Fighting the Good — and Endless — Fight

By Paul Thomas, Managing EditorThe Center for Medicines in the Public Interest (CMPI) recently projected that counterfeit drug sales will reach $75 billion in 2010, up some 92% from 2005. That’s a steady growth of 13% a year. The business of selling fake drugs is a “global industry,” said the center’s director Peter Pitts, and as such represents a major public health risk. By 2010, Pitts estimates, some 20% of the global pharmaceutical trade will be in counterfeit drugs, up from 11% this year. Pitts says his forecasts (click here to access the PDF document) are conservative, given that they’re not far from those made by the World Health Organization (WHO) several years ago, when data on the global counterfeiting explosion first came out.  CMPI fingers importation as the key problem, but anyone who has read Katherine Eban’s “Dangerous Doses” knows that the domestic front is just as critical. Is there some good news in FDA’s latest statistics on counterfeiting? The Agency has reported that the number of newly initiated counterfeit drug cases has fallen in 2005 — 32 cases so far this year, as compared with 58 in 2004. This may be due to a “deterrent effect” that prior cases are having, said FDA associate commissioner Randall Lutter, Ph.D., at last fall’s NACDS/HDMA Healthcare Adoption Summit. The numbers may be misleading, however, Lutter admitted, due to the fact that many “new” cases are found to relate to prior cases, and thus are not tallied in the current year. (Read more of Lutter’s comments here.) Another deterrent is the fact that the pharmaceutical industry has gotten more sophisticated in its anticounterfeiting efforts. With Pfizer (maker of Viagra) and Purdue (of Oxycontin) leading the way, manufacturers have come to realize that they must utilize the right elements of the entire anticounterfeiting — and antidiversion — toolkit they have at their disposal. Purdue, for example, is piloting the latest RFID technologies in its plants and distribution channels, but it’s also installing surveillance cameras there and hiring undercover spies to patrol highways and shipping docks. Purdue’s chief security officer, Aaron Graham, is a former undercover investigator for FDA and knows that supply chain security is a mix of the high-tech and the cloak-and-dagger. Manufacturers are investing in RFID and advanced barcoding methods, of course, but also in spy-worthy technologies like holograms, color-shifting inks and laser etchings on tablets. Integrating those technologies with software that can meaningfully track and trace data throughout the supply chain is a major step that the industry is now taking as well. The recent agreement by Tagsys, Systech and SupplyScape to marry RFID tags and hardware, packaging line device and data management software, and e-Pedigree supply chain authentication software is a significant step in the drug security battle. It’s also a good sign that some of our top tech companies — such as Silicon Valley’s Oracle and Sun Microsytems — are pouring money into research and introducing their own pharma supply chain security applications. Billions of dollars are at stake in the cat-and-mouse game between criminals who counterfeit and the drug makers and authorities who try to foil them. But that also gives vendors a great incentive to build better mousetraps. Will the latest comprehensive solutions be enough to thwart the legion of master counterfeiters and shady wholesalers who view the world’s drug supply as the latest, greatest get-rich-quick racket? Not likely. Like the war on terror, the war on drug counterfeiting is a fact of modern life. To protect their livelihoods, drug manufacturers must always assume a state of amber alert. Victory belongs to the obsessively vigilant.