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Gardasil Side Effects Still Being Reported

Jun 6, 2008 | Parker Waichman LLP Garadsil, Merck's controversial cervical cancer vaccine, has been the subject of numerous side effects.   In one case, a 14-year-old woman named Katherine Kimzey, began experiencing debilitating headaches, fainting spells, and arthritis-like stiffness.  She became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure.  Because Katherine’s symptoms began soon after she received her second shot and symptoms seemed to match many of the 5,000 reports filed through a national database that monitors vaccine safety, Katherine’s mother, Michelle, believes the problems stem from Gardasil.  "When you read everybody's stories, they're too similar not to be related," Kimzey said.

Despite such anecdotes, officials with the Centers for Disease Control and Prevention (CDC) and doctors nationwide argue that concerns over the vaccine to prevent against cervical cancer—Gardasil—are unfounded and the significant side effects being reported are not related to Gardasil.  "The safety of the vaccine is being very closely monitored," said John Iskander, acting director for immunization safety at the CDC, which runs the database along with the Food and Drug Administration (FDA).

“There certainly have been high-profile suspected side effects, some reports of deaths," Iskander said, "but those have been investigated and they don't appear to have been causally related."

In January, we reported on the deaths of two young women oversees that were apparently linked to Gardasil.  Those deaths followed the deaths of three other young women—ages 12, 19, and 22—who died in the U.S. days after Gardasil was administered, with 1,700 other patients suffering adverse reactions.

But, Iskander maintains the recommendations have not changed and the vaccine will remain available.  Jennifer Allen, a spokeswoman for New Jersey-based Merck & Co.'s vaccine division, which makes Gardasil, said the company conducted clinical trials for 10 years and it remains confident in its product.

Gardasil was approved by the FDA two years ago for girls aged 9-26 and protects against sexually transmitted diseases caused by the human papillomavirus, or HPV, responsible for 70 percent of cervical cancers and 90 percent of genital warts.  Three shots are given over a six-month period.  Merck said 16 million doses have been administered since its approval.

Texas Governor Rick Perry issued an executive order last year requiring all sixth-grade girls get the shot; however, parents and conservative groups fought the mandate and the Legislature defeated the order.  The National Vaccine Information Center agreed, saying vaccine testing was not sufficient in girls under 12 and warned of adverse reactions such as extreme fatigue, arthritis, and loss of consciousness.  Co-founder and president, Barbara Loe Fisher, said she's frustrated the CDC "assumed safety" for Gardasil, which has been tested only with the Hepatitis B vaccine.  Girls often receive Gardasil with a meningitis vaccine and a tetanus, diphtheria, and pertussis booster.  

The FDA approved the vaccines separately, but studies on administering them together continue.  "Not only was Gardasil put on the fast track and licensed quickly," said Fisher, "but to say safety is assumed and you can give any vaccine with it is even more shocking."  The Texas Department of Health and Human Services said it had 210 reports of Gardasil reactions last year, eight required hospitalization.

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