"The current way that DSMBs are constituted and report has resulted in a loss of faith." NEJM
There is no evidence to indicate that children have been the beneficiaries of the Pediatric Exclusivity Provision of FDAMA (enacted in 1998): there is evidence that pharmaceutical companies have increased their profits from the legislation by at least $14 billion.
The catalyst for Dr. Elliott’s article was the tragic case of Dan Markingson, a 26-year old who committed suicide in May 2004, while enrolled in the CAFE trial, prescribed Seroquel. This case encapsulates the tragic consequences of a broken system which is not designed to detect the hazards for human subjects posed by market-driven research. Continue reading →
"He was one of the most prolific investigators in the area of postoperative pain management. His fraud sets back our knowledge in the field tremendously.” Dr. Steve Shafer, the editor in chief of Anesthesia & Analgesia. Continue reading →