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.
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"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 dvmMoms.com, "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
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"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
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"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, Injuryboard.com, November 14, 2007
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"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 News.com, December 6, 2007
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"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)


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