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8 More Deaths Linked to Gardasil HPV Vaccine

Only after filing a lawsuit against the FDA was Judicial Watch able to uncover New FDA Records Detailing an additional 8 deaths among an additional 1,824 Adverse Reaction Reports Related to Gardasil, Merck's Human Papillomavirus (HPV) Vaccine between May 10, 2007 and Sept. 7, 2007. The death reports include 12 and 13 year old girls. See: [Link]Although the HPV virus is prevalent, it is estimated that only 1% of those infected with HPV will eventually get cervical cancer. However, Merck's aggressively promoted HPV vaccine has already been implicated in 11 deaths since its approval last year.Diane M. Harper, the lead investigator of the HPV vaccine trial, an internationally recognized scientist, physician, professor and the director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center at Dartmouth Medical School in New Hampshire, has been searching for a possible vaccine for several of the more than 100 strains of HPV for 20 years. In March, 2007, Dr. Harper stated: "Giving it to 11-year-olds is a great big public health experiment." "There is also not enough evidence gathered on side effects to know that safety is not an issue."Given the sparse safety data and minimal efficacy data, AHRP is on record in opposition to mandatory HPV vaccination because it is reckless and irresponsible to mandate exposing 11- to 12-year-old girls to the risks of harm of a vaccine whose risk / benefit appears to be negative with each passing month. Why should citizens have to sue the FDA before obtaining vital information about lethal medical products that carry the FDA seal of approval? Underscoring the complicity of our government health oversight agencies--FDA and the Center for Disease Control--Medical News Today reports (below) the response of CDC and FDA officials who reflexively shield defective lethal medical products.Curtis , a CDC spokesperson, said "there have been fewer complaints about adverse effects associated with Gardasil than there have been for other drugs." If so, we need to investigate those defective, FDA-approved drugs.'s response to the evidence that several of the reports to FDA of deaths of girls and women who received Gardasil say that the patient had developed a blood clot, was "Gardasil is not known to increase risk of blood clots." It does not take a rocket scientist to know that most serious adverse drug /vaccine effects come to public light only after they have been unleashed prematurely on the market since the enactment of PDUFA (Prescription Drug User Fee Act, 1992). added that "Judicial Watch's analysis does not prove that Gardasil causes death and that the reports of women who died after receiving the vaccine statistically are normal within the population." AHRP challenges the CDC to provide the data to back up Mr. 's claim. Girls and young women are not predisposed to lethal blood clots! [Produce the detailed statistical analysis please instead of talking about it Mr .]

(Washington, DC) -- Judicial Watch, the public interest group that investigates and prosecutes government corruption, today released new documents obtained from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act, detailing 1,824 reports of adverse reactions to the vaccination for human papillomavirus (HPV), Gardasil, including as many as eight deaths related to the vaccine. Judicial Watch had previously obtained 1,637 reports relating to Gardasil on May 15, 2007, bringing the known total to 3,461 adverse reactions including eleven deaths since FDA approval. Among the new information uncovered by Judicial Watch:

20-Jun-2007: Information has been received.concerning a 17 year old female who in June 2007.was vaccinated with a first dose of Gardasil.During the evening of the same day, the patient was found unconscious (lifeless) by the mother. Resuscitation was performed by the emergency physician but was unsuccessful. The patient subsequently died. 12-Jun-2007: Information has been received.concerning a 12 year old female with a history of aortic and mitral valve insufficiency.who on 01-MAR-2007 was vaccinated IM into the left arm with a first does of Gardasil.On 01-MAR-2007 the patient presented to the ED with ventricular tachycardia and died. 28-Aug-2007: Initial and follow-up information has been received from a physician concerning an "otherwise healthy" 13 year old female who was vaccinated with her first and second doses of Gardasil. Subsequently, the patient experienced.paralysis from the chest down, lesions of the optic nerve.At the time of the report, the patient had not recovered."From May 10 to September 7, 2007, the 1,824 adverse vaccination reactions reported to the FDA via the Vaccine Adverse Event Reporting System (VAERS) included 347 serious reactions. Of the 77 women who received the vaccine while pregnant, 33 experienced side effects ranging from spontaneous abortion to fetal abnormities. Other serious side effects continue to be reported including, paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures."In light of this information, it is disturbing that state and local governments might mandate in any way this vaccine for young girls," said Judicial Watch President Tom Fitton. "These adverse reaction reports suggest the vaccine not only causes serious side effects, but might even be fatal."Judicial Watch filed its request on August 20, 2007, and received the adverse event reports from the FDA on September, 13 2007. (On October 3, 2007, Judicial Watch filed a new lawsuit against the FDA for its failure to fully respond to Judicial Watch's FOIA request as required by law.)Judicial Watch [Link]

FW Daily News article- Researcher blasts HPV marketing by Bevington [Link]Alliance for Human Research Protection [Link][Link] Judicial Watch Releases Analysis Of FDA Data Claiming Gardasil Vaccination Can Lead To Serious Health Problems, Death 08 Oct 2007 The conservative group Judicial Watch on Thursday released an analysis of FDA data that found Merck's human papillomavirus vaccine Gardasil might be dangerous or fatal to young women, members of the group said, CQ HealthBeat reports (Lubbes, CQ HealthBeat, 10/4).Gardasil in clinical trials has been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases, and about 99% effective in preventing HPV strains 6 and 11, which together with HPV strains 16 and 18 cause about 90% of genital wart cases among women not already infected with these strains. FDA in June 2006 approved Gardasil for sale and marketing to girls and women ages nine to 26, and CDC's Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine, which is given in a three-shot series (Kaiser Daily Women's Health Policy Report, 7/10). Analysis, CDC Data According to Judicial Watch, 3,461 complaints about Gardasil have been filed with FDA's Vaccine Adverse Event Report System since its approval last year, and 11 women died after exposure to the vaccine. In addition, some women developed severe health problems after receiving Gardasil, the analysis said. Curtis , a CDC spokesperson, said the agency has confirmed four deaths that occurred after the patients received Gardasil, but none of the deaths was linked directly to the vaccine. said that there have been fewer complaints about adverse effects associated with Gardasil than there have been for other drugs.Several of the reports to FDA of deaths of girls and women who received Gardasil note that the patient had developed a blood clot. said that Gardasil is not known to increase risk of blood clots. He added that Judicial Watch's analysis does not prove that Gardasil causes death and that the reports of women who died after receiving the vaccine statistically are normal within the population. According to CQ HealthBeat, there is disagreement over the data in part because the reports of adverse events come from several sources, including health professionals and pharmaceutical companies, which are required to disclose potential problems with vaccines, including rumors and third-party information. The Judicial Watch analysis includes a report about a doctor who at a conference heard about two patients dying after receiving Gardasil. Another incident involved the death of a 17-year-old girl immediately after receiving the vaccine, which was reported to FDA by "a gynecologist who was informed of the case from another gynecologist." Reaction Tom Fitton, president of Judicial Watch, said that if Gardasil is "as dangerous as it seems to be, it does not seem to be good public health policy." Kelley Dougherty, a spokesperson for Merck, said that it is impossible to determine whether the reports are actual fatalities related to the vaccine or rumors. The FDA only documents deaths that are reported but the agency does not show cause and effect, according to CQ HealthBeat. "There are no reporters that have a correlative effect," Dougherty said. said that Judicial Watch "is playing loose" with data on the vaccine. Fitton defended the group's analysis and added that it has filed a lawsuit against FDA to require the agency to provide more information about the vaccine. "The reports are what they are," Fitton said, adding, "The CDC can explain them away, and Merck can explain them away. I don't think it's just randomness" (CQ HealthBeat, 10/4).The analysis is available online. Bloomberg/Austin American-Statesman Examines Sales of Gardasil In related news, Bloomberg/Austin American-Statesman on Friday examined how Gardasil "could become the best-selling vaccine in history" as Merck "prepares to expand its use to men." According to Bloomberg/American-Statesman, Merck has made $1.4 billion in Gardasil sales in the drug's first year on the market. Merck is conducting studies to prove that Gardasil can prevent HPV infection in men. If the vaccine were approved for use in boys and men, annual sales of the vaccine could be as high as $10 billion, according to , an analyst at Wood Mackenzie Consultants (Cullen, Bloomberg/Austin American-Statesman, 10/5). You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at [Link] The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family FoundationC 2005 Advisory Board Company and Kaiser Family Foundation. Earlier|Later|Main Page Labels: Gardasil, Merck

Posted by Vera Hassner Sharav 10/25/2007 03:18:00 PM | Permalink

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