by Barbara Loe Fisher
It has been nearly two years since the FDA fast tracked the licensure of Merck’s GARDASIL vaccine and the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended it for universal use by all 11 year old girls. Calls for state mandates for sixth grade entry soon followed with Merck leading an aggressive lobbying campaign with pro-forced vaccination proponents talking about 12 year old girls having sex. The National Vaccine Information Center countered by publicly framing the debate about GARDASIL mandates as a product safety and informed consent issue: the vaccine had only been tested in fewer than 1200 girls under age 16 followed up for less than two years.
Now, a leading HPV vaccine researcher has spoken out opposing mandates in a three-part series produced by CBS4-TV in Miami. Speaking to investigative journalist Michele Gillen Harper said “We don’t know yet what’s going to happen when millions of doses of the vaccine have been given and to put in process a place that says you must have this vaccine, it means you must be part of a big public experiment. So we can’t do that until we have more data.”
It takes a lot of courage for any scientist or physician to stand up and speak out about the need for government, industry and physicians to embrace the precautionary principle: First, do no harm. Dr. Harper has upheld high standards for scientific and ethical integrity by responsibly calling for rigorous post- marketing surveillance of licensed HPV vaccines and adherence to the informed consent ethic.
The National Vaccine Information Center has received nearly 100 reports of serious health problems following vaccination. NVIC issued three reports on GARDASIL adverse events reported to the federal Vaccine Adverse Events Reporting System (VAERS). In August 2007, NVIC called on the CDC to warn doctors that the safety of giving GARDASIL simultaneously in combination with other vaccines had not been proven safe.
A family support group for those who have reported HPV vaccine reactions to NVIC is being created. If you or a loved one has suffered an HPV vaccine reaction, you can make a report to NVIC’s 26- year old Vaccine Reaction Registry by visiting their website. Please indicate if you would like to participate in the HPV Vaccine Reaction Family Support Group.
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“According to Dr. Diane Harper, “the vaccine has not been out long enough for us to have post marketing surveillance to really understand what all the potential side effects are going to be. We feel it is very safe.” However, she adds, “We don’t know yet what’s going to happen when millions of doses of the vaccine have been given and to put in process a place that says you must have this vaccine, it means you must be part of a big public experiment. So we can’t do that until we have more data.” Barbara Loe Fisher agrees. She took to the streets a grass roots fight credited with derailing many efforts around the country to mandate the vaccine. “It was the quickest effort I have ever seen in 25 years for a vaccine to be mandated,” says Fisher. A mother of a son who she say was left with learning disabilities following a routine vaccination in the 1980’s, Fisher is President and Co Founder of the National Vaccine Information Center. It is a non-profit independent clearinghouse for information on vaccines and disease. Fisher says her organization has been contacted by nearly 100 parents claiming their daughters have suffered some type of adverse reaction following a Gardasil shot - at times given in combination with other vaccines. She says many parents are frustrated in their search for answers and that they don’t know where to turn. She tells Gillen “the National Vaccine Information Center is getting reports every week, mostly mothers, of what is happening to their 11-year old girls after receiving Gardasil.” - CBS4-TV (Miami), Michele Gillen reporting (May 7, 2008)
“Bell says she now finds herself on a search for answers as to what happened to her daughter, Brittney, just weeks following an injection of Gardasil and a tetanus shot. The former cheerleader and runner’s left leg was mysteriously affected by paralysis. The family wants to know if the condition could have been triggered by the vaccines she received that day. Reported adverse events following vaccine injections, including Gardasil, have come under increasing scrutiny by parents reviewing them on the U.S. Vaccine Adverse Event Reporting System (VAERS)…..”Brittany’s case is at a quandary,” said Sean Cronin, attorney for the Bell family. Cronin says it is an uphill battle trying to investigate whether the Gardasil shot played any role in what has happened to Brittney. Christina Bell says Brittney’s pediatrician does not believe there is a link. Now the Bell family has learned that Merck can’t be sued over its Gardasil vaccine because it has been added to a federal list of vaccines recommended by the government. The vaccine manufacturers are insulated from liability.” - CBS4-TV (Miami), Michele Gillen reporting (May 25, 2008)
“Christina Bell’s daughter, Brittney, was one of the young girls who recieved the vaccine. Just weeks later, her life took a radical turn for the worse. Seemingly, in a moment’s time, Brittney’s left leg became paralyzed, her ankle swinging like a rag doll’s. Even with a shoe brace, she walks with a limp. “It’s hard for me to lift it up,” Brittney told Gillen. Brittney’s limb paralysis occurred shortly after the 12 year old went to the doctor for a routine tetanus shot for school…..Last February, the FDA told CBS4 that it was investigating reports of 13 deaths following an HPV vaccination. At the time, the agency said it was confident that none were tied to the vaccine and that reports of adverse events were under review but not considered anything out of the ordinary. An FDA spokeswoman told CBS4 this week that she could not provide an update on the number of reported events, including deaths. “I haven’t seen updated numbers for several months. We monitor on a daily basis but we don’t total it up. We are not seeing a problem,” said Susan Cruzan, spokesperson for the FDA…..Brittney’s mom said she can’t find a doctor willing to report an adverse reaction following the administration of her daughter’s vaccines. CBS4 informed her that parents, just like doctors, can report an adverse event and the Bell family has done just that.” - CBS4-TV (Miami), April 24, 2007
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