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Science & Society 10/6/03
A prescription for controversy

By Alex Markels
TULSA, OKLA.--When self-described former "Okie oilman" Carl Moore opened his Rx Depot store here last October to help locals buy inexpensive prescription drugs from Canada, the entrepreneur had no clue he would soon become a hero to his customers and a pariah to the U.S. Food and Drug Administration.

But that is exactly what happened after Moore sought to take advantage of the FDA's seemingly lax enforcement of a law barring the importation of foreign drugs. By setting up shop in a vacated ATM stall along Memorial Drive, one of Tulsa's main commercial drags, Moore figured he could facilitate drug purchases for folks unable to travel to Canada and wary of filling their prescriptions via mail order--practices the FDA now abides.

The decision quickly won him customers, but it raised the ire of government regulators and thrust Moore into the middle of a raging debate over importing drugs from countries like Canada, where government price controls, limited patent protection, and weaker currencies help keep drug prices as much as 80 percent below those in the United States.

Wins and losses. Moore, 59, a pool shark and good old boy who drives a mammoth pickup with "God Bless America" emblazoned on the tailgate, seems an unlikely crusader for the cause. A former college wrestler and minor-league baseball player, he made millions transporting oil by barge and then lost most of it when oil prices crashed in the 1980s. He was also the ultimate soccer dad to his son, Joe-Max, who went on to play professional soccer and become a member of the U.S. national team. Father and son got interested in importing drugs after the elder Moore's ex-wife, Joe-Max's mother, became ill with cancer, and the men discovered that the drugs she needed were cheaper in Canada. Carl and Joe-Max founded Rx Depot together.

Soon after Rx Depot opened its first storefront in the parking lot of Tulsa's Fontana Shopping Center--right by the Acura dealership and Monterrey's Mexican restaurant--a frail-looking woman walked in and asked the elder Moore for a price check on tamoxifen, a drug for treating breast cancer. When he told her it would cost $45, "she started crying," he recalls. The woman explained that she had stopped taking the drug a year earlier because she couldn't afford the $390 her local pharmacy charged for the same prescription. "She told me she felt she had a new lease on life," Moore says of the moment when he realized his new venture was more than just a potential moneymaker. "It changed my life, too. I started wondering how many more people were out there who couldn't afford the drugs they needed to live."

Moore got his answer pretty quickly. After a local newspaper ran a front-page story about the company's battle with state regulators, a line of eager customers formed outside. Despite the problems, Rx Depot grew rapidly; undaunted, Moore and a growing army of affiliates opened 85 stores in 26 states. Their mode of operation is simple. Customers arrive with their prescriptions and fill out a medical questionnaire, both of which are faxed to a Canadian pharmacy. There, the pharmacist consults with a physician, who approves the prescription. The drugs are then mailed directly to the customer, and Rx Depot receives a 10 percent commission from the Canadian pharmacy.

Comparison shopping. What's happening to Moore right now reflects the complexity and white-hot intensity of the debate. The FDA says the high cost of drugs in the United States can be traced to growing research and development costs and unrealistic price controls in other countries, but critics say much of the cost is really because of price gouging and increasing marketing expenditures. Regardless of who's right, the price differences between the United States and Canada are stark, and they've sent more customers north of the border. Last year, Americans purchased as much as $650 million worth of Canadian drugs, according to pharmaceutical consulting firm IMS Health. And the trend is accelerating. In September, the governors of Illinois and Iowa announced plans to seek Canadian drugs for state employees.

Although federal law prohibits anyone but pharmaceutical manufacturers from reimporting drugs, the FDA has long allowed Americans to buy up to a 90-day supply of some prescription drugs outside the country and bring it home. But the FDA has taken exception to new commercial operations like Rx Depot, which officials say lure customers with false promises about the safety of the drugs they help import. So in mid-September, the FDA--in cooperation with the Justice Department--sued Rx Depot and Moore, and a state court ordered the closure of Rx Depot's Oklahoma stores. The FDA is expected to argue for the closure of the rest of Rx Depot's outlets at a U.S. District Court hearing in Tulsa on October 8.

The problem, as the FDA sees it, is that Rx Depot is "selling unapproved, potentially dangerous drugs," says William Hubbard, the agency's associate commissioner for policy. He points to a recent FDA sting operation against Rx Depot, which found that an order for 60 pills of Serzone, an antidepressant, was filled with a package of 99 pills of APO-Nefazodone, an unapproved generic equivalent, that included improper directions.

But a lot of folks are now coming to the defense of firms like Rx Depot and angrily assailing the FDA's motives. "This isn't about safety; it's about profit margins," says Rep. Dan Burton, an Indiana Republican, who is one of several in Congress working on a possible fix. In July, the House of Representatives passed the bipartisan Gutknecht-Emerson bill, which would allow companies like Rx Depot, as well as drug wholesalers and pharmacies, to import prescription drugs from 25 industrialized countries. But observers say the bill's fate is uncertain in the Senate, because of strong opposition from both the FDA and the big pharmaceutical firms, which cite safety concerns.

For his part, Carl Moore figures the best way to change things is to fight it out with the FDA. A lifelong Republican, Moore says he gave up on the party after the FDA suit was filed. "I realized then these were politicians who won't listen to the public," he says. His Tulsa storefront is now transformed into a political headquarters of sorts, and last week Moore and his partners established a legal defense fund. They now answer customer calls with pleas to "call your congressman." "We're going to the mat on this one," he told a customer. Those who dropped by his office recently were happy to join up. "He's fighting the good fight," says Charles Bright, who showed up to fill a $500-a-month prescription. Told it couldn't be done in Oklahoma, he asked Moore for directions to the company's still-open store in neighboring Arkansas. "I just feel like big business is ripping us off too damn much," says the Sand Springs, Okla., retiree. "And if Carl here is willing to stick his neck out to change things, well, the least I can do is drive to Arkansas." It is, after all, a heck of a lot closer than Canada.

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