RE: Animal Studies

[Guest guest]

Excellent piece for real discussion - thanks Carl.

I'll take a stab at it from my knowledge base and perspective. See below in arial font and red; per and post comments isolated by "...........".

........................................................................... "Tony" Havics, CHMM, CIH, PEpH2, LLCPO Box 34140Indianapolis, IN 46234 cell90% of Risk Management is knowing where to place the decimal point...any consultant can give you the other 10%â„ This message is from pH2. This message and any attachments may contain legally privileged or confidential information, and are intended only for the individual or entity identified above as the addressee. If you are not the addressee, or if this message has been addressed to you in error, you are not authorized to read, copy, or distribute this message and any attachments, and we ask that you please delete this message and attachments (including all copies) and notify the sender by return e-mail or by phone at . Delivery of this message and any attachments to any person other than the intended recipient(s) is not intended in any way to waive confidentiality or a privilege. All personal messages express views only of the sender, which are not to be attributed to pH2 and may not be copied or distributed without this statement.-----Original Message-----From: iequality [mailto:iequality ] On Behalf Of Carl E. GrimesSent: Sunday, September 17, 2006 12:29 PMTo: iequality Subject: Animal StudiesAs I try to understand the compelling arguments on both sides of therecent debate of when it is scientifically valid to apply animalstudies to people, I have reached a point that I cannot answer.Here's my thought process in the hopes that the scientists andmedical experts on this group can help.IOM's report Damp Indoor Spaces and Health could not establishcausation or, more accurately, a strong association between humanhealth effects (other than some respiratory) and mold exposures.The same IOM report offered hundreds of studies that showed a widevariety of strong associations between non-respiratory effects andanimal or tissue exposure to mold.The IOM also said that the strong association of animal and tissuestudies cannot be directly applied (a more accurate term?) assuppporting evidence of a strong association for humans. Thereforeother studies specifically designed to address those issues arenecessary before association or non-association can be supported. AmI okay so far?The ACOEM study differs with the IOM study in one significant waybecause they did form a conclusion based on the application of ananimal study to humans.Further, although the ACOEM agrees with IOM that more research isneeded they apparently disagree that more research is needed beforenon-association can be supported. Am I understanding this positioncorrectly?So one issue I can't reconcile is when two authoritative bodies useprofessionally accepted (scientific?) methods to study the sameissue, how do they come to such different conclusions? Doesn't thatimply that either science is subjective, the choice can't bedetermined scientifically, or that non-scientific methods have beenutilized by at least one of the bodies?......................................Havics: For a suggestion, please seeWeinburg, Alvin M.: Science and Trans-Science. Minerva 10(2):209-222. 1972..............................But more importantly, and because the above question may beunanswerable, the other difficulty for me is how do I determine whichof the two studies to rely on for forming the authoritative basis formy judgements, advice and counsel?As scientists and medical experts, how do you make these types ofchoices? The options (other than a purely scientific method) I canthink of (I'm sure there are others) include: -Reliance on professional judgement. -Personal perference. -Sticking to a previous determination until evidence to the contrary (anomolies) is compelling. Which begs the question: How to determine when those anomolies become sufficiently compelling?.....................................................All three have been used and perhaps appropriately.

1. Where there is no evidence to gauge risk - personal preference and client's needs.

2. Where there is some evidence - professional jusgement of a group that contains both those well-versed in the details and those that understand broader implications. Remember that Shamos cited two studies indicating that given all the information, only 2-4% at most of the adult population would be able to make an independent scientific judgment (most of those being professional scientists or engineers). [ H. Shamos, PhD, in The Myth of Scientific Literacy, Rutgers University Press, 1995 (citing two studies)]

3. Where there is no or some evidence and the economics of the situation suggest that making the wrong decision (changing tract) would cause substantial mis-use of resources. [hence global warming debate] - then wait and see until compelling information is presented.

I personally prefer a tiered approach using each of these depending on the cost (resources and dollars) and the client's aversion to risk.

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If a "scientifically valid" method for resolving such dilemmasdoesn't exist, then how can either choice between contradictoryconclusions be held as scientifically supported?

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It is not then a scientrific question, but rather policy-based, thus requires a different arena to decide. See for further suggestion:

National Research Council: Science and Judgment in Risk Assessment. National Academy Press: Washington, DC. 1994.

National Research Council: Risk Assessment in the Federal Government: Managing The Process. National Academy Press: Washington, DC. 1983.

A great example is how states decided acceptable risk for contaminated property cleanup for underground storage tanks. It was decided in different ways and using different approaches. Despite this, two levels of risk were applied and each varied by 3 orders of magnitude. See attached a summary of a number of states from ca. 1996 that I used in a risk presentation in 2000.

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Because my specialty is working with individual exposures (inaddition to group exposures), this is not an abstract, rhetorical orconceptual question for me and is personally critical for my clients.All comments and discussion will be appreciated.Carl GrimesHealthy Habitats LLCFAIR USE NOTICE:This site contains copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available in our efforts to advance understanding of environmental, political, human rights, economic, democracy, scientific, and social justice issues, etc. We believe this constitutes a 'fair use' of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material on this site is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. For more information go to: http://www.law.cornell.edu/uscode/17/107.shtml. If you wish to use copyrighted material from this site for purposes of your own that go beyond 'fair use', you must obtain permission from the copyright owner.