Cervical Cancer And Gardasil
The Implications of Vaccinating for Human Papilloma Virus (HPV)
Gardasil was approved in 2006, but the hyped vaccine does not benefit the appropriate population and has not been tested for long-term safety.
Merck’s Cervical Cancer Vaccine
On June 8, 2006 the FDA approved Gardasil, made by Merck and Co., as a vaccine for women aged 9-26 years to protect against cervical abnormalities caused by infection with HPV strains 6, 11, 16, and 18. The FDA clinical study summary states that Gardasil does not prevent HPV infection; it protects against the development of cervical cancer which has been shown to be caused by persistent HPV infection.
Gardasil Safety
Long term safety and efficacy studies have not been done on Gardasil. The FDA approved the vaccine based on short term benefits (24 months after the first injection) in women aged 16-26 and a study showing an immune effect in girls aged 9-15. Though the 90-100% efficacy seen in the short term studies is impressive, there have been no studies about the safety of using the vaccine in young girls and no studies of the effect on pregnancies that may occur within 30 days of receiving the vaccine, though it is advised that women thought to be pregnant should not receive the vaccine. However, in the FDA approval it was noted that Merck has promised the FDA that those studies will be done “post-marketing”.
The Cervical Cancer Vaccine
The vaccine contains purified viral proteins, called L1. They are non-infectious, but have been shown to activate the immune system in an identical manner to HPV infection. The proteins are injected with an adjuvant, a substance that helps speed the actions of the protein within the vaccine. In the case of Gardasil the adjuvant is an aluminum salt, despite a 2001 research study which found that the HPV-16 L1 protein is sufficient for an immune response and does not need an adjuvant.
In clinical trials more than three quarters of subjects receiving injections of just the aluminum adjuvant had adverse skin reactions; 83% of subjects receiving Gardasil had reactions at the injection site. Only about half of participants who received injections of plain saline had reactions at the injection site. This implicates a problem with the adjuvant solution. Though reactions at the injection site are normal for intramuscular vaccinations, the high rate and the development of reactions up to 5 days after the injections raises questions about the safety of the vaccine.
Gardasil Side Effects
It is no surprise then that there have been reports of fainting and dizziness in young girls who receive the vaccine. The clinical trials saw over half of participants receiving the vaccine experience headaches, nausea, and fever (an indicator of anaphylactic reactions when in the absence of infection) up to 15 days after the vaccination was received. Now that vaccinations have been given to a larger population there are more prevalent adverse reactions including deaths. A
ccording to LifeSiteNews.com in October 2007, the US Government's Vaccine Adverse Event Reporting System (VAERS) lists 3,779 adverse effects with 52 of the cases deemed "life threatening" and 119 requiring hospitalization. A review of some of the files pertaining to the deaths, obtained by Judicial Watch from the FDA via the Freedom of Information Act, points to a trend of young girls with heart conditions or unrecognized flu infections having cardiovascular or systemic autoimmune reactions to the vaccine. The FDA is lacking much of the important information surrounding the deaths and has been sued by Judicial Watch for not being forthcoming with the information. The adverse side effects reported by many media outlets in the United States as well as the UK include paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures in otherwise healthy girls.
The Cost of Gardasil
The series of 3 shots costs, on average, $360 per girl and would be a huge profit for Merck since Gardasil is the only vaccine available for cervical cancer or HPV infection. In November 2007, Merck announced to stockholders that they are seeking FDA approval to vaccinate women up to age 45, despite clinical studies cutting off the ages of interest at 26. As stated by the BloggingStocks website, “[E]xpanding the market to older women could take the focus off that issue [of young girls receiving the vaccine] as well as increase Merck's market at the same time.”
Merck had also funded a legislative push to make the vaccine mandatory for school aged girls, spending a reported $250,000 in Texas, the first state to mandate vaccination. Merck backed off the legislative push in other states when reports of deaths began to surface and parent groups spoke up against mandated vaccination. The American College of Pediatricians has called for long term studies of efficacy and side effects before making the step forward.
References
- Kjaer, S.K. et al., 2002. Type specific persistence of high risk human papillomavirus (HPV) as indicator of high grade cervical squamous intraepithelial lesions in young women: population based prospective follow up study. BMJ (Clinical research ed.), 325(7364), p.572.
- Cuschieri, K.S. et al., 2005. Persistent high risk HPV infection associated with development of cervical neoplasia in a prospective population study. Journal of clinical pathology, 58(9), p.946-50.
