Brushing off the risks inherent in drug reimportation schemes, Minnesota Governor Tim Pawlenty has a standard retort: "Show me the dead Canadians."
There are now dead Canadians. The Royal Canadian Mounted Police this month charged Abadir Nasr, former owner of King West Pharmacy in Hamilton, Ontario, with selling counterfeit Norvasc. Five people who filled their heart medication prescriptions at the pharmacy died of heart attack or stroke. At press time yesterday evening, Gov. Pawlenty's office did not have a comment.
Amid the din for importing pharmaceuticals, politicians are ignoring the plan's legitimate health risks. Proponents smear the drug industry and opponents fret about economic costs. But drug reimportation's real harm is that it would import foreign regulatory standards and their burgeoning counterfeit drug trade.
Two bills pending in the Senate by Sens. Byron Dorgan (D-N.D.) and David Vitter (R-La.) would allow importation from Canada and Europe, among others. And today the Senate votes on an agricultural appropriations bill containing an amendment by Vitter* and Sen. Tom Coburn (R-Okla.) that would bar the Food and Drug Administration from preventing individuals from importing foreign meds. If the amendment garners 60 votes or more, it will become a stand-alone bill with a fine chance of reaching President Bush's desk.
Economically, reimportation is a fool's errand. Pharmaceutical companies sell their products at market prices. Companies must price their drugs so as to recoup research and development and marketing costs (new drugs cost as much as $500 million to develop, so a retail price of $5 or $10 a pill isn't so steep) and bring profits back to their investors. If the industry cannot charge Americans such prices, they'll have less incentive to develop new products.
While these drugs are less expensive in foreign markets, the pharmaceutical industry accounts for these governments' price controls. As Sally Pipes points out in Miracle Cure: How to Solve America's Health Care Crisis and Why Canada Isn't the Answer, the pharmaceutical market is segmented by country. The industry can price its products according to basic economics in the American marketplace, financing overall production. "Drug companies can tolerate price controls in developed countries like Canada as long as the prices cover marginal costs, and the country represents a small share of the market," Pipes writes. If Americans were to import their drugs from Canada at Canadian controlled prices, pharmaceutical companies would probably stop selling to Canada. Drug importation is a populist panacea.
YET IMPORTATION THREATENS AMERICAN health much more than it threatens common sense. Experts convened on Capitol Hill Tuesday by the Pacific Research Institute and the Center for Medicines in the Public Interest detailed how foreign drug markets are compromised by counterfeit medicines. Counterfeit medicines are those that have been deliberately mislabeled: they could contain the wrong ingredients, too many active ingredients, or too few active ingredients. The danger to the patient is manifold.
These are the markets from which some politicians propose we import. The World Health Organization estimates that 8 to 10 percent of pharmaceuticals sold worldwide are counterfeit. The counterfeit market doesn't stop at the European Union or Canadian borders, writes Graham Satchwell, a British counterfeiting investigations expert. The EU cannot track drug shipments, which is a problem for an economic zone that internally reimports (called "parallel trading") over 140 million drug packages a year. Some have estimated that 120 million counterfeit drugs are sold in the U.K. alone. "Once you allow the importation of drugs from Europe," Satchwell told conference attendees Tuesday, "You allow the importation of drugs from everywhere."
And as interest in Canadian drugs has grown, so have reports of online pharmacies shipping drugs not approved for the U.S. market. In a test last year, the GAO found that "16 of 18 drugs it ordered from Canadian pharmacies weren't approved for sale in the U.S." Canadian officials admit that the online pharmaceutical market is highly unregulated and difficult to track.
Though counterfeit drugs aren't absent in the U.S., our market cannot very well bear opening the floodgates. Carmen Catizone, executive director of the National Association of the Boards of Pharmacy, said Tuesday that given current strains on the FDA regulatory scheme, "It's amazing the system remains secure and safe." Drug reimportation "could be the straw that breaks the camel's back and compromises the U.S. distribution system," Catizone said.
Reimportation would expose the United States to the catastrophe that counterfeit medicines have wrought in less developed countries. The World Health Organization estimates that 25 percent of medicines traded in less developed countries are counterfeit. Other statistics from the developed world are startling: over 50% of antimalarials in Southeast Asia are counterfeit; authorities believe a fake meningitis vaccine is responsible for 2,500 deaths in Niger; and the Chinese government, usually reticent about admitting failure, estimates that counterfeit medicines cause 192,000 deaths a year in China.
Drug reimportation is a sovereignty question. Americans would surrender quality control and market forces to the countries from which we import. Drug reimportation supporters don't have the chutzpah to impose price controls, so they import them. As Prof. David Taylor of the London School of Pharmacy put it Tuesday, once you import foreign drugs, "you've surrendered your own government."
But most importantly, this is a safety question. Will Americans be more or less safe under drug reimportation? Politicians seem unconcerned with such trivialities. Health policy consultant Mike Tremblay succinctly formulated the issue Tuesday: "The consequences of getting it wrong are dead people." Will Gov. Pawlenty and Sens. Vitter and Dorgan wait for American bodies before they address the risks of importation?
*UPDATE (9.22.05. 10:40 a.m.): Sources on Capitol Hill tell TAS that Sen. David Vitter last night chose not to offer the drug reimportation amendment to the agriculture appropriations bill. TAS is told Vitter was not confident that he had the votes for passage. While the separate bills are still options, their chances of seeing floor votes are doubtful.
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