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GMU May 03, 2012

ROGER BATE RBATE@AEI.ORG LEGATUM FELLOW IN GLOBAL PROSPERITY AMERICAN ENTERPRISE INSTITUTE WASHINGTON, D.C. GMU May 03, 2012. Orson Welles as Harry Lime. The Media. The Threat. Are your drugs safe?. The Problem. 100,000 annual deaths

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GMU May 03, 2012

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  1. ROGER BATE RBATE@AEI.ORG LEGATUM FELLOW IN GLOBAL PROSPERITY AMERICAN ENTERPRISE INSTITUTE WASHINGTON, D.C. GMU May 03, 2012

  2. Orson Welles as Harry Lime The Media

  3. The Threat Are your drugs safe?

  4. The Problem • 100,000 annual deaths • 1 out of every 10 medications in emerging markets are ineffective

  5. The Research Drug samples from 19 cities worldwide

  6. The Research Online drug samples from 10 countries

  7. The Market Unregulated and often illegal $10 billion USD market Especially large in high-value BRICS markets

  8. The Market Emerging Markets • Key variables • income • illiteracy • political will • Unlicensed, unmonitored, unofficial retailers • Common medicines • Antimalarial • Antimycobacterials • Antibiotics

  9. The Market Developed Countries • Less danger in OECD, but problems still exist • Internet sales • Supply chain • Inferior API • Uncertain provenance of supply • Convoluted distribution networks • Criminal Networks

  10. Internet Sales Fake Chinese packaging

  11. Definitions • Research • Causes • Moving Forward • International Treaty

  12. Definitions

  13. Degraded Improperly stored or transported

  14. Substandard • Active Pharmaceutical Ingredients (API) • Wrong dose • Wrong ingredient • Poorly formulated • Contains lethal impurities • Lacks Good Manufacturing Practices (GMP)

  15. Falsified • Intentionally deceive patient • Include counterfeit pharmaceuticals and intellectual property violations

  16. Falsified

  17. Falsified

  18. Drug Types Are we discussing the same issues?

  19. Research

  20. Research Over 2,500 samples • Malaria • Tuberculosis (TB) • Bacterial infections

  21. Analysis Testing: • MiniLab • Raman Spectrometer NAFDAQ staff trained on Truscan

  22. Analysis

  23. Analysis

  24. Results • 12% of total sample failed quality tests, • 5% were falsified products • many had zero API • 7% substandard or degraded • Vast majority breach trademark • Substantial difference in price for substandard products but not for fake ones

  25. FailureRate by City

  26. Results • 12% of total samples failed quality tests • 5% of total samples were falsified products • Many with zero-API (Active Pharmaceutical Ingredient) • 7% other • Vast majority breach trademark • Substantial difference in price for substandard products but not for fake ones

  27. Results • 12% of total samples failed quality tests • 5% of total samples were falsified products • Many with zero-API (Active Pharmaceutical Ingredient) • 7% other • Vast majority breach trademark • Substantial difference in price for substandard products but not for fake ones

  28. Substandard Cheaper than quality drugs by up to 40%

  29. Fake Products No significant discount

  30. Price Analysis By city GDP

  31. Origin and Causes

  32. Causes • Inferior API • Non-GMP • Poorly formulated • Contain lethal impurities • Degraded

  33. Avastin Case, March-April 2012 • European Avastin has the company label ‘Roche,’ whereas US brands do not • Fakes had ‘Roche’ label • 19 US medical practices across at least 3 states purchased unapproved cancer medicines

  34. Deaths Fake Internet Viagra USA USA Fake Heparin Inferior API causing shortages and dangerous products USA Emerging Markets Substandard products due to inferior API and excipients Global Lethal impurities in falsified products Africa Poorly formulated medicines and fake medicines

  35. Active Pharmaceutical Ingredients (API) Intentional contamination • Chinese Heparin caused149 deaths in the US Most problems are unintentional • non-certified plants making chemicals

  36. Over 70% of API is made in India and China They have many high quality suppliers… but some subcontractor premises are “physically dirty”* * Phillipe Andre, European Auditor, School of Pharmaceutical Science and Technology at Tianjin University, China

  37. Auditor Phillipe Andre: “Drug companies misinformed about source of 39% of drug substances purchased from China.” “Only 6% of Chinese companies provide impurity profiles of chemicals exported.”

  38. “Residues of solvents and potentially genotoxic catalysts are rarely controlled.” “94% of audits of Chinese drug substances bought by overseas firms are conducted after purchase.”

  39. Food and Drug Administration FDA is increasing inspections: • Once every 30 months in the US • At best once every 13 years in China; sometimes “staged”

  40. Food and Drug Administration • Food and Drug Administration Companies: • The best line of defense • They should pool and deepen audits: RX-360

  41. Causes Good Manufacturing Practices (GMP) • There are high quality as well as low quality companies: it’s hard to distinguish

  42. GMP Procedure Simplest Acetaminophen production

  43. GMP Procedure Simplest Acetaminophen production

  44. GMP Procedure Simplest Acetaminophen production

  45. GMP Procedure Simplest Acetaminophen production

  46. GMP Procedure Simplest Acetaminophen production

  47. Role of Investigators Final Producer

  48. Role of Investigators Processing

  49. Role of Investigators Storage

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