NVIC Releases GARDASIL Report - Merck Stops Mandate Push

"Merck & Co. will stop lobbying state officials to require that girls receive the company's Gardasil cervical cancer vaccine before they can attend school. Merck made the decision after groups including the American Academy of Pediatrics said there wasn't enough state funding to pay for the $360 vaccine or public acceptance, said Rick Haupt, director of medical affairs for Merck's vaccine division, in a telephone interview today....The vaccine is Merck's most important new product, capable of generating as much as $3 billion in annual sales, analysts have said. Revenue from Gardasil in the fourth quarter reached $155 million.... Starting in 2008, Texas girls ages 11 and 12 will be required to have the vaccine before entering sixth grade. The shots will cost the state $50 million the first year....A group called the National Vaccine Information Center said yesterday that its analysis of reports to U.S. regulators found cases of serious side effects to Gardasil. One was Guillain-Barre Syndrome, a disorder in which the body's immune system attacks part of the nervous system." - Shannon Pettypiece and Angela Zimm, Bloomberg News , February 20, 2007, Merck Stops Campaign to Mandate Gardasil Vaccine Use

"Merck & Co., bowing to pressure from parents and medical groups, is immediately suspending its lobbying campaign to persuade state legislatures to mandate that adolescent girls get the company's new vaccine against cervical cancer as a requirement for school attendance....Legislatures in roughly 20 states have introduced measures that would mandate girls have the vaccine to attend school, but none has passed so far. However, Texas Gov. Rick Perry on Feb. 2 issued an executive order requiring that schoolgirls get the vaccinations, triggering protests from lawmakers in that state, who may seek to pass a law of overturning the order. A group of parents worried that vaccines harm some children, the National Vaccine Information Center, has been publicizing reports of side effects - mostly dizziness and fainting - in several dozen people getting Gardasil, which is approved for use in females ages 9 to 26. The group questions whether it was tested in enough young girls. Officials with the Centers for Disease Control and Prevention, however, say that reports of side effects through the end of January show don't raise any red flags." - Linda Johnson, Associated Press February 20, 2007, Merck Suspends Lobbying for Cervical Cancer Vaccine Mandate

Barbara Loe Fisher Commentary:

About 12 hours after PROVE president Dawn Richardson and scores of parents and doctors testified in the Texas state legislature, protesting the HPV vaccine mandate being imposed on 11 year old girls in that state by the Governor of Texas, Merck announced it was ending its aggressive lobbying campaign to get GARDASIL mandated in every state. Dawn used advance information provided to her by NVIC from the Report on VAERS and GARDASIL that NVIC released today (below) in her testimony, arguing that the vaccine had not been tested adequately for safety in little girls and was already causing too many reactions. The Texas legislature is in the process of building a bi-partisan coalition to pass legislation that will overturn Governor Rick Perry's Executive order mandating the vaccine for all sixth grade girls.

The backlash in Texas is also being felt in other states, as parents are letting legislators know they are tired of having every vaccine, which industry produces and the CDC recommends for universal use in all children, automatically mandated by the states for school entry. From now on, perhaps citizens and their elected officials will work together to more carefully evaluate the necessity for and safety and efficacy of new vaccines which those, who are operating and profiting from the mass vaccination system, lobby to have mandated.

With 56 doses of 16 vaccines recommended by the CDC for use by all children by age 12 and more than 3 dozen of those already mandated in most states, a careful examination of each new vaccine that industry markets is long overdue. The fact that many highly vaccinated children are suffering with chronic disease and disability, with 1 in 150 autistic, 1 in 6 learning delayed and millions more asthmatic and diabetic, makes it even more important for the FDA and CDC to redouble their efforts to hold vaccine manufacturers to high standards for proof of safety for vaccines before they are licensed and recommended for universal use by all children.

After 25 years, the vaccine safety and informed consent movement led by parents of vaccine injured children has become a national voice for those who want truth, transparency and freedom of choice when it comes to making vaccination decisions for themselves and their children. Today, many more Americans are joining with NVIC and declaring: No forced vaccination. Not in America.

VACCINE SAFETY GROUP RELEASES GARDASIL REACTION REPORT

Calls on FDA and CDC to Warn Doctors and Parents to Report to VAERS

(Feb. 21) Washington, D.C. – The National Vaccine Information Center (NVIC) today released a new analysis of the federal Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck’s GARDASIL) during the last six months of 2006. Out of the 385 individual GARDASIL adverse event reports made to VAERS, two-thirds required additional medical care and about one-third of all reports were for children 16-years-old and under, with nearly 25 percent of those children having received simultaneously one or more of the 18 vaccines that Merck did not study in combination with GARDASIL. NVIC is calling on the FDA and CDC to warn parents and doctors that GARDASIL should not be combined with other vaccines and that young girls should be monitored for at least 24 hours for syncopal (collapse/fainting) episodes that can be accompanied by seizure activity, as well as symptoms of tingling, numbness and loss of sensation in the fingers and limbs, all of which should be reported to VAERS immediately.

“Because Merck only studied GARDASIL in fewer than 1200 girls under age 16 in pre-licensure trials, it is critical that doctors and parents be made aware of the nature of the initial adverse event reports coming into VAERS and that they report serious health problems after vaccination when they occur,” said NVIC President Barbara Loe Fisher. “There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a GARDASIL vaccination compared to those getting a Tdap (tetanus-diphtheria- acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre Syndrome. And doctors who give GARDASIL in combination with other vaccines are basically conducting an experiment on their young patients because Merck has not published any safety data for simultaneous vaccination with any vaccine except hepatitis B vaccine.”

According to NVIC’s report, a majority of GARDASIL adverse event reports to VAERS involved those who suffered fever, nausea, headache or pain; 14 percent were for syncopal episodes with or without neurological signs; and 8 percent experienced tingling, numbness and loss of sensation, facial paralysis or Guillain-Barre Syndrome. Although adverse event reports to VAERS do not prove causation, they can provide an early warning sign that a new vaccine may be causing health problems that could be important. For example, reports to VAERS of bowel blockage (intussusception) in babies following receipt of Merck’s Rota Teq (rotavirus) vaccine prompted the FDA to issue a public warning to doctors and consumers on Feb. 13.

“About 4 reports per day were filed with VAERS in December 2006 for the HPV vaccine,” said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. “Some of these girls are being injured when they collapse after getting the vaccine and others are complaining of neurological symptoms that should not be ignored. Doctors and nurses should take note of the patient safety issues related to giving this vaccine. Giving GARDASIL simultaneously with any of the 18 vaccines Merck did not study in combination is not an evidence- based guideline and should involve informed consent and a signed patient release. To avoid unnecessary injuries, teenage girls should be vaccinated laying down, not be left unattended and probably should not walk or drive themselves home from the doctor’s office after they get vaccinated.”

NVIC also found that there were several VAERS reports of HPV infection, genital warts and cervical lesions after GARDASIL vaccination. It is unknown if the girls were infected with HPV before being vaccinated or if GARDASIL failed to protect them. One case of HPV infection occurred in a 22-year-old girl who had participated in a Merck GARDASIL trial in 2003 when she had shown “strong conversion to all 4 vaccine types” but “tested positive for high risk HPV” in 2006, according to the VAERS report.

In a May 18, 2006 Background Document for the FDA Vaccines and Related Biological Products Advisory Committee (VRPBAC), the FDA staff stated that Merck clinical trial data indicated there may be “the potential for GARDASIL to enhance cervical disease in subjects who had evidence of persistent infection with vaccine-relevant HPV types prior to vaccination.” Girls and women now being vaccinated with GARDASIL are not routinely being tested for active HPV infection before vaccination.

The FDA staff also questioned whether the “HPV types not contained in the vaccine might offset the overall clinical effectiveness of the vaccine.” There are more than 15 types of HPV associated with cervical cancer but GARDASIL only contains HPV types 16 and 18. It is unknown whether non-vaccine HPV types will become more dominant in the future. However, there are indications this could occur because some of the seven strains of pneumococcal contained in Wyeth’s PREVNAR vaccine, which was recommended by the CDC for universal use in all babies in 2000, have been replaced by some of the more than 80 other pneumococcal strains not contained in the vaccine.

VAERS is a passive surveillance system and depends upon voluntary reporting of serious health problems following vaccination, even though safety provisions in the National Childhood Vaccine Injury Act of 1986 mandated that health care providers report vaccine adverse events. There have been estimates that fewer than 10 percent, even as low as 1 to 4 percent, of adverse events which occur after prescription drug or vaccine use are ever reported to government adverse event reporting systems.

“If only 1 to 4 percent of all adverse events associated with GARDASIL vaccination are being reported to VAERS, there could have been up to 38,000 health problems after GARDASIL vaccination in 2006 which were never reported,” said Fisher. “How many girls are really having short-term health problems associated with getting this vaccine that could turn into long-term neurological or immune system disorders? And how many will go on to develop fertility problems, cancer or damage to their genes, all of which Merck admits in its product insert that it has not studied at all? We just don’t know enough to be mandating GARDASIL for anyone, much less vulnerable 11 to 12 year old girls entering puberty.”

For a copy of NVIC’s Report on VAERS and GARDASIL, references for this statement and information about how to report a vaccine reaction to VAERS, go to www.nvic.org.