​Gardasil and Cervical Cancer

​The U.S. Food and Drug Administration approved the Gardasil human papillomavirus (HPV) vaccine in 2006 after being “fast-tracked” over six short months. The FDA’s fast-track process is designed to facilitate the development, and expedite the review of, drugs or vaccines to treat serious conditions and fill an unmet medical need.

Some have argued that Merck received fast-track approval based on the company’s theory that HPV alone causes cervical cancer, and that Gardasil could eliminate cervical cancer and other HPV-associated cancers. According to Gardasil lawsuits, Merck’s theory is unproven. Gardasil has never been shown to prevent cervical or any other kind of cancer.

Merck has expressly represented through statements it made in its publications, television advertisements, billboards, print advertisements, online advertisements and website, and other written materials intended for consumers, patients, parents of minor-aged patients, medical providers and the general public, that Gardasil was safe and effective at preventing cancer.

For example, Merck’s “One Less” television and print advertisement campaign stated that Gardasil was safe and effective in preventing cervical cancer, that Gardasil was a “cervical cancer vaccine” and that any young girl who was vaccinated with Gardasil would be “one less” woman with cervical cancer. The ubiquitous nature of these Gardasil commercials and the Gardasil marketing campaign gave the impression that cervical cancer was on the rise and more prevalent than it actually was, and that all good mothers vaccinate their daughters with the “cervical cancer vaccine.”

According to data from the National Cancer Institute’s (“NCI”) Surveillance, Epidemiology and End Results Program (“SEER”), the incidence of deaths from cervical cancer prior to Gardasil’s introduction in the U.S. had been steadily declining for years and, in 2006, was 2.4 per 100,000 women or approximately 1 in every 42,000 women. The currently available rate is essentially unchanged, 2.2 per 100,000 women, based on data through 2017.

The median age of death from cervical cancer is 58, and teenage girls essentially have zero risk of dying from cervical cancer.

Public health officials have long recommended the Pap test (also known as Pap Smear), which detects abnormalities in cervical tissue, as the most effective frontline public health response to the disease.

Since its introduction, cervical cancer screening through the Pap test has reduced the rates of cervical cancer in developed countries by up to 80%. Incidences of cervical cancer have been declining dramatically worldwide as countries have implemented Pap screening programs.

New cases of cervical cancer in the U.S. affect approximately 0.6% of women in their lifetime. For those who are diagnosed, cervical cancer is largely treatable, with a five-year survival rate of over 90% when the cancer is caught early.

Our firm believes the FDA’s fast-track approval of Gardasil left unanswered material questions relating to the vaccine’s effectiveness and safety, especially considering some research has shown that Gardasil may increase the risk of developing cervical cancer.

Medical researchers have identified more than 200 strains of the HPV virus. Of those, 12-18 strains are linked to cervical cancer.

Gardasil was brought to market to prevent just four strains of HPV (HPV Strain Types 6, 11, 16, and 18), of which only two (Types 16 and 18) are linked to cervical cancer. Subsequently, Merck sought approval for Gardasil 9, which contains the same ingredients as the original Gardasil, but in higher quantities that purportedly guarded against five additional HPV strains (HPV Strain Types 31, 33, 45, 52 and 58).

Cervical cancer is a multi-factor disease with persistent HPV infections seeming to play a role, along with many other environmental and genetic factors, including smoking cigarettes or exposure to other toxic smoke sources, long-term use of oral contraceptives, nutritional deficiencies, multiple births (especially beginning at an early age), obesity, inflammation, and other factors. Not all cervical cancer is associated with HPV types in the vaccines and not all cervical cancer is associated with HPV at all.

Merck has claimed that Gardasil can eliminate cervical cancer and other HPV-associated cancers. However, according to Gardasil lawsuits, Merck knows that the Gardasil vaccines cannot eliminate all cervical cancer or any other cancer that may be associated with HPV. In fact, some studies indicate that Gardasil may actually cause the cancer it purportedly prevents.

Contrary to Merck’s Claims, Gardasil May Increase the Risk of Developing Cervical Cancer

​Merck markets its Gardasil vaccines as anti-cancer products. However, the original Gardasil label states: “Gardasil has not been evaluated for the potential to cause carcinogenicity or genotoxicity.” The Gardasil 9 label states: “Gardasil 9 has not been evaluated for the potential to cause carcinogenicity, genotoxicity or impairment of male fertility.”

According to the Gardasil litigation, the HPV vaccines may themselves actually cause cancer or mutagenetic changes that can lead to cancer.

Peer-reviewed studies, including the Centers for Disease Control and Prevention’s (CDC) own studies, suggest that the suppression of the HPV strains targeted by Gardasil may actually open the ecological niche for replacement by more virulent strains. Put more simply, the research indicates Gardasil may increase the chances of getting cancer.

These studies include:

• Comparison of HPV prevalence between HPV-vaccinated and non-vaccinated young adult women (20–26 years) – Fangjian Guo et al. (2015)
• Shift in prevalence of HPV types in cervical cytology specimens in the era of HPV vaccinations – Sonja Fischer et al. (2016)
• Biased Cochrane Report Ignores Flaws in HPV Vaccine Studies, and Studies of HPV Type Replacement – J. Lyons-Weiler (2018)