Gardasil Research versus Marketing: The Reality of One Less

Back in 2006 when the Gardasil commercial first aired, the marketing mavens at Merck had us all humming along about how we wanted to be ‘one less.’ Now – 7 years and a myriad of articles, claims and additional research later, the question remains; what does it mean to be ‘one less’ and is it worth the price?

What is Gardasil? Gardasil is a vaccine approved by the FDA and recommended by the CDC as a preventative measure against four strains of HPV that are known to cause 70% of cervical cancer cases and 90% of genital warts. The vaccine must be administered over the course of a year via several injections. It is recommended for those who are not yet sexually active (i.e. younger girls, aged 9-12).

What is HPV and how is it related to Cervical Cancer? There are over 100 strains of HPV (Human papilloma virus) with approximately 30 of them being sexually transmitted. Research has found that, in rare cases, approximately 10 of those 30 strains can lead to cervical cancer. Most women are diagnosed with HPV via an abnormal Pap test. There is no cure for HPV and in most cases the infection goes away and the virus remains dormant within the body.

It is estimated that at least 20 million people in the US already have HPV; with about 50 percent of sexually active men and women at risk for acquiring a genital HPV infection during their lifetime. According to the CDC every year in the United States, about 10,000 women develop cervical cancer, and 3,700 die from it. Although cervical cancer is the second-leading cause of cancer deaths among women around the world, it ranks between 15th – 17th for cancer death in developed nations such as the US and Australia.

What do we know about the effectiveness of Gardasil? Unfortunately, the answer is not much. Despite information put forth by the US CDC, Health Canada, Australian TGA, and the UK MHRA, the efficacy of Gardasil in preventing cervical cancer has not been demonstrated. According to an article published in the Annals of Medicine, the longest follow-up data from phase II trials for Gardasil are on average 8 years. However, invasive cervical cancer takes up to 20 – 40 years after initial infection to develop into cervical cancer.  Currently the death rate in the US from cervical cancer, according to World Health Organization (WHO) data (1.7/100,000), is 2.5 times lower than the rate of serious adverse reactions from Gardasil as reported by the Vaccine Adverse Event Reporting System (VAERS) (4.3 per 100,000 doses)

Since the vaccine is so new, and follow-up trials less than a decade old, the long-term health risks of Gardasil are still widely unknown. Adverse side effects have included death, convulsions, syncope, paraesthesia, paralysis, Guillain–Barré syndrome (GBS), transverse myelitis, facial palsy, chronic fatigue syndrome, anaphylaxis, autoimmune disorders, deep vein thrombosis, pulmonary embolisms, and pancreatitis.

Is it worth the cost? The vaccine only works against 4 HPV strains and annual pap screens are still needed to detect cervical cancer.  The full injection sequence costs an approximate 400 USD, which is more than the cost of a pap screen. This nullifies any cost savings from the vaccine. In countries where cervical cancer deaths are the highest (Uganda, Nigeria, Ghana), the cost of Gardasil makes it an nonviable option. Current research suggests that by targeting other risk factors such as smoking, the use of oral contraceptives and chronic inflammation in conjunction with the already recommended and proven effective annual Pap test, global minimization of cervical cancer is likely – at equivalent or higher rates than those hypothesized for Gardasil.

For now, until more is known on the effectiveness and risks of Gardasil it may be better to be one more who goes for their annual exam and partakes in safe sexual practices than being an undetermined ‘one less.’

Hormones Matter^TM is conducting research on the side effects and adverse events associated with Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey.