Bay Area Reporter - November 3, 2005
Matthew S. Bajko, m.bajko@ebar.com

Dr. Jeffrey Klausner, director of the San Francisco health department's STD prevention section, filed a citizen petition on August 5, 2004 with the Food and Drug Administration asking the agency to reclassify the medications, including Pfizer's Viagra, ISOC Inc.'s Cialis, and GlaxoSmithKline's Levitra, as Schedule III controlled substances. Under such classification, anyone in possession of the drugs could face local or state prosecution, and dealers of the substances, if caught, could be given up to five years in prison and a fine of $250,000 for a first offense.

The move met with fierce opposition from the companies as well as gay health advocates and other medical professionals, who argued changing the classification would make it harder for those who legitimately needed the drugs to obtain them. San Francisco AIDS czar Jeff Sheehy went even further, calling Klausner's petition "AIDSphobic and homophobic," and in August of this year asked the city's Human Rights Commission to investigate the matter.

At a national conference in September to discuss the health concerns surrounding PDE-5 inhibitors, the class of drugs to which erectile dysfunction medications belong, Klausner's proposal once again met with opposition. One cardiologist warned if the FDA placed the drugs under Schedule III it would only increase the black market sale of the medications. Others argued that the move was unneeded because the drugs are already illegal to use without a prescription.

Writing against Klausner's proposal in the San Francisco Medical Society magazine, Dr. Charles Moser argued that the impact on the spread of STDs by changing the drugs' schedule "would be minuscule at best" and that "there is no indication that individuals using these drugs are clogging the emergency departments or local physician offices with complications from their illicit PDE-5 inhibitor use."

Faced with ever mounting criticism to his plan, Klausner told the Bay Area Reporter on Friday, October 28 he had relented and was dropping his request with the FDA.

"Given the community's concern that scheduling Viagra could reduce its access to those who medically need it, I no longer support making it a controlled substance," said Klausner.

Asked what changed his mind, Klausner said it was the combination of the local opposition and the sentiment among his colleagues at the conference.

"Having talked to different members of the community, having listened to their concerns on the impact scheduling could have on access," persuaded him to alter course said Klausner. "I would agree that the advocacy played a role."

However, Klausner said he has no regrets about filing the petition because data continues to show a connection between new HIV infections and use of Viagra.

"At the time it was completely appropriate and it has resulted in a very careful assessment of the role of these drugs in the continued transmission of STDs and HIV," he said. "It is still very high in new cases of HIV infections. In those people infected in the past two weeks at least half of those have used Viagra, and at least half of new syphilis cases have used Viagra."

Told of Klausner's decision, Sheehy, a gay HIV-positive man who volunteers as Mayor Gavin Newsom's adviser on HIV and AIDS policy, commended him for listening to the community's concerns.

"The fact he is willing to recalibrate his course of action based on legitimate concerns from the community is a sign of strength and an example he is doing a great job. He works hard," said Sheehy, who called Klausner an innovator. "When someone innovates some stuff they do is going to be great. But sometimes the stuff they do will have consequences they didn't intend."

When Klausner went public with his FDA application and put a link to it on the health department's Web site, Sheehy worked behind the scenes to have the link removed. This August, in response to comments Klausner made about his application in a B.A.R. story on the drop in the city's syphilis rates, Sheehy filed his request with the city's HRC and said at the time that "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. 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."

Sex and drugs

The real culprit in the transmission of HIV and STDs is not Viagra, argued Sheehy, but crystal meth use and unsafe sexual behaviors. In a letter to the editor, Sheehy wrote that "there is a correlation or association between crystal meth use, Viagra use and risky sexual behavior ? take away the Viagra and crystal use will still lead to risky behavior. However, successfully address crystal and Viagra is no longer an issue."

Sheehy also expressed dismay at Klausner's comments at the national conference, which came after the two had met to discuss the issue. While the heated rhetoric may have gotten personal, Sheehy said he had no remorse about his earlier comments. The dialogue it generated was healthy for the community, he said, and he only had praise for Klausner and his new stance.

"I think Dr. Klausner is a passionate and aggressive STD control officer and I admire him for that. He does great work for the city. I think we should encourage that kind of dedication and hard work," said Sheehy, adding "I think it is even more notable he is open and receptive to having dialogue with the community and taking action based on the concerns expressed by the community. I never thought his motivation was to malign; he wasn't out to hurt anybody. It never was a question of intent, it was a question of outcome, of implication."

Stop AIDS Project spokesman Jason Riggs said whether or not one supported Klausner's actions, they did draw a national spotlight on the issue.

"What it did was spark some discussion on how different people use Viagra. Some people are very concerned about its usage with recreational drugs. Others shared stories about how they used it to maintain safer sex practices," said Riggs.

While the agency remained neutral on Klausner's push to reschedule the drugs, Riggs said Stop AIDS does see drugs like Viagra as "double edge sword(s)."

"Some people use it with other recreational drugs to maintain an erection when using crystal meth. The two drugs in combination can lead to HIV transmission. Klausner is correct in his concerns in how the drug is used in that way," said Riggs. "The double edge sword is a lot of men report using Viagra because they can't maintain an erection when using condoms. It helps them to continue practicing safe sex. Other people report when they are on HIV meds it can be difficult for them to maintain an erection, therefore taking Viagra on meds helps them stay on their drug schedule, which is also a good public health measure."

Klausner said he has no regrets about filing the citizens petition last summer, saying that by doing so "it was never my intention to limit access" to the drugs. While he withdrew the reclassification request, Klausner is sticking to his other requests, including the need to change the warning labels on the drugs and curtail direct marketing of the drugs to consumers. As stated in his application, Klausner wants all labels for erectile dysfunction drugs to warn users that the medications increase the risk for new STDs, including HIV infection.

"I still believe the label needs to be stronger to say use of these medications may increase the spread of STDs. Particularly, those with multiple sex partners should be concerned about herpes, gonorrhea, syphilis, chlamydia, and HIV infection. That all needs to be on the label," he said.

Riggs said an argument could be made for why the drugs' labeling should be changed to include warnings about the transmission of HIV and other STDs.

"People have to understand prolonged sexual activity can increase their chances of getting HIV and STDs because of rips and tears in both the penis and anus. Prolonged sexual activity, even with condoms, the condom takes a beating so people who have prolonged sexual activity with Viagra or for any reason have to make sure their condom is in one piece. Doing that on the label may be not the best way but a step in the right direction," said Riggs.

Klausner also continues to criticize how the makers of the drugs market their products, especially television commercials and the use of professional athletes as spokespeople for the drugs, such as the Viagra-sponsored NASCAR team.

"I think those are inappropriate," said Klausner.

Sheehy said he does support changing the labels, and as for the marketing, his stance goes beyond Klausner's wanting to see restrictions placed on the advertising campaigns.

"I don't think prescription medications should be marketed at all. Whether it is Vioxx, Kaletra, or Viagra, they shouldn't be marketed to the public to begin with," he said. "In terms of educating people, I think it is a good thing. People need to discuss this and having the company take part in those conversations by changing their label, I think, is a good thing. Viagra isn't candy."

Representatives from the drug companies did not return calls seeking comment.

Due to the attention Klausner has brought to the issue, health professionals are now developing national guidelines on the use of PDE-5 medications by HIV-positive people. Raymond Rosen, the director of the Center for Sexual Medicine in New Jersey, is overseeing the process.

Klausner said he is still hopeful the FDA will act on those parts of his petition he has not withdrawn. He said he has not received any communication from the federal agency since January, when the FDA said it needed more time to review the matter. But an FDA spokeswoman told the Washington Blade in October that "the label information is adequate because the science does not indicate a causal relationship of PDE-5 inhibitors and STDs."

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