By Hilary White

November 18, 2008 ( – Gardasil, the vaccine being pushed by governments around the world to combat the spread of human papillomavirus (HPV), has been linked in Fiji with 3 cases of outbreaks of genital warts among primary school students. HPV, the most common sexually transmitted infection which causes genital warts, has been linked to the development of cervical cancer in women and governments around the world are implementing mandatory vaccination programs using Gardasil. 

With the Fijian government pressing forward with mass vaccination programs, Matelita Ragogo, writing in the Fiji Times, asks, “Are our girls guinea pigs?”

She reports that within three months of the government approving Gardasil vaccinations for school girls, three primary school students were reported to have “reacted negatively” to the vaccination. Ragogo points out that although the Fijian government has approved the vaccine for use on young girls, the testing process for the drug is not expected to be completed until 2009. Nevertheless, the US Food and Drug Administration (FDA) has “fast-tracked” approval of the drug after a six-month review process. 

Earlier this year, Judicial Watch, a non-profit watchdog group, listed 21 deaths and 9749 “adverse reactions” linked to Gardasil, including 78 outbreaks of genital warts and 10 miscarriages. Judicial Watch uncovered documents through the Freedom of Information Act that show the FDA received reports of 10 deaths associated with Gardasil since September 2007, and 140 “serious” reports of adverse reactions, including 27 “life threatening” cases, 10 spontaneous abortions, and 6 cases of the debilitating Guillain-Barre Syndrome since January 2008.

In Fiji, Ragogo writes, “Effectively, Cabinet approved a vaccine which is still being tested so no one can be sure of its effectiveness or long-term side effects. Our children are guinea pigs for a money-making, I mean, drug-making, machine.”

In a television interview with CBS News in May, Dr. Diane Harper, the specialist who helped develop the Gardasil vaccine, said making the vaccination mandatory is “a real danger zone.”

“The vaccine has not been out long enough for us to have post-marketing surveillance to really understand what all of the potential side effects are going to be,” Harper said. “To put in place a process that says you must have this vaccine means that you must be part of a big public experiment and so we can’t do that. We can’t have that until we have more data.”

At the same time, a recently published article in the Journal of Law, Medicine & Ethics has criticized the pressure in the US for states to make Gardasil vaccinations a mandatory requirement of school attendance. Calling it “premature,” the article’s authors assert that Gardasil is relatively new and long-term safety and effectiveness in the general population is unknown. Long-term testing is required before the drug’s effectiveness can be established. They also warn that since the HPV vaccine does not represent a public health necessity, issues of constitutionality can be raised against mandatory vaccinations.

Nevertheless, Merck has recently published findings that Gardasil may also be used by men, a development that would considerably expand the drug’s market base. The studies have shown that Gardasil can be used as protection against genital warts in men, potentially precancerous lesions, and to prevent penile and anal cancers.

The male market for Gardasil is mainly to be found among the active homosexual population who are at significantly higher risk for genital warts and anal cancer than is the general population. A 2005 study in San Francisco found that 95 per cent of HIV-infected gay men also had anal HPV infection, of which 50 percent had precancerous HPV-caused lesions. HPV type 16 is also associated with oropharyngeal squamous-cell carcinoma, a form of throat cancer. 

A similar drug, Cervarix, has also been approved for use in mass vaccinations in the UK. Cervarix is designed to prevent infection by only two HPV types out of an estimated 30 to 40 existing types, compared to Gardasil’s four.

Read related coverage:

One U.K. Catholic School Stands against HPV Vaccination

Controversial HPV Vaccine Causing One Death Per Month: FDA Report