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Politics : Foreign Affairs Discussion Group -- Ignore unavailable to you. Want to Upgrade?

To: Ilaine who wrote (97082)	5/1/2003 8:15:54 PM
From: KLP	Respond to of 281500

If SARS should ever take hold like the 1918 Spanish flu that killed 20-40 MILLION people.... FA will certainly be impacted...(how is that for an understatement?) The Spanish Influenza 1918 vortex.is 888888888888888888888888888888 law.uh.edu The Ethics of Seeking the Killer Flu By S. Van McCrary, Health Law and Policy Institute It occurred to me this week that October is approaching rapidly, and with it comes time for my annual flu immunization. In recent years, interest in, and research on, influenza has been expanding dramatically. A visible example of this phenomenon was the widespread media coverage of the scientific hunt for the "bird flu"--a previously unknown strain which killed a small number of persons in Hong Kong in 1997. Another manifestation of expanding interest is the ongoing search for the virus that caused the influenza pandemic of 1918, which killed an estimated 20 to 40 million persons worldwide--more deaths than occurred during the "black plague" of the 14th century. >>>>>>>>>>>>>>>>>An overriding concern of the guidelines is that the risks presented to researchers and the public at large be minimized. Closely aligned with risk assessment is the recognition of uncertainty, i.e., that some risks are difficult to quantify given the current state of scientific knowledge. To make their specific recommendations, the Asilomar researchers sought to balance the level and certainty of potential risks with the level of containment practices and development of containment technology. The main principles are that (1) containment must be an essential part of the experimental design, and (2) the effectiveness of containment should match as closely as possible the estimated risks (in the event risks are not determinable, error should fall on the side of caution). In addition, the guidelines require that: (1) voluntary consent be obtained from field and laboratory workers after appropriate disclosure of the nature of the experiment and the possible risks; (2) high quality training of personnel be an essential component of good containment practices; and (3) ongoing surveillance of workers' health be maintained to ascertain whether safety is being preserved. Generally, the ethical approach of the guidelines is utilitarian in origin, recognizing the moral acceptability of a tradeoff between risk to the researchers and the public, and possible benefits to society as a whole. The guidelines specifically categorized containment practices into four groups, as follows: (1) minimal risk--where the hazards accurately can be assessed and are expected to be minimal (requires only lab coats, mechanical pipetting devices, and other routine precautions); (2) low risk--involving novel biotypes where existing knowledge indicates there is limited potential for harm (requires limited lab access, biosafety cabinets for storage of samples, etc.); (3) moderate risk--where there is a probability of dealing with a biological agent with significant pathogenicity (requires gloves, laminar air flow hoods, filters for all waste product lines, etc.); and (4) high risk--where the potential for ecological disruption or pathogenicity of the organism could be severe and thereby pose a serious biohazard to lab personnel or the public (requires air locks, a negative pressure environment, clothing changes and showers, waste treatment systems, etc.). Major issues for applicability of the Asilomar standards to the influenza research include: (1) whether the containment technology to be used is properly matched to the risks of contamination as currently understood; (2) whether all laboratory and field workers involved received appropriate training and disclosure of potential risks, and voluntarily consented to participate; and (3) whether generalizable knowledge is likely to result from the project. Fortunately, the researchers involved in the Norwegian "flu hunt" proved to be very concerned about the ethical implications of their work. A member of the team stated that the "first obligation" of the researchers was safety--to protect against the possible escape of viral particles into the environment. To achieve this goal, strong containment precautions were taken against spread of infectious organisms, including: (1) covering the entire site with a negative-pressure tent containing a special air lock; (2) using "space suits" with self-contained breathing apparatus; and (3) transporting all samples to secure laboratories prior to working on them. The potential hazard posed by the 1918 influenza virus clearly meets the criteria established in the "high risk" containment category and requires the most stringent containment precautions applicable; even if the actual risk is later determined not to be severe, there is sufficient uncertainty regarding the lingering virulence of the organism to warrant this degree of caution. Containment technology today has progressed to the point where safeguards are adequate to lower the risk to the point where it is counterbalanced by the expected social benefits. Further, the potential for acquiring generalizable knowledge appears high from this research and the goal is persuasive--to prevent another influenza pandemic of the type experienced during 1918. Thus, even though there is a small but real risk from this research, the potential benefits appear clearly to outweigh such a risk from a societal perspective. If the researchers are successful in determining the complete genetic structure of the 1918 virus, the benefits in terms of preventing future devastating outbreaks could be incalculable. As a postscript, the preliminary results of the project were made public in early September. It turned out that the bodies were not in permafrost and thus had undergone some decomposition; however, the researchers were able to obtain tissue samples from some of the bodies. This makes it likely that there might be less valuable information derived from the samples than if they had consistently been frozen. Nonetheless, the team expressed optimism and reported that they could know within three months whether the samples were likely to produce significant results. It may be up to three additional years, before the analysis is completed. <<<<<<<<<<< 09/29/98