|Posted on January 1, 2005|
Currently, the Food and Drug Administration Center for Veterinary Medicine allows, and sometimes even requires, placebo control studies of new pain control medications in circumstances where there are already CVM-approved pain management products available. In November, on a recommendation from the AVMA Council on Research, the board authorized the AVMA to send a letter to the CVM to oppose this practice.
The Council on Research believes the current practice may result in unnecessary pain and suffering, particularly because current methods to assess pain in animals may be unreliable. The council has also learned that there is a strong sentiment among individuals in practice, academia, and industry that the FDA-CVM, at best, condones, and, at worst, encourages, the use of a placebo group in studies evaluating analgesics in clinical practices. The council believes that rescue analgesic practices are not sufficient to address the issue. Rescue analgesics are used for placebo group animals who clearly show signs of pain.
The AVMA will urge the FDA to prohibit placebo control studies for assessment or approval of new pain control medications in circumstances where there are already CVM-approved pain management products available. It will also urge the FDA to require that only positive controls be used in these prospective, randomized, parallel or crossover dose studies.