SEX DRUGS CALLED AVENUE TO HIV

Makers, US Agencies Set To Study Their Misuse

WASHINGTON -- Richard Gallo's experience is shared by thousands of
men who sometimes find other men through e-mail messages that read:
"Do you want to PNP?" It stands for "party and play." To party, they
take crystal methamphetamine, which reduces inhibitions but also
their ability to have sex. To play, they pop Viagra at the same time.
Gallo, a 28-year-old Boston resident, said he had many such sexual encounters.

That worries public health officials who say the drug combination
promotes risky, unprotected sex with multiple partners.

Drug companies and government agencies, including the Food and Drug
Administration, are scheduled to meet today and tomorrow in Maryland
to discuss how the erectile dysfunction drugs Cialis, Levitra, and
Viagra might be contributing to the transmission of HIV and other diseases.

Gallo, who worked in the porn industry, received hundreds of Viagra
pills for free. After work, he popped them to party and play.

"We're talking days. Days, not hours," he said. One drug-fueled sex
marathon lasted "10 days in a row," he recalled. "No eating, no
sleeping." Gallo, now sober for a year, said taking the drugs
together made him feel "invincible."

They are also potentially deadly.

Last year, a New York man was infected by a strain of HIV that
overwhelms almost every drug treatment. The source of his infection:
Sex with two Connecticut men who warned him they were HIV-positive. A
doctor said crystal meth impaired the New York man's decision-making.

In cities across the nation, including Boston, reports of new cases
of sexually transmitted diseases between men are on the rise. One
reason, some health officials say, is the misuse of Viagra.

Dr. Jeffrey D. Klausner of the San Francisco Department of Public
Health said that city was poised to eliminate syphilis in 2000. Now,
there are thousands of new cases. He said gay men seeking treatment
for sexually transmitted diseases report an average of 18 partners in
the prior two months.

His research also links erectile dysfunction drugs with risky sexual
behavior and an increase in sexually transmitted diseases in Chicago,
Los Angeles, and New York. Klausner said drug companies should curb
free samples and limit refills of erectile dysfunction drugs, which
are used by more than 20 million American men.

Klausner, who filed a citizen petition with the FDA to address
problems caused by misuse of erectile dysfunction drugs, wants
federal drug regulators to step up efforts to thwart their illegal
distribution, perhaps calling them controlled substances.

"The FDA, actually, can do a lot," he said. "They can require the
manufacturers to do more education at the population level. They can
require the manufacturers to educate the doctors and the prescribers.
They can encourage the manufacturers to modify their advertising and
marketing efforts."

Pfizer Inc., manufacturer of Viagra, has promoted educational
outreach, including a "safe sex" message that is more tailored to the
general population than to gay men who have high-risk sex.

"We strongly support efforts to prevent the spread of STDs and HIV
through education of safe-sex practices, including the use of
condoms," said Michal Fishman, a Pfizer spokeswoman.

Ken Mayer, medical research director at Boston's Fenway Community
Health, said an educational push targeted at gay men who use drugs to
enhance sex could also help dispel the growing perception by some
that HIV is a manageable, not fatal, infection.

According to the results of a recent one-year study, 18 percent of
Boston men seeking treatment for a new sexually transmitted disease
said they used Viagra during the preceding month. Nearly 8 percent
had used crystal meth, and 10 percent had used Ecstasy, a drug that
makes users feel euphoric.

But Mayer said he is uncertain whether drug companies would embrace
his idea of advertising the health risks for men who use erectile
dysfunction drugs in combination with other substances.

"I think there is a real reticence on the part of these companies to
do this kind of advertising, because they don't want their drugs to
be perceived as 'gay' drugs. But in reality, I think this data says
they are," Mayer said.

Dan Shames, director of the FDA's division of reproductive and
urologic drugs, is scheduled to participate in a panel at the
Maryland meeting that will seek to examine who is responsible for
stemming the worrisome trend. "We're sympathetic, but not sure what
our particular agency can do," Shames said.

The FDA can require stronger warnings on labels, but such
instructions are geared toward prescribed use of the drugs, not for
when they are taken with substances like crystal meth.

"As far as FDA and labeling is concerned, a lot of this is really,
really off-label," Shames said.