HPV and Gardasil
Gardasil is a vaccine used to prevent certain strains of the human papillomavirus (HPV), with a specific focus on types 16, 18, 6 and 11. The US Food and Drug Administration (FDA) approved the vaccine for this use on June 8, 2006.
The purpose of the vaccine is to try to reduce the rate of infection of HPV 16 and 18 which has been linked to causing 70 percent of cervical cancers. These two strains of HPV are also responsible for many vulvar, penile, anal and vaginal cancers. The vaccine is also meant to prevent infection from the HPV strains that cause genital warts. Approximately 90 percent of genital wart outbreaks are caused by the strains 6 and 11.
The vaccine is only effective if given before a person becomes infected with HPV. It does not treat an existing infection. For this reason, the US Food and Drug Administration (FDA) recommended that the vaccine be administered before potential sexual activity. It's suggested that the vaccine is given during the preteen years.
The vaccine is manufactured by Merck & Co., Inc., one of the largest pharmaceutical companies in the world. The company is based in Whitehouse Station, New Jersey and has been in business for more than a century. Merck & Co was established in 1891 as an American subsidiary of a German company. The US confiscated the company during World War I in 1917 and then it was later set up as an independent company.
Merck & Co describes itself as "a global research-driven pharmaceutical company." It was involved in the clinical studies of Gardasil, although it was not involved in the original development of the vaccine in the 1980s.
The US National Cancer Institute, the University of Rochester and Georgetown University were all originally involved in the research that eventually led to the development of the vaccine. But it wasn't until 1991 that real progress started to be made when Australian researchers at the University of Queensland discovered they could form virus-like particles (VLP) that worked to activate the immune system. The structure of these early VLPs was weak and it took another two years before scientists were able to generate a morphologically correct HPV 16 VLPs. The Journal of the National Cancer Institute reports that this discovery was made by the US National Cancer and that these morphologically correct HPV 16 VLPs are the basis of the HPV 16 component of Gardasil.
The vaccine has gone through numerous clinical trials. Merk & Co. was involved in some of these clinical studies. The company was responsible for a Phase III study called Females United to Unilaterally Reduce Endo/Ectocervical Disease (FUTURE II).
FUTURE II was a randomized double-blind study. This means that participants were selected randomly and that all the persons involved in the study in no way knew anything about the experiment that might bias their opinions and reporting which would invalidate the results.
More than 12,000 women from thirteen countries participated in the study. The women were between the ages of 16 to 26. The women were injected with either a placebo or Gardasil on the first day of the study, in the second month of the study, and in the sixth month of the study. According to results of the study published in the New England Journal of Medicine, the women who received the vaccine showed a "significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than did those in the placebo group."
There have been reports that Merk & Co tested the vaccine on hundreds of 11- and 12-year-old girls which led to ethical concerns about the clinical trials.