continued "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?"