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Dr. Donnica Discusses Cervical Cancer Vaccine on GMA

(Far Hills NJ, 4/6/05): Dr. Donnica Moore, President of Sapphire Women's Health Group and host of DrDonnica.com will appear on ABC's "Good Morning America" tomorrow, April 7, 2005 to discuss exciting data about the cervical cancer vaccine in development just released in the medical journal Lancet Oncology. These new data confirm previous studies showing that a vaccine to prevent human papilloma virus (HPV)--the sexually transmitted virus that causes cervical cancer and genital warts--could reduce persistent infection and disease by 90%. "This is important information for all women and men," emphasizes Dr. Donnica "because HPV infection is widely spread throughout the majority of our adult population, and most people don't know that they are infected."

Up to 70% of sexually active women will become infected with HPV during their lifetime. Worldwide, cervical cancer is the second most common cause of cancer-related death in women. HPV causes nearly 470,000 cases of cervical cancer each year. Although most cases of cervical cancer occur in the developing world where routine cervical screening programs are not readily available, in 2004 nearly 31,000 women died from cervical cancer in Europe and more than 4,000 women died from cervical cancer in the United States. HPV infections are also responsible for genital warts in 1-2% of young adults. Genital warts can cause pain as well as sexual dysfunction. Recurrence is common and treatment is inconvenient, uncomfortable, and expensive.

There are more than 100 strains of HPV which have been identified. Ten of them have been shown to significantly increase the risk of cervical cancer. This study, conducted by Luisa Villa (Ludwig Institute for Cancer Research, Brazil) and colleagues, tested the effectiveness of a vaccine which targets four strains of HPV: types 16 and 18, which are associated with 70% of cervical cancers and types 6 and 9, which are associated with 90% of genital warts. The study evaluated 552 healthy women aged 16-23 from Brazil, Europe and the USA. These women were not pregnant, had no previous abnormal cervical smears and reported a history of four or fewer sexual partners. 277 women were randomly assigned to receive 3 doses of the intramuscular vaccine over a 6 month period; 275 women received a placebo. The women were followed up for 36 months and underwent regular gynecological examinations, tests for HPV DNA, and cervical smears. After 3 years, the incidence of persistent infection or disease with HPV 6, 11, 16, or 18 fell by 90% in those who received the vaccine compared with those who took the placebo. The vaccine was 100% effective against precancerous cervical lesions and genital warts associated with these four HPV types. There were no vaccine related serious adverse events reported.

The study authors suggest that universal HPV vaccination might be most effective if implemented in 10-13 year olds, who are likely to be HPV negative. According to another study, a female college student had a 60% likelihood of becoming infected with HPV during her four years in college. Vaccinating 10 to 13 year olds is likely to meet with some resistance, however, by parents reluctant  to admit that their children might become prematurely sexually active or might ever become at risk for a sexually transmitted infection.  Dr. Donnica wants to dispel any stigma associated with HPV infection. "Contracting an HPV infection doesn't mean that you're promiscuous; it means that you had sex one time with one person who probably didn't even know that they were infected," she said.

Dr. Villa comments that "In the developed world, full implementation of cervical-cancer screening has substantially shifted the burden of HPV infection from cervical cancer mortality to management of precancerous lesions. In these countries, in addition to further reduction in incidence of cervical cancer, universal HPV vaccination might decrease the medical, psychological, and economic costs associated with the management of abnormalities detected by screening. Inclusion of HPV 6 and 11 in a vaccine could also diminish the incidence of genital warts. In developing countries that have not implemented screening programs for cervical cancer, a universal HPV vaccine could substantially reduce the incidence of the disease."

There are currently two different vaccines for HPV in development. The one studied in this clinical trial is expected to enter the FDA approval process sometime in 2005. It is hoped to be available in the United States in 2006. Until then, to reduce your risk of cervical cancer, practice safe sex, have routine Pap smears, and if you are a woman over 30 years old, ask your doctor if you should have the DNA with Pap test which can identify if you have been infected with HPV.

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