The Human papillomavirus (HPV) vaccine, Gardasil, is produced, patented, and heavily marketed around the world by Merck & Co. It was approved by the Federal Drug Administration (FDA) in June 2006 for use in females between the ages of nine and 26. The drug was rushed to approval after a six-month priority review process reserved for products with the potential to fill an unmet medical need. The safety evaluation trials have not yet been concluded and the final safety report is still pending. Since the FDA approval, Merck has waged an aggressive lobbying campaign with state governments to mandate their exclusive patented drug for young girls and they succeeded in some states. Although The Minnesota Department of Health is promoting the vaccination, they are recommending that the vaccine NOT be made mandatory for girls in the Minnesota school system until more research is conducted and evaluated.
What is HPV?
HPV is a sexually transmitted virus. There are more than 100 strains of the HPV virus; thirty of them are considered to be more harmful and fifteen are high-risk for potentially leading to cervical cancer in the future. Many HPV strains do go away on their own without leading to complications or cancer. However, the high-risk strains can lead to future cervical cancers and/or genital warts.
Cervical cancer from HPV?
HPV infections have been shown to lead to future cervical cancer in women. However, of the approximate 11,000 cervical cancers found annually in the United States, most occurred in women who have never had a pap smear or had not had one within the previous five years. Most of the cervical cancer deaths occur in poor countries where regular screening is not being performed. Cervical cancer can be 100 percent treatable with regular pap exams. Pap exams detect pre-cancer cells on the cervix where early detection and removal of those cells prevents cervical cancer from occurring.
What does the HPV vaccine do?
The vaccine, given in three doses over a six month period, protects against four of the more serious HPV strains. Two of the strains are those that can lead to future cervical cancer and two are those that can lead to genital warts.
What does the HPV vaccine not do?
The vaccine does not cure any HPV strain already present and does not cure cancer. It will not protect against all types of HPV that can lead to cervical cancer and therefore, it is imperative that women still receive regular annual pap exams. The vaccine also does not protect against other sexually transmitted diseases (STDs) such as, HIV, Herpes, Syphilis, Gonorrhea, or Chlamydia. The vaccine is effective for only four to five years. Therefore, a nine year old receiving the vaccine would no longer be protected by age 14.
What are the side effects of Gardasil?
According to the Vaccine Adverse Event Reporting System (VAERS) obtained by Judicial Watch, side effects include pain and swelling at the site of injection, fainting, headache, seizures, nausea, fever, blood clots, outbreak of warts and blisters on the genitals, face, hands, and feet, paralysis, and Guillain-Barre Syndrome. Last August, The Journal of the American Medical Association (JAMA) reported 12,424 adverse events from use of the drug Gardasil with 772 of them serious. VAERS reports show that at least 18 people have died after receiving Gardasil.
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CBS report
Is the HPV vaccine, Gardasil, safe?
Merck and the Centers for Disease Control and Prevention claim the vaccine is safe. Many do not agree and The Judicial Watch is at the forefront of monitoring the safety of Gardasil. They request and receive all VAERS reports and their website contains important and detailed information. Anyone contemplating receiving this vaccine for herself or a daughter is encouraged to review the information.
How can HPV be prevented without Gardasil?
Because Gardasil protects against only four of the many HPV strains, further precautions are still necessary to prevent the other strains as well as other STDs. Parents are encouraged to speak to their children about sexual risks. Although not full proof, condoms are still the most highly recommended method for preventing all STDs. However, in the case of HPV, any area of the skin not covered by a condom has the potential to spread the virus.
How much does the vaccine cost?
Gardasil is currently on the market for $180 for the first dose and $165 for each of the second and third doses. The total cost for the vaccine (all three doses) is $510.
How much is Merck making on the vaccine?
Merck’s cut is $500 per vaccine (all three doses). With 23 million doses distributed to date, Merck's revenues exceed billions on their new patented drug.
References:
FDA
Journal of the American Medical Association
Institute of Science in Society
Judicial Watch
Minnesota Public Radio
Wikipedia
Buzzdroid
Centers for Disease Control and Prevention
Comments
Great article!
Yes! Great article!
My only concern is you make it sound like the drug was rushed to approval after only a six-mont review. But I was concerned enough to look at the CDC website and they said the safety of this vaccine was studied in 5 clinical trials before it was licensed. There were over 21,000 girls and women ages 9 through 26 in the clinical trials before it was approved.
But lots of lots of good points!
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