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Ethical issues in international medical research

Ethical issues in international medical research. Danielle Bromwich Department of Philosophy University of Massachusetts, Boston d anielle.bromwich@umb.edu. Brief introduction. Hello! I’m Danielle. Philosopher PhD from the University of Toronto Bioethicist

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Ethical issues in international medical research

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  1. Ethical issues in international medical research Danielle Bromwich Department of Philosophy University of Massachusetts, Boston danielle.bromwich@umb.edu

  2. Brief introduction

  3. Hello! I’m Danielle • Philosopher • PhD from the University of Toronto • Bioethicist • Post-doc in the Clinical Center at the National Institutes of Health • Visiting researcher at the Brocher Foundation in Geneva • Assistant Professor of Philosophy at UMB • Phil 222 (Moral Issues in Medicine) and Phil 337 (The Ethics of Human Subjects Research)

  4. The need for international medical research

  5. The 10/90 gap • MSF, late 1990s • 10% of global spending on health research is devoted to conditions that make up 90% of the global disease burden • Diseases that adversely impact the world’s poorest populations • Lack of research on tropical infectious diseases • Lack of research on improving access to effective treatments

  6. Early HIV/AIDs research in sub-Saharan Africa

  7. HIV and AIDs in sub-Saharan Africa • Most heavily affected region of the global epidemic • People living with HIV (2011) • 23.5 million reside in sub-Saharan Africa • 69% of the global burden • Pregnant women with HIV (2011) • 92% reside in sub-Saharan Africa • Children who acquire HIV (2011) • 90% reside in sub-Saharan Africa

  8. HIV infections & AIDs-related deaths • HIV infection in sub-Saharan Africa • 1.8 million in 2011 • 25 % decline since 2001 (2.4 million) • AIDs-related deaths in sub-Saharan Africa • 1.2 million in 2011 • 32% decline since 2005 (1.8. million) • The results of the medical research and coverage

  9. Perinatal HIV transmission (I) • Coverage in sub-Saharan Africa • 59% coverage of perinatal transmission prevention services • 6 countries achieved coverage of more than 75% • Botswana, Ghana, Namibia, South Africa, Swaziland and Zambia • 7 countries reported coverage of less than 25% • Congo, Eritrea, Ethiopia, Nigeria and South Sudan

  10. Perinatal HIV transmission (II) • Mid-1990s • Approximately 1,000 HIV-infected babies were born every day in Africa • 1998 • Women in sub-Saharan Africa “infected through heterosexual sex, are the fastest growing group with HIV infection, and infected women are the principle source of infected children” Grady, “Science in the Service of Healing” Hasting Center Report 1998: 35

  11. Breakthrough HIV research (1994) • AZT regimen (076 regimen) shown to reduce perinatal HIV transmission by 70% (from a baseline rate of 16-25%) • U.S. Public Health Service recommended that the 076 regimen be recognized as the standard care treatment for HIV-infected pregnant women

  12. Can you anticipate the problems with using the AZT regimen in sub-Saharan Africa?

  13. Problem 1: cost • The 076 regimen was expensive • In 1994, $1,000 per person • Most HIV-infected pregnant women live in sub-Saharan Africa • Countries with annual budgets of approx $10 per person • AZT was unaffordable for those who desperately needed it

  14. Problem 2: complexity • Treatment started in the second trimester • Necessary to receive the drug for a minimum of 12 weeks • Taken orally 5 times a day • Administered intravenously during labor • Taken orally 4 times a day, after birth for 6 weeks • No breastfeeding • Not practically possible in sub-Saharan Africa • Pregnant women often start prenatal care too late for the regime to work • Most are home births • Most women have no choice but to breastfeed

  15. The WHO’s controversial solution

  16. A regimen for these women • In 1994, the WHO met to discuss developing an effective and affordable regimen for these women. • They proposed conducting randomized controlled trials (RCTs) of shorter and simpler regimes of AZT against placebo controls

  17. The trials • 16 trials were developed for 11 countries • 15 were conducted with placebo controls • 6 of the 15 were sponsored by NIH and the CDC • 5 were funded by non US governments • 1 was funded by the Joint United Nations Programme on HIV/AIDS (UNAIDS)

  18. The controversy • Public Citizen’s Health Research Groupresearchers wrote letters to the US secretary for DHHS and a commentary in the NEJM condemning the research as unethical • They were supported by the NEJM editor, Marcia Angell • The Director of NIH and Director of CDC wrote a reply defending the research

  19. The ethical challenge How should we balance the need to develop effective and affordable treatments these women while avoiding exploitation?

  20. Medical research ethics • The purpose of medical research is to produce knowledge • It is not designed to benefit individual research participants • Research participation involves risk for the benefit of others • Many requirements are necessary to make research ethical

  21. Ethics of study design • The requirement of clinical equipoise • Equipoise exists when there is genuine uncertainty among the scientific community about the superior treatment • The requirement of standard of care • Members of the control group ought to be given the current standard of care for the condition being studied

  22. Ideal vs. non-ideal conditions • Certain issues do not arise in ideal conditions • For example, the standard of care issue • In non-ideal conditions (where many things are unjust), what is permissible? • Does reinterpreting our ethical requirements add to the injustice? • Or is it ethically appropriate given the well-meaning goals of the research?

  23. Discussion The ethics of the WHO solution

  24. Discussion questions • What is the standard care treatment for HIV-infected pregnant women? • Is there genuine uncertainty among the scientific community about whether AZT is superior to placebo? • Given your answers to (1) and (2) what concerns might you have about the WHO’s solution? • If you’re concerned, do you think that these trials should have been stopped? • What argument could be made in favor of these trials? • Can you think of points relating to clinical equipoise or standard of care? • Do you think that these trials exploited the participants (women in sub-Saharan Africa) or benefitted them or both? • What else would you want built in to the study design to ensure against exploitation?

  25. Another case: the Surfaxin trial

  26. Background: Bolivia (2005) • One of the least developed countries in South America • Two thirds of population live below the poverty line • (21% are undernourished) • Life expectancy: adults: 63.9 years (2005) • Infant mortality is high • Babies: 53 per 1,000 live births • Children under 5: 66 per 1,000 children • 7% GDP is spent on healthcare

  27. Background: RDS • Respiratory Distress Syndrome (RDS) • Common and potentially fatal disease in premature babies • Insufficient surfactant in the lungs • Medically indicated treatment • IV fluids, mechanical ventilation, surfactant replacement therapy

  28. Background: surfactant therapy • Surfactant replacement therapy has resulted in a 34% reduction in neonatal morality • Still RDS is the 4th leading cause of infant morality in US • Accounts for half of infant deaths in developing world • Surfactant theory is approved for use in Latin America • But it is expensive: US $1,100-2,400 per child • Per capita spending: US $60-225

  29. Background: US surfactant trials • FDA has approved 4 surfactants since 1990 • 1990: Exosurf. PCT (all received ventilation) • 1991: Survanta. PCT and ACT • 1998: Infasurf. ACT against Exosurf and Survanta • 1999: Curosurf. ACT

  30. The Surfaxin trial (I) • 2000, Discovery Labs (US) wanted to test Surfaxin, a new surfactant • Deliberated with the FDA about appropriate study designs • Problems with ACT in US to Exosurf • Proposed a PCT in Bolivia

  31. The Surfaxin trial (II) • 650 premature babies with RDS were to be enrolled • Sponsor would provide necessary equipment • Ventilators, antibiotics, endotracheal tubes • American neonatologists, training of locals • Intubated babies would either get a spray of Surfaxin or air without any drug • Discovery Labs planned to market Surfaxin to US and Europe • No specific plans for marketing it to Latin American

  32. How D-labs responded • D-Lab did not proceed with the proposed trial • The dominant ethical view of such trials prompted them to move • from a placebo-control trial on a poor and vulnerable population • to an active-control trial on a rich population • They conducted a Phase II trial in the USA

  33. Class discussion • Ethically speaking, how does this trial differ from the short course AZT trials? • Do you think that it was fair to select Bolivian infants for this trial? • Are there special concerns with conducting research with infants? • What arguments could be made in favor of this trial being conducted in Bolivia? • If you were an research ethics committee member, would you have approved this trial, suggested amendments, or not approved it?

  34. Thank you!

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