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Merck Drug Company Drops Campaign for Mandatory HPV Vaccine

Alarm raised over incomplete disclosure of serious side effects

By Gudrun Schultz

WHITEHOUSE STATION, New Jersey, February 21, 2007 (LifeSiteNews.com) - The drug company Merck & Co. has canceled nationwide lobbying efforts to make their new vaccine against the sexually transmitted human papilloma virus mandatory for all school girls.

Growing opposition among family and medical organizations, along with allegations that the vaccine was inadequately tested and had produced serious side effects, together convinced the massive drug conglomerate to pull back from campaign efforts promoting the Gardasil vaccine, Bloomberg reported Feb.20.

Among the groups opposed to the campaign was the American Academy of Pediatrics and the U.S. Centers for Disease Control and Prevention in Atlanta.

“Merck’s early push was not the way to go,” said Larry Pickering, executive secretary of the Advisory Committee on Immunization Practices (ACIP) for the CDC. “We want to convince people to use the vaccine because of its benefits.”

The vaccine’s benefits were sharply questioned by the National Vaccine Information Center prior to the CDC’s approval of the Gardasil vaccine for all pre-adolescent girls in June 2006.

In a statement to the press June 27, 2006, the NVIC criticized the Food and Drug Administration for “fast-tracking) the vaccine without adequate tests of its safety for young girls, and accused Merck of obscuring side effects that resulted from clinical trials of the vaccine.

“Merck and the FDA have not been completely honest with the people about the pre-licensure clinical trials," said NVIC president Barbara Loe Fisher. "Merck's pre and post-licensure marketing strategy has positioned mass use of this vaccine by pre-teens as a morality play in order to avoid talking about the flawed science they used to get it licensed. This is not just about teenagers having sex, it is also about whether Gardasil has been proven safe and effective for little girls.”

In particular, the use of aluminum in the vaccine and placebo used in trials raised concern, since studies have linked aluminum to brain cell death and joint inflammation. About 60 percent of those participating in trials experienced headache, fever, nausea, dizziness, vomiting, or diarrhea, the NVIC reported. Among those who received Gardasil, more serious side effects included gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis.

"Merck and the FDA do not reveal in public documents exactly how many 9 to 15 year old girls were in the clinical trials, how many of them received hepatitis B vaccine and Gardasil simultaneously, and how many of them had serious adverse events after being injected with Gardasil or the aluminum placebo,” the statement said.

“Clinical trial investigators dismissed most of the 102 Gardasil and placebo associated serious adverse events, including 17 deaths, that occurred in the clinical trials as unrelated.

"There is too little long term safety and efficacy data, especially in young girls, and too little labeling information on contraindications for the CDC to recommend Gardasil for universal use, which is a signal for states to mandate it," said Fisher. "Nobody at Merck, the CDC or FDA know if the injection of Gardasil into all pre-teen girls -- especially simultaneously with hepatitis B vaccine -- will make some of them more likely to develop arthritis or other inflammatory autoimmune and brain disorders as teenagers and adults.

More than 20 states are considering legislation that would make the vaccine mandatory for all girls entering high school. Texas Gov. Rick Perry earlier this month bypassed the state legislature to push through a requirement that girls aged 11-12 receive the shot, with an opt-out clause included for parents who object.

Apart from the revelation of serious health concerns and inadequate testing of the vaccine, parents and concerned groups have objected to the vaccine’s promotion for girls and young women, since HPV is a sexually transmitted disease linked to promiscuity.

Read NVIC statement on dangers of Gardasil:
http://www.prnewswire.com/news/index_mail.shtml?ACCT=104&...

See previous LifeSiteNews coverage:

Drug Conglomerate funds campaign to impose Mandatory HPV Vaccine on Young Girls
http://www.lifesitenews.com/ldn/2007/feb/07020204.html

Texas Gov. Issues Executive Order Approving Mandatory HPV Vaccines for Girls 9-11
http://www.lifesitenews.com/ldn/2007/feb/07020505.html

HPV Condom Study Shows The Failure of Condom Education
http://www.lifesitenews.com/ldn/2006/jun/06063009.html

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