Transcript Ethical Dilemmas in Public Health Researches that have private

By: Godofreda ( Jody ) V. Dalmacion, MD,MSc.
Member, Ethics Review Board
University of the Philippines, Manila-NIH
Outline
 Public Health Research versus clinical trials
 Description of partnership in public health research
 Case study
 Ethical issues
 Ruminations
 Directions
Public health research versus Clinical
trials
Clinical Trials
 Therapeutic obligation to
treat individual patient
 Treat irrespective of social
consideration
 Code of medical and research
ethics prioritizes individual
autonomy
Public Health
 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
 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
Problems
 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
Government-public agenciestraditional provider
Public-NGO partnership
Public-private partnership
Description of Public-Private
Partnership (PPP)
The core partners
provide a joint
sharing of efforts
and benefits
Committed to the
creation of social
value (improved
health) especially
for disadvantaged
population
Involve at least one
private for profit
organization with at
least one not for profit
organization
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 resources
 Complex social and behavioral problems
 Rapid disease transmission across national boundaries
 Reduced state responsibilities
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
Philantropic drug donation
programs
Drug
company
Drug and
target
disease(s)
Public health
goal
Program
manager
Major
partners
Merck
Mectizan:
Onchocerciasis
Lymphatic
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 and
GSK
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?
Issues of Partnership
Accountability
Transparency
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.
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.
 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 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
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
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
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
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
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.