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International Health

International Health. Ethical Dilemmas. Christopher F. Barañano MS 2004 Tinsley Harrison Society Tuesday January 13, 2004. Ethics Revisited. Begging the question, reduction ad absurduum, ad hominem Mill’s Principle of Harm

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International Health

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  1. International Health Ethical Dilemmas Christopher F. Barañano MS 2004 Tinsley Harrison Society Tuesday January 13, 2004

  2. Ethics Revisited • Begging the question, reduction ad absurduum, ad hominem • Mill’s Principle of Harm • The Greeks, Christian Ethics, Natural Law, Social Contract,Kantian Ethics, Utilitarianism • MEDICAL ETHICS • Case Based Reasoning

  3. Overview

  4. Abuse of Vulnerable Populations • International Research Projects/ Product Trials • Historical Precedents • Ethical Guideline

  5. The Body Hunters • 11 months reporting effort led by Joe Stephens, Deborah Nelson and Mary Pat Flaherty of The Washington Post • Nigereria, Bulgaria, Hong Kong, Costa Rica, Thailand, Hungary, Argentina, China, Russia, Switzerland • 6 Part Series 12/17/00-12/22/00

  6. Pfizer Trovan-Trovafloxacin in Kano, Nigeria January ´96

  7. Setting 120 new patients every day 20%mortality(15,800 deaths) sharing Kano Infectious Disease Hospital with Charitable Intervention providing Chlaramphenicol Trovan pending FDA apporval Outcome equal mortality increase joint pain failed to win approval for Trovan in children Pfizer Clinic Closed in 3wk The Body Hunters ¨Exporting Human Experiments¨

  8. The Stats on Int’l Rx Research • 1980 FDA begins accepting new Rx applications based on foreign research • 1995-1999 increased 3x • affects 27% of applications • In South America, researchers registered to perform studies with FDA grew from 5 to 453 from ’91 to ’99 • Eastern Europe, 1 to 429 • South Africa, 2 to 266

  9. Corporate Economics of Research • Average people tested before a Rx can be marketed in US= 4k • Average Cost of 1 day delay in marketing= est. $1.3 million • Western Europe= $10k/subject • Russia= $3k/subject

  10. Physician/Regulator Economics Psychiatrist in Budapest= $178/month Stipend from Rx Research= $1-2k/pt. Ethics boards salary in Hungary= $100/month Full time inspector in Hungary= 1 FDA inspectors for foreign sites= 11 FDA rejects 12-15% of application from developing countries vs. 4% from US Tools available for FDA disciplining foreign MD’s? Export Administration Act (revised August, ’01)

  11. Uninformed Consent/Right to Withdrawal • Educational level, cultural differences “translation of placebo?” • Oral vs Written • Van Tx Research Ltd.- Estonia Recruitment • Aripiprazole Zeldox Psych Trials by Bristol-Myer Squibb, Otsuka, and Pfizer South African AIDS Trial 88% felt compelled to participate 1/3 felt compelled to take part 1/3 care would suffer if refused 99% believed the hospital would not allow them to quit once they started FREEDOM OF CHOICE

  12. Anhui Project • China Eugenics Law of 1995, History of Sterilization • Illiteracy Rate of 70% • Harvard University and Millennium Pharmaceuticals, NIH and March for Dimes

  13. Duty to the Community • Incentives of free health exams. discounted health care, and “health card” provided by local hospitals funded through research project • “Thought work” with Communist Government to promote volunteering • Federal Investigation by Department of Health and Human Services

  14. Latin America’s Unique Advantage • US Trained Doctors • CRO “Contract Research Organizations” • Treatment Naïve Conditions mirror the US • Opposite Seasons

  15. Cariporide GUARDIAN Trials by Aventis • Naval Hospital Case, Argentina • FDA approved trial 11,500 pts in 23 countries • Cardiologist paid $2700/patient now being investigated for murder • forged signatures • false EKGs • Success or Failure?

  16. FAIR SUBJECT SELECTION • Sceintific goals not vulnerabiility or privilege • “convenient” availability invalid criteria • Minimized risk by characteristics of group “…as far as possible, groups and individuals who bear the risks and burdens of research should be in a position to enjoy its benefits and those who may benefit should share some of the risks and burdens…”

  17. RRV-TV Vaccine • Rhesus Rotavirus Tetravalent Vaccine • 29-68% efficacy in preventing diarrhea • 90% efficacy in severe diarrhea • 1/10k added intussusception risk • 600k children in 3rd world/year mt • Up to 1/200 in some countries vs 20 deaths/year in US • In US, 1 life=20-40 cases intussusception • In 3rd World 50 lives=1 case of intussusception • Potential alternatives 3 years away as of ’00 • ETHICALLY VALID PLACEBO VS VACCINE STUDIES IN 3rd WORLD

  18. Nuremberg Code- Declaration of Helsinki- Belmont Report- Intl Guidelines for Biomedical Research Involving Human Subjects US Bioethical Guidelines- “voluntary¨ U.S. v Brandt “adequately ïnformed¨ Tuskegee, protect the vulnerable Apply Helsinki to 3rd world vaccine drug trial, meet ethical standards of host country, fruits of research be made available to population studied “legally effective consent in writing” Informed Consent Guidelines

  19. Thailand • US Army Doctor in Lampang, Thailand • Viral Load of Cervical Fluid and Blood • ’94 proposal for observational study • AZT proven effective late ’94 • ’96 grant from NIH $1million • Harvard AZT study in region • Thai Government’s plans to expand • ’97 request to redirect $15k for AZT declined • 3month later July 1997 AZT from Government Started • 101 Women received no AZT, 22 children born with HIV • How far have we come from Tuskegee?

  20. Uniform Care Requirement45 Code of Federal Regulation 46 US DHHS • ALL participants of clinical research WHEREVER it is conducted • Theory: Double Standards permit exploitation • Theory vs Application in a setting of limited resource • Example: Early vs Delayed Initiation of HAART Ethics of Clinical Research in the Developing World Nature Reviews, March 2002.

  21. Placebo Studies • ’97 AZT Placebo Test by CDC in Bangkok • Reduced dose vs US • No infant AZT vs US • Instrumental in shaping Thai Health Policy • Shorter coarse now provided free for pregnant women

  22. Thai VaxGen Vaccine Study • Denied • pledge of care for subjects who became HIV positive during test • guarantee of reduced price if found effective • profit sharing or manufacturing plant • Efforts to lower prices promised in exchange for access to Bankok’s Drug Clinics • US test group:placebo= 2: 3 • Thai test group:placebo= 1:2 • Bowl of rice/five friends • $9/day =to salary of taxi driver

  23. Ethical Debate “race to the bottom” vs “ethical imperialism” • Informed Consent • Research Design Ethics Review • Post Trial Benefits

  24. 7 Requirement of Ethical Research What Makes Clinical Research Ethical. JAMA, May 24, 2000 • Social or Scientific Value • Scientific Validity • Fair Subject Selection • Favorable risk-benefit ratio • Independent Review • Informed Consent • Respect for potential and enrolled subjects • Withdrawal permitted • Confidentiality • Update with new risks and benefits information • Informing subjects of results of research • Maintaining welfare of subjects

  25. Overview

  26. Neglecting the AIDS Epidemic in Sub-Saharan Africa • 22 million deaths/year • 83% in Sub-Saharan Africa • 40 million currently infected • 71% in Sub-Saharan Africa • 15-24 yo face the highest risk • 50% total infected, die before 35yo • 1.4 million children, 1.1 million in Sub Saharan Africa alone, • 200 new children every day • Projected 20 million by 2010 • 1.75% of people positive for HIV receive ARV therapy

  27. ACHAP(African Comprehensive HIV/AIDS Partnership) • Joint Initiative Between • Government of Botswana • Bill and Melinda Gates Foundation • Merck Corporation Foundation

  28. Botswana • 39% HIV infection rate (highest in Africa) • $50 million each from Merck and BMG Foundation • Stable democracy • 4 Goals • 1. Reduce HIV infection and transmission • Improve accessibility • Improve prophylaxis, opportunistic treatment and HAART • 4, Strengthen health care system

  29. Corporate Responsibility • Entity created by law, still a person within society • Traditional Free Market View • Profit is King • Duty to the Shareholders • Revisionist View • Recognizes profit making function • HOWEVER argues corporations need not make the MAXIMUM amount of profit • Other motives • Sustain future markets • Improve public relations • Tax breaks and reduced regulatory control • Duty to increase access to ARV

  30. Merck- Bristol Meyers Squibb- Abbott Laboratories- $50 million to ACHAP, $25 million in ARV Rx Videx/Zerit at $1/day, relief from patent restrictions, $100 million/5yrs to train doctors and expand community outreach efforts Selling Novir/Kaletra at 90% cost of US Corporate Pledges

  31. US: $7k/year/drug $12-15k/year cocktail Africa: $650/year/drug As low as $365/year Average annual budget $3-400 /family/year Average allocation for health $10/person/year Costs of Therapy • 1999 Avg Profit Margin for 10 largest Rx Companies= 30% • A $406 billion dollar industry • Abbott Laboratories • Sales of $16.3 billion • Net earnings of $2.9 billion

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