Merck & Co. has failed in its quest to convince federal regulators to expand approval of Gardasil for older women. Yesterday, the Food & Drug Administration (FDA) said it was delaying its approval of Merck’s application at this time because it had questions regarding Gardasil’s effectiveness in women ages 27 – 45. Gardasil is already approved for use in girls and women ages 9 – 26.

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 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.

Merck has been working on expanding the approved uses of Gardasil in an effort to spur sales growth. But in a letter to the company, the FDA said there were questions that Merck will need to answer before the agency can complete its review. Merck would not specify what those questions were, but said it would reply to the FDA’s letter next month.

Some experts have questioned the wisdom of approving Gardasil for the older group, because most women in that age group who are sexually active have already been exposed to the strains of HPV Gardasil is supposed to prevent.

Merck said it also failed to win FDA approval to expand Gardasil to protect against more strains of HPV, and is dropping those efforts. However, the company still plans to work to gain approval for Gardasil to be administered to boys.

Gardasil has been the subject of controversy ever since Merck introduced it. 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 has made similar efforts in Europe. 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.

But many have questioned Merck’s heavy-handed attempts to make Gardasil mandatory, as well as the company’s claims that it is virtually side effect free. Earlier this month, the European Medicines Agency reported that two young women died shortly after being administered Gardasil, and three such deaths have been reported in the US.

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. 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.

As some have pointed out, Judicial Watch is a conservative organization with an agenda. But Judicial Watch is not along in voicing concerns about the safety of Gardasil. In May, Dr. Diane Harper, a top expert on the HPV who, while working as a professor at Dartmouth College, served as a researcher on study trials for Gardasil, questioned efforts to make the vaccine mandatory. In an interview with a Florida TV station, Dr. Harper said 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.” she said.