MyTurn: A Reasonable Doubt

Published February 1, 2004

Thanks to increased border security in the wake of September 11, seizures of diluted and counterfeit drugs entering the U.S. from Asia, Europe, and other locations have increased dramatically over the past two years.

American consumers seeking prescription medications at cheaper prices through unregulated storefront operations, directly from Canadian sources or over the Internet, are foolishly ignoring a reasonable doubt as to the safety of their medicines.

Elizabeth G. Durant, executive director of trade programs at the U.S. Customs Service, told the Senate Committee on Aging, “Because we are looking at more things, we are finding more things in every arena.” Durant noted millions of prescriptions enter the U.S. through the mail each year as people search for lower-priced drugs.

She also noted the disturbing trend toward increasing bulk shipments of drugs, further escalating the risk counterfeit drugs could get past inspectors and find their way into the medicine cabinets of unsuspecting consumers. Customs officials are inundated by prescription drugs coming across borders, by mail or on persons who cross the border from Canada or Mexico.

We’re a Target

A number of governors and federal legislators insist the drugs purchased in Canada are safe. They also criticize those of us who raise the “safety issue” for laying down a “smokescreen,” saying we’re nothing more than shills for big corporate pharmaceutical interests. If that’s so, then so is Health Canada, the Canadian government’s counterpart to our Department of Health and Human Services. Health Canada steadfastly refuses to vouch for the safety of drugs sold out of Canada into the U.S. How can they? Forty percent of the medicines in their drug supply don’t come from Canadian sources, or even from the U.S.–they come from overseas.

America’s huge market for prescription drugs is a tempting target for counterfeiters, and the growing interest in importation makes Canada an attractive port into the U.S. Louisiana Democrat Senator John Breaux, a member of the Finance Committee, said, “Counterfeiting concerns make it impossible to guarantee the safety of drugs imported from Canada or other countries.”

One recent proposal to legalize importation, sponsored by Senators Byron Dorgan (D-North Dakota) and Deborah Stabenow (D-Michigan), illustrates a cavalier disregard for consumer safety. Breaux said no law could protect the chain of custody between the time the drugs leave the U.S. and the time they return. “We can guarantee that they’ll be cheap,” said Breaux, “but we can’t guarantee that they’ll be safe.”

A similar proposal passed Congress and was signed into law by President Bill Clinton in 2000. The law was never implemented because of a reasonable doubt: Health officials in the Clinton and Bush administrations refuse to certify that imported drugs meet U.S. safety standards.

More Smokescreens?, an independent research firm focused on evaluating online pharmacies and comparing prices, found 30 percent of Canadian online pharmacies surveyed had no verifiable affiliation with a licensed pharmacy.

Noted Dr. Tod Cooperman, “Six pharmacies of the 20 surveyed declined to provide information about who dispensed their drugs.” He further stated it is difficult to tell whether the pharmacies are operating illegally, because some simply may not want to disclose information due to controversy on both sides of the border over online-pharmacy operations. “It is possible some Canadian Internet pharmacies may be obtaining drugs illegally from wholesalers or offshore sources,” Cooperman said.

The research firm also found several Internet pharmacies didn’t provide secure financial transactions online, didn’t ensure privacy of information, or didn’t provide reliable contact information. Only six of the 20 sites met all the firm’s criteria for protecting consumer safety and privacy. All six were accredited online extensions of licensed brick-and-mortar pharmacies like Walgreens, Eckerds, and Rite-Aide.

Health Risk

Bogus drugs remain undetected if they do not make people obviously sick. Their effects, however, are potentially more insidious, as patients may simply fail to recover from their illnesses.

In a documented and under-reported event last year, a Michigan boy complained the growth hormone shots he was getting were giving him a burning sensation. After an analysis, it was discovered the boy was being injected with contaminated insulin. The investigators traced the mislabeled, impure product to a pharmacy in Orlando, Florida, which had purchased the product from a primary wholesaler.

Tracing back even further, it was discovered the drug previously went through three secondary wholesalers. The trail went cold at the last unlicensed wholesaler who was unable, or not required, to document where the drug came from.

Not all of the mislabeled and counterfeit insulin has been recovered. Some of it is still out there, somewhere, being injected into sick children and adults, causing pain and possibly deaths.

Anybody who thinks writing about this very real problem is just blowing smoke either isn’t paying attention or is blowing smoke of his own.

Conrad F. Meier is managing editor of Health Care News. His email address is [email protected].