Near Death by HPV GARDASIL

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. http://www.nvic.org/Diseases/HPV/pr022107HP V.htm

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 at http://www.medalerts.org/vaersdb/index.html.

( 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.

Vaccine recall!

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.
http://www.miamiherald.com/852/story/342264.ht ml

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: http://www.fda.gov/cber/recalls/merckhib121107. htm

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 at: http://www.cdc.gov/od/oc/media/transcripts.htm

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.
http://www.gao.gov/new.items/d02987.pdf

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. http://vaccineawakening.blogspot.co m/search?q=At+Risk%3A+Truth+About+Vaccines% 2C+Lawsuits+%26+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) at http://wonder.cdc.gov/wonder/help/vaers /VAERS_brochure.pdf

NVIC has maintained a Vaccine Reaction Registry since 1982. To report a vaccine reaction, injury or death to NVIC, go to
http:/ /www.nvic.org/Report/reaction.htm or to post a vaccine reaction report that will be available to the public on the International Memorial for Vaccine Victims, go to http://www.vaccinememorial.org

Evil Wicked Vaccines

The parents of more than 2,300 students in Prince George's County, Maryland, could face fines of $50 a day and 10 days in jail if their children do not meet the state's immunization requirements.

Prince George's has been struggling to get its 131,000 students immunized for chicken pox and hepatitis B, as is required by the state. More than 2,300 students have not been immunized, and have therefore been barred from attending schools.

School officials have previously made calls, sent letters and conducted home visits in attempts to make arrangements for free appointments for the shots.

The most recent round of letters ordered the parents to show up at Prince George's Circuit Court for a court hearing and free on-the-spot vaccinations of up to 17 required doses.

Any child lacking immunizations can be expelled, and their parents then brought up on truancy charges, which can result in a 10-day jail sentence for the first offence, and 30 days for a second.

Angry and upset parents called county’s action “intimidating,” and “very heavy handed.”

School officials deemed the court action a “success,” as the number of children lacking vaccinations dropped from 2,300 to about 1,100 by Friday November 16. That leaves about 900 children out of compliance with the vaccination requirements, said school system spokesman John White.

The Association of American Physicians and Surgeons (AAPS) issued a press release condemning Maryland’s vaccine roundup, promising to do everything it can to support parents who refuse to immunize their children.

“This power play obliterates informed consent and parental rights,” said Kathryn Serkes, director of policy for the AAPS, one of the few national physician groups that refuse corporate funding from pharmaceutical companies. “This campaign of intimidation to brutally enforce blanket vaccine mandates by government agencies and the school district gives no consideration for the rights of the parents or the individual medical condition of the child.”

The AAPS press release goes on to state, “Children should be carefully screened, medical records taken and decisions made carefully – not in an ad hoc assembly-line clinic in a county courtroom and under the brutal watch of law enforcement. This is a man-made disaster ready and waiting to detonate. Children could receive a dangerous cocktail of several vaccines without proper examinations.”

“The procedure is reckless and subjects children to the risk of severe reactions. Physicians would not be allowed to treat children in this way, without individual histories and physical exams – or informed consent,” said Jane M. Orient, M.D., AAPS Executive Director.

Interestingly, the state's attorney, Mr. Glenn Ivey himself apparently has no problem invoking his own right to informed consent and parental control. In a radio interview on Thursday, November 15, he admitted that he has chosen to refuse the hepatitis B vaccines for his own children. The AAPS stated that Mr. Ivey’s “galling hypocrisy” clearly demonstrates that not every vaccine is right for every child.

Sources:

• Washington Post November 14, 2007

• Association of American Physicians and Surgeons Press Release November 16, 2007