Last month, thieves cut through the roof of an Eli Lilly warehouse in Enfield, Conn, shimmied down a rope, disabled the alarms and made off with $75 million worth of psychiatric drugs, including the antidepressants Prozac and Cymbalta and the antipsychotic Zyprexa. It is thought to have been the largest pharmaceutical theft in history.
News reports expressed some puzzlement over the crime. Why would burglars go after medicines rather than diamonds or art? And when did pharmaceutical thieves graduate from Oxycontin stickups to the big time?
The answers lie in our haphazardly regulated pharmaceutical supply chain and the dangerous gray market that intersects it. As soon as medicines leave manufacturers loading docks, they enter a market teeming with middlemen, many legitimate but some not. The drugs may move through a dozen hands, through small secondary wholesalers and repackagers. With so many middlemen involved, thieves can easily unload stolen drugs, which may be resold to pharmacies and hospitals and dispensed to you and me.
If the drugs are real, why should we care? Because pharmaceuticals need to be stored properly generally in dry air at a steady temperature. Thieves and the secondary wholesalers who buy from them don’t mind keeping their products in hot, humid conditions, which can degrade medicines or even alter their chemical composition.
Last June, after 129,000 vials of Novo Nordisk’s long-acting insulin were stolen from a parked truck in North Carolina, the Food and Drug Administration warned diabetes patients not to take drugs with the stolen lot numbers. But it was too late. The vials turned up in a Texas medical center. Because the insulin had not been refrigerated, patients who used it developed unsafe blood-sugar levels. The authorities have recovered only 2 percent of the missing vials.
Vials of stolen or diverted drugs can also wind up in the hands of counterfeiters, who may relabel them or even replace their contents with cheaper ingredients. Such counterfeits also find their way into the legitimate supply. In 2002, Timothy Fagan, a 16-year-old on Long Island, experienced painful spasms after getting a diverted dose of Epogen to treat his anemia after a liver transplant. The drug had been relabeled, stored in the back of a strip club and ultimately resold to a national wholesaler and dispensed by a pharmacy.
In the wake of the Connecticut theft, Eli Lilly tried to reassure consumers by asserting that the American drug distribution system is tightly controlled and monitored, making it extremely difficult for stolen product to make it to patients through legitimate channels. Yet common sense tells us that you don’t steal a big volume of anything unless you know you can resell it.
Pharmaceuticals account for only 5 percent of all cargo thefts, according to FreightWatch International, a freight security company. This is far less than electronics, the most-stolen kind of cargo, which account for almost a fourth. But drugs are in first place in the category of value per incident. Last year, while the average electronics theft amounted to $814,000, the average pharmaceutical theft was worth $4 million. Since 2006, the number of drug thefts has quadrupled.
Consumers could be protected from this. Track-and-trace technology can put a unique code on each bottle, even each pill produced. Unfortunately, Eli Lilly’s psychiatric drugs left that Connecticut warehouse with neither. Drug companies are apparently reluctant to pay the nominal cost of tagging pills and bottles (only about 25 cents a bottle, after an initial investment of $1 million to $2 million). Unlike consumers, they are protected from theft by insurance. The F.D.A. should require that drug makers tag every bottle.
Without track-and-trace technology the only way a manufacturer can retrieve stolen drugs is to recall all the packages in the affected lot number, but that may include thousands when only a few hundred have been stolen. Manufacturers are understandably reluctant to issue such large, costly recalls.
With track-and-trace technology, on the other hand, it is easy to find the packages that are safely in the possession of legitimate wholesalers, hospitals and drugstores. A limited recall is therefore easier. With an Internet connection and an electronic reader, institutions that are licensed to buy drugs would be able to cross-check inventory against a central database to find out if drugs on their shelves had been stolen. And if stolen drugs were that easy to detect, the market for them would quickly shrink.
Katherine Eban is the author of “Dangerous Doses: A True Story of Cops, Counterfeiters and the Contamination of America’s Drug Supply.” J. Aaron Graham, a former agent for the Food and Drug Administration’s Office of Criminal Investigations, was the chief security officer for Purdue Pharma from 2002 to 2008.