What's the Latest News on GARDASIL?

On June 25, 2008, the Food and Drug Administration (FDA) denied approval of GARDASIL for use in women between the ages of 27 and 45.

The drug, manufactured by Merck & Co., has been heralded as the leading vaccine in targeting and preventing the growth of four strains of human papilloma viruses (HPV), two of which have been said to cause cervical cancer.

Human papilloma viruses, more commonly called HPVs, are numerous genotypes causing various human warts, like the common warts found on hands and feet, plantar warts, and genital warts, including some 15 known strains associated with the production of cervical cancer.

Makers of the drug and its proponents have been claiming GARDASIL prevents cervical cancer, an unsubstantiated claim as girls and women involved in initial drug trials, who numbered less than 30,000, were not tracked until the usual age of the onset of cervical cancer, which occurs between the ages of 35 to 45. The average length of follow up study was less than five years.

In April 2006, according to a PharmaceuticalOnline.com article, Merck & Co. Inc., a self professed global research-driven pharmaceutical company under new leadership, proclaimed itself, among other things, ”....(the company) that investors can look to first for growth among pharmaceutical companies....”, relying heavily on its new line of vaccine products to produce much of that forecasted growth.

In June 2006, GARDASIL was approved by the FDA for use in girls ages 9 through women aged 26. The drug is currently being marketed worldwide with GARDASIL, during one of its first quarters, according to Bloomberg.com, netting $390 million.

In my second article posted here at NowPublic, published more than a year ago, writing about the marketing of GARDASIL in my piece entitled, Creating a Market for and Testing HPV Vaccines, I began with a quote from the American Cancer Society web site:

Seventy percent (70%) of human papilloma virus (HPV) infections are typically gone within one year and 90% are gone within 2 years.

Also stated at the web site:

Most people will never know if they have HPV because no significant disease develops and the immune system suppresses the virus. A small percent of people with HPV will have the virus for a longer time and will develop cell changes that may lead over many years to cervical or other anogenital cancer.

From the National Cancer Institute, found at cancer.gov, it states:

Are there specific types of HPV that are associated with cancer?             Some types of HPV are referred to as “low-risk” viruses because they rarely cause lesions that develop into cancer. HPV types that are more likely to lead to the development of cancer are referred to as “high-risk.” Both high-risk and low-risk types of HPV can cause the growth of abnormal cells, but only the high-risk types of HPV lead to cancer. Sexually transmitted, high-risk HPVs include types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, and 73 (4). These high-risk types of HPV cause growths on the cervix that are usually flat and nearly invisible, as compared with the external warts caused by low-risk types HPV–6 and HPV–11. HPV types 16 and 18 together cause about 70 percent of cervical cancers (4, 5). It is important to note, however, that the great majority of high-risk HPV infections go away on their own and do not cause cancer (5).

GARDASIL targets four HPV strains, two of which, HPV 16 and 18, are being identified above as being responsible for 70% of cervical cancers.

Concerns have been raised by physicians noting the possibility that vaccination against two of fifteen known HPV strains linked to cancer may result in other strains becoming more aggressive.

According to this article, cervical cancer among the age groups of girls and women in the United States being vaccinated with GARDASIL, girls and women between the ages of 9 and 26, is rare, with approximately 3 to 4 cases per 100,000 or 30 to 40 cases of cervical cancer per 1 million girls and women or .00003% to .00004% ( 3 to 4 hundred thousandths of one percent) reported in that age category.

Until a thoroughly independent study of this and all future HPV vaccines is commissioned and completed, which has not occurred to date, it is merely healthy skepticism to seek more information on a product when the company that is responsible for all of the good and glowing news regarding the product is the only resource from which everyone else is getting their information. It has been reported, Merck settled some 27,000 claims, representing 47,000 claimants and 265 possible class action lawsuits related to allegations of death and injuries by Vioxx, three years after removing the drug from market, for $4.85 billion.

Merck & Co. credits the sale of GARDASIL with helping to reclaim monetary losses that occurred after damages and loss of life that appeared to be linked to the use of Vioxx, which resulted in one of the largest monetary awards for settlement of claims resulting from the drug's use.

As of June 23, 2008, Merck & Co. is in the process of a appealing a suit concerning Vioxx, filed in Missouri.

My first article at NowPublic, Public Health or Profit? What Drives the HPV Vaccination Campaign?, highlighted sets of circumstances that surrounded the timing and introduction of GARDASIL onto the drug market.            

Merck & Co. predicts this recent refusal by the FDA will slow earlier projected profits anticipated to result from the approval and expansion of the age groups for the use of GARDASIL among women.

The public must come to understand that FDA approval doesn't mean a drug is not without it's dangers.

Click here for a related article of interest.

Also at NowPublic:

Ten Facts About HPV and GARDASIL,

Health and Safety Versus Profit ,

The Partnership Between Gov't, Business and Genetic Research 

The Politics and PR of Cervical Cancer