The precautionary principle

980 views
910 views

Published on

Presented to the Plasma Protein Forum of the PPTA, Washington DC June 2009

Published in: Health & Medicine
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
980
On SlideShare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
2
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

The precautionary principle

  1. 1. Precautionism and plasma protein therapies PPTA Workshop International Plasma Protein Congress Paris March 2, 2009
  2. 2. “ The frequency of major crashes of Western-built jetliners in Europe jumped by more than one-third last year compared with 2007, according to the latest statistics released by the International Air Transport Association, or IATA. The rate climbed to almost one accident per two million flights in 2008, compared with one in roughly three million flights throughout the preceding three years.”
  3. 3. Science Fiction? <ul><li>The practice of hunting and consuming chimpanzees in some parts of Africa leads to a chimpanzee virus crossing the species barrier into humans, with consequent amplification through blood borne risk activities. </li></ul><ul><li>A mutation in a physiological protein in cattle generates a slow acting infectious form associated with a novel pathology. Rendering of cattle carcasses into industrial feed results in amplification and recycling of the infection. </li></ul><ul><li>Animal importation into New York results in the infection of local mosquitoes by a virus mostly localized to the Middle East and Africa. It is amplified through birds and infects humans as secondary hosts. </li></ul>
  4. 4. Good turning bad Examples of blood safety measures having deleterious outcomes (challengeable) HCV antibody testing HCV transmission by IVIG Heat treatment of FVIII Development of FVIII antibodies Plasma depletion of RCCs Y Enterocolitica infections Use of RCCs rather than whole blood Association with increase in deaths from maternal haemorrhage
  5. 5. (Willie) Murphy’s Law(s) Christchurch 2003 <ul><li>Safety is control of risk, not avoidance of risk </li></ul><ul><ul><li>Because you can do the former, not the latter </li></ul></ul><ul><li>Patients may be better safeguarded now than they were fifteen years ago </li></ul><ul><ul><li>(would they agree? Do they think that the blood industry achieved that of it’s own free will?) </li></ul></ul><ul><li>But the environment in which blood is collected is just as unsafe as it ever was </li></ul><ul><ul><li>and no amount of inactivation or testing will change that. </li></ul></ul>
  6. 6. Precautionary Principle European Commission COM (2000)1 <ul><li>“ Where there is uncertainty as to the existence or extent of risks to human health...institutions may take protective measures without having to wait until the reality and seriousness of those risks become fully apparent.” </li></ul><ul><li>[EC Court ruling of 5 May 1998 on EC decision to ban export of UK beef.] </li></ul>
  7. 8. Place of the European “Precautionary Principle” in Decisions about Risks European Commission COM (2000)1 <ul><li>The “Precautionary Principle” describes an approach to managing a risk that cannot be accurately and confidently assessed. </li></ul><ul><li>Society has the right to establish a level of protection against risk that it deems appropriate. </li></ul><ul><li>Risk must be assessed, managed, and communicated to the public. </li></ul><ul><li>Decisions on acceptable level of risk are political, based on science and public concern. </li></ul>
  8. 9. Applications of the precautionary principle Shared concepts (1) advocating anticipatory action to prevent harm (2) shifting some of the burden of proof to the proponents of new technologies to show safety (3) advocating a consideration of all alternatives to a new technology including doing nothing (4) incorporating all affected parties in the decision-making process concerning adopting a new technology
  9. 10. Guidelines for Application of the Precautionary Principle* Proportionality &quot;Measures...must not be disproportionate to the desired level of protection and must not aim at zero risk&quot; Nondiscrimination &quot;comparable situations should not be treated differently and... different situations should not be treated in the same way, unless there are objective grounds for doing so.&quot; Consistency &quot;measures...should be comparable in nature and scope with measures already taken in equivalent areas in which all the scientific data are available.&quot; Examination of the benefits and costs of action or lack of action &quot;This examination should include an economic cost/benefit analysis when this is appropriate and feasible. However, other analysis methods...may also be relevant&quot; Examination of scientific developments &quot;The measures must be of a provisional nature pending the availability of more reliable scientific data&quot;... &quot;scientific research shall be continued with a view to obtaining more complete data.&quot; *EC Commentary, 2 February 2000
  10. 11. &quot;Preventive action should be taken when there is evidence that a potentially disease-causing agent is or may be blood borne, even when there is no evidence that recipients have been affected. If harm can occur, it should be assumed that it will occur. If there are no measures that will entirely prevent the harm, measures that may only partially prevent transmission should be taken&quot; You said it Judge
  11. 12. Any Risk-Management Measure Based on the European Precautionary Principle Should be ... European Commission COM (2000)1 <ul><li>Proportional to the level of protection chosen </li></ul><ul><li>Non-discriminatory in application </li></ul><ul><li>Consistent with similar measures taken previously </li></ul><ul><li>Based on risk-benefit analysis (not necessarily quantitative) </li></ul><ul><li>Subject to review when new scientific information becomes available </li></ul><ul><li>Explicit in assigning responsibility for producing scientific information to improve risk assessment </li></ul>
  12. 13. Any Risk-Management Measure Based on the European Precautionary Principle Should be ... European Commission COM (2000)1 <ul><li>Proportional to the level of protection chosen </li></ul><ul><li>Non-discriminatory in application </li></ul><ul><li>Consistent with similar measures taken previously </li></ul><ul><li>Based on risk-benefit analysis (not necessarily quantitative) </li></ul><ul><li>Subject to review when new scientific information becomes available </li></ul><ul><li>Explicit in assigning responsibility for producing scientific information to improve risk assessment </li></ul>Grant et al NEJM 349:25, 2003 SARS - ? Blood risk
  13. 14. Philosophy of Risk 1. We can tell the future from the past : linear analysis 2. We can’t tell the future from the past: non-linear, non-deterministic, chaotic WG Murphy 2003
  14. 15. Philosophies of risk <ul><li>Linear analysis </li></ul><ul><li>We can tell the future from the past: </li></ul><ul><ul><li>valid over small scales of time, space and matter </li></ul></ul><ul><ul><ul><li>e.g. weather here, today </li></ul></ul></ul><ul><ul><ul><li>evidence-based medicine </li></ul></ul></ul><ul><ul><li>Ignores or deliberately excludes the noise in complex systems </li></ul></ul><ul><li>Non-linear analysis </li></ul><ul><li>We can’t tell the future from the past: </li></ul><ul><ul><li>invalid over large scales of time and space </li></ul></ul><ul><ul><ul><li>e.g. weather in Cleethorpes, July 16 th 2005 </li></ul></ul></ul><ul><ul><ul><li>Global warming, etc </li></ul></ul></ul>
  15. 16. A linear process <ul><li>Introduction of measures to decrease HIV transfusion risk </li></ul>
  16. 17. A non-linear process <ul><li>The process for rendering animals for processing to meat and bone meal (MBM) for feeding cattle is changed to allow extraction of other products </li></ul><ul><li>Infectious agents from animals sick with TSEs enter the human food chain through contaminated beef products </li></ul><ul><li>The agents passaged into humans cause a new disease </li></ul><ul><li>The disease is transmitted though blood and infects other humans </li></ul>
  17. 18. Controlling Chaotic risks <ul><li>Accepting the possibility of disaster </li></ul><ul><ul><li>limiting the possibility of a disastrous event </li></ul></ul><ul><ul><li>limiting the impact of disaster </li></ul></ul><ul><li>Limiting the impact of disaster </li></ul><ul><ul><li>Control as much as possible: </li></ul></ul><ul><ul><ul><ul><li>layers of protection </li></ul></ul></ul></ul><ul><ul><ul><ul><li>cellular environment </li></ul></ul></ul></ul><ul><li>Alternative engineering </li></ul>
  18. 19. Evidence Based measures The Precautionary Principle <ul><li>Develop systematic research mechanisms </li></ul><ul><li>Continuous training </li></ul><ul><li>Embrace harmonisation - constructively </li></ul><ul><li>Risk as low as reasonably achievable (ALARA) </li></ul><ul><li>Consider societal/individual values & expectations </li></ul><ul><li>Transparency </li></ul>

×