Wednesday, November 25, 2009

Health

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Crossing Borders

Drugs bought from Canada can save your money but may also risk your life. Here's how to save both

By Josh Fischman
Posted 9/12/04

The half-dozen elderly people meeting at Horseshoe Pond Place, an independent living facility in Concord, N.H., were, for once, impressed with a government initiative. In their quest to afford the drugs that, in many cases, keep them alive, they had tried to sort through assistance programs offered by pharmaceutical companies and the new Medicare discount cards, all in a pricing landscape that changes from one day to the next. But when Gov. Craig Benson came to Horseshoe Pond to explain the state's website with links to Canadian pharmacies, Virginia North, 77, voiced approval. "He asked us to throw out the names of drugs we used. I said Lopid." She takes the heart drug to reduce her triglyceride levels. "I pay $150 for 90 days. Through this Internet, I could get it for $50 for 90 days. I think that's great," she says.

Benson is one of seven governors, along with mayors from cities such as Springfield, Mass., and Columbia, S.C., who have kicked off or announced programs in the past year that make it easy to get cheaper medicine from Canada, where price controls keep costs low. "I can't tell you how many seniors I've met who simply cannot afford their drugs," says Benson. And it's not just seniors but young people and new parents and working, middle-aged couples. Many New Hampshire residents used to ride buses across the border to fill their prescriptions. "Why should we make old people sit on buses for three or four hours, when they can do it through the Internet where it's easier and safer?" Benson asks.

Because it isn't safer, answers the FDA; in fact it is downright dangerous. "You can not only lose your money but also your health," says William Hubbard, the FDA's associate commissioner for policy and planning. Drugs from Internet pharmacies, even those in nice, safe Canada, could be counterfeit, tainted, mislabeled, and unapproved (story, Page 46). And Hubbard and others worry that the state programs remove such drugs from FDA inspection. "Apparently these pharmacies will sell you anything," Hubbard says. "And once you tell the FDA to get out of the way, it's 'Katy, bar the door!' "

Is this literally a case of your money or your life? Must people choose between safe drugs and affordable drugs? Not really. There are some risks, but it turns out there are also steps careful consumers can--and should--take to safeguard both wallet and health. Choose Canadian pharmacies wisely: Some of the state programs have actually sent inspectors to specific pharmacies to check their supply and their practices for safety. You should also be careful about the medications you request, using the Canadian sites for refills only after you and your U.S. doctor know how the drugs affect you. "I think our website has stepped in to provide people with quality assurances," says Kevin Goodno, commissioner of human services in Minnesota, which runs an importation program. "We feel the pharmacies we use meet or even exceed the standards of Minnesota pharmacies." Adds Scott McKibbin, who helped design the Illinois plan, set to kick off by the end of the month: "Myself, my wife, and our four kids will be in this program. So there's no way I'm compromising on safety."

McKibbin, Goodno, and others began looking across the border as prescription drug prices soared in this country, rising much faster than the rate of inflation. The average cost of widely used brand-name drugs went from $33.76 in 2000 to $60.38 in 2003, according to a study by the AARP Public Policy Institute. "So what you see is sick people choosing not to buy drugs, and in my view that's the real health risk here," says Goodno. "We felt we had to do something."

That something turned out to be Canadian imports, which were attractive for two reasons. First, the Canadian government has a national healthcare system that sets drug prices, which can be 70 percent lower than in the United States (table, Page 44). Second, the Canadian drug-safety system mirrors that of the United States, with a federal agency--Health Canada--regulating drugs based on therapeutic value and good manufacturing standards, and with local pharmacy boards licensing and inspecting all pharmacies.

Loose law. Plus, while the U.S. government has been adamant about keeping American drugs under FDA oversight, blocking all unapproved imports, the agency--so far--has interpreted the law to allow a "personal use" exemption, which means a person with a valid U.S. prescription from a doctor can bring in up to a 90-day supply of a drug.

Minnesota was the first state to put all these elements together. It sent a team of pharmacy inspectors to Canada who looked at the credentials, licensing, suppliers, and volume capacity of eight pharmacies interested in selling to the American public. The state selected two of these pharmacies for a site, minnesotarxconnect.com, that launched early this year: Total Care Pharmacy in Calgary and Granville Pharmacy in Vancouver. (Two more pharmacies were added this spring.)

At the site, consumers are provided a list of drugs and advised to order only refills and not to order narcotics. They download an application in which they list their complete medical history and attach a valid U.S. prescription, and fax it to the pharmacy. The pharmacy forwards the information to a Canadian physician for review, and the doctor then writes it up as a Canadian prescription (U.S. prescriptions are not valid in Canada). Payment is usually by credit card, and in two to three weeks the customer gets a 90-day supply of the drug. Insurance companies generally reimburse for the drugs as they would for U.S. prescriptions.

Wisconsin, after its own inspections, soon followed with a similar system ( drugsavings .wi.gov) with similar requirements for both consumers and drugstores. North Dakota and New Hampshire also added websites, which link directly to the Canadian stores, which have their own patient information forms. A few cities, such as Columbia, S.C., and Washington, D.C., have added "tagalong" links to city web pages that direct consumers to the state sites. (Springfield, Mass., has gone even further and contracted with a Canadian drug clearinghouse to supply specific drugs to city employees and retirees.)

All this due diligence sounds good on paper, say Hubbard and other critics, but in reality the programs have serious holes. "The big problem is that Canada can't supply all these drugs from legitimate sources," says Marvin Shepherd, director of the pharmacoeconomics center at the University of Texas-Austin. The country has a small population, and drug companies such as Pfizer and GlaxoSmithKline limit what they send north of the border. Pharmacies are thought to turn to sources like China, Israel, and Mexico to fill American orders. "We don't really know the pedigree of these drugs," says Tom McGinnis, FDA's director of pharmacy affairs. Druggists may think they are getting the real deal from their wholesalers and distributors, but the products may be manufactured badly or not equivalent to FDA-approved medications. Indeed, Hubbard listed 15 violations of good pharmacy practice that turned up in Minnesota's own inspections and noted that Wisconsin's Canadian partners shipped unapproved drugs in violation of their contract with the state.

That sounds worrisome. But Goodno points out that of Hubbard's 15 violations, 12 applied to the pharmacies Minnesota rejected, not to the four they actually partnered with. As for unapproved drugs sent to Wisconsin, Sue Reinardy of the state health department says they were generics approved but not yet available in the United States, and the ban on them wasn't clear in the contracts; pharmacies stopped sending them as soon as this was clarified. "This actually contradicts the FDA objections that we're out of control," says Dave Robertson, president of Calgary's Total Care. "As soon as they told us to stop, we stopped."

The real thing? But what about counterfeit or faulty products? It doesn't appear to be a real Canadian problem. This spring, the Government Accountability Office, the investigative arm of Congress, ordered 11 different drugs from more than 60 different Internet pharmacies, including 18 Canadian ones. The GAO sent the medicines--such as the cholesterol drug Lipitor and the arthritis drug Celebrex--back to the original manufacturers to check their chemistry and activity. "In other words, we asked them to tell us if this was indeed their drug," says Marcia Crosse, who directed the study. None of the drugs from Canada were fakes. And the Canadian drugs had fewer problems in certain areas (specifically improper shipping or no pharmacy label attached to prescriptions) than did even the U.S. pharmacies. "I don't think you can say, based on our small sample, that it's absolutely safe," says Crosse. "But we certainly felt more comfortable with Canada."

To increase your comfort level, if you decide to go the Canadian route, it would be wise to take several steps. The FDA isn't wrong: There are bad guys out there. So deal with the pharmacies already vetted by states; you don't have to be a state resident to use these websites. Try a new drug first from a U.S. pharmacy, to check for side effects, and then use the Canadian pharmacy for refills. Don't order anything that needs to be refrigerated, like insulin, because you never know what will happen during shipping. And compare labels with your U.S. prescription. If the directions are not the same--and some Canadian labeling requirements are different--check with your doctor before using the drug. Don't order Canadian generics; because there's more generic drug competition in the United States, driving prices down, American generics are usually cheaper.

Cheaper and safer drugs, after all, is what this is all about.

MAPLE LEAF MEDICINES

At least seven states have started--or are about to start--programs to import prescription drugs from Canada because of their lower costs.

CANADA

NORTH DAKOTA

MINNESOTA

WISCONSIN

ILLINOIS

VERMONT

NEW HAMPSHIRE

RHODE ISLAND

ILLINOIS

Program, to be launched this fall, will allow uninsured Illinois residents to refill maintenance prescriptions from Canada and Europe.

www.affordabledrugs.il.gov

MINNESOTA

Website links patients to four Canadian pharmacies, vetted by the state health department, that refill prescriptions.

www.minnesotarxconnect.com

NEW HAMPSHIRE

Website links consumers to two Canadian pharmacies.

www.state.nh.us/governor/prescription/prescription.html

NORTH DAKOTA

State website first offers generic alternatives, then links consumers to two Canadian pharmacies.

www.discovernd.com/prescription-drug.html

RHODE ISLAND

Passed law allowing Canadian pharmacies to seek state licenses for direct sales.

Law to take effect in 2005

VERMONT

Proposed contract with Canadian company to import drugs for state employees.

Proposal rejected by FDA; state now suing agency

WISCONSIN

Website links patients to three Canadian pharmacies, inspected by state officials, that refill prescriptions.

www.drugsavings.wi.gov

Stephen Rountree--USN&WR

Values abroad

Prescription prices are lower in Canada and the United Kingdom than in the United States, though doubts remain about the safety of imported drugs.

DRUG USED FOR U.S. CANADA U.K.

Aciphex Heartburn $422 $172 $178

Plavix Blood thinner 397 213 257

Lipitor Cholesterol 214 162 158

Celebrex Pain/arthritis 271 149 188

Actos Diabetes 542 377 286

Zocor Cholesterol 423 231 263

Norvasc Blood pressure 166 145 134

Protonix Heartburn 381 202 206

Vioxx Pain/arthritis 322 138 221

Neurontin Seizure/pain 275 202 238

Celexa Depression 281 138 160

Asacol Colitis 127 63 86

U.S. prices for a three-month supply from a retail pharmacy versus overseas prices, including shipping costs. Source: State of Illinois

With Susan Brink

This story appears in the September 20, 2004 print edition of U.S. News & World Report.

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