Gardasil, the Cancer Vaccine: What the Manufacturer's Package Insert Tells Us

Few vaccines have generated as much controversy as Gardasil. Conservative religious groups decry that it encourages premarital sex and promiscuity, anti-vaccination groups criticize the lack of safety studies, and about 20 state governments are doing their best to make this "miraculous cancer vaccine" mandatory for young girls. Parents who resist this new vaccine are being put on the spot for selfishly leaving their daughters exposed to a dangerous sexually transmitted disease. Scientists are revealing evidence that it may also protect boys and men.

So what is the big deal about Gardasil? What is it supposed to do, and what is it actually doing?

"One Less"

Visit Gardasil.com and you will learn how you can become "One less life affected by cervical cancer." Human Papillomavirus (HPV) Types 6, 11, 16 and 18 cause "70% of cervical cancer cases" and "90% of genital warts cases." The virus is spread through any kind of genital contact, not just intercourse.
People can carry the virus without knowing it and unwittingly pass it on. The Centers For Disease Control estimate that 20 million people in the United States had HPV in 2005.

It is worth noting that not all of those cases are caused by the strains present Gardasil. Gardasil protects against 4 types of HPV. There a over 100, with 30-40 of them being sexually transmitted.

What Are The Cervical Cancer Rates?

According to Cancer.org, "Only some women with pre-cancerous changes of the cervix will develop cancer. This process usually takes several years but sometimes can happen in less than a year. For most women, pre-cancerous cells will remain unchanged and go away without any treatment. But if these pre-cancers are treated, almost all true cancers can be prevented." Between 1955 and 1992, cervical cancer rates dropped over 70% due to pap screenings. Most cases occur in middle-aged women, and it is rare in women under age 20. The 5-year survival rate for cervical cancer is 72%.

Cancer.org points out that one should "keep in mind that 5-year survival rates are based on patients diagnosed and initially treated more than 5 years ago. Improvements in treatment often result in a more favorable outlook for recently diagnosed patients."

Somewhere between 3,000 and 4,000 women from all age groups die from cervical cancer each year. Approximately 9,800 new cases of cervical cancer are diagnosed each year.

HPV has an incubation period of about 10-15 years. Since the average cervical cancer patient is in her forties, most HPV is contracted while a woman is in her twenties.

What Are Cervical Cancer Risk Factors?

As states previously, millions of women will contract HPV without ever experiencing symptoms or developing cervical cancer. Risk factors that increase a woman's chance of actually developing a chronic HPV infection include "HIV infection, smoking, long-time use of oral contraceptives, and co-infection with herpes simplex virus or Chlamydia." ( source link )

About Gardasil

Gardasil is a vaccine developed by the pharmaceutical company Merck. It is intended to protect against certain strains of HPV and is marketed toward teenagers and young women, despite the greatest risks being for women over 35. It was licensed on June 8, 2006 and is estimated to provide protection for approximately 5 years. As previously stated, most women contract HPV in their twenties, so if she receives Gardasil as a teenager, she will likely need a booster later on to realize any protection.

Merck's package insert for Gardasil can be viewed in its entirety here.

Important information from the package insert to note:

One of the main ingredients is aluminum, which is toxic and has been recently linked to Gulf War Syndrome. Animal and human studies have proven aluminum to cause nerve cell death (link to a sample study).

As with all other vaccines, Merck is not required by law to determine if Gardasil can cause cancer or impair fertility. A test in rats allegedly showed no effect on fertility or fetal survival. However, it is not known if this would be the same for human females.

Adverse reactions observed during clinical trials included:

Pain
Swelling
Pruritus
Erythema
Fever
Nausea
Dizziness
Pyrexia
Nasopharyngitis
Vomiting
Diarrhea
Myalgia
Cough
Urticaria (hives)
Toothache
Upper respiratory tract infection
Malaise
Arthralgia
Insomnia
Nasal congestion
Gastroenteritis
Appendicitis
Pelvic inflammatory disease
Bronchospasm
Asthma
Arthritis

Safety Studies Lacking
Merck safety studies included less than 1200 girls under age 16 before releasing Gardasil.

According to the National Vaccine Information Center, "The FDA allowed Merck to use a potentially reactive aluminum containing placebo as a control for most trial participants, rather than a non-reactive saline solution placebo. A reactive placebo can artificially increase the appearance of safety of an experimental drug or vaccine in a clinical trial. Gardasil contains 225 mcg of aluminum and, although aluminum adjuvants have been used in vaccines for decades, they were never tested for safety in clinical trials. Merck and the FDA did not disclose how much aluminum was in the placebo."

No studies have been done to determine Gardasil's interaction with other vaccines when administered at the same time.

Physicians from the University of California, San Francisco, have joined the growing number of medical professionals concerned with widespread use of Gardasil. As reported in the San Francisco Chronicle, "At this stage, vaccination can still be considered experimental," said Dr. Karen McCune, an associate professor of obstetrics and gynecology at UCSF, who co-authored the editorial. "To be discussing mandatory vaccination when the main clinical trials are still ongoing seems extremely premature. We're feeling like the enthusiasm is driving policy rather than data." ( source link )

Loss of Consciousness and Loss of Muscle Control

Since is release, reactions to Gardasil have been steadily streaming in, showing up on the government's Vaccine Adverse Events Reporting System (VAERS) and in the news. Since this is a new vaccine given to older girls, it is frequently given by itself, which makes it easier to determine that it is Gardasil itself causing the reactions, and not other vaccines.

Since its release in June 2006, 1261 adverse reactions have been reported. 146 of those reports include fainting or loss of consciousness within moments after a Gardasil injection. 829 of those reports include emergency room visits for such things as losing sensation or movement in the limbs or face, paralysis, convulsions, Guillain-Barre Syndrome, syncope (a fancy word meaning brief loss of consciousness, swooning, dizziness), and high-pitched screaming (in an adult, not a child).

Deaths

Judicial Watch, a group dedicated to combating government corruption, recently discovered three deaths directly related to the Gardasil vaccine. Information on these deaths was obtained by requesting documentation from the FDA by means of the Freedom of Information Act. Those documents detail 1,637 adverse reactions. In their report, they noted "Three deaths were related to the vaccine. One physician's assistant reported that a female patient "died of a blood clot three hours after getting the Gardasil vaccine." Two other reports, on girls 12 and 19, reported deaths relating to heart problems and/or blood clotting." ( source link )

Included in those listed adverse reactions are 18 pregnant women who experienced spontaneous abortion or fetal abnormalities.

The CDC Itself Opposes Making Gardasil Mandatory

Dr. Jon Abramson, chairman of the Centers for Disease Control and Prevention's advisory committee on immunization practices, recently advised that Gardasil should not be made mandatory for school attendance, and that Merck should not lobby states to make the vaccine compulsory. He and other panel members cite that it cervical cancer is not an infectious disease and mass inoculations would be costly. Gardasil is currently the most expensive vaccine on the market. ( source link )