2005N-0394 FDAs Communication of Drug Safety Information; Public Hearing
FDA Comment Number : EC3
Submitter : Ms. Sadhana Dhruvakumar Date & Time: 11/18/2005 02:11:44
Organization : People for the Ethical Treatment of Animals
Category : International Association
Issue Areas/Comments
GENERAL
GENERAL
Pre-clinical test results should be made publicly available. Some clinical results are collected and made public (e.g., on clinicaltrials.gov) and there is an increasing public outcry for all clinical testing results to be published. Similarly, publicizing pre-clinical test results is necessary to protect both individuals who participate in clinical trials and those who experience post-marketing adverse events. Since animal data are notoriously difficult to extrapolate to humans and are increasingly acknowledged to be problematic for human risk assessment, prospective drug- takers deserve to know whether the drug has been tested for safety only using these unvalidated methods or using modern human-relevant methods. The FDA's white paper on the Critical Path Initiative stated that 92% of drugs that pass pre-clinical (mostly animal) tests go on to fail in the clinic and that pre-clinical systems clearly need modernization. Publishing pre-clinical test results is the only way to retrospectively analyze which pre-clinical tests are not working to protect people so that we may replace them with more predictive systems. For example, Vioxx was heart- healthy in animal trials but putatively causes heart attacks in some patients. If this type of data was made available and animal models were found to consistently mis-predict clinical cardiac events, animal models for cardiac toxicity can be replaced by validated in vitro tests and other alternatives. However, poor preclinical models are perpetuated by the secrecy surrounding preclinical testing and drug submissions, which prevents better protection of patients.