Editorial: The Ethics for Early Evidence

 

Dr. Steven Pearson of the Institute for Clinical and Economic Review at the ITA recently published an editorial with colleagues in the New England Journal of Medicine titled “The Ethics of Early Evidence – Preparing for a Possible Breakthrough in Alzheimer’s Disease.”  Researchers recently demonstrated the drug bexarotene is effective in treating Alzheimer’s disease in a mouse model with significant reversal of neural and cognitive defects.  While the results from this animal study are premature to recommend for treatment in humans, bexarotene has already been approved by the FDA for other uses such as treatment of non-Hodgkin’s lymphoma and therefore physicians could prescribe it for off-label indications.  The authors outline the ethical issues that are raised in this situation through case studies and highlight the importance of a stakeholder group to provide guidance on how to address the potential demand for this drug.