There is a general agreement that piracy; counterfeiting and passing off are unfair. However, there is often surreptitious - or even open - sympathy for, say, those who purchase counterfeit designer fashions or the latest technical gadgets. The pirate is even sometimes represented as a daring evil hero. In this book, Prof. Dora Nkem Akunyili, Director General of Nigeria's National Agency for Food and Drug Administration and Control, presents a unique study of a global phenomenon in which law-breaking and profiteering prevail at the cost of human health and life - and of the ways in which this can be fought by appropriate legislation, regulation and enforcement.
Long the scourge of developing countries, fake pills are now increasingly common in the United States. The explosion of Internet commerce, coupled with globalization and increased pharmaceutical use has led to an unprecedented vulnerability in the U.S. drug supply. Today, an estimated 80% of our drugs are manufactured overseas, mostly in India and China. Every link along this supply chain offers an opportunity for counterfeiters, and increasingly, they are breaking in. In 2008, fake doses of the blood thinner Heparin killed 81 people worldwide and resulted in hundreds of severe allergic reactions in the United States. In 2012, a counterfeit version of the cancer drug Avastin, containing no active chemotherapy ingredient, was widely distributed in the United States. In early 2013, a drug trafficker named Francis Ortiz Gonzalez was sentenced to prison for distributing an assortment of counterfeit, Chinese-made pharmaceuticals across America. By the time he was arrested, he had already sold over 140,000 fake pills to customers. Even when the U.S. system works, as it mostly does, consumers are increasingly circumventing the safeguards. Skyrocketing health care costs in the U.S. have forced more Americans to become "medical tourists" seeking drugs, life-saving treatments and transplants abroad, sometimes in countries with rampant counterfeit drug problems and no FDA. Bitter Pills will heighten the public's awareness about counterfeit drugs, critically examine possible solutions, and help people protect themselves. Author Muhammad H. Zaman pays special attention to the science and engineering behind both counterfeit and legitimate drugs, and the role of a "technological fix" for the fake drug problem. Increasingly, fake drugs affect us all.
This book overviews and integrates the business and technical issues that pharmaceutical companies need to know in order to combat the major global problem of counterfeit medicines. In addition to discussion of the problems, the author Davison addresses analytical techniques scientists use to detect counterfeits and presents some possible solutions to the threat of counterfeit medical products. Coverage moves from basic overview of the problem, costs / risks to consumers (toxic products, mistrust of drug companies) and business (revenue loss, public trust), government oversight and regulation, authentication strategies (packaging, analytical techniques), product tracking and supply chain, and case studies from around the globe.
"Discusses the economic and financial consequences of pharmaceutical product counterfeiting and describes some of the measures that can be taken to counteract their impact"--Provided by publisher.
This report has been commissioned by the Council of Europe as part of its ongoing activities to minimise the public health risks posed by the production of counterfeit medicines. It is based on surveys undertaken in 2003-04 within Council of Europe member states, as well as amongst pharmaceutical manufacturers and wholesalers in Europe. Issues considered include: the current and estimated market and trade matters, national and international co-operation between regulatory authorities, the adequacy of legal, judicial and administrative systems, and professional training aspects.
The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.
Roger Bate has spend years on the trail of counterfeit medicines in Asia, Africa, and the Middle East, learning the anatomy of a nebulous, far-reaching black market that has resulted in countless deaths and injuries around the world. Phake: The Deadly World of Falsified and Substandard Medicines is the culmination of Bate's research and travels—both a fascinating first hand account of the counterfeit drug trade and an incisive policy analysis with important ramifications for decision makers in the U.S. Food and Drug Administration and the international World Health Organization.
