One Less? Evaluating the High Cost of GARDASIL

by Barbara Loe Fisher

To view a TV news story on the HPV Vaccine controversy, click here.

The debate about whether all young girls should routinely be vaccinated with HPV vaccine continues to be a big topic of discussion in homes and doctors' offices around the country. At the same time, reports of serious reactions to Merck's HPV vaccine, GARDASIL, continue to pile up. Last month, a young 15 year old soccer player and star athlete in Kansas almost died within three hours of being injected with GARDASIL. In September, a 12 year old Florida girl who played softball and ran cross country suddenly collapsed shortly after getting a shot of GARDASIL and became paralyzed. Twenty-eight American women, who were pregnant when they were injected with GARDASIL vaccine, have miscarried their babies.

Last year at this time, Merck was giving marching orders to lobbyists and teaming up with politicians to ram school mandates for 11 year old girls to get injected with three doses of its new and very expensive HPV Vaccine, GARDASIL. Never mind that GARDASIL had only been studied in less than 1200 girls under age 16 in pre-licensure clinical trials and was not tested for safety in combination with other vaccines like meningococcal and TdaP vaccines routinely given to pre-adolescents today.

Merck failed to make the case that the only opposition to the proposed mandates was coming from parents who did not want their pre-teen daughters to get a vaccine for a sexually transmitted disease because of religious beliefs and moral convictions. NVIC argued that, beyond the moral and parental rights issues, there was a legitimate case to be made that GARDASIL should not be mandated because of outstanding product safety issues. At the end of the day, parents across the nation made it made it clear that they did not want three doses of a poorly tested vaccine for a sexually transmitted infection that cannot be acquired in the school setting to be added to school mandates that already include dozens of doses of vaccines.

The proposed HPV vaccine mandates failed in all the states in 2007 but that did not prevent GARDASIL from becoming a blockbuster new product for Merck and it does not mean that Merck and pro-forced vaccination proponents will not try again in 2008 to get laws passed requiring its use. One Wall Street guru has predicted the $300 million Merck made this year will grow to more than $4 billion. In fact, brisk GARDASIL sales was one reason why, despite the $4.85 billion the drug maker had to pay for patients injured by painkiller Vioxx, the company turned a profit in 2007.

NVIC issued three reports in 2007 analyzing GARDASIL reaction reports being filed in the federal Vaccine Adverse Events Reporting System (VAERS) by nurses, doctors and patients. To date, the FDA VAERS data reveal that more than 4,000 GARDASIL adverse events have been reported to VAERS through October 2007. Descriptions of these vaccine reaction reports can be viewed and VAERS database searches made on NVIC's website.

(Click here and here to access the GARDASIL reaction reports directly)

On August 15, 2007, NVIC wrote a letter to the Centers for Disease Control accompanied by a detailed NVIC analysis of increased GBS and other serious adverse event reports in VAERS that have occurred when GARDASIL is given at the same time with meningococcal vaccine (Menactra) asking the CDC to issue an advisory to doctors and parents to be cautious when administering GARDASIL with Menactra. The CDC quickly dismissed the significance of the increased risk of injecting GARDASIL simultaneously with Menactra and refused to alert anyone to the potential increased risk.

Now a new study, which was funded by Kaiser (CDC's research partner) and authored by researchers with financial ties to vaccine manufacturers, has been published in a medical journal in a pro-active pre-damage, damage control attempt to dismiss the serious autoimmune and other negative health outcomes following HPV vaccination as "a coincidence." Because teenagers and adult women can talk (while babies cannot), those who are in the business of hyping HPV vaccination for profit and power know they will have a much bigger problem covering up the brain and immune system damage that occurs when healthy girls and women are injected with HPV vaccine. Just like Merck tried to make opposition to HPV vaccine mandates all about sex, so public health officials and doctors promoting HPV vaccination are going to try to sweep HPV vaccine reactions under the carpet using the unscientific but convenient "coincidence" defense.

Lost in all the hype for young girls to be "One Less" is discussion of the basic facts about HPV infection in America :

* The majority of women clear the HPV virus from their bodies naturally but women with risk factors, such as HIV infection, smoking, long-time use of oral contraceptives, and co-infection with herpes simplex virus or chlamydia, are at higher risk for chronic HPV infection.
* Between 1955 and 1992, cervical cancer deaths in American women dropped by 74 percent due to routine pap smears.
* There are about 9,800 new cases of cervical cancer annually diagnosed in the U.S., which represents .007 percent out of the approximately 1,372,000 new cancer cases of all types diagnosed.
* There are about 3,700 deaths in mostly older American women annually attributed to HPV-related cervical cancer, which is about .006 percent of the approximately 570,000 cancer deaths that occur in the U.S.
* Most cervical pre-cancers develop slowly, so nearly all cervical cancers can be prevented with regular pap smear screening and prompt treatment.
"We already are asking our children to get more than 50 doses of vaccines by age twelve!" says the National Vaccine Information Center's Barbara Loe Fisher. If you have a daughter, there maybe one more vaccine on the list. Twenty-six states and the District of Columbia have introduced legislation requiring girls, as young as eleven, to get the vaccine that could prevent the Human Papillomavirus. "As a mother you kind of want to wrap your child in bubble wrap and just protect them from anything you can." Janet Riessman says protecting her daughter, Sage, from the virus which can cause cervical cancer was an easy decision. "For me it was all prevention." But some parents and even healthcare advocates have questions about safety. Barbara Loe Fisher tells, "It was only studied on less than 1,200 girls under the age of 16." This HPV vaccine has been on the market for little over a year. There have already been more than 4,000 reported adverse reactions and at least three people have died. The FDA and the CDC say these numbers may not tell the full story. And they claim most reactions have been minor. "The 4,000 adverse events that have been reported could be just the tip of the iceberg," says Loe Fisher. She says half of those reactions were serious enough to send girls to the emergency room. She's concerned about making the HPV vaccine mandatory." - Lesli Foster, WUSA-TV , November 28, 2007
"A Lawrence couple is furious over a new government-approved vaccine designed to prevent a type of cancer. They say it almost killed their daughter and significantly altered her life. 15-year-old Marissa Omon is an athlete. The daughter of a Nigerian soccer player she played basketball, volleyball and track, until now. Surgeons put a defibrillator inside her chest Monday night fearing her heart could stop at any moment. "HPV [vaccine] cost my daughter. It almost cost her her life," said Edem Omon. Edem Omon is convinced his healthy, athletic teenage daughter Miranda almost died because of a vaccine doctors gave her to prevent cervical cancer....Edem said he reluctantly allowed a doctor to give her the HPV vaccine. "He convinced me the drug was safe," said Edem. Less than three hours later, while practicing basketball at Free State High School, Miranda suddenly collapsed. Her heart stopped. Paramedics needed a defibrillator to revive her. Miranda was rushed to Children's Mercy where she spent several days unable to walk or talk. Doctors ran a battery of tests, CT scans, x-rays and biopsies. They could find no explanation for Miranda's sudden heart problem. They say they do not believe the HPV vaccine has anything to do with it." Larry Seward, KSHB-TV, November 13, 2007
"Christina Bell says she had seen ads for the vaccine so after consulting with her doctor she agreed to have her 12-year-old daughter, Brittany vaccinated. Two months ago the Florida girl suddenly collapsed. Her mother says Brittany used to play softball and run cross country. Now she can't feel her legs. Kelley Dougherty of Merck tells IB News that paralysis is not one of the recognized side effects of Gardasil use and is not even on the warning label." - Jane Akre,, November 14, 2007
"Since June 2006, when the HPV vaccine Gardasil was approved by the Food and Drug Administration, there have been 28 reported cases in which pregnant women miscarried after receiving the vaccine. Nonetheless, based on the clinical trials done prior to approval of the drug - which indicated that miscarriages among pregnant women given Gardasil were statistically consistent with miscarriages among women given placebos and in the general population - the FDA remains convinced the vaccine is safe and is not further investigating its effect on pregnant women. In May, a 24-year-old woman suffered a miscarriage, which an investigator in a report issued to the federal government said, "may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy." In July, a 17-year-old girl from Texas was unaware she was pregnant when she got her second dose of Gardasil. She miscarried, but the cause of the miscarriage hasn't been determined, according to a report. The reasons for two other miscarriages this year in Florida - one by a 16-year-old and another by a 24-year-old both - are undetermined, according to reports. But it is known that both women had Gardasil vaccinations shortly before the miscarriages." - Fred Lukas, CNS, December 6, 2007
"Concerns about supposed adverse effects of vaccines seem to occur regularly. Usually the evidence for the adverse effect leading to the scare derives from some case reports rather than from trials or carefully conducted comparative studies. Spontaneous reports of suspected adverse drug reactions, including those to vaccines, remain an important source of new information for monitoring the safety of medicines. However, suspicion about an event does not demonstrate causality. Many suspected adverse drug reactions are simply coincident in time with administration of the drug or vaccine. During the next few years, there will be vaccines introduced to groups of people who have not traditionally been vaccinated. Pandemic flu vaccine may be given to age groups who have not been, in large scale, recipients of vaccines. The human papilloma virus (HPV) disease burden and the outstanding efficacy profile of the novel HPV vaccines are such that these vaccines are currently being implemented or considered for implementation in many industrialized countries......We are concerned that the large-scale implementation of HPV vaccines in industrialized countries could reactivate the vaccine-safety debates linking vaccination to autoimmune diseases. This could possibly represent a major issue for the sustainability of HPV immunization programs in industrialized countries, and consequently for their implementation in developing countries where they are most needed...." - Claire-Anne Siegrist, MD et al., Pediatr Infect Dis J. 2008;26(11):979-984 (Subscription required)


Merck Recalls HIB Vaccine: Contamination Risk

by Barbara Loe Fisher

In what appears to be a pattern involving vaccine quality control production problems, on Dec. 12, 2007 Merck & Co. announced that it was recalling 13 Lots containing 1.2 million doses of HIB vaccine (PedvaxHIB and the combination COMVAX containing HIB and hepatitis B vaccines) for possible contamination with the common bacterium called Bacillus cereus (B. cereus). The microorganism makes spores that causes diarrhea and vomiting from eating contaminated foods (also known as food poisoning). Reportedly, a piece of equipment in Merck's West Point, PA manufacturing facility failed a sterility test and the bacterium was identified.

The CDC recommends that infants receive HIB vaccine at two, four and 12-15 months. The 13 lots of HIB containing vaccines began to be distributed in April 2007 and had expiration dates of 2009 and 2010. The FDA has released a list of the HIB vaccine Lot numbers.

At a 5 p.m. Dec. 12 press teleconference, CDC officials reportedly said that there is no proof the 13 Lots of HIB vaccine suspected of being contaminated are, in fact, contaminated. However, they added that if some HIB Lots are contaminated with B. cereus bacteria, then healthy children could experience skin irritation around the site of the injection and children with weakened immune systems could suffer more serious health problems within a week of vaccination In a media advisory, the CDC indicated that a transcript of the press teleconference would be made available.

This is not the first time that Merck has had a quality control problem in its vaccine manufacturing plants. In August 2001, Merck temporarily suspended operations in one of its facilities manufacturing MMR and Varicella (chicken pox) vaccines to address issues raised by FDA inspectors during a plant inspection and to make modifications to its facility. According to the 2002 GAO report, the time it took to make plant modifications and difficulties in meeting FDA manufacturing requirements contributed to shortages of MMR and varicella vaccines between the end of 2001 and summer of 2002.

Almost all of the vaccine shortages that the U.S. has experienced in the past two decades have been due to vaccine manufacturer production and government regulation compliance problems, even though vaccine patent-holders and those advocating mandatory use of all vaccines licensed for children have attempted blame vaccine injury lawsuits for vaccine shortages.

Merck, which produces about half of the 14 million doses of HIB vaccine administered to American babies, will be unable to supply HIB vaccine to the U.S. for at least nine months according to Merck officials. French pharmaceutical giant, Sanofi-Aventis, is reported to be considering ramping up production of its HIB vaccine to fill in the U.S. HIB supply gap.

In the meantime, parents who have recently gotten their infants vaccinated with HIB vaccine are left to wonder if their babies will get sick because they got a vaccine contaminated with bacteria. Only time will tell. All suspected HIB vaccine reactions should be immediately reported to the federal Vaccine Adverse Events Reporting System (VAERS).

NVIC has maintained a Vaccine Reaction Registry since 1982. You can report a vaccine reaction, injury or death or to post a vaccine reaction report that will be available to the public on the International Memorial for Vaccine Victims, go to

Sticking It To Children in New Jersey

by Barbara Loe Fisher

It wasn't like any of the parents, who showed up in Trenton on Dec. 10, 2007 to witness members of the New Jersey Public Health Council vote on a new vaccine mandates proposed by state health department officials, were surprised by the thumbs-up 7-2-2 vote by political appointee members of the Council. For the past two decades every time state health department officials have pushed to require children to get another new vaccine to attend school, the new vaccine has been automatically added to state vaccine mandates under rule making authority held by state health officials and without a vote by the people. Hoping to set precedent for other states to follow suit, this time New Jersey officials are ramming through mandates that will ban babies and toddlers from daycare or pre-school without two doses of influenza vaccine and three doses of pneumococcal vaccine while sixth graders will have to show proof by Sept. 1, 2008 that they have gotten a dose of TdaP and meningococcal vaccine.

New Jersey is about to become the first state to make children get flu shots despite a lack of scientific evidence that influenza vaccine is very effective in preventing Type A or Type B influenza in children.
If NJ Health Commissioner Fred Jacobs and NJ Governor Joe Corzine approve the new requirements written by health department officials, then New Jersey will lead the nation in vaccine mandates by forcing children to get 35 doses of 13 vaccines.

Federal and state health officials refuse to publish credible scientific evidence that demonstrates it is necessary or healthy to force children to get so many vaccinations by sixth grade. They also continue to deny that the doubling of the numbers of vaccines mandated for child use over the past quarter century has contributed to the dramatic increase in chronic disease and disability among American children during that same time period. Today, 1 American child in 6 is learning disabled; 1 in 9 has asthma; 1 in 94- 150 develops autism; 1 in 450 is diabetic. New Jersey is reported to have the highest autism rate in the nation: 1 child in 94 living in New Jersey develops autism.

Sue Collins, co-founder of the New Jersey Alliance for Informed Choice in Vaccination (NJAICV at and longtime leader of a grassroots effort to institute conscientious belief exemption to vaccination in New Jersey, said that many parents oppose the new vaccine mandates: "We deserve a choice, not a mandate. It's our right to decide what toxic substances we inject into our children," she said. 1/nyregion/11vaccine.html?_r=1&oref=slogin New Jersey Assemblywoman Charlotte Vandervalk (R- Westwood), who is the sponsor of a bill to insert conscientious belief exemption into New Jersey vaccine laws, told the Council "Children of this state are assaulted with shot after shot before they go to school," she said. "Don't force it on those who have these objections. This is America. What's happened to our freedom?"

The National Vaccine Information Center joins with NJAICV and other organizations representing parents and children opposing the new vaccine mandates and supporting the addition of conscientious belief exemption to vaccine laws in New Jersey, including Advocates for Children's Health Affected by Mercury Poisoning (A-CHAMP), Association of American Physicians and Surgeons (AAPS), Autism One, Autism Research Institute, Children Having Everybody Upset About Shots (C.H.E.R.U.B.S), Generation Rescue, Holistic Moms Network, National Autism Association (NAA), Network Organization for Vaccine Awareness and Choice (NOVAC), Talk About Curing Autism (TACA), Taper Safely, Unlocking Autism (UA), and US Autism and Aspergers Association (USAAA). Coalition for Mercury-free Drugs (CoMeD, Inc.) supports replacing all state vaccine mandates with "opt-in" laws and SafeMinds opposes continued use of mercury in vaccines.

The fate of the new vaccine mandates proposed by the NJ state health department now rests with the retiring Commissioner of Health, Fred Jacobs, appointed by Governor Joe Corzine and the Governor himself. Fred Jacobs is expected to rule on the new mandates by Dec. 18 and can be contacted at Governor Corzine can be contacted at

In addition, New Jersey residents who are interested in contacting their state Assemblyperson or Senator about the need to secure a conscientious belief exemption to vaccination, can find out how to do that at . To help other parents work in New Jersey on this issue, contact NJAICV's Sue Collins at (See copy of NJ Conscientious Belief Exemption bill below). To find out more about how to educate members of your community about vaccination and the right to informed consent to vaccination, go to NVIC's website at or contact NVIC at

NJ Health Council Votes Dec. 10 On New Vaccine Mandates

by Barbara Loe Fisher

The New Jersey Public Health Council is scheduled to meet on Monday, December 10, 2007 at 11 a.m. to vote on whether to approve adoption of rules written by the New Jersey Department of Health that would require children to get three doses of pneumoccocal vaccine and two doses of influenza vaccine to attend daycare or pre-school and one dose each of tetanus, diphtheria, pertussis (TdaP) and meningococcal vaccine to attend sixth grade. If the Council votes to approve the new mandates sought by state public health officials, the mandates will apply to all children entering daycare or school on September 1, 2008.

The NJ Public Health Council meeting will be held on Dec. 10 at 11 a.m in the Auditorium (1st Floor) of the New Jersey Department of Health and Senior Services, Market and Warren Streets, Trenton, New Jersey. New Jersey would become the first state to require influenza vaccine for daycare and pre-school and the first state to require meningococcal vaccine for sixth graders if the new mandates are approved by the Council. The additional nine doses of vaccines would be added to 26 doses of vaccines (diphtheria (4), tetanus (4), pertussis (4), HIB (3), measles (2), mumps (1), rubella (1), polio (3), hepatitis B (3), chicken pox (1)) the State already requires for daycare or school, bringing the total to 35 doses of 13 mandated vaccines.

The NJ Department of Health has the power under rule making authority given to the agency by the NJ state legislature to mandate new vaccines after holding public hearings and taking public comments. A public hearing was held on these proposed new vaccine mandates on Jan. 26, 2007 and the public comment period ended on Feb. 16. 2007. A 125 page summary of the public hearing and public comments received by the health department reveals that the majority of the 103 comments from the public opposed the new vaccine mandates. s/bc/documents/phc_final_adoption_857_4.pdf

Supporters of the mandates included state public health and education officials, the American Academy of Pediatrics and vaccine manufacturer, Sanofi Pasteur, which markets three of the new vaccines that would be required (TdaP, influenza and meningococcal vaccines), among others. In a memo from retiring NJ Commissioner of Health, Fred Jacobs, M.D., J.D. to Herbert Yardley, Chair of the NJ Public Health Council, Jacobs notes that "Some parents rights groups, vaccine critics, autism advocacy organizations and alternative medicine practitioners will likely continue to oppose existing requirements, these recently adopted new vaccine requirements, and future immunization requirements as they have since the mid-1980's....There is increasing resistance from the public on new state vaccine mandates and a demand for more informed parental choice in vaccinations for children...." miss/bc/documents/phc_memo_adoption_857_4.pdf

Exemptions to vaccination in New Jersey include a medical exemption that must be written by a medical doctor or a religious exemption, which requires citizens to write a letter explaining how vaccination "conflicts with the pupil's exercise of bona fide religious tenets or practices." The law makes it clear that a "general philosophical or moral objection" to receiving one or more vaccines "shall not be sufficient for an exemption on religious grounds." The law further states that "religious affiliated schools or child care centers shall have the authority to withhold or grant a religious exemption" for students attending their schools "without challenge by any secular health authority." site/NewJersey.htm

The citizens of New Jersey have not had an opportunity to vote, through their elected representatives, on whether they want their children to be required to be injected with nine more doses of vaccines or be denied an education. The power to add or remove vaccine mandates currently resides entirely in the hands of employees of the NJ Health Department and members of the NJ Public Health Council.

NJ Health Commissioner Fred Jacobs can be contacted at

NJ Public Health Council Chair, Herbert Yardley, who is also the Health Officer for Sussex County, can be contacted at

The Governor of New Jersey, Joe Corzine, can be reached at

If you want to change the way new vaccines are mandated in your state and/or support the addition of conscientious belief exemption to state vaccine laws, you must work with the state legislators you have elected to represent you. If you are a resident of New Jersey and want to let your state legislators know how you feel about nine more doses of vaccines being added to vaccine mandates, go to asp

The National Vaccine Information Center has been working in New Jersey and many states as well as nationally since 1982 to educate citizens and their elected representatives about the need to institute vaccine safety and informed consent protections in the U.S. mass vaccination system. Some states have formed local groups, such as the New Jersey Alliance for Informed Choice in Vaccination ( headed by co-founder Sue Collins.

The National Vaccine Information Center stands with other parent organizations such as ACHAMP, Generation Rescue, TACA, NAA, Holistic Moms Network and others in opposing new vaccine mandates for children in New Jersey and supports the addition of conscientious belief exemption to vaccination in New Jersey and all states. If you are interested in working to educate citizens in your community and state about vaccination and the need for informed consent protections in your state laws, contact NVIC at

To report a vaccine reaction, go to
and to post a vaccine reaction report on NVIC's International Memorial for Vaccine Victims, go

NVIC's Vicky Debold Appointed As Consumer Rep on FDA Vaccine Committee

Vicky Debold, RN, PhD has been appointed to represent consumers on the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the Food and Drug Administration (FDA), which votes on the scientific evidence presented by vaccine manufacturers seeking licenses to market new vaccines in the U.S.. Dr. Debold, who is Director of Patient Safety for the National Vaccine Information Center (NVIC), was appointed by the FDA after she was selected by an independent consumer's representative nominating group. Her two-year term can be extended to four years at the discretion of the FDA.

Dr. Debold has worked as a health policy analyst for the U.S. Congress at the Physician Payment Review Commission; the Michigan Health and Safety Coalition; and the Michigan State Commission on Patient Safety. Additionally she has served as an Assistant Professor at the University of Michigan and an Associate Professor and Director of the Health Systems Management Program at the University of Detroit , Mercy.

Her doctoral degree is from the University of Michigan (1999) - School of Public Health (Health Services Organization and Policy) and the School of Nursing (Health Systems Administration). She was a University of Michigan Regent's Fellow and completed her post-doctoral fellowship in health systems research.

Dr. Debold's son, her only child, experienced serious, long-term health problems following receipt of seven live virus and killed bacterial vaccines at 15 months of age in 1998, including autism spectrum disorder symptoms. She has been involved in research and advocacy for autism-focused non-profit organizations, including SafeMinds, National Autism Association, US Autism and Asperger Association and the Oakland County Chapter, Autism Society of America.

VRBPAC meetings are open to the public and members of the public may speak during public comment times. Dr. Debold's first meeting as consumer representative will be February 20-21, 2008 at the Hilton Gaithersburg Hotel, Gaithersburg, Maryland.

NVIC President and Co-founder Barbara Loe Fisher served as the consumer member of VRBPAC between 1999 and 2003. Online transcripts and background material for VRBPAC meetings held between 1998 and 2008, which contain discussions of the pre-licensure scientific evidence for safety and efficacy presented by vaccine manufacturers for experimental and previously licensed vaccines, can be accessed at