Is Gardasil to Blame in Teen Deaths and Adverse Effects?

Washington, DCThe numbers are staggering. Less than two years after the approval of Gardasil, the much touted vaccine supposed to prevent cervical cancer in young women, several deaths and thousands of cases of adverse effects have been reported.

When Gardasil was approved in June 2006, clinical trials reassured the Federal Drug Administration (FDA) that the drug was 90-100 percent effective in preventing some strains of human papillonmavirus (HPV) that cause cervical cancer. And, just as noteworthy, its manufacturers claimed, the vaccine was all but free of side effects.

Despite assurances, eighteen deaths between June 2006 and April 2008 are under investigation due to their close timing with an injection of Gardasil, and almost 8,000 reports of adverse effects are piling up in the Vaccine Adverse Effects Reporting System, operated jointly by the FDA and the Centers for Disease Control and Preventions (CDC).

CDC's acting director for immunizations safety, Dr. John Iskander, says that none of the ten deaths investigated so far show conclusive evidence that Gardasil created adverse reactions in the young girls, or those suffering from reported side effects of paralysis, seizures and brain damage.

Families of the affected girls are drawing their own conclusions. A 17-year-old from New York collapsed and died two days after the last of three Gardasil injections. The autopsy did not pinpoint a cause and the doctor suspects heart-rhythm disorder. A 12-year-old with no prior health issues died in her sleep three weeks after her Gardasil vaccine. An 11-year-old suffered a heart attack three days after being administered the shot, which the doctor was said to attribute to a severe reaction to the drug.

In a massive print and TV marketing campaign, Merck & Co. originally presented Gardasil as not only safe, but a necessity. In fact, the company had gone as far urging legislatures in all 50 states to make the vaccine mandatory for all school age girls. Texas was the only state that complied before criticism from the media and other organization caused Merck to withdraw its push. But between the ubiquitous but catchy ads, the doctor's recommendations and a natural fear of cancer, an estimated eight million American girls between nine and twenty-six have received Gardasil shots, many in the familiar surrounding of their schools.

A federal law created in 1986 dictates that victims of vaccine side effects can file claims under the Victim Injury Compensation Program and receive financial aid but cannot sue the pharmaceutical company itself. Merck has, nonetheless, has been named in two suits filed on behalf of girls who had been given the shots at middle school and rapidly began suffering side effect.

Jessalee Parsons, 15, of Oklahoma says she started vomiting the day she got her shot and her claim says she subsequently developed pancreatitis. Although healthy all her life, Jessalee has been in and out of hospitals for the past year.

Jessica Vega of Nevada came down with Guillain-Barre Syndrome, an immune system disorder that leads to paralysis, a week after her second Gardasil shot. Rhonda Vega, Jessie's mother, told a New York newspaper that protecting girls from cervical cancer was fabulous, "but if this is what's going to happen, they need to research it more."

Thirty others have since reported suffering from Guillain-Barre syndrome after getting the vaccine, including a 13-year-old who began having headaches and became lethargic immediately after her shots, then developed paralysis in her left leg within days, and still walks with a limp after weeks of using a walker.

Dr. Diane Harper, an expert on HPV who worked as a researcher on the vaccine's study trials at Dartmouth College, questioned the safety of Gardasil in its present state. She told a Florida TV station that not enough post-marketing surveillance has been done to ensure the manufacturer's claim of no side effects that were dangerous to young women.

While the cases continue to mount, Merck is clinging to the notion of coincidence behind the common symptoms suffered by the young girls and the timing of their illness in relation to a Gardasil shot. Company spokesperson, Kelley Dougherty, was reported to have said in a statement that "an event report does not mean that a causal effect between the occurrence and the vaccine has been established--just that event occurred after vaccination".