Gardasil in clinical trials has been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases, and about 99% effective in preventing HPV strains 6 and 11, which together with HPV strains 16 and 18 cause about 90% of genital wart cases among women not already infected with these strains. FDA in June 2006 approved Gardasil for sale and marketing to girls and women ages nine to 26, and CDC's Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine, which is given in a three-shot series (Kaiser Daily Women's Health Policy Report, 7/10).
Analysis, CDC Data
According to Judicial Watch, 3,461 complaints about Gardasil have been filed with FDA's Vaccine Adverse Event Report System since its approval last year, and 11 women died after exposure to the vaccine. In addition, some women developed severe health problems after receiving Gardasil, the analysis said. Curtis Allen, a CDC spokesperson, said the agency has confirmed four deaths that occurred after the patients received Gardasil, but none of the deaths was linked directly to the vaccine. Allen said that there have been fewer complaints about adverse effects associated with Gardasil than there have been for other drugs.
Several of the reports to FDA of deaths of girls and women who received Gardasil note that the patient had developed a blood clot. Allen said that Gardasil is not known to increase risk of blood clots. He added that Judicial Watch's analysis does not prove that Gardasil causes death and that the reports of women who died after receiving the vaccine statistically are normal within the population.
According to CQ HealthBeat, there is disagreement over the data in part because the reports of adverse events come from several sources, including health professionals and pharmaceutical companies, which are required to disclose potential problems with vaccines, including rumors and third-party information. The Judicial Watch analysis includes a report about a doctor who at a conference heard about two patients dying after receiving Gardasil. Another incident involved the death of a 17-year-old girl immediately after receiving the vaccine, which was reported to FDA by "a gynecologist who was informed of the case from another gynecologist."
Reaction
Tom Fitton, president of Judicial Watch, said that if Gardasil is "as dangerous as it seems to be, it does not seem to be good public health policy." Kelley Dougherty, a spokesperson for Merck, said that it is impossible to determine whether the reports are actual fatalities related to the vaccine or rumors. The FDA only documents deaths that are reported but the agency does not show cause and effect, according to CQ HealthBeat. "There are no reporters that have a correlative effect," Dougherty said.
Allen said that Judicial Watch "is playing loose" with data on the vaccine. Fitton defended the group's analysis and added that it has filed a lawsuit against FDA to require the agency to provide more information about the vaccine. "The reports are what they are," Fitton said, adding, "The CDC can explain them away, and Merck can explain them away. I don't think it's just randomness" (CQ HealthBeat, 10/4).
The analysis is available online.
Bloomberg/Austin American-Statesman Examines Sales of Gardasil
In related news, Bloomberg/Austin American-Statesman on Friday examined how Gardasil "could become the best-selling vaccine in history" as Merck "prepares to expand its use to men." According to Bloomberg/American-Statesman, Merck has made $1.4 billion in Gardasil sales in the drug's first year on the market. Merck is conducting studies to prove that Gardasil can prevent HPV infection in men. If the vaccine were approved for use in boys and men, annual sales of the vaccine could be as high as $10 billion, according to Lisa Kelly, an analyst at Wood Mackenzie Consultants (Cullen, Bloomberg/Austin American-Statesman, 10/5).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
View drug information on Gardasil.
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