Gardasil Adverse Event Reports Include 28 Miscarriages, yet FDA Nixes Further Safety ReviewsDec 7, 2007 | Parker Waichman LLP
The Gardasil cervical cancer vaccine has been linked to miscarriages in 28 women in the US, yet Merck, the vaccine's manufacturer and the Food & Drug Administration (FDA) insist Gardasil is safe. Despite the miscarriage reports, the FDA says it has no intention of subjecting Gardasil to further safety reviews.
Gardasil was approved by the FDA in June 2006. At the time of its approval, Merck & Co., the maker of Gardasil, said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (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.
Since its approval, Merck has claimed that Gardasil is practically side effect free, with pain at the injection site being the most common complaint about the vaccine. Yet since its approval, the FDA Vaccine Adverse Event Reporting System has received 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil. In several instances, blood clots were reported to have occurred after the administration of Gardasil. Other side effects including paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures were also reported. Of the 77 women who received the Gardasil vaccine while pregnant, 33 experienced side effects ranging from spontaneous abortion to fetal abnormities.
Those reports included 28 women who miscarried after receiving Gardasil. In May, a 24-year-old woman suffered a miscarriage, which an investigator in a report issued to the federal government said, "may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy." In July, a 17-year-old girl from Texas was unaware she was pregnant when she got her second dose of Gardasil. She miscarried, but the cause of the miscarriage hasn't been determined, according to a report. The reasons for two other miscarriages this year in Florida - one by a 16-year-old and another by a 24-year-old both - are undetermined, according to reports. But it is known that both women had Gardasil vaccinations shortly before the miscarriages.
As of now, there is no way to know exactly how - or if - Gardasil played a role in these miscarriage, or in any of the other adverse events that have been reported to the FDA. A thorough safety review is the only way to determine if Gardasil is truly safe. But so far, the FDA is refusing to revisit the vaccine.
Following 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.
Both Merck and the FDA insist that the side effects reports on Gardasil are no different than other drugs, and that none of the adverse reactions have yet to be directly connected to the vaccine. Yet it seems hard to believe that all of the adverse reports linked to Gardasil could be coincidence. And taken in this light, it would seem that efforts to make the Gardasil vaccine mandatory are ill advised until more research can be done on Gardasil's potential side effects