloma virus (HPV). ... See all stories on this topic » On guard against Gardasil OneNewsNow The human papillomavirus (HPV) is thought in some cases to lead to cervical cancer, so Governor Jerry Brown has approved legislation that allows girls as young as 12 years old to obtain the Gardasil vaccine without their parents' knowledge. ... See all stories on this topic »-OneNewsNow Girls' HPV vaccination rates falling short Reuters There are two vaccines that can prevent infection with certain cancer-related strains of HPV: Merck'sGardasil and GlaxoSmithKline's Cervarix, both of which cost about $400 for three doses. The study also found some other factors linked to a girl's ... See all stories on this topic » Immunization clinic Thursday, Nov. 10 Centerville Daily Iowegian B, HPV (Gardasil), and Meningococcal (Menactra). Flu vaccine is also be available at our clinic. Immunizations are free to children with Medicaid, children with no health insurance, and to children whose health insurance doesn't pay for immunizations. ... See all stories on this topic » 12-Year-Olds To Get Gardasil Without Parents' Consent The Moral Liberal As if this weren't atrocious enough, the costly vaccine (Gardasil)—linked to dozens of deaths and thousands of debilitating side effects— will be largely financed with taxpayer dollars. Worse yet is that a disturbing number of girls and young women ... See all stories on this topic » HAVE YOUR SAY: Women taking Gardasil manufacturer to court Knox Leader Naomi Snell is taking court action over an allegedly adverse reaction to the Gardasilvaccine. Picture: Eugene Hyland A MONASH resident who says she suffered MS-like symptoms after having the Gardasil cervical cancer vaccine is leading a group of women ... See all stories on this topic »-Knox Leader Vaccinating boys flawed and dangerous Voxy "The message to young people is that they are protected but shots of Gardasil won't inoculate people from other negative consequences, both physical and emotional. We are tip-toeing around the fundamental issue of the myth of 'safe sex' and what values ... See all stories on this topic » Companies & Markets: Cancer Vaccines Market Set to Change MarketWatch (press release) The prophylactic cancer vaccines market experienced high growth in the historic period due to the launch of Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) and Cervarix (human papillomavirus bivalent (types ... See all stories on this topic » Gardasil Injury Victims Hold Press Conference Republican Candidates Invited Age of Autism “Chris died 18 days after her third dose of Gardasil.” “Brittney didn't want this vaccine in the first place.” When Governor Rick Perry mandated the HPV vaccine in Texas, the response from the public and the legislature was a clear one, that families ... See all stories on this topic » Vaccinations yes, tanning beds no California Catholic Daily Jerry Brown yesterday signed into law the so-called 'Gardasil bill,' a measure vigorously opposed by California's bishops. The bishops had repeatedly urged Catholics to contact the governor to ask him to veto the bill, which will allow minors to ... UPI NewsTrack TopNews UPI.com The HPV vaccine, Gardasil, approved in 2006, and Cervarix, approved in 2009, is given in three doses. Gardasil also protects against most genital warts and also protects against anal, vaginal and vulvar cancers, all of which are associated with certain ... See all stories on this topic » In response to HPV immunizations for a 6th grader by Pastor Jason Olson Estherville Daily News We, at Woman to Woman Clinic would like to educate our community regarding the Gardasilvaccine. We support our Emmet County Public Health Department in the education of our children in regards to Gardasil vaccine. Gardasil is about the protection and ... See all stories on this topic » You Docs: Answers to questions about sperm size, probiotics and the Gardasil ... OregonLive.com Q. I recently saw an article on a natural health site that said the Gardasil vaccine is contaminated and causing "devastating" side effects in adolescent girls who get the shots. Is this true or political propaganda? A. Who would have thought an ... See all stories on this topic » Vaccination for Cervical Cancer; Necessary for both Girls and Boys TopNews New Zealand Gardasil, the cervical cancer vaccination, helps protecting you from various types of sexually transmitted diseases. It offers protection against HPV (human papilloma virus) that is also sexually transmitted and is known for causing 70% cervical cancer ... See all stories on this topic »-TopNews New Zealand Don't be fooled – it's still zealot Tony underneath Sydney Morning Herald I know that this article is predominantly to do with womans concerns (Gardasil, maternity leave & RU486 and if I was a woman I would be saying yes to all 3 ) but it should also be noted that Mr. NO Tony Abbott has been doing the rounds of blue collar... See all stories on this topic »-Sydney Morning Herald US study finds link between HPV and heart disease Montreal Gazette The HPV vaccine Gardasil. US researchers have found evidence of a link between human papillomavirus infection and heart disease in women who have no other risk factors, said a first-of-its-kind study published Monday. WASHINGTON -- US researchers have ... See all stories on this topic » Good reasons to get HPV shot Honolulu Star-Advertiser Certain types of human papilloma virus (HPV) are linked to cervical cancer, so when two vaccines for adolescents were developed to counter it -- first Gardasil in 2006 and then Cervarix three years later -- that was trumpeted as excellent medical news. ... See all stories on this topic » The GOP Tax Code Diet -- Flatter, Thinner, Riskier The Fiscal Times The days of Gardasil vaccines (Perry problem) and changes from one book edition to another (Romney problem) are receding in the rear-view mirror. Even Rep. Paul Ryan commented during a conference call this week that the GOP debate has entered a ... See all stories on this topic »-The Fiscal Times HPV shots leave doctor with doubts Kansas City Star The University of Missouri-Kansas City Medical School professor and OB/GYN was deeply involved in the patient studies that led to FDA approval of the two HPV vaccines,Gardasil and the less-used Cervarix. After her initial euphoria that there finally ... See all stories on this topic »-Kansas City Star Boys should receive HPV vaccine NJ.com (blog) When my mom told me about the Gardasil vaccine, I was determined that I didn't need it. Then, about a year ago, my uncle got throat cancer from HPV. I realized then that I should've considered the vaccine from the start. I got my first shot in June. ... See all stories on this topic »-NJ.com (blog) Pharmacists fret about true power of vaccine Hong Kong Standard At present, Cervarix and Gardasil - made by Merck - are the only vaccines used against the cancer-causing papillomaviruses. But Chui also argues that the vaccines are only 70percent effective against viruses rather than the 100percent performances that ... See all stories on this topic » HPV vaccine: Not just for women Medill Reports: Chicago Gardasil, the HPV vaccine made by Merck & Co., protects men and women from the four most common types of human papillomavirus, two that cause cancers and two that cause genital warts, or condyloma, according to the Centers for Disease Control and ... See all stories on this topic »-Medill Reports: Chicago Secret Government Workshop on Transparency Exposed Right Side News A few weeks ago, the Gardasil vaccine controversy resurfaced because of the discussion about Texas Governor Rick Perry's decision in February 2007 to require sixth grade girls to be administered the Gardasil vaccine against Human Papillomavirus (HPV). ... See all stories on this topic » Your 2 Cents' Worth: Tuesday, Nov. 1, 2011 DesMoinesRegister.com My granddaughter got both shots of Gardasil when she was 13. She recently gave birth to her first child, and now has HPV. So much for the do all, be all, end all drug that was supposed to prevent this from happening! If the government suggests it, ... See all stories on this topic » Pacira gets FDA blessing for pain drug; Japan approves Parabolic's API production; FiercePharma Report > An Australian woman sued Merck's ($MRK) domestic unit, alleging that a Gardasilinjection triggered her neurological problems. Story > Vertex Pharmaceuticals ($VRTX) got three new price targets from analysts, with UBS assigning a $47 target, ... See all stories on this topic » Health digest Columbus Telegram Also available will be Tetanus boosters, Menactra, Influenza, and Gardasil. All children must be accompanied by a parent or guardian, and a record of all previous immunizations is required. A small administrative fee will be charged; however, ... See all stories on this topic » 3 Standout Stocks on the Dow Jones Industrial Average Wall St. Cheat Sheet Merck (NYSE:MRK): Merck rises on the recommendation for the broader use of its Gardasilvaccine. The HPV is vaccine currently recommended for women and girls, but it should now include boys ages 11-12 and boys over 13 who haven't had the vaccine. ... See all stories on this topic » Presidential Hopefuls: Michele Bachmann National Catholic Register Rick Perry's 2007 executive order requiring teenage girls to receive the Gardasilvaccine, designed to prevent a form of cancer caused by the human papilloma virus (HPV), which is transmitted by sexual intercourse. But even some of the candidate's ... See all stories on this topic »-National Catholic Register Five Things Ankeny Residents Should Know: Student Health, Fire Safety and ... Patch.com If so, a female practitioner from Venus Family Planning will be available on campus Wednesday to see currently enrolled DMACC students for pap smears, breast exams, birth control, STI testing andGardasil immunizations for free or at reduced cost. ... See all stories on this topic » The court and the next president eTaiwan News The only vaccine approved for boys – Merck's Gardasil – is expensive. It typically costs $390 for all three doses. A public insurance program pays for poor and uninsured children, and Merck has assistance programs. But, as Gardiner Harris reported in ... See all stories on this topic » Free cervical cancer vaccine coming Zambia Daily Mail Ministry of Health permanent secretary Peter Mwaba said an announcement will soon be made on the arrival of the vaccine, known as Gardasil, which prevents the cancer-carrying Human Papilloma Virus (HPV). The virus is mostly spread through sexual ... See all stories on this topic » Beacon NewsFlashes – October 31, 2011 The AIDS Beacon HPV Vaccine May Prevent Anal Cancer In Men Who Have Sex With Men – Results from a large international study indicate that the human papillomavirus (HPV) vaccine Gardasil effectively prevents anal pre-cancerous lesions in men who have sex with men. ... See all stories on this topic » Selected 3rd-quarter drug sales for Merck & Co. The Associated Press ... Isentress HIV treatment $343 million $278 million up 23 percent Nasonex Allergies $266 million $259 million down 3 percent Temodar Brain cancer $223 million $254 million down 12 percentGardasil HPV vaccine $445 million $316 million up 41 percent. See all stories on this topic » Do boys need this shot? Poll Position The most common drug used for these vaccinations is Gardasil. There was a great deal of controversy surrounding HPV vaccines for young girls to help prevent cervical cancer. Now, with the CDC recommendation for boys and young men the issue is once ... See all stories on this topic » Talk with your child about the HPV vaccine Lexington Herald Leader There are two vaccines for HPV: Gardasil and Cervarix. They work by preventing the most common strains of HPV that can cause cervical cancer; Gardasil might also prevent some strains of HPV that can cause genital warts. ... See all stories on this topic »-Lexington Herald Leader US Stocks Finish Slightly Higher, Capping Week Of Big Gains Wall Street Journal Shares of Merck rose 80 cents, or 2.3%, to 35.11, after the blue-chip pharmaceutical company's third-quarter profit soared and revenue jumped 8% on higher sales of diabetes drugs and its Gardasilcervical-cancer vaccine. ... See all stories on this topic » CHAREN: Republicans offending Hispanics Odessa American Instead, they will have been treated to the candidates' views on Rick Perry's decision to mandateGardasil vaccines (delivered by what Rep. Bachmann histrionically called “a government needle”), a spirited discussion about whether Mitt Romney was quick ... See all stories on this topic » Earnings Preview: Merck Trading Up Ahead of Q3 Earnings (MRK) Financial News Network Online In the previous quarter, Merck announced positive clinical results for several drugs: Isentress, Delura, Odanacatib, and Gardasil. In fact, the CDC voted to expand the use of Gardasil. Investors will also look for updates on the progress of its new ... See all stories on this topic » |
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