The Politics and PR of Cervical Cancer
The Center for Media and Democracy has completed a four part series of articles, The Politics and PR of Cervical Cancer, about the first FDA approved human papillomavirus (HPV) vaccine GARDASIL, manufactured by Merck & Co., Inc., alleged to aid in the prevention of cervical cancer, and a number of issues and facts surrounding the promotion of its use and HPV vaccines.
The web page containing the link to this series also provides links to related articles and resources for the series.
This series covers many issues of interest for those seeking more information surrounding the recent promotion of HPV vaccines and the products being sold.
From the American Cancer Society website:
HPV is short for human papilloma (pap-ah-LO-mah) virus. HPVs are a group of over 100 related viruses. Each HPV virus in the group is given a number, which is called an HPV type. HPVs are called papilloma viruses because some of the HPV types cause warts, or papillomas, which are non-cancerous tumors.
Can HPV be treated?
Treatments cannot cure HPV. However, most genital HPV infections go away with the help of the body’s immune system. Seventy percent (70%) of HPV infections are typically gone within one year and 90% are gone within 2 years. Treatments are available for genital warts, for the pre-cancer cell changes that HPV can cause, and for cervical and other HPV-associated anogenital cancers.
From an article I wrote in March 2007 entitled Public Health or Profit? What Drives the HPV Vaccination Campaign?:
In April 2006 and according to a PharmaceuticalOnline.com article, Merck & Co. Inc., a self professed global research-driven pharmaceutical company, under new leadership and poised to become, among other things, ”....(the company) that investors can look to first for growth among pharmaceutical companies....”, in the process of restructuring the company, decided to begin a new focus for the company, which was revealed at its Annual Meeting of Stockholders.
This article states:
“....(T)he first strategic action is the decision to concentrate research and development efforts in nine therapeutic areas; Alzheimer's disease, atherosclerosis, cardiovascular disease, diabetes, novel vaccines, obesity, cancer, pain and sleep disorders. These areas were selected because of the opportunity Merck believes they provide, both due to the enormous unmet need that exists and because of the likelihood that the Company can make a real difference in discovering effective, safe and highly desired treatments.”
Since the creation of GARDASIL by Merck & Co., Inc., a push by the company to have its vaccine approved by the Food and Drug Administration (FDA) has become a reality, with approval occurring in June 2006.
Merck & Co., Inc. launched its ONE LESS campaign for GARDASIL, beginning in the fall of 2006 in November, on radio, television and the Internet, encouraging female consumers and mothers to ask their physicians about GARDASIL.
In its product insert for GARDASIL, on page 8 of this link, Merck states:
GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity.
Carcinogenicity refers to a substance's link to causing cancer.
This document states that those in the field of cellular biology define genotoxicity as genetic poison, meaning there is a potential for harm at the cellular level.
Another quote found at the American Cancer Society web site states:
Although nearly all cervical cancers are related to HPV, most genital HPV infections do not cause cervical cancer. Most people who test positive for genital HPV DNA in research studies eventually test negative, often within 6 to 12 months.
In my previously linked article above and in the article, Creating a Market for and Testing HPV Vaccines, I raised concerns related to the motives of Merck, the manufacturer of GARDASIL and GlaxoSmithKline, which began a head to head comparative study, earlier this year, of Merck's vaccine versus the GlaxoSmithKline vaccine, Cervarix.
According to product information for Cervarix, GlaxoSmithKline's candidate for approval by the Food and Drug Administration (FDA) for use as a vaccine to prevent the development of several HPV strains, its use is intended for girls and women ages 10 to 45. To date, this vaccine has not been tested in males.
The above linked document states that the duration of protection upon receipt of this vaccine has not been established. As in the case of GARDASIL, Cervarix also has not been investigated for its possible harm at a cellular level nor has this drug been tested for possible cancer causing agents.
In the United States, anyone seeking damages against a vaccine manufacturer for vaccine related injuries must first file a complaint in the United States Court of Federal Claims also known as Vaccine Court. Amendments to the rules governing Vaccine Court have been enacted as of November 15, 2007.
It is of interest to note an article, originally found at Drug Pipeline News, stated that in February 2005, Merck entered into an agreement with GlaxoSmithKline that would have Merck pay royalties to GlaxoSmithKline, with an upfront payment to be followed by an ongoing percentage of royalties from GARDASIL's sales, as settlement for competing patent claims related to the development of their respective vaccines.
Please note, at the 'sales' link in the previous paragraph, it states that pricing " .... and the absence of mandatory vaccination" are identified as " .... a barrier to rapid penetration in the all-important US marketplace."
The reality of Merck's agreement to pay royalties to GlaxoSmithKline would seem to highlight the necessity for Merck to garner as much profit from the sale of GARDASIL as can be obtained to offset it's payments to GlaxoSmithKline.
Since GARDASIL's approval in June 2006, Congress has been lobbied heavily to enact legislation to make the inoculation of girls mandatory, girls as young as 9 years of age, in a number of states, including Texas and California.