FDA to Rush Expanded Approval of GardasilMar 20, 2008 | Parker Waichman LLP
Gardasil, Merck's cervical cancer vaccine, could soon be approved for use in women ages 27 through 45. The Food and Drug Administration (FDA) has agreed to put Merck's application for expanded approval of Gardasil - already approved for women and girls ages 9 through 26 - on the fast track. The FDA decision to grant Merck's Gardasil application priority review will surely disturb many who are concerned over the high number of side effects reported in relationship to Gardasil, and who object to Merck's heavy handed attempts to convince state legislatures to make Gardasil mandatory for young girls.
At the time of its approval, Merck said that clinical trials had proven Gardasil to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. But Gardasil is not without risks that, some say those risks have been downplayed by Merck and the FDA. 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. Oddly, Judicial Watch was only able to obtain the FDA’s reports on Gardasil after it filed a Freedom of Information Act request with the agency.
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. There have also been a handful of deaths that occurred following the administration of Gardasil. Three young women in the US died shortly after receiving Gardasil, while two other women in Europe also died after the vaccine was administered. Despite all of these reports, Merck continues to market Gardasil as virtually side-effect free. Thus far, the FDA has refused to conduct a formal safety review of Gardasil.
Now, the FDA has agreed to speed up its review of Merck's application to expand marketing of its Gardasil cervical cancer vaccine to women aged 27 through 45. The designation means that the FDA is expected to make its decision on the marketing application within 6 months, rather than within the agency's typical 10-month review period.
Gardasil has been the subject of controversy, not just because of possible side effects associated with it, but also because of Merck's extremely aggressive campaign to make Gardasil mandatory for young girls. Following its approval, the Centers for Disease Control recommended that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Merck was more than happy to echo these recommendations, and actually began an intensive lobbying effort to convince state health authorities to make Gardasil vaccinations mandatory for young girls. Recently, 20 states pushed for federal mandates to make Gardasil mandatory for sixth grade girls.
This strategy has worked well for Merck. Gardasil had fourth-quarter global sales of $339 million, helping to drive Merck's total global revenue from vaccines to $1.1 billion.