Despite Canada’s excellent drug control system and millions of individual experiences that verify the safety of personal medication importation from Canada, the multinational drug cartel and elements in the US government still issue dire warnings about the dangers of that hugely economical practice. The most recent of these scare tactics alleges a potential for counterfeit drugs from Canadian pharmacies.

However, recent media reports about counterfeiting within the US drug market indicate that patients directly importing medications are less likely to receive a counterfeit drug from Canada than if they obtained their medication in the US. In fact, while the US has reported several high-profile cases of counterfeit drugs this year, Canada has had none. Could it be that all this "finger pointing" might be intended to protect drug manufacturers’ profits and to detract from fallacies in the US system?

THE CANADIAN CONTROLS SYSTEM

A recent (US) Congressional Research Service analysis…has confirmed that "the Canadian regulatory system for prescription drugs is comparable in all substantive respects to that in the United States…and that all Canadian prescription drug manufacturing facilities and distribution facilities must meet strict good manufacturing practices and that Canada maintains strict chain of custody requirements.

All prescription drugs on the Canadian market must be approved for sale to Canadian consumers and must include contact information of every company that has handled the product along the chain of distribution, and all prescription drugs approved for sale in Canada carry a distinctive numerical code used to track the product. In addition, every prescription drug manufacturer, wholesaler, and distributor in Canada must be licensed by the federal government, and every pharmacy and pharmacist must be licensed by their provincial government."

MEANWHILE, BACK IN THE USA…

(There is) what some (US) investigators are calling the biggest jump in (US) fake-drug cases in more than a decade. The investigators admit the cases show there are growing holes in the U.S. drug safety net…(a US) investigator… says, ''It's a nationwide (US) problem.'' Some recent examples are:

· A Florida grand jury investigating (US) pharmaceutical wholesalers indicted 19 people on charges of peddling bogus or diluted medications often prescribed for cancer and AIDS patients.

· Investigators say ten types of counterfeit drugs moved through Florida in the past two years.

· Dozens of the 1,458 prescription drug wholesalers in Florida were under investigation on suspicion that they had substituted genuine medications with weaker or bogus drugs.

· The FDA has opened 73 investigations into counterfeit or tampered-with drugs (within the US) since 1998, with an uptick in the past two years.

· Inspectors in South Florida alone seized $20 million worth of adulterated pharmaceuticals in the past year.

· Some (US) wholesalers purchase drugs that have been stolen, illegally imported or adulterated…and are often not required to show documentation of where they purchased the drugs. Yet efforts to oversee the practice by requiring documentation every time drugs are bought or sold - all the way back to when they leave the factory - have been fought by the (US) wholesale industry, which says such rules are burdensome.

· The FDA has never fully implemented a 1988 (US) law aimed at tracing drugs to their source.

One (US) wholesaler was recently found to have 339 cartons of counterfeit Procrit in its warehouses.

· Counterfeits of Serostim (California); Zyprexa (Michigan, Illinois, Minnesota, and Wisconsin); and Epogen and Procrit, (nationwide) have recently been found in distributors within the US.

· The FDA…has announced…investigation of counterfeit Lipitor repackaged by Med-Pro, a pharmaceutical repackaging company based in Lexington, Nebraska.

· A Florida grand jury stated, ''Uneducated, inexperienced . . . rank amateurs, many with criminal records, make up a sizable portion of Florida's drug wholesalers. In most (US) states, it's too easy to get a wholesaler's license to distribute drugs to pharmacies and hospitals. Hundreds - and in some states, thousands - of wholesalers are licensed."

· Some secondary (US) wholesalers - and no one knows exactly how many - obtain medications illicitly, buying drugs at a discount from (US) pharmacies or on the black market from Medicaid patients.

· In Nevada, a (US) secondary wholesaler was charged with failing to keep records on $34 million of drugs it bought and sold from 1998 to 2000. The Nevada State Board of Pharmacy said the firm's refusal to produce inventory records prevented regulators from tracing the drugs to their sources.

· And finally, in congressional testimony, William Hubbard, the FDA's Associate Commissioner of Policy and Planning, said, ‘‘it is easy to see how this (the internal US) system . . . facilitates the entry of counterfeit and otherwise unsafe drugs into the (US) marketplace.''

WHY COUNTERFEITERS TARGET THE INTERNAL US MARKET AND DISTRIBUTION SYSTEM

Any counterfeiter wants to maximize profits before being exposed. To do this, a drug counterfeiter will sell the fake product into the most expensive drug market (the USA); the counterfeiter will seek out the largest and most profitable market (the USA); and to move the most fake product before discovery, the counterfeiter will seek out the broadest and most rapid distribution system (the USA). To do otherwise would be akin to counterfeiting Mexican pesos to buy Mexican sombreros to resell in the US one at a time.

Simple logic implies that no counterfeiter would sell fakes into the strictly-regulated Canadian system (at a much lower price than in the US), hoping that the fake product would then be peddled across the border to American consumers one prescription at a time. Instead - as with the fake Lipitor – to get the most volume and most immediate profit, the astute counterfeiter "dumps" large bulk quantities of his fake directly into the US distribution system of repackagers, secondary wholesalers, diverters, etc., thereby enabling him to "take the most money and run" before the fakes are discovered as they move into the retail (consumer) market - where rapid exposure and notification will be almost certain.

This is why American media are reporting items like this: USA TODAY - May 15, 2003 – "Fake drugs show up in U.S. pharmacies. As prescription prices rise, counterfeiters chase profits. As more high-priced prescription medications hit the (US) market, they are proving irresistible to counterfeiters, who have successfully slipped fake, mislabeled and mishandled drugs into U.S. pharmacies. (US counterfeiting) is fueled by three things: increasingly sophisticated forged labels, an abundance of small wholesalers buying and reselling medications, and a growing number of expensive new treatments that can net forgers large profits."

The recent US Congressional Research Service analysis indicates that the only real difference between prescription drugs in the United States and Canada is the enormous difference in price, and one FDA official is quoted as saying, "Canada has drug regulations and testing systems that are comparable to ours in the U.S., which makes it (direct importation) a little safer." But, media reports like these suggest that drugs imported from Canada may be just a whole lot safer than some obtained in the US!