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Ethical Dilemmas in Public Health Researches that have private partners

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By: Godofreda ( Jody ) V. Dalmacion, MD,MSc. Member, Ethics Review Board ... Pfizer and Edna McConnell Clark Foundation. GSK. Albendazole: Lymphatic filariasis ... – PowerPoint PPT presentation

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Title: Ethical Dilemmas in Public Health Researches that have private partners


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
  • Public Health
  • 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

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 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

6
Real worldWe live in a morally pluralistic
society inevitably, moral appeals will conflict
when determining a public policy
7
6 -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

8
Partnerships in Public Health
9
Description of Public-Private Partnership (PPP)
10
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

11
Problems of Traditional Public Health groups
  • Limited financial resources
  • Complex social and behavioral problems
  • Rapid disease transmission across national
    boundaries
  • Reduced state responsibilities

12
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

13
Philantropic drug donation programs
14
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?

15
Issues of Partnership
16
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.

17
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.

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

19
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

20
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

21
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

22
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

23
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

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.

25
From those who have much Much is also expected
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