Sunday, July 27, 2008

Doctors come out in support of cervical cancer vaccine


New York, NY


While Not Risk-Free, Benefits of Gardasil Most Likely Outweigh Risks
It's a rite of passage, the stuff of Norman Rockwell paintings. From birth through old age, we stoically endure the jabs of needles meant to ward off disease of one kind or another. Yet vaccines occupy a tenuous position in many Americans' psyches.
Gardasil
One dose of Gardasil is seen in this file photo. Merck & Co., which developed the vaccine, reported... Expand
One dose of Gardasil is seen in this file photo. Merck & Co., which developed the vaccine, reported in April 2008 that it nearly doubled its first-quarter profit. The drugmaker cited a $1.4 billion payment from a partner drug company and sales up slightly from last year. Collapse
(AP Photo/Harry Cabluck)

Two years after its introduction, the so-called "cervical cancer" vaccine, Gardasil, has found itself squarely in the crosshairs. Previously healthy girls, playing soccer and going to prom, are suddenly falling ill, struck by incomprehensibly tragic diseases. Many are paralyzed, a number of them have died.

What is happening to these girls? And, people want to know, what is to blame?

Many of them had recently received Gardasil, a vaccine against HPV (human papilloma virus), a sexually transmitted virus that is largely responsible for 11,000 cases of cervical cancer resulting in 3,600 deaths a year.

Still, leading pediatricians and vaccine safety experts overwhelmingly say they will continue to recommend the vaccination to patients — even to their own daughters.

Dr. Kevin Ault, who has been involved in HPV vaccine research for more than a decade and has authored several articles about the topic, is arranging for his daughter to get the vaccine in a few weeks. He says he is reassured by what he knows from the first 13 million doses, stating "the vaccine is safe."

Dr. Andrew Racine oversees two large academic practices with more than 50,000 visits per year and says he routinely offers Gardasil to all his adolescent female patients; he has not seen any adverse events, apart from pain at the injection site. He also has made sure that both of his teenage daughters have been immunized.

And Dr. Charles Shubin, a practicing pediatrician for almost 40 years, has given Gardasil to more than 1,000 of his patients,and has experienced no negative reactions from patients at all, "not even minor complaints."

Though the practitioners and researchers we interviewed aren't currently expressing concerns about the safety profile of Gardasil, they did stress the importance of continuing to closely monitor the vaccine's safety.

Following FDA approval, vaccines are subject to an ongoing adverse event monitoring system. Dr. Leo Twiggs, Chair of Obstetrics and Gynecology at the University of Miami, notes, "The system which evaluates vaccine safety is well constructed to look out for public safety."

Doctors state they will be looking to recommendations coming from the FDA and CDC, in addition to peer reviewed journals for guidance. Dr. Donna Shoupe a professor of Obstetrics and Gynecology at the University of Southern California, says, "What they say will have tremendous influence and they need to get this one right."

Vaccine-Related Events: As Bad as They Seem?

Since the U.S. Food and Drug Administration approved the HPV vaccine two years ago, doctors have given more than 16 million doses of the vaccine to approximately eight million girls.

In that same time period, more than 8,000 vaccine-related events have been reported via the Vaccine Adverse Events Reporting System, a safety surveillance program that is coordinated by the FDA and U.S. Centers for Disease Control and Prevention. The system was designed to collect information about possible side effects (also called "adverse events") that occur following immunization with licensed vaccines. Read more, "Doctors come out in support of cervical cancer vaccine."

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