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As Gardasil Side Effects Climb, Questions Linger About its Effectiveness

Aug 12, 2008 | Parker Waichman LLP Reports of Gardasil side effects - as well as the controversy surrounding the cervical cancer vaccine - continue to grow.  According to an analysis released June 30 by the Washington, D.C.-based public interest group Judicial Watch, there have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006.  What's more, some experts argue that  there is not enough evidence available yet to prove that Gardasil is as effective at preventing cervical cancer as Merck says it is.

According to the Judicial Watch report, Gardasil side effects reported since its approval to the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis.  

VAERS is a voluntary system used by doctors, patients and drug companies to report side effects with vaccines to the Food & Drug Administration (FDA).  However,  a 2004 study published in the New England Journal of Medicine found that only around 10 percent of all side effects are ever reported to VAERS.  So the true number of Gardasil side effects could be significantly higher.

Right now, it has not been proven which side effects were caused by Gardasil.  But the shear number indicates that the issue needs more study - something that neither Merck nor the FDA seem willing to do.

What also needs more study is Merck's claim that Gardasil prevents 70 percent of all cervical cancer.  Gardasil protects against the two strains of Human Papillomavirus (HPV) most likely to cause cervical cancer, but experts say that is not enough to back Merck's assertions.  In an article in the Sun-Sentinal, Dr. Karen Smith-McCune, an obstetrician and gynecologist at the UC San Francisco School of Medicine, said that tests of Gardasil before the FDA approved  it didn't run long enough to prove that conclusively - especially since it can take a decade for someone exposed to HPV to develop the cancer.

"Even though it guards against two HPV strains, the other HPV types need to be taken into account," Smith-McCune says. "It will take a long time before we know the true efficacy of the vaccine."

Another researcher who actually worked on Gardasil clinical trials also disputed Merck's 70 percent claim in the same article.  "If we vaccinate every single 12-year-old, it should reduce by half the number of cervical cancers in the next 35 years," said Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at Dartmouth Medical School. "With Pap screening, we've reduced it by nearly 75%."

In May during an interview with a Florida TV station, Dr. Harper criticized Merck’s efforts to make Gardasil mandatory.  In the interview, Dr. Harper said that there has not been enough post-marketing surveillance of Gardasil to insure that it is free of side effects that could prove particularly dangerous to young girls. “We don’t know yet what’s going to happen when millions of doses of the vaccine have been given and to put in place a process that says you must have this vaccine, it means you must be part of a big public experiment. So we can’t do that until we have more data.” she said.

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