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Despite Serious Reactions in Girls, Merck Looking at Gardasil for Boys

Jun 17, 2008 | Parker Waichman LLP

Merck & Co., the maker of the Gardasil cervical cancer vaccine, has boys in its crosshairs.  Merck already heavily promotes - and some say forces - the use of Gardasil for young girls.  Now Merck is conducting research to see if Gardasil could also be administered to boys.  But not everyone is convinced that giving Gardasil to girls or boys is a good idea, because the vaccine has been tied to a number of side effects, and even fatalities.

The American Social Health Association reports that over half of all people will suffer from a sexually transmitted disease or infection at some point in their lives.  The human papillomavirus, or HPV, is one of the least noticeable, but potentially most life-threatening of such infections.  Worse, most HPV carriers are never diagnosed and never realize they carry the virus.  HPV is the leading cause of cervical cancer and has become the second-leading cause of cancer death for women worldwide.

"It's never detected, they are never aware of it, and their immune system suppresses it before they ever know about it in the vast majority of cases," said Fred Wyand, spokesman for the American Social Health Association.

Researchers are now looking at whether Gardasil should be given to boys to prevent HPV transmission in the rarer and deadly cancers that can occur in men.  "There is probably no reason to think it would not be effective in boys and because HPV is passed back and forth, immunizing a large part of the population would limit transmission," said Dr. Jonathan L. Temte, associate professor in the Department of Family Medicine at the University of Wisconsin School of Medicine and Public Health.  Although men don't risk cervical cancer, they are half of the equation when it comes to sexually transmitted diseases and are at increased risks for throat, genital, and anal cancers from HPV infection.  The maker of Gardasil, Merck & Co., is collecting data to “consider whether boys should receive the inoculation as well.”

Gardasil was approved by the FDA two years ago for girls aged 9-26 and protects against sexually transmitted diseases caused by four particularly dangerous strains of HPV in women that are responsible for 70 percent of cervical cancers and 90 percent of genital warts.  Three shots are given over six-months.  Merck said 16 million doses have been administered since its approval.

The U.S. Centers for Disease Control and Prevention recommends 11- and 12-year-old girls receive Gardasil as part of school vaccination efforts.  But there have been serious problems.  A 14-year-old girl named Katherine Kimzey experienced 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.

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.  Last week, European regulators reported two more Gardasil linked deaths.


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