MEDICATIONS U.S. government, researchers vow to fight counterfeiters

Making fake prescription drugs is quite profitable, an official says.
BALTIMORE (AP) -- For two months after emergency surgery to replace a diseased liver, 16-year-old Timothy Fagan lived a nightmare, injecting weekly a drug that was supposed to help him heal.
Several hours after each shot, his muscles would cramp so violently that he often limped for days. Doctors assumed Fagan just wasn't responding to the medicine meant to boost his red blood cells.
Fagan discovered he was the victim of fraud when a subsidiary of the CVS pharmacy chain told him it had received a federal alert about counterfeit Epogen. A check of the labeling on the packages he was shipped indicated they were fake.
Fagan, now a student at Iona College in New Rochelle, N.Y, said the drug's manufacturer, Amgen, later told him the counterfeit contained only a fraction of the listed drug content.
Two years later, the mystery lingers: Food and Drug Administration officials confirm they're investigating, but Fagan still doesn't know how he wound up with the counterfeit drugs.
Victim filed suit
Fagan -- who filed a lawsuit in August 2003 against Amgen, CVS and its subsidiary, and the drug's distributor -- was the victim of a lucrative and dangerous counterfeit drug trade finding its way into America's pharmacies and medicine cabinets.
The federal government urged manufacturers in February to consider using new technology -- which includes tiny hidden transmitters and baked-in chemical "fingerprints" -- and researchers say some new ID tricks will be in products this year.
But despite the promise of high-tech developments, experts say counterfeiters have never had it better, thanks in part to gaps in the distribution system and more people buying increasingly expensive drugs over the Internet and abroad.
It's estimated that less than 1 percent of drugs in this country are fake. But FDA officials say they're seeing larger volumes of counterfeits and better organized operations. Federal counterfeit drug investigations have risen from five a year through the late 1990s to 22 last year, said William Hubbard, an associate FDA commissioner.
Hubbard said some officials estimate it's more profitable to fake a prescription drug than to import cocaine or heroin.
Will problem grow?
The FDA worries the problem will only get worse as more people travel abroad or visit Internet sites -- some of which buy medicines in countries with drug stocks rife with counterfeits -- to fill prescriptions that can cost hundreds of dollars per dose.
Counterfeiters are also becoming more adept at insinuating their fakes into the massive U.S. distribution system.
Officials say ensuring the system's integrity will prove daunting.
Three national distributors -- AmerisourceBergen, McKesson and Cardinal Health -- supply the majority of prescription drugs that reach U.S. retail pharmacies. Those companies say that between 97 percent and 99 percent of their product comes directly from the manufacturer; the remainder is supplied by thousands of other U.S. wholesalers -- estimates vary from 7,000 to 30,000.
"The question is, where do those [other] wholesalers get their products?" said Frank Palumbo, executive director of the University of Maryland's Center on Drugs and Public Policy. "We just don't know."
Sharing regulation burden
The problem, experts say, is that federal and state agencies share the burden of regulating drugs. In a state with lax policies, it's easier for a distributor to get a license. No national regulation exists to trace the path any particular drug takes from manufacturer to pharmacy, said Lew Kontnik, an author and security consultant for pharmaceutical companies.
In February, the National Association of Boards of Pharmacy created model rules that could be used by states to tighten regulations governing distributors' licensing. But the FDA, in its much-anticipated February report, said it won't order drug companies to adopt security measures to combat fraud. Instead, it will ask the industry to come up with its own technology plan.
The result has led to drug companies, distributors and government officials scrambling to evaluate and implement new technologies and security measures.