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World AIDS Day Marks 20th Anniversary
World AIDS Day, marked annually on December 1, celebrates its 20th anniversary this year. The theme for 2008 event is leadership, continuing the theme of last year. Promoted with the slogan “Stop AIDS. Keep the Promise,” the aim of the leadership campaign is to highlight the discrepancy between promises made to stop the spread of AIDS and the actions that need to be and have been taken to follow through on these promises.
To celebrate the 2007 and 2008 World AIDS Day theme of leadership, the World AIDS Campaign launched the Stop AIDS Leadership Pledge in November 2007. In collaboration with partner organizations around the globe, this initiative asks people from all over the world to  pledge their leadership to help stop AIDS. Aiming for a goal of 100,000 pledges, organizers will use these commitments to create exhibitions, banners and other visibility actions during events in 2008 and 2009.
Individuals can take the leadership pledge at the World AIDS day site, opting to either speak to friends and family members about AIDS, write a letter or join a rally demanding universal access, or volunteer or donate to an AIDS cause. A list of pledges made across the globe can be viewed at the World AIDS campaign site.
The Centers for Disease Control and Prevention (CDC), in partnership with the Department of Health and Human Services, are also working to promote World AIDS Day through the website www.AIDS.gov and its  “Facing AIDS: World AIDS Day 2008” Campaign. “Facing AIDS” is a web-based campaign that focused on ways individuals can take action to show support for those living with HIV and AIDS and raise awareness as well.
CDC’s efforts also focus on HIV testing, creating web buttons to promote HIV testing for use on social networking sites such as Facebook and MySpace, and utilizing text messaging to connect people with local resources. With this latter service, cell phone users can send a text message of their zip code to “KNOWIT” (566948). to receive a text message containing one or more local HIV testing sites.
For more information about HIV and AIDS, visit the ASHA site and message board forums.
FDA Issues Final Rule on Condom Labeling
After an extended review, the federal Food and Drug Administration (FDA) recently published final rules governing the labeling of male latex condoms. Following the evaluation of both clinical and epidemiological research as well as public comments on proposed changes to labeling, the FDA concluded that “scientific evidence today continues to fully support the overall effectiveness of latex condoms in reducing the risk of transmission of common STIs.”
Changes to condom labeling were originally proposed in 2005. Among the proposed changes at that time included language specific to STDs: “Condoms provide less protection for certain STDs, including genital herpes and human papillomavirus (HPV) infection, that can also be  spread by contact with infected skin outside the area covered by the condom. Condoms cannot protect against these STDs when they are spread in this way.”
When the FDA solicited public comment on the suggested changes in 2005, they received more than 100 responses from consumers,
health professionals, industry, academia, state and Federal government
agencies, as well as professional societies and organizations. After a review of public comment, as well as current research on condom effectiveness, the FDA concluded that recent studies confirmed that latex condoms can reduce transmission risk, and cited recent studies on HPV specifically that provided additional evidence to support this conclusion.
As stated in the federal register, “The benefit of this final rule is that establishing the labeling guidance as a special control ensures that manufacturers will provide consumers with the information they need to make an informed decision regarding the use of latex condoms and to use them safely and effectively. The labeling guidance helps ensure that information provided to consumers does not undervalue the overall STI-risk reduction provided by latex condom use, but does not exaggerate the effectiveness of latex condoms against certain types of STIs.”
This final rule will go into effect January 9, 2009. While latex condoms that were legally marketed prior to the effective date of this final rule will have 11 months from that date to comply with the new labeling requirements, new products will be required to comply immediately upon the rule taking effect.
HPV Vaccine Shown to Prevent Genital Warts in Men
Recent results of a Phase III clinical trial involving Gardasil, a vaccine against four strains of human papillomavirus (HPV), indicate that the vaccine may help prevent genital warts in boys and men. Results of the study, funded by Merck, the manufacturer of Gardasil, were presented earlier this month at the annual meeting of the European Research Organization on Genital Infection and Neoplasia (EUROGIN).
Currently in the U.S., Gardasil is only approved for use in for girls and women aged 9-26. Yet while the vaccine provides protection against two strains of HPV associated with 70 percent of cervical cancer in females, it also protects against strains of HPV that cause genital warts that  effect both males and females.
The study evaluated approximately 4000 males between 16 through 23 years of age. Study participants received either three doses of Gardasil at regular intervals or a placebo. All participants were followed for 36 months. At the time of vaccination, participants had no evidence of genital lesions, no history of genital warts and five or fewer lifetime sexual partners.
Participants who were vaccinated with Gardasil were approximately 90 percent less likely to develop genital warts than those that received a placebo. No study participants experienced any serious side effects related to vaccination.
Merck intends to submit a supplemental Biologics License Application for Gardasil to the FDA by the end of 2008 for the use of the vaccine in boys and men ages 9 to 26 for the prevention of genital warts.
ASHA’s fact sheet on HPV vaccines addresses some of the most common questions about Gardasil and other vaccines in development. ASHA’s website also offers recent data on the safety of Gardasil.
Previous issues are available through the ASHA eNews archives. |
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