Judicial Watch Publishes FDA Data On Adverse Events Associated With Gardasil

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Women's Health / Gynecology
Article Date: 28 May 2007 - 3:00 PST

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The Washington, D.C.-based group Judicial Watch recently published FDA data on adverse events associated with Merck's human papillomavirus vaccine Gardasil, the Wall Street Journal reports. According to the Journal, Judicial Watch obtained the data through a Freedom of Information Act request.

There have been 1,637 reports of adverse events associated with Gardasil, and FDA considers 136 of them serious, the Journal reports. According to the Journal, the number of adverse reactions is not unusually high because two million to three million women have received the vaccine. Most adverse reactions were minor, such as pain or itching at the injection site and dizziness. The serious reactions included seizures and Guillain-Barre Syndrome, a life-threatening disorder in which the immune system attacks nerves and induces paralysis. According to the data, 18 pregnant women who received Gardasil experienced complications, such as miscarriages or fetal abnormalities. In addition, three people who received the vaccine died.

CDC, FDA and Merck have said that the adverse events likely were unrelated to the vaccine and were caused by underlying health problems or other factors, the Journal reports. According to CDC, two of the three women who died were taking oral contraceptives and died of blood clots, which are associated with oral contraceptives. The third, a 12-year-old girl, had heart disease and died of a heart inflammation triggered by the flu.

Of the 18 adverse events experienced by pregnant women, 16 involved miscarriages. Richard Haupt, executive director of medical affairs for Merck, said that Gardasil likely did not cause the miscarriages, adding that miscarriages are common during the first three months of pregnancy. According to the Journal, one pregnant woman was found to have an abnormal fetus and another woman's fetus was found to have an increased risk of fetal defects; however, outcomes have not been reported in the two cases. According to Haupt, the vaccine is not recommended for pregnant women because it has not been "systematically studied" in a large population of pregnant women, not because of an increased risk of birth defects.

FDA last year during its review of Gardasil noted the possibility of congenital abnormalities associated with the vaccine. Merck has compiled a registry of pregnant women who have received the vaccine to monitor its effect on the population. According to Merck, the registry, which lists 300 pregnant women, includes no reports of congenital abnormalities.

Reaction
FDA spokesperson Karen Riley said the agency has been monitoring adverse events associated with Gardasil but has not "seen anything at this point that would suggest we'd make any changes in the product." John Iskander, acting director of the Immunization Safety Office at CDC, said, "None of the information I'm aware of or have seen suggests that there's any pattern here linking birth outcomes to the vaccine." Iskander added that pregnant women who have received the vaccine should "make sure they're enrolled in the registry and make sure they keep up with their routine prenatal care" (Carreyrou, Wall Street Journal, 5/24). Tom Fitton, president of Judicial Watch, said the reports "read like a catalog of horrors," adding, "Any state or local government now beset by Merck's lobbying campaigns to mandate [Gardasil] for young girls ought to take a look at these adverse health reports."

44% of Parents Support Mandatory HPV Vaccination, Poll Finds
A University of Michigan Health System poll conducted online among 1,342 parents found that 44% support mandatory HPV vaccination for girls, 30% are neutral on the issue and 26% oppose mandatory vaccination, the Washington Times reports (Harper, Washington Times, 5/24).

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