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Vasomax erectile drug for sale in Tijuana, illegal in San Diego

On the market for three-four months

— 'Yes, we have it," says Victor Ramírez of the Botica Sherr pharmacy at Third and Constitución. "It costs $10.09 per pill." He's talking about what some say will be Viagra's first real competition, a new-generation male-potency pill with fewer side effects: Vasomax -- or "Z-Max," as it is branded in the Mexican market -- is a pill designed to give your sex life a distinct lift.

And the pill has fans in high places.

"Submitted to the FDA last summer," gushed Playboy magazine recently, "this pill is based on phentolamine, one of the drugs currently used in penile injections. Phentolamine relaxes smooth-muscle cells in the penis, allowing that hot intake of blood that brings us such pride of ownership. Nobody likes to talk specific when the FDA is scrutinizing a drug, but tests so far apparently show that Vasomax works faster than Viagra, with fewer side effects. It also appears to be effective on milder cases of impotence. Under the name Z-Max, Vasomax has already been approved by Mexican authorities and is for sale across the border."

"It has been legal in Mexico for a year, and on the market in Tijuana for three or four months," confirms Ramírez. "Customers for it are 75 percent American. And even though it's cheaper [$10 versus $15 for Viagra] most of them still buy Viagra."

Ramírez's advantage -- and some San Diegans' only problem -- is that Vasomax is still banned in the U.S.

Vasomax seeks to duplicate Viagra's stimulation of bloodflow to the penis using a different method. Viagra, the Pfizer product that caused a worldwide sensation when it was launched, helps men with their erections by targeting a key enzyme that regulates blood flow to the penis. Vasomax blocks the effects of anxiety at nerve endings, according to Dr. Drogo Montague, head of the Center for Sexual Function at the Cleveland Clinic in Ohio.

Speaking to MSNBC during the annual meeting of the American Urological Association in San Diego, Montague said Vasomax doesn't have the same dangers for men with heart problems as Viagra, which he says can potentially cause dangerous blood-pressure drops for men taking nitroglycerine medication.

And the good news on Vasomax continues, according to Dr. Irwin Goldstein, of the Vasomax Study Group in Boston. In his group's tests, the only side effects (in fewer than 1 in 10 patients) were headaches. Of 750 men with minimum erectile dysfunction, Vasomax helped between 37 and 45 percent to achieve erections, depending on the dose given.

It's no surprise that the pharmaceutical giant Schering-Plough has been pushing hard to get Vasomax on the market. The race to get a piece of the male-impotence drug market, predicted to reach $4 billion, is making it one of the hottest areas of medicine today. Thirty million American males may be suffering from some form of erectile dysfunction. Statistically, that would imply 350,000 men in San Diego County alone face the problem. Yet only an estimated 5 percent of them so far seek treatment.

Perhaps that's because even though first Viagra and now Vasomax claim to be user-friendly, "on-demand" erection-creators, males in the past have had reason to fear the remedy more than the malady. Existing remedies have been financially and physically challenging. The penile implant costs thousands of dollars. Vacuum pumps (with which you literally pump up an erection) are awkward. Till now, erection-stimulating medications have had to be administered by catheter or injected by needle.

Yet now, at least for San Diegans, Vasomax is available just across the border, in easy-to-take, quick-disintegrating pill form. Although the FDA hasn't given its approval, Mexican health authorities have. The fact that many of the thousand or so pharmacies situated near the border stock it leads some observers to expect a smuggling bonanza of what U.S. Customs agents call "rat-packers," couriers crossing the border several times daily to transport the drug north for illegal sales in the U.S.

And that's not difficult to do. According to a 1996 Texas study, the amount of illicit pharmaceutical products and medicines traveling north across the border is staggering.

"One in four U.S. residents returning from visits to Mexico brings back medicines," says the influential report, written by Marvin Shepherd, administrator at the University of Texas's College of Pharmacy. "And most of those [medicines] brought back across the border are for illicit use."

With 40 million people crossing annually into San Diego at San Ysidro, by Shepherd's measure ten million of them are probably carrying medicines, the majority "for illicit use." That breaks down to 27,000 people crossing into the U.S. at San Ysidro every day carrying what amounts to millions of dollars' worth of pharmaceuticals.

And according to Shepherd, U.S. Customs, overwhelmed in its battle to catch the "real" drug traffickers of cocaine and other illegal "recreational" drugs, hardly notices.

"In our survey, almost 90 percent of all the drugs coming across the border were controlled substances. People were going down solely for the purpose of buying [pharmaceutical] drugs. Some would make multiple trips -- two or three a day -- and come back with a 90-day supply, the maximum allowed, then go back and get another 90-day supply. They could bring back approximately 300 Valium any one time. Eleven thousand Valium tablets and 4000 Rohypnol tablets [a depressant known as the "date-rape" drug] were legally declared every day at a single bridge-crossing in Laredo, Texas. If you extrapolate that out across the border, there's millions of dollars coming across each day. Customs are snowed under. They can't control it. They've got their hands full."

"We certainly have people 'rat-pack' small amounts of pharmaceuticals [through the San Ysidro border crossing]," admits Vince Bond, of the U.S. Customs Service in San Diego. "They appear to legally bring them in, personal-use quantities, [but] then they store them, and when they achieve a large quantity [through multiple trips] they truck it up to Los Angeles. We see an evolving pattern of pharmaceuticals being smuggled into the U.S. from Mexico. There seems to be a trend in this country to self-diagnose and self-medicate. A growing number of people on fixed incomes or retired, whose medical insurance does not cover pharmaceuticals or who don't have insurance, are going across the nation's borders into Mexico or Canada to acquire medications.

"From October 1, 1998, to the end of December 1998 we had 107 pharmaceutical seizures. We issued penalties totaling $16,910 and we made six arrests. For a variety of pharmaceuticals. The total [amount] seized was between 28,000 and 30,000 dosage units. Antibiotics, injectable penicillin, ketamine -- a veterinary drug used to relax animals so they can be examined...it's also a date-rape drug -- Darvon, a relaxant, Rohypnol, lots of Valium seizures, and also steroids."

Oddly enough, Viagra hasn't figured largely on Bond's screen. "In that same time period we only had three Viagra seizures. One for 3 tablets, one for 14 tablets, and one for 20 tablets. And we're talking all five California border stations."

And Vasomax? Bond says so far he hasn't heard of anyone being caught smuggling the drug through the border, or even declaring it.

Could that be because of doubts about how well Vasomax works?

"There are two big issues with Vasomax," says Manuel P. Asensio, chairman, president, and CEO of Asensio & Company, a New York-based investment bank and securities brokerage firm. He cites questions about the drug's efficacy and claims it can't compete with Viagra.

Asensio admits his company's stock-in-trade is to "talk down" stocks, that "short-sell" is his business, but he insists that his conclusions are based on solid research and have been given a de facto confirmation by the FDA.

Zonagen, the Texas-based developer of Vasomax, and Schering-Plough, which has acquired Vasomax's global marketing rights, suffered an apparent setback when the FDA required the company to appear before an advisory panel review set for this month. Zonagen/Schering-Plough declined to do so, citing "ongoing studies" that "should enhance the regulatory filing and the commercial product profile for Vasomax."

"I'm not going to make any comments about efficacy," says Bill O'Donnell, spokesman for Schering-Plough, "because the product is not approved yet in the United States."

The FDA is very cautious in commenting on its actions. "All I can tell you," says Susan Cruzan of the Washington, D.C.-based FDA, "is that [Zonagen] have done the clinical trials and submitted an application for a review to FDA. The process is, when FDA has questions about something, we take it to an advisory committee. A company can choose not to do that, and in this case they said that [they chose not to do that] publicly."

Schering-Plough, in a press release dated May 10, recognized that the FDA was expected to issue a "non-approvable" letter, in effect turning down its new drug application for Vasomax.

But they evidently intend to try again. "Although we are disappointed with this delay," wrote Joseph S. Podolski, Zonagen's president and CEO, "we believe that the additional data from Schering-Plough's studies are important to the long-term success of Vasomax."

And problems of approval in this country aren't holding up the company's worldwide market search. "Schering-Plough is continuing to seek regulatory approvals for Vasomax in countries outside the U.S.," says its press release, "having launched the product in Mexico in June 1998 and in Brazil in April 1999. A regulatory application was filed in the United Kingdom in August 1998 as the first step in a mutual recognition procedure for the European Union."

Cruzan is tight-lipped about Vasomax's chances here. "Under our regulations, all that is proprietary information," she says, "unless [Schering-Plough agreed and] we took it to an advisory committee meeting and made it public. It's not yet an approved drug. And that's pretty much all I can tell you."

Back on Constitución, the single "Zeta-Max," or "Z-Max" pill sits encased in foil beside its big box on the glass counter. The pharmacist's assistant looks up expectantly.

"So. You want to buy it?"

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— 'Yes, we have it," says Victor Ramírez of the Botica Sherr pharmacy at Third and Constitución. "It costs $10.09 per pill." He's talking about what some say will be Viagra's first real competition, a new-generation male-potency pill with fewer side effects: Vasomax -- or "Z-Max," as it is branded in the Mexican market -- is a pill designed to give your sex life a distinct lift.

And the pill has fans in high places.

"Submitted to the FDA last summer," gushed Playboy magazine recently, "this pill is based on phentolamine, one of the drugs currently used in penile injections. Phentolamine relaxes smooth-muscle cells in the penis, allowing that hot intake of blood that brings us such pride of ownership. Nobody likes to talk specific when the FDA is scrutinizing a drug, but tests so far apparently show that Vasomax works faster than Viagra, with fewer side effects. It also appears to be effective on milder cases of impotence. Under the name Z-Max, Vasomax has already been approved by Mexican authorities and is for sale across the border."

"It has been legal in Mexico for a year, and on the market in Tijuana for three or four months," confirms Ramírez. "Customers for it are 75 percent American. And even though it's cheaper [$10 versus $15 for Viagra] most of them still buy Viagra."

Ramírez's advantage -- and some San Diegans' only problem -- is that Vasomax is still banned in the U.S.

Vasomax seeks to duplicate Viagra's stimulation of bloodflow to the penis using a different method. Viagra, the Pfizer product that caused a worldwide sensation when it was launched, helps men with their erections by targeting a key enzyme that regulates blood flow to the penis. Vasomax blocks the effects of anxiety at nerve endings, according to Dr. Drogo Montague, head of the Center for Sexual Function at the Cleveland Clinic in Ohio.

Speaking to MSNBC during the annual meeting of the American Urological Association in San Diego, Montague said Vasomax doesn't have the same dangers for men with heart problems as Viagra, which he says can potentially cause dangerous blood-pressure drops for men taking nitroglycerine medication.

And the good news on Vasomax continues, according to Dr. Irwin Goldstein, of the Vasomax Study Group in Boston. In his group's tests, the only side effects (in fewer than 1 in 10 patients) were headaches. Of 750 men with minimum erectile dysfunction, Vasomax helped between 37 and 45 percent to achieve erections, depending on the dose given.

It's no surprise that the pharmaceutical giant Schering-Plough has been pushing hard to get Vasomax on the market. The race to get a piece of the male-impotence drug market, predicted to reach $4 billion, is making it one of the hottest areas of medicine today. Thirty million American males may be suffering from some form of erectile dysfunction. Statistically, that would imply 350,000 men in San Diego County alone face the problem. Yet only an estimated 5 percent of them so far seek treatment.

Perhaps that's because even though first Viagra and now Vasomax claim to be user-friendly, "on-demand" erection-creators, males in the past have had reason to fear the remedy more than the malady. Existing remedies have been financially and physically challenging. The penile implant costs thousands of dollars. Vacuum pumps (with which you literally pump up an erection) are awkward. Till now, erection-stimulating medications have had to be administered by catheter or injected by needle.

Yet now, at least for San Diegans, Vasomax is available just across the border, in easy-to-take, quick-disintegrating pill form. Although the FDA hasn't given its approval, Mexican health authorities have. The fact that many of the thousand or so pharmacies situated near the border stock it leads some observers to expect a smuggling bonanza of what U.S. Customs agents call "rat-packers," couriers crossing the border several times daily to transport the drug north for illegal sales in the U.S.

And that's not difficult to do. According to a 1996 Texas study, the amount of illicit pharmaceutical products and medicines traveling north across the border is staggering.

"One in four U.S. residents returning from visits to Mexico brings back medicines," says the influential report, written by Marvin Shepherd, administrator at the University of Texas's College of Pharmacy. "And most of those [medicines] brought back across the border are for illicit use."

With 40 million people crossing annually into San Diego at San Ysidro, by Shepherd's measure ten million of them are probably carrying medicines, the majority "for illicit use." That breaks down to 27,000 people crossing into the U.S. at San Ysidro every day carrying what amounts to millions of dollars' worth of pharmaceuticals.

And according to Shepherd, U.S. Customs, overwhelmed in its battle to catch the "real" drug traffickers of cocaine and other illegal "recreational" drugs, hardly notices.

"In our survey, almost 90 percent of all the drugs coming across the border were controlled substances. People were going down solely for the purpose of buying [pharmaceutical] drugs. Some would make multiple trips -- two or three a day -- and come back with a 90-day supply, the maximum allowed, then go back and get another 90-day supply. They could bring back approximately 300 Valium any one time. Eleven thousand Valium tablets and 4000 Rohypnol tablets [a depressant known as the "date-rape" drug] were legally declared every day at a single bridge-crossing in Laredo, Texas. If you extrapolate that out across the border, there's millions of dollars coming across each day. Customs are snowed under. They can't control it. They've got their hands full."

"We certainly have people 'rat-pack' small amounts of pharmaceuticals [through the San Ysidro border crossing]," admits Vince Bond, of the U.S. Customs Service in San Diego. "They appear to legally bring them in, personal-use quantities, [but] then they store them, and when they achieve a large quantity [through multiple trips] they truck it up to Los Angeles. We see an evolving pattern of pharmaceuticals being smuggled into the U.S. from Mexico. There seems to be a trend in this country to self-diagnose and self-medicate. A growing number of people on fixed incomes or retired, whose medical insurance does not cover pharmaceuticals or who don't have insurance, are going across the nation's borders into Mexico or Canada to acquire medications.

"From October 1, 1998, to the end of December 1998 we had 107 pharmaceutical seizures. We issued penalties totaling $16,910 and we made six arrests. For a variety of pharmaceuticals. The total [amount] seized was between 28,000 and 30,000 dosage units. Antibiotics, injectable penicillin, ketamine -- a veterinary drug used to relax animals so they can be examined...it's also a date-rape drug -- Darvon, a relaxant, Rohypnol, lots of Valium seizures, and also steroids."

Oddly enough, Viagra hasn't figured largely on Bond's screen. "In that same time period we only had three Viagra seizures. One for 3 tablets, one for 14 tablets, and one for 20 tablets. And we're talking all five California border stations."

And Vasomax? Bond says so far he hasn't heard of anyone being caught smuggling the drug through the border, or even declaring it.

Could that be because of doubts about how well Vasomax works?

"There are two big issues with Vasomax," says Manuel P. Asensio, chairman, president, and CEO of Asensio & Company, a New York-based investment bank and securities brokerage firm. He cites questions about the drug's efficacy and claims it can't compete with Viagra.

Asensio admits his company's stock-in-trade is to "talk down" stocks, that "short-sell" is his business, but he insists that his conclusions are based on solid research and have been given a de facto confirmation by the FDA.

Zonagen, the Texas-based developer of Vasomax, and Schering-Plough, which has acquired Vasomax's global marketing rights, suffered an apparent setback when the FDA required the company to appear before an advisory panel review set for this month. Zonagen/Schering-Plough declined to do so, citing "ongoing studies" that "should enhance the regulatory filing and the commercial product profile for Vasomax."

"I'm not going to make any comments about efficacy," says Bill O'Donnell, spokesman for Schering-Plough, "because the product is not approved yet in the United States."

The FDA is very cautious in commenting on its actions. "All I can tell you," says Susan Cruzan of the Washington, D.C.-based FDA, "is that [Zonagen] have done the clinical trials and submitted an application for a review to FDA. The process is, when FDA has questions about something, we take it to an advisory committee. A company can choose not to do that, and in this case they said that [they chose not to do that] publicly."

Schering-Plough, in a press release dated May 10, recognized that the FDA was expected to issue a "non-approvable" letter, in effect turning down its new drug application for Vasomax.

But they evidently intend to try again. "Although we are disappointed with this delay," wrote Joseph S. Podolski, Zonagen's president and CEO, "we believe that the additional data from Schering-Plough's studies are important to the long-term success of Vasomax."

And problems of approval in this country aren't holding up the company's worldwide market search. "Schering-Plough is continuing to seek regulatory approvals for Vasomax in countries outside the U.S.," says its press release, "having launched the product in Mexico in June 1998 and in Brazil in April 1999. A regulatory application was filed in the United Kingdom in August 1998 as the first step in a mutual recognition procedure for the European Union."

Cruzan is tight-lipped about Vasomax's chances here. "Under our regulations, all that is proprietary information," she says, "unless [Schering-Plough agreed and] we took it to an advisory committee meeting and made it public. It's not yet an approved drug. And that's pretty much all I can tell you."

Back on Constitución, the single "Zeta-Max," or "Z-Max" pill sits encased in foil beside its big box on the glass counter. The pharmacist's assistant looks up expectantly.

"So. You want to buy it?"

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