Bay Area Reporter - August 18, 2005
Matthew S. Bajko, m.bajko@ebar.com

Dr. Jeffrey Klausner, director of San Francisco's sexually transmitted diseases prevention section, filed a citizen petition on August 5, 2004 with the Food and Drug Administration asking the agency to reclassify the erectile dysfunction drug as a controlled substance and require Pfizer, the maker of the drug, to warn users that "Viagra increases the risk for new STDs, including HIV infection" in its labeling. The FDA has yet to act on Klausner's petition, saying the issue is complicated and it needs more time.

"Jeff Klausner wants the dicks of people with HIV in his back pocket and he wants us to ask him permission to use it. And I am not giving him my dick," said an outraged Sheehy, a gay HIV-positive man who volunteers as Mayor Gavin Newsom's adviser on HIV and AIDS policy. "Jeff Klausner is specifically targeting gay men with HIV. This is not what city funds should be used for. There is no science to justify this."

Klausner, who is on vacation, did not respond to calls to his pager seeking comment this week. Last August he told the B.A.R. he decided to file the petition based on studies that linked the use of Viagra and similar drugs to an increase in sexual partners, STDs and HIV among gay men. Citing the ease by which men can obtain the drug without a doctor's prescription from thousands of Internet sites, Klausner contended at the time that an "effective step" to reduce such recreational use would be to classify Viagra as a Schedule III controlled substance under the Controlled Substances Act. Klausner's petition would also impact ISOC Inc., the maker of Cialis and GlaxoSmithKline, the maker of Levitra, two other popular erectile dysfunction drugs.

"Some might consider it a more draconian or controlling or strict way to reduce the use of the drugs, which could adversely impact the people who really need the drug. We are cognizant of the fact the drug has a medical usefulness but you have to balance the risks and make it a controlled substance to limit access to those who actually need the drug," Klausner said at the time.

Larry Brinkin, a compliance officer with the HRC, said he would forward Sheehy's request to the commission's LGBT advisory committee.

"We have not really looked at something like this in past. We don't usually tell doctors how to practice medicine," he said.

But Brinkin said there is precedent for the commission to take action in the matter, pointing to its stands on such healthcare issues as extending city healthcare benefits to cover gender reassignment surgeries for city workers and what doctors should do in the case of intersex babies. If the commission does take up the matter, the earliest a public hearing could take place would be late September or October.

Stop AIDS Project spokesman Jason Riggs said while the agency does not support Klausner's petition, nevertheless, it does not view it as being AIDSphobic or homophobic.

"Viagra use is a double-edged sword. It is difficult to say this tool should be taken away from some people because others are abusing it," said Riggs. "On the one hand people tend to use it with crystal meth and the prolonged sexual effects they are able to have with Viagra puts them at increased risk for HIV and other STDs. On the other hand people report using it helps them maintain an erection when they have a condom on. For them it is a harm reduction strategy."

Health Commissioner Jim Illig, an openly gay man, said called Sheehy's move absurd, adding he agrees with Klausner that Viagra should be a controlled substance.

"I certainly don't see it as homophobic. I trust the DPH STD specialist," said Illig. "If this is what he thinks, I think it is probably a good idea. Jeff Klausner is a professional in the field of knowing what contributes to STD transmission. I am standing behind my health department's judgment."

Sheehy decided to go public with his charges about the Viagra reclassification after a story in last week's Bay Area Reporter reported on a 27 percent drop in the city's syphilis cases and mentioned Klausner's Viagra petition and an upcoming national conference that will examine the role erectile dysfunction drugs play in the spread of HIV and other STDs. In a telephone interview, Sheehy argued that to criminalize Viagra use is to criminalize people's capacity to have sex.

"He is trying to change the classification and that means he wants people to be arrested for possession of Viagra. I have a horror of narcotics officers flooding dance clubs and sex clubs arresting gay men for possession of Viagra, which is explicit in what Klausner is proposing," said Sheehy, who noted using Viagra without a prescription is already illegal. "This is all taking place when we are having falling HIV and STD rates. So gay men have shown that they hear public health prevention messages and are taking action to protect each other. There is no reason to put gay men with HIV in jail for possession of Viagra."

However, it is unclear if Sheehy's fears are founded. Under the act, someone caught in possession of a Schedule III drug would likely face local or state prosecution, and in San Francisco the district attorney's office and police narcotics officers are more interested in dealers than drug users, who usually are ordered into rehabilitation programs instead of jail. For dealers, a trafficking offense of a Substance III drug could lead to up to five years in prison and a fine of $250,000 for a first offense. In more conservative parts of the country, though, some fear the classification could very well be used as a weapon against gay men.

In an interview earlier this month, Klausner said his goal is not to limit the availability of the drug but to restrict its use to people who need the drug for medical purposes. He said while the city's syphilis cases are on the decline, Viagra use is a leading cause for the continuing high number of cases of the STD, with almost half of the men with syphilis reporting some use of erectile dysfunction drugs. During the first six months of 2005, the city recorded 251 cases of syphilis, down from 346 during the first six months of 2004 but still far outnumbering the average of 10 cases a year in the early 1990s.

The concern, he said, is using Viagra and similar drugs causes more blood flow to the penis, leading to a more erect penis that is more susceptible to getting syphilis than a lesser erect penis.

"The penis is harder, more stretched, and more likely to be infected," said Klausner.

But Klausner's request has been questioned by other health officials and opposed by the maker of the drug and HIV-positive men. Some argue instead of focusing on Viagra, the real culprit is crystal use by gay men.

"You can take Viagra out and we will still have HIV and STD transmission, especially among crystal meth users," said Sheehy. "However, if you take crystal meth out, Viagra is not a problem."

As Sheehy pointed out in his letter to the HRC, "While risky sex occurs among men using crystal meth and Viagra, it is the crystal meth that alters judgment and relaxes inhibitions. One could take away the Viagra and significant risky sex will still occur among crystal meth users as it did before the appearance of Viagra."

New study

A new study in the journal AIDS this month seems to bear out such arguments. San Francisco researchers reported that crystal meth users were three times more likely to contract HIV than non-users. They also cite that among those who reported using the drug during sex, the likelihood was four times as high.

"We do think use of Viagra with crystal meth is a problem. That is why we have begun a prevention campaign around the abuse of crystal meth," said Riggs. "We do see use of crystal meth and other drugs mixed with sex is potentially an explosive situation."

Sheehy raised concerns privately last year after the health department posted a link to Klausner's petition on its Web site and asked people to send letters of support to the FDA. At the time, Sheehy worked behind the scenes to convince Health Director Dr. Mitch Katz to remove the link from the Web site. The department did remove the link off its homepage, and as of this week, the only information that remained on the Web site was the press release from last August announcing Klausner's petition.

In questioning Klausner's stance on Viagra, Sheehy also questions the data the city has collected on the use of the drug. In saying gay men in San Francisco report higher than average usage of Viagra, Sheehy charges that Klausner is missing several key pieces of demographic information on the city's gay population.

Sheehy maintains that a significant portion of the 65,000 gay men who live here are over 50 and most likely suffer from erectile dysfunction. He also said one must consider the fact the gay community suffers higher rates of depression and that antidepressant use is associated with erectile dysfunction.

In addition, he pointed out that at least 20 to 30 percent of the gay community is HIV-positive and upwards of 80 percent of those people are treated with antiretrovirals, which can cause erectile dysfunction.

"If you were to put all those numbers together and mix it up, you will probably come out with a number close to 30 percent of the gay community is using Viagra. Yet most have appropriate medical reasons for using Viagra," he said. "Whether or not they go to a doctor to get Viagra should be irrelevant. And it shouldn't put them at risk for incarceration."

The fight over Viagra is also emboldening Sheehy's and others' push to eliminate Klausner's DPH staff position altogether. Instead of having a separate STD control director, their proposal calls for bringing STD control under the auspices of the city's HIV prevention director. The argument they make is that since STDs can increase a person's chances of getting HIV, it doesn't make sense to have two departments working independently of each other.

"I have recommended, by the way, to the mayor, that those two positions be combined. What is a better use of money? Jeff Klausner criminalizing Viagra use and arresting gay men or funding Positive Resource Center and helping gay men with HIV get jobs and health insurance?" asked Sheehy.

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