In the face of increasing reports of adverse events and death rates that are 400% higher than with other vaccines, Merck continues to maintain that its controversial Gardasil vaccine is safe and continues to push for wider use. One group Merck would especially like to gain approval for is older women (currently, the vaccine is not approved for women over 27 years old). Despite Merck’s claims to the contrary, studies have actually shown that Gardasil and its sister vaccine Cervarix (from GlaxoSmithKline) provide no protection for women already exposed to the HPV virus and in fact present highly elevated risks for already exposed women as well as for expectant mothers.
The more sexually active a woman is, the greater the chances she will encounter exposure to HPV viruses. Likewise, the older a woman is the more sexual encounters she will likely have had and thus the greater the risk of HPV exposure. Information provided for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in May 2006 revealed that when the vaccine is administered to a woman with a dormant or harmless form of HPV, the virus can become activated, increasing the likelihood of precancerous lesions developing by a staggering 44.6 percent.
Not one to let negative study results stand in the way of a highly profitable cash cow drug (see Vioxx), Merck decided that the groups in the study were “unbalanced” and played with the figures to eliminate women who were at higher risk to begin with. After the figure juggling the added risk was estimated to be only 11 percent.
Merck initially reported to the FDA that “it is not known whether Gardasil can cause fetal harm when administered to a pregnant woman” and continues to downplay risks for expectant mothers. However, studies have shown that pregnant women have a higher risk for adverse reactions, including miscarriages.
The Vaccine Adverse Event Reporting System (VAERS) has reported 45 cases of spontaneous abortion, or miscarriage, following vaccination with Gardasil. At the time the vaccine was approved, five babies had been born with congenital birth defects after their mothers had been immunized with Gardasil, as opposed to a placebo group that had zero. Later reports put the number of birth defects in the vaccinated group closer to 40.
The risks to already exposed women and expectant mothers are magnified by the fact that there are no screenings recommended for existing HPV viruses or pregnancy – despite clear evidence of increased dangers and no protection. As the small print on the Cervarix product insert states: “Cervarix does not prevent HPV-related lesions in women infected with HPV 16 or HPV 18 at the time of vaccination and has not been shown to have a therapeutic effect.”
As previously reported, Merck’s studies on Gardasil safety have been skewed from the outset due to using a “loaded” placebo. Instead of a normal saline solution, Merck removed only the HPV virus from their vaccine and thus used a placebo which contained such dangerous components as aluminum, polysorbate 80 and sodium borate.
Merck’s promotion and defense of Gardasil are reminiscent of their previous blockbuster drug Vioxx. It took years and ultimately upwards of 60,000 deaths before Vioxx was finally pulled from the market. During the same time Merck was touting Vioxx’s safety, it was also hiding and doctoring negative study results and paying doctors for signatures on papers ghost-written by Merck.
What you won’t see Merck reporting is the fact that nearly all cases of HPV are actually self-limiting. In other words, unless there is a weakened immune system, the body fixes HPV viruses all by itself.