Counterfeit Colgate toothpaste containing diethylene glycol, a poisonous chemical used in antifreeze, 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 and other cosmetics and drugs. In 1997, for example, 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 goods move freely among the 27 E.U. member states through a system called parallel trade. And because the E.U. does not require drug importers to record product information like batch numbers, its 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 E.U., where there are ample opportunities for counterfeits to enter the legitimate supply chain.
Canada is no safer. Most large Canadian Internet pharmacies admit to purchasing many of their drugs from the European Union. So even Canadian drugs are exposed to the risks of European 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 enforcedperfect conditions for manufacturing and distributing fake 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 six months. These small risksespecially when combined with the potential financial rewardshave contributed to the rapid growth of counterfeiting.
By 2010, its estimated that global counterfeit drug sales will total $75 billion.
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 terrorist ring with ties to Hezbollah has been importing counterfeit drugs into the U.S. through Canada.
In other words, contrary to what advocates of importation declare, simply mandating safety by legislative fiat will not make imports safer. Without fundamental regulatory reforms in the countries where counterfeits are produced, the FDAs efforts will be futile.
Allowing the importation of pharmaceuticals 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 Americas 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 FDA.
from the Oct. 24-30, 2007, issue