Cervical Cancer and Vaccination

Cervical cancer develops when normal cells in the cervix (“neck of the uterus”: The lower narrow portion of the uterus, where it joins with the top end of the vagina. Appears cylindrical in shape and protrudes through the upper anterior vaginal wall. Medical equipment can visible view half of the length.) change into cancer cells. This normally takes several years to develop however in some patients, happens in a very short period of time. Cervical cancer is the second leading cancer killer of women. According to the World Health Organization, 288,000 women each year die of this disease, mainly attributed to sexually transmitting the Human Papilloma Virus or HPV. Most cases of cervical cancer occurs in poor countries where women do not have regular Pap test, which can detect cancer or pre-cancerous cells early enough, for treatment or cure. Expected in 2006, more than 9,700 US women will develop cervical cancer and about 3,700 women will die. Symptoms include: Abnormal bleeding (Happens only after cervical cells become cancerous and invade neighboring tissues), unusual vaginal discharge, bleeding between regular menstrual periods or after sexual intercourse, pain during intercourse, difficulty or pain during urination, pain in the pelvic area, and pre- or post-menopausal bleeding. Merck pharmaceutical company has developed a vaccine for cervical cancer, and hopefully will be approved by the FDA in June 2006. Besides, GlaxoSmithKline is developing another type of vaccine.

Recommend women eighteen and older or onset of sexual activity have a Pap test. Pap test is a screening test for malignant and pre-maligent changes in the cervix. A positive result may require further diagnostic procedure, which may include biopsies. The process of this test, gently scraps cells from the cervix, smearing them onto a microscope slide, and sending it to a pathologist for examination. The classification of Pap Test results, within a range of Class “I” (Normal) to Class ‘V” (Suspicious for an invasive cancer). The result of a Pap test is not 100 percent accurate, and sometimes misinterpretation of the slide occurs by the pathology laboratory. Ten percent of women with obvious visible palpable cervical cancer have a non-suspicious Pap test. This test is conducted during a pelvic examination. The examination is performed to evaluate the female reproductive tract, includes the vagina, cervix, uterus, ovaries, and fallopian tubes. The physician uses an instrument called a speculum, opens the vagina just enough to allow light to observe the surface of the skin. Besides, physician uses lubricated gloves to feel for any abnormalities of the female organs. Also, maybe a cotton swab will be used to take a sample of fluid from the vagina or cervix containing cells. The sample will be send to a laboratory for testing.

Studies suggest the cervical cancer or cervical dysplasia caused by Human Papilloma Virus (HPV) or contributes to this cancer. The same virus causes genital wart or condyloma (sexually transmitted Disease (STD)). Certainly a possibility, HPV may have been present for years. Seventy-five percent of women are exposed to HPV at some point in their lives.
There are over sixty subtypes of HPV and only a few directly or associated to cause cervical cancer or dysplasis, which needs to be treated.

Treatment for cervical cancer depends on various factors including: age, general health, tumor size, stage of the disease, speed of cell growth and degree of spreading, effect of female hormones on tumor size and patient’s desire to have children in the future.

A vaccine for cervical cancer is undergoing tests by Merck & Company and GlaxoSmithKline. Merck’s vaccine (Gardasil) will provide 100 percent protection, against two of the most common cancers (70 percent), causing HPV strains of 16 and 18. Also, the vaccine would prevent two causes of genital warts (HPV 6 and 11 strains) -sexually transmitted infection affecting up to two percent of adults. Previous test results of 12,000 women, (ages 16 to 26 from thirteen countries) confirms the effectiveness of the vaccine. The vaccine would trigger the body’s immune system to attack the Human Papiloma Virus. Concerns of this vaccine: Some women that have undergone testing of this vaccine, developed dangerous pancreas lesions caused by HPV types. Dr. Nancy Miller, an FDA reviewer, cautioned that Gardasil does not necessarily protect against one or more of the four viruses in people already infected before they get the vaccine, and can increase the risk for precursors to cervical cancer. Also, previous test documentation, revealed five children born with birth defects to women who received the vaccine, around the time of conception. Merck said “highly unlikely”, Gardasil related to the birth defects. The vaccine maybe helpful for men, have intercourse with other men. However, Merck has not disclosed any data on whether the vaccine works in men. GlaxoSmithKline has a competing rival vaccine under review called Cervarix. Cervarix targets HPV types 16 and 18, the highest risk type. As of May 2006, Cervix is under Phase three trials testing, (Gardasil had gone through Phase two and three, which requires for FDA approval) and expected to be submitted to the FDA for approval by the end of 2006. However, this vaccine does not provide wart protection. Also, according to research studies, Cervarix should be effective for more than four years. Gardasil and Cervarix would be administered in three doses. The second dose is given two months after the first dose. The third dose is given four months, after the second dose.

Controversy concerning cervical cancer vaccine, conservatives oppose to a mandatory vaccine for young women (receive the vaccine before puberty), because taking the vaccine may encourage some women to be more sexually active, believing the vaccine will prevent in the future getting this sexual transmitted disease.

In 2006, Merck submitted their vaccine (Gardasil) to the Food and Drug Administration for review. In May 2006, FDA advisory committee voted 13 – 0 to endorse the safety and effectiveness of Merck and Company Gardasil, which blocks viruses that cause cervical cancer. Their recommendation includes giving the vaccine to girls eleven to twelve years old. Also, considering the recommendation for administering the vaccine to females 13 to 26 years old. The company expects the vaccine will reduce worldwide deaths by two-thirds. The administration for the vaccine includes three shots over six months, cost between: $300 to $500. Unfortunately, the current cost may impede worldwide vaccination. Expected by June 8, 2006, the FDA will provide their decision, if Gardasill will be approved, based upon the advisory committee recommendation. If this vaccine is approved, will reduce health care costs by reducing the number of cancers and pre-cancerous conditions requiring expensive treatment. Financial analysts believe Gardasil sales could exceed $1 billion a year for Merck. The company is seeking to license Gardasil in more than 50 countries.

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