Think of clinical trial data as a window on the efficacy and safety of a drug. Think of data protection and trade secrecy as soot. The above picture? This is the public view on drug safety and efficacy. According to a recent report in Nature Biotechnology (Feb 2011), medicine may be getting some soapy water… Continue reading Dirty Windows of Drug Development
Tag: safety
CAR Accidents: Unexpected and Serious Toxicity in Gene Transfer Immunotherapy
This month’s issue of Molecular Therapy– the premium journal covering developments in gene transfer- reports two deaths in recent cancer gene transfer studies. Both studies involved a similar anti-cancer strategy, in which a patient’s T cells are genetically modified to mount a strong and sudden immune attack against the patient’s cancer (the particular genetic modification… Continue reading CAR Accidents: Unexpected and Serious Toxicity in Gene Transfer Immunotherapy
Guinea Pig Nation?
Here is an irresistible news headline: “Public Policy That Makes Test Subjects of Us All.”(New York Times, April 6, 2009). Then you open to the story only to discover, to your disappointment, that the piece is written by John Tierney, probably the most uninformed and underqualified members of the NYTimes staff. His argument is ridiculous:… Continue reading Guinea Pig Nation?
Age of Risk: Biologicals
Approving new drugs is a risky business. Despite best efforts (and frankly, some less than best efforts), newly approved drugs frequently turn out to have unexpected toxicities. One example is unexpected heart toxicity associated with the use of the common pain-killers like rofecoxib (i.e. Vioxx). Another is the surprising heart toxicity associated with the wonder… Continue reading Age of Risk: Biologicals