by Barbara Loe Fisher
While Merck has pulled in $1.5B from sales of GARDASIL vaccine worldwide, there are continuing reports that girls are being crippled and dying after getting the HPV vaccine fast tracked and licensed by the FDA in 2006. Although the roll-out of GARDASIL with an unparalleled multi-million dollar mass media advertising blitz has created a profitable market for the drug company that took huge losses from Vioxx injury/death lawsuits, the persistent reports of Guillain Barre Syndrome (GBS) paralysis, arthritis, seizures and sudden loss of consciousness within 24 hours of vaccination continue to haunt the marketing campaign.
Last week Judicial Watch issued a report on more than 8,000 GARDASIL reaction reports to the federal Vaccine Adverse Event Reporting System (VAERS) obtained under the Freedom of Information Act (FOIA). A search of the VAERS database , which includes reaction reports through April 30, 2008 released to the public by the FDA, reveals nearly 6,700 reports of injury and death after GARDASIL. Two GARDASIL vaccine injury claims recently were filed in the federal Vaccine Injury Compensation Program under the National Childhood Vaccine Injury Act of 1986.
Exactly two years ago, NVIC sounded the first public warning about GARDASIL risks pointing out that Merck had not adequately proven the vaccine was safe and effective to give to girls under age 16. NVIC pointed out that pre- licensure trials were flawed because they used an aluminum containing placebo that may have masked the true reactivity of GARDASIL, which also contains 225 mcg of aluminum. Like mercury, aluminum can cause inflammation in the body and kill brain cells.
The fact that Merck had only studied the vaccine in fewer than 1200 girls under age 16 and followed them up for less than two years before licensure did not seem to bother doctors working for the CDC’s Advisory Committee on Immunization Practices (ACIP), who saluted Merck smartly and promptly recommended that all 11 year old girls entering sixth grade get three doses.
By the end of 2006, Merck had marshaled its well- paid lobbying forces bolstered by a flashy television advertising campaign in an unprecedented effort to persuade legislators in every state to turn CDC recommendations into law and pass HPV vaccine mandates. Texas Governor Rick Perry went so far as to issue an Executive Order mandating the vaccine for all sixth grade girls.
GARDASIL had only been on the market for a few months and nobody, including Merck, knew the full range of side effects when GARDASIL was given to millions of girls entering puberty. Nevertheless, the pressure was on young girls, their parents and state legislators to trust blindly that the vaccine had no real risks.
In early 2007, NVIC again warned the public that there were significant risks associated with GARDASIL , especially when it was combined with other vaccines. NVIC warned that there was evidence that giving GARDASIL during active HPV infection may increase the risk for cervical cancer while girls were not being tested for active HPV infection before getting vaccinated. NVIC also advised that girls should not drive home after getting the shot because of the risk for sudden loss of consciousness after leaving the doctor’s office.
In March 2007, the CDC admitted that there was no scientific evidence that GARDASIL can be safely co- administered with other vaccines (like TDaP, meningococcal, varicella, MMR, influenza). Even so, without a second thought, the CDC urged doctors to assume safety and go ahead and give GARDASIL simultaneously with other vaccines.
By end of May 2007 almost every state had rejected proposed mandates for GARDASIL vaccine and there were more than 2,000 GARDASIL adverse events reported to VAERS. In August 2007, NVIC released a comprehensive analysis of GARDASIL reaction reports to VAERS and a critique of the CDC’s universal use recommendation. In a letter, NVIC asked the CDC to warn doctors that the simultaneous administration of Menactra with GARDASIL increases the risk for GBS and other serious adverse event reports.
The CDC chose to blow off NVIC’s report and do nothing.
Two years after licensure, it is clear that GARDASIL has plenty of risks for young girls. Among the more than 130 GARDASIL reaction reports that have been filed with NVIC’s 26-year old Vaccine Reaction Registry is one that was posted by a mother, who witnessed what happened to her daughter on the International Memorial for Vaccine Victims.
Amanda’s mother describes her daughter as “a beautiful, active girl that was brought down.” Only 14 when she was vaccinated, Amanda “became weak, tired and sick to her stomach” but the symptoms subsided. One week after the second HPV vaccination, her legs “became very weak and she started losing feeling in her feet.” She was hospitalized in the Intensive Care Unit for four days with a diagnosis of Guillain-Barre Syndrome.
Amanda’s mother said “The doctors thought we were CRAZY when we mentioned that the HPV vaccine could cause this.”
“Amanda is constantly sick,” says her Mom. “Something has suppressed her immune system so badly she can barely function. The depression got really bad because she is experiencing a lot of pain in her knees now and can’t do any sports. She was once very active and right now can barely go to school We were told me her doctors that there is nothing more that they can do and that she could use a good psychiatrist.”
How many more girls like Amanda and her mother have had their futures stolen by a vaccine that is supposed to prevent a viral infection that is cleared without any residual effects by more than 90 percent of all who get it to prevent a cancer that causes less than 1 percent of all new cancer cases and cancer deaths in the U.S. every year? Did Amanda and her mother know that cervical cancer can be prevented nearly 100 percent of the time with annual pap smears and early intervention when pre-cancerous cervical lesions are diagnosed?
Or did Amanda’s Mom believe Amanda would be “one less” because a pediatrician told her so?
NVIC continues to receive reports from grieving mothers and fathers who can’t find doctors to treat their once-healthy daughters who are now chronically ill and disabled after being injected with GARDASIL. In almost every case, the doctors are denying the vaccine had anything to do with what happened.
The tragic denial by the medical profession of the harm vaccines can do continues decade after decade after decade. When will doctors stop being marketers of pharmaceutical products and implementers of government policy and embrace the moral imperative to “first, do no harm?”
The “its all a coincidence” defense mounted by doctors when something bad happens after vaccination is illogical, unscientific and dangerous. When will Americans get up off their knees and stop worshipping men and women in white coats who do not know what they are doing?
“Katherine Kimzey started suffering debilitating headaches, fainting spells and arthritis-like stiffness last November. Six weeks later, the 14-year-old Dallas resident became so dizzy she could barely walk. She was hospitalized and missed three weeks of school. Then, she had a seizure. For weeks, she bounced back and forth between specialists and was eventually diagnosed with epilepsy. Katherine’s mother, Michelle Kimzey, now believes her daughter’s symptoms were caused by a new vaccine that was supposed to protect her against cervical cancer…… The HPV vaccine has generated debate across the country and in Texas. Gov. Rick Perry issued an executive order in February 2007 requiring that all sixth-grade girls get the HPV shot. But angry parents and conservative groups fought the mandate, fearing it condoned premarital sex and took away parental rights. The Legislature defeated the order last April. The National Vaccine Information Center heralded the decision, saying that testing of the vaccine was not extensive enough in girls under 12. The nonprofit center had already started warning about the possibility of adverse reactions such as extreme fatigue, arthritis and loss of consciousness. Barbara Loe Fisher, co-founder and president of the center, said she’s frustrated that the CDC has “assumed safety” for Gardasil, which has been tested only in conjunction with the vaccine for Hepatitis B. Today, girls often receive the Gardasil shot at the same time as a meningitis vaccine and another new booster that immunizes against tetanus, diphtheria and pertussis. The FDA has approved all the vaccines separately, but studies on administering them together are still ongoing. “Not only was Gardasil put on the fast track and licensed quickly,” said Ms. Fisher, “but to say safety is assumed and you can give any vaccine with it is even more shocking.” – Jessica Myers, Dallas Morning News (June 6, 2008) http: //www.dallasnews.com/sharedcontent/dws/news/local news/stories/DN- vaccine_06met.ART.North.Edition1.46ef875.html
“Gardasil has been a shot in the arm for pharmaceutical giant Merck. The company had been reeling from the withdrawal of its anti-arthritis drug Vioxx because of increased risk of heart attacks and resulting lawsuits. Now, however, Merck’s new vaccine against the human papilloma virus (HPV) – aimed at combating cervical cancer – has been deployed worldwide, earning an estimated $1.5 billion in sales. But the drug is coming under increasing fire from anti-vaccine activists. Already very vocal about childhood innoculations, now they are expressing concern about the effects of Merck’s drug on young girls, a primary focus of the company’s big ad campaign…..”This issue is not going away as more and more vaccines are brought to the market,” Barbara Loe Fisher, president of the National Vaccine Information Center (NVIC) who became an activist after a serious reaction in her son to a DPT vaccine (a combined innoculation against Diptheria, Whooping Cough – pertussis – and Tetanus). Fisher, who has served on an Federal Drug Administration consumer advisory committee on vaccines, takes issue with the CDC’s read of the VAERS Gardasil reports. Her organization, NVIC, has called on the CDC and FDA to warn the public that Gardasil has been associated with at least 15 cases of Guillain-Barre Syndrome (GBS), an autoimmune disorder; and it says there is an increased risk for GBS when Gardasil is co- administered with other vaccines, particularly Menactra, a meningitis vaccine….NVIC is concerned about the growing number of vaccinations required by schools and the push, in some public health quarters, to mandate more vaccines. The political fight has been taken to New York and New Jersey. New York state public health officials have endorsed state legislation that would take the CDC’s recommended vaccine list for children and declare it to be mandatory, Fisher says, and she sees that as a move that should alarm parents. Vaccinations should be voluntary, Fisher says, and be made with “informed consent” by parents.” – Hilary Hylton-Austin, Time/CNN (June 19, 2008) http://www.time.com/time/health/artic le/0,8599,1816507,00.html
“Judicial Watch, the public interest group that investigates and prosecutes government corruption, today released a report based on new documents obtained from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act, detailing reports of adverse reactions to the vaccination for human papillomavirus (HPV), Gardasil. The adverse reactions include 10 deaths since September, 2007. (The total number of death reports is at least 18 and as many as 20.) The FDA also produced 140 “serious” reports (27 of which were categorized as “life threatening”), 10 spontaneous abortions and six cases of Guillain-Barre Syndrome – all since January 2008.” – Judicial Watch (June 30, 2008) http://www.judicialwatch.org/news/2008/jun/judicial- watch-uncovers-new-fda-records-detailing-ten-new- deaths-140-serious-adverse-e
“About a month after being vaccinated against the cervical cancer-causing HPV virus, 13- year-old Jenny Tetlock missed the lowest hurdle in gym class, the first hint of the degenerative muscle disease that, 15 months later, has left the previously healthy teenager nearly completely paralyzed….Her father, Philip Tetlock, a psychology professor at UC- Berkeley’s Haas School of Business, has embarked on an odyssey to find out whether the vaccine or random coincidence is to blame….. Tetlock, though, wonders if Jenny carries genes that predisposed her to problems with the Gardasil vaccine. At age 10, Jenny developed a rare skin disease called pityriasis lichenoides that’s thought to be triggered by an overactive immune system, and her grandmother died of a nervous system disease. Could it be that certain genetic tendencies make some people more likely to develop severe reactions from vaccines?….Jenny endures terrible suffering each day.”….. “She must watch her capacity to control her own body gradually ebb away-and each day her hopes of ever having a normal human life recede ever further into memory. The disease is cruel beyond belief.” – Deborah Kotz, US News & World Report (July 2, 2008) http://www.usnews.com/blogs/on- women/2008/07/02/is-hpv-vaccine-to-blame-for-a- teens-paralysis.html
“Lawyers last month 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. Healthy all her life, her family says, Jesalee has been hospitalized on and off for more than a year. She restricts her diet, takes pain pills and misses many school days. “I’m pretty sick all the time,” she said. The other claim was filed for Jessica Vega of Nevada, who came down with Guillain-Barré Syndrome, an immune-system disorder, at age 14 – a week after her second Gardasil shot. Thirty others have reported the syndrome after getting the vaccine. JESSICA’S mom, Rhonda Vega, says the girl’s lower legs and arms were paralyzed, but she’s learned to walk again. “Protecting girls against cervical cancer is a fabulous thing, but if this is what’s going to happen, they need to research it more,” she said……Merck spokeswoman Kelley Dougherty said the company “actively monitors” reports of side effects. “An event report does not mean that a causal relationship between an event and vaccination has been established – just that the event occurred after vaccination,” she said. – Susan Edelman and Bruce Golding, New York Post (July 6, 2008) http://w ww.nypost.com/seven/07062008/news/nationalnews/f eds_warning_shot_118716.htm