Tag: drug approval

Vice President Mike Pence is a supporter of right-to-try, having signed Indiana's right-to-try bill into law when he was the Governor of Indiana.

The cruel sham that is right-to-try raises its ugly head at the federal level again

Ill-advised right-to-try bills are spreading like kudzu through state legislatures. Now federal legislators want to insert right-to-try language into the bill that funds FDA drug approval. Given the support of powerful Republicans like Vice President Mike Pence for right-to-try, is it too late to stop this juggernaut and protect patients?

/ April 17, 2017
Randomized controlled clinical trial

Whither the randomized controlled clinical trial?

With the rise of precision medicine and genomics, the conventional randomized clinical trial appears more and more outdated. Fortunately, clinical trials are evolving, but will it be enough to incorporate the numerous advances in "-omic" medicine in a rigorous scientific manner to benefit patients?

/ June 20, 2016

Lessons from the History of Insulin

On my recent trip to Nashville for CSICon, I took advantage of the long hours on the plane to read Breakthrough: Elizabeth Hughes, the Discovery of Insulin, and the Making of a Medical Miracle, by Thea Cooper and Arthur Ainsberg. One of our commenters recommended it. I’m not sure who (was it Chris?), but I want to thank you. It’s the history...

/ November 6, 2012

Dabigatran: A Promising Alternative to Warfarin

On October 19, 2010, the FDA approved a long-awaited new drug, dabigatran, expected to replace warfarin (Coumadin) as a better way to prevent blood clots in susceptible patients. This provides an opportunity to re-visit several issues that we have addressed before, including Big Pharma tactics, drug approval by the FDA, deciding what is adequate evidence, applying science to clinical practice, and making...

/ November 16, 2010