An anti-epileptic drug (AED) currently under development caused 10% of the mice in the study to develop liver failure. The metabolism of the majority of AEDs is through hepatic biotransformation; Vigabatrin and Gabapentin are two exceptions. The afflicted mice in the new AED study were receiving the highest daily dose of the drug, which caused a metabolite to form in the liver of the mice, leading to the hepatotoxicity, indicating that this AED falls into the category of the majority of AEDs being bio-transformed through hepatic metabolism. Deciding if this AED should continue being developed for use on humans relies on further investigation into the potential benefits versus risks. Several questions need to be addressed, and a risk-benefit analysis conducted. To begin with, the pros and cons of reliability of using a mouse model for prediction of human response needs to be evaluated. There are several reasons that mice are used ubiquitously in lab research when studying human diseases. Most importantly is the commonality between the genome of humans and the genome …show more content…
The drug may be effective in mouse trials and ineffective in humans. This could be due to environmental factors, genetic variability, age of onset of certain diseases like heart disease, and even the way in which human diseases can be mimicked in mice. Moreover, in many cases, the immune systems of the mice being tested may not be as fully functional as the immune systems in humans. If these test mice who developed liver failure were receiving the highest daily dose, what was this dose in relation to the dose threshold? If the dose in the 90% of other test mice was still controlling seizures without hepatotoxic results, and if development of the AED is continued, the dosing in humans should follow that of the mice who did not develop liver failure, allowing the body to detoxify the