By: Godofreda ( Jody ) V. Dalmacion, MD,MSc.

Member, Ethics Review BoardUniversity of the Philippines, Manila-NIH

OutlinePublic Health Research versus clinical trialsDescription of partnership in public health

researchCase studyEthical issues RuminationsDirections

Public health research versus Clinical trialsClinical 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

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

Ethics in public health Proposed framework ProblemsPH 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

Partnerships in Public Health

Description of Public-Private Partnership (PPP)

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

Problems of Traditional Public Health groups Limited financial resourcesComplex social and behavioral problemsRapid disease transmission across national

boundariesReduced state responsibilities

Future of public-private partnershipGlobal health problems require global solutionsAnd 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

Philantropic drug donation programsDrug

companyDrug and target disease(s)

Public health goal

Program manager

Major partners

Merck Mectizan: OnchocerciasisLymphatic filariasis

Elimination of onchocerciasis ( and lymphatic filariasis)

Mectizan Donation Program in the Task Force for Child Survival & Development

Merck and Task Force for Child Survival & Development

Pfizer Zithromax: Trachoma

Elimination of blinding trachoma

International Trachoma Initiative

Pfizer and Edna McConnell Clark Foundation

GSK Albendazole: Lymphatic filariasis

Elimination of lymphatic filariasis

WHO WHO andGSK

IssuesHow 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?

Issues of Partnership

Case StudyLymphatic 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.

5-year Mass Drug Administration ProgramMass 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 launchedAlbendazole was donated by Glaxo Smith & Kline

through WHO to the Department of Health.

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

Some adverse experiences during the MDA4 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

SequelaHealth 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

Result of consultative meetingGSK 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

RuminationsWhat 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

CritiqueKent 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

DirectionsDefine 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.