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Gardasil Is Safe Says CDC, Sets Aside Risks

Posted by Jane Akre
Friday, October 24, 2008 1:15 PM EST
Category: Major Medical, Protecting Your Family
Tags: Merck, Human Papillomavirus, Cervical Cancer, FDA and Prescription Drugs

Gardasil is safe says CDC despite the risks.



IMAGE SOURCE: © ©iStockphoto/ girl being vaccinated/ author: pflorendo


The federal government says Gardasil is safe.

That is just the latest federal proclamation promoting the controversial drug by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).

The promotion has included an unprecedented full page endorsement on the federal agencies web sites which name the drug, Gardasil, and its maker Merck

The CDC and FDA say they’ve looked at the more than 10,000 adverse events and 22 unexplained deaths of young women, and conclude the vaccine’s benefits continue to outweigh its risks.   

Gardasil is currently the only drug approved by the FDA for the prevention of human papillomavirus or HPV. It is given to young girls before they are sexually active, and approved for ages 11 to 26.

Data from a two-year post-approval marketing of the vaccine was presented to a CDC vaccine panel Wednesday, along with the adverse events reports, which are collected by the FDA and CDC.

Marking two years since approval, The CDC reports that a study of 370,000 doses given to young women and girls found no evidence that the vaccine increased the risk of blood clots, Guillain-Barre Syndrome, a neurological disorder, stroke, blood clots, fainting, anaphylaxis reaction, or other serious side effects.

“There were no associations found that suggested an elevated risk,” said John Iskander, acting director for the Immunization Safety Office.

The CDC reports that of the adverse reports- 94 percent are not serious. Of the deaths – the CDC reports that “the cause of death was explained by factors other than the vaccine.”

The CDC is ignoring its own unexplained adverse events data, charges the nonprofit Washington D.C. group, Judicial Watch (JW).  It has requested and been denied adverse health effects reported to the FDA’s own Vaccine Adverse Event Reporting system (VAERS).   

JW then had to file a freedom of information request to obtain the reports from the federal agency.

So far among the 22 deaths of young women, most occurring in healthy young teens with no preexisting conditions and have no explanation, says Tegan Millspaw, research analyst JW. 

She tells IB News, “There have been 11 cases where girls got the vaccine and within the week they died. The autopsy results were negative, but all were similar cases. The FDA didn’t do a thorough job examining them and if they did they didn’t make available to the public.”

The CDC says the deaths are not linked to the vaccine.

“I’ve talked to mothers who say their doctors said the adverse reaction was caused by the vaccine, but the CDC and FDA didn’t do anything about the reports, “says Millspaw.

Millspaw says the federal agencies say the adverse reports are unreliable since anyone can make them, though generally they are made by medical doctors treating patients.

The FDA recently denied drug maker, Merck’s request to approve the drug for adult women, but Millspaw says the agency has refused to disclose the basis for that decision.  “If they have nothing to hide, why are they? I’ve never seen a drug promoted and pushed like this one. “

The CDC estimates that 25 percent of girls ages 11 to 17 have received Gardasil.

Gardasil protects against two types of the virus that cause cervical cancer and two types that cause genital warts. 

Hopes are it will reduce the almost 4,000 cervical cancer deaths each year in the U.S.

Besides the concern about the safety of the vaccine, others feel it may promote promiscuity; may have to be given again as a booster to be effective; at $375 for a three-shot series is too expensive; may give false assurances that it prevents sexually transmitted diseases; and may cut down on the number of PAP smears that women are recommended to receive annually.

Numerous studies find that HPV is transmitted through skin contact, not through bodily fluids. A report in the New England Journal of Medicine finds using condoms is effective in preventing HPV.

An HPV test may be the most accurate screening tool for cervical cancer.  An HPV test looks for changes in the genetic material of the human papillomavirus.   

Pap smears are credited with the 70 to 80 percent decline in the incidents of cervical cancer in the U.S. A Pap smear is the first line of defense which takes a collection of cells from the cervix, looking for changes in those cells.

Eight out of ten women will be exposed to the HPV over their lifetime. A person’s own immune system generally keeps the virus in check. #

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