Bay Area Reporter - October 6, 2005
Bob Roehr

Klausner has long called for stricter controls on the availability of these drugs, specifically Viagra, and last month, he took his message to a conference on PDE-5 inhibitors, the class of drugs to which ED drugs belong, which took place outside of Washington, D.C. on September 26-27.

Klausner's move has been met with harsh criticism among some San Francisco AIDS activists. In August, Jeff Sheehy, Mayor Gavin Newsom's AIDS policy adviser, asked the San Francisco Human Rights Commission to investigate the appropriateness of using city funds to advance the criminalization of Viagra use by gay men. Last year Klausner petitioned the Food and Drug Administration, asking the agency to reclassify Viagra as a controlled substance.

"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," Sheehy told the Bay Area Reporter at the time.

Reached Tuesday, October 4, Sheehy said that he met with Klausner before the conference and said that Klausner understood his concern. Sheehy said he was "disappointed" with Klausner's remarks at the conference, when told of them by a reporter.

"He had assured me that he understood how coercive and threatening his initiative was to gay men and those with HIV," Sheehy said.

The drugs are used to treat erectile dysfunction, including ED associated with aspects of HIV infection and side effects that may arise from drugs used to treat HIV. Use of methamphetamine may also result in ED, so-called crystal dick, and many meth users also use drugs such as Viagra to compensate for it.

Klausner based his views on a 2001 survey of 844 men at STD clinics "that suggested an association between the use of Viagra and increased risk of the spread of HIV and STDs, as well as increased risk of being infected with an STD." He urged Pfizer, the manufacturer of Viagra, to conduct an educational campaign about these risks.

Over the ensuing years Klausner tied use of Viagra to increased risk of syphilis in the outbreak in San Francisco, and to increased incidence of rectal gonorrhea. He outlined the association between use of Viagra and crystal meth, alone and in combination, and increased risk for acquisition and transmission of STDs including HIV. Klausner acknowledged that causality and the contribution of each factor to that increased risk remains a murky area.

"As a public health official, I have a different threshold for response. My goal is to protect the people who are uninfected and HIV-negative," Klausner said at the conference.

A 2004 meeting with the FDA left Klausner frustrated. "I was really struck by the lack of acknowledgement by the FDA that they were a public health agency charged with the protection of public health in the United States," he said. They told him that the FDA was a regulatory agency and that public health was the responsibility of the Centers for Disease Control and Prevention.

Later that year Klausner submitted his citizens petition to the FDA to change the product label, conduct education activities, and reclassify PDE-5 inhibitors as controlled substances. The latter would require that all prescriptions be placed in a federal registry; apply tougher standards to pharmacies distributing the drug; limit the number of refills; and add tougher penalties to people caught with the drug without a prescription.

Klausner was widely criticized for that move, and the Department of Public Health removed the link to Klausner's petition from its Web site.

At the conference, Klausner admitted that his plan would entail "a huge amount of work and cost," while "the benefits would be limited." He has more hope for consumer education and an end to all consumer advertising for these drugs. The FDA continues to consider the petition.

"People really don't get the [legal] constraints we have, and our role," responded Daniel Shames, who heads up the section of the FDA responsible for these drugs. "We are a regulatory agency with limitations on what we can and cannot do." It primarily affects the label on the drug that companies write to inform physicians.

"The labels are essentially owned by the manufacturers ... so far, the evidence that we see would not justify changing the label, at this time," he said. Shames added that the First Amendment affords great freedom of speech and the courts have interpreted this to include commercial speech.

Defending Viagra

At the conference, Graham Jackson, a London cardiologist, said that 30 percent of patients with ED have cardiovascular diseases, while others have hypertension, high cholesterol, or diabetes. He urged the conference to see erectile dysfunction as a marker for other medical problems and as an opportunity to practice preventative medicine by treating the underlying conditions.

"If we don't do that, ED can stand for early death," he said.

Jackson and his colleagues have seen over 500 cardio patients with erectile dysfunction and have prescribed PED-5 inhibitors. "There were no acute events [in terms of cardiac event] - the guidelines work," Jackson concluded. Clinical trials are under way on a number of other uses for the class of drugs.

Jackson said they treat their HIV patients the same as every other patient. "People transmit diseases, not tablets. The importance of education cannot be over-emphasized, but that has to go with an understanding of behavior in order to change it," he said.

He fears that controls on the prescription and sales of the drugs "will deny the majority the benefit, and the majority are benefiting substantially. It will create a black market where we will have no control; at least we have some control now over the situation and patient education." Jackson compared it to the failed attempts of prohibition on the sale of alcohol in the US.

"What matters is that the drugs work and they give patients back their dreams," Jackson added.

Atlanta HIV physician David Malebranche offered the example of a patient of his who had been HIV-positive for 20 years; had a multiple drug resistant virus and was on a salvage regimen; and had been using testosterone recreationally for a dozen years. He recently had been to a circuit party where he had unprotected sex, and asked for a test for syphilis, as well as for prescriptions for both testosterone and Viagra.

"I decided to say no to both," Malebranche said. "I had an obligation as a physician and a provider to look out for this individual's health, even if he was not going to. He should be worried about the things that he could be getting from other people, with his compromised immune system."

"As a public health official ... he has got a multi-drug resistant strain, and he is going to parties, and having sex with multiple partners," Malebranche said. Somebody could acquire that resistant strain. "Whose responsibility is that?" he asked.

"We need guidelines, but they can't be ones that say that every person is the same and every situation is the same," Malebranche said. "We need a broad approach that says, treat each individual as an individual, but with the larger public health context in mind."

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