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Expanded Use of Gardasil Approved by the FDA

Posted by Chrissie Cole
Monday, September 15, 2008 12:15 PM EST
Category: Major Medical
Tags: FDA & Prescription Drugs, Defective and Dangerous Drugs, Gardasil Cervical Cancer Vaccine, Cervical Cancer, Vaginal Cancer, Vulva Cancer, HPV, Merck Pharmaceuticals

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


The U.S. Food and Drug Administration (FDA) on Friday announced the approval of the vaccine Gardasil, manufactured by Merck Pharmaceuticals, for prevention of vaginal and vulva cancer caused by types 16 and 18 of the Human Papillomavirus (HPV).

These two types of HPV cause 70 percent of cervical cancers and are known to also cause some vaginal and vulvar cancers, although, the percentages are not defined, according to the FDA.

An estimated 20 million Americans carry HPV, not all of them develop into cancer. And about 5,000 women develop vaginal and vulva cancer each year.

An estimated 11,070 cases of cervical cancer will be diagnosed and 3,870 women will die this year in the United States, according to The American Cancer Society.

“There is strong evidence showing Gardasil can help prevent vaginal and vulvar cancers due to the same viruses it also helps protect against in cervical cancer,” said Jesse L. Goodman, MD., M.P.H., director of the FDA’s Center for Biologics Evaluation and research.

Gardasil Hype

The Gardasil vaccine has been the center of much debate and controversy. The New England Journal of Medicine and New York Times both recently called into question “if there is adequate evidence to support the routine use of the vaccine to protect against cervical cancer.”

The hype surrounding Gardasil, isn’t the sole result of extreme marketing measures by Merck, but rather the result of over-the-top promotional efforts by the American news media, according to a new report by a pro-business media watchdog group.

The report was collected by the Business Media Institute, a branch of the conservative watchdog group Media Research Center. At the very least, the report offers a thought provoking view on the media’s role in railing the profile of the vaccine.

The report cites many examples, including:

For “The Early Show” on CBS, on January 1, 2007, Dr. Emily Senay said that the “top medical breakthrough [of 2006] has to be the Gardasil cancer vaccine for cervical cancer.

On June 8, 2006 Brian Williams of NBC, called Gardasil a “triumph in medicine and science.” He referred to Gardasil as the “first cancer prevention vaccine” on December 28, 2006 urging parents to vaccinate their children.

Read the full report called “About-Face: Media Outlets Turn on ‘Cancer Vaccine’ Maker.”

The media flux has since turned against Gardasil, largely, because more information is now available regarding its use.

Gardasil Debate

A Flint teen has become part of the growing debate over the alleged effects from Gardasil.

TaQuaria Williams, 17, was featured in a CNN report last month sharing details of the illnesses she has been suffering after receiving just one dose of Gardasil in December.

According to TaQuaria’s father, Sammie White, she began having headaches and became irritable after getting the vaccine at a doctor’s urging.

By February, she had broken out with a rash over her body and her feet and hands were swollen due to poor circulation, her father said. She has also been diagnosed with a connective tissue disorder, which is a form of lupus.

According to her father, she has never been sick until now and she currently takes six to seven pills every day.

This isn’t an isolated case - the Gardasil debate is complicated and ongoing.

In another case, 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.

The FDA approved Gardasil in June 2006, hailed as an important breakthrough in the fight against cancer for women.

Since its approval, however, the U.S. Centers for Disease Control and Prevention (CDC) has reported 6,667 incidents of adverse events occurring after vaccinations.

About 9 percent of reported cases were minor and included headaches and soreness. The remaining 6 percent were more serious and included hospitalization, a life-threatening illness, permanent disability and death.

Seventeen women have died after getting the shot, but no connection between the deaths and Gardasil could be formally established, according to the CDC.

More research needs to be done on the vaccine, says Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, a nonprofit educational organization that focuses on preventing vaccine related deaths and injuries.

The teen - who once excelled at academics - will not be starting her senior year of high school with the rest of her classmates.

“She’s too weak. She can barely walk because her legs and feet are swollen and achy,” Sammie White said. “But her hopes remain high. She is looking for a miracle.” #


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