Avandia, a Case of Deja Vu all over again
" A causal role for antidepressants in inducing suicidality has been established in pediatric patients."
Doctors On the Take-Engaging in Vairous Dubious Activities for Cash / Stock Options Tue, 16 Aug 2005 A series of current articles in The Wall Street Journal, the Journal of the American Medical Association (JAMA), and the New York Times describe the many questionable non-medical income-producing activities that America¹s physicians…
Federal Investigation of ARDS Study (Accute Respiratory Distress) OHRP conducted a compliance oversight evaluation of the 12 major sites participating in this clinical trial. OHRP’s determination letters documenting the outcomes of these evaluations can be viewed at the OHRP website at the following URLs: Note: OHRP found that federal informed…
Johns Hopkins Admits Fault in Fatal Experiment July 17, 2001 The experiment that killed Ellen Roche, a healthy 24 year old volunteer–who was clearly not informed about the risks she was incurring by breathing hexamethonium–demonstrates that there are no protections that ordinary people can rely on, when they become research…
A group of patient and social justice advocates plan to form an Alliance for Human Research Protection to provide oversight on clinical research from laypersons’ point of view, says John H. Noble Jr., a founder and professor of social justice at the Catholic University of America. He lambastes Internal Review Boards (IRBs) designed to protect human subjects as agents of institutions "who are hustling the bucks" from industry and other sources. Noble says IRBs need to be "severed from research institutions" and provided adequate resources as part of the accepted overhead costs of conducting clinical trials.
IOM committee members were highly critical of FDA’s advisory panels that regularly “recommend” approval without analyzing the safety data.