It all began on a sweltering summer day about four years ago. A few dozen people boarded a bus in Bennington and drove north to Canada in search of affordable prescription drugs. Most were senior citizens, but others suffered from chronic diseases so painful or debilitating they had to be carried on and off at each stop. Though the trip took 12 hours, the riders later said they felt energized by what they were doing -- which was breaking the law. Re-importing American-made prescription drugs from Canada is illegal, but the U.S. government turns a blind eye if people return with a 90-day supply or less for their own use.
It wasn't long before politicians and candidates from Maine to Montana were making runs for the border with their constituents, saving them hundreds, if not thousands, of dollars per trip on life-saving medicines. Thanks to a favorable exchange rate and government price controls, Canadian prescription drugs cost a fraction of the price they're sold for in the United States. But the trips were time-consuming and exhausting, and many people were too sick or frail to make the journey.
"When we got back, I remember thinking, 'This is totally ridiculous,'" recalls Dr. Elizabeth Wennar, CEO of United Health Alliance of Bennington, which helped organize the first bus trip from Vermont. "There's got to be a better way."
Wennar got in touch with several Canadian pharmacies and set up a Web site and a toll-free number so Bennington-area patients could buy Canadian meds without ever leaving their home -- or the country. "The next thing you know, we were getting letters, phone calls and had bags of letters being dragged in to us," says Wennar. "It was heart-wrenching but we couldn't say, 'No, we can't help you.'"
Soon, the nonprofit Medicine Assist program was helping thousands of people from every state buy cheaper pills from Canada, unleashing a torrent of other cross-border prescription drug sales. Today, about 150 Internet and mail-order pharmacies in Canada market exclusively to American consumers. The U.S. Food and Drug Admini-stration estimates that two million parcels containing prescription drugs enter this country each year from abroad. Recently, a handful of companies have even begun opening storefronts in the U.S. where consumers can walk in and fax their prescriptions directly to a Canadian pharmacy. One such outfit, called Discount Prescription Services, opened in April in South Burlington.
This nascent cottage industry hasn't escaped the attention of the pharmaceutical industry, which has decided to do something to stop it. In the last few months, two firms, Glaxo SmithKline (GSK) and Astra-Zeneca, stopped selling medications to Canadian pharmacies that market directly to U.S. customers. The drug companies say the proliferation of Canadian-based Internet drug stores has put a drain on Canadian supplies and led to medication shortages for Canadian consumers. They also warn that the sale of medicines from Canadian and other foreign pharmacies, which are unregulated by the FDA, puts Americans at risk by exposing them to drugs that are counterfeit, expired, contaminated or stored under unsafe conditions.
But longtime critics of the pharmaceutical industry, like Rep. Bernie Sanders, say they've heard this complaint before. Sanders, who was the first member of Congress to take constituents across the border, says there's no evidence that American drug buyers are harming the Canadian health-care system. And he calls this latest move by GSK and AstraZeneca just another ploy to intimidate American consumers into paying exorbitant prices for drugs -- many of which were developed at U.S. taxpayers' expense.
So Sanders has introduced legislation to prevent the industry from discriminating against Canadian distributors. The long-term goal, he emphasizes, isn't to get Americans buying their meds from Canada, but to force American drug makers into lowering their prices in the U.S. to levels comparable to those in Canada and Europe. And with Congress poised to debate a prescription-drug benefit for Medicare recipients, it appears Sanders and Big Pharma are heading for a showdown.
At stake are billions of dollars in profits for the pharmaceutical industry -- and potentially billions of dollars in expenses for U.S. taxpayers if Medicare eventually has to foot the bill. Currently, about 65 million Americans have no prescription drug coverage, including 11.6 million Medicare recipients. Prescription drugs are now the nation's fastest-growing health-care expenditure. In 2001 alone the average price of medicine rose at more than six times the rate of inflation. That same year, when most U.S. businesses were in an economic slump, the 10 biggest U.S. pharmaceutical companies saw their gross profits jump by 33 percent, according to Fortune magazine.
But drug manufacturers insist the debate over drug re-importation isn't about profits. It's about ensuring Americans access to safe and effective drugs. Nancy Pekarek, U.S. spokesperson for Glaxo SmithKline, says the unregulated medicine trade over the Internet exposes Americans to dangerous, ineffective and potentially harmful drugs. About 8 percent of all pills sold in the United States are counterfeit, she says. And while GSK has no statistics on how many people are harmed by bogus meds sold over the Internet, Pekarek says she has heard numerous reports of people receiving incorrect dosages, instructions written in foreign languages or the wrong drug entirely when they buy online. "You don't even know where an Internet pharmacy is," Pekarek warns. "It may have a Canadian flag on it, but it could be anywhere."
The FDA also advises American consumers against purchasing medicine through the Internet except from reputable dealers within the United States. Although the FDA recognizes that many Internet sites are genuine and offer consumers convenience, privacy and low prices, it warns against so-called "rogue sites" that either sell unapproved drugs or sidestep normal pharmacy safeguards. For example, some sites do not require that patients have a doctor's prescription; others have no pharmacist on the premises watching for dangerous or potentially life-threatening drug interactions.
Wennar at Medicine Assist doesn't deny there are unscrupulous drug peddlers in cyberspace, especially when it comes to feel-good or "boutique" drugs like Viagra. "Do I believe there are bad guys on the Internet? Absolutely! I deal with them every day."
In fact, Wennar wrote her doctoral thesis on drug re-importation policy and gives seminars to the FBI on the subject. But she refutes the pharmaceutical industry's claim that Canadian pharmacies are unsafe or unregulated. All the pharmacies that work with Medicine Assist abide by the rigorous standards of the Canadian pharmaceutical industry. All have doctors or pharmacists on the premises and all are accredited by the Internet and Mail Order Pharmacy Accreditation Commission. "The drug companies talk about Canada like it's a third-world country," Wennar says. "Canada actually has more layers in place than we do for oversight because their system is more regulated."
Sanders doesn't dismiss legitimate safety concerns, either; he just says the problem is overblown. During a Congressional hearing last month, he asked one FDA spokesman: Out of the one million or so Americans who buy their pills from Canada, how many have reported problems such as inappropriate dosages, mislabeled packages or adulterated medicines? None, the spokesman admitted. "Zero for one million. That's not a bad percentage," Sanders says.
This fight has nothing to do with the safety of the Canadian drug supply, Sanders asserts. It's about a government policy that is driven entirely by campaign contributions from Washington's most powerful lobby. The Center for Responsive Politics reports that the pharmaceutical industry fed more than $20 million into congressional coffers during the 2002 election cycle -- nearly 80 percent of which went to Republicans. "What you have is the Bush administration working in collusion with the drug companies to make it harder for Americans to buy safe and affordable medicine in Canada," Sanders says. "The reality is, this is 100 percent political."
Meanwhile, critics contend, the real public health threat is that millions of Americans cannot afford their medications. Congressional health experts estimate that one in five seniors skips dosages or goes without medications altogether because he or she cannot afford them. This is the same problem, notes Wennar, that forced patients to get on the bus for Canada four years ago. "A drug is only effective if someone can buy it and take it," she says. "If you can't afford to take it, it's worthless."
Recently, the FDA began taking a closer look at the Canadian pharmacy outlets cropping up in this country. One in Arkansas was shut down several months ago for distributing medicines without a pharmacist on the premises. Wennar also warns that these outfits may compromise patients' privacy and safety.
But Albert Beauchesne of Discount Prescription Services in South Burlington says there's nothing illegal or unscrupulous about what he's doing -- like Medicine Assist, he's simply providing a public service. He says his company handles no medications itself, but just gathers patients' information and puts them in touch with whichever Canadian pharmacy can offer them the lowest price.
"Most seniors don't know how to order off the Internet," says Beauchesne. "They want to see someone. They want to talk to someone. They want someone to address their needs. These people are just trying to get their medications at a price they can afford. That's our job."
Meanwhile, Sanders has attracted unlikely allies in this fight. Rep. Dan Burton, a conservative Republican from Indiana, is a co-sponsor of the Preserving Access to Safe, Affordable Canadian Medicines Act of 2003. While his bill does not yet have a Senate sponsor, Sanders says most Democrats -- and a number of other House Republicans -- have indicated their support for the measure.
In another political twist, Sanders, who is no fan of free-trade agreements, says the Canadian government may file a complaint of anti-competitive behavior against the drug companies under the rules of the FTAA. "I always get a kick out of the free traders," he says. "They think it's great that we can buy any product we want from China and throw American workers out on the street, but buying highly regulated medicine from Canada is just the worst thing in the world."
For folks like Wennar, the fight for affordable prescription drugs is less about legalities than ethics. "Physicians aren't politicians," she says. "And physicians know one thing: If my patients cannot follow the treatment plan that I prescribed, they can't get better and they can't manage their illness. And isn't that our whole objective?"