f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 283 [Entry Date] 04/20/2011 at 03:33:25 PM [Affiliation] Self [Comments] 
Comment 1: Response: NO. Many of the recommendations contained in the 2011 Guide are not based on scientific evidence, and could seriously impede progress in research that will benefit public health. Most recommendations will require significant costly alterations for institutions and investigators. Examples of recommendations that have little scientific basis and could negatively impact research progress are as follows: The recommendation for use of pharmaceutical-grade drugs: There is no evidence that pharmaceutical-grade drugs would improve animal welfare. Moreover, research could be impeded because commercially available pharmaceutical-grade formulations are often single concentrations that make it difficult or impossible to manipulate drug dose or to compare different vehicles. Moreover, pharmaceutical-grade drugs will increase the cost of pharmacological research by 500 to 1,000 times in some instances. Recommendations for Constraints on multiple procedures in animals: It is often in the best interest of science to conduct longitudinal studies in animal subjects using repeated measures in an own control design. Some nonhuman primates live for more than 25 years, and repeated measures are often necessary to answer research questions. Repeated surgeries are often necessary to repair or prolong the life of surgically implanted experimental devices. Recommendations for Paired housing for nonhuman primates: Despite the attractive "face validity" of paired housing and the opportunity for physical contact between pairs of nonhuman primates recommended in the 2011 Guide, this would place animals at risk for injury and death. Aggression in response to any surprise (a novel noise, person, pain, etc.) may lead the dominant member of the pair to attack/kill the weaker or more submissive cage mate. Studies that require implantation of any device such as an IV catheter to evaluate medication effectiveness could not be conducted. Recommendations for Changes in cage size: There is no scientific justification for modifications in cage sizes and configurations specified in the 1996 edition of the Guide. The cost to institutions and to investigators would be astronomical! Comment 2: Response: Implementation of any changes to the 1996 Guide should be delayed for at least five years (March 2015) to allow NIH to gather scientific evidence to support or to refute the many problematic recommendations proposed in the 2011 Guide. The requirement for additional oversight will add to an already onerous regulatory burden that eventually will be unsustainable for many research institutions. The ultimate impact will be serious damage to this nation's preeminent leadership in health-related research. The NIH must recognize that lobbying efforts by groups opposed to all research with animals, such as the Humane Society of America and the Physicians for Social Responsibility, are reflected in the proposed changes to the Guide. It would be most unfortunate if NIH standards for insuring animal welfare were primarily influenced by the well-funded political agenda of those organizations opposed to all research on animals, rather than humane concerns for animal welfare and commitment to advances in science.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals