Title: Ethical Dilemmas in Public Health Researches that have private partners
1By Godofreda ( Jody ) V. Dalmacion,
MD,MSc. Member, Ethics Review Board University of
the Philippines, Manila-NIH
2Outline
- Public Health Research versus clinical trials
- Description of partnership in public health
research - Case study
- Ethical issues
- Ruminations
- Directions
3Public health research versus Clinical trials
- 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
4Defining 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
5Ethics in public health
- 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 patients 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
6Real worldWe live in a morally pluralistic
society inevitably, moral appeals will conflict
when determining a public policy
76 -step ethics framework for public health
- What are the goals of the program?
- How effective is the program?
- Burden of the program?
- a. Risk to privacy and confidentiality
- b. Risk to liberty and self determination
- c. Risk to justice
- Can burden be minimized without compromising
benefits? - Is program implemented fairly?
- How can benefits and burden of program be fairly
balanced?
- Reduce mortality and morbidity
- Health programs are imposed and not sought by the
citizens - Ex. Disease reporting distributionally unfair
since burdens are borne by those with the
disease Contract tracing threat to privacy - Ex. Screening vs. mandatory program
- HIV screening for all vs a group
- Avoid stereotyping implementation
8Partnerships in Public Health
9Description of Public-Private Partnership (PPP)
10But 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
11Problems of Traditional Public Health groups
- Limited financial resources
- Complex social and behavioral problems
- Rapid disease transmission across national
boundaries - Reduced state responsibilities
12Future 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
13Philantropic drug donation programs
14Issues
- 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?
15Issues of Partnership
16Case 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.
175-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.
18- 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
19Some 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
20Sequela
- 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
21Result 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
22Ruminations
- 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
23Critique
- 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
24 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.
25From those who have much Much is also expected