The Deadly World of Fake Drugs
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The Deadly World of Fake Drugs This document provides an overview of the many seizures of fake drugs around the globe. Compiling data from the manufacture, sale, and distribution of fake and substandard drugs from over 100 countries, this document illustrates the global nature of the trade, and highlights the riskiest regions. While it is impossible to determine the scale of the problem, the examples below illustrate that the trade in fake and poor-quality medicines is far too large, and far too deadly, to be ignored. The Deadly World of Fake Drugs The burden of fake and substandard drugs is not evenly distributed across the globe. Even where reporting systems are weak and the media is not free, most reported instances of substandard medicines occur in poorer countries, where poor regulation allows criminals to easily infiltrate weak supply chains. Although rich nations face fewer breakdowns in their regulation and supply systems, they are certainly not safe from this threat. This document provides a plethora of examples of the manufacture, sale, and distribution of fake and substandard drug examples from all over the world. Where possible, data has been summarized to report problems at the continental, regional and national levels. Although no comprehensive data on the magnitude of the counterfeit drug trade exists, this document illustrates the breadth, depth, and danger of the problem globally. Many of these examples were compiled from local news sources. Countries without a free press may not appear at all in the following pages, but it is doubtful that the lack of evidence reflects an inconsequential number of substandard drugs. It is much more likely that these locations have a major problem with counterfeit and substandard drugs but data for these locations are simply unavailable. Evidence we do have suggests that counterfeit products are as much a problem in locations without a free press as they are elsewhere. In fact, in some countries like North Korea, counterfeiting operations are part of a vast, government-sponsored enterprise. Some stories of major counterfeiting rings involve numerous countries. Since the reader may only be interested in a specific countries, key statistics from the study are quoted in each location they pertain to, resulting in some overlap. Finally, because of the nature of the literally hundreds of sources cited in this section, it is inevitable that there will be a confusion of definitions. What one reporter, government agency, police statement, pharmaceutical company, academic researcher and others may call a fake product, their peers may not. For this reason, the reports in this chapter should not be viewed as necessarily comparable. In some instances it is possible to tell the claims made apart but overall it is not, and therefore is rarely attempted. With this major caveat in mind, this document hopefully provides a useful detail of the widespread and dangerous nature of dangerous medicines. Emily Putze, Eva Conway, Maura Reilly and Olivia Madrid helped compile this document. I. Developed Countries North America Counterfeit medication is a recognized and well-documented problem in the United States. A major case recorded in 1937, involved the deaths of than one hundred Americans after consuming medicine that contained the dangerous solvent diethylene glycol.1 Since then, a great deal of information has been gathered with regard to the prevalence of fake drugs in the United States, including extensive enforcement records, media reports and comprehensive studies. But while the size of the market is certainly lower than one percent, exactly how much lower is impossible to determine. In 2003, the Pharmaceutical Security Institute (PSI), a partnership of pharmaceutical companies, reported the value of seized counterfeit and diverted drugs in the United States to be roughly USD 200 million.2 Since 2003, most sources indicate the value has increased. The most commonly counterfeited drugs are “lifestyle” drugs, including erectile dysfunction medications, weight loss drugs, Botox, and hair regeneration products. In addition, psychotropic drugs, high-cholesterol treatments, AIDS medications, and more common medicines such as aspirin and anti-histamines are also frequently counterfeited. Most of the counterfeit and substandard drugs found in the United States are probably purchased online, but fakes have managed to infiltrate the legitimate supply chain as well. For instance, in early 2001, counterfeit Serostim, an AIDS drug, was found in two California pharmacies, and in 2003, fake Lipitor (a medication for high cholesterol) was discovered in pharmacies across the US. 3,4 While locally produced counterfeits have been discovered, drug seizures indicate that the majority of fakes are either imported from countries like China and India or smuggled across the Mexican and Canadian borders. Several agencies, including the US FDA’s Counterfeit Drug Task Force, the Drug Enforcement Agency (DEA), and Customs and Border Protection, regularly conduct seizures of counterfeit pharmaceuticals. In a notable drug bust in 2004, customs seized 3,000 packages of suspected counterfeits. 180 of the packages were analyzed, revealing that 67 percent contained drugs that either were never approved by the FDA or had been withdrawn from the US market for safety 1 Bate, Roger. “Making A Killing: The Deadly Implications of the Counterfeit Drug Trade.” AEI Press (2008), available at http://www.aei.org/docLib/20080520_MakingaKillingnew.pdf (accessed Mar 5 2010). 2 Buzzeo, Ronald W. “Counterfeit Pharmaceuticals and the Public Health.” The Wall Street Journal (Oct 4 2005), available at: http://online.wsj.com/ad/article/cigna/SB112838268960659014.html?mod=sponsored_by_cigna (accessed Mar 5 2010). 3 Appleby, Julie. “Fake Drugs Show Up in US Pharmacies.” USA Today (Mar 14 2003), available at http://www.usatoday.com/money/industries/health/drugs/2003-05-14-fakedrug-cover_x.htm (accessed Mar 5 2010). 4 “FDA Uncovers More Fake Lipitor.” USA Today (Jun 3 2003), available at http://www.usatoday.com/news/health/2003-06-03-fake-lipitor_x.htm (accessed Apr 9 2010). reasons. 28 percent contained controlled substances banned from importation, and 5 percent of the packages contained no API.5 In November 2009, a national crackdown uncovered nearly 800 packages of alleged fake or suspicious prescription drugs (including Viagra for erectile dysfunction), Vicodin (a pain reliever), and Claritin (an anti-histamine)), and 68 allegedly unauthorized online pharmacies were shut down. Some of the drugs had as much as three times the amount of API than is typically prescribed, while others contained no API at all or consisted of harmful substances like drywall material, antifreeze and yellow highway paint.6 Enforcement officials are especially alert in places with high levels of international travel. For example, in Miami, investigators found ten different types of counterfeit drugs in the period from 2001 to 2003. Among these drugs were anemia medications Procrit and Epogen, a schizophrenia drug Zyprexa, an antifungal Diflucan, and AIDS drugs Serostim, Combivir and Retrovir.7 In October 2009, a shipment containing 21,600 Viagra pills was seized at Miami International Airport, and was determined to contain counterfeits that originated in India.8 In addition to drug seizures, there have been many convictions of counterfeiters in the US. In January 2009, a Chinese man was sentenced to 6½ years in prison for distributing counterfeit and misbranded medicines.9 Later that year, a Dallas man was convicted for conspiring to distribute counterfeit erectile dysfunction drugs and received a maximum sentence of 10 years in federal prison and a USD 250,000 fine.10 The most common way that counterfeit and substandard drugs infiltrate the US market is probably through the Internet, usually from international sources. A 2004 study by the US Government Accountability Office found that four out of twenty-one medicines ordered from websites outside the United States or Canada were counterfeit.11 None of the foreign pharmacies—located in a range of countries, including Argentina, Costa Rica, India, Spain, and 5 Spake, Amanda. “Fake Drugs, Real Worries.” U.S. News & World Report (Sep 12 2004), available at http://health.usnews.com/usnews/health/articles/040920/20internet.htm (accessed Mar 5 2010). 6 Mui, Ylan Q. “Crackdown Targets Counterfeit Drugs.” The Washington Post (Nov 20 2009), available at http://www.washingtonpost.com/wp-dyn/content/article/2009/11/19/AR2009111904229.html (accessed Mar 5 2010). 7 Appleby, Julie. “Fake Drugs Show Up in US Pharmacies.” USA Today (Mar 14 2003), available at http://www.usatoday.com/money/industries/health/drugs/2003-05-14-fakedrug-cover_x.htm (accessed Mar 5 2010). 8 “Fake Viagra Seized in Miami.” The CNN Wire (Oct 23 2009), available at http://cnnwire.blogs.cnn.com/2009/10/23/fake-viagra-seized-in-miami/ (accessed Feb 23 2011). 9 “Dallas Man Convicted for Distributing Counterfeit Pharmaceutical Drugs.” U.S. Immigration and Customs Enforcement (Mar 23 2009), available at http://www.ice.gov/news/releases/0903/090320portland.htm (accessed Feb 23 2011). 10 “Dallas Man Convicted for Distributing Counterfeit Pharmaceutical Drugs.” U.S. Immigration and Customs Enforcement (Mar 23 2009), available at http://www.ice.gov/news/releases/0903/090320portland.htm (accessed Feb 23 2011). 11 “Internet Pharmacies: Some Pose Safety Risks for Consumers.” United States Government Accountability Office Report to the Chairman, Permanent Subcommittee