Phake: the deadly world of falsified and substandard medicines

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.