Gardasil Update: The Damage and The Death Count Rise Date: Thu, 16 Aug 2007 16:22:12 -0500 (CDT) ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYI Judicial Watch and the National Vaccine Information Center (NVIC) have separately issued updates involving serious adverse event reports about Merck's HPV (Gardasil) vaccine. Most serious are a statistically significant risk linking Gardasil when co-administered with other vaccines, in particular, meningococcal vaccine (Menactral). NVIC reports: "as of May 31, there have been 2,227 Gardasil adverse events filed with VAERS, including 13 suspected or confirmed cases of GBS (two more GBS reports were made in June for a total of 15) and 239 cases of syncope (fainting with temporary loss of consciousness), many of which resulted in head injuries and fractures. Seven deaths have been reported after receipt of Gardasil." A total of 1,930 reported Gardasil adverse events involved administration of Gardasil alone, and 135 adverse events involved co-administration of Gardasil with Menactra. ABC News reports that Earlier this year, the CDC did say there wasn't enough evidence to prove Gardasil could be used safely with other vaccines. http://abclocal.go.com/wls/story?section=health&id=5572168 What justification do officials of the Center for Disease Control and Prevention offer for their encouragement to physicians to co- administer Menactra and other vaccines with Gardasil when severe adverse event reports should raise alarms about safety ? CDC officials' record of massive waste and inappropriate perks---as documented in a report by Sen. Tom Coburn, a practicing physician and ranking member of the Senate Subcommittee on Federal Financial Management Gov't Information and International Security--give one little trust in CDC policies. Contact: Vera Hassner Sharav 212-595-8974 veracare@ahrp.org ~~~~~~~ National Vaccine Information Center Press Release August 15, 2006 NVIC Analysis Shows Greater Risk of GBS Reports When HPV Vaccine Is Given with Meningococcal and Other Vaccines Washington, August 15, 2007 - The National Vaccine Information Center (NVIC) today issued a new report on HPV vaccine (GardasilR) safety analyzing adverse event reports to the federal Vaccine Adverse Event Reporting System (VAERS). The analysis gives evidence for a reported association in VAERS between Gardasil and Guillain-Barre Syndrome (GBS), with a statistically significant increased risk of GBS and other serious adverse event reports when Gardasil is co- administered with other vaccines, especially meningococcal vaccine (MenactraR). NVIC is calling on the Centers for Disease Control (CDC) to issue an Advisory and amend its March 12 policy by alerting the public that Gardasil has been associated with 15 cases of GBS and an increased risk of GBS and other serious adverse event reports made to VAERS when the vaccine is administered simultaneously with Menactra and other vaccines. "The precautionary principle dictates that good science should precede CDC vaccine policy recommendations," said Barbara Loe Fisher, NVIC co-founder and president. "Parents have a right to expect proof of safety and not assumption of safety before new vaccines, like Gardasil, are given simultaneously with other vaccines to their children. GBS is a disorder in which the body's immune system attacks part of the peripheral nervous system, and can cause total paralysis. "Our analysis of Gardasil reports to VAERS indicates there was a two to 12 times greater likelihood that serious adverse events, such as GBS, were reported when Gardasil was given in combination with Menactra rather than given alone," said Vicky Debold, PhD, RN, NVIC director of patient safety. "Accepted scientific standards indicate that these findings are statistically significant and cannot be dismissed as coincidence. In particular, the available VAERS data show there was a more than 1,000 percent increased risk of GBS reports following Gardasil administration when Menactra was given at the same time." Reported GBS and Other Serious Adverse Events NVIC found that, as of May 31, there have been 2,227 Gardasil adverse events filed with VAERS, including 13 suspected or confirmed cases of GBS (two more GBS reports were made in June for a total of 15) and 239 cases of syncope (fainting with temporary loss of consciousness), many of which resulted in head injuries and fractures. Seven deaths have been reported after receipt of Gardasil. Nearly 10 percent of all Gardasil adverse event reports to VAERS involved avoidable medical errors. A total of 1,930 reported Gardasil adverse events involved administration of Gardasil alone, and 135 adverse events involved co-administration of Gardasil with Menactra. NVIC's comparative analysis of those two categories of VAERS reports indicates that when Gardasil was given simultaneously with Menactra rather than alone, there was a statistically significant increased risk of reported adverse events: -respiratory problem reports increased by 114 percent; -cardiac problems reports increased by 118 percent; -neuromuscular and coordination problem reports increased by 234 percent; -convulsions and central nervous system problem reports increased by 301 percent; -reports of injuries from falls after unconsciousness increased by 674 percent; and -GBS reports increased by 1,130 percent. On February 21, NVIC expressed concern about the safety of administering Gardasil simultaneously with other vaccines because the manufacturer (Merck), the FDA and the CDC had not provided evidence to the public that co-administration was safe. (1) On March 12, the CDC published recommendations for Gardasil use in MMWR that acknowledged there is a lack of evidence that Gardasil can be safely administered with other vaccines, while encouraging physicians to co- administer Menactra and other vaccines with Gardasil based on assumption of safety. (2) Adverse Event Reports to NVIC: Shannon Nelson Nineteen Gardasil adverse event reports from 12 states have been made to NVIC's Vaccine Reaction Registry involving unconsciousness and injury, convulsions, numbness, weakness and other neuromuscular and coordination problems and GBS. Shannon Nelson, 18, a Chicago area athlete, musician and artist entering college reported to NVIC that she received HPV vaccine (Gardasil), meningococcal vaccine (Menactra) and chicken pox vaccine (Varivax R) simultaneously on June 21. Symptoms of tingling, numbness and muscle weakness began within a week and progressively got worse. By July 3 she could barely walk or raise her arms. She was hospitalized, paralyzed with GBS on July 5, and spent 22 days in the hospital. "Before the shots, I ran six miles a day," said Nelson. "The doctors told me that I might have been put on a respirator if I hadn't been in such good shape," she said. "I am out of the hospital now and getting a lot of physical therapy. I just want to go to college and do the things I did before, like play the guitar and draw or even just be able to smile. My Mom and I wish we had known about HPV vaccine risks, especially what could happen if I got other vaccines at the same time." To view a copy of NVIC's report on HPV vaccine (Gardasil) safety, go here To report a vaccine reaction, go here References: 1) Vaccine Safety Group Releases Gardasil Report : Calls on FDA and CDC to Warn Doctors and Parents to Report to VAERS, February 21, 2007. 2) Centers for Disease Control and Prevention. Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report (MMWR) Early Release 2007 ; 56 March 12, 2007:1-24. Learn more about vaccines, diseases and how to protect your informed consent rights at www.nvic.org National Vaccine Information Center 204 Mill Street Vienna, VA 22180 phone: 703-938-0342 ________________________________ http://sayingnotovaccines.blogspot. com/2007/ 07/gardasil- damage-and- death-count- rise.html Gardasil: The Damage and The Death Count Rise Wednesday, July 25, 2007 In February, 2007, 82 reports of adverse reactions to the Gardasil vaccine. In June, there were 1,600 reports and now, by mid-July, the number of reported reactions has risen to 2,207. The breakdown of those stats is even worse than the total number: a.. 31 were considered life threatening; b.. 1385 required emergency room visits; 451 had not recovered; c.. 51 females were disabled; d.. 5 girls--ages 12, 15, 19 and two unknown--had died. Judicial Watch reported that "Side effects published by Merck & Co. warn the public about potential pain, fever, nausea, dizziness and itching after receiving the vaccine. Indeed, 77% of the adverse reactions reported are typical side effects to vaccinations. But other more serious side effects reported include paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures." It is reported that 3,700 women die per year from cervical cancer. Note that deaths are among women, not children. Yet children are being maimed and killed by this vaccine. Call your State legislator; our collective voices must become louder than the voice of Merck's lobbyists. We must all work together to this vaccine from becoming mandatory in every state. ~~~~~~~~~ http://www.usatoday.com/news/washington/2007-06-12-cdc-coburn_N.htm By Matt Kelley USA TODAY June 13, 2007 WASHINGTON - A Republican senator Tuesday released a report critical of spending at the federal Centers for Disease Control and Prevention (CDC), saying the agency "has wasted and continues to waste hundreds of millions of tax dollars, but keeps asking taxpayers for more." Sen. Tom Coburn, a practicing physician and ranking member of an oversight subcommittee, issued a 115-page minority office report questioning the CDC's spending on projects including an employee fitness center with $200,000 in equipment such as zero-gravity chairs and a mood-enhancing light show, and a $1.7 million effort to have accurate medical information portrayed in movies and TV shows. A CDC spokesman said the agency provided Coburn with "exhaustive information" and had reorganized its management to improve efficiency. "We strive day in and day out to fulfill our commitment to the American taxpayer," CDC spokesman Tom Skinner said. Coburn said he believes the CDC does important work to protect and improve public health that should not be undermined by wasteful spending. The Oklahoma senator said he plans to issue similar reports about other agencies but did not say which ones. Coburn's report on the CDC provided details on a massive construction project at the CDC's headquarters in Atlanta that has exceeded $1 billion. The new buildings include a $106 million communications center with a 70-foot-wide-by-25-foot-tall wall of plasma video screens for visitors, the report says. The center is named after Sen. Tom Harkin, an Iowa Democrat who was the ranking member of the Senate Appropriations subcommittee overseeing CDC spending. A video production studio at the center cost $18.6 million, the report says. The new construction includes a $110 million headquarters building named after Sen. Arlen Specter, a Pennsylvania Republican who is the former chairman of the subcommittee shaping the CDC budget. Coburn's report says the CDC spent $9.8 million on furniture for the building. Another building at the campus houses the new fitness center, whose amenities include "quiet rooms" where workers can relax in zero-gravity chairs while watching a show of pastel-colored lights, the report says. Skinner said the buildings and their furnishings aren't a waste of money. "We have first-rate facilities for first-rate employees," Skinner said. "After years of neglect, we finally have what we need to move forward and accomplish our mission." Coburn's report criticizes the $1.7 million the agency has spent since 2001 on a Hollywood liaison office providing expertise for TV shows such as ER and 24. The current project director is a former CDC employee who worked on its "Entertainment Education Program" before leaving the agency in 2002, the report says. Coburn called such spending wasteful in his report. "It is hard to argue in this day and age that television producers do not have an incentive, without federal taxpayer involvement, to get their story lines correct," the report says. Skinner defends the program as "an unusual and effective way to reach people" with messages about their health. "It's been a positive program for us and one we think has been well received and instrumental about getting information about health protection to millions of people," Skinner said. FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which has not always been specifically authorized by the copyright owner. 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