Looking for drug bargains across the border? If so, you might do well to remember two timeless maxims: "If it sounds too good to be true, it probably is," and "There's a sucker born every minute."
The U.S. has the highest prescription drug costs in the world, prompting many people to seek savings by buying their medicines from Canadian or Mexican pharmacies.
But if you're looking for a cheaper way to get that cholesterol-lowering statin drug your doctor prescribed, do yourself and your heart a favor: Consider that the "Zocor" you buy across the border may be a sham.
The town of Los Algodones in the Mexican state of Baja California, just across the border from Yuma, Ariz., is a sleepy little village with a booming medical and pharmaceutical business. The town has only 10 or so streets, but about 250 doctors and dentists practice there, according to the Mexican newspaper El Universal. These medical professionals funnel business to the 20 or so pharmacies in the town that are ready to take patients' money and dispense medication at fantastic savings.
But as the FDA warned in a bulletin issued July 30, 2004, buyer beware. The agency reported that individual Americans shopping in Mexican pharmacies bought drugs purported to be the statin Zocor and the muscle spasm-reliever Soma, both of which turned out to be bogus. "Tests indicate that the counterfeit Zocor did not contain any active ingredient and that the counterfeit [Soma] differed in potency when compared to the authentic product." The phony Soma had much less active medicine than the real McCoy, the FDA reported.
Mexican drug authorities said that they are trying to track down the source of the fraudulent drugs.
The practice of peddling fake medicines to unsuspecting consumers isn't limited to our neighbors, however. As WebMD reported in June 2000, the U.S. government has been aware since 1991 that counterfeit drugs are making their way into the U.S. market through a variety of channels. In 2003, the FDA issued a recall notice of fake Lipitor pills -- another cholesterol-lowering statin -- shipped from a distributor in Kansas City, Mo. The agency has also issued alerts about contaminated, counterfeit batches of the anemia drug Procrit, bogus Viagra, sham contraceptive patches that don't do anything to prevent pregnancy, and alleged "generic" versions of drugs for which there are no approved generic versions available in the U.S.
Handled With Care?
The government is right to warn consumers about the dangers of using unregulated drugs, but simply issuing warnings about drug safety without addressing the underlying economic issues is like putting a small bandage on a large wound, says Gail Shearer, director of health policy analysis for Consumers Union.
"The tragedy right now is that the government has really been asleep at the switch and not paying enough attention to the fact that reimported drugs are a reality of the marketplace. Really not enough has been done to protect people and to help guide people who are doing it," Shearer says.
For its part, the FDA warns that drug safety regulations differ from one country to the next and that people who buy drugs over the Internet or across the border can't be sure that the drugs they're getting have been properly handled. Even when the drugs come from a reliable manufacturer, some medications, such as liquid antibiotics, may not get the refrigeration they require. Other drugs may lose potency after only a few months as they sit in storage or may be sold past their expiration dates.
The FDA cautions that potential health risks from imported drugs include:- Uncertainties about quality assurance procedures in manufacturing plants not monitored by the FDA
- Potential counterfeit drugs packaged to look like the real thing
- Presence of "untested substances" that may be unsafe or not be legal for use in the U.S.
- Lack of medical supervision of patients taking drugs that require close monitoring and dose adjustment, such as diabetes medications and anticoagulants (blood thinners)
- Problems with labeling about proper use and storage of medications, or labels that are printed in an unfamiliar language
Good Neighbor Policy
Critics of cross-border pharmacies also warn that regulations that apply to drugs sold within a country to that country's citizens may not apply to drugs sold only for export. They point to Canada, for example, which requires that all drugs sold in Canada to Canadian citizens be approved for use by Health Canada, the federal agency that is the equivalent of the FDA and the CDC in the U.S. But if a drug is made only for export outside Canada, the watchdog agency does not apply the same rules and standards.
"If a drug is made in Canada and only intended for export, not for domestic use, there are different regulations that are applied," says Joel Lexchin, MD, associate professor in the School of Health Policy and Management at York University in Toronto, Ontario. But Lexchin says that should not be a concern to American consumers. "As far as I know, everything that's being purchased by Americans is also being used by Canadians, so that sort of the thing is just not an issue."
Indeed, Jirina Vlk, a spokesperson for Health Canada, tells WebMD that in many cases the Canadian regulations may be more stringent than those of the U.S. For example, the antidepressant Prozac is approved for use in children under the age of 18 in the U.S., but not in Canada, so the Canadian product will contain warnings about using the drug in children.
Lexchin points out that the chemicals used to make drugs in both Canada and the U.S. may come from many different countries. "When you buy a drug in the United States that is supposedly manufactured in the United States, it may have been tableted or made into a cream there, but the ingredients that are in there may have come from a variety of different countries, and the FDA does not consider that those are unsafe."
And he has an answer for people who seek relief from high prescription drug prices from foreign sources. "The secret to American drug prices is not to be importing from Canada or New Zealand or Australia. The solution is for you guys to decide that you want to do something about your drug prices."
Gail Shearer from Consumers Union agrees:
"We have failed abysmally at finding a way to make drugs affordable to our population, and it's time to just think a little bit more creatively," she tells WebMD. "Yes, I think there are win-win scenarios that could benefit consumers without destroying drug companies, but for too long the discussion has been dominated by special interests. It's time to address these policies in a systematic way and find a way to make drugs affordable for everybody."
