Sociology of Health and Illness sociologist John Abraham (photo credit: eddiemcfish 2008)
Tag: FDA
Dirty Windows of Drug Development
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
The Need for Speed: GAO Reports on Accelerated Approval
Several blog posts ago, I wrote about the policy of accelerated approval (briefly, a mechanism whereby new drugs can be approved for sale by the FDA before definitive evidence of efficacy and safety are available). In that post, I reported on a recent paper where the authors claimed that, all things considered, accelerated approval enabled… Continue reading The Need for Speed: GAO Reports on Accelerated Approval
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
Goodbye, Helsinki
According to recent news reports, the U.S. FDA recently decided to abandon its endorsement of the Declaration of Helsinki when sponsors submit clinical trial data obtained overseas. The Declaration of Helsinki (DoH)- which was first adopted in 1964- is the World Medical Association’s statement on ethical requirements for human experimentation. According to an editorial in… Continue reading Goodbye, Helsinki
Teddy’s Frowning
This blog primarily covers the ethics of translational clinical trials. Products tested in such studies, should they progress towards licensure, will eventually fall under the oversight of drug regulatory agencies like the FDA. How prepared will the FDA be to protect the public once these highly complex interventions are introduced to clinical practice? And when… Continue reading Teddy’s Frowning