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October 2009 Archives

For Immediate Release: Oct. 16, 2009

Media Inquiries: Shelly Burgess, 301-796-4651,
Consumer Inquiries: 888-INFO-FDA

FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys

The U.S. Food and Drug Administration today approved use of the vaccine Gardasil for the prevention of genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26.

Each year, about 2 out of every 1,000 men in the United States are newly diagnosed with genital warts.

Gardasil currently is approved for use in girls and women ages 9 through 26 for the prevention of cervical, vulvar and vaginal cancer caused by HPV types 16 and 18; precancerous lesions caused by types 6, 11, 16, and 18; and genital warts caused by types 6 and 11.

HPV is the most common sexually transmitted infection in the United States and most genital warts are caused by HPV infection.

"This vaccine is the first preventive therapy against genital warts in boys and men ages 9 through 26, and, as a result, fewer men will need to undergo treatment for genital warts," said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research.

Gardasil's effectiveness was studied in a randomized trial of 4,055 males ages 16 through 26 years old. The results showed that in men who were not infected by HPV types 6 and 11 at the start of the study, Gardasil was nearly 90 percent effective in preventing genital warts caused by infection with HPV types 6 and 11.

Studies were conducted to measure the immune response to the vaccine in boys ages 9 through 15. The results showed that the immune response was as good as that found in the 16 through 26 years age group, indicating that the vaccine should have similar effectiveness.

The manufacturer will conduct postmarketing studies to obtain additional information on the safety and effectiveness of Gardasil in boys and men.

Gardasil is given as three injections over a 6-month period. Headache, fever and pain at the injection site, itching, redness, swelling and bruising, were the most common side effects observed.

Gardasil is manufactured by Merck and Company Inc. of Whitehouse Station, N.J.

Gardasil product information:

Operation Allied Again Meth

Posted by Project NEON on October 14, 2009 4:45 PM

2009 Anti-Meth Ad Campaign

Posted by Project NEON on October 14, 2009 4:03 PM

2009 Anti-Meth Ad Campaign
View campaign:

Office of National Drug Control Policy's National Youth Anti-Drug Media Campaign has coordinated the National Anti-Meth Campaign since 2007. Using national data as a guide, the campaign has reached out to areas and populations hardest hit by meth, through TV, radio, print, and online advertising, as well as media events.

The 2009 Anti-Meth Campaign, which launches in September 2009, focuses on preventing methamphetamine use - and raising awareness about treatment and recovery. The target audience for this campaign is young adults ages 18 to 34, as well as family and friends of someone who may be using meth. This young adult target was specifically chosen because methamphetamine initiation and usage rates are highest in this age group nationwide.

The 2009 Anti-Meth Campaign's TV, billboard, radio, print, and online ads will run from September to November in 16 states with the highest methamphetamine use rates, as well as a small group of Midwest states with high levels of reported meth lab seizures and incidents, according to national data. The 16 states are: Alaska, Washington, Oregon, Nevada, Wyoming, Arizona, New Mexico, Oklahoma, Arkansas, Missouri, Iowa, Minnesota, Illinois, Indiana, Kentucky, and Nebraska. Additionally, radio ads and online search ads will run in all states during the same time period.

At the conclusion of the campaign in November, many of the ads will be available as free, customizable public service announcements (PSAs) for use by local non-profits, government offices, and other organizations. The TV ads will be available as free customizable PSAs in early 2010.

Washington Meth Situation and Prevalence

Posted by Project NEON on October 14, 2009 3:58 PM

Meth Situation and Prevalence
Get Treatment Help
Call 206.323.1768

Methamphetamine is a widely abused drug in Washington and one which impacts all levels of the community. Crystal methamphetamine (aka "ice"), which dominates the market as the preferred form of methamphetamine, is readily available throughout the state. Mexican drug trafficking organizations are primarily responsible for the importation and distribution of methamphetamine in Washington, most of which is now produced in Mexico. Clandestine methamphetamine lab activity within the state has decreased over the years. This is likely due in part to state and federal legislation, which has hindered accessibility to chemicals such as pseudoephedrine. (Source: Drug Enforcement Administration, Washington State Factsheet, 2008)

According to 2004-2007 data from the National Survey on Drug Use and Health, approximately 1.45% of persons aged 12 or older in Washington reported using methamphetamine within the past year. (Source: Substance Abuse and Mental Health Services Administration, National Survey on Drug Use and Health, 2004, 2005, 2006, and 2007)

Results of a 2008 survey of Washington students show that approximately 2.8% of 8th graders, 4.7% of 10th graders, and 5.6% of 12th graders reported using methamphetamine at least once during their lives. (Washington State Department of Health, State Youth Survey, 2008, 2009)

The Washington State Attorney General's Office provides information regarding the effect of methamphetamine on the state through the Operation: Allied Against Meth section of their Web site. Law enforcement efforts, the effect of methamphetamine on children, education and community outreach, relevant legislation, and additional resources are provided.

A drop in group for gay/bi men in recovery from Crystal meth

Posted by Project NEON on October 14, 2009 9:23 AM

**Strength Over Speed (SOS) a grassroots, all volunteer community based project whose mission is to help gay and bisexual men maintain recovery from crystal meth addiction and Seattle Counseling Service, a unique resource to help members of the LGBT communities navigate the path to recovery and wellness, collborate to provide Crystal Clear - a safe, welcoming drop-in group for gay/bi men in recovery from crystal meth.

If you are a gay/bi man who has started on the road to recovery or is well traveled on that road and need additional support - drop -in!

Every Tuesday from 6 pm - 7:30 pm at Seattle Counseling Service (1216 Pine st @ Melrose).

Crystal Clear is free and light refreshment and snacks are provided.
206.323.1768 x 209 for more info

**Additional SOS meetings:
303 17th Ave E. @ Thomas (Dunshee House)

Harborview's Madison Clinic - Ground Floor, West Wing*

303 17th Ave E. @ Thomas (Dunshee House)

1002 E. Seneca, enter lower E. parking lot (Lifelong AIDS Alliance)

New Chemically-activated Antigen Could Expedite Development Of HIV Vaccine
ScienceDaily (Sep. 30, 2009) -- Scientists working to develop a vaccine for the human immunodeficiency virus (HIV) report they have created the first antigen that induces protective antibodies capable of blocking infection of human cells by genetically-diverse strains of HIV. The new antigen differs from previously-tested vaccines by virtue of its chemically-activated property that enables close sharing of electrons and produces strong covalent bonding. Researchers used a mouse model to generate the antibodies.
The report by researchers at The University of Texas Health Science Center at Houston is online and will appear in a print issue of the Journal of Biological Chemistry in November.
"The complexity of HIV has for long thwarted development of an effective HIV vaccine. Our findings open a new path toward an effective preventative and therapeutic vaccine," said Sudhir Paul, Ph.D., the study's senior author and a professor in the Department of Pathology and Laboratory Medicine at The University of Texas Medical School at Houston. "The new antigen is a prototype vaccine. This prototype successfully eliminates nature's restrictions on the production of broadly-neutralizing antibodies to HIV by the immune system."
Thirty-three million people were living with HIV at the end of 2007, according to the World Health Organization. That same year, nearly 3 million people became newly infected, and 2 million died of acquired immunodeficiency syndrome or AIDS, which occurs at the most advanced stages of HIV infection. Vaccines work by introducing an antigen into the body, which spurs the immune system to produce antibodies that guard against infection. Previously-tested HIV vaccine candidates stimulated vigorous production of antibodies to the mutable segments of the virus envelope. But, these vaccine candidates did not stimulate the production of antibodies to the regions essential for virus attachment to host T cells, the process that initiates infection.
Scientists in Paul's laboratory used a chemically-activated form of the HIV envelope protein gp120 to stimulate the production of mouse monoclonal antibodies that block infection of cultured human cells by genetically-diverse HIV strains from around the world. Paul said these same antibodies can be found in humans who remain free of AIDS despite long-term HIV infection. "HIV infection itself stimulates production of this class of antibodies, but the amount is too small to control infection. The challenge is to boost production of the protective antibodies in humans using a vaccine."
Because of the genetic variability of HIV, most antibodies fail to stop infection initiated by thousands of different HIV strains responsible for the pandemic. "Dr. Paul's team has developed a revolutionary antibody technology and used it to overcome major obstacles to a vaccine for HIV. They identified antibodies that neutralized 100 percent of strains drawn from the major viral subtypes. Furthermore, they have developed ways to immunize animals to produce them. No previous vaccine candidate has even approached these objectives," said Robert L. Hunter, M.D., Ph.D., professor and chairman of the Department of Pathology and Laboratory Medicine at the UT Medical School at Houston.
The vaccine prototype builds on Paul's earlier discovery that a tiny stretch of amino acids numbered 421-433 in gp120 can serve as the Achilles heel of HIV. "Unlike the changeable regions of its envelope, this region must remain constant to attach to T cells. Equally important, HIV can survive only if the body's immune system fails to produce antibodies to this region. The virus minimizes production of antibodies to the vulnerable region because it also silences B lymphocytes, the cells responsible for producing antibodies," Paul said. "In nature, microbial antigens stimulate antibody synthesis when they bind antibodies on the surface of B cells by weak noncovalent forces. In the case of HIV, noncovalent binding of its cell attachment site induces a state of B cell tolerance, permitting infection to proceed unchecked. Our covalent vaccination approach breaks the tolerance and stimulates production of antibodies that inactivate the virus."
The tolerance signal is converted to a stimulatory signal because strong covalent binding to the B cells liberates a large amount of energy that is not available in traditional binding reactions, Paul said. Moreover, the prototype vaccine contains two modular antigenic regions. Binding of one region generates a stimulatory signal that overcomes the tolerance signal.
"There is another advantage. B cells have the unique capability of producing antibodies adapted to recognize the chemical groups we placed in the prototype vaccine. The adaptations impart enzyme-like activity to the antibodies, which results in exceptionally stable HIV binding, and sometimes, in catalytic breakdown of the viral coat. Consequently, the antibodies inactivate HIV effectively," Paul said.
"The failure of previous HIV vaccine trials has produced pessimism about the prospect of effective HIV vaccination. Our approach is promising but additional studies are necessary. To expedite development of the vaccine, we must maximize the antibody response and focus it even more at the HIV cellular attachment site," said Yasuhiro Nishiyama, Ph.D., lead author and an associate professor at UT Medical School.
"While the prototype vaccine induces antibodies that neutralize infection of isolated human cells, we must also show that the antibodies prevent the natural process of infection within the body," said Stephanie Planque, Ph.D., co-author and researcher in Paul's laboratory.
"The induction of antibodies that neutralize infection of human blood cells by diverse strains of HIV from various parts of the world is an important milestone. This is an entirely new vaccination approach that might bypass the natural constraints on developing effective immunity against HIV," said Carl Hanson, Ph.D., study co-author and head of the Retrovirus Diagnostic Section of the Viral and Rickettsial Disease Laboratory of the California Department of Public Health.
Others contributors in the study from the Department of Pathology and Laboratory Medicine at the UT Medical School, were: Yukie Mitsuda, Ph.D.; Giovanni Nitti; Hiroaki Taguchi, Ph.D.; Lei Jin, Ph.D.; Jindrich Symersky, Ph.D.; Stephane Boivin, Ph.D.; and Marcin Sienczyk, Ph.D. Maria Salas of the Viral and Rickettsial Disease Laboratory also contributed to the study.
The journal article is titled "Towards Effective HIV Vaccination: Induction of Binary Epitope Reactive Antibodies with Broad HIV Neutralizing Activity." The research was funded by the National Institutes of Health and the Texas Higher Education Coordinating Board.
Adapted from materials provided by University of Texas Health Science Center at Houston.

Study Highlights HIV/AIDS Challenge In American Prison System

Posted by Project NEON on October 1, 2009 9:49 AM

Study Highlights HIV/AIDS Challenge In American Prison System

ScienceDaily (Sep. 30, 2009) -- HIV/AIDS is up to five times more prevalent in American prisons than in the general population. Adherence to treatment programs can be strictly monitored in prison. However, once prisoners are released, medical monitoring becomes problematic. A new study by Dr. Nitika Pant Pai - an Assistant professor of Medicine and a medical scientist at the Research Institute of the MUHC - suggests the majority (76%) of inmates take their antiretroviral treatment (ART) intermittently once they leave prison, representing a higher risk to the general population.
"Over a period of 9 years, we studied 512 HIV positive repeat offender inmates from the San Francisco County jail system," says Dr. Pant Pai. "Our results show that only 15% continuously took their ART between incarcerations or after their release." According to the study, published in the journal PLoS ONE, these figures highlight a lack of effectiveness on the part of medical monitoring services for these people outside prison.
"Taking ART intermittently is a problem because it depletes the CD4 count - the immunizing cells that fight infection - and increases the probability of developing resistance to the virus," says Dr. Pant Pai. "The risk for rapid disease progression becomes higher and presents a risk for public health transmission of HIV to their partners." According to the study those on intermittent therapy were 1.5 times more likely to have higher virus load than those on continuous therapy; those who never received therapy were 3 times more likely to have a higher VL.
"The optimal solution for treating patients and controlling the HIV/Aids epidemic in the USA is to ensure continuous therapy," explains Dr. Milton Estes, medical director of Forensic AIDS Project, San Francisco. "To achieve this we must work on various aspects of the prisoner's lives, such as marginalization, psychiatric problems and drug use, both before and after their departure from prison." According to Dr. Jacqueline Tulsky, senior author of the study, "This research highlights the need to examine ART policies inside and outside correctional settings with a view to establishing effective life long management of HIV in prisoners."
"This research is the first observational study in American prisons to evaluate the impact of antiretroviral treatment (ART) over a nine year period. It demonstrates the need for effective community transition and prison release programs to optimize ART given in jails," explains Dr. Pant Pai.
The article was co-authored by Dr. Nitika Pant Pai, Infection and Immunity Axis at the RI-MUHC, Dr. Milton Estes, Forensic AIDS Project, Department of Public Health, San Francisco, Dr. Erica E.M. Moodie, Department of Epidemiology and Biostatistics, McGill University, Dr. Arthur L Reingold, Epidemiology Division, University of California, Berkeley, USA, Dr. Jacqueline P Tulsky, University of California, San Francisco, Positive Health Program, San Francisco General Hospital, USA.
Funding was provided by a grant from the National Institutes of Health.
Adapted from materials provided by McGill University Health Centre, via EurekAlert!, a service of AAAS.

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