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July 30, 2014

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Wonder drug for men no success story

Pharmacist’s now-defunct creation — Vegas Mixx — and its suggestive ad campaign coming under scrutiny

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Leila Navidi

Vegas Mixx was a treatment for male sexual dysfunction using two drugs — Diazepam and Sildenafil, better known as Valium and Viagra. 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.”

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Vegas Mixx

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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.”

Silber owned the pharmacy with entertainer Danny Gans, who was known for his squeaky-clean Christian image and died May 1 of a prescription narcotics overdose.

Gans was not aware of Vegas Mixx, Silber said. “As you could probably guess, he would not have approved,” he said.

As reported on “Face to Face With Jon Ralston,” Silber took the Vegas Mixx Web site down about a month ago. And now, after years of effort, Silber says, he no longer fills prescriptions for the drug. Vegas Mixx was a bust.

But Silber could face bigger troubles. Green Valley Drugs is a compounding pharmacy — meaning it can combine unique mixes of drugs, based on a doctor’s prescription — but may have been operating outside the bounds of its license. That could lead to investigations by the Nevada State Pharmacy Board and the U.S. Food and Drug Administration.

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.”

Licensed in 25 states

Illegal or not, the rise and fall of Vegas Mixx provides insight into the fringes of the business of medicine in Las Vegas.

Silber and Matteson were interviewed for this story in Silber’s corner office at Green Valley Drugs, in a business park in the Whitney Ranch development in Henderson. The company’s lobby is adorned with framed thank-you notes for Silber, who supports Little League teams and is chairman of the Nevada Childhood Cancer Foundation. The company, which is also known as Green Valley Med, is licensed in 25 states and brings in millions of dollars monthly as a compounding pharmacy and medical supplier, Silber said.

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.

Matteson recalled the optimism when they launched the product: “It’s Business 101 — find a need and fill it.”

Referral by Internet

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.”

Silber and Matteson downplay the conversations with Magnus and Goldsmith, who is involved in a lawsuit with Green Valley Drugs. They said they found a medical director, whose name they would not reveal, and that to their knowledge, Vegas Mixx was never distributed without an actual patient examination that resulted in a prescription.

Never a big seller

To Silber and Matteson’s disappointment, Vegas Mixx never gained traction in the marketplace. They said that perhaps 100 doctors filled prescriptions of 10 to 20 pills each. The pills were advertised online as costing between $10 and $17.50 each, depending on the formula.

Pinson, from the pharmacy board, was aware of Vegas Mixx because of queries by Face to Face. But in 2007, about the same time Green Valley Drugs was making Vegas Mixx, the board sent out a memo to pharmacists regarding “some questionable compounding practices ... with regard to the supplying of physicians of certain compounded medications.”

Silber said that before the memo, he thought that as long as a doctor had a license to dispense drugs — as opposed to just writing prescriptions, which is the case with most physicians — a pharmacy could sell the dispensing doctor’s compounds just like any other medication. After receiving the memo, Silber hired an attorney to provide a legal opinion on the matter.

“It is our understanding that Green Valley Med is in complete compliance of all state and federal guidelines,” Silber said.

The FDA would not comment for this story, but forwarded the Sun its compliance policy guide for compounding pharmacies. Compounding traditionally refers to making reasonable quantities of drugs “upon receipt of a valid prescription for an individually identified patient from a licensed practitioner,” the guide states. The FDA will “seriously consider enforcement action” when a pharmacy compounds drugs “in anticipation of receiving prescriptions,” the guide said.

In an unrelated issue, the pharmacy board investigated and disciplined Silber in 2004 after he missed a technician’s error while working as a pharmacist at a Sav-on Pharmacy. Pharmacy board records show that the label was supposed to instruct the patient to take doses of 1/2 to 1 cc of Roxanol — a highly concentrated form of morphine. But the label said 1/2 to one teaspoon of Roxanol. The patient’s wife watched him take hydrocodone and then drink directly from the Roxanol bottle, and he later died, pharmacy board records show.

Silber told the Sun that he did make an error by not catching the mislabeled drug, but that the patient intentionally killed himself, which is why the board’s discipline was light, a $500 fine.

Silber said he has not heard from the pharmacy board or FDA about an investigation into Vegas Mixx.

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