FDA approved cervical cancer vaccine.

On June 8, 2006 the FDA approved the HPV (human papilloma virus) and cervical cancer vaccine. After years of research, the FDA finally approved the drug Gardisil, a vaccine that has the ability to prevent health complications related to the human papilloma virus (HPV) and significantly decrease the rates of cervical cancer correlated to HPV. Considering the fact that in the US, 80 percent of women are said to have HPV by age 50, this vaccine can be considered a huge breakthrough for women's health. The vaccine works by affecting HPV types 6, 11, 16, and 18. Though there are many other strains of HPV, HPV 16 and 18 are reportedly responsible for about 70 percent of cases of cervical cancer, and HPV 6 and 11 with approximately 90 percent of the cases of genital warts. This means that a significant number of cases of cancer and genital warts related to HPV could be preventable if women receive the vaccine.

The vaccine is a three part injection recommended to girls and women between the ages of 9 and 26. Because the vaccine has been shown to be more effective when given prior to an individual's exposure to the virus, the FDA recommends that girls be given the vaccine as early as possible and stresses the fact that adolescents are an important group to vaccinate against HPV. If the vaccine is readily available and used by a majority of young women, the face of women's health could change considerably.

The approval of Gardisil has not come without controversy, though, and sexual politics have come into play surrounding the use of the vaccine. Some conservative groups have questioned the idea of approving Gardisil for young women fearing that it will encourage sexual promiscuity. Many of these groups support the vaccine as a medical tool but urge avoidance of its use, if possible, with sexual abstinence encouraged as the solution to HPV-related health issues. Groups in favor of the vaccine argue that the benefits are tremendous and should be taken advantage of to the fullest, which means administering it to young women as early as possible. It appears that public support leans in favor of the vaccine, as a survey of 525 mothers with children as young as 11 years old revealed that 80 percent would allow their daughters to receive a vaccine that helps prevent cervical cancer. However, the vaccine itself is being called the cervical cancer vaccine in the public media, not the HPV vaccine. This may be an attempt to emphasize the cancer prevention aspect of the drug, as opposed to the STD-prevention aspect to make it a more palatable medical solution for the mainstream public.

Other concerns outside the political arena have focused around price and side effects. The catalog price for Gardasil is $120 per dose; factor in three doses and you have a grand total of $360--a price that is on the high side for vaccinations. In response to the steep price, Merck has created a new patient-assistance program for vaccines. The company will provide free vaccines to uninsured adults who are considered unable to afford it, which will hopefully make the vaccine more accessible to a wider population of women in the U.S. Future research on Gardisil also hopes to test its affect on treating HPV related health issues in men, which would make it affective for an even wider population of people.

As with all vaccines and drugs, a common concern is the safety and the possible side effects. Studies report that Gardisil was generally well-tolerated, with fewer than 0.1 percent of participants discontinuing use due to adverse effects. Participants experiencing side effects complained of pain, swelling, erythema, fever, and pruritis, along with injection-site pain. As with any medical decision, it will be up to individuals to take responsibility for the decision to vaccinate themselves or their daughters, according to the information that is available and the cost/benefit analyses of receiving the treatment.

On a large scale, the benefits of Gardisil include a decreased rate of cervical cancer and genital warts, decreased medical costs associated with those complications, and the fact that developments and research in areas significant to women's health are being funded, approved, and made available to the general public.

For more information, you can look at the research from Merck & Co. at their website: www.merck.com and the press release from the FDA at www.fda.gov/bbs/topics/NEWS/2006/ NEW01385.html.

ACOG News Release: May 9, 2006

ACOG Recommends First Ob-Gyn Visit in Early Teens

The American College of Obstetricians and Gynecologists (ACOG) reaffirms its recommendation that teenage girls first visit an ob-gyn between the ages of 13 and 15 in a new committee opinion published in the May 2006 issue of Obstetrics & Gynecology. This initial reproductive health visit will help teens develop a relationship with their ob-gyn before they need to seek care for a specific health issue. The committee opinion details ACOG recommendations for the scope of the visit, discussion topics, and ways to address confidentiality concerns.

The early teen years are an ideal time for an initial ob-gyn office visit that focuses on screening and preventive health care. "During these years, young teens face new issues regarding sexual and reproductive health and development on a daily basis. It's important that they develop a relationship with their ob-gyn," says Marc Laufer, MD, chair of ACOG's Committee on Adolescent Health Care. "Interaction with an ob-gyn they trust allows teens to get answers to questions that they may be too embarrassed or afraid to raise with parents and friends. Ob-gyns also can encourage teens to adopt healthy lifestyle habits that they can carry into adulthood."

Physicians can discuss normal development, menstruation, sexuality, healthy eating habits, safety and injury prevention, and date rape prevention with teens. It also gives ob-gyns an opportunity to address problems that may require early intervention such as eating disorders and weight issues, blood pressure problems, and mental health issues such as anxiety, depression, and physical, sexual, and emotional abuse.

"Teens who are nervous about receiving a pelvic exam can rest easy. A pelvic exam is rarely necessary during the initial visit, unless indicated by medical history," Dr. Laufer adds. Because ACOG recommends that young women have their first Pap test approximately three years after vaginal intercourse but before age 21, teens may visit the ob-gyn several times before a speculum or pelvic exam is needed. However, ob-gyns may recommend a pelvic exam if the teen has had an abnormal puberty (pubertal aberrancy), abnormal bleeding, or abdominal or pelvic pain.

"The first reproductive health visit is an excellent time to discuss pregnancy prevention and sexually transmitted infections," says Lesley Breech, MD, vice chair of the Committee on Adolescent Health Care. Today, more than 85% of adolescents become sexually active during the teen years--nearly one-third of ninth graders and more than 60% of 12th graders report having had sexual intercourse, and the US has the highest teen pregnancy rate of any industrialized nation. "Physicians can use the visit as an opportunity to provide teens with early and accurate information about sex. We can talk about how to use condoms correctly and the various types of contraception that are available, such as emergency contraception, before they start having sex," Dr. Breech adds. If a teen is already sexually active at the time of her first visit, she can be screened for certain sexually transmitted infections through a urine sample.

Parents are encouraged to get involved. The first visit provides an opportunity for parents or guardians to meet the physician, alleviate fears, and develop trust. Parents also can encourage a positive relationship between their daughter and her ob-gyn. Ob-gyns can greet parents and teens together to give a thorough explanation of the visit and confidentiality issues. The exam and discussion should then continue between physician and teen alone to ensure privacy.

Committee Opinion #335, "The Initial Reproductive Health Visit," was published in the May 2006 issue of Obstetrics & Gynecology.