Gardasil, HPV and Cervical Cancer
A Controversial Vaccine with Great Benefits and Side Effects
Watch-dogs have been warning against Gardasil for months because of adverse effects yet some states are making the vaccines mandatory for girls as young as 9 years old.
According to the Center for Disease Control (CDC), there have been 3345 adverse reactions to the vaccine Gardasil reported in the first nine months of 2007. Since the CDC reporting system for adverse drug reactions is voluntary, estimates are that 1 to 10% of actual events are reported. It’s possible, therefore that the actual number of adverse reactions is in the 30,000 to 300,000 range.
Legislators are trying to decide whether to require this expensive and controversial vaccination but the decision is proving difficult. While the vaccine would be completely unnecessary in a society that practiced sexual abstinence before marriage and monogamy afterwards, the reality is that the virus HPV is causing cancer at alarming rates.
The vaccine is effective against four strains of the HPV virus; two are responsible for 70% of cervical cancers, the others cause genital warts. The virus is transmitted through sexual contact and is the nation’s most common sexually transmitted disease with about 6 million cases per year leading to an estimated 9,700 cases of cervical cancer.
Even though watch-dog groups have been warning against Gardasil for several months because of adverse effects, some states are making the vaccines mandatory for girls as young as 9 years old in an effort to prevent HPV from spreading.
The CDC reported on August 15, 2007 that over 7 million doses of Gardasil had been distributed at a cost of $300 to $500 per dose. Their report states that the number of reported adverse reactions is about half of the number normally reported for a new medication. It goes on to say that the deaths are being investigated.
The 3,345 adverse reports reported to the CDC include five deaths from Gardasil vaccinations:
- A 19-year old woman was vaccinated with Gardasil on 3/12/07; she collapsed and died from a pulmonary embolism on 3/26/07.
- Two females of unknown age died of thrombosis after being vaccinated with Gardasil.
- A 15-year old girl died of respiratory failure after she was vaccinated with Gardasil; details are unavailable.
- An 11-year old girl died of thrombosis within a month of vaccination with Gardasil.
Four other reported deaths during the nine-month period involved pregnant women loosing their babies after the vaccination. Women who are pregnant must not be vaccinated.
Hundreds of the more serious adverse effects, some immediately after the vaccination while the patient was still in the doctor’s office, were associated with irregularities in the circulatory and nervous systems. They included fainting, being unresponsive, pallor, dizziness, falls, seizures, tremors, facial spasms, being short of breath, temporary deafness, and vision irregularities.
The majority of the less serious reactions reported to the CDC involved itching, pain, nausea, headaches—the sort of reactions that are common in many medications.
George Sawaya, an associate professor of OBGYN at UC-San Francisco, recommends a cautious approach. He wrote in an article for the New England Journal of Medicine on May 10, "A cautious approach may be warranted in light of important unanswered questions about overall vaccine effectiveness, duration of protection, and adverse effects that may emerge over time. HPV vaccination has the potential for profound public health benefit if the most optimistic scenario of effectiveness is realized."
Resources:
- Vaccine Adverse Event Reporting System (VAERS) http://vaers.hhs.gov/info.htm
- George F. Sawaya, M.D. and Karen Smith-McCune, M.D., Ph.D., "HPV Vaccination--More Answers, More Questions," New England Journal of Medicine, May 10, 2007, http://content.nejm.org/cgi/content/full/356/19/1991
- CDC, Office of the Chief Science Officer, HPV: Gardasil and GBS, factsheet issued on 8/15/2007.
- CDC, HPV Vaccine: Q&A Concerning Safety and efficacy of Gardasil, downloaded from http://www.cdc.gov/vaccines/vpd-vac/hpv/downloads/vac-faqs-vacsafe-efficacy.pdf
