San Francisco Chronicle - The Voice of the West, 901 Mission Street, San Francisco, CA 94119 - Wednesday, July 23, 1997 - Page A1
Louis Freedberg, Chronicle Washington Bureau
In response, the national Centers for Disease Control and Prevention in Atlanta will bring together researchers, physicians and AIDS advocates for a two-day conference that begins tomorrow, the first step toward establishing guidelines regarding the practice.
"The problem is that there is no direct data yet to show that this will be effective," said Dr. Dawn Smith, an epidemiologist at the CDC. "We are excited about any prevention possibility, but we are not so excited that we can ignore how it will be used and what its downsides will be."
According to Dr. James Kahn, assistant clinical professor of medicine at the University of California at San Francisco and co-director of the study, it will be limited to 500 participants and is designed to determine whether early intervention -- combined with education and efforts at behavioral change -- can reduce the spread of HIV, the virus that causes AIDS.
The major concern of CDC experts is that a "morning after" approach -- actually a 30-day treatment -- may encourage people to engage in high-risk behavior. This, experts worry, could undermine the central strategy in the fight to end the epidemic: preventing people from getting the virus in the first place.
"We would not want this to be used as a widespread form of prevention," said Dr. Helene Gayle, director of the CDC's National Center for HIV Prevention. "It is still going to be better for people to engage in safe behavior."
PROGRAM BEGINS IN FALL
San Francisco's pioneering Post-Exposure Prevention program will begin in the fall. Anyone who has had unsafe sex or shared a needle with someone they believe might be HIV-positive can show up at San Francisco General Hospital within 72 hours of possible exposure -- and preferably much sooner -- seeking treatment. After being interviewed and examined, they may be put on a rigorous, 30- day combination drug regimen in the hope of killing the virus before it spreads throughout the immune system.
San Francisco's approach is generating enormous interest. Canada, South Africa and several European countries are considering introducing "morning after" treatment for rape victims and other at-risk populations. State and local health departments in the United States as well as international health agencies are considering similar policies.
Because of the burgeoning interest, federal officials say there is some urgency to develop guidelines to help shape these programs. Federal officials are concerned that if "morning after" programs are introduced improperly, they could further the spread of AIDS instead of preventing it. The Atlanta meeting, they say, will be the first step toward developing guidelines, which they hope to issue before the end of the year.
WORRY ABOUT SIDE EFFECTS
The CDC is also questioning whether the cost of the one-month treatment -- as much as $1,000 -- is justifiable, especially when many being treated will probably not have the virus. The agency is also worried about the potential side effects of anti-HIV drugs, like nausea, severe diarrhea and fatigue, or in some cases even more severe risks like bone marrow failure.
Another concern is that the people who volunteer for treatment will not follow through carefully on the program. If that happens, the drugs may become ineffective, even if the person contracts the virus in the future.
One indication of the lack of consensus on "morning after" treatments is that experts are still trying to settle on an appropriate name for it. Experts say the term "morning after" is wrong because it suggests popping a single pill the day after exposure. The official term "post-exposure prophylaxis" is too much of a mouthful, they agree, but alternatives like "post- exposure prevention" or "post-exposure treatment" are not much better.
NO UNANIMITY AMONG ADVOCATES
Even within the AIDS advocacy community, there is no unanimity on the usefulness of the approach. Some welcome it, while others are much more cautions.
"We have to prevent every single case of AIDS transmission," said Dr. Arthur Amman, president of the American Foundation on AIDS Research. "It is a way to prevent someone from accidental exposure to the virus. It is something that needs to be done."
On the other hand, Daniel Zingale, executive director of AIDS Action, the leading AIDS advocacy organization in Washington, said that even if it proves to be effective, it should not be viewed as a substitute for practicing safe sex. "I hope no one looks at this as a reason to be less vigilant or responsible," he said.
These concerns were addressed in an influential article in April's New England Journal of Medicine, authored by Dr. Mitchell Katz, San Francisco's director of public health and co-director of the post-exposure study with Kahn and Dr. Julie Gerberding, a UCSF researcher. They made it clear that one kind of patient should not be signed up for treatment: "Those who intend to continue their high- risk behavior."
`We urge that this treatment be used judiciously and only in the context of a comprehensive program of prevention," Katz and Gerberding wrote.
For now, the main worry among federal health officials is not San Francisco's program, because it will be implemented by UCSF researchers. "We're going to be studying it at the same we're doing it," said Dr. Thomas Coates, director of the AIDS Research Institute at UCSF.
Rather, they worry that similar programs around the country will spring up -- either formally or informally -- without the benefit of the latest scientific research or authoritative guidance from scientists and health officials.
UNKNOWN NUMBERS
Officials do not know how many people will request the treatment if it becomes widely available. Dan Wohlfeiler of the Stop AIDS Project in San Francisco says he believes fears that tens of thousands of people will demand treatment are unfounded. "I don't share the knee-jerk response that this is going to automatically increase the number of people having unsafe sex," he said.
At the same time, he said, "This may not work, and this would be an awfully premature decision for people to decide based on this or any other treatment that it is OK to take off their condoms."
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