Vaccine for cancer-causing STI awaits FDA approval

by Beacon Staff • November 9, 2005

Pharmaceutical giant Merck & Company said it has created Gardasil, a drug found to be effective in immunizing against four common strains of the human papillomavirus (commonly known as HPV), based on results from three clinical studies.,"There may not be a cure for the most prevalent sexually transmitted infection (STI) among college students, but a new vaccine is offering some hope.

Pharmaceutical giant Merck & Company said it has created Gardasil, a drug found to be effective in immunizing against four common strains of the human papillomavirus (commonly known as HPV), based on results from three clinical studies.

Two of these strains are considered "high-risk" because they cause cell abnormalities in women that can sometimes lead to cervical pre-cancers and cervical cancer.

The other two "low-risk" strains cause genital warts instead of the "usually flat and invisible" high-risk types of the virus, according to the National Cancer Institute Web site, www.cancer.gov.

While the Food and Drug Administration (FDA) has not yet approved its use in the United States, if the drug is approved, it may be available to the public by next year.

HPV is the most common STI in the United States, according to the American Social Health Association's Web site www.ashastd.org. There are over 100 different strains of the virus, which is not necessarily prevented by condom use, the ASHA said.

More than 20 million people in the United States have HPV. Almost three out of four people between 15 and 49 will contract the virus in their lifetime, ASHA said. Because the virus is asymptomatic and undetectable, HPV can be spread among sexual partners unconsciously, ASHA said.

Merck's clinical studies have included adolescent men and women between the ages of 10 and 23, the pharmaceutical company said. The Resource Foundation Web site, www.resourcefnd.org, names high school and college students as the group with the highest risk of contracting the virus, and ASHA said that two-thirds of sexually transmitted infections are found in people under the age of 25.

For many young people the vast amount of complex information about HPV is difficult to comb through.

Nico Raineau, a freshman film major, had heard of HPV but wasn't aware of its symptoms or its connection with cervical cancer. "I just assume anything with letters is an STD," he said.The correlation between cervical cancer and HPV is often not understood. Marissa Rosado, a freshman TV/video major said that she was aware of the connection but thought the virus just caused warts.

For those women found to have abnormal or precancerous cell growth on her cervix, often caused by HPV, ASHA said, a health provider will usually call this cervical dysplasia. (Other possible names of the abnormal cell changes are: precancerous cells, cervical intraepithelial neoplasia, squamous intraepithelial lesions or warts on the cervix.) The resulting cancer can be life-threatening, so the impact of a vaccine on HPV could make the difference between life and death.

The possibilities of preventing cervical dysplasia causing HPV are higher by vaccinating both sexes because men are often the carriers of the virus and unknowingly infect their female partners, Merck said. Therefore it would be important for both sexes to get vaccinated with Gardasil before or soon after they become sexually active.

The implications of the drug, however, especially for teenaged and college-aged sexually active populations, including both males and females, are complicated.

Because people would ideally receive the vaccine before they become sexually active, Mary Jane Horton of Ms. Magazine recently wrote that parents might be hesitant to consider a child's future sexuality and to vaccinate their pre-teen for a sexually transmitted disease.

Horton believes that "if the vaccination is earmarked for cancer prevention-and the aspect of sexually transmitted disease downplayed-then more parents will be supportive."

Emerson's health care professionals share this concern. "You have to look at the current state of vaccines in the United States and the parents' perception of them," said Jane Powers, nurse practitioner and director of the Center for Health and Wellness. "Many [parents] are in denial that their kids will ever be sexually active," she said.

This could mean that, if the vaccine isn't given as a necessary precaution before a person becomes sexually active, then young people will have to actively seek the treatment on their own.

Alli Bizon, a freshman marketing communications and new media major, said that she has heard about HPV but did not know what it was. "[HPV] kind of freaks me out, but I don't plan on getting myself into a situation like that, but I guess you never know what's out there or who has something," Bizon said. "I think that the vaccine is a great idea. I think it is really helpful, and that it is a way to stay safe and still have freedom."

Freshman film major Chris Cullari said he did not know much about cervical cancer but he might get vaccinated if the drug was available. "Well, I wouldn't rule it out," Cullari said. "How much would they charge you for it?"

Bizon, however, said she was unsure about whether she would consider getting vaccinated. "In my current situation, it's not something that I would really worry about because I'm always really careful about protecting myself," Bizon said.

For those who are infected by HPV, the ACS said it is a common disease that a normal, healthy immune system can generally fight off on its own. If the immune system weakened, however, by cigarette smoking or alcohol consumption for example, then the virus can cause changes in cervical cells that can lead to cancer.

The American Cancer Society (ACS) stresses the importance of annual Pap tests for women to catch any abnormalities in cervical cells early, to increase the odds of preventing the manifestation of cervical cancer. A Pap test is taken by a gynecologist during a pelvic exam and consists of swabbing the cervix with a long brush or cotton tipped applicator to gather tissue which is then examined under a microscope for abnormal cells.

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