Opening door to imported drugs is not without risks
|Opening door to imported drugs is not without risks
Counterfeit Colgate toothpaste containing diethylene glycol, a poisonous chemical used in antifreeze and marked as being manufactured "in South Africa," recently turned up in discount grocery stores all over the East Coast.
This dangerous chemical has long been used by chemical companies in China as a substitute for more expensive glycerin, an ingredient necessary for toothpaste, soap, cosmetics and drugs. In 1997, fever syrup laced with diethylene glycol traced to China killed dozens of Haitian children. After years of assurances that the Chinese government had cracked down on the practice, the same fate later befell 100 young Panamanians. Mass poisonings from diethylene glycol have also been reported in Bangladesh, Argentina, Nigeria and India.
Previously only a problem in the developing world, the toxin now threatens U.S. consumers. If even toothpaste is susceptible to contamination by unregulated foreign companies, imagine the potential for disaster in something as lucrative as fake drugs.
Several members of Congress have introduced legislation to allow the importation of pharmaceuticals from abroad, promising that imports will be closely scrutinized and only permitted from certain countries.
But the reality is not so simple.
First, obtaining drugs from nations like Britain and France offers little protection, because chemicals, pharmaceuticals and other consumer goods move freely among the 27 European Union member states through a system of "parallel trade." And because the EU does not require drug importers to record such product information as batch numbers, it's quite common for goods to travel outside official distribution channels. Therefore, drugs purchased from "safe" countries may well have originated in Latvia, Cyprus or elsewhere in the EU, where there are ample opportunities for counterfeit drugs to enter the legitimate supply chain.
Canada is no safer. Most large Internet pharmacies there admit to purchasing many of their drugs from the EU. So even Canadian drugs are exposed to the risks of European parallel trade.
Indeed, the World Health Organization estimates that up to 10 percent of globally traded drugs are counterfeit. Most originate in Asia and Latin America, where technology is making production cheaper and safety regulations are poorly enforced -- perfect conditions for manufacturing and distributing fake drugs. Counterfeiters are also adept at producing phony source codes and sophisticated graphic labeling to mimic brand-name products. And smuggling networks routinely exploit corrupt public officials and create shadow mailing addresses to move drugs across borders and over the Internet.
Case in point: drugs for treating malaria. The Journal of Tropical Medicine and International Health found over half the anti-malarial medication bought in Southeast Asia in 2003 to be counterfeit. More than 1 million deaths annually are attributed to malaria, but it's extremely likely that many of those deaths are actually the result of bad drugs.
Making matters even more worrisome, penalties for counterfeiters are relatively slight. In South America, selling cocaine will land a person in jail for 15 years, but making and selling fake medicine gets the perpetrator 6 months and out on bail in days. These small risks have contributed to the rapid growth of counterfeiting.
It's estimated that global counterfeit drug sales will total $75 billion by 2010.
According to the federal Joint Terrorism Task Force, terrorists have also proven adept at exploiting weakened chains of pharmaceutical custody in North America. In a recent report, the task force revealed that a global terrorist ring with ties to Hezbollah has been importing counterfeit drugs to the U.S. by way of Canada.
Because of the wide-ranging scope of counterfeiting, it's nearly impossible for the Food and Drug Administration to guarantee the safety of imported drugs, even if they enter the U.S. from supposedly reputable nations.
The FDA's Counterfeit Drug Task Force, on which I served as a founding member, has attempted to launch an electronic tracking system to monitor drug manufacturers and distribution channels, but the process has been stalled because of high costs and a lack of cooperation from foreign countries. Countries like Brazil, India, China and Thailand would rather aid their growing and largely unregulated domestic pharmaceutical industries than inhibit them with internationally accepted safety standards.
Contrary to what advocates of importation declare, simply mandating safety by legislative fiat will not make imported drugs safer. Without fundamental regulatory reforms in the countries where counterfeits are produced, the FDA's efforts will be futile.
Allowing the importation of prescription drugs with the ostensible purpose of saving consumers a few bucks is a dangerous response to high drug prices. Congress has a responsibility to protect Americans from overseas threats, not expose them to those hazards.
Unfortunately, Congress seems not to have learned from America's recent ordeal with tainted toothpaste.
Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former associate commissioner of the Food and Drug Administration.
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