By: Godofreda ( Jody ) V. Dalmacion, MD,MSc. Member, Ethics Review Board University of the Philippines, Manila-NIH

1. By: Godofreda ( Jody ) V. Dalmacion, MD,MSc. Member, Ethics Review Board University of the Philippines, Manila-NIH

2. Outline • Public Health Research versus clinical trials • Description of partnership in public health research • Case study • Ethical issues • Ruminations • Directions

3. Public health research versus Clinical trials Clinical Trials Public Health • Therapeutic obligation to treat individual patient • Treat irrespective of social consideration • Code of medical and research ethics prioritizes individual autonomy • Obligation to improve health of population • Grounded on societal responsibility to reduce social inequities • Codes of health care ethics imperfect for public health. It should be concerned with the extent of its reach and infringement of individual liberties

4. Defining research when it comes public health • Although some public health activities can clearly be classified as research or not, others are not clear cut • In 1993, CDC has identified three critical areas of public health practice for which confusion exists with regard to which activities are and are not research • These are public health surveillance, emergency response and program evaluation • Unless designed to develop generalizable knowledge, they are activities and NOT research

5. Ethics in public health Proposed framework Problems • PH practitioners may turn to medical or bioethics for professional moral direction • Codes of restraint, a code to preserve fairly and appropriately the negative rights of citizen to non interference • Code should emphasize positive rights of patient for social justice • Not always applicable especially in possible breach of patient’s confidentiality eg. Result of HIV testing • The Law has vested the power to ensure the safety and health of a population on public health • No analogous framework in bioethics

6. Real world:We live in a morally pluralistic society inevitably, moral appeals will conflict when determining a public policy

7. Partnerships in Public Health

8. Description of Public-Private Partnership (PPP)

9. But why has the issue of PPP become so prominent on the international policy agenda at this time? • One reason is that new public health problems are being pushed onto the international policy agenda by Non governmental organizations that have gained influence in the past two decades • These problems often involve issues of health equity between the rich and the poor of the world • Neither public or private organizations are capable of resolving such problem on their own

10. Problems of Traditional Public Health groups • Limited financial resources • Complex social and behavioral problems • Rapid disease transmission across national boundaries • Reduced state responsibilities

11. Future of public-private partnership • Global health problems require global solutions • And public-private partnerships are increasingly called on to provide these solutions (2000 Reich) • The most common partnerships are between pharmaceutical companies with Universities or Government • Yet we know little about the conditions on how it operates and when partnerships succeed

12. Philantropic drug donation programs

13. Issues • How do organizations with different values , interests and worldviews come together to address and resolve essential public health issues? • What are the criteria for evaluating the success of public-private partnership (PPP) • Who sets those criteria and with what kinds of accountability and transparency?

14. Issues of Partnership

15. Case Study • Lymphatic filariasis is endemic throughout most of the southern half of the Philippine archipelago afflicting 45 of the 77 provinces. • In the Philippines, areas endemic for the parasite are in regions with highest incidence of poverty and eliminating the disease in these areas provides significant opportunities to alleviate poverty and reduce inequalities in health.

16. 5-year Mass Drug Administration Program • Mass treatment with single dose of DEC given yearly has shown to effectively kill the parasite but adding Albendazole has increased to 99% the killing effect on the adult worm. Nevertheless, the ideal treatment regimen still needs to be defined despite growing medical literatures attesting to the safety of the combination. • In the early 2000 the MDA program was launched • Albendazole was donated by Glaxo Smith & Kline through WHO to the Department of Health.

17. In 2003 , MDA with DEC and Albendazole was administered in many areas endemic for the condition • Since it was considered a program and not research , it did not pass Technical Review • Unfortunately this resulted to quite a number of unexpected deaths which was not seen with DEC given alone

18. Some adverse experiences during the MDA • 4 deaths were reported in 2 municipalities among recipients of the MDA with the youngest at 4 years old and the oldest a 70 year old man • 7 reports of adverse reactions ranging from allergy, abdominal pain, watery diarrhea, scrotal enlargement and hematoma were observed in one province. • A young mother in her mid thirty who was just bringing her son to school where the MDA was being conducted also died after administration of the drug

19. Sequela • Health officers of the regions involved had to secretly bring out the midwives and nurses connected with the MDA to escape the wrath of the townsfolk and relatives • An investigation was conducted and a meeting in Manila ensued attended by DOH , GSK foreign and local consultants , WHO representative and external evaluators like myself

20. Result of consultative meeting • GSK denies responsibility for the ADR since no evidence pre-existed regarding death from the same treatment regimen • GSK will continue to administer their own adverse experience report form which goes to their Pharmacovigilance office in England • The government agency improves her Adverse Event Monitoring Scheme • GSK is not accountable for the adverse events since it was not research and drugs were mere donations of the company to WHO

21. Ruminations • What is public? What is private? • Who decides? Should the recipients participate in the design, implementation and oversight of partnership? • Who is a partner? Is the recipient of drug donations, partners? • If so, what kind of governance structure could allow the participation of recipients to promote accountability but still assure effectiveness • How should partnerships relate to international health agencies such as the WHO

22. Critique • Kent Buse and Gill Walt express serious concern that partnerships often circumvent the organization of the UN • They are worried about the accountability of partnerships, their effect on global standards and norms decided by UN agencies and the potential negative effect on global inequities

23. Directions • Define partnership both in context and ethical implications? • Realize that between poor and rich countries, equality on relationship may be grounded on inequality • Be sensitive to cultural ,social and economic diversities • If a research is scientifically unsound, it is likely to be ethically unsound. Similarly, partnership in public health should also be based on sound goals and less for cost reasons.

24. From those who have much; Much is also expected