Phake: the deadly world of falsified and substandard medicines

Description

"Drug trade, pharmaceutical industry, counterfeit drugs, product counterfeiting"--Provided by publisher. Preface -- Introduction -- Part I. The deadly world of dangerous medicines -- 1. Historical examples of dangerous medicines -- China-U.S. Heparin scandal -- DEG: the sweet, syrupy killer -- Tuberculosis: poor-quality medicines contribute to drug resistance -- 2. Understanding the problem -- What are dangerous drugs? -- Guessing the value of the fake-drug market -- The worsening state of dangerous medicines: a growing problem -- When cheap becomes expensive: why quality matters -- The importance of good manufacturing practice -- The crucial role of medical regulatory authorities -- How diversion can lead to counterfeiting -- 3. Overview of research findings and possible solutions -- Identifying source and target -- Field research -- What can be done? -- Part II. Dangerous drug problems by location -- 4. Africa -- Counterfeit malaria treatments and growing drug resistance -- Nigeria's medical regulatory authority steps up -- Everyone blames foreigners -- NAFDAC's new leadership -- Deploying new technology -- Has Orhii improved drug quality? -- A shift to local production -- Combating corruption -- Political will -- Changing buying behavior takes time -- Fraud and theft: an entry point for fake drugs from East Africa to Nigeria -- East African investigations -- Diverted donor drugs in Togo -- On the trail of stolen medicines -- Post Hartcourt and Onitsha -- 5. India -- Tracking the counterfeiters -- Major manufacturers -- Fake-market size -- Drug production oversight: the Ranbaxy saga -- Whistleblowers and informants -- Indian exports to Africa -- International networks -- Why India should favor more international cooperation -- 6. China -- Discovering the source -- Locating the (legal) source of substandard ingredients -- The battle against counterfeiters in China -- Waking the dragon: China begins to make an effort -- Made in India, faked in China -- The way forward in China -- 7. Middle East -- The vicious cycle begins: Iraq -- Dangerous dealings: fakes infiltrate the markets -- The smuggling ring expands: Syria and Jordan -- Middle Eastern governments confront the counterfeit trade -- Looking ahead: more challenges to come -- Conclusion -- 8. Other emerging markets -- Russia -- Latin America -- Southeast Asia -- Turkey -- Conclusion -- 9. The online drug market -- The case for universal jurisdiction -- Internet pharmacies: are the benefits worth the costs? -- A study of credentials -- Credentialed sites are safe, but buyer beware (of junk mail) -- Part III. Drug-quality assessments -- 10, Factors to consider for research -- Bringing a medicine to market -- Testing drugs for quality -- The minilab -- Handheld spectrometers -- What we procured from where -- 11. Results: what we found -- More detailed analysis with more limited datasets -- The role of registration -- Variability analysis -- Survey of pharmacists -- 12. Results broken down for Africa, India, and other markets -- Africa -- India -- Remaining cities tested -- 13. Interpreting and discussing the results and their relevance -- Comparing percent API in various failures: breakdowns of the data -- What role does price play in quality? -- Further price analysis -- African price data -- Regulation, income, and literacy rate: an analysis of possible confounding variables -- Regulation -- Macrolevel analysis -- Counterfeit or substandard? -- Part IV. The way forward -- 14. Developing medical regulatory authorities: the U.S. FDA as a case study -- Why an FDA? It's all about economics -- The creation of the FDA -- Drug regulation and the market's decisions -- The Massengill massacre -- The FDA's expanding authority -- The FDA and China -- Challenges to MRA development -- Limits to international assistance -- Priorities for MRAs in developing countries -- The MRA role in protection through registration -- Registration is a means, not the end -- Challenges to implementation -- 15. International cooperation against criminals and the lethal trade in fake medicines -- Counterfeit medicines and international law -- The extent and effects of medicine counterfeiting -- Goals, doctrines, and proposals for a counterfeit medicines treaty -- Counterfeiting crimes are widespread and systematic -- WHO authority to negotiate a treaty against medicine counterfeiting -- A call to action -- Final thoughts and recent developments -- 16. A market for products of varying quality and the intellectual property debate -- Approaches to GMP -- In the end, it is all about endogenous growth.