HPV Vaccine Gardasil Under Investigation For Adverse Events, New York Post Reports

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Litigation / Medical Malpractice
Article Date: 09 Jul 2008 - 6:00 PDT

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Lawyers for two girls who received Merck's human papillomavirus vaccine Gardasil last month filed the first two claims under the federal Vaccine Injury Compensation Program, the New York Post reports.

One of the girls, Jesalee Parsons of Oklahoma, developed pancreatitis shortly after receiving the vaccine, according to her claim. The other girl, Jessica Vega of Nevada, claims that she developed the immune condition Guillain-Barre Syndrome one week after receiving the second of Gardasil's three doses. According to the Post, Gardasil was added to the list of vaccines that are protected from lawsuits under a 1980s law. However, people can receive compensation under the Vaccine Injury Compensation Program if they can prove a vaccine likely caused a condition.

According to the Post, federal health officials have reported nearly 8,000 "adverse events" in girls and women who have received the vaccination, and officials are investigating claims that the vaccine caused serious health problems and 18 deaths in the U.S. John Iskander, CDC's acting director for immunization safety, said a review of 10 confirmed deaths allegedly linked to Gardasil found no common thread. He said that officials "concluded to the degree of certainty possible" that Gardasil was not the cause of the deaths. Iskander said physicians hold special meetings weekly to review new cases and compare them with prior cases.

According to Merck, the vaccine has been given to more than eight million girls and women in the U.S. since FDA approved it two years ago (Edelman/Golding, New York Post, 7/6). The vaccine in clinical trials has been shown to prevent infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases, and to prevent infection with HPV strains 6 and 11, which cause about 90% of genital warts cases (Daily Women's Health Policy Report, 3/21).

Kelley Dougherty, a Merck spokesperson, said the company "actively monitors" reports of Gardasil's side effects. Dougherty added, "An event report does not mean that a causal relationship between an event and vaccination has been established -- just that the event occurred after vaccination" (New York Post, 7/6).

CBS' "Evening News" on Monday reported on adverse event reports related to Gardasil (Attkisson, "Evening News," CBS, 7/7).

CNN's "Newsroom" on Monday also reported on the adverse event reports. The segment includes comments from CNN medical correspondent Elizabeth Cohen (Phillips, "Newsroom," CNN, 7/7).

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