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Science and Policy Making in Public Health


Lecture to Canberra University May 2009

Lecture to Canberra University May 2009

Published in Health & Medicine , Business
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  • 1. Science and Policy Making in Public Health The example of Blood Safety Albert Farrugia Senior Director Global Access, Plasma Protein Therapeutics Association 2003-2008 Senior Principal Research Scientist, Australian Department of Health and Ageing University of Canberra, Faculty of Applied Science May 2009
  • 2. In this discussion, I will seek to make the following points
    • Policy making in government is complex and often erratic and confused
    • While most governments promulgate cost-effectiveness in health care spending, blood safety measures have been relatively insulated from this measure
    • Cost – effectiveness in blood safety engages blood experts – AND NO ONE ELSE
    • Public opinion supports a high level of willingness to pay for blood safety – real and perceived – and this is only modestly influenced by scientific knowledge
    • Therefore, measures to further enhance the safety of blood should continue to be introduced, while focus of scrutiny should be the evidence base for the therapies themselves
  • 3. Pillars of Australian health policy inputs E B M CE PRECAUTIONI SM
  • 4. Contributors to policy choices
    • Values
    • Interests
    • Resources
    • Mediated through institutions
    • Determined by politics
    Volatile mixture - ? Agreement on process
  • 5. Policy choices are
    • Made at a range of levels within governments, which are
    • “ An amorphous mass of interlocking organisations attempting to provide for the many public service demands of a modern industrial society” and have to be
    • Negotiated across agencies, which
      • Are dispersed and diffuse
      • Disagree and overlap
      • Pursue contrary understandings of policy objectives
      • Obstruct unacceptable (to them) choices
      • Contest decisions at various levels within themselves
      • Remake decisions during implementations
    • As a result - policy making is “inherently difficult, frustrating and only partially effective”
  • 6. Decision making in the Australian blood system
    • Areas involved in blood :
    • Acute Care Division
    • Regulatory Policy Division
    • Population Health Division
    • Etc
    • Areas involved in blood :
    • Blood & Tissues Unit
    • Drug Safety Branch
    • Devices Section
    • Manufacturing Assessment Branch
    • Etc
  • 7. Decision making and implementation
    • Interests
      • Seek to shape procedures
      • Intervene at strategic moments
      • Challenge the validity of administrative decisions
    • Implementation
      • Delivery cannot be guaranteed
      • Need to ensure understanding and respect
      • Complex processes demand discretion
      • Discretion means policy process seldom concluded
      • Few processes are entirely authoritive
      • Fewer decisions are quite final
  • 8. Furler 2001 “ Health Policy Electoral Populism Research-based evidence Selectively exploits and reinforces community (mis)-conceptions
    • Value for money
    • equity
    • health outcomes
    • etc
    May entail political risk
  • 9.
    • Public Service Priorities
    • Get government re-elected
    • Deliver micoreconomic reform (while husbanding votes)
    • Deliver better population health outcomes (without affecting 1 & 2)
    • through
    • awareness of mood in marginal electorates
    • understanding of swinging voters’ core values
    • knowledge of market research mechanisms
    Furler 2001
  • 10.  
  • 11. HIV Risks in Repeat Donors in Europe andU.S. versus Australia Australia 1/00 - 6/03 0.54 (6 SC in 2.6 million donations) 0.12 (1/ 6.1 million) Residual Risk per 10 6 Repeat Donations Incidence Rate per 10 5 Person-Years (95% CI) Dates Country 0.5 1.0 1.6 (1.0 - 2.3) 1/96 - 12/00 US 0.5 0.7 1.6 (1.2 - 2.0) 1/00 - 12/01 1.1 2.3 3.8 (2.8 - 5.0) 1/96 - 12/00 Italy 1.0 1.9 3.2 (2.2 - 4.5) 1/97 - 12/99 Spain 0.2 0.4 0.7 (0.5 - 1.1) 1/97 – NA (EPFA) Central Europe 0.4 0.7 1.2 (0.7 - 2.0) 1/98 - 12/00 France Serology / NAT Estimate Serology Estimate Glynn, Kleinman, Wright, Busch. Transfusion 42:966-72, 2002; Australian Red Cross Blood Services data courtesy of Dr. Clive Seed, 7/03
  • 12.  
  • 13. The other side of NAT Simmonds et al 2002
  • 14.  
  • 15.  
  • 16. Staginnus 2006 CE of platelet bacterial testing
  • 17. Australian Government review of alternatives to homologous blood donation
    • Pre-operative autologous donation should not be promoted, for the following reasons:
    • · While pre-operative autologous donation reduces the need for homologous blood, any benefit from avoiding the adverse effects of homologous blood has to be balanced against the risks associated with the use of autologous blood or any blood product;
    • · The chance of receiving a transfusion is significantly increased in those with autologous blood available, magnifying these risks and increasing the costs; and
    • · In the absence of formal modelling or a properly conducted clinical trial, it is difficult to determine whether the benefits of autologous donation will definitely outweigh the harms.
  • 18.  
  • 19. Cost of Australian Blood Sector 0.71% of total health care expenditure 29%
  • 20. Optimal versus maximal safety
    • Conference - 9/11/96 - by the Medical Advisory Commission to the Blood Transfusion Council of the Netherlands Red Cross, addressing the issues of 'maximal' versus 'optimal' safety measures for the blood supply.
    • Invited were blood transfusion specialists, clinicians, representatives of patient interest groups, the Ministry and Inspectorate of Health and members of parliament.
    • Transfusion experts and clinicians were found to advocate an optimal course, following strategies of evidence-based medicine, cost-benefit analyses and medical technology assessment.
    • Patient groups depending on blood products, such as haemophilia patients would rather opt for maximal safety.
    • Insurance companies would choose likewise, to exclude any risk if possible.
    • Health care juridical advisers would advise to choose for optimal safety, but to reserve funds covering the differences with 'maximal safety' in case of litigation.
    • Politicians and the general public would sooner choose for maximal rather than optimal security.
    • The overall impression persists that however small the statistical risk may be, in the eyes of many it is unacceptable. “This view is very stubborn.”
    van der Poel at al Ned Tijdschr Geneeskd. 1998 Feb 7;142(6):285-8
  • 21.
    • Cross section of Australians questioned about the importance of costs in setting priorities in health care.
    • Generally, respondents felt unfair to discriminate against patients with high cost illness and that costs should not be a major factor in prioritising.
    • Majority maintained this view when confronted with its implications in terms total number of people who could be treated and their own chance of receiving treatment if they fall ill.
    • Results suggest that
      • Concern with allocative efficiency, as usually envisaged by the economists, is not shared by the general public
      • Cost-effectiveness approach may be an excessively simple value system upon resource allocation decision making.
  • 22. Willingness to pay for autologous donation Moxey at al Transfusion Medicine, 2005, 15, 19–32
  • 23. Perceptions and preferences regarding PAD Lee et al Transfusion 38:757-763, 1989 Study group Study questions Informed Uninformed p Concern re allogeneic transfusions – 0 to 10 (10 = extreme worry) 6 7 0.75 % selecting 10 28 27 0.73 Median willingness to pay $1100 $1900 0.095 Prefer EPO over PAD % Yes 44 41 0.545 No 19 23 Not sure 37 36 Prefer PAD despite elimination of all infectious agents from allogeneic blood 56 66 0.202 Yes 56 66 0.202 No 20 17 Not sure 24 18 Prefer PAD even if not recommended by a physician Yes, definitely 47 44 0.323 Yes, probably 29 30 Not sure 11 10 Probably not 13 12 Definitely not 1 4
  • 24. Evidence-based decision making versus (precautionary) risk management approach Definitive clinical or epidemio-logical evidence of benefit before application of the measure Attempt to balance risk prevented by implementation of the measure, versus risk remaining without its introduction, based on incomplete information
  • 25. The “threat” of pharmaco-economics
    • “ What we are seeing, in both Factor VIII and Factor IX is in fact the market has grown rather than necessarily plasma-derived being used less. So when we were the sole fractionator before recombinant there was a lot of rationing of haemophilic patients, probably as low as - we only probably had about 1.6 IUs per head of population. We now have a target in Australia of 3 international units per hit of population, of which I think plasma will represent 1.8 to 2 and recombinant 1……. But, in essence, I know Canada has gone to a different solution in that scenario. I think it is an expensive solution. I'm not sure clinically it is superior, but it is what it is. I think that in Australia, because we believe in pharmaco-economics, the recombinant products for patients who are well stabilized on plasma-derived there is no evidence that it is a useful thing to do…. because in very few other areas of medicine have we seen such an expensive - such a lot of money spent for such little clinical gain.”
    • Dr Brian McNamee
    • Open Forum
    • Plasma Self-sufficiency in Canada - is it a matter of safety?
    • National Blood Safety Council
    • March 29-30, 2001
  • 26. Blood infections in US hemophiliac birth cohorts CDC survey HBV (▪), HCV (▴), and HIV-1 (◯) The proportion was zero for HIV after 1984, for HCV after 1992, and for HBV after 1993.
  • 27. Efficacy of recombinant vs plasma concentrates Blood 109, 546-551. 2007
  • 28. Variant CJD
    • BSE emerged as major epidemic in United Kingdom in 1980s and 1990s
      • related to feed material used
      • >180,000 cattle infected
      • hundreds of cases of BSE in Europe
        • exported British cattle
        • native born bovines fed materials derived from UK
    • Magnitude of human epidemic unknown
      • early prediction of many thousands of deaths
      • latest scientific data suggest no more than few hundred deaths
      • incubation period very long
    • Transfusion and vCJD
    • state of knowledge - 2003
      • evidence of transfusion transmissibility elusive
        • theoretical considerations suggest possible risk
        • scientific data show some cross species transmissibility by blood in animal experiments
        • applicability of animal data remains controversial
        • epidemiology has not supported the risk
    • state of knowledge - 2009
      • evidence of at least 3 transfusion derived vCJD from fresh components
      • most recently putative transmission to hemophiliac
    • Donor deferral policies:
    • entirely precautionary (and highly controversial) when implemented
    • are they now justified in light of new knowledge?
  • 29.  
  • 30. Reality check
    • Power is diffuse - no single “decision-making process”
    • Implementation generates options - and new policy
    • Process must bend to meet circumstances
    • Problems vary so policy formulation adjusts over time and place
    • Political processes are by nature ad hoc , pragmatic and confused
    • Long term financial strategies may need to cede to immediate political priorities