By John Connolly

ROCKVILLE, Maryland, December 10, 2007 ( – Rather than investigate thousands of complaints of adverse effects including reports of miscarriage in a Human Papillomavirus (HPV) vaccine, the FDA has chosen to ignore the complaints and continue paving the way to make the drug mandatory in schools throughout the U.S.

Gardasil, a vaccine designed to prevent HPV, was approved by the FDA in June 2006 for girls as young as nine years old. Since that time, more than 3,000 adverse reactions were reported to the FDA, including eleven deaths and twenty-eight miscarriages. The deaths were caused by blood clotting, one case in a girl who was only twelve years old.

Gardasil co-creator Ian Frazer and manufacturer CSL dismissed allegations of the deaths being associated with the drug, claiming the women died of unrelated causes.

The miscarriages were all caused soon after the administration of Gardasil, in girls and women who were not aware they were pregnant. Although the drug’s packaging states there is no evidence it will cause impaired female fertility or harm the fetus.

Despite the complaints, the FDA said it is only concerned about dizziness as a side effect immediately after the administration of the drug. FDA spokeswoman Karen Riley downplayed the miscarriages, saying that girls should have taken the drug before becoming sexually active, not after.

“If you’re pregnant, then it means you’ve been sexually active,” she said. “So it would be somewhat dubious to get a vaccine you’re supposed to have before you’re sexually active.”

Massachusetts, New Jersey, and Virginia have already made the drug mandatory in their schools in an effort to prevent HPV, a sexually transmitted disease and the leading cause of cervical cancer.  Thirty-eight states are considering making the Gardasil vaccine mandatory as well.

Judicial Watch, a U.S. government watchdog organization, gathered the information on the drug’s adverse effects and traced its progress through legislation. Judicial Watch also noted large donations to key politicians originating from Merck, Gardasil’s developer. 

“Merck lobbied for these mandates,” said Judicial Watch president Tom Fitton in an interview with Cybercast News Service. “There are moral issues here. But the primary issue is public health and safety. It’s interesting why our government downplays the apparent adverse reactions of Gardasil. Why are drugs with a distinct social agenda getting less scrutiny in the approval process?”

Concerned Women for America (CWA), an organization pledged to protect and promote Biblical values among all citizens, has expressed shock that the FDA would not take the reported incidents seriously.

“It’s interesting so many drugs have taken so long to process and these are approved almost immediately,” said a spokeswoman for CWA. “The refusal to investigate is a disservice to women around the world.”

See previous coverage:

Deaths Associated with HPV Vaccine Start Rolling In, Over 3500 Adverse Affects Reported

Drug Conglomerate funds campaign to impose Mandatory HPV Vaccine on Young Girls

US Death Toll Associated with HPV Vaccine Jumps to 11 with 3779 Adverse Reactions Reported