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Gardasil: More Adverse Reactions and Scandals

Feb 4, 2009 | Parker Waichman LLP

Despite Merck & Co.'s claims that  Gardasil is safe, stories abound over devastating reactions to the three-shot inoculations that claim to prevent some—not all—types of the human Papillomavirus (HPV).

For instance, after just one injection a 13-year-old girl was diagnosed with Acute Pancreatitis, spent nearly 100 days in the hospital, and underwent two surgeries to remove Pseudocysts.  Her family filed a petition for vaccine compensation seeking damages from the government.  

A group of Australian researchers found young women there who received the drug t were five to 20 times likelier to suffer rare and severe allergic reactions.  In the U.S., a 20-year-old woman suffered a stroke after receiving a second Gardasil injection.  Two women overseas died after receiving their Gardasil injections and those deaths followed the deaths of three other young women who died in the U.S. days after Gardasil was administered.  

A 14-year-old girl experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure.  Another 13-year-old began showing signs of a degenerative muscle disease after her third Gardasil injection; she is almost completely paralyzed.

Now, the Rocky Mountain News is reporting about a 16-year-old girl who is sick all the time with constant exhaustion and nausea; hair falling out in clumps, ongoing episodes of passing out, numbness, and paralysis; dangerously low blood pressure; and severe back spasms that cause her to stop breathing.  The family is convinced the reactions are a result of Gardasil vaccinations, which in her case, were given with a meningitis vaccine.

Although industry claims the Gardasil-meningitis combination is safe, and although the combination is routinely administered, Rocky Mountain News points out that Gardasil has never been clinically tested in this combination.  As a matter-of-fact, the meningitis vaccine was not available when clinical testing for Gardasil was first being conducted, so the U.S. Food and Drug Administration (FDA) agreed to test it after licensure was granted said Neal Halsey, director of the Institute for Vaccine Safety at Johns Hopkins Bloomberg School of Public Health.  Those clinical results remain pending.

Worse, says Rocky Mountain News, according to the National Vaccine Information Center, Gardasil reactions increase when given with the meningitis vaccine.  Also, Halsey reported that general guidelines allow for two or three inactivated vaccines—and Gardasil and the meningitis vaccinations fall into this category—to be administered conjunctively without an expectation of increased adverse events.

Merck and Co.'s Gardasil was licensed in 2006 by the FDA and both the Centers for Disease Control and Prevention (CDC) and Merck say it is safe; however, as of late summer, the federal Vaccine Adverse Event Reporting System (VAERS) logged 10,326 reports of reactions to Gardasil, according to the CDC, including reports of Guillain-Barre syndrome, a rare disorder that causes muscle weakness, blood clots, and death.  

Gardasil accounted for about 20 percent of reactions reported to VAERS in 2007-2008 according to Barbara Loe Fisher, co- founder and president of the National Vaccine Information Center.  “To say that … 10,000 reports of reactions, injuries, 30 deaths is all a coincidence is simply not scientifically responsible," Fisher told the Rocky Mountain News. "You have perfectly healthy girls go in and get this shot and then suffer a pattern, a very clear pattern of injury, and some of them are dying. This is not acceptable."  Side effects reported  involve brain inflammation; immune system dysfunction; tingling and numbness in the hands, feet and legs; severe headaches; strokes; joint pain; muscle weakness; seizures; and memory loss Fisher said.

The Vue Weekly points out that many believe over-immunization is a major contributor to the rise in autoimmune disease and parents are often pressured to immunize.  But, in the case of Gardasil, perhaps avoiding the vaccine might not be so irresponsible given that, as The Vue pointed out, “the research was done by those who stand to gain magnificently” and the drug has been the focus of “an extensive public relations campaign” but “has been subjected to little independent scientific review.”

Of note, the Vue points out that the Nobel Prize Committee—which awarded the 2008 Nobel Prize in Medicine to German scientist Harald zur Hauser for his work linking HPV to cervical cancer—is facing investigation over bribery allegations for taking payments from the drug company that own the patents and collects royalties on both—U.S. and overseas—HPV vaccines.  Also, said the Vue, an FDA document stated that, “identifying and typing HPV infection does not bear a direct relationship to stratification of the risk for cervical cancer.  Most acute infections caused by HPV are self-limiting. It is the persistent HPV infection that may act as a tumor promoter in cancer induction ... most infections are short-lived and not associated with cervical cancer.”  Perhaps the vaccine is not so critical after-all.


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