The Vegas Mixx story.

Pharmacist Scot Silber thought he was sitting on a gold mine when he developed a drug compound to help men suffering from sexual dysfunction.

Silber, part-owner of Green Valley Drugs, combined Valium and Viagra into a single pill and called it Vegas Mixx. He advertised it with the promise that the combination would mellow the mind, relax the muscle that causes ejaculation and provide a lasting erection.


Silber invested thousands of dollars in research and an edgy Internet marketing campaign, promising men in obscene terms on a Web site that they could perform “like a porn star.”


Larry Pinson, executive director of the pharmacy board, would not say whether the board was investigating Green Valley Drugs. And while he could not talk specifically about Vegas Mixx, he said that generally speaking, compounding pharmacies are allowed to make drugs only to fill individual patient prescriptions, versus making batches in advance and then marketing their availability.


According to Silber and his marketing agent, Dale Matteson, Vegas Mixx was initially produced in quantities large enough to provide samples to urologists, family doctors and medical spas.


A compounding pharmacy should not be making samples, Pinson said.


“If you make batches, that’s manufacturing and you have to be licensed by the FDA to do that,” Pinson said. “A compounding pharmacy can only compound prescriptions that are patient-specific. Making samples is not patient-specific. You can’t make up batches of a drug and give them to doctors to do what they want. That’s manufacturing.”

Vegas Mixx was never going to become the company’s primary product, Silber said, but the men thought they had found a product that would be successful. In December 2006, Silber hired a researcher who concluded that between one-third and two-thirds of men suffer from premature ejaculation. “The market is huge! The market is wide open!” proclaims a presentation by the researcher.


The combination of Diazepam and Sildenafil, better known by the brand names Valium and Viagra, solved the problem, Silber said. The anti-anxiety drug Valium relaxed the mind, allowing a man who suffered from premature ejaculation to perform without worries. The Viagra relaxed the muscle that causes ejaculation and prolonged the erection.


The Vegas Mixx Web site — aimed at guys who come to Vegas for a fling — used crude terms: “Vegas Mixx ... makes you rock hard, and keeps you that way. Enjoy the ride.”


Silber and Matteson don’t apologize for their style of marketing. They say they were going after a young demographic of men who like to party.


Silber and Matteson initially hoped to use the Vegas Mixx Web site to refer patients to local doctors, who would perform examinations and prescribe the drug. The site promised easy access to the drugs: “Even if you are in Vegas from out of town to play, we can accommodate a quick MD visit and a quick RX for a long-lasting experience.”


And this is where they may have been treading on dangerous ground legally, according to two doctors who met with them as they were developing the drug.


About two years ago, Dr. Warren Magnus and his then-business partner, Dr. Ivan Goldsmith, were taken to lunch by the men and recruited to join the team. The pitch was that the Web site would funnel patients to the doctors, who would prescribe the Valium-Viagra mix.

According to Magnus, prescribing the drug legally required a physical examination. But Silber told the doctors, according to Magnus, that Internet evaluations and medical histories would take the place of the physical examination.


“They were looking for doctors to sign up, to basically put themselves in the clear on dispensing (controlled) substances,” Magnus said.


The proposal made Magnus uncomfortable. He said that even if it was OK with Viagra, which he was unsure about, it could not possibly be OK to bypass actual examinations to prescribe Valium, a controlled substance closely monitored by the Drug Enforcement Administration.


“There’s far too much legal exposure — if not an outright violation of the law — to prescribe for people you’ve never seen,” Magnus said.


Magnus said he operates on the “cutting edge” of medicine — he’s involved with anti-aging therapies, for instance — but “when I smell a rat I run like hell. I distanced myself as quickly as possible.”


No comments:

Post a Comment