Gardasil Researcher Criticizes Moves to Make HPV Vaccine MandatoryMay 8, 2008 | Parker Waichman LLP
A scientist who helped Merck & Co. conduct clinical trials for the cervical cancer vaccine Gardasil is questioning efforts to mandate the controversial vaccine for young girls, whether their parents want them to have it or not. Dr. Diane Harper, a top expert on the Human Papillomavirus (HPV), says Merck's aggressive campaign to convince states to adopt mandatory Gardasil vaccine guidelines enters into a "real danger zone."
Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of HPV that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers.
Just weeks after its approval, the Centers for Disease Control (CDC) recommended that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Merck was more than happy to echo the CDC recommendations, and actually began an intensive lobbying effort to convince state health authorities to make Gardasil vaccinations mandatory for young girls. Merck’s heavy promotion of Gardasil has been effective, as some analysts estimate that Gardasil could net the company as much as $1.4 billion in its first full year on the market.
Dr. Harper, who has dedicated two decades of her career to research on HPV, told Florida TV station WFOR-TV that the rush to recommend and mandate the vaccination of very young girls "went too fast without any breaks." Dr. Harper says that there has not been enough post-marketing surveillance of Gardasil to insure that it is free of side effects that could prove particularly dangerous to young girls. "We don't know yet what's going to happen when millions of doses of the vaccine have been given and to put in place a process that says you must have this vaccine, it means you must be part of a big public experiment. So we can't do that until we have more data." Dr. Harper said.
Dr. Harper's concerns are well-founded as the FDA has received reports of possible reactions to Gardasil. A 2007 analysis by Judicial Watch of Gardasil adverse event reports revealed that there had been at least 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil. According to Judicial Watch, in several instances, blood clots were reported to have occurred after the administration of Gardasil. The Gardasil side effect reports also included 28 women who miscarried after receiving Gardasil. Other side effects reported to the FDA included paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures were also reported. As some have pointed out, Judicial Watch is a conservative organization with an agenda. But Judicial Watch did not fabricate these adverse event reports, and the seriousness of some of them indicate a need for further investigation.
While working as a professor at Dartmouth College Dr. Harper served as a researcher on study trials for Gardasil and another HPV vaccine, Cervarix, which is being developed by GlaxoSmithKline. In fact, she is the lead author on two Cervarix papers. While Dr. Harper said says she is convinced HPV vaccines can help prevent cancers in the long run, she believes that parents and women should have a choice. Dr. Harper said she would also be opposed to any measure to make Cervarix mandatory if it receives FDA approval.