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Trying a Pill to Prevent HIV
Worldwide Trials of Drug to Stem HIV Infections Raises Behavioral Questions
By LAUREN COX
ABC News Medical Unit
January. 20, 2009
In a massive medical trial on three continents, doctors are testing a controversial pill that could temporarily boost immunity against HIV before a person is even exposed to the virus. If the pill works safely, doctors must then address whether such a drug, if made widely available, could actually worsen the AIDS epidemic.
The pre-exposure pill undergoing testing seems promising, since HIV drugs taken within days after exposure to the virus have been shown to reduce the risk of infection by 80 percent. But public health officials debate whether people at high risk for the virus, such as men who have sex with men, would be more likely to set aside the use of condoms to instead rely on a drug regimen that doesn't provide full protection against the disease, which is spread by contact with the blood or semen of an infected person.
Dennis, a 47-year-old gay man from Atlanta, is one of the test subjects for the new pill. He calls himself "blessed" for escaping the HIV epidemic that hit many of his friends in the 1980s. But his HIV-negative status hasn't stopped him from having sex with infected partners.
"If you just say that you're not going to have sex with anyone who's HIV positive , here you're eliminating a whole bunch of wonderful people," said Dennis, who asked that his last name be withheld. "How shallow would that be?"
He was recruited for the clinical trial for PreP, or pre-exposure prophylaxis for HIV prevention, with a drug called tenofovir.
"I was eager to take it," said Dennis. Since he was already using condoms, he said, "It couldn't hurt. I'll know in June if I was taking the real McCoy, or if it was the fake pill."
Soon after he started the trial, he noticed the doctors were trying to study his behavior as much as the drug's side effects. Each time he went for a monthly checkup, HIV test and counseling, Dennis said the director of the study, Lynwood Miller at the AIDS Research Consortium of Atlanta, kept asking him about his sex practices.
"I don't think I was any more promiscuous just because I was taking the drug," he said. "I didn't put myself at risk just to test the drug. I'm not that crazy."
Behavior Could Determine Fate of HIV Drug
But doctors worry that others who are at risk for HIV might well put aside their condoms for unprotected sex -- relying on the partial protection of the drug.
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AIDS group alleges Viagra ads promote drug's recreational use
CNN: POSTED: 2:15 p.m. EST, January 22, 2007
WASHINGTON (AP) -- An AIDS organization sued Pfizer Inc. on Monday over ads the group says encourage use of Viagra as a party drug. The nonprofit group said such recreational use furthers the spread of HIV and other sexually transmitted diseases.
The suit, filed in Los Angeles by the AIDS Healthcare Foundation, calls Pfizer's ads for the impotence drug false and misleading. The suit echoes allegations made in an ad campaign announced by the group last month.
The nonprofit group alleges the marketing of Viagra has fostered an increase in the spread of STDs. Studies have found the drug is used -- illegally -- in conjunction with crystal methamphetamine to form a party drug "cocktail."
While crystal meth can heighten sexual desire, it also can impair the ability to have an erection, said Michael Weinstein, president of the AIDS Healthcare Foundation. "In order to satisfy that heightened desire, you have to take Viagra," Weinstein told reporters.
Pfizer denied it promotes the recreational use of its blockbuster drug. In 2005, Pfizer had $860 million in U.S. Viagra sales, according to IMS Health Inc.
The suit, filed in Los Angeles Superior Court, seeks to halt the New York company from running ads like those that have promoted the drug's use on New Year's Eve and Super Bowl Sunday, said Tom Myers, the AIDS group's legal counsel. The ads, which included taglines like "Be this Sunday's MVP" encourage recreational use, the group alleges.
The suit also seeks to force Pfizer to undertake a public information campaign on the dangers of misusing and abusing the prescription drug. Furthermore, it seeks an unspecified amount to cover an increase in treatment costs borne by the nonprofit group, which runs free treatment clinics.
Pfizer said it and a company foundation already support AIDS prevention efforts, including a three-year, $6 million project undertaken in 2003 in nine Southern states.
The advertisements in question featured younger-looking men than did earlier Viagra ads that used retired Sen. Bob Dole, then in his 70s, as a pitchman. Myers said the newer ads imply the drug is meant to enhance the sexual experience and not to treat a medical condition.
A Pfizer official warned against confusing age with the degree of impotence.
"The age of the personality that's always seen in promotional materials doesn't necessarily depict severity," said Dr. Ivan Levinson, senior medical director for Pfizer Urology and Sexual Health.
The AIDS Healthcare Foundation also wants the Food and Drug Administration to step up its oversight of Viagra ads.
An FDA spokeswoman didn't immediately return a message left seeking comment.
In 2004, the FDA warned Pfizer that some television ads for Viagra made it clear the drug was for sex, but failed to note it was to treat impotence. The ads also failed to provide information on its major side effects, according to the letter.
Filing of the suit came as Pfizer announced it would cut 10,000 jobs in seeking to trim its annual costs by $2 billion.
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by Lucile Scott, February/March 2007
Is exclusively picking sexual partners of the same HIV status —a tactic called serosorting—the safe way to condomless pleasure and freedom from transmission worries... or is it risky self-segregation?
In the late ’90s, having lived with HIV for more than a decade, Robert Brandon Sandor found himself, thanks to the protease revolution, suddenly looking at a longer life expectancy-—and looking for love. Like many other HIV positive men, Sandor prefers to date and have sex only with positive men, both because he wants emotional support from someone who understands the strain of life with HIV and because he desires to once again engage in unprotected sex. However, short of wearing a T-shirt proclaiming his HIV status and romantic inclinations, he had few ways of locating other positive partners at the time. “There were no HIV-positive-only sex parties, socials, dating services or online hookup sites,” he says. So in April 1999, the resourceful Sandor placed an ad in NYC’s free gay magazine HX for a sex party he organized, called POZ Club—NYC (unaffiliated with this magazine). It was one of the first publicly advertised positive-only parties in the country. Sandor soon branded the monthly soiree Brandon’s POZ Party and took it digital, helping more men find the party’s dates and locations and letting them meet via an Internet message board.
Today, cyberspace offers dozens of options for positive people to look for casual sex or relationships, such as online profiles that allow them to anonymously proclaim their HIV status, positive or negative, before even swapping hellos. Since mainstream heterosexual-oriented hookup websites infrequently mention users’ HIV status, more and more straight people are pursuing HIV positive encounters on positive-only dating sites. “There is a greater sense of self-esteem, empowerment, belonging and support,” says Sandor of the benefits of same-status loving.
Many positive people have based sexual and romantic choices on serostatus since the beginning of the epidemic, but this type of personal choice has become known by its clinical label: serosorting. Same-status, or seroconcordant, love can alleviate pressures around things like disclosure, fears of infection and being with a lover who doesn’t understand life with meds and HIV. While some define serosorting as having only same-status mates, others define it as selecting sexual practices, such as condomless sex, based on knowing a partner’s status, whether the same or different. The latter definition is now supported by no less an authority than the San Francisco Department of Public Health (SFDPH) as an effective HIV prevention tactic, while other urban health departments, from Seattle to Denver to New York, are currently researching serosorting’s potential to drive down new infections.
SFDPH predicts that new HIV infections among men who have sex with men (MSM) citywide will be about 20% lower in 2006 than in 2001. The department attributes the phenomenon primarily to serosorting, which studies show has been on the rise among MSM in the Bay Area since the late ’90s. Despite such evidence, the SFDPH still shocked many AIDS advocates and people with HIV last November, when it plastered the town with psychedelic posters featuring giant silhouettes of buff naked men embracing in erotic poses with their HIV status—sometimes the same for each couple, sometimes opposite—branded on their shoulders. The caption read: STATUS-SORTING IS A PREVENTION STRATEGY.
It seemed that even before the glue could dry on all the posters, AIDS community members from across the nation had begun to weigh in on the campaign, the first in the U.S. to support serosorting as a prevention strategy. Some applauded that a big-city health department finally acknowledged that two decades of feeding gay men an all-condom- all-the-time prevention approach might not be realistic, especially in a post-HAART world. “The serosorting behavior our participants have reported could have reduced the number of new infections caused by people having random sexual occurrences by 99%,” says Jeff McConnell, project director of the Positive Partner Study at the University of California, San Francisco’s J. David Gladstone Institutes.
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Martin Delaney - The accomplishments of people living with HIV/AIDS
by Mark Hubbard - January 26, 2009
Last Monday, the National Institute of Allergies and Infectious Diseases awarded a Director’s Special Recognition Award to Martin for his many contributions to the fight against HIV/AIDS.
By now, many of you know that Martin Delaney (of Project Inform) died peacefully Friday morning surrounded by friends and family in San Francisco.
At last year’s Positive Living conference in Fort Walton Beach, Florida, Martin provided the annual treatment update. Martin only missed one meeting in the conference’s eleven-year history, having had a heart attack a week before the event. Positively Living is one of very few U.S. conferences remaining that are targeted specifically (and almost exclusively) to PLWHAs. A member of the audience was so inspired by Martin’s remarks concerning the role of activism in the history of HIV/AIDS that he approached Martin and conference organizer Butch McKay about creating a session on the subject for this year’s event.
As the gentleman and Martin began emailing back and forth, they copied Butch with the product of their efforts. For some reason the correspondence petered out in March of this year. Earlier this week, as a member of the conference planning committee, I volunteered to help format the rough document. This year’s Positive Living will feature a special tribute to Martin. I can’t think of a better way to honor his memory than to pass on this version of what Butch has deemed the “Delaney Declaration.”
The Delaney Declaration
By Martin Delaney
The entire human population benefited from the way AIDS first struck the gay community. Many people wanted to blame the spread of AIDS on gay people, but the facts are exactly the opposite. The epidemic would have been dramatically worse if it had struck any other group than gay people.
Most diseases uniformly strike an entire population, spreading lightly across all economic, geographic, racial, and gender groups. As a result, nothing really unifies the patient population other than the disease itself. As a consequence, people do not bond together or organize to fight the disease because they have nothing in common that connects them.
You can see this in virtually all other major diseases. There may be millions of people who have a disease but they fail to organize to fight it. They don’t demonstrate, they don’t group together to influence the Congress, they don’t develop media strategies. They just go on with their various local groups and families and fight the disease simply as individuals.
In great contrast, when AIDS hit the gay community with unparalleled specificity, it struck a group that already identified itself as a community across the entire nation. It struck a group of people who were already organized politically with skills to influence both local and national government; it struck a population that that already knew it had to fight for its rights, even fight to survive. It knew how to use the media. It knew it had to take care of its own because no one else would. It knew it had to fight back or die.
We [the gay community] were in San Francisco, Los Angeles, New York and every other major country, yet linked together. Wherever, we were a part of a whole. We were in the scientific community; we were in the NIH (the United States’ medical research agency, the National Institutes of Health). We were in the drug companies and in Congress. Because of this unique situation, AIDS faced a far more formidable and organized enemy than had ever before been the case. Had AIDS simply hit across all the general segments of society, like other diseases, it would have encountered far less resistance. People getting the disease would have had nothing in common with each other, no underlying links or abilities, or any need to see itself as a fighting force. It would have been just another disease and it would have been treated like just another disease.
But we know it was not just another disease. It was far cleverer, more dangerous, and spread quietly because it acted slowly. It continued to spread for decades before society would even know it was there. In contrast when it struck the gay community, our underlying culture made it visible much more quickly. Within a few short years, we were able to see that it was sexually transmitted.
The normal rules for people with life threatening illnesses didn’t work very well. Usually such people are too sick to do anything about it. We saw our entire community under siege; we knew we had to change the rules or we would all be dead.
We hollered about it in the media, we went to the FDA (the United States’ Food and Drug Administration) and the NIH, we marched in Washington, got people on committees and proposed new ideas and new ways of thinking about science and the treatment of people with terrible diseases. WE changed the rules, first for ourselves but ultimately for everyone facing a life threatening disease. WE wouldn’t just listen to our doctor either. We recognized that they worked for us, that we were in charge of our lives and our bodies. We taught each other to demand that our doctors act as partners, not as dictators. We changed the doctor patient relationship. We realized that patient education was ultimately going to be done either by drug companies or by the patient community itself; we organized ourselves to teach ourselves.
We became a voice that could counter, when necessary, the messages of the drug companies, drug company advertising, and everything the companies did that affected us. As activists, we formed teams to speak up for our community regarding clinical trials.
The accomplishments of people living with AIDS:
1.Having an instrumental role in changing the rules for drug discovery, development and approval for life threatening illnesses
2.Greatly speeding up access to new drugs, both in and outside of clinical trials.
3.Changing the mindset of researchers about the wisdom of providing early access to experimental drugs.
4.Patient empowerment - helping people understand that they don’t have to be victims of a disease, but can instead be leaders in the fight against it.
5.Changing the patient mindset from hopelessness to hope; helping people see that there is always something you can do.
6.Demonstrating that you don’t have to be a scientist to influence science and have it serve people.
7.Discovering how to be taken seriously by scientists, academics and government bureaucrats, and how to influence them with without making them the enemy.
8.Learning how to organize to influence government policy.
by Lucile Scott - January 2007
Thursday, February 10, 2005 Posted: 3:25 PM EST
Will a federal bill finally legalize jailhouse condoms?
Condoms are illegal in most American penal systems, yet 40% to 60% of inmates report engaging in sexual activity, and HIV rates among the incarcerated are up to eight times that of the general population. Last September, Rep. Barbara Lee (D-Calif.) introduced a federal bill to slip latex behind federal prison bars. (Condoms are currently permitted in jails in only a few cities, including Los Angeles, and in the state of Vermont.) Less than three weeks later, Republican Gov. Arnold Schwarzenegger vetoed a California bill—approved by the state legislature—that would have legalized condoms in state prisons. “We need to break the silence and get our heads out of the sand,” says Lee. “Sexual activity does occur in prisons, and we must allow condoms.”
One-third of African-American men pass through the penal system and, due to higher incarceration and HIV rates, are 3.5 times more likely to die from AIDS while in prison than their white counterparts. More than 90% of all inmates are eventually released, many unknowingly infected with HIV, meaning that rising HIV rates in prisons fuel the epidemic on the outside, where it is the leading cause of death in black women between the ages of 24 and 35.
Schwarzenegger’s office would not comment and instead referred POZ to the governor’s veto statement, which argues that the bill conflicts with the existing penal code, which bans sex in prisons. “We were definitely surprised,” says Sean Barry of the Community HIV/AIDS Mobilization Project, which last October helped push to get condoms in Philadelphia prisons for the first time. “It may have been an example of him tending to the interests of social conservatives before an election instead of focusing on what would benefit the state.” Lee says, “I was appalled.”
In addition to permitting condoms in prison, Lee’s bill would also improve access to HIV education, testing, counseling and treatment for the incarcerated. Lee says that while it may be hard to get her bill passed under a conservative administration, “We will fight until it gets done.” Barry adds that even if the bill doesn’t pass, it will help turn talk of HIV in prison toward evidence-based prevention strategies that actually reduce HIV rates. The perfect inside job.
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New York to tout official city condom
CNN: POSTED: 12:15 p.m. EST, January 25, 2007
Mayor Michael Bloomberg's administration wants to reduce rates of sexually transmitted diseases and AIDS, and part of the strategy is the aggressive promotion of free condoms. Officials say more people will use them if they have jazzy packaging.
One idea is a subway theme, with maps on the wrappers.
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"Brands work, and people use branded items more than they use nonbranded items, whether it's a cola or a medicine even," Health Commissioner Thomas Frieden said.
New York hands out 1.5 million free condoms each month, or about 18 million a year. Hundreds of organizations get free condoms from the city and distribute them at health clinics, bars, restaurants, nail salons, nightclubs and even prisons.
Widespread free distribution started after Frieden became health commissioner in 2002 and found that the city's STD clinics were limiting each patient to just a small number.
"I thought that was nuts -- of all the people you'd like to have an unlimited supply of condoms, it's people who have an STD," Frieden said. "Condoms work; they're just not where they need to be as often as they need to be."
There is even a bowl of condoms outside Frieden's office.
More than 100,000 New Yorkers are living with HIV and AIDS. AIDS remains the third-leading cause of death among New Yorkers under 65.
The number of condoms distributed by the city multiplied several times over after the health department launched its online ordering system in 2005.
Individuals cannot order, but any organization or venue can request unlimited free condoms.