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A microbicide is a chemical
agent that kills a microbe—any infectious agent such as gonorrhea,
syphilis or HIV. And while there are some 60 compounds under
investigation for use as possible microbicides, research and
development efforts are at this point targeting the product
for use by women, for the vagina—primarily serving as a contraceptive
tool. And while that’s good news for women, discussion about
and research aimed at developing an anal microbicide is much
farther away.
“The push for microbicides
is not a gay or heterosexual issue—it’s important for all
of us,” Pickett said. “Anal sex isn’t something in which only
gay men engage. But we [gay men] need to especially weigh
in and say ‘we want rectal microbicides.’ This forum is the
first step. But gay men need a greater consciousness because
with microbicides comes the potential for us to have safer
sexual lives.”
Robles likened the importance
of the discussion to the steps taken when a new film is about
to be released: “We have to begin now with promotional efforts
so when the product is ready for public use, people will know
about them and how to use them more effectively. It’s all
about increasing public awareness and then motivating voters
to contact elected officials demanding more dollars for research
and development. We want to prepare people for the day when
they’ll be able to go to the corner store for a few groceries
and the microbicide of their choice.”
Robles said interest in both
vaginal and rectal microbicides has increased as the rate
of HIV/AIDS infection, particularly among African-American
women, continues to rise.
“We have to be creative
in the [microbicide] movement prevention strategies,” she
said. “Usually the leading pharmaceuticals provide funding
for new drug development, but not in this case. Most of the
dollars at this point are coming from smaller biotech companies
and private donors. Even after first hearing about the potential
of microbicides almost eight years ago, we still are only
in the first phase of the three required by the federal Food
and Drug Administration (FDA).” All new drugs intended for
specific therapeutic indications must first undergo three
steps: pre-clinical research and development, clinical trials
that study the efficacy and safety of the drug in humans and
permission to market the drug—a process that in the three
stages can take up to 12 years. And, even after a new drug
is released on the market, the FDA continues to monitor the
drug for adverse or toxic reactions which may take several
years for negative effects to manifest and be discovered.
Robles said that Pickett was the real push behind the forum,
but now it’s time for other gay men to share their views and
concerns—to become vocal and active.
“Microbicides are already
being discussed to help women—now the same message regarding
the potential effects and appropriate use for gay men need
to take place,” Robles said. “The reality is that rectal microbicides
will benefit not just the MSM population [men who have sex
with men] but heterosexual couples as well. But the process
is going too slow. There are only two rectal microbicides
in phase one trials—none in phase two or three.”
Dr. Christoff said the failure
of nonoxynol-9 (N-9) for rectal use is instructive. “N-9 is
all there was and basically still is on the market,” he said.
“It’s been used by women as a spermicide to prevent pregnancy
for decades, and some gay men have sought out lubricants containing
N-9 in the hope that it might add some protection against
HIV. But it was never tested in the rectum. Now subsequent
research indicates that N-9 can irritate tissue in the vagina
and even increase the risk of contracting HIV. Furthermore,
the vaginal and rectal walls are two very different environments—too
different to assume that drugs developed for one may be appropriate
for the other.” Christoff added that due to the large number
of volunteers needed when rectal microbicides reach the clinical
trial stage, serious questions of efficacy will certainly
arise.
“Not only will we need
a huge at-risk population, but some patients will become infected
with HIV and other STDs in the testing process,” he said.
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